Cardiovascular diseases (CVDs) are the leading cause of death worldwide, making the development of self-management strategies crucial for preventing complications and improving clinical outcomes. This process involves symptom monitoring, treatment adherence, emotional management and a healthy lifestyle, among others. Reliable instruments are necessary to measure self-management, requiring robust psychometric properties. In this way, this COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)-based systematic review aims to assess the quality of specific self-management instruments for adults with CVDs.

This systematic review will follow the COSMIN and be reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol. Searches will be conducted in seven databases: MEDLINE, Web of Science, Scopus, PsycINFO, EMBASE and CINAHL. Additionally, a manual search will be performed on PROQOLID, PROMIS and The Medical Outcome Trust websites. Studies on the development and validation of patient-reported instruments measuring specific self-management for individuals with CVDs will be included, without language or date restrictions. The search will be performed in November 2025, with the final version of the review expected to be completed in October 2026. Data extraction will follow COSMIN recommendations. The Modified Grading of Recommendations, Assessment, Development and Evaluation approach will be used to determine the quality of evidence. Instruments will be categorised according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer involved in case of discrepancies. Additionally, the content of the instruments will be analysed and linked to the International Classification of Functioning, Disability and Health, following international recommendations.

This study does not require ethics committee approval as it is a review of published data. The review results will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

CRD42024605969.

To examine the effects of 12 weeks group-based peer-led aquatic high-intensity interval training (AHIIT) compared with aquatic moderate continuous training (AMICT) on patient-reported outcome measures (PROMs) and quality-adjusted life-years (QALYs).

A single-blind, parallel-group, randomised trial with a 1:1 allocation ratio.

Community-based setting.

89 participants (mean age 62 (SD 13) years) with rheumatic and musculoskeletal diseases, including hip and knee osteoarthritis, fibromyalgia, rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, were randomly allocated to an AHIIT (n=44) or an AMICT (n=45) group.

The intervention consisted of AHIIT (four intervals of 4 min at high intensity, Borg scale 14–18) or AMICT (Borg scale 12–13), conducted twice weekly for 12 weeks.

Outcomes included disease activity (measured by the Patient Global Assessment), fatigue, pain and health-related quality of life (HRQoL), measured by the EQ-5D utility index (five-dimensional health status measure) and EQ VAS (self-rated overall health scale) for overall health, physical and social activities. All outcomes were assessed at baseline, 3 months and 6 months. To compare the overall benefit of these interventions, QALYs were estimated based on HRQoL. Linear mixed models for repeated measures were used to estimate the mean difference (95% CI) in outcomes.

No statistically significant differences between the groups were found in any outcomes at either three or 6 months (p>0.05).

No difference between the groups was found on PROMs and QALYs. Future research should include larger sample sizes and a non-exercising control group to better determine the efficacy of AHIIT and clarify the role of exercise intensity in symptom management.

NCT05209802.

Preoperative prehabilitation programmes for patients with colorectal cancer have been shown to reduce complications and hospital length of stay. However, supervised weekly physiotherapy is expensive and timeconsuming for both healthcare professionals and patients, leading to suboptimal implementation of prehabilitation programmes. A previous study demonstrated that offering home-based prehabilitation through an app is feasible and leads to outcomes comparable to supervised prehabilitation programmes. This study was conducted at a single hospital. To expand this promising modality nationwide, it is essential to identify key implementation determinants. We therefore initiated this multicentre study involving a more diverse and heterogeneous patient population. The findings of this study will provide valuable input for scaling strategies for prehabilitation programmes in the Netherlands and beyond.

In this prospective multicentre cohort study, approximately 300 patients with colorectal cancer scheduled for curative surgery will be enrolled over 12 months. The study adopts a hybrid type 3 design, reporting clinical outcomes while exploring implementation-related factors. Five hospitals with varied profiles (academic, non-academic teaching and general hospitals) and geographical locations (urban and rural, high and low socioeconomic areas) are participating. The primary endpoint is the identification of barriers and facilitators, using both qualitative (interviews) and quantitative (user statistics, questionnaires) data from stakeholders. Secondary endpoints include fitness and clinical outcomes such as complications and mortality.

This study was approved by the METC (Medisch Ethische Toetsings Commissie / Dutch Medical Ethics Committee) and was established not to apply to the Medical Research Involving Human Subjects Act (WMO / Wet Medisch Wetenschappelijk Onderzoek met mensen); submission was 21 April 2025. The app is proven safe and feasible in earlier studies and is CE certified (Conformité Européenne). Informed consent will be obtained from all patients (Supplement 1). Adverse events will be monitored and reported. Only researchers will have access to the final dataset. Results will be disseminated through publications, patient group briefings and implementation feedback to healthcare workers. Plans for sharing deidentified individual clinical trial participant-level data consist of quotes from interviews held on stakeholders. This study protocol adheres to the SPIRIT guidelines.

As of 2024, 123.2 million people had been forcibly displaced as a result of persecution, armed conflict or climate-related catastrophes, and these numbers are predicted to rise. There is a growing awareness of possible intergenerational effects of trauma on life-course health and well-being, however few studies have followed individuals longitudinally starting prenatally. This paper describes the first large prenatal birth cohort study in a refugee context in a lower middle-income country. This study aims to investigate the potential lifespan health and developmental implications of being born into a protracted humanitarian context, and what factors can buffer from the adversity posed by conflict and displacement.

We outline our approach of recruiting, consenting and gathering data from pregnant Rohingya refugee and host community women (N=2888; 80% Rohingya) over the course of 12 months in Cox’s Bazar, Bangladesh.

A fifth wave of data collection, when children were 6 months old, was completed in April 2025. Rohingya women were substantially less literate; were marrying and having children at slightly younger ages, were more likely to live in crowded, resource-limited households and exhibited higher rates of clinically significant post-traumatic stress disorder and anxiety than host community women.

There is a critical need for research in displaced populations in order to elucidate potentially lasting transgenerational impacts of experiencing conflict and displacement trauma, and the prenatal and postnatal factors that support health and development across the life span. The next follow-up is planned when the children turn 36 months of age (starting March 2026).

This study compared the effectiveness of first-time use of faster aspart with rapid-acting insulin analogues in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D).

This retrospective cohort study used data from 1 January 2017 to 8 May 2021 captured in the Clinical Practice Research Datalink Aurum database in the UK.

Patients with T1D or T2D either initiating faster aspart or another rapid-acting insulin analogue (‘new users’) or switching from a rapid-acting insulin analogue to faster aspart or to another rapid-acting insulin analogue (‘switchers’) were included. The index date was the date of first prescription of faster aspart or a rapid-acting insulin analogue, or of switching to a different rapid-acting analogue or to faster aspart.

A total of 9695 and 2170 patients were included in the new users (T1D, 1737; T2D, 7958) and switchers cohorts (T1D, 1764; T2D, 406), respectively.

Glycated haemoglobin (HbA1c) change at 6 months, occurrence of hypoglycaemia from index to 12 months post-index and treatment persistency from index to discontinuation or censoring.

Numerically greater reductions were observed with faster aspart than rapid-acting insulins in T1D switchers and new users in change in HbA1c at 6 months. Patients with T1D who switched to faster aspart experienced a significant reduction in rate of hypoglycaemia (p=0.0021). Treatment persistency was higher with faster aspart than with rapid-acting insulins among T1D switchers. No distinction in treatment persistency was observed between the treatment groups for T1D new users or T2D switchers.

Reductions in HbA1c were numerically larger with faster aspart in three of four subgroups. There was higher treatment persistency with faster aspart vs rapid-acting insulin analogues among T1D switchers.

NN1218-4967.

Inappropriate medication use among surgical patients poses significant risks, including antibiotic resistance, complications, mortality, increased healthcare costs and challenges in pain management. This study aimed to assess the extent of inappropriate antibiotic and analgesic prescriptions, treatment adequacy and contributing factors.

A hospital-based cross-sectional study was conducted among patients admitted to surgical wards in three comprehensive specialised hospitals in northwest Ethiopia.

All eligible adult patients admitted to the surgical wards during the data collection period were included in the study.

The primary outcomes were the appropriateness of antibiotic and analgesic prescriptions. To assess patients’ pain perception and the effectiveness of pain management strategies, the American Pain Society Patient Outcome Questionnaire was used. The Pain Management Index was employed to evaluate the treatment adequacy. The RAND (Research and Development)-modified Delphi method was applied to reach expert consensus on best practices for antibiotic prescribing. Additionally, the national standard treatment guideline was used to benchmark prescribing practices. Binary logistic regression was used to identify factors associated with inappropriate prescriptions of antibiotics and analgesics.

The prevalence of inappropriate antibiotics use was 67.5% and 42.2% of patients received inappropriate analgesic prescriptions. Moreover, 51.6% of patients experienced inadequate pain management. Significant factors associated with inappropriate antibiotic prescription included the presence of comorbidities (adjsuted OR (AOR) 3.34, 95% CI 1.88 to 5.92), lack of laboratory tests (AOR 0.26, 95% CI 0.16 to 0.43, higher number of medications (AOR 2.71, 95% CI 1.62 to 4.52) and contaminated wound class (AOR 3.13, 95% CI 1.58 to 6.20). For inappropriate analgesic prescription, pain due to disease (AOR 8.69, 95% CI 1.73 to 4.62), mixed causes of pain (AOR 7.20, 95% CI 1.43 to 6.31), head and facial pain (AOR 0.14, 95% CI 0.05 to 0.39) and an increased number of medications (AOR 2.75, 95% CI 1.72 to 4.41) were significant factors.

The majority of the patients admitted to surgical wards were found to receive inappropriate antibiotic and analgesic medications. Prescribers should pay attention to patients with comorbid diseases, receiving multiple medications. Additionally, routine laboratory tests are essential for guiding antibiotic therapy and improving patient outcomes in surgical wards.

Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18–19 years.

Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18–19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.

This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will be enrolled in the study following their informed written consent. Results will be submitted for publication. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guidelines will be used for reporting.

NCT06509776.

To identify gait biomechanical characteristics associated with pain and cartilage damage in individuals with patellofemoral joint osteoarthritis (PFJ OA) during a stair descent activity.

Cross-sectional observational study.

University-based motion analysis laboratory and musculoskeletal imaging centre.

83 participants entered the study; 66 participants (41 female, 25 male) completed all components required for this analysis. Participants were recruited via electronic health records following clinical knee MRI. Inclusion criteria included MRI-confirmed patellofemoral cartilage lesions using Whole Organ MRI Score (WORMS) gradings (WORMS >1), pain during stair ambulation, body mass index (BMI) ≤35 and informed consent. Exclusion criteria were tibiofemoral abnormalities (WORMS >1), prior knee trauma, gait-altering conditions, MRI contraindications or pregnancy.

Primary outcomes included knee joint kinematics and during stair descent, assessed during three-dimensional motion capture, patient-reported outcomes from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire and WORMS gradings to assess severity of cartilage abnormalities. Regression analyses were performed to examine correlations of biomechanics, age and BMI with pain and cartilage damage. Analyses were also performed on male and female participants separately.

Significant associations were found between biomechanical characteristics and KOOS scores (pain, symptoms and patellofemoral) as well as cartilage damage. For the whole cohort, greater knee flexion at late stance was linked to worse KOOS scores (β=0.53 to 0.71, p

Altered knee biomechanics during stair descent are linked to worse knee pain, function and cartilage damage in PFJ OA, with sex-specific differences emphasising the need for individualised interventions to address movement abnormalities.

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

ISRCTN17922845.

The study aims to explore the experiences of adolescent girls with the onset of their first menstruation in the context of Pakistan and to highlight the sociocultural aspects that shape those experiences.

The study employs an exploratory phenomenological approach.

This study has been conducted at a public sector higher education institute, University of the Punjab, Pakistan. Female students enrolled in the first semester of the undergraduate degree programme were included in the study using a predefined inclusion and exclusion criteria.

Data was collected from six 18 years old girls who had their menarche in the last 6 years through face-to-face in-depth interviews using a semi-structured interview guide from June 2024 to August 2024. The interviews were audio-recorded given the written consent of the participants. Transcripts were analysed thematically following Braun and Clarke’s framework.

Thematic analysis of six interviews revealed three major themes: (1) Experience of first blood: emotional, social and practical difficulties; (2) The problem of mismanagement of first menstruation and the strategies used; and (3) Restrictions during menstruations. The study found that adolescent girls are provided with little to no prior knowledge regarding menarche and menstruation that causes various complexities and vulnerabilities. The social and cultural expectations and the gendered norms construct the experiences of the adolescent girls regarding their first menstruation, while the idea of womanhood is preserved in the society by restricting, isolating and alienating the adolescent girls and modifying their conduct and behaviour accordingly.

Menarche is often experienced as distressing, secretive and isolating for adolescent girls in Pakistan. Educational interventions in families and schools are needed to provide accurate, timely information and to support girls in navigating this transition with confidence and dignity.

The primary objective of this study is to investigate the perceived need and attitudinal perspectives regarding menstrual leave policies among young women in rural South India. The secondary objective was to determine the socio-demographic, menstrual and workplace-related factors associated with attitudes towards menstrual leave among young women.

An analytical cross-sectional study was performed from May 2023 to August 2023.

In a rural district of Tamil Nadu, South India.

The study encompassed 955 young female students above 18 years of age enrolled in educational institutions in a rural district of Tamil Nadu, India. Participants were pursuing diverse professional programmes including medical, dental, allied health sciences, pharmacy and engineering courses.

The primary outcomes included assessment of basic menstrual characteristics (age of menarche, regularity, product usage and pain experiences), pain evaluation using the WaLIDD scale (which measured working ability, anatomical pain location, pain intensity via Wong Baker scale and pain duration) and attitude assessment through a 10-dimension Likert scale. The attitude assessment explored both supportive factors (pain management, environmental considerations, medical leave allocation, menstruation normalisation and performance impact) and potential concerns (medicalisation, perceptions of fragility, stigma, disclosure issues and abnormal leave usage). Secondary outcome measures encompassed the analysis of factors influencing these attitudes, followed by a multivariable linear regression model to identify significant predictors.

Among 955 female students (mean age 19.56±1.33 years), the majority supported menstrual leave for maintaining hygiene (82.3%) and managing dysmenorrhoea (75.8%). A substantial proportion (64.4%) viewed it as a means of normalising menstruation discourse, while 61.6% believed it could enhance workplace performance. However, concerns existed about medicalising menstruation (47.9%) and reinforcing gender stereotypes (43.4%). Multivariate analysis revealed that medical students (B=0.67, 95% CI: 1.34 to 2.00), those with graduate-educated fathers (B=1.64, 95% CI: 0.31 to 2.97), earlier age at menarche (B=–0.23, 95% CI: –0.45 to –0.01) and participants reporting menstrual interference with daily activities (B=0.96, 95% CI: 0.02 to 0.89) held significantly more positive attitudes.

While young women generally support menstrual leave policies, particularly for hygiene and pain management, there are significant concerns about workplace stigmatisation and gender stereotyping. Educational background, parental education and personal menstrual experiences significantly influence attitudes toward menstrual leave. These findings suggest the need for carefully structured menstrual leave policies that balance biological needs with workplace/student place equality concerns.

Non-communicable diseases (NCDs), such as diabetes, cardiovascular diseases and cancer, are major global public health concerns. Diet quality—particularly the consumption of ultra-processed foods—has been associated with increased risk of NCDs. Traditional cohort studies are often expensive and logistically complex. The NutriNet-Brasil cohort leverages a web-based approach, offering a cost-effective and practical solution for comprehensive data collection and long-term follow-up.

Recruitments began in January 2020 through mass media, social media campaigns and collaborations with health organisations. Eligible participants are adults (aged ≥18 years) living in Brazil with internet access. Participants complete self-administered online questionnaires covering dietary intake, health status and other health determinants. Dietary assessment is based on the Nova classification system, which categorises foods by their level of processing.

Over 88 000 participants have completed the initial questionnaire. The cohort is predominantly women (79.9%) and highly educated (67.9% had completed higher education). The web-based design enabled the development and application of innovative dietary assessment tools, including the Nova24h and the Nova24hScreener, specifically designed to evaluate food processing levels. These tools have shown good performance in capturing dietary patterns and are central to the cohort’s aim. The online platform facilitates efficient recruitment, data collection and participant retention.

NutriNet-Brasil is pioneering the development of web-based cohort methodologies and instruments tailored to food processing research. Future work includes leveraging collaborations with national and international research centres to conduct multidisciplinary analyses and inform public health policies.