bluuebunny/crossref_metadata_2025 huggingface dataset:
Risk of atrial fibrillation and association with other diseases: protocol of the derivation and international external validation of a prediction model using nationwide population-based electronic health records
Authors: Nadarajah Ramesh , Wu Jianhua , Arbel Ronen , Haim Moti , Zahger Doron , Benita Talish Razi , Rokach Lior , Cowan J Campbell , Gale Chris P
Published: December 2023

Introduction

Atrial fibrillation (AF) is a major public health issue and there is rationale for the early diagnosis of AF before the first complication occurs. Previous AF screening research is limited by low yields of new cases and strokes prevented in the screened populations. For AF screening to be clinically and cost-effective, the efficiency of identification of newly diagnosed AF needs to be improved and the intervention offered may have to extend beyond oral anticoagulation for stroke prophylaxis. Previous prediction models for incident AF have been limited by their data sources and methodologies.

Methods and analysis

We will investigate the application of random forest and multivariable logistic regression to predict incident AF within a 6-month prediction horizon, that is, a time-window consistent with conducting investigation for AF. The Clinical Practice Research Datalink (CPRD)-GOLD dataset will be used for derivation, and the Clalit Health Services (CHS) dataset will be used for international external geographical validation. Analyses will include metrics of prediction performance and clinical utility. We will create Kaplan-Meier plots for individuals identified as higher and lower predicted risk of AF and derive the cumulative incidence rate for non-AF cardio-renal-metabolic diseases and death over the longer term to establish how predicted AF risk is associated with a range of new non-AF disease states.

Ethics and dissemination

Permission for CPRD-GOLD was obtained from CPRD (ref no: 19_076). The CPRD ethical approval committee approved the study. CHS Helsinki committee approval 21-0169 and data usage committee approval 901. The results will be submitted as a research paper for publication to a peer-reviewed journal and presented at peer-reviewed conferences.

Trial registration number

A systematic review to guide the overall project was registered on PROSPERO (registration number CRD42021245093). The study was registered on ClinicalTrials.gov (NCT05837364).
Prevalence of mental disorders and high rates of absenteeism from work among healthcare professionals in Slovenia: a retrospective study
Authors: Korošec Darja , Vrbnjak Dominika , Štiglic Gregor
Published: December 2023

Objectives

To investigate the prevalence of mental disorders and the higher rates of absenteeism from work among healthcare workers employed in Slovenia by analysing the prevalence of sick leave and medication prescriptions for treatment of mental health and behavioural disorders from 2015 to 2020.

Design

Retrospective analysis of nationwide data on absenteeism and prescription of medications for treatment of mental health and behavioural disorders (anxiolytics, antipsychotics, antidepressants).

Setting

National databases of the National Institute of Public Health in Slovenia.

Participants

All employed healthcare workers (35 008 in December 2020): dentists, midwives, nurses, nursing assistants, pharmacists and physicians in Slovenia from 2015 to 2020.

Results

The most time spent on sick leave by male healthcare workers aged >50 was for ‘neoplasms’ (71.50 days on average), followed by ‘mental health and behavioural disorders’ (62.08 days on average). Female healthcare workers under 40 years old spent the most time on sick leave for ‘pregnancy, childbirth, and the postpartum period (puerperium)’, causing an average of 58.38 days of sick leave. From 2015 to 2020, the highest increase in prescribed medications for treatment of mental health and behavioural disorders was among nursing assistants (an increase of 38.42%), pharmacists (an increase of 29.36%) and nurses (an increase of 26.61%); since the COVID-19 pandemic, an increase of 12.36% was found among dentists, an increase of 11.51% among pharmacists and an increase of 11.36% among nurses.

Conclusion

The prescription of medications for treatment of mental health and behavioural disorders was on the rise from 2015 to 2020. The importance of employee health to individuals and society necessitates the systematisation of effective prevention programmes as well as programmes to assist those in need, especially health workers, whose work contributes significantly to maintaining public health.
What should be measured and reported in clinical trials for the treatment of patients with acute pancreatitis? A study protocol for establishing a core outcome set
Authors: Shen Yuxin , Hu Chen , Li Ling , Chen Zhiyao , Chen Weiwei , Lin Ziqi , Zhu Ping , Tan Qingyuan , Huang Wei , Sun Xin , Deng Lihui , Xia Qing
Published: December 2023

Introduction

Acute pancreatitis (AP) is characterised by inflammation of the exocrine pancreas, which potentially leads to local complications and organ failure resulting in significant morbidity and mortality. A long-term follow-up by an experienced team is needed. Currently, a variety of outcome measures are used in clinical trials for patients with AP. However, due to heterogeneous and selective outcome reporting across trials of interventions, it is hard to combine or compare the trial results compromising systematic evaluations of effectiveness and safety. A core outcome set is demanded to standardise reporting for the management of AP in clinical trials, so as to conduct systematic reviews and to improve the quality of the existing evidence base on the management of AP. We designed a study to establish a core outcome set (COS) on what indicators should be measured and reported in clinical trials of patients with AP (COS-AP).

Methods and analysis

This study protocol outlines the following five phases: Phase I will be a systematic review of randomised control trials and semistructured interviews with patients to initially establish a preliminary list of potential outcomes. Phase II will be the recruitment of key stakeholders’ groups comprising experts in pancreatic disease, clinical researchers, methodologists, journal editors and patients. Phase III will be two rounds of the Delphi surveys with key stakeholder groups. Phase IV will be a consensus on the outcomes that should be included in a final COS-AP. Phase V will be dissemination of COS-AP.

Ethics and dissemination

Ethical approval for this study was obtained from the Biomedical Research Ethics Committee (BREC) of West China Hospital of Sichuan University (2020 No.691). The findings will be disseminated in peer-reviewed journals and meetings.

Trial registration

This study was registered with Core Outcome Measures in Effectiveness Trials (COMET) database as study 2573.
Application of ventilator-associated events (VAE) in ventilator-associated pneumonia (VAP) notified in Brazil (IMPACTO MR-PAV): a protocol for a cohort study
Authors: Nascimento Giovanna Marssola , Gomes Rodrigues Daniela Laranja , Mangas Catarino Daniela Ghidetti , Piastrelli Filipe Teixeira , Cheno Maysa Yukari , Braz Katia Cristina Camonda , Oliveira Alves Lucas Bassolli , Avezum Álvaro , Veiga Viviane C , Zavascki Alexandre Prehn , Tomazini Bruno , Besen Bruno , Pereira Adriano José , Marques de Pinho Ana Paula Neves , De Oliveira Junior Haliton Alves
Published: December 2023

Introduction

Certain criteria for ventilator-associated events (VAE) definition might influence the type of an event, its detection rate and consequently the resource expenditure in intensive care unit. TheImpact of Infections by Antimicrobial-Resistant Microorganisms - Ventilator-Associated Pneumonia(IMPACTO MR-PAV) aims to evaluate the incidence and diagnostic accuracy of ventilator-associated pneumonia (VAP) using the current criteria for VAP surveillance in Brazil versus the VAE criteria defined by the US National Healthcare Safety Network-Center for Diseases Control and Prevention (CDC) criteria.

Methods and analysis

The study will be conducted in around 15 centres across Brazil from October 2022 to December 2023. Trained healthcare professionals will collect data and compare the incidence of VAP using both the current criteria for VAP surveillance in Brazil and the VAE criteria defined by the CDC. The accuracy of the two criteria for identifying VAP will also be analysed. It will also characterise other events associated with mechanical ventilation (ventilator-associated condition, infection-related ventilator-associated complication) and adjudicate VAP reported to the Brazilian Health Regulatory Agency (ANVISA) using current epidemiological diagnostic criteria.

Ethics and dissemination

This study was approved by the Institutional Review Board under the number 52354721.0.1001.0070. The study’s primary outcome measure will be the incidence of VAP using the two different surveillance criteria, and the secondary outcome measures will be the accuracy of the two criteria for identifying VAP and the adjudication of VAP reported to ANVISA. The results will contribute to the improvement of VAP surveillance in Brazil and may have implications for other countries that use similar criteria.

Trial registration number

NCT05589727; Clinicaltrials.gov.
Key performance indicators in extracorporeal membrane oxygenation (ECMO): protocol for a systematic review
Authors: Tisminetzky Manuel , Nepomuceno Roman , Kung Janice Y , Singh Gurmeet , Parhar Ken Kuljit Singh , Bagshaw Sean M , Fan Eddy , Rewa Oleksa
Published: December 2023

Introduction

Extracorporeal membrane oxygenation (ECMO) is an intervention used in critically ill patients with severe cardiopulmonary failure that is expensive and resource intensive and requires specialised care. There remains a significant practice variation in its application. This systematic review will assess the evidence for key performance indicators (KPIs) in ECMO.

Methods and analysis

We will search Ovid MEDLINE, Ovid EMBASE, Cumulative Index to Nursing and Allied Health Literature and the Cochrane Library including the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials and databases from the National Information Center of Health Services Research and Health Care Technology, for studies involving KPIs in ECMO. We will rate methodological quality using the Newcastle-Ottawa Quality Assessment Scale. Randomized controlled trials (RCTs) will be evaluated with the Cochrane Risk of Bias tool, and qualitative studies will be evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN checklist). Grey literature sources will be searched for technical reports, practice guidelines and conference proceedings. We will identify relevant organisations, industry leaders and non-profit organisations that represent key opinion leads in the use of ECMO. We will search the Agency of Healthcare Research and Quality National Quality Measures Clearinghouse for ECMO-related KPIs. Studies will be included if they contain quality measures that occur in critically ill patients and are associated with ECMO. The analysis will be primarily descriptive. Each KPI will be evaluated for importance, scientific acceptability, utility and feasibility using the four criteria proposed by the US Strategic Framework Board for a National Quality Measurement and Reporting System. Finally, KPIs will be evaluated for their potential operational characteristics, their potential to be integrated into electronic medical records and their affordability, if applicable.

Ethics and dissemination

Ethical approval is not required as no primary data will be collected. Findings will be published in a peer-reviewed journal and presented at academic.

PROSPERO registration number

9 August 2022. CRD42022349910.
Effect of percutaneous cerebral oximetry-guided anaesthetic management on postoperative delirium in older adults undergoing off-pump coronary artery bypass grafting: study protocol for a single-centre prospective randomised controlled trial in a tertiary academic hospital in China
Authors: Tian Lijuan , Wang Hongbai , Jia Yuan , Jin Lei , Zhou Chenghui , Zhou Hongyan , Yuan Su
Published: December 2023

Introduction

Postoperative delirium is a prominent and clinically important complication in older adults after coronary artery bypass grafting (CABG) surgery, resulting in prolonged hospital stay, long-term cognitive impairment and increased morbidity and mortality. Many studies have shown that cerebral desaturation is associated with increased risk of postoperative delirium during on-pump cardiac surgery. However, few studies have focused on the effect of optimising regional cerebral oxygen saturation (rSO2) on postoperative delirium during off-pump CABG. The purpose of this study is to investigate whether intraoperative anaesthetic management based on percutaneous cerebral oximetry monitoring decreases the incidence of postoperative delirium in older adults undergoing off-pump CABG.

Methods

This single-centre randomised controlled trial will randomly assign 200 patients to the intervention group or the control group at a ratio of 1:1. The patients in the intervention group will be observed by percutaneous cerebral oximetry monitoring that the desaturation (a drop of more than 20% from baseline value or rSO2less than 55% for >60 consecutive seconds at either probe) during the procedure triggered the intervention strategies, while the cerebral oximetry data of the control group will be hidden from the clinical team and patients will be anaesthetised by the usual anaesthetic management. The primary outcome will be the incidence of postoperative delirium during the first 7 days after off-pump CABG. Delirium will be comprehensively evaluated by the combination of the Richmond Agitation Sedation Scale and the Confusion Assessment Method for the intensive care unit. The secondary outcomes will include the incidence of postoperative acute kidney injury and myocardial infarction during the hospital stay, as well as the intensive care unit and hospital length of stay.

Ethics and dissemination

This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2022–1824). Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal.

Trial registration number

ChiCTR2300068537.
Systematic review and meta-analysis of disease clustering in multimorbidity: a study protocol
Authors: Ferris Jennifer , Fiedeldey Lean K , Kim Boah , Clemens Felicity , Irvine Mike A , Hosseini Sogol Haji , Smolina Kate , Wister Andrew
Published: December 2023

Introduction

Multimorbidity is defined as the presence of two or more chronic diseases. Co-occurring diseases can have synergistic negative effects, and are associated with significant impacts on individual health outcomes and healthcare systems. However, the specific effects of diseases in combination will vary between different diseases. Identifying which diseases are most likely to co-occur in multimorbidity is an important step towards population health assessment and development of policies to prevent and manage multimorbidity more effectively and efficiently. The goal of this project is to conduct a systematic review and meta-analysis of studies of disease clustering in multimorbidity, in order to identify multimorbid disease clusters and test their stability.

Methods and analysis

We will review data from studies of multimorbidity that have used data clustering methodologies to reveal patterns of disease co-occurrence. We propose a network-based meta-analytic approach to perform meta-clustering on a select list of chronic diseases that are identified as priorities for multimorbidity research. We will assess the stability of obtained disease clusters across the research literature to date, in order to evaluate the strength of evidence for specific disease patterns in multimorbidity.

Ethics and dissemination

This study does not require ethics approval as the work is based on published research studies. The study findings will be published in a peer-reviewed journal and disseminated through conference presentations and meetings with knowledge users in health systems and public health spheres.

PROSPERO registration number

CRD42023411249.
Use of external control arms in immune-mediated inflammatory diseases: a systematic review
Authors: Zayadi Alexa , Edge Robert , Parker Claire E , Macdonald John K , Neustifter Blue , Chang Joshua , Zhong Guowei , Singh Siddharth , Feagan Brian G , Ma Christopher , Jairath Vipul
Published: December 2023

Objectives

External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).

Design

Systematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality.

Data sources

Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023.

Eligibility criteria

Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bowel disease, pouchitis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and atopic dermatitis in which an ECA was used as the comparator.

Data extraction and synthesis

Two authors independently screened the search results in duplicate. The characteristics of included studies, external data source(s), outcomes and statistical methods were recorded, and the quality of the ECA data source was assessed by two independent authors.

Results

Forty-three studies met the inclusion criteria (inflammatory bowel disease: 16, pouchitis: 1, rheumatoid arthritis: 12, juvenile idiopathic arthritis: 1, ankylosing spondylitis: 5, psoriasis: 3, multiple indications: 4). The majority of these trials were single-arm (33/43) and enrolled adult patients (34/43). All included studies used a historical control rather than a contemporaneous ECA. In RCTs, ECAs were most often derived from the placebo arm of another RCT (6/10). In single-arm trials, historical case series were the most common ECA source (19/33). Most studies (31/43) did not employ a statistical approach to generate the ECA from historical data.

Conclusions

Standardised ECA methodology and reporting conventions are lacking for IMIDs trials. The establishment of ECA reporting guidelines may enhance the rigour and transparency of future research.
Large language model-based information extraction from free-text radiology reports: a scoping review protocol
Authors: Reichenpfader Daniel , Müller Henning , Denecke Kerstin
Published: December 2023

Introduction

Radiological imaging is one of the most frequently performed diagnostic tests worldwide. The free-text contained in radiology reports is currently only rarely used for secondary use purposes, including research and predictive analysis. However, this data might be made available by means of information extraction (IE), based on natural language processing (NLP). Recently, a new approach to NLP, large language models (LLMs), has gained momentum and continues to improve performance of IE-related tasks. The objective of this scoping review is to show the state of research regarding IE from free-text radiology reports based on LLMs, to investigate applied methods and to guide future research by showing open challenges and limitations of current approaches. To our knowledge, no systematic or scoping review of IE from radiology reports based on LLMs has been published. Existing publications are outdated and do not comprise LLM-based methods.

Methods and analysis

This protocol is designed based on theJBI Manual for Evidence Synthesis, chapter 11.2: ‘Development of a scoping review protocol’. Inclusion criteria and a search strategy comprising four databases (PubMed, IEEE Xplore, Web of Science Core Collection and ACM Digital Library) are defined. Furthermore, we describe the screening process, data charting, analysis and presentation of extracted data.

Ethics and dissemination

This protocol describes the methodology of a scoping literature review and does not comprise research on or with humans, animals or their data. Therefore, no ethical approval is required. After the publication of this protocol and the conduct of the review, its results are going to be published in an open access journal dedicated to biomedical informatics/digital health.
Effects of non-invasive brain stimulation over supplementary motor area in people with Parkinson’s disease: a protocol for a systematic review and meta-analysis of randomised controlled trials
Authors: Wei Yixin , Ye Saiqing , Jiang Hanhong , Chen Yawen , Qiu Yitong , Zhang Li , Ma Runting , Gao Qiang
Published: December 2023

Introduction

Individuals with Parkinson’s disease (PD) often experience initial hesitation, slowness of movements, decreased balance and impaired standing ability, which can significantly impact their independence. Transcranial magnetic stimulation and transcranial direct current stimulation are two widely used and promising non-invasive brain stimulation (NIBS) modalities for treating PD. The supplementary motor area (SMA), associated with motor behaviour and processing, has received increasing attention as a potential stimulation target to alleviate PD-related symptoms. However, the data on NIBS over SMA in PD individuals are inconsistent and has not been synthesised. In this article, we will review the evidence for NIBS over SMA in PD individuals and evaluate its efficacy in improving PD function.

Method and analysis

Randomised controlled clinical trials comparing the effects of NIBS and sham stimulation on motor function, activities of daily living and participation for people with PD will be included. A detailed computer-aided search of the literature will be performed from inception to February 2023 in the following databases: PubMed, EMBASE, Physiotherapy Evidence Database (PEDro), Web of Science (WOS) and The Chinese National Knowledge Infrastructure (CNKI). Two independent reviewers will screen articles for relevance and methodological validity. The PEDro scale will be used to evaluate the risk of bias of selected studies. Data from included studies will be extracted by two independent reviewers through a customised, preset data extraction sheet.

Ethics and dissemination

Ethical approval is not required for this systematic review. The study’s findings will be presented at scientific meetings and published in peer-reviewed journals.

PROSPERO registration number

CRD42023399945.
Specialist healthcare services for concussion/mild traumatic brain injury in England: a consensus statement using modified Delphi methodology
Authors: Karvandi Elika , Helmy Adel , Kolias Angelos G , Belli Antonio , Ganau Mario , Gomes Clint , Grey Michael , Griffiths Michael , Griffiths Timothy , Griffiths Philippa , Holliman Damian , Jenkins Peter , Jones Ben , Lawrence Tim , McLoughlin Terence , McMahon Catherine , Messahel Shrouk , Newton Joanne , Noad Rupert , Raymont Vanessa , Sharma Kanchan , Sylvester Richard , Tadmor Daniel , Whitfield Peter , Wilson Mark , Woodberry Emma , Parker Michael , Hutchinson Peter John
Published: December 2023

Objective

To establish a consensus on the structure and process of healthcare services for patients with concussion in England to facilitate better healthcare quality and patient outcome.

Design

This consensus study followed the modified Delphi methodology with five phases: participant identification, item development, two rounds of voting and a meeting to finalise the consensus statements. The predefined threshold for agreement was set at ≥70%.

Setting

Specialist outpatient services.

Participants

Members of the UK Head Injury Network were invited to participate. The network consists of clinical specialists in head injury practising in emergency medicine, neurology, neuropsychology, neurosurgery, paediatric medicine, rehabilitation medicine and sports and exercise medicine in England.

Primary outcome measure

A consensus statement on the structure and process of specialist outpatient care for patients with concussion in England.

Results

55 items were voted on in the first round. 29 items were removed following the first voting round and 3 items were removed following the second voting round. Items were modified where appropriate. A final 18 statements reached consensus covering 3 main topics in specialist healthcare services for concussion; care pathway to structured follow-up, prognosis and measures of recovery, and provision of outpatient clinics.

Conclusions

This work presents statements on how the healthcare services for patients with concussion in England could be redesigned to meet their health needs. Future work will seek to implement these into the clinical pathway.
Comparative analysis of story-grammar development: a cross-sectional study of Tamil-speaking child cochlear implant users and hearing peers in Tamil Nadu, India
Authors: Muthu Jenithaa , Venkatraman Krupa , Ganesh Latika
Published: December 2023

Objective

This cross-sectional comparative study aimed to analyse and compare the story-grammar components in Tamil-speaking children with and without hearing impairment (HI) narratives.

Design

The study used a cross-sectional, comparative design to assess and compare narrative structures.

Setting

Data were collected at the Sri Ramachandra Institute of Higher Education and Research in Chennai, India.

Participants

30 children participated in the study, including 15 children with severe to profound hearing loss who used cochlear implants and 15 with normal hearing. The participants were language-age-matched children aged 3–5 years, proficient in Tamil.

Interventions

No specific interventions were implemented in this study.

Main outcome measures

The primary outcome measures focused on story-grammar components, including settings, characters, initiating events, internal plans, attempts, outcomes, and resolution. These components were evaluated through narrative retellings by the children.

Results

Analysis of the narratives revealed significant differences between the two groups. Children with normal hearing demonstrated a higher representation of story-grammar elements than children with HI.

Conclusions

The findings suggest that children with normal hearing exhibit a more proficient understanding and utilisation of story structure in their story-telling than children with HI. This study highlights the importance of narrative analysis in language assessment, particularly for children with HI. Tailored interventions incorporating appropriate language stimulation techniques are needed to enhance children’s narrative skills with HI. Further research in this area is warranted.
Cultural, sociopolitical, environmental and built assets supporting health and well-being in Torres Strait Island communities: protocol for a scoping review
Authors: Webb Torres , Meldrum Kathryn , Kilburn Melissa , Wallace Valda , Russell Sarah , Quigley Rachel , Strivens Edward
Published: December 2023

Introduction

Risks to an individual’s health should be considered alongside the environmental, sociocultural and sociopolitical context(s) in which they live. Environmental mapping is an approach to identifying enablers and barriers to health within a community. The Indigenous Indicator Classification System (IICS) framework has been used to map the environment in Australian Indigenous communities. The IICS is a four-level nested hierarchical framework with subject groups including culture, sociopolitical and built at the top of the hierarchy and indicators at the bottom. The objective of this scoping review is to map the cultural, sociopolitical, environmental and built assets that support health and well-being that exist in each Torres Strait Island community.

Methods and analysis

This review will be conducted according the Joanna Briggs Institute (JBI) method for scoping reviews. It will include sources that identify cultural, sociopolitical, environmental and built assets that support health and well-being that exist in each Torres Strait Island community. Databases to be searched include: Informit; Scopus; Web of Science; HealthInfoNet, BioOne Complete and Green File. Sources of unpublished and grey literature will be located using Google and Google Scholar. Searches will be limited to the English language and literature published since January 2018 to ensure that the assets mapped reflect current conditions on each island. Data that answers the research question will be extracted from sources and recorded in an adaptation of the IICS. Quantitative analysis of the data will include summing each asset for individual islands and their associated clusters. Data will be presented graphically, diagrammatically, or in tabular form depending on what approach best conveys its meaning.

Ethics and dissemination

The Far North Queensland Human Research Ethics Committee (reference HREC/2022/QCH/88 155-1624) has approved this study. Dissemination of the review’s findings will be led by Torres Strait Islander members of the research team through conferences and peer-reviewed publications.
Barriers and facilitators for developing a prehospital emergency care system evaluation tool (PEC-SET) for low-resource settings: a qualitative analysis
Authors: Joiner Anjni , Blewer Audrey L , Pek Pin Pin , Ostbye Truls , Staton Catherine A , Silvalila Meilya , Ong Marcus , Nadarajan Gayathri Devi
Published: December 2023

Objectives

Strengthening of emergency care systems, including prehospital systems, can reduce death and disability. We aimed to identify perspectives on barriers and facilitators relating to the development and implementation of a prehospital emergency care system assessment tool (PEC-SET) from prehospital providers representing several South and Southeast (SE) Asian countries.

Design

We conducted a qualitative study using focus group discussions (FGD) informed by the Consolidated Framework for Implementation Research (CFIR). FGDs were conducted in English, audioconferencing/videoconferencing was recorded, transcribed verbatim and coded using an inductive and deductive approach. Participants suggested specific elements to be measured within three main ‘pillars’ of disease conditions proposed by the research team of the tool being developed (cardiovascular, trauma and perinatal emergencies).

Setting

We explored the perspectives of medical directors in six low-income and middle-income countries (LMICs) in South and SE Asia.

Participants

A total of 16 participants were interviewed (1 Vietnam, 4 Philippines, 4 Thailand, 5 Malaysia, 1 Indonesia and 1 Pakistan) as a part of 4 focus groups.

Results

Themes identified within the four CFIR constructs included: (1) Intervention characteristics: importance of developing an contextually specific tool, need for generalisability, trialling in one geographical area or with one pillar before expanding; (2) Inner setting: data transfer barriers, workforce shortages; (3) Outer setting: underdevelopment of EMS nationally; need for further EMS system development prior to implementing a tool and (4) Individual characteristics: lack of buy-in by prehospital personnel. Elements proposed by participants included both process and outcome measures.

Conclusions

Through the CFIR framework, we identified several themes which can provide a basis for codeveloping a PEC-SET for LMICs with local stakeholders. This work may inform development of quality improvement tools in LMIC PEC systems.
Vocal tasks for acoustic and/or auditory perceptual analysis for discriminating individuals with and without voice disorders: a systematic review protocol
Authors: Gunjawate Dhanshree R , Chacon Antonia Margarita , Nguyen Duy Duong , Madill Catherine
Published: December 2023

Objective

The primary objective of the present systematic review is to: (1) identify the current vocal tasks being used for acoustic and/or auditory perceptual analysis to differentiate between individuals with and without voice disorders. The secondary objectives are to: (2) evaluate the evidence of the sensitivity, specificity and accuracy of those vocal tasks for acoustic and/or auditory perceptual analysis in discriminating the individuals with voice disorders from those without; and (3) compare the values between the vocal tasks in discriminating individuals with voice disorders from those without.

Method and analysis

We search the following electronic databases: MEDLINE, EMBASE, CINAHL, Scopus, Web of Science Core Collection, PubMed Central and Google Scholar. Grey literature searches will include ProQuest Dissertations and Theses, ClinicalTrials.gov and the Cochrane Register of Controlled Trials. Websites of professional organisations and textbooks will be hand searched for relevant information related to the research question. Study screening, selection and data extraction will be conducted independently by two reviewers. Any disagreements will be resolved by discussion or by involving a third reviewer.

The methodological quality of the included studies will be appraised using the relevant Critical Appraisal Tools by JBI. The clinical guidelines and recommendations for voice assessment by professional bodies will be appraised using the Reporting Items for practice Guidelines in HealThcare (RIGHT) checklist. The findings will be presented in the form of an information matrix with the tasks identified tabulated against the nature of the task, dimensions being tested, and their accuracy, sensitivity, and specificity in identifying individuals with voice problems.

Ethics and dissemination

Formal ethics approval is not required. The findings will be presented at national and international conferences and published in a peer-reviewed journal.

PROSPERO registration number

CRD42023431634.
Qualitative study of COVID-19 patient experiences with non-invasive ventilation and pronation: strategies to enhance treatment adherence
Authors: Brugnolli Anna , Chini Gabriele , Scartezzini Riccardo , Ambrosi Elisa
Published: December 2023

Introduction

Non-invasive ventilation (NIV) treatment combined with pronation in patients with COVID-19 respiratory failure has been shown to be effective in improving respiratory function and better patient outcomes. These patients may experience discomfort or anxiety that may reduce adherence to treatment.

Objective

The aim of this study was to explore and describe the subjective experiences of patients undergoing helmet NIV and pronation during hospitalisation for COVID-19 respiratory failure, with a focus on the elements of care and strategies adopted by patients that enabled good adaptation to treatments.

Method

A qualitative descriptive study, using face-to-face interviews, was carried out with a purposeful sample of 20 participants discharged from a pulmonary intensive care unit who underwent helmet continuous positive airway pressure and pronation during hospitalisation for COVID-19.

Results

Content analysis of the transcripts revealed feelings and experiences related to illness and treatments, strategies for managing one’s own negative thoughts, and practical strategies of one’s own and healthcare workers to facilitate adaptation to pronation and helmet. Experience was reflected in five major topics related to specific time points and settings: feelings and experiences, helmet and pronation: heavy but beneficial, positive thinking strategies, patients’ practical strategies, support of healthcare professionals (HCPs).

Conclusions

This study may be useful to HCPs to improve the quality and appropriateness of care they provide.
Exploring dietary perception, beliefs and practices among pregnant adolescents, their husbands and healthcare providers in West Arsi, Central Ethiopia: a phenomenological study
Authors: Tesfaye Adane , Wondimagegne Yohanness Addisu , Tamiru Dessalegn , Belachew Tefera
Published: December 2023

Background

The two most physically active stages of life, pregnancy and adolescence, put the pregnant adolescent under a lot of stress. Adolescence is a crucial era in women’s nutrition that is frequently overlooked.

Objective

This study aimed to explore dietary perceptions, beliefs and practices among pregnant Adolescents in West Arsi, Central Ethiopia.

Design

A qualitative method, specifically, a phenomenological research design, was carried out from February to March 2023.

Settings

This study was conducted in the West Arsi zone, Oromia, Ethiopia, in four randomly selected districts.

Participants

Thirty participants, 12 pregnant adolescents, 8 husbands of pregnant adolescents and 10 healthcare providers were purposefully selected and participated.

Methods

In-depth and key informant interviews were conducted. To create relevant codes, subthemes and themes, ATLAS.ti V.7.1 software was used. An inductive qualitative data analysis approach was used. The results were presented using respondents’ clear verbatim and thematic analysis.

Results

The findings were organised into four major themes: (1) low nutritional awareness, (2) poor dietary practice, (3) barriers to good dietary practice and (4) facilitators for good dietary practice. A low perceived severity (one’s belief of the seriousness) of undernutrition and low perceived benefits (one’s belief of the benefits) of balanced nutrition have been reported. A monotonous diet (one type food usually cereal based), no change in dietary practices during pregnancy, and low intake of animal food sources (meat, egg and milk) were found under dietary practices. One of the most striking findings to emerge from this study is the Alliance for Development (AFD), the former Women Development Army, which can be a great facilitator of good dietary practice. Husbands’ involvement in nutrition education and specific nutrition training for healthcare providers are the other facilitators identified in this study. The lack of nutrition education, misconceptions and economic problems are barriers to dietary practices.

Conclusion

This study found a low nutritional awareness and poor dietary practices. Further experimental studies are recommended to assess whether AFD is capable of delivering effective nutrition interventions that improve dietary practice of pregnant.
Roles and experiences of informal caregivers of older adults in community and healthcare system navigation: a scoping review
Authors: Kim Boah , Wister Andrew , O’dea Eireann , Mitchell Barbara A , Li Lun , Kadowaki Laura
Published: December 2023

Objective

Informal caregivers are playing a vital role in improving the degree to which older adults access community and healthcare systems in a more seamless and timely manner, thereby fulfilling their complex needs. It is critical to understand their experiences and perspectives while navigating these systems. This review aimed to identify and organise the research findings on the roles and experiences of informal caregivers of older adults while navigating community and healthcare systems.

Design

This scoping review was undertaken according to the Joanna Briggs Institute’s Reviewer manual. Four databases were used: AgeLine, PsycINFO, CINAHL and Medline to capture literature with a focus on informal caregivers whose care recipients are aged 55 years or older. Articles were included if they focused on examining the experience, perspective and/or role of informal caregivers in providing care for their older care recipients, while articles were excluded if they only focused on healthcare professionals or older adults.

Results

A total of 24 studies were identified that met the study inclusion criteria. This review elucidated the roles of caregivers as a primary system navigator and as an advocate for older adults. Numerous challenges/barriers in system navigation were uncovered, such as lack of consistency in fragmented systems, as well as facilitators, including interface/coordination roles. Finally, recommendations for better system navigation such as caregiver engagement and integration of continuity of care services were identified.

Conclusion

The need to raise the visibility of the roles and experiences of informal caregivers in system navigation was highlighted. Further research needs to focus on implementing interventions for informal caregivers incorporating a care coordinator to fill the care gap within community and healthcare systems. This review has the potential to foster greater integration of community and healthcare systems.
Protocol for the Tallaght University Hospital Institute for Memory and Cognition-Biobank for Research in Ageing and Neurodegeneration
Authors: Dyer Adam H , Dolphin Helena , O’Connor Antoinette , Morrison Laura , Sedgwick Gavin , McFeely Aoife , Killeen Emily , Gallagher Conal , Davey Naomi , Connolly Eimear , Lyons Shane , Young Conor , Gaffney Christine , Ennis Ruth , McHale Cathy , Joseph Jasmine , Knight Graham , Kelly Emmet , O’Farrelly Cliona , Bourke Nollaig M , Fallon Aoife , O’Dowd Sean , Kennelly Sean P
Published: December 2023

Introduction

Alzheimer’s disease and other dementias affect >50 million individuals globally and are characterised by broad clinical and biological heterogeneity. Cohort and biobank studies have played a critical role in advancing the understanding of disease pathophysiology and in identifying novel diagnostic and treatment approaches. However, further discovery and validation cohorts are required to clarify the real-world utility of new biomarkers, facilitate research into the development of novel therapies and advance our understanding of the clinical heterogeneity and pathobiology of neurodegenerative diseases.

Methods and analysis

The Tallaght University Hospital Institute for Memory and Cognition Biobank for Research in Ageing and Neurodegeneration (TIMC-BRAiN) will recruit 1000 individuals over 5 years. Participants, who are undergoing diagnostic workup in the TIMC Memory Assessment and Support Service (TIMC-MASS), will opt to donate clinical data and biological samples to a biobank. All participants will complete a detailed clinical, neuropsychological and dementia severity assessment (including Addenbrooke’s Cognitive Assessment, Repeatable Battery for Assessment of Neuropsychological Status, Clinical Dementia Rating Scale). Participants undergoing venepuncture/lumbar puncture as part of the clinical workup will be offered the opportunity to donate additional blood (serum/plasma/whole blood) and cerebrospinal fluid samples for longitudinal storage in the TIMC-BRAiN biobank. Participants are followed at 18-month intervals for repeat clinical and cognitive assessments. Anonymised clinical data and biological samples will be stored securely in a central repository and used to facilitate future studies concerned with advancing the diagnosis and treatment of neurodegenerative diseases.

Ethics and dissemination

Ethical approval has been granted by the St. James’s Hospital/Tallaght University Hospital Joint Research Ethics Committee (Project ID: 2159), which operates in compliance with the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 and ICH Good Clinical Practice Guidelines. Findings using TIMC-BRAiN will be published in a timely and open-access fashion.
ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden—a phase III randomised double-blinded placebo-controlled study
Authors: Rodriguez-Wallberg Kenny A , Nilsson Hanna Pauline , Bergh Jonas , Malmros Johan , Ljungman Per , Foukakis Theodoros , Stragliotto Christina Linder , Friman Erika Isaksson , Linderholm Barbro , Valachis Antonis , Andersson Anne , Harrysson Sara , Vennström Lovisa , Frisk Per , Mörse Helena , Eloranta Sandra
Published: December 2023

Background

Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.

Methods and analysis

A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14–42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer.

Ethics and dissemination

This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database.

Study registration

The National Institutional review board in Sweden dnr:2021–03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253.

Trial registration number

NCT05328258; EudraCT number:2020-004780-71.