To prospectively assess pregnancy-related care sought and obstacles and stress experienced by newly pregnant people.

The ADAPT Study, a longitudinal cohort study, followed 2015 non-pregnant participants aged 15–34 years for a year. Those with confirmed incident pregnancies were followed through their pregnancies and for 3 years.

We recruited participants from 23 reproductive and primary care facilities located in five southwestern states with different sociopolitical reproductive health contexts (restrictive, Arizona and West Texas; protective, southeastern California, Nevada and New Mexico).

334 people reported a new pregnancy within 1 year of enrolment; 324 with outcome data are included in this analysis.

Types of pregnancy care sought (‘Have you looked into where or how you could get (prenatal care, abortion care or adoption services)?’) and care-seeking stress (‘How stressful was it to find (prenatal, abortion or adoption) care for this pregnancy?’).

Most participants (83%, 270/324) sought prenatal care; 43% (138/324) sought abortion care; and 5% (17/324) sought adoption services. Overall, 17%, 29% and 23%, respectively, reported that care-seeking was extremely/quite a bit stressful. Abortion care-seeking was associated with significantly more stress than seeking prenatal care in the ordinal (adjusted odds ratio (aOR 1.70, 95% CI 1.10 to 2.62) but not logistic (aOR 1.33, 95% CI 0.74 to 2.38) model. Adoption care-seeking stress did not differ from prenatal care-seeking stress in either model. Participants who experienced any type of abortion care-seeking obstacle and those recruited in a state with a restrictive policy environment (aOR 2.72, 95% CI 1.09 to 6.80) reported more care-seeking stress than their counterparts.

People who seek pregnancy care often experience some care-seeking stress, regardless of the type of care they seek. Findings point to the need to reduce the burden of the pregnancy care-seeking process across all types of pregnancy care.

NCT03888404.

Weight stigma and internalised weight bias are associated with poor mental, social and physical health. Weight-neutral approaches prioritise well-being and sustainable health behaviours. However, the feasibility and acceptability of weight-neutral interventions remain uncertain.

Weight-Neutral Health Intervention (WIN) is an investigator-initiated single-arm feasibility study enrolling 56 adults with body mass index ≥30 kg/m² in the Capital Region of Denmark. The study investigates a codesigned weight-neutral health intervention. The 6-month intervention comprises 1 preparatory session and 11 group sessions led by trained practitioners, focusing on intuitive eating, body acceptance and self-compassion; optional components include support-network events, up to three individual online sessions and access to ‘size-inclusive yoga’ and ‘body competence’ courses. The primary feasibility outcome is follow-up completion. Recruitment proportion and adherence are secondary feasibility outcomes. These will be assessed using a set of predefined ‘traffic-light’ stop/go progression criteria. Exploratory feasibility outcomes include data completeness for other outcomes and participant engagement with the intervention. Exploratory clinical outcomes include questionnaire data (quality of life, depression, weight bias internalisation, eating behaviours, self-esteem, body image, stress and life satisfaction), clinical measures (weight, heart rate and blood pressure), biomarkers (blood samples and hair cortisol), 7-day actigraphy (physical activity and sleep) and serious adverse events. Qualitative interviews, focus groups and fieldnotes will be used to explore acceptability and contextual factors. If progression criteria are met, the study will inform the design of a pragmatic, multicentre, randomised trial. The exploratory outcomes will inform outcome selection, setting, sample size and procedures.

Approved by the Regional Ethics Committee of the Capital Region of Denmark (H-25013213). Results will be disseminated through peer-reviewed publications, conferences and public platforms.

NCT06922630.

Treatment for women with endometriosis is only partially or temporarily effective. Moreover, medical hormonal treatment is associated with debilitating side effects and interferes with fertility, while surgery has a relatively high risk of complications. Meanwhile, women with endometriosis show increasing interest in implementing lifestyle interventions to alleviate symptoms and improve health-related quality of life (HRQoL). Integrating these lifestyle interventions can provide a holistic approach to the treatment of this debilitating disease. However, scientific evidence supporting the effectiveness of these interventions is limited. This study is designed to investigate the effectiveness of two lifestyle interventions and the combination of both: an anti-inflammatory diet intervention (AIDI) could improve immune cell function and reduce inflammation, resulting in improved HRQoL and alleviating pain. In addition, the integration of cognitive behavioural therapy (CBT) aims to provide insight into pain mechanisms and coping with pain, and to assist in sustaining dietary adjustments.

The Pain in Endometriosis And the Relation to Lifestyle (PEARL) study is a five-arm randomised controlled trial with a pre-post factorial design with two factors: an AIDI and CBT. The study population will consist of 250 premenopausal women, of whom 200 are diagnosed with endometriosis and experience pain symptoms and 50 are healthy controls (HC). Women with endometriosis will be recruited from one academic tertiary and five secondary hospitals in the Netherlands. They will be randomised (1:1:1:1) among four intervention groups: standard care (SC) (SC group), SC and an AIDI (SC + AIDI group), SC and CBT (SC + CBT group), and SC, AIDI and CBT (SC + AIDI + CBT group). Women with endometriosis will visit the hospital twice during the intervention period, at the start (T0) and end (T2) of the 13-week intervention period. HC will not undergo any of the interventions and will have one hospital visit (T0). Participants will complete questionnaires regarding pain symptoms, HRQoL, physical activity level, sleep, diet quality, pain cognitions, and stress at T0 and T2. Furthermore, they are instructed to collect menstrual effluent, a vaginal swab and a faecal sample. During the study visits, peripheral blood will be drawn and scalp hair samples will be taken. The primary outcome is average pain, measured using a numerical rating scale. Secondary outcomes focus on HRQoL, inflammation, immune system characteristics, vaginal- and gut microbiome, and hair cortisol levels. These are considered to reflect potentially underlying mechanisms of the effect of both interventions on the primary outcome. Biological samples and questionnaires of women with endometriosis and HC will be compared to establish the differences in secondary outcomes.

This study protocol has been approved (approval number: NL86247.091.24) by the METC Oost-Nederland from Radboud University Medical Centre on July 11, 2024. Prior to participation, participants are required to provide informed consent. The results will be widely disseminated through scientific peer-reviewed journals, and presentation to a broad audience in scientific meetings, congresses, patient meetings, as well as in policy-relevant forums.

NCT06332560.

Deep brain stimulation (DBS) for dystonia is effective but programming optimisation can take months. Local field potentials (LFPs) recorded by the Medtronic Percept device may provide biomarkers to guide stimulation. This study will prospectively evaluate whether chronic LFP profiles correlate with clinical outcomes and can inform DBS programming strategies.

LFP-DYT is a single-centre, multi-phase observational study at Newcastle upon Tyne National Health Service (NHS) Foundation Trust. An internal pilot (Cohort 1) will refine recording workflows, followed by Cohort 2 (traditional programming with LFP recordings) and Cohort 3 (LFP-informed programming). 20–25 adults with primary dystonia undergoing globus pallidus internus DBS will be recruited. The study combines chronic LFP sensing with neurophysiology (electromyography, electroencephalography), motor inhibition testing (stop-signal reaction time), patient-reported outcomes and wearable sensor monitoring (STAT-ON) to provide a comprehensive multi-modal assessment framework. Primary outcome: reproducibility of alpha–theta frequency LFP peaks and concordance with optimal stimulation site. Secondary outcomes include stimulation and medication effects on LFP profiles, clinical improvement (Toronto Western Spasmodic Torticollis Rating Scale-2 (TWSTRS-2), Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS)) and beta-band activity as a marker of stimulation-related bradykinesia. Analyses will be descriptive and exploratory. Feasibility outcomes, including recruitment rates, retention and data completeness, will inform design and power calculations for future multi-centre trials.

The study has NHS Research Ethics Committee approval from the East Midlands—Derby Research Ethics Committee (REC reference: 24/EM/0246; IRAS ID: 337426). All participants will provide informed consent. Data will be pseudonymised and stored on secure NHS servers. Results will be disseminated via peer-reviewed publications, conferences and participant summaries. De-identified data and analysis code will be available on reasonable request.

NCT07309133.

To evaluate the effectiveness of early administration of excitatory amino acid (EAA) inhibitors on long-term neurological outcomes in adults with acute moderate to severe traumatic brain injury (TBI).

Systematic review and meta-analysis of randomised controlled trials (RCTs).

MEDLINE, EMBASE, Cochrane CENTRAL, Web of Science, WHO International Clinical Trials Registry Platform and ClinicalTrials.gov from inception to January 2026.

RCTs comparing EAA inhibitors with placebo, standard care or any other interventions were included. Trials enrolled adult patients (≥18 years) with moderate to severe TBI (Glasgow Coma Scale score ≤12) receiving the intervention within the acute phase of care (first week).

Pairs of reviewers independently screened trials, extracted data, assessed the risk of bias (RoB) with the Cochrane RoB tool 2 and graded the certainty of evidence using the Grades of Recommendation, Assessment, Development and Evaluation approach. Random effects models were used for all effect measures and trial sequential analyses (TSA) were performed for each outcome.

The primary outcome was long-term neurological function at 6 months (or the nearest earlier time point), assessed with the Glasgow Outcome Scale (GOS) or extended version (GOS-E), using the classical definitions of an unfavourable outcome (GOS 1–3 or GOS-E 1–4).

28 trials enrolling 4238 patients were included. Early administration of EAA inhibitors was not associated with reduced unfavourable neurological outcomes (relative risk 0.93 (95% CI (0.84 to 1.03); I²=40%; 15 trials, n=3613, moderate certainty). No statistically significant difference was observed based on EAA inhibitor type, timing or duration of administration, RoB or TBI severity. Mortality, intensive care unit lengths of stay and mean intracranial pressure were not statistically different between groups, but hospital length of stay was reduced in the EAA inhibitors group. The early use of EAA inhibitors was not associated with adverse events (low certainty). TSA showed insufficient power for the primary outcome.

In adults with moderate to severe TBI, the early administration of EAA inhibitors was not associated with a reduction of unfavourable neurological outcomes. Further high-quality and adequately powered RCTs are required to clarify their role in TBI management.

CRD42025635527.

First Nations, Inuit and Métis Peoples in Canada continue to face significant disparities in healthcare access compared with non-Indigenous populations. Understanding their experiences in accessing healthcare is essential for addressing systemic barriers and promoting equitable, patient-centred care. Although existing studies have identified various barriers and facilitators to accessing healthcare, a lack of synthesised qualitative evidence delves into the intricacies of patients’ experiences. This systematic review aims to investigate Indigenous patients’ experiences with mainstream Canadian healthcare services and their recommendations for service improvement through a meta-synthesis of qualitative literature.

Meta-aggregation will be used to conduct a systematic review of qualitative studies and qualitative components of mixed-methods studies exploring experiences of Indigenous patients accessing mainstream healthcare services in Canada. Papers published in English will be searched using electronic databases, including MEDLINE, APA PsycINFO, CINAHL, Global Health, the Bibliography of Indigenous Peoples in North America and Web of Science. A comprehensive list of non-indexed and grey literature will also be searched to ensure the inclusion of community-based and non-peer-reviewed evidence. Studies meeting the inclusion criteria will be assessed for methodological quality using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research and the Aboriginal and Torres Strait Islander Quality Appraisal Tool. The review will involve the extraction of findings, categorisation into themes and synthesis into broader insights guided by the JBI meta-aggregation approach. An Indigenous advisory committee will guide the process, including interpretation of findings and ensuring alignment with Indigenous health research principles.

Ethics approval is not required for this study as it is based on a secondary analysis of publicly available primary studies. The completed review will be published in a peer-reviewed manuscript. Findings will also be shared with relevant Indigenous organisations and community partners through plain-language summaries and community-engaged knowledge-sharing activities.

CRD420250656486.

Most patients with health conditions necessitating time off work consult in primary care. Offering vocational advice (VA) early within this setting may help them to return to work and reduce sickness absence. Previous research shows the benefits of VA interventions for musculoskeletal pain in primary care, but an intervention for a much broader primary care patient population has yet to be tested. The Work And Vocational advicE feasibility study tested patient identification and recruitment methods, explored participants’ experiences of being invited to the study and their experiences of receiving VA.

A mixed method, single arm feasibility study comprising both quantitative and qualitative analysis of recruitment and participation in the study.

Primary care.

The study included participant follow-up by fortnightly Short Message Service text and 6-week questionnaire. Stop/go criteria focus on recruitment and intervention engagement. The semistructured interviews explored participants’ experiences of recruitment and receipt and engagement with the intervention.

19 participants were recruited (4.3% response rate). Identification of participants via retrospective fit-note searches was reasonably successful (13/19 (68%) identified), recruitment stop/go criteria were met with ≥50% of those eligible and expressing an interest recruited. The stop/go criterion for intervention engagement was met with 16/19 (86%) participants having at least one contact with a vocational support worker. Five participants were interviewed; they reported positive experiences of recruitment and felt the VA intervention was acceptable.

This study demonstrates that delivering VA in primary care is feasible and acceptable. To ensure a future trial is feasible, recruitment strategies and data collection methods require additional refinement.

NCT04543097.

Older inpatients face a higher risk of delirium, falls and functional decline during hospital stays. Volunteer programmes have been shown to improve patient outcomes in single settings, but little is known about their implementation and spread across multiple care environments. This study describes the implementation and system-wide spread of Maximizing Ageing Using Volunteer Engagement (MAUVE)—a volunteer-based programme supporting older patients’ cognitive, physical and social well-being—and evaluates its impact on healthcare staff satisfaction.

A prospective observational service evaluation.

Emergency department, seven acute in-patient care units and two transitional care units within a Canadian hospital system from January to December 2019.

Older patients receiving care, volunteers delivering interventions and front-line nursing staff.

Trained volunteers delivered up to six types of interventions targeting patients’ cognitive stimulation, physical activity, social engagement, functional support, orientation and companionship.

Staff satisfaction with the MAUVE programme was measured using a structured survey administered 6 months after programme implementation. Data on patients and volunteers—including the number and type of interventions delivered, volunteer hours and patient reach—were also collected to assess feasibility and programme uptake.

Over 12 months, 94 volunteers delivered 31 593 interventions to 3568 unique patients across three care settings. Front-line staff reported high satisfaction with the MAUVE programme, noting that volunteers enhanced patient care and enabled more direct patient interaction by staff.

The MAUVE programme is the first known volunteer-led patient engagement programme to be successfully implemented across acute, emergency and transitional care settings. This service evaluation demonstrates that structured volunteer engagement can support older patients’ well-being while enhancing staff satisfaction and enabling front-line care providers to deliver more direct care.

Countries face challenges in maternal and newborn care (MNC) regarding costs, workforce and sustainability. Organising integrated care is increasingly seen as a way to address these challenges. The evidence on the optimal organisation of integrated MNC in order to improve outcomes is limited.

(1) To study associations between organisational elements of integrated care and maternal and neonatal health outcomes, experiences of women and professionals, healthcare costs and care processes and (2) to examine how the different dimensions of integrated care, as defined by the Rainbow Model of Integrated Care, are reflected in the literature addressing these organisational elements.

We included 288 papers and identified 23 organisational elements, grouped into 6 categories: personal continuity of care; interventions to improve interdisciplinary collaboration and coordination; care by a midwife; alternative payment models (non-fee-for-service); place of birth outside the obstetric unit and woman-centred care. Personal continuity, care by a midwife and births outside obstetric units were most consistently associated with improved maternal and newborn outcomes, positive experiences for women and professionals and potential cost savings, particularly where well-coordinated multidisciplinary care was established. Positive professional experiences of collaboration depended on clear roles, mutual trust and respectful interdisciplinary behaviour. Evidence on collaboration interventions and alternative payment models was inconclusive. Most studies emphasised clinical and professional aspects rather than organisational integration, with implementation barriers linked to prevailing biomedical system orientations.

Although the literature provides substantial evidence of organisational elements that contribute to improved outcomes, a significant gap remains in understanding how to overcome the barriers in sustainable implementation of these elements within healthcare systems. Interpreted through a systems and transition science lens, these findings suggest that strengthening integrated maternity care requires system-level changes aligning with WHO policy directions towards midwifery models of person-centred care.

Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

ISRCTN12216466.

There is limited evidence regarding the outcomes and impacts of Patient and public involvement (PPI) in research, mainly based on narrative studies. Existing frameworks for supporting and evaluating PPI often require adaptation to specific contexts, and comprehensive instruments are needed. From an international perspective, strengthening the scientific foundation that underpins PPI is crucial to generate stronger evidence to understand which approaches work best, in which contexts, and with what effects.

To promote PPI implementation in German health research, this project aims to (1) Establish an evaluation framework, (2) Develop a modular evaluation tool in the form of a questionnaire and (3) Pilot and psychometrically validate the tool.

A three-phase mixed methods approach will be employed, integrating qualitative and quantitative data. First, we will explore with researchers, research partners and other stakeholders in health services research what contributes to meaningful and successful PPI through a web-based survey and focus groups. Findings are discussed in a codesign workshop in which participants agree on an evaluation framework based on a LOGIC model. Second, items from international instruments that evaluate PPI are deductively assigned to the evaluation framework. Further items are developed based on the focus groups from phase 1. Cognitive pretests and qualitative review will be conducted with researchers and patients in order to refine the item pool and develop the evaluation tool. Third, the evaluation tool with modules for researchers and patients will be piloted in a web-based survey. Data analysis will include thematic analysis for qualitative data and descriptive and psychometric analyses for quantitative data. A participatory research team will provide ongoing support throughout all project phases.

Ethical approval has been obtained from the Local Ethics Committee of the Centre for Psychosocial Medicine, University Medical Centre Hamburg-Eppendorf (LPEK-0889). The study will follow the principles of the Helsinki Declaration and good scientific practice. Results will be disseminated at national and international conferences, public symposiums and in peer-reviewed journals, contributing to the internationally developing field of PPI in research and addressing relevant research gaps.