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10 Recommended core outcome domains for tendinopathy derived from a delphi of patients and health care professionals: the groningen ISTS2018 consensus
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  1. Bill Vicenzino1,
  2. Robert-Jan de Vos2,
  3. Håkan Alfredson3,
  4. Roald Bahr4,5,
  5. Andrew Carr6,
  6. Jill Cook6,
  7. Brooke Coombes7,
  8. Siu Ngor Fu8,
  9. Karin Gravare Silbernagel9,
  10. Alison Grimaldi1,10,
  11. Jeremy Lewis11,12,
  12. Nicola Maffulli26,27,
  13. S Peter Magnusson13,14,
  14. Peter Malliaras15,
  15. Sean McAuliffe5,
  16. Edwin H Oei16,
  17. Craig Purdam,
  18. Jonathan Rees17,27,
  19. Ebonie Rio6,
  20. Aex Scot18,
  21. Cathy Speed19,
  22. Inge van den Akker-Scheek20,21,
  23. Adam Weir22,23,24,
  24. Jennifer Moriatis Wolf25,
  25. J (Hans) Zwerver20
  1. 1The University of Queensland: School of Health and Rehabilitation Sciences, Australia
  2. 2Erasmus MC University Medical Centre, The Netherlands
  3. 3Sports Medicine Unit, University of Umeå, Sweden, Sweden
  4. 4Oslo Sports Trauma Research Center, Norwegian School of Sport Sciences, Norway
  5. 5Aspetar Orthopedic and Sports Medicine Hospital, Qatar
  6. 6La Trobe University Sport and Exercise Medicine Research Centre, Australia
  7. 7Griffith University, Australia
  8. 8Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong (SAR)
  9. 9Department of Physical Therapy, University of Delaware, USA
  10. 10Physiotec, Tarragindi, Australia
  11. 11University of Hertfordshire, School of Health and Midwifery, UK
  12. 12Central London Community Healthcare NHS trust, London, UK
  13. 13Department of Physical Therapy, Bispebjerg Hospital, Denmark
  14. 14Department of Sports Medicine, Bispebjerg Hospital, Denmark
  15. 15Department of Physiotherapy, Monash University, Australia
  16. 16Erasmus MC, University Medical Center; Department of Radiology and Nuclear Medicine, The Netherlands
  17. 17Fortius Clinic, UK
  18. 18Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Canada
  19. 19Professor of Sports Medicine and Human Performance, Cardiff metropolitan University, Cardiff, UK
  20. 20University of Groningen, University Medical Center Groningen, Department of Sport and Exercise Medicine, The Netherlands
  21. 21University of Groningen, University Medical Center Groningen, Department of Orthopedics, The Netherlands
  22. 22Erasmus MC Center for Groin Injuries, Department of Orthopaedics, Erasmus MC University Medical Centre, The Netherlands
  23. 23Aspetar Sports Groin Pain Centre, Aspetar Orthopaedic and Sports Hospital, Qatar
  24. 24Sport medicine and exercise clinic Haarlem (SBK), The Netherlands
  25. 25Department of Orthopaedic Surgery, University of Chicago, USA
  26. 26Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Italy
  27. 27Centre for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, Mile End Hospital, UK

Abstract

Introduction Tendinopathy (local tendon pain associated with physical activity) is a challenge to treat despite recent advances. One factor contributing to this challenge is our limited ability to synthesise/meta-analyse research findings, which is further compounded by a lack of valid outcome measures. We determined the core outcome domains against which outcome measures could be recommended.

Materials and methods We conducted a Delphi study of patients and health care professionals (HCP) in two parts: an online survey and consensus meeting. Online survey items were extracted from clinical trial reports. Agree, disagree, or unsure were options in response to: ‘The ‘item’ is important enough to be included in a core domain set of tendinopathy’. A-priori criterion of ≥70% participant agreement was deemed for selection of a core domain.

Results 32 patients and 28 HCP (92% had >10 years of tendinopathy experience, 71% consulted >10 cases per month) completed the online survey. 2 patients and 15 HCP attended the consensus meeting. Of the original 24 items (from trial reports); 9 were core: Patient overall rating, participation, pain on activity/loading, disability, function, physical function capacity, quality of life, psychology, and pain over a specified timeframe. Eight items were not core domains: range of motion, palpation, clinical examination, structure, pain on examination or without other specification, drop out, and sensory modality pain. Remaining seven items did not meet criterion.

Conclusion The core domain set serves as a guide for reporting of outcomes in clinical trials. Further research should determine these outcomes for each specific tendon.

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