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Using real-world evidence to evaluate the long-term health and economic impact of the digital tool Grohealth W8Buddy supporting access to specialist weight management services: a protocol for a cohort observational study

Por: Deo · P. S. · Grove · A. · Zhang · M. · Abrams · K. R. · Auguste · P. · Barber · T. M. · Gazeley · T. · Green · R. · Griffiths · F. · Hazlehurst · J. · Hee · S. W. · Kaura · A. · Mallipedhi · A. · OToole · S. · Panesar · A. · Parsons · N. · Scott · E. · Summers · C. · Thind · M. · Thorpe · M.
Introduction

Obesity affects over a quarter of the UK population and can lead to serious health issues. NHS Specialist Weight Management Services (WMS) offer treatments including lifestyle advice, psychological support and medications, but access and availability vary by region. Although around 4 million people could be eligible for NHS Specialist WMS annually, capacity is limited to 35 000, severely limiting overall access for those who need it. While digital technology has started to be used in WMS, more evidence is needed to confirm its long-term effectiveness, acceptability and cost-effectiveness. This study explores the use of Gro Health W8Buddy, a digital platform and app providing remote Specialist WMS. It aims to determine the long-term health benefits of remote WMS pathway Gro Health W8Buddy compared with standard NHS WMS delivered in hospitals, and to improve patients access to services.

Methods and analysis

The study is a real-world evaluation with observational data collection. We will recruit 450 study participants from four NHS specialist WMS who will choose either standard NHS WMS or the digital pathway Gro Health W8Buddy. Participants are being given the option to choose their pathway to generate real-world evidence. We will measure and analyse health outcomes including weight loss, time taken to be treated and cost-effectiveness, at 18 months and follow up at 24 months for later analysis (outside of this core funding). We will gather experiential data from patients and healthcare professionals through surveys, observation and interviews.

Ethics and dissemination

Ethical approval has been obtained from NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (Supplementary Figure 3) (REC reference: 25/EM/0147). Our findings will be disseminated through academic publications, conference presentations and stakeholder engagement.

Trial registration

ISRCTN89168871; Pre-results.

Trajectories of Recovery after ACutE and cRitical illness (TRACER): a prospective observational study protocol

Por: Gonzalez-Seguel · F. · Summers · L. A. · Fresenko · L. E. · Long · D. E. · Scott · L. N. · Slone · S. A. · Shankara Bhaktula · S. · Wen · Y. · Miller · B. F. · Morris · P. E. · Salyer · A. L. · Kalema · A. G. · Montgomery-Yates · A. A. · Dupont-Versteegden · E. E. · Mayer · K. P. · T
Introduction

Patients who survive admission to intensive care unit (ICU) for critical illness are at high risk of developing muscle atrophy and weakness, commonly diagnosed as ICU-acquired weakness (ICUAW). The development of ICUAW is closely linked to long-term symptoms and impairments known as post-intensive care syndrome (PICS). Despite heightened recognition of impairments, there is limited research supporting effective interventions to improve muscle and physical outcomes after hospital discharge. Prior to developing and testing interventions for ICU survivors, it is imperative to understand the trajectory of muscle and physical function recovery following an ICU stay. The purpose of this study is to longitudinally investigate skeletal muscle health and physical function outcomes after ICU admission.

Methods and analysis

This protocol describes a single site, prospective, observational study in adult patients who have survived a critical illness (ie, sepsis or acute respiratory failure). Patients will participate in a battery of testing including primary outcomes: muscle power and physical function; and secondary outcomes: muscle strength, muscle size, endurance and physical activity (by accelerometry) at hospital discharge and 3, 6, and 12 months post-discharge. A subset of patients will participate in muscle biopsy and venipuncture. To examine if the trajectory of recovery predicts primary outcomes, we will perform multivariate linear regression models in 150 evaluable patients. To examine differences in molecular and cellular outcomes in plasma and muscle tissue, a control group of community-dwelling adults without history of an ICU stay will be enrolled as a comparator group. Enrolment started on 18 October 2022 with an estimated completion date of 1 August 2027.

Ethics and dissemination

This protocol was approved by the University of Kentucky Office of Research Integrity Medical Internal Review Board (# 77407), with patients providing informed written consent. We anticipate our findings to establish recovery trajectories, improving the classification of patients who experience sustained physical disability. Improved identification of recovery trajectories of muscle and physical function enables future studies to employ an individually targeted rehabilitation approach, that is, precision medicine, with the goal of improving patient outcomes. The cellular findings will support the development of novel interventions specifically designed for detecting underlying mechanisms. We intend to disseminate findings to patients, healthcare professionals, the public and other relevant groups via conference presentations and manuscripts without publication restrictions.

Trial registration number

NCT05537298.

Developing consolidated guidelines for reporting and evaluation of studies using transcranial electrical stimulation (CoRE-tES): protocol for an international Delphi study and expert consensus process

Por: Suhood · A. Y. · Summers · S. · Pascual-Leone · A. · Nitsche · M. A. · Ziemann · U. · Bikson · M. · Lefaucheur · J.-P. · Brunoni · A. R. · Bestmann · S. · Chipchase · L. S. · Razza · L. B. · Cavaleri · R.
Introduction

In recent decades, transcranial electrical stimulation (tES) has become a widely used non-invasive method for modulating brain function in clinical and non-clinical populations. However, existing tES trials exhibit substantial methodological heterogeneity, often limiting the reproducibility and interpretability of findings. There currently exists a paucity of consensus-driven, standardised recommendations outlining the key factors that should be reported and/or controlled in tES studies. Accordingly, this project aims to develop Consolidated Guidelines for Reporting and Evaluation of studies using tES (CoRE-tES), a tool designed to assess the methodological quality and reporting of laboratory-based and home-based tES studies. These guidelines will support improved quality, consistency, replication and transparency in research involving tES modalities, including transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation.

Methods and analysis

CoRE-tES will be developed and disseminated over five stages. Stage 1 will comprise a review of recent tES literature to assess methodological and reporting quality. Stage 2 will employ a Delphi process to seek agreement among international tES experts on a list of items for inclusion in CoRE-tES. In stage 3, a consensus meeting will be held to synthesise and prioritise the agreed items to form CoRE-tES. Stage 4 will involve production of the final CoRE-tES checklist and an accompanying evaluation and elaboration document. In stage 5, CoRE-tES will be disseminated via journal publication, conferences, professional meetings and social media campaigns.

Ethics and dissemination

Ethics approval has been obtained from the Western Sydney University Human Research Ethics Committee (approval number H16803). Findings will be disseminated through scientific conferences and peer-reviewed journal publications, and CoRE-tES will be indexed on the Enhancing the QUAlity and Transparency Of health Research Network website.

How do primary care consultation dynamics affect the timeliness of cancer diagnosis in people with one or more long-term conditions? A qualitative study

Por: Valasaki · M. · Carter · M. · Winder · R. · Shephard · E. · Valderas · J. M. · Merriel · S. W. D. · Farmer · L. · Summers · B. · Dean · S. G. · Morgan-Trimmer · S.
Objectives

To explore how pre-existing conditions affect the diagnostic process for potential cancer in primary care patients.

Design

Qualitative interview study using thematic analysis underpinned by a critical realist approach.

Setting

Primary care practices recruited through four Clinical Research Networks and UK health charities across England.

Participants

Interviews were conducted with 75 patients with one or more pre-existing conditions (anxiety/depression, diabetes, obesity, chronic obstructive pulmonary disease, Parkinson’s disease or multiple long-term conditions (four or more)) and 28 primary care professionals (general practitioners and nurses).

Results

The study identified legitimacy as a central theme influencing patient trajectories in the health system while trying to receive a diagnosis for symptoms with which they presented to primary care. Patients engaged in self-triage to determine whether symptoms were ‘legitimate’ enough to seek care. Subsequent triaging steps (by receptionists, nurses and online systems) acted as gatekeepers, with decisions influenced by effectiveness of describing the symptom and subjective impressions. During consultations, clinicians relied on a mix of symptom narrative clarity, medical history and objective ‘metrics’ (eg, blood results, family history) to determine legitimacy for further investigations. Pre-existing conditions could either lower the threshold for referrals or obscure potential cancer symptoms. The stigma associated with mental health diagnoses often undermined perceived legitimacy and contributed to delays.

Conclusions

Legitimacy is continuously negotiated throughout the diagnostic pathway. It is shaped by social, moral and biomedical judgements. To promote early cancer diagnosis for patients with pre-existing conditions, clinicians must make legitimacy assessments explicit, reduce stigma especially around mental health and standardise triage processes.

Immunomodulatory therapies in community-acquired pneumonia: a protocol for a systematic review and network meta-analysis

Por: Flower · L. · Newman · J. · Couturier · D.-L. · Law · M. · Summers · C.
Introduction

Community-acquired pneumonia is the leading global cause of infection-related death. A subset of patients with pneumonia develops aberrant immune responses, resulting in harmful inflammation, tissue damage and significant mortality. Immunomodulatory therapies aim to blunt this dysregulated immune response and reduce resultant injury. No consensus exists on the use or impacts of immunomodulatory therapies in the management of community-acquired pneumonia. This protocol describes the methods we will use to undertake a systematic review and network meta-analysis of the effects of immunomodulatory therapies on the mortality of patients with community-acquired pneumonia.

Methods

We will undertake a systematic review and network meta-analysis investigating the use of immunomodulatory therapies in community-acquired pneumonia. Our protocol has been developed and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines and prospectively registered with PROSPERO (CRD42024565301). The primary objectives of this work are to compare the impact of immunomodulatory therapies on 28-day and 90-day mortality in adult patients admitted to hospital with a primary diagnosis of community-acquired pneumonia. The secondary objectives of this work are to identify any differences in the effectiveness of these immunomodulatory therapies in managing community-acquired pneumonia of differing aetiology and severity.

We will conduct a literature search of Medline, Embase, Scopus, Web of Science and Global Health for all relevant articles until 30 June 2024. All observational, interventional and epidemiological studies published in English will be included, and each type of study design will be examined separately. All studies will have their titles and abstracts independently screened by two reviewers, followed by a full article eligibility review and data extraction. A third reviewer will adjudicate any disagreements. Data extracted will include, but not be limited to, the study design, country in which it was undertaken, patient characteristics (eg, age, sex, cause of CAP, severity of CAP), details regarding the immunomodulatory therapy and dosing used and the 28-day and 90-day mortality of each study arm.

Analysis

The risk of bias will be assessed using the Risk of Bias in Non-randomised Studies - of Exposure tool for non-randomised studies and the Cochrane Risk of Bias 2 tool for randomised control trials. The quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations for network meta-analysis framework. A quantitative synthesis of data is planned for 28-day and 90-day mortality rates.

We will fit a random-effects network meta-analysis model that includes random effects for between-study heterogeneity and for inconsistency. This will be done using the metafor package for R. We will use a contrast-based approach, modelling estimated treatment effects using reference treatments. In the case of the primary objective, this will be the log odds ratio (OR) of mortality in one treatment compared with another.

Each type of study design will be examined separately. Treatments using the same immunotherapy at different doses may be grouped if appropriate.

Ethical approval and dissemination

This will be a systematic review of published literature; therefore, ethical approval is not required. To ensure communication of our findings, we will publish our results in a peer-reviewed journal and present our findings at appropriate local, national and international meetings.

PROSPERO registration number

CRD42024565301.

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