International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.

Systematic review.

Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.

All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.

Search results were independently screened by at least two reviewers and data were extracted into a proforma.

38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.

International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.

osf-registrations-yvtjb-v1.

Armed conflicts and intimate partner violence (IPV) impose a burden on individual and societal well-being. Given the history of armed conflict in Afghanistan and the high prevalence of IPV, this study aims to examine the influence of armed conflicts on IPV among Afghan women.

Multilevel logistic regression models were applied to the 2015 Afghanistan Demographic and Health Survey (N=10 414 women aged 15–49). Armed conflict severity was measured using the conflict index issued by the Office for the Coordination of Humanitarian Affairs, IPV was measured by three types of violence, including emotional, physical and sexual violence. All analyses were conducted by using STATA V.15.1.

Over 52% of women experienced at least one type of IPV, with 33.01%, 49.07%, and 8.99% experiencing emotional, physical, and sexual violence, respectively. The regression results show that armed conflicts were significantly and positively associated with the experience of all types of IPV. In addition, the association between armed conflicts and the experience of emotional IPV was positively moderated by women’s attitudes towards IPV.

Our findings suggest that women living in high-conflict regions were more prone to experience IPV, particularly women with positive attitudes towards IPV. Promoting progressive gender roles, women’s empowerment, awareness of IPV and inclusion of women in conflict resolution will help deal with the issue of IPV.

Chronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.

The eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS₄) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.

The study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.

ACTRN12622000440729.

Hypothalamic hamartomas (HHs) are deep-seated congenital lesions that typically lead to pharmacoresistant epilepsy and a catastrophic encephalopathic syndrome characterised by severe neuropsychological impairment and decline in quality of life. A variety of surgical approaches and technologies are available for the treatment of HH-related pharmacoresistant epilepsy. There remains, however, a paucity of literature directly comparing their relative efficacy and safety. This protocol aims to facilitate a systematic review and meta-analysis that will characterise and compare the probability of seizure freedom and relevant postoperative complications across different surgical techniques performed for the treatment of HH-related pharmacoresistant epilepsy.

This protocol was developed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Individual Participant Data guidelines. Three major databases, PubMed, Embase and Scopus, will be systematically searched from database inception and without language restrictions for relevant articles using our predefined search strategy. Title–abstract and full text screening using inclusion and exclusion criteria created a priori will be performed by two independent reviewers to identify eligible articles. Conflicts will be resolved via discussion with a third team member. Following data extraction of both study-level and individual patient data (IPD), a study-level and IPD meta-analysis will be performed. Study-level analysis will focus on assessing the degree of heterogeneity in the data and quantifying overall seizure outcomes for each surgical technique. The IPD analysis will use multivariable regression to determine perioperative predictors of seizure freedom and complications that can guide patient and technique selection.

This work will not require ethics approval as it will be solely based on previously published and available data. The results of this review will be shared via conference presentation and submission to peer-reviewed neurosurgical journals.

CRD42022378876.

Immediate postnatal care is a critical intervention to reduce maternal and neonatal morbidity and mortality; however, many women and newborns receive inadequate postnatal care timely and effectively during the first 24 hours following childbirth. Therefore, this study aimed to assess the immediate postnatal care guidelines implementation and its associated factors among healthcare providers in the East Shewa zone public health facilities, Oromia, Ethiopia.

Facility-based cross-sectional study was conducted from 13 September 2022 to 28 October 2022.

The study was conducted in 6 hospitals and 19 health centres in the East Shewa zone.

All healthcare providers who work in the maternity ward of the East Shewa zone public health facilities were the source population while all healthcare providers who work in the maternity ward of the randomly selected East Shewa zone public health facilities were the study population. Healthcare providers who were assigned to the delivery and postnatal ward during data collection were included in the study. Healthcare providers, who are not on duty for annual, maternity, sick and study leave, were excluded from the study.

A structured self-administered questionnaire and observational checklist were used for data collection. The questionnaires were pretested and data were collected by the Kobo toolbox software. Data were analysed by using the SPSS V.25. Binary logistic regression (bivariate and multivariable) analyses were done to identify significantly associated variables, and finally, an adjusted OR (AOR) at a 95% CI was used to declare significant variables depending on a p

The study revealed that 196 healthcare providers with a response rate of 97.03% were included in this study. The overall proportion of healthcare providers who have a good implementation of immediate postnatal care guidelines was 44.4% (95% CI 37.3% to 51.6%). Providers who received basic emergency obstetrics and newborn care training (AOR 3.72, 95% CI 1.7 to 8.1), working in a tertiary-level hospital (AOR 3.85, 95% CI 1.3 to 11.2), and who had maternal and newborn care guidelines in their facility (AOR 3.2, 95% CI 1.5 to 6.6) were significantly associated factors with good implementation of immediate postnatal care guidelines.

Implementation of the immediate postnatal care guideline by healthcare providers in the maternity ward was found low as less than half of healthcare providers have good implementation. Receiving basic emergency obstetrics and newborn care training, having maternal and newborn care guidelines in their facility, and working in a tertiary-level hospital were significantly associated factors with good implementation of immediate postnatal care guidelines.

To establish a consensus on the structure and process of healthcare services for patients with concussion in England to facilitate better healthcare quality and patient outcome.

This consensus study followed the modified Delphi methodology with five phases: participant identification, item development, two rounds of voting and a meeting to finalise the consensus statements. The predefined threshold for agreement was set at ≥70%.

Specialist outpatient services.

Members of the UK Head Injury Network were invited to participate. The network consists of clinical specialists in head injury practising in emergency medicine, neurology, neuropsychology, neurosurgery, paediatric medicine, rehabilitation medicine and sports and exercise medicine in England.

A consensus statement on the structure and process of specialist outpatient care for patients with concussion in England.

55 items were voted on in the first round. 29 items were removed following the first voting round and 3 items were removed following the second voting round. Items were modified where appropriate. A final 18 statements reached consensus covering 3 main topics in specialist healthcare services for concussion; care pathway to structured follow-up, prognosis and measures of recovery, and provision of outpatient clinics.

This work presents statements on how the healthcare services for patients with concussion in England could be redesigned to meet their health needs. Future work will seek to implement these into the clinical pathway.

Global morbidity from enteric infections and diarrhoea remains high in children in low-income and middle-income countries, despite significant investment over recent decades in health systems and water and sanitation infrastructure. Other types of societal development may be required to reduce disease burden. Ecological research on the influence of household and neighbourhood societal development on pathogen transmission dynamics between humans, animals and the environment could identify more effective strategies for preventing enteric infections.

The ‘enteric pathome’—that is, the communities of viral, bacterial and parasitic pathogens transmitted from human and animal faeces through the environment is taxonomically complex in high burden settings. This integrated cohort-exposure assessment study leverages natural socioeconomic spectrums of development to study how pathome complexity is influenced by household and neighbourhood infrastructure and hygiene conditions. We are enrolling under 12-month-old children in low-income and middle-income neighbourhoods of two Kenyan cities (Nairobi and Kisumu) into a ‘short-cohort’ study involving repeat testing of child faeces for enteric pathogens. A mid-study exposure assessment documenting infrastructural, behavioural, spatial, climate, environmental and zoonotic factors characterises pathogen exposure pathways in household and neighbourhood settings. These data will be used to inform and validate statistical and agent-based models (ABM) that identify individual or combined intervention strategies for reducing multipathogen transmission between humans, animals and environment in urban Kenya.

The protocols for human subjects’ research were approved by Institutional Review Boards at the University of Iowa (ID-202004606) and AMREF Health Africa (ID-ESRC P887/2020), and a national permit was obtained from the Kenya National Commission for Science Technology and Innovation (ID# P/21/8441). The study was registered on Clinicaltrials.gov (Identifier: NCT05322655) and is in pre-results stage. Protocols for research on animals were approved by the University of Iowa Animal Care and Use Committee (ID 0042302).

In this study, we used the information generated by community members during an intervention design process to understand the features needed for a successful community participatory intervention to improve child health.

We conducted a concurrent mixed-methods study (November 2019–March 2020) to inform the design and evaluation of a community–facility linkage participatory intervention.

Kiyawa Local Government Area (Jigawa State, Nigeria)—population of 230 000 (n=425 villages).

Qualitative data included 12 community conversations with caregivers of children under-5 (men, older and younger women; n=9 per group), 3 focus group discussions (n=10) with ward development committee members and interviews with facility heads (n=3). Quantitative data comprised household surveys (n=3464) with compound heads (n=1803) and women (n=1661).

We analysed qualitative data with thematic network analysis and the surveys with linear regression—results were triangulated in the interpretation phase. Participants identified the following areas of focus: community health education; facility infrastructure, equipment and staff improvements; raising funds to make these changes. Community involvement, cooperation and empowerment were recognised as a strategy to improve child health, and the presence of intermediate bodies (development committees) was deemed important to improve communication and solve problems between community and facility members. The survey showed functional community relations’ dynamics, with high levels of internal cohesion (78%), efficacy in solving problems together (79%) and fairness of the local leaders (82%).

Combining the results from this study and critical theories on successful participation identified community-informed features for a contextually tailored community–facility link intervention. The need to promote a more inclusive approach to future child health interventions was highlighted. In addition to health education campaigns, the relationship between community and healthcare providers needs strengthening, and development committees were identified as an essential feature for successfully linking communities and facilities for child health.

ISRCTN39213655.