To identify barriers to hospital participation in controlled cluster trials of clinical decision support (CDS) and potential strategies for addressing barriers.

Qualitative descriptive design comprising semistructured interviews.

Five hospitals in New South Wales and one hospital in Queensland, Australia.

Senior hospital staff, including department directors, chief information officers and those working in health informatics teams.

20 senior hospital staff took part. Barriers to hospital-level recruitment primarily related to perceptions of risk associated with not implementing CDS as a control site. Perceived risks included reductions in patient safety, reputational risk and increased likelihood that benefits would not be achieved following electronic medical record (EMR) implementation without CDS alerts in place. Senior staff recommended clear communication of trial information to all relevant stakeholders as a key strategy for boosting hospital-level participation in trials.

Hospital participation in controlled cluster trials of CDS is hindered by perceptions that adopting an EMR without CDS is risky for both patients and organisations. The improvements in safety expected to follow CDS implementation makes it challenging and counterintuitive for hospitals to implement EMR without incorporating CDS alerts for the purposes of a research trial. To counteract these barriers, clear communication regarding the evidence base and rationale for a controlled trial is needed.

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.

PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.

PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand’s Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences.

NCT04778514, NCT04778527.

Group B streptococcus (GBS), or Streptococcus agalactiae, remains a leading cause of neonatal morbidity and mortality. Canadian guidelines advise universal maternal screening for GBS colonisation in pregnancy in conjunction with selective antibiotic therapy. This results in over 1000 pregnant individuals receiving antibiotic therapy to prevent one case of early-onset neonatal GBS disease, and over 20 000 pregnant individuals receiving antibiotic therapy to prevent one neonatal death. Given the growing concern regarding the risk of negative sequela from antibiotic exposure, it is vital that alternative approaches to reduce maternal GBS colonisation are explored.

Preliminary studies suggest some probiotic strains could confer protection in pregnancy against GBS colonisation.

This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks’ gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis.

There was no patient or public involvement in the design of the study protocol.

This study protocol received ethics approval from the University of British Columbia’s Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications.

NCT03407157.

Public policymakers are increasingly engaged in participatory model building processes, such as group model building. Understanding the impacts of policymaker participation in these processes on policymakers is important given that their decisions often have significant influence on the dynamics of complex systems that affect health. Little is known about the extent to which the impacts of participatory model building on public policymakers have been evaluated or the methods and measures used to evaluate these impacts.

A scoping review protocol was developed with the objectives of: (1) scoping studies that have evaluated the impacts of facilitated participatory model building processes on public policymakers who participated in these processes; and (2) describing methods and measures used to evaluate impacts and the main findings of these evaluations. The Joanna Briggs Institute’s Population, Concept, Context framework was used to formulate the article identification process. Seven electronic databases—MEDLINE (Ovid), ProQuest Health and Medical, Scopus, Web of Science, Embase (Ovid), CINAHL Complete and PsycInfo—will be searched. Identified articles will be screened according to inclusion and exclusion criteria and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist for scoping reviews will be used and reported. A data extraction tool will collect information across three domains: study characteristics, methods and measures, and findings. The review will be conducted using Covidence, a systematic review data management platform.

The scoping review produced will generate an overview of how public policymaker engagement in participatory model building processes has been evaluated. Findings will be disseminated through peer-reviewed publications and to communities of practice that convene policymakers in participatory model building processes. This review will not require ethics approval because it is not human subject research.

Patients diagnosed with colorectal cancer living in more deprived areas experience worse survival than those in more affluent areas. Those living in more deprived areas face barriers to accessing timely, quality healthcare. These barriers may contribute to socioeconomic inequalities in survival. We evaluated the literature for any association between socioeconomic group, hospital delay and treatments received among patients with colorectal cancer in the UK, a country with universal healthcare.

MEDLINE, EMBASE, CINAHL, CENTRAL, SCIE, AMED and PsycINFO were searched from inception to January 2023. Grey literature, including HMIC, BASE and Google Advanced Search, and forward and backward citation searches were conducted. Two reviewers independently reviewed titles, abstracts and full-text articles. Observational UK-based studies were included if they reported socioeconomic measures and an association with either hospital delay or treatments received. The QUIPS tool assessed bias risk, and a narrative synthesis was conducted. The review is reported to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020.

41 of the 7209 identified references were included. 12 studies evaluated 7 different hospital intervals. There was a significant association between area-level deprivation and a longer time from first presentation in primary care to diagnosis. 32 studies evaluated treatments received. There were socioeconomic inequalities in surgery and chemotherapy but not radiotherapy.

Patients with colorectal cancer face inequalities across the cancer care continuum. Further research is needed to understand why and what evidence-based actions can reduce these inequalities in treatment. Qualitative research of patients and clinicians conducted across various settings would provide a rich understanding of the complex factors that drive these inequalities. Further research should also consider using a causal approach to future studies to considerably strengthen the interpretation. Clinicians can try and mitigate some potential causes of colorectal cancer inequalities, including signposting to financial advice and patient transport schemes.

CRD42022347652.

Standard treatment for patients with intermediate or locally advanced rectal cancer is (chemo)radiotherapy followed by total mesorectal excision (TME) surgery. In recent years, organ preservation aiming at improving quality of life has been explored. Patients with a complete clinical response to (chemo)radiotherapy can be managed safely with a watch-and-wait approach. However, the optimal organ-preserving treatment strategy for patients with a good, but not complete clinical response remains unclear. The aim of the OPAXX study is to determine the rate of organ preservation that can be achieved in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy by additional local treatment options.

The OPAXX study is a Dutch multicentre study that investigates the efficacy of two additional local treatments aiming at organ preservation in patients with a good, but not complete response to neoadjuvant treatment (ie near-complete response or a small residual tumour mass

The trial protocol has been approved by the medical ethics committee of the Netherlands Cancer Institute (METC20.1276/M20PAX). Informed consent will be obtained from all participants. The trial results will be published in an international peer-reviewed journal.

NCT05772923.

Healthcare workers were prioritised to receive the COVID-19 vaccine in Nigeria. Administration of COVID-19 vaccination in Nigeria was challenging because of a lack of trust in vaccine safety and vaccine effectiveness among healthcare workers, who are expected to provide reliable information about vaccines and vaccine-preventable diseases in the communities. Hence, their acceptance and attitudes towards COVID-19 preventive practices could influence the acceptance of the vaccine by the local population. This cross-sectional study assessed the acceptance of the COVID-19 vaccine among healthcare workers in Katsina State. We predicted the variables that increased the vaccine acceptance using logistic regression analysis.

This hospital-based study was conducted at primary, secondary and tertiary healthcare facilities in Nigeria.

A total of 793 healthcare workers were included in this study. Of these, 65.4% (n=519) were male.

To assess acceptance of COVID-19 vaccine measures, and factors increasing acceptance among healthcare workers.

Of the healthcare workers, 80% (638) were tested for the SARS-CoV-2, of whom 10.8% (n=65) tested positive. Approximately 97% (n=765) of them believed that the COVID-19 vaccine was safe, and 90% (n=714) received the first dose of the vaccine. Healthcare workers between 30 and 39 years were more likely to accept the vaccine (aOR: 7.06; 95% CI 2.36 to 21.07; p

Our findings showed that the age and prior COVID-19 testing were the main factors influencing the acceptance of the COVID-19 vaccine. There was high acceptance of the COVID-19 vaccine among healthcare workers in Katsina State, Nigeria. Future studies should focus on the completion of doses and serological testing for immunity.

Informal caregivers are playing a vital role in improving the degree to which older adults access community and healthcare systems in a more seamless and timely manner, thereby fulfilling their complex needs. It is critical to understand their experiences and perspectives while navigating these systems. This review aimed to identify and organise the research findings on the roles and experiences of informal caregivers of older adults while navigating community and healthcare systems.

This scoping review was undertaken according to the Joanna Briggs Institute’s Reviewer manual. Four databases were used: AgeLine, PsycINFO, CINAHL and Medline to capture literature with a focus on informal caregivers whose care recipients are aged 55 years or older. Articles were included if they focused on examining the experience, perspective and/or role of informal caregivers in providing care for their older care recipients, while articles were excluded if they only focused on healthcare professionals or older adults.

A total of 24 studies were identified that met the study inclusion criteria. This review elucidated the roles of caregivers as a primary system navigator and as an advocate for older adults. Numerous challenges/barriers in system navigation were uncovered, such as lack of consistency in fragmented systems, as well as facilitators, including interface/coordination roles. Finally, recommendations for better system navigation such as caregiver engagement and integration of continuity of care services were identified.

The need to raise the visibility of the roles and experiences of informal caregivers in system navigation was highlighted. Further research needs to focus on implementing interventions for informal caregivers incorporating a care coordinator to fill the care gap within community and healthcare systems. This review has the potential to foster greater integration of community and healthcare systems.

Despite evidence for the efficacy and effectiveness of hand hygiene in reducing the transmission of infectious diseases, there are gaps in global normative guidance around hand hygiene in community settings. The goal of this review is to systematically retrieve and synthesise available evidence on hand hygiene in community settings across four areas: (1) effective hand hygiene; (2) minimum requirements; (3) behaviour change and (4) government measures.

This protocol entails a two-phased approach to identify relevant studies for multiple related systematic reviews. Phase 1 involves a broad search to capture all studies on hand hygiene in community settings. Databases, trial registries, expert consultations and hand searches of reference lists will be used to ensure an exhaustive search. A comprehensive, electronic search strategy will be used to identify studies indexed in PubMed, Web of Science, EMBASE, CINAHL, Global Health, Cochrane Library, Global Index Medicus, Scopus, PAIS Index, WHO IRIS, UN Digital Library and World Bank eLibrary published in English from January 1980 to March 2023. The outcome of phase 1 will be a reduced sample of studies from which further screening, specific to research questions across the four key areas can be performed. Two reviewers will independently assess each study for inclusion and disagreements will be resolved by a third reviewer. Quantitative and qualitative data will be extracted following best practices. We will assess all studies using the Mixed Method Appraisal Tool. All effect measures pertaining to review outcomes will be reported and a narrative synthesis of all studies will be presented including ‘data-driven’ descriptive themes and ‘theory-driven’ analytical themes as applicable.

This systematic review is exempt from ethics approval because the work is carried out on published documents. The findings of the reviews will be disseminated in related peer-reviewed journals.

CRD42023429145.