To explore how well the primary care system in Scotland works for adults with intellectual disabilities (ID), using the rate of unplanned hospital admissions for ambulatory care sensitive conditions (ACSC) as a proxy indicator. As part of this, to investigate those rates and rate ratios among adults with ID and without ID, adjusting for the prevalence of a given ACSC in each population. The secondary aim was to explore deaths due to ACSC among the ID and no-ID populations.

A population-based retrospective cohort data linkage study of adult respondents to Scotland’s 2011 Census. Self-reported or proxy-reported ID status from the Census was linked to hospital admissions data and deaths data. The cohort was followed until the end of 2019. The prevalence of ACSCs in each population was calculated from aggregate-level data published by the National Health Service, as it was not possible to use the linked dataset for this purpose.

Whole population of Scotland.

People aged 18+ on census day (27 March 2011), including all adults with ID (n=16 840) and a 15% randomly selected comparator sample of adults without ID (n=566 074).

Crude and age-sex standardised incidence rates and ratios; cumulative incidence; prevalence ratios. The exposure was ID status, and the outcomes were (1) unplanned ACSC hospital admission, (2) death with an ACSC condition listed as the main cause on the death certificate and (3) death with an ACSC condition listed as one of the causes on the death certificate.

Adults with ID under the age of 55 had only a slightly higher risk of an unplanned ACSC hospitalisation than their general population counterparts (standardised incidence ratio 1.11; 95% CI 1.03 to 1.20). After adjusting for different ACSC prevalence in ID and non-ID cohorts, this difference in risk disappeared. These findings contrast with existing evidence from England, where a much higher unadjusted risk of unplanned ACSC hospitalisations was found among people with ID. Adults with ID had a higher risk of dying due to ACSC than adults without ID (standardised mortality ratio 2.54; 95% CI 2.19 to 2.95).

Our findings on unplanned ACSC hospitalisations suggest that the primary care system in Scotland appears to be similarly effective for adults with ID than for adults without ID. However, the higher risk of dying from ACSC among people with ID suggests that this system is less effective for people with ID. Future research should investigate this tension and aim to understand why the operation of the primary healthcare system seems to be worse with regards to ACSC mortality than with regards to unplanned ACSC hospitalisations.

Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, ³Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

Artificial intelligence (AI) is rapidly evolving, offering an expanding suite of capabilities that go beyond the traditional focus on prediction and classification. Generative AI (GenAI) and agentic AI could create transformative practices to support real-world evidence (RWE) generation for health research by streamlining studies, accelerating insights and improving decision-making. However, there is no published overview available describing the range of applications in RWE generation. This review aims to describe where and how genAI and agentic AI are applied across the domains of healthcare research tasks for RWE generation. Additionally, to map applications by tasks and methods across the product lifecycle continuum, and to identify emerging gaps and opportunities.

This Living Scoping Review (LSR) will include studies reporting an application and/or evaluation of genAI or agentic AI applied to one or more RWE generation research tasks. Searches will be conducted in Embase, MEDLINE and additional sources (eg, grey literature). Citations will be independently screened by two human senior reviewers for a substantive training dataset and a commercially available screening algorithm (Robot Screener) will complete screening with a human reviewer. The LSR will include reports of studies (primary or reviews) describing and/or evaluating the application of any genAI model for RWE generation in healthcare, in English, published from 1 January 2025 to the date of search. Data will be extracted from all studies included in the LSR by one independent senior reviewer using a piloted template, with 10% quality check by a second senior reviewer. Descriptive statistics will be used to summarise the applications of genAI per RWE research task, and the results of genAI evaluations. Thematic analysis will be used to describe genAI application patterns, trends, gaps and opportunities. The LSR protocol and reports will be updated annually, and findings will be published on a publicly available website (eg, ISPE—the International Society for Pharmacoepidemiology).

Ethical approval is not required due to use of previously published data. Planned dissemination includes peer-reviewed publication, presentation and short summaries.

Human papillomavirus (HPV) is one of the most common sexually transmitted diseases and affects the quality of life (QoL) of individuals, necessitating interventions beyond physical treatments. The aim of this study is to determine the effectiveness of individual supportive counselling on the QoL in women with high-risk HPV.

This randomised clinical trial will include 80 women with HPV who will be selected from 2025 to 2026 in Babol, Iran. Following selection based on inclusion criteria, samples will be randomly allocated to intervention and control groups. Then, they will complete demographic–social questionnaires, QoL in HPV patients and general health questionnaires. Individuals in the intervention group will receive 4 weekly online supportive counselling sessions in addition to routine care. The control group will receive routine care. Both groups will complete the questionnaires again at 6 weeks and 4 months postbaseline. Data will be analysed using SPSS V.26 software and statistical tests including ², t-test and repeated measures analysis of variance, and regression models if necessary. A significance level of 5% will be used for the tests.

This study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.082). The trial will adhere to the ethical principles of the Declaration of Helsinki. Findings will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.

IRCT20180218038783N11, 14 September 2025.

This pilot study aimed to estimate the prevalence of frailty, prefrailty and multimorbidity among adults aged 40–69 in Montenegro and to assess the feasibility of measuring these conditions in primary care to inform the design of a future large-scale study. We also aimed to examine differences in frailty scores and chronic disease burden across age subgroups, describe the profiles of prefrail/frail versus robust individuals and contextualise the findings within a broader public health framework.

Cross-sectional pilot study.

Primary healthcare centre, Podgorica, Montenegro.

A total of 165 adults aged 40–69 were recruited during routine follow-up visits for chronic conditions or preventive check-ups with their primary care physicians. Patients with acute conditions or injuries were excluded.

Primary outcomes were the prevalence of frailty and prefrailty (based on an adapted Fried frailty phenotype) and multimorbidity (defined as ≥2 coexisting chronic conditions). Secondary outcomes included comparisons of frailty scores and the number of chronic conditions across age subgroups (40–54, 55–64, 65–69), as well as sociodemographic and clinical differences between prefrail/frail and robust participants. Historic national mortality and healthcare utilisation trends since 2012 were also analysed.

Frailty and prefrailty prevalence was 6.1% (95% CI 2.9% to 10.8%) and 46.7% (95% CI 38.8% to 54.5%), respectively, while multimorbidity affected 23% of participants (95% CI 16.8% to 30.2%). The number of chronic diseases and frailty score increased significantly across age groups (p

This pilot study demonstrates that assessing frailty, prefrailty and multimorbidity in primary care settings in Montenegro is feasible and provides essential insights for designing a future large-scale study. Our preliminary evidence revealed a considerable proportion of prefrail individuals and a smaller proportion of frail individuals, as well as a notable burden of multimorbidity among adults aged 40–69 in Montenegro, particularly among those aged ≥55. This group could benefit from more timely preventive interventions at the primary care level, early detection of prefrailty, frailty and multimorbidity, which would ultimately enhance the resilience of the national healthcare system.

Increasing reports of life-threatening complications in young children exposed to skin-lightening products present a significant public health concern, yet this issue remains under-researched.

To determine the prevalence, maternal perceptions and predictors of early childhood exposure to skin-lightening products among mothers in Southwestern Nigeria.

A cross-sectional, questionnaire-based study.

Three randomly selected government-owned primary healthcare facilities in Ile-Ife, Nigeria.

Three hundred and sixty-nine mothers aged ≥18 years, each with at least one child under 5, recruited by simple random sampling. Data were collected between May and July 2024 using pretested, interviewer–administer semistructured questionnaires. Mothers with acutely ill children were excluded.

Primary outcome was the use of skin lightening products on children while secondary outcomes included maternal use, perceptions and sociodemographic/familial predictors.

Participants’ ages ranged from 18 to 54 years (mean: 30.92±6.11 years). Overall, 19.5% (n=72) mothers practised early childhood skin lightening, with 80.6% of exposed children

This study highlights a high prevalence of early childhood exposure to lightening products in a semiurban Nigerian community, with maternal use emerging as a key associated factor. Although awareness of potential health risks was common, aesthetic preferences for lighter skin tones appeared to outweigh safety concerns. These findings highlight the need for culturally sensitive interventions and further research to inform strategies that promote safer childhood skin-care practices.

Barcode medication administration (BCMA) systems are increasingly being implemented in hospital settings, with the aim of decreasing medication administration errors. However, the majority of the literature demonstrating the value of BCMA in supporting patient safety is from the USA. Furthermore, little is known about the underlying mechanisms that support its use. This study aims to explore the impact of BCMA on patient safety including medication admisntration errors and nursing time spent providing direct patient care, in terms of what works, for whom, under what circumstances, and how.

We will use a mixed-methods realist evaluation. The study will be conducted in four phases, at two London NHS teaching trusts and one South West Region NHS Trust using different electronic health record systems. Phase 1 will involve documentary analysis and a narrative review to develop an initial programme theory for how BCMA is expected to work. Phase 2 will use interviews with key informants to refine this programme theory. The programme theory will then be tested in phase 3 using mixed methods: (1) observation of nurses’ medication administration; (2) analysis of alert data from the BCMA systems to understand the alerts’ clinical significance and utility and (3) interviews with nurses and hospital inpatients to explore their views. These data will be triangulated to refine and finalise the programme theory in phase 4, together with recommendations for practice.

The Study Coordination Centre has obtained approval (24/SC/0326) from the Oxford B NHS Research Ethics Committee and the Health Research Authority. The study’s findings will be presented at scientific meetings and published in peer-reviewed journals. Additionally, summaries of the findings will be produced, targeted at relevant groups such as healthcare professionals, policy-makers and study participants.

Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.

Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).

Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.

NCT05131685.

There is an urgent need to better understand how information from circulating tumour DNA (ctDNA) can be integrated into routine care for patients with advanced solid cancer.

The implementation of liquid biopsies in routine care of patients with advanced solid cancer trial (LIQPLAT) is a single-centre, single-arm trial investigating the implementation of ctDNA in the routine care of patients with advanced solid cancer. We present a mixed-methods process evaluation embedded in the LIQPLAT trial, following Medical Research Council guidance and the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. We show a logic model, which details the causal chain and related assumptions from recruiting patients into the trial to the goal of improving quality of life and survival. Data collection is longitudinal and includes: semistructured interviews with healthcare professionals (pathologists, biologists, oncologists; planned n=20) and patients (planned n=15) to identify implementation barriers and facilitators; recordings of molecular tumour board meetings to analyse clinical decision-making; the 23-item Normalisation MeAsure Development survey for healthcare professionals (planned n=20) at four time points. Quantitative data from hospital records will be used to assess implementation outcomes like patient acceptance rates and ctDNA workflow success. Qualitative data will undergo thematic and content analysis, and quantitative data will be analysed using a Bayesian framework.

The LIQPLAT trial was approved by the regional ethics committee of Northwestern and Central Switzerland (BASEC 2024-00358). The qualitative aspects of the process evaluation were exempted from ethics review according to the Swiss Human Research Act. We follow guidelines for data security, confidentiality and information governance. Results will be submitted for publication in peer-reviewed journals and discussed at conferences.

NCT06367751, SNCTP000005844.

Major depressive disorder (MDD) is a disabling disease and is recognised as a serious, public health concern. In this study, we aimed to determine the burden and trends of MDD in Iran.

Secondary data from the Global Burden of Disease study were used to analyse the time trend and geographical distribution of age-standardised rate incidence and disability-adjusted life years (DALYs) of MDD from 1990 to 2021 by sex and province, in Iran. Join point regression and ArcGIS software were used for these estimations.

Incidence and DALYs.

The trend analysis from 1990 to 2021 generally showed an increasing trend of incidence and DALYs. The highest annual percent change (APC) for incidence (6.594 95% UI: 3.727, 9.473) and DALYs (6.396 95% UI: 3.552, 9.286) of MDD in Iran was observed from 2019 to 2021 segment. Also, the geographical distribution analysis showed that the highest average annual percent change (AAPC) for incidence and DALYs of MDD in both sexes was, respectively, in Kurdistan province (0.774; [95% UI: 0.619, 0.976] and Yazd province (0.760; [95% UI: 0.601, 0.918]). Finally, the highest incidence and DALYs for MDD in 2021 were in Kerman and Fars provinces and the lowest in East Azarbayejan, Lorestan, Hamedan, Chahar Mahal and Bakhtiari, Golestan and Khorasan-e-Razavi provinces.

The findings of this study indicate an increasing trend in the burden of MDD in Iran and show the necessity of creating national policies and preventive and therapeutic measures for mental health disorders in the population.

With the growing older population, ensuring effective, accessible nutritional support within primary care as a first line of medical care is becoming increasingly important. Nutritional counselling is a promising approach to enhancing health outcomes and independence among older adults. However, a stronger evidence base is needed to assess its true effect and inform clinical decisions. Additionally, food insecurity remains an under-recognised issue in this population and is often overlooked in primary care settings. This highlights the need for simple, practical methods to identify those at risk. This study aimed to assess the effectiveness of nutritional intervention provided to older people and determine which nutrients may indicate food insecurity in primary care settings in Tehran.

The study will be conducted in two phases. The first phase is a prospective cohort study (single cohort). The second phase is a cross-sectional study on older people who refer to primary care settings affiliated with the Tehran University of Medical Sciences. In the first phase, the effectiveness of nutritional interventions – including counselling and diet – is evaluated based on anthropometric indicators (weight, waist circumference, calf circumference, arm circumference and waist-to-height ratio), blood pressure and scores from the Mini Nutritional Assessment, health-related quality of life, dietary intake and physical activity. Assessments will be evaluated prospectively at the beginning of the study, after 3 months, and at the end of the study. In the second phase of the cross-sectional study, by examining dietary intake and food insecurity, we will identify the specific nutrient or food group that serves as an indicator of food insecurity in the diet of older individuals. Intakes below 50% and 75% of the recommended daily allowance will be analysed. Through sensitivity and specificity analysis, we will identify which nutrient or food group is strongly associated with food insecurity in older people.

This study received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1402.474). Study findings will be disseminated through peer-reviewed journal articles, presentations at national and international conferences and meetings with the Iranian Ministry of Health, facility and community stakeholders.

69772

This study aims to develop a methodology to retrieve, harmonise and evaluate the completeness of national body mass index (BMI) data from linked electronic health record (EHR) sources to build a longitudinal research-ready data asset (RRDA).

A longitudinal study of BMI records spanning 23 years (1 January 2000 to 31 December 2022) from four data sources.

The national BMI RRDA is created within the Secure Anonymised Information Linkage (Databank), encompassing the entire population of Wales, UK.

We built a methodology that provides a reproducible framework for extracting and harmonising BMI data from four major linked EHRs across two age groups: children and young people (CYP; 2–18 years old) and adults (19 years and older). The methodology is adaptable across different trusted research environments. We evaluated the completeness and retention of records over 1-, 5- and 23-year periods by calculating the proportion of missing data relative to each year’s population.

We retrieved 53.4 million records for 3.2 million individuals across Wales from 1st January 2000 to 31 December 2022. Among these, 3% of CYP and 34% of adults had repeat BMI measurements recorded over periods ranging from 5 to 23 years. Throughout the entire population of Wales during this period, 49% of CYP and 26% of adults had at least one BMI reading recorded, resulting in a missingness rate of 51% for CYP and 74% for adults. Preserving BMI information by retaining the most recently recorded BMI over 1-, 5- and 23-year intervals from 2022 showed coverage rates of 10%, 33% and 68%, respectively, for CYP, and 25%, 51% and 73%, respectively, for adults.

Our findings highlight substantial variations in BMI data availability and retention across CYP and adults, as well as time periods within EHR in Wales. Wider adoption of this approach can enhance standardised approaches in using accessible measures like BMI to assess disease risk in population-based studies, strengthening public health initiatives and research efforts.

Severe mental disorders are associated with increased risk of metabolic dysfunction. Identifying those subgroups at higher risk may help to inform more effective early intervention. The objective of this study was to compare metabolic profiles across three proposed pathophysiological subtypes of common mood disorders (‘hyperarousal-anxious depression’, ‘circadian-bipolar spectrum’ and ‘neurodevelopmental-psychosis’).

751 young people (aged 16–25 years; mean age 19.67±2.69) were recruited from early intervention mental health services between 2004 and 2024 and assigned to two mood disorder subgroups (hyperarousal-anxious depression (n=656) and circadian-bipolar spectrum (n=95)). We conducted cross-sectional assessments and between-group comparisons of metabolic and immune risk factors. Immune-metabolic markers included body mass index (BMI), fasting glucose (FG), fasting insulin, Homeostasis Model Assessment-Insulin Resistance (HOMA2-IR), C reactive protein and blood lipids.

Individuals in the circadian-bipolar spectrum subgroup had significantly elevated FG (F=5.75, p=0.04), HOMA2-IR (F=4.86, p=0.03) and triglycerides (F=4.98, p=0.03) as compared with those in the hyperarousal-anxious depression subgroup. As the larger hyperarousal-anxious depression subgroup is the most generic type, and weight gain is also a characteristic of the circadian-bipolar subgroup, we then differentiated those with the hyperarousal-anxious subtype on the basis of low versus high BMI (2 vs ≥25 kg/m², respectively). The ‘circadian-bipolar’ group had higher FG, FI and HOMA2-IR than those in the hyperarousal-anxious-depression group with low BMI.

Circadian disturbance may be driving increased rates of metabolic dysfunction among youth with emerging mood disorders, while increased BMI also remains a key determinant. Implications for assessment and early interventions are discussed.

The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

ISRCTN68786622.

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m² and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

ISRCTN68786622.

Childbirth can have psychological, social and emotional effects on women and their families. Psychological birth trauma (PBT) is defined as the emotional distress and mental health challenges resulting from negative or distressing experiences during the childbirth process. Labour management plays an important role in the health of women and children. Consequently, the study aims to assess the status of PBT among Iranian women, identify factors influencing it and suggest effective preventive strategies.

This study is a mixed-method research with an explanatory sequential approach. The first phase is quantitative and cross-sectional, involving 300 postpartum women visiting health centres in Tabriz-Iran. In this phase, cluster sampling will be used, and data will be collected using the following questionnaires: Sociodemographic and Obstetric Characteristics, Birth Trauma Scale, PTSD Symptom Scale 1, Perceived Quality of Care Scale, Childbirth Experience Questionnaire version 2.0, Edinburgh Postpartum Depression Scale, Postpartum Specific Anxiety Scale Research Short-Form and the questionnaire on the desire for subsequent pregnancy. The second phase is qualitative, and participants will be selected based on the results of the quantitative phase and extreme cases, using purposive sampling. Data analysis will be performed using qualitative content analysis with a conventional approach. Qualitative data will be collected through in-depth and semi-structured individual interviews with open-ended questions. In the third phase, strategies to prevent childbirth psychological trauma will be designed by integrating the results of the quantitative and qualitative studies, reviewing the literature and gathering expert opinions using a modified Delphi study. Examining PBT and its influencing factors can provide culturally relevant, evidence-based strategies. These strategies can be effective in improving the quality of care for women during childbirth.

This study has received approval from the Ethics Committee of Tabriz University of Medical Sciences in Tabriz, Iran (code number: IR.TBZMED.REC.1402.945). All participants will provide written informed consent before taking part in the study. The outcomes will be shared through articles published in journals, presentations at medical conferences, the validation of a reliable scale for assessing the level of PBT in postpartum women, and the provision of strategies to prevent childbirth psychological trauma. These resources will be valuable for policymakers and healthcare providers.