Beyond statistical significance:Embracing minimal clinically important difference for better patient care

The minimal clinically important difference(MCID)represents a pivotal metric in bridging the gap between statistical significance and clinical relevance,addressing the direct impact of medical interventions from the patient's perspective.This comprehensive review analyzes the evolution,applications,and challenges of MCID across medical specialties,emphasizing its necessity in ensuring that clinical outcomes not only demonstrate statistical significance but also offer genuine clinical utility that aligns with patient expectations and needs.We discuss the evolution of MCID since its inception in the 1980s,its current applications across various medical specialties,and the methodologies used in its calculation,highlighting both anchor-based and distribution-based approaches.Furthermore,the paper delves into the challenges associated with the application of MCID,such as methodological variability and the interpretation difficulties that arise in clinical settings.Recommendations for the future include standardizing MCID calculation methods,enhancing patient involvement in setting MCID thresholds,and extending research to incorporate diverse global perspectives.These steps are critical to refining the role of MCID in patient-centered healthcare,addressing existing gaps in methodology and interpretation,and ensuring that medical interventions lead to significant,patient-perceived improvements.

The minimal clinically important difference for gait speed in significant unilateral vestibular hypofunction after vestibular rehabilitation

Gait speed is a valid measure of both physical function and vestibular health.Vestibular rehabilitation is useful to improve gait speed for patients with vestibular hypofunction,yet there is little data to indicate how changes in gait speed reflect changes in patient-reported health outcomes.We determined the minimal clinically important difference in the gait speed of patients with unilateral vestibular hypofunction,mostly due to deafferentation surgery,as anchored to the Dizziness Handicap Index and the Activities Balance Confidence scale,validated using regression analysis,change difference,receiveroperator characteristic curve,and average change methods.After six weeks of vestibular rehabilitation,a change in gait speed from 0.20 to 0.34 m/s with 95%confidence was required for the patients to perceive a significant reduction in perception of dizziness and improved balance confidence.

High rate of clinically relevant improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis

BACKGROUND The minimal clinically important difference(MCID)is defined as the smallest meaningful change in a health domain that a patient would identify as important.Thus,an improvement that exceeds the MCID can be used to define a successful treatment for the individual patient.AIM To quantify the rate of clinical improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis.METHODS Patients were treated with the Global Unite total shoulder platform arthroplasty between March 2017 and February 2019 at Herlev and Gentofte Hospital,Denmark.The patients were evaluated preoperatively and 3 months,6 months,12 months,and 24 months postoperatively using the Western Ontario Osteoarthritis of the Shoulder index(WOOS),Oxford Shoulder Score(OSS)and Constant-Murley Score(CMS).The rate of clinically relevant improvement was defined as the proportion of patients who had an improvement 24 months postoperatively that exceeded the MCID.Based on previous literature,MCID for WOOS,OSS,and CMS were defined as 12.3,4.3,and 12.8 respectively.RESULTS Forty-nine patients with a Global Unite total shoulder platform arthroplasty were included for the final analysis.Mean age at the time of surgery was 66 years(range 49.0-79.0,SD:8.3)and 65%were women.One patient was revised within the two years follow-up.The mean improvement from the preoperative assessment to the two-year follow-up was 46.1 points[95%confidence interval(95%CI):39.7-53.3,P<0.005]for WOOS,18.2 points(95%CI:15.5-21.0,P<0.005)for OSS and 37.8 points(95%CI:31.5-44.0,P<0.005)for CMS.Two years postoperatively,41 patients(87%)had an improvement in WOOS that exceeded the MCID,45 patients(94%)had an improvement in OSS that exceeded the MCID,and 42 patients(88%)had an improvement in CMS that exceeded the MCID.CONCLUSION Based on three shoulder-specific outcome measures we find that approximately 90%of patients has a clinically relevant improvement.This is a clear message when informing patients about their prognosis.

Interval estimation for minimal clinically important difference and its classification error via a bootstrap scheme

With the improved knowledge on clinical relevance and more convenient access to the patientreported outcome data,clinical researchers prefer to adopt minimal clinically important difference(MCID)rather than statistical significance as a testing standard to examine the effectiveness of certain intervention or treatment in clinical trials.A practical method to determining the MCID is based on the diagnostic measurement.By using this approach,the MCID can be formulated as the solution of a large margin classification problem.However,this method only produces the point estimation,hence lacks ways to evaluate its performance.In this paper,we introduce an m-out-of-n bootstrap approach which provides the interval estimations for MCID and its classification error,an associated accuracy measure for performance assessment.A variety of extensive simulation studies are implemented to show the advantages of our proposed method.Analysis of the chondral lesions and meniscus procedures(ChAMP)trial is our motivating example and is used to illustrate our method.

Evaluation of Reported Statistical Inferences

Someone or the other is always pointing to a published study to justify a point of view or the need for a change in what we do or how we live. There are so many such studies, many reported in top-notch journals, reporting results inconsistent across and often inconsistent within. It is in the interest of increasing the credibility of science, and to safeguard the general public living with its overt and covert influence, to filter good science from bad. Some inferences are good, even when counter-intuitive or seemingly inconsistent, and are likely to withstand scrutiny and some others may represent marginal effects in the aggregate not entirely useful for individual choices or decisions, and are often non-reproducible. The New York Times featured an article in August 2018 debunking some of the reported studies supporting testing for Vitamin D deficiencies and the recommendation of large supplemental doses of Vitamin D. Some of these Vitamin D claims, among other claims, were reported as not holding up on replication in controlled trials [1]. We have noted in Ref. [2] that we need to be wary as individuals about reported signals detected in studies using stochastic data, even when these aggregate signals are of a large magnitude. We demonstrated discordance rates of 30% or higher between subject level assessments of effect and the conclusion drawn in the aggregate. Here we will provide a computation of this discordant proportion as well as post-hoc assessments of aggregate inferences, with emphasis on evaluating studies with time-to-event endpoints such as those in cancer trials. Similar evaluations for continuous, binomial data and correlations are also provided. We also discuss the use of response thresholds.

Is Manipulative Therapy Clinically Necessary for Relief of Neck Pain？A Systematic Review and Meta-Analysis

Objective：To summarize and critically assess the efficacy of Eastern and Western manipulative therapies for the treatment of neck pain in adults. Methods：A search of Pub Med/MEDLINE, the Cochrane Central Register of Controlled Trials, Clinical Trials.gov, EMBASE, etc. from their inception date to January 2014 with Chinese, Japanese, and Korean databases. Two reviewers independently selected randomized controlled trials（RCTs） with negative control or blank control, extracted data and assessed methodological quality. Meta-analysis and levels of evidence were performed by Revman5.1 and Grades of Recommendations Assessment, Development and Evaluation（GRADE） approach. Results：Nineteen clinical trials with adequate randomization were included in this review, 11 of them had a low risk of bias. The primary outcome for shortterm pain had no significant differences, however, the secondary outcome, only the Numerical Pain Rating Scale（NPRS） score of intermediate-term [n=916, pooled mean differences（MD） =–0.29, P=0.02], the Neck Disability Index（NDI） score of short-term（n=1,145, pooled MD=–2.10, P〈0.01）, and intermediate-term（n=987, pooled MD=–1.45, P=0.01） were significantly reduced with moderate quality evidence. However, it supported the minimally clinically important difference（MCID） of the Visual Analogue Scale and NPRS pain score to be 13 mm, while NDI was 3.5 points. The meta-analysis only suggested a trend in favor of manipulative therapy rather than clinical significance. Conclusions：The results do not support the existing evidences for the clinical value of Eastern or Western manipulative therapy for neck pain of short-term follow-up according to MCIDs. The limitations of our review related to blinding, allocation concealment and small sample size.