bluuebunny/crossref_metadata_2025_split huggingface dataset:
Helping people with psychosis with a low-cost intervention DIALOG+: protocol for the economic evaluation in a randomised control trial in India and Pakistan
Authors: Malik Ashar Muhammad , Peppl Renata , Sajun Sana Zehra Zehra , Qureshi Onaiza , Priya Krishna , Sarwar Hufsa , Ramachandran Padmavati , Venkatraman Lakshmi , Evans-Lacko Sara , Bird Victoria Jane 
Published: January 2025

BackgroundApproximately 69%–89% of people with severe mental illnesses, particularly psychosis, experience a treatment gap in low- and middle-income countries (LMICs) due to factors such as low public spending on health and weak healthcare systems. The PIECEs project aims to assess the effectiveness and cost-effectiveness of a solution-focused resource-oriented approach (DIALOG+) for improving the quality of life and mental well-being of people with psychosis in India and Pakistan.MethodsThe research design of this analysis is an economic evaluation piggybacked on the PIECEs randomised control trial to test the feasibility of DIALOG+ in India and Pakistan. It implies a cost-utility analysis with a health system perspective. The costs include the cost of the intervention, the cost of healthcare providers and the cost to the household. The primary outcome will be quality-adjusted life years. Incremental cost, incremental effectiveness and incremental cost-effectiveness ratios will be calculated using linear regression models with a hierarchical data structure. A probabilistic sensitivity analysis will be carried out to test for the uncertainty surrounding the estimates of cost-effectiveness.DiscussionThis study will provide evidence of a patient-centred approach to improve the quality of community-based care for people with psychosis in India and Pakistan. The economic evaluation will support efforts to scale up low-cost healthcare interventions such as DIALOG+ to rural and unserved areas, which is otherwise challenging in the resource-constrained health systems in many LMICs.ConclusionThe evidence on the cost-effectiveness of DIALOG+ will contribute to efforts to improve community-based care and the quality of life for millions of people suffering from mental health problems in India and Pakistan who experience psychosis.Ethics and disseminationThis study is approved by the Queen Mary Ethics of Research Committee (UK), Institutional Ethics Committee of SCARF (India), IRD’s Independent Institutional Review Board (IRD_IRB_2021_01_005) (Pakistan), Karawan-e-Hayat Management Committee (Institutional Approval) (Pakistan), Jinnah Postgraduate Medical Centre Research Committee (NO.F.2-81/2021-GENL/60224/JPMC) (Pakistan), Aga Khan’s Ethics Research Committee (2021-5933-17533) (Pakistan) and National Bio-Ethics Committee, Pakistan (Ref: No.4–87/NBC-774/22/2037 Date: 17 May 2022).The findings of this research will be widely disseminated through research publications and engagement with the communities and the healthcare providers in the public and not-for-profit sectors.Trial registration numberISRCTN13022816.
Five-year trajectories of symptom severity, physical and mental functioning in patients with persistent somatic symptoms: the PROSPECTS cohort study
Authors: Barends Hieke , van der Horst Henriëtte E , van der Wouden Johannes C , Claassen Nikki , Dekker Joost , Hoekstra Trynke 
Published: January 2025

ObjectivesKnowledge about the long-term course and prognosis of persistent somatic symptoms (PSS) is important to improve clinical decision-making and guidance for patients with PSS. Therefore, we aimed to: (1) identify distinct 5-year trajectories of symptom severity, physical and mental functioning in adult patients with PSS and (2) explore patient characteristics associated with these trajectories.DesignWe used longitudinal data (seven measurements over a 5-year period) of the PROSPECTS study: a prospective cohort of adult patients with PSS. We applied Latent Class Growth Mixture Modelling to identify distinct trajectories for the three outcomes.Setting and participantsPatients were recruited in general practices and specialised treatment facilities for PSS throughout the Netherlands. The study population consisted of participants with three or more measurements available (n=297).Primary outcome measuresSymptom severity (Patient Health Questionnaire 15), physical and mental functioning (RAND-36 Physical Component Summary and Mental Component Summary).ResultsFor symptom severity, we identified two ‘stable’ trajectories: ‘severe symptoms, stable’ (15.8%) and ‘moderate symptoms, stable’ (84.2%). For physical functioning, we identified three trajectories: ‘poor physical functioning, marked improvement’ (8.5%); ‘poor physical functioning, stable’ (34.7%) and ‘moderate physical functioning, slight improvement’ (56.8%). For mental functioning, we identified three trajectories: ‘poor mental functioning, marked improvement’ (13.9%); ‘moderate mental functioning, deterioration’ (12.2%) and ‘moderate mental functioning, slight improvement’ (73.8%). Patients’ characteristics such as personal, social and environmental background, illness stressors, comorbid diseases, cognitive, emotional and behavioural responses varied for the distinct trajectories.ConclusionsWe identified distinct 5-year trajectories for the three outcomes. Our findings suggest a high prevalence of persistence of symptoms and limited improvement in physical and mental functioning in the majority of patients with PSS. In a small proportion of patients, we identified trajectories that showed considerable physical or mental improvement or deterioration. Patient characteristics differed for the identified trajectories and may guide early recognition, although predictive studies are warranted.
Exploring the relationship between professional roles and behavioural intentions in chronic kidney disease management: a cross-sectional study among primary and specialist health professionals in Shanghai, China
Authors: Wu Liutao , Wang Wenyi , Liang Yan 
Published: January 2025

ObjectivesGeneral practitioners, nephrologists and renal nurses play key roles in professional integration in chronic kidney disease (CKD) management. Professional roles may influence professionals’ behavioural intentions, namely, the degree to which individuals formulate behavioural plans to attain a behavioural goal. However, little is known about the relationship between professional roles and their behavioural intentions in CKD management. Therefore, in this study, we aimed to explore the relationship between professional roles and their behavioural intentions in CKD management and the mediating role of normative and functional factors.DesignCross-sectional.SettingA cross-sectional survey study was conducted in Shanghai, China.ParticipantsA total of 244 responses were obtained, including 145 from general practitioners, 37 from nephrologists and 62 from renal nurses. We used a self-administered questionnaire to collect data through hospital unit/Community Health Service Centre visits. We performed exploratory factor analysis for behavioural intentions in CKD management. The Karlson-Holm-Breen method was used to decompose the total effect of roles on behavioural intentions in CKD management into direct and indirect (ie, mediational) effects and to calculate the mediated percentage.ResultsThe indirect effect of personal norm (should CKD management be included in daily work or not) accounted for 51.91% of the total effect of nephrologists on one-to-multiple CKD management intentions and 43.79% of the total effect of renal nurses on one-to-multiple CKD management intentions.ConclusionOur results support the mediating pathways of personal norms on the relationship between roles and behavioural intentions, but the mediating role of functional factors was not supported. These findings suggest that enhancing the personal norms of general practitioners may benefit their behavioural intentions in CKD management.
Exploring intersectional determinants of, and interventions for, low uptake of human papillomavirus vaccine in sub-Saharan Africa: a scoping review protocol
Authors: Kailemia Peter Ntoiti , Mukami Victoria 
Published: January 2025

IntroductionCervical cancer is the most diagnosed cancer and the leading cause of cancer-related death in 36 low- and middle-income countries, with the majority located in sub-Saharan Africa (SSA), South America and Southeastern Asia. The highest regional incidence and mortality occur in SSA. Despite the high efficacy and cost-effectiveness of the human papillomavirus (HPV) vaccine in preventing cervical cancer, its uptake remains unacceptably low in SSA. This scoping review aims to integrate evidence from SSA on social determinants of HPV vaccine uptake with complementary evidence on interventions to promote its uptake.Methods and analysisThe proposed review will be conducted following the guidelines of the Joanna Briggs Institute Scoping Review Methodology Group. Additionally, a sequential explanatory design will guide the integration of determinant evidence with intervention evidence. This scoping review will be reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews checklist. Six databases, PubMed/MEDLINE, LIVIVO, Google Scholar, BASE (Grey Literature), preprint databases (eg, OSF and medRxiv) and African Journals Online will be searched, with results limited to English language publications and those published from 2006 to 2024. Two forms will be used for data extraction from determinant and intervention studies by two independent reviewers. A narrative summary of evidence from both determinant and intervention studies will be conducted. Furthermore, a multilevel analysis will be conducted to explore the intersections of determinants across socioecological levels of health behaviour. A further integrative cross-study analysis of results from determinant and intervention studies will be conducted, where the determinant evidence will be used to interrogate the intervention evidence. Data will be presented in tables and matrices.Ethics and disseminationNo ethical approval will be required for this study because it will be based on data collected from publicly available records. The review results will be disseminated widely through a peer-reviewed publication and other forums such as workshops, conferences and meetings with local health administrators, policymakers and other wider stakeholder engagements.
Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study
Authors: Ajjan Ramzi A , Battelino Tadej , Seufert J , Blin Patrick , de Pouvourville Gérard , Vicaut Eric , Carcaillon-Bentata Laure , Levrat-Guillen Fleur , Cosson Emmanuel , Joubert Michael 
Published: January 2025

IntroductionGlycated haemoglobin (HbA1c) is currently the gold standard for assessing glycaemic control in diabetes, given the established relationship with microvascular and macrovascular complications in this condition. However, HbA1c is affected by non-glycaemic factors, while also failing to provide data on hypoglycaemic exposure and glucose variability, which are associated with adverse vascular outcomes. Continuous glucose monitoring (CGM)-derived glucose metrics provide a more comprehensive assessment of glycaemia, but their role in predicting future vascular complications remains unclear. Here, we present the protocol for a real-world cohort study, aiming to establish the relationship between CGM-derived glycaemic metrics and the incidence of macrovascular and/or microvascular complications in people with diabetes.Methods and analysisThis cohort study will use data from all CGM new users (FreeStyle Libre system) in France who uploaded their glycaemic values onto the LibreView cloud-based system, linked with data from the French nationwideSystème National des Données de Santéclaims database. The study is expected to include a minimum of 70 000 individuals with diabetes with a first date of glucose data upload to the LibreView platform after 1 January 2018 and with a 6-year follow-up period. The primary outcomes are the first occurrence of new macrovascular or microvascular complications, analysed as a composite outcome and separately. Secondary outcomes will include all-cause mortality and hospital admissions for any cause. This longitudinal study will provide key data on the relationship between CGM-derived glycaemic metrics and micro/macrovascular complications in diabetes. This will have an impact on routine clinical practice by setting targets for the different glycaemic markers, based on robust outcome data, thus helping to optimise glucose management in diabetes.Ethics and disseminationThe study data-collection protocol is approved by the French National Commission for Informatics and Liberties, including approval from theComité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé. This study complies with French and European regulations, including those relating to the General Data Protection Regulation. This study uses pseudonymous information, not requiring informed consent. Dissemination plans include full publication of the study outcomes in peer-reviewed journal(s) with open access and presentations at national and international diabetes and cardiovascular conferences.
Utilisation of outpatient care immediately before emergency admission for ambulatory care-sensitive conditions in Japan: a retrospective observational study
Authors: Nagashima Ryotaro , Kato Hirotaka , Matsuzaki Tatsuya , Nagahama Takayoshi , Goto Rei 
Published: January 2025

ObjectiveThis study assessed whether patients with potentially preventable emergency admissions had limited access to outpatient care immediately before admission and whether they received appropriate outpatient care during their outpatient visits.DesignRetrospective observational study.SettingLinked outpatient and inpatient care records obtained from a nationwide claims database in Japan.ParticipantsPatients who experienced emergency admissions for ambulatory care-sensitive conditions between April 2005 and March 2020. Patient and regional characteristics were examined to assess the types of patients who faced difficulties with outpatient visits and receiving outpatient care related to the disease that resulted in admissions (hereafter referred to as admission-related outpatient care).Main outcome measures(1) Whether patients had an outpatient visit during the 2 weeks preceding admission and (2) whether patients received admission-related outpatient care during the 2 weeks before admission.ResultsThis study included 18 449 emergency admissions for ambulatory care-sensitive conditions, representing 16.3% (18 449/113 669) of all emergency admissions in our data. Among patients with emergency admissions for ambulatory care-sensitive conditions, 37.4% did not have an outpatient visit within the 2 weeks preceding admission and 29.9% did not receive admission-related outpatient care despite having an outpatient visit. In total, 67.4% did not receive admission-related outpatient care during the 2 weeks preceding admission. Patients in their 40s and 50s were less likely to have outpatient visits and receive admission-related outpatient care before admission. No evidence associates regional characteristics with outpatient visits and receiving admission-related outpatient care before admission.ConclusionMost patients who underwent emergency admissions for ambulatory care-sensitive conditions did not have an outpatient visit or receive admission-related outpatient care, despite having an outpatient visit immediately before admission. Our findings suggest that emergency admissions may be prevented by improving access to timely and effective outpatient care.
Review protocol for a systematic review and meta-analysis on HIV inequities in transgender and non-binary populations
Authors: Lucas Ruby , Moodley Ruwenne , Garcia Gutiérrez Jessie M. , Bambilla Audren J K , Singh Dil , Rogers Hannah , Sherwood Jennifer , Dusic Emerson , Giovenco Danielle , Sun Shufang , Operario Don , Restar Arjee 
Published: January 2025

Introduction
Global disparities in HIV prevalence among transgender women are well documented. However, current epidemiological literature on HIV disparities demonstrates gaps in research that include the diversity within transgender populations—for example, transgender men and non-binary trans people across global regions. This systematic review and meta-analysis protocol aims to summarise global HIV inequities among all transgender and non-binary (trans) populations. The objectives of this review are to estimate pooled HIV prevalence and prevention outcomes (pre-exposure prophylaxis and antiretroviral therapy) and differences by gender identity, global regions and self-report versus lab-confirmed findings among trans adults worldwide.

Methods and analysis
We will conduct a systematic review of all studies on HIV outcomes among trans youth and adults (aged 15+ years) published between 2000 and 2024, following the Preferred Reporting Items for Systematic Review and Meta-Analysis Prereporting guidelines. We will use Covidence software for the title and abstract screening, full-text review and data abstraction processes. We will summarise the study’s descriptive statistics and conduct meta-analyses of extracted data points to calculate and synthesise pooled findings and effect size. Specifically, we will use the Mantel–Haenszel method with random effects to model our meta-analyses and the DerSimonian and Laird Q test for heterogeneity testing. We will conduct a narrative synthesis on the areas of research that have been conducted to improve HIV prevention and treatment among trans populations and summarise their findings. Subgroup analyses by gender identity, global regions and self-report versus lab-confirmed findings will be conducted.

Ethics and dissemination
Ethics approval is not applicable for this review since we will not be collecting primary data. The results will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number
The protocol is registered in the International Prospective Register of Systematic Reviews database (PROSPERO ID: CRD42022357285).
Intrauterine metformin exposure and adiposity outcomes in children: a systematic review and meta-analysis
Authors: Fu Jennifer , Tabbara Najla , Tomlinson George , Murphy Kellie E , Hamilton Jill , Feig Denice S 
Published: January 2025

ObjectiveThe study aims to assess the effect of intrauterine metformin exposure on offspring adiposity measures in childhood.DesignSystematic review and meta-analysis.Data sourcesMedline, Embase and Cochrane Central were searched from inception to 4 October 2024.Eligibility criteria for selecting studiesFollow-up studies of randomised-controlled trials and observational studies involving metformin use in pregnancy for any insulin-resistant maternal condition were included.Data extraction and synthesisTwo reviewers independently extracted data and completed risk-of-bias assessments using either Cochrane Risk-Of-Bias tool V.2 or Risk of Bias in Non-Randomised Studies of Exposure depending on study design. Meta-analyses were conducted using the generic inversed variance method in a random-effects model. Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess certainty of evidence.Results18 studies reporting on 7975 children with metformin exposure in utero and over 1 million children without metformin exposure were included. At the oldest age of follow-up reported (weighted mean age of 4.4 years), children with metformin exposure for any maternal indication had comparable body mass index (BMI) with their non-exposed peers (standardised mean difference (SMD) −0.02; 95% CI: −0.11, 0.07; low certainty). When stratified by age at follow-up, while metformin-exposed children had slightly higher BMI at 1–3 years of age (SMD 0.15; 95% CI: 0.04, 0.27; low certainty), no difference remained between the two groups by ages 3–6 and 6–11 years. When stratified by maternal diagnosis, no difference in BMI was found in the diabetes and obesity subgroups, while in the polycystic ovary syndrome subgroup metformin-exposed children were heavier than non-exposed peers (SMD 0.31; 95% CI: 0, 0.62; low certainty). No difference was seen in overweight, obesity or waist circumference.ConclusionsMetformin-exposed children did not differ in adiposity measures compared with their non-exposed peers in later childhood. This adds to the growing body of evidence supporting the long-term safety of metformin use in pregnancy.PROSPERO registration numberCRD42023394464.
Application of core functions and forms in complex health intervention research: a scoping review protocol
Authors: Fox Katelyn , Passey Debbie , Kang Eunyoung , Zeigen Laura , Kenzie Erin , Austin Jessica D , Meadows Rachel J , Fernandez Maria E , Perez Jolles Monica 
Published: January 2025

IntroductionThe ability of healthcare, community and public health systems to effectively implement and disseminate research innovations depends on contextual factors at multiple interconnected levels of influence (eg, the innovation, individual, provider/implementor, organisation and health system). Recently, there has been an increase in the development of complex interventions designed to target multiple levels, designed for or adapted to the context in which they are delivered. Two concepts from complex systems thinking have been increasingly used to operationalise such interventions—core functions (theory and evidence-driven purposes of interventions) and forms (adaptable activities that perform each core function). However, there is a gap in the literature regarding how these concepts are being applied in intervention design and evaluation and implementation strategies. To fill this gap and advance understanding of complex health interventions, this scoping review will:Identify how functions and forms are defined and operationalised across complex health implementation research studies.Describe methodological approaches to identify or apply the concepts of core functions and forms to the design and evaluation of complex health interventions and implementation strategies.Methods and analysisThis review will follow the methodological approach of Arksey and O’Malley. The search strategy will include electronic databases (PubMed, Scopus, Embase, CINAHL and Web of Science) and reference lists and citations of exemplar papers in the field. The literature search will be designed to capture research applying the concepts of core functions and forms in healthcare and public health complex interventions. The search will be restricted to studies published in English in peer-reviewed academic journals. Two coders will screen study titles and abstracts, followed by full-text reviews. One researcher will extract the data and a second will review it for any omissions or errors. An inductive content analysis will be used to categorise the nature of how studies define and operationalise core functions and forms. The scope of the work in this area and methodology (eg, measures selection and analytic approaches) will be described narratively. Results will be presented to experts in the field and their input will be used to further contextualise the findings.Ethics and disseminationThis project does not require ethics approval. We will share the findings and data results will be shared via peer-reviewed journals.Trial registration numberhttps://doi.org/10.17605/OSF.IO/YQFP7