As nearly two-thirds of women presenting at their first antenatal visit are either overweight or obese in urban South Africa, the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and non-communicable diseases. This protocol describes the planned economic evaluation of an individually randomised controlled trial of a complex continuum of care intervention targeting women and children in Soweto, South Africa (Bukhali trial).

The economic evaluation of the Bukhali trial will be conducted as a within-trial analysis from both provider and societal perspectives. Incremental costs and health outcomes of the continuum of care intervention will be compared with standard care. The economic impact on implementing agencies (programme costs), healthcare providers, participants and their households will be estimated. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of child adiposity at age years averted. Additionally, ICERs will also be reported in terms of cost per quality-adjusted life year gained. If Bukhali demonstrates effectiveness, we will employ a decision analytical model to examine the cost-effectiveness of the intervention over a child’s lifetime. A Markov model will be used to estimate long-term health benefits, healthcare costs and cost-effectiveness. Probabilistic sensitivity analyses will be conducted to explore uncertainty and ensure robust results. An analysis will be conducted to assess the equity impact of the intervention, by comparing intervention impact within quintiles of socioeconomic status.

The Bukhali trial economic evaluation has ethical approval from the Human Ethics Research Committee of the University of the Witwatersrand, Johannesburg, South Africa (M240162). The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.

Pan African Clinical Trials Registry (PACTR201903750173871; https://pactr.samrc.ac.za).

Inappropriate antibiotic prescribing is a major cause of antimicrobial resistance (AMR). The aim of this study was to explore paediatric general practitioners’ (GP Peds) antibiotic prescription practice in suspected respiratory tract infections (RTIs), using the capability–opportunity–motivation–behaviour framework.

The design is a qualitative study based on individual, semistructured telephone or virtual interviews.

Paediatric general practice in Hungary. We applied stratified maximum variation sampling to cover the categories of age, sex and geographical location of participants.

We interviewed 22 GP Peds. Nine were male and 13 were female: 2 of them were less than 40 years old, 14 were between 40 and 60 years, and 6 were above 60 years. 10 worked in low-antibiotic prescription areas, 5 in areas with medium levels of antibiotic prescription, 3 in high-antibiotic prescription areas, and 4 in and around the capital city.

Study participants had varying antibiotic prescription preferences. Personal experience and physical examination play a central role in GP Peds’ diagnostic and treatment practice. Participants emphasised the need to treat children in their entirety, taking their personal medical record, social background and sometimes parents’ preferences into account, besides the acute clinical manifestation of RTI. Most respondents were confident they apply the most effective therapy even if, in some cases, this meant prescribing medicines with a higher chance of contributing to the development of AMR. Some participants felt antibiotic prescription frequency has decreased in recent years.

Our findings suggest that a more prudent attitude toward antibiotic prescribing may have become more common but also highlight relevant gaps in both physicians’ and public knowledge of antibiotics and AMR. To reinforce awareness and close remaining gaps, Hungary should adopt its national AMR National Action Plan and further increase its efforts towards active professional communication and feedback for primary care physicians.

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Systematic review.

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

CRD42022282565.

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

https://doi.org/10.17605/OSF.IO/RWY27.

Breast cancer survivors have an increased risk for chronic fatigue and altered gut microbiota composition, both with negative health and quality of life affects. Exercise modestly improves fatigue and is linked to gut microbial diversity and production of beneficial metabolites. Studies suggest that gut microbiota composition is a potential mechanism underlying fatigue response to exercise. Randomised controlled trials testing the effects of exercise on the gut microbiome are limited and there is a scarcity of findings specific to breast cancer survivors. The objective of this study is to determine if fitness-related modifications to gut microbiota occur and, if so, mediate the effects of aerobic exercise on fatigue response.

The research is a randomised controlled trial among breast cancer survivors aged 18–74 with fatigue. The primary aim is to determine the effects of aerobic exercise training compared with an attention control on gut microbiota composition. The secondary study aims are to test if exercise training (1) affects the gut microbiota composition directly and/or indirectly through inflammation (serum cytokines), autonomic nervous system (heart rate variability) or hypothalamic-pituitary-adrenal axis mediators (hair cortisol assays), and (2) effects on fatigue are direct and/or indirect through changes in the gut microbiota composition. All participants receive a standardised controlled diet. Assessments occur at baseline, 5 weeks, 10 weeks and 15 weeks (5 weeks post intervention completion). Faecal samples collect the gut microbiome and 16S gene sequencing will identify the microbiome. Fatigue is measured by a 13-item multidimensional fatigue scale.

The University of Alabama at Birmingham Institutional Review Board (IRB) approved this study on 15 May 2019, UAB IRB#30000320. A Data and Safety Monitoring Board convenes annually or more often if indicated. Findings will be disseminated in peer-reviewed journals and conference presentations.

ClinicalTrials.gov, NCT04088708.

Potentially harmful non-steroidal anti-inflammatory drugs (NSAIDs) utilisation persists at undesirable rates worldwide. The purpose of this paper is to review the literature on interventions to de-implement potentially harmful NSAIDs in healthcare settings and to suggest directions for future research.

Scoping review.

PubMed, CINAHL, Embase, Cochrane Central and Google Scholar (1 January 2000 to 31 May 2022).

Studies reporting on the effectiveness of interventions to systematically reduce potentially harmful NSAID utilisation in healthcare settings.

Using Covidence systematic review software, we extracted study and intervention characteristics, including the effectiveness of interventions in reducing NSAID utilisation.

From 7818 articles initially identified, 68 were included in the review. Most studies took place in European countries (45.6%) or the USA (35.3%), with randomised controlled trial as the most common design (55.9%). Interventions were largely clinician-facing (76.2%) and delivered in primary care (60.2%) but were rarely (14.9%) guided by an implementation model, framework or theory. Academic detailing, clinical decision support or electronic medical record interventions, performance reports and pharmacist review were frequent approaches employed. NSAID use was most commonly classified as potentially harmful based on patients’ age (55.8%), history of gastrointestinal disorders (47.1%), or history of kidney disease (38.2%). Only 7.4% of interventions focused on over-the-counter (OTC) NSAIDs in addition to prescription. The majority of studies (76.2%) reported a reduction in the utilisation of potentially harmful NSAIDs. Few studies (5.9%) evaluated pain or quality of life following NSAIDs discontinuation.

Many varied interventions to de-implement potentially harmful NSAIDs have been applied in healthcare settings worldwide. Based on these findings and identified knowledge gaps, further efforts to comprehensively evaluate the effectiveness of interventions and the combination of intervention characteristics associated with effective de-implementation are needed. In addition, future work should be guided by de-implementation theory, focus on OTC NSAIDs and incorporate patient-focused strategies and outcomes, including the evaluation of unintended consequences of the intervention.

Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.

We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.

No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.

CRD42022347881.

This study set out to understand how (which elements), in what context and why (which mechanisms) interventions are successful in reducing (problematic) alcohol use among older adults, from the perspective of professionals providing these interventions.

Guided by a realist evaluation approach, an existing initial programme theory (IPT) on working elements in alcohol interventions was evaluated by conducting semistructured interviews with professionals.

These professionals (N=20) provide interventions across several contexts: with or without practitioner involvement; in-person or not and in an individual or group setting. Data were coded and links between contexts, elements, mechanisms and outcomes were sought for to confirm, refute or refine the IPT.

From the perspective of professionals, there are several general working elements in interventions for older adults: (1) pointing out risks and consequences of drinking behaviour; (2) paying attention to abstinence; (3) promoting contact with peers; (4) providing personalised content and (5) providing support. We also found context-specific working elements: (1) providing personalised conversations and motivational interviewing with practitioners; (2) ensuring safety, trust and a sense of connection and a location nearby home or a location that people are familiar with in person and (3) sharing experiences and tips in group interventions. Furthermore, the mechanisms awareness and accessible and low threshold participation were important contributors to positive intervention outcomes.

In addition to the IPT, our findings emphasise the need for social contact and support, personalised content, and strong relationships (both between client and practitioner, and client and peers) in interventions for older adults.

The new WHO Labour Care Guide (LCG), also regarded as the ‘next-generation partograph’, is a core component of 2018 WHO consolidated guidelines on intrapartum care for positive childbirth experience. The Ugandan Ministry of Health is in the process of adopting the new WHO LCG with no local context-specific data to inform this transition. We will explore potential barriers and facilitators to healthcare providers’ (HCPs) sustained engagement in labour monitoring in Mbarara city, Southwestern Uganda, and use the data to refine the new WHO LCG and develop a suitable implementation strategy to effectively integrate LCG into routine maternity care in Uganda. We shall then assess effectiveness, validity and other preliminary implementation outcomes of using the new LCG in detecting prolonged labour.

The study will use a mixed-methods approach to identify key LCG user perspectives to refine and customise the WHO LCG among 120 HCPs and stakeholders involved in maternity care and labour monitoring within facilities in Southwestern Uganda. The refined prototype will be deployed and used to monitor labour in all 14 basic and comprehensive emergency obstetric and newborn care facilities in the study area. We will review labour outcomes of 520 patients monitored using the new LCG and compare these outcomes with a historical cohort of 520 patients monitored using the partograph. The main effectiveness outcome will be the proportion of women diagnosed with prolonged labour and/or obstructed labour.

Ethical approval was obtained from the Mbarara University of Science and Technology Research Ethics Committee (MUST-2023-808) and Uganda National Council for Science and Technology (HS2864ES). We shall obtain written informed consent from each participant. The results of this study will be published in international peer-reviewed journals and presented to the Ugandan Ministry of Health as policy briefs and at selected national/international conferences.

NCT05979194.

Understanding human mobility’s role in malaria transmission is critical to successful control and elimination. However, common approaches to measuring mobility are ill-equipped for remote regions such as the Amazon. This study develops a network survey to quantify the effect of community connectivity and mobility on malaria transmission.

We measure community connectivity across the study area using a respondent driven sampling design among key informants who are at least 18 years of age. 45 initial communities will be selected: 10 in Brazil, 10 in Ecuador and 25 in Peru. Participants will be recruited in each initial node and administered a survey to obtain data on each community’s mobility patterns. Survey responses will be ranked and the 2–3 most connected communities will then be selected and surveyed. This process will be repeated for a third round of data collection. Community network matrices will be linked with each country’s malaria surveillance system to test the effects of mobility on disease risk.

This study protocol has been approved by the institutional review boards of Duke University (USA), Universidad San Francisco de Quito (Ecuador), Universidad Peruana Cayetano Heredia (Peru) and Universidade Federal Minas Gerais (Brazil). Results will be disseminated in communities by the end of the study.

An important obstacle in the fight against diabetic retinopathy (DR) is the use of a classification system based on old imaging techniques and insufficient data to accurately predict its evolution. New imaging techniques generate new valuable data, but we lack an adapted classification based on these data. The main objective of the Evaluation Intelligente de la Rétinopathie Diabétique, Intelligent evaluation of DR (EviRed) project is to develop and validate a system assisting the ophthalmologist in decision-making during DR follow-up by improving the prediction of its evolution.

A cohort of up to 5000 patients with diabetes will be recruited from 18 diabetology departments and 14 ophthalmology departments, in public or private hospitals in France and followed for an average of 2 years. Each year, systemic health data as well as ophthalmological data will be collected. Both eyes will be imaged by using different imaging modalities including widefield photography, optical coherence tomography (OCT) and OCT-angiography. The EviRed cohort will be divided into two groups: one group will be randomly selected in each stratum during the inclusion period to be representative of the general diabetic population. Their data will be used for validating the algorithms (validation cohort). The data for the remaining patients (training cohort) will be used to train the algorithms.

The study protocol was approved by the French South-West and Overseas Ethics Committee 4 on 28 August 2020 (CPP2020-07-060b/2020-A01725-34/20.06.16.41433). Prior to the start of the study, each patient will provide a written informed consent documenting his or her agreement to participate in the clinical trial. Results of this research will be disseminated in peer-reviewed publications and conference presentations. The database will also be available for further study or development that could benefit patients.

NCT04624737

It is important to promote resilience in preadolescence; however, there is limited research on children’s understandings and experiences of resilience. Quantitative approaches may not capture dynamic and context-specific aspects of resilience. Resilience research has historically focused on white, middle-class Western adults and adolescents, creating an evidence gap regarding diverse experiences of resilience in middle childhood which could inform interventions. East London’s Muslim community represents a diverse, growing population. Despite being disproportionately affected by deprivation and racial and cultural discrimination, this population is under-represented in resilience research. Using participatory and arts-based methods, this study aims to explore lived experiences and perceptions of resilience in black and South Asian Muslim children living in East London.

We propose a qualitative study, grounded in embodied inquiry, consisting of a participatory workshop with 6–12 children and their parents/carers to explore lived experiences and perceptions of resilience. Participants will be identified and recruited from community settings in East London. Eligible participants will be English-speaking Muslims who identify as being black or South Asian, have a child aged 8–12 years and live in East London. The workshop (approx. 3.5 hours) will take place at an Islamic community centre and will include body mapping with children and a focus group discussion with parents/carers to explore resilience perspectives and meanings. Participants will also complete a demographic survey. Workshop audio recordings will be transcribed verbatim and body maps and other paper-based activities will be photographed. Data will be analysed using systematic visuo-textual analysis which affords equal importance to visual and textual data.

The Queen Mary Ethics of Research Committee at Queen Mary University of London has approved this study (approval date: 9 October 2023; ref: QME23.0042). The researchers plan to publish the results in peer-reviewed journals and present findings at academic conferences.

Globally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services.

A non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported.

Ethics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals.

Australian New Zealand Clinical Trials Registry—ACTRN12622001010785.