bluuebunny/crossref_metadata_2025_split huggingface dataset:
LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial
Authors: Antoun Lina , Middleton Lee , Smith Paul , Saridogan Ertan , Cooper Kevin , Brocklehurst Peter , McKinnon William , Bevan Sheriden , Woolley Rebecca , Jones Laura , Fullard Jayne , Morgan Monique , Roberts Tracy , Clark T Justin 
Published: September 2023

IntroductionThere is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy has been slow, the situation is changing with greater familiarity, better training, better equipment and increased proficiency in the technique. Thus, a large, robust, multicentre randomised controlled trial (RCT) is needed to compare contemporary laparoscopic hysterectomy with abdominal hysterectomy to determine the safest and most cost-effective technique.Methods and analysisA parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. A within trial-based economic evaluation will explore the cost-effectiveness of laparoscopic hysterectomy compared with open abdominal hysterectomy. We will aim to recruit 3250 women requiring a hysterectomy for a benign gynaecological condition and who were suitable for either laparoscopic or open techniques. The primary outcome is major complications up to six completed weeks postsurgery and the key secondary outcome is time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation is to be cost per QALY at 12 months’ postsurgery. A secondary analysis is to be undertaken to generate costs per major surgical complication avoided and costs per return to normal activities.Ethics and disseminationThe study was approved by the West Midlands-Edgbaston Research Ethics Committee, 18 February 2021 (Ethics ref: 21/WM/0019). REC approval for the protocol version 2.0 dated 2 February 2021 was issued on 18 February 2021.We will present the findings in national and international conferences. We will also aim to publish the findings in high impact peer-reviewed journals. We will disseminate the completed paper to the Department of Health, the Scientific Advisory Committees of the RCOG, the Royal College of Nurses (RCN) and the BSGE.Trial registration numberISRCTN14566195.
Development and validation of a multimodal feature fusion prognostic model for lumbar degenerative disease based on machine learning: a study protocol
Authors: Wang Zhipeng , Zhao Xiyun , Li Yuanzhen , Zhang Hongwei , Qin Daping , Qi Xin , Chen Yixin , Zhang Xiaogang 
Published: September 2023

IntroductionLumbar degenerative disease (LDD) is one of the most common reasons for patients to present with low back pain. Proper evaluation and treatment of patients with LDD are important, which clinicians perform using a variety of predictors for guidance in choosing the most appropriate treatment. Because evidence on which treatment is best for LDD is limited, the purpose of this study is to establish a clinical prediction model based on machine learning (ML) to accurately predict outcomes of patients with LDDs in the early stages by their clinical characteristics and imaging changes.Methods and analysisIn this study, we develop and validate a clinical prognostic model to determine whether patients will experience complications within 6 months after percutaneous endoscopic lumbar discectomy (PELD). Baseline data will be collected from patients’ electronic medical records. As of now, we have recruited a total of 580 participants (n=400 for development, n=180 for validation). The study’s primary outcome will be the incidence of complications within 6 months after PELD. We will use an ML algorithm and a multiple logistic regression analysis model to screen factors affecting surgical efficacy. We will evaluate the calibration and differentiation performance of the model by the area under the curve. Sensitivity (Sen), specificity, positive predictive value and negative predictive value will be reported in the validation data set, with a target of 80% Sen. The results of this study could better illustrate the performance of the clinical prediction model, ultimately helping both clinicians and patients.Ethics and disseminationEthical approval was obtained from the medical ethics committee of the Affiliated Hospital of Gansu University of Traditional Chinese Medicine (Lanzhou, China; No. 2022-57). Findings and related data will be disseminated in peer-reviewed journals, at conferences, and through open scientific frameworks.Trial registration numberChinese Clinical Trial Register (www.chictr.org.cn) No. ChiCTR2200064421.
Prevalence of and factors associated with the use of gender-affirming hormonal therapy outside the reference regimen among transgender people in a community-led clinic in Metro Manila, Philippines: a retrospective cross-sectional study
Authors: Eustaquio Patrick C , Dela Cruz Jan Dio Miguel , Araña Yanyan , Rosos Bubbles , Rosadiño John Danvic T , Pagtakhan Ronivin G , Regencia Zypher Jude G , Baja Emmanuel S 
Published: September 2023

ObjectivesWe aimed to describe the gender-affirming hormonal therapy (GAHT) intake behaviour and regimen and the factors associated with the use of hormones inconsistent with reference GAHT regimen among transgender people in the Philippines.DesignCross-sectional study.SettingTransgender community clinic in Metro Manila, Philippines from March 2017 to December 2019.ParticipantsGender-affirming care-seeking individuals of at least 18 years old, who self-identified as transgender or non-binary, and who self-reported current or previous use of GAHT at baseline consult.Primary outcome measuresReported drugs and/or administration routes not congruent with the World Professional Association for Transgender Health Standard of Care eighth edition were classified as hormone use outside the reference regimen.Results253 transgender people reported current or previous intake of GAHT. Many trans women and transfeminine people (TWTFP; 58.9%, 86/146) reported using oral contraceptive pills (OCPs), whereas most trans men (TM; 73.8%, 79/107) reported injecting testosterone esters. Furthermore, 59.7% (151/253) used hormones outside the reference regimen, widely using OCP and anabolic steroids among TWTFP and TM, respectively. TWTFP (crude prevalence ratio, PR, 3.52; 95% CI 2.35 to 5.49) and those who take unprescribed GAHT (crude PR 2.37; 95% CI 1.08 to 6.68) were more likely to use hormones outside the reference regimen than TM and taking healthcare provider-prescribed GAHT, respectively. On adjusting for covariates, the prevalence of using hormones outside the reference regimen was approximately three times higher (adjusted PR 3.22; 95% CI 2.09 to 5.12) among TWTFP than TM.ConclusionTrans people act on their high unmet gender-affirming care needs by taking unprescribed GAHT, many outside the reference regimen. Structural changes in the health system are warranted, including strengthened community-based self-administration practices.
Cross-sectional analysis of factors associated with medication adherence in western Kenya
Authors: Gala Pooja , Kamano Jemima H , Vazquez Sanchez Manuel , Mugo Richard , Orango Vitalis , Pastakia Sonak , Horowitz Carol , Hogan Joseph W , Vedanthan Rajesh 
Published: September 2023

ObjectivesPoor medication adherence in low-income and middle-income countries is a major cause of suboptimal hypertension and diabetes control. We aimed to identify key factors associated with medication adherence in western Kenya, with a focus on cost-related and economic wealth factors.SettingWe conducted a cross-sectional analysis of baseline data of participants enrolled in the Bridging Income Generation with Group Integrated Care study in western Kenya.ParticipantsAll participants were ≥35 years old with either diabetes or hypertension who had been prescribed medications in the past 3 months.Primary and secondary outcome measuresBaseline data included sociodemographic characteristics, wealth and economic status and medication adherence information. Predictors of medication adherence were separated into the five WHO dimensions of medication adherence: condition-related factors (comorbidities), patient-related factors (psychological factors, alcohol use), therapy-related factors (number of prescription medications), economic-related factors (monthly income, cost of transportation, monthly cost of medications) and health system-related factors (health insurance, time to travel to the health facility). A multivariable analysis, controlling for age and sex, was conducted to determine drivers of suboptimal medication adherence in each overarching category.ResultsThe analysis included 1496 participants (73.7% women) with a mean age of 60 years (range 35–97). The majority of participants had hypertension (69.2%), 8.8% had diabetes and 22.1% had both hypertension and diabetes. Suboptimal medication adherence was reported by 71.2% of participants. Economic factors were associated with medication adherence. In multivariable analysis that investigated specific subtypes of costs, transportation costs were found to be associated with worse medication adherence. In contrast, we found no evidence of association between monthly medication costs and medication adherence.ConclusionSuboptimal medication adherence is highly prevalent in Kenya, and primary-associated factors include costs, particularly indirect costs of transportation. Addressing all economic factors associated with medication adherence will be important to improve outcomes for non-communicable diseases.Trial registration numberNCT02501746.
Organisational challenges of pain management in neonatal intensive care unit: a qualitative study
Authors: Neshat Hanieh , Hassankhani Hadi , Jabraeili Mahnaz , Negarandeh Reza 
Published: September 2023

ObjectivesDespite credible evidence, optimal neonates’ pain management in the neonatal intensive care unit (NICU) is a challenging issue. In this regard, the organisational context is an essential factor. The existing challenges vary depending on the context, and investigating them can help to improve the quality of care. The study aimed to explore organisational challenges to neonates’ pain management in the NICU.MethodsThis qualitative study included 31 nurses and physicians in the NICU of Children’s Hospital, Tabriz, Iran. Data collection was done through individual and focus group interviews. For data analysis, we used conventional content analysis.ResultsThe identified challenges included organisational culture (poor interprofessional collaboration and low parental participation), organisational structure (lack of unified approach in relieving pain and limited supervision for pain management) and organisational resources (lack of time due to high workload and inadequate educational programmes).ConclusionsMany organisational factors consistently affect neonatal pain management. Adopting some approaches to enhance the cooperation of treatment team members, holding educational programmes, proper organisational supervision and implementing a unified neonatal-based pain management programme could improve neonatal pain management.
HIDDEN2: Study protocol for the hospital deep vein thrombosis detection study in patients with cancer receiving palliative care
Authors: Kitson Terri , Osborne Emma , Noble Simon , Pease Nikki , Alikhan Raza , Bryant Catherine , Groves Tristan , Wallace Rebecca , Walker Sarah , Seddon Kathy , Smith Deb , Raisanen Lawrence , Smith Joanna , Thomas Ian , Upton Laura , Casbard Angela 
Published: September 2023

IntroductionMedical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices.ObjectiveTo better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency.DesignMulticentre, observational cohort study.SettingSecondary care acute hospitals in South Wales, UK.PatientsWe plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration.Primary outcomePresence of lower extremity DVT.Secondary outcomesSymptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration.AnalysisThe study statistical analysis plan will document analysis, methodology and procedures.Ethics and disseminationEthical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)—the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.
Exploring barriers and enablers to simulation-based training in emergency departments: an international qualitative study (BEST-ED Study)
Authors: Jee Marcus , Murphy Ella , Umana Etimbuk , O'Connor Paul , Khamoudes Daniel , McNicholl Brian , O’Donnell John J , James Binchy 
Published: September 2023

IntroductionSimulation-based training (SBT) has gained significant traction within emergency medicine. The growing body of evidence describes the benefits that SBT can bring. However, identifying barriers and enablers when establishing successful SBT programmes in busy emergency departments (EDs), and ensuring longevity of such programmes, can be difficult.ObjectiveWe aim to identify barriers and enablers to SBT in busy EDs.MethodsWe explored and analysed the thoughts, experience and opinions of professionals involved in SBT and organisational support. 32 participants across 15 international sites were invited to a semistructured interview process. We included participants from a variety of backgrounds, from clinical staff to management staff. Transcribed interview data was classified and coded based on capability, opportunity and motivation behaviour (COM-B) domains and analysed based on theoretical domains framework. Frequency of the most mentioned thematic domain among participants is reported.ResultsThe interview data revealed several common themes, including the following: knowledge and skills (90%), support and leadership (96%), mental barriers (87.5%), local culture (96.6%), dedicated space (65.2%), time constraints (46.8%), social influence (87.5%), education (90.6%), professional development (68.75%), exams (59.3%) and personal goals (93.75%). Management staff was observed to prioritise resource, staffing and flow, while the clinical cohort tended to focus on specialty and personal development when it came to simulation training in the ED.ConclusionPotential barriers and enablers to SBT and in situ simulation for EDs were identified through interviews conducted in this study. The central themes in terms of barriers and enablers were local culture, leadership, individual needs, resources and optimisation. A tailored approach is vital for establishing a successful SBT and in situ simulation programme.
HPV prevalence and genotype distribution among 38 056 women in Weifang, China: a cross-sectional study
Authors: Liu Mengmeng , Zhang Xuguang , Guo Lulu , Sun Wanli , Jiang Xuanli 
Published: September 2023

ObjectivesHuman papillomavirus (HPV) infection is closely associated with cervical cancer, especially the persistent infection of high-risk HPV (HR-HPV) genotypes. Therefore, investigating the HPV prevalence, age-specific, genotype distribution and the impact of the COVID-19 pandemic among large populations was essential for HPV screening and optimising vaccination.DesignThis was a cross-sectional study.MethodsA total of 38 056 cervical epithelial cell specimens were collected in Weifang city from January 2018 to December 2022. The study was divided into seven age groups based on the age of the participants. HPV genotype testing was performed by using a commercial kit which is designed for the detection of 23 HPV genotypes.ResultA total of 8998 women were infected with HPV, with an overall positive rate of 23.64% (8998/38 056). Single infection of HPV was dominant among different age groups, which accounted for 71.33% of total infections. The most prevalent genotype was HR-HPV 16 (4.33%), followed by 52, 58, 53 and 68. Low-risk HPV (LR-HPV) 42 exhibited the highest prevalence (2.19%) among six LR-HPV genotypes, representing a novel finding. There was a significant difference in the prevalence across different age groups (p<0.01), with the highest prevalence in the group under 25 years old. During the 3 year COVID-19 breakout period, the number of HPV samples received in 2020, 2021 and 2022 was reduced by 24.03%, 14.79% and 24.76%, respectively. In 2018–2022, the annual prevalence varied between 21.09% and 25.30%, with a decreasing trend, while the prevalence of HR-HPV 39, 56, 31 and LR-HPV 42 increased.ConclusionThis study indicates a high-HPV infection rate and age-specific distribution characteristics of HPV genotype infections, as well as analyses of the impact of the COVID-19 outbreak on the HPV prevalence, which provides an epidemiological basis for the control and prevention of HPV infection in this region.
Impact of medical students’ socioeconomic backgrounds on medical school application, admission and migration in Japan: a web-based survey
Authors: Suzuki Yasuyuki , Tsunekawa Koji , Takeda Yuko , Cleland Jennifer , Saiki Takuya 
Published: September 2023

ObjectivesThe aim of this study was to clarify and compare the socioeconomic backgrounds of medical students with those of other health professions and non-health faculty students in an era of increasing inequity in Japanese society.DesignThis was a quantitative nationwide study. Data were collected by a cross-sectional web-based anonymous questionnaire.SettingData from years 3 and 4 medical, health professions and non-health faculty students across Japan were collected in 2021.ParticipantsParticipants were 1991 students from medical schools, 224 from dental, 419 from pharmacy, 326 from nursing, 144 from other health professions and 207 from non-health faculties.ResultsThe proportion of high-income families (>18 million yen: ca. US$140 000) among medical students was 25.6%, higher than that of pharmacy (8.7%) and nursing students (4.1%) (p<0.01). One-third of medical students had a physician parent, more common than in non-medical students (p<0.01). Students who only applied to public medical schools and a regional quota ‘Chiiki-waku’ students with scholarship had lower family income and physician parents compared with those who applied to private medical schools (p<0.01), but they still had higher physician parents compared with non-medical students (p<0.01). Logistic regression revealed that having a physician parent (p<0.01), aspiring to the present profession during elementary school (p<0.01) and private upper secondary school graduation (p<0.01) predicted the likelihood of studying medicine. There were regional differences of backgrounds among medical students, and 80% of medical students with urban backgrounds intended to work in urban localities after graduation.ConclusionsThis study provides evidence that medical students in Japan hail from urban and higher income classes and physicians’ families. This finding has implications for the health workforce maldistribution in Japan. Widening the diversity of medical students is essential for solving physician workforce issues and meeting broad healthcare needs.
Comorbidities, symptoms and end-of-life medication use in hospitalised decedents before and during the COVID-19 pandemic: a retrospective regional cohort study in Ottawa, Canada
Authors: Lawlor Peter , Cohen Leila , Adeli Samantha Rose , Besserer Ella , Gratton Valérie , Murphy Rebekah , Warmels Grace , Bruni Adrianna , Kabir Monisha , Noel Chelsea , Heidinger Brandon , Anderson Koby , Arsenault-Mehta Kyle , Wooller Krista , Lapenskie Julie , Webber Colleen , Bedard Daniel , Enright Paula , Desjardins Isabelle , Bhimji Khadija , Dyason Claire , Iyengar Akshai , Bush Shirley H , Isenberg Sarina , Tanuseputro Peter , Vanderspank-Wright Brandi , Downar James , Parsons Henrique 
Published: September 2023

ObjectiveTo compare comorbidities, symptoms and end-of-life (EoL) palliative medication (antisecretories, opioids, antipsychotics and sedatives) use among decedents before and during the COVID-19 pandemic.DesignIn a retrospective cohort study, decedent records in three acute care hospitals were abstracted, generating a prepandemic (November 2019–February 2020) group (pre-COVID) and two intrapandemic (March–August 2020, wave 1) groups, one without (COVID-ve) and one with COVID-19 infection (COVID+ve). Control group decedents were matched 2:1 on age, sex and care service (medicine/intensive care unit (ICU)) with COVID+ve decedents.SettingThree regional acute care teaching hospitals in Ottawa, CanadaParticipantsDecedents (N=425): COVID+ve (n=85), COVID-ve (n=170) and pre-COVID (n=170).Main outcome measuresData were abstracted regarding demographics, admission comorbidities and symptoms, and EoL medication use; opioid doses were standardised to parenteral morphine equivalent daily dose (MEDD), and the predictors of upper quartile MEDD in the last 24 hours of life were examined in multivariable logistic regression with adjusted ORs (aORs) and 95% CIs.ResultsThe prevalence of dementia (41% vs 28% and 26%, p=0.03), breathlessness (63.5% vs 42% and 47%, p<0.01), cough (40% vs 27% and 19%, p<0.01) and fever (54% vs 9% and 13.5%) was higher in COVID+ve versus pre-COVID and COVID-ve groups, respectively. The median (IQR) of MEDD over the last 72 hours of life was 16.7 (9–36.5) vs 13.5 (5.7–21.8) and 10.5 (5.3–23.8) for COVID+ve versus pre-COVID and COVID-ve groups, respectively, (p=0.007). Male sex, COVID+ve grouping, ICU death and high-flow nasal cannula use predicted upper quartile MEDD dose, aORs (95% CIs): 1.84 (1.05 to 3.22), 2.62 (1.29 to 5.3), 5.14 (2.47 to 10.7) and 1.93 (1.05 to 3.52), respectively. COVID+ve group decedents used highest lorazepam and propofol doses.ConclusionsCOVID-19 decedents, particularly those in ICU, required higher EoL opioid and sedating medication doses than matched prepandemic or intrapandemic controls. These findings should inform and guide clinical practice.