Minimal important difference of change in patient-specific goals in severe emphysema patients.
Ontology highlight
ABSTRACT:
SUBMITTER: Hartman JE
PROVIDER: S-EPMC7569157 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
Publications
Minimal important difference of change in patient-specific goals in severe emphysema patients.
Hartman Jorine E JE Klooster Karin K Koster T David TD van Dijk Marlies M Slebos Dirk-Jan DJ
ERJ open research 20201019 4
<b>Change in patient's personal treatment goals is an important patient-reported outcome and can be measured by the patient-specific complaints (PSC) questionnaire. This paper establishes the MID for this questionnaire as -5.9 points.</b> https://bit.ly/3kwvWKM. ...[more]
Similar Datasets
Project description:Our aim was to determine the minimal important difference (MID) for 6-min walk distance (6MWD) and maximal cycle exercise capacity (MCEC) in patients with severe chronic obstructive pulmonary disease (COPD). 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4-6 weeks of pre-trial rehabilitation, and 6 months after randomisation to surgery or medical care. The St George's Respiratory Questionnaire (domain and total scores) and University of California San Diego Shortness of Breath Questionnaire (total score) served as anchors for anchor-based MID estimates. In order to calculate distribution-based estimates, we used the standard error of measurement, Cohen's effect size and the empirical rule effect size. Anchor-based estimates for the 6MWD were 18.9 m (95% CI 18.1-20.1 m), 24.2 m (95% CI 23.4-25.4 m), 24.6 m (95% CI 23.4-25.7 m) and 26.4 m (95% CI 25.4-27.4 m), which were similar to distribution-based MID estimates of 25.7, 26.8 and 30.6 m. For MCEC, anchor-based estimates for the MID were 2.2 W (95% CI 2.0-2.4 W), 3.2 W (95% CI 3.0-3.4 W), 3.2 W (95% CI 3.0-3.4 W) and 3.3 W (95% CI 3.0-3.5 W), while distribution-based estimates were 5.3 and 5.5 W. We suggest a MID of 26 ± 2 m for 6MWD and 4 ± 1 W for MCEC for patients with severe COPD.
| S-EPMC5516638 | biostudies-literature
Project description:OBJECTIVE:Valid, reliable, and clinically relevant outcome measures are necessary in clinical studies of snake envenomation. The aim of this study was to evaluate the psychometric (validity and reliability) and clinimetric (minimal clinically important difference [MCID]) properties of the Patient-Specific Functional Scale (PSFS) in snakebite envenomation. METHODS:We performed a secondary analysis of two existing snakebite trials that measured clinical outcomes using the PSFS as well as other quality of life and functional assessments. Data were collected at 3, 7, 10, and 17 days. Reliability was determined using Cronbach's alpha for internal consistency and the intraclass correlation coefficient (ICC) for temporal stability at 10 and 17 days. Validity was assessed using concurrent validity correlating with the other assessments. The MCID was evaluated using the following criteria: (1) the distribution of stable patients according to both standard error of measurement (SEM) and responsiveness techniques, and (2) anchor-based methods to compare between individuals and to detect discriminant ability of a positive change with a receiver operator characteristic (ROC) curve and optimal cutoff point. RESULTS:A total of 86 patients were evaluated in this study. The average PSFS scores were 5.37 (SD 3.23), 7.95 (SD 2.22), and 9.12 (SD 1.37) at 3, 7, and 10 days, respectively. Negligible floor effect was observed (maximum of 8% at 3 days); however, a ceiling effect was observed at 17 days (25%). The PSFS showed good reliability with an internal consistency of 0.91 (Cronbach's alpha) (95% CI 0.88, 0.95) and a temporal stability of 0.83 (ICC) (95% CI 0.72, 0.89). The PSFS showed a strong positive correlation with quality of life and functional assessments. The MCID was approximately 1.0 for all methods. CONCLUSIONS:With an MCID of approximately 1 point, the PSFS is a valid and reliable tool to assess quality of life and functionality in patients with snake envenomation.
| S-EPMC6400437 | biostudies-literature
Project description:BACKGROUND:Using a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation. METHODS:We used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline. RESULTS:Three hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates. CONCLUSION:This practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues. TRIAL REGISTRATION:NCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.
| S-EPMC7251729 | biostudies-literature
Project description:BACKGROUND:Changes in physical activity (PA) are difficult to interpret because no framework of minimal important difference (MID) exists. We aimed to determine the minimal important difference (MID) in physical activity (PA) in patients with Chronic Obstructive Pulmonary Disease and to clinically validate this MID by evaluating its impact on time to first COPD-related hospitalization. METHODS:PA was objectively measured for one week in 74 patients before and after three months of rehabilitation (rehabilitation sample). In addition the intraclass correlation coefficient was measured in 30 patients (test-retest sample), by measuring PA for two consecutive weeks. Daily number of steps was chosen as outcome measurement. Different distribution and anchor based methods were chosen to calculate the MID. Time to first hospitalization due to an exacerbation was compared between patients exceeding the MID and those who did not. RESULTS:Calculation of the MID resulted in 599 (Standard Error of Measurement), 1029 (empirical rule effect size), 1072 (Cohen's effect size) and 1131 (0.5SD) steps.day-1. An anchor based estimation could not be obtained because of the lack of a sufficiently related anchor. The time to the first hospital admission was significantly different between patients exceeding the MID and patients who did not, using the Standard Error of Measurement as cutoff. CONCLUSIONS:The MID after pulmonary rehabilitation lies between 600 and 1100 steps.day-1. The clinical importance of this change is supported by a reduced risk for hospital admission in those patients with more than 600 steps improvement.
| S-EPMC4849755 | biostudies-literature
Project description:BACKGROUND: The modified version of the Pulmonary Functional Status and Dyspnea Questionnaire (PFSDQ-M) is used in patients with COPD to obtain information about their functional status. It consists of 3 components (change in activities, dyspnea and fatigue) ranging from 0 to 100 and has been shown to be responsive following pulmonary rehabilitation (PR). The interpretation of changes in PFSDQ-M score after an intervention is difficult in the absence of the minimal important difference (MID) of the PFSDQ-M. This study aims at investigating the MID of the PFSDQ-M. METHODS: We enrolled 301 patients with COPD (FEV1 42?±?15%pred) that completed the PFSDQ-M before and after a 3-month PR program (?Chronic Respiratory Disease Questionnaire (CRDQ) +16?±?12 points, ?Six-minute walking distance (6MWD) +47?±?89 m, both p?<?0.001). An anchor-based approach consisted of calculating the correlation between the ?PFSDQ-M and anchors with an established MID (?CRDQ and ?6MWD). Linear regression analyses were performed to predict the MID from these anchors. Secondly several distribution-based approaches (Cohen's effect size, empirical rule effect size and standard error of measurement method) were used. RESULTS: Anchor-based estimates for the different PFSDQ-M-components were between -3 and -5 points based on CRDQ score and -6 (only calculated for change in activities) based on 6MWD. Using the distribution-based methods, the estimates of MID ranged from -3 to -5 points for the different components. CONCLUSIONS: We concluded that the estimate of MID of the PFSDQ-M after pulmonary rehabilitation corresponds to a change of 5 points (range - 3 to -6) in each component in patients with severe COPD.
| S-EPMC3667081 | biostudies-literature
Project description:Introduction and hypothesisPatient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) in pelvic organ prolapse (POP) surgery.MethodsWe used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified.ResultsThe MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9-25.0 (median 24.2) points for PFDI-20 and 9.0-12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7-62.5 (median 60.0) for PFDI-20 and 16.7-17.7 (median 17.2) for POPDI-6.ConclusionA mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state.
| S-EPMC8642346 | biostudies-literature
Project description:OBJECTIVE:To determine Glittre-ADL test minimal important difference in patients with chronic obstructive pulmonary disease. METHODS:This is quasi-experimental study. Sixty patients with moderate to very severe chronic obstructive pulmonary disease (age 64.1, SD=9.09 years; forced expiratory volume in the first second 37.9, SD=13.0% predicted participated in a pulmonary rehabilitation program based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and resistance training for upper limbs and lower limbs. The main outcomes were the Glittre-ADL test and six-minute walk test, before and after 24 sessions of pulmonary rehabilitation. The minimal important difference was established using the distribution and anchor-based methods. RESULTS:Patients improved their functional capacity after the pulmonary rehabilitation. The effect sizes of Glittre-ADL test and six-minute walk test improvement were similar (0.45 vs 0.44, respectively). The established minimal important differences ranged from -0.38 to -1.05. The reduction of 0.38min (23s) corresponded to a sensitivity of 64% and a specificity of 69% with an area under the curve of 0.66 (95%CI 0.51-0.81; p=0.04). Subjects who achieved the minimal important difference of -0.38min for the Glittre-ADL test had a superior improvement of approximately 42m in the six-minute walk test when compared to patients who did not. CONCLUSIONS:The present findings suggest -0.38min as the minimal important difference in the time spent in the Glittre-ADL test after 24 sessions of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. TRIAL REGISTRATION:NCT03251781 (https://clinicaltrials.gov/ct2/show/NCT03251781).
| S-EPMC6994309 | biostudies-literature
Project description:BackgroundThe results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well.ObjectiveTo determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS).MethodsWe used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100?mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds.ResultsDifferent MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20?mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2?mm for pain at rest, 9?mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83.ConclusionWe recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20?mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9?mm for pain on arm activity, 80 points for CS, and 11 points for SST.Trial registrationClinicalTrials.gov NCT00428870 (first registered January 29, 2007).
| S-EPMC7937213 | biostudies-literature
Project description:Estimates of the minimal clinically important difference (MCID) for physical activity (PA) in chronic obstructive pulmonary disease (COPD) are needed. The objective is to provide an anchor-based estimate of the MCID for daily step count. PA was promoted in persons with COPD using a pedometer (Omron HJ-720ITC) alone or a pedometer plus interactive website for 3 months. Participants wore the pedometer daily and received phone calls monthly to ascertain medical events. Medical events were counted when a participant self-reported that he/she had (1) worsening of breathing, (2) change to breathing medications, (3) medical care from an emergency room for any reason, or (4) hospitalization for any reason. Generalized linear regression models assessed daily step count as change at the end of study and averaged over the 15, 31, or 61 days centered on the event, in those with an event compared to those without one. All categories of events carried equal weight in the analyses. We studied 93 persons, 46 of whom had an event. Participants who experienced an event had a decrease of 1086 (95% confidence interval (CI): -2124 to -48) or 887 (95% CI: -2030 to 257) steps/day in the pedometer plus website or pedometer alone groups, respectively, compared to those without one. In the days centered on an event, participants who had an event experienced a decrease of 882-983 steps/day (pedometer plus website) or a decrease of 351-495 steps/day (pedometer alone), compared to those without one. The MCID for PA in COPD ranges from 350 steps/day to 1100 steps/day.
| S-EPMC6302974 | biostudies-literature
Project description:Pedometer step count improves with pulmonary rehabilitation and deteriorates with time. The MCID for improvement and deterioration is 427 and -456 steps, respectively, but there is uncertainty about the reliability of these estimates. https://bit.ly/3ci97Jh.
| S-EPMC7983253 | biostudies-literature