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Evaluating Physical Outcomes in Acute Respiratory Distress Syndrome Survivors: Validity, Responsiveness, and Minimal Important Difference of 4-Meter Gait Speed Test.

ABSTRACT: To examine the reliability, validity, responsiveness, and minimal important difference of the 4-m gait speed test in acute respiratory distress syndrome survivors.Secondary analyses of data from two longitudinal follow-up studies of acute respiratory distress syndrome survivors. Test-retest and inter-rater reliability, construct validity (convergent, discriminant, and known group), predictive validity, and responsiveness were examined. The minimal important difference was estimated using anchor- and distribution-based approaches.A national multicenter prospective study (ARDSNet Long-Term Outcome Study) and a multisite prospective study in Baltimore, MD (Improving Care of Acute Lung Injury Patients).Acute respiratory distress syndrome survivors with 4-m gait speed assessment up to 60 months after acute respiratory distress syndrome (ARDSNet Long-Term Outcome Study, n = 184; Improving Care of Acute Lung Injury Patients, n = 122).Not applicable.Four-meter gait speed was assessed at 6- and 12-month follow-up (ARDSNet Long-Term Outcome Study) and 36-, 48-, and 60-month follow-up (Improving Care of Acute Lung Injury Patients). Excellent test-retest (intraclass correlation, 0.89-0.99 across studies and follow-up) and inter-rater (intraclass correlation, 0.97) reliability were found. Convergent validity was supported by moderate-to-strong correlations (69% of 32 > 0.40) with other physical function measures. Discriminant validity was supported by weak correlations (86% of 28 < 0.30) with mental health measures. Survivors with impaired versus nonimpaired measures of muscle strength and pulmonary function had significantly slower 4-m gait speed (all but one p < 0.05). Furthermore, 4-m gait speed significantly predicted future hospitalization and health-related quality of life. Gait speed changes were consistent with reported changes in function, supporting responsiveness. The estimated 4-m gait speed minimal important difference was 0.03-0.06 m/s.The 4-m gait speed is a reliable, valid, and responsive measure of physical function in acute respiratory distress syndrome survivors. The estimated minimal important difference will facilitate sample size calculations for clinical studies evaluating the 4-m gait speed test in acute respiratory distress syndrome survivors.

SUBMITTER: Chan KS

PROVIDER: S-EPMC5206972 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Evaluating Physical Outcomes in Acute Respiratory Distress Syndrome Survivors: Validity, Responsiveness, and Minimal Important Difference of 4-Meter Gait Speed Test.

Chan Kitty S KS Aronson Friedman Lisa L Dinglas Victor D VD Hough Catherine L CL Morris Peter E PE Mendez-Tellez Pedro A PA Jackson James C JC Ely E Wesley EW Hopkins Ramona O RO Needham Dale M DM

Critical care medicine 20160501 5

<h4>Objective</h4>To examine the reliability, validity, responsiveness, and minimal important difference of the 4-m gait speed test in acute respiratory distress syndrome survivors.<h4>Design</h4>Secondary analyses of data from two longitudinal follow-up studies of acute respiratory distress syndrome survivors. Test-retest and inter-rater reliability, construct validity (convergent, discriminant, and known group), predictive validity, and responsiveness were examined. The minimal important diffe ...[more]

PMID: 26963329

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Project description:BACKGROUND:Idiopathic pulmonary fibrosis (IPF) specific version of St. George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease questionnaire (K-BILD) are validated health-related quality of life (HRQL) instruments, but no or limited data exist on their responsiveness and minimal clinically important difference (MCID). The objectives of this study were to assess responsiveness of SGRQ-I and K-BILD and determine MCID separately for deterioration and improvement in a large, prospective cohort of patients with IPF in a real-world setting. METHODS:Consecutive patients with IPF were recruited. SGRQ-I, K-BILD, SGRQ, Shortness of Breath Questionnaire, pulmonary function tests and 6-min walk test measurements were obtained at baseline and at six and 12?months; at six and 12?months, patients also completed Global Rating of Change Scales. Responsiveness was assessed using correlation coefficients and linear regression. Cox regression was used for mortality analyses. MCID was estimated using receiver operating characteristic curves with separate analyses for improvement and deterioration. RESULTS:A total of 150 IPF patients were included and 124 completed the 12-month follow-up. Based on all HRQL anchors and most physiological anchors, responsiveness analyses supported the evidence pointing towards SGRQ-I and K-BILD as responsive instruments. Multivariate analyses showed an association between SGRQ-I and mortality (HR: 1.18, 95% CI: 1.02 to 1.36, p?=?0.03) and a trend was found for K-BILD (HR: 0.82, 95% CI: 0.64 to 1.05, p?=?0.12). MCID was estimated for all domains of SGRQ-I and K-BILD. MCID for improvement differed from deterioration for both SGRQ-I Total (3.9 and 4.9) and K-BILD Total (4.7 and 2.7). CONCLUSIONS:SGRQ-I and K-BILD were responsive to change concerning both HRQL and most physiological anchors. MCID was determined separately for improvement and deterioration, resulting in different estimates; especially a smaller estimate for deterioration compared to improvement in K-BILD. TRIAL REGISTRATION:Clinicaltrials.gov, no. NCT02818712. Registered 30 June 2016.

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.

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Project description:BackgroundThe Multiple Sclerosis Questionnaire for Physical Therapists (MSQPT) is a patient-rated outcome questionnaire for evaluating the rehabilitation of persons with multiple sclerosis (MS). Responsiveness was evaluated, and minimal important difference (MID) estimates were calculated to provide thresholds for clinical change for four items, three sections and the total score of the MSQPT.MethodsThis multicentre study used a combined distribution- and anchor-based approach with multiple anchors and multiple rating of change questions. Responsiveness was evaluated using effect size, standardized response mean (SRM), modified SRM and relative efficiency. For distribution-based MID estimates, 0.2 and 0.33 standard deviations (SD), standard error of measurement (SEM) and minimal detectable change were used. Triangulation of anchor- and distribution-based MID estimates provided a range of MID values for each of the four items, the three sections and the total score of the MSQPT. The MID values were tested for their sensitivity and specificity for amelioration and deterioration for each of the four items, the three sections and the total score of the MSQPT. The MID values of each item and section and of the total score with the best sensitivity and specificity were selected as thresholds for clinical change. The outcome measures were the MSQPT, Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS), rating of change questionnaires, Expanded Disability Status Scale, 6-metre timed walking test, Berg Balance Scale and 6-minute walking test.ResultsThe effect size ranged from 0.46 to 1.49. The SRM data showed comparable results. The modified SRM ranged from 0.00 to 0.60. Anchor-based MID estimates were very low and were comparable with SD- and SEM-based estimates. The MSQPT was more responsive than the HAQUAMS in detecting improvement but less responsive in finding deterioration. The best MID estimates of the items, sections and total score, expressed in percentage of their maximum score, were between 5.4% (activity) and 22% (item 10) change for improvement and between 5.7% (total score) and 22% (item 10) change for deterioration.ConclusionsThe MSQPT is a responsive questionnaire with an adequate MID that may be used as threshold for change during rehabilitation of MS patients.Trial registrationThis trial was retrospectively (01/24/2015) registered in ClinicalTrials.gov as NCT02346279.

Project description:BackgroundThe discriminatory ability of multi-attribute utility (MAU) measures compared to condition-specific measures (CSM) in assessing health-related quality of life (HRQoL) among patients with chronic obstructive pulmonary disease (COPD) is an unsettled issue. This study investigated the quality of life of patients with COPD with three different HRQoL instruments and examined whether they could differentiate between adjacent severity groups in a statistically and clinically meaningful manner. In the process, the minimal clinically important differences (MCID) of the EQ-5D utility index were estimated.MethodsCross-sectional survey data were collected from patients with mild to very severe COPD in South Korea. In addition to demographic and clinical information, the following HRQoL questionnaires were used: The three-level five-dimensional Euro-Quality of Life tool (EQ-5D-3L), the EQ-Visual Analog Scale (EQ-VAS), and the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Patients' health-related quality of life was analyzed with reference to severity groups based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. To investigate the discriminatory ability of the HRQoL instruments between COPD severity groups, tests examining variance, covariance, and standardized mean difference were performed. After estimating the MCID of the EQ-5D utility index using the anchor-based method, we investigated whether the differences in the EQ-5D utility scores between groups exceeded the clinically meaningful minimum level.ResultsA total of 298 patients completed this study. All the quality of life scores showed statistically significant differences between the GOLD severity groups. The pooled MCID estimate for the EQ-5D utility index was 0.028 (range: 0.017-0.033). Even after adjusting for other factors affecting quality of life, the EQ-5D utility index differentiated the GOLD groups well.ConclusionsWe conclude that the EQ-5D utility index is a valid instrument for measuring the quality of life of patients with COPD, and the pooled MCID estimate for the EQ-5D utility index was 0.028.

Dataset Information

Evaluating Physical Outcomes in Acute Respiratory Distress Syndrome Survivors: Validity, Responsiveness, and Minimal Important Difference of 4-Meter Gait Speed Test.

Publications

Evaluating Physical Outcomes in Acute Respiratory Distress Syndrome Survivors: Validity, Responsiveness, and Minimal Important Difference of 4-Meter Gait Speed Test.

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