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Randomised controlled trials for improving health outcomes for people living with multiple long-term conditions: protocol for a systematic review of methodological approaches, risk of bias and reporting quality

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posted on 2025-07-30, 14:00 authored by Lisong ZhangLisong Zhang, Elizabeth FisherElizabeth Fisher, Naomi BradburyNaomi Bradbury, Natalie DarkoNatalie Darko, Kamlesh KhuntiKamlesh Khunti, Selina LockSelina Lock, Sally J. Singh, Sharon A. Simpson, Ellesha SmithEllesha Smith, Susan M. Smith, Rod S. Taylor, Miles Witham, Hannah YoungHannah Young, Laura GrayLaura Gray
<p dir="ltr">Introduction</p><p dir="ltr">The number of people living with multiple long-term conditions (MLTC or multimorbidity) is increasing. There have been national and international calls for more and better research in this clinical area. This systematic review will assess the methodological approaches, risk of bias and standards of reporting of the included trials. This study will benchmark current methodological practice and identify areas for improvement.</p><p dir="ltr"><br></p><p dir="ltr">Methods and analysis</p><p dir="ltr">MEDLINE, Scopus, CINAHL, CENTRAL and the International Research Community in Multimorbidity database will be searched from January 1999 to identify randomised controlled trials conducted with the aim of improving health outcomes for people living with MLTCs. Study screening, data extraction and the risk of bias assessment will be conducted independently by two reviewers. Data to be extracted will include study descriptors, design and analysis characteristics, methodological quality, bias and standard of reporting. A narrative synthesis will be conducted to summarise current methodological practice and to identify areas for improvement.</p><p dir="ltr"><br></p><p dir="ltr">Ethics and dissemination</p><p dir="ltr">Ethical approval is not required. The results of the review will be published in a peer-reviewed journal and shared via conferences and webinars.</p><p dir="ltr"><br></p><p dir="ltr">PROSPERO registration number: CRD42024595925</p>

Funding

Identifying methodological uncertainties in the design and analysis of trials in people living with multiple long-term conditions

National Institute for Health Research

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National Institute for Health and Care Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and Leicester NIHR Biomedical Research Centre (BRC)

History

Author affiliation

College of Life Sciences Population Health Sciences

Version

  • VoR (Version of Record)

Published in

PLoS ONE

Volume

20

Issue

6

Pagination

e0325742

Publisher

Public Library of Science

issn

1932-6203

eissn

1932-6203

Copyright date

2025

Available date

2025-07-30

Language

en

Deposited by

Professor Laura Gray

Deposit date

2025-05-29

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