Dataset Information

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.

ABSTRACT:

Background

The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well.

Objective

To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS).

Methods

We used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100?mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds.

Results

Different MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20?mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2?mm for pain at rest, 9?mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83.

Conclusion

We recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20?mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9?mm for pain on arm activity, 80 points for CS, and 11 points for SST.

Trial registration

ClinicalTrials.gov NCT00428870 (first registered January 29, 2007).

SUBMITTER: Kanto K

PROVIDER: S-EPMC7937213 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.

Kanto Kari K Lähdeoja Tuomas T Paavola Mika M Aronen Pasi P Järvinen Teppo L N TLN Jokihaara Jarkko J Ardern Clare L CL Karjalainen Teemu V TV Taimela Simo S

BMC medical research methodology 20210306 1

<h4>Background</h4>The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well.<h4>Objective</h4>To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS).<h4>Methods</h4>We used data from t ...[more]

PMID: 33676417

Similar Datasets

Project description:BackgroundThe Oxford Elbow Score (OES) and the short version of Disabilities of Arms, Shoulder and Hand (QuickDASH) are common patient-reported outcomes for people with elbow problems. Our primary objective was to define thresholds for the Minimal Important Difference (MID) and Patient-Acceptable Symptom State (PASS) for the OES and QuickDASH. The secondary aim was to compare the longitudinal validity of these outcome measures.MethodsWe recruited 97 patients with clinically-diagnosed tennis elbow for a prospective observational cohort study in a pragmatic clinical setting. Fifty-five participants received no specific intervention, 14 underwent surgery (11 as primary treatment and 4 during follow-up), and 28 received either botulinum toxin injection or platelet rich plasma injection. We collected OES (0 to 100, higher is better) and QuickDASH (0 to 100, higher is worse), and global rating of change (as an external transition anchor question) at six weeks, three months, six months and 12 months. We defined MID and PASS values using three approaches. To assess the longitudinal validity of the measures, we calculated the Spearman's correlation coefficient between the change in the outcome scores and external transition anchor question, and the Area Under the Curve (AUC) from a receiver operating characteristics (ROC) analysis. To assess signal-to-noise ratio, we calculated standardized response means.ResultsDepending on the method, MID values ranged from 16 to 21 for OES Pain; 10 to 17 for OES Function; 14 to 28 for OES Social-psychological; 14 to 20 for OES Total score, and - 7 to -9 for QuickDASH. Patient-Acceptable Symptom State (PASS) cut offs were 74 to 84 for OES Pain; 88 to 91 for OES Function; 75 to 78 with OES Social-psychological; 80 to 81 with OES Total score and 19 to 23 with Quick-DASH. OES had stronger correlations with the anchor items, and AUC values suggested superior discrimination (between improved and not improved) compared with QuickDASH. OES also had superior signal-to-noise ratio compared with QuickDASH.ConclusionThe study provides MID and PASS values for OES and QuickDASH. Due to better longitudinal validity, OES may be a better choice for clinical trials.Trial registrationClinicalTrials.gov NCT02425982 (first registered April 24, 2015).

Project description:BackgroundArthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression.MethodsWe did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011.FindingsBetween Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference -1·3 points (95% CI -3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5-5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8-6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group).InterpretationSurgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process.FundingArthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).

Dataset Information

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.

Background

Objective

Methods

Results

Conclusion

Trial registration

Publications

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets