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.
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
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 .