Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. The Minimally Clinically Important Difference in Generic Utility-Based Measures Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Evaluating minimal clinically important differences for the acne-specific quality of life questionnaire Responsiveness and minimal clinically important difference for the EQ-5D in chronic rhinosinusitis. Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Can inpatient multidisciplinary rehabilitation improve health-related quality of life in MS patients on the long term - The Danish MS Hospitals Rehabilitation Study. Evaluating clinically meaningful change on the ITP-PAQ: preliminary estimates of minimal important differences. Minimal clinically important differences in Incontinence Quality-of-Life scores in stress urinary incontinence. Meaningful Gait Speed Improvement During the First 60 Days Poststroke: Minimal Clinically Important Difference Sufficiently Important Difference: Expanding the Framework of Clinical Significance Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. Measurement of health status. Ascertaining the minimal clinically important difference. Comparison of distribution- and anchor-based approaches to infer changes in health-related quality of life of prostate cancer survivors. Evaluation of the effect of non-surgical periodontal treatment on oral health-related quality of life: estimation of minimal important differences 1 year after treatment. The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach. Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial. Validation of a consensus-based minimal clinically important difference (MCID) threshold using an objective functional external anchor. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis.
Objectives : To establish a link between the minimal important difference ( MID ) and the st and ard error of measurement ( SEM ) for all responsive dimensions of the Asthma Quality of Life Question naire ( AQLQ ) . Methods : Secondary data analysis of baseline and follow-up interview data from 198 out patients with asthma enrolled in a r and omized controlled trial and receiving care at a major urban academic medical center 's general medicine clinics . Domain statistics for baseline and follow-up interviews were examined for the AQLQ . The baseline SEM values were compared with established AQLQ MID st and ards using weighted κ values . Results : One SEM identified the MID in responsive AQLQ dimensions . Weighted κ values ( 0.88–0.93 ) vali date d excellent agreement between these two criteria . Conclusion : This is the third study to support using one SEM to identify important individual change in health-related quality of life ( HRQoL ) measures . However , refinement of the process for determining a measure 's clinical ly meaningful differences is still needed to secure a link between the SEM and the identification of relevant HRQoL change over time Health-related quality of life ( HrQOL ) assessment s are gaining importance as outcome measures in cancer clinical trials . A recently published clinical trial reported statistically significant ( P<0.001 ) increases in haemoglobin ( Hb ) levels and significantly ( P<0.01 ) increased HrQOL scores following the administration of recombinant human erythropoietin ( r-HuEPO , epoetin alfa ) versus placebo to anaemic cancer patients who received non-platinum chemotherapy . This study employed five cancer-specific HrQOL instruments . Hb and HrQOL data from this trial were analysed to estimate the minimally important difference ( MID ) in HrQOL measures that could be interpreted as clinical ly meaningful , with Hb level selected as the best external st and ard . Patients were assigned to two groups : improved ( Hb increases of > /=1 g/dL ) or stable ( change in Hb of-1 g/dL to < 1 g/dL ) . The MID was first determined as the difference between the mean changes in HrQOL in the improved group versus the stable group . By this analysis , the differences in HrQOL scores between the epoetin alfa group and the placebo group were clinical ly important for all Hb-sensitive , cancer-specific HrQOL evaluations . Linear regression analyses performed to provide estimates of the MID for specific values of Hb change confirmed that the differences in HrQOL scores between patient groups were clinical ly significant . These analyses were repeated using a data set from a separate clinical trial , which further supported the conclusion that observed HrQOL changes demonstrated in the multicentre , double-blind study were clinical ly important . These methods provide one means for interpreting the clinical relevance of changes in HrQOL evaluated in clinical trials Purpose : To evaluate the use of utility-based generic quality of life measures for establishing the minimally clinical ly important difference ( MCID ) . Background : Utility-based quality of life measures place levels of wellness on a continuum anchored by death ( 0.00 ) and optimum function ( 1.00 ) . Preference measurement studies are used to define the meaning of points along the continuum . Health states that differ by less than 0.03 units can not be discriminated by panels of judges as different from one another . Thus , 0.03 is a reasonable MCID for these measures . Method : Three published studies of patients with Chronic Obstructive Pulmonary Disease ( COPD ) reported data on the Quality of Well-being Scale ( QWB ) before and after pulmonary rehabilitation . One of the studies also r and omly assigned patients to lung volume reduction surgery or to maximal medical therapy . These patients were followed for an average of 29 months . Results : All three evaluations of pulmonary rehabilitation showed changes on the QWB in excess of the proposed 0.03 MCID . QWB changes for patients assigned to lung volume reduction surgery were close to the MCID threshold at one year but grew stronger in subsequent years . Using Norman 's 0.50 st and ard deviation method , all three estimates of rehabilitation effectiveness and the outcomes one year following surgery fall below the MCID . Conclusion : Different methods for estimating MCID lead to different conclusions about the meaning of quality of life changes following pulmonary rehabilitation and lung volume reduction surgery . The preference scaling system in generic utility-based quality of life measures provides a metric that is directly interpretable and avoids many of the criticisms of MCID measures . The method is sensitive enough to suggest clinical ly meaningful benefits of rehabilitation and surgery . Further , quality adjusted life years offer a valuable metric for policy analysis . Utility-based measures of health related quality of life should gain greater use in COPD outcomes research OBJECTIVE To compare the st and ard error of measurement ( SEM ) with established st and ards for clinical ly relevant intra-individual change in an evaluation of health-related quality of life . DESIGN Secondary analysis of data from a r and omized controlled trial . SUBJECTS Six hundred and five out patients with a history of cardiac problems attending the general medicine clinics of a major academic medical center . MEASURES Baseline and follow-up interviews included a modified version of the Chronic Heart Failure Question naire ( CHQ )  and the SF-36 .  The SEM values corresponding to established st and ards for minimal clinical ly important differences ( MCIDs ) on the CHQ were determined . Individual change on the SF-36 was explored using the same SEM criterion . RESULTS One-SEM changes in this population corresponded well to the patient-driven MCID st and ards on all CHQ dimensions ( weighted kappas ( 0.87 ; P < 0.001 ) . The distributions of out patients who improved , remained stable , or declined ( defined by the one-SEM criterion ) were generally consistent between CHQ dimensions and SF-36 subscales . CONCLUSIONS The use of the SEM to evaluate individual patient change should be explored among other health-related quality of life instruments with established st and ards for clinical ly relevant differences . Only then can it be determined whether the one-SEM criterion can be consistently applied as a proxy for clinical ly meaningful change Abstract Background : The Acne-Specific Quality of Life Question naire ( Acne-QoL ) is a responsive , reliable and valid instrument developed to measure the impact of facial acne across four dimensions of patient QOL . Score changes on this instrument have been used to report statistically significant treatment advantages for a low-dose oral contraceptive ( Estrostep ® ) , containing norethisterone ( norethindrone ) acetate ( NA ) 1 mg and ethinylestradiol ( EE ) [ 20 , 30 , 35 mg ] as compared with placebo in women with moderate acne vulgaris . However , the question remained if these statistically significant results were also clinical ly meaningful . Objectives : To evaluate the statistically significant Acne-QoL benefits observed with NA/EE in terms of their clinical significance , and to compare the three different approaches for defining a minimal clinical ly important difference ( MCID ) for the Acne-QoL instrument . Methods : Since the optimum method for estimating MCIDs has yet to be established , three different published approaches for determining MCIDs were applied and compared using data from two r and omised , double-blind , placebocontrolled studies of the efficacy of NA/EE in the treatment of facial acne . Results : Although the approaches differed substantially , the result ing MCID estimates were comparable . Specifically , the MCID estimates ranged from 0.50–10.3 mean change per item , depending on the domain . The results showed that the statistically significant treatment advantages for NA/EE were also clinical ly significant . Conclusion : When applied to the change scores present , the results showed that the statistically significant treatment advantages for NA/EE were also clinical ly significant BACKGROUND The 5-dimensional EuroQol question naire ( EQ-5D ) is vali date d to measure general health-related quality of life ( QOL ) . Our objective was to determine the responsiveness and minimal clinical ly important difference ( MCID ) of the EQ-5D health utility value ( EQ-5D HUV ) and visual analog scale ( EQ-5D VAS ) in chronic rhinosinusitis ( CRS ) . METHODS 203 adults undergoing medical management for CRS were prospect ively recruited . General health-related QOL ( using EQ-5D HUV and EQ-5D VAS ) and CRS-specific QOL ( using the 22-item Sinonasal Outcome Test [ SNOT-22 ] ) were measured at enrollment and a subsequent follow-up time point 2 - 12 months later . At follow-up , participants also rated change in general health as Much worse , A little worse , About the same , A little better or Much better compared to enrollment . The EQ-5D HUV and EQ-5D VAS MCIDs were calculated using distribution-based , anchor-based , and receiver operator characteristic ( ROC ) curve-based methods . RESULTS Change in SNOT-22 score was correlated with EQ-5D HUV and EQ-5D VAS change . Using the different methods of calculating MCID , we find the EQ-5D HUV MCID to be 0.04 and EQ-5D VAS MCID to be 8.0 . The calculated EQ-5D MCIDs had approximately a sensitivity of 40 - 50 % and specificity of 80 % in detecting patients experiencing noticeable improvement in general health . CONCLUSIONS The EQ-5D responds well to changing CRS symptomatology . We propose MCIDs for EQ-5D HUV of 0.04 and EQ-5D VAS of 8 in CRS patients , which although specific , are not sensitive for detecting patients experiencing improvement in general health Background The primary aim of rheumatoid arthritis ( RA ) treatment is to induce remission , the absence of disease activity . The objective of this study was to explore the association between clinical endpoints used to gauge RA treatment efficacy and patient-reported outcomes of health-related quality of life , fatigue , and physical function in RA patients treated with secukinumab in a phase 2 r and omized controlled trial ( RCT ) . Method Adult RA patients ( n = 237 ) with incomplete responses to methotrexate were r and omized equally to receive monthly s.c . injections of secukinumab 25 mg , 75 mg , 150 mg , 300 mg or placebo . Clinical endpoints used in this study included the ACR response criteria and its components and simplified disease activity score . Patient-reported outcomes ( PRO ) included Health Assessment Question naire-Disability Index ( HAQ-DI ) , Medical Outcomes Study Short Form-36 [ SF-36 ] Survey , and Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-Fatigue ) . Patients were categorized into mutually exclusive groups according to the magnitude and direction of change from baseline to week 16 in each clinical endpoint . Definitions of minimal important differences [ MID ] in each clinical endpoint were used to categorize patients , as well as thresholds beyond MID . Mean changes from baseline to week 16 were computed for each PRO and analyses of variance to test the differences in PRO changes observed across groups of patients that differed in each clinical endpoint . Analyses were limited to patients r and omized to secukinumab treatment . All dose groups were combined ( n = 187 ) . Results Mean changes from baseline in each PRO differed significantly across groups of patients in the expected direction . With few exceptions , there was considerable agreement between clinical endpoints and PROs concerning the magnitude of change defined as clinical ly meaningful . More importantly , results demonstrated that greater improvements in clinical endpoints were associated with incrementally better improvements in HRQoL , fatigue , and physical function . Conclusion Results of this study show considerable agreement between minimal thresholds of improvement established for PROs and clinical outcome measures used in RA treatment studies and provide thresholds to be considered in gauging the importance of a treatment effect that goes beyond what is considered as minimally important for PRO measures RATIONALE The 6-minute-walk test ( 6MWT ) is a practical and clinical ly meaningful measure of exercise tolerance with favorable performance characteristics in various cardiac and pulmonary diseases . Performance characteristics in patients with idiopathic pulmonary fibrosis ( IPF ) have not been systematic ally evaluated . OBJECTIVES To assess the reliability , validity , and responsiveness of the 6MWT and estimate the minimal clinical ly important difference ( MCID ) in patients with IPF . METHODS The study population included all subjects completing a 6MWT in a clinical trial evaluating interferon gamma-1b ( n = 822 ) .  Six-minute walk distance ( 6MWD )  and other parameters were measured at baseline and at 24-week intervals using a st and ardized protocol . Parametric and distribution-independent correlation coefficients were used to assess the strength of the relationships between 6MWD and measures of pulmonary function , dyspnea , and health-related quality of life . Both distribution-based and anchor-based methods were used to estimate the MCID . MEASUREMENTS AND MAIN RESULTS Comparison of two proximal measures of 6MWD ( mean interval , 24 d ) demonstrated good reliability ( coefficient = 0.83 ; P < 0.001 ) . 6MWD was weakly correlated with measures of physiologic function and health-related quality of life ; however , values were consistently and significantly lower for patients with the poorest functional status , suggesting good construct validity . Importantly , change in 6MWD was highly predictive of mortality ; a 24-week decline of greater than 50 m was associated with a fourfold increase in risk of death at 1 year ( hazard ratio , 4.27 ; 95 % confidence interval , 2.57- 7.10 ; P < 0.001 ) . The estimated MCID was 24 - 45 m. CONCLUSIONS The 6MWT is a reliable , valid , and responsive measure of disease status and a valid endpoint for clinical trials in IPF BACKGROUND Inpatient multidisciplinary rehabilitation ( MDR ) can improve health-related quality of life ( HRQoL ) in multiple sclerosis ( MS ) patients . However , the evidence of a long-term benefit is limited . OBJECTIVES To investigate the long-term effectiveness of inpatient MDR on HRQoL in MS patients . METHODS We conducted a r and omized controlled partial crossover trial with 427 MS patients . RESULTS Statistical significant long-term improvements in HRQoL were found in three of the six outcome measures at 12-month follow-up . Three in four suggested minimal clinical ly important differences ( MCIDs ) were unmet . CONCLUSION These results indicate that the administration of inpatient MDR may lead to long-lasting improvements in HRQoL in MS patients OBJECTIVE Interpretation of data from health-related quality of life ( HRQoL ) question naires can be enhanced with the availability of minimally important difference ( MID ) estimates . This information will aid clinicians in interpreting HRQoL differences within patients over time and between treatment groups . The Immune Thrombocytopenic Purpura (ITP)-Patient  Assessment Question naire ( PAQ ) is the only comprehensive HRQoL question naire available for adults with ITP . RESEARCH DESIGN AND METHODS Forty centers from within the US and Europe enrolled ITP patients into one of two multicenter , r and omized , placebo-controlled , double-blind , 6-month , phase III clinical trials of romiplostim . Patients enrolled in these studies self-administered the ITP-PAQ and two items assessing global change ( anchors ) at baseline and weeks 4 , 12 , and 24 . Using data from the ITP-PAQ and these two anchors , an anchor-based estimate was computed and combined with the st and ard error of measurement and st and ard deviation to compute a distribution-based estimate in order to provide an MID range for each of the 11 scales of the ITP-PAQ . RESULTS A total of 125 patients participated in these clinical trials and provided data for use in these analyses . Combining results from anchor- and distribution-based approaches , MID values were computed for 9 of the 11 scales . MIDs ranged from 8 to 12 points for Symptoms , Bother , Psychological , Overall QOL , Social Activity , Menstrual Symptoms , and Fertility , while the range was 10 to 15 points for the Fatigue and Activity scales of the ITP-PAQ . These estimates , while slightly higher than other published MID estimates , were consistent with moderate effect sizes . CONCLUSIONS These MID estimates will serve as a useful tool to research ers and clinicians using the ITP-PAQ , providing guidance for interpretation of baseline scores as well as changes in ITP-PAQ scores over time . Additional work should be done to finalize these initial estimates using more appropriate anchors that correlate more highly with the ITP-PAQ scales 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 Background When people with stroke recover gait speed , they report improved function and reduced disability . However , the minimal amount of change in gait speed that is clinical ly meaningful and associated with an important difference in function for people poststroke has not been determined . Objective The purpose of this study was to determine the minimal clinical ly important difference ( MCID ) for comfortable gait speed ( CGS ) associated with an improvement in the modified Rankin Scale ( mRS ) score for people between 20 to 60 days poststroke . Design This was a prospect i ve , longitudinal , cohort study . Methods The participants in this study were 283 people with first-time stroke prospect ively enrolled in the ongoing Locomotor Experience Applied Post Stroke ( LEAPS ) multi-site r and omized clinical trial . Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke . Improvement of ≥1 on the mRS was used to detect meaningful change in disability level . Results Mean ( SD ) CGS was 0.18 ( 0.16 ) m/s at 20 days and 0.39 ( 0.22 ) m/s at 60 days poststroke . Among all participants , 47.3 % experienced an improvement in disability level ≥1 . The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS . Limitations Because the mRS is not a gait-specific measure of disability , the estimated MCID for CGS was only 73.9 % sensitive and 57.0 % specific for detecting improvement in mRS scores . Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s . Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not . Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke Background . It is generally agreed that r and omized controlled trials should be powered to detect small but clinical ly significant treatment effects . Toward these ends , minimal important difference ( MID ) was proposed as a benchmark for design ing trials and for interpreting health-related quality -of-life instrument scores . MID was defined in 1989 as “ the smallest difference in score in the domain of interest which patients perceive as beneficial and which would m and ate , in the absence of troubling side effects and excessive cost , a change in the patient ’s management . ” Objective . 1 ) To exp and the idea of minimal clinical ly important difference so as to take into account harms as well as benefits . 2 ) To propose concepts and methods with which to do so . Summary . The authors define sufficiently important difference ( SID ) as the smallest amount of patient-valued benefit that an intervention would require to justify associated costs , risks , and other harms . As a means toward estimation of SID , the authors propose benefit-harm tradeoff methods , in which domains of benefit and harm are systematic ally traded off against each other and assessed in relation to the global decision of whether a treatment choice is worthwhile . Specific SID estimates can be used to power and interpret clinical trials or to inform health services research and /or public health policy . This article briefly describes the evolution of the important difference concept and outlines similarities and differences between MID and SID OBJECTIVES To study responsiveness and establish the minimal clinical ly important differences ( MCIDs ) and minimal detectable change ( MDC ) in patients undergoing total knee replacement ( TKR ) using the Short Form 36 ( SF-36 ) and Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . METHODS Prospect i ve observational study in three public hospitals of all consecutive patients on waiting lists to undergo TKR intervention with diagnosis of knee osteoarthritis ( OA ) . Patients were asked to complete before the intervention and at 6 months and 2 years afterward the  SF-36 and the WOMAC health-related quality of life question naires ( HRQoL ) , and additional transition questions which measured the changes in their joint at 6 months . In both question naires the possible range of values is from 0 to 100 points . RESULTS In WOMAC improvement at 6 months after a TKR was between 27 ( stiffness ) and 31 points ( pain ) . The SF-36 showed improvements between the 28.3 points of role physical and 2.79 of general health . From 6 months to 2 years , WOMAC improvements were between 2 and 6 points . The MCID ranged from 14.52 ( stiffness ) to 22.87 ( pain ) on the WOMAC and in the physical domains of SF-36 from 11.56 ( physical function ) to 16.86 ( bodily pain ) . On the WOMAC , the MDC ranged from 13.11 ( function ) to 29.12 ( stiffness ) , and on SF-36 from 19.50 ( physical function ) to 41.23 ( social functioning ) . CONCLUSIONS The MCID for TKR is around 15 on WOMAC , while with the SF-36 of at least 10 points . These values should not be considered as absolute thresholds BACKGROUND Health-related quality of life ( HRQoL ) is an important element for consideration in treatment decisions in patients with relapsed/refractory multiple myeloma ( RRMM ) . The pivotal MM-003 ( A Phase 3 , Multicenter , R and omized , Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone vs. High-Dose Dexamethasone in Patients With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study [ NIMBUS ] ) r and omized , open-label , multicenter , phase III trial demonstrated improved progression-free survival ( PFS ) and prolonged overall survival ( OS ) with pomalidomide ( POM ) plus low-dose dexamethasone ( POM + LoDEX ) versus high-dose dexamethasone ( HiDEX ) in patients with RRMM in whom lenalidomide ( LEN ) and bortezomib ( BORT ) had failed . MM-003 also investigated HRQoL as a predefined secondary end point . PATIENTS AND METHODS Recruited patients ( n = 455 ) were refractory to their last treatment and had failed LEN and BORT after ≥ 2 consecutive cycles of each ( alone or in combination ) . Eight clinical ly relevant and vali date d HRQoL domains from the European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-C30 , EORTC QLQ-MY20 , and EQ-5D question naires were selected for analysis . Time to symptom worsening based on minimally important differences ( MIDs ) was calculated . RESULTS Clinical ly meaningful improvements in HRQoL as determined by MIDs , regression analyses , and best response analyses were observed more frequently in patients receiving POM + LoDEX than in those receiving HiDEX . POM + LoDEX significantly extended median time to clinical ly meaningful worsening in HRQoL versus HiDEX in 4 HRQoL domains and demonstrated a trend in an additional 3 domains . Patients in the HiDEX arm experienced earlier HRQoL deterioration compared with those in the POM + LoDEX arm in each domain analyzed . CONCLUSION POM + LoDEX offer good clinical outcomes that lead to improved and prolonged HRQoL  compared with HiDEX in patients with RRMM and end-stage disease 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 OBJECTIVE To determine the minimal important difference ( MID ) in generic and prostate-specific health-related quality of life ( HRQoL ) using distribution- and anchor-based methods . STUDY DESIGN AND SETTING Prospect i ve cohort study of 602 newly diagnosed prostate cancer patients recruited from an urban academic hospital and a Veterans Administration hospital . Participants completed generic ( SF-36 ) and prostate-specific HRQoL surveys at baseline and at 3 , 6 , 12 , and 24 months posttreatment . Anchor-based and distribution-based methods were used to develop MID estimates . We compared the proportion of participants returning to baseline based on MID estimates from the two methods . RESULTS MID estimates derived from combining distribution- and anchor-based methods for the SF-36 subscales are physical function = 7 , role physical = 14 , role emotional = 12 , vitality = 9 , mental health = 6 , social function = 9 , bodily pain = 9 , and general health = 8 ; and for the prostate-specific scales are urinary function = 8 , bowel function = 7 , sexual function = 8 , urinary bother = 9 , bowel bother = 8 , and sexual bother = 11 . Proportions of participants returning to baseline values corresponding to MID estimates from the two methods were comparable . CONCLUSIONS This is the first study to assess the MID for generic and prostate-specific HRQoL using anchor-based and distribution-based methods . Although variation exists in the MID estimates derived from these two methods , the recovery patterns corresponding to these estimates were comparable AIM To evaluate an individually tailored oral health educational programme on patient-reported outcome compared with a st and ard oral health educational programme , assess change over time and determine minimal important differences ( MID ) in change scores for two different oral health related quality of life ( OHRQoL ) instrument after non-surgical periodontal treatment ( NSPT ) . MATERIAL S AND METHODS In a r and omized controlled trial evaluating two educational programmes , patients ( n = 87 ) with chronic periodontitis completed a question naire at baseline and after 12 months . OHRQoL was assessed with the General Oral Health Assessment Index ( GOHAI ) and the UK oral health-related quality -of-life measure ( OHQoL-UK ) . In addition , patients ' global rating of oral health and socio-demographic variables were recorded . The MID was estimated with anchor-based and distributions-based methods . RESULTS There were no differences between the two educational groups . The OHRQoL was significantly improved after treatment . The MID was approximately five for OHQoL-UK with a moderate ES , and three for GOHAI with a Small ES , and 46 - 50 % of the patients showed improvements beyond the MID . CONCLUSION Both oral health educational groups reported higher scores in OHRQoL after NSPT result ing in more positive well-being ( OHQoL-UK ) and less frequent oral problems ( GOHAI ) . OHQoL-UK gave a greater effect size and mean change scores but both instruments were associated with the participants ' self-rated change in oral health . The changes were meaningful for the patients supported by the estimated MID OBJECTIVE To identify the minimal clinical ly important difference ( MCID ) for the Montgomery-Asberg Depression Rating Scale ( MADRS ) in r and omised studies of depression , and to cross-vali date the estimated MCID . DESIGN AND METHODS  Placebo-treated patients from three similarly- design ed , 8-week , double-blind , r and omised depression trials with a stable health status between baseline and Week 1 ( ' no change ' rating on the Clinical Global Impression-Improvement scale ) were eligible . To calculate the MCID using the distribution-based approach , the st and ard deviation was estimated using baseline MADRS data while the reliability parameter was measured as the intraclass correlation coefficient between baseline and Week 1 . For cross-validation , patients from an observational study were matched to identify the ' MCID  change ' ( MADRS change from baseline to endpoint score plus the estimated MCID ) and ' control ' groups . Comparisons of clinical and health-related quality of life measures were performed . RESULTS In total , 177 placebo-treated patients were identified .  MCID estimates for MADRS ranged from 1.6 to 1.9 . A total of 105 matched pairs were identified for the cross-validation analyses . Mean change from baseline in MADRS scores ( 10.6 + /- 8.5 vs. 12.5 + /- 7.9 , p = 0.038 ) and remission rates ( 71.6 % vs. 57.1 % , p < 0.05 ) significantly differed between the ' MCID change ' and ' control ' groups at endpoint . Numerically higher response rates and greater improvements in HRQoL scores in the ' MCID change ' group were also found . CONCLUSION These preliminary findings support the value of the estimated MCID for the MADRS and may aid decision makers in evaluating antidepressant treatment effects and improving long-term patient outcomes OBJECTIVE To determine the minimal clinical ly important differences ( MCID ) in the patient-reported outcomes of activity ( 0 - 30 , number of days of limitation ) , fatigue ( 0 = none , 100 = complete ) , and sleep quality ( 0 = no problems , 100 = worst case ) for patients with rheumatoid arthritis ( RA ) . METHODS Two r and omized controlled trials comparing abatacept to placebo  in RA patients were considered : ATTAIN ( n = 391 ) and AIM ( n = 652 ) . An internal anchor-based approach was used to derive the MCID using the Health Assessment Question naire , patient global assessment , and pain as anchors . Minimal important change in activity , fatigue , and sleep were determined by estimating mean changes in these outcomes in patients showing change in a narrow range about the MCID of the internal anchor . Correlation analysis was used to determine the consistency of the changes in the outcomes and anchors , and a Delphi process was used to determine the final MCID values . RESULTS For the 2 trials , consistent patterns of change for activity , fatigue , and sleep and the internal anchors were found with correlations in the range of 0.5 , 0.7 , and 0.4 , respectively . The mean changes for activity , fatigue , and sleep in a narrow range about the MCID of the 3 internal anchors corresponding to the 2 trials were : 3.4 to 4.3 for activity ; 6.7 to 17.0 for fatigue ; and 4.1 to 7.3 for sleep . Following the Delphi process the MCID determined were 4 for activity , 10 for fatigue , and 6 for sleep . CONCLUSION These MCID for activity limitation , fatigue , and sleep problems can be used in design ing clinical trials and providing benchmarks in assessing patient improvement OBJECTIVE To evaluate the effect of rituximab treatment on health-related quality of life ( HRQOL ) in patients with active rheumatoid arthritis ( RA ) , who have had an inadequate response to disease-modifying antirheumatic drugs , including biologic agents . METHODS A r and omized , multicenter , double-blind , placebo-controlled clinical trial involving 367 rheumatoid factor-positive patients was conducted . Patients received 2 infusions 2 weeks apart of placebo ( n = 122 ) , rituximab 500 mg ( n = 123 ) , or rituximab 1000 mg ( n = 122 ) , with or without glucocorticoids . All patients received stable doses of methotrexate ( 10 25 mg/wk ) . Measures included SF-36 , assessed at baseline and at 24 weeks , as well as the HAQ and FACIT-Fatigue scale assessed at baseline and monthly for 24 weeks . Patients exceeding prespecified minimal clinical ly important differences ( MCID ) were examined . Clinical efficacy measurements ( ACR20/50/70 and EULAR responses ) were compared with HRQOL outcomes . RESULTS At 24 weeks , the rituximab 500 mg and 1000 mg groups both reported statistically significantly greater improvements on the SF-36 physical component summary ( 4.37 and 4.89 points higher , respectively , vs placebo ; p < 0.001 ) . SF-36 physical function , bodily pain , vitality , social function , and role-physical subscale scores also statistically significantly improved vs placebo . At 24 weeks , 62.6 % and 67.2 % of the rituximab 500 mg and 1000 mg groups , respectively , exceeded the MCID of 0.22 in HAQ ( p < 0.001 ) . For FACIT-Fatigue , 55.3 % and 65.6 % of patients exceeded the MCID of 3.5 points compared with 35.2 % of placebo over 24 weeks ( p < 0.001 ) . ACR20/50/70 and EULAR responders demonstrated greater improvements in mean baseline to 24 week changes in SF-36 and FACIT-Fatigue scores compared with nonresponders ( p < 0.05 ) . CONCLUSION Both rituximab doses in combination with methotrexate were effective in improving all HRQOL outcomes in patients with active RA consistent with clinical efficacy 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 OBJECTIVE To define clinical ly meaningful changes in 2 widely used health-related quality of life ( HQL ) instruments in studies of patients with rheumatoid arthritis ( RA ) . METHODS Patients with RA ( n = 693 ) who were enrolled in 2 double-blind , placebo-controlled clinical trials completed the Short Form 36 ( SF-36 ) modified health survey and the Health Assessment Question naire ( HAQ ) disability index at baseline and 6-week followup assessment s. Data on 5 RA severity measures were also collected at baseline and at 6 weeks ( patient and physician global assessment s , joint swelling and tenderness counts , and global pain assessment ) . Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure . RESULTS With few exceptions , changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure . Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessment s and patient pain assessment than to changes in the joint swelling and tenderness counts . CONCLUSION Based on these results , minimally important changes in the SF-36 scales and HAQ disability scores were determined , which will be useful in interpreting HQL results in clinical trials
We observed a lack of consistency in the application of methods for computing MID or MCID for generic and disease-specific HRQoL measures .
The anchor-based method yields conservative estimates of MID or MCID , compared to the distribution-based method .
OBJECTIVES The objective of the study was to assess the usability of minimal important difference ( MID ) and minimal clinical ly important difference ( MCID ) for measuring meaningful changes in disease-specific and generic health-related quality -of-life ( HRQoL ) outcomes in patient-centered care .