bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparing the effectiveness and cost-effectiveness of text-message reminders and telephone patient navigation to improve the uptake of faecal immunochemical test screening among non-responders in London: a randomised controlled trial protocol
Authors: Duffy Thomas , Gil Natalie , Siddique Benzeer , Duffy Stephen , Prentice Andrew , Marshall Sarah , Djedovic Natasha K , Lewis Michael , Ruwende Josephine , von Wagner Christian , Kerrison Robert 
Published: June 2024

IntroductionParticipation in bowel cancer screening is lower in regions where there is high ethnic diversity and/or socioeconomic deprivation. Interventions, such as text message reminders and patient navigation (PN), have the potential to increase participation in these areas. As such, there is interest in the comparative effectiveness of these interventions to increase bowel cancer screening participation, as well as their relative cost-effectiveness.Methods and analysisThis study will use a three-arm randomised controlled trial design to compare the effectiveness and cost-effectiveness of text message reminders and PN to increase the uptake of bowel cancer screening in London. Participants will be individuals who have not returned a completed faecal immunochemical test kit within 13 weeks of receiving a routine invitation from the London bowel cancer screening hub. Participants will be randomised (in a 1:1:1 ratio) to receive either (1) usual care (ie, ‘no intervention’), (2) a text message reminder at 13 weeks, followed by repeated text message reminders at 15, 17 and 19 weeks (in the event of non-response) or (3) a text message reminder at 13 weeks, followed by PN telephone calls at 15, 17 and 19 weeks in the event of non-response. The primary endpoint will be participation in bowel cancer screening, defined as ‘the return of a completed kit by week 24’. Statistical analysis will use multivariate logistic regression and will incorporate pairwise comparisons of all three groups, adjusted for multiple testing.Ethics and disseminationApprovals to conduct the research have been obtained from University College London’s Joint Research Office (Ref: 150666), the Screening Research, Innovation and Development Advisory Committee (‘RIDAC’, Ref: 2223 014 BCSP Kerrison), the Health Research Authority (Ref: 22/WM/0212) and the Confidentiality Advisory Group (Ref: 22/CAG/0140). Results will be conveyed to stakeholders, notably those managing the screening programme and published in peer-reviewed journals/presented at academic conferences.Trial registration numberISRCTN17245519
Promotive and protective effects of community-related positive childhood experiences on adult health outcomes in the context of adverse childhood experiences: a nationwide cross-sectional survey in Japan
Authors: Mitani Haruyo , Kondo Naoki , Amemiya Airi , Tabuchi Takahiro 
Published: June 2024

ObjectiveAlthough adverse childhood experiences (ACEs) are associated with poor health in adulthood, positive childhood experiences (PCEs) can reduce the risk of negative health outcomes. This study aimed to investigate whether PCEs in the community (CPCEs, ie, trusted adults other than parents, supportive friends, belongingness to school, or community traditions) would have an independent effect on better health outcomes and moderate the association between ACEs and adult illnesses.DesignCross-sectional survey.SettingData were gathered from a nationwide, cross-sectional internet survey conducted in Japan in 2022.ParticipantsThis study included 28 617 Japanese adults aged 18–82 years (51.1% female; mean age=48.1 years).Primary and secondary outcome measuresThe associations among self-reported ACEs, CPCEs before the age of 18 years and current chronic diseases (eg, cancer and depression) were investigated using multivariable logistic regression models.ResultsCPCEs were associated with lower odds of adult diseases (such as stroke, chronic obstructive pulmonary disease (COPD), chronic pain, depression, suicidal ideation and severe psychological distress) after adjusting for ACEs. More CPCEs weakened the association between ACEs and adult diseases. Specifically, among those with ACEs, ≥3 CPCEs (vs 0–2 CPCEs) lowered the adjusted prevalence by ≥50% for stroke (2.4% to 1.2%), COPD (2.2% to 0.7%) and severe psychological distress (16.4% to 7.4%).ConclusionCPCEs could reduce ACE-related risk of poor physical and mental health in later life. Early-life interventions that enhance PCEs in schools and/or neighbourhoods are recommended.
Improving diagnostic of cervical dysplasia among postmenopausal women aged ≥50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study)
Authors: Bertelsen Vibe Munk , Tranberg Mette , Petersen Lone Kjeld , Booth Berit , Bor Pinar 
Published: June 2024

IntroductionColposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal women, as the majority will have a non-visible transformation zone, resulting in increased risk of missing disease, a diagnostic cone biopsy and prolonged follow-up with repeated colposcopies. This study will be among the first to investigate, if treatment with vaginal oestrogen prior to colposcopy will improve the colposcopy performance, to ensure accurate and timely diagnosis of precancerous cervical lesions among postmenopausal women.Methods and analysisA randomised blinded controlled multicentre study. Enrolment will be performed at gynaecology departments in Central Denmark Region and Region of Southern Denmark. A total of 150 postmenopausal women aged ≥50 years referred for colposcopy due to abnormal cervical screening results will be randomised 1:1 to either pretreatment with vaginal application of Vagifem 30 µg or placebo once a day for 14 days prior to colposcopy. The primary outcome will be to compare the percentage of women in the two groups with a visible transformation zone at colposcopy, and biopsies representative of the transformation zone. Secondary outcomes will be the proportion of detected cervical intraepithelial neoplasia grade 2 or higher in the cervical biopsies; the proportion of diagnostics cone biopsies; the patients’ report on possible side effects and compliance to the pretreatment.Ethics and disseminationThe study has been approved by the Central Denmark Region Committee on Biomedical Research Ethics (1-10-72-34-22), the Central Denmark Regions’ Research Unit (1-16-02-72-22) and The Danish Health Authority (Danish Medicine Agency; 2022015030). The study’s EudraCT number is (1-23-456; 2022-000269-42) and it is registered onwww.clinicaltrials.gov. The local Good Clinical Practice (GCP) unit will supervise and monitor the study closely before, during and after the study period. Findings will be disseminated in peer-reviewed scientific journals and presented in relevant conferences.Trial registration numberNCT05283421.
Feasibility and acceptability of general practitioners using sit–stand desks: a feasibility trial
Authors: Biddle Gregory James Hamilton , Thomas Nicholas , Edwardson Charlotte L , Clemes Stacy A , Daley Amanda J 
Published: June 2024

ObjectivesThe primary aim of this study was to investigate the feasibility and acceptability of general practitioners (GPs) using sit–stand desks to facilitate standing during consultations. A further aim was to examine the views of patients about GPs standing for their consultations.DesignA pre–post single-group experimental trial design.SettingGeneral practices in England, UK.Participants42 GPs (working a minimum of five clinical sessions per week) and 301 patients (aged ≥18 years).InterventionsThe intervention consisted of each GP having a sit–stand desk (Opløft Sit-Stand Platform) installed in their consultation room for 4 working weeks. Sit–stand desks allow users to switch, in a few seconds, between a sitting and standing position and vice versa, by adjusting the height of the desk.Main outcome measuresTo test feasibility and acceptability, GPs reported their views about using sit–stand desks at work at baseline and follow-up. Sitting time and physical activity were also measured via accelerometer at baseline and follow-up. Patients who attended a consultation where their GP was standing were asked to complete an exit questionnaire about the perceived impact on the consultation.ResultsMost GPs reported using their sit–stand desk daily (n=28, 75.7%). 16 GPs (44.4%) used their sit–stand desk during face-to-face consultations every day. Most GPs and patients did not view that GPs standing during face-to-face consultations impacted the doctor–patient relationship (GPs; 73.5%, patients; 83.7%). GPs’ sitting time during work was 121 min per day lower (95% CI: −165 to −77.58) at follow-up compared with baseline.ConclusionsUse of sit–stand desks is acceptable within general practice and may reduce sitting time in GPs. This may benefit GPs and help reduce sitting time in patients.Trial registration numberISRCTN76982860.
PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations (the PERISCOPE trial) – a study protocol for a pragmatic, UK multicentre, superiority randomised controlled trial with an internal pilot, economic evaluation and nested qualitative study
Authors: Brady Samantha , Mott Andrew , Carlisle Katie , Abhishek Abhishek , Adamson Joy , Coates Laura , van Duren Bernard , Emery Paul , Goodman Susan Marion , Hewitt Catherine , Li Jinshuo , Mandefield Laura , Parkinson Gillian , Marzo-Ortega Helena , Maxwell James , Nanchahal Jagdeep , Rangan Amar , Richards Duncan , Ronaldson Sarah , Shepherd Susan , Taylor Johanna , Wilkinson Jeremy Mark , Pandit Hemant , Mankia Kulveer Singh 
Published: June 2024

IntroductionBiological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT).Methods and analysisPERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients’ and clinicians’ acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively.Ethics and disseminationEthical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period.Trial registration numberISRCTN17691638.
Sexual health services for adolescents on Reunion Island: results from a descriptive interview-based study
Authors: Reynaud Danielle , Laboureur Estelle , Marimoutou Catherine , Cartron Emmanuelle 
Published: June 2024

ObjectivesTo describe the experiences of sexual health services available for adolescents aged 15–19 years on Reunion Island.DesignA qualitative descriptive study was conducted from 3 December 2022 to 24 October 2023. Data were analysed using the phenomenological interpretative method.SettingCentre Hospitalier Universitaire of Reunion Island.Participants15 participants were recruited through convenience sampling, but 3 of them did not attend the interviews.InterventionsFace-to-face or videoconferencing open-ended individual interviews.Primary and secondary outcome measuresBarriers and facilitators to access sexual health services, relationship between adolescents and healthcare professionals when using these services and suggestions made by adolescents for improving access to care and quality of care.ResultsIn total, 12 adolescents were included with most being female (11 with a mean age of 18 years). Most interviewees were in a relationship, lived in urban areas and had sexual intercourse (nine, respectively). Participants attended high school, university and preparatory college (four, respectively). Most interviews were face to face (11). The mean duration of the interviews was 32 min. Two themes revealing the experiences of sexual health services emerged. Participants described maintaining sexual health as a difficult journey in their quest for information about sexual health and the available services provided. Participants demonstrated that they had the ability to cope with the consequences of unprotected sex.ConclusionsTo date, sexual health services available on Reunion Island may not meet the needs of adolescents. Implementation of a strategy aimed at providing young people with skills, addressing their needs and working with them in a collaborative manner may be necessary. Appropriate teaching methods and the training of healthcare professionals should also be considered.
When medical assistance in dying is not a last resort option: survey of the Canadian public
Authors: Choi William J W , Astrachan Isabel Marie , Sinaii Ninet , Kim Scott Yung Ho 
Published: June 2024

ObjectivesWhat are the Canadian public’s understanding of and views toward medical assistance in dying (MAID) in persons refusing recommended treatment or lacking access to standard treatment or resources?Design/settingAn online survey assessed knowledge of and support for Canadian MAID law, and views about four specific scenarios in a two (medical or psychiatric) by two (treatment refusal or lack of access) design.ParticipantsA quota sample (N=2140) matched to the 2021 Canadian census by age, gender, income, education and province.Main outcomesParticipants’ level of support for MAID in general and in the four specific scenarios.ResultsOnly 12.1% correctly answered ≥4 of 5 knowledge questions about the MAID law; only 19.2% knew terminal illness is not required and 20.2% knew treatment refusal is compatible with eligibility. 73.3% of participants expressed support for the MAID law in general, matching a nationally representative poll that used the same question. 40.4% of respondents supported MAID for mental illnesses. Support for MAID in the scenarios depicting refusal or lack of access to treatment ranged from 23.2% (lack of access in medical condition) to 32.0% (treatment refusal in medical illness). Older age, more education, higher income, lower religious attendance or being white was associated with greater support for MAID in general but was either negatively associated or not associated with support for MAID in the four refusal or lack of access scenarios.ConclusionsMost Canadians support the current MAID law but appear unaware that MAID cases they do not support are compatible with that law. The lower support for MAID in the four scenarios cuts across sociodemographics. The gap between current policy and public opinion warrants further study. For jurisdictions debating MAID, opinion surveys may need to go beyond assessing general attitudes, and target knowledge and views regarding implications of legalisation.
Epidemiology and morbidity of spina bifida in Hispanic Americans: a systematic review
Authors: Abdelmageed Sunny , Votoupal Megan , Lam Sandi K , Garcia Roxanna M 
Published: June 2024

ObjectiveTo comprehensively describe the epidemiology and morbidity of spina bifida in Hispanic Americans and identify risk factors associated with the increased prevalence of spina bifida.DesignA systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Data sourcesThree databases (MEDLINE, Embase and Scopus) were searched between inception of the database and June 2023. Study designs included case–control, descriptive, cross-sectional and databases.Eligibility criteriaObservational and experimental analytical studies reporting epidemiology or morbidity of spina bifida in Hispanic Americans or Latinx individuals were eligible.Data extraction and synthesisData were extracted independently by authors. Descriptive analysis was used to summarise findings.ResultsOf 392 publications, 32 studies met inclusion criteria. Study periods ranged from 1955 to 2020. A total of 50 382 patients with spina bifida were included and 13 209 identified as Hispanic American (26.2%). Five studies report higher prevalence of spina bifida at birth per 10 000 births in Hispanic Americans compared with non-Hispanic white individuals, while one reported no significant difference (2.11 vs 2.24). Risk factors associated with spina bifida included prenatal exposures, sociodemographic factors and maternal clinical characteristics. Lower levels of maternal education, age and income were associated with an increased risk of spina bifida. Eleven papers found spina bifida had high morbidity among Hispanic Americans resulting in high financial, physical and socioeconomic impacts. There was high study heterogeneity that can be explained by the varying time periods and geographical distribution.ConclusionIncreased prevalence and morbidity of spina bifida in Hispanic Americans are due to a variety of inter-related factors relating to existing health disparities. High heterogeneity across the studies suggests a need for future studies and increased standardisation of reporting guidelines.
Gut microbiota signatures of vulnerability to food addiction in mice and humans
Authors: Samulėnaitė Solveiga , García-Blanco Alejandra , Mayneris-Perxachs Jordi , Domingo-Rodríguez Laura , Cabana-Domínguez Judit , Fernàndez-Castillo Noèlia , Gago-García Edurne , Pineda-Cirera Laura , Burokas Aurelijus , Espinosa-Carrasco Jose , Arboleya Silvia , Latorre Jessica , Stanton Catherine , Hosomi Koji , Kunisawa Jun , Cormand Bru , Fernández-Real Jose Manuel , Maldonado Rafael , Martín-García Elena 
Published: June 2024

Objective
Food addiction is a multifactorial disorder characterised by a loss of control over food intake that may promote obesity and alter gut microbiota composition. We have investigated the potential involvement of the gut microbiota in the mechanisms underlying food addiction.

Design
We used the Yale Food Addiction Scale (YFAS) 2.0 criteria to classify extreme food addiction in mouse and human subpopulations to identify gut microbiota signatures associated with vulnerability to this disorder.

Results

Both animal and human cohorts showed important similarities in the gut microbiota signatures linked to food addiction. The signatures suggested possible non-beneficial effects of bacteria belonging to the Proteobacteria phylum and potential protective effects of Actinobacteria against the development of food addiction in both cohorts of humans and mice. A decreased relative abundance of the species
Blautia wexlerae
was observed in addicted humans and of
Blautia
genus in addicted mice. Administration of the non-digestible carbohydrates, lactulose and rhamnose, known to favour
Blautia
growth, led to increased relative abundance of
Blautia
in mice faeces in parallel with dramatic improvements in food addiction. A similar improvement was revealed after oral administration of
Blautia wexlerae
as a beneficial microbe.

Conclusion
By understanding the crosstalk between this behavioural alteration and gut microbiota, these findings constitute a step forward to future treatments for food addiction and related eating disorders.
APOLLO: neo-adjuvant pembrolizumab for primary vulvar squamous cell carcinoma—a multicenter, single-arm, phase II, clinical proof-of-concept study
Authors: van Poelgeest M I E , Kortekaas Kim E , van Doorn Helena C , Oonk Maaike , Nijman Hans W , Boere Ingrid , Eerkens Anneke L , Reyners Anna K L , Ewing-Graham Patricia C , Bart Joost , Bosse Tjalling , Welters Marij J P , Kroep Judith R , van der Burg Sjoerd H 
Published: June 2024

BackgroundVulvar squamous cell carcinoma (VSCC) is a rare cancer for which the cornerstone of treatment is surgery with high complication rates. The unmet need is a less radical and more effective treatment for VSCC.Primary ObjectivesTo investigate the impact of mono-immunotherapy pembrolizumab as neoadjuvant treatment for primary resectable VSCC patients.Study HypothesisSome primary VSCC patients display a specific immune profile which is associated with better survival. In other tumors, this profile is associated with a better response to programmed cell death protein 1 (PD-1) checkpoint blockade which may reinvigorate tumor-specific T cells. This potentially results in a reduced tumor load and less radical surgery and/or adjuvant treatment in patients with this immune profile.Trial DesignThis is an investigator-initiated, prospective, single arm, multicenter, phase II clinical trial.Inclusion CriteriaPatients with VSCC clinical stage International Federation of Gynecology and Obstetrics (FIGO) I-III (2021) eligible for primary surgery, with at least one measurable lesion of at least one dimension ≥10 mm in the largest diameter, are included in this study.Main Exclusion CriteriaPatients not suitable for surgery and/or previously treated with immunomodulatory agents, and/or who suffer from comorbidities that may interfere with PD-1 blockade, are excluded from the study.EndpointsThe clinical efficacy of neoadjuvant pembrolizumab in VSCC is measured by an objective change in tumor size according to the Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) and documented by calipers using standardized digital photography with a reference ruler. In addition, the activation, proliferation, and migration of T cells in the tumor will be studied. The secondary endpoints are pathological complete responses at the time of surgery, feasibility, and safety.Sample Size40 patients with FIGO I-III (2021) primary VSCC will be enrolled.Estimated Dates for Completing Accrual and Presenting ResultsThe intervention phase started in July 2023 and will continue until July 2025. The expected completion of the entire study is July 2026.Trial Registration NumberNCT05761132