Publications by authors named "Sarah Markham"

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.

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Implementation 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.

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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.

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Introduction: 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.

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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).

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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.

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Disability 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.

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Domestic 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.

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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.

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Article Synopsis
  • A systematic review and meta-analysis examined the mortality risk from infectious diseases (excluding COVID-19) in individuals with severe mental illness (SMI) like schizophrenia and bipolar disorder.
  • The analysis included 29 studies, revealing that those with SMI are more than twice as likely to die from any infectious disease and over three times more likely to die from respiratory infections compared to the general population.
  • Variations in findings were influenced by factors such as the specific SMI diagnosis, gender, and the type of infection studied.
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  • The study investigates how using small datasets to select an optimal cutoff score for the Patient Health Questionnaire-9 (PHQ-9) can lead to inaccurate results.
  • Researchers evaluated whether data-driven methods for cutoff selection resulted in scores that were significantly different from the true population optimal score and if these methods produced biased accuracy estimates.
  • Findings showed that many small studies frequently failed to identify the correct optimal cutoff score, particularly in smaller samples, leading to an overestimation of test sensitivity.
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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.

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  • The Geriatric Depression Scale (GDS-15), commonly used to gauge depression in older adults, shows that a score of ≥5 identifies higher prevalence (34.2%) compared to the Structured Clinical Interview (SCID) which shows a lower prevalence (14.8%).
  • An analysis of data from 14 studies involving over 3,600 participants found that using GDS-15 with a cutoff of ≥8 aligns much closer to SCID results, with only a minor difference (-0.3%).
  • While GDS-15 ≥5 greatly overestimates depression prevalence, the suggested cutoff of ≥8 might be more accurate but has too much variation to be reliably implemented; hence, validated diagnostic
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  • Randomised controlled trials often use surrogate endpoints instead of direct outcomes to enhance efficiency and reduce costs, but this can lead to increased uncertainty regarding treatment effects and intervention harms.
  • A new guideline, known as CONSORT-Surrogate, provides a checklist for reporting trials that utilize surrogate endpoints, ensuring better clarity and transparency in the results.
  • The recommended checklist, tailored for all stakeholders involved in clinical trials, aims to improve the reporting quality of these studies and ultimately reduce wasted research efforts.
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Article Synopsis
  • Randomised controlled trials often use surrogate endpoints instead of direct outcomes to save time, cost, and ethical concerns, but this can create uncertainty about the actual treatment effects and potential harms.
  • The SPIRIT-Surrogate is a new guideline to enhance the reporting standards for trial protocols that use surrogate endpoints, building on the existing SPIRIT checklist.
  • This guideline includes nine modified items, encouraging all stakeholders to adopt it, which aims to improve trial design, transparency, and ultimately reduce wasted research efforts.
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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.

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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.

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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.

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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.

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Article Synopsis
  • * Statistically significant differential item functioning (DIF) was found for most questionnaire items, but this had minimal impact on total scores.
  • * Researchers and clinicians can choose the administration method based on what works best for patients, considering preferences, feasibility, or cost, as score differences were negligible.
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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.

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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.

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