bluuebunny/crossref_metadata_2025_split huggingface dataset:
Understanding the health system utilisation and reasons for avoidable mortality after fatal injury within a Three-Delays framework in Karonga, Northern Malawi: a retrospective analysis of verbal autopsy data
Authors: Whitaker John , Edem Idara , Amoah Abena S , Dube Albert , D’Ambruoso Lucia , Rickard Rory F , Leather Andy J M , Davies Justine 
Published: April 2024

ObjectivesTo use verbal autopsy (VA) data to understand health system utilisation and the potential avoidability associated with fatal injury. Then to categorise any evident barriers driving avoidable delays to care within a Three-Delays framework that considers delays to seeking (Delay 1), reaching (Delay 2) or receiving (Delay 3) quality injury care.DesignRetrospective analysis of existing VA data routinely collected by a demographic surveillance site.SettingKaronga Health and Demographic Surveillance Site (HDSS) population, Northern Malawi.ParticipantsFatally injured members of the HDSS.Primary and secondary outcome measuresThe primary outcome was the proportion of fatal injury deaths that were potentially avoidable. Secondary outcomes were the delay stage and corresponding barriers associated with avoidable deaths and the health system utilisation for fatal injuries within the health system.ResultsOf the 252 deaths due to external causes, 185 injury-related deaths were analysed. Deaths were predominantly among young males (median age 30, IQR 11–48), 71.9% (133/185). 35.1% (65/185) were assessed as potentially avoidable. Delay 1 was implicated in 30.8% (20/65) of potentially avoidable deaths, Delay 2 in 61.5% (40/65) and Delay 3 in 75.4% (49/65). Within Delay 1, ‘healthcare literacy’ was most commonly implicated barrier in 75% (15/20). Within Delay 2, ‘communication’ and ‘prehospital care’ were the most commonly implicated in 92.5% (37/40). Within Delay 3, ‘physical resources’ were most commonly implicated, 85.7% (42/49).ConclusionsVA is feasible for studying pathways to care and health system responsiveness in avoidable deaths following injury and ascertaining the delays that contribute to deaths. A large proportion of injury deaths were avoidable, and we have identified several barriers as potential targets for intervention. Refining and integrating VA with other health system assessment methods is likely necessary to holistically understand an injury care health system.
Navigating duplication in pharmacovigilance databases: a scoping review
Authors: Kiguba Ronald , Isabirye Gerald , Mayengo Julius , Owiny Jonathan , Tregunno Phil , Harrison Kendal , Pirmohamed Munir , Ndagije Helen Byomire 
Published: April 2024

ObjectivesPharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data integrity. This scoping review sought to provide a comprehensive understanding of duplication in pharmacovigilance databases worldwide.DesignA scoping review.Data sourcesReviewers comprehensively searched the literature in PubMed, Web of Science, Wiley Online Library, EBSCOhost, Google Scholar and other relevant websites.Eligibility criteriaPeer-reviewed publications and grey literature, without language restriction, describing duplication and/or methods relevant to duplication in pharmacovigilance databases from inception to 1 September 2023.Data extraction and synthesisWe used the Joanna Briggs Institute guidelines for scoping reviews and conformed with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Two reviewers independently screened titles, abstracts and full texts. One reviewer extracted the data and performed descriptive analysis, which the second reviewer assessed. Disagreements were resolved by discussion and consensus or in consultation with a third reviewer.ResultsWe screened 22 745 unique titles and 156 were eligible for full-text review. Of the 156 titles, 58 (47 peer-reviewed; 11 grey literature) fulfilled the inclusion criteria for the scoping review. Included titles addressed the extent (5 papers), prevention strategies (15 papers), causes (32 papers), detection methods (25 papers), management strategies (24 papers) and implications (14 papers) of duplication in pharmacovigilance databases. The papers overlapped, discussing more than one field. Advances in artificial intelligence, particularly natural language processing, hold promise in enhancing the efficiency and precision of deduplication of large and complex pharmacovigilance databases.ConclusionDuplication in pharmacovigilance databases compromises risk assessment and decision-making, potentially threatening patient safety. Therefore, efficient duplicate prevention, detection and management are essential for more reliable pharmacovigilance data. To minimise duplication, consistent use of worldwide unique identifiers as the key case identifiers is recommended alongside recent advances in artificial intelligence.
Dry cupping as an adjuvant treatment of individuals with severe pneumonia: study protocol for a placebo-controlled, randomised study
Authors: Li Wen , Chung Shuet Ling , Lei Ming , Yang Xiaofang , Jin Zhu 
Published: April 2024

BackgroundSevere pneumonia (SP) stands as one of the most prevalent critical illnesses encountered in clinical practice, characterised by its rapid onset and progression, numerous complications and elevated mortality rates. While modern medical interventions primarily focus on symptomatic management such as anti-infective therapy and mechanical ventilation, challenges including high drug resistance and suboptimal therapeutic outcomes for certain patients persist. Dry cupping as an ancient practice with over a millennium of clinical use in China is renowned for its convenience and perceived clinical efficacy in various illnesses. Nevertheless, the lack of well-designed studies assessing its effects remains a notable gap in the literature. This protocol describes a placebo-controlled, randomised, single-blind study to evaluate the efficacy and safety of dry cupping as an adjuvant treatment for SP.Methods and analysis66 patients diagnosed with SP, aged 18–80 years, will be randomly divided into two groups: intervention group, receiving 10 times of dry cupping treatment; control group, receiving placebo dry cupping therapy. Both applications are used in bilateral Fei Shu (BL13), Pi Shu (BL21) and Shen Shu (BL22) cupping. The application will be conducted once a day for 10 days. Participants will be assessed before treatment (D0), after the first intervention (D1), after the fifth intervention (D5) and after treatment ended (D10). The assessments include blood oxygen saturation, respiratory rate, traditional Chinese medicine symptom score, inflammatory response, mechanical ventilation time and oxygen condition.Ethics and disseminationThis protocol has been approved by the Ethics Committee of Shanghai Seventh People’s Hospital (2023-7th-HIBR-070). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.Trial registration numberChiCTR2300076958.
Use of headphones for the delivery of music programs for people with dementia in long-term care homes: a scoping review protocol
Authors: Hung Lillian , Wong Karen Lok Yi , Huang Kitty , Cheung Daphne Sze Ki , Yeo Myung Sun , Kim Soo JI 
Published: April 2024

IntroductionDementia affects the quality of life. Excessive noise in care environments can exacerbate stress and related symptoms. Headphone-based music interventions may help improve the quality of life for people with dementia in long-term care homes. This review aims to explore and synthesise research on headphone-based music interventions for people with dementia in long-term care homes, focusing on enablers and barriers to implementing headphone-based music interventions.Methods and analysisJoanna Briggs Institute guidance for scoping review and Preferred Reporting Items for Scoping Reviews and Meta-analyses extension for Scoping Reviews will guide the review and report process. CINAHL, MEDLINE, Embase, Web of Science, Scopus, AgeLine, PsycINFO and ProQuest databases will be searched for relevant literature from June 2010 to January 2024, supplemented by hand searches and Google for grey literature. Two research assistants will independently screen citations, followed by a full-text review. Data will be extracted using a data extraction tool. We will present the data in a table with narratives that answer the questions of the scoping review.Ethics and disseminationThis scoping review does not require ethics approval and participation consent, as all data will be publicly available. The scoping review results will be disseminated through conference presentations and an open-access publication in a peer-reviewed journal. The findings will provide practical insights into the adoption and efficacy of headphone-based music programmes for dementia in long-term care homes, contributing to education, practice, policy and future research.
The Pediatric Autism Research Cohort (PARC) Study: protocol for a patient-oriented prospective study examining trajectories of functioning in children with autism
Authors: Kata Anna , McPhee Patrick G. , Chen Yun-Ju , Zwaigenbaum Lonnie , Singal Deepa , Roncadin Caroline , Bennett Teresa , Carter Melissa , Di Rezze Briano , Drmic Irene , Duku Eric , Fournier Sherry , Frei Julia , Gentles Stephen J. , Georgiades Kathy , Hanlon-Dearman Ana , Hoult Lorraine , Kelley Elizabeth , Koller Judah , de Camargo Olaf Kraus , Lai Jonathan , Mahoney Bill , Mesterman Ronit , Ng Olivia , Robertson Sue , Rosenbaum Peter , Salt Mackenzie , Zubairi Mohammad S , Georgiades Stelios 
Published: April 2024

IntroductionThe developmentally variable nature of autism poses challenges in providing timely services tailored to a child’s needs. Despite a recent focus on longitudinal research, priority-setting initiatives with stakeholders highlighted the importance of studying a child’s day-to-day functioning and social determinants of health to inform clinical care. To address this, we are conducting a pragmatic multi-site, patient-oriented longitudinal investigation: thePediatric Autism Research Cohort(PARC) Study. In young children (<7 years of age) newly diagnosed with autism, we will: (1) examine variability in trajectories of adaptive functioning from the point of diagnosis into transition to school; and (2) identify factors associated with trajectories of adaptive functioning.Methods and analysisWe aim to recruit 1300 children under 7 years of age with a recent (within 12 months) diagnosis of autism from seven sites: six in Canada; one in Israel. Participants will be followed prospectively from diagnosis to age 8 years, with assessments at 6-month intervals. Parents/caregivers will complete questionnaires administered via a customized online research portal. Following each assessment timepoint, families will receive a research summary report describing their child’s progress on adaptive functioning and related domains. Analysis of the longitudinal data will map trajectories and examine child, family and service characteristics associated with chronogeneity (interindividual and intraindividual heterogeneity over time) and possible trajectory turning points around sensitive periods like the transition to school.Ethics and disseminationEthics approvals have been received by all sites. All parents/respondents will provide informed consent when enrolling in the study. Using an integrated knowledge translation approach, where stakeholders are directly engaged in the research process, thePARC Studywill identify factors associated with trajectories of functioning in children with autism. Resulting evidence will be shared with government policy makers to inform provincial and national programs. Findings will be disseminated at conferences and published in peer-reviewed journals.
Severity and impact of digestive impairment perceived by patients with systemic sclerosis: a cross-sectional study
Authors: Cano-García Laura , Redondo-Rodríguez Rocío , Mena-Vázquez Natalia , Manrique-Arija Sara , García-Studer Aimara , Ortiz-Marquez Fernando , Borregón-Garrido Paula , Fernández-Nebro Antonio 
Published: April 2024

ObjectivesTo describe the severity and impact of gastrointestinal involvement in patients with systemic sclerosis (SSc) and identify associated factors.Patients and methodsNon-controlled cross-sectional study of patients with SSc (2013 American College of Rheumatology/European League Against Rheumatism criteria). The main variables were severity of gastrointestinal involvement according to the University of California, Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 instrument (UCLA SCTC GIT 2.0) and dysphagia according to the Eating Assessment Tool-10 (EAT-10). We evaluated reflux, distension, diarrhoea, faecal soilage, constipation, emotional well-being and social functioning, as well as dysphagia. Clinical and epidemiological data were collected using the Mini Nutritional Assessment Short Form (MNA-SF) and the EuroQol-5D-3L. The degree of skin fibrosis was assessed using the modified Rodnan skin score (mRSS). Multivariate models were constructed to analyse factors associated with gastrointestinal involvement and dysphagia.ResultsOf the 75 patients with SSc included, 58.7% had moderate, severe or very severe reflux, 57.4% had constipation according to UCLA SCTC GIT 2.0 and 49.7% had abdominal distension. Gastrointestinal symptoms interfered significantly with social functioning (42.7%) and emotional well-being (40.0%). Dysphagia (EAT-10≥3) was recorded in 52% of patients, and according to MNA-SF poor nutrition in 30.7%, and clear malnutrition requiring a nutritional intervention in 5.3%. Multivariate adjustment revealed an association between severity of gastrointestinal symptoms according to the mRSS (β=0.249; p=0.002) and Visual Analogue Scale 3-Level EuroQol-5D (VAS-EQ-5D-3L) (β=–0.302; p=0.001), whereas presence of dysphagia was associated with the mRSS (OR=2.794; p=0.015), VAS-EQ-5D-3L (OR=0.950; p=0.005) and malnutrition (MNA-SF≤7; OR=3.920; p=0.041).ConclusionsPatients with SSc frequently present severe gastrointestinal symptoms. These are associated with poor quality of life, more severe skin involvement and malnutrition.
Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY)
Authors: Trocheris-Fumery Ottilie , Scetbon Cecilia , Flet Thibault , Meynier Jonathan , Sellier Magali , Rumbach Matthieu , Badaoui Rachid , Villeret Léonie , Tarpin Paul , Abou-Arab Osama , Bar Stephane , Dupont Herve 
Published: April 2024

BackgroundPost-induction anaesthesia often promotes intraoperative hypotension (IOH) that can worsen postoperative outcomes. This study aims to assess the benefit of norepinephrine versus ephedrine at the induction of anaesthesia to prevent postoperative complications following major abdominal surgery by preventing IOH.Methods and analysisThe EPON STUDY is a prospective single-centre randomised controlled trial with the planned inclusion of 500 patients scheduled for major abdominal surgery at the Amiens University Hospital. The inclusion criteria are patients aged over 50 years weighing more than 50 kg with an American Society of Anesthesiologists physical status score of ≥2 undergoing major abdominal surgery under general anaesthesia. Patients are allocated either to the intervention group (n=250) or the standard group (n=250). In the intervention group, the prevention of post-induction IOH is performed with norepinephrine (dilution to 0.016 mg/mL) using an electric syringe pump at a rate of 0.48 mg/h (30 mL/h) from the start of anaesthesia and then titrated to achieve the haemodynamic target. In the control group, the prevention of post-induction IOH is performed with manual titration of ephedrine, with a maximal dose of 30 mg, followed by perfusion with norepinephrine. In both groups, the haemodynamic target to maintain is a mean arterial pressure (MAP) of 65 mm Hg or 70 mm Hg for patients with a medical history of hypertension. An intention-to-treat analysis will be performed. The primary outcome is the Clavien–Dindo score assessed up to 30 days postoperatively. The secondary endpoints are the length of hospital stay and length of stay in an intensive care unit/postoperative care unit; postoperative renal function; postoperative cardiovascular, respiratory, neurological, haematological and infectious complications at 1 month; and volume of intraoperative vascular filling and mortality at 1 month.Ethics and disseminationEthical approval was obtained from the committee of protection of the persons of Ile de France in May 2021 (number 21 05 41). The authors will be involved in disseminating the research findings (through attending conferences and co-authoring papers). The results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.Trial registration numberNCT05276596.
Study protocol to assess aflatoxin M1 health risks versus benefits of dairy consumption in Ethiopian children: an epidemiological trial and risk-benefit analysis
Authors: Wu Felicia , Headey Derek , Hirvonen Kalle , Pokharel Ashish , Tessema Masresha 
Published: April 2024

IntroductionIn Sidama, Ethiopia, animal-source foods can be difficult to access. Milk has important nutrients for child growth, but carries the risk of aflatoxin M1(AFM1) contamination. AFM1is a metabolite of the mycotoxin aflatoxin B1(AFB1) in dairy feed; cows secrete AFM1in milk when their feed contains AFB1produced byAspergillusfungi in maize, nuts and oilseeds. It is unknown whether AFM1compromises child growth and health.Methods and analysisThis protocol paper describes our study in Sidama to determine the impact of milk consumption and AFM1on child growth in the first 18 months of life. We will collect baseline and end-line data on dairy production, socioeconomic and nutritional factors of 1000 dairy-owning households with children ages 6–18 months at baseline; and gather samples of milk and dairy feed and child anthropometrics. We will conduct phone interviews every 6 months to ascertain changes in practices or child health. Dairy feed will be tested for AFB1; milk for AFM1, pathogens and nutrients. Controlling for herd size, socioeconomic, nutritional and behavioural factors, we will determine the association between child anthropometrics and milk consumption, as well as AFM1exposure. We will examine whether AFM1exposure affects child growth in the first 18 months of life, and weigh the benefits and risks of milk consumption.Ethics and disseminationThe protocol is approved by the Institutional Review Boards of the Ethiopian Public Health Institute (EPHI-IRB-481–2022), Michigan State University (STUDY00007996) and International Food Policy Research Institute (DSGD-23–0102). Written informed consent will be obtained from all participants, who may withdraw from the study at any time. Confidentiality of collected data will be given high priority during each stage of data handling. The study’s findings will be disseminated through stakeholder workshops, local and international conferences, journal articles and technical reports.
Frequency of self-directed dying in the Netherlands: research protocol of a cross-sectional mixed-methods study
Authors: Bosma Fenne , Stoppelenburg Arianne , van der Heide Agnes , van de Vathorst Suzanne 
Published: April 2024

IntroductionIn the Netherlands, assisting in suicide is allowed for physicians and regulated by the Termination of Life on Request and Assisted Suicide (review procedures) Act. However, some people decide to end their lives outside the medical domain, without a physician’s help. Two approaches for such self-directed dying are voluntary stopping eating and drinking (VSED) and independently taking lethal medication attended by a confidant (ILMC). The frequency of deaths by either of these methods in the Netherlands was examined in 2007. Since then, there have been societal, political and healthcare developments which may have had an influence on the frequency of self-directed dying. The primary objective of this study is to estimate how many people in the Netherlands currently die by VSED or ILMC. Secondary objectives include providing insight in the characteristics and quality of dying of people who choose for self-directed dying.Methods and analysisThis cross-sectional study consists of an online questionnaire study (January to February 2024) among a randomly drawn sample (n=37 500) from a representative panel of the Dutch adult population in which participants are asked about potential experiences of close relatives choosing for VSED or ILMC. A two-stage screening procedure will be used to determine whether the respondents’ experiences represent a death by VSED or ILMC. Additional interviews (n=40) will be held with questionnaire respondents indicating their willingness to participate (May to September 2024). Quantitative data will be analysed using SPSS software, and qualitative data will be thematically analysed using NVivo software.Ethics and disseminationThe study obtained approval from the Medical Research Ethics Committee of the Erasmus Medical Center, under number MEC-2023-0689. Informed consent will be sought from study participants in line with General Data Protection Regulation legislation. Results of the study will be disseminated through publications in scientific journals and conference presentations.Trial registration numberNCT06186791.
Reducing inpatient opioid consumption after caesarean delivery: effects of an opioid stewardship programme and racial impact in a community hospital
Authors: Kim Daniel Dongiu , Chiang Eric , Volio Andrew , Skolaris Alexis , Nutcharoen Aratara , Vogan Eric , Krivanek Kevin , Ayad Sabry Salama 
Published: April 2024

Caesarean section is the most common inpatient surgery in the USA, with more than 1.1 million procedures in 2020. Similar to other surgical procedures, healthcare providers rely on opioids for postoperative pain management. However, current evidence shows that postpartum patients usually experience less pain due to pregnancy-related physiological changes. Owing to the current opioid crisis, public health agencies urge providers to provide rational opioid prescriptions. In addition, a personalised postoperative opioid prescription may benefit racial minorities since research shows that this population receives fewer opioids despite greater pain levels. Our project aimed to reduce inpatient opioid consumption after caesarean delivery within 6 months of the implementation of an opioid stewardship programme.A retrospective analysis of inpatient opioid consumption after caesarean delivery was conducted to determine the baseline, design the opioid stewardship programme and set goals. The plan-do-study-act method was used to implement the programme, and the results were analysed using a controlled interrupted time-series method.After implementing the opioid stewardship programme, we observed an average of 80% reduction (ratio of geometric means 0.2; 95% CI 0.2 to 0.3; p<0.001) in inpatient opioid consumption. The institution designated as control did not experience relevant changes in inpatient opioid prescriptions during the study period. In addition, the hospital where the programme was implemented was unable to reduce the difference in inpatient opioid demand between African Americans and Caucasians.Our project showed that an opioid stewardship programme for patients undergoing caesarean delivery can effectively reduce inpatient opioid use. PDSA, as a quality improvement method, is essential to address the problem, measure the results and adjust the programme to achieve goals.