Dataset Information

Core outcomes sets for studies evaluating critical illness and patient recovery.

ABSTRACT:

Purpose of review

Given the growing body of critical care clinical research publications, core outcome sets (COSs) are important to help mitigate heterogeneity in outcomes assessed and measurement instruments used, and have potential to reduce research waste. This article provides an update on COS projects in critical care medicine, and related resources and tools for COS developers.

Recent findings

We identified 28 unique COS projects, of which 15 have published results as of May 2020. COS topics relevant to critical care medicine include mechanical ventilation, cardiology, stroke, rehabilitation, and long-term outcomes (LTOs) after critical illness. There are four COS projects for coronavirus disease 2019 (COVID-19), with a 'meta-COS' summarizing common outcomes across these projects. To help facilitate COS development, there are existing resources, standards, guidelines, and tools available from the Core Outcome Measures in Effectiveness Trials Initiative (www.comet-initiative.org/) and the National Institutes of Health-funded Improve LTO project (www.improvelto.com/).

Summary

Many COS projects have been completed in critical care, with more on-going COS projects, including foci from across the spectrum of acute critical care, COVID-19, critical care rehabilitation, and patient recovery and LTOs. Extensive resources are accessible to help facilitate rigorous COS development.

SUBMITTER: Dinglas VD

PROVIDER: S-EPMC8314715 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Life course studies are designed to "collect once, use multiple times" for observational and, increasingly, interventional research. Core Outcome Sets (COS) are minimum sets developed for clinical trials by multi-stakeholder consensus methodologies. We aimed to synthesize published COS that might guide outcomes selection for early life cohorts with an interventional focus. We searched PubMed, Medline, COMET, and CROWN for COS published before January 2021 relevant to four life stages (pregnancy, newborns, children <8 years, and parents (adults aged 18-50 years)). We synthesized core outcomes into overarching constructs. From 46 COS we synthesized 414 core outcomes into 118 constructs. "Quality of life", "adverse events", "medication use", "hospitalization", and "mortality" were consistent across all stages. For pregnancy, common constructs included "preterm birth", "delivery mode", "pre-eclampsia", "gestational weight gain", "gestational diabetes", and "hemorrhage"; for newborns, "birthweight", "small for gestational age", "neurological damage", and "morbidity" and "infection/sepsis"; for pediatrics, "pain", "gastrointestinal morbidity", "growth/weight", "breastfeeding", "feeding problems", "hearing", "neurodevelopmental morbidity", and "social development"; and for adults, "disease burden", "mental health", "neurological function/stroke", and "cardiovascular health/morbidity". This COS synthesis generated outcome constructs that are of high value to stakeholders (participants, health providers, services), relevant to life course research, and could position cohorts for trial capabilities. We synthesized existing Core Outcome Sets as a transparent methodology that could prioritize outcomes for lifecourse cohorts with an interventional focus. "Quality of life", "adverse events", "medication use", "hospitalization", and "mortality" are important outcomes across pregnancy, newborns, childhood, and early-to-mid-adulthood (the age range relevant to parents). Other common outcomes (such as "birthweight", "cognitive function/ability", "psychological health") are also highly relevant to lifecourse research. This synthesis could assist new early life cohorts to pre-select outcomes that are of high value to stakeholders (participants, health providers, services), are relevant to lifecourse research, and could position them for future trials and interventional capability.