Minimal Clinically Important Differences in 6-Minute Walk Test in Patients With HFrEF and Iron Deficiency

Khan, Muhammad Shahzeb; Anker, Stefan D.; Friede, Tim; Jankowska, Ewa A.; Metra, Marco; Piña, Ileana L.; Coats, Andrew J.S.; Rosano, Giuseppe; Roubert, Bernard; Goehring, Udo‐Michael; Dorigotti, Fabio; Comín‐Colet, Josep; Veldhuisen, Dirk J. van; Filippatos, Gerasimos; Ponikowski, Piotr; Butler, Javed

doi:10.1016/j.cardfail.2022.10.423

Cited by 15 publications

(7 citation statements)

References 34 publications

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“…The authors demonstrated that a change in KCCQ-TSS of >9 points in HFrEF and >7 points in HFpEF patients represents the MCID for improvement [ 30 ]. Finally, another study used an anchor-based approached to assess the MCID for 6MWD in patients with HF and iron deficiency [ 31 ]. In this study, the patient global assessment (PGA), a health-related QoL tool based on a Likert scale, was administered to patients and was used as a clinical anchor [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

“…Finally, another study used an anchor-based approached to assess the MCID for 6MWD in patients with HF and iron deficiency [ 31 ]. In this study, the patient global assessment (PGA), a health-related QoL tool based on a Likert scale, was administered to patients and was used as a clinical anchor [ 31 ]. The authors demonstrated that the MCID for improvement in exercise capacity on the 6MWT was 14–15 m in patients with HFrEF and iron deficiency.…”

Section: Discussionmentioning

confidence: 99%

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Demystifying the Value of Minimal Clinically Important Difference in the Cardiothoracic Surgery Context

Magouliotis

Bareka

Rad

et al. 2023

Life

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The aim of this review is to describe the different statistical methods used in estimating the minimal clinically important difference (MCID) for the assessment of quality of life (QOL)-related and clinical improvement interventions, along with their implementation in cardiothoracic surgery. A thorough literature search was performed in three databases (PubMed/Medline, Scopus, Google Scholar) for relevant articles from 1980 to 2022. We included articles that implemented and assessed statistical methods used to estimate the concept of MCID in cardiothoracic surgery. MCID has been successfully implemented in several medical specialties. Anchor-based and distribution-based methods are the most common approaches when evaluating the MCID. Nonetheless, we found only five studies investigating the MCID in the context of cardiothoracic surgery. Four of them used anchor-based approaches, and one used both anchor-based and distribution-based methods. MCID values were very variable depending on the methods applied, as was the clinical context of the study. The variables of interest were certain QOL measuring questionnaires, used as anchors. Multiple anchors and methods were applied, leading to different estimations of MCID. Since cardiothoracic surgery is related to important perioperative morbidity, MCID might represent an important and efficient adjunct tool to interpret clinical outcomes. The need for MCID methodology implementation is even higher in patients with heart failure undergoing cardiac surgery. More studies are needed to validate different MCID methods in this context.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Demystifying the Value of Minimal Clinically Important Difference in the Cardiothoracic Surgery Context

Magouliotis

Bareka

Rad

et al. 2023

Life

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“…26 In a recent study, 14 m was reported as the minimal clinically important difference (MCID) in patients with HF and reduced ejection fraction. 27 However, MCID depends on the underlying condition, comorbidities, and the patients' self-perception. Previous trials on exercise training in HF demonstrated significant improvement in 6MWT distance.…”

Section: Discussionmentioning

confidence: 99%

“…The 6MWT is a widely used measure of submaximal exercise capacity 26 . In a recent study, 14 m was reported as the minimal clinically important difference (MCID) in patients with HF and reduced ejection fraction 27 . However, MCID depends on the underlying condition, comorbidities, and the patients' self‐perception.…”

Section: Discussionmentioning

confidence: 99%

“…Ex‐VAD demonstrated a mean increase of 43.4 m in the 6MWT. This order of magnitude can be considered clinically relevant 27 for the group of patients studied in Ex‐VAD, and may be very important for the patients' well‐being and mobility in everyday life. Furthermore, it is considerably higher than in most pharmacological HF trials 29,30 …”

Section: Discussionmentioning

confidence: 99%

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Supervised exercise training in patients with advanced heart failure and left ventricular assist device: A multicentre randomized controlled trial (Ex‐VAD trial)

Feuerstein,

Schoenrath,

Belyavskiy

et al. 2023

European J of Heart Fail

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AimsSmall studies and observations suggested that exercise training may improve peak oxygen consumption (peakVO2) in patients with advanced heart failure and left ventricular assist device (LVAD). We investigated whether in this patient group a supervised exercise training can improve exercise capacity.Methods and resultsIn this multicentre, prospective, randomized, controlled trial, patients with stable heart failure and LVAD were randomly assigned (2:1) to 12 weeks of supervised exercise training or usual care, with 12 weeks of follow‐up. The primary endpoint was the change in peakVO2 after 12 weeks (51 patients provided a power of 90% with an expected group difference in peakVO2 of 3 ml/kg/min). Secondary endpoints included changes in submaximal exercise capacity and quality of life. Among 64 patients enrolled (97% male, mean age 56 years), 54 were included in the analysis. Mean difference in the change of peakVO2 after 12 weeks was 0.826 ml/min/kg (95% confidence interval [CI] −0.37, 2.03; p = 0.183). There was a positive effect of exercise training on 6‐min walk distance with a mean increase in the intervention group by 43.4 m (95% CI 16.9, 69.9; p = 0.0024), and on the Kansas City Cardiomyopathy Questionnaire physical domain score (mean 14.3, 95% CI 3.7, 24.9; p = 0.0124), both after 12 weeks. The overall adherence was high (71%), and there were no differences in adverse events between groups.ConclusionIn patients with advanced heart failure and LVAD, 12 weeks of exercise training did not improve peakVO2 but demonstrated positive effects on submaximal exercise capacity and physical quality of life.

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Changes in 6‐min walk test is an independent predictor of death in chronic heart failure with reduced ejection fraction

Myhre,

Kleiven,

Berge

et al. 2024

European J of Heart Fail

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AimsFunctional capacity provides important clinical information in patients with heart failure (HF) and reduced ejection fraction (HFrEF). The 6‐min walk test (6MWT) is a simple and inexpensive tool for assessing functional capacity and risk. Although change in 6MWT is frequently used as a surrogate outcome in HF trials, the association with mortality is unclear. We aimed to assess the prognostic importance of changes in 6MWT.Methods and resultsPatients with chronic HFrEF referred to HF outpatient clinics in Norway completed a 6MWT at the first visit (baseline) and at a stable follow‐up visit after treatment optimization (follow‐up). Absolute and relative changes in 6MWT were analysed in association with mortality risk using Cox regression models and flexible cubic splines. The study included 3636 HFrEF patients aged 67.3 ± 11.6 years, 23% women, with left ventricular ejection fraction 30 ± 7%. At baseline, mean 6MWT was 438 ± 125 m, median N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) 1574 (732–3093) ng/L, and 27% had New York Heart Association (NYHA) class III/IV. After optimization of guideline‐directed medical therapy (median 147 [86–240] days), 6MWT increased by mean 40 ± 74 m, NT‐proBNP decreased by median 425 (14–1322) ng/L, and NYHA class improved in 38% of patients. Patients with greater improvements in 6MWT were younger, with greater improvements in NYHA class (r = 0.27, p < 0.001) and larger reductions in NT‐proBNP concentrations (r = 0.19, p < 0.001). After mean 845 ± 595 days, 419 (11.5%) patients were dead. Both absolute and relative changes in 6MWT were non‐linearly associated with survival, attenuating as 6MWT increased. A 50 m increase in 6MWT was associated with a 17% lower mortality risk (hazard ratio 0.84, 95% confidence interval 0.77–0.90, p < 0.001) in the fully adjusted model, including changes in NYHA class, NT‐proBNP concentrations, and other established risk factors. The associations were more pronounced in patients with lower baseline 6MWT and higher age.ConclusionImprovement in 6MWT in patients with HFrEF is associated with increased survival, independent of changes in NT‐proBNP and NYHA class. These findings support 6MWT change as a surrogate outcome in HF trials.

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Minimal Clinically Important Differences in 6-Minute Walk Test in Patients With HFrEF and Iron Deficiency

Cited by 15 publications

References 34 publications

Demystifying the Value of Minimal Clinically Important Difference in the Cardiothoracic Surgery Context

Demystifying the Value of Minimal Clinically Important Difference in the Cardiothoracic Surgery Context

Supervised exercise training in patients with advanced heart failure and left ventricular assist device: A multicentre randomized controlled trial (Ex‐VAD trial)

Changes in 6‐min walk test is an independent predictor of death in chronic heart failure with reduced ejection fraction

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