bluuebunny/crossref_metadata_2025_split huggingface dataset:
Estimating the smallest worthwhile difference of antidepressants: a cross-sectional survey
Authors: Sahker Ethan , Furukawa Toshi A , Luo Yan , Ferreira Manuela L , Okazaki Kaori , Chevance Astrid , Markham Sarah , Ede Roger , Leucht Stefan , Cipriani Andrea , Salanti Georgia 
Published: January 2024

BackgroundApproximately 30% of patients experience substantial improvement in depression after 2 months without treatment, and 45% with antidepressants. The smallest worthwhile difference (SWD) refers to an intervention’s smallest beneficial effect over a comparison patients deem worthwhile given treatment burdens (harms, expenses and inconveniences), but is undetermined for antidepressants.ObjectiveEstimating the SWD of commonly prescribed antidepressants for depression compared to no treatment.MethodsThe SWD was estimated as a patient-required difference in response rates between antidepressants and no treatment after 2 months. An online cross-sectional survey using Prolific, MQ Mental Health and Amazon Mechanical Turk crowdsourcing services in the UK and USA between October 2022 and January 2023 garnered participants (N=935) that were a mean age of 44.1 (SD=13.9) and 66% women (n=617).FindingsOf 935 participants, 124 reported moderate-to-severe depressive symptoms but were not in treatment, 390 were in treatment and 495 reported absent-to-mild symptoms with or without treatment experiences. The median SWD was a 20% (IQR=10–30%) difference in response rates for people with moderate-to-severe depressive symptoms, not in treatment, and willing to consider antidepressants, and 25% (IQR=10–35%) for the full sample.ConclusionsOur observed SWDs mean that the current 15% antidepressant benefit over no treatment was sufficient for one in three people to accept antidepressants given the burdens, but two in three expected greater treatment benefits.ImplicationsWhile a minority may be satisfied with the best currently available antidepressants, more effective and/or less burdensome medications are needed, with more attention given to patient perspectives.
Novel proteomics-based plasma test for early detection of multiple cancers in the general population
Authors: Budnik Bogdan , Amirkhani Hossein , Forouzanfar Mohammad H , Afshin Ashkan 
Published: January 2024

ObjectiveEarly detection of cancer is crucial for reducing the global burden of cancer, but effective screening tests for many cancers do not exist. This study aimed to develop a novel proteome-based multi-cancer screening test that can detect early-stage cancers with high accuracy.Methods and analysisWe collected plasma samples from 440 individuals, healthy and diagnosed with 18 early-stage solid tumours. Using proximity extension assay, we measured more than 3000 high-abundance and low-abundance proteins in each sample. Then, using a multi-step statistical approach, we identified a limited set of sex-specific proteins that could detect early-stage cancers and their tissue of origin with high accuracy.ResultsOur sex-specific cancer detection panels consisting of 10 proteins showed high accuracy for both males (area under the curve (AUC): 0.98, 95% CI 0.96, 1) and females (AUC: 0.983, 95% CI 0.95, 1.00). At stage I and at the specificity of 99%, our panels were able to identify 93% (95% CI 79%, 100%) of cancers among males and 84% (95% CI 68%, 100%) of cancers among females. Our sex-specific localisation panels consisted of 150 proteins and were able to identify the tissue of origin of most cancers in more than 80% of cases. The analysis of the plasma concentrations of proteins selected showed that almost all the proteins were in the low-concentration part of the human plasma proteome.ConclusionThe proteome-based screening test showed promising performance compared with other technologies and could be a starting point for developing a new generation of screening tests for the early detection of cancer.
Primary care system-level training and support programme for the secondary prevention of domestic violence and abuse: a cost-effectiveness feasibility model
Authors: Cochrane Madeleine , Szilassy Eszter , Coope Caroline , Emsley Elizabeth , Johnson Medina , Feder Gene , Barbosa Estela Capelas 
Published: January 2024

ObjectivesThis study aimed to evaluate the prospective cost-effectiveness of the Identification and Referral to Improve Safety plus (IRIS+) intervention compared with usual care using feasibility data derived from seven UK general practice sites.MethodA cost–utility analysis was conducted to assess the potential cost-effectiveness of IRIS+, an enhanced model of the UK’s usual care. IRIS+ assisted primary care staff in identifying, documenting and referring not only women, but also men and children who may have experienced domestic violence/abuse as victims, perpetrators or both. A perpetrator group programme was not part of the intervention per se but was linked to the IRIS+ intervention via a referral pathway and signposting. A Markov model was constructed from a societal perspective to estimate mean incremental costs and quality-adjusted life years (QALYs) of IRIS+ compared with to usual care over a 10-year time horizon.ResultsThe IRIS+ intervention saved £92 per patient and produced QALY gains of 0.003. The incremental net monetary benefit was positive (£145) and the IRIS+ intervention was cost-effective in 55% of simulations at a cost-effectiveness threshold of £20 000 per QALY.ConclusionThe IRIS+ intervention could be cost-effective or even cost saving from a societal perspective in the UK, though there are large uncertainties, reflected in the confidence intervals and simulation results.
Integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomised controlled trial protocol
Authors: Norris Shane A , Zarowsky Christina , Murphy Katherine , Ware Lisa Jayne , Lombard Carl , Matjila Mushi , Chivese Tawanda , Muhwava Lorrein Shamiso , Mutabazi Jean Claude , Harbron Janetta , Fairall Lara R , Lambert Estelle , Levitt Naomi 
Published: January 2024

IntroductionSouth Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months’ post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package.Methods and analysesConvergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24–36 weeks’ gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6–8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6–8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention.Ethics and disseminationEthics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers.Protocol version1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries.Trial registration numberPAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).
Baduanjin exercise intervention trial: research protocol of a randomised controlled trial for frail kidney transplant recipients
Authors: Lin Keke , Fang Jiaxin , Zhang Shuping , Ding Zhenshan , Hu Yanbin , Zhang Bei , Guo Xuejie , Liu Hongxia , Zhao Peiyu 
Published: January 2024

IntroductionFrailty is one of the most common comorbidities in kidney transplant recipients (KTRs). Physical, psychological and social frailty could be improved by exercise intervention. Baduanjin, also known as Eight-section Brocades, is a type of traditional Chinese medicine exercise characterised by the interplay between physical postures and movements, breathing and mind. It can help frail patients strengthen their upper and lower body muscles, improve their mood, quality of life and frailty. However, the effectiveness of Baduanjin on frail KTRs remains unknown. Therefore, we will conduct a randomised controlled trial (RCT) to evaluate the effectiveness of Baduanjin on frail KTRs.Methods and analysisThis protocol describes an assessor and analyst blinded, parallel RCT for frail KTRs comparing Baduanjin group (n=72) with care-as-usual group (n=72). The primary outcomes are frailty assessed by Frailty Phenotype scale and Tilburg Frailty Indicator scale, and muscle strength assessed by a grip strength metre. The secondary outcomes are quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (MOS SF-36) and depression assessed by the Hospital Anxiety and Depression Scale. All these data will be collected at the baseline, after 3, 6, 9 and 12 months, respectively. Two-way mixed analysis of variance (ANOVA) will be used to test the effectiveness of Baduanjin exercise. Qualitative interviews with participants in the intervention group will also be performed after 6 months. Themes will be extracted from interview transcripts using NVivo software.Ethics and disseminationThe Ethics Committees of Beijing University of Chinese Medicine (2022BZYLL1018) and China-Japan Friendship Hospital (2022-KY-250) had approved the study. The organ donors were all from China-Japan Friendship Hospital. They provided informed consent and they were not executed prisoners. We have providedBMJ Openwith documentation from the hospital that indicates that the organs will be harvested ethically. The findings of this study will be disseminated through peer-reviewed journals, international conferences, media reports and briefings.Trial registration numberChiCTR2100041730
Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
Authors: Li Meng Chen Michelle , Cheng Yu Kin , Cui Can , Chow Simon Kwoon Ho , Wong Ronald Man Yeung , Kwok Timothy CY , Siu Parco M , Yang Minghui , Tian Maoyi , Rubin Clinton , Welch A A , Qin Ling , Law Sheung Wai , Cheung Wing Hoi 
Published: January 2024

IntroductionSarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.Methods and analysisIn this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.Ethics and disseminationThis study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.Trial registration numberNCT05525039.
Non-operative versus operative treatment of suprasyndesmotic ankle fractures: protocol for a prospective, multicentre, randomised controlled trial
Authors: Saatvedt Ola , Riiser Martin , Frihagen Frede , Figved Wender , Madsen Jan Erik , Molund Marius , Furunes Håvard 
Published: January 2024

IntroductionSurgery is widely recognised as the treatment of choice for suprasyndesmotic ankle fractures, because of the assumption that these injuries yield instability of the ankle joint. Stability assessment of ankle fractures using weightbearing radiographs is now used regularly to guide the treatment of transsyndesmotic and infrasyndesmotic ankle fractures. Patients with a congruent ankle joint on weightbearing radiographs can be treated non-operatively with excellent results. Weightbearing radiographs are, however, rarely performed on suprasyndesmotic fractures due to the assumed unstable nature of these fractures. If weightbearing radiographs can be used to identify suprasyndesmotic fractures suitable for non-operative treatment, we may save patients from the potential burdens of surgery.Our aim is to compare the efficacy of operative and non-operative treatment of patients with suprasyndesmotic ankle fractures that reduce on weightbearing radiographs.Methods and analysisA non-inferiority randomised controlled trial involving 120 patients will be conducted. A total of 120 patients with suprasyndesmotic ankle fractures with an initial radiographic medial clear space of <7 mm will be subjected to weightbearing radiographs. If the tibio-talar joint is completely reduced, we will randomise in a 1:1 ratio to either operative treatment including reduction and fixation of the syndesmosis or non-operative treatment with an orthosis. The primary study outcome is patient-reported ankle function and symptoms as measured by the Olerud-Molander Ankle Score at 2-year follow-up. Secondary outcomes include the Manchester-Oxford Foot Questionnaire, range of motion, radiographic results and rates of adverse events.Ethics and disseminationThe Regional Committee for Medical and Health Research South East, group A (permission number: 169307), has granted ethics approval. The results of this study will provide valuable insights for developing future diagnostic and treatment strategies for a common fracture type. The findings will be shared through publication in peer-reviewed journals and presentations at conferences.Trial registration numberNCT04615650.
Comparison of healthcare quality for uninsured and underinsured children through community health centres in Canada and the USA: a scoping review protocol
Authors: Suleman Shazeen , Calleja Sabine , Parmar Puneet Kaur , Cohen Eyal 
Published: January 2024

IntroductionChildren and youth who are uninsured or underinsured in Canada and the USA have limited options where they can receive healthcare. In both countries, community health centres (CHCs) have been established as a solution to provide quality care to children without adequate insurance, including those who are newcomers or refugees. However, little is known about how well these models deliver paediatric care. Cross-country analysis provides an important viewpoint to identify areas of success and growth. The purpose of this scoping review is to compare quality of care for uninsured and underinsured children through CHCs in the USA and Canada.MethodsThis scoping review follows the methodological guidelines from the Joanna Briggs Institute Evidence synthesis. The protocol has been registered with the Open Science Framework Registries and can be accessed online. A search will be conducted in electronic databases of peer-reviewed literature (Ovid MEDLINE ALL, CINAHL Complete via EbscoHost, Scopus; Health Business Elite via EbscoHost and Sociological Abstracts via ProQuest) as well as the grey literature. Two reviewers will review all titles and abstracts for inclusion in full-text review. Studies that meet inclusion criteria will be included in full-text review. Data will be extracted into Covidence, using the Donabedian model as a conceptual framework. Findings will be synthesised in a narrative format.Ethics and disseminationAs this study only uses publicly available data, ethics approval is not required. Findings will be shared at national and international conferences and published in a peer-reviewed journal. In addition, findings will be prepared into a policy brief or white paper to be shared with relevant policy stakeholders to advocate for a better model of care for marginalised children and youth.
Elements of organisation of integrated maternity care and their associations with outcomes: a scoping review protocol
Authors: Liebregts Jolanda , Goodarzi Bahareh , Valentijn Pim P , Downe Soo , Erwich Jan Jaap , Burchell George , Batenburg Ronald , de Vries Eline F , de Jonge Ank , Verhoeven Corine J M 
Published: January 2024

IntroductionIntegrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes.Methods and analysisWe will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’.Ethics and disseminationSince this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations.The findings of this scoping review will give insight into the nature and effectiveness of elements of integrated care and will generate hypotheses for further research.
Early detection of clinically significant prostate cancer: protocol summary and statistical analysis plan for the ProScreen randomised trial
Authors: Nevalainen Jaakko , Raitanen Jani , Natunen Kari , Kilpeläinen Tuomas , Rannikko Antti , Tammela Teuvo , Auvinen Anssi 
Published: January 2024

IntroductionEvidence on the effectiveness of prostate cancer screening based on prostate-specific antigen is inconclusive and suggests a questionable balance between benefits and harms due to overdiagnosis, and complications from biopsies and overtreatment. However, diagnostic accuracy studies have shown that detection of clinically insignificant prostate cancer can be reduced by MRI combined with targeted biopsies.The aim of the paper is to describe the analysis of the ProScreen randomised trial to assess the performance of the novel screening algorithm in terms of the primary outcome, prostate cancer mortality and secondary outcomes as intermediate indicators of screening benefits and harms of screening.MethodsThe trial aims to recruit at least 111 000 men to achieve sufficient statistical power for the primary outcome. Men will be allocated in a 1:3 ratio to the screening and control arms. Interim analysis is planned at 10 years of follow-up, and the final analysis at 15 years. Difference between the trial arms in prostate cancer mortality will be assessed by Gray’s test using intention-to-screen analysis of randomised men. Secondary outcomes will be the incidence of prostate cancer by disease aggressiveness, progression to advanced prostate cancer, death due to any cause and cost-effectiveness of screening.Ethics and disseminationThe trial protocol was reviewed by the ethical committee of the Helsinki University Hospital (2910/2017). Results will be disseminated through publications in international peer-reviewed journals and at scientific meetings.Trial registration numberNCT03423303
Examining age, period and cohort effects in attitude change to childhood vaccinations in a representative New Zealand survey: a multiyear cohort-sequential growth modelling study
Authors: Hayes Emily , Yogeeswaran Kumar , Zubielevitch Elena , Lee Carol H J , Cording Jacinta , Sibley Chris G 
Published: January 2024

ObjectivesVaccinations are an important preventative measure in reducing the spread of infectious diseases worldwide. However, concerns of undervaccination during childhood have become increasingly common. The current study aims to investigate changes in attitudes towards childhood vaccinations prior to the COVID-19 pandemic using a national sample from New Zealand.DesignAge-based, period-based, and cohort-based changes were assessed using cohort-sequential latent growth modelling in 11 overlapping birth cohorts, which spanned the ages of 23–79 years.Setting and participantsData were taken from the New Zealand Attitudes and Values Study where 58 654 adults completed at least one wave across a 7-year period (2013 and 2015–2019).ResultsThe period-based and cohort-based models fit the data equally well (χ2(282)=8547.93, p<0.001, comparative fit index, CFI=0.894, root mean square error of approximation, (RMSEA)=0.074, standardised root mean square residual, SRMR=0.105; χ2(273)=8514.87, p<0.001, CFI=0.894, RMSEA=0.075, SRMR=0.105, respectively) suggesting societal factors contribute to childhood vaccination attitudes. Additionally, the findings suggest attitudes towards childhood vaccinations were becoming increasingly more positive in all birth cohorts (ps<0.001), with younger and older birth cohorts exhibiting even positive attitudes compared with middle-aged cohorts.ConclusionOverall, both the cohort-based and period-based models reveal changes in vaccination attitudes suggesting that even prior to the COVID-19 pandemic, societal influences had an impact on attitudes towards childhood vaccination.