In cluster randomised trials (CRT), groups (rather than individuals) are randomised to intervention and control conditions. Since the publication of the Ottawa Statement on the Ethical Design and Conduct of CRTs, the accurate identification of research participants has continued to challenge researchers and research ethics committees.

In this article, we focus on CRTs involving healthcare providers and provide a practical framework for applying Ottawa Statement criteria for identifying research participants. We illustrate key lessons with example CRTs.

Study procedures should be analysed in relation to the study objective. A study intervention confers research participant status on healthcare providers if the study objective is to evaluate its effect and it is delivered to or targeted at healthcare providers. A data collection procedure confers research participant status on healthcare providers if it informs a study outcome used to achieve the study objective and it involves interactions between researchers and healthcare providers to collect their data, or the collection of healthcare providers’ identifiable private information.

In CRTs, healthcare providers may be research participants because of study interventions, data collection procedures, or both; conversely, they may simply be research collaborators. Some study interventions confer research participant status on both healthcare providers and patients. Collecting data on healthcare provider behaviour may confer research participant status on healthcare providers.

Accurately identifying research participants in CRTs is essential to their ethical conduct. When healthcare providers are research participants, their rights and welfare should be protected in accordance with research ethics guidelines.

Treatment with bevacizumab achieves both tumour stabilisation or regression and preservation or improvement of hearing. However, the efficacy of bevacizumab varies between patients and within patients. Side effects due to bevacizumab treatment are also common. It would be of value to predict therapeutic response prior to initiating therapy to prevent unnecessary exposure in patients unlikely to benefit.

We aim to recruit 25 patients with NF2-related schwannomatosis (NF2) with bilateral vestibular schwannomas. Patients will receive an intravenous injection of 37 MBq [⁸⁹Zr]bevacizumab followed by positron emission tomography (PET)/CT imaging 4 days later. After clinical evaluation at baseline, patients undergo bevacizumab treatment and are followed up at 3 and 6 months. The primary objective is to examine associations between pretreatment [⁸⁹Zr]bevacizumab uptake on PET/CT and changes in multiple hearing outcomes and radiological characteristics of the target tumour following treatment. Secondary outcome measures include vestibular functioning, patient reported outcome measures, cranial nerve functionality, peripheral neurology, non-target schwannoma response and renal function. Given the explorative nature of the study, associations between PET-derived metrics and clinical and radiological outcomes will be examined without formal hypothesis testing, using generalised estimating equations to account for within-patient correlation. Pairwise associations will be summarised in an association matrix with multiplicity addressed using an all-resolutions inference approach, and findings will be considered hypothesis generating.

This study was submitted via the Clinical Trials Information System reviewed and approved by the Medical Research Ethics Committee Leiden–The Hague–Delft Delft. The study findings will be disseminated through publication in peer-reviewed scientific journals and by presentation at national and international conferences.

The trial is registered at ClinicalTrials.gov Protocol Registration and Results System under the registration ID: NCT05685836.

To determine the prevalence of presbyopia and associated risk factors among Bangladeshi recipients of elderly social safety net payments who were not currently using mobile financial services (MFS) and demonstrated numeracy, dexterity and cognitive prerequisites for smartphone use during eligibility screening for the Transforming Households with Refraction and Innovative Financial Technology (THRIFT) trial. Accessing these payments requires use of online banking, as with a smartphone.

Cross-sectional analysis of trial eligibility screening data.

Community-based screening conducted in two rural subdistricts in Kurigram District, Bangladesh.

Among 13 944 Old Age Allowance and Widows’ Allowance (WA) beneficiaries screened, 953 met trial eligibility criteria, including passing a smartphone readiness assessment and completing near vision examinations.

Presbyopia, defined as binocular presenting near visual acuity of N6.3 or worse, correctable to at least N5 with near vision glasses and with distance vision of ≥6/12 in both eyes.

Among 953 participants (mean age 61.4±7.2 years, 62.6% women), presbyopia prevalence was 62.6% (95% CI 59.5 to 65.7). Presbyopia was significantly positively associated with female gender (adjusted prevalence ratio (APR)=1.19, 95% CI 1.02 to 1.41) and receiving WA (APR=1.20, 95% CI 1.04 to 1.38) in multivariable analyses.

This study highlights a substantial burden of uncorrected presbyopia among a prescreened, randomised control trial-eligible subgroup of social safety net beneficiaries in rural Bangladesh, who were not currently using MFS but demonstrated cognitive and functional capacity to use mobile phones, potentially hampering their ability to carry out online banking. Delivery of reading glasses may improve digital financial access and facilitate broader financial inclusion, a hypothesis currently being tested in the parent THRIFT trial.

NCT05510687.

To date, few studies have investigated the factors associated with musculoskeletal patients’ willingness to donate biological samples and their knowledge regarding the use of such samples. We investigated the associations between these distinct knowledge factors, patients’ willingness to donate and socio-demographic factors.

Cross-sectional survey.

Musculoskeletal outpatient clinics across four sites in England, representing varied demographic populations.

A total of 469 adult patients attending musculoskeletal appointments were recruited through convenience sampling.

Ordinal regression models were employed to identify socio-demographic and clinical predictors of patients’ willingness to donate biological samples. Other outcome measures specifically in two areas of patient knowledge include: (1) knowledge of sample use and (2) knowledge of surgical waste tissue value and management.

Only 37% of participants were aware of the term ‘biobank’. Despite this, participants showed a high level of knowledge regarding both biological sample use and surgical waste tissue management, although their understanding varied considerably by ethnicity and education. Participants with no formal education exhibited a lower level of knowledge in both areas related to sample use and surgical waste tissue management for biomedical research ((OR 0.30, 95% CI 0.14 to 0.61; p=0.001); (OR=0.29, 95% CI 0.16 to 0.52, p

Despite low awareness, musculoskeletal patients showed a high willingness to participate in biobanking. However, significant disparities by ethnicity and education persist. Targeted, inclusive engagement strategies are needed to address under-representation and foster informed, equitable participation of musculoskeletal patients in biomedical research.

To develop a machine learning (ML)-based risk prediction model for 1-year mortality in ST-elevation myocardial infarction (STEMI) patients undergoing primary or rescue percutaneous coronary intervention.

Patient data, including demographic, clinical, biochemical, imaging and procedural details, were extracted from electronic medical records. Data were split into training (80%) and test (20%) sets. Eight supervised learning algorithms were evaluated: least absolute shrinkage and selection operator, ridge, Elastic Net (EN, decision tree, support vector machine, random forest, AdaBoost and gradient boosting. Feature selection was performed sequentially with subsets of the top 5/10/15/20/25/30 features. Model hyperparameters were optimised using fivefold cross-validation with area under the curve (AUC) as the scoring metric.

Single, tertiary Australian centre.

We analysed data from 1863 consecutive STEMI patients treated at a tertiary Australian centre from July 2010 to December 2019.

The primary outcome was 1-year all-cause mortality.

The 1-year mortality rate was 13.6% (n=254) in our cohort. The EN model with five key features (parsimonious model) demonstrated superior performance, achieving an AUC of 0.821, which was comparable to the full 30-variable model (AUC 0.821). Advanced age, pre-hospital cardiac arrest and management with balloon angioplasty alone were identified as predictors of increased mortality risk, while family history of premature coronary disease and higher left ventricular ejection fraction were associated with improved survival. To facilitate clinical implementation, we developed a user-friendly web application for individualised risk assessment.

Our ML model accurately predicts 1-year mortality in STEMI patients using only five clinical variables. This tool offers improved accuracy and ease of use compared with existing risk stratification methods, potentially enhancing patient stratification and guiding treatment decisions in STEMI management.

Many researchers conduct a process evaluation alongside an effectiveness trial of a public health intervention to better understand mechanisms behind observed effects. Yet, there is no standardised, scientifically accepted guideline for reporting such process evaluations, which impedes interpretation and comparison of study results. The aim of this project was to develop a consensus-based and expert-based guideline for reporting process evaluations of public health interventions conducted alongside an effectiveness trial.

We conducted an e-Delphi study with a large panel of international experts.

Based on purposive sampling, we invited 137 international experts that had been involved in the design of process evaluations, researchers who published high-profile process evaluations or frameworks, editors of journals that publish process evaluations, and authors of other reporting guidelines.

Based on a literature search, a first draft of the reporting guideline included 32 items, which was proposed to panel members during the first round. Of the invited 137 invited international experts, 73 (53%) participated in at least one round of the e-Delphi study. Participants rated the inclusion and comprehensibility of the proposed items on a 5-point Likert scale and provided comments and suggestions for relevance and definitions of the items. Adjustments to the items and descriptions were proposed to the e-Delphi panel until consensus of ≥67% for each individual item was reached. In total, 64 (88% of 73) completed round 2, and 55 (76% of 73) completed round 3. This resulted in 19 items that are included in the consensus-based process evaluation reporting guideline for public health intervention studies (CONPHES) guideline. The items cover a detailed description of the intervention that is evaluated, the implementation strategies applied, and underlying causal pathways, and the role of the delivery and support team. The guideline also requires describing the evaluation framework and how evaluation outcomes were assessed. Lastly, the guideline includes items on providing a detailed description of applied analyses (both quantitative and qualitative) and measures for assuring quality. The guideline is accompanied by an Explanation and Elaboration document, with a more detailed explanation of each item.

We expect that the CONPHES reporting guideline for process evaluations of public health interventions can improve the reporting of process evaluations of interventions aimed at promoting public health. This can potentially facilitate more effective translation of public health research into practice and contribute to improving both individual and population health outcomes.

Rheumatoid arthritis (RA) is a heterogeneous disease, which current treatment guidelines insufficiently accommodate, as they predominantly emphasise the suppression of disease activity. However, a step towards personalised medicine is preferred to further optimise treatment and requires homogeneous subgroups with similarities in pathophysiological mechanisms and treatment responses. Prior research has already demonstrated notable differences in the pathophysiology of patients with autoantibody-positive and autoantibody-negative RA, as well as differences in treatment responses, which may serve as a strong basis for personalised medicine. Additionally, there is evidence suggesting that an early treatment response is indicative of future courses. Based on these findings, we designed a personalised medicine trial in RA that compares the effectiveness and cost-effectiveness of a tailor-made approach with routine care.

The PeRsonalIsed Medicine in RA (PRIMERA) trial is a multicentre, open-label, randomised controlled trial that includes 300 adult patients with newly diagnosed, DMARD-naïve RA, according to 2010 American College of Rheumatology/EULAR criteria. Patients are randomised into either routine care or a tailor-made approach. Both management approaches use a treat-to-target strategy, aiming for low disease activity (LDA, Disease Activity Score using 44 joints (DAS) ≤2.4). In routine care, initial treatment consists of methotrexate along with a single intramuscular dose of glucocorticoids (GCs) and treatment can be intensified after 3, 7 and 10 months if LDA is not reached. Conversely, initial treatment in the tailor-made approach depends on the presence of autoantibodies, with patients with autoantibody-positive and autoantibody-negative RA starting with hydroxychloroquine or methotrexate together with a single intramuscular dose of GCs, respectively. Medication intensifications will be allowed at months 1, 3, 4, 7 and 10. Intensifications at months 1 and 4 depend on whether patients have an early sufficient response to GCs and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively. The tailor-made approach is superior to routine care if no more biological DMARDs (bDMARDs) or tsDMARDs are used after 10 months of treatment, while the mean DAS over time is lower. Our primary outcome is the proportional difference in bDMARD or tsDMARD usage after 10 months of treatment between routine care and the tailor-made approach. Secondary outcomes are DAS over time, time to achieve LDA, cost-effectiveness and patient-reported outcome measurements over time.

Ethical approval has been granted by Erasmus MC Medical Ethics Review Committee (MEC-2020-0825). The results will be disseminated through peer-review journals and medical congresses.

ISRCTN16170070.

Ambulatory care sensitive conditions (ACSCs) are conditions for which the provision of timely and skilled primary care can reduce risks of hospitalisation when preventing, treating or controlling a disease. For this reason, hospitalisations for ACSC have been commonly employed by health systems as an indicator of effectiveness for the primary level of care. This study aims to evaluate whether the provision of primary care services by physicians with residency training in family medicine is associated with rates of general hospitalisations for ACSCs in the Brazilian Unified Health System network in the city of Belo Horizonte, Brazil.

Longitudinal ecological study using a Generalised Linear Model for Gamma-distributed variables.

Primary healthcare centres in Belo Horizonte, Brazil, from January 2017 to December 2021, aggregated at the primary healthcare centres level.

Data aggregated at the primary healthcare centre level, encompassing socioeconomic, professional and health-related variables.

Incidence rates of hospitalisations for ACSCs, adjusted for age and sex.

After adjusting for age, sex and socioeconomic variables using the Health Vulnerability Index, a higher concentration of family physicians was significantly associated with a lower incidence of hospitalisations for ACSCs. If all physicians in the primary care network were family physicians, compared with a scenario in which none were, an estimated 11.89% reduction in hospitalisations would be expected (95% CI 7.3% to 16.3%, p

The findings suggest that specialisation in family medicine positively impacts health outcomes by reducing hospitalisations for ACSCs. These results can inform the development of evidence-based public policies to enhance primary care effectiveness.

Oral health research provides evidence for policy and practice, yet no study has comprehensively mapped the scope of oral health research in Malaysia. The COVID-19 pandemic has also created a great impact on oral healthcare in Malaysia, including the dental care delivery. Additionally, there is a notable lack of research focusing on oral health during and after the COVID-19 pandemic. Therefore, this scoping review will aim to map the landscape of oral health research conducted in Malaysia and identify key topics, study designs, populations studied and gaps in the literature, in order to inform future research priorities and policy, particularly in the post-COVID-19 era.

The methodology draws on Arksey and O’Malleys’ seminal framework for the scoping review and will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review (PRISMA-ScR) guidelines. We will search five major electronic databases—PubMed, Scopus, ProQuest, Cochrane and Web of Science—as well as selected grey literature sources (eg, theses, dissertations and conference proceedings) for studies published in English from January 2014 to December 2024. Studies of any design related to oral health in Malaysia will be included. Two reviewers will be performing title and abstract screening, in which they will be working independently. The included publication will undergo a full-text review, and references cited in these studies will be examined following the inclusion criteria. The PRISMA-ScR flow diagram will be used as a guide throughout the process. Data will be extracted, analysed and charted according to key categories identified in the included publications. A narrative synthesis and descriptive statistics will be presented.

The results of this scoping review will illustrate an overview and provide a better understanding regarding the oral health research in the Malaysian context; whether research has already been conducted, is currently ongoing and is still needed; and which areas should be prioritised for future investigation. As this review will use publicly available literature, formal ethics approval will not be required. The findings will be submitted for publication in an open-access peer-reviewed journal, presented at national and regional conferences and shared with Malaysian dental professional bodies and relevant stakeholders.

The protocol of this scoping review is registered with the Open Science Framework and is available at osf.io/hjq6m.

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.