To investigate whether women who experienced pelvic girdle pain (PGP) during pregnancy were able to engage in meaningful activities at 4 months and 3 years post partum, and to identify factors associated with long-term functional outcomes.

Long-term follow-up of a randomised controlled trial comparing acupuncture and transcutaneous electrical nerve stimulation for pregnancy-related PGP.

Physiotherapy outpatient clinics in Sweden.

In total, 113 pregnant women with clinically verified PGP were randomised in the original trial; 86 participated in the initial study phase, 77 attended the 4-month follow-up and 57 completed the 3-year follow-up questionnaire.

The primary outcome was functioning, assessed using the Patient-Specific Functional Scale (PSFS). Secondary outcomes included self-reported PGP, overall functioning and the prognostic value of pelvic pain provocation tests at 4 months post partum for persistent PGP at 3 years.

3 years post partum, the mean PSFS score was 8.64, and 45.6% of the participants scored 10, indicating full return to baseline activities. In repeated linear regression analyses, estimated PSFS scores were approximately 3 points lower at baseline and post-treatment compared with the 3-year follow-up (both p

Most women with pregnancy-related PGP regained functioning by 4 months post partum, and this recovery was sustained at 3 years. The number of positive pelvic provocation tests at 4 months post partum predicted persistent pain at 3 years, suggesting potential prognostic value for identifying women at risk of long-term PGP and informing postpartum follow-up strategies.

In ‘FoU i Sverige’ (R&D in Sweden) No. 12726. https://www.researchweb.org/is/sverige/project/127261.

Social camouflaging (SC; ie, the concealing of autistic traits to socially assimilate) is associated with poor mental health, self-identity and quality of life outcomes, yet its typology, consequences and contextual triggers remain unexplored in autistic adolescents. Further study is necessary to identify protective factors against the potentially negative outcomes associated with SC to promote long-term well-being.

The current project will investigate SC in youth and its mental health, cognitive and neurophysiological correlates. Camouflaging will be captured by triangulating self-reported and caregiver-reported SC behaviours, as well as SC behaviours in day-to-day contexts using intensive longitudinal methods (ie, daily diaries). Non-autistic, self-identifying autistic and formally diagnosed autistic adolescents aged 15–18 years (N=150) will be recruited. Adolescents and caregivers will complete rating scales to assess mental health, and adolescents will complete in-lab cognitive assessments of attention, executive function, intellectual ability and theory of mind. Brain neurophysiological function and cortisol concentration over time will be measured during the same visit using electroencephalography and hair samples, respectively. Over the following 7 days, adolescents will complete daily diaries using their smartphones. The daily diaries pose survey questions about the type and degree of SC behaviour used within their daily environment, including the social context, individuals who are present and current well-being. Adolescents will also complete brief performance-based cognitive assessments of attention and executive function integrated within the daily diary surveys. Finally, adolescents and their parents will complete a follow-up of SC behaviours and mental health at 3 months. Correlations and regression analyses will be conducted to explore the associations between SC and mental health/cognitive outcomes and how baseline measures of cognition, mental health and SC predict patterns seen on the daily diaries. Multilevel modelling will be used, nesting daily data to capture within-person and between-group differences in contextual predictors of camouflaging behaviour. Results will contribute to current understanding of the typology of camouflaging, as well as inform intervention to mitigate mental health challenges for autistic youth.

This project is approved by the University of Victoria Human Research Ethics Board (#23–0013) and the University of Calgary Conjoint Faculties Research Ethics Board (#23–0641). Informed consent will be obtained from caregivers and adolescent participants, and safety procedures will be put in place to support the adolescent should mental health concerns arise. Results will be disseminated through academic publications and conferences, as well as summarised and communicated to interested participants and relevant stakeholders.

Depression and sub-diagnostic depressive syndromes are prevalent and associated with suffering and reduced life expectancy. Access to care is limited even in countries with developed healthcare systems. In this context, it is important to strengthen the self-management expertise of people suffering from depressive symptoms. Smartphones offer the possibilities for improved self-management based on long-term monitoring of symptoms.

The present multicentre randomised controlled trial (the Protecting mental health in times of change (MENTINA) trial) aims to evaluate whether (1) daily smartphone-based monitoring and automatic rule-based feedback+smartphone-based outcome evaluations versus (2) smartphone-based outcome evaluations alone will improve depressive symptoms and other clinically relevant outcomes in participants with current depressive symptoms and/or one or more prior depressive episodes during a 12-month trial period.

The MENTINA trial is a multicentre randomised controlled parallel-group trial conducted in Denmark, Germany and Spain. Participants with current depressive symptoms and/or one or more previous depressive episodes are invited to participate. The included participants will be randomised to (1) daily smartphone-based monitoring and automatic rule-based feedback+outcome evaluations via smartphone (intervention group) or (2) outcome evaluations via smartphone alone (control group). All participants can continue with ongoing treatment in case they receive it. The trial started in May 2025 and has currently included 115 participants. The outcomes are differences between the intervention group and the control group in (1) Patient Health Questionnaire 9-items (PHQ-9) measured every 14th day during the 12-month trial period (primary), (2) WHO Quality of Life-BREF, Generalised Anxiety Disorder-7, monthly change in PHQ-9, proportion of participants with ≥50% reduction in PHQ-9, remission rate defined as PHQ-9≤9 and ≥5-point improvement, PHQ-9 scores after 6 months, area under the curve for PHQ-9 over the 12 months trial period, subgroup analyses in PHQ-9 in participants with or without lifetime depression, Perceived Stress Scale, user-reported healthcare contacts, usability of the app and negative effects, number of depressive episodes+duration and depressive-free days based on PHQ-9. A total of 660 participants will be included in the MENTINA trial.

The MENTINA trial is funded by the European Union under Grant Agreement No. 101 080 651. Ethical approval and approval from Medical Agencies have been obtained from Denmark (CIV-25-02-051094), Germany (CIV-25-02-05109) and Spain (CIV-25-02-051094). The results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patients’ organisations and media outlets.

NCT06919133.

Version 6, January 2026.

Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.

An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.

Online.

Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.

Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.

Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.

The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.

Demographic change is resulting in a growing number of individuals requiring nursing care, while the availability of professional caregivers is simultaneously declining. This imbalance places increasing pressure on care provision, particularly in home settings and rural areas. Primary care services are also under pressure. Digital solutions such as teleconsultations are considered promising strategies to support intersectoral collaboration in long-term care and to mitigate existing gaps in service provision.

Seven teleconsultation projects in long-term care are being conducted using a mixed-methods design aligned with the phases of the Medical Research Council framework: with a focus on the feasibility phase. Data on structural conditions, usage patterns and user acceptance will be collected through standardised instruments (including Unified Theory of Acceptance and Use of Technology and Fit between Individuals, Task and Technology). In addition, focus groups and interviews will be carried out. The quantitative analysis will include descriptive and inferential statistical methods and will be complemented by a cost–consequence analysis. The qualitative data will be analysed using structuring content analysis. The aim is to provide a context-informed and theory-informed assessment of the implementation and potential impact of telemedical consultations.

The study has been approved by the Ethics Committee in Tübingen. Participation is voluntary and based on written informed consent. Data protection is ensured in accordance with the GDPR (General Data Protection Regulation); all data are pseudonymised and processed separately. Results will be communicated in a target group-appropriate manner and published in scientific journals. Practice-oriented recommendations will be developed to support the further advancement of telemedical care in nursing.

Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.

The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.

No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.

The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).

Studies have demonstrated the positive impact of falls prevention interventions for high-risk older adults who have experienced a severe fall. However, uptake and adherence rates remain low. The purpose of this study is to assess the capabilities, opportunities and motivations of older adults following a fall with subsequent presentation to the emergency department and direct discharge home in relation to falls prevention measures.

This study, conducted as part of the ‘Sentinel fall presenting to the emergency department’ project at the Carl von Ossietzky University Oldenburg in Germany, involved a participatory research team (PRT). It was a qualitative study based on focus group interviews undertaken between June and October 2022, analysed in accordance with qualitative content analysis following Kuckartz. The Theoretical Domains Framework forms the basis of the deductive category system. PRT members collaborated as co-researchers in conducting and analysing the focus groups.

12 focus groups were conducted (N=52). The participants were older adults (≥60 years) who had received outpatient care in an emergency department following a fall (N=41) and their relatives (N=11).

Interviewees indicated that both knowledge of available support options and the ability to self-evaluate are important following a fall. Additionally, health circumstances, such as limitations resulting from fall-related consequences, influence the adoption of falls prevention measures. Social influences, as well as environmental context and resources, were also discussed, reflecting participants’ preferences for intervention design, such as having a central point of contact and specific courses on fall training. Moreover, the fall event itself may strengthen the perceived need for preventive measures, whereas a fear of falling can lead to reduced or modified activity levels.

To improve the engagement of older adults in falls prevention interventions following a fall, the establishment of a central point of contact could be considered. Individual tailored interventions, including psychological support as well as specific fall training, are needed.

DRKS00025949.

Low anterior resection syndrome (LARS) is a common functional complication after sphincter-preserving surgery for rectal cancer that significantly impairs the quality of life. Current postoperative management strategies are suboptimal, and effective preventive approaches are lacking. This study aims to evaluate the impact of a mobile-based, knowledge-enhanced digital intervention for reducing the incidence of major LARS.

This is a multicentre, open-label, parallel-group, randomised controlled trial to be conducted across three academic medical centres in Korea.

A total of 300 adult patients who underwent low anterior resection or stoma reversal after rectal cancer surgery will be randomly assigned in a 1:1 ratio to the intervention group (mobile digital programme) or the control group (standard educational materials). The digital programme includes daily symptom monitoring, exercise suggestions, dietary recommendations and structured feedback from healthcare providers during clinical visits based on outcomes. The primary outcome is the incidence of major LARS (score ≥30) at 12 months postoperatively. Secondary outcomes include longitudinal changes in LARS score, quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), EORTC QLQ-Colorectal Cancer 29 (CR29)), European Quality of Life 5 Dimensions Level Version (EQ-5D-5L), patient satisfaction and programme adherence. Statistical analyses will include stratified chi-squared tests and mixed-effects models based on the intention-to-treat principle.

The trial received ethical approval from the Institutional Review Board of the National Cancer Centre, Korea. Written informed consent will be obtained from all participants. The findings will be disseminated through peer-reviewed publications and conference presentations.

NCT07041515.

In the last 60 years, newborn bloodspot screening (NBS) has expanded as a public health intervention from a single severe childhood genetic disease (SCGD) to up to as many as 80 SCGD and testing of ~40 million newborns/year worldwide. However, the gap between current NBS and its potential to increase the efficiency, effectiveness and global equity of healthcare delivery for SCGD is large and rapidly growing. There are now effective therapeutic interventions—drugs, diets, devices and surgeries—for up to 2000 SCGD. Since almost all SCGD can be identified by bloodspot genome sequencing, it has been a longstanding goal to supplement current NBS with genome sequencing-based NBS (gNBS) for all eligible SCGD. We recently described a novel gNBS platform (named Begin Newborn Genome Sequencing (BeginNGS)) with the potential to overcome several major challenges to gNBS (cost, scalability, false positives and an unprepared healthcare workforce). A pilot clinical trial of BeginNGS for 412 SCGD in a level IV neonatal intensive care unit (NICU) had a true positive rate of 4.2%, sensitivity of 83%, positive predictive value of 100% and clinical utility rate of 4.2%, indicating readiness of the platform for use in a powered, multicentre study.

The BeginNGS study is a single group, international, multicentre, adaptive clinical trial to compare utility, acceptability, feasibility and cost-effectiveness of BeginNGS gNBS (experimental intervention) with standard NBS (control). A minimum of 10 000 neonates (aged 50 000 US children per year.

This study was approved by the WCG Clinical institutional review board on 14 February 2024, and the most recent amendment approved on 7 October 2025 (approval number 20235517). Study findings will be shared through research consortium workshops, national and international conferences, community presentations and peer-reviewed journals.

NCT06306521.

Heightened rates of mental illness among children, young people and forcibly displaced adults are well-documented. Despite this, access to care in host countries is often low. Problem-management plus (PM+) is an intervention developed by the WHO that can be delivered through task-shifting by lay counsellors and has been shown to be effective in numerous studies. At the same time, it has been shown that PM+ has a limited effect on traumatic stress symptoms, a common problem among forcibly displaced individuals. In turn, to further these benefits, a novel emotional processing (EP) module has been developed to be adjunctively delivered alongside PM+(PM+EP).

The current study is a randomised controlled feasibility and acceptability study. 60 participants aged 16–25 will be randomly allocated to either PM+, PM+EP or care as usual. The primary outcome of this study will be the feasibility and acceptability of the delivery of PM+EP in forcibly displaced youth. Secondary outcomes are self-rated measures of distress, depression and anxiety, post-traumatic stress disorder, personally identified problems, hope, use of services and medications, general well-being and social support.

Following ethical approval in February 2024, recruitment commenced in October 2024. Study completion is anticipated by December 2025. Findings will be disseminated via peer-reviewed publications, conference presentations and communication with relevant stakeholders.

NCT06878092.

Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.

This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.

This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.

NCT05523479.

Despite advances in the physiotherapy management of low back pain (LBP) worldwide, studies indicate that there is a large variation in the quality of physiotherapy management for LBP in Nigeria. This clinical trial aims to evaluate the implementation of individualised physiotherapy for chronic LBP in Nigeria using the Specific Treatment Of Problems of the Spine (STOPS) approach.

This will be an implementation clinical trial using a non-randomised, prospective, sequential comparison design. One hundred and fifty-four participants with chronic LBP will be recruited at one hospital in Nigeria. In phase I, participants will receive 11 sessions of usual physiotherapy care. In phase II, consenting physiotherapists will undergo training in the implementation of the STOPS treatment approach, led by the original Australian developers. In phase III, participants will receive 11 sessions of individualised physiotherapy using the STOPS approach. Patient evaluation in phases I and III will be measured at baseline and at 5, 10, 26 and 52 weeks, and will evaluate the clinical outcomes (including primary outcomes of pain intensity measured with a 0–10 Numerical Rating Scale, and activity limitation measured via the Oswestry) and cost-effectiveness from the healthcare perspective (incremental healthcare costs relative to incremental quality adjusted life-years gained on the EuroQOL-5D-5L). Physiotherapist outcomes will include confidence in treating LBP and implementation behaviour measured at the start of phase I and at the end of phases I, II and III. Implementation feasibility and qualitative analysis of patient and physiotherapist experiences will also be explored.

The trial has been approved by the Human Research Ethics Committees of La Trobe University, Australia (HEC22278) and Federal Medical Centre (FMC) Nguru, Yobe State, Nigeria (FMC/N/CL.SERV/355/VOL IV/131). The study results will be shared through peer-reviewed journals and conferences.

PACTR202305707317550.