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

Roos, Ewa M; Boyle, Eleanor; Frobell, Richard B; Lohmander, L Stefan; Ingelsrud, Lina Holm

doi:10.1136/bjsports-2018-100260

Cited by 80Statistical Methods in Clinical TrialsMusculoskeletal pain and rehabilitationMeta-analysis and systematic reviews

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

Roos, Ewa M, Boyle, Eleanor, Frobell, Richard B, Lohmander, L Stefan, Ingelsrud, Lina Holm·2019·British Journal of Sports Medicine

DOI 10.1136/bjsports-2018-100260

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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 (KOOS 4) 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 KOOS 4. PASS: About 50% of participants in both treatment arms reported their KOOS 4 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.

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Responsiveness and the Minimal Important Change of Knee Injury and Osteoarthritis Outcome Score Following Physiotherapy Intervention in Iraqi People with Knee Osteoarthritis
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Self-citation

Authors: Roos, E. M., Boyle, E., Frobell, R. B., Lohmander, L. S., & Ingelsrud, L. H.
Affiliations: University of Southern Denmark (DK)
Lund University (SE)
Orthopaedics, Department of Clinical Sciences Lund, Faculty of Medicine, Lunds Universitet, Lund, Sweden
Corresponding author: Roos, Ewa M
ORCID: Roos, Ewa M
Boyle, Eleanor
Frobell, Richard B
Ingelsrud, Lina Holm
Venue: British Journal of Sports Medicine
Publisher: BMJ
Published: 2019-05-09
Volume: 53
Issue: 23
Pages: 1474-1478
ISSN: 0306-3674 (ISSN-L)
1473-0480
DOI: 10.1136/bjsports-2018-100260
OpenAlex: W2944307193
Cited by: 80
References: 18
Citations by year: 2026: 15 · 2025: 11 · 2024: 13 · 2023: 15 · 2022: 11 · 2021: 5 · 2020: 9 · 2019: 1
FWCI: 5.07
Type: journal article
Language: en
Open access: closed
Locations: British Journal of Sports Medicine (publishedVersion)
PubMed (publishedVersion)
Lund University Publications (Lund University) (submittedVersion)
HighWire Press Open Archive (submittedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: minimal important change, patient acceptable symptom state, treatment failure, patient-reported outcomes, KOOS, acute ACL injury, exercise therapy, shared decision-making, outcome interpretation
MeSH terms: Anterior Cruciate Ligament Injuries, Patient Reported Outcome Measures, Adult, Data Interpretation, Statistical, Exercise Therapy, Female, Humans, Male, Randomized Controlled Trials as Topic, Treatment Outcome, Anterior Cruciate Ligament Reconstruction

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