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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. LU ; Boyle, Eleanor; Frobell, Richard B. LU ; Lohmander, L. Stefan LU and Ingelsrud, Lina Holm (2019) In British journal of sports medicine
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... (More)


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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Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
knee ACL, knee surgery, measurement, randomised controlled trial, rehabilitation
in
British journal of sports medicine
publisher
BMJ Publishing Group
external identifiers
  • scopus:85065589124
ISSN
0306-3674
DOI
10.1136/bjsports-2018-100260
language
English
LU publication?
yes
id
84e645fd-fff3-4786-963f-ee5dad6a875a
date added to LUP
2019-05-24 14:46:12
date last changed
2019-06-19 04:13:33
@article{84e645fd-fff3-4786-963f-ee5dad6a875a,
  abstract     = {<p><br>
                                                         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                             <br>
                            <sub>4</sub><br>
                                                         ) 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                             <br>
                            <sub>4</sub><br>
                                                         . PASS: About 50% of participants in both treatment arms reported their KOOS                             <br>
                            <sub>4</sub><br>
                                                          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.                         <br>
                        </p>},
  author       = {Roos, Ewa M. and Boyle, Eleanor and Frobell, Richard B. and Lohmander, L. Stefan and Ingelsrud, Lina Holm},
  issn         = {0306-3674},
  keyword      = {knee ACL,knee surgery,measurement,randomised controlled trial,rehabilitation},
  language     = {eng},
  month        = {05},
  publisher    = {BMJ Publishing Group},
  series       = {British journal of sports medicine},
  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},
  url          = {http://dx.doi.org/10.1136/bjsports-2018-100260},
  year         = {2019},
}