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Prescribing practices of healthcare professionals regarding multivitamins and mineral supplements in Pakistan: a cross-sectional study

Por: Mubashir · M. · Naz · S. · Shabbir · M. · Zehra · N. · Majid · H. · Jafri · L. · Habib · A. · Iqbal · R.
Background

Multivitamins and minerals (MVMs) are readily available dietary supplements that help prevent nutritional deficiencies and boost energy. This study examined the prescribing and consultation practices of healthcare professionals (HCPs) related to MVM supplements in Pakistan.

Methods

This cross-sectional study used a web-based structured questionnaire to collect data from HCPs from February 2021 to January 2022. The study link, which included a consent form and questionnaire, was circulated on social media platforms, and all individuals who provided consent and completed the forms were included in the study.

Results

A total of 524 HCPs participated in the study, with the majority being males, holding MBBS or Fellow of the College of Physicians and Surgeons qualifications, and working in urban settings. Findings revealed that HCPs prescribe MVMs for varied reasons. We assessed differences based on various factors like gender, education level, area of practice and specialty. Most of the differences observed were not statistically significant, except for a few related to area of practice and education level that were found significant. The primary conditions prompting MVM prescriptions included osteoporosis and bone pain (80% for vitamin D and calcium), fatigue and weakness (over 70% for iron) and numbness/tingling (more than half for folate and vitamin B12). Regarding biospecimen analysis before prescribing MVMs, 46% of HCPs required laboratory investigations before prescribing vitamin D and calcium and 60% for iron prescriptions. Common formulations prescribed include cholecalciferol for vitamin D deficiency (62%) and ferrous sulfate for iron deficiency (76%).

Conclusion

Our study findings highlight that the prescribing practices of MVMs by HCPs are primarily in line with the known physiological roles of these supplements. However, a few identified gaps in practices highlight the need for standardised guidelines to ensure patients’ health and well-being.

First population-based study on non-communicable diseases and risk factors in northeastern Iran: Sabzevar cohort profile

Por: Ghorat · F. · Chaman · R. · Javadinia · S. A. · Rad · M. · Mohammadzadeh · M. · Hassanpour · K. · Foroumandi · E. · Nazarzadeh · M. · Saghi · M. H. · Salari · M. · Bidel · Z. · Eghtesad · S. · Gohari · A. · Mohammadi · Z. · Borghabani · R. · Ghorbani · M. M. · Moslem · A. · Norouzi · S.
Purpose

Non-communicable diseases (NCDs) have become the leading cause of mortality globally, with a sharp rise in Iran due to lifestyle changes and urbanisation. Although many NCD risk factors are modifiable, limited understanding of their determinants hinders effective prevention. To address this, the Prospective Epidemiological Research Studies in Iran (PERSIAN) Cohort was established in 2014 to study NCDs nationwide. The Sabzevar PERSIAN Cohort Study (SPECS) is the first in northeastern Iran, aiming to investigate environmental and social factors influencing NCDs in a unique regional context.

Participants

SPECS enrolled 5174 adults (aged 35–70 years) in northeastern Iran between January 2018 and January 2019 through a census and an online registration process. The baseline data collection included demographic verification, informed consent, health questionnaires, anthropometric measurements and biological samples (blood, urine, hair, nails). The annual follow-up began in April 2019, with full reassessments every 5 years over a 15-year period. The data is gathered via an active and passive follow-up, supported by trained staff and registry linkages.

Findings to date

Of the 5174 participants, 4241 (81%) remained in the study. Among the cohort, 54.5% were female, with a mean age of 50.5 years. The majority were married (93.5%), and nearly half had at least high-school education (46.5%) and moderate socioeconomic status (49.4%). Drug abuse history (smoking/drugs) was reported by about 15% of the sample. The mean body mass index was 26.9 kg/m², and the average blood pressure was higher in males (118.1/74.0 mm Hg) than in females (111.5/70.2 mm Hg). The common conditions included hypertension (22.8%), kidney stones (22.4%), fatty liver (15.4%) and diabetes (13.8%). Cancer had the highest treatment rate (100%), while fatty liver had the lowest (70.1%). Stroke had the highest mean age of onset (51.2 years), and epilepsy the lowest (23.7 years). All health data were self-reported.

Future plans

SPECS, part of the national PERSIAN cohort initiative, is the only adult NCD-focused study in Khorasan Razavi. Its 15-year follow-up aims to generate region-specific insights into the incidence of NCDs and their risk factors. The ethnically homogeneous sample enhances statistical power, and the findings may inform culturally tailored health policies. While self-reported data have limitations due to bias, high initial participation and access to free healthcare support long-term engagement, especially among lower-income groups.

Cohort profile: Sub-cohort study on the second phase of the Chiba Study of Mother and Child Health (C-MACH), Japan

Purpose

The second phase of the Chiba Study of Mother and Child Health (C-MACH) was initiated to investigate how environmental exposures from the fetal period to early childhood influence maternal and child health outcomes. The sub-cohort focuses specifically on detailed assessments of indoor environmental factors and neighbourhood-built and social environments. By integrating environmental metrics with biological, behavioural and sociodemographic data, the study aims to elucidate their role in the development of allergies, neurodevelopmental disorders and other non-communicable diseases in early life.

Participants

Between June 2021 and April 2023, 505 pregnant women were enrolled in the second phase of the C-MACH main study. Of these, 298 participants consented to join the sub-cohort study, including 258 in the sleep and physical activity monitoring option (Option 1) and 148 in the indoor allergen exposure sub-study (Option 2). The study includes biological sampling, environmental monitoring and repeated questionnaire surveys. At baseline, 253 live births were recorded from 251 pregnancies.

Findings to date

Of the 298 women, 272 completed early pregnancy questionnaires. The mean maternal age was 33.1 years (SD 4.6); 97.8% were married. University-level education was reported by 51.0% of mothers and 53.7% of fathers. Most households had an annual income of 6 to

Future plans

Longitudinal follow-up will continue until the children reach age 15. Future analyses will examine associations between environmental exposures and allergic, developmental, endocrine/metabolic and obesity-related outcomes.

Impact of treatment-induced thrombosis on the prognosis of acute lymphoblastic leukaemia: a protocol for a systematic review and meta-analysis

Por: Mkhwanazi · Z. A. · Fabunmi · O. A. · Nkambule · B. B.
Introduction

Therapy-associated thrombosis remains a challenge in the management of patients with acute lymphoblastic leukaemia (ALL). Thrombosis associated with asparaginase-containing chemotherapy complicates patient management strategies, prompting the need for effective prophylaxis. Assessing the relationship between chemotherapy-induced thrombosis and patient outcomes is crucial for optimising ALL management strategies. The aim of this systematic review is to provide a synthesis on whether the development of thrombosis during asparaginase-containing chemotherapy regimens impacts the overall and event-free survival of patients with ALL.

Methods and analysis

Data sources: to identify relevant studies, a comprehensive search will be conducted on the major electronic databases, including MEDLINE (PubMed), Web of Science (Clarivate), Academic Search Complete (EBSCOhost), clinicaltrial.gov and the Cochrane Central Register of Controlled Trials from inception to 30 January 2026.

Inclusion criteria for selecting studies: randomised and non-randomised clinical studies evaluating the impact of asparaginase-containing chemotherapy-associated thrombosis on survival outcomes in patients with ALL will be included. Two reviewers will independently screen the retrieved studies, extract data and assess study quality using a predefined criteria. A narrative synthesis will be undertaken, and if feasible, meta-analyses will be conducted. A subgroup and sensitivity analysis will be performed to explain the sources of heterogeneity. The quality of cumulative evidence will be assessed using the grading of recommendations assessment, development and evaluation tool. The findings from this systematic review will inform evidence-based clinical guidelines for thrombosis risk assessment and management in patients with ALL, potentially improving treatment outcomes and reducing thrombosis-related morbidity.

Ethics and dissemination

No ethical approval will be required and the findings of this meta-analysis will be published in a peer-reviewed journal.

Trial registration number

CRD42024532665.

Evaluating the delivery of trauma and orthopaedic education in UK medical schools: a national cross-sectional survey protocol (TENDON study)

Por: Nazar · N. · OHanlon · C. · Kolhe · S. · Bellamy · M. · Barberon · M. · Khajuria · A. · Low · W. X. · Geetala · R. · Chahal · K. · Banaszkiewicz · P. · McCaskie · A. · McDonnell · S.
Introduction

Musculoskeletal (MSK) conditions account for up to one-third of general practice consultations and over one-fifth of emergency department attendances in the UK. Postpandemic, the elective orthopaedic surgery backlog remains one of the most substantial across surgical specialties. Despite this burden, undergraduate exposure to trauma and orthopaedics (T&O) remains limited and inconsistent. Most UK medical students receive only 2–3 weeks of T&O teaching, with up to 40% of foundation doctors feeling underprepared to manage MSK conditions. The Evaluation of Trauma and Orthopaedic Teaching in Medical Schools Nationally (TENDON Study) aims to evaluate the current state of undergraduate T&O education in UK medical schools from both student and educator perspectives.

Methods and analysis

This national, prospective, cross-sectional survey will be conducted between 25 July and 27 October 2025. A dual-instrument electronic survey was developed through Qualtrics, informed by the British Orthopaedic Association (BOA) Undergraduate Curriculum and UK Medical Licensing Assessment content map. Participants will include medical students (Years 1–6), foundation doctors and orthopaedic educators recruited through British Orthopaedic Medical Students Association and BOA networks, and designated school representatives. Survey domains include curriculum coverage, teaching methods, clinical exposure and self-reported competence. Quantitative data will be analysed using descriptive and inferential statistics; qualitative data will undergo thematic analysis. Reporting will follow the Checklist for Reporting Of Survey Studies framework, with relevant elements drawn from the Checklist for Reporting Results of Internet E-Surveys checklist.

Ethics and dissemination

Ethical approval was obtained from the Human Biology Research Ethics Committee, University of Cambridge. Findings will be disseminated via peer-reviewed publication, conference presentations and summary reports to curriculum leads and relevant educational bodies.

Cervical high-risk human papillomavirus infection and its associated risk factors: a community-based cross-sectional study in hard-to-reach areas in Bangladesh

Por: Nazrul · N. · Rahman · A. · de Fouw · M. · Campbell · C. · Koot · J. · Kulsum · M. U. · Ahmed · M. S. · Haider · S. S. · Hossain · M. A. · Islam · K. M. · Nessa · A. · Amrin · M. · Stekelenburg · J. · Beltman · J. J.
Objectives

This study aimed to determine the prevalence of cervical high-risk human papillomavirus (hrHPV) in a community-based setting and its risk factors association in women living in hard-to-reach areas in Bangladesh.

Design

A cross-sectional study

Setting

The study was carried out in six subdistricts, located in hard-to-reach and climate-impacted regions of Bangladesh.

Participants

A total of 8000 married women aged 30–60 years were invited for screening. Women who were unable to give consent, were pregnant or had a hysterectomy with removal of the cervix, previous screening less than 5 years, or treatment of the cervix or had symptoms of potential cervical cancer were excluded.

Interventions

A community-based hrHPV self-collected screening for cervical cancer was conducted from June 2022 to July 2023.

Main outcome measures

Prevalence of cervical hrHPV and risk factor association.

Results

11 127 women were eligible for screening; 7850 women submitted hrHPV self-swabs, 7828 valid HPV test results were reported and 164 women (2.1%) tested hrHPV positive. Women living in the North were 2.1 times more likely to be hrHPV positive compared with women living in the South (adjusted OR (AOR)=2.1, 95% CI: 1.5 to 3.8, p=0.023) and widowed women were 3.0 times more likely to be hrHPV positive than married women (AOR=3.0, 95% CI: 1.7 to 5.3, p=0.001). Another risk factor associated with testing hrHPV positive was the use of hormonal contraceptives for 5 years and above (AOR=7.0, 95% CI: 2.0 to 24.4, p=0.002).

Conclusion

The study identified a low overall prevalence of hrHPV infection (2.1%) among women in hard-to-reach areas in Bangladesh, with some regional variations. Higher prevalence was observed in widowed compared with married women and among women reporting more than 5 years of hormonal contraceptive use. This study shows no evidence of particularly high-risk groups in hard-to-reach areas in Bangladesh. The findings support the feasibility of implementing a nationwide hr-HPV-based self-sampling strategy as a viable approach to reach WHO targets for reducing the burden of cervical cancer. Recommendation for policymakers to support future research to identify hrHPV prevalence among women in comparable groups in other geographically remote areas in Bangladesh.

Trial registration number

NCT05234112.

Public-private mix for tuberculosis in urban health systems in least-developed, low-income and lower-middle-income countries and territories: a systematic review

Por: Vidyasagaran · A. L. · Teixeira de Siqueira Filha · N. · Kakchapati · S. · Hall · T. F. · Naznin · B. · Tajree · J. · Quayyum · Z. · Joshi · D. · Sibeudu · F. T. · Ogbozor · P. A. · Arize · I. N. · Shrestha · G. · Golder · S. · Ahsan · M. · Adhikary · S. · Agwu · P. · Elsey · H.
Objective

To evaluate the impact of public–private mix (PPM) models for tuberculosis (TB) on health, process and system outcomes, adopting the WHO’s definition of PPM, which is a strategic partnership between national TB programmes and healthcare providers, both public and private, to deliver high-quality TB diagnosis and treatment.

Design

Systematic review without meta-analysis using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.

Data sources

EMBASE, MEDLINE, Health Management Information Consortium, Social Sciences Citation Index, Science Citation Index, Emerging Sources Citation Index, CENTRAL, Database of Disability and Inclusion Information Resources, WHO Library Database and 3ie.

Eligibility criteria

We included all primary studies examining PPM models delivering TB services in urban health sectors in least-developed, low-income and lower–middle-income countries and territories.

Data extraction and synthesis

17 reviewers were involved in data extraction in COVIDENCE using a prepiloted template. All extractions were completed by a single reviewer and checked by a second reviewer. Quality appraisal was carried out using the mixed-methods appraisal tool, covering mixed-methods, qualitative and quantitative study designs. Narrative synthesis was carried out by tabulating and summarising studies according to PPM models and reported in line with the synthesis without meta-analysis guidelines.

Results

Of the 57 included studies, covering quantitative (n=41), qualitative (n=6) and mixed-method (n=10) designs, the majority were from Southeast Asia (n=37). PPM models had overall positive results on TB treatment outcomes, access and coverage and value for money. They are linked with improved TB health workers’ skills and service delivery. Most outcomes tended to favour interface models, although with considerable heterogeneity. Inconsistent implementation of national TB guidelines, uncoordinated referrals and lack of trust among partners were identified as areas of improvement. Evidence was lacking on the involvement of informal providers within PPM models.

Conclusions

PPM models can be effective and cost-effective for TB care in urban low- and middle-income countries contexts, particularly when levels of mistrust between public and private sectors are addressed through principles of equal partnership. The evidence indicates that this may be more achievable when an interface organisation manages the partnership.

PROSPERO registration number

CRD42021289509.

Association of fine particulate matter exposure during pregnancy and stillbirth rates in Pakistan: a cross-sectional study

Por: Hameed · W. · Usmani · B. A. · Rehman · S. U. · Ahmed · M. · Allana · A. · Minaz · A. · Ahmed · Z. · Fatmi · Z.
Objectives

This study assessed the association between fine particulate matter (PM2.5) exposure during pregnancy and stillbirth in Pakistan. We hypothesised that higher PM2.5 exposure is linked to increased stillbirth risk.

Design

A cross-sectional study using secondary data from the 2017 to 2018 Pakistan Demographic and Health Survey (PDHS), combined with satellite-derived PM2.5 exposure data.

Setting

The study covered urban and rural areas across Pakistan, including all four provinces (Punjab, Sindh, Khyber Pakhtunkhwa and Baluchistan) and administrative regions (Gilgit-Baltistan (GB), Islamabad, Federally Administered Tribal Areas and Azad Jammu Kashmir).

Participants

The study included 9172 married women aged 15–49 with at least one birth in the past 5 years. Women with incomplete pregnancy outcome data were excluded.

Exposure assessment

PM2.5 exposure was estimated using satellite data, matching PDHS clusters with the nearest air quality point via MATLAB. Monthly average exposure was categorised into quartiles.

Primary outcome

Stillbirth, defined as pregnancy loss at ≥28 weeks gestation.

Results

Multivariable logistic regression was used to assess the association between PM2.5 and stillbirth, adjusting for maternal age, gravidity, wealth index, birth interval, previous adverse pregnancy outcome and region of residence. The stillbirth rate in Pakistan for the most recent pregnancy was 17.0 (14.5–19.9) per 1000 births, with highest rates (28.9) in Baluchistan province. The mean level of PM2.5 exposure in Pakistan was 53.96 (SD 20.42; range 5.9–209.4) µg/m3. PM2.5 exposure was higher for urban (56.43) than rural (51.87) pregnancies, highest in Sindh (78.06) and lowest in GB (13.41) provinces. For every 1 µg/m3 average increase in PM2.5 during the pregnancy period, there was approximately 1% increase in stillbirth.

Conclusions

Increased PM2.5 exposure was strongly associated with stillbirth risk. This underscores the need for targeted public health interventions, such as government regulations, emission controls and clean energy initiatives to protect pregnant women in high-risk areas.

Impact of clinical decision support software on empirical antibiotic prescribing and patient outcomes: a systematic review and meta-analysis

Por: Hatton · C. · Quarton · S. · Livesey · A. · Alenazi · B. A. · Jeff · C. · Sapey · E.
Objectives

To identify Clinical Decision Support Software (CDSS) that have been implemented in hospital which aim to influence empirical antibiotic prescribing, and to establish their impact on antibiotic prescribing and patient outcomes.

Design

Systematic review & meta-analysis.

Data sources

MEDLINE, Cochrane Central Register of Controlled Trials and Embase were searched from their inception to February 2024.

Eligibility criteria

Studies evaluating the impact of digital CDSS with the primary purpose of influencing initial empirical antibiotic prescribing for patients with acute infection in hospital.

Data extraction and synthesis

Study characteristics, intervention characteristics and outcome data were extracted independently by two reviewers. Outcomes were grouped into four domains including clinical outcomes (mortality, length of stay, readmission rates), antibiotic appropriateness (guideline adherence, coverage of causative organism), antimicrobial stewardship and health economics. Risk of bias assessment was conducted using Risk of Bias In Non-randomised Studies - of Interventions for non-randomised studies and Cochrane Risk of Bias 2 for randomised studies. Outcome data with sufficient reporting and homogeneity were synthesised quantitatively using a random-effects meta-analysis; other outcomes were synthesised qualitatively.

Results

15 full texts met the eligibility criteria after screening 7984 unique studies. Low-quality evidence suggested that implementation of CDSS was associated with lower mortality (OR 0.76, 95% CI 0.57 to 1.01) and improved adherence to antibiotic prescribing guidelines (OR 1.75, 95% CI 1.26 to 2.43). No change in length of stay or readmission rates were observed. Coverage of the causative organism was similar after CDSS implementation (OR 1.26, 95% CI 0.97 to 1.63). High-quality evidence supported the association between CDSS implementation and reduced broad-spectrum antibiotic prescribing.

Conclusions

CDSS can be used to reduce the unnecessary prescribing of broad-spectrum antibiotics. Further high-quality studies are required to establish whether their implementation also results in improvements in other outcomes.

PROSPERO registration number

CRD42024501185.

Attitudes, awareness and experience of Italian women undergoing non-invasive prenatal testing (NIPT): a nationwide cross-sectional study

Por: Godino · L. · Nardi · E. · Lanzoni · G. · Pompilii · E. · Calabrese · S. · Bertonazzi · B. · Carrara · M. · Gazineo · D. · Turchetti · D.
Objectives

Despite the increasing availability of non-invasive prenatal testing (NIPT), women’s experiences and motivations remain largely unknown. The use of NIPT is increasing in Italy; however, its organisation and access paths vary considerably. Women may undergo testing in either public or private facilities, where differences in pretest information, testing procedures and result communication may influence their experience. This study aims to investigate the attitudes, awareness and experiences of Italian women undergoing NIPT.

Design

A cross-sectional anonymous online survey was conducted via social media in the period March–August 2023.

Setting

This nationwide study was conducted in Italy.

Participants

Women over 18 years old who had undergone NIPT were included.

Results

Responders were 4154 women from every part of Italy. Most participants perceived the information provided during pre-NIPT counselling as extremely/very clear (68.2%) and helpful (72.5%), with higher proportions observed when counselling was delivered by geneticists. The mean knowledge score was 12.3 (range: 0–15) and was statistically higher for women with higher education level and prior NIPT experience. Half of the women reported no change in their perceived risk of having a child with chromosomal abnormalities after pre-NIPT counselling, and risk perception reduction was associated with lower knowledge scores. Pretest negative emotions were common (54.9%) and influenced by testing context, information sources and reasons for testing. Most women reported a positive impact from results (92.7%), shaped by information delivery made and prior knowledge. Regret was rare (3.0%) and linked to reasons and perceived risk changes. Overall, satisfaction was high (97.3%), particularly among those prioritising informed decision-making.

Conclusions

Improving personalised counselling and education throughout the NIPT journey seems crucial to minimise negative emotional impacts, highlighting the need for well-trained healthcare professionals.

Enablers and barriers of e-learning utilising smart technologies in type 2 diabetes care for clinicians: a systematic review

Por: Alanazi · M. M. · Fellas · A. · Bridge · P. · Acharya · S. · Santos · D. · Sculley · D. · Girones · X. · Coda · A.
Objectives

Continuous Glucose Monitoring (CGM) supports Type 2 Diabetes (T2D) management, but healthcare professionals (HCPs) often face challenges interpreting data. E-learning platforms can enhance knowledge, skills and confidence. This systematic review identified enablers and barriers to e-learning for CGM interpretation.

Design

Systematic review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Data sources

PubMed, Ovid MEDLINE, Ovid Embase, Cochrane Library, Scopus, Web of Science and CINAHL were searched on 7 February 2024.

Eligibility criteria for selecting studies

Studies of HCPs using e-learning for T2D management were included, both comparative and non-comparative. Outcomes included enablers and barriers. Eligible designs were randomised, quasi-experimental, controlled before-and-after and observational studies. No restrictions on setting or language; conference abstracts included if full text was available

Data extraction and synthesis

Two reviewers independently screened and extracted data using a predefined form; disagreements were resolved by a third reviewer. Thematic analysis identified key enablers and barriers. Methodological quality was assessed using the Downs and Black checklist, and findings were synthesised narratively.

Results

Four studies met inclusion criteria, including 6790 participants (physicians, nurses, midwives and medical residents). E-learning improved knowledge and skills. Emami et al reported increased knowledge of T2D diagnosis and treatment (p=0.001), while Okuroğlu and Alpar found improvements in diabetes care knowledge and skills (pet al noted enhanced self-reported performance (p=0.03) and 84% satisfaction. Enablers included flexibility and accessibility, while barriers involved time constraints, resistance to change and methodological limitations (self-selection bias, lack of blinding). Study quality ranged from fair (three studies) to poor (one study).

Conclusion

Based on current evidence, it is unclear if e-learning can significantly enhance HCPs’ knowledge, skills and confidence in T2D management. Barriers such as time constraints and resistance to change remain, and the limited number and quality of studies restrict the generalisability of these findings. E-learning may offer potential benefits, but further robust randomised controlled trials are needed to evaluate long-term outcomes and strategies to overcome these challenges.

PROSPERO registration number

CRD42023455156.

Realist review of informal carer involvement in the transition of medicines-related care for patients moving from hospital to home

Por: Richardson · C. L. · Cooper · M. · Atkinson · O. · Black · D. · Lindsey · L. · Cooper · C. · Nazar · H. · Wong · G. · Hughes · C.
Objective

The aim of this work was to understand carer involvement in transitions of care from hospital to home in relation to medicines management. Specifically, via a realist review, to describe how carers provide support, to what extent do they support patients and under what circumstances are carers able to provide support towards patient care in relation to medicines management.

Design

A realist review was conducted in line with a published protocol and as registered via PROSPERO (CRD42021262827). An initial programme theory (PT) was developed before searches of three databases, PubMed, CINHAL and EMBASE, were conducted in accordance with eligibility criteria. Data were extracted from eligible studies and synthesised into realist causal explanations in the form of Context-Mechanism-Outcome-Configurations (CMOCs) and the PT was refined. Throughout the review, a patient and PPIE group (n≥5) was involved, meeting five times, to inform the research focus and develop CMOCs and the PT by providing feedback and ensuring they capture the carer experience.

Results

Following title and abstract screening of 4835 papers, the final number of included articles was 208. The evidence synthesis identified 31 CMOCs which were categorised into three themes: (1) continuum of support; (2) understanding the carers’ priorities, role and responsibilities through shared decision-making (SDM) and (3) access to appropriate materials, resources and support information. These themes were formed into an updated PT with accompanying narrative that explained the transition from hospital to home involving carers in medicines management and identified possible areas for future intervention development.

Conclusion

This review provides insights and recommendations on how carers can be better supported when managing medicines when patients are discharged from hospital. Carers need a continuum of support throughout and following the transition. Healthcare professionals can support this by understanding the carer’s priorities, role and responsibilities through SDM during the hospital stay. Consequently, carers can then be offered access to appropriate materials, resources and support information which allows them to provide better care relating to medicines in the long term.

Understanding and reframing clinical errors through just culture: protocol for the DECIDE mixed-methods study in Spanish healthcare and community contexts

Por: Mira · J. J. · Lorenzo · S. · Aranaz-Andres · J. M. · Macias-Maroto · M. · Cobos-Vargas · A. · Moreno Campoy · E. E. · Perez-Perez · P. · Trillo-Lopez · P. · Corpas-Nogales · E. · Gea Velazquez de Castro · M. T. · Arencibia-Jimenez · M. · Asencio · A. · Diez Herrero · D. · Molina
Introduction

Patient safety culture plays a crucial role in reducing clinical errors. By improving healthcare professionals’ and patients’ understanding of human fallibility and error attribution, patient care can be enhanced, fostering greater engagement from both groups. A Just Culture approach, which balances accountability and learning from errors, is a key factor in fostering this safety culture. The DECIDE Project aims to: (1) examine the conceptualisation of human fallibility within and beyond healthcare, (2) identify barriers and facilitators to Just Culture adoption, (3) assess the impact of psychoeducational interventions on professionals’ and social leaders’ attitudes toward clinical errors and (4) develop a roadmap for Just Culture implementation in healthcare.

Methods and analysis

A 36-month mixed-methods study including qualitative research, a survey of 1255 healthcare professionals, an experimental study with 180 participants (60 per arm) testing interventions based on cognitive dissonance and reasoned action theories and a consensus conference to develop a Just Culture roadmap. Participants include professionals from hospitals, primary care, long-term care, nursing homes and social leaders in Spain. The qualitative data collected during stages 1 and 4 will be analysed using MAXQDA software. In identifying factors related to the implementation of Just Culture during stage 2, ANOVA, t-tests and multiple linear regression will be conducted. To examine the effects of the interventions in phase 3, a linear mixed-effects model for repeated measures will be employed.

Ethics and dissemination

This study has received ethical approval from three institutional review boards. Findings will be disseminated through peer-reviewed publications, conference presentations and policy recommendations aimed at integrating Just Culture into national and international patient safety strategies. By promoting a constructive approach to errors, the project could enhance incident reporting, strengthen professional engagement in safety policies and foster a culture of learning and accountability. Its findings will guide policy recommendations for integrating Just Culture into national and international patient safety strategies, with potential applications beyond Spain.

ClinicalTrials.gov identifier

NCT06835517.

Clinical outcomes, cost-effectiveness and implementation of individualised physiotherapy using the Specific Treatment Of Problems of the Spine (STOPS) approach for chronic low back pain in Nigeria: a protocol for a prospective sequential clinical trial

Por: Danazumi · M. S. · Ford · J. · Kaka · B. · Hahne · A.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

PACTR202305707317550.

Art therapy with Mandala: study protocol for a randomised controlled clinical trial on anxiety and health status among pregnant women in Northern Iran

Por: Nazmi · S. · Behmanesh · F. · Nikbakht · H. A. · Govahi · M. · Hamidia · A.
Introduction

Pregnancy is a period of physiological, psychological, hormonal and social changes. Mothers experience pregnancy anxiety during this period. One treatment used to reduce anxiety is Mandala colouring. In the present study, we intend to determine the effectiveness of Mandala colouring on anxiety and health status in the second trimester of pregnancy in pregnant women.

Methods and analysis

In this randomised controlled clinical trial study, 60 women with a gestational age of 14–28 weeks and 43–96 scores on the Vandenberg Pregnancy Anxiety Questionnaire will be selected by convenience sampling and will be assigned to intervention and control groups by block randomisation. Information will be collected using demographic and midwifery, Vandenberg Pregnancy Anxiety and General Health Questionnaires. For pregnant women in the intervention group, Mandala colouring will be performed for 6 days, with each session lasting 30 min. The control group will receive routine care. Analyses will be done using SPSS V.22 software.

Ethics and dissemination

This study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.REC.1402.129). The trial will adhere to the ethical principles of the Declaration of Helsinki. Findings will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.

Trial registration number

Iranian Registry of Clinical Trials (IRCT20180218038783N6).

Impact of computerised visual-motor integration and visual perception training games on handwriting and visual skills in children with spastic cerebral palsy: study protocol for a randomised controlled trial

Por: kazemnazhand_Asl · A. · Dalvand · H. · Dadgar · H. · Khorrami-Nejad · M. · Rahsepar Fard · K.
Introduction

Visual perception and visual-motor integration skills are key predictors of handwriting. Children with cerebral palsy often experience difficulties in these areas, which can negatively affect handwriting. Interventions targeting these skills may improve handwriting outcomes in this population.

Methods and analysis

This single-blind (data analyst blinded), three-arm randomised controlled trial will include 30 children with spastic cerebral palsy. Participants will be randomly allocated to one of three groups: (1) a computerised visual-motor integration training group, (2) a computerised visual perception training group or (3) a control group. Randomisation will be performed using a stratified permuted block design based on cerebral palsy subtype (hemiplegia, diplegia and quadriplegia). Each intervention group will receive 20 individual sessions (two times per week for 10 weeks) using validated computerised games. The primary outcome is handwriting performance, assessed by the Persian Handwriting Assessment Tool. Secondary outcomes include visual-motor integration, assessed by the Beery–Buktenica Developmental Test of Visual–Motor Integration, and visual perception, assessed by the Test of Visual–Perceptual Skills–Revised.

Ethics and dissemination

This study was approved by the Ethics Committee of Tehran University of Medical Sciences. Written informed consent will be obtained from parents. Participation is voluntary, free and confidential. Control group participants may receive the intervention after the trial. Results will be published in peer-reviewed journals and shared with relevant stakeholders.

Trial registration number

IRCT20230219057447N1.

Municipal multidimensional poverty increases the risk of acute myocardial infarction: a retrospective cohort study with sex-stratified analyses in Chiles public health system

Por: Bello-Escamilla · N. · Pino · P. · Nazzal · C.
Objectives

To estimate the association between municipal multidimensional poverty (MMDP) and the risk of a first hospitalised acute myocardial infarction (AMI) among users of the Chilean public health system, and to examine whether this association differs by sex.

Design

Multilevel analysis of a retrospective cohort study.

Setting

Primary level of care across 138 municipalities in Chile.

Participants

A total of 137,162 individuals aged ≥45 years were included, comprising 83,598 women and 53,564 men, all enrolled in the cardiovascular health programme of the Chilean public health system due to the presence of cardiovascular risk factors such as hypertension, type 2 diabetes, dyslipidaemia or tobacco use. Individuals with a prior history of AMI were excluded. Participants were clustered by municipality and followed from 1 January 2015 to 30 April 2019. Sociodemographic and clinical data at the individual level were obtained from electronic health records and linked to municipal-level poverty indicators from the National Socioeconomic Characterization Survey.

Outcome measures

The primary outcome was the time to first hospitalised AMI . Cox proportional hazard models with a shared frailty term were used to assess the association between MMDP (defined as being in the upper quartile of the index) and AMI incidence. Models were adjusted for individual sociodemographic characteristics, behavioural risk factors (eg, smoking, diet and physical activity), and biological conditions (eg, hypertension, type 2 diabetes and dyslipidaemia). Sex-stratified analyses were conducted to explore potential differences in the association.

Results

MMDP was significantly associated with an increased risk of AMI (HR 1.32, 95% CI 1.06 to 1.64) after adjustment for individual-level risk factors. In stratified models, the association remained significant among women (HR 1.30, 95% CI 1.01 to 1.68), but not among men (HR 1.10, 95% CI 0.93 to 1.31).

Conclusion

Residing in municipalities with high levels of multidimensional poverty is associated with an increased risk of AMI among individuals with cardiovascular risk factors, particularly women. These findings underscore the need for intersectoral policies to address the structural determinants of cardiovascular health.

Swallowing prehabilitation for people with head and neck cancer: a pilot cluster-randomised feasibility trial of the SIP SMART intervention

Por: Govender · R. · Wang · J. · Marston · L. · Pizzo · E. · Taylor · S. · Nazareth · I.
Objectives

To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.

Design

Two-arm cluster-randomised pilot trial: SIP SMART2 trial.

Setting and participants

Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.

Interventions

Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.

Outcomes

Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.

Results

12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.

Conclusions

It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.

Trial registration number

ISRCTN12377415.

Designing a strategic purchasing framework for urban primary healthcare services in Bangladesh: a protocol for a mixed-method study with a discrete choice experiment

Por: Naznin · B. · Kashfi · F. · Sehrin · F. · Dawkins · B. · Brown · G. W. · Ensor · T. · Huque · R. · Quayyum · Z. · Elsey · H.
Introduction

Rapid urbanisation in Bangladesh has posed significant challenges to the urban health system, particularly in the delivery of primary healthcare (PHC). The country’s PHC system is fragmented, involving public, non-government organization (NGO), private and informal providers, leading to inequitable access, high out-of-pocket expenditure and inefficiencies. Strategic purchasing, which links resource allocation to health priorities and outcomes, offers a potential pathway to strengthening urban PHC systems. This study aims to assess the current urban PHC system, examine stakeholders’ perspectives on the feasibility of strategic purchasing, understand community health needs and preferences and develop a policy framework for strategically purchasing PHC services in urban settings.

Method and analysis

This study will follow a sequential mixed-methods approach, integrating qualitative and quantitative data. A scoping review will be conducted to assess the characteristics and funding modalities of the existing urban PHC purchasing mechanisms. Key informant interviews with stakeholders, including policy makers and health experts, will explore the strengths and challenges of the current urban PHC system and the feasibility of implementing strategic purchasing. Community healthcare needs and preferences will be examined through in-depth interviews (IDIs), focus group discussions (FGDs) and a discrete choice experiment (DCE) survey in urban informal settlements. Insights from IDIs and FGDs will inform the DCE survey, which will present hypothetical scenarios to participants to identify the most important attributes for improving PHC services. Qualitative data will be coded deductively and inductively, and DCE data will be analysed using latent class models, with sensitivity analyses conducted using the multinomial logit model. Findings will contribute to the development of a strategic purchasing framework, validated through consultation workshops with health system stakeholders.

Ethics and dissemination

Ethical approval has been obtained from the ethics committees in both Bangladesh and the UK. Findings will be disseminated through workshops, peer-reviewed publications, policy briefs and conference presentations.

Perampanel for alleviation of secondary injury in traumatic brain injury (PEACE-TBI): a protocol for a phase-II multicentre randomised clinical trial

Por: Yamamoto · R. · Tamura · R. · Morimoto · Y. · Nakaya · M. · Terao · S. · Shoji · T. · Kanazawa · T. · Sasao · R. · Inaba · M. · Shimizu · M. · Kuranari · Y. · Katayama · M. · Ueno · K. · Oishi · Y. · Nakamura · A. · Kikuo · Y. · Murakami · R. · Homma · K. · Wakahara · S. · Ishikawa · K. · Kosu
Introduction

Traumatic brain injury (TBI) often causes permanent neurological dysfunction. Although no medication has been validated yet to prevent secondary injury of brain tissue, recent animal studies have reported that perampanel, a glutamine receptor antagonist, could improve the neurological functions of animals with TBI by mitigating the abnormal calcium influx and cell death around the site of primary injury. The present study aims to elucidate the efficacy of perampanel administration in improving the neurological function of patients with TBI.

Methods and analysis

The perampanel for alleviation of secondary injury in TBI trial is a multicentre, phase-II, open-label randomised controlled trial targeting patients with mild-to-moderate TBI. This trial will include adult TBI patients with a Glasgow Coma Scale score of 9–14 from five tertiary centres. Patients with epilepsy as a comorbidity, delayed presentation of symptoms (>24 hours after injury) or Injury Severity Score of ≥25 will be excluded. The study participants will be randomly assigned to either the perampanel group (2 mg/day) or the control group (fosphenytoin administered at a dose of 15–18 mg/kg/day, followed by 5–7.5 mg/kg/day of fosphenytoin). In both groups, the medication will be initiated within 12 hours of the TBI diagnosis and continued for 7 days. The antiepileptic drugs can be increased, changed or added as necessary if early post-traumatic seizures are observed. The primary outcome is favourable neurological outcome, defined as a Glasgow Outcome Scale Extended score of ≥5 at 90 days after the TBI diagnosis, which will then be compared between the groups through an intention-to-treat analysis.

Ethics and dissemination

The present study has been approved by the Certified Review Board of Keio at the principal institution (approval number: N20240004). Written informed consent will be obtained from all participants or their legal representatives. The results will be disseminated via publications and presentations.

Trial registration number

Japan Registry of Clinical Trials (jRCTs031250067).

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