Health‐related quality of life after restrictive versus liberal RBC transfusion for cardiac surgery: Sub‐study from a randomized clinical trial

Abstract

Background Transfusion Requirements in Cardiac Surgery III (TRICS III), a multi‐center randomized controlled trial, demonstrated clinical non‐inferiority for restrictive versus liberal RBC transfusion for patients undergoing cardiac surgery. However, it is uncertain if transfusion strategy affects long‐term health‐related quality of life (HRQOL). Study Design and Methods In this planned sub‐study of Australian patients in TRICS III, we sought to determine the non‐inferiority of restrictive versus liberal transfusion strategy on long‐term HRQOL and to describe clinical outcomes 24 months postoperatively. The restrictive strategy involved transfusing RBCs when hemoglobin was <7.5 g/dl; the transfusion triggers in the liberal group were: <9.5 g/L intraoperatively, <9.5 g/L in intensive care, or <8.5 g/dl on the ward. HRQOL assessments were performed using the 36‐item short form survey version 2 (SF‐36v2). Primary outcome was non‐inferiority of summary measures of SF‐36v2 at 12 months, (non‐inferiority margin: −0.25 effect size; restrictive minus liberal scores). Secondary outcomes included non‐inferiority of HRQOL at 18 and 24 months. Results Six hundred seventeen Australian patients received allocated randomization; HRQOL data were available for 208/311 in restrictive and 217/306 in liberal group. After multiple imputation, non‐inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non‐inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality‐adjusted life years or composite clinical outcomes up to 24 months after surgery. Discussion The non‐inferiority of a restrictive compared to a liberal transfusion strategy was not established for long‐term HRQOL in this dataset.

An analysis of quality of life and functional outcomes as reported in randomized trials for red cell transfusions

“…For example, one study found worse QoL outcomes at 12, 18, and 24 months in participants exposed to a restrictive as compared to a liberal transfusion strategy. However, we believe it is unlikely that transfusion administered many months before would impact QoL so many months later 32 . Measuring functional outcomes within days to few weeks seems more likely to relate to a specific transfusion strategy rather than longer time periods.…”

“… 10–30 Three additional RCTs reporting outcomes of fatigue or other QoL measures were identified in the updated search (Table 1). 31,32 Two trials were excluded because the scores for each arm were not available in a format that could be used for analysis, 33,34 and one trial was excluded for evaluating immediate versus delayed transfusion 35 …”

“…However, we believe it is unlikely that transfusion administered many months before would impact QoL so many months later. 32 Measuring functional outcomes within days to few weeks seems more likely to relate to a specific transfusion strategy rather than longer time periods.…”

Postoperative transfusion hemoglobin threshold and functional recovery after high‐risk oncologic surgery: A randomized controlled pilot study

“…Level of disability and quality of life are important outcomes when considering patients with chronic diseases. Postoperative functional recovery has also become a rising concern and focus 14,15 . Recently, dedicated scales, including the 12‐item WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0) and the QoR‐15 (Quality of Recovery, 15 items), have been used to document patient‐centered outcomes in recent randomized controlled trials and observational studies in perioperative setting 2,16–19 …”

“…Postoperative functional recovery has also become a rising concern and focus. 14,15 Recently, dedicated scales, including the 12-item WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0) and the QoR-15 (Quality of Recovery, 15 items), have been used to document patient-centered outcomes in recent randomized controlled trials and observational studies in perioperative setting. 2,[16][17][18][19] Pilot studies to test feasibility and acceptability are essential to validate the design of large randomized trials.…”