Developing Core Outcome Sets for Pleural Interventional Trials

Heterogeneity in outcome measures in clinical interventional trials cause a vast amount of research waste. This is due to perfectly well-designed studies not being incorporated into systematic reviews due to the inconsistency in outcome measures. The variability in outcome measures chosen by researchers can be influenced by the magnitude and tide of results, a phenomenon known as outcome reporting bias. This conundrum also affects the research in pleural interventional trials with a particular lack of patient centred outcome measures. This study aims to develop a set of core outcome measures to be used by pleural interventional trials, as a bare minimum, in order to tackle this problem.

A long list of outcome measures was constructed through a scoping review of the literature, complemented by thematic analysis of semi-structured interviews with key stakeholders. This long list was streamlined by the researcher in a meeting with four independent reviewers and entered into a modified two stage Delphi process. The Delphi process included both patients and practitioners scoring each included outcome measure on a 9-point scale. Participants were given an opportunity to advise on the list of outcome measures enrolled into the Delphi, ensuring it was an iterative process.

The synthesis of a ‘long list’ of outcomes elicited 9 outcome measures, entered into a Delphi process with a total of 78 participants. The Delphi process refined the long list into a core outcome set, consisting of 4 outcome measures.

An all-encompassing core outcome set was developed, tailored to the key stakeholders pertaining to pleural interventions. Incorporation of this core outcome set in relevant research projects will be a primary step to the standardisation of outcome measures, allowing for meaningful synthesis of evidence from the comparison of independent studies.

Further work must be done to assess the uptake and efficacy of these outcome measures.

Contributors

Dr Zain Habib - Researcher completing manuscript
Dr Sion Williams - Supervisor
Prof Paul Brocklehurst - Supervisor

Further Study Information

Current Stage: Completed – pending publication
Date: August 2018 - August 2020
Funding source(s): Bangor University


Health Area

Disease Category: Other

Disease Name: Pleural disease

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Procedure

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Patient/ support group representatives
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Survey

A long list of outcome measures was constructed through a scoping review of the literature, complemented by thematic analysis of semi-structured interviews with key stakeholders. This long list was streamlined by the researcher in a meeting with four independent reviewers and entered into a modified two stage Delphi process. The Delphi process included both patients and practitioners scoring each included outcome measure on a 9-point scale. Participants were given an opportunity to advise on the list of outcome measures enrolled into the Delphi, ensuring it was an iterative process.

The synthesis of a ‘long list’ of outcomes elicited 9 outcome measures, entered into a Delphi process with a total of 78 participants. The Delphi process refined the long list into a core outcome set, consisting of 4 outcome measures.

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