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☐ ☆ ✇ BMJ Open

Assessing the accuracy of health facility typology in representing the availability of health services: a case study in Mali

Por: Petragallo · S. · Timoner · P. · Hierink · F. · Fuhrer · C. · Toure · O. · Iknane · A. · Coulibaly · Y. · Fall · I.-S. · Ray · N. — Marzo 21st 2024 at 16:38
Introduction

Using health facility types as a measure of service availability is a common approach in international standards for health system policy and planning. However, this proxy may not accurately reflect the actual availability of specific health services.

Objective

This study aims to evaluate the reliability of health facility typology as an indicator of specific health service availability and explore whether certain facility types consistently provide particular services.

Design

We analysed a comprehensive dataset containing information from 1725 health facilities in Mali. To uncover and visualise patterns within the dataset, we used two analytical techniques: Multiple Correspondence Analysis and Between-Class Analysis. These analyses allowed us to quantitatively measure the influence of health facility types on the variation in health service provisioning. Additionally, we developed and calculated a Consistency Index, which assesses the consistency of a health facility type in providing specific health services. By examining various health facilities and services, we sought to determine the accuracy of facility types as indicators of service availability.

Setting

The study focused on the health system in Mali as a case study.

Results

Our findings indicate that using health facility types as a proxy for service availability in Mali is not an accurate representation. We observed that most of the variation in service provision does not stem from differences between facility types but rather within facility types. This suggests that relying solely on health facility typology may lead to an incomplete understanding of health service availability.

Conclusions

These results have significant implications for health policy and planning. The reliance on health facility types as indicators for health system policy and planning should be reconsidered. A more nuanced and evidence-based understanding of health service availability is crucial for effective health policy and planning, as well as for the assessment and monitoring of health systems.

☐ ☆ ✇ BMJ Open

Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial

Por: Phillips · A. E. · Afghani · E. · Akshintala · V. S. · Benos · P. Y. · Das · R. · Drewes · A. M. · Easler · J. · Faghih · M. · Gabbert · C. · Halappa · V. · Khashab · M. A. · Olesen · S. S. · Saloman · J. L. · Sholosh · B. · Slivka · A. · Wang · T. · Yadav · D. · Singh · V. K. — Marzo 21st 2024 at 16:38
Introduction

Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected individuals less likely to respond to conventional therapies. Endotherapy or surgical decompression is offered to patients with pancreatic duct obstruction. However, the response to treatment is unpredictable. Pancreatic quantitative sensory testing (P-QST), an investigative technique of standardised stimulations to test the pain system in CP, has been used for phenotyping patients into three mutually exclusive groups: no central sensitisation, segmental sensitisation (pancreatic viscerotome) and widespread hyperalgesia suggestive of supraspinal central sensitisation. We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for painful CP.

Methods and analysis

This observational clinical trial will enrol 150 patients from the University of Pittsburgh, Johns Hopkins and Indiana University. Participants will undergo pretreatment phenotyping with P-QST. Treatment will be pancreatic endotherapy or surgery for clearance of painful pancreatic duct obstruction. Primary outcome: average pain score over the preceding 7 days measured by Numeric Rating Scale at 6 months postintervention. Secondary outcomes will include changes in opioid use during follow-up, and patient-reported outcomes in pain and quality of life at 3, 6 and 12 months after the intervention. Exploratory outcomes will include creation of a model for individualised prediction of response to invasive treatment.

Ethics and dissemination

The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for individualised prediction of treatment response for widespread use. This trial was approved by the University of Pittsburgh Institutional Review Board. Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.

Trial registration number

NCT04996628.

☐ ☆ ✇ BMJ Open

Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study

Por: Harvey · S. · Stone · M. · Zingelman · S. · Copland · D. A. · Kilkenny · M. F. · Godecke · E. · Cadilhac · D. A. · Kim · J. · Olaiya · M. T. · Rose · M. L. · Breitenstein · C. · Shrubsole · K. · OHalloran · R. · Hill · A. J. · Hersh · D. · Mainstone · K. · Mainstone · P. · Unsworth · C. A — Marzo 21st 2024 at 16:38
Introduction

People with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum dataset was developed in partnership with people with lived experience of aphasia, clinicians and researchers to address this gap. It comprises sociodemographic characteristics, quality indicators, treatment descriptors and outcome measurement instruments. We present a protocol to pilot the MEASuRES minimum dataset in clinical practice, describe the factors that hinder or support implementation and determine meaningful thresholds of clinical change for core outcome measurement instruments.

Methods and analysis

This research aims to deliver a comprehensive quality assessment toolkit for poststroke aphasia services in four studies. A multicentre pilot study (study 1) will test the administration of the MEASuRES minimum dataset within five Australian health services. An embedded mixed-methods process evaluation (study 2) will evaluate the performance of the minimum dataset and explore its clinical applicability. A consensus study (study 3) will establish consumer-informed thresholds of meaningful change on core aphasia outcome constructs, which will then be used to establish minimal important change values for corresponding core outcome measurement instruments (study 4).

Ethics and dissemination

Studies 1 and 2 have been registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623001313628). Ethics approval has been obtained from the Royal Brisbane and Women’s Hospital (HREC/2023/MNHB/95293) and The University of Queensland (2022/HE001946 and 2023/HE001175). Study findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant stakeholders including healthcare providers, policy-makers, stroke and rehabilitation audit and clinical quality registry custodians, consumer support organisations, and individuals with aphasia and their families.

☐ ☆ ✇ BMJ Open

Cohort profile: The Health, Food, Purchases and Lifestyle (SMIL) cohort - a Danish open cohort

Por: Sorensen · K. K. · Andersen · M. P. · Moller · F. T. · Eves · C. · Junker · T. G. · Zareini · B. · Torp-Pedersen · C. — Marzo 20th 2024 at 16:56
Purpose

The Health, Food, Purchases and Lifestyle (SMIL) cohort is a prospective open Danish cohort that collects electronic consumer purchase data, which can be linked to Danish nationwide administrative health and social registries. This paper provides an overview of the cohort’s baseline characteristics and marginal differences in the monetary percentage spent on food groups by sex, age and hour of the day.

Participants

As of 31 December 2022, the cohort included 11 214 users of a smartphone-based receipt collection application who consented to share their unique identification number for linkage to registries in Denmark. In 2022, the composition of the cohort was as follows: 62% were men while 24% were aged 45–55. The cohort had a median of 63 (IQR 26–116) unique shopping trips. The cohort included participants with a range of health statuses. Notably, 21% of participants had a history of cardiovascular disease and 8% had diabetes before donating receipts.

Findings to date

The feasibility of translating consumer purchase data to operationalisable food groups and merging with registers has been demonstrated. We further demonstrated differences in marginal distributions which revealed disparities in the amount of money spent on various food groups by sex and age, as well as systematic variations by the hour of the day. For example, men under 30 spent 8.2% of their total reported expenditure on sugary drinks, while women under 30 spent 6.5%, men over 30 spent 4.3% and women over 30 spent 3.9%.

Future plans

The SMIL cohort is characterised by its dynamic, continuously updated database, offering an opportunity to explore the relationship between diet and disease without the limitations of self-reported data. Currently encompassing data from 2018 to 2022, data collection is set to continue. We expect data collection to continue for many years and we are taking several initiatives to increase the cohort.

☐ ☆ ✇ BMJ Open

Work environment and hypertension in industrial settings in Benin in 2019: a cross-sectional study

Por: Adjobimey · M. · Houehanou · C. Y. · Cisse · I. M. · Mikponhoue · R. · Hountohotegbe · E. · Tchibozo · C. · Adjogou · A. · Dossougbete · V. · Gounongbe · F. · Ayelo · P. A. · Hinson · V. · Houinato · D. S. — Marzo 20th 2024 at 16:56
Objective

To determine the association between occupational factors, particularly psychosocial factors, and hypertension.

Design

Descriptive and analytical cross-sectional study using logistic multivariate regression.

Setting

Fifteen cotton ginning plants in Benin.

Participants

Permanent and occasional workers in the cotton ginning industry.

Data collection

Data on sociodemographic, occupational, behavioural and clinical history characteristics were collected using a number of standardised, interviewer-administered questionnaires. These questionnaires were based on the WHO’s non-communicable disease questionnaire, Karasek questionnaire and Siegrist questionnaire. Weight, height and blood pressure were measured. Any worker with systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg according to the WHO criteria was considered hypertensive, as was any subject on antihypertensive treatment even if blood pressure was normal.

Results

A total of 1883 workers were included, with a male to female ratio of 9.08. Of these, 510 suffered from hypertension (27.1%, 95% CI 25.1 to 29.2). In the multivariate analysis, the risk factors identified were occupational stress (adjusted OR (aOR)=3.96, 95% CI 1.28 to 12.2), age ≥25 years (aOR=2.77, 95% CI 1.55 to 4.96), body mass index of 25–30 kg/m2 (aOR=1.71, 95% CI 1.32 to 2.2), body mass index >30 kg/m2 (aOR=2.74, 95% CI 1.84 to 4.09), permanent worker status (aOR=1.66, 95% CI 1.44 to 2.41) and seniority in the textile sector >5 years (aOR=2.18, 95% CI 1.7 to 2.8). Recognition at work emerged as an effect-modifying factor subject to stratification.

Conclusions

Occupational factors, particularly job strain and recognition at work, are modifiable factors associated with hypertension in the ginning plants sector and deserve to be corrected through occupational health promotion and prevention.

☐ ☆ ✇ BMJ Open

Temporal trends of ambulance time intervals for suspected stroke/transient ischaemic attack (TIA) before and during the COVID-19 pandemic in Ireland: a quasi-experimental study

Por: Burton · E. · Quinn · R. · Crosbie-Staunton · K. · Deasy · C. · Masterson · S. · O'Donnell · C. · Merwick · A. · Willis · D. · Kearney · P. M. · Mc Carthy · V. J. C. · Buckley · C. M. — Marzo 20th 2024 at 16:56
Objectives

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

Design

We conducted a secondary data analysis with a quasi-experimental design.

Setting

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

Primary and secondary outcome measures

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

Participants

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

Results

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

Conclusions

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

☐ ☆ ✇ BMJ Open

Predictive machine learning models for ascending aortic dilatation in patients with bicuspid and tricuspid aortic valves undergoing cardiothoracic surgery: a prospective, single-centre and observational study

Por: Gaye · B. · Vignac · M. · Gadin · J. R. · Ladouceur · M. · Caidahl · K. · Olsson · C. · Franco-Cereceda · A. · Eriksson · P. · Björck · H. M. — Marzo 20th 2024 at 16:56
Objectives

The objective of this study was to develop clinical classifiers aiming to identify prevalent ascending aortic dilatation in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).

Design and setting

A prospective, single-centre and observational cohort.

Participants

The study involved 543 BAV and 491 TAV patients with aortic valve disease and/or ascending aortic dilatation, excluding those with coronary artery disease, undergoing cardiothoracic surgery at the Karolinska University Hospital (Sweden).

Main outcome measures

Predictors of high risk of ascending aortic dilatation (defined as ascending aorta with a diameter above 40 mm) were identified through the application of machine learning algorithms and classic logistic regression models.

Exposures

Comprehensive multidimensional data, including valve morphology, clinical information, family history of cardiovascular diseases, prevalent diseases, demographic details, lifestyle factors, and medication.

Results

BAV patients, with an average age of 60.4±12.4 years, showed a higher frequency of aortic dilatation (45.3%) compared with TAV patients, who had an average age of 70.4±9.1 years (28.9% dilatation, p

Conclusion and recommendation

Cardiovascular risk profiles appear to be more predictive of aortopathy in TAV patients than in patients with BAV. This adds evidence to the fact that BAV-associated and TAV-associated aortopathy involves different pathways to aneurysm formation and highlights the need for specific aneurysm preventions in these patients. Further, our results highlight that machine learning approaches do not outperform classical prediction methods in addressing complex interactions and non-linear relations between variables.

☐ ☆ ✇ BMJ Open

Implementation of an antibiotic resistance surveillance tool in Madagascar, the TSARA project: a prospective, observational, multicentre, hospital-based study protocol

Por: Elias · C. · Raad · M. · Rasoanandrasana · S. · Raherinandrasana · A. H. · Andriananja · V. · Raberahona · M. · Moore · C. E. · Randria · M. · Raskine · L. · Vanhems · P. · Babin · F.-X. — Marzo 20th 2024 at 05:26
Introduction

Antimicrobial resistance (AMR) has become a significant public health threat. Without any interventions, it has been modelled that AMR will account for an estimated 10 million deaths annually by 2050, this mainly affects low/middle-income countries. AMR has a systemic negative perspective affecting the overall healthcare system down to the patient’s personal outcome. In response to this issue, the WHO urged countries to provide antimicrobial stewardship programmes (ASPs). ASPs in hospitals are a vital component of national action plans for AMR, and have been shown to significantly reduce AMR, in particular in low-income countries such as Madagascar.

As part of an ASP, AMR surveillance provides essential information needed to guide medical practice. We developed an AMR surveillance tool—Technique de Surveillance Actualisée de la Résistance aux Antimicrobiens (TSARA)—with the support of the Mérieux Foundation. TSARA combines bacteriological and clinical information to provide a better understanding of the scope and the effects of AMR in Madagascar, where no such surveillance tool exists.

Methods and analysis

A prospective, observational, hospital-based study was carried out for data collection using a standardised data collection tool, called TSARA deployed in 2023 in 10 hospitals in Madagascar participating in the national Malagasy laboratory network (Réseau des Laboratoires à Madagascar (RESAMAD)). Any hospitalised patient where the clinician decided to take a bacterial sample is included. As a prospective study, individual isolate-level data and antimicrobial susceptibility information on pathogens were collected routinely from the bacteriology laboratory and compiled with clinical information retrieved from face-to-face interviews with the patient and completed using medical records where necessary. Analysis of the local ecology, resistance rates and antibiotic prescription patterns were collected.

Ethics and dissemination

This protocol obtained ethical approval from the Malagasy Ethical Committee n°07-MSANP/SG/AGMED/CNPV/CERBM on 24 January 2023. Findings generated were shared with national health stakeholders, microbiologists, members of the RESAMAD network and the Malagasy academic society of infectious diseases.

☐ ☆ ✇ BMJ Open

Inter-reviewer reliability of human literature reviewing and implications for the introduction of machine-assisted systematic reviews: a mixed-methods review

Por: Hanegraaf · P. · Wondimu · A. · Mosselman · J. J. · de Jong · R. · Abogunrin · S. · Queiros · L. · Lane · M. · Postma · M. J. · Boersma · C. · van der Schans · J. — Marzo 20th 2024 at 05:26
Objectives

Our main objective is to assess the inter-reviewer reliability (IRR) reported in published systematic literature reviews (SLRs). Our secondary objective is to determine the expected IRR by authors of SLRs for both human and machine-assisted reviews.

Methods

We performed a review of SLRs of randomised controlled trials using the PubMed and Embase databases. Data were extracted on IRR by means of Cohen’s kappa score of abstract/title screening, full-text screening and data extraction in combination with review team size, items screened and the quality of the review was assessed with the A MeaSurement Tool to Assess systematic Reviews 2. In addition, we performed a survey of authors of SLRs on their expectations of machine learning automation and human performed IRR in SLRs.

Results

After removal of duplicates, 836 articles were screened for abstract, and 413 were screened full text. In total, 45 eligible articles were included. The average Cohen’s kappa score reported was 0.82 (SD=0.11, n=12) for abstract screening, 0.77 (SD=0.18, n=14) for full-text screening, 0.86 (SD=0.07, n=15) for the whole screening process and 0.88 (SD=0.08, n=16) for data extraction. No association was observed between the IRR reported and review team size, items screened and quality of the SLR. The survey (n=37) showed overlapping expected Cohen’s kappa values ranging between approximately 0.6–0.9 for either human or machine learning-assisted SLRs. No trend was observed between reviewer experience and expected IRR. Authors expect a higher-than-average IRR for machine learning-assisted SLR compared with human based SLR in both screening and data extraction.

Conclusion

Currently, it is not common to report on IRR in the scientific literature for either human and machine learning-assisted SLRs. This mixed-methods review gives first guidance on the human IRR benchmark, which could be used as a minimal threshold for IRR in machine learning-assisted SLRs.

PROSPERO registration number

CRD42023386706.

☐ ☆ ✇ BMJ Open

Perceptions and experiences of paramedics managing people with non-traumatic low back pain: a qualitative study of Australian paramedics

Por: Vella · S. P. · Simpson · P. · Bendall · J. C. · Pickles · K. · Copp · T. · Swain · M. S. · Maher · C. G. · Machado · G. C. — Marzo 20th 2024 at 05:26
Background

Paramedics are often first providers of care to patients experiencing non-traumatic low back pain (LBP), though their perspectives and experiences with managing these cases remain unclear.

Objectives

This study explored paramedic views of the management of non-traumatic LBP including their role and experience with LBP management, barriers to referral and awareness of ambulance service guidelines.

Design

Qualitative study using semistructured interviews conducted between January and April 2023.

Setting

New South Wales Ambulance service.

Participants

A purposive sample of 30 paramedics of different specialities employed by New South Wales Ambulance were recruited.

Results

Paramedic accounts demonstrated the complexity, challenge, frustration and reward associated with managing non-traumatic LBP. Paramedics perceived that their primary role focused on the assessment of LBP, and that calls to ambulance services were often driven by misconceptions surrounding the management of LBP, and a person’s pain severity. Access to health services, patient factors, defensive medicine, paramedic training and education and knowledge of guidelines influenced paramedic management of LBP.

Conclusion

Paramedics often provide care to non-traumatic LBP cases yet depending on the type of paramedic speciality find these cases to be frustrating, challenging or rewarding to manage due to barriers to referral including access to health services, location, patient factors and uncertainty relating to litigation. Future research should explore patient perspectives towards ambulance service use for the management of their LBP.

☐ ☆ ✇ BMJ Open

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D. — Marzo 20th 2024 at 05:26
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

☐ ☆ ✇ BMJ Open

Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B. — Marzo 20th 2024 at 05:26
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

☐ ☆ ✇ BMJ Open

Exploring the pharmacists role in optimising antithrombotic therapy in primary care: a qualitative study

Por: van Paassen · J. G. · Tan · J. P. · Deneer · V. H. M. · Bouvy · M. L. — Marzo 20th 2024 at 03:21
Objective

In antithrombotic therapy, the balance between efficacy and safety is delicate, which makes it challenging for healthcare professionals, including pharmacists, to optimise therapy. Pharmacists may play an important role in optimising antithrombotic therapy, but especially in primary care, this role has not been elucidated. Here, we study how community pharmacists (pharmacists in primary care) perceive their current and future role in antithrombotic therapy.

Design

We conducted a qualitative study using semi-structured interviews. The interview protocol and subsequent analysis were based on the Theoretical Domains Framework, and the findings were interpreted with the Capability Opportunity Motivation – Behaviour System.

Setting and participants

The interview participants were community pharmacists, located across the Netherlands, from the Utrecht Pharmacy Practice network for Education and Research.

Results

We interviewed 16 community pharmacists between February and August 2021 and identified several major themes which were important for the pharmacist’s role in antithrombotic therapy. Pharmacists felt responsible for the outcome of antithrombotic treatment and intended to invest in their role in antithrombotic therapy. Pharmacists did, however, experience barriers to their role in antithrombotic therapy, like a lack of access to clinical information such as the indication of antithrombotic treatment and a lack of specific knowledge on this treatment.

Conclusion

Community pharmacists perceive a role for themselves in antithrombotic therapy. To fulfil this role, several preconditions must be met.

☐ ☆ ✇ BMJ Open

What Matters to Aboriginal and Torres Strait Islander Youth (WM2Y): a study protocol to develop a national youth well-being measure

Por: Garvey · G. · Howard · K. · Garvey · D. · Dickson · M. · Howell · M. · Butler · T. L. · Cadet-James · Y. · Cunningham · J. · Bainbridge · R. · McGorry · P. · Williamson · A. · Anderson · K. M. — Marzo 20th 2024 at 03:21
Introduction

Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.

To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).

Methods and analysis

This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.

Ethics and dissemination

Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.

☐ ☆ ✇ BMJ Open

Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol

Por: Stehlik · P. · Dowsett · C. · Camacho · X. · Falster · M. O. · Lim · R. · Nasreen · S. · Pratt · N. L. · Pearson · S.-A. · Henry · D. — Marzo 20th 2024 at 03:21
Background

Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning—specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?

Methods and analysis

We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set).

Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.

By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly.

Ethics and dissemination

As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers.

Registration

https://doi.org/10.17605/OSF.IO/ZHDKR

☐ ☆ ✇ BMJ Open

Socioeconomic inequalities in skilled attendance at birth and caesarean section rates in Myanmar 2015-2016: a cross-sectional study

Por: Show · K. L. · Maung · T. M. · Disney · G. · Bohren · M. A. · Lumbiganon · P. · Ngamjarus · C. — Marzo 19th 2024 at 04:02
Objectives

This study aims to assess inequalities in skilled birth attendance and utilisation of caesarean section (CS) in Myanmar.

Study design

Cross-sectional study design.

Setting and population

We used secondary data from the Myanmar Demographic and Health Survey (2015–2016). Our outcome measures of skilled birth attendance and utilisation of CS were taken from the most recent birth of interviewed women. Absolute and relative inequalities across several sociodemographic characteristics were assessed and evaluated by calculating rate differences, rate ratio and concentration indexes.

Results

More than one-third (36%, 95% CI 32.5% to 39.4%) of women gave birth without a skilled birth attendant present at their most recent birth. 40.7% (95% CI 37.8% to 43.7%) gave birth in healthcare facilities, and the CS rate was 19.7% (95% CI 17.9% to 21.8%) for their most recent birth. The highest proportion of birth without a skilled provider was found in the hilly regions and rural residents, poorest and less educated women, and those with less than four antenatal care visits. Inequalities in birth without a skilled provider were observed across regions, place of residence, wealth quintile, education level and number of antenatal care taken. The highest rate of CS was found among plain regions and urban residents, richest women, more than secondary education, those with more than four antenatal care visits and in private health facilities. Inequalities in CS utilisation were observed across place of residence, wealth quintiles, education level, number of antenatal care taken and type of health facilities.

Conclusion

This study provides evidence regarding inequalities in maternal health service utilisation in Myanmar. Increasing maternal health service availability and accessibility, promoting quality of care and health education campaigns to increase maternal health services utilisation are recommended.

☐ ☆ ✇ BMJ Open

Geographical variation in perceptions, attitudes and barriers to mental health care-seeking across the UK: a cross-sectional study

Por: Wang · R. A. H. · Smittenaar · P. · Thomas · T. · Kamal · Z. · Kemp · H. · Sgaier · S. K. — Marzo 19th 2024 at 04:02
Objectives

To examine the relative importance of the drivers of mental health care-seeking intention and how these, along with intention itself, are geographically distributed across integrated care systems (ICS) and health boards (HBs) in the UK. Also, to examine the degree of acceptance of virtual modes of care.

Design

Community-based cross-sectional survey.

Participants and setting

A national online survey of 17 309 adults between August and September 2021 recruited via a research technology company, Lucid. Sample size quotas were set to ensure coverage across the UK and match population distributions for gender, age and ethnicity. After exclusions, 16 835 participants remained (54% female, 89% white).

Main outcome measures

Care-seeking intention, using a continuous measure of likelihood and a categorical measure of estimated time to seek professional help for a future mental health difficulty.

Results

20.5% (95% CI 19.8% to 21.2%) reported that they would significantly delay or never seek mental healthcare, ranging from 8.3% to 25.7% across ICS/HBs. Multilevel regression analysis showed mental health knowledge was the most predictive of care-seeking intention, followed by attitudes towards others with mental illness and a combination of stigma, negative attitudes to treatment and instrumental barriers to accessing care. The model explained 17% of the variance. There was substantial geographical variation in prevalence of preclinical symptoms of depression and anxiety, attitudes to mental health, and barriers to care, leading to complex ICS/HB profiles. Remote and self-guided therapies did not pose as a major barrier to care with more than half of respondents likely or very likely to use them.

Conclusions

Our locally relevant and actionable findings suggest possible interventions that may improve care-seeking intention and indicate which of these interventions need to be geographically tailored to have maximal effect.

☐ ☆ ✇ BMJ Open

Association between individual-level socioeconomic factors and intimate partner violence victimisation in women: a systematic review protocol

Por: Reyal · H. P. · Dissanayake · N. · Gunarathna · H. · Soysa · D. · Fernando · M. S. · Senarathna · L. — Marzo 19th 2024 at 04:02
Introduction

Intimate partner violence (IPV) is a global public health problem. Although both men and women experience IPV, the burden is more on women. To address IPV effectively, it is important to understand the factors that cause IPV including the socioeconomic factors. However, there is an inadequacy of knowledge on how socioeconomic factors at different levels affect IPV. Hence, the objective is to review the individual-level socioeconomic factors associated with IPV victimisation of women and girls.

Methods and analysis

The search strategy was developed to identify publications from January 2010 to 30 June 2024. The selected electronic databases of PubMed/MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, Scopus and Science Direct will be searched. The eligibility criteria for data collection are based on participants/population (women and girls), exposure (socioeconomic factors) and outcome (IPV). In primary search, the title and abstracts will be screened and reference lists of selected articles will be screened for additional studies. Two researchers will independently screen the articles, and in any disagreements, a third researcher will be consulted. The data will be tabulated to present the study and participant characteristics, comparison descriptors between victims and non-victims, inclusion and exclusion criteria, primary and secondary outcomes data, results, limitations and implications. A quality assessment will be performed on the selected studies to avoid bias. A narrative synthesis will summarise the findings.

Ethics and dissemination

Ethical approval was waived because only secondary data are used. The protocol will be published, and the findings will be disseminated via publication in a peer-reviewed journal.

PROSPERO registration number

CRD42022373535.

☐ ☆ ✇ BMJ Open

Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial

Por: Ganeshalingam · A. A. · Uhrenholt · N. G. · Arnfred · S. · Gaede · P. H. · Bilenberg · N. · Frystyk · J. — Marzo 19th 2024 at 04:02
Introduction

Subjects with schizophrenia have a 2–3 fold higher mortality rate than the general population and a reduced life expectancy of 10–20 years. Approximately one-third of this excess mortality has been attributed to obesity-related type 2 diabetes (T2D) and to cardiovascular disease. Glucagon-like peptide-1 (GLP-1) analogues increase satiety and delay gastric emptying, thereby reducing food intake and weight. GLP-1 analogues also exert beneficial effects on cardiovascular outcomes in high-risk patients with T2D.

Our aim is to investigate whether 30 weeks add-on treatment with the GLP-1 analogue semaglutide can reduce HbA1c sufficiently to reverse pre-diabetes and the metabolic syndrome in overweight schizophrenic patients.

Methods and analysis

We will perform a 30 week, two-armed, multicentre, superiority, double-blinded, randomised trial investigating the effect of weekly injections of semaglutide versus placebo in mental health facilities in Region of Southern Denmark and Region of Zealand, Denmark. In total, 154 adults with schizophrenia spectrum disease, aged 18–60 years treated with second generation antipsychotic treatment, HbA1c 39–47 mmol/mol and body mass index >27 kg/m2 will be randomised to injections of 1.0 mg semaglutide or placebo. The primary outcome is changes in HbA1c. Secondary outcomes encompass metabolic measures, psychotic symptoms and quality of life. Exploratory outcomes encompass insulin sensitivity, cardiovascular risk profile, medication adherence, general well-being and physical activity.

Ethics and dissemination

This study will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This research has obtained approval from both the Danish Medicines Agency and The Regional Committees on Health Research Ethics for Southern Denmark.

Trial registration number

NCT05193578 European Clinical Trials Database Number (EudraCT) 2020-004374-22, Regional Ethical Committee number S-20200182.

☐ ☆ ✇ BMJ Open

Exploration of Latina/Hispanic womens experiences living with non-alcoholic fatty liver disease: a qualitative study with patients in Houston

Por: Heredia · N. I. · Mendoza Duque · E. · Ayieko · S. · Averyt · A. · McNeill · L. H. · Hwang · J. P. · Fernandez · M. E. — Marzo 15th 2024 at 14:25
Objectives

A deeper understanding of the lived experiences of Hispanic patients with non-alcoholic fatty liver disease (NAFLD) can help guide the development of behavioural programmes that facilitate NAFLD management. This paper explores Hispanic women’s experiences living with NAFLD.

Design, setting, participants

We collected brief sociodemographic questionnaires and conducted in-depth interviews with 12 low-income (all had household income ≤USD$55 000 per year) Hispanic women with NAFLD from the Houston area. Transcripts were audio-recorded and transcribed. We developed a coding scheme and used thematic analysis to identify emergent themes, supported by Atlas.ti.

Results

Participants identified physicians as their main information source on NAFLD but also consulted the internet, family, friends and peers. Many were still left wanting more information. Participants identified family history, sedentary lifestyles, poor diet and comorbid conditions as causes for their NAFLD. Participants also reported emotional distress after diagnosis. Participants experienced both successes and challenges in making lifestyle changes in nutrition and physical activity. Some participants received desired social support in managing NAFLD, although there were conflicting feelings about spousal support.

Conclusion

Multifaceted programming that improves patient–provider communication, conveys accurate information and enhances social support is needed to support Hispanic women in managing NAFLD.

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