Key Methodological Features of Randomized Controlled Trials of Alzheimer’s Disease Therapy The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Determining the minimum clinically important differences for outcomes in the DOMINO trial. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit Testing minimal clinically important difference: consensus or conundrum? When should hypertension be treated? The different perspectives of Canadian family physicians and patients. Microvascular decompression for classic trigeminal neuralgia: determination of minimum clinically important difference in pain improvement for patient reported outcomes. Warfarin for atrial fibrillation. The patient's perspective. Validation of a consensus-based minimal clinically important difference (MCID) threshold using an objective functional external anchor. Minimal clinically important differences of 3 patient-rated outcomes instruments. Outcome measures in chronic low back pain Percutaneous stereotactic radiofrequency lesioning for trigeminal neuralgia: determination of minimum clinically important difference in pain improvement for patient-reported outcomes. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). Preoperative PROMIS Scores Predict Postoperative Success in Foot and Ankle Patients Outcome tools used for ambulatory children with cerebral palsy: responsiveness and minimum clinically important differences. Minimal clinically important differences in Incontinence Quality-of-Life scores in stress urinary incontinence. The intra- and interrater reliability of the action research arm test: a practical test of upper extremity function in patients with stroke. Responsiveness and Interpretability of the Portuguese Version of the Neck Disability Index in Patients With Chronic Neck Pain Undergoing Physiotherapy Relevant change in radiological progression in patients with hip osteoarthritis. II. Determination using an expert opinion approach. Measurement of health status. Ascertaining the minimal clinically important difference.
Background : The results of clinical trials are routinely presented in terms of statistical significance , which may or may not indicate clinical significance . Analysis of the minimal clinical ly important difference ( MCID ) of cognitive scales has received little attention to date . Objectives : By review ing the key method ological features ( sample size , duration , statistical and clinical significance ) of clinical trials examining the efficacy of tacrine in the treatment of Alzheimer ’s disease ( AD ) , we assessed their ability to detect clinical ly important changes in cognition . Design : The value for the MCID of the  Mini-Mental State Examination ( MMSE )  was determined by surveying specialists in neurology and geriatric medicine . This value was then used to interpret the clinical significance of the results of published r and omized controlled trials ( RCTs ) assessing the efficacy of tacrine in the treatment of AD and to retrospectively determine their optimal sample size and trial duration . Results : The mean survey MCID for the MMSE was 3.72 ( 95 % confidence interval 3.50–3.95 ) points . Only 2 of 12 tacrine RCTs using the MMSE found a statistically significant difference in MMSE scores for patients taking tacrine  compared with those taking placebo . These improvements were not clinical ly significant when compared with the survey MMSE MCID . For parallel trials of tacrine in AD , the smallest sample size and minimum trial duration required to demonstrate a clinical ly significant difference were calculated to be 53 subjects and 1 year , respectively . Five of the 7 parallel trials met the required sample size ; however , none of them met the criteria for trial duration . Conclusions : When using the MMSE as an outcome measure , no tacrine trial reported results that were clinical ly significant as perceived by clinicians working with dementia patients . Application of a range of plausible MCIDs to the parallel design RCTs also demonstrated that 2 of 7 of these trials did not have sufficient sample size , and none had sufficient duration of treatment to reliably detect clinical ly meaningful changes in cognition . Future clinical trials in this area will need to incorporate the evolving knowledge of MCIDs in order to increase their chance of detecting clinical ly relevant results Background The  Patient-rated Wrist Evaluation ( PRWE ) is a commonly used instrument in upper extremity surgery and in research . However , to recognize a treatment effect expressed as a change in PRWE , it is important to be aware of the minimum clinical ly important difference ( MCID ) and the minimum detectable change ( MDC ) . The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change , while the MDC is defined as the smallest amount of change that can be detected by an outcome measure . A numerical change in score that is less than the MCID , even when statistically significant , does not represent a true clinical ly relevant change . To our knowledge , the  MCID  and MDC of the PRWE have not been determined in patients with distal radius fractures . Questions / Purpose sWe asked : ( 1 ) What is the  MCID  of the PRWE score for patients with distal radius fractures ? ( 2 ) What is the MDC of the PRWE ? Methods Our prospect i ve cohort study included 102 patients with a distal radius fracture and a median age of 59 years ( interquartile range [ IQR ] , 48–66 years ) . All patients completed the PRWE question naire during each of two separate visits . At the second visit , patients were asked to indicate the degree of clinical change they appreciated since the previous visit . Accordingly , patients were categorized in two groups : ( 1 ) minimally improved or ( 2 ) no change . The groups were used to anchor the changes observed in the PRWE score to patients ’ perspectives of what was clinical ly important . We determined the MCID using an anchor-based receiver operator characteristic method . In this context , the change in the PRWE score was considered a diagnostic test , and the anchor ( minimally improved or no change as noted by the patients from visit to visit ) was the gold st and ard . The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID . Results In our study , the MCID of the PRWE was 11.5 points . The area under the curve was 0.54 ( 95 % CI , 0.37–0.70 ) for the pain subscale and 0.71 ( 95 % CI , 0.57−0.85 ) for the function subscale . We determined the MDC to be 11.0 points . Conclusions We determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID . Clinical Relevance We recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinical ly relevant difference when evaluating the effects of treatments and when performing sample -size calculations on studies of distal radius fractures BACKGROUND CONTEXT The impact of  lumbar spinal surgery  is commonly evaluated with three patient-reported outcome measures : Oswestry Disability Index ( ODI ) , the physical component summary ( PCS ) of the Short Form of the Medical Outcomes Study ( SF-36 ) , and pain scales . A minimum clinical ly important difference ( MCID ) is a threshold used to measure the effect of clinical treatments . Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method . PURPOSE This study has three purpose s. First , to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID . Second , to determine a statistically sound and clinical ly meaningful MCID for ODI , PCS , back pain scale , and leg pain scale in lumbar spine surgery patients . Third , to compare the discriminative ability of two anchors : a global health assessment and a rating of satisfaction with the results of the surgery . STUDY DESIGN This study is a review of prospect ively collected patient-reported outcomes data . PATIENT SAMPLE A total of 454 patients from a large data base of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study . OUTCOME MEASURES Preoperative and 1-year postoperative scores for ODI , PCS , back pain scale , leg pain scale , health transition item ( HTI ) of the SF-36 , and Satisfaction with Results scales . METHODS ODI , SF-36 , and pain scales were administered before and 1 year after spinal surgery . Several c and i date MCID calculation methods were applied to the data and the result ing values were compared . The HTI of the SF-36 was used as the anchor and compared with a second anchor ( Satisfaction with Results scale ) . RESULTS Potential MCID calculations yielded a range of values : fivefold for ODI , PCS , and leg pain , 10-fold for back pain . Threshold values obtained with the two anchors were very similar . CONCLUSIONS The minimum detectable change ( MDC ) appears as a statistically and clinical ly appropriate MCID value . MCID values in this sample were 12.8 points for ODI , 4.9 points for PCS , 1.2 points for back pain , and 1.6 points for leg pain BACKGROUND Although less likely to be reported in clinical trials than expressions of the statistical significance of differences in outcomes , whether or not a treatment has delivered a specified minimum clinical ly important difference ( MCID ) is also relevant to patients and their caregivers and doctors . Many dementia treatment r and omised controlled trials ( RCTs ) have not reported MCIDs and , where they have been done , observed differences have not reached these . METHODS As part of the development of the Statistical Analysis Plan for the DOMINO trial , investigators met to consider expert opinion- and distribution-based values for the MCID and triangulated these to provide appropriate values for three outcome measures , the  St and ardised Mini-mental State Examination ( sMMSE ) , Bristol Activities of Daily Living Scale ( BADLS ) and Neuropsychiatric Inventory ( NPI ) . Only st and ard deviations ( SD ) were presented to investigators who remained blind to treatment allocation . RESULTS Adoption of values for MCIDs based upon 0.4 of the SD of the change in score from baseline on the sMMSE , BADLS and NPI in the first 127 participants to complete DOMINO yielded MCIDs of 1.4 points for sMMSE , 3.5 for BADLS and 8.0 for NPI . CONCLUSIONS Reference to MCIDs is important for the full interpretation of the results of dementia trials and those conducting such trials should be open about the way in which they have determined and chosen their values for the MCIDs BACKGROUND Despite widespread adoption of the six-item erectile function ( EF ) domain of the International Index of Erectile Function ( IIEF ) as a clinical trial end point , there are currently no objective data on what constitutes a minimal clinical ly important difference ( MCID ) in the EF domain . OBJECTIVE Estimate the MCID for the IIEF EF domain . DESIGN , SETTING , AND PARTICIPANTS Anchor-based MCIDs were estimated using data from 17 r and omized , double-blind , placebo-controlled , parallel-group clinical trials of the phosphodiesterase type 5 inhibitor ( PDE5-I ) tadalafil for 3345 patients treated for 12 wk . MEASUREMENTS The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7 : " Over the past 4 weeks , when you attempted sexual intercourse how often was it satisfactory for you ? " MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies ( n=11 ) by comparing patients with and without minimal improvement ( n=863 ) . MCIDs were vali date d in the remaining six studies ( n=377 ) . RESULTS AND LIMITATIONS The ROC-based MCID for the EF domain was 4 , with estimated sensitivity and specificity of 0.74 and 0.73 , respectively . MCIDs varied significantly ( p<0.0001 ) according to baseline ED severity ( mild : 2 ; moderate : 5 ; severe : 7 ) . MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region , ED etiology , and age group . MCIDs did not differ by age group , geographic region , or ED etiology . Current analyses were based on 17 clinical trials of tadalafil . Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies . CONCLUSIONS The context ualization of treatment-related changes in terms of clinical ly relevant improvement is essential to underst and ing treatment efficacy , to interpreting results across studies , and to managing patients effectively . This analysis provides , for the first time , anchor-based estimates of MCIDs in the EF domain score of the IIEF BACKGROUND CONTEXT The Neck Disability Index ( NDI ) , the short form-36 ( SF-36 ) physical component summary ( PCS ) , and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical spine surgery . The minimum clinical ly important difference ( MCID ) is a threshold of improvement that is clinical ly relevant to the patient . However , the true goal is to provide the patient with a substantial clinical benefit ( SCB ) . PURPOSE This study determines the MCID and SCB using common anchor-based methods for NDI , PCS , and pain scales for arm and neck pain in patients undergoing cervical spine fusion for degenerative disorders . STUDY DESIGN / SETTING The study setting is a longitudinal cohort in a multisurgeon spine specialty clinic . PATIENT SAMPLE The sample comprises 505 patients who underwent a cervical fusion for degenerative spine conditions and who have prospect ively collected outcome scores with a minimum 1-year follow-up . OUTCOME MEASURES The outcome measures of the study were NDI , SF-36 , and numeric rating scales for arm and neck pain . METHODS The MCID and SCB values for NDI , PCS , and pain scales for arm and neck pain were determined using receiver operating characteristic ( ROC ) curve analysis with the Health Transition Item of the SF-36 as an anchor . The Health Transition Item asks a patient " Compared to one year ago , how would you rate your health in general now ? " with answers ranging from " Much Better , " " Somewhat Better , " " About the Same , " " Somewhat Worse , " to " Much Worse . " An ROC curve was constructed for each measure . The ROC curve-derived MCID was the change score with equal sensitivity and specificity to distinguish the " Somewhat Better " from the " About the Same " patients . The ROC curve-derived SCB was the change score with equal sensitivity and specificity to distinguish the " Much Better " from the " Somewhat Better " patients . Distribution-based methods including the st and ard error of the mean and the minimum detectable change were also used to calculate MCID . RESULTS The calculated MCID is 7.5 for the NDI , 4.1 for SF-36 PCS , and 2.5 for arm and neck pain . The calculated SCB is 9.5 for the NDI , 6.5 for SF-36 PCS , and 3.5 for arm and neck pain . CONCLUSIONS Patients with an eight-point decrease in NDI , a 4.1-point increase in PCS , and a three-point decrease in arm or neck pain can detect a minimally clinical ly important change . Patients with a 10-point decrease in NDI , a 6.5-point increase in PCS , and a four-point decrease in arm or neck pain can detect an SCB after cervical spine fusion Background The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes ( PROs ) : Neck Disability Index ( NDI ) , Visual Analog Scale ( VAS ) for pain , and Short Form-36 ( SF-36 ) Physical ( PCS ) and Mental ( MCS ) Component Summary . However , the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear . In this context , the concept of minimum clinical ly important difference ( MCID ) is developing into the st and ard by which to evaluate treatments , patient satisfaction and cost-effectiveness . Methods Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospect i ve blinded data base . PROs ( NDI , PCS , MCS and VAS ) were collected preoperatively , and together with blinded Surgeon Ratings ( SR ) at 3 months and 6 months post-surgery . Four anchor-based approaches were used to calculate different MCIDs . Three anchors ( VAS , HTI ( Health Transition Item of the SF-36 ) and SR ) were used to evaluate surgery outcome . The best clinical ly and statistically relevant MCID was chosen . Results On average , all patients presented with a statistically significant improvement ( p < 0.001 ) postoperatively for NDI ( 27.42 to 19.42 ) , PCS ( 33.02 to 42.03 ) , MCS ( 44 to 50.74 ) and VAS ( 2.85 to 1.93 ) . The four MCID anchor-based approaches yielded a range of values for each PRO : 2.23–16.59 for PCS , 0.11–16.27 for MCS and 2.72–12.08 for NDI . When compared to the VAS and HTI anchors , the area under the ROC curve was greater for SR . This finding suggests that SR may be a more reliable anchor for MCID calculation . Conclusion The MDC ( minimum detectable change ) approach together with the SR anchor appears to be the most appropriate MCID method . It offers the greatest area under the ROC curve ( threshold above the 95 % CI ) , and the choice of the anchor did not significantly affect this result . MCID values for this data set were 5.6 for PCS , 5.12 for MCS and 2.41 for NDI BACKGROUND CONTEXT Various method ologies have been used in attempting to eluci date a st and ard method for calculating minimal clinical ly important difference ( MCID ) . A consensus-based decision ( Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials [ IMMPACT ] group ) suggested a 30 % reduction from baseline as a means to define the MCID of self-report back pain measures . Additionally , important psychometric issues need to be addressed regarding use of an independent measure of the same construct as an external criterion , instead of simply using another self-report measure , when using an anchor-based approach to MCID . PURPOSE The purpose was to test the validity of recently published guidelines regarding MCID using self-report back pain measures and objective socioeconomic outcomes . STUDY DESIGN / SETTING This is a prospect i ve study assessing change scores on commonly used spinal pain assessment measures in patients with chronic disabling occupational spinal disorders ( CDOSDs ) treated in a regional referral rehabilitation center performing interdisciplinary functional restoration . PATIENT SAMPLE The study consisted of consecutive cohort of patients ( N=1,180 ) with CDOSDs completing a functional restoration program . OUTCOMES MEASURES Self-report measures including the Oswestry Disability Index ( ODI ) and the physical component summary ( PCS ) and mental component summary ( MCS ) of the Short Form-36 ( SF-36 ) obtained before and after treatment , were compared with objective socioeconomically relevant outcomes obtained 1 year after treatment ( ie , work status and additional health-care utilization ) , that were the external criteria for evaluating MCID . METHODS Pre- to posttreatment improvement was calculated separately for each measure , and subjects were divided into two groups based on the change in scores relative to baseline : 30 % or greater versus less than 30 % improvement . One-year posttreatment objective socioeconomic outcomes were used as independent external criteria relevant to the CDOSD population . This population is often studied as the most costly and problematic cohort in spine care . RESULTS The ODI and SF-36 MCS were not associated with any of the objective 1-year outcomes used as external criteria . Reduced post-rehabilitation health-care utilization ( based on the percentage of patients pursuing health care from a new provider ) was weakly associated with 30 % or greater improvement on the SF-36 PCS , relative to patients whose scores changed by less than 30 % relative to baseline ( 17.0 % vs. 21.1 % ) . The same was true for the ODI and return-to-work . CONCLUSIONS When objective and independent criteria are used ( socioeconomic outcomes ) in a CDOSD cohort , the 30 % improvement in the ODI and SF-36 may not be a valid MCID index . This replicates similar conclusions made by an independent research group using a distribution-based approach to MCID . The validity of the MCID concept rests on future research using objective external criteria . Moreover , there remains a question whether the term " important " in MCID can be unequivocally and operationally defined as a reliable construct BACKGROUND Hypertension guidelines from different organizations often specify different treatment thresholds , and none explicitly state how these thresholds were chosen . This study was undertaken to determine the treatment thresholds of family physicians and hypertensive patients for mild , uncomplicated essential hypertension . A subject 's treatment threshold can be determined by eliciting the minimum reduction in cardiovascular risk that he or she feels outweighs the inconvenience , costs and side effects of antihypertensive therapy ( the minimal clinical ly important difference [ MCID ] ) . METHODS The study subjects consisted of a r and om sample of family physicians and a consecutive sample of hypertensive patients without overt cardiovascular disease from Ottawa and Edmonton . To determine participants ' MCIDs , we used a survey employing hypothetical scenarios ( each depicting a different baseline cardiovascular risk ) and a probability trade-off tool . RESULTS Of 94 family physicians and 146 patients approached for the study , 72 and 74 participated respectively . There was marked variability in the MCIDs of both groups . In general , patients were less likely to want antihypertensive therapy than physicians , particularly when baseline cardiovascular risks were low : 49 % v. 64 % ( p = 0.06 ) , 68 % v. 92 % ( p < 0.001 ) and 86 % v. 100 % ( p = 0.001 ) for 5-year cardiovascular risks of 2 % , 5 % and 10 % respectively . Moreover , patients expressed larger MCIDs ( i.e. , wanted greater benefits before accepting therapy ) than physicians . However , a subgroup of patients ( 15 % to 26 % , depending on the scenario ) wanted treatment even if there was no anticipated benefit . Multivariate analysis showed that no sociodemographic factors strongly predicted the MCIDs of either group . INTERPRETATION Guidelines that set treatment thresholds on the basis of physician or expert opinion may not accurately reflect the preferences of hypertensive patients . There is a need for patient decision aids and attention to patient preferences when initiation of antihypertensive therapy is considered for the prevention of cardiovascular disease . Further research is needed to define treatment thresholds for other chronic conditions and in other groups BACKGROUND Outcomes studies use patient-reported outcome ( PRO ) measurements to assess treatment effectiveness , but can lack direct clinical meaning . Minimum clinical ly important difference ( MCID ) calculation provides a point estimate of the critical threshold needed to achieve clinical ly relevant treatment effectiveness . MCID remains uninvestigated for microvascular decompression ( MVD ) , a common surgical procedure for trigeminal neuralgia . OBJECTIVE We aim ed to determine MCID for the most commonly used PRO measures of pain after MVD : Visual Analog Scale ( VAS ) and Barrow Neurological Institute Pain Scale ( BNI-PS ) . METHODS Sixty consecutive patients with classic trigeminal neuralgia who decided to undergo MVD by a single surgeon were prospect ively assessed with  VAS  and BNI-PS preoperatively and 2 years postoperatively . Three anchors were used to assign each patient 's outcome . We then used 3 well-established , anchor-based methods to calculate MCID . RESULTS Patients experienced significant improvement in both VAS ( 9.9 vs. 2.0 , P < .001 ) and BNI-PS ( 5.0 vs. 1.9 , P < .001 ) after MVD . The area under the receiver-operating characteristic curve was greater for BNI-PS than for VAS for all 3 anchors , indicating that BNI-PS is probably better suited for calculating MCID . The 3 MCID calculation methods generated a range of  MCID values for each of the PROs ( VAS : 1.40 - 8.87 , BNI-PS : 0.95 - 3.26 ) . CONCLUSION MVD-specific MCID is highly variable based on calculation technique . Some of these calculations appear to either overestimate or underestimate the patients ' preoperative expectations . When the different MCID methods are averaged , the results are clinical ly appropriate and consistent with preoperative expectations . The average MCID for VAS is 6.25 and for BNI-PS is 2.44 OBJECTIVE To determine the minimal clinical ly important difference ( MCID ) of warfarin therapy for the treatment of nonvalvular atrial fibrillation from the perspective of patients using 2 different elicitation methods . DESIGN All patients completed 2 face-to-face interviews , which were 2 weeks apart . For each interview , they were r and omized to receive 1 of 2 elicitation methods : ping-ponging or starting at the known efficacy . SETTING The practice s of 2 university-affiliated family medicine centers ( 8 physicians each ) , 14 community-based family physicians , and 2 cardiologists . PATIENTS Sixty-four patients with nonvalvular atrial fibrillation who were initiated with warfarin therapy at least 3 months before the study . INTERVENTION During each interview , the patients ' MCIDs were determined by using ( 1 ) a pictorial flip chart to describe atrial fibrillation ; the consequences of a minor stroke , a major stroke , and a major bleeding episode ; the chance of stroke if not taking warfarin ; the chance of a major bleeding episode if taking warfarin ; examples of the inconvenience , minor side effects , and costs of warfarin therapy ; and then ( 2 ) 1 of the 2 elicitation methods to determine their MCIDs ( the smallest reduction in stroke risk at which the patients were willing to take warfarin ) . Patients ' knowledge of their stroke risk , acceptability of the interview process , and factors determining their preferences were also assessed . MAIN RESULTS Given a baseline risk of having a stroke in the next 2 years , if not taking warfarin , of 10 of 100 , the mean MCID was 2.01 of 100 ( 95 % confidence interval , 1.60 - 2.42 ) . Fifty-two percent of the patients would take warfarin for an absolute decrease in stroke risk of 1 % over 2 years . Before eliciting their MCIDs , patients showed poor knowledge of their stroke risk , which improved afterward . The interview process was well accepted by the patients . The MCID using the ping-ponging elicitation method was 1.015 of 100 smaller compared with use of the starting at the known efficacy method ( P = .01 ) . CONCLUSIONS We were able to determine the MCID of warfarin therapy for the prevention of stroke from the perspective of patients with nonvalvular atrial fibrillation . Their MCIDs were much smaller than those that have been implied by some experts and clinicians . The interview process , using the flip chart approach , appeared to improve the patients ' knowledge of their disease and its consequences and treatment . The method used to elicit the patients ' MCIDs can have a clinical ly important effect on patient responses . The method used in our study can be generalized to other conditions and , thus , could be helpful in 3 ways : ( 1 ) from a clinical decision-making perspective , it could facilitate patient-physician communication ; ( 2 ) it could clarify the patient perspective when interpreting the results of previously completed trials ; and ( 3 ) it could be used to derive more clinical ly relevant sample sizes for r and omized treatment trials BACKGROUND CONTEXT The minimal clinical ly important difference ( MCID ) is defined as the smallest change in an outcome that a patient would perceive as meaningful . The Initiative on Methods , Measurement and Assessment in Clinical Trials ( IMMPACT ) group proposed defining the MCID as a 30 % improvement in self-reported pain or function . However , this MCID threshold has not been vali date d against an objective physical measure . PURPOSE To test the validity of the IMMPACT-based MCID threshold , using an objective physical measure as an external anchor . STUDY DESIGN / SETTING Prospect i ve study of chronic disabling occupational lumbar disorder ( CDOLD ) patients completing a functional restoration program . PATIENT SAMPLE A consecutive cohort of 743 CDOLD patients . OUTCOME MEASURES Self-report measures of pain-related function were compared with an objective lifting measure , the progressive isoinertial lifting evaluation ( PILE ) , obtained after treatment . METHODS The association between reporting 30 % or greater improvement ( the IMMPACT 's MCID key criterion ) and the PILE score after treatment was assessed . RESULTS A 30 % or greater improvement on the self-report measures was significantly associated with improvement in physical function on the PILE task . CONCLUSIONS Despite extensive use of the MCID to evaluate effects of treatment in spinal disorders , this is the first empirical documentation of the validity of the IMMPACT 's 30 % change criterion compared with an objective physical anchor PURPOSE Patient-rated instruments are increasingly used to measure orthopedic outcomes . However , the clinical relevance of modest score changes on such instruments is often unclear . This study was design ed to define the minimal clinical ly important differences ( MCIDs ) of the Disabilities of the Arm , Shoulder , and H and ( DASH ) , QuickDASH ( subset of DASH ) , and Patient-Rated Wrist Evaluation ( PRWE ) question naires for atraumatic conditions of the h and , wrist , and forearm . METHODS We prospect ively analyzed 102 patients undergoing nonoperative treatment for isolated tendinitis , arthritis , or nerve compression syndromes from the forearm to the h and . By phone , patients completed the DASH , QuickDASH , and PRWE at enrollment and at 2 weeks ( n = 78 used in the analysis ) and 4 weeks ( n = 24 used in the analysis ) after initiating treatment . Patients reporting clinical improvement each contributed a single data point categorized as no change ( n = 41 ) , minimal improvement ( n = 30 ) , or marked improvement ( n = 31 ) via a vali date d anchor-based approach . We calculated the MCID as the mean change score for each outcome measure in the minimal improvement group . RESULTS The MCID ( 95 % confidence interval ) for the DASH was 10 ( 5 - 15 ) . The MCID for the QuickDASH was 14 ( 9 - 20 ) . The MCID was 14 ( 8 - 20 ) for the PRWE . The MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement . The MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores . CONCLUSIONS Longitudinal changes on the DASH of 10 points , on the QuickDASH of 14 points , and on the PRWE of 14 points represent minimal clinical ly important changes . We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients . These MCID values may provide a basis for sample size calculations for future investigation using these common patient-rated outcome measures . TYPE OF STUDY /LEVEL OF EVIDENCE Diagnostic III The purpose of this prospect i ve , single site cohort quasi-experimental study was to determine the responsiveness of the numerical rating scale ( NRS ) , Rol and –Morris disability question naire ( RMDQ ) , Oswestry disability index ( ODI ) , pain self-efficacy question naire ( PSEQ ) and the patient-specific functional scale ( PSFS ) in order to determine which would best measure clinical ly meaningful change in a chronic low back pain ( LBP ) population . Several patient-based outcome instruments are currently used to measure treatment effect in the chronic LBP population . However , there is a lack of consensus on what constitutes a “ successful ” outcome , how an important improvement/deterioration has been defined and which outcome measure(s ) best captures the effectiveness of therapeutic interventions for the chronic LBP population . Sixty-three consecutive patients with chronic LBP referred to a back exercise and education class participated in this study ; 48 of the 63 patients had complete data . Five question naires were administered initially and after the 5-week back class intervention . Also at 5 weeks , patients completed a global impression of change as a reflection of meaningful change in patient status . Score changes in the five different question naires were subjected to both distribution- and anchor-based methods : st and ard error of measurement ( SEM ) and receiver operating characteristic ( ROC ) curves to define clinical improvement . From these methods , the minimal clinical ly important difference ( MCID ) defined as the smallest difference that patients and clinicians perceive to be worthwhile is presented for each instrument . Based on the SEM , a point score change of 2.4 in the NRS , 5 in the RMDQ , 17 in the ODI , 11 on the PSEQ , and 1.4 on the PSFS corresponded to the MCID . Based on ROC curve analysis , a point score change of 4 points for both the NRS and RMDQ , 8 points for the ODI , 9 points for the PSEQ and 2 points for the PSFS corresponded to the MCID . The ROC analysis demonstrated that both the PSEQ and PSFS are responsive to clinical ly important change over time . The NRS was found to be least responsive . The exact value of the MCID is not a fixed value and is dependent on the assessment method used to calculate the score change . Based on ROC curve analysis the PSFS and PSEQ were more responsive than the other scales in measuring change in patients with chronic LBP following participation in a back class programme . However , due to the small sample size , the lack of observed worsening of symptoms over time , the single centre and intervention studied these results which need to be interpreted with caution BACKGROUND The Visual Analog Scale ( VAS ) and the Barrow Neurological Institute Pain Scale ( BNI-PS ) are 2 patient-reported outcome ( PRO ) tools frequently used to rate pain from trigeminal neuralgia ( TN ) . Outcomes studies often use these patient-reported outcomes to assess treatment effectiveness , but it is unknown exactly what degree of change in the numerical scores constitutes the minimum clinical ly important difference ( MCID ) . MCID remains uninvestigated for percutaneous stereotactic radiofrequency lesioning ( RFL ) , a common surgical procedure for TN . OBJECTIVE To determine MCID values for the VAS and BNI-PS in patients undergoing RFL . METHODS Forty-three consecutive patients with TN who underwent RFL by a single surgeon were prospect ively assessed with the VAS and BNI-PS preoperatively and 3 years postoperatively . Three anchors were used to assign each patient 's outcome : satisfaction , willingness to have the surgery again , and Health Transition Index . We then used 3 well-established , anchor-based methods to calculate MCID : average change , minimum detectable change , and change difference . RESULTS Patients experienced substantial improvement in both VAS ( 9.81 vs 3.35 ; P < .001 ) and BNI-PS ( 4.95 vs 2.44 ; P < .001 ) after RFL . The 3 MCID calculation methods generated a range of MCID values for each of the PROs ( VAS , 4.13 - 8.20 ; BNI-PS , 1.03 - 3.30 ) . The area under the receiver-operating characteristic curve was greater for BNI-PS compared with VAS for all 3 anchors , indicating that BNI-PS is probably better suited for calculating MCID . CONCLUSION RFL-specific MCID is variable on the basis of the calculation technique . With the use of the minimum detectable change calculation method with the Health Transition Index anchor , the minimum clinical ly important difference is 4.49 for VAS and 1.16 for BNI-PS after RFL for TN . ABBREVIATIONS AUC , area under the receiver-operating characteristic curveBNI-PS , Barrow Neurological Institute Pain ScaleHTI , Health Transition IndexMCID , minimum clinical ly important differenceMDC , minimum detectable changePRO , patient-reported outcome RFL , percutaneous stereotactic radiofrequency lesioningTN , trigeminal neuralgiaVAS , Visual Analog Scale STUDY DESIGN Prospect i ve , single-group observational design . OBJECTIVES To determine the minimal clinical ly important difference ( MCID ) for the Disabilities of the Arm , Shoulder and H and ( DASH ) outcome measure and its shortened version ( QuickDASH ) in patients with upper-limb musculoskeletal disorders , using a triangulation of distribution- and anchor-based approaches . BACKGROUND Meaningful threshold change values of outcome tools are crucial for the clinical decision-making process . METHODS The DASH and QuickDASH were administered to 255 patients ( mean ± SD age , 49 ± 15 years ; 156 women ) before and after a physical therapy program .  The external anchor administered after the program was a 7-point global rating of change scale . RESULTS The test-retest reliability of the DASH and QuickDASH was high ( intraclass correlation coefficient model 2,1 = 0.93 and 0.91 , respectively ; n = 30 ) . The minimum detectable change at the 90 % confidence level was 10.81 points for the DASH and 12.85 points for the QuickDASH . After triangulation of these results with those of the mean-change approach and receiver-operating-characteristic-curve analysis , the following MCID values were selected : 10.83 points for the DASH ( sensitivity , 82 % ; specificity , 74 % ) and 15.91 points for the QuickDASH ( sensitivity , 79 % ; specificity , 75 % ) . After treatment , the MCID threshold was reached/surpassed by 61 % of subjects using the DASH and 57 % using the QuickDASH . CONCLUSION The MCID values from this study for the DASH ( 10.83 points ) and the QuickDASH ( 15.91 points ) could represent the lower boundary for a range of MCID values ( reasonably useful for different population s and context ual characteristics ) . The upper boundary may be represented by the 15 points for the DASH and 20 points for the QuickDASH proposed by the DASH website Background : The use of patient-reported outcomes continues to exp and beyond the scope of clinical research to involve st and ard of care assessment s across orthopedic practice s. It is currently unclear how to interpret and apply this information in the daily care of patients in a foot and ankle clinic . We prospect ively examined the relationship between preoperative patient-reported outcomes ( PROMIS Physical Function , Pain Interference and Depression scores ) , determined minimal clinical important differences for these values , and assessed if these preoperative values were predictors of improvement after operative intervention . Methods : Prospect i ve collection of all consecutive patient visits to a multisurgeon tertiary foot and ankle clinic was obtained between February 2015 and April 2016 . This consisted of 16 023 unique visits across 7996 patients , with 3611 new patients . Patients undergoing elective operative intervention were identified by ICD-9 and CPT code .  PROMIS physical function , pain interference , and depression scores were assessed at initial and follow-up visits . Minimum clinical ly important differences ( MCIDs ) were calculated using a distribution-based method . Receiver operating characteristic ( ROC ) curves were calculated to determine whether preoperative PROMIS scores were predictive of achieving MCID . Cutoff values for PROMIS scores that would predict achieving MCID and not achieving MCID with 95 % specificity were determined . Prognostic pre- and posttest probabilities based off these cutoffs were calculated . Patients with a minimum of 7-month follow-up ( mean 9.9 ) who completed all PROMIS domains were included , result ing in 61 patients . Results : ROC curves demonstrated that preoperative physical function scores were predictive of postoperative improvement in physical function ( area under the curve [ AUC ] 0.83 ) . Similarly , preoperative pain interference scores were predictive of postoperative pain improvement ( AUC 0.73 ) and preoperative depression scores were also predictive of postoperative depression improvement ( AUC 0.74 ) . Patients with preoperative physical function T score below 29.7 had an 83 % probability of achieving a clinical ly meaningful improvement in function as defined by MCID . Patients with preoperative physical function T score above 42 had a 94 % probability of failing to achieve MCID . Patients with preoperative pain above 67.2 had a 66 % probability of achieving MCID , whereas patients with preoperative pain below 55 had a 95 % probability of failing to achieve MCID . Patients with preoperative depression below 41.5 had a 90 % probability of failing to achieve MCID . Conclusion : Patient-reported outcomes ( PROMIS ) scores obtained preoperatively predicted improvement in foot and ankle surgery . Threshold levels in physical function , pain interference , and depression can be shared with patients as they decide whether surgery is a good option and helps place a numerical value on patient expectations . Physical function scores below 29.7 were likely to improve with surgery , whereas those patients with scores above 42 were unlikely to make gains in function . Patients with pain scores less than 55 were similarly unlikely to improve , whereas those with scores above 67 had clinical ly significant pain reduction postoperatively . Reported prognostic cutoff values help to provide guidance to both the surgeon and the patient and can aid in shared decision making for treatment . Level of Evidence : Level II , prognostic study This prospect i ve longitudinal multicenter study of ambulatory children with cerebral palsy ( CP ) examined changes in outcome tool score over time , tool responsiveness , and used a systematic method for defining minimum clinical ly important differences ( MCIDs ) . Three hundred and eighty-one participants with CP ( Gross Motor Function Classification System [ GMFCS ] Levels I-III ; age range 4 - 18y , mean age 11y [ SD 4y 4mo ] ; 265 diplegia , 116 hemiplegia ; 230 males , 151 females ) . At baseline and follow-up at least 1 year later , Functional Assessment Question naire , Gross Motor Function Measure , Pediatric Quality of Life Inventory , Pediatric Outcomes Data Collection Instrument , Pediatric Functional Independence Measure , temporal-spatial gait parameters , and oxygen cost were collected . Adjusted st and ardized response means determined tool responsiveness for nonsurgical ( n=292 ) and surgical ( n=87 ) groups at GMFCS Levels I to III . Most scores reaching medium or large effect sizes were for GMFCS Level III . Nonsurgical group change scores were used to calculate MCID thresholds for ambulatory children with CP . These values were verified by examining participants who changed GMFCS levels . Tools measuring function were responsive when a change large enough to cause a change in GMFCS level occurred . MCID thresholds assess change in study population s over time , and serve as the basis for design ing prospect i ve intervention studies OBJECTIVES To determine the clinical ly relevant reference points for the Incontinence Quality of Life ( I-QOL ) question naire scores in women with stress urinary incontinence and compare them with the treatment effects observed with duloxetine and placebo . METHODS Using data from 1133 women with predominant stress urinary incontinence in two r and omized ,  placebo-controlled duloxetine  studies , the within-treatment and between-treatment minimal clinical ly important differences ( MCIDs ) were obtained by anchoring the I-QOL scores to the vali date d Patient Global Impression of Improvement scale ( PGI-I ) . The within-treatment MCID ( mean I-QOL for women rating their condition " a little better " with treatment ) and between-treatment MCID ( difference in scores between the group ratings of " no change " and " a little better " ) were derived . The treatment effects were compared with these MCIDs . Real-time urinary diaries were completed , along with the I-QOL and PGI-I. RESULTS The within-treatment and between-treatment MCID for the I-QOL total score was 6.3 and 2.5 , respectively . The total and subscale scores had almost identical MCIDs . Duloxetine 80 mg significantly improved the I-QOL total and subscale scores . Treatment differences in the I-QOL scores exceeded the between-treatment MCID and the duloxetine  I-QOL treatment effect exceeded the within-treatment MCID . The number of patients needed to treat to gain an additional I-QOL responder was 6.8 . CONCLUSIONS Improvements in I-QOL scores should be greater than the within-treatment MCID , and differences between two treatments should be greater than the between-treatment MCIDs , for statistically significant differences to be considered clinical ly meaningful . We propose 2.5 points as a reasonable guide for the I-QOL between-treatment MCID and 6.3 points for the within-treatment MCID OBJECTIVES To determine the intra- and interrater reliability of the Action Research Arm ( ARA ) test , to assess its ability to detect a minimal clinical ly important difference ( MCID ) of 5.7 points , and to identify less reliable test items . DESIGN Intrarater reliability of the sum scores and of individual items was assessed by comparing ( 1 ) the ratings of the laboratory measurements of 20 patients with the ratings of the same measurements recorded on videotape by the original rater , and ( 2 ) the repeated ratings of videotaped measurements by the same rater . Interrater reliability was assessed by comparing the ratings of the videotaped measurements of 2 raters . The result ing limits of agreement were compared with the MCID . PATIENTS Stratified sample , based on the intake ARA score , of 20 chronic stroke patients ( median age , 62yr ; median time since stroke onset , 3.6yr ; mean intake ARA score , 29.2 ) . MAIN OUTCOME MEASURES Spearman 's rank-order correlation coefficient ( Spearman 's rho ) ; intraclass correlation coefficient ( ICC ) ; mean difference and limits of agreement , based on ARA sum scores ; and weighted kappa , based on individual items . RESULTS All intra- and interrater Spearman 's rho and ICC values were higher than .98 . The mean difference between ratings was highest for the interrater pair ( .75 ; 95 % confidence interval , .02 - 1.48 ) , suggesting a small systematic difference between raters . Intrarater limits of agreement were -1.66 to 2.26 ; interrater limits of agreement were -2.35 to 3.85 . Median weighted kappas exceeded .92 . CONCLUSION The high intra- and interrater reliability of the ARA test was confirmed , as was its ability to detect a clinical ly relevant difference of 5.7 points Study Design . A prospect i ve cohort study with a 7‐week follow‐up of 113 patients with chronic neck pain undergoing physiotherapy . Objective . To examine the responsiveness of the Portuguese Version of the Neck Disability Index ( NDI‐PT ) , and to determine the minimal clinical ly important difference ( MCID ) , minimal detectable change ( MDC ) , and floor/ceiling effects . Summary of Background Data . Studies that determine MDC and MCID are needed to provide more accurate outcome evaluation and critically assess potential relevant sources for differences in the minimal important change values for the NDI . Methods . The NDI‐PT was administered twice : at the baseline and after 7 weeks of physiotherapy treatment . A Global Transition Scale was used as an external criterion measure to distinguish between improved and nonimproved patients ’ scores between baseline and follow‐up . The responsiveness of the NDI‐PT was assessed through anchor‐based methods ( correlation coefficient and receiver operating characteristics curves — ROC curves ) . The MCID was estimated by the ROC curve method , and the MDC through the st and ard Error of Measurement ( SEM ) . Results . The NDI‐PT revealed moderate responsiveness when applied to patients with chronic neck pain undergoing physiotherapy ( & rgr ; = 0.328 and area under the curve of 0.595 , 95 % confidence interval : 0.484–0.706 ) . The MDC achieved 12 points , whereas the MCID was found to be 5.5 points . A complementary ROC analysis based on percentage differences in NDI‐PT scores from baseline revealed an optimal cutoff point of 27 % . The optimal cutoff point was found to be dependent of disability baseline scores . Conclusion . The NDI‐PT demonstrated moderate levels of responsiveness . The amount of change in question naire scores perceived by the patient to be meaningful is smaller than the amount of change required to be statistically 95 % confident that score change is not just measurement error . Level of Evidence : AIM To determine the minimum clinical ly important difference ( MCID ) in joint space width ( JSW ) progression in patients with hip osteoarthritis ( OA ) , based upon evaluation by a panel of clinical experts as a gold st and ard . METHODS A sample of 298 patients with hip OA was selected from a multicentre , prospect i ve , longitudinal , 3-yr follow-up study . A pelvic radiograph was obtained at entry and after 3 yr . For each film , the narrowest JSW was measured using a 0.1-mm graduated magnifying glass . The difference between baseline and 3-yr follow-up JSW was calculated . Two senior rheumatologists , who were experts in osteoarthritis , evaluated each pair of films and noted whether a clinical ly relevant deterioration in osteoarthritis stage occurred at 3 yr compared with baseline . Interobserver reliabilities were evaluated using the kappa coefficient and proportions of agreements . Then , for each measured difference in JSW ( 0.1 mm per 0.1 mm ) , the sensitivity and specificity for MCID , defined as the assessment of expert 1 , expert 2 or a combination of both , were calculated . This allowed us to obtain , from graphic representations of the correct classification probabilities , the best measured JSW threshold , with the maximal true positive and the minimal false positive results . RESULTS The mean measured change in JSW was -0.63 + /- 0.74 mm . Experts 1 and 2 considered the decrease in JSW to be clinical ly relevant in 122 ( 40.9 % ) and 100 pairs ( 33.6 % ) respectively . The proportion of agreements between the experts was 79.9 % , with a kappa coefficient of 0.572 . The best measured JSW threshold was -0.4 mm for expert 1 , expert 2 and the combination of both ; sensitivity and specificity were 0.75 and 0.8 , 0.71 and 0.72 , and 0.75 and 0.7 respectively . CONCLUSION This study suggests that a change of at least 0.4 mm in the radiological JSW could be considered clinical ly relevant . Other studies using other sets of patients and other methods are needed for validation In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials
Absolute MCID was strongly associated with baseline pain , explaining approximately two-thirds of the variation , and to a lesser degree with the operational definition of minimum pain relief and clinical condition .
MCID  for chronic pain relief vary considerably .
Baseline pain is strongly associated with absolute , but not relative , measures .
To a much lesser degree , MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition .
BACKGROUND The minimum clinical ly important difference ( MCID ) is used to interpret the relevance of treatment effects , e.g. , when developing clinical guidelines , evaluating trial results or planning sample sizes .
There is currently no agreement on an appropriate MCID in chronic pain and little is known about which context ual factors cause variation .
METHODS This is a systematic review .