bluuebunny/crossref_metadata_2025_split huggingface dataset:
Spontaneous rupture of breast pseudoaneurysm: a rare case
Authors: Mafra Joana , Pires Verena , Andrade Cláudia , Rodrigues Ângela Reis 
Published: November 2023

Ehlers-Danlos syndrome (EDS) type IV is a hereditary autosomal dominant disease associated with skin and vascular fragility, hyperextensibility and joint hypermobility. Spontaneous arterial rupture is one of its higher-risk features.The authors describe a case of a woman with EDS type IV who presented with a spontaneous breast haematoma associated with a pseudoaneurysm of a branch of the left internal mammary artery. The patient underwent a minimally invasive endovascular approach that was uneventful. However, 6 months later, she presented in the emergency room with a similar episode on the contralateral breast. There were no signs of active bleeding, and she stayed under surveillance. Nine months later, she was asymptomatic.Aneurysms of branches of the internal mammary artery are rare and prone to rupture. Early diagnosis and treatment are imperative, and this case demonstrates that an endovascular approach is a safe treatment option.
Intrapartum care measures and indicators for monitoring the implementation of WHO recommendations for a positive childbirth experience: a scoping review
Authors: Vallely Lauren Hannah , Shalit Anna , Nguyen Renae , Althabe Fernando , Pingray Verónica , Bonet Mercedes , Armari Elizabeth , Bohren Meghan , Homer Caroline , Vogel Joshua Peter 
Published: November 2023

ObjectiveWe aimed to identify all available studies describing measures or indicators used to monitor 41 intrapartum care practices described in the 2018 WHO intrapartum care recommendations, with a view to informing development of standardised measurement of implementing these recommendations.DesignSystematic scoping review.MethodsWe conducted a scoping review to identify studies reporting measures of intrapartum care published between 1 January 2000 and 28 June 2021. Primary and secondary outcome measures included study characteristics (publication year, journal, country and World Bank classification) and intrapartum care measure characteristics (definition, numerator, denominator, measurement level and measurement approach). We searched MEDLINE, EMBASE, CINAHL, Cochrane Library, the Maternity and Infant Care Database, Global Index Medicus and grey literature using structured search terms related to included recommendations, focusing on respectful and supportive care, and clinical practices performed throughout labour and birth. The measures identified were classified by the WHO recommendation and their characteristics reported.ResultsWe identified 150 studies which described 1331 intrapartum care measures. These measures corresponded to 35 of the 41 included WHO recommendations, and represented all domains of the WHO recommendations (care throughout labour and birth, first stage of labour, second stage of labour, third stage of labour). A total of 40.1% (534 of 1331 measures) of measures were related to respectful maternity care. Most studies used a questionnaire or survey measurement approach (522 of 1331 measures, 39.2%).ConclusionThis scoping review presents a database of existing intrapartum care measures used to monitor the quality of intrapartum care globally. There is no clear consensus on a core set of measures for evaluating the practice of the WHO’s intrapartum care recommendations. This review provides a foundation to support the development of a core set of internationally standardised intrapartum care measures for the WHO intrapartum care recommendations, highlighting key areas requiring consensus and validation, and measure development.
Impact of SARS-CoV-2 infection on patients with systemic lupus erythematosus in England prior to vaccination: a retrospective observational cohort study
Authors: Rabe Adrian Paul J , Loke Wei Jie , Kalyani Rubana N , Tummala Raj , Stirnadel-Farrant Heide A , Were John , Winthrop Kevin L 
Published: November 2023

ObjectivesDetermine the prevaccination healthcare impact of COVID-19 in patients with systemic lupus erythematosus (SLE) in England.DesignRetrospective cohort study of adult patients with SLE from 1 May to 31 October 2020.SettingClinical Practice Research Datalink (CPRD) Aurum and Hospital Episode Statistics (HES) databases from general practitioners across England combining primary care and other health-related data.ParticipantsOverall, 6145 adults with confirmed SLE diagnosis ≥1 year prior to 1 May 2020 were included. Most patients were women (91.0%), white (67.1%), and diagnosed with SLE at age <50 (70.8%). Patients were excluded if they had a COVID-19 diagnosis before 1 May 2020.Primary and secondary outcome measuresDemographics and clinical characteristics were compared. COVID-19 severity was determined by patient care required and procedure/diagnosis codes. COVID-19 cumulative incidence, hospitalisation rates, lengths of stay and mortality rates were determined and stratified by SLE and COVID-19 severity.ResultsOf 6145 patients, 3927 had mild, 1288 moderate and 930 severe SLE at baseline. The majority of patients with moderate to severe SLE were on oral corticosteroids and antimalarial treatments. Overall, 54/6145 (0.88%) patients with SLE acquired and were diagnosed with COVID-19, with 45 classified as mild, 6 moderate and 3 severe COVID-19. Cumulative incidence was higher in patients with severe SLE (1.4%) compared with patients classified as mild (0.8%) or moderate (0.8%). Ten COVID-19-specific hospital admissions occurred (n=6 moderate; n=4 severe). Regardless of COVID-19 status, hospital admission rates and length of stay increased with SLE severity. Of 54 patients with SLE diagnosed with COVID-19, 1 (1.9%) COVID-19-related death was recorded in a patient with both severe SLE and severe COVID-19.ConclusionsSLE severity did not appear to impact COVID-19 outcomes in this study. The COVID-19 pandemic is evolving and follow-up studies are needed to understand the relationship between COVID-19 and SLE.
Why do some people who had a stroke not receive the recommended 45 min of occupational therapy and physiotherapy? A Delphi study
Authors: Clark Beth , Truman Juliette , Whitall Jill , Hughes Ann-Marie , Turk Ruth , Burridge Jane 
Published: November 2023

ObjectivesTo gain a consensus among therapists for reasons why a person who had a stroke may not receive the Royal College of Physicians’ recommended minimum of 45 min of daily therapy.DesignThree-round remote e-Delphi study.SettingNational study, based in the UK.ParticipantsOccupational therapists and physiotherapists with experience of delivering therapy after stroke and awareness of the 45 min guideline.ResultsForty-five therapists consented to participate in the study. Thirty-five (78%) completed round one, 29 of 35 (83%) completed round 2 and 26 of 29 (90%) completed round three. A consensus (75%) was reached for 32 statements. Reasons why a person may not receive 45 min were related to the suitability of the guideline for the individual (based on factors like therapy tolerance or medical status) or the capability of the service to provide the intervention. In addition to the statements for which there was a consensus, 32 concepts did not reach a consensus. Specifically, there was a lack of consensus concerning the suitability of the guideline for people receiving Early Supported Discharge (ESD) services and a lack of agreement about whether people who need more than 45 min of therapy actually receive it.ConclusionSome people do not receive 45 min of therapy as they are considered unsuitable for it and some do not receive it due to services’ inability to provide it. It is unclear which reasons for guideline non-achievement are most common. Future research should focus on why the guideline is not achieved in ESD, and why people who require more than 45 min may not receive it. This could contribute to practical guidance for therapists to optimise therapy delivery for people after stroke.
Association between white blood cell count and adverse pregnancy outcomes: a retrospective cohort study from a tertiary hospital in China
Authors: Zhang Yu , Qian Yiling , Liu Chuanwei , Fan Xiaofang , Li Xuesong , Song Yuping , Fan Yujuan , Hu Zheng , Yang Jialin 
Published: November 2023

ObjectivesThis study aimed to clarify the relationship between white blood cell (WBC) and adverse pregnancy outcomes.DesignA total of 25 270 pregnant women underwent peripheral blood white blood cell count tests in the first, second and third trimesters. Adverse pregnancy outcomes were gestational hypertension, pre-eclampsia, gestational diabetes mellitus, preterm birth, low birth weight, caesarean delivery, macrosomia and fetal distress. Due to acute infectious disease or other diseases, 1127 were excluded.SettingMinhang Hospital, China.ParticipantsA total of 24 143 pregnant women were included in this study.Primary and secondary outcome measuresThe primary outcome was the adverse pregnancy outcomes.ResultsFor the 24 143 participants, we calculated adjusted ORs for adverse pregnancy outcomes associated with an increased WBC count. For gestational hypertension, the ORs were 1.18 (95% CI, 1.05 to 1.24) in the first trimester and 1.10 (1.06 to 1.13) in the second trimester; for pre-eclampsia, ORs were 1.14 (95% CI, 1.47 to 1.64) in the first trimester and 1.10 (1.05 to 1.16) in the second trimester; for gestational diabetes mellitus, ORs were 1.06 (95% CI, 1.00 to 1.13) in the first trimester and 1.10 (1.04 to 1.16) in the second trimester; for preterm birth, ORs were 1.12 (95% CI, 1.06 to 1.18) in the first trimester, 1.10 (1.06 to 1.13) in the second trimester and 1.12 (1.09 to 1.15) in the third trimester; for low birth weight, ORs were 1.09 (95% CI, 1.02 to 1.17) in the first trimester, 1.03 (0.99 to 1.08) in the second trimester and 1.12 (1.08 to 1.16) in the third trimester. Significant associations were not observed obviously for caesarean delivery, macrosomia and fetal distress.ConclusionsOur results indicate strong, continuous associations of maternal WBC count with increased risks of adverse pregnancy outcomes.
Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study
Authors: Hirata Taiki , Kawaguchi Takashi , Azuma Kanako , Torii Ayako , Usui Hiroaki , Kim Soan , Hayama Tatsuya , Hirate Daisuke , Kawahara Yosuke , Kumihashi Yuki , Chisaka Tomomi , Wako Tetsuya , Yoshimura Akinobu , Miyaji Tempei , Yamaguchi Takuhiro 
Published: November 2023

IntroductionThe use of immune checkpoint inhibitors (ICIs) is rapidly expanding in cancer treatment. ICIs have a unique safety profile, characterised by immune-related adverse events (irAEs). The safety profile of ICIs lacks patient experience and perspectives. This study primarily aims to obtain a database for descriptive research on the status of irAEs using the Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) in patients with gastrointestinal cancer, lung cancer and malignant pleural mesothelioma treated with regimens containing ICIs.Methods and analysisThis is an ongoing, multicentre, observational study in Japan. Eligible patients must be at least 20 years old and have been diagnosed with lung cancer, malignant pleural mesothelioma or gastrointestinal cancer and plan to use ICIs. Participants will install the electronic PRO (ePRO) application and report adverse events via ePRO using PRO-CTCAE once weekly for up to 48 weeks. A registry will be established using background information obtained from medical records. The sample size is determined by 1 year projection without using statistical methods. Statistical analyses will include point estimates and 95% CIs for the incidence of each adverse event by cancer type and regimen at each time point.Ethics and disseminationThis research will be conducted per the Declaration of Helsinki, the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare, and the revised Personal Information Protection Law. The study protocol was approved by the Ethics Committee (approval ID T2021-0180) of Tokyo Medical University Hospital on 15 October 2021.Registration detailsThe study began enrolling patients in December 2021. The target enrolment is 260; as of October 2022, 141 have been enrolled, and the enrolment is scheduled to end on 30 June 2023.Trial registration numberUMIN000046418
‘It’s the stuff they can do better than us’: case studies of general practice surgeries’ experiences of optimising the skill-mix contribution of practice-based pharmacists in Wales
Authors: Bartlett Sophie , Bullock Alison , Morris Felicity 
Published: November 2023

ObjectivePharmacists are increasingly joining the general practice skill-mix. Research is still in relative infancy, but barriers and facilitators to their integration are emerging, as well as indications that pharmacists’ skillset remain underutilised. This study explores first-hand experiences and perspectives among general practice teams of the processes that underpin the effective integration and sustained contribution of pharmacists in general practice.Design and settingThis research employed a qualitative case study approach involving general practice teams in Wales. Data were collected from eight general practices where each practice represented one case study. Data were collected via online interviews (one-to-one or group) and written feedback. Data were pattern coded and analysed thematically through a constant comparative approach. Data interpretations were confirmed with participants and wider general practice teams.ParticipantsEight general practice teams across Wales (comprising combinations of practice and business managers, general practitioners (GPs) and general practice pharmacists) represented eight case studies. Cases were required to have had experience of working with a general practice pharmacist.ResultsData were yielded from five practice managers, two GPs, three general practice pharmacists and a business manager. A total of 3 hours and 2 min of interview data was recorded as well as 2038 words of written feedback. Three foundations to pharmacists’ effective contribution to general practice were identified: defining the role (through identifying the right pharmacist, mapping skillset to demand and utilising the increasing need for specialist skills), appropriate infrastructure and workforce review, and an appropriate employment model.ConclusionPharmacists are becoming increasingly critical to the general practice skill-mix and utilisation of their specialist skillset is crucial. This paper identifies how to enable the effective integration and sustained contribution of pharmacists to general practice.
Evaluation of ALBA device for upper extremity motor function in adults with subacute and chronic acquired brain injury: a randomised controlled trial protocol in a tertiary clinic of the metropolitan region of Chile
Authors: Salazar-Cifuentes Pamela , Contreras Thomas , Hernández Emilio , Leiva-Abarca Evelyn , Castro-Flores Paola , San Juan Daniela , Araneda Rodrigo , Ebner-Karestinos Daniela 
Published: November 2023

IntroductionStroke is a significant worldwide cause of death and a prevalent contributor to long-term disability among adults. Survivors commonly encounter a wide array of motor, sensory and cognitive impairments. Rehabilitation interventions, mainly targeting the upper extremities, include a wide array of components, although the evidence indicates that the intensity of practice and task-specific training play crucial roles in facilitating effective results. Assisted therapy with electronic devices designed for the affected upper extremity could be employed to enable partial or total control of this limb, while simultaneously incorporating the aforementioned characteristics in the rehabilitation process.Methods and analysis32 adults who had a subacute or chronic stroke, aged over 18 years old, will be included for this randomised controlled trial aiming to determine the non-inferiority effect of the inclusion of a robotic device (ALBA) to regular treatment against only regular rehabilitation. Participants will be assessed before and after 4 weeks of intervention and at 3 months of follow-up. The primary outcome will be the Fugl-Meyer assessment for upper extremities; secondary outcomes will include the questionnaires Functional Independence Measure, Medical Outcomes Study 36-item Short-Form Health Survey as well as the System Usability Scale.Ethics and disseminationFull ethical approval was obtained for this study from the scientific and ethical review board Servicio de Salud Metropolitano Oriente of Santiago (approval number: SSMOriente030522), and the recommendations of the Chilean law no 20120 of 7 September 2006, concerning scientific research in the human being, its genome and human cloning, will be followed. Ahead of inclusion, potential participants will read and sign a written informed consent form. Future findings will be presented and published in conferences and peer-reviewed journals.Trial registration numberInternational ClinicalTrials.gov Registry (NCT05824416;https://clinicaltrials.gov/ct2/show/NCT05824416?term=uMOV&draw=2&rank=1).
Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol
Authors: Tsze Daniel S , Kuppermann Nathan , Casper T Charles , Barney Bradley J , Richer Lawrence P , Liberman Danica B , Okada Pamela J , Morris Claudia R , Myers Sage R , Soung Jane K , Mistry Rakesh D , Babcock Lynn , Spencer Sandra P , Johnson Michael D , Klein Eileen J , Quayle Kimberly S , Steele Dale W , Cruz Andrea T , Rogers Alexander J , Thomas Danny G , Grupp-Phelan Jacqueline M , Johnson Tiffani J , Dayan Peter S 
Published: November 2023

IntroductionHeadache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.Methods and analysisProspective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score<14, intoxication, known pregnancy, history of intracranial surgery, known structural abnormality of the brain, pre-existing condition predisposing to an intracranial abnormality or intracranial hypertension, head injury within 14 days or not speaking English or Spanish. Clinicians complete a standardised history and physical examination of all eligible patients. Primary outcome is the presence of an EIA as determined by neuroimaging or clinical follow-up. We will use binary recursive partitioning and multiple regression analyses to create and internally validate the risk stratification model.Ethics and disseminationEthics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.
A Phase I/II Study of GSK525762 Combined with Fulvestrant in Patients with Hormone Receptor–positive/HER2-negative Advanced or Metastatic Breast Cancer
Authors: Cescon David W. , Hilton John , Morales Murilo Serafin , Layman Rachel M. , Pluard Timothy , Yeo Belinda , Park In Hae , Provencher Louise , Kim Sung-Bae , Im Young-Hyuck , Wyce Anastasia , Krishnatry Anu Shilpa , Hicks Kirsty , Zhang Qu , Barbash Olena , Khaled Ahmed , Horner Thierry , Dhar Arindam , Oliveira Mafalda , Sparano Joseph A. 
Published: November 2023

Abstract

Purpose:
Endocrine-based therapy is the initial primary treatment option for hormone receptor–positive and human epidermal growth factor receptor 2-negative (HR+/HER2−) metastatic breast cancer (mBC). However, patients eventually experience disease progression due to resistance to endocrine therapy. Molibresib (GSK525762) is a small-molecule inhibitor of bromodomain and extraterminal (BET) family proteins (BRD2, BRD3, BRD4, and BRDT). Preclinical data suggested that the combination of molibresib with endocrine therapy might overcome endocrine resistance. This study aimed to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy [objective response rate (ORR)] of molibresib combined with fulvestrant in women with HR+/HER2− mBC.

Patients and Methods:
In this phase I/II dose-escalation and dose-expansion study, patients received oral molibresib 60 or 80 mg once daily in combination with intramuscular fulvestrant. Patients enrolled had relapsed/refractory, advanced/metastatic HR+/HER2− breast cancer with disease progression on prior treatment with an aromatase inhibitor, with or without a cyclin-dependent kinase 4/6 inhibitor.

Results:
The study included 123 patients. The most common treatment-related adverse events (AE) were nausea (52%), dysgeusia (49%), and fatigue (45%). At a 60-mg dosage of molibresib, &gt;90% of patients experienced treatment-related AE. Grade 3 or 4 treatment-related AE were observed in 47% and 48% of patients treated with molibresib 60 mg and molibresib 80 mg, respectively. The ORR was 13% [95% confidence interval (CI), 8–20], not meeting the 25% threshold for proceeding to phase II. Among 82 patients with detected circulating tumor DNA and clinical outcome at study enrollment, a strong association was observed between the detection of copy-number amplification and poor progression-free survival (HR, 2.89; 95% CI, 1.73–4.83; P &lt; 0.0001).

Conclusions:
Molibresib in combination with fulvestrant did not demonstrate clinically meaningful activity in this study.