Development of a core outcome set for general intensive care unit patients—A protocol

Abstract

Introduction Different outcomes are reported in randomised clinical trials (RCTs) in intensive care unit (ICU) patients, and no core outcome set (COS) is available for ICU patients in general. Accordingly, we aim to develop a COS for ICU patients in general. Methods The COS will be developed in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Handbook, using a modified Delphi consensus process and semi‐structured interviews involving adults who have survived acute admission to an ICU, family members, clinicians, researchers and other stakeholders. The modified Delphi process will include two steps. Step 1: conduction of a modified Delphi survey, developed and informed by combining the outputs of a literature search of outcomes in previous COSs and semi‐structured interviews with key stakeholders. We plan at least two survey rounds to obtain consensus and refine the COS. Step 2: a consensus process regarding instruments or definitions to be recommended for the measurements of the outcomes selected in Step 1. A ‘patient and public involvement panel’ consisting of a smaller group of patients, family members, clinicians and researchers will be included in the development, analysis and interpretation of the COS. Discussion The outlined multiple method studies will establish a COS for ICU patients in general, which may be used to increase the standardisation and comparability of results of RCTs conducted in patients in the ICU setting.

Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review

“…A large variety of different functional/cognitive/neurologic outcomes were reported, and, similarly, a relatively large number of different HRQoL outcomes were reported, in line with previous findings in both ICU survivors and other patient categories (37–39). This hampers comparison and meta-analysis of trial results and stresses the need for a generally applicable core outcome set for use in adult ICU patients (17). Although some variation in outcomes may be appropriate or unavoidable (especially for functional/cognitive/neurologic outcomes), many outcomes were relatively similar, and increased standardization seems both warranted and feasible.…”

“…Patient-important outcomes other than mortality, however, come with challenges. Given the lack of widely accepted core outcome sets for research in adult general ICU patients (15)(16)(17), there is substantial variation in the reported nonmortality patient-important outcomes and definitions and handling of similar outcomes often differ (18)(19)(20), as does the handling (or operationalization) of mortality. Mortality may be treated as a distinct value in a categorical scale, as the lowest value on a continuous scale, or somewhere between the extremes of a scale, as for, e.g., some healthrelated quality of life (HRQoL) outcomes in which some health states are considered worse than death (19,21).…”

The Rise of Adaptive Platform Trials in Critical Care

“…INCEPT uses adaptive stopping, arm dropping, and allocation ratios based on predefined criteria, simulations, and sequential Bayesian analyses ( 16 ). The primary and guiding outcomes will be based on a core outcome set for general ICU patients developed in the INCEPT group together with patients, family members, clinicians, and researchers ( 17 ). These stakeholders will also be involved in planning consent processes and prioritizing interventions.…”

Health‐related quality of life trajectories in critical illness: Protocol for a Monte Carlo simulation study

“…Indeed, one could speculate that survival alone is not enough: although it is likely the key patient‐centred outcome at the time of ICU admission, survival to achieve a reasonable quality of life may be considered to have primacy after ICU and hospital discharge. In line with this, HRQoL is recommended as a core outcome in ICU trials for acute respiratory distress syndrome patients 3 and is expected to be among the platform‐wide core outcomes in the Intensive Care Platform Trial (INCEPT) 4 . Although subtler aspects of the multiple dimensions of HRQoL may elude low‐resolution tools including the 5‐level EQ‐5D (EQ‐5D‐5L), 5 such tools are convenient, efficient and have good user characteristics.…”

“…In line with this, HRQoL is recommended as a core outcome in ICU trials for acute respiratory distress syndrome patients 3 and is expected to be among the platform-wide core outcomes in the Intensive Care Platform Trial (INCEPT). 4 Although subtler aspects of the multiple dimensions of HRQoL may elude low-resolution tools including the 5-level EQ-5D (EQ-5D-5L), 5 such tools are convenient, efficient and have good user characteristics.…”