Including Patient-Reported Outcomes and Patient-Reported Resource-Use Questionnaires in Studies

http://www.pcori.org (accessed March 17, 2014). Institute of Medicine, http://www.nap.edu/openbook.php?record_id=12648 (accessed March 21, 2014). Inglehart, 2009, Prioritizing comparative-effectiveness research—IOM recommendations, NEJM, 361, 325, 10.1056/NEJMp0904133 Pandharipande, 2009, Comparative effectiveness research: what it means for radiology, Radiology, 253, 600, 10.1148/radiol.2533091286 http://www.ahrq.gov/(accessed March 17, 2014). Chassany, 2002, Patient-reported outcomes: the example of health-related quality of life—a European guidance document for the improved integration of health-related quality of life assessment in the drug regulation process, DIJ, 36, 209 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf (accesses March 12, 2014). United States Health and Human Services, Food and Drug Administration, guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims, December 2009. (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, accessed March 12, 2014). 1998 McDowell, 1996 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm (accessed March 18, 2014). http://phi.uhce.ox.ac.uk/home.php, (accessed March 17, 2014). Revicki, 2007, Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier, Qual Life Res, 16, 717, 10.1007/s11136-006-9153-5 Patrick, 2011, Content validity—Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1-Eliciting concepts for a new PRO instrument, Value Health, 14, 967, 10.1016/j.jval.2011.06.014 Patrick, 2011, Content validity—Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2 – assessing respondent understanding, Value Health, 14, 978, 10.1016/j.jval.2011.06.013 http://www.nihpromis.org/about/overview (accessed March 13, 2014). http://www.assessmentcenter.net/documents/InstrumentLibrary.pdf, accessed March 21, 2014). Gold MR, Siegel JE, Russell LB, et al. Cost-effectiveness in health and medicine. 1996. Ramsey, 2005, Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report, Value in Health, 8, 521, 10.1111/j.1524-4733.2005.00045.x Neumann, 2004 Drummond, 2005 Wilson, 1995, Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes, JAMA, 273, 59, 10.1001/jama.1995.03520250075037 http://www.who.int/classifications/icf/en/; accessed on March 14, 2014. Calvert, 2013, The CONSORT patient-reported outcome (PRO) extension: implications for clinical trials and practice, Health and Quality of Life Outcomes, 11, 184, 10.1186/1477-7525-11-184 Gondek, 2007, Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels, J Clin Oncol, 25, 5087, 10.1200/JCO.2007.11.3845 Garrison, 2011, Using cost-effectiveness analysis to support R&D portfolio prioritization for product innovations in measles vaccination, J Infectious Diseases, 204, S124, 10.1093/infdis/jir114 Hollingworth, 2007, Technology assessment in radiology: putting the evidence in evidence-based radiology, Radiology, 244, 31, 10.1148/radiol.2441051790 Smeets, 2011, Arthritis Care & Research, 63, S158, 10.1002/acr.20542 Roland, 1983, A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain, Spine (Phila Pa 1976), 8, 141, 10.1097/00007632-198303000-00004 Roland, 2000, The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire, Spine (Phila Pa 1976), 25, 3115, 10.1097/00007632-200012150-00006 Fairbank, 1980, The Oswestry Low Back Pain Disability Questionnaire, Physiotherapy, 66, 271 Graves, 2012, Early imaging for acute low back pain one-year health and disability outcomes among Washington State workers, Spine, 37, 1617, 10.1097/BRS.0b013e318251887b Friedly, 2012, Study protocol–Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults, BioMed Central Musculoskeletal Disorders, 13, 48, 10.1186/1471-2474-13-48 Sloan, 2007, Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute–sponsored clinical trials networks, J Clin Oncol, 25, 5070, 10.1200/JCO.2007.12.7670 Brunner, 2007, Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute–sponsored clinical trials networks, J Clin Oncol, 25, 5051, 10.1200/JCO.2007.11.3324 Minasian, 2007, Health-related quality of life and symptom management research sponsored by the National Cancer Institute, J Clin Oncol, 25, 5128, 10.1200/JCO.2007.12.6672 Osoba, 2011, Health-related quality of life and cancer clinical trials, Therapeutic Advances in Medical Oncology, 3, 57, 10.1177/1758834010395342 Billingham, 1999, Methods for the analysis of quality-of-life and survival data in health technology assessment, Health Technol Assess, 3, 10.3310/hta3100 Center for Medical Technology Policy, Recommendations for incorporating patient-reported outcomes (PROs) into clinical comparative effectiveness research (CER) in adult oncology, effectiveness guidance document, Published Version 1.0, May 20, 2012. (http://www.cmtpnet.org/resource-center/view/egd-on-patient-reported-outcomes-in-cer-and-adult-oncology/; accessed March 17, 2014). Yanez, 2013, The FACT-G7: a rapid version of the functional assessment of cancer therapy-general (FACT-G) for monitoring symptoms and concerns in oncology practice and research, Annals of Oncology, 24, 1073, 10.1093/annonc/mds539 http://www.facit.org/FACITOrg/Questionnaires (accessed March 21, 2014). Carlos, 2012, Patient centered outcomes in imaging: quantifying value, JACR, 9, 725