Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for clinical studies of the invasive management of malignant pleural mesothelioma: The COS-iMeso Initiative

General Information

Summary:
Malignant pleural mesothelioma is a cancer of the membranes lining the lung and chest cavity, most often seen in patients with a historical occupational exposure to asbestos dust 2-6 decades prior to manifestation of disease. Around 2,500 new patients are diagnosed annually in the United Kingdom, with a median survival of around nine months from the time of diagnosis. Patients often carry a heavy morbidity burden, with symptomatic restriction and severe limitation of quality of life.

There are currently several treatment modalities available to patients, which seek to slow disease progression, palliate symptoms, improve quality of life, and increase survival. The evidence-base to support informed decision-making between different treatment options and combinations is often limited.

Thoracic surgical oncology practitioners contribute to the management of these patients across the care spectrum, including in diagnosis, in the management of symptoms and complications associated with pleural fluid accumulation, and in attempted radical treatment by removal of all visible disease on the affected side of the chest.

This remains a field with much clinical uncertainty and of active research interest. A Priority Setting Partnership was set up under the auspices of the James Lind Alliance, and published the top 10 priorities and 52 verified unanswered questions in December 2014.

Clinical trials of surgical management and other invasive treatments for mesothelioma are particularly challenging to conduct. Many have historically struggled to recruit patients. This further underpins the importance of careful trial design, including informed selection of outcomes and measures so as to facilitate the meaningful combining of results from across different research initiatives.


This study aims to address the heterogeneity and lack of comprehensive stakeholder-defined outcome sets for clinical research in the interventional management of pleural mesothelioma.

Contributors:
Mr Edward Caruana (Specialist Registrar in Thoracic Surgery, University Hospitals of Leicester / Doctoral Fellow in Clinical Trials Research, University of Nottingham) - Principal Investigator
Mr Apostolos Nakas (Consultant in Thoracic Surgery, University Hospitals of Leicester / Lead for Mesothelioma, East Midlands Lung Cancer and Mesothelioma) - Supervisor

Further Study Information

Current Stage:
Ongoing
Date:
November 2019 - June 2020
Funding source(s):
None

Health Area

Disease Category
Cancer

Disease Name
Malignant pleural mesothelioma

Target Population

Age Range
18 - 80

Sex
Either


Nature / type of Intervention
Procedure
Surgery

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Literature review

We will adopt a mixed-methods approach in four distinct stages.
[Stage 1] A scoping review of the existing literature, including relevant clinical trials and systematic reviews of observational trials, will be conducted to identify outcome measures that have been used in previous clinical trials.
[Stage 2] Focus groups with patients, carers and bereaved carers will be facilitated with the support of the Research Design Service (East Midlands) who offer support in qualitative research and patient and public involvement, specifically. The aim of these focus groups will be to determine what outcomes are important to patients and carers themselves.
[Stage 3] The collated outcomes from the first two stages will be distributed by means of an electronic Delphi survey of researchers, clinicians, carers and patients who will be asked to rank outcomes in terms of importance.
[Stage 4] A consensus meeting with all stakeholders will be convened to agree on the final core outcome set.


Stakeholders Involved

Charities
Clinical experts
Consumers (patients)
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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