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.

The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.

QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.

QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.

Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.

The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.

Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.

This study aimed to determine the prevalence of non-communicable diseases (NCDs) among pregnant women in Sri Lanka and examine the association between NCDs and maternal and fetal outcomes.

A hospital-based, descriptive cross-sectional study.

The study was conducted in three tertiary care hospitals in the Western Province and one intermediate obstetrics care facility in the Southern Province of Sri Lanka, encompassing diverse, multiethnic populations, over 3 months.

Data from 1350 pregnant women were collected from discharged bed head tickets of the postnatal obstetric wards using a standardised checklist.

The primary outcomes were the prevalence of NCDs. Secondary outcomes included associations between maternal NCDs and adverse fetal outcomes such as preterm births and neonatal complications.

Among the participants, 68.5% (n=926) had one or more NCDs, with anaemia (37.9%), obesity (18.1%), gestational diabetes mellitus (14.9%) and hypertensive disorders (13.6%) being the most prevalent. Women with NCDs were at significantly higher odds of adverse fetal outcomes, including preterm birth (OR=2.3, 95% CI: 1.5 to 3.4), neonatal sepsis (OR=2.5, 95% CI: 1.5 to 4.04) and hypoglycaemia (OR=3.5, 95% CI: 1.2 to 10.0). Maternal complications, including postpartum haemorrhage (3.3%) and placental abruption (0.7%), were also more frequent in this group.

NCDs are highly prevalent among pregnant women in Sri Lanka and are significantly associated with adverse maternal and fetal outcomes. Enhanced screening and management strategies during antenatal care are essential to mitigate risks and improve health outcomes, aligning with global efforts to reduce maternal and neonatal morbidity and mortality.

This study addresses the limited evidence of the impact of product characteristics on demand for and the substitutability of electronic cigarettes (e-cigarettes) or heated tobacco products for combusted cigarettes among people who smoke and have newly begun to use e-cigarettes.

A sample of 318 adults who smoke and recently initiated/reinitiated e-cigarette use participated in an online volumetric choice experiment in 2020–2021 to assess stated preferences for consumption and own and cross-price elasticities of three e-cigarette options (cig-a-like, vape pen or tank, closed pod system), heated tobacco product (IQOS) and their usual brand of cigarettes. Product attributes manipulated were price, flavour, level of harm, how well the product reduces cravings to smoke, and how discretely the product can be used. Multilevel zero-inflated negative binomial models were used to model the purchased quantities.

Cigarettes were preferred over all alternatives. However, demand for cig-a-likes, but not IQOS, increased when cigarette prices were higher. Higher prices for e-cigarettes and IQOS did not increase demand for cigarettes. The odds of buying e-cigarettes/IQOS were higher when their harm was stated as low or unknown versus being similar to cigarettes (ie, very high). Other attributes (including various flavour options) were not significantly associated with demand for e-cigarettes or IQOS.

People who smoke and recently began using e-cigarettes might substitute cig-a-likes for cigarettes when cigarette prices are higher. Policies to increase the cost of combusted cigarettes as well as communicate lower relative harm and low absolute harm of e-cigarettes may facilitate switching behaviour.

Histopathological evaluation of prostate biopsies using the Gleason scoring system is critical for prostate cancer diagnosis and treatment selection. However, grading variability among pathologists can lead to inconsistent assessments, risking inappropriate treatment. Similar challenges complicate the assessment of other prognostic features like cribriform cancer morphology and perineural invasion. Many pathology departments are also facing an increasingly unsustainable workload due to rising prostate cancer incidence and a decreasing pathologist workforce coinciding with increasing requirements for more complex assessments and reporting. Digital pathology and artificial intelligence (AI) algorithms for analysing whole slide images show promise in improving the accuracy and efficiency of histopathological assessments. Studies have demonstrated AI’s capability to diagnose and grade prostate cancer comparably to expert pathologists. However, external validations on diverse data sets have been limited and often show reduced performance. Historically, there have been no well-established guidelines for AI study designs and validation methods. Diagnostic assessments of AI systems often lack preregistered protocols and rigorous external cohort sampling, essential for reliable evidence of their safety and accuracy.

This study protocol covers the retrospective validation of an AI system for prostate biopsy assessment. The primary objective of the study is to develop a high-performing and robust AI model for diagnosis and Gleason scoring of prostate cancer in core needle biopsies, and at scale evaluate whether it can generalise to fully external data from independent patients, pathology laboratories and digitalisation platforms. The secondary objectives cover AI performance in estimating cancer extent and detecting cribriform prostate cancer and perineural invasion. This protocol outlines the steps for data collection, predefined partitioning of data cohorts for AI model training and validation, model development and predetermined statistical analyses, ensuring systematic development and comprehensive validation of the system. The protocol adheres to Transparent Reporting of a multivariable prediction model of Individual Prognosis Or Diagnosis+AI (TRIPOD+AI), Protocol Items for External Cohort Evaluation of a Deep Learning System in Cancer Diagnostics (PIECES), Checklist for AI in Medical Imaging (CLAIM) and other relevant best practices.

Data collection and usage were approved by the respective ethical review boards of each participating clinical laboratory, and centralised anonymised data handling was approved by the Swedish Ethical Review Authority. The study will be conducted in agreement with the Helsinki Declaration. The findings will be disseminated in peer-reviewed publications (open access).

Caesarean birth (CB) under neuraxial anaesthesia (NA) is the most performed inpatient operation in the UK. The incidence of intraoperative pain during caesarean delivery performed under neuraxial anaesthesia is unclear, with limited data that used patient-reported measures to investigate intraoperative pain. The short- and medium-term impacts on patients of this adverse event are unknown.

We will undertake a multicentre, prospective observational cohort study to evaluate the incidence and impact of pain experienced by patients during CB performed under neuraxial anaesthesia. Routine audit data will be collected for all patients undergoing caesarean delivery for any indication during a 1 week window at participating hospitals within the UK and Queensland, Australia. The dataset will include patient, anaesthetic, obstetric and neonatal risk factors for intraoperative pain. Local investigators will then seek informed consent from patients either before or within 24 hours of delivery to record patient experience and patient-reported outcomes at 24 hours and 6 weeks postdelivery. Local investigators at participating hospitals will also complete a survey evaluating compliance with evidence-based structural standards at their sites. The patient characteristics, structures, processes and outcomes will be described. Inferential techniques will be used to evaluate the relationship between risk factors and postoperative outcomes.

This study received ethical approval from the Leicester Health Research Authority and Care Research Wales, REC reference 24/EM/0084) on 24 May 24. The study received ethical approval from the Human Research Ethics Committee of Metro North Health in Australia on 25 March 2024 (REC Ref HREC/2024/MNHA/103767). The results of the study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. The results will be disseminated via conference presentations, peer-reviewed academic journals and reports prepared for patients, the public and policy makers.

ISRCTN15269213.

Transition of care from hospital is a period when the risks of medication errors and adverse events are high, with 50% of adults discharged having at least one medication-related problem. Pharmacist-led medication reviews can reduce medication errors and unplanned readmission when completed promptly post-discharge; however, they are underutilised. A Transition of Care Stewardship pharmacist has been proposed to facilitate and coordinate a patient’s discharge process and facilitate a timely post-discharge medication review. Access to pharmacist medication review in rural and regional areas can be limited. This protocol describes a randomised controlled trial (RCT) to determine whether a virtual Transition of Care Stewardship pharmacist reduces medication-related harm in rural and regional Australia.

Multicentre RCT involving patients at high risk of medication-related harm discharged from regional and rural hospitals to a domiciliary residence. Eligible patients must be aged≥18 years, admitted under a medical specialty, be discharged to a domiciliary setting, have a regular general practitioner (GP) or be willing to visit a GP or an Aboriginal Medical Service after discharge for medical follow-up, have a Medicare card and be at high risk of readmission. High risk of readmission is defined as either a previous admission to the hospital or Emergency Department (ED) presentation in the past 6 months AND≥three regular medications OR on at least ONE high-risk medication. A total of 922 participants will be recruited into the study. Enrolled participants will be randomised to the intervention or control (usual care). The intervention will include a virtual Transition Of Care Stewardship pharmacist to ensure that patients receive discharge medication reconciliation, medication counselling, medication list and communicate directly with primary care providers to facilitate a timely post-discharge medication review. Usual care will include informing the patient’s clinical inpatient treating team that the patient is at high risk of medication misadventure and may benefit from a post-discharge Home Medicines Review (a GP-referred pharmacist medication review funded by the Australian Government).

Data analysis will be performed on a modified intent-to-treat basis. The primary outcome assessed is a composite of a first unplanned medication-related hospitalisation or ED presentation within 30 days of hospital discharge. Comparisons between the intervention and usual care groups for the primary outcome will be made using a mixed-effects logistic regression model, adjusting for site-level clustering as a random effect.

This study is approved to be conducted at the Western New South Wales Local Health District via the Research Ethics and Governance Information System (approval number: 2023/ETH00978). To ensure the needs of Aboriginal and Torres Strait Islander patients are appropriately addressed, ethics for this study were submitted and approved by the Aboriginal Health and Medical Research Council (approval number: 2148/23). Manuscripts resulting from this trial will be submitted to peer-reviewed journals. Results may also be disseminated at scientific conferences and meetings with key stakeholders.

ACTRN12623000727640.

A substantial portion of the 3.6 million births per year in the USA (approximately 25%–30%) occur in the context of adverse pregnancy outcomes (APOs), including preterm birth (PTB), hypertensive disorders of pregnancy (HDP) and small-for-gestational-age (SGA) birth. Black individuals have a 2–3-fold higher risk of APOs and a similarly increased risk of maternal morbidity and mortality compared with White individuals. Adverse social determinants of health (SDoH) are at the root of this disparity and contribute to it through multiple mechanisms. Maternal anaemia is an upstream factor associated with severe maternal morbidity, maternal mortality and other APOs and is also associated with adverse SDoH. Effectively and efficiently addressing social needs arising from adverse SDoH in the obstetric setting can be difficult due to varying patient preferences, resource accessibility and clinic workflows. The Better Birth Outcomes Through Technology, Education and Reporting (BETTER) intervention attempts to account for these barriers by encouraging patients to address social needs through motivational interviewing and by sending recurring text messages that provide links to multiple kinds of social service resources.

We will use a two-arm randomised controlled trial to evaluate the effects of providing patients with a motivational interviewing session and text messages with links to multiple resources to address their social needs compared with patients receiving usual care. We will recruit 550 pregnant individuals less than 21 weeks of gestation from two university prenatal clinics that primarily serve Medicaid-covered individuals in an urban city in the Midwestern USA. We will assess whether the intervention reduces the primary outcome of maternal anaemia measured as haemoglobin

The Ohio State University (OSU) Institutional Review Board (IRB) approved this study (IRB: 2023H0065; date: 21 February 2024). All protocol amendments will be communicated for approval to the OSU IRB. We plan to share results in peer-reviewed journal articles and academic conferences as well as with the larger American Heart Association (AHA) Pregnancy, Postpartum and Postnatal Health: Enhancing Quality and Access to Achieve Equitable Maternal and Infant Health (P3 EQUATE) Network on maternal health, including clinicians, community members and social service providers. Following the trial, we will make deidentified data publicly available in compliance with AHA policy and federal regulations.

NCT06261398.

Targeted oxygenation protocols in mechanically ventilated patients are critical in avoiding the deleterious effects of hypoxaemia and hyperoxaemia. Peripheral oxygen saturation (SpO2) is a practical metric that commonly drives oxygen titration protocols and guidelines but has inaccuracies attributable to patient variability that can lead to occult hypoxaemia. Conversely, arterial oxygen saturation (SaO2) offers accuracy but is costly and invasive. We aim to develop a novel approach to targeted oxygenation that collectively uses the accuracy of SaO2 and the feasibility of SpO2 to mitigate occult hypoxaemia and prevent hyperoxaemia.

The Optimization of Inspired Oxygen during Mechanical Ventilation trial is a pragmatic stepped wedge, open label, cluster-randomised controlled trial of an algorithm-based SpO2-SaO2 electronic alert-based oxygen titration protocol. The intervention arm includes targeted oxygenation via an electronic SpO2-SaO2 driven alert protocol. The control group will be subjected to oxygen titration according to standard practice. Within the intervention arm, patients will be assigned to groups with different SpO2 targets based on the degree of SpO2-SaO2 difference. In the ‘Conserve O2’ group, where SpO2SaO2 by 1–2%, electronic alerts will be used to titrate FiO2 to a target SpO2 of 90–94%. In the ‘Boosted O2’ group, where SpO2>SaO2 by 3–5%, electronic alerts will be used to titrate FiO2 to a target SpO2 of 93–97%. Patients with an SpO2-SaO2 difference >5% in either direction will be monitored but not assigned to either group. The sample size to determine efficacy is 1620 subjects, randomised over 60 weeks. The primary outcome is the proportion of time during mechanical ventilation spent within the target range, SpO2 of 90–94% (Conserve O2) or SpO2 of 93–97% (Boosted O2) at any FiO2. Secondary outcomes include the proportion of time with SpO2 >94% or SpO2 >97% with FiO2 ≤0.4 within each respective algorithm, the proportion of time with SpO2

The protocol was approved by The Ohio State University Institutional Review Board (Protocol # 2023H0016) and is registered at ClinicalTrials.gov (NCT 05923853). Progress and safety of the trial are monitored by an independent Data and Safety Monitoring Board. Study results will be published in peer-reviewed medical journals. This study is being carried out with a waiver of consent as participation in the study presents no more than minimal incremental risk compared with routine clinical care for mechanically ventilated critically ill adults outside of the study.

NCT05923853.

All those born with functioning ovaries will eventually experience menopause, and many will be symptomatic. However, significant gaps in the evidence base for menopause care remain. This National Institute for Health and Care Research James Lind Alliance Menopause Priority Setting Partnership (MAPS) will engage with clinicians and those with lived experience globally to determine the leading priorities for future menopause research.

MAPS will follow the established James Lind Alliance methodology which has already resulted in over 100 ‘top 10’ research priorities across health domains. It will be led by a steering group comprised of clinicians and lived experience members. Leveraging the networks of steering group members and partner organisations, the priority setting partnership will identify evidence uncertainties using an online survey. Evidence checking will be undertaken to determine which questions have already been answered. Prioritisation will be done in two stages, initially by online survey and then at a face-to-face workshop.

Ethical approval was not required. The final top 10 priorities for menopause, as ranked by stakeholders at the final consensus workshop, will be disseminated in the relevant peer-reviewed journals. A final report will be available on the MAPS and James Lind Alliance websites. The leading priorities will inform the future global research agenda for menopause.

To assess the effectiveness of random capillary blood glucose as a diagnostic tool for type 2 diabetes and determine optimal cut-off values for adults in Bangladesh.

Cross-sectional diagnostic accuracy study.

16 diabetes centres were selected randomly from all eight administrative divisions of Bangladesh.

A total of 3200 adults aged 18 years and older were recruited using systematic random sampling between May and September 2022.

The primary outcome was the diagnostic accuracy of random capillary blood glucose compared to fasting plasma glucose, 2-hour plasma glucose after a 75-gram glucose load and glycated haemoglobin. Secondary outcomes included sensitivity, specificity, area under the curve and agreement with the other diagnostic tests.

Random capillary blood glucose showed a strong positive correlation and high concordance with fasting plasma glucose, 2-hour plasma glucose and glycated haemoglobin. A cut-off value of ≥8.7 mmol/L demonstrated improved diagnostic performance compared with the currently used cut-off of ≥11.1 mmol/L. This new threshold yielded higher sensitivity, specificity, area under the curve and agreement with other standard diagnostic tests. Notably, hyperglycaemic symptoms were not required for diagnosis. The number needed to screen to identify one case of type 2 diabetes using the ≥8.7 mmol/L cut-off was 2.74, lower than that for fasting plasma glucose (2.86) and random capillary blood glucose ≥11.1 mmol/L (4.68).

Random capillary blood glucose may be an effective and affordable diagnostic tool for type 2 diabetes in resource-limited settings. The proposed cut-off of ≥8.7 mmol/L offers improved diagnostic accuracy and reflects the population’s glucose distribution pattern.

The COVID-19 pandemic has had a significant impact on medical education, with many institutions shifting to online learning to ensure the safety of students and staff. However, there appears to be a decline in in-person attendance at medical schools across the UK and worldwide following the relaxation of social distancing rules and the reinstatement of in-person teaching. Importantly, this trend was also observed before the pandemic. While reflected within the literature, there is currently no systematic review describing these changes. We aim to find out how medical students’ attendance is changing as documented within the literature and its impact on their educational outcomes.

This systematic review followed the guidelines of the Centre of Research and Dissemination, Moose and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We searched the major databases of Medline via Ovid, Embase via Ovid, Scopus, Web of Science, British Education Index via EBSCOhost and ERIC via EBSCOhost in September 2023. Two reviewers independently screened each paper and extracted the data, with a third reviewer for dispute resolution. All studies reporting on medical students from various universities, both graduate and undergraduate, and describing changes in attendance and/or students’ educational outcomes were included. Risk of bias in individual studies was assessed using the Agency for Healthcare Research and Quality tool. A narrative synthesis of the findings from all included studies was done.

12 papers were included in the analysis. Primary aim: Of the eight papers that measured attendance data over more than one academic year, only one paper demonstrated a statistically significant decrease while one paper demonstrated a statistically significant increase in attendance over the observational period. Other papers either did not perform statistical tests or did not demonstrate statistical significance. Secondary aims: Most papers showed a general positive correlation between attendance and educational outcomes. No studies explicitly explored reasons for changes in attendance seen. Only one paper outlined a possible strategy to address changes in attendance, a mandatory attendance policy, which has mixed outcomes.

Despite widespread anecdotally reported attendance decline post-COVID-19, overall, there was no consistent change in attendance noted. However, there was a large heterogeneity in the studies included. Further research is required to elucidate trends in attendance and its impact on medical education.

The benefits of physical activity (PA) are compelling for all ages and abilities. For children with cerebral palsy (CP), two distinct health behaviours, being physically active and reducing sedentary time, are critical to target as an early intervention to reduce long-term morbidity. One approach may be to increase PA participation by empowering parents who are key to making family lifestyle changes. This study will compare Active Start Active Future, a participation-focused intervention, to usual care in a mixed-methods randomised waitlist-controlled trial.

A total of 40 children with CP (3–7 years), classified in Gross Motor Function Classification System (GMFCS) levels II–V, will be stratified (GMFCS II vs III, IV vs V) and randomised to receive either (1) Active Start Active Future, an 8-week intervention for 1 hour per week in any setting or (2) usual care followed by delayed intervention. Active Start Active Future aims to increase PA and reduce sedentary behaviour of young children with CP by providing participatory opportunities to promote PA behaviour change. Outcomes will be measured at baseline (T1), immediately postintervention at 8 weeks (T2) and at 26 weeks postbaseline (T3). The primary outcomes are the Canadian Occupational Performance Measure for both child and parent participation goals and child physical performance goal. Secondary outcomes include daily time spent in moderate to vigorous PA and sedentary time, gross motor function, quality of life, barriers to participation for the children and parents’ PA and sedentary time. Intervention acceptability and experiences of PA participation will be explored using a qualitative descriptive approach.

The Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/23/QCHQ/100850) and The University of Queensland Human Research Ethics Committee (2024/HE000054) have approved this study. The results of the study will be disseminated to families and community agencies as guided by our advisory group and as conference abstracts and presentations, peer-reviewed articles in scientific journals and institution newsletters and media releases.

ACTRN12624000042549, Universal Trial Number: U1111-1300-7421; Australian New Zealand Clinical Trials Registry.

The enteric microbiota drives inflammation in Crohn’s disease. Yet, there are no placebo controlled trials evaluating the efficacy and safety of faecal microbiota transplantation (FMT) in inducing and maintaining remission in patients with active Crohn’s disease. The Microbial Restoration (MIRO) study aims to establish this evidence.

At two specialist inflammatory bowel disease centres, 120 enrolled patients will have a 3-week period of diet optimisation (removal of ultra-processed foods) together with a 7-day course of antibiotics (to facilitate subsequent FMT engraftment). Patients will then be stratified to upper gut (for disease proximal to the splenic flexure) or lower gut (distal to the splenic flexure) disease. Patients will then be randomised in a 2:1 ratio to receive anaerobically prepared stool or placebo for 8 weeks either by gastroscopy, or colonoscopy and enemas. Clinical response at 8 weeks (Crohn’s Disease Activity Index (CDAI) reduction ≥100 points or to 70) receive FMT for weeks 8–16.

Patients achieving clinical response from FMT after 8 or 16 weeks will be randomised in a 1:1 ratio to either a 44-week maintenance phase of FMT or placebo. Patients will receive FMT from one donor throughout the study.

The MIRO study will establish whether FMT is an effective and safe therapy to induce and maintain remission in patients with active Crohn’s disease.

Ethical approval has been received by the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC-A 084/21). The results will be disseminated in peer-reviewed journals and presented at international conferences.

ClinicalTrials.gov: NCT04970446; Registered on 20 July 2021.

Unintended pregnancies pose significant public health challenges globally, particularly in the Middle East and North Africa (MENA) region, where cultural, religious and societal factors play the most substantial role. This systematic review and meta-analysis investigated the pooled prevalence and factors associated with unintended pregnancies in the MENA region.

We conducted a systematic review to identify relevant studies in Medical Literature Analysis and Retriaval System (MEDLINE), Embase and Scopus published on unintended pregnancies until July 2024. We included studies that were conducted on unintended pregnancy prevalence within MENA countries and employed suitable measurement tools. We analysed data from 40 studies involving 34 837 participants across the region, including Egypt, Iran, Saudi Arabia and Qatar. We used a random-effects model to estimate the pooled prevalence of unintended pregnancy.

In this meta-analysis, we found that the overall prevalence of unintended pregnancy was 27.0% (95% CI 25.0% to 30.0%) in the MENA region, and the certainty of the evidence was moderate. Saudi Arabia had the highest prevalence of unintended pregnancy at 32.0% (95% CI 27.0% to 38.0%). A lower prevalence, 10.0% (95% CI 8.0% to 14.0%), was found in the studies that used validated tools compared with non-validated tools to measure unintended pregnancy. Between 2006 and 2010, the prevalence was 34.0% (95% CI 28.0% to 40.0%), the highest compared to other time periods . Age, rural areas, education, employment, economic status, parity, gravidity, history of miscarriage, previous pregnancies or abortion, non-use or failure of contraception methods, limited antenatal care, were associated with unintended pregnancies.

Our findings suggest that the MENA region faces a substantial burden of unintended pregnancies, with variations among countries and over time. The results emphasise the need for evidence-based interventions to address this issue, focusing on factors associated with unintended pregnancy.