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
AIM: To investigate the Chinese version of the Low Vision Quality of Life Questionnaire(CLVQOL) as an instrument for obtaining clinically important changes after cataract surgery.METHODS: Patients underwent cataract s...AIM: To investigate the Chinese version of the Low Vision Quality of Life Questionnaire(CLVQOL) as an instrument for obtaining clinically important changes after cataract surgery.METHODS: Patients underwent cataract surgery in Shanghai General Hospital, Shanghai Jiao Tong University, who fit the inclusion criteria were recruited. Two CLVQOLs were administered, including a preoperative CLVQOL and a CLVQOL at the end of the 3 mo follow-up period, and were completed using face-to-face interviews or phone interviews conducted by trained investigators. The minimal clinically important difference(MCID) was calculated using an anchor-based method and a distribution method. In addition, the responsiveness of the questionnaire was measured.RESULTS: A total of 155 residents were enrolled. The average visual acuity(VA) preoperatively was 0.08(SD=0.05), and it increased to 0.47(SD=0.28) at the end of followup. Statistically significant positive changes in the CLVQOL scores indicated significant improvement of vision related quality of life after cataract surgery. With the larger value between the two results as the final value, the MCID values of the CLVQOL(scores of the four scales as well as the total score) were 8.94, 2.61, 4.34, 3.10 and 17.63, respectively. The CLVQOL has both good internal and external responsiveness.CONCLUSION: CLVQOL scores are appropriate instruments for obtaining clinically important changes after cataract surgery. This study is an effective exploration for establishingcataract surgery efficacy standards, which helps clinical and scientific research workers in ophthalmology to gain a more in-depth understanding when using CLVQOL.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
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
目的评估皮肤病生活质量指数（dermatology life quality index，DLQ1）在寻常性银屑病患者进行临床研究中的临床最小重要差值（minimal clinical important differences，MCID）。方法依托在2个中心进行的临床试验“耳穴贴压加西药局...目的评估皮肤病生活质量指数（dermatology life quality index，DLQ1）在寻常性银屑病患者进行临床研究中的临床最小重要差值（minimal clinical important differences，MCID）。方法依托在2个中心进行的临床试验“耳穴贴压加西药局部用药治疗寻常性银屑病的随机对照研究”（注册号为：ChiCTR—TRC．14004916）进行评估。该研究纳入100例合格病例，随机分成治疗组（51例）采用耳穴叠加得肤宝外用治疗和对照组（49例）单纯采用得肤宝外用治疗。在治疗的0周、4周让患者自行填写DLQI进行生活质量评估，并采用分布法和效标法分别对DLQI的耳穴治疗寻常性银屑病患者中MCID进行估算。结果在这个临床研究中，采用分布法估算的DLQI的MCID波动于0．23—2．58之间，采用效标法估算的MCID值为2．53。结论本研究中DLQI的临床最小重要差异值为2．53，代表患者评分下降2．53时皮损达到好转；使用效标法和分布法评估DLQI的MCID，对临床及量表研究具有重要的参考价值。展开更多
最小临床意义差值(minimal clinically important difference,MCID)的常用估算方法包括效标法、分布法和文献分析法等。目前MCID的估算方法众多且不统一,给MCID的确定、结果解释和应用带来了困难。鉴于目前各种估算方法均存在一定局限,...最小临床意义差值(minimal clinically important difference,MCID)的常用估算方法包括效标法、分布法和文献分析法等。目前MCID的估算方法众多且不统一,给MCID的确定、结果解释和应用带来了困难。鉴于目前各种估算方法均存在一定局限,建议同时使用多种估算方法获得多个MCID初步估算值,并以效标法为主、其他方法为辅或将多种方法通过统计整合的估算值来确定最终的MCID。MCID可协助进行临床研究结果的临床意义判断、样本量估算以及临床决策等,在具体应用之前,应充分了解该MCID的估算方法和样本特征等相关细节以判断是否适用于所开展的研究或临床场景。展开更多
目的确定膝骨关节炎患者全膝关节置换后美国特种外科医院膝关节评分(hospital for special surgery knee score,HSS)的最小临床重要差异(minimal clinically important difference,MCID)。方法回顾性分析2017年1月-2018年6月解放军总医...目的确定膝骨关节炎患者全膝关节置换后美国特种外科医院膝关节评分(hospital for special surgery knee score,HSS)的最小临床重要差异(minimal clinically important difference,MCID)。方法回顾性分析2017年1月-2018年6月解放军总医院第一医学中心关节外科诊断为膝骨关节炎并行单侧全膝关节置换治疗的患者。记录患者术前HSS评分、术后1年的HSS评分及术后1年满意度调查结果。采用锚法(Anchor-based approach)将患者满意度作为分组指标,简单线性回归分析确定HSS评分的MCID。结果413例患者的平均年龄(66.0±7.8)岁,男性93例(22.5%),女性320例(77.5%)。全膝关节置换后1年HSS评分平均提高34.33分(95%CI:33.11~35.54)。术后1年满意度评价极其满意59例,非常满意131例,满意177例,一般34例,不满意/糟糕12例;各组患者术前和术后1年HSS评分均有改变:极其满意组44.96(95%CI:42.51~47.41),非常满意组38.44(95%CI:36.74~40.14),比较满意组32.26(95%CI:30.71~33.81),一般组20.45(95%CI:17.35~23.55),不满意/糟糕组8.08(95%CI:2.83~13.34)。HSS评分的MCID为9.18(95%CI:6.37~11.98)。结论本研究确定了膝骨关节炎患者全膝关节置换后HSS评分的最小临床重要差异为9.18分,建议膝骨关节炎患者全膝关节置换治疗1年后HSS评分变化高于此分数作为有临床意义的评价阈值。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.
文摘AIM: To investigate the Chinese version of the Low Vision Quality of Life Questionnaire(CLVQOL) as an instrument for obtaining clinically important changes after cataract surgery.METHODS: Patients underwent cataract surgery in Shanghai General Hospital, Shanghai Jiao Tong University, who fit the inclusion criteria were recruited. Two CLVQOLs were administered, including a preoperative CLVQOL and a CLVQOL at the end of the 3 mo follow-up period, and were completed using face-to-face interviews or phone interviews conducted by trained investigators. The minimal clinically important difference(MCID) was calculated using an anchor-based method and a distribution method. In addition, the responsiveness of the questionnaire was measured.RESULTS: A total of 155 residents were enrolled. The average visual acuity(VA) preoperatively was 0.08(SD=0.05), and it increased to 0.47(SD=0.28) at the end of followup. Statistically significant positive changes in the CLVQOL scores indicated significant improvement of vision related quality of life after cataract surgery. With the larger value between the two results as the final value, the MCID values of the CLVQOL(scores of the four scales as well as the total score) were 8.94, 2.61, 4.34, 3.10 and 17.63, respectively. The CLVQOL has both good internal and external responsiveness.CONCLUSION: CLVQOL scores are appropriate instruments for obtaining clinically important changes after cataract surgery. This study is an effective exploration for establishingcataract surgery efficacy standards, which helps clinical and scientific research workers in ophthalmology to gain a more in-depth understanding when using CLVQOL.
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 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.
文摘目的评估皮肤病生活质量指数（dermatology life quality index，DLQ1）在寻常性银屑病患者进行临床研究中的临床最小重要差值（minimal clinical important differences，MCID）。方法依托在2个中心进行的临床试验“耳穴贴压加西药局部用药治疗寻常性银屑病的随机对照研究”（注册号为：ChiCTR—TRC．14004916）进行评估。该研究纳入100例合格病例，随机分成治疗组（51例）采用耳穴叠加得肤宝外用治疗和对照组（49例）单纯采用得肤宝外用治疗。在治疗的0周、4周让患者自行填写DLQI进行生活质量评估，并采用分布法和效标法分别对DLQI的耳穴治疗寻常性银屑病患者中MCID进行估算。结果在这个临床研究中，采用分布法估算的DLQI的MCID波动于0．23—2．58之间，采用效标法估算的MCID值为2．53。结论本研究中DLQI的临床最小重要差异值为2．53，代表患者评分下降2．53时皮损达到好转；使用效标法和分布法评估DLQI的MCID，对临床及量表研究具有重要的参考价值。
文摘最小临床意义差值(minimal clinically important difference,MCID)的常用估算方法包括效标法、分布法和文献分析法等。目前MCID的估算方法众多且不统一,给MCID的确定、结果解释和应用带来了困难。鉴于目前各种估算方法均存在一定局限,建议同时使用多种估算方法获得多个MCID初步估算值,并以效标法为主、其他方法为辅或将多种方法通过统计整合的估算值来确定最终的MCID。MCID可协助进行临床研究结果的临床意义判断、样本量估算以及临床决策等,在具体应用之前,应充分了解该MCID的估算方法和样本特征等相关细节以判断是否适用于所开展的研究或临床场景。
文摘目的确定膝骨关节炎患者全膝关节置换后美国特种外科医院膝关节评分(hospital for special surgery knee score,HSS)的最小临床重要差异(minimal clinically important difference,MCID)。方法回顾性分析2017年1月-2018年6月解放军总医院第一医学中心关节外科诊断为膝骨关节炎并行单侧全膝关节置换治疗的患者。记录患者术前HSS评分、术后1年的HSS评分及术后1年满意度调查结果。采用锚法(Anchor-based approach)将患者满意度作为分组指标,简单线性回归分析确定HSS评分的MCID。结果413例患者的平均年龄(66.0±7.8)岁,男性93例(22.5%),女性320例(77.5%)。全膝关节置换后1年HSS评分平均提高34.33分(95%CI:33.11~35.54)。术后1年满意度评价极其满意59例,非常满意131例,满意177例,一般34例,不满意/糟糕12例;各组患者术前和术后1年HSS评分均有改变:极其满意组44.96(95%CI:42.51~47.41),非常满意组38.44(95%CI:36.74~40.14),比较满意组32.26(95%CI:30.71~33.81),一般组20.45(95%CI:17.35~23.55),不满意/糟糕组8.08(95%CI:2.83~13.34)。HSS评分的MCID为9.18(95%CI:6.37~11.98)。结论本研究确定了膝骨关节炎患者全膝关节置换后HSS评分的最小临床重要差异为9.18分,建议膝骨关节炎患者全膝关节置换治疗1年后HSS评分变化高于此分数作为有临床意义的评价阈值。
