Funded: ME / CFS: An evidence map of research studies and how these address key themes in the JLA PSP research priorities

Abstract:

Background

Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is a chronic neurological disease, with fluctuating symptoms affecting multiple body systems, including nervous and immune systems. ME/CFS affects around 250,000 people in the UK and 17 million people worldwide. In 2022, the James Lind Alliance (JLA) priority setting partnership (PSP) for ME/CFS reached consensus on the top 10+ research questions, comprising a series of broad, overlapping questions focused on the biomedical cause, diagnosis and treatment of ME/CFS. To support and encourage future informed, high quality, useful collaborative research and research funding, worldwide, a comprehensive map of existing research evidence (and evidence gaps) is essential.

Synthesis of research evidence relating to ME/CFS is recognised as challenging due to the use of a wide range of diverse case definitions and diagnostic criteria. Historically, clinical labels have lacked consistency, and diagnostic criteria have varied leading to inconsistencies in patient groups within studies. Diagnostic criteria in which post-exertional malaise (PEM, sometimes referred to as post-exertional symptom exacerbation) is a core component include CCC (Canadian Consensus Criteria, ICC (International Consensus Criteria), IOM (Institute of Medicine) and National Institute for Health and Care Excellence (NICE). Other diagnostic criteria in which PEM is not a core component include Oxford and Fukuda criteria.

A comprehensive map of existing research evidence, including all research regardless of clinical terms and diagnostic criteria, will bring together studies which include varied populations of patients. It is therefore is essential that the diagnostic criteria used in studies are central to mapping of this evidence.

Objective

Produce an evidence map of national and international research in ME/CFS, taking into account diagnostic criteria, and showing how current research maps against key themes covered by the JLA PSP research priorities.

Methods

We will search the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL. We will restrict the searches by date starting from 1 January 2018 to 29 May 2023 and by language to English only. We will follow Campbell Evidence and Gap Map Guidance and PRISMA-ScR guidelines. Two reviewers will independently perform study selection and data extraction/coding. Two different reviewers will resolve disagreements. We will produce an interactive evidence map and narrative synthesis summarising the volume (number and size of studies) and key characteristics (e.g. study design, country, population) of the research evidence relating to key areas of ME/CFS (according to the themes and subthemes that have been identified).

The narrative synthesis will report the volume of studies by diagnostic criteria. The synthesis will provide a commentary on the characteristics of the people included in the studies, with reference to severity of ME/CFS, gender and ethnicity. This commentary will not bring together the results of the identified studies.

Discussion

An evidence map summarises what evidence is available and where there are gaps in evidence; it does not summarise or attempt to analyse what the evidence says. The aim of the evidence map is to support and encourage future research and research funding.

This evidence map will be conducted by NIHR Evidence Synthesis Scotland InitiativE (NESSIE), which is funded by the NIHR Evidence Synthesis Programme (ESP). NIHR ESP has asked NESSIE to conduct this work in a response to a request from the DHSC (Science, Research and Evidence Directorate). Our plans have been informed through discussions with key stakeholders, including representatives from the ME Research Collaborative Patient Advisory Group (MERC PAG) and ME/CFS Research Working Group.

https://fundingawards.nihr.ac.uk/award/NIHR159926

 

I'd think more highly of it if I thought it would actually change anything. Will it reduce the number of studies like that normal CBT vs (nude exercise?) CBT one? Will it reduce the number whose results are based on questionnaires? Will any decision-makers bother to read the "narrative synthesis"?