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☐ ☆ ✇ BMJ Open

Pragmatic, open-label, multicentre, randomised controlled trial to guide initial therapy for immune checkpoint inhibitor-induced inflammatory arthritis comparing standard of care (prednisolone) to adalimumab without glucocorticoids: REACT trial protocol

Por: Fisher · B. A. · Rowe · A. · Hodson · C. · Wilkhu · M. · Williams · E. · Turner · E. · Allard · A. · Blake · T. · Bombardieri · M. · Cope · A. P. · Dubey · S. · Mankia · K. · Malley · T. · Moore · O. · Payne · M. · Plummer · R. · Tilby · M. · Tillett · T. · Wong · E. · Wu · Y. · Filer · A. · Pra — Marzo 3rd 2026 at 13:40
Introduction

Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.

A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.

Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.

Methods and analysis

REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).

The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.

Ethics and dissemination

The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

ISRCTN18217497.

☐ ☆ ✇ BMJ Open

Hepatitis B virus infection and its determinants among pregnant women in Ethiopia: protocol for umbrella review of systematic review and meta-analysis 2025

Por: Bekele · M. · Oche · W. O. · Geltore · T. E. · Sileshi · E. · Hadaro · T. S. · Alano · B. A. · Abera · W. — Marzo 3rd 2026 at 13:40
Introduction

Among the five hepatitis viruses, the hepatitis B virus (HBV) is a major cause of serious acute and chronic liver infections worldwide. The major public health impact of HBV infection arises from chronic liver disease, including cirrhosis and hepatocellular carcinoma, which predominantly affects young and middle-aged adults of both sexes. Therefore, preventive interventions focusing on mothers and infants are critical due to vertical and early childhood transmission dynamics.

HBV prevalence largely varies among pregnant women in Ethiopia because of multiple interrelated factors. This umbrella review will consolidate all existing systematic reviews and create a more reliable picture of HBV infection and its determinants among pregnant women in Ethiopia.

Methods and analysis

This umbrella review will be conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses reporting standards. The review will focus on identifying and integrating evidence from eligible systematic reviews and meta-analyses, with methodological quality appraised using the MeaSurement Tool to Assess systematic Reviews instrument. A comprehensive literature search strategy will be developed using relevant Medical Subject Headings alongside free-text keywords. Electronic searches will be conducted in PubMed/MEDLINE, African Journals Online, Web of Science, Scopus and Google Scholar. Statistical heterogeneity among the included reviews will be quantified using the I² statistic. Data management and meta-analytic procedures will be performed using STATA version 17, and effect estimates will be presented with corresponding 95% CIs to determine statistical precision.

Ethics and dissemination

This review uses only published or publicly available data, so ethics approval is not required. Findings will be disseminated via peer-reviewed publications, conference presentations and shared with policymakers, healthcare partners, clinicians and patients to inform policy, enhance education and guide future research.

PROSPERO registration number

PROSPERO (CRD420251118982).

☐ ☆ ✇ BMJ Open

Knowledge, attitudes and practices toward skin cancer prevention among Malaysian adults: a cross-sectional online survey

Por: Mohammed · A. H. · Hassan · B. A. R. · Wong · Y. J. · Ying · L. H. · Hong · M. L. B. · Nee · A. W. S. · Ying · L. S. · Ramachandram · D. S. · Hassan · H. S. · Jia · L. J. · Dujaili · J. · Blebil · A. — Febrero 22nd 2026 at 18:08
Objectives

To assess the levels of knowledge, attitudes and practices (KAP) toward skin cancer prevention among Malaysian adults and to examine differences in KAP across socio-demographic groups.

Design

Cross-sectional online survey.

Setting

Community-based study conducted in Malaysia using social media recruitment.

Participants

A total of 386 adults aged ≥18 years residing in Malaysia. Most participants were young adults (86.3%), female (55.4%) and of Chinese ethnicity (65.5%). Healthcare professionals were excluded.

Primary and secondary outcome measures

Primary outcomes were levels of knowledge, attitude and preventive practices toward skin cancer, measured using the validated KAP-SC-Q (Knowledge, Attitude and Practice of Skin Cancer Questionnaire) and categorised as poor, moderate or good. Secondary outcomes included differences in KAP across socio-demographic and clinical characteristics, analysed using independent t-tests and 2 tests.

Results

Over half of participants demonstrated poor knowledge of skin cancer (56.0%) and the vast majority showed inadequate preventive practices (84.2%), while attitudes toward skin cancer were predominantly positive (62.4%). Significant differences in mean KAP scores and categorical levels were observed across several socio-demographic variables. Participants with tertiary education had higher knowledge (14.32 vs 12.61) and attitude scores (20.01 vs 15.95; p

Conclusions

Malaysian adults exhibited limited knowledge and very poor preventive practices toward skin cancer despite generally positive attitudes. These findings highlight substantial gaps between awareness and behaviour and support the need for targeted public health interventions to correct misconceptions, improve risk perception especially in high-risk groups and promote effective ultraviolet protection behaviours.

☐ ☆ ✇ BMJ Open

Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial

Por: Sage · L. · Hart · E. · Meyer · N. · Hnilicka · O. · Penkin · A. · Poteat · T. C. · Aguayo-Romero · R. · Comstock · B. A. · STRIVE Publications Committee · Dy · G. W. · Blasdel · Corman · Deutsch · Gallo · Gore · Marsiglio · Sevelius · Solo — Febrero 12th 2026 at 19:06
Introduction

Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

Methods and analysis

The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Ethics and dissemination

Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

Trial registration number

NCT06436560.

☐ ☆ ✇ BMJ Open

Is intensive behavioural change enhanced with dialectical behavioural therapy feasible for weight management in adolescents living with higher body weight? A protocol for a pilot randomised controlled trial in three centres in Canada

Por: Cameron · E. E. · Morrison · K. M. · Ho · J. · Roos · L. · Katz · L. · Mushquash · A. · Dart · A. · Wicklow · B. A. · Senechal · M. · Jung · M. E. · Strachan · S. M. · Afifi · T. O. · Archibald · M. · Andrade · B. · Hadjiyannakis · S. · Hamilton · J. · Slaght · J. · Penner · K. · Balshaw — Febrero 12th 2026 at 19:06
Introduction

For adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges.

Methods and analysis

The feasibility of a dialectical behavioural therapy (DBT)–enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14–17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms.

Ethics and dissemination

This study has received ethical approval from the University of Manitoba’s Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management.

Trial registration number

NCT05338944.

☐ ☆ ✇ BMJ Open

Essential newborn care practices and determinants in Ethiopia: a multilevel analysis of national survey data

Por: Mekonnen · T. S. · Delie · A. M. · Hailu · M. · Mehari · M. G. · Bizuneh · G. K. · Mengistie · B. A. — Febrero 12th 2026 at 19:06
Objectives

To assess the prevalence and determinants of essential newborn care (ENC) practices among Ethiopian mothers using the 2023 Performance Monitoring for Action (PMA) dataset.

Design

A cross-sectional analysis of the nationally representative 2023 PMA Ethiopia survey.

Participants

A total of 1933 mothers with complete data on ENC practices were included.

Setting

Ethiopia, using a multi-stage stratified cluster sample.

Primary outcome measures

ENC, defined as the adoption of at least four of five WHO-recommended practices: immediate drying, delayed bathing, skin-to-skin contact, clean cord care and early initiation of breastfeeding.

Results

Overall, 32.1% (95% CI 28.1% to 36.0%) of mothers practised at least four ENC components. Coverage was highest for immediate drying (95.4%) and delayed bathing (87.3%), but lower for skin-to-skin contact (53.6%) and clean cord care (64.5%). Health facility delivery showed a strong association with higher ENC practice (adjusted OR (AOR)=106.00; 95% CI 46.14 to 243.54). Mothers who were spouses, rather than household heads, had higher odds of practising ENC (AOR=2.88; 95% CI 1.20 to 6.89) and those mothers with parity two or three had higher odds of practising ENC compared with first-time mothers (AOR=2.00; 95% CI 1.33 to 3.02 and AOR=3.39; 95% CI 1.76 to 6.53, respectively). Lack of postnatal care attendance was negatively associated with ENC (AOR=0.56; 95% CI 0.37 to 0.85). Regional disparities were observed, with mothers in the Southern Nations, Nationalities and Peoples’ region being significantly less likely to practise ENC compared with those in Addis Ababa (AOR=0.31; 95% CI 0.15 to 0.64). All results are based on weighted data to ensure national representativeness.

Conclusion

The prevalence of ENC practices remains low in Ethiopia. Health facility delivery, maternal role in the household, parity and region of residence were significant predictors of ENC practice. Strengthening facility-based delivery, promoting maternal empowerment and addressing regional disparities are essential to improving newborn health outcomes in the country and achieving Sustainable Development Goal 3.

☐ ☆ ✇ BMJ Open

Prevalence, factors and association with academic performance of anaemia in Kandahar schoolchildren: a cross-sectional analytical study

Por: Rahimi · B. A. · Lali · W. M. · Saeed · K. M. I. · Ahmadzai · S. A. H. · Akbari · K. · Mukhlis · A. H. · Azimi · M. — Febrero 4th 2026 at 15:16
Objectives

This study aimed to investigate the prevalence and associated factors of anaemia and its association with the academic performance of schoolchildren in Kandahar, Afghanistan.

Design

This was a cross-sectional analytical study.

Setting and participants

This was a school-based study conducted among 1866 schoolchildren aged 6–14 years in Kandahar city from September to December 2023. Haemoglobin concentration was measured using a portable HemoCue Hb 301 analyser, while the WHO age-adjusted cut-off for haemoglobin was used to classify anaemia. Data were analysed by using descriptive statistics, the ² test and multivariate logistic regression.

Results

In this study, the mean age of the children was 9.1 years, 61.1% (1138/1866) were boys, 83.6% (1560/1866) had illiterate mothers, and 81.3% (1517/1866) belonged to poor families. Prevalence of anaemia among schoolchildren was 64.1% (1196/1866), while 20.8% (388/1866), 41.7% (778/1866), and 1.6% (30/1866) were suffering from mild, moderate and severe anaemia, respectively. Main associated factors of anaemia were being male (adjusted OR (AOR) 1.4, 95% CI 1.1 to 1.7, p=0.003), unemployed father (AOR 1.5, 95% CI 1.1 to 2.2, p=0.020), poor family (AOR 2.3, 95% CI 1.8 to 2.9, p

Conclusions

Prevalence of anaemia was very high and is a severe public health problem in schoolchildren of Kandahar. Based on the known consequences of anaemia on academic performance, the education and health authorities of Afghanistan should take serious steps to alleviate this problem. Periodic iron supplementation and deworming, as well as daily iron-rich mid-day meal programmes, should be started for both boys and girls in schools.

☐ ☆ ✇ BMJ Open

Discharge outcomes and associated patient-level factors in Ontarios remote care monitoring programme: a population-based survival analysis

Por: Egbujie · B. A. · Kilby-Lechman · D. · Woo · K. · Tran · J. — Enero 29th 2026 at 14:19
Objectives

This study examined discharge outcomes and their predictors among patients enrolled in remote patient monitoring (RPM) support in Ontario, Canada.

Design

A 6-month competing risk survival analysis.

Setting

Community-dwelling patients in Ontario, Canada.

Participants

Patients enrolled between 1 April 2024 and 27 February 2025.

Interventions

RPM programme patients are provided with wearable smart devices to monitor falls, medication non-adherence and wandering. Alerts from these devices trigger a response from the programme team, ranging from just a call back to further escalation support channels.

Primary and secondary outcome measures

Four competing discharge outcomes were analysed: (1) positive discharge, (2) death, (3) admission to long-term care (LTC) or hospice and (4) discontinuation due to functional incompatibility with devices.

Results

Within 6 months, 208 (2.2%) patients died, 118 (1.2%) were admitted to an LTC/hospice, and 82 (0.9%) discontinued due to device unsuitability, while 185 (1.9%) achieved ‘positive service discontinuation’. A dementia diagnosis at enrolment was consistently associated with all negative discharge outcomes: positive discharge (HR 0.00, 95% CI 0.00 to 0.00), admission to LTC or hospice (HR 1.95, 95% CI 1.25 to 3.04) and mortality (HR 0.62, 95% CI 0.39 to 1.12). And unsurprisingly, a cancer diagnosis at enrolment was associated with higher hazards of death (HR 2.5, 95% CI 1.77 to 3.52), while language spoken and escalation events were associated with discharge outcomes.

Conclusions

Most RPM programme patients remain in the programme 6 months after enrolment, while a few achieve positive discontinuation. Discharge outcomes were influenced by several factors, most notably dementia diagnosis at enrolment. By leveraging predictive factors such as diagnosis at enrolment, escalation events and referral contexts, RPM programmes can optimise interventions to enhance patient transitions and improve outcomes.

☐ ☆ ✇ BMJ Open

Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial: a protocol for a pragmatic randomised study of diverticulitis treatment in the USA

Por: Hantouli · M. N. · Schmicker · R. H. · Tufte · J. E. · Ali · F. G. · Bennett · R. D. · Cohan · J. N. · Comstock · B. A. · Curran · T. · Davidson · G. H. · Eisenstein · S. · Fischkoff · K. N. · Fleming · F. J. · Gribovskaja-Rupp · I. · Jafari · M. D. · Kessler · L. G. · Krane · M. K. — Enero 8th 2026 at 13:18
Introduction

Each year, millions of people experience recurrent diverticulitis episodes. Elective sigmoid colon resection reduces the risk of recurrence, but The American Society of Colon and Rectal Surgeons recommends individualising surgical decisions based on the impact of the condition on a patient’s quality of life (QoL). However, no threshold for QoL impairment has been established to guide decision-making, and evidence comparing elective colectomy with medical management in terms of QoL limitation is limited. To address these gaps and to guide treatment decision-making, we designed the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial.

The COSMID trial is a large, pragmatic randomised trial including patients with QoL-limiting diverticulitis that aims to determine if partial colectomy is superior to medical management and explore subgroups that are more likely to respond to each treatment.

Methods and analysis

COSMID will recruit 250 English-speaking and Spanish-speaking adults with imaging-confirmed and QoL-limiting diverticulitis (defined using a modified diverticulitis-related QoL survey). Participants are randomly assigned to undergo elective partial colectomy or receive comprehensive medical management (eg, selected from options including fibre, probiotics, mesalamine and rifaximin). A total of 100 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary outcome is the time-averaged score of the Gastrointestinal Quality of Life Index at 6, 9 and 12 months after randomisation. Secondary outcomes include clinical adverse events, healthcare utilisation, recurrent episodes of diverticulitis and additional patient-reported outcomes like the Diverticulitis Quality of Life instrument, decisional regret and work productivity. Exploratory analyses aim to identify differential treatment effects based on patients’ characteristics.

Ethics and dissemination

This trial was approved by the Vanderbilt Institutional Review Board (IRB) on 26 August 2019 (IRB #191217). Vanderbilt serves as the institutional review board of record for the following study sites: Albany Medical College, Allegheny Health, Atrium Health Carolinas Medical Center, Virginia Mason Medical Center, Boston University Medical Center, Cedars-Sinai Medical Center, UT Health Lyndon B. Johnson Hospital, Medical University of South Carolina, New York-Presbyterian Queens, Stanford University, University of Pennsylvania, University of California San Diego, University of California San Francisco, University of Colorado Denver, University of Florida, University of Iowa, University of Utah, University of Washington Medical Center, University of South Florida, University of Rochester Medical Center, University of Texas Southwestern Medical Center, Virginia Commonwealth University, Lahey Hospital & Medical Center, Weill Cornell Medical Center and Northwell Health. Rush University Medical Center (approved 8 January 2020), Columbia University Medical Center (approved 28 January 2020), Northwestern University (approved 19 March 2020), Mount Carmel Health System (approved 5 May 2020) and Memorial Health University Medical Center (approved 4 April 2022) are regulated and were approved by their respective IRBs. Results from this trial will be presented at international conferences and published in peer-reviewed journals.

Trial registration number

NCT04095663.

☐ ☆ ✇ BMJ Open

Integrating the Common Elements Treatment Approach and motivational interviewing to improve HIV pre-exposure prophylaxis engagement among women who use drugs in Tanzania: protocol for a pilot randomised controlled trial

Por: Saleem · H. · Atkins · K. · Skavenski · S. · Nonyane · B. A. · Chitamwebwa · F. · Mtaita · S. · Mwansa · D. · Luswetula · A. · Murray · L. K. · Likindikoki · S. — Enero 8th 2026 at 13:18
Introduction

Women who use drugs in Tanzania face a disproportionately high burden of HIV and mental health disorders. Despite the availability of pre-exposure prophylaxis (PrEP), uptake remains low, highlighting the need for integrated, scalable interventions that address co-occurring substance use and mental health challenges. Motivational interviewing (MI) and cognitive-behavioural approaches, such as the Common Elements Treatment Approach (CETA), show promise for enhancing HIV prevention outcomes in this population. This study presents the protocol for a pilot feasibility trial assessing the acceptability, feasibility and preliminary efficacy of MI for PrEP (MI-PrEP) and a combined CETA and MI-PrEP intervention (CETA + MI-PrEP) to improve PrEP engagement among women who use drugs in Tanzania.

Methods and analysis

This individually randomised, parallel-group pilot trial will be conducted in Dar es Salaam, Tanzania, guided by the situated Information, Motivation and Behavioral Skills model. Eligible participants are adult women who use heroin, report recent drug-related or sex-related HIV risk behaviours, are HIV-negative and exhibit symptoms of depression, anxiety or post-traumatic stress disorder. Participants are randomised to one of three arms: MI-PrEP, CETA + MI-PrEP or enhanced treatment as usual. Interventions are delivered face-to-face by trained counsellors. Feasibility and acceptability will be assessed using recruitment and retention data, surveys and qualitative interviews. Preliminary effects will be measured for PrEP initiation, symptoms of common mental disorders and substance use.

Ethics and dissemination

Ethical approval has been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4830). Results will be disseminated through ClinicalTrials.gov, peer-reviewed publications, conferences, presentations and research briefings to community stakeholders.

Trial registration

ClinicalTrials.gov ID: NCT06835751. Initially registered 14 February 2025, https://clinicaltrials.gov/study/NCT06835751, last updated 5 December 2025.

☐ ☆ ✇ BMJ Open

Mapping implementation barriers and facilitators of a physical activity consultation in the Portuguese primary healthcare: a qualitative approach combining the Tailored Implementation for Chronic Diseases and Behaviour Change Wheel frameworks

Por: Silva · C. S. · Silva · M. N. · Encantado · J. · Franco · S. · Rosa · B. A. · Mendes · R. · Teixeira · P. J. · Godinho · C. A. — Diciembre 31st 2025 at 11:30
Objective

Despite evidence of the cost-effectiveness of physical activity (PA) promotion interventions in healthcare settings, translating them into practice remains challenging. This study aimed to identify implementation barriers and facilitators of a Portuguese PA consultation programme implemented in primary healthcare of the Portuguese National Health Service. Additionally, it sought to inform future implementation strategies, using a theoretically based approach.

Design

Qualitative interview study, using both deductive and inductive approaches.

Setting

Primary healthcare units across all health administration regions of mainland Portugal.

Participants

Twenty-eight participants (six medical doctors, five exercise professionals and 17 patients) from all health regions of the country, involved in the implementation of the Portuguese PA prescription consultation.

Results

Fifty-three categories of determinants were identified, using the Tailored Implementation for Chronic Diseases framework. Key barriers included ineffective referral processes to the consultation, challenges in integrating the intervention with existing healthcare demands and insufficient local/regional prioritisation of PA promotion. Key facilitators included high intervention acceptability, diverse community PA resources and good interpersonal skills of implementers. Drawing on the Behaviour Change Wheel, theoretically based inputs to design strategies addressing each barrier were provided.

Conclusions

The implementation of PA consultation was influenced by a broad range of determinants. The most frequently reported barriers are primarily structural and opportunity-related, suggesting system-level implementation strategies are most appropriate. Future strategies should consider implementing clinical standards/orientations for PA promotion, providing institutional incentives based on the attainment of PA indicators, expanding consultation coverage and diversifying referral strategies, reinforcing health system-community partnerships and strengthening training opportunities for implementers. These findings offer relevant insights for enhancing the future implementation of PA consultations, for scaling them up and, ultimately, to increase their effectiveness.

☐ ☆ ✇ BMJ Open

Prevalence and determinants of underweight and overweight/obesity among Ghanaian children: a cross-sectional study using DHS data in Ghana

Por: Dam · K. M. · Alhassan · P. D. A. · Addai · J. · Apanga · S. · Adjei-Mensah · E. · Sienso · B. A. · Boakye · G. · Bawa · A. W. · Tamal · C. · Seneadza · N. A. H. · Abdul-Mumin · A. · Nuertey · B. D. — Diciembre 19th 2025 at 11:20
Background

There is a global rise in the burden of childhood obesity, increasing the risk of early onset adult obesity. Most developing countries face the double burden of malnutrition; overnutrition as overweight/obesity and undernutrition.

Objectives

To determine the current burden and determinants of childhood thinness, overweight and obesity using national survey data.

Design

Data from a cross-sectional survey conducted in 2022 were used.

Setting

Data from the seventh Demographic Health Survey conducted in Ghana were used.

Participants

The participants included 4417 children ≤59 months.

Method

The seventh Ghana Demographic Health Survey in 2022 employed a two-stage stratified cluster sampling design, selecting 618 clusters to create a nationally representative sample. Weight and height were measured using the SECA 874U scale and Shorrboard, respectively. Children’s heights were measured recumbent (24 months). Multivariate logistic regression was used to assess the relationship between thinness and obesity, as well as the independent factors.

Outcome variable

The outcome variable was obesity, determined by a WHZ of >+2SD.

Results

The weighted prevalence of overweight/obesity and thinness in children under 5 years is 9.9% and 5.2%, respectively. Children who were overweight or obese had a mean age of 23.11 months, those who were thin or severely thin had a lower mean age of 21.02 months, and those with normal nutritional status were relatively older, with a mean age of 28.41 months. The Upper West, Northeast and Northern regions had the lowest densities of obesity. In the multivariate logistic regression model, children residing in Ashanti, Oti, Northern, North East and Upper East regions had significantly reduced odds of being obese compared with those in the Ahafo region. The average haemoglobin for those overweight/obese was 10.8 g/dL, and 10.7 g/dL for those who were normal and marginally reduced, 10.5 g/dL for those who were thin.

Conclusion

Regional disparities, maternal nutritional status, socioeconomic conditions and unsafe water sources were significant determinants of child nutrition outcomes. These findings call for targeted, multipronged interventions that integrate maternal-child nutrition, safe water, sanitation and regional context.

☐ ☆ ✇ BMJ Open

Can we Save the rectum by watchful waiting or transanal microsurgery following shorT-course radiotherapy and Additional local oR systemic Treatment for early-stage REctal Cancer? STARTREC-3 protocol for a non-randomised, multicentre, phase II platform stu

Por: de Vries · S. E. N. · Couwenberg · A. M. · Marijnen · C. A. M. · Beets · G. L. · Burger · J. W. · Chalabi · M. · de Groot · J. W. · Intven · M. · Peulen · H. M. · Roodhart · J. M. L. · de Wilt · J. H. W. · Grotenhuis · B. A. — Diciembre 17th 2025 at 11:54
Introduction

Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.

Objective

The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.

Methods

STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.

Ethics and dissemination

The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.

Trial registration number

CTIS EU 2024-514620-17-00

☐ ☆ ✇ BMJ Open

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. — Diciembre 12th 2025 at 18:11
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.

☐ ☆ ✇ BMJ Open

Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+

Por: Daneman · N. · Johnstone · J. · Lee · T. C. · MacFadden · D. R. · McDonald · E. G. · Morpeth · S. C. · Ong · S. W. X. · Paterson · D. L. · Pinto · R. L. · Rishu · A. · Rogers · B. A. · Yahav · D. · Coburn · B. · Daley · P. · Das · P. · Fiest · K. · Findlater · A. · Fralick · M. · George · M — Diciembre 5th 2025 at 09:25
Objectives

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Design

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Setting

Ten hospitals across four Canadian provinces.

Participants

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

Interventions

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Primary outcome measures

Domain-specific recruitment rates and protocol adherence.

Results

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

Conclusions

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

Trial registration number

NCT05893147.

☐ ☆ ✇ BMJ Open

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. — Noviembre 28th 2025 at 03:17
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.

☐ ☆ ✇ BMJ Open

Inappropriate prescription of antibiotics and analgesics, treatment adequacy and associated factors among surgical patients: an observational study in comprehensive specialised hospitals, northwest Ethiopia

Por: Zeleke · T. K. · Getachew · M. · Tegegne · B. A. · Teshome · A. H. · Yismaw · M. B. · Bazezew · Z. A. · Kemal · L. K. · Abebe · R. B. — Octubre 23rd 2025 at 09:28
Objective

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.

Design and setting

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

Participants

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

Main outcomes measures

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.

Results

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.

Conclusion

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.

☐ ☆ ✇ BMJ Open

Assessing the potential utility of large language models for assisting community health workers: protocol for a prospective, observational study in Rwanda

Por: Menon · V. · Shimelash · N. · Rutunda · S. · Nshimiyimana · C. · Archer · L. · Emmanuel-Fabula · M. · Berhe · D. F. · Gill · J. · Hezagira · E. · Remera · E. · Riley · R. · Wong · R. · Denniston · A. K. · Mateen · B. A. · Liu · X. — Octubre 14th 2025 at 10:58
Introduction

Community health workers (CHWs) are critical to healthcare delivery in low-resource settings but often lack formal clinical training, limiting their decision-making. Large language models (LLMs) could provide real-time, context-specific support to improve referrals and management plans. This study aims to evaluate the potential utility of LLMs in assisting CHW decision-making in Rwanda.

Methods and analysis

This is a prospective, observational study conducted in Nyabihu and Musanze districts, Rwanda. Audio recordings of CHW-patient consultations will be transcribed and analysed by an LLM to generate referral decisions, differential diagnoses and management plans. These outputs, alongside CHW decisions, will be evaluated against a clinical expert panel’s consensus. The primary outcome is the appropriateness of referral decisions. Secondary outcomes include diagnostic accuracy, management plan quality, and patient and user perceptions to ambient recording of consultations. Sample size is set at 800 consultations (400 per district), powered to detect a 15–20 percentage point improvement in referral appropriateness.

Ethics and dissemination

Ethical approval has been obtained from the Rwandan National Ethics Committee (RNEC) (Ref number: RNEC 853/2025) in June 2025, recruitment started in July 2025 and results are expected in late 2025. Results will be disseminated via stakeholder meetings, academic conferences and peer-reviewed publication.

Trial registration number

PACTR202504601308784.

☐ ☆ ✇ BMJ Open

Knowledge and attitude of parents towards the human papillomavirus vaccine for their daughters and associated factors in Debre Tabor town, northwest Ethiopia: a community-based cross-sectional study

Por: Aragaw · G. M. · Aynalem · G. L. · Abiy · S. A. · Taye · E. B. · Chernet · S. A. · Haile · T. T. · Tsega · N. T. · Mesele · T. T. · Seyoum · A. T. · Tsega · A. G. · Mengistie · B. A. — Octubre 6th 2025 at 02:14
Objective

This study aims to assess parents’ knowledge and attitude towards the human papillomavirus (HPV) vaccination of their daughters and the associated factors in Debre Tabor town, northwest Ethiopia.

Design

A community-based cross-sectional study.

Setting

Debre Tabor town, Northwest Ethiopia.

Participants

A total of 702 participants were included in the study, with a response rate of 98.2%. Three out of the six kebeles in the town were randomly selected, and participants within the selected kebeles were recruited through a cluster sampling technique. An interviewer-administered structured questionnaire was used to collect data from 15 December 2021 to 15 February 2022.

Primary and secondary outcome measures

Parents’ level of knowledge and attitude towards the HPV vaccination of their daughters, and the associated factors.

Results

In the study, parents’ knowledge and attitude towards HPV vaccination were found to be 46.4% (95% CI 42.7% to 50.1%) and 61.5% (95% CI 58.0% to 65.2%), respectively. Parents with a higher level of education (adjusted OR (AOR)=2.27; 95% CI 1.39 to 3.69), media exposure (AOR=3.36; 95% CI 1.21 to 9.33) and a good attitude towards the HPV vaccine (AOR=8.81; 95% CI 5.78 to 13.44) were significantly associated factors that affect parents’ level of knowledge. Positive subjective norms (AOR=1.53; 95% CI 1.01 to 2.31) and perceived behavioural control towards the HPV vaccine (AOR=3.48; 95% CI 2.37 to 5.10) had statistically significant associations with parents’ attitude.

Conclusions

In this study, more than half of parents had poor knowledge of the HPV and its vaccination, while the majority of the participants showed a favourable attitude to the vaccine. Educational attainment, media exposure and a positive attitude were significantly associated with parental knowledge, and parents’ attitude was positively influenced by subjective norms and perceived behavioural control. This suggests a need to increase the parents’ level of awareness through educational interventions, particularly via media and community engagement. To improve the acceptance and uptake of the HPV vaccination, it is important to address negative attitudes and common misconceptions among parents on the safety, efficacy and necessity of the vaccine for their daughters.

☐ ☆ ✇ BMJ Open

Hospital discharge planning in cardiac care: study protocol for a mixed-methods study on the implementation, influencing factors and quality of care in Germany

Por: Imhof · L. · Bartels · R. · Blum · K. · Blume · K. S. · Fleischer · S. · Gottschalk · S. · Heber · R. · Horenkamp-Sonntag · D. · Meyer · G. · Remppis · B. A. · Schneider · U. · Schreyoegg · J. · Winter · V. — Agosto 8th 2025 at 11:02
Introduction

Discharge planning (DP) is essential to ensure continuity of care during patient transitions between inpatient and outpatient settings. Although DP has been legally required for all hospitals in Germany since 2017, several studies show considerable variation in its implementation, likely due to differences in structural characteristics and organisational processes. Both quality and efficiency-enhancing DP processes are particularly important in the context of cardiovascular disease, which is the leading cause of mortality and a major contributor to healthcare costs in Germany. The ‘Ready to Discharge’ (R2D) project investigates the implementation status, influencing factors and outcomes of DP in cardiac units of German hospitals. By integrating quantitative and qualitative data, we aim to identify best practices and provide actionable recommendations for improving DP processes.

Methods and analysis

A mixed-methods study design will be used. Quantitative analyses will be based on primary data from hospital and patient surveys combined with secondary data from health insurance claims and hospital quality reports. Key outcome measures will include healthcare utilisation outcomes (eg, readmissions, emergency department visits), patient health status outcomes (eg, patient satisfaction, self-rated health) and medication-related outcomes (eg, medication adherence). Qualitative interviews with healthcare professionals will enrich the findings by providing insights into barriers and facilitators to DP.

Ethics and dissemination

This study was approved by the Ethics Committee of Bergische University of Wuppertal and the German Federal Office for Social Security. Informed consent will be obtained for all primary data collections. Hospital managing directors will be informed prior to the hospital survey and will be able to withdraw consent. Patients can withdraw their consent at any time. Secondary data will be analysed in pseudonymised form to ensure patient confidentiality. Results will be disseminated through workshops, regional and international conferences and peer-reviewed publications.

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