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Ayer — Octubre 2nd 2025Tus fuentes RSS

Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia
Objectives

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

120 clinical pharmacists with experience in conducting SMRs in primary care.

Results

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

Conclusions

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Adherence to the recommended diabetic retinopathy screening guidelines in pregnant women with pregestational diabetes: a cross-sectional survey study

Por: Widyaputri · F. · Rogers · S. L. · Nankervis · A. J. · Conn · J. J. · Shub · A. · Staffieri · S. E. · Sasongko · M. B. · Fagan · X. J. · Symons · R. C. A. · Lim · L. L.
Objective

Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Design

Cross-sectional survey study, as part of a larger prospective cohort study.

Setting

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Participants

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

Primary and secondary outcome measures

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

Results

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Conclusions

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.

Comparison of thyroid hormone abnormalities among men with primary and secondary infertility: a cross-sectional study in Benin City, Nigeria

Por: Asiriuwa · I. · Emokpae · M. A. · Osaikhuwuomwan · A. J.
Objective

Male infertility can be primary or secondary, depending on whether pregnancy has been achieved before or not, but thyroid gland involvement is rarely investigated in the laboratory work-up. This study aimed to assess thyroid hormone abnormalities among primary and secondary infertile men.

Design

This is a cross-sectional study involving male partners of infertile couples presenting at the fertility clinic with an established diagnosis of infertility after review by the clinician. Males with proven fertility served as controls.

Setting

The study was conducted at the Human Reproduction and Research Programme unit and the Chemical Pathology Laboratory of the University of Benin Teaching Hospital, Benin City, Edo State, Nigeria.

Participants

This study involved 200 participants who consisted of 50 controls (fertile men) and 150 infertile men (80 primary infertile men and 70 secondary infertile men). The participants were reviewed by a clinician, and a semen analysis was done to ascertain their fertility status.

Results

The results show that sperm indices, such as sperm count, total motility, progressive motility, viable sperm cells, normal forms and volume were significantly lower (p

Conclusion

Thyroid abnormalities were more predominant among secondary infertile men than primary infertile men in this study.

Dementia-related volumetric assessments in neuroradiology reports: a natural language processing-based study

Por: Mayers · A. J. · Roberts · A. · Venkataraman · A. V. · Booth · C. · Stewart · R.
Objectives

Structural MRI of the brain is routinely performed on patients referred to memory clinics; however, resulting radiology reports, including volumetric assessments, are conventionally stored as unstructured free text. We sought to use natural language processing (NLP) to extract text relating to intracranial volumetric assessment from brain MRI text reports to enhance routine data availability for research purposes.

Setting

Electronic records from a large mental healthcare provider serving a geographic catchment of 1.3 million residents in four boroughs of south London, UK.

Design

A corpus of 4007 de-identified brain MRI reports from patients referred to memory assessment services. An NLP algorithm was developed, using a span categorisation approach, to extract six binary (presence/absence) categories from the text reports: (i) global volume loss, (ii) hippocampal/medial temporal lobe volume loss and (iii) other lobar/regional volume loss. Distributions of these categories were evaluated.

Results

The overall F1 score for the six categories was 0.89 (precision 0.92, recall 0.86), with the following precision/recall for each category: presence of global volume loss 0.95/0.95, absence of global volume loss 0.94/0.77, presence of regional volume loss 0.80/0.58, absence of regional volume loss 0.91/0.93, presence of hippocampal volume loss 0.90/0.88, and absence of hippocampal volume loss 0.94/0.92.

Conclusions

These results support the feasibility and accuracy of using NLP techniques to extract volumetric assessments from radiology reports, and the potential for automated generation of novel meta-data from dementia assessments in electronic health records.

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PUTRA-CV study protocol: a multicentre observational study of ethnic-specific genetic variants and dietary patterns in relation to lipoprotein(a) levels and their association with coronary artery disease severity in Malaysian adults

Por: Pannirselvam · S. · C Thambiah · S. · Appannah · G. · Ling · K. H. · Samsudin · I. N. · Hooper · A. J. · Yusoff · M. R. · Zakaria · A. F. · Razali · R. · Kiong · G. L. S. · Zahari Sham · S. Y. · Lai · Y. Y. · Abdul Rahman · T. H. · Zainal Abidin · I.
Introduction

Although low-density lipoprotein cholesterol (LDL-C) is established as the primary cardiovascular disease (CVD) risk factor, some individuals with LDL-C within desirable limits still develop coronary artery disease (CAD). Lipoprotein(a) (Lp(a)) has emerged as a genetically determined independent risk factor for CVD. This study aims to investigate Lp(a) by determining its association with coronary artery stenosis severity, identifying its ethnic-specific genetic determinants and assessing its relationship with an energy-dense dietary pattern.

Methods and analysis

The PUTRA-CV study is a 3-year, multicentre, case-control observational study involving adult patients who have undergone coronary angiography. The primary outcome is the association between Lp(a) levels and the severity of angiographic CAD (assessed by Gensini or Syntax score). Secondary outcomes include the frequencies of Lp(a)-associated single nucleotide polymorphisms (SNPs) (rs10455872 and rs3798220) and the association between dietary patterns and Lp(a) levels. Lp(a) will be measured using a particle-enhanced immunoturbidimetric method, and SNPs will be genotyped using high-resolution melting. Dietary intake will be assessed using a validated semiquantitative food frequency questionnaire. Data will be analysed using SPSS. Descriptive statistics will be used to summarise population characteristics. Bivariate analyses will use chi-square (2), independent t-tests or Mann-Whitney U tests as appropriate. The independent association between Lp(a) and coronary artery stenosis severity will be determined using multivariable logistic regression, adjusting for confounders. Empirically driven dietary patterns will be derived using reduced rank regression, and their association with Lp(a) will be assessed. For genetic analysis, allele frequencies of the LPA SNPs rs10455872 and rs3798220 will be calculated and compared between cases and controls.

Ethics and dissemination

Ethical approval has been obtained from the ethics committees of the Ministry of Health Malaysia (NMRR ID-24-00877-2ID-IIR), Universiti Putra Malaysia (JKEUPM-2024–246), Universiti Teknologi MARA (REC/07/2024-OT/FB/2) and Universiti Malaya Medical Centre (MREC ID NO: 2 02 453–13692). The findings will be disseminated via peer-reviewed journals and conferences.

Remote intentional music listening intervention to support mental health in individuals with chronic stroke: study protocol for a feasibility trial

Por: Provias · V. · Kucukoglu · M. A. · Robinson · A. · Yandun-Oyola · S. · He · R. · Palumbo · A. · Sihvonen · A. J. · Shi · Y. · Malgaroli · M. · Schambra · H. · Fuentes · M. · Ripolles · P.
Introduction

Poststroke depression affects approximately 30% of stroke survivors and is linked to worse functional outcomes, cognitive decline, reduced quality of life and increased mortality. While early treatment of poststroke mental health conditions is critical, current pharmacological options offer limited efficacy. Music listening interventions are a promising, low-risk, accessible and affordable alternative that may enhance recovery through engagement of reward-related brain circuits. However, most music listening studies have focused on the acute stage of stroke, lack objective measures of music engagement and rarely assess underlying neural mechanisms. To address these gaps, we propose a feasibility study of a remotely delivered music-listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural and physiological changes.

Methods and analysis

We will conduct a parallel group randomised controlled feasibility trial enrolling 60 patients with chronic stroke from a well-characterised stroke registry in New York City. Participants will be randomised to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week preintervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (ie, track identity, duration and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioural outcomes related to mental health will be assessed at baseline, preintervention, postintervention and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity and heart rate) will be collected preintervention and postintervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, treatment fidelity, feasibility, acceptability and participant burden. Secondary outcomes include recruitment and randomisation rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for poststroke mental health recovery.

Ethics and dissemination

The study was approved by New York University’s Institutional Review Board (FY2024-8826). All human participants will provide written informed consent prior to participation and will be adequately compensated for their time. Results will be reported in peer-reviewed journals.

Trial registration number

NCT07127159.

Clinical practice guidelines for the care of people experiencing chronic primary pain: protocol for a systematic review with interpretation against an established chronic pain care priority framework

Por: Briggs · A. M. · Siegfried · N. · Waller · R. · OConnell · N. E. · Romero · L. · Klem · N.-R. · Ampiah · P. K. · Belton · J. L. · Blyth · F. M. · De Morgan · S. · Lord · S. M. · Nicholas · M. · OSullivan · P. B. · Shakya · A. · Smith · A. J. · Slater · H.
Introduction

Most clinical practice guidelines (CPGs) for assessing and managing people’s chronic pain focus on specific pain conditions, body sites or life course stages. This creates complexity for clinicians making care choices in the absence of a diagnosis and/or where a person experiences more than one pain condition. Specific to this context is the ICD-11 classification of chronic primary pain where an experience of pain cannot be better accounted for by another condition. CPGs for chronic primary pain, agnostic to condition or body part, may support clinicians towards best pain care since many of the principles of person-centred chronic pain care are transdiagnostic. The two aims of this systematic review are to (1) identify and appraise CPGs for chronic primary pain, relevant across the life course and (2) map the CPG content against a pain care priority framework to evaluate the extent to which the CPG content aligns with the priorities of people with lived chronic pain experience.

Methods and analysis

We will systematically search nine scholarly databases, the Epistemonikos database and international and national guidelines clearinghouses. CPGs published within 2015–2025, in any language, that offer recommendations about assessment and/or management of chronic primary pain for people of any age, excluding hospitalised inpatients or institutionalised populations, will be included. Pairs of reviewers will independently screen citations for eligibility and appraise CPG quality and implementation potential using the Appraisal of Guidelines for Research and Evaluation (AGREE)-II and the AGREE-Recommendations Excellence tools, respectively. Data extraction will include the citation and scope characteristics of each CPG, methods used to develop recommendations, verbatim recommendations, guiding principles or practice information and narrative excerpts related to the GRADE Evidence-to-Decision (EtD) considerations (or equivalent). We will use the PROGRESS-PLUS framework as a checklist to identify whether determinants of health equity were considered by guideline developers. CPG recommendations will be organised according to common topics and categorised in a matrix according to strength and direction. Qualitative content analysis will be used to synthesise excerpts relating to GRADE EtD considerations (or equivalent), and we will map extracted data against an established chronic pain care priority framework to determine the extent to which the CPGs align with values and preferences of people with lived experience. Interpretation will be informed by an interdisciplinary Advisory Group, including lived experience partners.

Ethics and dissemination

Ethical approval is not required for this systematic review. Results will be disseminated through publication in an open-access peer-reviewed journal, through professional societies, and integrated into education curricula and public-facing resources. Reporting will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.

PROSPERO registration number

CRD420251000482.

Evaluating the health and well-being effects of increasing biodiversity within multiple small parks in Edinburgh, UK: a protocol for a mixed-methods, longitudinal, pre-post natural experiment

Por: Malden · S. · McDougall · C. W. · Ward Thompson · C. · Wendelboe-Nelson · C. · Ross-Perez · A. · Clemens · T. · Mason · S. · Villegas-Diaz · R. · Hoadley · A. · Hunter · A. · Jepson · R. · Williams · A. J.
Introduction

Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.

Methods and analysis

This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.

Ethics and dissemination

This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.

iHEART trial: study protocol for a German multicentre randomised controlled trial on the feasibility and acceptance of an internet-based preoperative intervention to optimise patient expectations and improve outcomes after heart surgery

Por: Compere · V. N. · Balci · S. · Heinz · C. · Schade-Brittinger · C. · Rastan · A. J. · Salzmann-Djufri · M. · Niemann · B. · Boening · A. · Choi · Y.-H. · Zarski · A.-C. · Laferton · J. · Euteneuer · F. · Rief · W. · Salzmann · S.
Introduction

Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.

Methods and analysis

In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based guidance (iEXPECT limited). The intervention includes four 20 min online modules addressing surgical benefits, side effects and coping strategies. Modules are accompanied by personalised guidance provided through feedback on each module via email or telephone (three before surgery, three booster sessions at 6, 12 and 18 weeks postsurgery). Assessments occur at baseline (5–21 days before surgery), preoperatively (day before surgery), 7 days postsurgery and 6 months later. Primary feasibility outcomes include recruitment (≥1 participant/week/centre), retention (≥49% completing 6-month follow-up including biomarkers) and engagement (≥75% completing ≥1 presurgery module). Acceptability is measured by self-reported enjoyment, usefulness and impact, with acceptance defined as mean scores >3.4 (5-point Likert scale) and CSQ-I ratings. Secondary outcomes include psychological measures, inflammatory markers and heart rate variability.

Ethics and dissemination

Ethical approval was granted by the Ethics Committees of Philipps University Marburg (AZ 229/23 BO) and the University of Giessen (AZ 186/23). All participants provide written informed consent. Results will be shared via publications, conferences and public outreach with relevant consumer advocacy groups.

Trial registration number

DRKS00033284.

LDL-C achievement in patients with coronary artery disease: a study protocol for the EDHIPO-MARCA retrospective registry

Por: Cordoba-Melo · B. D. · Arango-Ibanez · J. P. · Posso-Marin · S. · Ruiz · A. J. · Molina · D. I. · Gomez-Mesa · J. E.
Introduction

Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.

Methods and analysis

This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.

Ethics and dissemination

This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.

Epidemiology and risk factors of Alzheimers disease and related dementias in South and Southeast Asia: a systematic review and meta-analysis protocol

Por: Rahman · M. · Tabassum · A. · Sultana · S. · Saha · T. · Nayeem · M. A. J. · Jahan · I. · Hasan · I. · Hayat · S. · Papri · N. · Islam · Z.
Background

Alzheimer’s disease (AD) impacts over 55 million individuals worldwide and remains the leading cause of dementia (60–70% of cases). By 2050, South and Southeast Asia are projected to have an older adult population more than double, bearing a major share of Alzheimer’s disease burden. This will exert a heavy strain on healthcare systems, particularly in resource-limited countries where support and infrastructure are already stretched. Despite this, no review has yet explored the regional epidemiology and associated risk factors in this context. Thus, this study protocol outlines to synthesise prevailing evidence from these densely populated regions, particularly low- and middle-income nations within South and Southeast Asia.

Methods

This review will include studies that reported epidemiological characteristics including prevalence, age of onset, mortality, and risk factors of AD and related dementias comprising in South and Southeast Asian regions. Studies published in any language from inception to date will be extracted from PubMed, Scopus, CINAHL, EMBASE and APA PsycNet, following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) and Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. We will also search grey literature sources and screen the reference lists of the articles selected for full-text review to identify additional relevant studies. Observational studies including case–control, cohort, and cross-sectional designs reporting desired outcomes will be included and appraised for quality assessment with the modified Newcastle-Ottawa Scale (mNOS). The included articles will be appraised by two independent reviewers, with a third resolving any conflicts. Pooled estimates of prevalence, age of onset and mortality will be analysed using random effect meta-analysis (REML) model. Associated risk factors, including modifiable and non-modifiable will be narratively synthesised. Forest plots will be used to visualise the findings, and heterogeneity across the included studies will be assessed using the I² and Cochrane’s Q statistics. Potential publication bias will be assessed using a funnel plot along with the Begg’s and Egger’s tests. Sensitivity and subgroup analyses will also be conducted to assess the robustness of pooled estimates and to explore potential sources of heterogeneity. Statistical analysis will be conducted using Rstudio (v.4.3.2) and GraphPad Prism V.9.0.2.

Ethics and disseminations

The systematic review is focused on the analysis of secondary data from published literature; thus, no ethical approval will be needed. The protocol will follow international standard guidelines, findings will be reported in a reputed journal and disseminated through (inter)national conferences, webinars and key stakeholders to inform policy, research and AD management strategies.

PROSPERO registration number

CRD 420251047105.

Treating nightmares in post-traumatic stress disorder with the {alpha}-adrenergic agents clonidine and doxazosin: protocol for a phase II randomised, double-blind, placebo-controlled parallel-group study (ClonDoTrial)

Por: Roepke · S. · Schoofs · N. · Priebe · K. · Wuelfing · F. · Roehle · R. · Maslahati · T. · Stieglbauer · K. · Biedermann · S. · Schaefer · I. · Gallinat · J. · Ethofer · T. · Fallgatter · A. J. · Hanewald · B. · Mulert · C. · Schmahl · C. · Otte · C. · Koglin · S.
Introduction

Intrusive nightmares are a hallmark symptom of post-traumatic stress disorder (PTSD), contributing significantly to psychiatric comorbidities, impaired physical health and diminished social functioning. Currently, no pharmacological treatments are specifically approved for managing PTSD-related nightmares. However, emerging evidence suggests that adrenoceptor-targeting agents may offer therapeutic potential. Notably, clonidine and doxazosin have demonstrated efficacy in reducing PTSD-associated nightmares, as indicated by findings from open-label studies and small randomised controlled trials.

Methods and analysis

This study is a multicentre, double-blind, randomised (1:1:1), placebo-controlled, parallel-group interventional trial. A total of 189 eligible patients will be randomly assigned to receive clonidine, doxazosin or placebo, with a once-daily oral dose administered at bedtime for 10 weeks. The primary efficacy endpoint is the Clinician-Administered PTSD Scale B2 score at week 10, which measures the frequency and intensity of nightmares. Secondary efficacy endpoints include other PTSD-specific symptoms. Additionally, the safety of clonidine and doxazosin will be assessed.

Ethics and dissemination

The study was approved by the Ethics Committee of the State of Berlin (Ethik-Kommission des Landes Berlin) (Reference: 21-683-Haupt-IV E 13), on 14 March 2022 and by the relevant federal authority, the Bundesinstitut für Arzneimittel und Medizinprodukte, reference 4044931. The study was conducted in accordance with the relevant guidelines and regulations. The study results will be published in peer-reviewed journals and presented at both national and international conferences.

Trial registration number

NCT05360953, EudraCT 2021-000319-21.

Magnitude of low back pain and associated factors among primary school teachers in Borama City, Somaliland: an institutional-based cross-sectional study

Por: Shegere · M. M. · Abdilahi · A. M. · Ali · S. Y. · Farah · N. B. · Adem · B. A. · Nour · A. J.
Objectives

The goal of the study was to determine the magnitude and contributing factors of low back pain among primary school teachers in Borama Town, Somaliland.

Design

An institution-based descriptive cross-sectional study design was employed. Simple random sampling was used to select the study units from each school.

Setting

The study was conducted in Borama, Somaliland.

Participants

A total of 268 primary school teachers participated in the study.

Outcome measures

The primary outcome of the study was the prevalence of low back pain.

Results

The study found that 51.5% of school teachers had low back pain. There was a strong link between low back pain and having a higher Body Mass Index (adjusted OR (AOR)=2.63) and stress at work (AOR=3.34). Sleep disturbance (AOR=1.73), lifting heavy materials (AOR=1.67) and a history of low back injury (AOR=2.12) were also significant predictors of low back pain.

Conclusion

More than half of primary school teachers had low back pain over the past 12 months. Higher Body Mass Index, history of low back injury, stress at work, lifting heavy material and sleep disturbance were significant and independent predictors of low back pain among primary school teachers.

Effect of medical-grade honey (L-Mesitran) for cervical intraepithelial neoplasia II: protocol for a multicentre cohort pilot study (HONEY FOR CIN II study)

Por: Prop · J. · De Vos van Steenwijk · P. · Lardenoije · C. M. J. G. · Cremers · N. A. J. · Morre · S. A. · Mongula · J.
Introduction

High-grade squamous intraepithelial lesions are caused by persistent high-risk human papillomavirus (hr-HPV) infections and are subdivided into cervical intraepithelial neoplasia (CIN) lesions: CIN II (moderate) and CIN III (severe). Current treatment options for CIN II include large loop excision of the transformation zone, imiquimod and expectant management. Each treatment option has its drawbacks, and therefore, a non-invasive treatment is desirable. Preliminary evidence shows that medical-grade honey (MGH) has antiviral activity and might be able to modulate the vaginal microbiome, reduce local inflammation or directly influence the intralesional immune response within cervical tissues. Therefore, this study aims to investigate the possible effect of MGH on hr-HPV clearance and to investigate the possible underlying mechanisms contributing to the regression of CIN II lesions.

Methods and analysis

This study is performed in the Zuyderland Medical Centre and Maastricht University Medical Centre+. A total of 60 eligible women with newly histologically confirmed CIN II will receive MGH (L-Mesitran Soft) for intravaginal use for 6 months. The primary objective is to investigate the effect of MGH on the hr-HPV clearance after 6 months. Secondary aims are the effect of MGH on the regression of CIN II lesions, clearance of hr-HPV at 12 and 24 months and the role of the vaginal microbiome, local immune system and intravaginal inflammatory status in response to MGH. Moreover, data on quality of life, side effects and compliance will be collected.

Ethics and dissemination

Ethical approval from the Medical Ethics Review Committee of the Zuyderland Medical Centre Heerlen has been obtained (NL86044.096.24 on 24 April 2024). The results will be presented to researchers and healthcare professionals through conferences, meetings and publications in international journals.

Trial registration number

NCT06219018.

Exploring alterations in sleep-related physiological and psychological outcomes across the menstrual cycle in young, healthy women without sleep disorders: a US-based pilot study protocol

Por: Conti · F. · Hakonsson · Z. · Durmer · J. S. · Galpin · A. J.
Introduction

Research suggests that hormonal fluctuations may contribute to sleep-related physiological and psychological outcomes that differentially affect women’s overall health and well-being. Yet, systematic enquiries on this potential interaction across the menstrual cycle are scant.

Methods and analysis

This protocol paper describes a pilot observational study investigating changes in objective and subjective sleep measures, metabolic biomarkers (body temperature, blood glucose and hormonal concentrations) and psychological outcomes (depressive symptoms, menstrual cycle-related pain and psychological distress), in a cohort of healthy premenopausal women aged 18–35, regularly menstruating, and without sleep disorders. Participants’ sleep is monitored every night over the course of two full menstrual cycles using a Food and Drug Administration (FDA)-approved diagnostic ring from SleepImage and via next morning self-reports (ie, sleep diaries). To minimise the likelihood of undiagnosed sleep disorders, participants also complete two nights of at-home polysomnography. Daily hormonal concentrations are assessed via morning urinalysis using the Mira Fertility Monitor while transitions between hormonal phases are further confirmed by biochemical assays. Body temperature, blood glucose concentrations, diet and physical activity behaviours are continuously recorded using wearable devices and smartphone apps from Oura and Levels. The primary outcomes of this study are total sleep time and sleep quality. Secondary outcomes include sleep onset latency, wakefulness after sleep onset, sleep staging, daytime sleepiness, respiratory rate, resting heart rate, heart rate variability and subjective mood. This study will provide novel data to disentangle the intricate relationship between sleep behaviours, mental well-being and menstrual health in premenopausal women.

Ethics and dissemination

The study was approved by the Institutional Review Board at Parker University (protocol number PUIRB-2025-3). Study findings will be presented in peer-reviewed publications and at academic conferences.

Development of START-EDI guidelines for reporting equality, diversity and inclusion in research: a study protocol

Por: Fadel · M. G. · Kettley-Linsell · H. · Boshier · P. R. · Barnes · R. · Newby · C. · Manyara · A. M. · Buckle · P. · Vyas · D. A. · Hepburn · J. · Edgar-Jones · P. · Rai · T. · Nicholson · B. D. · Cross · A. J. · Sharples · L. D. · Hopewell · S. · Cohen · J. F. · Welch · V. · Bossuyt · P.
Introduction

Acknowledging equality, diversity and inclusion (EDI) in research is not only a moral imperative but also an important step in avoiding bias and ensuring generalisability of results. This protocol describes the development of STAndards for ReporTing EDI (START-EDI) in research, which will provide a set of minimum standards to help researchers improve their consistency, completeness and transparency in EDI reporting. We anticipate that these guidelines will benefit authors, reviewers, editors, funding organisations, healthcare providers, patients and the public.

Methods and analysis

To create START-EDI reporting guidelines, the following five stages are proposed: (i) establish a diverse, multidisciplinary Steering Committee that will lead and coordinate guideline development; (ii) a systematic review to identify the essential principles and methodological approaches for EDI to generate preliminary checklist items; (iii) conduct an international Delphi process to reach a consensus on the checklist items; (iv) finalise the reporting guidelines and create a separate explanation and elaboration document; and (v) broad dissemination and implementation of START-EDI guidelines. We will work with patient and public involvement representatives and under-served groups in research throughout the project stages.

Ethics and dissemination

The study has received ethical approval from the Imperial College London Research Ethics Committee (study ID: 7592283). The reporting guidelines will be published in open access peer-reviewed publications and presented in international conferences, and disseminated through community networks and forums.

Trial registration number

The project is pre-registered within the Open Science Framework (https://osf.io/8udbq/) and the Enhancing the Quality and Transparency of Health Research Network.

Impact of left ventricular end-diastolic pressure on clinical outcomes in patients with ST-elevation myocardial infarction (Hunter LVEDP Study): a prospective, single-centre study

Por: Khan · A. A. · Williams · T. · Ray · M. · Al-Omary · M. S. · Taylor · J. · Collins · N. · Attia · J. · Boyle · A. J.
Objectives

Elevated left ventricular end-diastolic pressure (LVEDP) in ST-segment elevation myocardial infarction (STEMI) has been studied in patients who received thrombolysis or who were treated early in the primary percutaneous coronary intervention (PCI) era; LVEDP was found to be a predictor of adverse outcomes in these retrospective post hoc analyses. The aim of the current analysis is to assess the prognostic value of the elevated LVEDP in STEMI patients undergoing primary PCI in current contemporary practice.

Design

Prospective, single-centre study.

Participants

Our study enrolled STEMI patients with elevated LVEDP undergoing primary PCI at John Hunter Hospital, Newcastle, Australia.

Primary outcome measure

The primary endpoint was the combination of 12-month all-cause mortality and heart failure admissions, comparing different quartiles of LVEDP.

Results

A total of 997 patients underwent primary PCI at our hospital during the 5-year study period (age: 64±13 years, males: 73%; n=728) from 1 January 2015 to 31 December 2019. The median LVEDP for the whole cohort was 27 mm Hg (IQR: 22–31 mm Hg). The median LVEDP was 17 mm Hg (IQR: 13–18 mm Hg) and 33 mm Hg (IQR: 30–36 mm Hg) for 1st and 4th quartiles respectively (p

Conclusions

LVEDP is an independent predictor of adverse outcomes in STEMI patients, despite a relatively normal LVEF. Further prospective studies are needed to assess the effects of early reduction in LVEDP on the prognosis.

Effectiveness of education and training programmes to help clinicians assess and classify perineal tears: a systematic review

Por: Simpson · G. · Philip · M. · Richards · A. · Eggleston · A. J. · Vogel · J. P. · Wilson · A. N. · Homer · C.
Objective

For every 100 women having a vaginal birth, approximately four will experience a severe (third-degree or fourth-degree) perineal tear. Severe perineal tears are associated with significant short-term and long-term consequences if not recognised and repaired. There are global efforts to reduce incidence of severe perineal tears including initiatives to strengthen education and training of clinicians in perineal anatomy and perineal tear assessment and classification. This systematic review aimed to describe and evaluate the effectiveness of these initiatives.

Design

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

Data sources

Medline (Ovid), CINAHL Complete (EBSCO), MIDIRS and EMBASE (Ovid) were searched through 15 February 2024.

Eligibility criteria

Studies reporting simple or complex interventions aimed at improving the skills and knowledge of clinicians in perineal anatomy and/or the clinical assessment and classification of perineal tears were eligible.

Data extraction and synthesis

Two reviewers independently screened studies for eligibility and appraised the quality of individual studies using the Cochrane Risk of Bias (RoB) 2.0 tool or Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool.

Results

In total, 7645 citations were screened and 39 studies included. We identified nine unique interventions including training programmes, short workshops and senior obstetrician supervision. Many studies were from high-income countries, in primary care settings and at high risk of bias.

Conclusions

Effective education included practical components, such as hands-on skills and training in perineal anatomy, assessment and classification, rather than senior supervision alone. Ongoing review of practice appears to be crucial for maintaining knowledge and skills. Future research should focus on interventions tailored to limited-resource settings, and the optimal length and intensity of training programmes to assess and classify perineal tears.

PROSPERO registration number

CRD42020185431.

Prevalence and determinants of hypertension among adults of reproductive age in Tanzania: analysis of a cross-sectional Demographic and Health Survey

Por: Lutambi · A. M. · Mnyagatwa · P. M. · Busunge · A. J. · Dodo · E. B. · Mwinga · G. P. · Nagai · H. T. · Mkama · Y. J. · Chilongani · J. E. · Kapyolo · E. P. · Matemba · L. E. · Emidi · B.
Objective

We aimed to estimate prevalence and identify determinants of hypertension in adults aged 15–49 years in Tanzania.

Design

We analysed cross-sectional survey data from the 2022 Tanzania Demographic and Health Survey and Malaria Indicator Survey conducted between February and July 2022. Descriptive statistical analysis, logistic regression, machine learning and geospatial methods were used to estimate prevalence and determine determinants of hypertension.

Setting

Tanzania.

Participants

A total of 13 385 participants aged 15–49 years were included in the analysis.

Primary outcome

The primary outcome variable was hypertension, defined as either systolic blood pressure (BP)≥140 and/or diastolic BP≥90 mm Hg or under anti-hypertensive drugs.

Results

The prevalence of hypertension among adults of reproductive age was 11% (95% CIs 10.09 to 11.56) in Tanzania, varying significantly across risk factors. Prevalence was high in people aged 40–49 (22.11%, 95% CI 20.07 to 24.29) and obese (23.69%, 95% CI 20.67 to 27.00). The mean prevalence of hypertension was also high in the southern, eastern, western, southern highlands, north-west and north-eastern part of the country, correlating with the spatial distribution of older age (30–49) and higher body mass index (BMI) (≥25). Individuals aged 40–49 had nearly six times (adjusted OR (AOR): 5.68, 95% CI 4.10 to 7.83) the odds of hypertension relative to those aged 15–19. Obese individuals had higher odds (AOR: 2.88, 95% CI 2.01 to 4.13) compared with overweight individuals (AOR: 1.93, 95% CI 1.36 to 2.74). Machine learning results showed age and BMI as the most important determinants of hypertension and that significant interactions between risk factors exist.

Conclusion

The prevalence of hypertension varied across risk factors and the strongest determinants of hypertension in adults of reproductive age were age and BMI.

Arm Based on LEg blood pressures (ABLE-BP): can systolic ankle blood pressure measurements predict systolic arm blood pressure? An individual participant data meta-analysis from the INTERPRESS-IPD Collaboration

Por: McDonagh · S. T. J. · Warren · F. C. · Sheppard · J. P. · Boddy · K. · Farmer · L. · Shore · H. · Williams · P. · Lewis · P. S. · Fordham · A. J. · Martin · U. · Aboyans · V. · Clark · C. E. · on behalf of the INTERPRESS-IPD Collaborators · White · Price · Ferrucci · Erbel · Westeri
Objectives

To determine associations between arm and ankle systolic blood pressures (SBPs), develop and validate a multivariable model predicting arm SBP from ankle SBP, and investigate associations between ankle SBP, cardiovascular disease and mortality.

Design

Ankle-arm SBP differences were examined in two-stage individual participant data (IPD) meta-analyses using multivariable hierarchical linear regression models. Models were used to derive and validate a prediction model for arm SBP based on ankle SBP. Model performance was assessed using area under the receiver operating characteristic (AUROC) curve analyses. Prognostic associations of ankle SBP with outcomes were examined using Cox proportional hazards models.

Data sources

Searches identified cohorts for the Inter-arm Blood Pressure Difference IPD (INTERPRESS-IPD) Collaboration from Medline, Old Medline, Medline in process, Embase and CINAHL databases from inception until January 2017; unpublished data were also sought. Required primary outcomes were all-cause mortality, cardiovascular mortality, and/or fatal and non-fatal cardiovascular events.

Eligibility criteria

Prospective studies from community, primary care or general clinic settings, without language restriction, that recorded SBP in both arms were eligible. Adults aged ≥18 years with SBP measured in all four limbs, in a supine position, were included in the current analyses. People with peripheral artery disease were excluded.

Data extraction and synthesis

Anonymised datasets were individually cleaned and then combined into a single dataset for the INTERPRESS-IPD Collaboration.

Results

The current dataset included 33 710 participants from 14 studies; mean age 58 years, 45% female, mean baseline arm blood pressure 138/80 (SD: 20/12) mm Hg. Mean ankle SBP was 12.0 mm Hg (95% CI 8.8 to 15.2) higher than arm SBP. The multivariable model predicting arm SBP from ankle SBP demonstrated excellent performance (AUROC curves, sensitivities and specificities were >0.82, 0.80 and 0.82, respectively, at all BP thresholds from 130 to 160 mm Hg). Model performance was superior to existing arithmetic formulae.

Ankle SBP was neither associated with all-cause nor cardiovascular mortality (HR 1.000 (0.997 to 1.002; p=0.682) and 1.001 (0.996 to 1.005; p=0.840), respectively). However, lower-reading ankle SBP was associated with fatal or non-fatal cardiovascular events (HR 1.005 (1.002 to 1.007; p

Conclusions

On average, ankle SBP is 12 mm Hg higher than arm SBP. Estimating individual arm SBP from ankle SBP measurements with a multivariable model is more accurate than existing fixed arithmetic formulae. This model, operationalised in an online calculator (https://ablebp.research.exeter.ac.uk/), could facilitate hypertension management and cardiovascular care for people unable to have arm SBP measured.

PROSPERO registration number

CRD42015031227.

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