bluuebunny/crossref_metadata_2025_split huggingface dataset:
HypoFocal SRT Trial: Ultra-hypofractionated focal salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy; single-arm phase II study; clinical trial protocol
Authors: Mathier Etienne , Althaus Alexander , Zwahlen Daniel , Lustenberger Jens , Zamboglou Constantinos , De Bari Berardino , Aebersold Daniel M , Guckenberger Matthias , Zilli Thomas , Shelan Mohamed 
Published: January 2024

IntroductionDespite radical prostatectomy (RP) and radiotherapy (RT) being established treatments for localised prostate cancer, a significant number of patients experience recurrent disease. While conventionally fractionated RT is still being used as a standard treatment in the postoperative setting, ultra-hypofractionated RT has emerged as a viable option with encouraging results in patients with localised disease in the primary setting. In addition, recent technological advancements in RT delivery and precise definition of isolated macroscopic recurrence within the prostate bed using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multiparametric MRI (mpMRI) allow the exploration of ultra-hypofractionated schedules in the salvage setting using five fractions.Methods and analysisIn this single-arm prospective phase II multicentre trial, 36 patients with node-negative prostate adenocarcinoma treated with RP at least 6 months before trial registration, tumour stage pT2a–3b, R0–1, pN0 or cN0 according to the UICC TNM 2009 and evidence of measurable local recurrence within the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months, will be included. The patients will undergo focal ultra-hypofractionated salvage RT with 34 Gy in five fractions every other day to the site of local recurrence in combination with 6 months of androgen deprivation therapy. The primary outcome of this study is biochemical relapse-free survival at 2 years. Secondary outcomes include acute side effects (until 90 days after the end of RT) of grade 3 or higher based on Common Terminology Criteria for Adverse Events V.5, progression-free survival, metastasis-free survival, late side effects and the quality of life (based on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, QLQ-PR25).Ethics and disseminationThe study has received ethical approval from the Ethics Commission of the Canton of Bern (KEK-BE 2022-01026). Academic dissemination will occur through publications and conference presentations.Trial registration numberNCT05746806.
Clinical evaluation of the reference intervals for diabetes in Chinese geriatric population: a cross-sectional cohort study protocol
Authors: Zhou Chenglong , Li Jun , Wu Xiaochu , Qi Xinhao , Liu Fei 
Published: January 2024

IntroductionDiabetes mellitus (DM) is an important health issue that affects the ageing population. China has the largest geriatric population and the largest number of diabetes cases in the world. This poses a significant challenge for healthcare providers and policymakers. Haemoglobin A1C (HbA1c), which is one of the diagnostic criteria for diabetes, is affected by many factors such as pregnancy, age, race and anaemia. Glycated albumin (GA) is not influenced by factors that affect HbA1c concentrations, although it has been used in the diagnosis of diabetes in a few people. The aim of this study protocol is to determine reference intervals (RIs) of HbA1c and GA for the diagnosis of older adults with diabetes in China and to assess the optimal cut-off values for these parameters from a health economic perspective.Methods and analysisThis cross-sectional survey study will recruit 1278 community-dwelling older adults aged 60–89 in Chengdu City. The data collection process will involve a questionnaire survey, a comprehensive physical examination and the collection of blood samples for laboratory testing. Data analyses will be conducted on the pooled sample and stratified by gender, age or other demographic features if necessary. Rates will be compared using the χ2 test or Fisher test and receiver operating characteristic (ROC) curves will be used to identify the most effective threshold values for HbA1c and GA for diagnosing diabetes among older adults in China.Ethics and disseminationThe study protocol was approved by the ethics review board of the Bioethics Subcommittee of West China Hospital, Sichuan University (Approval No. 1705 in 2022). The study’s results will be disseminated through peer-reviewed journals and scientific conferences.Trial registration numberChiCTR2300070831
We are complex beings: comparison of statistical methods to capture and account for intersectionality
Authors: Levandowski Brooke A , Pro George C , Rietberg-Miller Susan B , Camplain Ricky 
Published: January 2024

ObjectivesIntersectionality conceptualises how different parts of our identity compound, creating unique and multifaceted experiences of oppression. Our objective was to explore and compare several quantitative analytical approaches to measure interactions among four sociodemographic variables and interpret the relative impact of axes of marginalisation on self-reported health, to visualise the potential elevated impact of intersectionality on health outcomes.DesignSecondary analysis of National Epidemiologic Survey on Alcohol and Related Conditions-III, a nationally representative cross-sectional study of 36 309 non-institutionalised US citizens aged 18 years or older.Primary outcome measuresWe assessed the effect of interactions among race/ethnicity, disability status, sexual orientation and income level on a self-reported health outcome with three approaches: non-intersectional multivariate regression, intersectional multivariate regression with a single multicategorical predictor variable and intersectional multivariate regression with two-way interactions.ResultsMultivariate regression with a single multicategorical predictor variable allows for more flexibility in a logistic regression problem. In the fully fitted model, compared with individuals who were white, above the poverty level, had no disability and were heterosexual (referent), only those who were white, above the poverty level, had no disability and were gay/lesbian/bisexual/not sure (LGBQ+) demonstrated no significant difference in the odds of reporting excellent/very good health (aOR=0.90, 95% CI=0.71 to 1.13, p=0.36). Multivariate regression with two-way interactions modelled the extent that the relationship between each predictor and outcome depended on the value of a third predictor variable, allowing social position variation at several intersections. For example, compared with heterosexual individuals, LGBQ+ individuals had lower odds of reporting better health among whites (aOR=0.94, 95% CI=0.93 to 0.95) but higher odds of reporting better health among Black Indigenous People of Color (BIPOC) individuals (aOR=1.13, 95% CI=1.11 to 1.15).ConclusionThese quantitative approaches help us to understand compounding intersectional experiences within healthcare, to plan interventions and policies that address multiple needs simultaneously.
Effect of safety and security equipment on patient and visitor violence towards nurses in multiple public hospitals of China during the COVID-19 pandemic: a retrospective, difference-in-difference analysis
Authors: Hu Yanzhen , Huang Ju , Zhao Dan , Zhang Cheng , Xia Jinghua , Lu Xue-mei 
Published: January 2024

ObjectivesThis study aimed to analyse whether safety and security equipment decreased patient and visitor violence (PVV) towards nurses in the COVID-19 period and quantify to what extent safety and security equipment affects PVV.DesignControlled before and after study and difference-in-difference (DID) analysis.SettingA large hospital medical group, consisting of three public tertiary teaching hospitals, namely, Xinjiekou Branch, Huilongguan Branch and Xinlongze Branch of Beijing Jishuitan Hospital, located in the west and north parts of Beijing, China.ParticipantsA panel of nine departments recruited using two-step sampling method, administered online surveys in 2021 and 2022. A total of 632 eligible nurses participated in the survey in 2021 and 725 eligible nurses in 2022.MeasuresWe assessed impacts of the safety and security equipment on the PVV. The policy had been enacted in June 2020, and the corresponding measures were established after mid-December 2020, and therefore, we use a DID design to evaluate changes in nurses’ PVV incidence. Departments are classified as either department installed or non installed, and nurses are classified based on their department.ResultsWithin the treatment group, the incidence of physical PVV significantly decreased from 13.8% in 2020 to 2.0% in 2021. In the control group, the incidence of physical PVV increased from 0.6% in 2020 to 2.7% in 2021. The application of the safety and security equipment decreased the incidence of physical PVV by 13.93% (95% CI: −23.52% to −4.34%). In contrast, no difference was observed between the treatment and control groups for the incidence of psychological PVV (6.23%, 95% CI: −11.56% to 24.02%) and overall PVV (0.88, 95% CI: −20.90% to 22.66%).ConclusionThe safety and security equipment reduced the incidence of physical PVV towards nurses. For hospital managers in public hospitals, longer-term strategies roadmap for PVV prevention measures are needed to create a more supportive work environment in employees.
Balancing between being the most valuable player (MVP) and passing the ball: a qualitative study of support when living with chronic pain in Sweden
Authors: Lilja Veronica , Wallström Sara , Saarijärvi Markus , Lundberg Mari , Segertoft Vivi-Anne , Ekman Inger 
Published: January 2024

ObjectiveThis study aimed to elucidate the meaning of lived experiences of support from social networks and the healthcare sector in persons with chronic pain.DesignA qualitative, phenomenological hermeneutic method was used to analyse interview data.SettingParticipants were recruited from patient organisations in Sweden.ParticipantsTen (seven women, two men and one non-binary) individuals with chronic musculoskeletal pain were included.FindingsThe meaning of lived experiences of support in persons with chronic pain involves balancing between being the most valuable player (MVP) and passing the ball, meaning balancing between being a capable person and accepting support to be that capable person.ConclusionFor participants who lived with chronic pain, support means balancing between being capable (the MVP) and willing to accept support (passing the ball), which aligns with the concept of person-centred care. Our findings may be useful for policy-makers, managers and clinical professionals when planning and performing care for persons with chronic pain. Future research should focus on how the healthcare sector can create support to enable persons with chronic pain to be the MVP while being able to pass the ball to their social networks and the healthcare sector.
Maternal responsibility and omission of complexity: an exploration of the portrayal of gestational diabetes mellitus in Danish written media
Authors: Eskildsen Fiona Ryom , Davidsen Emma , Sørensen Jane Brandt , Kragelund Nielsen Karoline 
Published: January 2024

ObjectivesGestational diabetes mellitus (GDM) has implications for the future health of both mother and offspring, and there is a risk that mothers are held responsible and blamed for their own and their offspring’s long-term health. The media plays a significant role in shaping public perceptions of health. Therefore, our study aimed to investigate how GDM and women with GDM are portrayed in Danish written media.DesignWe identified written newspaper articles reporting on GDM from 2018 to 2019 and analysed them using thematic network analysis and elements from critical discourse analysis.ResultsIn total, 130 articles were included in the analysis. Four themes emerged: (1) ways of introducing GDM, (2) descriptions of causes and prevention of GDM, (3) descriptions of consequences of GDM and (4) value-laden descriptions of GDM. GDM was often mentioned in relation to other conditions or factors and with lack of differentiation. Maternal responsibility was emphasised via oversimplified descriptions of causal relations, descriptions of individual agency and no emphasis on structural causes and preventive measures. GDM was positioned as resulting in ‘bad pregnancies’ using value-laden wordings.ConclusionWe identified various aspects of how GDM is portrayed in written media. The findings signal the importance of clear, nuanced and respectful communication on GDM, including conveying the complexity of the condition and the role of structural factors.
Home-based management of hypoxaemic COVID-19 patients: design of the Therapy@Home pilot study
Authors: Boeijen Josi A , van de Pol Alma C , van Uum Rick T , Venekamp Roderick P , Smit Karin , Kaasjager Karin A H , van den Broek Robert , Bijsterbosch Wilma , Schoonhoven Lisette , Rutten Frans H , Zwart Dorien L M 
Published: January 2024

IntroductionDuring the COVID-19 pandemic, hospital capacity was strained. Home-based care could relieve the hospital care system and improve patient well-being if safely organised.We designed an intervention embedded in a regional collaborative healthcare network for the home-based management of acutely ill COVID-19 patients requiring oxygen treatment. Here, we describe the design and pilot protocol for the evaluation of the feasibility of this complex intervention.Methods and analysisFollowing a participatory action research approach, the intervention was designed in four consecutive steps: (1) literature review and establishment of an expert panel; (2) concept design of essential intervention building blocks (acute medical care, acute nursing care, remote monitoring, equipment and technology, organisation and logistics); (3) safety assessments (prospective risk analysis and a simulation patient evaluation) and (4) description of the design of the pilot (feasibility) study aimed at including approximately 15–30 patients, sufficient for fine-tuning for a large-scale randomised intervention.Ethics and disseminationAll patients will provide written, informed consent. The study was approved by the Medical Ethics Review Committee of the University Medical Center Utrecht, the Netherlands (protocol NL77421.041.21). The preparatory steps (1–4) needed to perform the pilot are executed and described in this paper. The findings of the pilot will be published in academic journals. If we consider the complex intervention feasible, we aim to continue with a large-scale randomised controlled study evaluating the clinical effectiveness, safety and implementation of the complex intervention.
Swiss cohort on Traumatic Childbirth and Health (SwiTCH): protocol for a prospective, population-based cohort study on parents’ mental health from pregnancy to one year postpartum
Authors: Chanvrier Hélène , Rattaz Valentine , Offredi Valentin , Dupuis Marc , Horsch Antje 
Published: January 2024

IntroductionApproximately 4%–5% of mothers develop childbirth-related post-traumatic stress disorder (CB-PTSD) and approximately 12.3% of mothers develop some CB-PTSD symptoms (CB-PTSS). To date, there is a dearth of studies on fathers and other coparents. Parental CB-PTSD and CB-PTSS may have a negative impact not only on the parents but also on the infant. Understanding risk and protective factors of CB-PTSD for both parents and its consequences on the family is key to detecting or anticipating it, to developing interventions aimed at reducing its detrimental effects and to supporting parents.Methods and analysisThis study protocol describes an observational, population-based study, consisting of a longitudinal prospective cohort with online surveys at four time points. The population of interest consist of women, in the third trimester of pregnancy or at 6–12 weeks postpartum, and their partner/coparent, who will give birth or gave birth in the French-speaking part of Switzerland. The target sample size is 300–500 women and a proportional number of partners. The primary outcome of this study is the prevalence of CB-PTSD and CB-PTSS. The secondary outcomes focus on: (1) the impact of CB-PTSD and CB-PTSS on the marital and coparental relationships, the bonding with the infant, parental burnout and healthcare seeking behaviours, (2) the role of the childbirth experience in the development of CB-PTSD and CB-PTSS and (3) the social and economic determinants of CB-PTSD and CB-PTSS.Ethics and disseminationEthical approval was granted by the human research ethics committee of the Canton de Vaud (study number 2022-00284). All study participants signed an informed consent form. Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media.Trial registration numberNCT05865704.
Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis – a parallel arm, non-randomised feasibility pilot study protocol
Authors: Gill Jasleen Kaur , Pucci Maria , Samudio Ana , Ahmed Tibyan , Siddiqui Rabail , Edwards Nathaniel , Marticorena Rosa M , Donnelly Sandra , Lok Charmaine , Wentlandt Kirsten , Wolofsky Kayla , Mucsi Istvan 
Published: January 2024

IntroductionPatients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis.Methods and analysisThis is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach.Ethics and disseminationEthical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings.Protocol version4 (16 November 2022).Trial registration numberNCT05515991.
Designing a Library of Lived Experience for Mental Health: integrated realist synthesis and experience-based co-design study in UK mental health services
Authors: Marshall Paul , Barbrook John , Collins Grace , Foster Sheena , Glossop Zoe , Inkster Clare , Jebb Paul , Johnston Rose , Jones Steven H , Khan Hameed , Lodge Christopher , Machin Karen , Michalak Erin , Powell Sarah , Russell Samantha , Rycroft-Malone Jo , Slade Mike , Whittaker Lesley , Lobban Fiona 
Published: January 2024

ObjectiveLiving Library events involve people being trained as living ‘Books’, who then discuss aspects of their personal experiences in direct conversation with attendees, referred to as ‘Readers’. This study sought to generate a realist programme theory and a theory-informed implementation guide for a Library of Lived Experience for Mental Health (LoLEM).DesignIntegrated realist synthesis and experience-based co-design.SettingTen online workshops with participants based in the North of England.ParticipantsThirty-one participants with a combination of personal experience of using mental health services, caring for someone with mental health difficulties and/or working in mental health support roles.ResultsDatabase searches identified 30 published and grey literature evidence sources which were integrated with data from 10 online co-design workshops conducted over 12 months. The analysis generated a programme theory comprising five context-mechanism-outcome (CMO) configurations. Findings highlight how establishing psychological safety is foundational to productive Living Library events (CMO 1). For Readers, direct conversations humanise others’ experiences (CMO 2) and provide the opportunity to flexibly explore new ways of living (CMO 3). Through participation in a Living Library, Books may experience personal empowerment (CMO 4), while the process of self-authoring and co-editing their story (CMO 5) can contribute to personal development. This programme theory informed the co-design of an implementation guide highlighting the importance of tailoring event design and participant support to the contexts in which LoLEM events are held.ConclusionsThe LoLEM has appeal across stakeholder groups and can be applied flexibly in a range of mental health-related settings. Implementation and evaluation are required to better understand the positive and negative impacts on Books and Readers.Trial registration numberPROSPERO CRD42022312789.
Early-life diet and risk of inflammatory bowel disease: a pooled study in two Scandinavian birth cohorts
Authors: Guo Annie , Ludvigsson Johnny , Brantsæter Anne Lise , Klingberg Sofia , Östensson Malin , Størdal Ketil , Mårild Karl 
Published: January 2024

ObjectiveWe assessed whether early-life diet quality and food intake frequencies were associated with subsequent IBD.DesignProspectively recorded 1-year and 3-year questionnaires in children from the All Babies in Southeast Sweden and The Norwegian Mother, Father and Child Cohort Study were used to assess diet quality using a Healthy Eating Index and intake frequency of food groups. IBD was defined as >2 diagnoses in national patient registers. Cox regression yielded HRs adjusted (aHRs) for child’s sex, parental IBD, origin, education level and maternal comorbidities. Cohort-specific results were pooled using a random-effects model.ResultsDuring 1 304 433 person-years of follow-up, we followed 81 280 participants from birth through childhood and adolescence, whereof 307 were diagnosed with IBD. Compared with low diet quality, medium and high diet quality at 1 year of age were associated with a reduced risk of IBD (pooled aHR 0.75 (95% CI=0.58 to 0.98) and 0.75 (95% CI=0.56 to 1.00)). The pooled aHR per increase of category was 0.86 (0.74 to 0.99). Pooled aHR for children 1 year old with high versus low fish intake was 0.70 (95% CI=0.49 to 1.00) for IBD, and showed association with reduced risk of UC (pooled aHR=0.46; 95% CI=0.21, 0.99). Higher vegetable intake at 1 year was associated with a risk reduction in IBD. Intake of sugar-sweetened beverages was associated with an increased risk of IBD. Diet quality at 3 years was not associated with IBD.ConclusionIn this Scandinavian birth cohort, high diet quality and fish intake in early life were associated with a reduced risk of IBD.