bluuebunny/crossref_metadata_2025_split huggingface dataset:
Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial
Authors: Lehtinen Matti , Lagheden Camilla , Luostarinen Tapio , Eriksson Tiina , Apter Dan , Bly Anne , Gray Penelope , Harjula Katja , Heikkilä Kaisa , Hokkanen Mari , Karttunen Heidi , Kuortti Marjo , Nieminen Pekka , Nummela Mervi , Paavonen J , Palmroth Johanna , Petäjä Tiina , Pukkala Eero , Soderlund-Strand Anna , Veivo Ulla , Dillner Joakim 
Published: December 2021

BackgroundHuman papillomavirus (HPV) vaccination protects against HPV, a necessary risk factor for cervical cancer. We now report results from population-based follow-up of randomised cohorts that vaccination provides HPV-type-specific protection against invasive cancer.MethodsIndividually and/or cluster randomised cohorts of HPV-vaccinated and non-vaccinated women were enrolled in 2002–2005. HPV vaccine cohorts comprised originally 16–17 year-old HPV 16/18-vaccinated PATRICIA (NCT00122681) and 012 trial (NCT00169494) participants (2465) and HPV6/11/16/18-vaccinated FUTURE II (NCT00092534) participants (866). Altogether, 3341 vaccines were followed by the Finnish Cancer Registry in the same way as 16 526 non-HPV-vaccinated controls. The control cohort stemmed from 15 665 originally 18–19 years-old women enrolled in 2003 (6499) or 2005 (9166) and 861 placebo recipients of the FUTURE II trial. The follow-up started 6 months after the clinical trials in 2007 and 2009 and ended in 2019. It was age aligned for the cohorts.FindingsDuring a follow-up time of up to 11 years, we identified 17 HPV-positive invasive cancer cases (14 cervical cancers, 1 vaginal cancer, 1 vulvar cancer and 1 tongue cancer) in the non-HPV-vaccinated cohorts and no cases in the HPV-vaccinated cohorts. HPV typing of diagnostic tumour blocks found HPV16 in nine cervical cancer cases, HPV18, HPV33 and HPV52 each in two cases and HPV45 in one cervical cancer case. The vaginal, vulvar and tongue cancer cases were, respectively, positive for HPV16, HPV52/66 and HPV213. Intention-to-treat vaccine efficacy against all HPV-positive cancers was 100% (95% CI 2 to 100, p<0.05).InterpretationVaccination is effective against invasive HPV-positive cancer.Trial registration numberNCT00122681, Post-results;NCT00169494, Post-results;NCT00092534, Post-results.
Serious game to promote socioemotional learning and mental health (emoTIC): a study protocol for randomised controlled trial
Authors: De la Barrera Usue , Postigo-Zegarra Silvia , Mónaco Estefanía , Gil-Gómez José-Antonio , Montoya-Castilla Inmaculada 
Published: December 2021

IntroductionThe development of emotional competences may be a protective factor for mental health problems, promoting well-being at such a complex age as adolescence. Technologies may be used to carry out this empowerment because adolescents are attracted to them. The purpose of the study is to design a serious game based on the Mayeret al’s emotional intelligence ability model and analyse the effectiveness of theemoTICprogramme to develop emotional competences, well-being, mental health, and personal strengths immediately after completion and at 12 months.Methods and analysisThe new version ofemoTICwill be designed following the suggestions of the adolescents who participated in the pilot study and the results obtained from the statistical analysis. The participants will be 385 adolescents aged 11–16 years who will be randomly assigned to the control group and the experimental group. The experimental group will complete theemoTICprogramme. The primary outcomes include emotional competences and subjective well-being. The secondary outcomes are self-esteem; general self-efficacy; personality; social and personal responsibility; school social climate; somatic complaints; depression, anxiety and stress symptoms; emotional and behavioural difficulties; suicidal behaviour; and subjective happiness. Data will be collected at three moments: baseline (T1), immediately post-intervention (T2) and 12-month follow-up (T3). The effectiveness of the programme will be analysed using different statistical packages.Ethics and disseminationThe study has been approved by the Ethics Commission of the University of Valencia (H152865096049), and the standards of the Declaration of Helsinki to collect the data will be followed. Results will be disseminated across the scientific community.Trial registration numberClinicalTrials.gov Registry (NCT04414449).Trial sponsorUniversity of Valencia. Principal investigator: Inmaculada Montoya-Castilla.
More GP contacts and poorer health of informal caregivers with low socioeconomic status in Germany: results from the population-based DEGS1 and the cross-sectional GPCare-1 study
Authors: Gavrilov Boris , Schmidt Manuela , Kasten Stefanie , Sommer Samira , Hunzelar Carmen , Bockheim Florian , Paños-Willuhn Joana , Offenberg Luisa , Oberholz Maja , Ikar Nur , Weltermann Birgitta 
Published: December 2021

ObjectivesInformal caregivers are known to have poorer mental health. Risk factors for caregiver burden include low education, female gender, cohabitation with the care recipient and lack of resources. General practitioners (GPs) have an important role in supporting caregivers. Drawing on data from two surveys, associations between caregivers’ socioeconomic status (SES), psychophysical health and GP contacts are analysed.DesignCross-sectional study. The study draws on data from two surveys (German Health Interview and Examination Survey for Adults, DEGS1 and General Practice Care-1, GPCare-1).SettingGermany.ParticipantsDEGS1: German general population (18+ years) n=7987. GPCare-1: general practice patients (18+ years) n=813.Primary outcomePsychophysical health, GP contacts and communication.MethodsUsing representative DEGS1 data, the prevalence of informal caregivers, caregivers’ burden, chronic stress, various health conditions and frequency of GP contacts were evaluated stratified by SES. Data from the GPCare-1 study addressed caregivers’ experiences and communication preferences with GPs.ResultsIn the DEGS1, the prevalence of caregivers was 6.5%. Compared with non-caregivers, caregivers scored significantly higher for chronic stress (15.45 vs 11.90), self-reported poor health (37.6% vs 23.7%) and GP visits last year (3.95 vs 3.11), while lifestyle and chronic diseases were similar. Compared with caregivers with medium/high SES, those with low SES had a significantly lower prevalence of high/medium caregiver burden (47.9% vs 67.7%) but poorer self-reported health (56.9% vs 33.0%), while other characteristics did not differ. In the GPCare-1 study, the prevalence of caregivers was 12.6%. The majority of them felt that their GP takes their problems seriously (63.6%) without difference by SES.ConclusionCaregivers with low SES constitute an especially high-risk group for psychological strain, requiring special GP attention to support their needs.
Target and actual sample sizes for studies from two trial registries from 1999 to 2020: an observational study
Authors: Barnett Adrian Gerard , Glasziou Paul 
Published: December 2021

ObjectivesTo investigate differences between target and actual sample sizes, and what study characteristics were associated with sample sizes.DesignObservational study.SettingThe large trial registries of clinicaltrials.gov (starting in 1999) and ANZCTR (starting in 2005) through to 2021.ParticipantsOver 280 000 interventional studies excluding studies that were withheld, terminated for safety reasons or were expanded access.Main outcome measuresThe actual and target sample sizes, and the within-study ratio of the actual to target sample size.ResultsMost studies were small: the median actual sample sizes in the two databases were 60 and 52. There was a decrease over time in the target sample size of 9%–10% per 5 years, and a larger decrease of 18%–21% per 5 years for the actual sample size. The actual-to-target sample size ratio was 4.1% lower per 5 years, meaning more studies (on average) failed to hit their target sample size.ConclusionRegistered studies are more often under-recruited than over-recruited and worryingly both target and actual sample sizes appear to have decreased over time, as has the within-study gap between the target and actual sample size. Declining sample sizes and ongoing concerns about underpowered studies mean more research is needed into barriers and facilitators for improving recruitment and accessing data.
Association between haemorrhoids and Graves’ disease: a retrospective cohort study using data from Taiwan’s Longitudinal Health Insurance Database
Authors: Zhong Shang-Rong , Chen Hsin-Hung , Liao Chun-Cheng , Su Chun-Hung , Yip Hei-Tung , Kao Chia-Hung 
Published: December 2021

ObjectiveTo evaluate the relationship between haemorrhoids and Graves’ disease (GD).SettingUsing the nationwide data from Taiwan’s Longitudinal Health Insurance Database.ParticipantsWe conducted a retrospective study, stratified patients by International Classification of Diseases, Ninth Revision, Clinical Modification disease code and compared the incidence rate of GD between patients with and without haemorrhoids. The study period was from 2000 to 2010, with exclusion of patients with diagnosed haemorrhoids before 2000 or after 2009, and we analysed the HR of GD in the univariable and multivariable models as well as the cumulative incidence curves of GD by using Kaplan-Meier curves.ResultThis study included 13 165 and 52 660 patients with and without haemorrhoids, respectively. The mean follow-up duration was approximately 6 years. The incidence rate of GD was 1.57 and 1.13 per 1000 person-years in patients with and without haemorrhoids, respectively. The area under the cumulative incidence curve of GD in patients with haemorrhoids was higher than that of patients without haemorrhoids. The risk of GD increased by 1.39 times (95% CI 1.13 to 1.71) in patients with haemorrhoids compared with patients without haemorrhoids. In the subgroup analysis, women with haemorrhoids had a higher risk of GD (adjusted HR 1.44; 95% CI 1.13 to 1.83). Patients with haemorrhoids aged 30–39 years were more likely to develop GD (adjusted HR 1.73; 95% CI 1.18 to 2.55).ConclusionThe findings of this study indicate that patients with haemorrhoids may have an increased risk of GD compared with other potential confounding factors.
Effects of artificial intelligence-SsupporTed Automated NutRiTional Intervention on LDL cholesterol Control in Patients with Familial Hypercholesterolaemia (iSTART-FH): protocol for a randomised controlled trial
Authors: Tada Hayato , Okada Hirofumi , Nomura Akihiro , Usui Soichiro , Sakata Kenji , Hayashi Kenshi , Fujino Noboru , Yasugi Ayaka , Takahara Shizuko , Imai Yasuhito , Takamura Masayuki , Kawashiri Masa-aki 
Published: December 2021

IntroductionFamilial hypercholesterolaemia (FH) is an autosomal dominant inherited genetic disease that has an extremely elevated cardiovascular risk because of their significantly elevated low-density lipoprotein (LDL) cholesterol. Nutritional intervention is needed in improving LDL cholesterol control in patients with FH but requires a considerable burden in manpower. Artificial intelligence (AI)-supported and mobile-supported nutritional intervention using this technique may be an alternative approach to traditional nutritional counselling in person. This study aims to test the hypothesis that AI-supported nutritional counselling is more effective in reducing LDL cholesterol than the in-person, face-to-face method in terms of improving LDL cholesterol control in patients with FH.Methods and analysisThis is a single-centre, unblinded, cross-over, randomised controlled study comparing the efficacy of AI-supported automated nutrition therapy with that of conventional human nutrition counselling in patients with FH. Patients with FH are recruited and randomly assigned to AI-supported nutrition counselling (n=30) and to face-to face nutrition counselling (n=30). We are using an Asken, a mobile application that has been specially modified for this study so that it follows the recommendations by the Japan Atherosclerosis Society. We started patient recruitment on 1 September 2020, and is scheduled to continue until 31 December 2022.Ethics and disseminationThis study is being conducted in compliance with the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and all other applicable laws and guidelines in Japan. The study protocol was approved by the Institutional Review Board of Kanazawa University on 13 April 2020 (IRB no. 2623-3); all recruited patients are required to provide written informed consent. We will disseminate the final results at international conferences and in a peer-reviewed journal.Trial registration numberUMIN000040198.
Opening closed doors: using machine learning to explore factors associated with marital sexual violence in a cross-sectional study from India
Authors: McDougal Lotus , Dehingia Nabamallika , Bhan Nandita , Singh Abhishek , McAuley Julian , Raj Anita 
Published: December 2021

ObjectivesSexual violence against women is pervasive in India. Most of this violence is experienced in the context of marriage, and rates of marital sexual violence (MSV) have been relatively stagnant over the past decade. This paper machine learning algorithms paired with qualitative thematic analysis to identify new and potentially modifiable factors influencing MSV in India.Design, setting and participantsThis cross-sectional analysis of secondary data used data from in-person interviews with ever-married women aged 15–49 who responded to gender-based violence questions in the nationally representative 2015–2016 National Family Health Survey (N=66 013), collected between 20 January 2015 and 4 December 2016. Analyses included iterative thematic analysis (L-1 regularised regression followed by iterative qualitative thematic coding of L-2 regularised regression results) and neural network modelling.Outcome measureParticipants reported their experiences of sexual violence perpetrated by their current (or most recent) husband in the previous 12 months. These responses were aggregated into any vs no recent MSV.ResultsNearly 7% of women experienced MSV in the past 12 months. Major themes associated with MSV through iterative thematic analysis included experiences of/exposure to violence, sexual behaviour, decision making and freedom of movement, sociodemographics, access to media, health knowledge, health system interaction, partner control, economic agency, reproductive and maternal history, and health status. A neural network model identified variables that largely corresponded to these themes.ConclusionsThis analysis identified several themes that may be promising avenues to identify and support women experiencing MSV, and to mitigate these traumatic experiences. In particular, amplifying screening activities at health encounters, especially among women who appear to have compromised health or restricted agency, may enable a greater number of women access to essential physical and emotional support services, and merits further consideration.
Lived experiences of healthcare workers on the front line during the COVID-19 pandemic: a qualitative interview study
Authors: Grailey Kate , Lound Adam , Brett Stephen 
Published: December 2021

ObjectivesThis study aimed to investigate the presence of perceived stressors, psychological safety and teamwork in healthcare professionals. As the timeframe for this study spanned the first wave of the COVID-19 pandemic, data were captured demonstrating the impact of the pandemic on these factors.DesignQualitative interview study.SettingAll staff working within the emergency and critical care departments of one National Health Service Trust in London, UK.ParticipantsForty-nine participants were recruited using a purposive sampling technique and interviewed when the first wave of the COVID-19 pandemic had subsided.Main outcome measuresEvaluation of changes in perceived stressors, psychological safety and teamwork in individuals working during the COVID-19 pandemic.ResultsThe thematic analysis relating to a participant’s lived experiences while working during COVID-19 led to the construction of five key themes, including ‘psychological effects’ and ‘changes in team dynamics’. Several psychological effects were described, including the presence of psychological distress and insights into the aetiology of moral injury. There was marked heterogeneity in participants’ response to COVID-19, particularly with respect to changes in team dynamics and the perception of a psychologically safe environment. Descriptions of improved team cohesiveness and camaraderie contrasted with stories of new barriers, notably due to the high workload and the impact of personal protective equipment. Building on these themes, a map of key changes arising due to the pandemic was developed, highlighting potential opportunities to provide targeted support.ConclusionsWorking on the front line of a pandemic can have significant implications for healthcare workers, putting them at risk of psychological distress and moral injury, as well as affecting team dynamics. There is striking heterogeneity in the manifestation of these challenges. Team leaders can use the themes and qualitative data from this study to help identify areas for management focus and individual and team support.
Resilient healthcare theory as a lens to research emergency department operations: a protocol for a scoping review
Authors: Chessum Peter Thomas , Sujan Mark , Xyrichis Andreas , Anderson Janet E 
Published: December 2021

IntroductionEmergency departments (EDs) are complex systems that have constant fluctuations in demand, creating mismatches with planned capacity. Despite the complexity of ED operations, quality and safety improvement are often approached in a reactive, linear and reductionist manner. There is increasing interest in adopting Resilient Healthcare (RHC) techniques based on complex systems thinking as a method for quality improvement and research in EDs. However, the evidence for this approach is still developing and it is not clear what techniques have been used so far and which are most effective. This scoping review will be conducted between March 2022 until May 2022. It seeks to examine the international literature for available reports that have adopted RHC theory to study ED operations and identify approaches used and proposed benefits.Methods and analysisThe methodology for scoping reviews outlined by Arksey and O’Malley (2005) will be followed, acknowledging refinements made to the scoping review process by Levacet al(2010). The methodology consists of five steps: (1) identifying the research question; (2) identifying the relevant literature; (3) study selection; (4) charting the data; and (5) collating, summarising and reporting the results. A two-stage approach will be undertaken to synthesise and report results: (1) numerical analysis of the nature and distribution of studies (the overall number of studies, country of origin, the most studied core function of ED, type of research design); and (2) a thematic mapping of the literature.Ethics and disseminationScoping review methodology synthesises published data and, therefore, does not require ethical approval. An article formatted in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses forScoping Reviews reporting guidance will be submitted for publication to a scientific journal. Findings will also be presented at relevant advanced practice conferences and disseminated within clinical and academic groups.
Adoption of opioid-prescribing guidelines in primary care: a realist synthesis of contextual factors
Authors: Jacobson Nora , Johnson Roberta A , Schlabach Christie , Incha Jillian , Madden Lynn , Almirall Daniel , Hennessey Garza Rose , Deyo Bri , Schumacher Nicholas , Stephenson Christine , Quanbeck Andrew 
Published: December 2021

ObjectiveAs part of an effort to design an implementation strategy tailoring tool, our research group sought to understand what is known about how contextual factors and prescriber characteristics affect the adoption of guideline-concordant opioid-prescribing practices in primary care settings.DesignWe conducted a realist synthesis of 71 articles.ResultsWe found that adoption is related to contextual factors at the individual, clinic, health system and environmental levels, which operate via intrapersonal, interpersonal, organisational and structural mechanisms.ConclusionA single static model cannot capture the complexity of the relationships between contexts, mechanisms and outcomes. Instead, a deeper understanding requires a dynamic model that conceptualises clusters of contextual factors and mechanisms that tend towards guideline concordance and clusters that tend toward non-concordance.Trail registration numberClinicalTrial.gov registration numberNCT04044521.
Efficacy and safety of 1.5% aqueous olanexidine gluconate antiseptic solution compared to 1% alcoholic chlorhexidine for the prevention of intravenous catheter-related infections (Apollo study): a protocol for a randomised controlled trial
Authors: Yasuda Hideto , Kashiura Masahiro , Kishihara Yuki , Hifumi Toru , Abe Takayuki , Sasaki Junichi , Moriya Takashi , Morikane Keita , Shime Nobuaki 
Published: December 2021

IntroductionChlorhexidine alcohol (1.0%–2.0%) is currently recommended as a skin disinfectant to be used prior to catheterisation for preventing catheter-related infections. However, chlorhexidine alcohol has various side effects and has little antibacterial effect on methicillin-resistantStaphylococcus aureus(MRSA). Therefore, MRSA remains a concern for catheter-related bloodstream infection (CRBSI) prevention. Olanedine, containing 1.5% olanexidine gluconate in aqueous solution, was developed in Japan in 2015 and is structurally similar to chlorhexidine. Olanexine has been used as a disinfectant against various gram-positive and gram-negative bacteria and MRSA. This study aims to compare the efficacy of 1.5% aqueous olanexidine gluconate and 1% chlorhexidine alcohol as skin antiseptics for the prevention of catheter-related infections.Methods and analysisThis Apollo study is an open-label, multicentre, non-inferiority, two-arm, parallel-group, randomised controlled trial conducted at 21 intensive care units (ICUs) and high-care units (HCUs) in Japan. All patients scheduled to be admitted to the ICU or HCU of a facility participating in this study, who require central venous catheter insertion are eligible. Eligible patients will be assigned to either the 1.5% aqueous olanexidine gluconate or 1% chlorhexidine alcohol group by randomisation in a ratio of 1:1 with stratification by centres. The antibacterial agents are to be used as a skin disinfectant before and during catheter placement. The primary endpoint is the proportion of catheter-related infections, defined as a composite of catheter-related sepsis without bacteraemia and CRBSI. A total of 1980 patients will be included in this study.Ethics and disseminationThis clinical trial was approved by the Institutional Review Board of Jichi Medical University and the ethics committees of the participating institutions. The study results will be disseminated through conferences, peer-reviewed publications and meetings with interested parties.Trial registration numberUniversity hospital Medical Information Network (registration ID: UMIN000042343). This registration includes all items in the WHO Trial Registration Data Set.Protocol versionThis protocol corresponds to the original protocol version 5.