Core Outcome Sets
Core Outcome Sets represent the minimum outcomes that should be measured and reported in all clinical trials of a specific health condition and are also suitable for use in clinical audit or research other than randomised trials. The development and implementation of a Core Outcome Set makes it easier for trial results to be compared, contrasted and combined, ultimately improving patient and health system outcomes and reducing research waste.
Sets in development:
- Adolescent depression
- Paediatric anxiety
- Literature review protocol (in preparation)
- Mucopolysaccharidoses (MPS)
- Study protocol: Howie et al 2021 (submitted)
Recently developed sets:
- Paediatric appendicitis
- Rare metabolic diseases (MCAD and PKU)
- Children with feeding tubes and neurological impairment
- Neonatal opioid abstinence syndrome
Reviews of Core Outcome Sets:
Commentaries and Letters to the Editor:
- Needed: guidance for reporting knowledge synthesis studies on measurement properties of outcome measurement instruments in health research. (Butcher et al. 2020)
- Counting what counts in trials 2.0: Response to “Trials for depressive disorder in adolescents: the emperor’s new clothes” (Butcher et al. 2020)
- From research to practice: the importance of outcome selection, measurement, and reporting in pediatric mental health research (Monga et al 2020)
- Counting what counts: the case for harmonized outcomes in child and youth mental health research (Szatmari et al 2019)
InsPECT: SPIRIT-Outcomes & CONSORT-Outcomes
Follow along our progress @TORCH_research
Inadequate outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, and build upon study findings, which in turn impacts evidence-based clinical and policy decision making.
To facilitate harmonized reporting of outcomes in published trial protocols and reports, TORCH is leading the development of new outcome-specific reporting extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines, known as the SPIRIT-Outcomes and CONSORT-Outcomes reporting guidelines, respectively.
The SPIRIT and CONSORT-Outcomes reporting extensions will provide the first evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, populations, and outcome types. They have the potential to benefit trialists, systematic reviewers, journal editors, medical writers, and patient groups.
As part of the InsPECT project, we are also assessing the current standard of outcome reporting in published clinical trials and cohort studies:
- Adolescent depression trials: Monsour et al 2020
- Cohort studies of neurodevelopmental outcomes in children born extremely preterm: Ding et al 2020
- Neonatal trials: Ongoing