bluuebunny/crossref_metadata_2025 huggingface dataset:
Success and safety of neonatal endotracheal tube exchanges: a NEAR4NEOS multicentre retrospective cohort study
Authors: Miller Kathleen , Pouppirt Nicole , Wildenhain Paul , Abou Mehrem Ayman , Brajkovic Ivana , DeMartino Cassandra , Glass Kristen , Hodgson Kate Alison , Jung Philipp , Moussa Ahmed , Puia-Dumitrescu Mihai , Quek Binhuey , Rumpel Jennifer , Shay Rebecca , Tingay David , Tyler Michelle D , Unrau Jennifer , Wagner Michael , Shults Justine , Nishisaki Akira , Foglia Elizabeth E , Herrick Heidi M
Published: February 2025

Objectives

To compare success and safety of endotracheal tube (ETT) exchanges with primary intubations and identify factors associated with ETT exchange outcomes.

Design

Retrospective observational study of prospectively collected National Emergency Airway Registry for Neonates data. ETT exchanges are the placement of a new ETT when one is already in place, whereas primary intubations do not have a pre-existing ETT. The primary outcome was first-attempt success. Secondary outcomes included number of attempts, adverse tracheal intubation-associated events (TIAEs), severe TIAEs, desaturation and bradycardia. Descriptive statistics compared characteristics for ETT exchanges and primary intubations. Univariable and multivariable analyses compared primary and secondary outcomes and identified factors independently associated with ETT exchange outcomes.

Results

A total of 1572 ETT exchanges and 9999 primary intubations across 21 sites were included from October 2014 to September 2022. ETT exchanges represented 2.3%–31.2% (mean 13.6%) of intubations across sites. Patient, provider and practice characteristics varied significantly between ETT exchanges and primary intubations. In univariable analyses, ETT exchanges were associated with higher first-attempt success (70.5% vs 53.6%; p<0.001) and fewer safety events. In multivariable analyses, ETT exchanges were associated with an increased adjusted OR (aOR) of first-attempt success (1.71; 95% CI 1.57 to 1.86; p<0.001). ETT exchanges were associated with lower aOR of all safety outcomes except severe TIAEs. Factors independently associated with ETT exchange first-attempt success included video laryngoscopy and paralytic premedication.

Conclusion

Compared with primary intubations, ETT exchanges were associated with higher first-attempt success and fewer safety events. Video laryngoscope and paralytic premedication were associated with improved ETT exchange outcomes.
Uterine rupture following motor vehicle collision: possible seatbelt induced lesions
Authors: Sousa Sara , Simões Costa Nuno , Valentim Lourenço Alexandre
Published: February 2025

Road traffic accidents rank among the leading non-obstetric causes of maternal and fetal death. We present a case of a motor vehicle collision involving a pregnant woman at term. In the initial evaluation, the patient was haemodynamically unstable and had an extensive abdominal haematoma. Abdominal ultrasound revealed fetal death and a significant quantity of intra-abdominal free fluid. An emergent exploratory laparotomy was performed, confirming a transverse uterine rupture, significant haemoperitoneum, and a dead fetus in the peritoneal cavity. Additional injuries included right infundibulopelvic ligament haematoma, rectus abdominis muscle section, dorsal vertebral body fracture and rib and ileopubic branch fractures. Uterine repair and right adnexectomy were performed. Despite fetal death, the patient survived, and the uterus and left adnexa were preserved.
Idiopathic retrograde duodenojejunal intussusception in a patient with multiple congenital anomalies
Authors: Lobo Liana Mae Jajurie , Lopez Marc Paul Jose , Deogracias Jan Miguel , Lim Michael Geoffrey Lee
Published: February 2025

This is a case of a woman in her late 20s with multiple musculoskeletal congenital anomalies presenting with a 1 week history of right lower quadrant abdominal pain. She was received dehydrated at the emergency department with a soft, non-tender abdomen. After resuscitation, CT imaging showed evidence of retrograde duodenojejunal intussusception. The patient eventually required a jejunal resection as intervention.
Left ventricular outflow track to left atrium fistula: a complication of enterococcal endocarditis and long-term outcome
Authors: Sicinschi Stefan , Modi Morni , Modi Kalgi
Published: February 2025

We describe a rare complication ofEnterococcus faecalisinfective aortic valve endocarditis with flail and perforated aortic valve leaflets causing torrential regurgitation, followed by secondary infection of the sub and supra-aortic structures causing cystic abscess of mitral aortic intervalvular fibrosa and pseudoaneurysm of the aorta. The mitral valve cystic abscess ruptured and caused a fistulous connection between the left ventricular outflow tract and the left atrium. The patient underwent surgical replacement of the aortic valve, repair of the mitral aortic fibrosa and repair of the aortic pseudoaneurysm. The persistent mitral valve fistula was treated with a conservative approach.
Two cases of highly concentrated hydrogen peroxide poisoning with portal venous gas treated using hyperbaric oxygen therapy
Authors: Vallélian Marie , Juillerat André , Sunic Matea , Schneider Claudio , Boet Sylvain
Published: February 2025

Hydrogen peroxide poisoning is a rare but potentially severe poisoning that can cause digestive tract irritation and/or gas embolism when ingested. The clinical presentation varies from asymptomatic patients to severe embolic consequences or even death. There is little evidence on the treatment of such poisoning to guide physicians in caring for these patients. This paper reports on two cases of highly concentrated hydrogen peroxide poisoning after accidental ingestion. Both patients showed evidence of portal venous gas, with one patient exhibiting significant symptoms while the other did not. Both were treated with hyperbaric oxygen therapy (HBOT), with a follow-up CT scan revealing a complete resolution of the portal venous gas. This suggests that HBOT is effective for both symptomatic and asymptomatic patients with portal venous gas and should be considered as an effective treatment option in cases of highly concentrated hydrogen peroxide poisoning.
Clival canal defect: a rare cause of recurrent meningitis and fungal brain abscess in an immune-competent child
Authors: John Sujonitha , Evans Jennifer , Warris Adilia , Hatcher James , Mok Quen
Published: February 2025

A girl in her early childhood years (2–5 years) presented with multiple episodes of meningitis. Following the sixth episode, she clinically deteriorated with the development of multiple brain abscesses and hydrocephalus, requiring a ventriculoperitoneal shunt and prolonged antibiotic and antifungal therapy. MRI of the brain revealed a possible anatomical defect at the C1 level of the cervical spine, communicating into the nasopharyngeal cavity. Needle aspiration of the brainstem collection confirmedAspergillus fumigatuson molecular testing. A transoral endoscopic adenoidectomy exposed an underlying mucosal defect communicating with the base of the clivus. Following successful repair of the defect, she showed significant improvement with no further episodes of meningitis.

This case highlights the benefit of a multidisciplinary team approach and the need for any patient with recurrent meningitis to undergo extensive evaluation. Long-term isavuconazole has shown excellent efficacy and tolerability in our case. Control of infection may not be possible without surgical correction.
Impact of exercise on musculoskeletal pain and disability in the postpartum period: a systematic review and meta-analysis
Authors: Ruchat Stephanie-May , Beamish Nicole , Pellerin Sophie , Usman Muhammad , Dufour Sinead , Meyer Sarah , Sivak Allison , Davenport Margie H
Published: February 2025

Objective

To examine the impact of exercise on musculoskeletal pain (low back pain (LBP), pelvic girdle pain (PGP), lumbopelvic pain (LBPP) and bodily pain) and kinesiophobia during the postpartum period.

Design

Systematic review with random effects meta-analysis.

Study eligibility criteria

Online databases were searched from database inception to 12 January 2024. Studies of all designs (except case studies) of any publication date or language were included if they contained information on the population (women and people in the first year postpartum), intervention (subjective or objective measures of frequency, intensity, duration, volume or type of exercise, alone (‘exercise-only’) or in combination with other interventions (eg, electrotherapy, infrared irradiation, ultrasound; ‘exercise+cointervention’)), comparator (no exercise or different exercise measures) and outcome (symptom severity of LBP/PGP/LBPP, related disability, bodily pain and kinesiophobia).

Results

37 studies (N=3769 participants) from 15 countries were included. Moderate certainty evidence showed that exercise-only interventions, including various strengthening exercises targeting the trunk muscles, were associated with a greater reduction in LBPP symptom severity (4 randomised controlled trials (RCTs), n=210; mean difference −2.21 points (on a 0–10 Visual Analogue Scale) 95% CI −3.33 to −1.08) and related disability (6 RCTs, n=296; standardised mean difference −1.17, 95% CI −1.92 to −0.43; large effect size) as compared with no exercise. Similar results were found for bodily pain (2 RCTs, n=318). Evidence was limited and inconclusive regarding the impact of exercise interventions on kinesiophobia.

Conclusion

Postnatal exercises, including a variety of muscular strengthening exercises targeting the trunk muscles, decrease the symptom severity of LBPP and related disability.
Professional experiences on use of the mental health act in ethnically diverse populations: a photovoice study
Authors: Bhui Kamaldeep , Mooney Roisin , Joseph Doreen , McCabe Rose , Newbigging Karen , McCrone Paul , Raghavan Raghu , Keating Frank , Husain Nusrat
Published: February 2025

Background

There are long-standing ethnic and racial inequalities in experiences and outcomes of severe mental illness, including compulsory admission and treatment (CAT).

Aims

To gather professional experiences about (1) remedies for ethnic inequalities in the use of the Mental Health Act ((MHA) 1983 and 2007) and (2) recommendations for improving care experiences and for reducing ethnic inequalities.

Method

We undertook a participatory research process using photovoice to gather experience data. Photographs were assembled and narrated by 17 professionals from a variety of disciplines. We undertook a thematic analysis.

Results

Ineffective communications between inpatient and community services, insufficient staff capacity, a lack of continuity of care and language and cultural constraints meant MHA assessments were lacking information, leading to elevated perceptions of risk. Practitioners felt helpless at times of staff shortages and often felt CAT could have been prevented. They felt voiceless and powerless and unable to challenge stereotypes and poor practice, especially if they were from a similar demographic (ethnicity) as a patient. Interdisciplinary disagreements and mistrust led to more risk-aversive practices. The legislation created an inflexible, risk-averse and defensive process in care. Police involvement added to concerns about criminalisation and stigma. There were more risk-averse practices when team members and families disagreed on care plans. More rehabilitation and recovery-orientated care are needed. Legislative compliance in a crisis conflicted with supportive and recovery-orientated care.

Conclusion

Clear standards are needed, including specific protocols for MHA assessment, police interactions, alternatives to admission, early intervention and continuity of care.
Trends in the utilisation of maternal and child healthcare services from the public and private health sectors in India, 2005–2021: an analysis of cross-sectional survey data
Authors: Purbey Anchal , Kumar Abhishek , Mozumdar Arupendra , Mishra Punit , Acharya Rajib , Saggurti Niranjan
Published: February 2025

Objectives

To estimate the levels and trends of maternal and child healthcare (MCH) service utilisation in India across subsidised and unsubsidised health sectors and to explore total market approach to identify geographies where the private sector has potential to improve MCH services in India.

Design and setting

This study used three recent rounds of the National Family Health Survey (NFHS), a cross-sectional survey in India, conducted in 2005–2006, 2015–2016 and 2019–2021. Bivariate analysis and multinomial logistic regression were used to estimate the utilisation of key MCH indicators from subsidised and unsubsidised health sectors. Market sustainability of key MCH indicators was assessed by level of MCH services and subsidisation.

Participants

36 850, 190 898 and 176 843 ever-married women aged 15–49 years, 4440, 22 500 and 15 334 children under 5 years of age with diarrhoea before the survey, and 2552, 6960 and 6117 children with symptoms of acute respiratory infections (ARI) in NFHS 2005–2006, 2015–2016 and 2019–2021, respectively.

Outcome measures

The study used three maternal healthcare indicators: women had four or more antenatal care (ANC) visits, had institutional delivery, and received postnatal care (PNC); and two child healthcare indicators: care seeking for ARI and diarrhoea.

Results

In India, utilisation of maternal healthcare services increased over the last 15 years: four or more ANC visits increased from 37% to 58% and PNC of mothers increased from 33% to 78% between 2005–2006 and 2019–2021. The results of the multivariate analysis showed that utilisation of ANC (67% from public vs 18% from private health facilities), institutional delivery (64% from public vs 25% from private health facilities) and PNC (73% from public vs 27% from private health facilities) was significantly higher (p<0.001) in public than in private health facilities. Care seeking for ARI and diarrhoea among children was significantly higher (p<0.001) in private than in public health facilities; care for ARI was 68% in private health facilities compared with 32% in public health facilities.

Conclusions

A targeted approach is needed to enhance the competitiveness of private sectors, especially in maternity care markets, to ensure the sustainability of healthcare services in India. Strengthening both the private and public sectors is crucial, with a focus on improving care quality and addressing regional disparities in access to maternal and child health services.
Mental health in public safety personnel with workplace injuries requiring surgery: a longitudinal population-wide administrative data study in Manitoba, Canada
Authors: Spiwak Rae , Gawaziuk Justin , Burton Lauren , Wightman Anthony , Comaskey Brenda , Sareen Jai , Chateau Dan , Bolton James , Turgeon Thomas , Kraut Allen , Mahar Alyson , Afifi Tracie O , Sareen Jitender , Mota Natalie , Nantais Jordan , Logsetty Sarvesh
Published: February 2025

Objectives

Public safety personnel (PSP) are responsible for ensuring the safety and security of communities, often putting their own lives and well-being at risk by performing dangerous and demanding work. As a result, these workers are particularly vulnerable to workplace-related physical and mental traumatic injuries. Research is needed to understand the mental health of PSP following traumatic physical injury to inform effective prevention programmes and interventions. The objective of this study was to investigate whether PSP with traumatic physical workplace injuries requiring surgery with anaesthetic have higher post-injury rates of mental disorders compared with the general population with similar non-workplace injuries.

Design

Retrospective longitudinal cohort study.

Setting

Population-based study using linked anonymised administrative data for PSP and the general population in Manitoba, Canada.

Participants

This study compared two groups hospitalised for a traumatic physical injury requiring surgery with anaesthetic between 1 January 2002 and 31 December 2018: (1) PSP (n=293) injured in the workplace and matched 1:5 on sex, age, geographical region and surgical procedure code with (2) individuals in the general population (GenPop) injured outside the workplace (no Workers Compensation Board claim) (n=1198).

Primary and secondary outcomes and measures

As planned in the study protocol, the prevalence of mental disorders including anxiety, depression and substance use was measured in the cohorts 2 years pre- and post-injury.

Results

This study found an elevated unadjusted risk of depression in PSP compared with the general population in the 2 years post-injury, adjusting for pre-injury mental health (rate ratio, 1.49; 95% CI, 1.02 to 2.17; p<0.0001). After adjusting, there were no significant differences in rates between the two cohorts; however, the significant group × care interaction term for depression suggests a greater risk for PSP compared with GenPop over time.

Conclusions

Our findings indicate that, compared with a matched cohort, PSP have an increased risk of depression from the pre-injury to post-injury period following a traumatic physical workplace injury. PSP have a unique mental health trajectory following workplace injury that should be considered when developing rehabilitation strategies for this important population.
Practices and knowledge of community pharmacists towards the use of proton pump inhibitors: a cross-sectional study in Jordan
Authors: Gharaibeh Lobna , Alameri Mariam Ahmad , AL-Hawamdeh Mai I , Daoud Enas , Atwan Randa , Lafi Zainab , Zakaraya Zainab Zaki
Published: February 2025

Objectives

The widespread use of proton pump inhibitors (PPIs) raised concerns on the safety of long-term use of these drugs. Community pharmacists have great responsibility of educating patients on these drugs which requires having adequate knowledge. The aim of this study was to assess the practices and knowledge of community pharmacists regarding PPIs.

Design

This was a cross-sectional study conducted by filling in a questionnaire. The questionnaire was developed after a comprehensive literature review and assessed knowledge and practices.

Settings

Community pharmacists with at least 1 year of experience working in a community pharmacy were enrolled in the study.

Participants

Community pharmacists with at least 1 year of experience working in a community pharmacy were enrolled in the study.

Primary outcome measures

The knowledge, attitudes, and practices of community pharmacists towards PPIs dispensing.

Results

A total of 459 community pharmacists were approached for participation in the study, 451 (98.3%) community pharmacists agreed to be enrolled. The most dispensed PPIs in Jordan were lansoprazole and the most commonly treated medical condition with PPIs was gastric ulcer. PPIs were dispensed by the pharmacists very frequently and one-fourth of the participants did not review instructions with patients to ensure their proper use of PPIs. Participants had an average knowledge of 6.1±1.7 (the highest knowledge score is 12). More than one-third of participants (180, 39.9%) had inadequate knowledge (a score of less than 6). Being a PharmD graduate was the only significant factor that predicted adequate knowledge in the logistic regression model, with an adjusted OR of 5.671, p=0.002.

Conclusion

To provide adequate pharmaceutical care services, community pharmacists must possess appropriate knowledge on different aspects of PPIs concerning administration, efficacy and long-term and short-term side effects.
How do serum cytokine levels change in myocarditis and inflammatory dilated cardiomyopathy relative to healthy individuals? A protocol for a systematic review and meta-analysis
Authors: Lewandowski Piotr , Baron Maciej , Rojek Marcin A , Goławski Marcin , Krystek Karol , Żegleń Magdalena , Zytkiewicz Pascal , Kancerek Jakub , Lis Klaudia Gabriela , Warecki Jakub , Kufel Jakub , Kuśpiel Kamila , Wojnicz Romuald
Published: February 2025

Introduction

Myocarditis is an inflammatory heart disease resulting from infections, toxic exposures or autoimmune reactions. Irrespective of the factors responsible for this disease, cytokines play an important role in regulating the immunological response involved in its development and progression. Accordingly, this protocol aims to conduct a systematic review and meta-analysis summarising previous research on serum and plasma levels of cytokines in patients with myocarditis and inflammatory dilated cardiomyopathy.

Methods and analysis

Four scientific databases: PubMed, Embase, Scopus and Web of Science, will be searched. The estimated date of the search will be 30 March 2024. Each stage of the review, including the study selection, data extraction, risk of bias and quality of evidence assessments, will be performed in duplicate. Studies meeting the following criteria will be eligible for inclusion: (1) studies involving ‘myocarditis’ or ‘inflammatory dilated cardiomyopathy’ and (2) studies are required to report serum levels of any cytokine. Meta-analyses will be used to summarise serum levels of each cytokine if possible. Subgroup analysis will be stratified by age, sex, sample size, New York Heart Association scale, cardiac Troponin T, N-terminal prohormone of brain natriuretic peptide, C reactive protein, number of lymphocytes per mm2in the endomyocardial biopsy.

Ethics approval and dissemination

This study does not require ethics approval. After completion, the results will be published in a peer-reviewed paper. Data generated during the study will be published in an open access repository.

PROSPERO registration number

CRD42024519625
Temporal trends in guideline-recommended medical therapy after an acute heart failure decompensation event: an observational analysis from Generator Heart Failure DataMart
Authors: Laborante Renzo , Delvinioti Agni , Tudor Andrada Mihaela , Lenkowicz Jacopo , Iacomini Chiara , Iaconelli Antonio , Paglianiti Donato Antonio , Galli Mattia , Rodolico Daniele , Patarnello Stefano , Restivo Attilio , Ciliberti Giuseppe , Rizzo Gaetano , Bianchini Emiliano , Busti Matteo , Sensini Luca , Valentini Vincenzo , Scambia Giovanni , Gasbarrini Antonio , Crea Filippo , Cesario Alfredo , Savarese Gianluigi , Patti Giuseppe , D'Amario Domenico
Published: February 2025

Objectives

To evaluate the trend of prescription of the four foundational therapies, and their impact on 30-day urgent re-admissions and all-cause death in patients with heart failure and reduced ejection fraction (HFrEF) following an acute decompensation event.

Design

Retrospective.

Setting

One tertiary referral centre.

Participants

999 consecutively patients admitted with a primary diagnosis of HFrEF between January 2020 and June 2023 were identified through a validated, high‐performance technology infrastructure based on artificial intelligence. The entire cohort was divided into three time periods based on two time points: September 2021 (ie, the release of the latest European guidelines) and January 2022 (ie, reimbursement for sodium-glucose cotransporter 2 (SGLT2) inhibitors).

Primary and secondary outcome measures

Trends and predictors of the prescription of each of the four foundational therapies and of the composite of all-cause death and rehospitalisation for urgent causes at 30 days.

Results

Among the 999 included patients, β-blockers were prescribed in 93% of patients, ACE inhibitor (ACEi)/angiotensin receptor blocker (ARB)/angiotensin–neprilysin receptor inhibitor (ARNi) in 73%, mineralocorticoid receptor antagonist in 30% and SGLT2 inhibitors in 18%. Over time, an increase in the prescription rate occurred only for SGLT2 inhibitors (3% vs 10% vs 32%, p<0.001), whereas the rate of the composite of all-cause death and rehospitalisation for urgent causes at 30 days remained stable (9.9% vs 10.3% vs 8.4%; p=ns). In multivariate analysis, the use of ACEi/ARB/ARNi was associated with a lower risk of 30-day all-cause death and urgent rehospitalisation (adjusted OR 0.38; 95% CI 0.24 to 0.59; p<0.01). Conversely, the prescription of furosemide at discharge (adjusted OR 2.25; 95% CI 95% 1.29 to 3.94; p<0.01) and a previous genitourinary infection (adjusted OR 4.02; 95% CI 1.67 to 9.68; p<0.01) were associated with higher risk of 30-day all-cause death and urgent rehospitalisation.

Conclusions

In our study, early adoption of guideline-recommended medical therapy is still limited, with a significant rise in SGLT2i prescriptions after January 2022 and a lower risk of the composite of all-cause death and urgent readmissions at 30 days restricted to the use of ACEi/ARB/ARNi.
Scoping review of happiness and well-being measurement: uses and implications for paediatric surgery in low- and middle-income contexts
Authors: Harrison Jillian , Pringle Cate , Dolan Carrie
Published: February 2025

Objective

This study aims to map and compare existing methodologies for creating happiness and well-being indices and examine their application to paediatric surgical interventions in low- and middle-income countries (LMICs).

Design

A scoping review methodology was used based on the guidelines published by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews.

Data sources

Literature was sourced from PubMed, ScienceDirect and Google Scholar, supplemented by references from relevant studies.

Eligibility criteria

Studies were selected based on relevance to LMIC settings, paediatric surgery and well-being or happiness outcomes. Inclusion criteria covered research on paediatric surgical interventions, well-being measures, happiness indices and studies on specific conditions impacting child well-being in LMICs. Exclusions applied to non-English studies, those with unclear methods, undefined well-being concepts, a focus on socioeconomic indices, surgical techniques over outcomes or those published before 2000. Eligible sources included research articles, review articles and technical reports.

Data extraction and synthesis

Two reviewers independently extracted data, including study characteristics, populations, methodologies and key findings. The data were organised in an Excel spreadsheet for clarity and accuracy. A total of 51 sources were initially identified, with 28 included in the final review.

Results

The review revealed a broad range of well-being measurement techniques, from national population-level indices to health-related quality-of-life measures. A key finding was the strong reciprocal relationship between subjective well-being and physical health: subjective well-being impacts health outcomes, while health outcomes influence subjective well-being. However, the lack of standardised methods for assessing well-being postsurgery, particularly in LMICs, leads to inconsistent and fragmented data that complicate resource allocation and comparisons between interventions.

Conclusions

This review highlights the importance of integrating comprehensive well-being measures, particularly subjective assessments, into paediatric surgical contexts within LMICs. Such integration is critical to enhance global health interventions and capture the broader impacts of surgical care on well-being and happiness.
Integrated malaria vector control strategies and their effectiveness in sub-Saharan Africa: a systematic review protocol for interventional studies
Authors: Kombate Gountante , Djalogue Lihanimpo , Ngangue Patrice , Soubeiga Kamba Andre-Marie , Grobbee Diederick E , van der Sande Marianne
Published: February 2025

Introduction

Sub-Saharan Africa has the highest malaria burden in the world. Several vector control strategies are being implemented to reduce mosquito density and protect the most vulnerable populations, such as children under 5 and pregnant women. This systematic review is designed to assess the effectiveness of integrated vector control versus single vector control interventions on malaria incidence and prevalence to guide decisions on controlling malaria vectors in sub-Saharan Africa.

Methods and analyses

We will systematically retrieve published and grey literature from electronic databases and clinical trial registries. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines will guide us in applying a systematic approach to screening, reviewing and extracting data. An inclusion criterion will be used to independently assess full-text copies of potentially relevant articles by two review authors. Risk of bias will be assessed using the Cochrane Risk of Bias Tool V.2 for randomised controlled trials and the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool for non-randomised intervention studies. A meta-analysis will be conducted based on studies that have reported a high level of evidence (risk ratios or ORs with 95% CIs). If substantial heterogeneity is encountered, subgroup analyses will be explored.

Ethics and dissemination

This review does not require ethical approval. The findings will be shared through open-access publications in peer-reviewed journals and presentations to stakeholders and international policymakers for malaria control.

PROSPERO registration number

CRD42024559088.
Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial)
Authors: Siefried Krista J , Acheson Liam , Clifford Brendan , Moller Carl , Brett Jonathan , Christmass Michael , Dunlop Adrian John , Haber Paul S , Jutras-Aswad Didier , Lintzeris Nicholas , Morley Kirsten , Shoptaw Steven , Trivedi Madhukar H , Ezard Nadine
Published: February 2025

Introduction

Methamphetamine use disorder is a global public health concern with no approved pharmacotherapies for its treatment. One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. Here, we report a trial protocol for an oral formulation of combined naltrexone and bupropion.

Methods and analysis

This single-arm, open-label pilot study will assess the safety and feasibility of oral naltrexone and bupropion (40 mg/450 mg daily in divided doses) in adults with methamphetamine use disorder. Participants (n=20) will be outpatients of a stimulant treatment program at an inner-city hospital in Sydney, Australia. The primary endpoint is Day 84. Participants will attend weekly study visits from Baseline to Week 12 and a follow-up telephone visit at Week 16. All participants will receive treatment as usual, such as psychosocial therapy. Primary outcomes are safety (measured by treatment-emergent adverse events (AEs)/adverse reactions) and feasibility (measured by the time taken to recruit, the proportion of ineligible participants, retention in the study and study medication adherence). Secondary outcomes will assess methamphetamine use, craving and withdrawal; treatment goals and expectations; physical and psychological well-being; depression and anxiety; and treatment satisfaction. Qualitative interviews will assess the acceptability of the intervention and outcome measures.

Ethics and dissemination

This study received ethics approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00549). Results will be submitted to peer-reviewed journals and scientific conferences, and a video abstract will be created to ensure that the findings are accessible to participants and people who use methamphetamines.

Trial registration number

ANZCTR: ACTRN12623000866606 (protocol V.2.1 dated 08 April 2024).
Assessing routine childhood vaccination acceptance, hesitancy and refusal in Cape Town, Western Cape, South Africa: a mixed-method study protocol
Authors: Mathebula Lindi , Cooper Sara , Zunza Moleen , Wiysonge Charles Shey
Published: February 2025

Introduction

Vaccines have proven to be one of the most effective ways to prevent infections. Since the introduction of the Expanded Programme on Immunisation worldwide by WHO in 1974, vaccines have saved more than 150 million lives and prevented countless illnesses and disabilities. In South Africa, vaccination has contributed substantially to the decline in under-five childhood deaths from 89 418 in 2005 to 47 409 in 2013. However, the country still has limitations in achieving optimal uptake of vaccines.

Methods

This study will use a mixed-methods design to identify the factors associated with acceptance, hesitancy and refusal of childhood vaccines in three subdistricts of the Cape Town Metropolitan Health District in South Africa. In phase I of the study, we aim to estimate the uptake of childhood vaccines and assess the factors associated with uptake among a representative sample of at least 236 caregivers of children aged 0–2 years in a cross-sectional study. For phase II of the study, we will explore the behavioural and social drivers of childhood vaccination from the perspective of caregivers of children aged 0–2 years using a purposively selected sample of 20–25 participants from phase I. Finally, for phase III of the study, we will explore the behavioural and social drivers of childhood vaccination from the perspective of 20–25 healthcare workers providing vaccinations to children aged 0–2 years purposively sampled from primary healthcare facilities.

Ethics and dissemination

Ethical approval was obtained from Stellenbosch University (S23/10/232). Various steps will be taken to ensure the anonymity and confidentiality of participants. Findings of the study will be shared with various healthcare stakeholders through conferences and presentations at relevant meetings.

Conclusion

Evidence from several studies conducted in South Africa shows a significant increase in vaccine hesitancy within the country. The findings of this study will provide insight into the characteristics associated with vaccine acceptance, hesitancy and refusal in Cape Town. The results will help inform the development of evidence-based interventions that can be implemented to improve vaccination coverage.
Midwives’ knowledge and perspectives on neonatal resuscitation and survival before and after Helping Babies Breathe training: a qualitative study in Uganda
Authors: Myrnerts Höök Susanna , Abrahamsson Marielle , Namusoko Sarah , Byamugisha Josaphat , Bergström Anna
Published: February 2025

Objectives

Birth asphyxia is a significant factor contributing to neonatal mortality, particularly in low- and middle-income countries where most neonatal deaths occur. Encouraging women to deliver in hospitals has become a pivotal strategy. Numerous training programmes, such as Helping Babies Breathe (HBB), have been designed to impart neonatal resuscitation and infant care skills to support breathing at birth. Limited attention has been given to exploring the perspectives and experiences of midwives and their hospital managers in translating the acquired knowledge from these programmes into practice. This study aims to explores the understanding, perspectives, and first-hand experiences related to the factors impacting neonatal resuscitation practices and survival, both pre-HBB and post-HBB training.

Design

Qualitative individual interviews and focus group discussions study. A data-driven inductive content analysis approach was used for the analysis.

Setting

The high-risk labour ward and theatre at a National Referral Hospital, Uganda.

Participants

45 clinically active midwives were enrolled; all had recently completed the HBB training programme.

Intervention

Semistructured individual interviews (n=2) and focus group discussions (n=43, distributed across seven groups) were held from 26 April to 4 May 2018. Discussions were audio-recorded and transcribed verbatim.

Results

Three emerging themes illustrated midwives’ knowledge, opinion on and experience of neonatal resuscitation and survival. Excessive workload, limited access to clean equipment, and ethical dilemmas hampered performance and neonatal survival. Midwives, facing inadequate support, strived to ensure patient safety. While HBB training addresses malpractices, additional training was needed.

Conclusions

Midwives had few opportunities to change their workload and improve their education. This highlights the need for a closer examination of the challenges faced by healthcare providers in ensuring effective neonatal resuscitation and survival in low-resource settings. To address this, we propose better routines for organising work, cleaning and maintaining equipment, and implementing better training routines.
Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2)
Authors: Piolanti Antonio , Mueller Janina , Waller Franziska , Heinrichs Nina , Simon Judith , Shenderovich Yulia , Sampathkumar Swetha , Wienand Dennis , Raleva Marija , Kunovski Ivo , Babii Viorel , Zhao Xiang , Moore Graham , Foran Heather M
Published: February 2025

Introduction

Adolescent mental health problems represent a significant global health issue, particularly in low- and middle-income countries, such as the Republic of North Macedonia and the Republic of Moldova. Effective and scalable interventions are urgently needed to address these challenges.

Methods and analysis

This protocol outlines a multicountry cluster randomised factorial trial, implemented according to the multiphase optimisation strategy (Phase 2), which evaluates the effectiveness and costs of three add-on components for the Parenting for Lifelong Health for Parents and Teens programme: adolescent mental health tools based on UNICEFs Helping Adolescents Thrive comics, adolescent peer support based on UNICEFs ‘I Support My Friends’ intervention and engagement booster designed to enhance attendance and programme completion through incentives. The study will recruit 720 families and involve 64 clusters in North Macedonia and Moldova. Primary outcomes will include adolescent internalising problems and social support, family functioning and attendance during the programme. Secondary outcomes will assess broader aspects of mental health among caregivers and adolescents, as well as implementation and cost outcomes. Data will be collected at baseline and postintervention, approximately, 8 weeks later. Statistical analyses will include regression models to assess the main and interaction effects of the intervention components and cost analyses.

Ethics and dissemination

The study received ethical approval from the University of Klagenfurt in Austria (approval number: 2023–013), the Medical Faculty at St. Cyril and Methodius University in North Macedonia (approval number: 03-2144/4) and the National Committee of Ethical Expertise for Clinical Trials in Moldova (approval number: 1476). The results will be disseminated through peer-reviewed journals, conferences, webinars in multiple languages, regional forums, stakeholder meetings with policymakers and practitioners, public communication through media engagement and open access platforms, including data sharing and early release of findings.

Trial registration details

Trial registration:NCT06562244; Project page:https://www.flourish-study.org/about.html
Sustainability of healthcare system improvements, programmes and interventions in acute care settings: protocol for a mixed methods systematic review
Authors: Ramsden Victoria , McInnes Elizabeth , Wilson Peter , Babl Franz E , Kuhn Lisa , Cowie Julie , Campbell Pauline , Middleton Sandy , Wilson Catherine , Straiton Nicola , Tavender Emma
Published: February 2025

Introduction

Sustaining evidence-based care is challenging in all clinical settings. Acute care settings have a unique set of contextual factors that may impact sustainability (eg, fast-paced, regular staff turnover). Much of the previous research explores sustainability across undifferentiated healthcare settings making it difficult to determine factors that influence sustainability in acute care settings. The aim of this review is to identify facilitators and barriers that influence the delivery of sustained healthcare interventions (eg, integration of clinical guidelines) within adult and paediatric hospital-based acute care settings.

Methods and analysis

A mixed methods systematic review updating Cowieet al’s(which included studies from 2008 to 2017) previously published systematic review will be conducted. The following databases will be searched: Medline, Embase, Cochrane Database of Systematic Reviews, CINAHL and Allied and Complementary Medicine (AMED), from November 2017 to the present for studies published in English. Relevant reference lists of included studies will be manually searched. Empirical quantitative and qualitative studies that report the sustainability of an intervention or programme in acute care settings using a theoretical framework(s), model(s) or theory(ies) to explore facilitators and barriers, will be included. Studies will be exported into Covidence (Melbourne) and pairs of reviewers will independently screen abstracts and full-text studies. The discussion will be used to resolve any disagreements and a third coauthor enlisted should a consensus not be reached. Two independent coauthors will extract key study characteristics and assess each study’s quality. Data will be extracted using Covidence (Melbourne). Evidence tables will be used to present descriptive data. Facilitators and barriers will be mapped to the Consolidated Framework for Sustainability Constructs in Healthcare and a narrative approach will be used to present key findings.

Ethics and dissemination

No primary data will be collected so formal ethical approval is not required. Findings will be disseminated through peer-reviewed publications, presented at international conferences and on social media.

PROSPERO registration number

PROSPERO CRD42024547535.
Effects of manual osteopathic interventions on psychometric and psychophysiological indicators of anxiety, depression and stress in adults: a systematic review and meta-analysis of randomised controlled trials
Authors: Gordon Tom C , Hope-Bell Josh , Draper-Rodi Jerry , MacMillan Andrew , Miller Danny , Edwards Darren J
Published: February 2025

Objectives

To evaluate whether osteopathic and related manual interventions improve adult mental health (depression, anxiety, stress) and psychophysiological measures (eg, heart rate variability, skin conductance).

Design

Systematic review and meta-analysis of randomised controlled trials (RCTs).

Data sources

PubMed, MEDLINE (Ovid), Scopus, Cochrane, and AMED, searched through September 2024.

Eligibility criteria

English-language RCTs with ≥30 participants investigating osteopathic or related manual therapies (eg, myofascial release, high-velocity low-amplitude thrusts) delivered by qualified practitioners, compared with no treatment or sham, and reporting immediate postintervention mental health or psychophysiological outcomes.

Data extraction and synthesis

Full-text screening, risk-of-bias assessment and data extraction were conducted independently by multiple reviewers using a standardised Joanna Briggs Institute (JBI) Extraction Form. Risk of bias was assessed using the JBI Critical Appraisal Checklist. For meta-analyses, Hedges’g(with 95% CIs) was calculated from postintervention means and SD. Random-effects models accounted for heterogeneity, and prediction intervals were calculated to assess uncertainty in effect estimates.

Results

20 RCTs were included. Osteopathic interventions reduced depression (Hedges’g=−0.47, 95% CI: −0.86 to –0.09, p=0.02) and increased skin conductance (Hedges’g=0.67, 95% CI: 0.00 to 1.34, p=0.05). Depression improvements were greater in pain populations (Hedges’g=−0.61, 95% CI: –1.06 to –0.17, p=0.01). However, wide prediction intervals and moderate heterogeneity indicate uncertainty in true effect sizes, and limited studies and sample sizes restrict assessment of publication bias.

Conclusions

Osteopathic and related manual therapies may reduce depression and influence certain psychophysiological markers, particularly in pain populations, but uncertainty and heterogeneity limit confidence. More rigorous, larger, and longitudinal RCTs are needed.

Trial registration number

This meta-analysis was not formally registered, though the protocol and search strategy can be found at Open Science Framework, registration identification:https://osf.io/jrtpx/.
Developing and piloting a peer quality improvement coaching protocol for front-line healthcare staff
Authors: Popivanov Petar , McCarthy Siobhan Eithne , Finn Mairead
Published: February 2025

Background

Improving the quality of patient care remains a global necessity. Despite system and professional benefits, current evidence indicates that the spread of improvement principles among front-line healthcare workers remains poor.

While education and training alone are unlikely to result in consistent improvement practice, coaching can play a critical role in sustainable, evidence-based improvement implementation. Peer quality improvement coaching (PQIC) places the power and agency in the shared relationship between coach and coachee to shape coachee quality improvement (QI) outcomes.

Study objective was to develop and pilot an evidence-based protocol for implementation and evaluation of a PQIC for front-line staff engaged in small to intermediate improvement efforts.

Methods

We conducted a multistage case-study design and implementation process. First, a systematised literature review identified themes about the theory and practice of QI coaching (QIC). Second, these themes guided the development of a PQIC protocol. Finally, the protocol was piloted and evaluated among staff in a single-centre tertiary maternity hospital. PQIC effectiveness was assessed using evaluation tools identified in the literature.

Results

Effectiveness; strategies and models; moderating factors and methods for evaluation of QIC emerged from the literature. Together with Bloom’s taxonomy and Kirkpatrick’s educational model, these themes informed the development of this PQIC protocol. It was piloted in three steps: education, coaching and evaluation. A survey revealed that the participants in the education step achieved excellent scores. Following the coaching journey, the coached multidisciplinary team leaders completed their improvement initiatives and demonstrated increased QI knowledge and skills measured by the ‘IHI improvement advisor self-assessment tool’ and ‘IHI assessment scale for collaboratives’.

Conclusion

Built on established education, peer coaching and QI concepts, this evidence-based PQIC protocol adds to international evidence on how to support front-line healthcare workers in their improvement efforts. Future research needs to assess protocol effectiveness across different settings.