bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness of an individually tailored complex intervention to improve activities and participation in nursing home residents with joint contractures (JointConEval): a multicentre pragmatic cluster-randomised controlled trial
Authors: Nguyen Natalie , Thalhammer Regina , Meyer Gabriele , Le Lien , Mansmann Ulrich , Vomhof Markus , Skudlik Stefanie , Beutner Katrin , Müller Martin 
Published: October 2023

ObjectiveThis study aims to examine the effects of the individually tailored complex intervention Participation Enabling Care in Nursing (PECAN) on activities and participation of residents with joint contractures.DesignMulticentre pragmatic cluster-randomised controlled trial.Setting35 nursing homes in Germany (August 2018–February 2020).Participants562 nursing home residents aged ≥65 years with ≥1 major joint contracture (303 intervention group, 259 control group).InterventionsNursing homes were randomised to PECAN (18 clusters) or optimised standard care (17 clusters) with researcher-concealed cluster allocation by facsimile. The intervention targeted impairments in activities and participation. Implementation included training and support for selected staff. Control group clusters received brief information.Primary and secondary outcome measuresThe primary endpoint PaArticular Scales combined residents’ activities and participation at 12 months. The secondary outcome comprised quality of life. Safety measures were falls, fall-related consequences and physical restraints. Residents, staff and researchers were unblinded. Data collection, data entry and statistical analysis were blinded. Primary analyses were intention-to-treat at cluster level and individual level using a generalised mixed-effect regression model and imputation of missing data.ResultsPrimary outcome analyses included 301 intervention group residents and 259 control group residents. The mean change on the Activities Scale was −1.47 points (SD 12.2) in the intervention group and 0.196 points (SD 12.5) in the control group and −3.87 points (SD 19.7) vs −3.18 points (SD 20.8) on the Participation Scale. The mean differences of changes between the groups were not statistically significant: Activities Scale: −1.72 (97.5% CI −6.05 to 2.61); Participation Scale: −1.24 (97.5% CI −7.02 to 4.45). We found no significant difference in the secondary outcome and no effects on safety measures.ConclusionThe complex intervention did not improve the activities and participation of nursing home residents on the PaArticular Scales at 12 months. Current nursing conditions in Germany may hamper implementation.Trial registration numberDRKS00015185.
Socio-demographic and clinical characteristics associated with retention in care among adults living with HIV and severe mental illness and reasons for loss to follow-up in Uganda: a mixed-methods study
Authors: Ojiambo Kevin Ouma , Nakku Juliet , Wangi Rachel Nante , Segawa Ivan , Ndagire Regina , Nangendo Joanita , Katahoire Anne , Semitala Fred 
Published: October 2023

ObjectiveThis study aimed to determine the socio-demographic and clinical characteristics associated with retention in care and reasons for loss to follow-up (LTFU) among people living with HIV (PLWH) with a known diagnosis of severe mental illness (SMI).DesignWe conducted a parallel convergent mixed-methods study. The quantitative study was used to determine the proportion and factors associated with retention in care among PLWH and SMI. The qualitative study explored reasons for LTFU.SettingThis study was conducted at two the HIV clinics of two tertiary hospitals in Uganda.ParticipantsWe reviewed records of 608 PLWH who started antiretroviral therapy (ART) and included participants who had a documented diagnosis of SMI.OutcomesThe primary outcome was retention in care. Age, gender, religion, tuberculosis (TB) status, WHO clinical stage, functional status, cluster of differentiation 4 (CD4) cell count, viral load and SMI diagnosis were among the predictor variables.ResultsWe collected data from 328 participants. Retention at 6 months was 43.3% compared with 35.7% at 12 months. Having an unsuppressed viral load (≥1000 copies/mL) (adjusted incidence risk ratio (IRR)=1.54, 95% CI: 1.17 to 2.03), being 36 years and below (adjusted IRR=0.94, 95% CI: 0.94 to 0.95), initial presentation at outpatient department (adjusted IRR=0.74, 95% CI: 0.57 to 0.96), having TB signs and symptoms (adjusted IRR=0.98 95% CI: 0.97 to 0.99) and being in lower WHO stages (I and II) (adjusted IRR=1.08, 95% CI: 1.02 to 1.14) at ART initiation were significantly associated with retention in care at 6 and 12 months. Inadequate social support, long waiting hours at the clinic, perceived stigma and discrimination, competing life activities, low socioeconomic status and poor adherence to psychiatric medication were barriers to retention in care.ConclusionTwelve-month retention in care remains low at 35.7% far below the 90% WHO target. There is a need to design and implement targeted interventions to address barriers to retention in care among PLWH and SMI.
Host, parasite and drug determinants of clinical outcomes following treatment of visceral leishmaniasis: a protocol for individual participant data meta-analysis
Authors: Kumar Rishikesh , Dahal Prabin , Singh-Phulgenda Sauman , Siddiqui Niyamat Ali , Munir Abdalla , Naylor Caitlin , Wilson James , Buck Gemma , Rahi Manju , Malaviya Paritosh , Alves Fabiana , Sundar Shyam , Ritmeijer Koert , Stepniewska Kasia , Guérin Philippe J , Pandey Krishna 
Published: October 2023

IntroductionVisceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. There is an observed variation in the efficacy of the current first-line therapies across different regions. Such heterogeneity could be a function of host, parasite and drug factors. An individual participant data meta-analysis (IPD-MA) is planned to explore the determinants of treatment outcomes.Methods and analysisThe Infectious Diseases Data Observatory (IDDO) VL living systematic review (IDDO VL LSR) library is an open-access resource of all published therapeutic studies in VL since 1980. For this current review, the search includes all clinical trials published between 1 January 1980 and 2 May 2021. Studies indexed in the IDDO VL LSR library were screened for eligibility for inclusion in this IPD-MA. Corresponding authors and principal investigators of the studies meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Authors agreeing to participate in this collaborative research were requested to share the IPD using the IDDO VL data platform. The IDDO VL data platform currently holds data sets from clinical trials standardised to a common data format and provides a unique opportunity to identify host, parasite and drug determinants of treatment outcomes. Multivariable regression models will be constructed to identify determinants of therapeutic outcomes using generalised linear mixed-effects models accounting for within-study site clustering.Ethics and disseminationThis IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (Exempt granted on 29 March 2023, OxTREC REF: IDDO) Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (Letter no: RMRI/EC/30/2022) on 04-07-2022. The results of this IPD-MA will be disseminated at conferences, IDDO website and any peer-reviewed publications. All publications will be open source. Findings of this research will be critically important for the control programmes at regional/global levels, policy makers and groups developing new VL treatments.PROSPERO registrationCRD42021284622.
Mediastinal lymph node dissection versus spared mediastinal lymph node dissection in stage IA non-small cell lung cancer presented as ground glass nodules: study protocol of a phase III, randomised, multicentre trial (MELDSIG) in China
Authors: Li Chenguang , Ni Yunfeng , Liu Changhao , Liu Renwang , Zhang Chenlei , Song Zuoqing , Liu Hongxu , Jiang Tao , Zhang Zhenfa 
Published: October 2023

IntroductionRadical surgery including mediastinal lymph node dissection is the standard treatment for early-stage non-small cell lung cancer (NSCLC). About 50% lung nodules are pure ground glass or part-solid nodules, which are predominantly clinical stage IA NSCLC. Non-solid nodules rarely develop mediastinal lymph node metastasis.Method and analysisA phase III study was started in China to evaluate the non-inferiority in overall survival of spared mediastinal lymph node dissection compared with mediastinal lymph node dissection in stage IA NSCLC. A total of 1362 patients will be enrolled from 4 institutions in 2–3 years. The second endpoints are relapse-free survival and perioperative data, including duration of hospitalisation, duration of chest tube placement, operation time, blood loss.Ethics and disseminationThis protocol has been reviewed and approved by the Clinical Research Review Board of Tianjin Medical University Cancer Institute and Hospital. The findings will be disseminated in peer-reviewed publications.Trial registration numberNCT04631770.
Cohort profile update: the Norwegian STORK Groruddalen (STORK G) pregnancy and birth cohort—the role of ethnicity and causal pathways for obesity, type 2 diabetes, cardiovascular disease and other health issues
Authors: Waage Christin W , Toftemo Ingun , Brænd Anja Maria , Sletner Line , Sommer Christine , Birkeland Kåre Inge , Richardsen Kåre Rønn , Shakeel Nilam , Vøllestad Nina Køpke , Jenum Anne Karen 
Published: October 2023

PurposeThe STORK Groruddalen cohort was set up in 2008 to explore ethnic differences in: (1)maternal health, primarily gestational diabetes (GDM) and related health issues during pregnancy and post partum, and effects of exposures on risk for type 2 diabetes, cardiovascular disease and other health issues, and (2)offspring’s growth and body composition, overweight/obesity and effects of early life exposures.Participants823 women (74% of invited) were followed from gestational week (GW) 15. Data were collected from 618 fathers. In total, 59% of women and 53% of fathers had origin from non-Western countries. Maternal mean age was 29.9 years (SD 4.9), and body mass index (BMI) 25.3 kg/m2(4.9). Data were obtained from 772 women (94%) at GW 28, and 662 women (80%) 14 weeks post partum. Eleven years post partum, 385 women (53% of eligible/47% of original cohort) attended, age was 42.0 years (4.8) and BMI 27.1 kg/m2(5.1). We have data for 783 children at birth, and for 586 at last time point, mean age 8.6 (0.5) years, weight 30.7 (6.8) kg and length 133.9 (6.3) cm.Findings to dateWe collected questionnaire data from parents, clinical measurements and blood samples from mothers, and data on children’s growth (mid-pregnancy to 8 years). Our biobank includes maternal blood and urine samples, biopsy material from placentas and umbilical venous cord blood. We found several clinically important differences inmaternal health, with higher risk in ethnic minority groups for GDM, insulin resistance, vitamin D and iron deficiency, depressive symptoms and physical inactivity. Contrasting patterns of fetal growth and risk of overweight/thinness at preschool age were observed across ethnic groups. Maternal GDM, obesity and high gestational weight gain were associated with children’s BMI trajectories.Future plansWe will examine the impact of maternal and fetal health and development during pregnancy on long-term outcomes for mothers and offspring.Trial registration numberProject title STORK G-2: Women and Risk of Type 2 DiabetesNCT03870724(ClinicalTrials.gov).
Combined surveillance and treatment register for children with cerebral palsy: the protocol of the Netherlands CP register
Authors: Andringa Aukje , Veerkamp Kirsten , Roebroeck Marij , Ketelaar Marjolijn , Klem Martijn , Dekkers Hurnet , Voorman Jeanine , van Driel Marieke , Buizer Annemieke 
Published: October 2023

IntroductionCerebral palsy (CP) is a childhood onset, lifelong, condition. Early detection and timely treatment of potential problems during the child’s development are important to prevent secondary impairments and improve function. Clinical management of children with CP requires a spectrum of multidisciplinary interventions, which have an impact on short-term and long-term outcomes. However, there is a lack of knowledge about a personalised approach in this heterogeneous population. Various CP registers with different aims have been developed worldwide, which has made an important contribution to our understanding of CP. The purpose of this protocol is to describe the unique design of a combined multidisciplinary surveillance and treatment register for children with CP in the Netherlands, which aims to improve quality of care and to enhance an individual treatment approach.Methods and analysisThe Netherlands CP Register combines a multidisciplinary surveillance programme with a standardised protocol for treatment registry. The register systematically collects real-life surveillance and treatment data of children with CP. The register contributes to daily care at the individual level by screening for potential secondary impairments using a decision-support tool, by visualising individual development using a dashboard, and by supporting goal setting and shared decision-making for interventions. The register provides a platform at the national level for quality of care improvement and a comprehensive database of real-life data allowing multicentre studies with a long-term follow-up. People with lived experience of CP, healthcare professionals from different disciplines and researchers collaborated in the development of the register.Ethics and disseminationThe Netherlands CP register was submitted to the Medical Ethics Review Committee of VU University Medical Center (Amsterdam, the Netherlands), who judged the register not to be subject to the Medical Research Involving Human Subjects Act. A scientific board reviews requests for dissemination of data from the register for specific research questions.
Improving hepatitis B screening and vaccination rates in a veterans affairs resident-based primary care clinic
Authors: Yu Zhuo Lin , Fisher Lisa 
Published: October 2023

IntroductionIn 2022, the Advisory Committee on Immunization Practices (ACIP) updated its recommendation regarding hepatitis B vaccination and advised vaccination for all adults aged 19–59 regardless of risk factors and those 60 years and older with risk factors. Adults 60 years and older without known risk factors may also be vaccinated. Our project aimed to spread awareness of the updated hepatitis B virus (HBV) vaccination guideline and improve HBV vaccination rates among veterans in a resident-based primary care clinic.MethodsPreintervention data were collected from October to December 2021 and post intervention data were collected from March to May 2022; patients seen in the clinic during these months were included. Patients were considered immune against HBV if they had positive anti-hepatitis B surface antigen and susceptible to infection if the hepatitis B panel was negative. Interventions included educating each resident group regarding current guidelines via multifaceted modalities. In addition, a reminder for checking hepatitis B status was embedded in the veterans affairs (VA) electronic medical record.ResultsIn the preintervention period from October to December 2021, a total of 1242 veterans were seen. 532 veterans had previous screening for hepatitis B immunity in the chart with 378 veterans negative for hepatitis B surface antibody. Of those 378 veterans, only 35 were vaccinated against hepatitis B during the time period studied. In the postintervention period, 1174 veterans were seen and 559 had prior hepatitis B immunity screening with 430 veterans negative for hepatitis B surface antibody. Of the 430 veterans with no immunity against HBV, 123 received hepatitis B vaccination during the time period studied, which is an increase of greater than 20% in the number of veterans vaccinated.DiscussionOur data suggest that HBV vaccination rate was suboptimal among the veteran population. A low-cost intervention could be beneficial in integrating new vaccination guidelines in the VA standard of care. Increased awareness of the updated HBV vaccination guideline would likely help to achieve the goal of full vaccination among the veteran population.
Reducing scope 3 carbon emissions in gastrointestinal endoscopy: results of the prospective study of the ‘Green Endoscopy Project Würzburg’
Authors: Henniger Dorothea , Lux Thomas , Windsheimer Max , Brand Markus , Weich Alexander , Kudlich Theodor , Schöttker Katrin , Hann Alexander , Meining Alexander 
Published: October 2023

ObjectiveCarbon emissions generated by gastrointestinal endoscopy have been recognised as a critical issue. Scope 3 emissions are mainly caused by the manufacturing, packaging and transportation of purchased goods. However, to our knowledge, there are no prospective data on the efficacy of measurements aimed to reduce scope 3 emissions.DesignThe study was performed in a medium-sized academic endoscopy unit. Manufacturers of endoscopic consumables were requested to answer a questionnaire on fabrication, origin, packaging and transport. Based on these data, alternative products were purchased whenever possible. In addition, staff was instructed on how to avoid waste. Thereafter, the carbon footprint of each item purchased was calculated from February to May 2023 (intervention period), and scope 3 emissions were compared with the same period of the previous year (control period).Results26 of 40 companies answered the questionnaire. 229 of 322 products were classified as unfavourable. A switch to alternative items was possible for 47/229 items (20.5%). 1666 endoscopies were performed during the intervention period compared with 1751 examinations during the control period (−4.1%). The number of instruments used decreased by 10.0% (3111 vs 3457). Using fewer and alternative products resulted in 11.5% less carbon emissions (7.09 vs 8.01 tons of carbon equivalent=tCO2 e). Separation of waste led to a reduction of 20.1% (26.55 vs 33.24 tCO2e). In total, carbon emissions could be reduced by 18.4%.ConclusionUse of fewer instruments per procedure, recycling packaging material and switching to alternative products can reduce carbon emissions without impairing the endoscopic workflow.
Consent-GPT: is it ethical to delegate procedural consent to conversational AI?
Authors: Allen Jemima Winifred , Earp Brian D , Koplin Julian , Wilkinson Dominic 
Published: October 2023

Obtaining informed consent from patients prior to a medical or surgical procedure is a fundamental part of safe and ethical clinical practice. Currently, it is routine for a significant part of the consent process to be delegated to members of the clinical team not performing the procedure (eg, junior doctors). However, it is common for consent-taking delegates to lack sufficient time and clinical knowledge to adequately promote patient autonomy and informed decision-making. Such problems might be addressed in a number of ways. One possible solution to this clinical dilemma is through the use of conversational artificial intelligence using large language models (LLMs). There is considerable interest in the potential benefits of such models in medicine. For delegated procedural consent, LLM could improve patients’ access to the relevant procedural information and therefore enhance informed decision-making.In this paper, we first outline a hypothetical example of delegation of consent to LLMs prior to surgery. We then discuss existing clinical guidelines for consent delegation and some of the ways in which current practice may fail to meet the ethical purposes of informed consent. We outline and discuss the ethical implications of delegating consent to LLMs in medicine concluding that at least in certain clinical situations, the benefits of LLMs potentially far outweigh those of current practices.
Microvascular reperfusion during endovascular therapy: the balance of supply and demand
Authors: Favilla Christopher G , Forti Rodrigo M , Carter Sarah , Kofke W Andrew , Kasner Scott E , Baker Wesley B , Yodh Arjun G , Messé Steven R , Cummings Stephanie , Kung David K , Burkhardt Jan Karl , Choudhri Omar A , Pukenas Bryan , Srinivasan Visish M , Hurst Robert W , Detre John A 
Published: October 2023

BackgroundEndovascular therapy (EVT) has revolutionized the treatment of acute stroke, but large vessel recanalization does not always result in tissue-level reperfusion. Cerebral blood flow (CBF) is not routinely monitored during EVT. We aimed to leverage diffuse correlation spectroscopy (DCS), a novel transcranial optical imaging technique, to assess the relationship between microvascular CBF and post-EVT outcomes.MethodsFrontal lobe CBF was monitored by DCS in 40 patients undergoing EVT. Baseline CBF deficit was calculated as the percentage of CBF impairment on pre-EVT CT perfusion. Microvascular reperfusion was calculated as the percentage increase in DCS-derived CBF that occurred with recanalization. The adequacy of reperfusion was defined by persistent CBF deficit, calculated as: baseline CBF deficit − microvascular reperfusion. A good functional outcome was defined as 90-day modified Rankin Scale score ≤2.ResultsThirty-six of 40 patients achieved successful recanalization, in whom microvascular reperfusion in itself was not associated with infarct volume or functional outcome. However, patients with good functional outcomes had a smaller persistent CBF deficit (median 1% (IQR −11%–16%)) than patients with poor outcomes (median 28% (IQR 2–50%)) (p=0.02). Smaller persistent CBF deficit was also associated with smaller infarct volume (p=0.004). Multivariate models confirmed that persistent CBF deficit was independently associated with infarct volume and functional outcome.ConclusionsCBF augmentation alone does not predict post-EVT outcomes, but when microvascular reperfusion closely matches the baseline CBF deficit, patients experience favorable clinical and radiographic outcomes. By recognizing inadequate reperfusion, bedside CBF monitoring may provide opportunities to personalize post-EVT care aimed at CBF optimization.