Background/aims: Existing regulatory and ethical guidance does not address real-life complexities in how clinical trial participants' level of participation may change. If these complexities are inappropriately managed, there may be negative consequences for trial participants and the integrity of trials they participate in. These concerns have been highlighted over many years, but there remains no single, comprehensive guidance for managing participation changes in ways that address real-life complexities while maximally promoting participant interests and trial integrity.
View Article and Find Full Text PDFImplementation research has emerged as a branch of healthcare research. It studies methods to promote the application of research findings into practice, and, thus, to improve the quality and effectiveness of services and care. Patient and public involvement (PPI) in implementation research is a means of bridging research and practice.
View Article and Find Full Text PDFHealth Technol Assess
March 2025
Background: Myalgic encephalomyelitis/chronic fatigue syndrome is a chronic condition, classified by the World Health Organization as a nervous system disease, impacting around 17 million people worldwide. Presentation involves persistent fatigue and postexertional malaise (a worsening of symptoms after minimal exertion) and a wide range of other symptoms. Case definitions have historically varied; postexertional malaise is a core diagnostic criterion in current definitions.
View Article and Find Full Text PDFIntroduction: The UK Longitudinal Linkage Collaboration (UK LLC) is the national Trusted Research Environment (TRE) for the UK's longitudinal research community, supporting the UK's unparalleled collection of Longitudinal Population Studies (LPS). Initially set up as a COVID-19 research resource, UK LLC is now a generic database for any research for the public good.
Objectives: UK LLC supports longitudinal research by providing record linkage and TRE services.
Objectives: The objective of this rapid review is to understand the reporting, role and quality of patient and public involvement and engagement (PPIE) in real world data and evidence (RWDE) research across the medicines development cycle.
Methods: We comprehensively searched, with no date restrictions, Medline and Embase databases for peer-reviewed literature and conference abstracts (Embase only) reporting PPIE in RWD studies. We also assessed PPIE in a sample of 100 NICE technology appraisals (TAs) comprising both single technology appraisals (STAs) and highly specialized technologies (HSTs).
ObjectiveWe summarize the key steps to develop and assess an innovative online, evidence-based tool that supports shared decision-making in routine care to personalize antidepressant treatment in adults with depression. This PETRUSHKA tool is part of the PETRUSHKA trial (Personalize antidEpressant Treatment foR Unipolar depreSsion combining individual cHoices, risKs, and big datA).MethodsThe PETRUSHKA tool: (a) is based on prediction models, which use a combination of advanced analytics, i.
View Article and Find Full Text PDFDisability is a multifaceted phenomenon, which complicates data collection about people with disabilities in surveys and censuses. A central issue is that the multiple underlying theoretical models about disability are seldomly made explicit yet strongly determine how data are collected and analysed by governments and organisations. It is crucial that such models together with other information about disability and its measurement are accessible and understood by everyone.
View Article and Find Full Text PDFDomestic abuse - abusive behaviour perpetrated by an adult towards another adult to whom they are personally connected (e.g. partners, ex-partners or family members) - damages mental health, increases mental health service use and challenges clinical management.
View Article and Find Full Text PDFBMJ Health Care Inform
January 2025
In this perspective article, we consider the use of predictive models in healthcare and associated challenges. We will argue that patients can play a valuable role in supporting the safe and practicable embedding of such tools and provide some examples.
View Article and Find Full Text PDFEClinicalMedicine
November 2024
JAMA Netw Open
November 2024
Individuals diagnosed with autism, attachment disorders, emotionally unstable personality disorder (EUPD) or complex post-traumatic stress disorder (CPTSD) can present with similar features. This renders differential and accurate diagnosis of these conditions difficult, leading to diagnostic overshadowing and misdiagnosis. The purpose of this study was to explore professionals' perspectives on the differential diagnosis of autism, attachment disorders and CPTSD in young people; and of autism, CPTSD and EUPD in adults.
View Article and Find Full Text PDFPurpose: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.
Methods: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.
Health Qual Life Outcomes
July 2024
Purpose: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.
Methods: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.
Purpose: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.
Methods: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.
J Clin Epidemiol
September 2024
Objectives: To use individual participant data meta-analysis (IPDMA) to estimate the minimal detectable change (MDC) of the Geriatric Depression Scale-15 (GDS-15) and to examine whether MDC may differ based on participant characteristics and study-level variables.
Study Design And Setting: This was a secondary analysis of data from an IPDMA on the depression screening accuracy of the GDS. Datasets from studies published in any language were eligible for the present study if they included GDS-15 scores for participants aged 60 or older.
Background And Objective: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.
Methods: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.
Background: Disability is often an essentialised and oversimplified concept. We propose refining this while incorporating the multidimensional nature of disability by increasing the use of existing survey questions and their corresponding data to enrich, broaden and inform understandings of disability.
Methods: We combined patient and public involvement and engagement (PPIE) with focus groups and concept mapping to collaboratively map disability survey questions into conceptual models of disability with six members of the public with lived experiences of disability.