How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

BackgroundIn cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population.MethodsInformed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed.ResultsOf the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %).ConclusionsThis study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes.

[1]  Caroline B. Terwee,et al.  Self-report fatigue questionnaires in multiple sclerosis, Parkinson’s disease and stroke: a systematic review of measurement properties , 2011, Quality of Life Research.

[2]  H. Williams,et al.  The Harmonizing Outcome Measures for Eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology. , 2015, The Journal of investigative dermatology.

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

[4]  C. Terwee,et al.  Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments , 2009, Quality of Life Research.

[5]  C. Terwee,et al.  Measurement properties of performance-based measures to assess physical function in hip and knee osteoarthritis: a systematic review. , 2012, Osteoarthritis and cartilage.

[6]  C. Terwee,et al.  Psychometric properties of vision‐related quality of life questionnaires: a systematic review , 2004, Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians.

[7]  C. Terwee,et al.  Bioelectrical impedance analysis to estimate body composition in children and adolescents: a systematic review and evidence appraisal of validity, responsiveness, reliability and measurement error , 2013, Obesity reviews : an official journal of the International Association for the Study of Obesity.

[8]  C. Terwee,et al.  The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study , 2010, Quality of Life Research.

[9]  C. Terwee,et al.  Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist , 2011, Quality of Life Research.

[10]  A. Carr,et al.  Primary total hip replacement surgery: a systematic review of outcomes and modelling of cost-effectiveness associated with different prostheses. , 1998, Health technology assessment.

[11]  C. Terwee,et al.  The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. , 2010, Journal of clinical epidemiology.

[12]  D. Hunter,et al.  Qualitative Research: Consensus methods for medical and health services research , 1995 .

[13]  C. Terwee,et al.  Core outcome domains for clinical trials in non-specific low back pain , 2015, European Spine Journal.

[14]  P. Tugwell,et al.  Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. , 2014, Journal of clinical epidemiology.

[15]  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.

[16]  D. Spiegelhalter,et al.  Consensus development methods, and their use in clinical guideline development. , 1998, Health technology assessment.

[17]  E. Mohammadi,et al.  Barriers and facilitators related to the implementation of a physiological track and trigger system: A systematic review of the qualitative evidence , 2017, International journal for quality in health care : journal of the International Society for Quality in Health Care.

[18]  C. Terwee,et al.  Quality criteria were proposed for measurement properties of health status questionnaires. , 2007, Journal of clinical epidemiology.

[19]  C. Terwee,et al.  The Six-Minute Walk Test in Chronic Pediatric Conditions: A Systematic Review of Measurement Properties , 2012, Physical Therapy.

[20]  H. Vet,et al.  The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. , 1998, Journal of clinical epidemiology.

[21]  Douglas G. Altman,et al.  Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey , 2016, PloS one.

[22]  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.

[23]  S. V. Elsland,et al.  Instruments to assess physical activity in patients with osteoarthritis of the hip or knee: a systematic review of measurement properties. , 2011, Osteoarthritis and cartilage.

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

[25]  L. McLeod,et al.  ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research , 2013, Quality of Life Research.

[26]  Mike Clarke,et al.  Standardising outcomes for clinical trials and systematic reviews , 2007, Trials.

[27]  L. Hartling,et al.  Primary Outcomes Reporting in Trials (PORTal): a systematic review of inadequate reporting in pediatric randomized controlled trials. , 2017, Journal of clinical epidemiology.

[28]  C B Terwee,et al.  Assessing the quality of available patient reported outcome measures for intermittent claudication: a systematic review using the COSMIN checklist. , 2015, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.