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, E. M., Boyle, E., Frobell, R. B., Lohmander, L. S., & Ingelsrud, L. H. British journal of sports medicine, 53(23):1474–1478, December, 2019. Place: England
doi  abstract   bibtex   
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.
@article{roos_it_2019,
	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.},
	volume = {53},
	copyright = {© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and  permissions. Published by BMJ.},
	issn = {1473-0480 0306-3674},
	doi = {10.1136/bjsports-2018-100260},
	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.},
	language = {eng},
	number = {23},
	journal = {British journal of sports medicine},
	author = {Roos, Ewa M. and Boyle, Eleanor and Frobell, Richard B. and Lohmander, L. Stefan and Ingelsrud, Lina Holm},
	month = dec,
	year = {2019},
	pmid = {31072841},
	note = {Place: England},
	keywords = {*Treatment Outcome, Adult, Anterior Cruciate Ligament Injuries/*surgery/*therapy, Anterior Cruciate Ligament Reconstruction, Data Interpretation, Statistical, Exercise Therapy, Female, Humans, Male, Patient Reported Outcome Measures, Randomized Controlled Trials as Topic/*standards, knee ACL, knee surgery, measurement, randomised controlled trial, rehabilitation},
	pages = {1474--1478}
}

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