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Table 1 Definitions of efficacy outcomes

From: Sex differences in CRT device implantation rates, efficacy, and complications following implantation: protocol for a systematic review and meta-analysis of cohort studies

Efficacy outcomes

Definitions

6-min walk test

Treadmill walking test to test exercise capacity in patients with chronic heart failure [60].

NYHA class reduction

Estimation of NYHA functional class [61] within 6 months after randomization [62]

LVEF improvement

Measured using 2-dimenionsonal Doppler-flow echocardiography [63] or used LV volume reduction

Peak oxygen consumption (pVO2)

Measurement of peak oxygen consumption per unit time at anaerobic threshold. The improvement will be assessed from baseline to 6 months [64]

Hospitalization

NA

All-cause mortality

NA

Quality of life

Questionnaire developed to assess patients perception on the impact of heart failure on their daily lifestyle [65]

Heart failure hospitalization

Includes patients that were admitted to any health facility for the treatment of heart failure symptoms for more than 24 h [66]

Composite response endpoint

Worsened: Patient death, worsening of heart failure resulting in hospitalization, therapeutic response is considered insufficient, worsening in NYHA class relative to previous observation or moderate-marked worsening of patient global assessment score at LOCF (last observation carried forward).

Improved: Patient has not worsened (as previously described) and shows improvement in NYHA class at LOCF and/or moderate-marked improvement in patient global assessment score at LOCF.

Unchanged: No indications of worsened nor improved health of patients [62].

All-cause mortality composite outcomes

All-cause mortality in combination with any other outcomes