bluuebunny/crossref_metadata_2025_split huggingface dataset:
The impact of delayed diagnosis and treatment due to COVID-19 on Australian thyroid cancer patients: a qualitative interview study
Authors: D'souza Bianka , Glover Anthony , Bavor Claire , Brown Benjamin , Dodd Rachael H , Lee James C , Millar Jeremy , Miller Julie A , Zalcberg John R , Serpell Jonathan , Ioannou Liane J , Nickel Brooke 
Published: April 2024

ObjectivesThe study aims to investigate the perceptions of patients with thyroid cancer on the potential impact of diagnosis and treatment delays during the COVID-19 pandemic.DesignThis study involved qualitative semi-structured telephone interviews. The interviews were transcribed verbatim, analysed using the thematic framework analysis method and reported using the Consolidated Criteria for Reporting Qualitative Research.SettingParticipants in the study were treated and/or managed at hospital sites across New South Wales and Victoria, Australia.Participants17 patients with thyroid cancer were interviewed and included in the analysis (14 females and 3 males).ResultsThe delays experienced by patients ranged from <3 months to >12 months. The patients reported about delays to diagnostic tests, delays to surgery and radioactive iodine treatment, perceived disease progression and, for some, the financial burden of choosing to go through private treatment to minimise the delay. Most patients also reported not wanting to experience delays any longer than they did, due to unease and anxiety.ConclusionsThis study highlights an increased psychological burden in patients with thyroid cancer who experienced delayed diagnosis and/or treatment during COVID-19. The impacts experienced by patients during this time may be similar in the case of other unexpected delays and highlight the need for regular clinical review during delays to diagnosis or treatment.
Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions
Authors: Gumber Leher , Agbeleye Opeyemi , Inskip Alex , Fairbairn Ross , Still Madeleine , Ouma Luke , Lozano-Kuehne Jingky , Bardgett Michelle , Isaacs John D , Wason James MS , Craig Dawn , Pratt Arthur G 
Published: April 2024

ObjectiveInternational trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.DesignSystematic review.Data sourcesMedline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.Eligibility criteriaAll studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.Data extraction and synthesisSearch results were independently screened by at least two reviewers and data were extracted into a proforma.Results38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.ConclusionsInternational collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.Open science framework registration numberosf-registrations-yvtjb-v1.
Real-world data evaluating Guy’s rapid diagnostic clinic as an alternate pathway for patients with FIT levels below 10
Authors: Monroy-Iglesias Maria Jose , Martin Sabine , Cargaleiro Carlos , Jones Geraint , Steward Lindsay , Murtagh Colette , Bruno Flaminia , Millwaters Juliet , Schizas Alexis , Watson Harriet , Haire Anna , Haire Kate , Moss Charlotte Louise , Russell Beth , Srirajaskanthan Raj , Van Hemelrijck Mieke , Dolly Saoirse 
Published: April 2024

ObjectiveTo analyse the effectiveness of rapid diagnostic clinics (RDCs) as an alternative pathway for patients with concerning symptoms and a faecal immunochemical test (FIT) result <10. Our primary endpoint was rate of colorectal cancer (CRC) detection. Second endpoints were rates of other cancers and gastrointestinal (GI) serious benign conditions. Finally, we analysed the specific pathway followed by FIT <10 patients with cancer at Guy’s and St Thomas NHS Foundation Trust (GSTT) RDC.DesignA retrospective and prospective cohort study.SettingGSTT RDC, one of England’s largest single-centre RDCs. Sociodemographic and clinical characteristics of FIT <10 patients were analysed descriptively.ParticipantsPatients with an FIT result <10, seen at GSTT RDC between 1 January 2020 and 5 May 2023.ResultsA total of 1299 patients with an FIT<10 were seen at GSTT RDC between January 2020 and May 2023. Of these, 66% (n=861) reported weight loss, 62% (n=805) pain, 37% (n=481) fatigue, 34% (n=444) were anaemic and 23% (n=301) had nausea and vomiting. Among these patients, 7% (n=88) received a cancer diagnosis, 36% (n=462) were identified as having a serious benign condition. Within the patients with cancer, 9% (n=8) were diagnosed with CRC. Among patients with serious benign conditions, 7% (n=31) were referred to colorectal, hepatopancreatobiliary, or upper GI specialists.ConclusionThis study demonstrates the effectiveness of RDCs as an alternate pathway for FIT <10 patients with ongoing clinical concerns. These results contribute to enhancing patient care and optimising resource allocation within the healthcare system.
Cost-effectiveness of a radio intervention to stimulate early childhood development: protocol for an economic evaluation of the SUNRISE trial in Burkina Faso
Authors: Palmer Tom , Clare Abbie , Fearon Pasco , Head Roy , Hill Zelee , Kagone Bassirou , Kirkwood Betty , Manu Alexander , Skordis Jolene 
Published: April 2024

IntroductionApproximately 250 million children under 5 years of age are at risk of poor development in low-income and middle-income countries. However, existing early childhood development (ECD) interventions can be expensive, labour intensive and challenging to deliver at scale. Mass media may offer an alternative approach to ECD intervention. This protocol describes the planned economic evaluation of a cluster-randomised controlled trial of a radio campaign promoting responsive caregiving and opportunities for early learning during the first 3 years of life in rural Burkina Faso (SUNRISEtrial).Methods and analysisThe economic evaluation of theSUNRISEtrial will be conducted as a within-trial analysis from the provider’s perspective. Incremental costs and health outcomes of the radio campaign will be compared with standard broadcasting (ie, ‘do nothing’ comparator). All costs associated with creating and broadcasting the radio campaign during intervention start-up and implementation will be captured. The cost per child under 3 years old reached by the intervention will be calculated. Incremental cost-effectiveness ratios will be calculated for the trial’s primary outcome (ie, incremental cost per SD of cognitive gain). A cost-consequence analysis will also be presented, whereby all relevant costs and outcomes are tabulated. Finally, an analysis will be conducted to assess the equity impact of the intervention.Ethics and disseminationTheSUNRISEtrial has ethical approval from the ethics committees of the Ministry of Health, Burkina Faso, University College London and the London School of Hygiene and Tropical Medicine. The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.Trial registration numberTheSUNRISEtrial was registered with ClinicalTrials.gov on 19 April 2019 (identifier:NCT05335395).
Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA)
Authors: van den Berg Rudolf , den Hartog Floris P J , Bali Christina , Matsagkas Miltiadis , Bevis Paul M , Earnshaw Jonothan J , Debus Eike S , Honig Susanne , Berrevoet Frederik , Detry Olivier , Stabilini Cesare , Muysoms Filip , Tanis Pieter J 
Published: April 2024

IntroductionIncisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.Methods and analysisWe will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.Ethics and disseminationNo new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.PROSPERO registration numberCRD42022347881.
How do people living with obesity who use obesity services perceive healthcare professionals’ representation of the disease on social media? An interpretative phenomenological analysis
Authors: Maher Sean , McHugh Joseph , Crotty Michael , Birney Susie , O’Connell Jean , Finucane Francis , Spooner Muirne 
Published: April 2024

ObjectivesThe objective of this study was to explore how people living with obesity who use obesity services perceive healthcare professionals’ (HCPs) online representation of the disease on social media. By exploring their perspective, we aimed to develop a framework to inform good practice around social media use for HCPs.DesignThis was a qualitative study using a phenomenological framework. Following in-depth semi-structured interviews, analysis was undertaken to identify superordinate themes relating to how HCPs portray living with obesity online.SettingPatient advocacy organisation (The Irish Coalition for People Living with Obesity) and three clinical sites offering obesity treatment in Ireland.Participants15 adult participants comprising of 12 women and 3 men who use social media and are living with obesity and who use obesity services.ResultsThree key themes of how people living with obesity who use obesity services perceive HCP’s online representation of the disease. (1) Negative experiences of HCPs—participants describe encountering weight stigma and bias on social media from HCPs that they characterised as simplistic and outdated conceptualisations. These engender shame, fear and anger. (2) Positive experience of HCPs—participants report social media allows HCPs to educate and inform public perception of obesity. Positive online experiences lead to feelings of inclusion, understanding and encouragement. (3) Expectations of HCPs—qualifications, professional titles and academic association affected the perceived trustworthiness of information and its impact on readers. Participants feel there is a duty of care for HCPs in obesity medicine to advocate and be active online to provide accurate medical information.ConclusionHCP’s use of social media has a powerful impact on people with obesity who use healthcare and obesity services. Social media is a key tool in obesity awareness and education. We propose the ‘3E’ framework—Empower, Evidence-Based and Educate and be educated to guide HCPs’ social media use.
Predictive performance of machine learning compared to statistical methods in time-to-event analysis of cardiovascular disease: a systematic review protocol
Authors: Suliman Abubaker , Masud Mohammad , Serhani Mohamed Adel , Abdullahi Aminu S. , Oulhaj Abderrahim 
Published: April 2024

BackgroundGlobally, cardiovascular disease (CVD) remains the leading cause of death, warranting effective management and prevention measures. Risk prediction tools are indispensable for directing primary and secondary prevention strategies for CVD and are critical for estimating CVD risk. Machine learning (ML) methodologies have experienced significant advancements across numerous practical domains in recent years. Several ML and statistical models predicting CVD time-to-event outcomes have been developed. However, it is not known as to which of the two model types—ML and statistical models—have higher discrimination and calibration in this regard. Hence, this planned work aims to systematically review studies that compare ML with statistical methods in terms of their predictive abilities in the case of time-to-event data with censoring.MethodsOriginal research articles published as prognostic prediction studies, which involved the development and/or validation of a prognostic model, within a peer-reviewed journal, using cohort or experimental design with at least a 12-month follow-up period will be systematically reviewed. The review process will adhere to the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies checklist.Ethics and disseminationEthical approval is not required for this review, as it will exclusively use data from published studies. The findings of this study will be published in an open-access journal and disseminated at scientific conferences.PROSPERO registration numberCRD42023484178.
Using an ecological model of health behaviour to identify factors associated with smoking behaviour among Buddhist novices in Thailand: a cross-sectional digital survey
Authors: Benjakul Sarunya , Nakju Saroj , Thitavisiddho (Wongsai) Wisit , Junjula Thawatchai 
Published: April 2024

ObjectiveBuddhist novices reside in Buddhist temples, which are legally designated as smoke-free areas. Nevertheless, similar to other men in their age group, they are susceptible to various risk factors that lead to smoking. This digital survey aimed to examine tobacco smoking and its associated factors among Buddhist novices in Thailand.DesignA cross-sectional digital survey.Setting88 temple-based schools in Thailand.ParticipantsA stratified two-stage cluster sampling method was employed to select 5371 novices. Data were collected between June and August 2022 using self-administered electronic questionnaires.MeasureDescriptive statistics and multivariable logistic regression analysis were used to identify the associated factors.ResultsOverall, 32.8% of the respondents reported they had tried smoking, and the average age of initiation was 12.4 years. In the past 30 days, 25.7% had smoked any tobacco product. Multiple factors following the ecological model of health behaviour were found to be statistically associated with smoking by 37.3%. Among these were intrapersonal-level factors, such as age, living in the southern region and attempted smoking. Two were interpersonal-level factors: the smoking behaviour of close relatives, specifically parents, and their respected monks. Two were institutional-level factors: perceiving that temple-based schools are smoke-free areas and exposure to secondhand smoke. Three factors at the community and policy levels were noticed tobacco advertising at the point of sale, social media and tobacco promotion.ConclusionThe findings of this study support the development of comprehensive intervention programmes that address the multiple factors to prevent Buddhist novices from smoking.
Identifying carers in general practice (STATUS QUO): a multicentre, cross-sectional study in England
Authors: Lawton Sarah , Mallen Christian , Hussain Zarish , Bajpai Ram , Muller Sara , Holmstrom Cath , Jinks Clare , Helliwell Toby 
Published: April 2024

ObjectivesTo determine General Practice (GP) recording of carer status and the number of patients self-identifying as carers, while self-completing an automated check-in screen prior to a GP consultation.DesignA descriptive cross-sectional study.Setting11 GPs in the West Midlands, England. Recruitment commenced in September 2019 and concluded in January 2020.ParticipantsAll patients aged 10 years and over, self-completing an automated check-in screen, were invited to participate during a 3-week recruitment period.Primary and secondary outcome measuresThe current coding of carers at participating GPs and the number of patients identifying themselves as a carer were primary outcome measures. Secondary outcome measures included the number of responses attained from automated check-in screens as a research data collection tool and whether carers felt supported in their carer role.Results80.3% (n=9301) of patients self-completing an automated check-in screen participated in QUantifying the identification Of carers in general practice (STATUS QUO Study) (62.6% (n=5822) female, mean age 52.9 years (10–98 years, SD=20.3)). Prior to recruitment, the clinical code used to denote a carer was identified in 2.7% (n=2739) of medical records across the participating GPs.10.1% (n=936) of participants identified themselves as a carer. They reported feeling supported with their own health and social care needs: always 19.3% (n=150), a lot of the time 13.2% (n=102), some of the time 40.8% (n=317) and never 26.7% (n=207).ConclusionsMany more participants self-identified as a carer than were recorded on participating GP lists. Improvements in the recording of the population’s caring status need to be actioned, to ensure that supportive implementation strategies for carers are effectively received. Using automated check-in facilities for research continues to provide high participation rates.
The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema – study protocol of a multicentre, randomised sham-controlled trial
Authors: Kleeven Alieske , Jonis Yasmine M J , Tielemans Hanneke , van Kuijk Sander , Kimman Merel , van der Hulst René , Vasilic Dalibor , Hummelink Stefan , Qiu Shan Shan 
Published: April 2024

IntroductionCancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL.Methods and analysisA multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness.Ethics and disseminationThe study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals.Trial registration numberNCT06082349.