167: RTOG Participating Physician and Research Associates Attitudes Regarding Clinical Trials:...
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strongly correlated with other prognostic factors. Ninety-two percent of DBC patients were empirically treated with antibiotics. Fourteen percent of patients required more invasive intervention, such as incision and drainage. Twenty-two percent experi- enced recurrent episodes of DBC. Ultimately, 2 patients (4%) underwent mastectomy for intractable breast pain related to DBC. Conclusions: This series represents the largest and most homogenous cohort of DBC patients analyzed to date. Although multifactorial, we believe DBC is primarily related to a bacterial infection in the setting of impaired lymphatic drainage. The majority of cases were successfully treated with empiric antibiotics. Invasive testing prior to a trial of antibiotics is low yield, does not affect treatment decisions, introduces further trauma to at-risk breast tissue, and may unnecessarily complicate mammographic surveillance and cosmetic outcome. Author Disclosure: D. Indelicato, None; S.R. Grobmyer, None; H. Newlin, None; H. Newlin, None; C.G. Morris, None; L.S. Haigh, None; E.M. Copeland, None; N.P. Mendenhall, None. 167 RTOG Participating Physician and Research Associates Attitudes Regarding Clinical Trials: Implications for Improving Recruitment E. M. Walker 1 , J. L. James 2 , S. Hartson Stine 2 , E. Gore 3 , B. Prestidge 4 , J. M. Michalski 5 , C. Gwede 6 , R. M. Chamberlain 7 , D. Watkins-Bruner 8 1 Henry Ford Health System, Detroit, MI, 2 RTOG Headquarters, Philadelphia, PA, 3 Medical College of Wisconsin, Milwakee, WI, 4 Cancer Therapy and Research, San Antonio, TX, 5 Mallinckrodt Institute of Radiology, St. Louis, MO, 6 Moffitt Cancer Center, Tampa, FL, 7 MD Anderson, Houston, TX, 8 University of Pennsylvannia, Philadelphia, PA Purpose/Objective(s): To assess how physician and clinical research associates (RAs) attitudes towards various clinical trials might influence patient accrual to Radiation Therapy Oncology Group (RTOG) clinical trials. Materials/Methods: A 35-question survey was developed by the RTOG Recruitment Working Group. Questions focused on attitudes and beliefs regarding clinical trials and recruitment and were based on a review of the literature and specific issues related to the group. In addition to the general survey, respondents were given a list of 8 scenarios used to present clinical trials to patients. The survey was developed using Survey Monkey© and distributed via email in November 2005 to the principal investigators (PIs) and RAs at 267 RTOG member institutions, and it was distributed at registration at the January 2006 RTOG semiannual meeting. In addition to comparing physician and RA attitudes as a group; physicians and RAs were matched by institution to assess whether attitudes within each institution were consistent. For the matched analysis, the agreement between PI and RA was of primary interest. For institutions which did not have a PI response, the investigator response was used. For institutions with multiple PI and RA respondents, a separate match was used for each PI/RA comparison. The weighted kappa statistic was used to determine the overall level of agreement between PI’s and RA’s, adjusting for institution. Results: A total of 252 surveys were returned from 95 (38%) RTOG physicians and 157 (62%) RAs. 196 (78%) respondents completed the online survey and an additional 56 (22%) completed the paper survey at the RTOG meeting. The online surveys were predominately completed by research associates (70%). 179 of the 267 RTOG member institutions were represented in the responses. The survey found that both PIs and RAs did not find that patients who declined participation in clinical research trials did so because of a preference for treatment at a non RTOG site or because they did not understand the concept of randomization. The survey found that generally there were four reasons why patients declined clinical trial participation. They include the lack of PCP support of the trial; the patient being personally overwhelmed by the diagnosis and options; patient preference for traditional/standard treatment and lastly a concern about insurance coverage if they went on trial. For the general survey questions the overall weighted kappa statistic showed significant moderate agreement between PIs and RAs when adjusting for institution [0.55, (0.51,0.60)]. Specifically, 5 items from the 30-item list showed moderate or high agreement. In response to the scenarios, when adjusting for institution, there was no significant difference between physicians and RAs [0.09, (-0.07,0.25)]. Conclusions: This survey demonstrates similarities in physician and RA attitudes and beliefs about patient recruitment to clinical trials within the same institution. Differences in and ambiguity about communication with the patient is of concern across institutions. Recommendations for trying to eliminate these differences will be made in this presentation. Author Disclosure: E.M. Walker, None; J.L. James, None; S. Hartson Stine, None; E. Gore, None; B. Prestidge, None; J.M. Michalski, None; C. Gwede, None; R.M. Chamberlain, None; D. Watkins-Bruner, None. 168 Cost-effectiveness of Lipid Screening in Hodgkin’s Disease Survivors A. B. Chen 1 , R. S. Punglia 2 , K. M. Kuntz 3 , P. M. Mauch 2 , A. K. Ng 2 1 Harvard Radiation Oncology Program, Boston, MA, 2 Dana-Farber Cancer Institute, Boston, MA, 3 Harvard School of Public Health, Boston, MA Purpose/Objective(s): Hodgkin’s disease (HD) survivors have an increased risk of developing coronary heart disease (CHD). Prior studies suggest this risk may be associated with modifiable cardiovascular risk factors, such as hyperlipidemia. We developed a decision analytic model to estimate the cost-effectiveness of early lipid screening and statin therapy in HD survivors. Materials/Methods: We developed a Markov decision analytic model to compare lipid screening every five years starting five years post-treatment versus no lipid screening in a hypothetical cohort of 25-year-old HD survivors treated with mediastinal irradiation. Patients who screened positive were then treated using statins. Using our model, we calculated life expectancy, quality-adjusted life expectancy, and lifetime costs of each screening option. Baseline probabilities, transition probabilities, and utilities were estimated from the HD and cardiac literature, as well as US population data. Costs of lipid screening, statin use, and myocardial infarction were estimated from Medicare fee schedules, the Drug Red Book, and published studies and were converted to 2005 US dollars using the medical care component of the Consumer Price Index. A discount rate of 3% per year was applied to cost-effectiveness estimates. Sensitivity analyses were performed by varying baseline estimates over plausible ranges, and different screening intervals were evaluated. S94 I. J. Radiation Oncology ● Biology ● Physics Volume 66, Number 3, Supplement, 2006
Transcript of 167: RTOG Participating Physician and Research Associates Attitudes Regarding Clinical Trials:...
strongly correlated with other prognostic factors. Ninety-two percent of DBC patients were empirically treated with antibiotics.Fourteen percent of patients required more invasive intervention, such as incision and drainage. Twenty-two percent experi-enced recurrent episodes of DBC. Ultimately, 2 patients (4%) underwent mastectomy for intractable breast pain related to DBC.
Conclusions: This series represents the largest and most homogenous cohort of DBC patients analyzed to date. Althoughmultifactorial, we believe DBC is primarily related to a bacterial infection in the setting of impaired lymphatic drainage. Themajority of cases were successfully treated with empiric antibiotics. Invasive testing prior to a trial of antibiotics is low yield,does not affect treatment decisions, introduces further trauma to at-risk breast tissue, and may unnecessarily complicatemammographic surveillance and cosmetic outcome.
Author Disclosure: D. Indelicato, None; S.R. Grobmyer, None; H. Newlin, None; H. Newlin, None; C.G. Morris, None; L.S.Haigh, None; E.M. Copeland, None; N.P. Mendenhall, None.
167 RTOG Participating Physician and Research Associates Attitudes Regarding Clinical Trials: Implicationsfor Improving Recruitment
E. M. Walker1, J. L. James2, S. Hartson Stine2, E. Gore3, B. Prestidge4, J. M. Michalski5, C. Gwede6, R. M. Chamberlain7,D. Watkins-Bruner8
1Henry Ford Health System, Detroit, MI, 2RTOG Headquarters, Philadelphia, PA, 3Medical College of Wisconsin,Milwakee, WI, 4Cancer Therapy and Research, San Antonio, TX, 5Mallinckrodt Institute of Radiology, St. Louis, MO,6Moffitt Cancer Center, Tampa, FL, 7MD Anderson, Houston, TX, 8University of Pennsylvannia, Philadelphia, PA
Purpose/Objective(s): To assess how physician and clinical research associates (RAs) attitudes towards various clinical trialsmight influence patient accrual to Radiation Therapy Oncology Group (RTOG) clinical trials.
Materials/Methods: A 35-question survey was developed by the RTOG Recruitment Working Group. Questions focused onattitudes and beliefs regarding clinical trials and recruitment and were based on a review of the literature and specific issuesrelated to the group. In addition to the general survey, respondents were given a list of 8 scenarios used to present clinical trialsto patients. The survey was developed using Survey Monkey© and distributed via email in November 2005 to the principalinvestigators (PIs) and RAs at 267 RTOG member institutions, and it was distributed at registration at the January 2006 RTOGsemiannual meeting. In addition to comparing physician and RA attitudes as a group; physicians and RAs were matched byinstitution to assess whether attitudes within each institution were consistent. For the matched analysis, the agreement betweenPI and RA was of primary interest. For institutions which did not have a PI response, the investigator response was used. Forinstitutions with multiple PI and RA respondents, a separate match was used for each PI/RA comparison. The weighted kappastatistic was used to determine the overall level of agreement between PI’s and RA’s, adjusting for institution.
Results: A total of 252 surveys were returned from 95 (38%) RTOG physicians and 157 (62%) RAs. 196 (78%) respondentscompleted the online survey and an additional 56 (22%) completed the paper survey at the RTOG meeting. The online surveyswere predominately completed by research associates (70%). 179 of the 267 RTOG member institutions were represented inthe responses. The survey found that both PIs and RAs did not find that patients who declined participation in clinical researchtrials did so because of a preference for treatment at a non RTOG site or because they did not understand the concept ofrandomization. The survey found that generally there were four reasons why patients declined clinical trial participation. Theyinclude the lack of PCP support of the trial; the patient being personally overwhelmed by the diagnosis and options; patientpreference for traditional/standard treatment and lastly a concern about insurance coverage if they went on trial. For the generalsurvey questions the overall weighted kappa statistic showed significant moderate agreement between PIs and RAs whenadjusting for institution [0.55, (0.51,0.60)]. Specifically, 5 items from the 30-item list showed moderate or high agreement. Inresponse to the scenarios, when adjusting for institution, there was no significant difference between physicians and RAs [0.09,(-0.07,0.25)].
Conclusions: This survey demonstrates similarities in physician and RA attitudes and beliefs about patient recruitment toclinical trials within the same institution. Differences in and ambiguity about communication with the patient is of concernacross institutions. Recommendations for trying to eliminate these differences will be made in this presentation.
Author Disclosure: E.M. Walker, None; J.L. James, None; S. Hartson Stine, None; E. Gore, None; B. Prestidge, None; J.M.Michalski, None; C. Gwede, None; R.M. Chamberlain, None; D. Watkins-Bruner, None.
168 Cost-effectiveness of Lipid Screening in Hodgkin’s Disease Survivors
A. B. Chen1, R. S. Punglia2, K. M. Kuntz3, P. M. Mauch2, A. K. Ng2
1Harvard Radiation Oncology Program, Boston, MA, 2Dana-Farber Cancer Institute, Boston, MA, 3Harvard School ofPublic Health, Boston, MA
Purpose/Objective(s): Hodgkin’s disease (HD) survivors have an increased risk of developing coronary heart disease (CHD).Prior studies suggest this risk may be associated with modifiable cardiovascular risk factors, such as hyperlipidemia. Wedeveloped a decision analytic model to estimate the cost-effectiveness of early lipid screening and statin therapy in HDsurvivors.
Materials/Methods: We developed a Markov decision analytic model to compare lipid screening every five years starting fiveyears post-treatment versus no lipid screening in a hypothetical cohort of 25-year-old HD survivors treated with mediastinalirradiation. Patients who screened positive were then treated using statins. Using our model, we calculated life expectancy,quality-adjusted life expectancy, and lifetime costs of each screening option. Baseline probabilities, transition probabilities, andutilities were estimated from the HD and cardiac literature, as well as US population data. Costs of lipid screening, statin use,and myocardial infarction were estimated from Medicare fee schedules, the Drug Red Book, and published studies and wereconverted to 2005 US dollars using the medical care component of the Consumer Price Index. A discount rate of 3% per yearwas applied to cost-effectiveness estimates. Sensitivity analyses were performed by varying baseline estimates over plausibleranges, and different screening intervals were evaluated.
S94 I. J. Radiation Oncology ● Biology ● Physics Volume 66, Number 3, Supplement, 2006
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