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Pain
Original article
Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study
  1. Matthew J Page1,2,
  2. Hsiaomin Huang3,
  3. Arianne P Verhagen4,
  4. Rachelle Buchbinder5,6 and
  5. Joel J Gagnier3,7
  1. 1School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  2. 2School of Social and Community Medicine, University of Bristol, Bristol, UK
  3. 3Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan, USA
  4. 4Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
  5. 5Monash Department of Clinical Epidemiology, Cabrini Institute and Monash University, Melbourne, Victoria, Australia
  6. 6Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  7. 7Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor,  Michigan, USA
  1. Correspondence to Dr Joel Gagnier; jgagnier{at}umich.edu

Abstract

Objective To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders.

Methods We performed an online modified Delphi study with an international, multidisciplinary and multistakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core.

Results In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: ‘pain’, ‘physical functioning’, ‘global assessment of treatment success’ and ‘health-related quality of life’. Two additional domains, ‘sleep functioning’ and ‘psychological functioning’, met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that ‘number of deaths’ was not a core domain, but insufficient agreement on whether or not several other domains, including ‘range of motion’ and ‘muscle strength’, were core domains.

Conclusions Based on international consensus from patients, clinicians and researchers, ‘pain’, ‘physical functioning’, ‘global assessment of treatment success’ and ‘health-related quality of life’ were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration.

  • Outcomes research
  • Patient perspective
  • Qualitative research

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/rmdopen-2016-000380

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    Footnotes

    • RB and JJG Contributed equally as senior authors of this work.

    • Contributors RB and JJG conceived the study design and obtained funding. MJP, HH and APV provided input on the study design. MJP and HH undertook the statistical analyses. MJP wrote the first draft of the manuscript. All authors contributed to revisions of the manuscript. All authors approved the final version of the submitted manuscript.

    • Funding This project was supported by funding from a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington Engagement Award #2072, and Outcome Measures in Rheumatology (OMERACT). MJP is supported by an Australian National Health and Medical Research Council (NHMRC) Early Career Fellowship (1088535). RB is supported by an Australian NHMRC Senior Principal Research Fellowship.

    • Competing interests None declared.

    • Ethics approval University of Michigan (HUM00102228).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All relevant data are within the paper and its Supporting Files.