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Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review.

ABSTRACT: OBJECTIVE:Patient-reported outcome scales determine response to treatment. The minimal clinically important difference of these scales is a measure of responsiveness: the smallest change in a score associated with a clinically important change to the patient. This study sought to summarize the literature on minimal clinically important difference for the most commonly reported shoulder outcome scales. DESIGN:A literature search of PubMed and EMBASE databases identified 193 citations, 27 of which met the inclusion/exclusion criteria. RESULTS:For rotator cuff tears, a minimal clinically important difference range of 9-26.9 was reported for American Shoulder and Elbow Surgeons, 8 or 10 for Constant, and 282.6-588.7 for the Western Ontario Rotator Cuff Index. For patients who underwent arthroplasty, a minimal clinically important difference range of 6.3-20.9 was reported for American Shoulder and Elbow Surgeons, 5.7-9.4 for Constant, and 14.1-20.6 for the Shoulder Pain and Disability Index. For proximal humeral fractures, a minimal clinically important difference range of 5.4-11.6 was reported for Constant and 8.1-13.0 for Disability of the Arm, Shoulder, and Hand. CONCLUSIONS:A wide range of minimal clinically important difference values was reported for each patient population and instrument. In the future, a uniform outcome instrument and minimal clinically important difference will be useful to measure clinically meaningful change across practices and the spectrum of shoulder diagnoses.

SUBMITTER: Dabija DI

PROVIDER: S-EPMC6649681 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review.

Dabija Dominique I DI Jain Nitin B NB

American journal of physical medicine & rehabilitation 20190801 8

<h4>Objective</h4>Patient-reported outcome scales determine response to treatment. The minimal clinically important difference of these scales is a measure of responsiveness: the smallest change in a score associated with a clinically important change to the patient. This study sought to summarize the literature on minimal clinically important difference for the most commonly reported shoulder outcome scales.<h4>Design</h4>A literature search of PubMed and EMBASE databases identified 193 citatio ...[more]

PMID: 31318747

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Project description:ImportancePatient-reported outcome measures (PROMs) allow clinicians and researchers to assess health-related information from a patient's perspective. These measures have been used more frequently over the last several decades, but an associated minimal clinically important difference (MCID) is needed to optimize their utility. This narrative review identified the top 100 most-cited otolaryngology-related PROM development and validation publications and assessed the presence and characteristics of the PROMs' associated MCID.ObservationsIn this narrative review, a literature search in Scopus and Web of Science was conducted on June 29, 2022, using keywords related to PROM development and validation studies in otolaryngology and reference lists. Studies that met the definition of a PROM and assessed an otolaryngologic disorder or study population were included for full-text review. After full-text review of 188 articles, the top 100 most-cited PROM development and validation publications, resulting in 106 total PROMs, were chosen for review. A total of 39 (37%) of the identified PROMs had an associated MCID. Of those reporting an MCID, 14 (35.9%) used an anchor-based method, 12 (30.8%) used a distribution-based method, 10 (25.6%) used both, and 3 (7.7%) did not specify or used neither method. Rhinology had the greatest number of PROMs with an associated MCID (16 of 24, 66%), and pediatrics had the fewest (1 of 13, 7.7%). The median number of citations of PROMs with an MCID was higher than those without an MCID.Conclusions and relevanceThe majority of the most-cited PROMs in otolaryngology lack an associated MCID. These data indicated that there are a multitude of PROMs that have been cited hundreds of times and used for decades without the ability to identify whether a particular change in score on the instrument is clinically meaningful. There is a need to determine and validate MCIDs for commonly used PROMs to aid clinical research and trial interpretation.

Project description:Several patient-reported outcome measures have been developed to assess health status in pulmonary arterial hypertension. The required change in instrument scores needed, to be seen as meaningful to the individual, however remain unknown. We sought to identify minimal clinically important differences in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and to validate these against objective markers of functional capacity. Minimal clinically important differences were established from a discovery cohort (n = 129) of consecutive incident cases of idiopathic pulmonary arterial hypertension with CAMPHOR scores recorded at treatment-naïve baseline and 4-12 months following pulmonary arterial hypertension therapy. An independent validation cohort (n = 87) was used to verify minimal clinically important differences. Concurrent measures of functional capacity relative to CAMPHOR scores were collected. Minimal clinically important differences were derived using anchor- and distributional-based approaches. In the discovery cohort, mean (SD) was 54.4 (16.4) years and 64% were female. Most patients (63%) were treated with sequential pulmonary arterial hypertension therapy. Baseline CAMPHOR scores were: Symptoms, 12 (7); Activity, 12 (7) and quality of life, 10 (7). Pulmonary arterial hypertension treatment resulted in significant improvements in CAMPHOR scores (p < 0.05). CAMPHOR minimal clinically important differences averaged across methods for health status improvement were: Symptoms, -4 points; Activity, -4 points and quality of life -3 points. CAMPHOR Activity score change ≥minimal clinically important difference was associated with significantly greater improvement in six-minute walk distance, in both discovery and validation populations. In conclusion, CAMPHOR scores are responsive to pulmonary arterial hypertension treatment. Minimal clinically important differences in pulmonary hypertension-specific scales may provide useful insights into treatment response in future clinical trials.

Project description:BackgroundA minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double-blind, placebo-controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1-7).ObjectivesTo estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor-based method.MethodsData were pooled from three 6-week double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: "low dose," which includes 40 or 50 mg/day; and "high dose," which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine- and placebo-treated) with a Clinical Global Impression of Change-Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved).ResultsThe least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: -2.4; high dose: -3.2; both, P < 0.001) versus placebo (-0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change-Tardive Dyskinesia score ≤3 at week 6 (mean change: -2.2; median change: -2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: -2.0; median change: -2).ConclusionsResults from an anchor-based method indicate that a 2-point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Project description:ObjectivesTo systematically review studies using machine learning (ML) algorithms to predict whether patients undergoing total knee or total hip arthroplasty achieve an improvement as high or higher than the minimal clinically important differences (MCID) in patient reported outcome measures (PROMs) (classification problem).MethodsStudies were eligible to be included in the review if they collected PROMs both pre- and postintervention, reported the method of MCID calculation and applied ML. ML was defined as a family of models which automatically learn from data when selecting features, identifying nonlinear relations or interactions. Predictive performance must have been assessed using common metrics. Studies were searched on MEDLINE, PubMed Central, Web of Science Core Collection, Google Scholar and Cochrane Library. Study selection and risk of bias assessment (ROB) was conducted by two independent researchers.Results517 studies were eligible for title and abstract screening. After screening title and abstract, 18 studies qualified for full-text screening. Finally, six studies were included. The most commonly applied ML algorithms were random forest and gradient boosting. Overall, eleven different ML algorithms have been applied in all papers. All studies reported at least fair predictive performance, with two reporting excellent performance. Sample size varied widely across studies, with 587 to 34,110 individuals observed. PROMs also varied widely across studies, with sixteen applied to TKA and six applied to THA. There was no single PROM utilized commonly in all studies. All studies calculated MCIDs for PROMs based on anchor-based or distribution-based methods or referred to literature which did so. Five studies reported variable importance for their models. Two studies were at high risk of bias.DiscussionNo ML model was identified to perform best at the problem stated, nor can any PROM said to be best predictable. Reporting standards must be improved to reduce risk of bias and improve comparability to other studies.

Dataset Information

Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review.

Publications

Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review.

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