OBJECTIVE: To identify which psychological and psychosocial constructs to include in a core outcome set to guide future clinical trials in the tendinopathy field.
DESIGN: Modified International Delphi study.
METHODS: In 3 online Delphi rounds, we presented 35 psychological and psychosocial constructs to an international panel of 38 clinician/researchers and people with tendinopathy. Using a 9-point Likert scale (1 = not important to include, 9 = critical to include), consensus for construct inclusion required =70% of respondents rating "extremely critical to include" (score =7) and =15% rating "not important to include" (score =3). Consensus for exclusion required =70% of respondents rating "not important to include" (score =3) and =15% of rating "critical to include" (score =7).
RESULTS: Thirty-six participants (95% of 38) completed round 1, 90% (n = 34) completed round 2, and 87% (n = 33) completed round 3. Four constructs were deemed important to include as part of a core outcome set: kinesiophobia (82%, median: 8, interquartile range [IQR]: 1.0), pain beliefs (76%, median: -7, IQR: 1.0), pain-related self-efficacy (71%, median: 7, IQR: 2.0), and fear-avoidance beliefs (73%, median: -7, IQR: 1.0). Six constructs were deemed not important to include: perceived injustice (82%), individual attitudes of family members (74%), social isolation and loneliness (73%), job satisfaction (73%), coping (70%), and educational attainment (70%). Clinician/researchers and people with tendinopathy reached consensus that kinesiophobia, pain beliefs, pain self-efficacy, and fear-avoidance beliefs were important psychological constructs to measure in tendinopathy clinical trials. J Orthop Sports Phys Ther 2024;54(1):1-12. Epub 20 September 2023. doi:10.2519/jospt.2023.11903.
To identify which psychological and psychosocial constructs to include in a core outcome set to guide future clinical trials in the tendinopathy field.
ContributorsCarl Stubbs, Sean McAuliffe, Ruth L Chimenti, Brooke K Coombes, Terry Haines, Luke Heales, Robert Jan de Vos, Greg Lehman, Adrian Mallows, Lori A Michner, Neal L Millar, Seth O'Neill, Kieran O'Sullivan, Melanie Plinsinga, Michael Rathleff, Ebonie Rio, Megan Ross, Jean-Sebastien Roy, Karin Gravare Silbernagel, Athol Thomson, Tim Trevail, Inge van den Akker-Scheek, Bill Vicenzino, Johan W S Vlaeyen, Rafael Zambelli Pinto, Peter Malliaras
Disease Category: Rehabilitation
Disease Name: Tendinopathy
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- Recommendations made
- Consensus meeting
- Delphi process
- Literature review
- Survey
Five stage processes including:
(1) Scoping review to extract available data on psychological and psychosocial outcomes measured in tendinopathy studies.
(2) Delphi on-line survey consisting of 3-iterations to determine ‘what’ psychological and psychosocial constructs are important to measure in tendinopathy research. International clinical and research experts in the field of tendinopathy will be invited to participate along with patient representatives who have experienced the condition.
(3) Identify existing outcome measurement instruments for a COS.
(4) Assessing the quality of the measurement properties of OMI’s.
(5) Consensus procedure to agree on the instruments for each outcome included in the COS.