This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.
A cross-sectional mixed methods online survey.
Primary care in England.
120 clinical pharmacists with experience in conducting SMRs in primary care.
Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.
These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.
We evaluated the performance of risk models that incorporate ambulatory ECG data and clinical information for prediction of healthcare expenditures related to heart failure (HF) and stroke events in treated and untreated patients.
A retrospective cohort study of Medicare patients who underwent Zio XT ambulatory monitoring in the USA was conducted between 2014 and 2020.
14-day ambulatory ECG data and claims data were evaluated in the study sample which included 89 923 patients in the HF hospitalisation group, 75 870 in the new-onset HF group and 90 159 in the stroke hospitalisation group. Predictive models for new-onset HF, HF hospitalisation and stroke hospitalisation were generated using LASSO Cox regression with ambulatory ECG variables and components of the CHA2DS2-VASc. For each outcome, we scored patients using standardised linear predictors from three composite risk models, and we evaluated the association between risk score and total Medicare cost.
The following hazard ratios per one SD increase in the new risk score were observed for the model that included all CHA2DS2-VASc components and ECG variables: HF hospitalisation in treated 2.94, 95% CI 2.75 to 3.15; new-onset HF in treated 1.84, 95% CI 1.75 to 1.93; HF hospitalisation in untreated 3.51, 95% CI 3.23 to 3.82; and new-onset HF in untreated 1.92, 95% CI 1.85 to 2.00. Risk scores generated by the model were also predictive of Medicare cost in both treated and untreated patients, with patients in the high-risk category for all outcomes having the greatest Medicare costs during 1 year of follow-up.
Integrating arrhythmia data from ambulatory ECG monitoring into clinical risk models allows for better prediction of healthcare utilisation and cost in both treated and untreated patients at high risk for HF and stroke events.
Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.
FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.
The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.
NCT04310930, ANZCTR12618001831279, 2020-000050-10,
Current treatments for alcohol use disorders (AUD) have limited efficacy. A previous 28-day pilot trial of N-acetyl cysteine (NAC) vs placebo found NAC to be feasible and safe, with evidence of improvement on some measures of alcohol consumption. Thus, the primary aim of the NAC-AUD study is to examine the therapeutic and cost-effectiveness of NAC vs placebo in improving treatment outcomes for AUD. We will also examine the (i) effect of NAC vs placebo on mood, markers of liver injury, cognition and hangover symptoms; and (ii) predictors of any response.
This double-blind trial will randomise participants with AUD to a 12-week regimen of either NAC (2400 mg/day) or placebo. All participants will receive medical management. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol (PEth). Secondary alcohol-related outcomes will include standard drinks per drinking day (SDDD) per week and absence of any HDDs. Other secondary outcomes will include markers of liver injury, depression, anxiety, craving, hangover symptoms, cognition and blood oxidative stress markers. We will also examine the cost-efficacy of NAC vs placebo.
Ethics approval for the study has been granted by The Sydney Local Health District Ethics Review Committee (X21-0342& HREC2021/ETH11614). There are no restrictions on publication from the sponsor or other parties.
Low-income adults with disabilities experience disproportionately high rates of food insecurity and preventable healthcare utilisation. The Supplemental Nutrition Assistance Program (SNAP) can reduce food insecurity and improve health, but there are accessibility gaps in the SNAP enrolment process. Existing outreach and enrolment assistance programmes have been shown to boost SNAP enrolment, but their health effects are understudied. This study estimates the effects of a SNAP outreach and enrolment assistance programme on health outcomes among low-income adults with disabilities.
The study pragmatically evaluates a programme that provided outreach and SNAP enrolment assistance for low-income households. The study leverages a random process that selected households for one of two types of outreach, including an information-only arm and an information plus enrolment assistance arm, which formed a control group by default. The study will estimate the effect of this programme among low-income adults with disabilities using Medicaid and SNAP administrative data. Study outcomes include emergency department, hospital and long-term nursing home utilisation. SNAP enrolment and benefit amounts are secondary study outcomes and will be tested as a mediating mechanism of action. The study will test effect heterogeneity based on race, ethnicity, age and chronic conditions.
The study, which relies on deidentified data, was determined to be exempt as human subjects research by the Institutional Review Boards at Johns Hopkins Medicine and the Michigan Department of Health and Human Services. The study is being conducted in ongoing consultation with an Advisory Group of experts in food advocacy and disability advocacy. In addition to disseminating findings in peer-reviewed publications, findings will be disseminated to state decision-makers and the community in partnership with an advisory group.
This systematic review explored the barriers and facilitators to the implementation of clinical practice guidelines (CPGs) among nurses in emergency departments (EDs) and critical care units (CCUs).
Systematic review.
A systematic review was performed using both qualitative and quantitative studies from five databases (CINAHL, Web of Science, Embase, Scopus and PubMed). The literature search was conducted in May 2024. The PRISMA framework was used to guide the review process. Findings were subject to a narrative, thematic analysis and critical appraisal.
Eighteen studies were identified that met the inclusion criteria, yielding three themes related to barriers and facilitators of guideline implementation: individual-level, guideline-level and organisational-level. Key barriers included lack of awareness of guidelines, lack of knowledge and skills, attitudes towards guidelines, resource limitations, lack of perceived support, complexity of guidelines and lack of training. Facilitators to guideline use included colleague support, adequate training, effective leadership and refinement of guidelines to ensure relevance, local adaptation and user-friendly content.
Numerous barriers to nurse implementation of CPGs exist in ED and CCU settings, reflecting a complex interplay of individual, CPG-related and organisational factors. To facilitate CPG implementation, it is important for staff to be educated and trained in their use, supported to implement (including resource allocation) and that CPGs are designed to be easily implemented in practice.
This systematic review highlights risk factors for poor CPG implementation and highlights the importance of addressing awareness, knowledge, resources and support for CPG use through targeted training, leadership and CPG design.
An analysis of barriers and facilitators to CPG implementation among nurses in ED and CCU settings provides an important opportunity to address a gap in the literature, facilitating the development of strategies to promote CPG use and enhance care quality among nurses in these specific contexts.
Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.
We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.
The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).
We report the collaborative views of a group of nurses, midwives and allied health professionals (NMAHPs) in the UK who have a genomics research remit or interest. Our group includes genetic counsellors under this diverse category of healthcare workers.
This group came together as part of the National Institute for Health and Social Care Research (NIHR) Genomics Research National Specialty Group. After responding to a survey to elicit the views of NMAHPs working in genomics, some of the original 45 respondents, along with others who learnt of the project by word of mouth, have worked together to produce this article.
The paper aims to set out in clear terms the value of NMAHPs to research that supports the patient-centred implementation of genomics in the National Health Service (NHS).
We discuss four potential areas where NMAHPs, in particular, can contribute to the research. These are patient perspectives and epistemic justice, psychosocial impacts, the familial nature of genomics and equity. We argue that this group (NMAHPs) represents a potentially underused resource for the NHS as it seeks to ensure that advances in genomics are translated into patient benefit.
We propose that NMAHPs, with our research expertise, are well placed to shape and deliver a research agenda that explores models of patient-centred care in the genomics era. We call for increased funding for NMAHP research roles and funding opportunities to deliver this fundamental work.
Frequency of general practitioners’ (GPs’) antibiotic prescribing for acute, self-limiting respiratory tract infections (aRTIs) is high. The practice environment and culture influence the clinical behaviour, including prescribing behaviour, of GP specialist vocational trainees (registrars). We aimed to assess inter-practice variability in registrars’ antibiotic prescribing.
This was a cross-sectional analysis from the Registrar Clinical Encounters in Training (ReCEnT) cohort study, from 2010 to 2020.
ReCEnT documents registrars’ clinical experiences and behaviours. Before 2016, 5 of 17 Australian training regions participated in ReCEnT. From 2016, three of nine regions (~40% of Australian registrars) participated.
3210 registrars (response rate 91.8%) from 1286 training practices contributed to the analysis.
The outcomes were prescription of an antibiotic for new diagnoses of (1) all aRTIs and (2) acute bronchitis diagnoses specifically. Prescribing percentages were calculated at the training practice level. Intraclass correlation coefficients (ICCs) were used to measure the ratio of interpractice variation to total variance. Median ORs (MORs) were also estimated to quantify interpractice variability.
Practice-level antibiotic prescribing percentages ranged from 0% to 100% for both aRTIs and acute bronchitis diagnoses in the primary analysis. ICCs for aRTI prescribing were 0.08 (unadjusted) and 0.02 (adjusted). For acute bronchitis, ICCs were 0.10 (unadjusted) and 0.05 (adjusted). MORs were 1.66 (unadjusted) and 1.32 (adjusted) for aRTIs. MORs for acute bronchitis were 1.80 (unadjusted) and 1.53 (adjusted). This indicates a marked variation in the odds of a patient receiving antibiotics for an aRTI if randomly attending different practices.
There was considerable interpractice variation in registrars’ antibiotic prescribing frequencies. Further research is required to examine the factors accounting for this variation and to develop practice-level interventions to reduce antibiotic prescribing in high-prescribing practices.
This study aims to assess the association between neighbourhood socioeconomic deprivation and outcomes reflecting comprehensive diabetes care (CDC).
Retrospective cohort study
US Medicare Advantage (MA) data, 2015–2020.
National sample of MA enrollees with diabetes.
Primary outcomes included six indicators of CDC from the Healthcare Effectiveness Data and Information Set: haemoglobin (Hb) A1c (HbA1c) testing, HbA1c control (9%), blood pressure control (
There were 827 227 enrolments included in the final analysis. After adjusting for demographic (age, sex, race/ethnicity and dual eligibility) and regional characteristics (rurality and primary care providers per capita), high neighbourhood deprivation was associated only with worse glycaemic control (for HbA1c>9%, risk ratio (RR) 1.04, 95% CI 1.02 to 1.07). This relationship was significant for white and Asian patients (RR 1.08, 95% CI 1.05 to 1.11 and RR 1.18, 95% CI 1.05 to 1.32, respectively); outcomes for black and Hispanic patients were worse overall but independent of neighbourhood deprivation (RR 1.00, 95% CI 0.96 to 1.05 and RR 0.98, 95% CI 0.94 to 1.03, respectively). In the fully adjusted model, neighbourhood deprivation was not associated with measures that directly reflect access to care, including the occurrence of HbA1c testing and receipt of eye exams (RR 0.99, 95% CI 0.94 to 1.04 and RR 1.03, 95% CI 1.00 to 1.05).
An increased risk of poor glycaemic control was observed for patients from areas of high neighbourhood deprivation, independent of individual socioeconomic status. Neighbourhood factors and their intersection with racial and ethnic disparities are important considerations for achieving equity in diabetes care.
To operationalize the Caring Life Course Theory (CLCT) as a framework for improving cardiac rehabilitation (CR) engagement and informing ways to address disparities in rural, low socio-economic areas.
A secondary analysis of data collected from 15 CR programmes to identify CR patterns through the CLCT lens using a mixed-methods approach. All analytical processes were conducted in NVivo, coding qualitative data through thematic analysis based on CLCT constructs. Relationships among these constructs were quantitatively assessed using Jaccard coefficients and hierarchical clustering via dendrogram analysis to identify related clusters.
A strong interconnectedness among constructs: ‘care from others’, ‘capability’, ‘care network’ and ‘care provision’ (coefficient = 1) highlights their entangled crucial role in CR. However, significant conceptual disparities between ‘care biography’ and ‘fundamental care’ (coefficient = 0.4) and between ‘self-care’ and ‘care biography’ (coefficient = 0.384615) indicate a need for more aligned and personalized care approaches within CR.
The CLCT provides a comprehensive theoretical and practical framework to address disparities in CR, facilitating a personalized approach to enhance engagement in rural and underserved regions.
Integrating CLCT into CR programme designs could effectively address participation challenges, demonstrating the theory's utility in developing targeted, accessible care interventions/solutions.
Explored the challenge of low CR engagement in rural, low socio-economic settings. Uncovered care provision, transitions and individual care biographies' relevance for CR engagement. Demonstrated the potential of CLCT to inform/transform CR services for underserved populations, impacting practices and outcomes.
EQUATOR—MMR-RHS.
A consumer co-researcher contributed to all study phases.
Predictive scoring systems support clinicians in decision-making by estimating the prognosis of patients in intensive care units (ICUs). However, there is limited evidence on the accuracy of these systems in predicting mortality and organ dysfunction in special populations. The aim of this review is to assess the performance of predictive scoring systems in forecasting mortality in adult ICU patients in relation to baseline kidney function. It is anticipated that the assessment of predictive scoring systems’ performance and patient outcomes in this review may reveal information that will contribute to improve the quality of care and outcomes for special or under-represented ICU patient populations. It might also inform future research and contribute to the development of novel risk prediction models to address identified gaps or unanswered questions.
This review will include only observational studies, as these allow us to assess the real-world performance of predictive scoring systems in ICU settings by examining the original validation studies. By excluding randomised trials, paediatric studies, case reports and machine learning-derived models, this review focuses on the direct practical use of the scoring systems in adult ICU patients. A comprehensive search of MEDLINE, Embase and Scopus was conducted from database inception to 10 October 2024. The data will be extracted on study characteristics, patient outcomes and performance metrics.
This review will analyse data from previously published studies; no ethical approval is required. All data that will be included in the analysis will be publicly available and will be included in the final manuscript. Results will be disseminated through publication in a peer-reviewed journal and will also be presented at seminars and conferences.
CRD42024611547.
Urban green and blue space (UGBS) interventions, such as the development of an urban greenway, have the potential to provide public health benefits and multiple co-benefits in the realms of the environment, economy and society. This paper presents the protocol for a 5-year follow-up evaluation of the public health benefits and co-benefits of an urban greenway in Belfast, UK.
The natural experiment evaluation uses a range of systems-oriented and mixed-method approaches. First, using group model building methods, we codeveloped a causal loop diagram with stakeholders to inform the evaluation framework. We will use other systems methods including viable systems modelling and soft systems methodology to understand the context of the system (ie, the intervention) and the stakeholders involved in the development, implementation and maintenance phases. The effectiveness evaluation includes a repeat cross-sectional household survey with a random sample of 1200 local residents (adults aged ≥16 years old) who live within 1 mile of the greenway. The survey is complemented with administrative data from the National Health Service. For the household survey, outcomes include physical activity, mental well-being, quality of life, social capital, perceptions of environment and biodiversity. From the administrative data, outcomes include prescription medications for a range of non-communicable diseases such as cardiovascular disease, type II diabetes mellitus, chronic respiratory and mental health conditions. We also investigate changes in infectious disease rates, including COVID-19, and maternal and child health outcomes such as birth weight and gestational diabetes. A range of economic evaluation methods, including a cost-effectiveness analysis and social return on investment (SROI), will be employed. Findings from the household survey and administrative data analysis will be further explored in focus groups with a subsample of those who complete the household survey and the local community to explore possible mechanistic pathways and other impacts beyond those measured. Process evaluation methods include intercept surveys and direct observation of the number and type of greenway visitors using the Systems for Observing Play and Recreation in Communities tool. Finally, we will use methods such as weight of evidence, simulation and group model building, each embedding participatory engagement with stakeholders to help us interpret, triangulate and synthesise the findings.
To our knowledge, this is one of the first natural experiments with a 5-year follow-up evaluation of an UGBS intervention. The findings will help inform future policy and practice on UGBS interventions intended to bring a range of public health benefits and co-benefits. Ethics approval was obtained from the Medicine, Health and Life Sciences Research Ethics Committee prior to the commencement of the study. All participants in the household survey and focus group workshops will provide written informed consent before taking part in the study. Findings will be reported to (1) participants and stakeholders; (2) funding bodies supporting the research; (3) local, regional and national governments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications.
The tobacco and nicotine industry fuels tobacco-related addiction, disease and death. Indigenous peoples experience a disproportionate burden of commercial tobacco-related morbidity and mortality. Over the past two decades, significant progress has been made in reducing smoking prevalence among Indigenous peoples; however, smoking remains a leading contributor to the burden of death and disease. This review will summarise evidence on commercial tobacco resistance and/or eradication strategies, including policy reforms, in relation to Indigenous peoples across Oceania, the Pacific Islands and North America.
This review will follow guidelines from the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews and will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. This review will consider academic and grey literature published since 1 January 2000. The following electronic databases will be searched for relevant primary research articles and commentaries: PubMed, Scopus, Informit, Web of Science and PsycINFO. Additional searches will be conducted in ProQuest to identify relevant grey literature. Papers will be screened by two reviewers to determine eligibility, followed by full-text data extraction. Findings will be synthesised descriptively for each review question and by region. Studies included in the review will be assessed against criteria for Indigenous engagement in research.
This protocol was led by Indigenous interests, needs and rights of Indigenous peoples, consistent with the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), the WHO’s Framework Convention on Tobacco Control and ethical practice. This review was conceptualised with Indigenous leadership and through engagement, including but not limited to the Indigenous lived experience of the authors (MK, E-ST, HC, PNH, PH, SAM, AW, SW and RM). This review supports the global goal of eradicating commercial tobacco-related harms – reframing commercial tobacco use as a structurally imposed harm sustained by colonial and commercial forces rather than personal choice. Findings from this review will be shared with Indigenous partners and communities who requested this work and will be submitted for peer-reviewed publication.
Open Science Framework https://osf.io/wxqcb
Providing information about the process of poststroke recovery, and individuals’ likely outlook can be challenging for professionals, which may lead to avoidance of this important issue, leaving patients’ and carers’ needs unmet in relation to understanding their recovery. We aimed to understand professionals’ experiences and views of providing information about recovery in stroke units.
Semistructured interviews were conducted as part of a wider ethnographic case study. A Framework approach to analysis was employed.
Two UK stroke units.
19 qualified stroke unit professionals with a range of experience levels participated, including doctors, physiotherapists, occupational therapists, speech and language therapists and a nurse.
Three themes and seven subthemes were generated. Participants across disciplines perceived that discussing recovery could have important benefits, although many lacked guidance about their roles in this domain. Skills in predicting recovery and sharing these predictions were learnt experientially, and therapists reported a lack of preparatory training and confidence, resulting in perceptions of mixed experiences for patients. Many professionals were worried about the consequences of sharing personalised predictions, including the impact on patients’ hope and motivation, and their ability to manage patients’ and families’ emotional responses. These concerns could result in professionals experiencing negative psychological consequences, for which limited formal support was available.
Stroke unit professionals perceive that providing information about recovery, including individualised predictions, to patients and carers has important benefits; however, they require additional guidance, support and training to confidently engage in this important area of clinical practice.
Congenital cytomegalovirus (cCMV) is an important cause of long-term childhood disability. In Australia, the identification and treatment practices and the long-term clinical and neurodevelopmental outcomes of children with cCMV are unknown. The Australasian cCMV Register (ACMVR) is a longitudinal register and resource for research that aims to describe and explore, in Australian children with cCMV: (1) their clinical characteristics over time, (2) antiviral therapy use/prescribing up to 1 year of age and (3) risk factors and potential avenues for prevention of adverse sequelae of the virus.
Children
Ethics and governance approvals, study database and a steering group have been established. Data collection is active in five sites across Australia.
The ACMVR will inform our understanding of the long-term outcomes for children with cCMV in Australia and provide a sampling frame and resource for recruitment in future clinical and epidemiological research to inform practice and policy. New opportunities for the establishment of additional study sites and collaborations with Australian maternity and fetal medicine researchers and with cCMV registries in other countries are currently being explored.
Rapid microbiological point-of-care tests (RM-POCTs) have the potential to reduce antimicrobial overuse for respiratory tract infections (RTIs). However, patient perspectives regarding RM-POCTs remain unclear. Therefore, this study aimed to explore patients’ and parents’ experiences using RM-POCTs for RTIs and their views on how RM-POCTs influence treatment decisions, symptom management and future consulting.
A qualitative study using in-depth, semistructured interviews. Data were analysed thematically, informed by a realist approach.
Interviewees were recruited from a multicentre, individually randomised controlled efficacy trial evaluating the use of a multiplex RM-POCT for suspected RTIs in primary care.
Purposive sample of primary care patients (n=21 adults, 9 parents) participating in the trial.
In general, participants viewed RM-POCTs favourably. Patients believed RM-POCTs reduced diagnostic uncertainty but emphasised that RM-POCTs should be used alongside clinical judgement. For some, additional information from RM-POCTs created positive outcome expectancies and reduced the perception that antibiotics were necessary. Others felt invalidated by RM-POCTs’ results or believed further support was necessary to understand when antibiotics were needed and how they could manage symptoms. While RM-POCTs may reduce reconsulting for the same illness, participants indicated future consulting behaviours would persist for self-limiting symptoms or health anxiety. Increased consulting may occur if patients perceive RM-POCTs to reduce pressure on primary care.
RM-POCT offers the potential to improve self-efficacy beliefs and reduce reconsulting for the same illness. Effective clinician communication and patient education may be beneficial alongside RM-POCTs to minimise unintended outcomes and enhance patients’ ability to determine when primary care attendance is necessary in the future.
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.
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 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.
Examples of poor research practices have received much attention in academic and public arenas. Such practices persist and threaten the health of the public and the reputation and impact of research and researchers.
In this article, we argue that research—though intended to improve health—can lead to patient harm through the proliferation of honest (though occasionally dishonest) yet unacceptable research practices.
We argue that deliberate dishonest research practices—termed questionable research practices—are widely prevalent and insidious and influenced by both individual and cultural factors. Drawing on credible conceptualisations of poor research practices, we define honest yet unacceptable research practices to be different from questionable research practices involving dishonesty, but just as serious due to their wide prevalence and damaging impacts. Finally, we present recommendations for people and organisations to better protect patients’ interests from honest yet unacceptable research practices.
Our recommendations can serve as the basis for preventing honest yet unacceptable poor research practices to safeguard public trust in health professions, researchers and practices.
Campaigns to support pictorial health warning labels (HWLs) for cigarettes have enhanced their effectiveness, but little to no research on campaign messages to support little cigars and cigarillos (LCC) pictorial HWLs exists. The goal of this study was to examine the effectiveness of messages to augment pictorial HWLs on LCCs among priority populations.
Online survey-based experiment.
Qualtrics research panel online of US adults, recruited between January and February 2023.
Adults ages 21–29 who reported current cigar use and reside in the USA.
Participants (n=315) were randomly assigned to one of three conditions: (1) messages designed to elaborate pictorial HWLs, (2) pictorial HWLs alone and (3) messages and pictorial HWLs paired together.
Within conditions, participants were shown six negative health effects of LCCs and answered questions about perceived message effectiveness (PME), negative affect, thinking about risks (TAR) and self-reported learning (SRL) as well as questions on quit intention, concern about their health and reactance. Using mixed-effects models and ANOVA, we evaluated for differences across conditions.
Most participants identified as male (60%) and either Black (45%) or White (45%). PME was very high across all three conditions (≥ 3.85) but no difference between conditions in a statistically significant manner (p=0.18). Mixed-effects models indicated that negative affect varied across conditions, highest in condition 2 (3.76; 95% CI 3.58, 3.94) and lowest in condition 3 (3.44; 95% CI 3.27, 3.61) (p=0.01), and showed no statistically significant difference between conditions for SRL (p=0.31) or TAR (p=0.43). No statistically significant difference was noted for quit intentions (p=0.16), health concern (p=0.28) or reactance (p=0.84).
Pictorial HWLs, campaign messages and the combination of the conditions were all perceived as very effective, with little differences in PME. Such findings indicate that pictorial HWLs on LCCs and communication messages about LCCs both appear as promising approaches to reducing LCC use among target populations. Longitudinal studies with ongoing exposure may identify factors that can enhance the effectiveness of campaign messages to enhance pictorial HWLs for LCCs.