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

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

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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.

Original languageEnglish
JournalBritish Journal of Sports Medicine
Volume53
Issue number23
Pages (from-to)1474-1478
ISSN0306-3674
DOIs
Publication statusPublished - Dec 2019

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Research Personnel
Treatment Failure
Knee Injuries
Knee Osteoarthritis
Orthopedics
Young Adult
Randomized Controlled Trials

Keywords

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

Cite this

@article{35fe7266d15448f98b7e6348a4627d9b,
title = "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",
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.",
keywords = "knee ACL, knee surgery, measurement, randomised controlled trial, rehabilitation",
author = "Roos, {Ewa M.} and Eleanor Boyle and Frobell, {Richard B.} and Lohmander, {L. Stefan} and Ingelsrud, {Lina Holm}",
year = "2019",
month = "12",
doi = "10.1136/bjsports-2018-100260",
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issn = "0306-3674",
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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. / Roos, Ewa M.; Boyle, Eleanor; Frobell, Richard B.; Lohmander, L. Stefan; Ingelsrud, Lina Holm.

In: British Journal of Sports Medicine, Vol. 53, No. 23, 12.2019, p. 1474-1478.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - It is good to feel better, but better to feel good

T2 - Whether a patient finds treatment successful' or not depends on the questions researchers ask

AU - Roos, Ewa M.

AU - Boyle, Eleanor

AU - Frobell, Richard B.

AU - Lohmander, L. Stefan

AU - Ingelsrud, Lina Holm

PY - 2019/12

Y1 - 2019/12

N2 - 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.

AB - 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.

KW - knee ACL

KW - knee surgery

KW - measurement

KW - randomised controlled trial

KW - rehabilitation

U2 - 10.1136/bjsports-2018-100260

DO - 10.1136/bjsports-2018-100260

M3 - Journal article

VL - 53

SP - 1474

EP - 1478

JO - British Journal of Sports Medicine

JF - British Journal of Sports Medicine

SN - 0306-3674

IS - 23

ER -