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Effects of interventional public health laws and regulations intended to reduce gambling-related harms: a realist review study protocol

Por: Fisher · M. · Piper · T. · Mavi · S. · Nambiar · J. · Sharma · P. K. · Kirby · J. · Melendez-Torres · G. J. · Montgomery · P. · Fewell · G. · Chandan · J. S. · Bedford · K.
Introduction

Gambling is now widely acknowledged to be a major public health (PH) issue. The Office for Health Improvement and Disparities conservatively estimated that gambling harm is associated with an annual cost of £1.05–£1.77 billion in England alone. Marionneau et al have categorised gambling harms into seven themes: (1) financial, (2) relationship/conflict, (3) emotional and psychological (mental health), (4) health decrements (physical health), (5) employment/education, (6) cultural and (7) criminal activity. In this understanding, gambling harms are not restricted to individual experiences: they also impact families, the wider community and society, and hence they require a whole systems, PH approach, anchored in population-level interventions to reduce harms. We aim to identify the effects of interventional PH laws and regulations on the harms associated with gambling.

Methods and analysis

We limit our focus to interventional PH laws and regulations within a comprehensive search of scientific and legal databases, grey literature and books. Following Population, Intervention, Comparator, Outcome, Study, Timing inclusion criteria, evidence will be screened and appraised in Covidence by two reviewers (MF and TP). Included evidence will be analysed and synthesised using a narrative synthesis approach. Methodological quality will be appraised using the relevant risk of bias tool. Randomised controlled trials will be assessed using the Cochrane risk of bias tool (RoB2), Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) will be used for other non-randomised studies. Qualitative studies will be appraised using the EPPI reviewer software for systematic reviewing.

Ethics and dissemination

The review protocol is registered with PROSPERO (International prospective register of systematic reviews) at the National Institute for Health Research and the Centre for Reviews and Dissemination (CRD) at the University of York (CRD42024574502). We aim to define a theory of change and produce a context-mechanism-outcome framework with relevant experts using the findings. We plan to disseminate the findings through peer-reviewed publications, meetings with relevant experts and international conference presentations.

Development and validation of critical appraisal tool for individual participant data meta-analysis: protocol for a modified e-Delphi study

Por: Otalike · E. G. · Clarke · M. · Veroniki · A. A. · Tricco · A. C. · Moher · D. · Shea · B. · Doherty-Kirby · A. · Kandala · N.-B. · Gagnier · J.
Introduction

Individual participant data meta-analysis (IPD-MA) is regarded as the gold standard for evidence synthesis. However, diverse recommendations and guidance on its conduct exist, and there is no consensus-based tool for the critical appraisal of a completed IPD-MA. We aim to close this gap by systematically identifying quality items and developing and validating a critical appraisal checklist for IPD-MA.

Methods and analysis

This study will comprise three phases, as follows:

Phase 1: a systematic methodology review to identify potential checklist domains and items; this will be conducted according to the Cochrane methods for systematic reviews and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analysis 2020 guidance. We will include studies that address methodological guides and essential statistical requirements for IPD-MA. We will use the proposed items to prepare a preliminary checklist for the e-Delphi study.

Phase 2: at least two rounds of an e-Delphi survey will be conducted among panels with expertise in IPD-MA research, consensus development, healthcare providers, journal editors, healthcare policymakers, patients and public partners from diverse geographic locations with experience in IPD-MA. Participants will use Qualtrics software to rate items on a 5-point Likert scale. The Wilcoxon matched signed rank test will estimate response stability across rounds. Consensus on including an item will be achieved if ≥75% of the panel rates the item as ‘strongly agree’ or ‘agree’ and items will be excluded if ≥75% rates it as ‘strongly disagree’ or ‘disagree’. A convenience sample of 10 reviewers with experience in conducting an IPD-MA will pilot-test the checklist to provide practical feedback that will be used to refine the checklist.

Phase 3: critical appraisal checklist validation: to improve confidence in the tool’s uptake, a subset of the e-Delphi participants and graduate students of epidemiology and biostatistics will conduct content validity and reliability testing, respectively, per the Consensus-based Standards for the Selection of Health Measurement Instruments.

Ethics and dissemination

Ethics approval has been obtained from the Western University Health Science Research Ethics Board in Canada. The validated checklist will be published in a peer-reviewed open-access journal and shared across the networks of this study’s steering committee, Cochrane IPD-MA group and the institutions’ social media platforms.

Parenting Acceptance and Commitment Therapy Online (PACT Online) for parents of children diagnosed with or with increased likelihood of neurodevelopmental disability: study protocol of a randomised controlled trial

Por: Whittingham · K. · Kirby · G. · Boyd · R. N. · Novak · I. · Mitchell · A. E. · Reid · N. · Keramat · S. A. · Hudry · K. · Barbaro · J. · Barfoot · J. · Ware · R. S. · Russo · F. · Heussler · H. · McGlade · A. · Bullot · A. · MacDonald · M. · Tran · T. · Harrington · S. · Sheffield · J. · Ols
Introduction

Approximately 1 in 13 Australian children have a neurodevelopmental disability. This project aims to assess the effectiveness and implementation of an online parenting support programme, Parenting Acceptance and Commitment Therapy (PACT) Online, for parents of children with neurodevelopmental disabilities for improving the parent–child relationship and parent and child outcomes.

Methods and analysis

This hybrid type 1 randomised controlled trial will focus on evaluating intervention effectiveness and understanding the context for implementation. The primary outcome is observed emotional availability within parent–child interactions assessed at postintervention (12 weeks postbaseline) with additional measurement at follow-up (6 months postbaseline). Secondary outcomes include (1) parent-reported emotional availability, (2) parental mindfulness, (3) parent mental health, (4) psychological flexibility, (5) adjustment to child’s disability, (6) health behaviour and (7) regulatory abilities as well as child outcomes of (1) mental health, (2) adaptive behaviour and (3) regulatory abilities. Evaluation of implementation will include an economic evaluation of costs and consequences, and an implementation analysis grounded in the consolidated framework for implementation research with a focus on contextual factors influencing implementation.

Ethics and dissemination

Ethical approval has been obtained from the University of Queensland Human Research Ethics Committee (023/HE000040). Dissemination of study outcomes will occur through the appropriate scientific channels. Long-term implementation will be grounded within the implementation analysis and occur in partnership with the partner organisations and consumer engagement panel. This will include releasing the PACT Online intervention as a massive open online course on the edX platform if support for intervention effectiveness and implementation is found.

Trial registration number

ACTRN12623000612617; this trial has been registered with the Australian New Zealand Clinical Trials Registry.

Point-of-care troponin tests to rule out acute myocardial infarction in the prehospital environment: a protocol for a systematic review and meta-analysis

Por: Albaqami · B. · Dinnes · J. · Moore · T. H. · Kirby · K. · Carley · S. D. · Aloufi · M. · Alqurashi · N. · Alghamdi · A. · Alsuwais · S. · Dawson · S. · Body · R.
Background

Chest pain is a major cause of emergency ambulance calls, often linked to acute myocardial infarction (AMI), a critical condition requiring immediate hospitalisation. Current diagnostic methods, such as history taking and ECG, have limitations, especially for non-ST-elevation myocardial infarction. High-sensitivity cardiac troponin (cTn) assays are more diagnostically sensitive, but the downside is that it needs hospital-based testing, which can delay diagnosis and the necessary treatment protocol. Point-of-care cTn testing, on the other hand, is much faster and done nearer to the patient; hence, it may fundamentally change the prehospital care pathway in terms of diagnostic accuracy, clinical utility and related safety.

Objective

To present a protocol for a systematic review and meta-analysis that will assess the diagnostic accuracy, clinical utility and safety of point of care (POC) troponin tests, with or without clinical decision aids, for ruling out AMI in adults presenting with cardiac chest pain to emergency ambulance services in prehospital settings.

Methods

This protocol follows BMJ guidelines and adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 reporting standards. It is registered with PROSPERO (ID: CRD42024533117). A comprehensive search strategy will identify relevant studies in MEDLINE, EMBASE and CINAHL, focusing on literature from 2000 onwards. Eligibility criteria include adults with chest pain suspected of AMI, excluding those with ST-elevation myocardial infarction. The primary target is type 1 AMI, with secondary outcomes including major adverse cardiac events at 30 days. Risk of bias assessment will be performed using tools such as Quality Assessment of Diagnostic Accuracy Studies version 2, Risk of Bias 2, and Risk of Bias in Non-randomised Studies of Interventions, while the quality of the economic evaluations will be appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Data items extracted will include patient demographics, test characteristics and outcomes. Where possible, meta-analyses will be conducted by fitting hierarchical models for diagnostic accuracy and random effects models for clinical and cost-effectiveness estimates. Subgroup analyses are proposed to quantify the effect of variables such as gender, ethnicity and type of troponin assay on the estimated parameters.

Ethics and dissemination

Ethical approval is not required. The results will be published in a peer-reviewed journal and presented at international conferences.

PROSPERO registration number

This protocol is registered with PROSPERO, the International Prospective Register of Systematic Reviews, under the ID CRD42024533117. Any future amendments will be updated in the PROSPERO record.

Evaluating musculoskeletal imaging communication interventions using behavioural science: a scoping review using the COM-B model

Por: Kirby · E. · MacMillan · A. · Brinkley · A. · X W Liew · B. · Bateman · A.
Objectives

Clinicians and patients have been found to attribute musculoskeletal (MSK) pain to normal age-related changes seen on imaging, which can negatively impact patient outcomes and increase healthcare costs. While some studies have tested interventions to improve how MSK imaging findings are communicated, their impact has been limited. Applying a behavioural science framework has the potential to identify the rationale and target of these interventions to inform future intervention design—an analysis that has not yet been conducted. This study aims to identify the Behaviour Change Techniques (BCTs), the behavioural targets and the theoretical basis of interventions seeking to affect the communication of MSK imaging.

Design

Scoping review using the Capability, Opportunity, Motivation - Behaviour (COM-B) model.

Data sources

Searches of MEDLINE, EMBASE, CINAHL, AMED and PsycINFO from inception to 9 February 2024.

Eligibility criteria for selecting studies

We included studies that have developed or evaluated interventions which target the communication of MSK imaging findings. Interventions targeting both patients and clinicians were included. Experimental and quasi-experimental study designs were included, and studies that focused on serious or specific known causes of MSK pain were excluded.

Data extraction and synthesis

Two independent authors extracted study participant data and intervention details. A theory of behaviour called the COM-B model was used to map the BCTs and behavioural components targeted by studies.

Results

We identified 11 studies from 2486 studies in our electronic search. 11 different BCTs were identified across 11 studies. The most common techniques were framing/reframing (nine studies), adding objects to the environment (eight studies), incompatible beliefs (seven studies) and avoidance/reducing exposure to cues for the behaviour (four studies). Only two studies (feasibility studies) used behavioural theory to guide their intervention design. While one study showed a large effect, most interventions had little to no impact on pain, disability, or fear over time.

Conclusion

This review highlighted a lack of studies targeting clinician knowledge and the provision of high-quality patient resources about the nature of MSK pain, even though the broader literature identifies both as enablers of effective health communication. Additionally, the absence of a theory-informed design likely resulted in attempts to reassure patients about normal age-related imaging findings without providing an alternate, more coherent explanation for symptoms. Future interventions should focus on enhancing clinician psychological capability (knowledge) as well as clinician and patient reflective motivation (beliefs) to enable more helpful explanations of MSK symptoms. The key challenge for future interventions will be achieving these aims in a way that is effective, consistent and practical.

Trial registration details

Open Science Framework (https://doi.org/10.17605/OSF.IO/ECYS8).

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