Non-response for health-related quality of life outcomes in ICU patients: A systematic review of the reporting in randomised trials

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Background: Health-related quality of life (HRQoL) is frequently assessed in randomised clinical trials (RCTs) in the intensive care unit (ICU), but data are limited regarding the proportions of patients without responses or not surviving to HRQoL follow-up and the handling of this. We aimed to describe the extent and pattern of missing HRQoL data in intensive care trials and describe how these data and deaths were handled statistically. Methods: We conducted a systematic review and meta-analysis following a published protocol. We searched PubMed, EMBASE, CINAHL and Cochrane Library for RCTs involving adult ICU patients reporting HRQoL as an outcome and excluded RCTs unobtainable in full text. We performed risk of bias assessment independently and in duplicate. Results: We included 196 outcomes from 88 RCTs published in the years 2002–2022; the numbers of patients alive and eligible to respond HRQoL were reported in 76% of trials. At follow-up, median 27% (interquartile range 14%–39%) of patients had died, and median 20% (9%–38%) of survivors did not respond across outcomes. Analyses of 80% of outcomes were restricted to complete cases only. The handling of non-survivors in analyses were reported for 46% of outcomes, with 26% of all outcomes reported as including non-survivors (using the value zero or the worst possible score). Conclusion: For HRQoL outcomes in ICU trials, we found that mortality at time of follow-up was high and non-response among survivors frequent. The reporting and statistical handling of these issues were insufficient, which may have biased results.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Volume67
Issue number7
Pages (from-to)842-852
Number of pages11
ISSN0001-5172
DOIs
Publication statusPublished - Aug 2023

Bibliographical note

Funding Information:
None of the authors have any relevant competing interests on the subject. The Department of Intensive Care, Rigshospitalet has received funding from The Novo Nordisk Foundation, Pfizer, Sygeforsikringen “danmark”, and Fresenius Kabi and conducted contract research for AM‐Pharma. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Publisher Copyright:
© 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

    Research areas

  • attrition bias, HRQoL, long-term outcomes, non-respondents, non-survival

ID: 362389360