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Triangulating Clinically Meaningful Change in the Six-minute Walk Test in Individuals with Chronic Heart Failure: A
Michael J Shoemaker1, Amy B Curtis, Eric Vangsnes
1Western Michigan University Interdisciplinary Health Sciences Program.
Insights
A change of approximately 45 meters on the six-minute walk test (6MWT) indicates a meaningful improvement for patients with chronic heart failure (CHF), exceeding measurement error and correlating with better aerobic capacity and quality of life.
Area of Science:
- Cardiology
- Rehabilitation Medicine
- Clinical Measurement
Background:
- The six-minute walk test (6MWT) is a common functional assessment in chronic heart failure (CHF).
- Determining a clinically meaningful change in 6MWT distance (Δ6MWT) is crucial for evaluating interventions in CHF patients.
- Existing data requires synthesis to establish a reliable threshold for meaningful improvement.
Purpose of the Study:
- To estimate the Δ6MWT that signifies a clinically meaningful improvement in individuals with CHF.
- To differentiate between measurement error and true change in 6MWT distance for CHF patients.
Main Methods:
- Systematic literature searches of CINAHL and MEDLINE databases were conducted.
- Included studies reported the intraclass correlation coefficient (ICC) of the 6MWT or used 6MWT as an endpoint in randomized controlled trials (RCTs) of exercise interventions for CHF.
- Minimum detectable difference (MDD) was calculated from ICCs, and receiver operating characteristic (ROC) curves analyzed Δ6MWT against effect sizes for aerobic capacity and health-related quality of life (HRQL).
Main Results:
- The mean MDD for 6MWT was 43.1(16.8) m, indicating the threshold for measurement error.
- A Δ6MWT of 40-45 m was associated with moderate effect sizes in aerobic capacity and HRQL in intervention groups.
- ROC curve analysis suggested thresholds of 19m, 32m, and 48m with varying sensitivity and specificity for discriminating between intervention and control groups.
Conclusions:
- A Δ6MWT of approximately 45 meters surpasses measurement error in CHF patients.
- This 45m threshold is associated with significant improvements in aerobic capacity and/or HRQL.
- This finding provides a valuable benchmark for interpreting 6MWT results in clinical trials and practice for CHF.
Purpose:
The purpose of the present review was to use existing, published data to provide an estimate of the amount of change in six-minute walk test distance (Δ6MWT) that represents a clinically meaningful change in individuals with chronic heart failure (CHF).
Methods:
THE PRESENT REVIEW INCLUDED TWO SEPARATE LITERATURE SEARCHES OF THE CINAHL AND MEDLINE DATABASES FOR ARTICLES THAT: (1) reported the intraclass correlation coefficient (ICC) of the 6MWT in individuals with CHF, and (2) used the 6MWT along with either aerobic capacity or health-related quality of life (HRQL) as study endpoints in randomized controlled trials (RCTs) of exercise-based intervention for individuals with CHF. The ICCs were used to calculate the minimum detectable difference (MDD) at the 95% confidence interval for each included study. The Δ6MWT associated with aerobic capacity and HRQL within-group effect sizes for the intervention and control groups in each included RCT was analyzed using receiver operating characteristic (ROC) curves.
Results:
Thirteen articles reported the ICC for the 6MWT. The mean (standard deviation) MDD calculated based on these data was 43.1(16.8) m. Eighteen RCTs measured the 6MWT and either aerobic capacity and/or HRQL. A Δ6MWT of 40-45 m was associated with at least moderate aerobic capacity and HRQL effect sizes in the intervention groups. The Δ6MWT thresholds that discriminated between intervention and control groups using ROC curves revealed the following sensitivity/specificity for the respective thresholds: 19 m, 94.4/83.3%, 32 m, 83.3/94.4%, and 48 m 44.4/100% (AUC = .935, p = .009, CI(95%) .855, 1.015).
Conclusions:
A Δ6MWT of approximately 45 m appears to exceed measurement error and be associated with significant changes in either aerobic capacity and/or HRQL.
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