Het is goed om je beter te voelen, maar je beter te voelen: of een patiënt de behandeling succesvol vindt, hangt af van de vragen die onderzoekers stellen

Het is goed om je beter te voelen, maar je beter te voelen: of een patiënt de behandeling succesvol vindt, hangt af van de vragen die onderzoekers stellen

november 28, 2019 0 Door admin

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It is good to feel better, but better to feel good: whether a patient finds treatment ‘successful’ or not depends on the questions researchers ask

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  1. Ewa M Roos1,
  2. Eleanor Boyle1,2,
  3. Richard B Frobell3,
  4. L Stefan Lohmander3,
  5. Lina Holm Ingelsrud1,4

  1. 1 Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark

  2. 2 Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada

  3. 3 Orthopaedics, Department of Clinical Sciences Lund, Faculty of Medicine, Lunds Universitet, Lund, Sweden

  4. 4 Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark
  1. Correspondence to Dr Ewa M Roos, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense 5230, Denmark; eroos{at}health.sdu.dk

Abstract

Introduction In sports physiotherapy, medicine and orthopaedic randomised controlled trials (RCT), the investigators (and readers) focus on the difference between groups in change scores from baseline to follow-up. Mean score changes are difficult to interpret (‘is an improvement of 20 units good?’), and follow-up scores may be more meaningful. We investigated how applying three different responder criteria to change and follow-up scores would affect the ‘outcome’ of RCTs. Responder criteria refers to participants’ perceptions of how the intervention affected them.

Methods We applied three different criteria—minimal important change (MIC), patient acceptable symptom state (PASS) and treatment failure (TF)—to the aggregate Knee injury and Osteoarthritis Outcome Score (KOOS4) and the five KOOS subscales, the primary and secondary outcomes of the KANON trial (ISRCTN84752559). This trial included young active adults with an acute ACL injury and compared two treatment strategies: exercise therapy plus early reconstructive surgery, and exercise therapy plus delayed reconstructive surgery, if needed.

Results MIC: At 2 years, more than 90% in the two treatment arms reported themselves to be minimally but importantly improved for the primary outcome KOOS4. PASS: About 50% of participants in both treatment arms reported their KOOS4 follow-up scores to be satisfactory. TF: Almost 10% of participants in both treatment arms found their outcomes so unsatisfactory that they thought their treatment had failed. There were no statistically significant or meaningful differences between treatment arms using these criteria.

Conclusion We applied change criteria as well as cross-sectional follow-up criteria to interpret trial outcomes with more clinical focus. We suggest researchers apply MIC, PASS and TF thresholds to enhance interpretation of KOOS and other patient-reported scores. The findings from this study can improve shared decision-making processes for people with an acute ACL injury.

  • knee ACL
  • knee surgery
  • measurement
  • rehabilitation
  • randomised controlled trial

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