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Initial National Priorities for Comparative Effectiveness Research (2009)

Chapter: Appendix B: Stakeholder Questionnaire

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Suggested Citation:"Appendix B: Stakeholder Questionnaire." Institute of Medicine. 2009. Initial National Priorities for Comparative Effectiveness Research. Washington, DC: The National Academies Press. doi: 10.17226/12648.
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Appendix B Stakeholder Questionnaire 171

172 APPENDIX B INITIAL NATIONAL PRIORITIES FOR CER B-3 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: Welcome to the Institute of Medicine's Questionnaire on Comparative Effec- tiveness Research Priorities BACKGROUND: The Institute of Medicine (IOM) requests your input for consideration of priori- ties for comparative effectiveness research (CER) as called for in the American Recovery and Reinvestment Act of 2009 (Stimulus Bill). In addition to allocating $400 million to the Secretary of Health and Human Services for CER, the legislation mandates that the IOM produce and submit a consensus report by June 30, 2009, that provides specific recommendations to Con- gress and the Secretary for expenditure of these funds. The legislation also requires the IOM committee to solicit and consider public input as it develops its recommendations. This questionnaire is a primary vehicle by which the committee will collect information on the priorities of all stakeholders in health care (e.g., patients, consumers, providers, state and fed- eral agencies, employers, manufacturers, policy makers). PUBLIC INPUT OPPORTUNITIES: Questionnaire: This questionnaire will be active from March 6 - March 27, 2009. All responses will be compiled into a database that will be reviewed by the commit- tee. Please note that with the exception of individuals' email addresses and phone numbers, all responses will also be placed in a public access file as required by fed- eral legislation. If you choose to omit contact information, your response will still be given full consideration. Public Meeting: A public meeting will be convened on March 20, 2009 in Wash- ington, DC, during which stakeholders, including members of the public, will be in- vited to present to the committee, as time allows. Information and registration in- structions are provided at the committee's website (www.iom.edu/cerpriorities). SAVING AND SUBMITTING YOUR RESPONSE: Saving: You will be able to leave the questionnaire and then return to it later; however, you must complete an entire page and move on to the next page to save your work. Submitting: When you have completed the questionnaire you will see a confirma- tion page and will then be taken back to the committee's website where you can find additional information about the committee's work. Printing: Please note that if you wish to print your responses, you must print each page when you are finished with it by using your web browser’s print menu op- tions.

APPENDIX B B-4 INITIAL NATIONAL PRIORITIES FOR173 CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: Instructions In the next 3 pages, you will have the opportunity to submit up to 3 comparative effectiveness studies for the committee's consideration. Please rank your suggested CER priorities as first, second, and third by entering them in that order. Once you have submitted your top 3 priorities, you will be asked what criteria you feel are most important in establishing a national set of priorities for CER. You will be asked to select and rank criteria (e.g., disease burden, disease severity, variation in care, cost, public interest, in- formation gap) as well as identify other criteria for the committee to consider. Lastly, you will be asked to provide recommendations to the committee regarding what new or enhanced capacities and infrastructure are needed to sustain a national CER enterprise. CER Scope The committee's working definition for CER is: “The generation and synthesis of evidence that com- pares the effectiveness of alternative methods to prevent, diagnose, treat, monitor, and improve de- livery of care for a clinical condition. The purpose of CER is to assist patients, clinicians, purchasers, and policy makers in making informed health decisions.” Please consider the following as you develop your suggested priority areas for study: Study Population: Identify a study population by disease entity, condition, susceptible population, or population affected. Alternative Interventions: Comparators might include systems of care as well as specific interventions to address the prevention, diagnosis, treatment, monitoring, or delivery of care. One comparator could be the current standard of care or usual care. Outcome of Interest: Please identify the health related risk, side effect or harm of greatest concern, and/or the health related benefit of greatest interest (e.g., patient- reported outcomes, surrogate endpoints [such as change in tumor size or laboratory pa- rameters], clinical event, death). Study Methods: CER can include analyses of existing data, observational studies (e.g., Framingham study), prospective trials, and systematic reviews of published studies. Overview of requested information We anticipate a high response rate to this questionnaire. Therefore, to facilitate the committee's re- view of each response, we ask that you characterize each of your priorities by specifying the follow- ing: A single sentence that frames your research question (include condition, compari- son, and outcome of interest) Justification for why the question should be a national priority Area to be studied (e.g., cardiovascular and peripheral vascular disease, racial and ethnic disparities in health care, nutrition) Comparators (i.e., include a comparison of two or more alternatives for the preven- tion, diagnosis, treatment, monitoring, or delivery of care for a clinical condition) Study design (e.g., analyses of existing data [systematic review], observational stud- ies [such as the Framingham study], and prospective trials) Study population (e.g., children/adolescents, elderly, special populations)

174 INITIAL NATIONAL PRIORITIES FOR CER APPENDIX B B-5 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: CER Priority (1 of 3) Describe your first priority by answering the following questions. *1. Please submit a single sentence that frames your research question. We request that your response specify a condition; a comparison of 2 or more alternatives for the prevention, diagnosis, treatment, monitoring, or delivery of care of the condition; and the study outcome(s) to be assessed (e.g., patient-reported outcomes, surrogate endpoints [such as change in tumor size or laboratory parameters], clinical event, death). For example: Compare the effectiveness of identifying pre-malignant lesions and early colon cancer by either virtual or actual colonoscopy in individuals at low to moderate risk of colon cancer. *2. Please provide justification for why this study should be a priority. Please consider the following criteria in your justification: disease burden increasing prevalence morbidity and mortality variability in care cost information gap (e.g., little is know about this topic) funding gap (e.g., minimal research is being done on this topic) public interest controversy disproportionate impact by subpopulation potential to act on the information once generated utility of the answer for decision making Please limit your response to 100 words. To verify that your text is within the limits, use this word count link. For example: Screening for colon cancer by colonoscopy identifies pre-malignant lesions and early cancers allowing for both prevention and cure. Many people needlessly delay this procedure because of perceived inconveniences or pain, and thus miss the potential benefits. Virtual colonoscopy may increase the number of people undergoing screening compared to the current number having colonoscopy, increase the number of pre-malignant and early cancers found, and reduce the death rate from colon cancer.

APPENDIX B 175 B-6 INITIAL NATIONAL PRIORITIES FOR CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: 3. Please specify the primary area to be studied in the left hand column. If your study involves multiple conditions, please mark the associated conditions in the right hand column. If you are unsure of how to characterize the condition described in questions 1 and 2 above, please indicate the specific condition/disease in the "other" box. Comorbidity Primary Condition (associated conditions—you (please select only one) may select more than one) Sexual Function and Reproductive Disorders Skin Disorders Cardiovascular and Peripheral Vascular Disease Eyes, Ears, Nose, and Throat Disorders Gastrointestinal System Disorders Immune System, Connective Tissue, and Joint Disorders Kidney and Urinary Tract Disorders Pancreatic Disorders Endocrinology and Metabolism Disorders (includes Dia- betes) Infectious Diseases (including HIV/AIDS) Liver and Biliary Tract Disease Musculoskeletal Disorders Neurologic Disorders Oncology and Hematology Psychiatric Disorders Respiratory Disease Trauma, Emergency Medicine, Critical Care Medicine Medical Aspects of Bioterrorism Nutrition (includes Obesity) Complementary and Alternative Medicine Alcoholism, Drug Dependency, and Overdosage Functional Limitation and Disabilities Birth and Developmental Disorders Genetics and Disease Regenerative Medicine (e.g., stem cell research) Safety and Quality of Health Care (e.g., delivery and organization of care) Racial and Ethnic Disparities Women's Health (including disorders during pregnancy) Pediatrics Geriatric Medicine Palliative and End-of-Life Care Other (please specify)

176 INITIAL NATIONAL PRIORITIES FOR CER APPENDIX B B-7 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: 4. For this priority, please select the type(s) of interventions to be compared. You may select more than one. Prevention Procedures – Surgery Testing, monitoring, and evaluation (e.g., lab, Devices (e.g., artificial joint, spinal cage, imaging, psychosocial and functional assess- stent, pacemaker, breast implants) ments) Systems of Care (e.g., organization, man- Standard of care/usual care (please elaborate agement, delivery of healthcare services) on the specific elements of standard of care in the "other" box) Provider/Patient Relationships (e.g., counsel- ing, education) Treatment – Behavioral Treatment pathways (e.g., strategy for early Treatment – Alternative stage prostate cancer, team approach to dia- Treatment – Pharmacological betes care vs. general care) Other (please specify) 5. For the topic you suggested, which of the following types of research would be most effective in providing the needed evidence? Synthesis of existing evidence (e.g., qualitative review, meta-analysis) Primary research using existing health care databases (might include electronic health record data or other clinical data) Primary research using prospective data collection without randomization (e.g., observational study, registry) Primary research through a prospective randomized trial Other (please specify) 6. Please describe the study population(s). You may select more than one. Population at Large Elderly Men Long-term care (institutionalized and home care) Women Ethnic sub-populations only Children/Adolescents Rare Diseases Adults (excluding elderly) Special Populations (e.g., pregnant women, Adults (including elderly) prisoners, low income, persons with disability)— please elaborate in the "other" box Other (please specify)

APPENDIX B 177 B-8 INITIAL NATIONAL PRIORITIES FOR CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: *7. Would you like to submit another priority? Yes No

178 INITIAL NATIONAL PRIORITIES FOR CER APPENDIX B B-9 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: CER Priority (2 of 3) Describe your second priority by answering the following questions. *8. Please submit a single sentence that frames your research question. We request that your response specify a condition; a comparison of 2 or more alternatives for the prevention, diagnosis, treatment, monitoring, or delivery of care of the condition; and the study outcome(s) to be assessed (e.g., patient-reported outcomes, surrogate endpoints [such as change in tumor size or laboratory parameters], clinical event, death). *9. Please provide justification for why this study should be a priority. Please consider the following criteria in your justification: disease burden increasing prevalence morbidity and mortality variability in care cost information gap (e.g., little is know about this topic) funding gap (e.g., minimal research is being done on this topic) public interest controversy disproportionate impact by subpopulation potential to act on the information once generated utility of the answer for decision making Please limit your response to 100 words. To verify that your text is within the limits, use this word count link.

APPENDIX B 179 B-10 INITIAL NATIONAL PRIORITIES FOR CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: 10. Please specify the primary area to be studied in the left hand column. If your study involves multiple conditions, please mark the associated conditions in the right hand column. If you are unsure of how to characterize the condition described in questions 8 and 9 above, please indicate the specific condition/disease in the "other" box. Comorbidity Primary Condition (associated conditions—you (please select only one) may select more than one) Sexual Function and Reproductive Disorders Skin Disorders Cardiovascular and Peripheral Vascular Disease Eyes, Ears, Nose, and Throat Disorders Gastrointestinal System Disorders Immune System, Connective Tissue, and Joint Disorders Kidney and Urinary Tract Disorders Pancreatic Disorders Endocrinology and Metabolism Disorders (includes Dia- betes) Infectious Diseases (including HIV/AIDS) Liver and Biliary Tract Disease Musculoskeletal Disorders Neurologic Disorders Oncology and Hematology Psychiatric Disorders Respiratory Disease Trauma, Emergency Medicine, Critical Care Medicine Medical Aspects of Bioterrorism Nutrition (includes Obesity) Complementary and Alternative Medicine Alcoholism, Drug Dependency, and Overdosage Functional Limitation and Disabilities Birth and Developmental Disorders Genetics and Disease Regenerative Medicine (e.g., stem cell research) Safety and Quality of Health Care (e.g., delivery and organization of care) Racial and Ethnic Disparities Women's Health (including disorders during pregnancy) Pediatrics Geriatric Medicine Palliative and End-of-Life Care Other (please specify)

180 INITIAL NATIONAL PRIORITIES FOR CER APPENDIX B B-11 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: 11. For this priority, please select the type(s) of interventions to be compared. You may select more than one. Prevention Procedures – Surgery Testing, monitoring, and evaluation (e.g., lab, Devices (e.g., artificial joint, spinal cage, imaging, psychosocial and functional assess- stent, pacemaker, breast implants) ments) Systems of Care (e.g., organization, man- Standard of care/usual care (please elaborate agement, delivery of healthcare services) on the specific elements of standard of care in the "other" box) Provider/Patient Relationships (e.g., counsel- ing, education) Treatment – Behavioral Treatment pathways (e.g., strategy for early Treatment – Alternative stage prostate cancer, team approach to dia- Treatment – Pharmacological betes care vs. general care) Other (please specify) 12. For the topic you suggested, which of the following types of research would be most effective in providing the needed evidence? Synthesis of existing evidence (e.g., qualitative review, meta-analysis) Primary research using existing health care databases (might include electronic health record data or other clinical data) Primary research using prospective data collection without randomization (e.g., observational study, registry) Primary research through a prospective randomized trial Other (please specify) 13. Please describe the study population(s). You may select more than one. Population at Large Elderly Men Long-term care (institutionalized and home care) Women Ethnic sub-populations only Children/Adolescents Rare Diseases Adults (excluding elderly) Special Populations (e.g., pregnant women, Adults (including elderly) prisoners, low income, persons with disability)— please elaborate in the "other" box Other (please specify)

APPENDIX B 181 B-12 INITIAL NATIONAL PRIORITIES FOR CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: *14. Would you like to submit another priority? Yes No

182 INITIAL NATIONAL PRIORITIES FOR CER APPENDIX B B-13 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: CER Priority (3 of 3) Describe your third priority by answering the following questions. *15. Please submit a single sentence that frames your research question. We request that your response specify a condition; a comparison of 2 or more alternatives for the prevention, diagnosis, treatment, monitoring, or delivery of care of the condition; and the study outcome(s) to be assessed (e.g., patient-reported outcomes, surrogate endpoints [such as change in tumor size or laboratory parameters], clinical event, death). *16. Please provide justification for why this study should be a priority. Please consider the following criteria in your justification: disease burden increasing prevalence morbidity and mortality variability in care cost information gap (e.g., little is know about this topic) funding gap (e.g., minimal research is being done on this topic) public interest controversy disproportionate impact by subpopulation potential to act on the information once generated utility of the answer for decision making Please limit your response to 100 words. To verify that your text is within the limits, use this word count link.

APPENDIX B 183 B-14 INITIAL NATIONAL PRIORITIES FOR CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: 17. Please specify the primary area to be studied in the left hand column. If your study involves multiple conditions, please mark the associated conditions in the right hand column. If you are unsure of how to characterize the condition described in questions 15 and 16 above, please indicate the specific condition/disease in the "other" box. Comorbidity Primary Condition (associated conditions—you (please select only one) may select more than one) Sexual Function and Reproductive Disorders Skin Disorders Cardiovascular and Peripheral Vascular Disease Eyes, Ears, Nose, and Throat Disorders Gastrointestinal System Disorders Immune System, Connective Tissue, and Joint Disorders Kidney and Urinary Tract Disorders Pancreatic Disorders Endocrinology and Metabolism Disorders (includes Dia- betes) Infectious Diseases (including HIV/AIDS) Liver and Biliary Tract Disease Musculoskeletal Disorders Neurologic Disorders Oncology and Hematology Psychiatric Disorders Respiratory Disease Trauma, Emergency Medicine, Critical Care Medicine Medical Aspects of Bioterrorism Nutrition (includes Obesity) Complementary and Alternative Medicine Alcoholism, Drug Dependency, and Overdosage Functional Limitation and Disabilities Birth and Developmental Disorders Genetics and Disease Regenerative Medicine (e.g., stem cell research) Safety and Quality of Health Care (e.g., delivery and organization of care) Racial and Ethnic Disparities Women's Health (including disorders during pregnancy) Pediatrics Geriatric Medicine Palliative and End-of-Life Care Other (please specify)

184 APPENDIX B INITIAL NATIONAL PRIORITIES FOR CER B-15 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: 18. For this priority, please select the type(s) of interventions to be compared. You may select more than one. Prevention Procedures – Surgery Testing, monitoring, and evaluation (e.g., lab, Devices (e.g., artificial joint, spinal cage, imaging, psychosocial and functional assess- stent, pacemaker, breast implants) ments) Systems of Care (e.g., organization, man- Standard of care/usual care (please elaborate agement, delivery of healthcare services) on the specific elements of standard of care in the "other" box) Provider/Patient Relationships (e.g., counsel- ing, education) Treatment – Behavioral Treatment pathways (e.g., strategy for early Treatment – Alternative stage prostate cancer, team approach to dia- Treatment – Pharmacological betes care vs. general care) Other (please specify) 19. For the topic you suggested, which of the following types of research would be most effective in providing the needed evidence? Synthesis of existing evidence (e.g., qualitative review, meta-analysis) Primary research using existing health care databases (might include electronic health record data or other clinical data) Primary research using prospective data collection without randomization (e.g., observational study, registry) Primary research through a prospective randomized trial Other (please specify) 20. Please describe the study population(s). You may select more than one. Population at Large Elderly Men Long-term care (institutionalized and home care) Women Ethnic sub-populations only Children/Adolescents Rare Diseases Adults (excluding elderly) Special Populations (e.g., pregnant women, Adults (including elderly) prisoners, low income, persons with disability)— please elaborate in the "other" box Other (please specify)

APPENDIX B 185 B-16 INITIAL NATIONAL PRIORITIES FOR CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: Criteria for Establishing Priorities *21. Briefly describe the process used to develop your priorities. Please limit your re- sponse to 100 words. To verify that your text is within the limits, use this word count link. *22. Please rank what criteria you, or your organization view as most important for setting national priorities for CER. Criteria in order of importance 1st 2nd 3rd 4th 5th Other(s) (specify and include rank) NOTE: The drop down choices for question 22 included the following: Disease burden Increasing prevalence Morbidity and mortality Variability in care Cost Information gap Funding gap Public interest Controversy Disproportionate impact by subpopulation Potential to act on the information Utility of the answer for decision making

186 INITIAL NATIONAL PRIORITIES FOR CER APPENDIX B B-17 IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: Additional Input Regarding CER Infrastructure Effective implementation of CER priorities may require investments in infrastructure. If you have suggestions on specific investments necessary to support expanded CER re- search, please submit your recommendations for the committee's consideration. *23. What are the highest priorities for developing new or enhanced systems, alli- ances, or capacities to sustain a national comparative effectiveness research enter- prise? You may select up to four. Increased workforce training (e.g., clinical researchers, epidemiologists, statisticians, informatics) Clinical trials support (e.g., ad hoc collaborations) Clinical data pooling and mining support Novel method development for data analysis and modeling Clinical registry development, application, and networking Creation of robust national registries for tracking both short- and long-term performance of therapeutic strategies, drugs, or devices Capacity to use electronic health records for safety and effectiveness monitoring Inclusion or creation of direct patient data entry (e.g., questionnaires, surveys, personal health records to provide patient-reported outcomes) Increased coordination of CER through existing Health and Human Services entities Creation of an independent institute for CER 24. Additional suggestions for infrastructure development for committee considera- tion. Please limit your response to 100 words. To verify that your text is within the limits, use this word count link.

APPENDIX B 187 B-18 INITIAL NATIONAL PRIORITIES FOR CER IOM COMMITTEE ON COMPARATIVE EFFECTIVENESS RESEARCH PRIORITIZATION: Demographic Information The following questions will help ensure that the committee has gathered input from a broad range of perspectives. 25. Please select a description that best describes your role or perspective: Employer Medical Administrator Government - Programs (e.g., Medicare, Nonprofit/Policy Institute Medicaid) Patient/Family (including family caregiver) Government - Research Professional Association Health Care Provider Public/Consumer Health Plan/Insurance Carrier Researcher Manufacturer (Device) Manufacturer (Drug or Biologic) Other (please specify) *26. Who are you representing with your response? Self Organization 27. Please provide your contact information (optional). Note that your email address and phone number will not be released to the public. If you choose to omit contact information, your response will still be given full consideration. Name: Organization: Title: Email Address: Phone Number:

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Clinical research presents health care providers with information on the natural history and clinical presentations of disease as well as diagnostic and treatment options. In today's healthcare system, patients, physicians, clinicians and family caregivers often lack the sufficient scientific data and evidence they need to determine the best course of treatment for the patients' medical conditions. Initial National Priorities for Comparative Effectiveness Research(CER) is designed to fill this knowledge gap by assisting patients and healthcare providers across diverse settings in making more informed decisions. In this 2009 report, the Institute of Medicine's Committee on Comparative Effectiveness Research Prioritization establishes a working definition of CER, develops a priority list of research topics, and identifies the necessary requirements to support a robust and sustainable CER enterprise.

As part of the 2009 American Recovery and Reinvestment Act, Congress appropriated $1.1 billion in federal support of CER, reflecting legislators' belief that better decisions about the use of health care could improve the public's health and reduce the cost of care. The Committee on Comparative Effectiveness Research Prioritization was successful in preparing a list 100 top priority CER topics and 10 recommendations for best practices in the field.

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