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Student paramedic experiences of group-based simulation activities used in assessment: a qualitative UK study

Por: Colthup · R. A. · Johnson · G. N. · Jenkins · R. J. · Runacres · J.
Objectives

This research aimed to explore student paramedics’ experiences of participating in group-based simulation activities used as part of their summative assessment. It sought to understand their perceptions of the effectiveness of group-based simulation in fostering learning and informing future assessment design.

Design

A qualitative questionnaire-based study.

Setting

A UK higher education institution.

Participants

A total of 34 first-year (level 4) student paramedics from the September 2022 to September 2023 cohorts.

Intervention

Following the completion of a summative assessment for the introduction to non-technical skills and simulation module, students were invited to reflect on their experiences of group-based simulation through an online questionnaire. The assessment incorporated team-based simulation scenarios intended to evaluate non-technical competencies within a realistic and supportive environment.

Results

Four key themes emerged through thematic analysis of the responses: experiential learning; autonomous learning; reflective learning; and support and learning. These themes provide insights into the pedagogical value of group-based simulation, with students identifying both individual and collective benefits in developing non-technical skills within a group assessment framework.

Conclusion

Group-based simulation assessments enhance student engagement and promote collaborative decision-making in a context that mimics real paramedic practice. While students often associate realism with increased confidence, their experiences highlight complex interactions between perceived fidelity, assessment pressure and learning. This underscores the need to further investigate how group dynamics and authenticity influence learning outcomes in assessment-focused simulations.

Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of Sao Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB ProCura)

Por: Rosa · C. D. · Ferrazoli · L. · dos Santos · D. P. · Pedace · C. · Soler-Camargo · N. C. · Silva-Pereira · T. T. · Brandao · A. P. · Bollela · V. R. · Cruz · A. L. G. · Feliciano · C. S. · Ferreira · P. R. A. · Jorge · E. P. · de Miranda · S. S. · de Oliveira · R. S. · Oliveira · M.
Introduction

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

Methods and analysis

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethics and dissemination

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

Trial registration number

U1111-1308-4669.

Large cohort study of postnatal events over 18 months in a not-for-profit referral centre in Vellore, South India

Por: Abraham · N. A. · Nagasamudra Devendrappa · V. · Mano R · G. · Pricilla · R. A. · Rathore · S. · Yenuberi · H. · Tirkey · R. S. · Shabeer · M. · Kumar · M. · Abraham · A. · Vijayaselvi · R. · George · A. · Abraham · K. · Prasanthi · A. · Minz · S. · Abraham · S. · Kurian · S. · Premkumar
Objective

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

Design

A prospective cohort study.

Setting

A large tertiary care centre.

Participants

12 245 women who delivered after 22 weeks gestation in the year 2022.

Interventions

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary and secondary outcome measures

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Results

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Conclusion

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

Trial registration number

CTRI/2022/03/041343.

Epidemiological assessment of mental health screening protocols for high school athlete participation in the USA, 2021

Por: Generoso · R. A. · Vasudevan · V. · Hamade · H. · Sylvester-Omorodion · P. · Wolohan · M.
Objectives

To examine state-level variation in mental health screening practices for high school athletes in the USA and evaluate associations between screening protocols and adolescent depression-related and suicide-related outcomes.

Design

Cross-sectional study of preparticipation examination (PPE) forms and Youth Risk Behaviour Surveillance System (YRBSS) data.

Setting

High school athletics across all 50 US states and the District of Columbia.

Participants

732 676 high school students who completed the 2021 YRBSS survey (grades 9–12).

Primary and secondary outcome measures

Prevalence of depressive symptoms and suicide-related behaviours, measured using YRBSS items on sadness/hopelessness, suicide ideation, planning, attempts and suicide attempts resulting in injury. State-level PPE forms were reviewed for presence and depth of mental health screening, including Patient Health Questionnaire-4 (PHQ-4) and eating disorder (ED) risk questions.

Results

Screening practices varied widely, ranging from no mention of mental health in some states to required evaluations with formal referral protocols in others. Of 732 676 students, 503 861 (68.7%) reported feeling sad or hopeless, 608 416 (83.0%) seriously considered suicide and 64 072 (8.8%) attempted suicide in the past year. States with required screening protocols had higher reported rates of depressive symptoms (71.0% vs 68.7%, p

Conclusions

High school athletes represent a vulnerable group in need of structured and standardised mental health screening. State-level screening policies were associated with lower suicide attempt rates, though causal inference is limited by the cross-sectional design. Standardised use of validated mental health tools may support early identification and intervention for at-risk adolescents.

Aetiological clustering of newly diagnosed type 2 diabetes using machine learning: a retrospective cross-sectional study in Dubai, UAE

Por: Dsouza · S. M. · Sulaiman · F. · Abdul · F. · Mulla · F. · Ahmed · F. S. · AlSharhan · M. · AlOlama · A. · Ali · N. · Abdulaziz · A. · Rafie · A. M. · Alnuaimi · S. · Goswami · N. · Khamis · A. H. · Bayoumi · R. A. L.
Objectives

Type 2 diabetes (T2D) is a complex disease with a heterogeneous clinical presentation. Recently, five distinct clusters of T2D have been identified in the Emirati population of long-standing T2D with complications. This study aimed to validate these clusters in newly diagnosed T2D patients without any complications and determine whether severe and mild phenotypes are detectable early in the disease course.

Design

Retrospective, cross-sectional, non-interventional study.

Setting

Primary healthcare centres in Dubai, UAE.

Participants

A total of 451 adults, including both Emiratis and expatriates, diagnosed with T2D in the last 5 years and without T2D-related complications at the time of visit, were enrolled. Patients with complications, incomplete clinical data or higher duration of T2D were excluded from the study.

Outcome measures

Identification of distinct T2D clusters using machine learning-based clustering analysis. Five clinical variables: age at diagnosis, body mass index, glycated haemoglobin, fasting serum insulin and fasting blood glucose served as predictors. Overlap between clusters was assessed via the Silhouette Index and Bayesian probability.

Results

Five clusters were identified, replicating prior findings: severe insulin-resistant diabetes (SIRD), severe insulin-deficient diabetes (SIDD), mild age-related diabetes (MARD), mild obesity-related diabetes (MOD) and mild early-onset diabetes (MEOD). As confirmed by a Silhouette Index and Bayesian probability of 1, 55.43% of the patients showed cluster-exclusiveness, while 44.56% of the cohort showed overlap between clusters. The highest overlap was recorded for mild forms of T2D in the order MOD>MARD>MEOD.

Conclusions

The study confirms that both severe and mild T2D phenotypes are present in newly diagnosed, complication-free patients, supporting the applicability of cluster-based classification early in disease. These results highlight the potential for personalised treatment strategies to optimise management and prevent complications. Future studies should investigate longitudinal outcomes and therapeutic response across clusters.

Early childhood exposure to skin-lightening products in Nigeria: prevalence, maternal perspectives and predictors from a cross-sectional study

Por: Ajani · A. A. · Omokanye · C. · Adebayo · A. · Adejumobi · R. A. · Ijiyode · B. · Ogundiran · M. O. · Torimiro · A. · Raheem · O. · Ijadunola · M.
Background

Increasing reports of life-threatening complications in young children exposed to skin-lightening products present a significant public health concern, yet this issue remains under-researched.

Objectives

To determine the prevalence, maternal perceptions and predictors of early childhood exposure to skin-lightening products among mothers in Southwestern Nigeria.

Design

A cross-sectional, questionnaire-based study.

Setting

Three randomly selected government-owned primary healthcare facilities in Ile-Ife, Nigeria.

Participants

Three hundred and sixty-nine mothers aged ≥18 years, each with at least one child under 5, recruited by simple random sampling. Data were collected between May and July 2024 using pretested, interviewer–administer semistructured questionnaires. Mothers with acutely ill children were excluded.

Primary outcome and secondary outcome measures

Primary outcome was the use of skin lightening products on children while secondary outcomes included maternal use, perceptions and sociodemographic/familial predictors.

Results

Participants’ ages ranged from 18 to 54 years (mean: 30.92±6.11 years). Overall, 19.5% (n=72) mothers practised early childhood skin lightening, with 80.6% of exposed children

Conclusion

This study highlights a high prevalence of early childhood exposure to lightening products in a semiurban Nigerian community, with maternal use emerging as a key associated factor. Although awareness of potential health risks was common, aesthetic preferences for lighter skin tones appeared to outweigh safety concerns. These findings highlight the need for culturally sensitive interventions and further research to inform strategies that promote safer childhood skin-care practices.

How prevalent are modifiable dementia risk factors in Ireland? A 12-year observational study in community-dwelling older adults

Por: McGarvey · C. · Kenny · R. A. · Kennelly · S. · Sexton · D. · Briggs · R.
Objectives

Dementia is potentially preventable and deferrable yet remains a major cause of disability, dependency and mortality worldwide. The 2024 Lancet Commission on dementia identified 14 modifiable dementia risk factors and estimated that addressing these could reduce dementia cases by up to 45%. The aim of this study is to assess dementia risk factor prevalence in adults ≥50 years participating in a nationally representative longitudinal study on ageing, providing crucial context for the delivery of dementia prevention.

Design and setting

The Irish Longitudinal Study on Ageing (TILDA) is a population-based prospective cohort study, representative of community-dwelling adults ≥50 years living in Ireland.

Participants

All participants from waves 1 (2009–2010): n=8171, 3 (2014–2015): n=6615 and 6 (2021–2023): n=4318 of TILDA were analysed over a 10.93 (±0.37) years of follow-up.

Results

70.6%, 61.1% and 54.2% of the population had ≥4 modifiable risk factors for dementia at consecutive waves, amounting to over 500 000 people with ≥4 modifiable risk factors for dementia on weighted population analysis at wave 6. 77% of those with severe decline in cognitive performance during follow-up had ≥4 risk factors at baseline. An estimated 32 480 cases of severe decline in cognitive performance during follow-up were potentially preventable if risk factors were addressed.

Conclusions

In a nationally representative sample of older European adults, there is a high prevalence of modifiable dementia risk factors. This highlights the need for greater attention on educating people on the concept of brain health through public health messaging as well as the development of a clinical framework focused on delivering on the opportunity of dementia prevention. Preventing and delaying dementia onset can have a significant impact on the compression of morbidity and increasing healthy lifespan in older age.

Do self-reported and objective hearing measures similarly relate to general and domain-specific cognition? Observational cohort study of older adults in England

Por: OShea · B. Q. · Milan · R. A. · Gross · A. L. · Powell · D. S. · Kobayashi · L. C. · Steptoe · A.
Objectives

We compared associations between self-reported and HearCheck screening device measures of hearing difficulty with subsequent general and domain-specific cognitive function in a population-based sample of older English adults.

Design

Observational cohort study.

Setting

Population-based sample of older adults in wave 7 of the English Longitudinal Study of Ageing (ELSA) in 2014/15 and its Healthy Cognitive Ageing Project (HCAP) in 2018.

Participants

N=1119 adults aged ≥62 years.

Primary outcome measures

Factor scores for general cognitive function and domains of memory, language, orientation and executive function were derived from the HCAP neuropsychological test battery (mean of 0 and SD of 1 for each). Hearing difficulty was assessed using a self-reported 5-point Likert-type scale and the HearCheck screening device, which administered a series of six tones in each ear.

Results

According to the HearCheck device, 48% of participants had a mild or moderate-to-severe hearing difficulty, while 25% self-reported fair or poor hearing. In multivariable-adjusted, population-weighted linear regression models, hearing difficulty identified via HearCheck was associated with worse general cognitive function (β=–0.34 SD units; 95% CI –0.60 to –0.07 for moderate-to-severe hearing difficulty vs good hearing) as well as worse function in domains of memory, language and executive function, each with a dose-response relationship. Self-reported hearing difficulty was not associated with general or domain-specific cognitive function.

Conclusions

Peripheral hearing ability, as captured by the HearCheck screening device, may have stronger relevance for later-life cognitive outcomes than the broader construct of perceived hearing difficulty in one’s daily environment that is captured by a self-reported measure.

Validation and cost-effectiveness of an mHealth tool for cognitive impairment detection in Peru: protocol for the IMPACT Salud observational study

Por: Cardenas · M. K. · Anza-Ramirez · C. · Bernabe-Ortiz · A. · Custodio · N. · Montesinos · R. · Miranda · J. J. · Da Re · M. · Belon-Hercilla · M. V. · Lazo-Porras · M. · Hawkins · J. · Diez-Canseco · F. · Moore · G. · Whiteley · W. · Calvo · R. A. · Cuba-Fuentes · M. S. · Landeiro · F.
Introduction

Dementia is a chronic and progressive neurological condition characterised by cognitive and functional impairment. It is often associated with multimorbidity and imposes a significant economic burden on healthcare systems and families, especially in low-income and middle-income countries. In Peru, where dementia cases are increasing rapidly, timely detection and referral for diagnosis is crucial. This protocol is part of the IMPACT Salud project in Peru. Here, we focus on a specific component aimed at validating an mHealth tool for the detection of cognitive and functional impairment and assessing its cost-effectiveness. We will also assess changes in cognitive and functional impairment as well as health economic outcomes over 1 year.

Methods and analysis

This observational study will be conducted in four geographically diverse regions of Peru. Community health workers are expected to contact approximately 32 000 participants (≥60 years) to apply an mHealth-enabled tool that includes cognitive and functional instruments: Ascertain Dementia 8, Peruvian version of Rowland Universal Dementia Assessment Scale and Pfeffer Functional Activities Questionnaire. From this large sample, we aim to find 3600 participants and their study partners to enrol and interview at baseline regarding sociodemographic characteristics, lifestyles, comorbidities and health economic data including resource use, costs and health-related quality of life (HR-QoL). Psychologists, blind to previous results, will assess dementia stage of the participants using an abbreviated Clinical Dementia Rating (CDR) scale. At 6-month follow-up, participants will complete a brief health economics questionnaire on resource use, costs and HR-QoL. To validate the accuracy of the detection tool, a subsample of 600 participants who completed the baseline will undergo a gold-standard clinical neuropsychological assessment. This subsample will participate in a 12-month follow-up, including health economics, cognitive and functional impairment tests and the CDR scale. Results will be analysed and presented by cognitive status, site, sex and multimorbidity profile. Finally, data from all stages and external sources will inform a decision model to implement a cost-effectiveness analysis of the detection tool at the national level.

Ethics and dissemination

The study received ethics approval in Peru (Universidad Peruana Cayetano Heredia: CONSTANCIA-CIEI-378-33-23) and in the UK (Imperial College London: ICREC/SETREC reference number 6647445). Informed consent will be obtained from participants and their study partners, considering the participant’s capacity to consent. For illiterate participants, consent will be obtained through a witnessed procedure involving study partners, with a fingerprint obtained instead of a signature. The results will be disseminated through conferences, published articles, public presentations (particularly to those involved in dementia care) and presentations or meetings with local health authorities.

Morphine for chronic breathlessness (MABEL) in the UK: a health economic evaluation of a multisite, parallel-group, dose titration, double-blind, randomised, placebo-controlled trial

Por: Atter · M. J. · Hall · P. · Evans · R. A. · Norrie · J. · Cohen · J. · Williams · B. · Chaudhuri · N. · Bajwah · S. · Higginson · I. · Pearson · M. · Currow · D. · Stewart · G. · Fallon · M. · Johnson · M.
Objectives

To compare costs and health consequences and to assess the cost-effectiveness of using low-dose oral long-acting morphine in people with chronic breathlessness.

Design

Within-trial planned cost-consequences and cost-effectiveness analysis of data from a multisite, parallel-group, double-blind, randomised, placebo-controlled trial of low-dose, long-acting morphine.

Setting

11 hospital outpatients across the UK.

Participants

Consenting adults with chronic breathlessness due to long-term cardiorespiratory conditions.

Intervention

5–10 mg two times a day oral long-acting morphine with a blinded laxative for 56 days.

Primary outcome measures

Mean and SD of healthcare resource use (HRU) by trial arm; mean differences and 95% CI of costs between trial arms.

Secondary outcome measures

Mean differences in 28- and 56-day quality-adjusted life years (QALYs based on EuroQol five-dimension five-level score), Short Form-six dimensional scores and ICEpop CAPability-Supportive Care Measure scores; cost-utility of long-acting morphine for chronic breathlessness.

Results

143 participants (75 morphine and 67 placebo) were randomised; 140 (90% power, males 66%, mean age 70.5 (SD 9.4)) formed the modified intention-to-treat population (participants receiving at least one dose of study medication). There were more inpatient and fewer outpatient services used by the morphine group versus the placebo. In the base-case analysis at 56 days, long-acting morphine was associated with similar mean per-patient costs and QALYs. There was an increase of £24 (95% CI –£395 to £552) and 0.002 (95% CI –0.004 to 0.008) QALYs. Hospitalisations were the main driver of cost differences. The corresponding incremental cost-effectiveness ratio was £12 000/QALY, with a probability of cost-effectiveness of 54% at a £20 000 willingness-to-pay threshold. In the scenario analysis that excluded costs of adverse events considered unrelated to long-acting morphine by site investigators and researchers, the probability of cost-effectiveness increased to 73%.

Conclusion

Oral morphine for chronic breathlessness is likely to be a cost-effective intervention provided adverse events are minimised, but the effect on outcome is small and cautious interpretation is warranted.

Trial registration number

ISRCTN87329095.

Intraoperative nursing workload and associated factors: a cross-sectional analysis from two Brazilian hospital surgical units

Por: Constante · E. C. · Poveda · V. d. B. · Oliveira · R. A.
Objective

To estimate the workload of the nursing team and its associated factors during the intraoperative period for adult patients undergoing elective and urgent/emergency surgeries.

Design

Cross-sectional study.

Setting

Surgical units of two hospitals in Brazil.

Data sources and sample size

We prospectively assessed the workload using the National Aeronautics and Space Administration – Task Load Index (NASA-TLX) score and analysed the electronic medical records of patients who agreed to participate in the study, from November 2023 to February 2024. We included data from 116 nursing professionals and 402 surgeries.

Results

Among the procedures analysed, the median raw NASA-TLX score in cardiac surgery was significantly higher (60.8; IQR 40.0–72.5 points) compared with the others. We observed that in the generalised linear model procedures over minutes presented around 25% greater workload compared with 120 min surgeries (1.252; 95% CI 1.1018 to 1.549) and patients classified as American Society of Anesthesiologists (ASA) physical status classification (ASA) III and IV exhibited approximately 24% higher workload compared with those classified as ASA I (1.241; 95% CI 1.003 to 1.550).

Conclusions

Surgical length and ASA physical status influence the workload. Thus, we suggest that surgical unit leaders give special attention to long-term surgical procedures and patient severity on perioperative workload when dimensioning nursing staff.

Surrogacy in Ghana: a qualitative study exploring recruitment processes, eligibility criteria, stigma and postnatal care experiences among surrogate mothers

Por: Amarteifio · D. A. · Hiadzi · R. A. · Tetteh · P. M. · Boafo · I. M.
Objective

Surrogacy has become a vital reproductive option for individuals and couples who are unable to conceive naturally. This study explores the experiences of surrogate mothers in Ghana, focusing on recruitment pathways, eligibility criteria, societal stigma and postnatal care experiences.

Design

Qualitative phenomenological research design was used, and data were collected through semi-structured interviews and analysed using thematic content analysis.

Setting

Three private agencies that source surrogate mothers for assisted reproduction facilities in Accra, Ghana. Data were collected between December 2020 and June 2021.

Participants

Twenty-one surrogate mothers aged 20–40 years who were either pregnant (gestational age ≥16 weeks) or had delivered within the past 2 years were recruited from three private agencies in Accra.

Results

Thematic analysis generated four themes: (1) recruitment pathways into surrogacy, (2) eligibility criteria and assessments, (3) experiences of stigma and concealment and (4) postnatal care and recovery. These themes illustrate how surrogate mothers in Ghana navigate recruitment processes, psychosocial and medical evaluations, societal stigma and challenges with discharge and follow-up care.

Conclusion

These findings underscore the need for systemic changes, including enhanced postnatal care, structured psychological evaluations and culturally sensitive interventions to reduce stigma.

Side effect profile and comparative tolerability of newer generation antidepressants in the acute treatment of major depressive disorder in children and adolescents: protocol for a systematic review and network meta-analysis

Por: Türkmen · C. · Sacu · S. · Furukawa · Y. · de Cates · A. N. · Schoevers · R. A. · Kamphuis · J. · Chevance · A. · Weisz · J. R. · Emslie · G. J. · Strawn · J. R. · Hetrick · S. E. · Efthimiou · O. · Salanti · G. · van Dalfsen · J. H. · Furukawa · T. A. · Cipriani · A.
Introduction

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

Methods and analysis

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

Ethics and dissemination

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

PROSPERO registration number

CRD420251011399.

E-Prem checklist-driven strategy to improve outcomes in extremely preterm and low birth weight infants: a quasi-experimental study at a national referral hospital in Indonesia

Por: Marsubrin · P. M. T. · Sugiyarto · K. L. J. · Oswari · J. S. · Yulianti · D. A. · Rohsiswatmo · R. · Roeslani · R. D. · Iskandar · R. A. T. P. · Sukarja · D. · Sjahrullah · M. A. R. · Kautsar · A. · Chaudhari · T.
Objectives

This study aims to assess how implementing a checklist for managing extremely preterm or extremely low birth weight infants can reduce mortality rates and morbidities.

Design

A quasi-experimental, before-and-after study.

Setting

Neonatal intensive care unit at Dr. Cipto Mangunkusumo National General Hospital, a national referral hospital in Indonesia.

Participant

86 infants were born at

Interventions

Implementation of a modified Canberra Health Services extremely preterm-early management checklist during the initial management of extremely preterm or low birth weight infants, including humidified gas resuscitation, thermal management, early surfactant administration and standardised first-hour care protocols.

Main outcome measures

The primary outcome was the mortality rate. Secondary outcomes included comorbidities such as hypothermia, hypoglycaemia, acidosis, intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL) and retinopathy of prematurity (ROP).

Results

A total of 86 extremely premature and/or extremely low birth weight infants were enrolled, 48 neonates prior to and 38 neonates after the use of the checklist. Baseline characteristics were comparable between groups (median gestational age 27 weeks in both groups, median birth weight 795 g vs 868.5 g, p=0.09). Mortality at discharge showed a non-significant reduction from 52.1% to 47.4% (p=0.664, 0.91, 95% CI 0.64 to 1.30). Significant reductions were observed in IVH (79.2% to 28.9%, p

Conclusions

Implementation of a systematic checklist was associated with significant reductions in IVH and ROP, though mortality reduction was not statistically significant. These findings suggest potential benefits of structured early care protocols, but the observational design limits causal inference.

Occurrence of advance care planning for persons with dementia, cancer and other chronic-progressive diseases in general practice: longitudinal analysis of data from health records linked with administrative data

Por: Hommel · D. · Azizi · B. · Visser · M. · Bolt · S. R. · Blom · J. W. · Janssen · D. J. A. · van Hout · H. P. J. · Francke · A. L. · Verheij · R. A. · Joling · K. J. · van der Steen · J. T.
Objectives

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Design

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Setting and participants

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Outcome measure

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

Results

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Conclusions

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

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.

Multimorbidity before, during and after pregnancy among women in low-income and middle-income countries: protocol for a scoping review

Por: Ramokolo · V. · Roomaney · R. A. · Maqungo · M. · Nyirenda · M. · Puri · P. · Yakubu · K. · Gummidi · B. · Zembe-Mkabile · W. · Xu · X. · McCauley · M.
Introduction

The co-occurrence of multiple long-term conditions, that is, multimorbidity, is increasing globally and is associated with lower quality of life and increased risk of death. The risk and prevalence of multimorbidity are higher among women compared with men, but currently, evidence focusing on women’s multiple long-term conditions during the perinatal period is limited. Existing evidence needs to be examined to determine the extent to which maternal multimorbidity or women’s multiple health needs related to pregnancy have been addressed, especially for women living in low-income and middle-income countries (LMICs) where this burden of disease is the highest. The objective of this scoping review is to map existing evidence in LMICs on (a) Study designs and data sources, (b) Context-relevant definitions and descriptions, (c) Associated risk and protective factors, (d) Relevant maternal and infant health outcomes and (e) Treatments and interventions used to manage multiple long-term conditions before, during and after pregnancy.

Methods and analysis

This scoping review will be conducted using Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement extension for scoping reviews. This review will include observational, experimental or quasi-experimental studies, as well as systematic or umbrella reviews, on multimorbidity in women of reproductive age (15–49 years) in prepregnancy, pregnancy or up to 6 weeks after childbirth in LMICs. The studies will focus on definitions, risk and protective factors and management strategies for multiple long-term conditions before, during and after pregnancy. Studies of morbidity in women with a single index condition or conditions that are not related to pregnancy or childbirth will be excluded. A search strategy will be developed using thesaurus (including MeSH) and free-text terms for ‘maternal morbidity’ or ‘multiple long-term conditions’ and associated keywords such as multimorbidity, co-morbidity and unmet health needs related to pregnancy and/or childbirth for women living in LMICs. Electronic (EBSCOhost (CINAHL Ultimate, STM Source, Medline Ultimate), Cochrane Library, Web of Science or Scopus and Google Scholar) and grey literature databases will be searched from database inception. Reference lists and bibliographies of key topic articles will also be searched, and any additional papers that meet the inclusion criteria will be obtained. There will be no limitations on dates or languages. Records will be independently screened, selected and extracted by two researchers. Data will be presented in tables and narrative summaries.

Ethics and dissemination

Ethics approval is not required as this scoping review will summarise previously published data. Findings from the review will be disseminated through various platforms, including peer-reviewed journals, conferences and community meetings.

Study registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/FYCR8).

Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM): findings from a process evaluation of a randomised feasibility study

Por: Brown · S. E. · Simpson · S. A. A. · Greaves · C. · Daw · P. · Dean · S. G. · Evans · R. A. · Withers · T. M. · Ahmed · Z. · Barber · S. · Barwell · G. · Doherty · P. J. · Gardiner · N. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · Manifield · J. R. · McIntosh · E. · Miller · D. · O
Objective

The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Design

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Setting

Three UK sites (two acute hospital settings, one community-based healthcare setting).

Participants

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

Intervention

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Results

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

Conclusions

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

Trial registration number

ISRCTN68786622.

Personalised exercise-rehabilitation for people with multiple long-term conditions (PERFORM): a randomised feasibility study

Por: Evans · R. A. · Simpson · S. A. · Manifield · J. R. · Ahmed · Z. · Barber · S. · Barwell · G. · Brown · S. E. · Daw · P. · Dean · S. G. · Doherty · P. J. · Fraser · H. · Gardiner · N. · Greaves · C. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · McIntosh · E. · Megaritis · D. · Mille
Objective

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

Design

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Setting

Three UK sites (two acute hospital settings, one community-based healthcare setting).

Participants

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

Intervention

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary and secondary outcome measures

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Results

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m2 and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Conclusions

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

Trial registration number

ISRCTN68786622.

Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E.
Objectives

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

Design

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

Setting

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Participants

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Interventions

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

Primary and secondary outcomes

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

Results

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

Conclusions

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

Trial registration number

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

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