Improving the relevance and consistency of outcomes in comparative effectiveness research.

Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues.

[1]  D. Altman,et al.  The COMET Initiative database: progress and activities update (2015) , 2017, Trials.

[2]  T. Skolarus,et al.  Re: Neil E. Martin, Laura Massey, Caleb Stowell, et al. Defining a Standard Set of Patient-centered Outcomes for Men with Localized Prostate Cancer. Eur Urol 2015;67:460-7. , 2016, European urology.

[3]  D. Altman,et al.  Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey , 2016, Trials.

[4]  P. Williamson,et al.  Re: Neil E. Martin, Laura Massey, Caleb Stowell, et al. Defining a Standard Set of Patient-centered Outcomes for Men with Localized Prostate Cancer. Eur Urol 2015;67:460-7. , 2015, European urology.

[5]  D. Altman,et al.  The COMET initiative database: progress and activities update (2014) , 2015, Trials.

[6]  C. Terwee,et al.  The quality of systematic reviews of health-related outcome measurement instruments , 2015, Quality of Life Research.

[7]  D. Altman,et al.  COS-STAR: a reporting guideline for studies developing core outcome sets (protocol) , 2015, Trials.

[8]  P. Williamson,et al.  Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews , 2015, Systematic Reviews.

[9]  P. Williamson,et al.  Core outcome sets and trial registries , 2015, Trials.

[10]  P. Williamson,et al.  Survey of new 2007 and 2011 Cochrane reviews found 37% of prespecified outcomes not reported. , 2015, Journal of clinical epidemiology.

[11]  D. Altman,et al.  Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews , 2014, BMJ : British Medical Journal.

[12]  D. Altman,et al.  Choosing Important Health Outcomes For Comparative Effectiveness Research: A Systematic Review. , 2014, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[13]  Steven J Frank,et al.  Defining a standard set of patient-centered outcomes for men with localized prostate cancer. , 2014, European urology.

[14]  D. Altman,et al.  The COMET Initiative database: progress and activities from 2011 to 2013 , 2014, Trials.

[15]  Carolyn M. Reilly,et al.  Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. , 2014, Journal of the National Cancer Institute.

[16]  C. Terwee,et al.  Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’ , 2014, Trials.

[17]  U. Dirnagl,et al.  Biomedical research: increasing value, reducing waste , 2014, The Lancet.

[18]  E. Basch Toward patient-centered drug development in oncology. , 2013, The New England journal of medicine.

[19]  C. Gamble,et al.  Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias — An Updated Review , 2013, PloS one.

[20]  Amy P Abernethy,et al.  Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. , 2013, JAMA internal medicine.

[21]  Elizabeth Gargon,et al.  Can a core outcome set improve the quality of systematic reviews? – a survey of the Co-ordinating Editors of Cochrane review groups , 2013, Trials.

[22]  David Moher,et al.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials , 2013, BMJ.

[23]  Amy P Abernethy,et al.  Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[24]  Jane M Blazeby,et al.  Developing core outcome sets for clinical trials: issues to consider , 2012, Trials.

[25]  D. Altman,et al.  Driving up the Quality and Relevance of Research Through the Use of Agreed Core Outcomes , 2012, Journal of health services research & policy.

[26]  J. Sterne,et al.  The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials , 2011, BMJ : British Medical Journal.

[27]  M. Drummond,et al.  Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study. , 2011, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[28]  G. Guyatt,et al.  GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. , 2011, Journal of clinical epidemiology.

[29]  Nicholas C. Ide,et al.  The ClinicalTrials.gov results database--update and key issues. , 2011, The New England journal of medicine.

[30]  P. Williamson,et al.  Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing Studies , 2011, PLoS medicine.

[31]  D. Moher,et al.  CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, BMC medicine.

[32]  Douglas G Altman,et al.  The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews , 2010, BMJ : British Medical Journal.

[33]  S. Greenfield,et al.  Comparative Effectiveness Research: A Report From the Institute of Medicine , 2009, Annals of Internal Medicine.

[34]  P. Glasziou,et al.  Avoidable waste in the production and reporting of research evidence , 2009, The Lancet.

[35]  P. Tugwell,et al.  OMERACT: An international initiative to improve outcome measurement in rheumatology , 2007, Trials.

[36]  Peter R. Orszag,et al.  Addressing rising health care costs--a view from the Congressional Budget Office. , 2007, The New England journal of medicine.

[37]  C. Adams,et al.  Content and quality of 10,000 controlled trials in schizophrenia over 60 years. , 2013, Schizophrenia bulletin.

[38]  David Geffen,et al.  Getting the Methods Right — The Foundation of Patient-Centered Outcomes Research , 2012 .

[39]  A. Oxman,et al.  understanding and rapid retrieval of key information. , 2010 .

[40]  P. Santaguida,et al.  Current Pharmacologic Treatment of Dementia: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians , 2008 .

[41]  A. Miller,et al.  Reporting results of cancer treatment , 1981, Cancer.