bluuebunny/crossref_metadata_2025_split huggingface dataset:
Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study
Authors: Altschuck Natalie , van Munster Marlena , Stümpel Johanne , Pedrosa David Jose , Wellach Ingmar , Boebinger Hannes , Geraedts Max 
Published: December 2024

IntroductionPeople with Parkinson’s disease (PwPD) experience a wide range of motor and non-motor symptoms that have a significant impact on their health and quality of life. Effective care management for PwPD involves monitoring symptoms at home, involving specialised multidisciplinary care providers and enhancing self-management skills. This study protocol describes the process evaluation within a randomised clinical trial to assess the implementation and its impact on patient health outcomes of ParkProReakt—a proactive, multidisciplinary, digitally supported care model for community-dwelling PwPD.Methods and analysisThe hybrid efficacy-implementation study will assess key implementation outcomes using the Medical Research Council framework for complex interventions alongside a randomised controlled trial. A combination of quantitative and qualitative methods will be used to assess process data from care providers and patients. The main process outcomes are fidelity, dose, feasibility and context. Context will be analysed through semistructured interviews and focus groups using the Consolidated Framework of Implementation Research. To elucidate potential facilitators and barriers to implementation and to gain deeper insights into the efficacy outcome data, quantitative and qualitative process data will be integrated at an interpretative level using mixed methods. In addition to process evaluation, potential indirect mechanisms of impact will be measured.Ethics and disseminationEthical approval for this study was obtained from the responsible state medical ethics committees in Hesse and Hamburg, Germany. Results will be communicated to the funding body and disseminated through scientific publications.Trial registrationThis study was registered with the German Registry for Clinical Studies (DRKS)—number: DRKS00031092.
Systematic review of the impact of the National Medication Price Negotiated Policy on the accessibility of drugs in China, 2016–2024
Authors: Peng Nan , Du Chenyu , Gong Yiran , Long Xiang , Wang Caiyi , Liu Pengcheng 
Published: December 2024

ObjectiveTo alleviate the economic burden of innovative drugs on patients in China, the government has been negotiating drug prices since 2016 to enhance their accessibility. This systematic review aimed to discuss the impact of the National Medication Price Negotiation Policy (NMPNP) on the accessibility of drugs in China in the years 2016–2024.DesignSystematically reviewed the studies’ findings and evaluated their quality using the Newcastle-Ottawa Scale (NOS) collaborative tool. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 were used to facilitate transparent and complete reporting of our systematic review.Data sourcesPubMed, Web of Science, CNKI and Wanfang were searched from 1 January 2016 to 1 October 2024.Eligibility criteria for selecting studiesThe inclusion criteria of this study is a quantitative study to evaluate the accessibility of negotiated drugs after the implementation of the NMPNP.Data extraction and synthesisTwo researchers independently searched the literature, extracted the data and cross-checked them. Any disagreements were resolved by discussion or consultation with a third party. The quality of systematic reviews was assessed using the NOS.ResultsA total of 32 studies were included in this review, 8 of the studies were assessed to be high quality based on the NOS, 17 as moderate quality and the remaining 7 as low quality. Most of them showed that after the implementation of the NMPNP, the availability, affordability, defined daily doses, hospital purchase volume and expenditure of negotiated drugs increased, and the price and defined daily dose cost of negotiated drugs decreased. However, a few studies found that some drugs are difficult to be admitted to hospitals and consumption dropped after the implementation of the NMPNP due to low clinical demand and weak competitiveness.ConclusionsThe implementation of NMPNP improved drug accessibility for patients and most regions had good implementation effects which can provide some insights for other countries. However, the high utilisation of successfully negotiated drugs has increased health insurance expenditures, potentially affecting the fund’s stability. This necessitates government regulation of both the use of these drugs and health insurance funds. Moreover, different regions and medical institutions had different development levels and resource allocations, resulting in uneven effects of the NMPNP which need to be improved in the future.
StUdy of Gestational diabetes And Risk using Electronic Data (SUGARED): a population-based cohort study—study protocol
Authors: Randall Deborah , Ibiebele Ibinabo , Nippita Tanya , Torvaldsen Siranda , Morris Jonathan M , Gallimore Felicity , Weir Tessa L , Glastras Sarah 
Published: December 2024

IntroductionThe incidence of gestational diabetes mellitus (GDM) in Australia has tripled in the last 20 years. Consequently, over 40 000 pregnancies are now diagnosed as ‘higher risk’ each year. This has increased antenatal surveillance and obstetric intervention, often in the form of delivery earlier than 39 weeks gestation. The StUdy of Gestational diabetes And Risk using Electronic Data (SUGARED) project aims to use large population-based and routinely collected linked health data to (1) personalise risk prediction of adverse pregnancy outcomes for women undergoing glucose tolerance testing, (2) guide optimal birth timing for women with diet-controlled GDM and (3) examine variation in GDM management and pregnancy outcomes in New South Wales (NSW), Australia.Methods and analysisThis retrospective cohort study using linked, routinely collected health data includes all women who gave birth from January 2016 to December 2020 in NSW. The cohort will include approximately 475 000 pregnancies, with >70 000 diagnosed with GDM. The study will link birth data to hospital data and birth/death registry data. In addition, clinical pathology results and detailed clinical information from a subset of public hospital pregnancies in 13 of 15 area health services will be linked. To address the three main aims, we will use statistical methods including logistic regression and K-fold cross-validation for risk prediction, a propensity-score matching ‘target trial’ method to examine birth timing, and multilevel modelling to examine hospital variation.Ethics and disseminationEthics approval for the study has been granted by the NSW Population and Health Services Research Ethics Committee. We will communicate evidence generated from SUGARED to the local health districts and their clinicians, as well as potentially optimising dissemination using existing digital infrastructure.
Specialist clinical pathways in audiology services for adults living with coexisting hearing loss and dementia: a scoping review protocol
Authors: Wenje Sophie Mai , Calvert Sian , Henshaw Helen , Spriggs Ruth V , Dening Tom , Hendron Elizabeth , Heffernan Eithne 
Published: December 2024

IntroductionBoth hearing loss and dementia are associated with ageing, and it is thought that many individuals living with dementia also live with hearing loss. Despite the large comorbidity between these two disorders, there remains a clear lack of established guidelines in audiological services for assessing and managing patients living with dementia. This scoping review aims to examine whether specialist clinical pathways exist in audiology services for people living with coexisting hearing loss and dementia and to describe the specific components and features of these pathways. This review will provide up-to-date information on clinical practice, identifying any gaps in care and in the literature to inform future research hypotheses and best practice guidelines.Methods and analysisThe methods are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. The following electronic databases will be searched: CINAHL, EMBASE, MEDLINE, PsycINFO, PubMed, Scopus and Web of Science. The eligibility criteria are defined according to the domains of the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation and Research type) search strategy tool. Primary research studies and select grey literature sources (eg, practice guidelines) will be eligible if published within the last 15 years. Studies eligible for inclusion must contain adults living with suspected or confirmed dementia, their carers, or clinicians within audiology services. Initial searches were performed on 31 January 2024 and will be updated before completion and submission of the review. Article quality will be appraised using an established tool: the Mixed Methods Appraisal Tool. The results will be synthesised and reported in line with reflexive thematic analysis guidelines.Ethics and disseminationNo ethical issues are foreseen as the review will collect secondary data only. Findings will be reported by peer-reviewed publication and by national and international academic conferences.
Association between immunosuppressive medications and COVID-19 hospitalisation and death: a retrospective cohort study
Authors: Sechrist Samantha J , Tang Emily , Arnold Benjamin F , Acharya Nisha R 
Published: December 2024

ImportanceImmunocompromised status is a risk factor for severe SARS-CoV-2 infection. Little is known about how systemic corticosteroid dose and concurrent use of immunosuppressants are associated with COVID-19 outcomes.ObjectiveTo assess the association between corticosteroid dose/duration and concurrent immunosuppressant use on COVID-19 hospitalisation and death in the era of COVID-19 vaccinations.DesignThis is a retrospective cohort study using a deidentified insurance claims database from 1 July 2020 to 30 June 30, 2022, with the risk period starting on 1 July 2021. Impact of corticosteroid exposures and concurrent use of other immunosuppressants was assessed with attributable risk analysis and Cox regression that included COVID-19 vaccination status and time-updated dichotomous immunosuppressive medication exposures.ParticipantsThere were 10 109 596 eligible patients enrolled during the risk period, each with at least 365 days of continuous enrolment prior to 1 July 2021.ExposuresSystemic corticosteroids, disease-modifying antirheumatic drugs (DMARDs), tumour necrosis factor-alpha inhibitors (TNFis) and other immunosuppressive drug categories.Main outcomesIncidence rate ratios and hazard ratios for COVID-19 hospitalisation and death.ResultsCorticosteroids were prescribed to 1 379 049 (13.6%) of 10 109 596 individuals. After adjustment, corticosteroids were associated with an increased risk of COVID-19 hospitalisation (HR: 5.40; 95% CI 5.27 to 5.53; p<0.0001) and death (HR: 5.90; 95% CI 5.59 to 6.22; p<0.0001). Among individuals exposed to corticosteroids without a record of COVID-19 vaccination, risks for COVID-19 hospitalisation and death were increased by 3- and 14.5-fold. The population attributable risk of corticosteroid use for COVID-19 hospitalisations was 13.9% (95% CI 13.5 to 14.3%). There was a significantly increased risk of COVID-19 hospitalisation associated with the use of corticosteroids plus DMARDs (HR: 1.55; 95% CI 1.42 to 1.70; p<0.0001) or plus TNFis (HR: 1.60; 95% CI 1.15 to 2.22; p=0.005).ConclusionsCorticosteroids are associated with greater risk of COVID-19 hospitalisation and death, especially among unvaccinated individuals. Concurrent use of DMARDs and TNFis with corticosteroids confers greater risk.
Exploring the factors associated with prelacteal feeds in Papua New Guinea: a population-based survey
Authors: Maviso McKenzie , Namosha Elias , Guldan Georgia S. 
Published: December 2024

BackgroundPrelacteal feeding disrupts early breastfeeding initiation and exclusive breastfeeding, and increases the risk of childhood illnesses and under-five mortality. Despite its negative health outcomes, newborns are given prelacteal feeds in Papua New Guinea (PNG). This study investigated the factors associated with prelacteal feeding practices among women in PNG.DesignA population-based cross-sectional study based on Demographic and Health Survey (DHS) data. Multivariable logistic regression using complex sample analysis was performed to control for the effects of potential confounders. Variables with p ≤ 0.05 were considered statistically significant.SettingPapua New Guinea.ParticipantsA total weighted sample of 4399 women was included in the study.Outcome measurePrelacteal feeds.ResultsAbout 10% of women provided prelacteal feeds to their infants. The most frequently reported prelacteal feed was plain water (71.7%), followed by grain-based (eg, noodles) (47.1%), dark green leafy vegetables (42.1%) and soup (39.7%). Women with no formal (Adjusted Odds Ratio (AOR) 1.4, 95% CI: 1.0–3.0) or primary (AOR 1.5, 95% CI: 1.0–2.9) education, who had a caesarean section (AOR 4.1, 95% CI: 2.4–7.2), had given birth at home or in the village (AOR 3.7, 95% CI: 2.1–6.8) and from the Islands region (AOR 2.3, 95% CI: 1.5–3.5) had higher odds of providing prelacteal feeds.ConclusionOur study revealed that providing prelacteal feeds is common in PNG. Tailored health education and behaviour change communication are necessary to address this harmful infant feeding practice. Furthermore, the promotion of facility-based births and early breastfeeding practices should be prioritised using existing strategies, especially for disadvantaged and rural women.
Longitudinal cholesterol trends across socioeconomic groups in Norway: the influence of lipid-lowering drugs in the population-based Tromsø Study 1994–2016
Authors: Vo Chi Quynh , Wilsgaard Tom , Samuelsen Per-Jostein , Mathiesen Ellisiv B , Sommerseth Hilde L , Eggen Anne Elise , Wisløff Torbjørn 
Published: December 2024

ObjectivesThere is limited evidence regarding the impact of lipid-lowering drugs (LLDs) on the socioeconomic gradient in a longitudinal perspective. The study investigates the longitudinal socioeconomic gradient in total cholesterol levels and whether this is affected by the use of LLDs.DesignPopulation-based cohort study.SettingSample from adult inhabitants of Tromsø municipality, Norway, who participated in the Tromsø Study (1994–2016).Participants17 550 participants of the population-based Tromsø Study in 1994–1995 who were non-users of LLD, aged 25–78 years at baseline and who attended one or more of three subsequent surveys in 2001, 2007–2008 and 2015–2016 were included in the study.Outcome measureSocioeconomic gradient in total cholesterol levels was compared among participants treated and not treated with LLDs during the observation period.ResultsThe total cholesterol levels across all educational groups increased from 1994–1995 to 2015–2016 among untreated women (+0.33 mmol/L to +0.48 mmol/L), except for those with primary education (−0.12 mmol/L). Total cholesterol levels decreased among untreated men (−0.40 mmol/L to −0.06 mmol/L, from lowest education to highest education), treated women (−1.88 mmol/L to −1.35 mmol/L) and men (−2.21 mmol/L to −1.84 mmol/L) across all educational groups. At baseline, we observed a significant inverse association between education and total cholesterol levels among non-users of LLDs. There was no clear educational gradient in total cholesterol levels among users of LLDs.ConclusionsUsers of LLDs experienced a more substantial decrease in total cholesterol levels over time compared with non-users. The educational gradient in total cholesterol levels observed among non-users of LLD was not apparent among users.
Paediatric Personalized Research Network Switzerland (SwissPedHealth): a joint paediatric national data stream
Authors: Mozun Rebeca , Belle Fabiën N , Agostini Andrea , Baumgartner Matthias R , Fellay Jacques , Forrest Christopher B , Froese D Sean , Giannoni Eric , Goetze Sandra , Hofmann Kathrin , Latzin Philipp , Lauener Roger , Martin Necker Aurélie , Ormond Kelly , Pachlopnik Schmid Jana , Pedrioli Patrick G A , Posfay-Barbe Klara M , Rauch Anita , M Schulzke Sven , Stocker Martin , Spycher Ben D , Vayena Effy , Welzel Tatjana , Zamboni Nicola , Vogt Julia E , Schlapbach Luregn J , Bielicki Julia A , Kuehni Claudia E 
Published: December 2024

IntroductionChildren represent a large and vulnerable patient group. However, the evidence base for most paediatric diagnostic and therapeutic procedures remains limited or is often inferred from adults. There is an urgency to improve paediatric healthcare provision based on real-world evidence generation. Digital transformation is a unique opportunity to shape a data-driven, agile, learning healthcare system and deliver more efficient and personalised care to children and their families. The goal of Paediatric Personalized Research Network Switzerland (SwissPedHealth) is to build a sustainable and scalable infrastructure to make routine clinical data from paediatric hospitals in Switzerland interoperable, standardised, quality-controlled, and ready for observational research, quality assurance, trials and health-policy creation. This study describes the design, aims and current achievements of SwissPedHealth.Methods and analysisSwissPedHealth was started in September 2022 as one of four national data streams co-funded by the Swiss Personalized Health Network (SPHN) and the Personalized Health and Related Technologies (PHRT). SwissPedHealth develops modular governance and regulatory strategies and harnesses SPHN automatisation procedures in collaboration with clinical data warehouses, the Data Coordination Center, Biomedical Information Technology Network, and other SPHN institutions and funded projects. The SwissPedHealth consortium is led by a multisite, multidisciplinary Steering Committee, incorporating patient and family representatives. The data stream contains work packages focusing on (1) governance and implementation of standardised data collection, (2) nested projects to test the feasibility of the data stream, (3) a lighthouse project that enriches the data stream by integrating multi-omics data, aiming to improve diagnoses of rare diseases and 4) engagement with families through patient and public involvement activities and bioethics interviews.Ethics and disseminationThe health database regulation of SwissPedHealth was approved by the ethics committee (AO_2022-00018). Research findings will be disseminated through national and international conferences and publications in peer-reviewed journals, and in lay language via online media and podcasts.
Pragmatic non-inferiority Randomised trial Investigating Needle aspiration versus ChEst drain for Secondary Spontaneous Pneumothorax (the PRINCE-SSP study): study protocol for a randomised non-inferiority trial
Authors: Walker Steven , Taylor Ellie , McAndrew Amy , Carlton Edward , Chaudhuri Ella , Ghorpade Pooja , Goodwin Charlotte , Connors James , Cook Heather , Luengo-Fernandez Ramon , Creanor Siobhan , Maskell Nick A 
Published: December 2024

IntroductionSecondary spontaneous pneumothorax (SSP) is a medical emergency where the lung collapses in the presence of underlying chronic lung disease. Current international clinical guidelines advise intercostal drain (ICD) insertion for SSP. However, in a previous small study needle aspiration (NA) has been shown to reduce length of hospital stay (LOHS) and reduce complications. We are evaluating the clinical and cost-effectiveness of an initial NA approach to the management of patients with SSP in the United Kingdom.Methods and analysisThe PRINCE-SSP (Pragmatic non-inferiority Randomised trial Investigating Needle aspiration vs ChEst drain for Secondary Spontaneous Pneumothorax) trial is a pragmatic, multicentre, open-label, parallel, two-group, randomised, non-inferiority trial to establish whether NA for SSP is non-inferior in terms of LOHS compared with ICD. We aim to recruit 110 patients from at least 15 UK NHS hospitals, over 18 months. Participants allocated to the intervention (NA) group will have an NA inserted at the presentation. Those allocated to the comparator (usual care) group will have an ICD inserted. Participants are followed up for 30 days. The primary outcome measure is initial LOHS, up to day 30 postrandomisation. Secondary outcomes include (but are not limited to) total LOHS including readmissions, complications, cost-effectiveness and patient-reported quality of life.Ethics and disseminationThis trial received Health Research Authority (HRA) approval from Wales Research Ethics Committee seven ethics committee (23/WA/0085). Results will be submitted for publication in a peer-reviewed journal. A plain English summary of the trial results will be prepared and disseminated with the help of our patient advisory group, including via social media, and provided to trial participants via post or email according to their preference.Trial registration numberISRCTN12644940.
Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial
Authors: Slevin Finbar , Alexander Sophie , Brown Sarah R , Carter Matthew , Choudhury Ananya , Clipson Alexandra , Din Omar , Dive Caroline , Gilbert Alexandra , Girvan Sean , Hingorani Mohan , Jain Suneil , Khoo Vincent , Lilley John , Murray Louise J , Naismith Olivia , Noutch Samantha , Oliveira Pedro , Pagett Christopher J H , Smith Alexandra , Talbot James , Webster Joanne , Henry Ann M 
Published: December 2024

IntroductionProstate cancer (PCa) is the most common cancer in men. Recurrence may occur in up to half of patients initially treated with curative intent for high-risk localised/locally advanced PCa. Pelvic nodal recurrence is common in this setting, but no clear standard of care exists for these patients, with potential therapeutic approaches including stereotactic body radiotherapy (SBRT) to the involved node(s) alone, extended nodal irradiation (ENI) to treat sites of potential micrometastatic spread in addition to involved node(s) and androgen deprivation therapy with or without additional systemic anticancer therapies. Based on observational studies, ENI is associated with promising metastasis-free survival (MFS) compared with SBRT and appears to result in low rates of severe late toxicity.Methods and analysisPelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer is a UK multicentre, open-label, phase III randomised controlled trial, which will deliver much needed, high-quality evidence of the impact on metastatic progression from ENI compared with SBRT in patients with PCa pelvic nodal recurrence. The trial will also evaluate the long-term toxicity of 5-fraction ENI compared with a standard 20-fraction schedule. The trail will randomise 480 participants in a ratio of 2:1:1 to SBRT, 5-fraction ENI or 20-fraction ENI from 35 to 40 UK radiotherapy sites over 4 years. Coprimary endpoints are MFS at 3 years and participant-reported late bowel toxicity at 3 years. Secondary endpoints include overall survival, biochemical progression-free survival, failure-free survival, patterns of failure, participant-reported/clinician-reported toxicity and health-related quality of life. Collection of blood and tissue samples will enable future evaluation of biomarkers of disease and toxicity and support stratification of salvage therapeutic approaches.Ethics and disseminationEthical approval was obtained from NHS Health Research Authority, East of England – Cambridgeshire and Hertfordshire Research Ethics Committee (24/EE/0099). Trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors guidelines.Trial registration numberISRCTN11089334, registered on 23 September 2024.