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Maternity care bundle for UK women with multiple long-term health conditions: coproduction workshops

Por: Hanley · S. · McCann · S. · Singh · M. · Vowles · Z. · Lee · S. I. · Plachcinski · R. · Nirantharakumar · K. · Black · M. · Locock · L. · Taylor · B.
Objective

The objective of this study is to co-produce a care bundle for women with multiple long-term health conditions (MLTC) that could be pilot tested and implemented in UK maternity services.

Design

Online co-production workshops each attended by 20–30 key interest holders.

Setting

United Kingdom, October 2023-February 2024.

Population

Women with experience of pregnancy with MLTC, healthcare professionals and other interest holders involved in commissioning, planning and delivering care for pregnant women with MLTC.

Methods

This study followed a three-step process: (1) a consolidated list of key components of care for pregnant women with MLTC was created through secondary analysis of prior collected qualitative data; (2) the list of care components was explored during four co-production workshops; and (3) findings from (1) and (2) were synthesised to develop a maternity care bundle of 4–5 key care components for pregnant women with MLTC.

Main outcome measures

A maternity care bundle of five key care components for pregnant women with MLTC.

Results

A list of 25 care components was refined to develop a proposed care bundle of five components. These were provisions of early and reliable medication advice and decision support; creation of a ‘goals of care summary’ accessible to women and the care team; provision of continuity of midwifery care throughout pregnancy and postnatal care; provision of a named care coordinator; and a formal postnatal handover of care from the multidisciplinary care team to the General Practitioner (GP) and secondary care team involving the woman.

Conclusions

This study coproduced an evidence-based care bundle for pregnant women with MLTC to enhance communication and ensure individualised care and support. Further collaborative work with women and professionals is required to refine, implement and evaluate its impact on outcomes.

Suicide attempts among Korean adolescents before, during and after the COVID-19 pandemic: a cross-sectional study

Por: Kim · S. I. · Kim · J. S. · Kim · S. M. · Hyun Han · D.
Objectives

This study aimed to examine the prevalence of suicide attempts among Korean adolescents before, during and after the COVID-19 pandemic and explore cross-sectional associations with demographic, psychological, behavioural and academic characteristics.

Design

Cross-sectional analysis of three nationally representative survey waves.

Setting

The Korean Youth Risk Behavior Survey (KYRBS), an annual school-based nationwide survey in South Korea.

Participants

Adolescents with available data on key variables who participated in the 2017 (n=61 861), 2020 (n=54 809) and 2023 (n=52 802) KYRBS.

Primary and secondary outcome measures

The primary outcome was a suicide attempt in the past 12 months. Secondary measures included age, sex, perceived socioeconomic status, sadness, perceived stress, alcohol use, tobacco use, lifetime drug use and subjective academic performance. These variables were measured using standardised single-item questions in the KYRBS, whereas associations were examined using multivariable logistic regression models adjusting for all covariates.

Results

Several characteristics demonstrated consistent associations with suicide attempts. In 2017, suicide attempts were most strongly associated with sadness (OR 6.47, 95% CI 5.68 to 7.37), drug use (OR 5.60, 95% CI 4.34 to 7.24) and stress (OR 1.74, 95% CI 1.63 to 1.85). During the pandemic (2020), sadness (OR 6.35, 95% CI 5.39 to 7.48), drug use (OR 4.56, 95% CI 3.38 to 6.14) and stress (OR 2.10, 95% CI 1.94 to 2.28) preserved the strong association. In 2023, the associations persisted for sadness (OR 5.06, 95% CI 4.48 to 5.71), drug use (OR 5.31, 95% CI 4.42 to 6.39) and tobacco use (OR 2.53, 95% CI 2.15 to 2.98). Socioeconomic status showed no significant association in 2017 (OR 0.98, 95% CI 0.93 to 1.04) but demonstrated modest associations in 2020 (OR 0.91, 95% CI 0.85 to 0.97) and 2023 (OR 0.89, 95% CI 0.84 to 0.94). Subjective academic performance showed inverse associations in 2017 (OR 0.92, 95% CI 0.88 to 0.96) and 2020 (OR 0.92, 95% CI 0.87 to 0.97) but not in 2023 (OR 0.96, 95% CI 0.92 to 1.00).

Conclusions

Across three survey years, suicide attempts among Korean adolescents co-occurred with multiple emotional, behavioural and contextual characteristics. The magnitude of these associations varied before, during and after the pandemic, suggesting that broader social and educational conditions may shape patterns of distress linked with suicidal behaviour. Integrated approaches addressing overlapping emotional, behavioural and socioeconomic challenges may support youth suicide prevention efforts.

Efficacy of paracetamol added to WHO step III opioids in chronic pain control: study protocol for a randomised, double-blind, placebo-controlled, non-inferiority, multicentre study in Switzerland

Por: Kotoula · C. · Wertli · M. M. · Streitberger · K. · Rothschild · S. I. · Limacher · A. · Hammann · F. · Krähenbühl · S. · Haschke · M. · Liakoni · E.
Introduction

The analgesic and antipyretic paracetamol (acetaminophen) is generally considered safe in therapeutic doses. The most important toxic effect is hepatotoxicity after supratherapeutic doses or in the presence of risk factors (eg, malnutrition, alcoholism). According to the WHO analgesic ladder, a combination of a non-opioid analgesic such as paracetamol with a strong opioid is recommended as step III treatment of patients with chronic pain, despite limited evidence for this approach. The main aim of this study is to test the hypothesis that paracetamol does not provide clinically relevant benefits when added to strong opioids in patients with chronic pain.

Methods and analysis

Investigator-initiated, randomised, double-blind, placebo-controlled, non-inferiority trial at two Swiss hospitals. A total of 140 patients with chronic pain requiring strong opioids and paracetamol ≥1.5 g/day for at least 7 days will be enrolled and randomised to either continued combination treatment or strong opioid plus placebo. In the first study phase (days 1–7), patients receive identically looking capsules containing either paracetamol at the exact dose previously used or a placebo. During a second study phase (days 7–14), all patients stop the blinded study medication (paracetamol and placebo) with follow-up to day 14. Adherence will be assessed by pill count and measurement of paracetamol and opioid serum concentrations. Patients are instructed to use a pain diary daily during the whole study. The primary outcome is the average pain score on day 7 using a 10 cm visual analogue scale (VAS). A difference between groups of ≤8 mm will be considered clinically irrelevant. Secondary outcomes will include VAS pain score on day 14, number of opioid rescue doses used, subjective ratings of overall feeling of well-being, quality of life, nausea/vomiting, drowsiness and constipation, and other adverse events, and potential effects of study drug concentrations and opioid receptor and cytochrome P450 (CYP) genotypes on the observed differences.

Ethics and dissemination

The study was approved by the Ethics Committee (Ethikkommission Bern, reference number 2021-01518) and the Swiss Agency for Therapeutic Products (Swissmedic, reference number 701286). Results will be published in open-access policy peer-reviewed journals. The study is funded by the Swiss National Science Foundation (grant number 32 003B_201072).

Trial registration number

NCT05088876.

Baseline sociodemographic and sexual and reproductive health characteristics of the AdSEARCH adolescent cohort study participants in rural Bangladesh: a cohort profile

Por: Alam · A. · Shiblee · S. I. · Rana · M. S. · Sheikh · S. P. · Rahman · F. N. · Sathi · S. S. · Alam · M. M. · Sharmin · I. · Arifeen · S. E. · Rahman · A. E. · Ahmed · A. · Nahar · Q.
Purpose

In Bangladesh, evidence on the long-term trajectory of adolescents' sexual and reproductive health (SRH) remains limited, largely due to the lack of longitudinal data to assess the changes over time. To address this gap, the Advancing Sexual and Reproductive Health and Rights (AdSEARCH) project of International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) set up an adolescent cohort study aimed at documenting changes in SRH knowledge, attitudes and practices, and identifying the factors affecting these changes. This article presents the baseline sociodemographic and SRH characteristics of this cohort as a pathway for future analyses.

Participants

This cohort study included 2713 adolescents from the Baliakandi Health and Demographic Surveillance System run by icddr,b. The cohort covered three age groups from girls and boys, giving a total of five cohorts: girls aged 12, 14 and 16 years; and boys aged 14 and 16 years. A total of seven rounds of data had been collected at 4-month intervals over 2-years follow-up period.

Findings from the baseline

The majority of adolescents were attending school (90%), and school dropouts were higher among boys. Around 17% of the respondents were involved in income-generating activities, which were mostly boys. Among girls, the mean age of menarche was 12.2 years. Overall, 6% of adolescents had major depressive disorder, with prevalence increasing with age. Gender differences were evident regarding knowledge about conception and contraception. Egalitarian attitudes towards social norms and gender roles were found higher among girls (52%) compared to boys (11%). The majority of adolescents reported experiencing social/verbal bullying (43%), followed by physical violence (38%) and cyberbullying (4%).

Future plans

This article presents the baseline findings only. A series of papers is in the pipeline for submission to different peer-reviewed journals. The findings from this study will be used to support data-driven policy formulation for future adolescent health programmes.

Observational study on the clinical epidemiology of infectious acute encephalitis syndrome including Nipah virus disease, Bangladesh: BASE cohort study protocol

Por: Hassan · M. Z. · Rojek · A. · Rahman · D. I. · Sultana · S. · Rahman · M. · Khaja Mafij Uddin · M. · Hossain · M. E. · Rahman · M. W. · Merson · L. · Garcia · E. · Dunning · J. · Bourner · J. · Choudhury · S. S. · Chowdhury · K. I. A. · Zaman · K. · Khan · S. I. · Tarik · M. H. · Yeasmin
Introduction

Nipah virus (NiV) is a bat-transmitted paramyxovirus causing recurrent, high-mortality outbreaks in South and South-East Asia. As a WHO priority pathogen, efforts are underway to develop therapies like monoclonal antibodies and small-molecule antivirals, which require evaluation in clinical trials. However, trial design is challenging due to limited understanding of NiV’s clinical characteristics. Given the rarity of NiV infections, strategies targeting improved outcomes for the broader acute encephalitis syndrome (AES) patient population, including those with NiV, are essential for advancing therapeutic research. To address these gaps, we designed the Bangladesh AES cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, as a clinical characterisation study to inform the design of clinical trials for NiV and AES more broadly.

Methods and analysis

This prospective cohort study will be conducted in Bangladesh, a NiV endemic country with annual outbreaks. In collaboration with the ongoing NiV surveillance programme in Bangladesh, we aim to enrol up to 2000 patients of all ages presenting with AES at three tertiary care hospitals within the Nipah belt. Patients who provide informed consent to participate will be monitored throughout their hospital stay until 90 days post enrolment. Data will be systematically collected through interviews and medical record reviews at several time points: on the day of enrolment, day 3, day 7, the day of critical care admission (if applicable), discharge day and 90 days post enrollment. Additionally, a portion of the cerebrospinal fluid collected under the concurrent NiV surveillance protocol will be tested for an array of viral and bacterial pathogens responsible for encephalitis at the International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) laboratory.

Ethics and dissemination

The study received ethical approval from the Oxford Tropical Research Ethics Committee, University of Oxford, UK (OxTREC Ref: 576–23) and the institutional review board of icddr,b, Bangladesh (icddr,b protocol number: 24016). By characterising the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimising the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Findings will be shared with participating hospitals, patients and relevant government stakeholders. Results will also be disseminated through conference presentations and peer-reviewed publications.

Clinical trial number

Not applicable (this is an observational study).

Postnatal care utilisation and health beliefs among mothers in the Jazan region of Saudi Arabia: a cross-sectional study

Por: Altraifi · A. A. · Albasheer · O. · Abdelwahab · S. I. · Chourasia · U. · Abdelmageed · M. M. · Hakami · A. M. · Khormi · A. H. · Medani · I. E. · Ali · S. A. · Habeeb · S. A. · Shebaly · G. A. · Somaily · M. M. · Harshan · S. M. · Ali · S. M. · Hukma · S. H.
Background

The postnatal period is critical for preventing maternal and neonatal morbidity and mortality. Globally, a significant proportion of maternal and neonatal deaths occur within the first 6 weeks after delivery. Timely and adequate postnatal care (PNC) can detect and manage life-threatening complications; however, service utilisation remains alarmingly low in many low- and middle-income countries, including Saudi Arabia. Addressing the behavioural and perceptual factors that influence service use is essential for improving health outcomes.

Objectives

This study aimed to assess mothers’ utilisation of PNC services and examine how their health beliefs and sociodemographic characteristics influence this behaviour.

Design

A cross-sectional study guided by the Health Belief Model (HBM) was conducted to explore predictors of PNC utilisation.

Setting

Eight primary healthcare (PHC) centres were randomly selected from 179 PHC centres distributed in the different governorates of the Jazan region of Saudi Arabia.

Participants

A total of 464 mothers were surveyed between October and December 2023 using an interviewer-administered questionnaire.

Primary and secondary outcome measures

The primary outcome was PNC utilisation, defined by the number of postnatal visits. The independent variables included sociodemographic characteristics and HBM constructs (perceived susceptibility, benefits, barriers and cues to action).

Results

In terms of PNC utilisation, 80.0% of participants had two or fewer postnatal visits, whereas 20.0% had three or more postnatal visits. Perceived barriers had the strongest influence (mean score 2.51±0.87), followed by cues to action (2.43±0.89), susceptibility (1.92±0.72) and benefits (1.86±0.64). In the multivariate analysis, perceived barriers, cues to action and perceived susceptibility were significantly associated with PNC utilisation, with adjusted ORs of 1.679 (95% CI: 1.007 to 2.799), 0.470 (95% CI: 0.256 to 0.863) and 0.405 (95% CI: 0.197 to 0.832), respectively.

Conclusions

PNC utilisation in the Jazan region remains suboptimal. Perceptual factors, particularly barriers and cues to action, play a central role in service use. Health interventions targeting these beliefs and improving follow-up mechanisms may help increase PNC engagement and improve maternal and infant health outcomes in Saudi Arabia.

Evaluating pharmacist prescribing education programmes: a realist synthesis protocol

Por: Xenos · K. · Rees · C. E. · Heslop · I. M. · Benrimoj · S. I. · Dineen-Griffin · S.
Introduction

Pharmacist prescribing has evolved to meet healthcare system needs, but the effectiveness, mechanisms and contextual factors influencing education programmes remain poorly understood. Realist approaches are fairly novel in pharmacy practice research. This realist synthesis aims to answer the question: to what extent do pharmacy prescribing education programs work (or not), for whom and under what circumstances, and why?

Methods and analysis

A realist methodology (realist synthesis) will be used to review the outcomes of programmes. Pawson’s key stages will be followed: (1) clarifying the scope; (2) determining the search strategy; (3) study selection; (4) extracting and analysing data; and (5) synthesising findings and drawing conclusions. The synthesis will follow Realist And Meta-narrative Evidence Syntheses–Evolving Standards publication guidelines. Data extracted will include the study characteristics, alongside the contexts, mechanisms and outcomes of varied pharmacy prescribing education programmes. The search strategy will include searching PubMed, Scopus, Web of Science and CINAHL Complete. An initial programme theory will use selected grey literature. Context-mechanism-outcome configurations will be identified, and recurring patterns will be synthesised to refine the initial programme theory.

Ethics and dissemination

Ethics approval is not required. Dissemination will be sought via peer-reviewed academic conferences and journals.

PROSPERO registration number

CRD420251056576.

Development of an algorithm for ethnicity recording in cohorts from the UK Clinical Practice Research Datalink primary care and linked Hospital Episode Statistics databases

Por: Shiekh · S. I. · Williams · R. · Axson · E. L.
Objective

To evaluate various prioritisation strategies within an algorithm designed to ascertain the most likely ethnicity and create a standardised methodology to benefit future research.

Design

Retrospective cohort study.

Setting

The Clinical Practice Research Datalink (CPRD) primary care and linked Hospital Episode Statistics (HES) data sets.

Participants

The population of 54 029 174 patients included all acceptable patients registered at English practices in CPRD GOLD or CPRD Aurum from the May 2023 to May 2022 builds, respectively.

Primary outcome measure

Ethnicity data within CPRD and HES data sets were identified by employing established code lists and subsequently categorised into broader ethnic groups. Changes were made to a previously used algorithm to assess their effect on ethnic categorisations. Modifications included prioritising primary over secondary care data, recent over frequent records and ‘non-other’ ethnicity categories. Different data sources were examined: CPRD with all HES data sets, CPRD with HES Admitted Patient Care (APC) only, CPRD only and HES APC only. Ethnic distributions from these variations were compared using counts and percentages, evaluating inter-rater reliability using Cohen’s kappa. Sensitivity analyses included repetition using only currently registered patients and after removing cases with unknown ethnicity. Ethnic distributions were compared with English Census 2021.

Results

There was almost perfect agreement in ethnicity distributions whether prioritising primary over secondary care data (kappa=1.0000, SE=0.0001), whether prioritising most frequently or most recently recorded data (kappa=0.9824, SE=0.0001) and whether prioritising ‘non-Other’ categories (kappa=0.9705, SE=0.0001). There was moderate agreement in ethnicity distributions when sourcing data from single data sources (CPRD only (kappa=0.5554, SE=0.0001) or HES APC only (kappa=0.5526, SE=0.0001)) compared with combined data sources (CPRD and HES datasets).

Conclusions

All variations of the algorithm produced similar population-level ethnicity distributions. Versions using data from multiple sources had higher inter-rater reliability than those using a subset of sources; however, there was little difference in categorisations produced by varying the hierarchical decision-making of the ethnicity algorithm. The CPRD population was representative of the English population in terms of ethnicity. While researchers should remain vigilant of the limitations of using these data, the CPRD Ethnicity Records provide a standardised and pragmatic approach to ascertaining ethnicity for future research.

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