Mental health issues among nurses are widespread and jeopardise healthcare systems and patient care.1 Yang et al2 conducted a pioneering scoping review using cohort study evidence to explore the risk factors and consequences...

Age acceleration in survivors of breast cancer is a critical issue because cancer and its treatment can increase structural and numerical chromosomal aberrations, while simultaneously shortening telomere length and changing ageing phenotype. Therefore, the current study will be using machine learning architectures to accurately predict the factors that contribute to age acceleration among survivors of breast cancer.

The Cancer Survivors’ Trajectories of Ageing Research (C*STAR) is a hospital-based cross-sectional study involving multi-ethnic Malaysian survivors of breast cancer and a non-breast cancer control group, frequency-matched by age group (±5 years), sex and ethnicity. The three main stages of this study will be conducted in the predictive model development. First, a set of validated questionnaires will be used to collect the data on modifiable factors of ageing phenotypes and behavioural determinants of health. Second, 3 mL non-fasting blood samples will be collected, and lymphocytes will be isolated to determine telomere length using real-time PCR as a biomarker of age acceleration. Lastly, a machine learning architecture will be deployed to identify modifiable factors that may contribute to age acceleration in survivors of breast cancer and controls, with these factors used as input and ageing biomarkers of telomere length as output. The study outcomes may serve as guidance to enhance the quality of life of survivors of breast cancer and hinder the recurrence of cancer while ageing successfully.

Ethical approval was obtained from the Research Ethics Committee, Universiti Kebangsaan Malaysia (JEP-2022-700) to carry out this study. Written informed consent will be obtained from each survivor of breast cancer and each cancer-free woman prior to participation. The results of this study will be published for future research and clinical applications.

A significant number of women die from pregnancy and childbirth complications globally, particularly in low and middle-income countries. Receiving at least four antenatal care (ANC) visits is important in reducing maternal and perinatal deaths. However, few studies have investigated the factors linked to the completion of ≥4 ANC visits in Nepal.

To investigate factors associated with attending ≥4 ANC visits in Sarlahi district of southern Nepal.

A secondary analysis was conducted on data from the Nepal Oil Massage Study (NOMS), a cluster-randomised, community-based longitudinal pregnancy trial including 34 village development committees. We investigated the associations between attendance of ≥4 ANC visits and socioeconomic, demographic, morbidity and pregnancy history factors using logistic regression; generalised estimating equations were used to account for multiple pregnancies per woman. All pregnancies resulting in a live birth (LB) (n=31 867) were included.

Attendance of ≥4 ANC visits.

31.4% of those pregnancies received 4+ ANC visits. Significant positive associations included socioeconomic factors such as participation in non-farming occupations for women (OR=1.52, 95% CI 1.19 to 1.93), higher education (OR=1.79, 95% CI 1.66 to 1.93) and wealth quintile (OR=1.44, 95% CI 1.31 to 1.59), nutritional status such as non-short stature (OR=1.17, 95% CI 1.07 to 1.27), obstetric history such as adequate interpregnancy interval (OR=1.31, 95% CI 1.19 to 1.45) and prior pregnancy but no LB (OR=2.14, 95% CI 1.57 to 2.92), symptoms such as vaginal bleeding (OR=1.35, 95% CI 1.11 to 1.65) and awareness of the government’s conditional cash transfer ANC programme (OR=2.26, 95% CI 2.01 to 2.54). Conversely, identifying as the Shudra caste (OR=0.56, 95% CI 0.47 to 0.67), maternal age below 18 or above 35 (OR=0.81, 95% CI 0.74 to 0.88; OR=0.77, 95% CI 0.62 to 0.96), preterm birth (OR=0.41, 95% CI 0.35 to 0.49), parity ≥1 (OR=0.66, 95% CI 0.61 to 0.72) and the presence of hypertension during pregnancy (OR=0.79, 95% CI 0.69 to 0.90) were associated with decreased likelihood of attending ≥4 ANC visits.

These findings demonstrate the importance of socioeconomic factors, including education, caste, wealth and occupation in completion of ≥4 ANC visits. In addition, biological factors including birth spacing, pregnancy complications and nutrition are important. The association with awareness of the government’s conditional cash transfer programme is a motivation for a full evaluation of whether expanding that programme might improve prenatal care.

The clinicaltrial.gov trial registration number for NOMS was NCT01177111.

The aim is to explore co-design facilitators’ perspectives and experiences of using co-design to improve intrapartum care in four sub-Saharan African settings. The inquiry focuses particularly on how they fostered engagement, built trust and mitigated unintended consequences during the co-design process.

Qualitative interview study with reflexive thematic analysis.

Sixteen public and private not-for-profit hospital-based maternity units in Benin, Malawi, Tanzania and Uganda (four per country).

A total population sample of 10 co-design facilitators involved in a hospital-based co-design project implemented in maternity units in Benin, Malawi, Tanzania and Uganda were interviewed. Semistructured interviews were conducted between December 2022 and January 2023.

Co-design facilitators viewed co-design as a collaborative process to develop contextually relevant solutions. Our findings elucidate their role in facilitating consensus-building and fostering stakeholder ownership amidst significant power divides. They described approaches co-design facilitators take to maintain ongoing stakeholder engagement and manage misaligned expectations in a trusting and collaborative environment, while being mindful of existing tensions and power imbalances. They also highlighted key challenges faced, including navigating norms, power imbalances and unintended consequences.

This study underscores the importance of power-sharing, fostering ownership and engaging end users equitably and continuously in co-design efforts, while also being aware of how to address its potential unintended consequences. Further research is needed to understand co-design facilitators’ impact on co-design and how to address unintended consequences for stakeholders during and after co-design activities in intrapartum interventions in low-resource settings.

Teenagers widely use digital devices for information sharing and other daily activities. Their heavy reliance on smartphones and tablets may contribute to repetitive-use injuries of the thumb.

This study aimed to investigate the prevalence of texting thumb (TT) among medical students and to identify the potential associations between TT and behavioural patterns during digital device use.

This cross-sectional study employed an online, self-developed questionnaire to assess demographic and behavioural patterns associated with smartphone use. Data on thumb pain and its features were evaluated for diagnostic purposes. This study comprised medical students from six medical schools in Jordan. Data were collected from 482 medical students, excluding those who did not meet the inclusion criteria.

The prevalence of TT was 34%, predominantly on the right side (53%) and at the thumb base (69%). The findings suggest that TT was significantly associated with specific behavioural patterns, including supporting the forearm (p=0.026, adjusted OR: 1.611; 95% CI 1.059 to 2.449), number of texting per day (p=0.005, adjusted OR: 1.319; 95% CI 1.086 to 1.603) and studying hours per day using a digital device (p=0.002, adjusted OR: 1.586; 95% CI 1.193 to 2.109). Also, students’ attitudes toward thumb pain were significantly associated with the TT (p=0.005, adjusted OR: 1.351; 95% CI 1.094 to 1.668).

Students’ attention to behavioural patterns is crucial when using digital devices. Supporting the forearm, limiting text message use, avoiding prolonged use of digital devices, never ignoring hand pain and resting the hand significantly reduce the risk of thumb overuse injury.

Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.

This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).

For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.

This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.

ISRCTN16415327.

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.

Pre-exposure prophylaxis (PrEP) use among cisgender female sex workers (FSWs), a population at disproportionately high HIV acquisition risk in Uganda, remains suboptimal. Uptake and continued use are constrained by barriers, such as limited clinical hours, long distances to access facility-based PrEP services, and high mobility among FSWs. Community pharmacies may offer a more accessible PrEP delivery model due to extended operating hours and convenient locations. This study aims to evaluate the accessibility and capacity of pharmacies in Kampala, Uganda, to serve as potential sites for PrEP delivery.

We will conduct a concurrent mixed-methods study combining geospatial mapping, structured surveys, a discrete choice experiment (DCE), and in-depth interviews (IDIs). First, the study will compare the reach and accessibility of PrEP services through community pharmacies versus public healthcare facilities. To highlight PrEP service reach, we will use geospatial analysis to map pharmacies, PrEP clinics, FSW hotspots (i.e., areas where sex is exchanged), and HIV incidence. We will also calculate a PrEP facility needs ratio (number of PrEP facilities/HIV incidence) for each of Kampala’s administrative divisions and estimate travel distance and time to access PrEP services using cost–distance analysis. Perceived accessibility of PrEP services will be assessed through FSW surveys (n=50) and IDIs (n=20–30), guided by Levesque’s framework. Then, we will evaluate pharmacy capacity via surveys (n=274) and IDIs (n=20–30), exploring infrastructure, resources, and staff perspectives, informed by the Consolidated Framework for Implementation Research. Additionally, a DCE will be embedded in the pharmacy survey to elicit staff preferences for delivery approaches and analysed using mixed logit models. Finally, we will integrate quantitative and qualitative findings to provide a broad assessment of whether pharmacies are suitable venues for PrEP delivery to FSWs in Kampala. Enrolment will begin by April 2026 for FSWs and July 2026 for pharmacy staff.

Ethical approval has been obtained from the Infectious Diseases Institute Research Ethics Committee (IDI-REC-2025-175) and the Uganda National Council for Science and Technology (HS6178ES). Written informed consent will be obtained from all participants. We will disseminate study findings through stakeholder meetings, scientific conferences, and peer-reviewed publications.

Prehospital care, though critical to injury survival, is largely unavailable in many low and middle-income countries, including Cameroon. Lay first responder (LFR) programmes train persons with high injury exposure in first-aid and emergency transport, but stakeholder buy-in from trainees and healthcare workers (HCWs) is essential. To design a context-appropriate prehospital care system, we evaluated barriers and facilitators of implementing a driver-based LFR programme in Cameroon.

In April 2023, we performed a mixed-methods evaluation targeting commercial mototaxi drivers and HCW in Limbe, Cameroon. Drivers were recruited for focus groups through union leaders. Trauma HCW at Limbe Regional Hospital completed Likert surveys and a subgroup completed semistructured interviews. Data collection focused on perceptions, barriers and facilitators of LFR programme implementation. Survey data were summarised using median and IQR. Interviews were recorded, transcribed, translated and analysed with open and axial coding using reflexive thematic analysis.

Overall, 92 mototaxi drivers and 34 HCWs participated in the LFR programme assessment. Among the HCW surveyed, 93% felt mototaxi drivers were capable of training as LFR but only 44% felt that drivers would be able to provide care safely. Interviews identified negative HCW perceptions of drivers, including drivers being uneducated and financially motivated, as key barriers, whereas driver exposure to injury was identified as a facilitator to LFR programme implementation. Driver groups demonstrated a positive perception of LFR training but identified unpaid time spent transporting injured persons as a significant barrier. Both groups described a need for hospital involvement in trainings and bidirectional standardised communication with HCW.

In Cameroon, driver-based LFR may facilitate increased prehospital care but further exploration of possible systems of collaboration that promote long-term success of the programme is required. Specifically, sustainable implementation will need to include clear bidirectional communication guidelines and provide driver incentive commensurate to effort.

The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.

To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.

We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.

We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.

This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).

34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.

SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.

Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.

For large primary spontaneous pneumothorax (PSP), drainage or simple aspiration are the two first-line treatment options. Outpatient ambulatory strategies have a success rate of almost 80% with few complications. New French recommendations suggest that an outpatient strategy should be preferred if an appropriate care network is in place. However, establishing this care network remains the main obstacle to the use of this strategy. Thus, outpatient management of PSP remains rare, which is neither optimal for the patient, with a likely impact on quality of life (QOL) and satisfaction with care, nor for the healthcare system, with increased costs. We hypothesise that outpatient treatment of PSP compared with usual inpatient management could improve quality of care and represent a more efficient, generalisable and sustainable strategy.

In this multicentre, cluster-controlled, randomised interventional study with stepped wedge implementation, patients aged 18–50 presenting to the emergency department (ED) with a first episode of large PSP will be enrolled in seven university hospitals in France. The main objective of this study is to evaluate the impact on changes in QOL of an ambulatory strategy for the management of large PSP in the ED compared with usual inpatient management. The primary outcome is the difference in QOL as measured by SF-36 score, between drain placement and 6 months. Clinical criteria (pulmonary expansion at 6 days, pain, dyspnoea, complications, recurrence), perceived quality of care (satisfaction, patient preference, anxiety) and ease of implementation of the care pathway will also be assessed. A cost-utility analysis will be carried out to evaluate the incremental cost-utility ratio at 1 year, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores.

Ethics approval has been obtained by the Comité de Protection des Personnes Nord Ouest III N° 2024-36. Study findings will be disseminated by publication in a high-impact international journal. Results will be presented at national and international emergency healthcare meetings, and participating patients notified of the main conclusions.

This trial is registered with Clinical Trials Registry NCT06471608. The trial protocol and statistical design are fully described in this study protocol. Additional data can be provided on reasonable request to the sponsor. Protocol version: V2.1 - 21/11/2024.

Kerato-lenticule extraction (KLEx) is a refractive surgery technique that, in contrast with femtosecond laser-assisted in situ keratomileusis (FS-LASIK), does not require the creation of a flap to correct refractive defects. The potential advantages of this technique are related to the absence of a flap and its complications. On the other hand, FS-LASIK is the most widely practised refractive surgery worldwide, as it offers excellent visual outcomes and is currently the gold standard of refractive surgery. The objective of this study is to compare the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or myopic astigmatism.

This double-masked, parallel-group, single-centre randomised clinical trial will enrol 80 eyes from adults with myopia or compound myopic astigmatism within the ranges sphere –0.50 to –12.00 D and cylinder –0.50 to –6.00 D, recruited at the Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico. Participants will be allocated to KLEx or FS-LASIK and assessed at baseline and 1 day, 1 week, 1, 3, 6 and 12 months postoperatively. The primary outcome is uncorrected visual acuity at all postoperative visits. Secondary outcomes include postoperative spherical equivalent, best-corrected visual acuity (BCVA), loss of ≥2 BCVA lines, the proportion of eyes within ±0.50 D of the refractive target, corneal aberrations over a 5 mm pupil, epithelial changes and adverse events. Participants and outcome assessors will be masked to the assigned surgical technique.

Participant confidentiality will be maintained with the publication of results. This study was approved by the research and ethics committee of the Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana (CI-017-2024). The study results will be disseminated in scientific articles published in peer-reviewed journals and presented through research posters at national and international conferences.

ClinicalTrials.gov registry (NCT06477081).

To examine how menstruation, contraceptive use and gender-based violence intersect to shape the sexual and reproductive health and autonomy of girls and young women in Kenya.

Qualitative study exploring girls and young women’s experiences with contraceptive use and menstrual management, using in-depth interviews and focus group discussions analysed through a reflexive thematic approach.

Four county-run family planning clinics in Uasin Gishu County, Kenya.

77 girls and young women aged 15–19 years (via 35 in-depth interviews and 7 focus group discussions) and 27 family planning clinic providers (via 5 focus group discussions).

Interviewees’ contributions suggest that covert contraceptive use, when discovered through menstrual monitoring, provoked intimate partner violence. Heavy menstrual bleeding, whether related to contraceptive use or not, was viewed as a sexual restriction and also fuelled intimate partner violence. Furthermore, the inability to afford sanitary pads, combined with the stigma surrounding menstruation, drove some girls and young women into exploitative sexual relationships, often resulting in unwanted or unintended pregnancies.

Menstrual bleeding and contraceptive use, both independently and in combination, affect girls and young women’s reproductive autonomy and overall health and well-being, particularly in relation to gender-based violence. Improving menstrual hygiene management, challenging the stigma and harmful norms tied to menstruation and contraception and ensuring safe contraceptive use are integral to improving sexual and reproductive health and autonomy and are requisite for preventing and eradicating gender-based violence.

Anxiety disorders, obsessive–compulsive disorder (OCD) and post-traumatic stress disorder (PTSD) are common in children and adolescents and can lead to significant impairment. Cognitive behavioural therapy (CBT) with exposure is the first-line treatment, yet approximately half of treated youth do not achieve full remission. Dysfunctional cognitions—negative automatic thoughts, maladaptive beliefs and distorted interpretations—are considered key targets of CBT, but evidence in youth is mixed and underpowered. This study will examine whether change in dysfunctional cognitions mediates treatment outcome in anxiety, OCD and PTSD symptoms and whether this association varies across individual characteristics.

An individual participant data meta-analysis (IPDMA) of randomised controlled trials of CBT for youth aged 5–18 years with anxiety disorders, OCD or PTSD will be conducted. The search strategy includes the databases APA PsycINFO, MEDLINE and Web of Science Core Collection from inception to 8 September 2025. It is supplemented by screening reference lists, trial registries, grey literature and outreach to relevant research groups. Eligible trials must include at least one validated measure of dysfunctional cognitions administered at minimum pre- and post-treatment, and clinical outcomes assessed at post-treatment and follow-up. The two primary outcomes are (1) child-reported symptom severity and (2) clinician-rated clinical severity. Data will be harmonised for dysfunctional cognition scores, moderators (age, gender, socioeconomic status, comorbidity), and primary outcomes. One-stage Bayesian mixed-effects models will examine whether changes in dysfunctional cognitions predict improvements in primary outcomes and whether these effects are moderated by individual characteristics. Missing data will be addressed using multiple imputation within the Bayesian framework, and study-level heterogeneity will be modelled using random intercepts and slopes.

All datasets will be de-identified and managed under General Data Protection Regulation standards. Each included trial will have ethical approval permitting data sharing and reuse, and the secondary analysis of the shared datasets has been approved by the University of Amsterdam. Findings will be disseminated via a peer-reviewed publication, scientific conferences and open sharing of analysis scripts and harmonisation procedures.

CRD420251139130.

Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).

This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.

The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.

NCT05777317.

Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Not applicable

To develop and validate a polycystic ovary syndrome (PCOS) case definition using administrative health data sources.

A validation study.

Secondary care centre outpatient gynaecology clinic in Calgary, Alberta, Canada.

3951 electronic health records of women aged 18–45 years who presented to a gynaecology clinic in Calgary, Canada, between January 2014 and December 2019 were reviewed. We identified 180 patients with PCOS using the Rotterdam criteria. Participants were excluded if they were biologically male, pregnant at the time of the consultation, did not meet the date criteria or if their consultation note was missing. The chart data were connected to the Practitioner Claims and the Discharge Abstract Database by personal health number.

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 68 case definitions for PCOS were estimated. Case definition performance was graded.

Of the 68 case definitions tested, none had high validity. The best performing case definitions were: (1) ≥3 instances of International Classification of Diseases-9 code 256.4 (polycystic ovaries) with exclusion codes (sensitivity 23.89%, specificity 99.59%, PPV 74.14%, NPV 96.35%) and (2) 626.X (irregular menstruation), 704.1 (hirsutism) and ≥3 instances of code 256.4 with exclusion codes (sensitivity 2.78%, specificity 99.97%, PPV 83.33%, NPV 95.40%).

We identified several case definitions for PCOS of moderate validity with high PPV (>70%) for case ascertainment in PCOS research in jurisdictions with similar administrative health data. These case definitions are limited by low sensitivity, which should be considered when interpreting research findings.

To ascertain the clinical impact, prevalence and associated determinants of delayed treatment intensification, defined as delaying the escalation of treatment plans for individuals with type 2 diabetes mellitus who fail to attain ideal glycaemic control, at the University of Gondar Comprehensive Specialised Hospital in Northwest Ethiopia.

A mixed-methods study.

University of Gondar Comprehensive Specialised Hospital.

420 patients with type 2 diabetes mellitus with poor glycaemic control after the index date were included in this study. A simple random sampling technique was employed to select the required sample size. Data were collected retrospectively and entered into EpiData V.4.6 and exported to Stata V.14.2 for analysis.

Multivariable logistic regression was used to identify factors associated with delayed treatment intensification. A p value of 0.05 in the multivariable analysis was considered statistically significant. Qualitative data were collected through in-depth interviews with eight selected healthcare providers, and thematic analysis was undertaken to identify the underlying barriers to timely treatment intensification.

Delayed treatment intensification.

The prevalence of delayed treatment intensification was 51.4% (95% CI 46.6% to 56.2%), with a median delay of 14 months (IQR: 7.5–42 months) from the index date. Among those experiencing delayed treatment intensification, 43.1% developed new chronic diabetic complications, including retinopathy (18.1%), neuropathy (14.4%) and nephropathy (6.0%). Other complications (hypertension, stroke, heart failure and diabetic foot ulcer) accounted for 4.64% of the cases. Significant predictors of delayed treatment intensification included longer duration of diabetes (adjusted ORs (AOR) 1.68; 95% CI 1.13 to 2.5), presence of comorbidities (AOR 1.83; 95% CI 1.04 to 3.2) and use of cardioprotective medications (AOR 1.59; 95% CI: 1.04 to 2.43). The qualitative findings revealed additional barriers contributing to delayed treatment intensification, including financial limitations, insufficient patient awareness and non-adherence among patients. Additionally, healthcare provider-related factors, including professional fatigue and knowledge gaps, as well as health institution-related factors such as inadequate healthcare infrastructure.

This study found a high prevalence of delayed treatment intensification (51.4%), associated with comorbidities, longer disease duration, low patient awareness, cardioprotective drug use and barriers related to the system and providers. To address these gaps, priorities should include strengthening patient education, scheduling regular reviews for high-risk patients and improving clinical decision support tools for timely treatment intensification. Enhancing healthcare infrastructure, such as medication supply and diagnostic services, and offering refresher training to reduce provider fatigue, are also crucial for improving the delivery of diabetes care.

Temporomandibular disorders (TMDs) are a prevalent group of musculoskeletal conditions affecting the temporomandibular joint, associated structures and masticatory muscles. The internet has become a primary source of health information for many patients; however, the readability, reliability, content and quality of online information on TMDs vary widely. A comprehensive synthesis of the characteristics and evaluation methods of such content is currently lacking.

This scoping review will follow the Joanna Briggs Institute methodology and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Peer-reviewed primary and secondary studies assessing online information on TMDs will be included if they report on readability, reliability, content or quality. Eligible information sources include publicly available websites, videos and social media; discussion forums and printed materials will be excluded. No language, date or geographical restrictions will be applied. A three-step search strategy will be implemented across PubMed, Web of Science, Embase, PsycINFO and CINAHL, followed by citation tracking. Screening will be conducted independently by two reviewers using Rayyan. Data will be extracted with a pilot-tested charting tool and synthesised narratively and descriptively in tabular and graphical formats.

As this study will only use data from publicly available sources, ethical approval is not required. Findings will be disseminated through publication in a peer-reviewed journal, conference presentations and professional networks, with the aim of guiding the development of accessible and reliable digital resources for individuals seeking information on TMDs.

This protocol has been prospectively registered on the Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/TAH7K.

The aim of this study was to prioritise a set of indicators to measure World Health Organization (WHO) quality-of-care standards for small and/or sick newborns (SSNB) in health facilities. The hypothesis is that monitoring prioritised indicators can support accountability mechanisms, assess and drive progress, and compare performance in quality-of-care (QoC) at subnational levels.

Prospective, iterative, deductive, stepwise process to prioritise a list of QoC indicators organised around the WHO Standards for improving the QoC for small and sick newborns in health facilities. A technical working group (TWG) used an iterative four-step deductive process: (1) articulation of conceptual framework and method for indicator development; (2) comprehensive review of existing global SSNB-relevant indicators; (3) development of indicator selection criteria; and (4) selection of indicators through consultations with a wide range of stakeholders at country, regional and global levels.

The indicators are prioritised for inpatient newborn care (typically called level 2 and 3 care) in high mortality/morbidity settings, where most preventable poor neonatal outcomes occur.

The TWG included 24 technical experts and leaders in SSNB QoC programming selected by WHO. Global perspectives were synthesised from an online survey of 172 respondents who represented different countries and levels of the health system, and a wide range of perspectives, including ministries of health, research institutions, technical and implementing partners, health workers and independent experts.

The 30 prioritised SSNB QoC indicators include 27 with metadata and 3 requiring further development; together, they cover all eight standard domains of the WHO quality framework. Among the established indicators, 10 were adopted from existing indicators and 17 adapted. The list contains a balance of indicators measuring inputs (n=6), processes (n=12) and outcome/impact (n=9).

The prioritised SSNB QoC indicators can be used at health facility, subnational and national levels, depending on the maturity of a country’s health information system. Their use in implementation, research and evaluation across diverse contexts has the potential to help drive action to improve quality of SSNB care. WHO and others could use this list for further prioritisation of a core set.