The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study
Abstract Background The smallest worthwhile effect (SWE) is the minimum benefit required in addition to that from a comparator for an intervention to be considered worthwhile by patients. We aimed to estimate the SWE for rotator cuff repair (with decompression and debridement) compared to either dec...
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BMC
2025-06-01
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| Online Access: | https://doi.org/10.1186/s13063-025-08902-x |
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| author | Harrison J. Hansford Rachelle Buchbinder Joshua R. Zadro James H. McAuley Manuela L. Ferreira Adriane Lewin Richard S. Page Ian A. Harris |
| author_facet | Harrison J. Hansford Rachelle Buchbinder Joshua R. Zadro James H. McAuley Manuela L. Ferreira Adriane Lewin Richard S. Page Ian A. Harris |
| author_sort | Harrison J. Hansford |
| collection | DOAJ |
| description | Abstract Background The smallest worthwhile effect (SWE) is the minimum benefit required in addition to that from a comparator for an intervention to be considered worthwhile by patients. We aimed to estimate the SWE for rotator cuff repair (with decompression and debridement) compared to either decompression and debridement alone or to non-surgical treatment for people with atraumatic shoulder pain. Methods Benefit-harm trade-off study. We recruited English-speaking adults aged 45–75 years with shoulder pain of intensity ≥ 4 (on a 0–10 scale) for ≥ 6 months to our online survey through paid advertising on Facebook. Participants must have sought care in the past 6 months and could not have had recent shoulder surgery or significant recent shoulder trauma. Participants were explained three treatments: rotator cuff repair (with subacromial decompression and debridement), subacromial decompression and debridement alone, and non-surgical treatment. Participants completed the benefit-harm trade-off survey to determine the SWE of improvements in pain and function for rotator cuff repair compared to the other treatments and again after one week to assess reliability. We used univariable linear regression to estimate associations between baseline characteristics and SWE. Results We recruited 56 participants. The mean ± standard deviation age was 58.4 ± 6.7 years, and 39 (70%) were female. For rotator cuff repair to be worthwhile compared to decompression and debridement alone, participants needed to see at least a median 40% (interquartile range (IQR) 20–62.5) between-group improvement in pain and function. Compared to non-surgical treatment, the SWE was a median 40% (IQR 30–60). On the Western Ontario Rotator Cuff (WORC) Index, the SWE values equate to a between-group improvement of 28/100 points (533/2100 on the raw WORC score). Female sex was associated with larger SWEs for both comparisons. Reliability analyses were underpowered, 25/56 (45%) provided follow-up data. The intraclass correlation coefficient estimates ranged from 0.60 to 0.77. Conclusions This SWE indicates the benefit required by people with shoulder pain to consider the costs and risks of surgical rotator cuff repair worthwhile is larger than previously estimated minimum clinically important differences (13.5–28/100 on the WORC Index). This SWE may be used to inform the design or interpret the findings of trials of these comparisons. Trial registration Open Science Framework (osf.io/crj9p). Registered retrospectively on 11/06/2024. |
| format | Article |
| id | doaj-art-ceaadcf4c5df4708a6b49f6c216ca23e |
| institution | DOAJ |
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| language | English |
| publishDate | 2025-06-01 |
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| spelling | doaj-art-ceaadcf4c5df4708a6b49f6c216ca23e2025-08-20T03:21:02ZengBMCTrials1745-62152025-06-012611910.1186/s13063-025-08902-xThe smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off studyHarrison J. Hansford0Rachelle Buchbinder1Joshua R. Zadro2James H. McAuley3Manuela L. Ferreira4Adriane Lewin5Richard S. Page6Ian A. Harris7School of Health Sciences, Faculty of Medicine and Health, UNSW SydneySchool of Public Health and Preventive Medicine, Musculoskeletal Health and Wiser Health Care Units, Monash UniversityThe University of Sydney, Sydney Musculoskeletal HealthSchool of Health Sciences, Faculty of Medicine and Health, UNSW SydneyThe University of Sydney, Sydney Musculoskeletal HealthSchool of Clinical Medicine, Faculty of Medicine and Health, UNSW SydneyAustralian Orthopaedic Association National Joint Replacement RegistrySchool of Clinical Medicine, Faculty of Medicine and Health, UNSW SydneyAbstract Background The smallest worthwhile effect (SWE) is the minimum benefit required in addition to that from a comparator for an intervention to be considered worthwhile by patients. We aimed to estimate the SWE for rotator cuff repair (with decompression and debridement) compared to either decompression and debridement alone or to non-surgical treatment for people with atraumatic shoulder pain. Methods Benefit-harm trade-off study. We recruited English-speaking adults aged 45–75 years with shoulder pain of intensity ≥ 4 (on a 0–10 scale) for ≥ 6 months to our online survey through paid advertising on Facebook. Participants must have sought care in the past 6 months and could not have had recent shoulder surgery or significant recent shoulder trauma. Participants were explained three treatments: rotator cuff repair (with subacromial decompression and debridement), subacromial decompression and debridement alone, and non-surgical treatment. Participants completed the benefit-harm trade-off survey to determine the SWE of improvements in pain and function for rotator cuff repair compared to the other treatments and again after one week to assess reliability. We used univariable linear regression to estimate associations between baseline characteristics and SWE. Results We recruited 56 participants. The mean ± standard deviation age was 58.4 ± 6.7 years, and 39 (70%) were female. For rotator cuff repair to be worthwhile compared to decompression and debridement alone, participants needed to see at least a median 40% (interquartile range (IQR) 20–62.5) between-group improvement in pain and function. Compared to non-surgical treatment, the SWE was a median 40% (IQR 30–60). On the Western Ontario Rotator Cuff (WORC) Index, the SWE values equate to a between-group improvement of 28/100 points (533/2100 on the raw WORC score). Female sex was associated with larger SWEs for both comparisons. Reliability analyses were underpowered, 25/56 (45%) provided follow-up data. The intraclass correlation coefficient estimates ranged from 0.60 to 0.77. Conclusions This SWE indicates the benefit required by people with shoulder pain to consider the costs and risks of surgical rotator cuff repair worthwhile is larger than previously estimated minimum clinically important differences (13.5–28/100 on the WORC Index). This SWE may be used to inform the design or interpret the findings of trials of these comparisons. Trial registration Open Science Framework (osf.io/crj9p). Registered retrospectively on 11/06/2024.https://doi.org/10.1186/s13063-025-08902-xSmallest worthwhile effectClinical importanceSurgeryShoulder painRotator cuff |
| spellingShingle | Harrison J. Hansford Rachelle Buchbinder Joshua R. Zadro James H. McAuley Manuela L. Ferreira Adriane Lewin Richard S. Page Ian A. Harris The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study Trials Smallest worthwhile effect Clinical importance Surgery Shoulder pain Rotator cuff |
| title | The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study |
| title_full | The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study |
| title_fullStr | The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study |
| title_full_unstemmed | The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study |
| title_short | The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study |
| title_sort | smallest worthwhile effect on pain and function for rotator cuff repair surgery a benefit harm trade off study |
| topic | Smallest worthwhile effect Clinical importance Surgery Shoulder pain Rotator cuff |
| url | https://doi.org/10.1186/s13063-025-08902-x |
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