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Published online 2013 Mar 28. doi: 10.5888/pcd10.110285
PMID: 23537519
Peer Reviewed
This article has been cited by other articles in PMC.
Abstract
Introduction
Oral health is an integral component of overall health and well-being. Very little Rhode Island state-level information exists on the determinants of tooth loss. The objective of this study was to systematically identify sociodemographic characteristics, health behaviors, health conditions and disabilities, and dental insurance coverage associated with tooth loss among noninstitutionalized adults in Rhode Island.
Methods
We analyzed Rhode Island’s 2008 and 2010 Behavioral Risk Factor Surveillance System survey data in 2011. The survey had 4 response categories for tooth loss: none, 1 to 5, 6 or more but not all, and all. We used multinomial logistic regression models to assess the relationship between 4 risk factor domains and tooth loss.
Results
An estimated 57.6% of Rhode Island adults had all their teeth, 28.9% had 1 to 5 missing teeth, 8.9% had 6 to 31 missing teeth, and 4.6% were edentulous. Respondents who had low income, low education, unhealthy behaviors (ie, were former or current smokers and did not engage in physical activity), chronic conditions (ie, diabetes and obesity) or disabilities, and no dental insurance coverage were more likely to have fewer teeth compared with their referent groups. However, the association of these variables with tooth loss was not uniform by age group.
Conclusion
Adults who report risky health behaviors or impaired health may be considered target subpopulations for prevention of tooth loss and promotion of good oral health.
MEDSCAPE CME
Medscape, LLC is pleased to provide online continuing medical education (CME) for this journal article, allowing clinicians the opportunity to earn CME credit.
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Medscape, LLC and Preventing Chronic Disease. Medscape, LLC is accredited by the ACCME to provide continuing medical education for physicians.
Medscape, LLC designates this Journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
All other clinicians completing this activity will be issued a certificate of participation. To participate in this journal CME activity: (1) review the learning objectives and author disclosures; (2) study the education content; (3) take the post-test with a 70% minimum passing score and complete the evaluation at www.medscape.org/journal/pcd (4) view/print certificate. Lagu barat sering di putar di tv 2018.
Release date: March 27, 2013; Expiration date: March 27, 2014
Learning Objectives
Upon completion of this activity, participants will be able to:
- Analyze sociodemographic factors associated with tooth loss among adults
- Hughes kettner vs 250 schematic diagram. Distinguish the most powerful sociodemographic predictor of tooth loss
- Evaluate the effect of physical activity on tooth loss
- Evaluate the effect of dental insurance coverage on tooth loss
EDITORS
Rosemarie Perrin, Editor, Ellen Taratus, Editor; Preventing Chronic Disease. Disclosure: Rosemarie Perrin and Ellen Taratus have disclosed no relevant financial relationships.
CME AUTHOR
Charles Vega, MD, Associate Professor and Residency Director, Department of Family Medicine, University of California-Irvine, Irvine. Disclosure: Charles P. Vega, MD, FAAFP, has disclosed no relevant financial relationships.
AUTHORS AND CREDENTIALS
Disclosures: Yongwen Jiang, PhD; Catherine A. Okoro, PhD, MS; Junhie Oh, BDS, MPH, have disclosed no relevant financial relationships. Deborah L. Fuller, DMD, MS served as an advisor or consultant for Metlife Priority Management Group.
Affiliations: Yongwen Jiang, Center for Health Data and Analysis, Rhode Island Department of Health and Brown University School of Medicine, Providence, Rhode Island; Catherine A. Okoro, Centers for Disease Control and Prevention, Atlanta, Georgia; Junhie Oh, Brown University School of Medicine and Rhode Island Department of Health, Providence, Rhode Island; Deborah L. Fuller, Rhode Island Department of Health, Providence, Rhode Island.
Introduction
Oral health is an integral component of overall health and well-being (1). Poor oral health can lead to decreased general health, limited social functioning, and decreased quality of life (,). Tooth loss is an indicator of poor oral health and may impair physical, psychological, and social functioning and influence self-esteem and communication. People with tooth loss may avoid conversations or avoid laughing or smiling (,). Tooth loss also can affect nutrition, including impaired chewing ability, resulting in decreased intake of meat and firm fruit (,). Most tooth loss is due to dental caries and periodontal disease, although other causes include orthodontic or prosthetic treatment needs and traumatic injuries (,–). Healthy People 2020 acknowledges the importance of maintaining permanent teeth by including an objective, OH-4, to decrease the proportion of adults who have ever had a permanent tooth extracted because of dental caries or periodontal disease (1).
Tooth loss is associated with smoking, inadequate oral hygiene, diabetes, hypertension, rheumatoid arthritis, depression, anxiety, obesity, anterior tooth type, and other risk factors including nutrition, alcohol consumption, socioeconomic status, lack of water fluoridation, and stress (,–). Despite numerous studies and reports to determine risk factors related to oral health, research has not systematically explored the relationship between tooth loss and sociodemographic determinants, health behaviors, health conditions and disabilities, and access to dental care. The Behavioral Risk Factor Surveillance System (BRFSS) collects population-based information on many health domains, including sociodemographics, health behaviors, health conditions and disabilities, and health care access, and enables the evaluation of several risk factors simultaneously. However, very little Rhode Island state-level information exists on the determinants of tooth loss. The objective of this study was to systematically identify sociodemographic characteristics, health behaviors, health conditions and disabilities, and dental insurance coverage associated with tooth loss among noninstitutionalized adults in Rhode Island (RI).
Methods
The BRFSS is an ongoing state-based surveillance system that uses standardized telephone surveys to assess the prevalence of key behavioral risk factors and chronic conditions among adults aged 18 years or older in all 50 states, the District of Columbia, and 3 US territories. Trained interviewers collect data monthly from an independent household probability sample drawn from the noninstitutionalized US adult population. In 2011 we analyzed data from the 2008 and 2010 Rhode Island BRFSS, which had a total sample size of 11,385 (4,786 in 2008 and 6,599 in 2010). Response rates, based on Council of American Survey Research Organizations guidelines, were 44.3% in 2008 and 47.6% in 2010, and a detailed description of the survey methods and questionnaire is available at www.cdc.gov/brfss.
Measurement of tooth loss
Rhode Island BRFSS respondents were asked, “How many of your permanent teeth have been removed because of tooth decay or gum disease? Include teeth lost to infection, but do not include teeth lost for other reasons, such as injury or orthodontics.” Survey respondents were asked to choose from 1 of 4 tooth-loss response categories: none, 1 to 5, 6 or more but not all, and all (edentulous).
Predictors
We chose 8 predictors of tooth loss on the basis of previous literature (-,–) and classified them into 4 domains (Box): sociodemographic status, health risk behaviors, health conditions and disabilities, and dental insurance coverage. Detailed definitions of the 8 predictors are available from www.health.ri.gov/data/details/definitions/behaviorrisksurveillancesystem.pdf.
Box. Questions to Assess the 8 Predictors of Tooth Loss by 4 Domains
Sociodemographic Determinants
Income: <$25,000; ≥$25,000
Education: High school degree or less; more than high school degree
Health Risk Behaviors
Cigarette smoking: Current smoker (smoked at least 100 cigarettes in lifetime and now smoke every day or some days); former smoker (smoked at least 100 cigarettes in lifetime but no longer smoke); never smoker (never smoked or smoked fewer than 100 cigarettes in lifetime)
Physical activity: Yes (participated in physical activity or exercise other than regular job such as running, calisthenics, golf, gardening, or walking during the past 30 days); no
Health Conditions and Disabilities
Diabetes: Has been told by a doctor that he/she has diabetes (gestational diabetes excluded); has not been told by a doctor that he/she has diabetes
Sanyo tv serial number lookup. Obesity: Not obese; obese, self-reported body mass index (weight in kilograms divided by square of height in meters) at or greater than 30 kg/m2
Disability: Yes (limited in any way in any activity because of any physical problem or using special equipment such as a cane, wheelchair, special bed, or special telephone); no
Dental insurance coverage
Dental insurance coverage: Yes (has any kind of insurance coverage that pays for some or all routine dental care, including dental insurance coverage, prepaid plans such as health maintenance organizations, or government plans such as Medicaid); no
Statistical analysis
In our preliminary analyses, we included age, sex, income, education, employment status, race/ethnicity, marital status, and urban/rural residence, but only age, income, and education were significantly related to tooth loss. We excluded heart disease and stroke from the preliminary analyses because very few respondents reported either condition. In the preliminary analyses, we examined dental visits and dental insurance coverage as predictors of tooth loss as well, but only dental insurance coverage was significantly related to tooth loss. The final analyses were restricted to age, tooth loss, and the 8 predictors. Our preliminary analysis found that age was the strongest predictor for tooth loss; therefore, we stratified our analyses by 3 age groups (18–44 years, 45–64 years, and ≥65 years).
Multiple imputation has been used to simulate missing data in sample surveys. To retain all valid data and maintain maximal sample size, we handled missing data through multiple imputation according to the methods of Jiang and Hesser (). We calculated prevalence estimates and χ2 statistics to identify significant associations between the 8 predictors and tooth loss. By using multinomial logistic regression, we also calculated adjusted odds ratios (AORs) and 95% confidence intervals (CIs) to assess the strength of the relationship between each predictor and the extent of tooth loss. The “0 missing teeth” group was the reference used to evaluate the potential risk effect of the 8 predictors. We also adjusted by age (treated as a continuous variable) within the age-stratified multivariate model, even though the analysis was age-stratified. We used 2-sided significance tests in all analyses. For all analyses, we considered only P values less than .05 significant. We used the PROC SURVEYFREQ and SURVEYLOGISTIC of SAS version 9.2 (SAS Institute Inc, Cary, North Carolina) to account for the complex survey design of the BRFSS.
Results
An estimated 57.6% of Rhode Island adults had all their teeth, 28.9% had 1 to 5 missing teeth, 8.9% had 6 to 31 missing teeth, and 4.6% were edentulous. Increasing trends exist between demographic characteristics, risk factors, and extent of tooth loss across age groups except for 0 missing teeth among adults aged 65 years or older (Table 1).
Table 1
Prevalence of Tooth Loss by Demographic Characteristics and Risk Factors, by Age Group, Rhode Island BRFSS Respondents (N = 11,385), 2008 and 2010a,b
Demographic Characteristic and Risk Factor | n (%) | % | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
18–44 y (n = 2,896), No. of Missing Teeth | 45–64 y (n = 4,743), No. of Missing Teeth | ≥65 y (n = 3,624), No. of Missing Teeth | |||||||||||
0 | 1–5 | 6–31 | All | 0 | 1–5 | 6–31 | All | 0 | 1–5 | 6–31 | All | ||
All respondents | 11,385 (100.0) | 77.5 | 20.2 | 1.9 | 0.4 | 48.1 | 38.1 | 10.0 | 3.8 | 22.4 | 34.6 | 25.9 | 17.1 |
Annual income, $ | |||||||||||||
<25,000 | 2,619 (21.4) | 62.9 | 32.5 | 4.0 | 0.7 | 26.5 | 39.2 | 23.2 | 11.0 | 17.1 | 25.6 | 29.2 | 28.1 |
≥25,000 | 7,146 (78.6) | 80.8 | 17.6 | 1.4 | 0.2 | 51.9 | 37.9 | 7.8 | 2.4 | 25.0 | 39.4 | 24.2 | 11.3 |
Education | |||||||||||||
≤High school degree | 4,333 (36.1) | 67.0 | 29.1 | 3.1 | 0.8 | 32.7 | 41.2 | 17.1 | 9.0 | 17.6 | 28.4 | 29.5 | 24.5 |
>High school degree | 7,028 (64.0) | 82.9 | 15.6 | 1.3 | 0.2 | 55.1 | 36.8 | 6.7 | 1.4 | 27.0 | 40.6 | 22.6 | 9.8 |
Smoking status | |||||||||||||
Never smoker | 5,690 (55.2) | 82.7 | 16.3 | 0.8 | 0.3 | 58.4 | 34.7 | 5.6 | 1.4 | 28.4 | 39.9 | 20.6 | 11.1 |
Former smokerb | 3,963 (28.3) | 73.3 | 23.5 | 3.2 | 0.1 | 43.0 | 42.7 | 10.7 | 3.7 | 17.8 | 31.7 | 31.1 | 19.4 |
Current smokerb | 1,689 (16.5) | 63.6 | 30.6 | 4.7 | 1.2 | 29.3 | 38.6 | 21.4 | 10.6 | 18.7 | 24.1 | 23.3 | 34.0 |
Physical activityc | |||||||||||||
Yes | 8,156 (75.8) | 80.5 | 17.6 | 1.6 | 0.3 | 51.9 | 37.1 | 8.5 | 2.5 | 23.9 | 37.6 | 25.1 | 13.5 |
No | 3,221 (24.2) | 65.3 | 30.6 | 3.3 | 0.8 | 36.2 | 41.3 | 14.9 | 7.7 | 19.6 | 29.2 | 27.6 | 23.6 |
Diabetes | |||||||||||||
No | 10,176 (92.4) | 77.7 | 20.1 | 1.8 | 0.4 | 49.9 | 37.8 | 9.0 | 3.2 | 23.4 | 36.6 | 24.4 | 15.6 |
Yes | 1,202 (7.6) | 69.1 | 23.2 | 5.6 | 2.1 | 29.3 | 41.5 | 20.1 | 9.2 | 17.7 | 25.6 | 32.8 | 23.9 |
Obese | |||||||||||||
No (BMI <30 kg/m2) | 8,171 (76.0) | 79.0 | 19.2 | 1.5 | 0.3 | 52.0 | 36.6 | 8.6 | 2.9 | 23.8 | 36.1 | 23.8 | 16.4 |
Yes (BMI ≥30 kg/m2) | 2,750 (24.0) | 72.8 | 23.9 | 3.0 | 0.3 | 37.7 | 42.2 | 13.7 | 6.4 | 17.2 | 29.8 | 33.8 | 19.3 |
Disability | |||||||||||||
No | 8,258 (79.1) | 79.7 | 18.6 | 1.4 | 0.3 | 53.3 | 36.9 | 7.4 | 2.5 | 25.4 | 35.8 | 24.0 | 14.8 |
Yes | 3,078 (20.9) | 61.8 | 31.2 | 5.7 | 1.4 | 32.4 | 41.8 | 18.0 | 7.9 | 17.1 | 32.6 | 29.3 | 21.0 |
Dental insurance coverage | |||||||||||||
Yes | 6,837 (67.3) | 80.4 | 17.6 | 1.6 | 0.4 | 51.4 | 38.4 | 8.1 | 2.2 | 26.0 | 40.0 | 25.2 | 8.8 |
No | 3,995 (32.7) | 70.8 | 26.2 | 2.7 | 0.3 | 38.1 | 38.3 | 15.3 | 8.3 | 19.9 | 31.6 | 26.4 | 22.2 |
Abbreviations: BRFSS, Behavioral Risk Factor Surveillance System; BMI, body mass index.
a All estimates were calculated using the raw data. All n values are unweighted; percentages are weighted. Subcategories may not sum to 11,385 because of missing values. Percentages may not sum to 100 because of rounding. We used χ2 test to test the difference in distribution of tooth loss by sociodemographics, health risk behaviors, health conditions and disabilities, and dental insurance coverage. All differences were significant (P < .001), except for diabetes (P = .02) and obesity (P = .01) among adults aged 18 to 44 years.
b Current smoker, defined as smoked at least 100 cigarettes in lifetime and now smoke every day or some days; former smoker, defined as smoked at least 100 cigarettes in lifetime but no longer smoke.
c Participated in physical activity or exercise other than regular job such as running, calisthenics, golf, gardening, or walking during the past 30 days.
Respondents who had low income, low education, unhealthy behaviors (ie, former or current smokers and did not engage in physical activity), chronic conditions (ie, diabetes and obesity) or disabilities, and no dental insurance coverage were more likely to have fewer teeth compared with their referent groups (Table 2). However, the association of these variables with tooth loss was not uniform by age group.
Table 2
Adjusted Odd Ratios of Tooth Loss for Demographic Characteristics and Risk Factors, Rhode Island Adults, 2008 and 2010a,b
Demographic Characteristic and Risk Factor | n1/n2c | AOR (95% CI) | ||
---|---|---|---|---|
1–5 Missing Teeth vs 0 Missing Teeth | 6–31 Missing Teeth vs 0 Missing Teeth | Edentulousd vs 0 Missing Teeth | ||
18–44 y | ||||
<$25,000 vs ≥$25,000 | 556/2,025 | 1.27 (1.07–1.50) | 1.63 (1.10–2.40) | 2.27 (1.20–4.30) |
≤High school degree vs >high school degree | 892/2,001 | 1.39 (1.20–1.61) | 1.41 (1.04–1.92) | 1.66 (0.91–3.03) |
Former smokere vs never smoker | 542/1,789 | 1.03 (0.84–1.25) | 1.33 (0.86–2.03) | 0.39 (0.13–1.15) |
Current smokere vs never smoker | 556/1,789 | 1.33 (1.07–1.65) | 1.99 (1.36–2.93) | 3.18 (1.10–9.17) |
No leisure time activityf vs leisure time activity | 630/2,263 | 1.22 (1.06–1.41) | 1.19 (0.85–1.67) | 1.12 (0.58–2.14) |
Diabetes vs no diabetes | 93/2,801 | 0.98 (0.75–1.28) | 1.35 (0.80–2.30) | 1.97 (0.51–7.66) |
Obese (BMI ≥30 kg/m2) vs not obese (BMI <30 kg/m2) | 693/2,079 | 1.09 (0.93–1.26) | 1.33 (0.99–1.79) | 0.98 (0.44–2.19) |
Disability vs no disability | 421/2,466 | 1.24 (1.02–1.52) | 1.62 (1.12–2.34) | 1.66 (0.94–2.91) |
No dental insurance vs dental insurance | 660/2,065 | 1.18 (1.00–1.38) | 1.18 (0.83–1.67) | 0.79 (0.42–1.51) |
45–64 y | ||||
<$25,000 vs ≥$25,000 | 841/3,405 | 1.20 (1.06–1.36) | 1.61 (1.35–1.91) | 1.52 (1.19–1.94) |
≤High school degree vs >high school degree | 1,551/3,187 | 1.27 (1.15–1.39) | 1.66 (1.44–1.90) | 2.52 (2.04–3.13) |
Former smokere vs never smoker | 1,674/2,233 | 1.08 (0.95–1.22) | 0.95 (0.80–1.13) | 0.93 (0.71–1.23) |
Current smokere vs never smoker | 818/2,233 | 1.35 (1.14–1.59) | 2.50 (2.01–3.10) | 3.51 (2.57–4.80) |
No leisure time activityf vs leisure time activity | 1,248/3,494 | 1.09 (0.99–1.20) | 1.11 (0.96–1.28) | 1.28 (1.04–1.57) |
Diabetes vs no diabetes | 483/4,257 | 1.19 (1.01–1.39) | 1.50 (1.21–1.85) | 1.53 (1.18–2.00) |
Obese (BMI ≥30 kd/m2) vs not obese (BMI <30) | 1,278/3,284 | 1.14 (1.04–1.26) | 1.22 (1.06–1.40) | 1.42 (1.14–1.79) |
Disability vs no disability | 1,319/3,402 | 1.20 (1.09–1.32) | 1.48 (1.27–1.71) | 1.55 (1.26–1.89) |
No dental insurance vs dental insurance | 1,217/3,341 | 1.02 (0.93–1.13) | 1.14 (0.98–1.33) | 1.54 (1.25–1.90) |
≥65 y | ||||
<$25,000 vs ≥$25,000 | 1,208/1,679 | 0.98 (0.86–1.12) | 1.12 (0.97–1.28) | 1.40 (1.20–1.63) |
≤High school degree vs >high school degree | 1,850/1,762 | 1.08 (0.96–1.21) | 1.40 (1.23–1.59) | 1.70 (1.46–1.98) |
Former smokere vs never smoker | 1,704/1,604 | 1.20 (1.00–1.44) | 1.47 (1.22–1.78) | 1.26 (1.02–1.54) |
Current smokere vs never smoker | 302/1,604 | 0.87 (0.65–1.17) | 1.18 (0.88–1.58) | 2.20 (1.60–3.02) |
No leisure time activityf vs leisure time activity | 1,309/2,311 | 0.95 (0.84–1.07) | 0.97 (0.85–1.10) | 1.09 (0.95–1.26) |
Diabetes vs no diabetes | 620/3,002 | 0.95 (0.81–1.11) | 1.19 (1.02–1.39) | 1.27 (1.06–1.52) |
Obese (BMI ≥30 kg/m2) vs not obese (BMI <30 kg/m2) | 773/2,737 | 1.04 (0.90–1.20) | 1.30 (1.12–1.51) | 1.20 (1.01–1.43) |
Disability vs no disability | 1,307/2,299 | 1.17 (1.04–1.32) | 1.24 (1.09–1.40) | 1.28 (1.11–1.47) |
No dental insurance vs dental insurance | 2,081/1,364 | 1.04 (0.94–1.16) | 1.12 (0.99–1.27) | 1.58 (1.36–1.84) |
Abbreviations: AOR, adjusted odds ratio; CI, confidence interval; BMI, body mass index.
a All estimates were calculated by using the data after multiple imputation.
b Analyses were adjusted for age (continuous) and all other variables in the table, even though the analysis was age-stratified.
c n1 denotes the unweighted sample n in the risk group, and n2 denotes the unweighted sample n in the low-risk group (referent).
d Because of the small sample size of edentulism among adults aged 18 to 44 years, the 95% CIs of the AORs are wide and indicate potentially unstable estimates.
e Current smoker, defined as smoked at least 100 cigarettes in lifetime and now smoke every day or some days; former smoker, defined as smoked at least 100 cigarettes in lifetime but no longer smoke.
f Participated in physical activity or exercise other than regular job such as running, calisthenics, golf, gardening, or walking during the past 30 days.
The likelihood of tooth loss increased when 6 of the 8 predictors of tooth loss (income and former smoker were not predictors) were present among adults aged 45 to 64 years (Table 2). Among adults aged 65 years or older, former smokers were more likely to report 6 to 31 missing teeth (AOR, 1.47; 95% CI, 1.22-1.78) and total tooth loss (AOR, 1.26; 95% CI, 1.02–1.54) than those who had never smoked. The strongest predictor of tooth loss among all age groups was current smoking status. In particular, among adults aged 45 to 64 years, current smokers were more likely to report tooth loss than those who had never smoked (1 to 5 missing teeth: AOR, 1.35; 95% CI, 1.14–1.59; 6 to 31 missing teeth: AOR, 2.50; 95% CI, 2.01–3.10; and total tooth loss: AOR, 3.51; 95% CI, 2.57–4.80). The same patterns also existed among the younger and older age groups. A significant relationship existed between no leisure time physical activity and 1 to 5 missing teeth in young adults but not among the other 2 age groups examined. Among middle-aged adults, those who had diabetes were more likely to report 1 to 5 missing teeth (AOR, 1.19; 95% CI, 1.01–1.39), 6 to 31 missing teeth (AOR, 1.50; 95% CI, 1.21–1.85) and total tooth loss (AOR, 1.53; 95% CI, 1.18–2.00) than those who did not have diabetes. Among middle-aged and older adults, those who had disabilities had an increasing trend in the odds of tooth loss compared with those who did not have disabilities. Not having dental insurance coverage was significantly related to complete tooth loss among middle-aged and older adults. Our data showed almost 1 in 3 Rhode Island adults lacks dental insurance coverage (32.7%) (Table 1), almost 4 times the percentage that lack medical insurance (8.6%) (calculated from 2008 and 2010 BRFSS data).
Discussion
We found that the likelihood of having a risk factor increased with extent of tooth loss and that a dose–response relationship was maintained among middle-aged and older adults. The relationships between risk factors and tooth loss differed by age groups. For instance, we found a significant relationship between lower income and 1 to 5 missing teeth among young and middle-aged adults but not among older adults. Being a former smoker was significantly related to having lost 1 to 5 teeth in older adults but not among young and middle-aged adults.
Lower income and fewer years of education increase risk for oral disease (,). Our study confirmed these findings: people with low income (<$25,000 year) and low education levels (less than a high school degree) had a higher prevalence of tooth loss compared with their reference groups, although education was a stronger predictor than income. Americans living in poverty were 3 times as likely to have untreated dental disease than those who were not (). People with higher incomes are more likely to have dental insurance coverage as a benefit and to practice oral disease prevention (). People with low incomes have cost barriers to oral health care, are less likely to be aware of the need for comprehensive, ongoing dental care, and are more likely to use tobacco and have a poor diet (1). Our study found that education beyond high school was inversely associated with the number of teeth lost, even after controlling for other confounders. Those with higher education levels are usually employed, tend to have higher income, and have higher demand for and use of oral health services. Conversely, lower education results in lack of oral health knowledge, insufficient preventive behaviors, and low use of oral health services (). Some have argued that access to dental care explains most of the socioeconomic disparities in oral health ().
Smoking is an established risk factor for poor oral health (). Cigarette smokers are more likely to have more missing teeth and to experience greater rates of tooth loss than nonsmokers (,21). Our results are consistent with previous studies that link smoking status to tooth loss (,). In 2004, the US Surgeon General reported that sufficient evidence exists to infer a causal relationship between smoking and periodontal disease (21). Several hypothesized mechanisms underlie the relationship between smoking and oral health, including impairment of the immune system, alteration of the bacterial environment, increase of endodontic diseases, and decrease of salivary function (). Millar and Locker found that current smokers were more likely to report oral health problems and less likely to use dental services than nonsmokers (), which may decrease early-stage diagnosis of oral health problems (). Cigarette smoking is a major modifiable risk factor for tooth loss. Smoking cessation can result in substantial improvements in oral health and could be an effective strategy to prevent tooth loss (,21). To prevent periodontal disease, and, ultimately, tooth loss, dentists and other health practitioners have an important role to play in tobacco control, including provision of brief smoking cessation advice and supportive materials during regular dental and health care visits (,).
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Physical activity may reduce periodontal disease risk (,). In our study, physical inactivity increased the likelihood of tooth loss, but most AORs were not significant. Data from the National Health and Nutrition Examination Survey show that physically active adults have a lower risk of periodontitis, and adults with periodontitis had elevated levels of C-reactive protein and white blood cell counts in the gingival crevicular fluid (). The underlying mechanism associating physical activity with tooth loss may be through enhancement of a person’s immunological response ().
One major complication of diabetes is periodontal disease, which in severe cases can lead to tooth loss (,). People with diabetes have a significantly higher prevalence of tooth loss (,). A relationship between diabetes and tooth loss is of public health interest (). Our findings confirm previous studies supporting an association between diabetes and oral health problems (,). The compromised immune response associated with diabetes may increase susceptibility to oral disease; conversely, good oral health may aid in glycemic control (). It is important to educate people with diabetes of their increased risk for tooth loss through multidisciplinary efforts. Diabetes control may be more important to maintaining a good periodontal condition than how long a person has been treated for diabetes ().
Obesity has emerged as a significant predictor of periodontal disease, and body mass index may influence total tooth loss via an association with periodontal disease (,). Our results support findings fromother studies (,).
People with disabilities are at greater risk for tooth loss, which may further compromise their health (). Our study showed that adults with disabilities were more likely to have tooth loss than those without disabilities. Poor oral hygiene and increased risk for oral diseases have been associated with limited manual dexterity; dry mouth caused by medication side effects; diet modification, such as high calorie/high sugar meal supplements and processed foods; and access to oral health care, such as the number of dental offices that are accessible to people with mobility limitations (). Early recognition and professional intervention, including oral health education, can ameliorate many of these problems ().
Regular dental visits, which are important for preventing tooth loss (), can detect and treat periodontal disease at an early stage to alter its natural progression (). However, preventive dental visits are restricted by costs (). Surveys have reported that people with dental insurance coverage are more likely to report a recent dental visit (,). Lack of preventive care may reflect differences in the availability of dental care, the ability to pay for dental services, or other barriers to receipt of dental services (eg, transportation, accessibility, competing time demands) (). Having no dental insurance coverage creates a financial access barrier to use of dental services (ie, routine dental examination and cleanings) and results in an increased risk of tooth loss.
This study has several limitations. First, because the BRFSS excludes institutionalized persons and those without landline telephones, it may underestimate the prevalence of tooth loss among Rhode Island adults. Second, BRFSS is a cross-sectional study, so it cannot establish causal relationships. Third, low BRFSS response rates may relate to potential issues (eg, noncoverage bias), which are not unique to Rhode Island. However, previous studies have demonstrated that BRFSS estimates are reliable, valid, and are comparable to other population surveys (). Additionally, although agreement exists between data on tooth loss based on self-reports and data based on clinical records, the potential for misclassification bias exists (,). Fourth, the BRFSS tooth-loss question assesses the number of teeth removed because of dental decay or gum disease but not for other reasons, such as injury or orthodontics. Thus, an inherent limitation exists in that survey respondents may not have differentiated actual cause of tooth loss in their response, resulting in an underestimation or overestimation of tooth loss. Finally, several previously reported predictors of tooth loss were not available for inclusion in this analysis, such as anterior tooth type, inadequate oral hygiene, hypertension, nutrition, stress level, and fluoridated water consumption (,). The BRFSS includes some questions every year and others in alternate years; oral health questions are asked in even years only. Therefore, we used the most recent oral health data available (ie, 2008 and 2010) to identify risk factors in 4 domains that were significantly associated with tooth loss.
Our study also has several strengths. First, although numerous studies (–,–,) have examined the relationship between these predictors and oral health, they examined the association between only 1 to 3 risk factors and oral health (,). Our study focused on a broad range of health-related risk factors related to tooth loss. Many factors are highly correlated and cannot be understood independent of other factors. When we focused on 1 factor associated with tooth loss, we controlled all other risk factors. Second, our study used different outcomes than those used in previous studies (–,). Furukawa et al () used “depth of periodontal pockets,” Kelbauskas et al () used “teeth surfaces with carious lesions,” Sanders et al () used “periodontitis case,” and Dye et al () used ”perceived dental treatment needs” as outcomes. Many of the studies tended to dichotomize oral health (,), categorizing adults as having or not having oral disease. We used 4 predefined response categories for tooth loss. This enabled us to examine the trend between health risk factors and the 4 categories of tooth loss among Rhode Island adults. Our study showed the same pattern for all the risk factors and tooth loss among adults aged 45 to 64 and 65 or older; the likelihood of self-reported risk factors increased with the level of respondent’s tooth loss. Third, our study is different from previous studies in population perspective and study design. Our study was a cross-sectional analysis representative of Rhode Island community-dwelling adults aged 18 years or older, whereas other studies were representative of the entire US adult population; were disease-, occupation-, or age cohort–specific; were conducted among non-US populations; or had another study design (,–,).
Our findings may be generalized to adult populations beyond this study and suggest that targeting interventions at high-risk groups is likely to improve oral health. Dentists and hygienists can provide education to patients to improve awareness of the tooth loss effects of smoking, lack of physical activity, and other negative health conditions (). Health promotion counseling should include the prevention and control of oral disease risk factors and the maintenance of good oral health (). The Rhode Island Oral Health Program can support and increase public awareness efforts to educate families about the importance of oral health as a part of overall health and well-being and can support increased access to preventive oral care through a dental home to reduce health disparities, especially for at-risk populations.
Acknowledgments
We thank Dr Jana E. Hesser for her comments and suggestions on the early stage of the study, Laurie Leonard for reviewing and commenting on drafts of this article, and the following staff of the Centers for Disease Control and Prevention for reviewing and commenting on the final draft: Gina Thornton-Evans, DDS, MPH, Lina Balluz, PhD, Chaoyang Li, MD, PhD, Carol A. Gotway Crawford, PhD, MS, Mei Lin, MD, MPH, MS, Barbara F. Gooch, DMD, MPH, Frederic E. Shaw, MD, JD, and David M. Homa, PhD, MPH. This work and the Rhode Island BRFSS, was supported in part by the Chronic Disease Prevention and Health Promotion Programs Cooperative Agreement 5U58DP122791-05. The oral health module added to Rhode Island’s BRFSS was supported in part by the Oral Health Program Centers for Disease Control and Prevention Cooperative Agreement 5U58DP001595-03. The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the Rhode Island Department of Health. The authors declare that there are no conflicts of interest.
Footnotes
The opinions expressed by authors contributing to this journal do not necessarily reflect the opinions of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions.
Suggested citation for this article: Jiang Y, Okoro CA, Oh J, Fuller DL. Sociodemographic and Health-Related Risk Factors Associated with Tooth Loss Among Adults in Rhode Island. Prev Chronic Dis 2013;10:110285. DOI: http://dx.doi.org/10.5888/pcd10.110285.
Post-Test Information
To obtain credit, you should first read the journal article. After reading the article, you should be able to answer the following, related, multiple-choice questions. To complete the questions (with a minimum 70% passing score) and earn continuing medical education (CME) credit, please go to http://www.medscape.org/journal/pcd. Credit cannot be obtained for tests completed on paper, although you may use the worksheet below to keep a record of your answers. You must be a registered user on Medscape.org. If you are not registered on Medscape.org, please click on the 'Register' link on the right hand side of the website to register. Only one answer is correct for each question. Once you successfully answer all post-test questions you will be able to view and/or print your certificate. For questions regarding the content of this activity, contact the accredited provider, [email protected]. For technical assistance, contact [email protected]. American Medical Association's Physician's Recognition Award (AMA PRA) credits are accepted in the US as evidence of participation in CME activities. For further information on this award, please refer to http://www.ama-assn.org/ama/pub/category/2922.html. The AMA has determined that physicians not licensed in the US who participate in this CME activity are eligible for AMA PRA Category 1 Credits™. Through agreements that the AMA has made with agencies in some countries, AMA PRA credit may be acceptable as evidence of participation in CME activities. If you are not licensed in the US, please complete the questions online, print the AMA PRA CME credit certificate and present it to your national medical association for review.
Post-Test Questions
Article Title: An Algorithm That Identifies Coronary and Heart Failure Events in the Electronic Health Record
CME Questions
- You are seeing a 60-year-old woman with several medical problems. Her dentist has provided a preoperative form for you prior to a planned extraction of 2 teeth, and you are concerned with this patient’s oral health. In the current study by Jiang and colleagues, which of the following variables was most associated with having fewer teeth?
- Lower educational attainment
- Single, divorced, or widowed status
- Rural vs urban residence
- A history of alcohol abuse
- Which of the following variables was strongest in predicting tooth loss in the current study?
- Lower educational attainment
- Lower income
- Current smoking status
- The absence of dental insurance
- The patient in Question # 1 does not exercise. Based on the current study, what should you consider regarding the relationship between physical activity and the risk of tooth loss?
- Physical activity was not associated in the risk of tooth loss in any study analysis
- Reduced amounts of physical activity increased the risk of tooth loss among all patient groups
- Physical activity predicted tooth loss only among older adults
- Physical activity predicted tooth loss only among younger adults
- The patient lacks dental insurance. In the current study, what role did dental insurance have in promoting tooth loss?
- Dental insurance was not associated in the risk of tooth loss in any study analysis
- Dental insurance was the most important variable associated with tooth loss
- A lack of dental insurance coverage predicted tooth loss only among middle-aged and older adults
- A lack of dental insurance coverage predicted tooth loss only among younger adults
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OR2020 THE OPERATING ROOM OF THE FUTURE WORKSHOP REPORT 18-20 March 2004 Turf Valley Conference Center Ellicott City, Maryland Workshop Conveners: Kevin Cleary, PhD, Deputy Director, ISIS Center, Georgetown University Seong K. Mun, PhD, Director, ISIS Center, Georgetown University Organizing Committee: Kevin Cleary, PhD, Georgetown University Medical Center, Program Director William DeVries, MD, Walter Reed Army Medical Center, Co-Director Elizabeth Bullitt, MD, University of North Carolina Ho Young Chung, MD, PhD, Georgetown University Medical Center Phil Corcoran, MD, Walter Reed Army Medical Center Eric J. Hanly, MD, Walter Reed Army Medical Center Ferenc Jolesz, MD, Brigham and Women's Hospital Cato T. Laurencin, MD, PhD, University of Virginia Heinz Lemke, PhD, Technical University of Berlin Micheal Marohn, MD, Johns Hopkins Medical Institutions Gerry Moses, PhD, U.S. Army Medical Research and Materiel Command Seong K. Mun, PhD, Georgetown University Medical Center Michael Pentecost, MD, Georgetown University Medical Center David Rattner, MD, Massachusetts General Hospital Rick Satava, MD, DARPA Noah Schenkman, MD, Walter Reed Army Medical Center Russell Taylor, PhD, Johns Hopkins University Report Authors: Kevin Cleary, PhD, Georgetown University Medical Center Audrey Kinsella, MA, MS, independent researcher/writer, Asheville, NC Workshop Supported By: National Science Foundation (BES-0341892) Telemedicine and Advanced Technology Research Center (W81XWH-04-1-0383) National Institutes of Health (NIBIB) (1 R13 EB03410-01) Corporate Sponsors: GE Medical Systems Karl Storz Endoscopy MedStar Health/Georgetown University Hospital
Olympus Surgical Division Siemens Corporate Research Stryker Endoscopy
OR2020: Operating Room of the Future Workshop. March 2004
Copyright © 2004 Imaging Science and Information Systems (ISIS) Center, Radiology Department, Georgetown University Medical Center. All rights reserved.
Front cover: Top left: 3D laser ablation therapy. Courtesy of Ferenc Jolesz, MD, Brigham and Women's Hospital. Full image appears on page 52. Middle right: CyberKnife® stereotactic radiosurgery system. Courtesy of Accuray, Inc. Full image appears on page 45. Bottom left: Simulation of surgical workflow in the modem operating room. Courtesy of Heinz Lemke, PhD, Technical University of Berlin. Full image appears on page 20.
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OR2020: Operating Room of the Future Workshop, March 2004
FOREWORD This report presents the results of a Workshop titled 'OR2020: The Operating Room of the Future,' held March 18-20, 2004, in Ellicott City, Maryland. The objective of the workshop was to identify the clinical and technical requirements for integrating advanced computer-assisted and robotic technologies into next generation operating rooms and interventional suites. This was done through a collaborative effort involving physicians, engineers, and scientists. First of all, I would like to thank the government agencies which provided the bulk of the workshop support: the National Science Foundation, the Army Medical and Materiel Research Command, and the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health. Without their support, the Workshop would not have been possible. I would also like to thank the corporate sponsors listed on page i and the back cover who enabled us to fund many of the special activities associated with the workshop, including the opening reception. Industrial participation is critical to the Operating Room of the Future, and it was gratifying to see so many industrial participants at the workshop. All of the organizing committee members deserve thanks, but I would especially like to thank the members of the Innovative Surgery Committee at Walter Reed Army Medical Center for their efforts. In particular, Phil Corcoran, William DeVries, Eric Hanly, Ernest Lockrow, Michael Marohn, and Noah Schenkman were instrumental in shaping the workshop and selecting the participants. At Georgetown University, both Seong K. Mun and Michael Pentecost were tireless advocates for the meeting and provided resources and support. At the Workshop itself, the student volunteers from Georgetown and Johns Hopkins were essential in keeping things running. Special thanks are due to Minh Vo, who was in charge of all of the logistics. My deepest gratitude is reserved for Audrey Kinsella, who drafted the final report and worked hard to ensure a quality product. Finally, I would like to thank all the participants, who enthusiastically participated in the workshop and contributed to the energetic discussion in the Working Groups. I hope that this report is an accurate reflection of their views and opinions - we had an extremely talented and outspoken group and it was not easy to synthesize all of this material. But if we can bring the concepts discussed here to fruition, it should lead to improved health care and the patient will be the ultimate beneficiary. Kevin Cleary, PhD Workshop Organizer Washington, DC December 2004 Email: [email protected] edu
OR2020: Operating Room of the Future Workshop. March 2004
iii
TABLE OF CONTENTS EXE C U TIVE SUM M ARY ............................................
1I
1 WO RK SH OP OVER V IE W ..........................................
2
1.1 Intro d u ctio n ................................................ 1.2 Common Themes and Recommendations ................ 1.3 1.4 1.5 1.6
. . 2 3
W ork ing G rou p s ............................................. . Workshop Rationale, Planning Process, and Execution ................. Pre-W orkshop Questionnaire ..................................... Report Overview ............................................ .
2 CHA PTER 2 A T A GLAN C E ........................................
5 6 8 13 14
Report of Working Group 1: OPERATIONAL EFFICIENCY AND WORKFLOW 2.1 2.2 2.3 2 .4
Overview: Common Procedures in Today's Operating Room .............. Clinical Needs: Issues in Access to Information and Standardized Practice .... Technical Requirements: Systems for Improving Workflow ............. R e searc h P rio rities ................................. .............
3 CH APTER 3 AT A GLAN CE ......................................
15 16 18 21 23
Report of Working Group 2: SYSTEMS INTEGRATION AND TECHNICAL STANDARDS
3.1 Overview: The Need for an Intraoperative and Integrated Systems Platform ... 24 3.2 Clinical Needs: Issues in Developing Integrated Operating Room System s and Technical Standards ................. 25 3.3 Technical Requirements: Standards and Tools for Improved Operating Room Process Integration ...................................... 27 3 .4 R esearch P riorities ........................................... . . 28 4 CH APTER 4 AT A G LANC E ........................................
29
Report of Working Group 3: TELECOLLABORATION 4.1 Introduction: A Historical View of Collaboration in the Surgical Theater and Potential Uses for Telecollaboration Today ......................... 4.2 Clinical Needs: Defining a Frontier Field ................ 4.3 Technical Requirements: Standardizing Services Specifically for the Operating Room ............................. ............ . 4.4 Research Priorities .........................
iv
30 31 36 37
OR2020: Operating Room of the Future Workshop, March 2004
39
5 CHAPTER 5 AT A GLAN CE ...................................... Report of Working Group 4: SURGICAL ROBOTICS 5.1 Overview: Robots and Their Needed Surgical Roles in Today's Operating Rooms ...................... 5.2 Clinical Needs: Design Issues for Targeting Best Uses for Surgical Robots ... 5.3 Technical Requirements: Needed Improvements and Safety Issues ....... .. 5.4 R esearch P riorities ..........................................
40 42 46 48 49
6 CH APTER 6 A T A GLAN CE ...................................... Report of Working Group 5: INTRAOPERATIVE IMAGING
50 6.1 Overview: Intraoperative Imaging Developments ....................... 6.2 Clinical Issues: The State of Intraoperative Imaging .................... 51 6.3 Technical Requirements: Needed Improvements in Imaging Quality 53 ...................... and Efficacy ...... .54 . .. . .......................................... 6 .4 R esearch P rio rities 56
7 CH APTER 7 AT A GLAN CE ...................................... Report of Working Group 6: SURGICAL INFORMATICS 7.1 Overview: Identifying the Work of a New Field ...................... 7.2 Clinical Issues: Achieving Optimal Performance by Using Surgical Inform atics in the Operating Room .......................... 7.3 Technical Needs: Foremost, Standards for Surgical Informatics ......... 7.4 Research P riorities .... ....... .............................. . . 8 APP E ND IC E S.................................................. 8.1 A ppendix A . W orkshop Program ................................. 8.2 Appendix B . W orkshop Participants ............................... 8.3 A ppendix C . B ibliography ......................................
0R2020: Operating Room of the Future Workshop, March 2004
57 58 60 62
. . 63 64 66 69
List of Figures Figure 1: W orkshop participants ........................................
3
Figure 2: Simulation of surgical workflow ................................
20
Figure 3: Operating Room of the Future at Massachusetts General Hospital ....... 26 Figure 4: Laproscopic telesurgery ................
35
Figure 5: CyberKnife® stereotactic radiosurgery system ..................... 45 Figure 6: 3D laser ablation therapy ........................................
52
Figure 7: 3D visualization for surgical planning ............................
61
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OR2020: Operating Room of the Future Workshop, March 2004
EXECUTIVE SUMMARY The modern operating room requires an increasing number of new surgical instruments, monitoring and imaging devices, information systems, and communication networks. While these individual technologies are improving, attention must also be paid to integrating all of these resources so as to improve the quality and efficiency of surgical procedures. The OR2020 Workshop was organized by the ISIS Center at Georgetown University to identify the clinical and technical requirements for integrating advanced computer-assisted and robotic technologies into the next generation operating rooms and interventional suites. The Workshop built on previous symposia, including the Operating Room of the Future (ORF) workshop sponsored by TATRC in 2002. Approximately 100 participants, including physicians, engineers, and scientists, met for two days in March 2004. The Workshop consisted of plenary sessions, a keynote speaker, and two breakout sessions which were divided by Working Groups. The six Working Groups represented key areas of research and development: 1. Operational Efficiency and Workflow 2. Systems Integration and Technical Standards 3. Telecollaboration 4. Surgical Robotics 5. Intraoperative Diagnosis and Imaging 6. Surgical Informatics From the Working Groups, five broad areas of technology requirements were identified: 1. Standards for devices and their use in the operating room (OR) are sorely needed. Every aspect of OR activity today is affected by their absence. This was a concern repeated often throughout the workshop. The OR team of the future must also be interdisciplinary, a theme noted by other related initiatives, including the NIH Roadmap and its Research Teams of the Future theme. 2. Interoperability of devices is essential for improved care and throughput. Currently, most devices and computer systems function as stand-alone islands of information. A 'plug and play' medical network is needed. 3. Surgical robotics continues to develop and will play a role in the Operating Room of the Future. Improvements in surgical robotics that build on their unique capabilities are needed. 4. Surgery-specific image acquisition, processing, and display are needed. The two-dimensional (2D) static images typically used today are not sufficient. Image processing and visualization tools must be made available to the operating room. 5. Communications issues must be addressed and aim toward attaining a common language, training requirements, and protocols. This goal also depends upon development of network standards to enable telecollaboration. The report consists of eight chapters, beginning with an overview in Chapter 1. The Working Group reports are given in Chapters 2-7. The appendices in Chapter 8 include the workshop program, the list of participants, and a bibliography.
OR 2020: Operating Room of the Future Workshop, March 2004
CHAPTER 1: WORKSHOP OVERVIEW
1.1
INTRODUCTION
The 'OR 2020 Workshop: Operating Room of the Future' was held on March 18-20, 2004, at Turf Valley Conference Center in Ellicott City near Baltimore, Maryland. The general objective of the workshop was to identify the clinical and technical requirements for deploying advanced computer-assisted and robotic technologies and biomedical modeling in next generation operating rooms and interventional suites. Integrated systems and the general character of the Operating Room of the Future (ORF) were defined, with the year 2020 used as a target timeframe. The workshop consisted of a series of plenary sessions and breakout meetings of the six Working Groups. Approximately 75 invited experts, both PhDs and MDs, participated. (See Figure 1 on the next page for a group photograph.) The OR 2020 workshop was organized by the Imaging Science and Information Systems (ISIS) Center, Department of Radiology, of the Georgetown University Medical Center, Washington, DC; the Innovative Surgery Committee at the Walter Reed Army Medical Center, Washington, DC, and the Telemedicine and Advanced Technology Research Center (TATRC) at Fort Detrick, Maryland. The workshop was supported by the U.S. Army Medical Research and Materiel Command, the National Science Foundation, and the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health. Corporate sponsors were GE Medical Systems, Karl Storz Endoscopy, MedStar Health/ Georgetown University Hospital, Olympus Surgical Division, Siemens Corporate Research, and Stryker Endoscopy. This chapter begins by summarizing the common themes and recommendations from the workshop. Next, the focuses of the six Working Groups are presented in brief, followed by a snapshot of the workshop's rationale, planning process, and execution. Summaries of participants' views on needs and expected changes in the ORF are then presented, based on responses to a pre-workshop questionnaire that was sent to all participants. This report can also be found on the World Wide Web, by starting at http ,:wxx xvvcamirgcorgetown edu and following the links to the workshops and the 0R2020 workshop. At the time this report was printed, we were also maintaining the conference web site at h~t~v xxxxxxor2020.orsg, and additional workshop materials such as some of the presentations can be found there. .
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Chapter 1: Workshop Overview
Figure 1: Photograph of participants
1.2
COMMON THEMES AND RECOMMENDATIONS
There were a number of common themes that were identified during the workshop and they are noted below. More details on the themes and specific recommendations related to them are presented in the Working Groups' reports (Chapters 2-7). The five common themes that were identified are as follows: 1. Standards for devices and their use in the operating room (OR) are sorely needed. Every aspect of OR activity today is affected by their absence, from nonstandardized and incomplete patient records, to varied and unstandardized imaging formats of visual information that is needed during surgeries, to varied and sometimes imprecise language used in communicating among surgical team members. 2. Interoperability of devices is needed for development of a smoothly operating OR as well as for improved surgeries. Currently, most devices and computer systems function as stand-alone islands of information and their use requires a great deal of surgeons' time and effort. 3. Surgical robotics continues to develop and its role in the Operating Room of the Future is still being defined. Improvements in surgical robotics are needed to build on their unique capabilities such as precision, accuracy, ability to withstand ionizing radiation, and dexterity in small spaces inside of the human body.
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Chapter 1: Workshop Overview
4. Improved, surgery-specific image processing and display are needed for effective use in the OR. The two-dimensional (2D) static images that are typically available in today's OR do not accommodate the 3D and real-time imaging needs of surgeons in most specialty disciplines. 5. Communications issues must be addressed and aim toward attaining a common language, training requirements, and protocols for effectively performing advanced surgeries and using telecommunications-ready tools as needed. The following recommendations were made, based on these five themes: 1. Standards, standards, standards. If there was an overarching theme of the workshop, this was it. Standards are needed in all areas, and must be developed through a concerted effort involving companies, government agencies, academic institutions, and perhaps standards organizations. Research studies of surgical workflow and efficiencies are required to develop practice standardization and thus realize improvements. 2. Progress on the first recommendation will also enable progress on device interoperability. It is recommended that research be devoted to developing common user interfaces among medical devices, and that the device industry take the lead in performing this research with input for academic institutions and government agencies. A 'plug and play' architecture for medical devices is also needed. 3. Research in surgical robotics should focus both on improving the capabilities of these systems and integrating them with the surgical workflow. These systems could ultimately help improve patient safety by incorporating built-in safety checks and integrating them both with imaging and the electronic patient record. 4. Attaining advanced and improved surgery-specific image processing and display systems requires engineers and designers to work with surgeons to identify the needs and risks in using these systems. Readily available and flexible, real-time 3D imaging systems that use one standard platform for all imaging modalities are needed in current and future ORs. It is recommended that manufacturers and the device industry as a whole be encouraged to build imaging products that enable surgery-specific work. 5. A well-developed, dedicated medical network is needed to enable routine telecollaboration. An industry-grounded meeting to be attended by government stakeholders (including lawmakers), industry developers, telecommunications industry personnel, and surgical personnel should be arranged to address the needs of telecollaboration in medicine and surgery.
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Chapter 1: Workshop Overn iew
1.3
WORKING GROUPS
The OR2020 workshop consisted of plenary sessions and Working Group meetings during an intensive two-day period. The Working Groups each were charged with investigating a specific clinical and technical area related to the ORF. The six Working Groups were as follows. Group 1: Operational Efficiency and Workflow; Group 2: Systems Integration and Technical Standards; Group 3: Telecollaboration; Group 4: Surgical Robotics; Group 5: Intraoperative Diagnosis and Imaging; Group 6: Surgical Informatics. A brief summary of each group's work is as follows: Working Group 1: Operational Efficiency and Workflow. This group focused on examining requirements for achieving increased efficiencies in the OR. These requirements focused on needed mechanisms for accessing and obtaining correct and current patient-related information and scheduling, and accessing use of correct surgical tools. The group also discussed developing surgical practice standards that define day-today, step-by-step surgical workflows. Working Group 2: Systems Integration and Technical Standards. This group focused on the need for interoperability among a broad range of devices that are used in the OR. To achieve seamless integration among devices, a standard interface for interoperability among these technologies could be developed using a plug and play platform. This group also discussed the need for device standards that will enable configurability and easy use of these tools in the OR. Working Group 3: Telecollaboration. This group focused on current and future uses of telecollaboration for purposes of remote consultation, mentoring, monitoring, robot manipulation, and other functions. An absence of standards in every facet of this form of telecommunications-assisted delivery was noted by this group. Standards are needed in areas related to clinical uses of telecollaboration (such as training). Other needed standards are related to technical requirements of telecollaboration (e.g., for a low latency data compression algorithm that will enable low bandwidth synchronized transmission of data to the OR). Finally, this group identified significant regulatory and legal hurdles that are slowing adoption of telecollaboration in the OR. Working Group 4: Surgical Robotics. This group discussed the many clinical benefits of using robotic systems, particularly those that complement and extend human capabilities in the OR. Meeting technical needs for improving surgical robotics use requires building on robots' unique capabilities, such as their advanced precision, accuracy, strength, and dexterity. This group also discussed the importance of risk and safety issues pertaining to the use of robots in the OR. Working Group 5: Intraoperative Imaiging. This group focused on a central issue in intraoperative imaging today: namely, the difficulty for surgeons to obtain information from imaging devices in the OR. The need to present images in interactive and 3D
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Chapter 1: Workshop Overview
imaging modalities, and for developing the capabilities to integrate and manipulate these data, were discussed. Working Group 6: Sur2ical Informatics. This group focused on defining the nascent discipline of surgical informatics and identifying certain limitations that are impeding its development. The group noted a particular need for informatics systems that integrate preoperative, operative, and postoperative information and make it available where and when needed. In addition, a set of unified standards for procedures and use of surgical informatics must be defined and implemented, this Working Group concluded. 1.4
WORKSHOP RATIONALE. PLANNING PROCESS. AND EXECUTION
1.4.1 Rationale A number of meetings that focused on needs in the ORF have been held in recent years. The OR2020 Workshop was committed to addressing issues that have consistently arisen at these meetings and elsewhere in discussion about the ORF. These issues include the need for widely adopted standards, concerns about ensuring patient safety, and the uncoordinated use of technology in the OR. Identifying mechanisms to address these issues and posing recommended solutions was the rationale for holding this workshop and inviting both clinical and technical experts to participate and share their views. 1.4.2 Planning Process Planning for the OR2020 Workshop began in the Fall of 2002, when the ISIS Center at Georgetown University Medical Center began to formulate a broader direction for studying the ORF and its needs and purposes. It was felt that organizing a workshop was a good way to obtain a better understanding of this field of growing interest and concern. Collaboration with the Walter Reed Innovative Surgery Committee and TATRC was initiated. Funding was solicited from various agencies, and preparations were begun in earnest in the Summer of 2003. The organizing committee met several times during the Fall of 2003 to create the final program and identify participants. Invitations were sent in late 2003, followed by a pre-Workshop questionnaire. The Workshop was held March 18-20, 2004. 1.4.3 Execution The Workshop consisted of plenary sessions and Working Group meetings. The plenary sessions were aimed at providing background for both clinical and technical areas. The Working Groups focused on specific areas of concern in the ORF, such as intraoperability of devices, telecollaboration needs, and surgical robotics. Each Working Group had a technical leader (PhD) and a clinical leader (MD). The Working Group
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leaders and participants are listed on the first page of each of the individual Working Group reports (Chapters 2-7). The Workshop program is presented as Appendix A on page 64. The OR2020 workshop began with a reception on the evening of Thursday, March 18, followed by an organizing committee and Working Group leaders' meeting. The opening session was held the next morning and included clinical and technical overviews on the evolution of surgery, a view of a testbed ORF at the Massachusetts General Hospital, and a panel discussion of surgical specialties and practitioners' needs in the ORF. These clinical plenary sessions were followed by technical presentations on topics such as device independence in the OR, the state-of-the-art in robotics, image-guided therapy, and surgery-specific workflow. Additional plenary sessions followed after a break, and included topics such as interventional oncology and the future of imaging. Meetings of the six Working Groups were interspersed throughout the workshop days, with time also allocated for summary presentations following most of the Working Group meetings. There were two extended breakout sessions for Working Group meetings. Each Working Group was assigned a specific task, as follows: Breakout Session 1: Current status and clinical requirements Task 1: Review contemporary issues in each Working Group's area in today's OR. Task 2: Define the clinical needs for contemporary and future ORs. Breakout Session 2: Technical requirements and research priority formulation Task 1: Based on clinical needs, define the technical requirements. Task 2: Summary. Prepare a list of research priorities and recommendations. Working Group status reports were presented twice during the Workshop, in 10-minute sessions to the entire conference audience following the first and second Breakout Sessions. To move forward quickly during the Workshop, a great deal of preparation was done prior to the Workshop. In particular, a pre-Workshop questionnaire was sent to all of the participants which asked them to identify research issues and suggest relevant references. The questionnaire served to get all of the participants thinking about the field and provided excellent background for the Workshop process. General questions included: 1. What are the main technical problems and research needs for the ORF? 2. What are the major infrastructure and administrative issues that must be addressed to develop the integrated ORE? As part of the questionnaire, participants were asked to recommend three papers that were relevant to the field and a bibliography was generated which is presented in Appendix C. Most of the participants responded and the responses were used to help generate a 31-page pre-Workshop report. This report provided general background for
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each Working Group, summarized the questionnaire responses, and included a bibliography. All of this effort served to acclimatize the participants beforehand so that informed discussion could move ahead quickly at the Workshop. The questionnaire itself and all of the responses are available on the Workshop's web site, as noted at the end of section 1.1.
1.5
NRE-WORKSHOP OUESTIONNAIRE
As noted, a pre-Workshop questionnaire was sent to all attendees, and in addition to several general questions, the questionnaire contained three specific questions for each Working Group: 1. What are the major technical problems relevant to your Working Group? 2. What other factors are relevant for your Working Group? 3. What procedures could benefit most from advances in this area? The responses to the specific questions from the Working Groups are briefly summarized here. Participants were encouraged to look at all the responses, and these were made available prior to the workshop. 1.5.1 Working Group 1. Operational Efficiency and Workflow Summary of responses 1.5.1.1 Major Technical Problems. From the questionnaire responses, participants agreed that information flow is a critical concept. One participant suggested that there is a lack of information technology for the OR; and another participant described this as a lack of situational awareness. Another participant suggested that automation (such as use of radio frequency identification devices, or RFID) could reduce time and errors while improving efficiency. Finally, it was suggested that there is a lack of real-time information regarding upstream and downstream processes, which makes the system slow to respond to variances that occur in the OR (and there can be a lot of variances). 1.5.1.2 Other Factors. Several other factors were identified as important for operational efficiency and workflow. The need for more training of staff was emphasized. The culture of the OR and its slow acceptance of new technology were listed as barriers. The myriad of paper records is a problem. Management of unplanned events (which is a regular occurrence) is difficult. In addition, one respondent noted that small increments of saved time that do not result in improved throughput (more cases or reduced overtime) are of limited utility. 1.5.1.3 Procedures. In attempting to identify procedures that could benefit most from improvements in operational efficiency and workflow, most respondents noted that all procedures could benefit. One respondent noted that these improvements were particularly suited to surgeons who do 60-to-80-minute procedures that have limited
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Chapter 1: Workshop Overview
variability. Another respondent noted that an additional benefit could be improved patient safety. 1.5.2 Working Group 2. Systems Integration and Technical Standards Summary of responses 1.5.2.1 Major Technical Problems. The major technical problem related to systems integration and technical standards is the lack of an accepted standard for device integration. The development of such a standard is no doubt a large undertaking, and one respondent suggested that what is needed is a clear understanding of surgical workflow and modeling tools. Another respondent noted that it is difficult to provide open systems while ensuring safety, security, and patient confidentiality. One more respondent stated that integrated control and communication systems require that manufacturers must be motivated by economic drivers, and must feel secure from experiencing legal and FDA repercussions. Finally, one respondent stated that there are no major technical problems and that the manufacturing sector has automated factory workflow for years with proprietary and nonproprietary systems. 1.5.2.2 Other Factors. There were a number of other factors listed by the questionnaire respondents. The proprietary interests of manufacturers were listed several times. One respondent stated that the manufacturers fear providing opportunities for competition. Another respondent noted that no large institution is pushing for standardization and that the regulatory environment discourages integration since the FDA clears devices only for specific 'indications for use.' Finally, one respondent stated that there is a lack of understanding (either too simplistic or overly complicated) of how systems integrate and of the issues that impinge on integration. 1.5.2.3 Procedures. In regard to defining procedures that can benefit most from advances in systems integration and technical standards, one respondent suggested that all OR procedures would benefit. Other respondents noted that minimally invasive procedures and image-guided procedures could benefit. 1.5.3 Working Group 3. Telecollaboration Summary of responses 1.5.3.1 Major Technical Problems. While there were many responses to this question, most of the responses did not actually list technical problems. Instead, respondents identified related issues such as the cost of equipment and infrastructure and the lack of adequate support staff. It was noted that there was a lack of clinical trials that demonstrate the value of telecollaboration. 1.5.3.2 Other Factors. Several other factors were mentioned as limiting the use of telecollaboration. The major other factor listed was medical liability, including licensure and credentialing. In addition, there is no practical system for financial compensation of
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telementoring or for accommodation of time-zone differences. The lack of acceptance by third-party payers and state licensing agencies was also listed, as was the difficulty of scheduling collaborating physicians. 1.5.3.3 Procedures. A number of different procedures were listed that could benefit most from advances in telecollaboration. One respondent felt that every surgeon performing basic procedures in community practice could benefit from the mentoring delivered by an expert observer. Similarly, for advanced procedures, expert physicians would like the support of national and international experts. Another respondent suggested that among the best applications of telecollaboration would be demonstrating/observing the first few of any procedures that were unfamiliar to a physician. Still another respondent listed image-guided therapies and laparoscopic and robotic-aided surgeries as particularly appropriate for telecollaboration. Also mentioned were time-sensitive procedures such as emergency trauma interventions and cardiac surgeries. One respondent listed as appropriate those procedures that are seldom performed by most practitioners - that is, those that are rare or those that are just becoming established routines. The same respondent also listed interventional procedures that require collaboration across disciplines such as cardio or vascular procedures. 1.5.4 Working Group 4. Surgical Robotics Summary of responses 1.5.4.1 Major Technical Problems. Many technical problems were listed by the respondents. It was noted that current surgical robots are too big and too expensive. The lack of haptics was noted by one respondent. Another comment was that there are not too many operations that actually benefit from robotics and it can actually be a productivity disabler. One respondent suggested that the equipment's fault tolerance needs to be improved. Another stated that robots are difficult to use and generally require more set-up time, especially when registration and/or fixation is required. Finally, one person suggested that robotics are not being adapted to the surgeon's working requirements and the patient's bodily needs. In terms of technical problems related to surgical instrumentation, one respondent noted that voice recognition is still not where it needs to be for real-world use. Another respondent listed the problems with minimally invasive surgery, including placement and navigation of the instruments. Respondents also listed the needs for both multimodality on-line instrument control and for an integrated view of all relevant navigation and physiological data. 1.5.4.2 Other Factors. Cost was the other major factor mentioned by respondents as limiting the use of robotics. Other issues included training, the large size of the instrument, and the lack of a demonstrated benefit for mainstream use of surgical robots.
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1.5.4.3 Procedures. Several different procedures were mentioned that could benefit from advances in robotics. One respondent stated that any minimally invasive procedure that is currently expensive to do (in terms of equipment or OR time) and is very demanding could benefit. Another respondent felt that it would be most beneficial for procedures, such as neurosurgery and heart surgery, that have a 'scaling barrier'. Lengthy procedures or procedures that demand prolonged or exact motor control were also mentioned as possibly benefiting from advances in robotics as was any procedure requiring complex reconstruction. Bone-oriented procedures were also mentioned. 1.5.5 Working Group 5. Intraoperative Diagnosis and Imaging Summary of responses 1.5.5.1 Major Technical Problems. A number of different technical problems were listed by the respondents. It was noted that high quality imaging devices such as CT and MRI are generally too large for the OR's physical environment. Radiation exposure is an issue for x-ray imaging, which is otherwise one of the more practical OR imaging modalities. Other respondents noted that devices designed for the OR have poor image quality, the information is still presented mostly 2D (no real-time 3D is available), and the information is anatomical only (i.e., it is non-functional). Another respondent noted the lack of integration of molecular imaging methods into intraoperative diagnosis. There is a need for better molecular tracers, both in marker intensity and specificity. One respondent listed the issues as biochemical sensitivity, spatial resolution, knowing what tracers are appropriate for a particular clinical task, equipment size, and other special environmental needs. More than one respondent stated that modeling is an issue. There is a lack of adequate models for virtual representations of internal organs. There is a need for real-time computation for deformable registration and reconstruction and updating of image models. Finally, it was noted that there is a need for more reliable and less expensive tracking devices. There is a lack of adequate software tools to conduct reliable intraoperative analysis, and an absence of consolidation of all of the intraoperative information into a comprehensive format. 1.5.5.2 Other Factors. There were several other factors mentioned as limiting the use of intraoperative diagnosis and imaging. These factors relate to how to best integrate the equipment into the OR and the surgical workflow. Other key factors concern questions of cost, reimbursement, and equipment ownership. One respondent noted that the equipment was disruptive to the flow of surgery. It is cumbersome, inconvenient, and requires collaboration with other departments to insure the availability of a technologist
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in the OR without whom the surgeon cannot operate. Another respondent listed other factors including sterile field violation, applications not designed for surgical OR interactions, and applications placed in geographically undesirable locations in the OR. 1.5.5.3 Procedures. A wide array of procedures were mentioned that could benefit from advances in intraoperative diagnosis and imaging. One respondent stated that most procedures were amenable to these advances but, in particular, the resection and therapy of malignant tumors would benefit most because use of this technology would allow the surgeon to remove all malignant tissue and reduce the damage to the neighboring anatomy. Another respondent similarly commented that all operations involving potential for vascular compromise of tissues were candidates, such as resection of brain tumors and metastases, resection of breast cancer, and auxiliary node sampling. Other procedures that would benefit from advances included: prostate brachytherapy and surgery; cardiac interventions, neurosurgery, liver surgery, lung surgery, cancer surgeries, and orthopedics. The biggest growth is believed to be in soft-tissue MIS procedures. In the specific case of x-ray CT, probably some of the more immediate applications to benefit from advances are spinal, skull-base, and sinus procedures. 1.5.6 Working Group 6. Surgical Informatics Summary of responses 1.5.6.1 Major Technical Problems. From the questionnaire responses, the major technical problem seems to be that surgical informatics is still evolving as a discipline. High quality surgical informatics systems do not seem to be available yet and there is no ontology or standard for their development. It is difficult to integrate the different types of information needed in surgical decision making into a coherent presentation and there is a need for decision support methods to integrate this information. There are no reliable content-based search techniques available and high performance computing has not been advantageously used. In the area of surgical atlases, major technical problems include building quality anatomical atlases for organs other than the brain (where some preliminary solutions exist) and building patient-specific biomedical and simulation models. One respondent also noted that the bioinformatics field has provided many useful tools for this type of work, but it should be expanded to fully include images, techniques, and situational searches. By 'situational searches,' the respondent is referring to something like an intelligent agent that could examine the ongoing surgical operation and provide suggestions. 1.5.6.2 Other Factors. Several others factors were mentioned by the respondents as limiting the use of surgical informatics. In particular, it was noted that there was a lack of validation studies to convince the leaders in surgery of the value of surgical informatics. It was also noted that adopting use of surgical informatics in the OR will require a total
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change of the intra-operative procedure, a different workflow, and most of all, additional cost in time of the surgery. Other factors limiting the use of surgical informatics that were listed by respondents included the need for a research OR that is charged with investigating the problems to be solved and the need to find surgeons who are willing to be involved in the development of these systems. The problems of cost and nursing turnover were also mentioned, along with the lack of inter-institution data accessibility and related regulations. 1.5.6.3 Procedures. Several different types of procedures were mentioned that could benefit from advances in surgical informatics. In particular, procedures with difficult or unusual complications, complex procedures that could benefit from extensive preplanning, and any procedure with a long patient history were mentioned. One respondent listed the categories of intraoperative pathology, telementoring, telesurgery, and virtual reality applications including training and mission rehearsal. Additional procedures suggested were orthopedics applications in which mechanical models were important, and neurosurgical procedures for which atlases would be beneficial. Another respondent listed tumor resection in critical organs and lymph node biopsies and resections. Finally, other suggestions included 1) bone procedures; 2) trauma care; and 3) vascular interventions, neural interventions, and tumor ablations.
1.6
REPORT OVERVIEW
The next six chapters (chapters 2-7) comprise the Working Group reports. Each report includes a capsule summary 'At a Glance' page, an overview, and reports on clinical needs, technical requirements, and research priorities. Appendices include the Workshop program, a list of participants, and a bibliography suggested by the participants.
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CHAPTER TWO AT A GLANCE: OPERATIONAL EFFICIENCY AND WORKFLOW
Overview Improvements in operational efficiency and workflow in today's operating room (OR) will significantly impact progress in the Operating Room of the Future (ORF). There is a particular need to adapt today's advanced technologies to meet specific surgical needs. Among these tasks is adapting technologies such as smart tracking for patient records, and radiofrequency identification devices (RFIDs) for locating information about patients and equipment. Doing so successfully is necessary to attain improved efficiency and workflow today and in the ORF. Clinical Needs Achieving '* '* '*
efficiencies in today's OR requires identifying mechanisms for: accessing and obtaining correct and current patient-related information. scheduling and accessing use of correct and operable surgical tools. developing consistent OR practices and prescribed workflow routines per procedure/per specialty.
Technical Requirements Research to address these clinical needs should focus on developing: 1. Smart cards or nodes that store patients' complete medical records. 2. Tracking mechanisms to address OR-wide fragmentation of information about surgical tools (their location, operability, and scheduled use). 3. A system for creating focused and well-trained work teams to ensure that consistently efficient surgeries are completed. 4. Technical standards for the OR that define day-to-day, step-by-step surgical workflows (per procedures and per variable cases). Research Priorities This Working Group identified these priorities as the development of: '• Means for accessing comprehensive and current medical records. '* Standardized tracking and locating of surgical instruments. '* Surgical practice standards in the OR that reach across all specialties. The full report of this Working Group appears on pages 15-22.
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CHAPTER 2: OPERATIONAL EFFICIENCY AND WORKFLOW .. THE REPORT OF WORKING GROUP 1 PARTICIPANTS Ernest Lockrow, DO, Uniformed Services University of the Health Sciences, Walter Reed Army Medical Center (Clinical Leader) Heinz Lemke, PhD, Technical University of Berlin (Technical Leader) Gary Dorfman, MD, National Cancer Institute Marie Egan, MS, RN, Massachusetts General Hospital Tim Ganous, MPA, University of Maryland Cristian Mihaescu, MS, University of Craiova Warren Sandberg, MD, Massachusetts General Hospital Robert Tham, PhD, University of Wisconsin-Madison Tom Winter, RN, Walter Reed Army Medical Center
2.1
OVERVIEW: COMMON PROCEDURES IN TODAY'S OPERATING ROOM
Standardized and improved workflow processes are central to ensuring the efficient operation of all hospital operating rooms (ORs) today. These processes are of particular importance in response to the continuing workforce shortages that are being experienced throughout the healthcare industry. Optimization of efficiencies in typical workflow processes is of special concern for health care providers, managers, and administrators, given the extent of OR-related costs in this, the most cost intensive sector of today's hospital. And there is a longer view that needs attention: Improvements in operational efficiency and workflow of today's OR will impact progress that will be achieved in the Operating Room of the Future (ORF). Key issues in improving operational efficiencies and workflow in the OR concern implementing better management of a multitude of preparatory information and tasks that are needed before and during actual surgeries. Ready access to patient-related information is a central problem today in OR facilities in every type of hospital (military, academic, and community). Without this access, the workflow is disrupted and surgeons are less productive. Therefore, the need to improve management of information pertaining to patients (their records and histories, their needs, their scheduling, and so on) is key to ensuring efficient OR workflow and patients' safety. Standardized information technology for scheduling inpatients' and outpatients' appointments, tests, and other procedures as well as for scheduling surgeries is critical for achieving improved efficiencies in the OR overall.
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Chapter 2: Operational Efficiency and Workflow
This Working Group identified key resources and technologies that could be adapted to improve efficiencies and workflow in the OR. They are 'key' in that they address the specific requirements of surgeons and their needs for improved workflow in the OR. Adaptations of, for instance, bar coding systems, radio frequency identification devices (RFIDs), and other tracking technologies were identified specifically as key for addressing chronic delays related to missing information about patients and surgical tools. And finally, a focus on modeling standardized surgical workflow practices for the OR was identified as an essential base from which to develop operational efficiency and workflow practices for the ORF. 2.2
CLINICAL NEEDS: ISSUES IN ACCESS TO INFORMATION AND STANDARDIZED
Probably the most pervasive problem in today's OR has less to do with surgical technical advances than with the need for mechanisms to access and obtain correct paperwork for patient-related information. Surgeons must divert much of their time and attention beyond the matter of performing surgery adeptly. They must instead deal with a myriad of manually generated paperwork per patient which is sometimes neither all complete nor up-to-date. The potential for inefficiencies and introducing patient safety issues is increased as a result. This Working Group discussed the very pressing need for a standardized access system from which surgeons and other OR personnel could obtain patient information and histories, patient room scheduling details, and information about location of equipment and the personnel who are trained to use it. Most particularly, there is a need for immediate access to patient information in the OR. Clinical Areas for Needed Improvements This Working Group identified and discussed three clinical areas needing improvement: 1. Poor access to patient and surgical information.
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'
Absence of a standard, computerized medical record for patients that documents their histories and their needs. These records must be current and complete. All future improvements on which these records are based (e.g., smart scheduling) depend on using a comprehensive electronic record as a template.
'
Disparate patient and medical information and imaging systems that do not 'talk' to each other, thus making accessibility issues difficult. An example of a standalone anesthesia record keeping system that is separate from the larger hospital
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information system (HIS) was provided as typical of such disparate islands of information that exist within hospitals. '
Multiple and disparate systems for tracking related work processes. For example, there are multiple scheduling systems used for tracking surgical in- and outpatients and another system for reserving surgical instruments and ORs.
'
For surgery, in particular, an absence of a surgery-oriented standard for obtaining and viewing multidimensional data about patients during surgery. Improved paper-based records are not the only issue: there is also a critical need for realtime information regarding upstream and downstream processes in the OR. Without this information, the system is slow to respond to variances (and there can be very many variances, this Working Group was quick to note).
All of these access issues affect today's clinical practice and are detrimental to making optimal use of surgeons' time and expertise. 2. Lack of consistent OR working practices or prescribed workflow routines. '* An absence of standardized devices/systems in the OR. Multiple computer operating systems (e.g., Windows-based and DOS systems) are routinely used in the same OR but information cannot be shared between them. '* Inflexible devices/systems that are currently in place. '* Slow processes of switching between applications (and so, switching is avoided). '* Inadequate presentation of data (text, 1D, 2D, 3D, 4D) during the intraoperative and perioperative phases of surgery. '* Unavailability of a user-configurable information environment. In addition, especially during surgery, there is a need for accessing consistent visual images, preferably with a touchscreen, regardless of the display system that is used. All told, today's surgeons who are using new technologies and imaging options appear to be adapting their immediate needs to what has been made available to them by manufacturers. They are devising 'work arounds' rather than using advanced technology to improve on their surgical work. 3. OR staff teamwork issues and communication deficiencies. Fragmented communications and varying levels of competency among OR team members are significant issues affecting efficiencies and improved workflow. These problems impact all aspects of surgery, including ensuring that:
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'* patients are appropriately prepared for surgery. '* patients' complete and up-to-date records are readily on hand. '* the correct tools are available and in the OR. '* a postoperative recovery area has been reserved. '* appropriate staff have been scheduled. Informed teamwork is key to improving operational efficiency and workflow. The islands of communications that are typical of today's OR process simply do not work, 2.3
TECHNICAL REOUIREMENTS: SYSTEMS FOR IMPROVING WORKFLOW
Today, fragmentation of patient information and other needed records impedes optimal operation of the OR. One of the most 'wished for' technical advances expressed by this Working Group was a 'patient-centric' medical record that would be available to all healthcare providers and so better direct each patient's care. Four of the most critical technical needs for improving OR efficiencies and workflow are as follows: 1) creating accessible medical records; 2) developing readable equipment locator/tracking mechanisms; 3) resolving OR teamwork/personnel issues; and 4) developing and following technical standards in the OR. The Working Group addressed these four issues separately as detailed below: 1) Creating accessible medical records This group suggested that a standardized system for identifying each patient is critical for improving OR efficiencies. These suggestions included: 1. Creation of a smart card or smart node to be placed on every patient. This mechanism would store a patient's medical record and could be accessed easily by providers. 2. Means for assigning a unique identifier to all patients for improving access to their records. Coupled with this suggestion was the requirement for a robust electronic architecture for obtaining this information. The Internet was the suggested means for access, rather than using/depending on a certain computer or operating system that an individual is used to. Security and privacy concerns then became important.
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2) Developing readable equipment locator/tracking mechanisms Information flow is critical to the optimal and efficient use of the OR. However, this flow pertains to information transfer beyond the detail that is included in patient records. Fragmentation of information about patients, tools (location and scheduling of their use), and other critical components of the surgical process is pervasive in today's OR and must be addressed. An integrated system for locating information and equipment is a key issue for improving OR efficiencies. This Working Group's suggested technical improvements for locating and tracking OR equipment included creation of OR-wide systems. Details about these systems are as follows. 1. Bar coding systems for identifying and tracking instruments and other equipment. These systems can help surgeons and other OR personnel locate equipment prior to the surgical procedure. This tracking can also help prevent the significant costs of unintentionally discarded or lost equipment post-surgery. 2. Standardized, automated tagging systems of all instruments and patients such as radiofrequency ID (RFID) of patients and equipment. Safety issues play a significant role here as well. There is a need for standardized scanning of patients after surgery and having each instrument tagged with an RFID mechanism to ensure that instruments have not been left inside patients. 3. Scheduling/tracking systems for specific equipment to have surgeons' preferred instruments in place. 3) Resolving OR teamwork/personnel issues Varying levels of competency among OR team members affect efficiency and workflow in the OR. Designing teams that work well together and are well trained from among inhouse staff is ideal, but many inconsistencies in scheduling and other issues have been shown to be a problem, this Working Group noted. In addition, cross-training usual OR staff is an inefficient use of resources. One participant of this Working Group (who drew on his hospital's own experience) suggested hiring and dedicating a staff of procedure-specific technicians. This process worked particularly well for certain procedures, like laparoscopic surgeries, for which enormous amounts of set-up time and expertise are required on the part of surgical technicians. In this instance, the hospital also contracted with a commercial firm for acquiring all procedure-related instruments, and that firm took responsibility for ordering and maintaining instruments. Doing so ensured that the correct and operable tools and
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personnel were in place. Increases in efficiencies were realized by working with an informed, regularly scheduled team. 4) Developing and following technical standards in the OR Standards for creating and integrating information about patients, equipment, and procedures are vitally needed at the outset in planning for an efficient ORF. To determine these standards, research is needed to define day-to-day, step-by-step surgical workflow practices and create surgery workflow models per procedures or per variable cases.
Figure 2: Simulation of surgical workflow (courtesy of Heinz Lemke, PhD, Technical University of Berlin)
An example that might be used to better understand (and eventually improve on) OR
workflows and efficiencies is the recent work by the Improving the Healthcare Enterprise (11E) initiative and its definitions of workflows and efficiencies in healthcare outside of the surgical room. This body of experts develops recommendations for the healthcare
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industry on how to implement standards. (Note: IHE's members do not develop the standards themselves.) Furthermore, the IHE initiative has developed 'integration profiles' that enable consistent access to images and reports for certain medical specialties (such as radiology). Surgical profiles have not been developed yet, but they are needed, as this Working Group noted, as is a 'surgical DICOM.' Today's DICOM standard is not suitable for many imaging types that are needed in the OR (e.g., it does not cover realtime, 2D, and 3D issues, nor does it address interactivity). 2.4
RESEARCH PRIORITIES
The following research needs were identified as priorities by this Working Group. '* Medical record access improvements. A comprehensive, accessible, and standardized patient medical record must be developed. Ideally, the language and computer system that are used for these records should be universally accessible and should not be machine- or software program-dependent. '
Equipment tracking improvements. There is a need for equipment tracking mechanisms to address the critical issue of fragmentation of information about the tools that are needed for pre-surgical planning for the actual surgical procedures. New mechanisms must provide means to locate needed detail about the tools, such as information about specific instruments (brands, types, and so on) that are required during a surgery. Technical means for enabling this tracking should involve standardized use of: 1. Radio frequency tracking of instruments and lap pads in the OR. Research should be focused on reducing the size of RFID tags and improving their performance in wet or other environments that are typically found in the surgical setting. 2. A bar coding system for tagging and locating instruments throughout the hospital. System-wide mechanisms for this tracking must be developed so that the correct instruments are in the right place as needed.
'
Practice standardization/improvements. Standardization of surgical practice across many spheres is needed to increase workflow efficiencies in the OR. These areas include standardization in: 1. Developing technology across the system (for technology used by surgeons, by nurses, and other team members) and across specialties (for technology used in endoscopy, radiology, and so on). Surgical practice itself also needs to
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be standardized and specific tools/brands decided upon in order for the surgical results to be consistent. 2. Scheduling of patients and comprehensive preoperative evaluation for their surgical procedures. 3. Preparing clinical teams who work together in the OR, with each member able to demonstrate skills in a particular technology's use. Increased education is obviously required to expand and refine team members' skill sets and enable them to plan ahead for next-day surgeries. 4. Defining and matching specific jobs/tasks and their roles in OR workflow processes. These roles need to be better defined to address the question: Who are the people that will be needed tomorrow in the OR? 5. Developing clinical guidelines per surgical specialty. Developing and following practice guidelines will achieve consistency in scheduling and undertaking routine pre-operative screening tasks, and otherwise better ready the patients for surgeries. 6. Acquiring surgery-oriented presentation of multidimensional data. Images ought to be consistent regardless of the display system that is used. 7. Developing standard operating procedures (SOPs) for the OR. A goal is to enable surgeries to operate like factories or assembly lines and produce a consistent, measurable product. 8. Studying individual work roles and activities to understand what people working in the OR do and say they do and why. Obtaining this information requires an ethnographic research study of the OR to be undertaken. From it, workflows can then be better defined from high to micro levels. As a result of studying the overall workflow practices that characterize today's OR (including readying patients, preparing tools, performing procedures, and so on), a better understanding can be acquired of how these tasks can be performed efficiently in the future. These findings could lead to development of a needed, standard process model of surgical workflow. As a result, planners would have better information from which to assign and plan for human and non-human involvement in an OR that operates efficiently and productively.
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CHAPTER THREE AT A GLANCE: SYSTEMS INTEGRATION AND TECHNICAL STANDARDS Overview There are wide ranges of medical devices used in today's operating rooms (ORs). However, many devices do not or cannot communicate among each other. A standard interface for interoperability among these technologies is therefore needed if simpler and seamless integration is to be achieved today and in the future. A platform comprising clinically connected devices that operate via plug and play standardization was the ultimate goal defined by this Working Group as desirable for the Operating Room of the Future (ORF). Clinical Needs This Working Group identified two critical steps for achieving systems integration and standards: 1. Defining information that is needed in the OR for clinical decision making. 2. Generating a systems platform for a multipurpose OR suite that facilitates reconfigurability for different surgical procedures and different surgeons needs and tastes. Technical Requirements A plug and play platform must be developed. Such a platform is believed to be key for communications and control of multiple devices used in the OR. Standards that need to be included in this configuration were identified, including features pertaining to bandwidth, speed, and synchronization capabilities of the configured devices. Research Priorities This Working Group identified four priority areas for research. Among the most important: '• Developing 'common' user interfaces among medical (especially imaging) devices. The device industry should take the lead on this research task. '* Devising and implementing a standard communications header for each device to identify itself, its task, ownership, and its capabilities. The full report of this Working Group appears on pages 24-28.
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CHAPTER 3: SYSTEMS INTEGRATION AND TECHNICAL STANDARDS . ,THE REPORT OF WORKING GROUP 2
Julian Goldman, MD, Massachusetts General Hospital (Clinical Leader) Rainin Shahidi, PhD, Stanford University (Technical Leader) Michael Browt,General Electric Global Research Rcmmhard Bucholz, MD, St. Louis University Laurence Clarke, PhD, National Cancer Institute Jeff Coltman~, PhD), Georgetown University Gilbert Devey, BS, Georgetown University Tony Epifane, Kyarl ctorz Endoscopy Michael Evans, Stryker Endoscopy Peter Kazanzides, PhD, Johns Hopkins University Walter Lapabiotte, Stryker Communications Dave Lieberman, Olympus Surgical William MacNeils, MS, Johns Hopkins University iSohmn Ranjan, MS, Georetown University 3.1
OVERVIEW: THENEED FOR AN LNTRAOPERATIVE AND INTEGRATED SYSTEMS PLATFORM
There are wide ranges of medical devices used in today's operating rooms (ORs). However, almost all of these devices operate independently or are incapable of communicating with other devices or technologies. Significant improvements in operating room efficiency and quality might be achieved by the design and implementation of an intraoperative and integrated systems platform. A standard interface for interoperability is needed for all technologies used in the OR if simpler and seamless integration is to be achieved. However, the integration should be driven not by what components and technology matches are possible but by what makes sense clinically. In terms of integrating surgical equipment, what makes sense is taking a broader approach than just dealing with surgical information. The approach must integrate and incorporate the 'physiological datastream'- that is, the anesthesia record, medical administration, and other information that is specific to the OR and patient activity.
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This Working Group devoted significant time to identifying the building blocks that are needed to clinically and technically generate system platforms for multipurpose OR suites. A platform comprising clinically connected devices (operating via plug and play standardization) was the end goal desired for the Operating Room of the Future (ORF).
3.2
CLINICAL NEEDS: ISSUES IN DEVELOPING INTEGRATED OPERATING ROOM SYSTEMS AND TECHNICAL STANDARDS
At least two significant steps were identified as critical for building new, more useable systems for the OR. These are: 1. Defining information that is mandatory in the OR. Laying the groundwork for building an integrated and standardized system for the OR requires, first of all, determining what information is needed for clinical decision-making. Clinical requirements must be defined and articulated by surgeons and associated personnel and then conveyed to engineers and industry developers. This information will eventually need to be integrated into OR information systems and made readily available to OR clinicians. These definitions of OR requirements must encompass not only the information and tools that are required in the OR but must also include and synthesize existing procedural protocols. There are currently varying types of protocols used in the OR. Clinical requirements (once identified) will define and generate the needed standards that represent a single, global protocol. Achieving this global protocol is the goal for attaining effective and measurable work in the OR. 2. Generating a systems platform for a multipurpose OR suite. A building block approach to defining clinical requirements and standards is needed from which to generate systems platforms for a multipurpose OR suite. Four key areas that must be addressed in standards development are as follows: imaging, visualization, control of devices, and communications. In addition, the platforms must facilitate reconfigurability that is needed for different procedures and for accommodating different surgeons' needs and tastes. The building blocks of the OR informational system also have to continually define engineering requirements and so enable the system to meet platform standards for an application-specific, protocol-based workflow. There have to be multi-level device integration and high bandwidth data communications when required. Too much technology? An issue that arose during this Working Group's discussion was: Is there too much technology in today's OR to allow for clinical efficiencies? A need for surgical
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operation-specific procedural maps was voiced, as was the need for technology (and 'modular technology, should needs change) that ought to be in the OR on a given day for achieving clinical efficiency. Ideally, each OR would be physically standardized to facilitate performing particular procedures and be physically mapped according to placement of tools and task-specific people.
Figure 3: Operating Room of the Future at Massachusetts General Hospital (courtesy of the Center for Integration of Medicine and Innovative Technology (CIMIT))
Planning for each procedure's requirements (and following specific, usual surgical routines) will indicate specific technology platforms that are needed for some procedures, not always for others. This standardized inventory is, as one group member noted, an extremely critical foundation from which to begin 'before you start filling your room with standards of seven other different technologies.' A goal may well be a requirement to design multipurpose, easily reconfigurable ORs. It was believed, however, that
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hospital administrators and hospital efficiency experts would not support separate ORs for each specialty. Standardization will occur only after the room is defined by the procedures (whichever operation is taking place). Improved use of technology and current OR clinical requirements demand that planners: 1. Make sure that all machines and imaging modalities can talk to each other (and not interfere with other devices). 2. Move away from the non-interoperable multitude of devices that are used in today's ORs and which function in isolation. 3. Work toward creating neither single devices nor single systems but rather reconfigurable platforms that are based on standardized clinical requirements. These standardized features are key to improved use and clinical applicationspecific control of technology in today's OR. In particular, varieties of imaging modalities must be capable of being fused (registered) and displayed together. 4. Aim toward creating an image correlation protocol standard to be used as needed. However, a long-term goal ought to be achieving multi-level device integration that enables operator control and procedure-targeted systems configuration and will be most useable in the ORF.
3.3
TECHNICAL REQUIREMENTS: STANDARDS AND TOOLS FOR IMPROVED OPERATING ROOM PROCESS INTEGRATION
The technology for creating standards or standardized interfaces among devices in today's OR needs to be identified. These systems must satisfy clinical requirements, and they must address what clinicians say they need in the OR. At the outset, a plug and play system for developing this interface appears to be key for communication and control between multiple devices. Identifying requirements for this platform is essential. Specifically, devices that need to work together have to be identified as do their requirements for operation (e.g., in terms of bandwidth, speed, and synchronization). Each device's range of capabilities has to be included in this configuration as well. Capabilities to transmit the status of its completed tasks to a designated location or via a built-in, real-time confirmation mechanism have to be included. Other features of the platform include authorization mechanisms for each device's use, and configurations that allow for only specified access to its capabilities by some designated users.
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In addition, devices of the same type must be assigned to a specific class. The class must be understood as having specific capabilities and standards. For instance, insuffulators as a class have many capabilities, but some have all capabilities and others only have a few of these. Surgeons in the OR need to know about the particular capabilities of the insuffulator on hand so as to plan their work accordingly. Although the need for building an improved platform is great and immediate, this Working Group agreed on the need for performing 'historical due diligence' of devicerelated standards that have failed to date. Investigating these standards and why they did not succeed is a task that should be undertaken. The successes of certain other standards, such as HL7, USB, and DICOM, also need to be included in the ongoing research on workable system integration and standards for the ORF.
3.4
RESEARCH PRIORITIES
At least four research areas were identified as priorities by this Working Group including: '• Developing 'common' user interfaces among medical (especially imaging) devices. The device industry needs to shoulder this research task. '* Devising a standard communications header for each device to identify itself, and, specifically, its task, ownership, and capabilities. '* Developing a broad, encompassing plug-and-play system among devices for communication and control in the OR. '* Undertaking historical research of device-related standards, and studying which have been developed, which did not work or were not used, and why they failed.
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CHAPTER FOUR AT A GLANCE: TELECOLLABORATION
Overview Telecollaboration as practiced in the operating room (OR) uses telecommunications technology to connect surgeons and other medical professionals to another OR and its personnel. Telecollaboration can enable remote consultation, evaluation, mentoring/proctoring, monitoring, and performance of surgical procedures. It is a very new area of service delivery and its limitations as discussed by this Working Group are indicative of a developing field that lacks a terminology, established expertise, and accepted delivery protocols. Clinical Needs Defining terminology for telecollaboration was one identified need. Disseminating knowledge of telecollaboration's applications is also important for those who are new to this field, so that they can better plan interactions and determine telecollaboration's potential usefulness for particular cases. A lack of standardized practice, available equipment, and limited training were the main limitations identified as currently preventing greater use of telecollaboration. Advantages of using telecollaboration that were identified included accessing remote experts to mentor at a distance and reduce the learning curve time for young surgeons who are unfamiliar with particular procedures. Technical Requirements Technical problems in telecollaboration relate to adapting the technology specifically to surgeons' needs in the OR, and included the following: 1. Need for decreased latency in video data compression. 2. Lack of a standardized telecommunications network for the OR. 3. Lack of standardized data, resulting in too many variables among data that are delivered to surgeons in the OR. Research Priorities Research priorities must focus on developing technical standards for telecollaboration to promote interoperability. Challenges for the development of the field include involving industry and political-arena representatives for improving a nation-wide communications network and addressing licensure and privacy issues so as to enable wider adoption of telecollaboration and its effective use. The full report of this Working Group appears on pages 30-38.
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CHAPTER 4: TELECOLLABORATION .. THE REPORT OF WORKING GROUP 3
PARTICIEPANTS Mehran Anvari, MD, McMaster University (Clinical Leader)
Eric J. Hanly, MD, Walter Reed Army Medical Center (Clinical Co-Leader) Noah Schenkman, MD, Walter Reed Army Medical Center (Clinical Co-Leader)
Robert Sc-abassi, MD, PhD, University of Pittsburgh (Technical Leader) Ho Young Chung, MD, PhD, Georgetown University Cato T. Laurencin, MD, PhD, University of Virginia Mingui Sun, PhD, University of Pittsburgh
4.1
INTRODUCTION: A HISTORICAL VIEW OF COLLABORATION IN THE SURGICAL THEATER AND POTENTIAL USES FOR TELECOLLABORATION TODAY
Telecollaboration in surgery is an innovative approach to sharing experience and expertise and is enabled by today's advanced communications technology. The operating room (OR) of the nineteenth century was surprisingly collaborative, however. Surgeons, nurses, consultants, and other members of the healthcare team, as well as medical students, nurses-in-training, and other learners were, in many cases, free to come and go to the OR as patient care and learning needs required. With a name that is now a misnomer in the countries that still use it today, the operating 'theater' was just that: a theater where people gathered around the process of surgery to contribute and learn. However, the advent of aseptic technique changed everything. The OR of the twentieth century can best be described as 'anti-collaborative.' To even get to an OR today, individuals must change clothes - donning scrubs, booties, bonnets, and masks; enter physically isolated 'suites' guarded by nurse managers whose principle objective (in the opinion of many would-be students at least) - is to block the entry of all but the most essential parties; timidly cross a brightly-colored line on the floor indicating the point of no return; and then finally enter further partitioned rooms. And all of this is just to get in the room! Should someone be so bold as to actually want to see the operative field, much less have physical contact with the patient, they must first cleanse themselves of integumental impurities and don yet another layer of sterile clothing. Thus the process of 'collaborating' with someone in the OR has become, not surprisingly, very intimidating, resulting in a drastically reduced dialogue between surgeons and consultants, surgeons and nurses, surgeons and students, and surgeons themselves.
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The OR of the twenty-first century can and must be different. Throughout the twentieth century, the introduction of local intercoms and telephones into hospitals began to reconnect the OR with the outside world. In the mid-1990s, the first telementoring in the OR using real time audio-video teleconferencing equipment furthered this connection, as did surgeons' use of telecommunication networks to remotely control a laparoscopic camera. On Sept 9, 2001, Jacques Marescaux ushered in the new millennium for OR telecollaboration when he controlled a Zeus telesurgical robot in Strasbourg, France from an office in New York City to perform the first transatlantic telerobotic laparoscopic cholecystectomy. The stage had thus been set for the advent of routine telecollaboration. There is a range of current uses of telecollaboration, which in the OR, can enable surgeons and other medical professionals and robots to communicate with each other regardless of location. Telecommunication between experts or between experts and less experienced professionals, students, or robots has multiple functions. It can be used for remote consultation, evaluation, mentoring/proctoring, monitoring, and manipulation, and for actually performing surgical procedures. Telecollaboration is particularly valuable in isolated areas where access to major centers and/or experts is difficult to achieve. It is particularly needed in rural settings as well as in remote areas such as on the battlefield, at sea, and in outer space. The field is still very new, however, and there are relatively few practitioners today. Nonetheless, technological advances in the past 25 years in video and computer communications have established the capabilities to enhance, compress, and transmit video signals and other information over long distances. More than ever, telecollaboration in today's OR is possible. This Working Group identified some key issues for improving the delivery of telecollaborated services for the OR. Among these was the absence of both clinical and technical standards, a problem that poses significant limitations to the development of this nascent field. Among the other major drawbacks are limited tools for educating students and practitioners about this field and its effective applications, and limited communications technology that has been specifically adapted to surgeons' needs in the OR.
4.2
CLINICAL NEEDS: DEFINING A FRONTIER FIELD
At the outset of discussion, this Working Group identified a need to define terminology for surgery-related telecollaboration. This need is particularly important for telesurgeons obtaining licensing privileges and specifying what activities will be performed during a tele-intervention (and for which they will subsequently submit payment requests). Terminology is also needed for health care planners who are assessing options and examining the potential usefulness of tele-interventions for particular cases.
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According to this Working Group, there is a great deal of misunderstanding about the meaning of'telecollaboration' in the OR. As a result, ill-defined and ambiguous terminology has surfaced. The following terms and definitions were discussed: Teleconsultation. Communication at a distance between two or more health professionals to 'discuss' the diagnosis, prognosis, and treatment of a particular patient's case. This includes, but is not limited to, the use of email, telephone, and audio-video teleconferencing to exchange information between an operating surgeon and one or more other providers. Tele-evaluation. The appraisal, typically including some type of physical examination, of a patient distant from the health care professional. The most common media type used for this process is audio-video teleconferencing. Telementoring/Teleproctoring. The teaching and supervision of a less experienced surgeon by a remotely located expert surgeon. Telementoring includes giving real-time advice about the various mechanical steps of a particular operation. Audio-video teleconferencing is fundamental to this activity. Oftentimes, telementoring is enhanced with the use of telestration devices. Telemonitoring. The observation of another surgeon's or surgeonin-training's performance during a surgical procedure. This practice can be thought of as 'telegrading' that is typically done in real time, but can be accomplished via store-and-forward technology. Telemonitoring usually includes some assessment of the operating surgeon by the expert, but without the real-time expression of that assessment. Telemanipulation. The remote operation of a device (e.g., camera, needle, instrument, etc.) for a specific purpose (e.g., visualization, biopsy, etc.). This activity necessitates that control signals be sent across telecommunications lines in order to move the device. Telemanipulation is a limited subset of telesurgery (defined next). Telesurgery/Telepresence surgery. The performance of surgery (including all tasks typically assigned to a surgeon) at a distance using remote control of surgical robots over telecommunications networks. Telesurgery is bimanual remote manipulation of the tissue being operated upon with complete real-time visual access to the operative field. When using telesurgery to operate in conjunction with a local surgeon, telesurgery allows the remotely
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located expert or consultant surgeon to 'take over' as necessary to demonstrate the 'next move,' or to actually perform the surgery. The sharing of expertise is key to all of these defined tele-activities. To date, surgical areas that have primarily been focused on telecollaborative efforts include neurosurgery, orthopedic surgery, and vascular surgery as well as telepathology. This terminology must be established to avoid confusion about the use of telecommunications-ready technology in the OR as well as to help people to better understand what the approaches are and how valuable they can be in teaching and mentoring. An overwhelming goal of telemedicine has been to replicate on-site activity from a distance. Much of what is measured in telemedicine and judged successful focuses on how closely (and without incident) these replicated activities have taken place. For this reason, four other terms that also affect the use of telecollaboration were defined by this Working Group. These are: Control Latency. The delay between when a remote surgeon moves a controller and when the surgical tool actually moves inside the patient. This time is a sum of the delays inherent to digitization of the controller movement, transmission of these digital signals to the patient's location, and electro-mechanical translation of these signals. Visual Discrepancy. The delay between when something moves in the operative field and when the surgeon visually appreciates such movement at the remote location. This time is a sum of the delays inherent to digitalization and compression of the video signal(s) by the CODEC(s), transmission of the signal(s) across telecommunication networks, and decompression of the signal(s) by the remote CODEC(s). Round-trip Delay. The sum of control latency and visual discrepancy - i.e., the time between when a remote surgeon moves a controller and when such translated movement is visually appreciated at the remote location. Jitter. Real-time variations in the amount of delay introduced by variable traffic in telecommunication networks.
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Limitations of the clinical uses of telecollaboration in the OR were identified by the Working Group, and included: * • • •
*
* * * * *
uncertain and nonstandardized reimbursement mechanisms and amounts for telemonitoring (at least in the U.S.) high set-up costs of equipment and systems uncertainties about licensure, credentialing, and other legal-related issues (which can vary from state to state) extensive set-up tasks and time required for readying both the robotic components of the surgery and the telecommunications infrastructure, thus increasing the amount of needed OR time time consuming tasks for coordinating participants in teleconsultations (e.g., between teams or between just two surgeons, matching their capabilities, pinpointing schedule availability times, and so forth) uncertainties about telemedicine's use and HIPAA (health insurance portability and accountability act) compliance and privacy issues varying amounts of skills among mentors and collaborators (making it difficult to estimate amounts of time needed for teleconsultations) language issues and time zone coordination issues, especially affecting international consults limited knowledge about telecollaboration among user or potential users - what is available, how easy it is to use, and identification of appropriate applications variations in quality of video resolution at different institutions (depending on network capabilities) and as are needed for different procedures. For instance, for a 352 by 240 VHS quality video, approximately 1 Mbps per second (a relatively large amount of bandwidth) is required to send compressed images for telesurgery and telementoring. Lesser bandwidth may be acceptable for other teleinteractions.
Many of these issues are clearly related to an emerging and evolving technical field. Particular advantages of using the technology were also identified (these, apart from telecollaboration providing access to specialty care and knowledge by remote providers). These advantages include: '* reduced need for on-site pathologists whose work can be done electronically on an as-needed basis (i.e., getting telepathology analyses immediately in the OR from surgical biopsies using a telerobot
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OR2020 THE OPERATING ROOM OF THE FUTURE WORKSHOP REPORT 18-20 March 2004 Turf Valley Conference Center Ellicott City, Maryland Workshop Conveners: Kevin Cleary, PhD, Deputy Director, ISIS Center, Georgetown University Seong K. Mun, PhD, Director, ISIS Center, Georgetown University Organizing Committee: Kevin Cleary, PhD, Georgetown University Medical Center, Program Director William DeVries, MD, Walter Reed Army Medical Center, Co-Director Elizabeth Bullitt, MD, University of North Carolina Ho Young Chung, MD, PhD, Georgetown University Medical Center Phil Corcoran, MD, Walter Reed Army Medical Center Eric J. Hanly, MD, Walter Reed Army Medical Center Ferenc Jolesz, MD, Brigham and Women's Hospital Cato T. Laurencin, MD, PhD, University of Virginia Heinz Lemke, PhD, Technical University of Berlin Micheal Marohn, MD, Johns Hopkins Medical Institutions Gerry Moses, PhD, U.S. Army Medical Research and Materiel Command Seong K. Mun, PhD, Georgetown University Medical Center Michael Pentecost, MD, Georgetown University Medical Center David Rattner, MD, Massachusetts General Hospital Rick Satava, MD, DARPA Noah Schenkman, MD, Walter Reed Army Medical Center Russell Taylor, PhD, Johns Hopkins University Report Authors: Kevin Cleary, PhD, Georgetown University Medical Center Audrey Kinsella, MA, MS, independent researcher/writer, Asheville, NC Workshop Supported By: National Science Foundation (BES-0341892) Telemedicine and Advanced Technology Research Center (W81XWH-04-1-0383) National Institutes of Health (NIBIB) (1 R13 EB03410-01) Corporate Sponsors: GE Medical Systems Karl Storz Endoscopy MedStar Health/Georgetown University Hospital
Olympus Surgical Division Siemens Corporate Research Stryker Endoscopy
OR2020: Operating Room of the Future Workshop. March 2004
Copyright © 2004 Imaging Science and Information Systems (ISIS) Center, Radiology Department, Georgetown University Medical Center. All rights reserved.
Front cover: Top left: 3D laser ablation therapy. Courtesy of Ferenc Jolesz, MD, Brigham and Women's Hospital. Full image appears on page 52. Middle right: CyberKnife® stereotactic radiosurgery system. Courtesy of Accuray, Inc. Full image appears on page 45. Bottom left: Simulation of surgical workflow in the modem operating room. Courtesy of Heinz Lemke, PhD, Technical University of Berlin. Full image appears on page 20.
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OR2020: Operating Room of the Future Workshop, March 2004
FOREWORD This report presents the results of a Workshop titled 'OR2020: The Operating Room of the Future,' held March 18-20, 2004, in Ellicott City, Maryland. The objective of the workshop was to identify the clinical and technical requirements for integrating advanced computer-assisted and robotic technologies into next generation operating rooms and interventional suites. This was done through a collaborative effort involving physicians, engineers, and scientists. First of all, I would like to thank the government agencies which provided the bulk of the workshop support: the National Science Foundation, the Army Medical and Materiel Research Command, and the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health. Without their support, the Workshop would not have been possible. I would also like to thank the corporate sponsors listed on page i and the back cover who enabled us to fund many of the special activities associated with the workshop, including the opening reception. Industrial participation is critical to the Operating Room of the Future, and it was gratifying to see so many industrial participants at the workshop. All of the organizing committee members deserve thanks, but I would especially like to thank the members of the Innovative Surgery Committee at Walter Reed Army Medical Center for their efforts. In particular, Phil Corcoran, William DeVries, Eric Hanly, Ernest Lockrow, Michael Marohn, and Noah Schenkman were instrumental in shaping the workshop and selecting the participants. At Georgetown University, both Seong K. Mun and Michael Pentecost were tireless advocates for the meeting and provided resources and support. At the Workshop itself, the student volunteers from Georgetown and Johns Hopkins were essential in keeping things running. Special thanks are due to Minh Vo, who was in charge of all of the logistics. My deepest gratitude is reserved for Audrey Kinsella, who drafted the final report and worked hard to ensure a quality product. Finally, I would like to thank all the participants, who enthusiastically participated in the workshop and contributed to the energetic discussion in the Working Groups. I hope that this report is an accurate reflection of their views and opinions - we had an extremely talented and outspoken group and it was not easy to synthesize all of this material. But if we can bring the concepts discussed here to fruition, it should lead to improved health care and the patient will be the ultimate beneficiary. Kevin Cleary, PhD Workshop Organizer Washington, DC December 2004 Email: [email protected] edu
OR2020: Operating Room of the Future Workshop. March 2004
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TABLE OF CONTENTS EXE C U TIVE SUM M ARY ............................................
1I
1 WO RK SH OP OVER V IE W ..........................................
2
1.1 Intro d u ctio n ................................................ 1.2 Common Themes and Recommendations ................ 1.3 1.4 1.5 1.6
. . 2 3
W ork ing G rou p s ............................................. . Workshop Rationale, Planning Process, and Execution ................. Pre-W orkshop Questionnaire ..................................... Report Overview ............................................ .
2 CHA PTER 2 A T A GLAN C E ........................................
5 6 8 13 14
Report of Working Group 1: OPERATIONAL EFFICIENCY AND WORKFLOW 2.1 2.2 2.3 2 .4
Overview: Common Procedures in Today's Operating Room .............. Clinical Needs: Issues in Access to Information and Standardized Practice .... Technical Requirements: Systems for Improving Workflow ............. R e searc h P rio rities ................................. .............
3 CH APTER 3 AT A GLAN CE ......................................
15 16 18 21 23
Report of Working Group 2: SYSTEMS INTEGRATION AND TECHNICAL STANDARDS
3.1 Overview: The Need for an Intraoperative and Integrated Systems Platform ... 24 3.2 Clinical Needs: Issues in Developing Integrated Operating Room System s and Technical Standards ................. 25 3.3 Technical Requirements: Standards and Tools for Improved Operating Room Process Integration ...................................... 27 3 .4 R esearch P riorities ........................................... . . 28 4 CH APTER 4 AT A G LANC E ........................................
29
Report of Working Group 3: TELECOLLABORATION 4.1 Introduction: A Historical View of Collaboration in the Surgical Theater and Potential Uses for Telecollaboration Today ......................... 4.2 Clinical Needs: Defining a Frontier Field ................ 4.3 Technical Requirements: Standardizing Services Specifically for the Operating Room ............................. ............ . 4.4 Research Priorities .........................
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30 31 36 37
OR2020: Operating Room of the Future Workshop, March 2004
39
5 CHAPTER 5 AT A GLAN CE ...................................... Report of Working Group 4: SURGICAL ROBOTICS 5.1 Overview: Robots and Their Needed Surgical Roles in Today's Operating Rooms ...................... 5.2 Clinical Needs: Design Issues for Targeting Best Uses for Surgical Robots ... 5.3 Technical Requirements: Needed Improvements and Safety Issues ....... .. 5.4 R esearch P riorities ..........................................
40 42 46 48 49
6 CH APTER 6 A T A GLAN CE ...................................... Report of Working Group 5: INTRAOPERATIVE IMAGING
50 6.1 Overview: Intraoperative Imaging Developments ....................... 6.2 Clinical Issues: The State of Intraoperative Imaging .................... 51 6.3 Technical Requirements: Needed Improvements in Imaging Quality 53 ...................... and Efficacy ...... .54 . .. . .......................................... 6 .4 R esearch P rio rities 56
7 CH APTER 7 AT A GLAN CE ...................................... Report of Working Group 6: SURGICAL INFORMATICS 7.1 Overview: Identifying the Work of a New Field ...................... 7.2 Clinical Issues: Achieving Optimal Performance by Using Surgical Inform atics in the Operating Room .......................... 7.3 Technical Needs: Foremost, Standards for Surgical Informatics ......... 7.4 Research P riorities .... ....... .............................. . . 8 APP E ND IC E S.................................................. 8.1 A ppendix A . W orkshop Program ................................. 8.2 Appendix B . W orkshop Participants ............................... 8.3 A ppendix C . B ibliography ......................................
0R2020: Operating Room of the Future Workshop, March 2004
57 58 60 62
. . 63 64 66 69
List of Figures Figure 1: W orkshop participants ........................................
3
Figure 2: Simulation of surgical workflow ................................
20
Figure 3: Operating Room of the Future at Massachusetts General Hospital ....... 26 Figure 4: Laproscopic telesurgery ................
35
Figure 5: CyberKnife® stereotactic radiosurgery system ..................... 45 Figure 6: 3D laser ablation therapy ........................................
52
Figure 7: 3D visualization for surgical planning ............................
61
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OR2020: Operating Room of the Future Workshop, March 2004
EXECUTIVE SUMMARY The modern operating room requires an increasing number of new surgical instruments, monitoring and imaging devices, information systems, and communication networks. While these individual technologies are improving, attention must also be paid to integrating all of these resources so as to improve the quality and efficiency of surgical procedures. The OR2020 Workshop was organized by the ISIS Center at Georgetown University to identify the clinical and technical requirements for integrating advanced computer-assisted and robotic technologies into the next generation operating rooms and interventional suites. The Workshop built on previous symposia, including the Operating Room of the Future (ORF) workshop sponsored by TATRC in 2002. Approximately 100 participants, including physicians, engineers, and scientists, met for two days in March 2004. The Workshop consisted of plenary sessions, a keynote speaker, and two breakout sessions which were divided by Working Groups. The six Working Groups represented key areas of research and development: 1. Operational Efficiency and Workflow 2. Systems Integration and Technical Standards 3. Telecollaboration 4. Surgical Robotics 5. Intraoperative Diagnosis and Imaging 6. Surgical Informatics From the Working Groups, five broad areas of technology requirements were identified: 1. Standards for devices and their use in the operating room (OR) are sorely needed. Every aspect of OR activity today is affected by their absence. This was a concern repeated often throughout the workshop. The OR team of the future must also be interdisciplinary, a theme noted by other related initiatives, including the NIH Roadmap and its Research Teams of the Future theme. 2. Interoperability of devices is essential for improved care and throughput. Currently, most devices and computer systems function as stand-alone islands of information. A 'plug and play' medical network is needed. 3. Surgical robotics continues to develop and will play a role in the Operating Room of the Future. Improvements in surgical robotics that build on their unique capabilities are needed. 4. Surgery-specific image acquisition, processing, and display are needed. The two-dimensional (2D) static images typically used today are not sufficient. Image processing and visualization tools must be made available to the operating room. 5. Communications issues must be addressed and aim toward attaining a common language, training requirements, and protocols. This goal also depends upon development of network standards to enable telecollaboration. The report consists of eight chapters, beginning with an overview in Chapter 1. The Working Group reports are given in Chapters 2-7. The appendices in Chapter 8 include the workshop program, the list of participants, and a bibliography.
OR 2020: Operating Room of the Future Workshop, March 2004
CHAPTER 1: WORKSHOP OVERVIEW
1.1
INTRODUCTION
The 'OR 2020 Workshop: Operating Room of the Future' was held on March 18-20, 2004, at Turf Valley Conference Center in Ellicott City near Baltimore, Maryland. The general objective of the workshop was to identify the clinical and technical requirements for deploying advanced computer-assisted and robotic technologies and biomedical modeling in next generation operating rooms and interventional suites. Integrated systems and the general character of the Operating Room of the Future (ORF) were defined, with the year 2020 used as a target timeframe. The workshop consisted of a series of plenary sessions and breakout meetings of the six Working Groups. Approximately 75 invited experts, both PhDs and MDs, participated. (See Figure 1 on the next page for a group photograph.) The OR 2020 workshop was organized by the Imaging Science and Information Systems (ISIS) Center, Department of Radiology, of the Georgetown University Medical Center, Washington, DC; the Innovative Surgery Committee at the Walter Reed Army Medical Center, Washington, DC, and the Telemedicine and Advanced Technology Research Center (TATRC) at Fort Detrick, Maryland. The workshop was supported by the U.S. Army Medical Research and Materiel Command, the National Science Foundation, and the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health. Corporate sponsors were GE Medical Systems, Karl Storz Endoscopy, MedStar Health/ Georgetown University Hospital, Olympus Surgical Division, Siemens Corporate Research, and Stryker Endoscopy. This chapter begins by summarizing the common themes and recommendations from the workshop. Next, the focuses of the six Working Groups are presented in brief, followed by a snapshot of the workshop's rationale, planning process, and execution. Summaries of participants' views on needs and expected changes in the ORF are then presented, based on responses to a pre-workshop questionnaire that was sent to all participants. This report can also be found on the World Wide Web, by starting at http ,:wxx xvvcamirgcorgetown edu and following the links to the workshops and the 0R2020 workshop. At the time this report was printed, we were also maintaining the conference web site at h~t~v xxxxxxor2020.orsg, and additional workshop materials such as some of the presentations can be found there. .
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Chapter 1: Workshop Overview
Figure 1: Photograph of participants
1.2
COMMON THEMES AND RECOMMENDATIONS
There were a number of common themes that were identified during the workshop and they are noted below. More details on the themes and specific recommendations related to them are presented in the Working Groups' reports (Chapters 2-7). The five common themes that were identified are as follows: 1. Standards for devices and their use in the operating room (OR) are sorely needed. Every aspect of OR activity today is affected by their absence, from nonstandardized and incomplete patient records, to varied and unstandardized imaging formats of visual information that is needed during surgeries, to varied and sometimes imprecise language used in communicating among surgical team members. 2. Interoperability of devices is needed for development of a smoothly operating OR as well as for improved surgeries. Currently, most devices and computer systems function as stand-alone islands of information and their use requires a great deal of surgeons' time and effort. 3. Surgical robotics continues to develop and its role in the Operating Room of the Future is still being defined. Improvements in surgical robotics are needed to build on their unique capabilities such as precision, accuracy, ability to withstand ionizing radiation, and dexterity in small spaces inside of the human body.
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4. Improved, surgery-specific image processing and display are needed for effective use in the OR. The two-dimensional (2D) static images that are typically available in today's OR do not accommodate the 3D and real-time imaging needs of surgeons in most specialty disciplines. 5. Communications issues must be addressed and aim toward attaining a common language, training requirements, and protocols for effectively performing advanced surgeries and using telecommunications-ready tools as needed. The following recommendations were made, based on these five themes: 1. Standards, standards, standards. If there was an overarching theme of the workshop, this was it. Standards are needed in all areas, and must be developed through a concerted effort involving companies, government agencies, academic institutions, and perhaps standards organizations. Research studies of surgical workflow and efficiencies are required to develop practice standardization and thus realize improvements. 2. Progress on the first recommendation will also enable progress on device interoperability. It is recommended that research be devoted to developing common user interfaces among medical devices, and that the device industry take the lead in performing this research with input for academic institutions and government agencies. A 'plug and play' architecture for medical devices is also needed. 3. Research in surgical robotics should focus both on improving the capabilities of these systems and integrating them with the surgical workflow. These systems could ultimately help improve patient safety by incorporating built-in safety checks and integrating them both with imaging and the electronic patient record. 4. Attaining advanced and improved surgery-specific image processing and display systems requires engineers and designers to work with surgeons to identify the needs and risks in using these systems. Readily available and flexible, real-time 3D imaging systems that use one standard platform for all imaging modalities are needed in current and future ORs. It is recommended that manufacturers and the device industry as a whole be encouraged to build imaging products that enable surgery-specific work. 5. A well-developed, dedicated medical network is needed to enable routine telecollaboration. An industry-grounded meeting to be attended by government stakeholders (including lawmakers), industry developers, telecommunications industry personnel, and surgical personnel should be arranged to address the needs of telecollaboration in medicine and surgery.
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Chapter 1: Workshop Overn iew
1.3
WORKING GROUPS
The OR2020 workshop consisted of plenary sessions and Working Group meetings during an intensive two-day period. The Working Groups each were charged with investigating a specific clinical and technical area related to the ORF. The six Working Groups were as follows. Group 1: Operational Efficiency and Workflow; Group 2: Systems Integration and Technical Standards; Group 3: Telecollaboration; Group 4: Surgical Robotics; Group 5: Intraoperative Diagnosis and Imaging; Group 6: Surgical Informatics. A brief summary of each group's work is as follows: Working Group 1: Operational Efficiency and Workflow. This group focused on examining requirements for achieving increased efficiencies in the OR. These requirements focused on needed mechanisms for accessing and obtaining correct and current patient-related information and scheduling, and accessing use of correct surgical tools. The group also discussed developing surgical practice standards that define day-today, step-by-step surgical workflows. Working Group 2: Systems Integration and Technical Standards. This group focused on the need for interoperability among a broad range of devices that are used in the OR. To achieve seamless integration among devices, a standard interface for interoperability among these technologies could be developed using a plug and play platform. This group also discussed the need for device standards that will enable configurability and easy use of these tools in the OR. Working Group 3: Telecollaboration. This group focused on current and future uses of telecollaboration for purposes of remote consultation, mentoring, monitoring, robot manipulation, and other functions. An absence of standards in every facet of this form of telecommunications-assisted delivery was noted by this group. Standards are needed in areas related to clinical uses of telecollaboration (such as training). Other needed standards are related to technical requirements of telecollaboration (e.g., for a low latency data compression algorithm that will enable low bandwidth synchronized transmission of data to the OR). Finally, this group identified significant regulatory and legal hurdles that are slowing adoption of telecollaboration in the OR. Working Group 4: Surgical Robotics. This group discussed the many clinical benefits of using robotic systems, particularly those that complement and extend human capabilities in the OR. Meeting technical needs for improving surgical robotics use requires building on robots' unique capabilities, such as their advanced precision, accuracy, strength, and dexterity. This group also discussed the importance of risk and safety issues pertaining to the use of robots in the OR. Working Group 5: Intraoperative Imaiging. This group focused on a central issue in intraoperative imaging today: namely, the difficulty for surgeons to obtain information from imaging devices in the OR. The need to present images in interactive and 3D
OR 2020: Operating Room of the Future Workshop, March 2004
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Chapter 1: Workshop Overview
imaging modalities, and for developing the capabilities to integrate and manipulate these data, were discussed. Working Group 6: Sur2ical Informatics. This group focused on defining the nascent discipline of surgical informatics and identifying certain limitations that are impeding its development. The group noted a particular need for informatics systems that integrate preoperative, operative, and postoperative information and make it available where and when needed. In addition, a set of unified standards for procedures and use of surgical informatics must be defined and implemented, this Working Group concluded. 1.4
WORKSHOP RATIONALE. PLANNING PROCESS. AND EXECUTION
1.4.1 Rationale A number of meetings that focused on needs in the ORF have been held in recent years. The OR2020 Workshop was committed to addressing issues that have consistently arisen at these meetings and elsewhere in discussion about the ORF. These issues include the need for widely adopted standards, concerns about ensuring patient safety, and the uncoordinated use of technology in the OR. Identifying mechanisms to address these issues and posing recommended solutions was the rationale for holding this workshop and inviting both clinical and technical experts to participate and share their views. 1.4.2 Planning Process Planning for the OR2020 Workshop began in the Fall of 2002, when the ISIS Center at Georgetown University Medical Center began to formulate a broader direction for studying the ORF and its needs and purposes. It was felt that organizing a workshop was a good way to obtain a better understanding of this field of growing interest and concern. Collaboration with the Walter Reed Innovative Surgery Committee and TATRC was initiated. Funding was solicited from various agencies, and preparations were begun in earnest in the Summer of 2003. The organizing committee met several times during the Fall of 2003 to create the final program and identify participants. Invitations were sent in late 2003, followed by a pre-Workshop questionnaire. The Workshop was held March 18-20, 2004. 1.4.3 Execution The Workshop consisted of plenary sessions and Working Group meetings. The plenary sessions were aimed at providing background for both clinical and technical areas. The Working Groups focused on specific areas of concern in the ORF, such as intraoperability of devices, telecollaboration needs, and surgical robotics. Each Working Group had a technical leader (PhD) and a clinical leader (MD). The Working Group
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Chapter 1: Workshop Overview
leaders and participants are listed on the first page of each of the individual Working Group reports (Chapters 2-7). The Workshop program is presented as Appendix A on page 64. The OR2020 workshop began with a reception on the evening of Thursday, March 18, followed by an organizing committee and Working Group leaders' meeting. The opening session was held the next morning and included clinical and technical overviews on the evolution of surgery, a view of a testbed ORF at the Massachusetts General Hospital, and a panel discussion of surgical specialties and practitioners' needs in the ORF. These clinical plenary sessions were followed by technical presentations on topics such as device independence in the OR, the state-of-the-art in robotics, image-guided therapy, and surgery-specific workflow. Additional plenary sessions followed after a break, and included topics such as interventional oncology and the future of imaging. Meetings of the six Working Groups were interspersed throughout the workshop days, with time also allocated for summary presentations following most of the Working Group meetings. There were two extended breakout sessions for Working Group meetings. Each Working Group was assigned a specific task, as follows: Breakout Session 1: Current status and clinical requirements Task 1: Review contemporary issues in each Working Group's area in today's OR. Task 2: Define the clinical needs for contemporary and future ORs. Breakout Session 2: Technical requirements and research priority formulation Task 1: Based on clinical needs, define the technical requirements. Task 2: Summary. Prepare a list of research priorities and recommendations. Working Group status reports were presented twice during the Workshop, in 10-minute sessions to the entire conference audience following the first and second Breakout Sessions. To move forward quickly during the Workshop, a great deal of preparation was done prior to the Workshop. In particular, a pre-Workshop questionnaire was sent to all of the participants which asked them to identify research issues and suggest relevant references. The questionnaire served to get all of the participants thinking about the field and provided excellent background for the Workshop process. General questions included: 1. What are the main technical problems and research needs for the ORF? 2. What are the major infrastructure and administrative issues that must be addressed to develop the integrated ORE? As part of the questionnaire, participants were asked to recommend three papers that were relevant to the field and a bibliography was generated which is presented in Appendix C. Most of the participants responded and the responses were used to help generate a 31-page pre-Workshop report. This report provided general background for
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each Working Group, summarized the questionnaire responses, and included a bibliography. All of this effort served to acclimatize the participants beforehand so that informed discussion could move ahead quickly at the Workshop. The questionnaire itself and all of the responses are available on the Workshop's web site, as noted at the end of section 1.1.
1.5
NRE-WORKSHOP OUESTIONNAIRE
As noted, a pre-Workshop questionnaire was sent to all attendees, and in addition to several general questions, the questionnaire contained three specific questions for each Working Group: 1. What are the major technical problems relevant to your Working Group? 2. What other factors are relevant for your Working Group? 3. What procedures could benefit most from advances in this area? The responses to the specific questions from the Working Groups are briefly summarized here. Participants were encouraged to look at all the responses, and these were made available prior to the workshop. 1.5.1 Working Group 1. Operational Efficiency and Workflow Summary of responses 1.5.1.1 Major Technical Problems. From the questionnaire responses, participants agreed that information flow is a critical concept. One participant suggested that there is a lack of information technology for the OR; and another participant described this as a lack of situational awareness. Another participant suggested that automation (such as use of radio frequency identification devices, or RFID) could reduce time and errors while improving efficiency. Finally, it was suggested that there is a lack of real-time information regarding upstream and downstream processes, which makes the system slow to respond to variances that occur in the OR (and there can be a lot of variances). 1.5.1.2 Other Factors. Several other factors were identified as important for operational efficiency and workflow. The need for more training of staff was emphasized. The culture of the OR and its slow acceptance of new technology were listed as barriers. The myriad of paper records is a problem. Management of unplanned events (which is a regular occurrence) is difficult. In addition, one respondent noted that small increments of saved time that do not result in improved throughput (more cases or reduced overtime) are of limited utility. 1.5.1.3 Procedures. In attempting to identify procedures that could benefit most from improvements in operational efficiency and workflow, most respondents noted that all procedures could benefit. One respondent noted that these improvements were particularly suited to surgeons who do 60-to-80-minute procedures that have limited
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Chapter 1: Workshop Overview
variability. Another respondent noted that an additional benefit could be improved patient safety. 1.5.2 Working Group 2. Systems Integration and Technical Standards Summary of responses 1.5.2.1 Major Technical Problems. The major technical problem related to systems integration and technical standards is the lack of an accepted standard for device integration. The development of such a standard is no doubt a large undertaking, and one respondent suggested that what is needed is a clear understanding of surgical workflow and modeling tools. Another respondent noted that it is difficult to provide open systems while ensuring safety, security, and patient confidentiality. One more respondent stated that integrated control and communication systems require that manufacturers must be motivated by economic drivers, and must feel secure from experiencing legal and FDA repercussions. Finally, one respondent stated that there are no major technical problems and that the manufacturing sector has automated factory workflow for years with proprietary and nonproprietary systems. 1.5.2.2 Other Factors. There were a number of other factors listed by the questionnaire respondents. The proprietary interests of manufacturers were listed several times. One respondent stated that the manufacturers fear providing opportunities for competition. Another respondent noted that no large institution is pushing for standardization and that the regulatory environment discourages integration since the FDA clears devices only for specific 'indications for use.' Finally, one respondent stated that there is a lack of understanding (either too simplistic or overly complicated) of how systems integrate and of the issues that impinge on integration. 1.5.2.3 Procedures. In regard to defining procedures that can benefit most from advances in systems integration and technical standards, one respondent suggested that all OR procedures would benefit. Other respondents noted that minimally invasive procedures and image-guided procedures could benefit. 1.5.3 Working Group 3. Telecollaboration Summary of responses 1.5.3.1 Major Technical Problems. While there were many responses to this question, most of the responses did not actually list technical problems. Instead, respondents identified related issues such as the cost of equipment and infrastructure and the lack of adequate support staff. It was noted that there was a lack of clinical trials that demonstrate the value of telecollaboration. 1.5.3.2 Other Factors. Several other factors were mentioned as limiting the use of telecollaboration. The major other factor listed was medical liability, including licensure and credentialing. In addition, there is no practical system for financial compensation of
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telementoring or for accommodation of time-zone differences. The lack of acceptance by third-party payers and state licensing agencies was also listed, as was the difficulty of scheduling collaborating physicians. 1.5.3.3 Procedures. A number of different procedures were listed that could benefit most from advances in telecollaboration. One respondent felt that every surgeon performing basic procedures in community practice could benefit from the mentoring delivered by an expert observer. Similarly, for advanced procedures, expert physicians would like the support of national and international experts. Another respondent suggested that among the best applications of telecollaboration would be demonstrating/observing the first few of any procedures that were unfamiliar to a physician. Still another respondent listed image-guided therapies and laparoscopic and robotic-aided surgeries as particularly appropriate for telecollaboration. Also mentioned were time-sensitive procedures such as emergency trauma interventions and cardiac surgeries. One respondent listed as appropriate those procedures that are seldom performed by most practitioners - that is, those that are rare or those that are just becoming established routines. The same respondent also listed interventional procedures that require collaboration across disciplines such as cardio or vascular procedures. 1.5.4 Working Group 4. Surgical Robotics Summary of responses 1.5.4.1 Major Technical Problems. Many technical problems were listed by the respondents. It was noted that current surgical robots are too big and too expensive. The lack of haptics was noted by one respondent. Another comment was that there are not too many operations that actually benefit from robotics and it can actually be a productivity disabler. One respondent suggested that the equipment's fault tolerance needs to be improved. Another stated that robots are difficult to use and generally require more set-up time, especially when registration and/or fixation is required. Finally, one person suggested that robotics are not being adapted to the surgeon's working requirements and the patient's bodily needs. In terms of technical problems related to surgical instrumentation, one respondent noted that voice recognition is still not where it needs to be for real-world use. Another respondent listed the problems with minimally invasive surgery, including placement and navigation of the instruments. Respondents also listed the needs for both multimodality on-line instrument control and for an integrated view of all relevant navigation and physiological data. 1.5.4.2 Other Factors. Cost was the other major factor mentioned by respondents as limiting the use of robotics. Other issues included training, the large size of the instrument, and the lack of a demonstrated benefit for mainstream use of surgical robots.
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Chapter 1: Workshop Overview
1.5.4.3 Procedures. Several different procedures were mentioned that could benefit from advances in robotics. One respondent stated that any minimally invasive procedure that is currently expensive to do (in terms of equipment or OR time) and is very demanding could benefit. Another respondent felt that it would be most beneficial for procedures, such as neurosurgery and heart surgery, that have a 'scaling barrier'. Lengthy procedures or procedures that demand prolonged or exact motor control were also mentioned as possibly benefiting from advances in robotics as was any procedure requiring complex reconstruction. Bone-oriented procedures were also mentioned. 1.5.5 Working Group 5. Intraoperative Diagnosis and Imaging Summary of responses 1.5.5.1 Major Technical Problems. A number of different technical problems were listed by the respondents. It was noted that high quality imaging devices such as CT and MRI are generally too large for the OR's physical environment. Radiation exposure is an issue for x-ray imaging, which is otherwise one of the more practical OR imaging modalities. Other respondents noted that devices designed for the OR have poor image quality, the information is still presented mostly 2D (no real-time 3D is available), and the information is anatomical only (i.e., it is non-functional). Another respondent noted the lack of integration of molecular imaging methods into intraoperative diagnosis. There is a need for better molecular tracers, both in marker intensity and specificity. One respondent listed the issues as biochemical sensitivity, spatial resolution, knowing what tracers are appropriate for a particular clinical task, equipment size, and other special environmental needs. More than one respondent stated that modeling is an issue. There is a lack of adequate models for virtual representations of internal organs. There is a need for real-time computation for deformable registration and reconstruction and updating of image models. Finally, it was noted that there is a need for more reliable and less expensive tracking devices. There is a lack of adequate software tools to conduct reliable intraoperative analysis, and an absence of consolidation of all of the intraoperative information into a comprehensive format. 1.5.5.2 Other Factors. There were several other factors mentioned as limiting the use of intraoperative diagnosis and imaging. These factors relate to how to best integrate the equipment into the OR and the surgical workflow. Other key factors concern questions of cost, reimbursement, and equipment ownership. One respondent noted that the equipment was disruptive to the flow of surgery. It is cumbersome, inconvenient, and requires collaboration with other departments to insure the availability of a technologist
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in the OR without whom the surgeon cannot operate. Another respondent listed other factors including sterile field violation, applications not designed for surgical OR interactions, and applications placed in geographically undesirable locations in the OR. 1.5.5.3 Procedures. A wide array of procedures were mentioned that could benefit from advances in intraoperative diagnosis and imaging. One respondent stated that most procedures were amenable to these advances but, in particular, the resection and therapy of malignant tumors would benefit most because use of this technology would allow the surgeon to remove all malignant tissue and reduce the damage to the neighboring anatomy. Another respondent similarly commented that all operations involving potential for vascular compromise of tissues were candidates, such as resection of brain tumors and metastases, resection of breast cancer, and auxiliary node sampling. Other procedures that would benefit from advances included: prostate brachytherapy and surgery; cardiac interventions, neurosurgery, liver surgery, lung surgery, cancer surgeries, and orthopedics. The biggest growth is believed to be in soft-tissue MIS procedures. In the specific case of x-ray CT, probably some of the more immediate applications to benefit from advances are spinal, skull-base, and sinus procedures. 1.5.6 Working Group 6. Surgical Informatics Summary of responses 1.5.6.1 Major Technical Problems. From the questionnaire responses, the major technical problem seems to be that surgical informatics is still evolving as a discipline. High quality surgical informatics systems do not seem to be available yet and there is no ontology or standard for their development. It is difficult to integrate the different types of information needed in surgical decision making into a coherent presentation and there is a need for decision support methods to integrate this information. There are no reliable content-based search techniques available and high performance computing has not been advantageously used. In the area of surgical atlases, major technical problems include building quality anatomical atlases for organs other than the brain (where some preliminary solutions exist) and building patient-specific biomedical and simulation models. One respondent also noted that the bioinformatics field has provided many useful tools for this type of work, but it should be expanded to fully include images, techniques, and situational searches. By 'situational searches,' the respondent is referring to something like an intelligent agent that could examine the ongoing surgical operation and provide suggestions. 1.5.6.2 Other Factors. Several others factors were mentioned by the respondents as limiting the use of surgical informatics. In particular, it was noted that there was a lack of validation studies to convince the leaders in surgery of the value of surgical informatics. It was also noted that adopting use of surgical informatics in the OR will require a total
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change of the intra-operative procedure, a different workflow, and most of all, additional cost in time of the surgery. Other factors limiting the use of surgical informatics that were listed by respondents included the need for a research OR that is charged with investigating the problems to be solved and the need to find surgeons who are willing to be involved in the development of these systems. The problems of cost and nursing turnover were also mentioned, along with the lack of inter-institution data accessibility and related regulations. 1.5.6.3 Procedures. Several different types of procedures were mentioned that could benefit from advances in surgical informatics. In particular, procedures with difficult or unusual complications, complex procedures that could benefit from extensive preplanning, and any procedure with a long patient history were mentioned. One respondent listed the categories of intraoperative pathology, telementoring, telesurgery, and virtual reality applications including training and mission rehearsal. Additional procedures suggested were orthopedics applications in which mechanical models were important, and neurosurgical procedures for which atlases would be beneficial. Another respondent listed tumor resection in critical organs and lymph node biopsies and resections. Finally, other suggestions included 1) bone procedures; 2) trauma care; and 3) vascular interventions, neural interventions, and tumor ablations.
1.6
REPORT OVERVIEW
The next six chapters (chapters 2-7) comprise the Working Group reports. Each report includes a capsule summary 'At a Glance' page, an overview, and reports on clinical needs, technical requirements, and research priorities. Appendices include the Workshop program, a list of participants, and a bibliography suggested by the participants.
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CHAPTER TWO AT A GLANCE: OPERATIONAL EFFICIENCY AND WORKFLOW
Overview Improvements in operational efficiency and workflow in today's operating room (OR) will significantly impact progress in the Operating Room of the Future (ORF). There is a particular need to adapt today's advanced technologies to meet specific surgical needs. Among these tasks is adapting technologies such as smart tracking for patient records, and radiofrequency identification devices (RFIDs) for locating information about patients and equipment. Doing so successfully is necessary to attain improved efficiency and workflow today and in the ORF. Clinical Needs Achieving '* '* '*
efficiencies in today's OR requires identifying mechanisms for: accessing and obtaining correct and current patient-related information. scheduling and accessing use of correct and operable surgical tools. developing consistent OR practices and prescribed workflow routines per procedure/per specialty.
Technical Requirements Research to address these clinical needs should focus on developing: 1. Smart cards or nodes that store patients' complete medical records. 2. Tracking mechanisms to address OR-wide fragmentation of information about surgical tools (their location, operability, and scheduled use). 3. A system for creating focused and well-trained work teams to ensure that consistently efficient surgeries are completed. 4. Technical standards for the OR that define day-to-day, step-by-step surgical workflows (per procedures and per variable cases). Research Priorities This Working Group identified these priorities as the development of: '• Means for accessing comprehensive and current medical records. '* Standardized tracking and locating of surgical instruments. '* Surgical practice standards in the OR that reach across all specialties. The full report of this Working Group appears on pages 15-22.
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CHAPTER 2: OPERATIONAL EFFICIENCY AND WORKFLOW .. THE REPORT OF WORKING GROUP 1 PARTICIPANTS Ernest Lockrow, DO, Uniformed Services University of the Health Sciences, Walter Reed Army Medical Center (Clinical Leader) Heinz Lemke, PhD, Technical University of Berlin (Technical Leader) Gary Dorfman, MD, National Cancer Institute Marie Egan, MS, RN, Massachusetts General Hospital Tim Ganous, MPA, University of Maryland Cristian Mihaescu, MS, University of Craiova Warren Sandberg, MD, Massachusetts General Hospital Robert Tham, PhD, University of Wisconsin-Madison Tom Winter, RN, Walter Reed Army Medical Center
2.1
OVERVIEW: COMMON PROCEDURES IN TODAY'S OPERATING ROOM
Standardized and improved workflow processes are central to ensuring the efficient operation of all hospital operating rooms (ORs) today. These processes are of particular importance in response to the continuing workforce shortages that are being experienced throughout the healthcare industry. Optimization of efficiencies in typical workflow processes is of special concern for health care providers, managers, and administrators, given the extent of OR-related costs in this, the most cost intensive sector of today's hospital. And there is a longer view that needs attention: Improvements in operational efficiency and workflow of today's OR will impact progress that will be achieved in the Operating Room of the Future (ORF). Key issues in improving operational efficiencies and workflow in the OR concern implementing better management of a multitude of preparatory information and tasks that are needed before and during actual surgeries. Ready access to patient-related information is a central problem today in OR facilities in every type of hospital (military, academic, and community). Without this access, the workflow is disrupted and surgeons are less productive. Therefore, the need to improve management of information pertaining to patients (their records and histories, their needs, their scheduling, and so on) is key to ensuring efficient OR workflow and patients' safety. Standardized information technology for scheduling inpatients' and outpatients' appointments, tests, and other procedures as well as for scheduling surgeries is critical for achieving improved efficiencies in the OR overall.
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This Working Group identified key resources and technologies that could be adapted to improve efficiencies and workflow in the OR. They are 'key' in that they address the specific requirements of surgeons and their needs for improved workflow in the OR. Adaptations of, for instance, bar coding systems, radio frequency identification devices (RFIDs), and other tracking technologies were identified specifically as key for addressing chronic delays related to missing information about patients and surgical tools. And finally, a focus on modeling standardized surgical workflow practices for the OR was identified as an essential base from which to develop operational efficiency and workflow practices for the ORF. 2.2
CLINICAL NEEDS: ISSUES IN ACCESS TO INFORMATION AND STANDARDIZED
Probably the most pervasive problem in today's OR has less to do with surgical technical advances than with the need for mechanisms to access and obtain correct paperwork for patient-related information. Surgeons must divert much of their time and attention beyond the matter of performing surgery adeptly. They must instead deal with a myriad of manually generated paperwork per patient which is sometimes neither all complete nor up-to-date. The potential for inefficiencies and introducing patient safety issues is increased as a result. This Working Group discussed the very pressing need for a standardized access system from which surgeons and other OR personnel could obtain patient information and histories, patient room scheduling details, and information about location of equipment and the personnel who are trained to use it. Most particularly, there is a need for immediate access to patient information in the OR. Clinical Areas for Needed Improvements This Working Group identified and discussed three clinical areas needing improvement: 1. Poor access to patient and surgical information.
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'
Absence of a standard, computerized medical record for patients that documents their histories and their needs. These records must be current and complete. All future improvements on which these records are based (e.g., smart scheduling) depend on using a comprehensive electronic record as a template.
'
Disparate patient and medical information and imaging systems that do not 'talk' to each other, thus making accessibility issues difficult. An example of a standalone anesthesia record keeping system that is separate from the larger hospital
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information system (HIS) was provided as typical of such disparate islands of information that exist within hospitals. '
Multiple and disparate systems for tracking related work processes. For example, there are multiple scheduling systems used for tracking surgical in- and outpatients and another system for reserving surgical instruments and ORs.
'
For surgery, in particular, an absence of a surgery-oriented standard for obtaining and viewing multidimensional data about patients during surgery. Improved paper-based records are not the only issue: there is also a critical need for realtime information regarding upstream and downstream processes in the OR. Without this information, the system is slow to respond to variances (and there can be very many variances, this Working Group was quick to note).
All of these access issues affect today's clinical practice and are detrimental to making optimal use of surgeons' time and expertise. 2. Lack of consistent OR working practices or prescribed workflow routines. '* An absence of standardized devices/systems in the OR. Multiple computer operating systems (e.g., Windows-based and DOS systems) are routinely used in the same OR but information cannot be shared between them. '* Inflexible devices/systems that are currently in place. '* Slow processes of switching between applications (and so, switching is avoided). '* Inadequate presentation of data (text, 1D, 2D, 3D, 4D) during the intraoperative and perioperative phases of surgery. '* Unavailability of a user-configurable information environment. In addition, especially during surgery, there is a need for accessing consistent visual images, preferably with a touchscreen, regardless of the display system that is used. All told, today's surgeons who are using new technologies and imaging options appear to be adapting their immediate needs to what has been made available to them by manufacturers. They are devising 'work arounds' rather than using advanced technology to improve on their surgical work. 3. OR staff teamwork issues and communication deficiencies. Fragmented communications and varying levels of competency among OR team members are significant issues affecting efficiencies and improved workflow. These problems impact all aspects of surgery, including ensuring that:
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'* patients are appropriately prepared for surgery. '* patients' complete and up-to-date records are readily on hand. '* the correct tools are available and in the OR. '* a postoperative recovery area has been reserved. '* appropriate staff have been scheduled. Informed teamwork is key to improving operational efficiency and workflow. The islands of communications that are typical of today's OR process simply do not work, 2.3
TECHNICAL REOUIREMENTS: SYSTEMS FOR IMPROVING WORKFLOW
Today, fragmentation of patient information and other needed records impedes optimal operation of the OR. One of the most 'wished for' technical advances expressed by this Working Group was a 'patient-centric' medical record that would be available to all healthcare providers and so better direct each patient's care. Four of the most critical technical needs for improving OR efficiencies and workflow are as follows: 1) creating accessible medical records; 2) developing readable equipment locator/tracking mechanisms; 3) resolving OR teamwork/personnel issues; and 4) developing and following technical standards in the OR. The Working Group addressed these four issues separately as detailed below: 1) Creating accessible medical records This group suggested that a standardized system for identifying each patient is critical for improving OR efficiencies. These suggestions included: 1. Creation of a smart card or smart node to be placed on every patient. This mechanism would store a patient's medical record and could be accessed easily by providers. 2. Means for assigning a unique identifier to all patients for improving access to their records. Coupled with this suggestion was the requirement for a robust electronic architecture for obtaining this information. The Internet was the suggested means for access, rather than using/depending on a certain computer or operating system that an individual is used to. Security and privacy concerns then became important.
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2) Developing readable equipment locator/tracking mechanisms Information flow is critical to the optimal and efficient use of the OR. However, this flow pertains to information transfer beyond the detail that is included in patient records. Fragmentation of information about patients, tools (location and scheduling of their use), and other critical components of the surgical process is pervasive in today's OR and must be addressed. An integrated system for locating information and equipment is a key issue for improving OR efficiencies. This Working Group's suggested technical improvements for locating and tracking OR equipment included creation of OR-wide systems. Details about these systems are as follows. 1. Bar coding systems for identifying and tracking instruments and other equipment. These systems can help surgeons and other OR personnel locate equipment prior to the surgical procedure. This tracking can also help prevent the significant costs of unintentionally discarded or lost equipment post-surgery. 2. Standardized, automated tagging systems of all instruments and patients such as radiofrequency ID (RFID) of patients and equipment. Safety issues play a significant role here as well. There is a need for standardized scanning of patients after surgery and having each instrument tagged with an RFID mechanism to ensure that instruments have not been left inside patients. 3. Scheduling/tracking systems for specific equipment to have surgeons' preferred instruments in place. 3) Resolving OR teamwork/personnel issues Varying levels of competency among OR team members affect efficiency and workflow in the OR. Designing teams that work well together and are well trained from among inhouse staff is ideal, but many inconsistencies in scheduling and other issues have been shown to be a problem, this Working Group noted. In addition, cross-training usual OR staff is an inefficient use of resources. One participant of this Working Group (who drew on his hospital's own experience) suggested hiring and dedicating a staff of procedure-specific technicians. This process worked particularly well for certain procedures, like laparoscopic surgeries, for which enormous amounts of set-up time and expertise are required on the part of surgical technicians. In this instance, the hospital also contracted with a commercial firm for acquiring all procedure-related instruments, and that firm took responsibility for ordering and maintaining instruments. Doing so ensured that the correct and operable tools and
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personnel were in place. Increases in efficiencies were realized by working with an informed, regularly scheduled team. 4) Developing and following technical standards in the OR Standards for creating and integrating information about patients, equipment, and procedures are vitally needed at the outset in planning for an efficient ORF. To determine these standards, research is needed to define day-to-day, step-by-step surgical workflow practices and create surgery workflow models per procedures or per variable cases.
Figure 2: Simulation of surgical workflow (courtesy of Heinz Lemke, PhD, Technical University of Berlin)
An example that might be used to better understand (and eventually improve on) OR
workflows and efficiencies is the recent work by the Improving the Healthcare Enterprise (11E) initiative and its definitions of workflows and efficiencies in healthcare outside of the surgical room. This body of experts develops recommendations for the healthcare
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industry on how to implement standards. (Note: IHE's members do not develop the standards themselves.) Furthermore, the IHE initiative has developed 'integration profiles' that enable consistent access to images and reports for certain medical specialties (such as radiology). Surgical profiles have not been developed yet, but they are needed, as this Working Group noted, as is a 'surgical DICOM.' Today's DICOM standard is not suitable for many imaging types that are needed in the OR (e.g., it does not cover realtime, 2D, and 3D issues, nor does it address interactivity). 2.4
RESEARCH PRIORITIES
The following research needs were identified as priorities by this Working Group. '* Medical record access improvements. A comprehensive, accessible, and standardized patient medical record must be developed. Ideally, the language and computer system that are used for these records should be universally accessible and should not be machine- or software program-dependent. '
Equipment tracking improvements. There is a need for equipment tracking mechanisms to address the critical issue of fragmentation of information about the tools that are needed for pre-surgical planning for the actual surgical procedures. New mechanisms must provide means to locate needed detail about the tools, such as information about specific instruments (brands, types, and so on) that are required during a surgery. Technical means for enabling this tracking should involve standardized use of: 1. Radio frequency tracking of instruments and lap pads in the OR. Research should be focused on reducing the size of RFID tags and improving their performance in wet or other environments that are typically found in the surgical setting. 2. A bar coding system for tagging and locating instruments throughout the hospital. System-wide mechanisms for this tracking must be developed so that the correct instruments are in the right place as needed.
'
Practice standardization/improvements. Standardization of surgical practice across many spheres is needed to increase workflow efficiencies in the OR. These areas include standardization in: 1. Developing technology across the system (for technology used by surgeons, by nurses, and other team members) and across specialties (for technology used in endoscopy, radiology, and so on). Surgical practice itself also needs to
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be standardized and specific tools/brands decided upon in order for the surgical results to be consistent. 2. Scheduling of patients and comprehensive preoperative evaluation for their surgical procedures. 3. Preparing clinical teams who work together in the OR, with each member able to demonstrate skills in a particular technology's use. Increased education is obviously required to expand and refine team members' skill sets and enable them to plan ahead for next-day surgeries. 4. Defining and matching specific jobs/tasks and their roles in OR workflow processes. These roles need to be better defined to address the question: Who are the people that will be needed tomorrow in the OR? 5. Developing clinical guidelines per surgical specialty. Developing and following practice guidelines will achieve consistency in scheduling and undertaking routine pre-operative screening tasks, and otherwise better ready the patients for surgeries. 6. Acquiring surgery-oriented presentation of multidimensional data. Images ought to be consistent regardless of the display system that is used. 7. Developing standard operating procedures (SOPs) for the OR. A goal is to enable surgeries to operate like factories or assembly lines and produce a consistent, measurable product. 8. Studying individual work roles and activities to understand what people working in the OR do and say they do and why. Obtaining this information requires an ethnographic research study of the OR to be undertaken. From it, workflows can then be better defined from high to micro levels. As a result of studying the overall workflow practices that characterize today's OR (including readying patients, preparing tools, performing procedures, and so on), a better understanding can be acquired of how these tasks can be performed efficiently in the future. These findings could lead to development of a needed, standard process model of surgical workflow. As a result, planners would have better information from which to assign and plan for human and non-human involvement in an OR that operates efficiently and productively.
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CHAPTER THREE AT A GLANCE: SYSTEMS INTEGRATION AND TECHNICAL STANDARDS Overview There are wide ranges of medical devices used in today's operating rooms (ORs). However, many devices do not or cannot communicate among each other. A standard interface for interoperability among these technologies is therefore needed if simpler and seamless integration is to be achieved today and in the future. A platform comprising clinically connected devices that operate via plug and play standardization was the ultimate goal defined by this Working Group as desirable for the Operating Room of the Future (ORF). Clinical Needs This Working Group identified two critical steps for achieving systems integration and standards: 1. Defining information that is needed in the OR for clinical decision making. 2. Generating a systems platform for a multipurpose OR suite that facilitates reconfigurability for different surgical procedures and different surgeons needs and tastes. Technical Requirements A plug and play platform must be developed. Such a platform is believed to be key for communications and control of multiple devices used in the OR. Standards that need to be included in this configuration were identified, including features pertaining to bandwidth, speed, and synchronization capabilities of the configured devices. Research Priorities This Working Group identified four priority areas for research. Among the most important: '• Developing 'common' user interfaces among medical (especially imaging) devices. The device industry should take the lead on this research task. '* Devising and implementing a standard communications header for each device to identify itself, its task, ownership, and its capabilities. The full report of this Working Group appears on pages 24-28.
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CHAPTER 3: SYSTEMS INTEGRATION AND TECHNICAL STANDARDS . ,THE REPORT OF WORKING GROUP 2
Julian Goldman, MD, Massachusetts General Hospital (Clinical Leader) Rainin Shahidi, PhD, Stanford University (Technical Leader) Michael Browt,General Electric Global Research Rcmmhard Bucholz, MD, St. Louis University Laurence Clarke, PhD, National Cancer Institute Jeff Coltman~, PhD), Georgetown University Gilbert Devey, BS, Georgetown University Tony Epifane, Kyarl ctorz Endoscopy Michael Evans, Stryker Endoscopy Peter Kazanzides, PhD, Johns Hopkins University Walter Lapabiotte, Stryker Communications Dave Lieberman, Olympus Surgical William MacNeils, MS, Johns Hopkins University iSohmn Ranjan, MS, Georetown University 3.1
OVERVIEW: THENEED FOR AN LNTRAOPERATIVE AND INTEGRATED SYSTEMS PLATFORM
There are wide ranges of medical devices used in today's operating rooms (ORs). However, almost all of these devices operate independently or are incapable of communicating with other devices or technologies. Significant improvements in operating room efficiency and quality might be achieved by the design and implementation of an intraoperative and integrated systems platform. A standard interface for interoperability is needed for all technologies used in the OR if simpler and seamless integration is to be achieved. However, the integration should be driven not by what components and technology matches are possible but by what makes sense clinically. In terms of integrating surgical equipment, what makes sense is taking a broader approach than just dealing with surgical information. The approach must integrate and incorporate the 'physiological datastream'- that is, the anesthesia record, medical administration, and other information that is specific to the OR and patient activity.
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This Working Group devoted significant time to identifying the building blocks that are needed to clinically and technically generate system platforms for multipurpose OR suites. A platform comprising clinically connected devices (operating via plug and play standardization) was the end goal desired for the Operating Room of the Future (ORF).
3.2
CLINICAL NEEDS: ISSUES IN DEVELOPING INTEGRATED OPERATING ROOM SYSTEMS AND TECHNICAL STANDARDS
At least two significant steps were identified as critical for building new, more useable systems for the OR. These are: 1. Defining information that is mandatory in the OR. Laying the groundwork for building an integrated and standardized system for the OR requires, first of all, determining what information is needed for clinical decision-making. Clinical requirements must be defined and articulated by surgeons and associated personnel and then conveyed to engineers and industry developers. This information will eventually need to be integrated into OR information systems and made readily available to OR clinicians. These definitions of OR requirements must encompass not only the information and tools that are required in the OR but must also include and synthesize existing procedural protocols. There are currently varying types of protocols used in the OR. Clinical requirements (once identified) will define and generate the needed standards that represent a single, global protocol. Achieving this global protocol is the goal for attaining effective and measurable work in the OR. 2. Generating a systems platform for a multipurpose OR suite. A building block approach to defining clinical requirements and standards is needed from which to generate systems platforms for a multipurpose OR suite. Four key areas that must be addressed in standards development are as follows: imaging, visualization, control of devices, and communications. In addition, the platforms must facilitate reconfigurability that is needed for different procedures and for accommodating different surgeons' needs and tastes. The building blocks of the OR informational system also have to continually define engineering requirements and so enable the system to meet platform standards for an application-specific, protocol-based workflow. There have to be multi-level device integration and high bandwidth data communications when required. Too much technology? An issue that arose during this Working Group's discussion was: Is there too much technology in today's OR to allow for clinical efficiencies? A need for surgical
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operation-specific procedural maps was voiced, as was the need for technology (and 'modular technology, should needs change) that ought to be in the OR on a given day for achieving clinical efficiency. Ideally, each OR would be physically standardized to facilitate performing particular procedures and be physically mapped according to placement of tools and task-specific people.
Figure 3: Operating Room of the Future at Massachusetts General Hospital (courtesy of the Center for Integration of Medicine and Innovative Technology (CIMIT))
Planning for each procedure's requirements (and following specific, usual surgical routines) will indicate specific technology platforms that are needed for some procedures, not always for others. This standardized inventory is, as one group member noted, an extremely critical foundation from which to begin 'before you start filling your room with standards of seven other different technologies.' A goal may well be a requirement to design multipurpose, easily reconfigurable ORs. It was believed, however, that
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hospital administrators and hospital efficiency experts would not support separate ORs for each specialty. Standardization will occur only after the room is defined by the procedures (whichever operation is taking place). Improved use of technology and current OR clinical requirements demand that planners: 1. Make sure that all machines and imaging modalities can talk to each other (and not interfere with other devices). 2. Move away from the non-interoperable multitude of devices that are used in today's ORs and which function in isolation. 3. Work toward creating neither single devices nor single systems but rather reconfigurable platforms that are based on standardized clinical requirements. These standardized features are key to improved use and clinical applicationspecific control of technology in today's OR. In particular, varieties of imaging modalities must be capable of being fused (registered) and displayed together. 4. Aim toward creating an image correlation protocol standard to be used as needed. However, a long-term goal ought to be achieving multi-level device integration that enables operator control and procedure-targeted systems configuration and will be most useable in the ORF.
3.3
TECHNICAL REQUIREMENTS: STANDARDS AND TOOLS FOR IMPROVED OPERATING ROOM PROCESS INTEGRATION
The technology for creating standards or standardized interfaces among devices in today's OR needs to be identified. These systems must satisfy clinical requirements, and they must address what clinicians say they need in the OR. At the outset, a plug and play system for developing this interface appears to be key for communication and control between multiple devices. Identifying requirements for this platform is essential. Specifically, devices that need to work together have to be identified as do their requirements for operation (e.g., in terms of bandwidth, speed, and synchronization). Each device's range of capabilities has to be included in this configuration as well. Capabilities to transmit the status of its completed tasks to a designated location or via a built-in, real-time confirmation mechanism have to be included. Other features of the platform include authorization mechanisms for each device's use, and configurations that allow for only specified access to its capabilities by some designated users.
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In addition, devices of the same type must be assigned to a specific class. The class must be understood as having specific capabilities and standards. For instance, insuffulators as a class have many capabilities, but some have all capabilities and others only have a few of these. Surgeons in the OR need to know about the particular capabilities of the insuffulator on hand so as to plan their work accordingly. Although the need for building an improved platform is great and immediate, this Working Group agreed on the need for performing 'historical due diligence' of devicerelated standards that have failed to date. Investigating these standards and why they did not succeed is a task that should be undertaken. The successes of certain other standards, such as HL7, USB, and DICOM, also need to be included in the ongoing research on workable system integration and standards for the ORF.
3.4
RESEARCH PRIORITIES
At least four research areas were identified as priorities by this Working Group including: '• Developing 'common' user interfaces among medical (especially imaging) devices. The device industry needs to shoulder this research task. '* Devising a standard communications header for each device to identify itself, and, specifically, its task, ownership, and capabilities. '* Developing a broad, encompassing plug-and-play system among devices for communication and control in the OR. '* Undertaking historical research of device-related standards, and studying which have been developed, which did not work or were not used, and why they failed.
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CHAPTER FOUR AT A GLANCE: TELECOLLABORATION
Overview Telecollaboration as practiced in the operating room (OR) uses telecommunications technology to connect surgeons and other medical professionals to another OR and its personnel. Telecollaboration can enable remote consultation, evaluation, mentoring/proctoring, monitoring, and performance of surgical procedures. It is a very new area of service delivery and its limitations as discussed by this Working Group are indicative of a developing field that lacks a terminology, established expertise, and accepted delivery protocols. Clinical Needs Defining terminology for telecollaboration was one identified need. Disseminating knowledge of telecollaboration's applications is also important for those who are new to this field, so that they can better plan interactions and determine telecollaboration's potential usefulness for particular cases. A lack of standardized practice, available equipment, and limited training were the main limitations identified as currently preventing greater use of telecollaboration. Advantages of using telecollaboration that were identified included accessing remote experts to mentor at a distance and reduce the learning curve time for young surgeons who are unfamiliar with particular procedures. Technical Requirements Technical problems in telecollaboration relate to adapting the technology specifically to surgeons' needs in the OR, and included the following: 1. Need for decreased latency in video data compression. 2. Lack of a standardized telecommunications network for the OR. 3. Lack of standardized data, resulting in too many variables among data that are delivered to surgeons in the OR. Research Priorities Research priorities must focus on developing technical standards for telecollaboration to promote interoperability. Challenges for the development of the field include involving industry and political-arena representatives for improving a nation-wide communications network and addressing licensure and privacy issues so as to enable wider adoption of telecollaboration and its effective use. The full report of this Working Group appears on pages 30-38.
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CHAPTER 4: TELECOLLABORATION .. THE REPORT OF WORKING GROUP 3
PARTICIEPANTS Mehran Anvari, MD, McMaster University (Clinical Leader)
Eric J. Hanly, MD, Walter Reed Army Medical Center (Clinical Co-Leader) Noah Schenkman, MD, Walter Reed Army Medical Center (Clinical Co-Leader)
Robert Sc-abassi, MD, PhD, University of Pittsburgh (Technical Leader) Ho Young Chung, MD, PhD, Georgetown University Cato T. Laurencin, MD, PhD, University of Virginia Mingui Sun, PhD, University of Pittsburgh
4.1
INTRODUCTION: A HISTORICAL VIEW OF COLLABORATION IN THE SURGICAL THEATER AND POTENTIAL USES FOR TELECOLLABORATION TODAY
Telecollaboration in surgery is an innovative approach to sharing experience and expertise and is enabled by today's advanced communications technology. The operating room (OR) of the nineteenth century was surprisingly collaborative, however. Surgeons, nurses, consultants, and other members of the healthcare team, as well as medical students, nurses-in-training, and other learners were, in many cases, free to come and go to the OR as patient care and learning needs required. With a name that is now a misnomer in the countries that still use it today, the operating 'theater' was just that: a theater where people gathered around the process of surgery to contribute and learn. However, the advent of aseptic technique changed everything. The OR of the twentieth century can best be described as 'anti-collaborative.' To even get to an OR today, individuals must change clothes - donning scrubs, booties, bonnets, and masks; enter physically isolated 'suites' guarded by nurse managers whose principle objective (in the opinion of many would-be students at least) - is to block the entry of all but the most essential parties; timidly cross a brightly-colored line on the floor indicating the point of no return; and then finally enter further partitioned rooms. And all of this is just to get in the room! Should someone be so bold as to actually want to see the operative field, much less have physical contact with the patient, they must first cleanse themselves of integumental impurities and don yet another layer of sterile clothing. Thus the process of 'collaborating' with someone in the OR has become, not surprisingly, very intimidating, resulting in a drastically reduced dialogue between surgeons and consultants, surgeons and nurses, surgeons and students, and surgeons themselves.
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Chapter 4: Telecollaboration
The OR of the twenty-first century can and must be different. Throughout the twentieth century, the introduction of local intercoms and telephones into hospitals began to reconnect the OR with the outside world. In the mid-1990s, the first telementoring in the OR using real time audio-video teleconferencing equipment furthered this connection, as did surgeons' use of telecommunication networks to remotely control a laparoscopic camera. On Sept 9, 2001, Jacques Marescaux ushered in the new millennium for OR telecollaboration when he controlled a Zeus telesurgical robot in Strasbourg, France from an office in New York City to perform the first transatlantic telerobotic laparoscopic cholecystectomy. The stage had thus been set for the advent of routine telecollaboration. There is a range of current uses of telecollaboration, which in the OR, can enable surgeons and other medical professionals and robots to communicate with each other regardless of location. Telecommunication between experts or between experts and less experienced professionals, students, or robots has multiple functions. It can be used for remote consultation, evaluation, mentoring/proctoring, monitoring, and manipulation, and for actually performing surgical procedures. Telecollaboration is particularly valuable in isolated areas where access to major centers and/or experts is difficult to achieve. It is particularly needed in rural settings as well as in remote areas such as on the battlefield, at sea, and in outer space. The field is still very new, however, and there are relatively few practitioners today. Nonetheless, technological advances in the past 25 years in video and computer communications have established the capabilities to enhance, compress, and transmit video signals and other information over long distances. More than ever, telecollaboration in today's OR is possible. This Working Group identified some key issues for improving the delivery of telecollaborated services for the OR. Among these was the absence of both clinical and technical standards, a problem that poses significant limitations to the development of this nascent field. Among the other major drawbacks are limited tools for educating students and practitioners about this field and its effective applications, and limited communications technology that has been specifically adapted to surgeons' needs in the OR.
4.2
CLINICAL NEEDS: DEFINING A FRONTIER FIELD
At the outset of discussion, this Working Group identified a need to define terminology for surgery-related telecollaboration. This need is particularly important for telesurgeons obtaining licensing privileges and specifying what activities will be performed during a tele-intervention (and for which they will subsequently submit payment requests). Terminology is also needed for health care planners who are assessing options and examining the potential usefulness of tele-interventions for particular cases.
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Chapter 4: Telecollaboration
According to this Working Group, there is a great deal of misunderstanding about the meaning of'telecollaboration' in the OR. As a result, ill-defined and ambiguous terminology has surfaced. The following terms and definitions were discussed: Teleconsultation. Communication at a distance between two or more health professionals to 'discuss' the diagnosis, prognosis, and treatment of a particular patient's case. This includes, but is not limited to, the use of email, telephone, and audio-video teleconferencing to exchange information between an operating surgeon and one or more other providers. Tele-evaluation. The appraisal, typically including some type of physical examination, of a patient distant from the health care professional. The most common media type used for this process is audio-video teleconferencing. Telementoring/Teleproctoring. The teaching and supervision of a less experienced surgeon by a remotely located expert surgeon. Telementoring includes giving real-time advice about the various mechanical steps of a particular operation. Audio-video teleconferencing is fundamental to this activity. Oftentimes, telementoring is enhanced with the use of telestration devices. Telemonitoring. The observation of another surgeon's or surgeonin-training's performance during a surgical procedure. This practice can be thought of as 'telegrading' that is typically done in real time, but can be accomplished via store-and-forward technology. Telemonitoring usually includes some assessment of the operating surgeon by the expert, but without the real-time expression of that assessment. Telemanipulation. The remote operation of a device (e.g., camera, needle, instrument, etc.) for a specific purpose (e.g., visualization, biopsy, etc.). This activity necessitates that control signals be sent across telecommunications lines in order to move the device. Telemanipulation is a limited subset of telesurgery (defined next). Telesurgery/Telepresence surgery. The performance of surgery (including all tasks typically assigned to a surgeon) at a distance using remote control of surgical robots over telecommunications networks. Telesurgery is bimanual remote manipulation of the tissue being operated upon with complete real-time visual access to the operative field. When using telesurgery to operate in conjunction with a local surgeon, telesurgery allows the remotely
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OR2020: Operating Room of the Future Workshop, March 2004
Chapter 4: Telecollaboration
located expert or consultant surgeon to 'take over' as necessary to demonstrate the 'next move,' or to actually perform the surgery. The sharing of expertise is key to all of these defined tele-activities. To date, surgical areas that have primarily been focused on telecollaborative efforts include neurosurgery, orthopedic surgery, and vascular surgery as well as telepathology. This terminology must be established to avoid confusion about the use of telecommunications-ready technology in the OR as well as to help people to better understand what the approaches are and how valuable they can be in teaching and mentoring. An overwhelming goal of telemedicine has been to replicate on-site activity from a distance. Much of what is measured in telemedicine and judged successful focuses on how closely (and without incident) these replicated activities have taken place. For this reason, four other terms that also affect the use of telecollaboration were defined by this Working Group. These are: Control Latency. The delay between when a remote surgeon moves a controller and when the surgical tool actually moves inside the patient. This time is a sum of the delays inherent to digitization of the controller movement, transmission of these digital signals to the patient's location, and electro-mechanical translation of these signals. Visual Discrepancy. The delay between when something moves in the operative field and when the surgeon visually appreciates such movement at the remote location. This time is a sum of the delays inherent to digitalization and compression of the video signal(s) by the CODEC(s), transmission of the signal(s) across telecommunication networks, and decompression of the signal(s) by the remote CODEC(s). Round-trip Delay. The sum of control latency and visual discrepancy - i.e., the time between when a remote surgeon moves a controller and when such translated movement is visually appreciated at the remote location. Jitter. Real-time variations in the amount of delay introduced by variable traffic in telecommunication networks.
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Chapter 4: Telecollaboration
Limitations of the clinical uses of telecollaboration in the OR were identified by the Working Group, and included: * • • •
*
* * * * *
uncertain and nonstandardized reimbursement mechanisms and amounts for telemonitoring (at least in the U.S.) high set-up costs of equipment and systems uncertainties about licensure, credentialing, and other legal-related issues (which can vary from state to state) extensive set-up tasks and time required for readying both the robotic components of the surgery and the telecommunications infrastructure, thus increasing the amount of needed OR time time consuming tasks for coordinating participants in teleconsultations (e.g., between teams or between just two surgeons, matching their capabilities, pinpointing schedule availability times, and so forth) uncertainties about telemedicine's use and HIPAA (health insurance portability and accountability act) compliance and privacy issues varying amounts of skills among mentors and collaborators (making it difficult to estimate amounts of time needed for teleconsultations) language issues and time zone coordination issues, especially affecting international consults limited knowledge about telecollaboration among user or potential users - what is available, how easy it is to use, and identification of appropriate applications variations in quality of video resolution at different institutions (depending on network capabilities) and as are needed for different procedures. For instance, for a 352 by 240 VHS quality video, approximately 1 Mbps per second (a relatively large amount of bandwidth) is required to send compressed images for telesurgery and telementoring. Lesser bandwidth may be acceptable for other teleinteractions.
Many of these issues are clearly related to an emerging and evolving technical field. Particular advantages of using the technology were also identified (these, apart from telecollaboration providing access to specialty care and knowledge by remote providers). These advantages include: '* reduced need for on-site pathologists whose work can be done electronically on an as-needed basis (i.e., getting telepathology analyses immediately in the OR from surgical biopsies using a telerobot