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 p...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.展开更多
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 ho...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.展开更多
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 statistica...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.展开更多
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 u...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.展开更多
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...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.展开更多
文摘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.
基金Michael C Schubert was funded by the Department of Defense under the Neurosensory and Rehabilitation Research Award Program (Grant award#W81XWH-15-1-0442)Lee Dibble was funded by the Telemedicine and Advanced Technology Research Center(TATRC) through the Army Medical Department Advanced Medical Technology Initiative (AAMTI)Brian J.Loyd was supported in part by the Foundation for Physical Therapy Research New Investigator Fellowship Training Initiative (NIFTI).
文摘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.
基金supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001412.
文摘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.
文摘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.
基金Supported by the National Natural Science Foundation of China(No.81373666)Municipal Hospitals Cutting-Edge Technologies Emerging Joint Project(No.SHDC12013113)+3 种基金Municipal Science and Technology Commission of Shanghai Chinese Medicine Key Project(No.14401970400)National Research Projects of the State Administration of Traditional Chinese Medicine(No.201407001-2)Traditional Chinese Medicine Research Foundation(No.2012L032A)Special Project of Scientific Research Base by State Administration of Traditional Chinese Medicine(No.JDZX2012118),China
文摘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.
