bluuebunny/crossref_metadata_2025_split huggingface dataset:
Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial
Authors: De Berti Marion , Le Gouge Amélie , Monmousseau Fanny , Gallot Denis , Sentilhes Loïc , Winer Norbert , Legendre Guillaume , Desbriere Raoul , Girault Aude , Pozzi Jordan , Gachon Bertrand , Barjat Thiphaine , Perrotin Franck , Brunet-Houdard Solène , Diguisto Caroline 
Published: April 2023

IntroductionIt remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins.Methods and analysisWe will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be ≥18 years with a singleton fetus in vertex presentation, at a term from ≥37+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score ≤6. Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment.Ethics and disseminationAll participants will provide written informed consent. The ethics committee ‘Comité de Protection des Personnes Ile de France VII’ approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences.Trial registration numberNCT04949633.
Appraisal of published guidelines in European countries addressing the clinical care of childhood sexual abuse: protocol for a systematic review
Authors: Otterman Gabriel , Nurmatov Ulugbek , Akhlaq Ather , Naughton Aideen , Kemp Alison Mary , Korhonen Laura , Jud Andreas , Vollmer Sandholm Mary Jo , Mora-Theuer Eva , Moultrie Sarah , Chalumeau Martin , Karst Wouter A , Greenbaum Jordan 
Published: April 2023

IntroductionChildhood sexual abuse (CSA) is a global public health problem with potentially severe health and mental health consequences. Healthcare professionals (HCPs) should be familiar with risk factors and potential indicators of CSA, and able to provide appropriate medical management. The WHO issued global guidelines for the clinical care of children with CSA, based on rigorous review of the evidence base. The current systematic review identifies existing CSA guidelines issued by government agencies and academic societies in the European Region and assesses their quality and clarity to illuminate strengths and identify opportunities for improvement.Methods and analysisThis 10-database systematic review will be conducted according to the Centre for Reviews and Dissemination guidelines and will be reported according to The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Guidance for HCPs regarding CSA, written by a national governmental agency or academic society of HCPs within 34 COST Action 19106 Network Countries (CANC) and published in peer-reviewed or grey literature between January 2012 and November 2022, is eligible for inclusion. Two independent researchers will search the international literature, screen, review and extract data. Included guidelines will be assessed for completeness and clarity, compared with the WHO 2017/2019 guidelines on CSA, and evaluated for consistency between the CANC guidelines. The Appraisal of Guidelines for Research and Evaluation II tool and Grading of Recommendations Assessment, Development and Evaluation methodology will be used to evaluate CANC guidelines. Descriptive statistics will summarise content similarities and differences between the WHO guidelines and national guidelines; data will be summarised using counts, frequencies, proportions and per cent agreement between country-specific guidelines and the WHO 2017/2019 guidelines.Ethics and disseminationThere are no individuals or protected health information involved and no safety issues identified. Results will be published in a peer-reviewed medical journal.PROSPERO registration numberCRD42022320747.
Value of improving patient safety: health economic considerations for rapid response systems–a rapid review of the literature and expert round table
Authors: Subbe Christian , Hughes Dyfrig A , Lewis Sally , Holmes Emily A , Kalkman Cor , So Ralph , Tranka Sumeshni , Welch John 
Published: April 2023

ObjectivesFailure to rescue deteriorating patients in hospital is a well-researched topic. We aimed to explore the impact of safer care on health economic considerations for clinicians, providers and policymakers.DesignWe undertook a rapid review of the available literature and convened a round table of international specialists in the field including experts on health economics and value-based healthcare to better understand health economics of clinical deterioration and impact of systems to reduce failure to rescue.ResultsOnly a limited number of publications have examined the health economic impact of failure to rescue. Literature examining this topic lacked detail and we identified no publications on long-term cost outside the hospital following a deterioration event. The recent pandemic has added limited literature on prevention of deterioration in the patients’ home.Cost-effectiveness and cost-efficiency are dependent on broader system effects of adverse events. We suggest including the care needs beyond the hospital and loss of income of patients and/or their informal carers as well as sickness of healthcare staff exposed to serious adverse events in the analysis of adverse events. They are likely to have a larger health economic impact than the direct attributable cost of the hospital admission of the patient suffering the adverse event. Premorbid status of a patient is a major confounder for health economic considerations.ConclusionIn order to optimise health at the population level, we must limit long-term effects of adverse events through improvement of our ability to rapidly recognise and respond to acute illness and worsening chronic illness both in the home and the hospital.
Hypothermia or hyperthermia, which is associated with patient outcomes in critically ill children with sepsis? —A retrospective study
Authors: Wang Huabin , Chang Yanhua , Xin Meiyun , Hou Tongshu , Han Lei , Zhang Ruipin , Liu Ziying , Sun Bing , Gan Lijun 
Published: April 2023

ObjectivesIn the early stage of sepsis, identifying high-risk paediatric patients with a poor prognosis and providing timely and adequate treatment are critical. This study aimed to evaluate the effect of average body temperature within 24 hours of admission on the short-term prognosis of paediatric patients with sepsis.DesignA retrospective cohort study.SettingA single-centre, tertiary care hospital in China, containing patient data from 2010 to 2018.Participants1144 patients with sepsis were included.InterventionNone.Primary and secondary outcome measuresThe main outcome measure was in-hospital mortality, which was defined as death from any cause during hospitalisation. The secondary outcome was the length of hospital stay.ResultsThe LOWESS method showed a roughly ‘U’-shaped relationship between body temperature on the first day and in-hospital mortality. Multivariate logistic regression showed that severe hypothermia (OR 14.72, 95% CI 4.84 to 44.75), mild hypothermia (OR 3.71, 95% CI 1.26 to 10.90), mild hyperthermia (OR 3.41, 95% CI 1.17 to 9.90) and severe hyperthermia (OR 5.15, 95% CI 1.84 to 14.43) were independent risk factors for in-hospital mortality. Compared with other variables, the Wald χ2value of temperature on the first day minus the degree of freedom was the highest.ConclusionsWhether hypothermic or hyperthermic, the more abnormal the temperature on the first day is, the higher the risk of in-hospital death in children with sepsis.
Clinical features, immunological interactions and household determinants of visceral leishmaniasis and malaria coinfections in West Pokot, Kenya: protocol for an observational study
Authors: van Dijk Norbert , Carter Jane , Omondi Wyckliff , Mens Petra , Schallig Henk 
Published: April 2023

IntroductionVisceral leishmaniasis (VL) and malaria are two deadly parasitic diseases that coexist in West Pokot County, Kenya. The local population is at considerable risk of coinfection with VL and malaria; however, few studies have described the clinical implications of this comorbidity. Questions remain regarding the immune responses responsible for possible predisposing or protective effects. Moreover, characterisation of environmental and household risk factors for co-acquiring VL and malaria is warranted to increase awareness and guide implementation of targeted control strategies. This protocol intends to address these knowledge gaps concerning VL–malaria coinfections.Methods and analysisThis observational research project will have a multimethod approach, starting with a cross-sectional study at Kacheliba Sub-County Hospital in West Pokot, Kenya. Patients with laboratory confirmation of a VL and/or malaria infection will be clinically assessed and symptomatology of monoinfections and coinfections will be compared. Second, a questionnaire will be addressed to all included patients and to healthy controls in local communities. This case–control study will aim to describe household and environmental determinants associated with VL–malaria coinfection. Lastly, blood samples will be collected from a small cohort of VL and malaria monoinfected and coinfected patients during treatment of their infection(s), and from healthy controls and asymptomatic VL and malaria cases recruited in local communities. These specimens will be used for serum cytokine measurements and molecular quantitation ofPlasmodiumandLeishmania. In this way, the immune response and parasite dynamics during VL–malaria coinfection will be characterised longitudinally and compared with those observed in clinical and asymptomatic monoinfections.Ethics and disseminationEthical approval was obtained from the Ethics and Scientific Research Committee of Amref Health Africa. The study findings will be presented at international conferences and published in open-access, peer-reviewed journals.Trial registration numberISRCTN Registry (ISRCTN15023306).
Safety and efficacy of post-haematopoietic cell transplantation maintenance therapy with blinatumomab for relapsed/refractory CD19-positive B-cell acute lymphoblastic leukaemia: protocol for a phase I–II, multicentre, non-blinded, non-controlled trial (JPLSG SCT-ALL-BLIN21)
Authors: Sakaguchi Hirotoshi , Umeda Katsustugu , Kato Itaru , Sakaguchi Kimiyoshi , Hiramatsu Hidefumi , Ishida Hiroyuki , Yabe Hiromasa , Goto Hiroaki , Kawahara Yuta , Yamashita Yuka Iijima , Sanada Masashi , Deguchi Takao , Takahashi Yoshiyuki , Saito Akiko , Noma Hisashi , Horibe Keizo , Taga Takashi , Adachi Souichi 
Published: April 2023

IntroductionRelapsed and refractory B-cell acute lymphoblastic leukaemia (R/R-B-ALL) is linked to a significant relapse rate after allogeneic haematopoietic cell transplantation (allo-HCT) in children, adolescents and young adults (CAYA). No standard treatment has been established to prevent relapse after allo-HCT for R/R-B-ALL, which is an unmet medical need. The administration of blinatumomab after allo-HCT is expected to enhance the antileukaemic effect on residual CD19-positive blasts by donor-derived CD3-positive T-cells.Methods and analysisThe goal of this multicentre, open-label, uncontrolled, phase I–II clinical trial is to assess the safety and effectiveness of post-transplant maintenance therapy with blinatumomab for CAYA patients (25 years old or younger) with CD19-positive R/R-B-ALL who have received allo-HCT beyond first complete remission (CR) and have CR with haematological recovery between 30 and 100 days after allo-HCT. Eighty-five paediatric institutions in Japan are participating in this study. Forty-one patients will enrol within 2.25-year enrolment period and follow-up period is 1 year. The primary endpoints are the treatment completion rate for phase I study and the 1-year graft-versus-host disease-free/relapse-free survival rate for phase II study, respectively.Ethics and disseminationThis research was approved by the Central Review Board at National Hospital Organization Nagoya Medical Center (Nagoya, Japan) on 21 January 2022 and was registered at the Japan Registry of Clinical Trials (jRCT) on 3 March 2022. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberjRCTs041210154.
Cohort profile: Netherlands Longitudinal Study on Hearing (NL-SH)
Authors: van Wier Marieke F , Jansen Lotte A , Goderie Thadé , Stam Mariska , Nachtegaal Janneke , van Beek Johannes H M , Lemke Ulrike , Anema Johannes R , Lissenberg-Witte Birgit I , Smits Cas , Kramer Sophia E 
Published: April 2023

PurposeThe Netherlands Longitudinal Study on Hearing (NL-SH) was set up to examine associations of hearing ability with psychosocial, work and health outcomes in working age adults.ParticipantsInclusion started in 2006 and is ongoing. Currently the sample comprises 2800 adults with normal and impaired hearing, aged 18–70 years at inclusion. Five-year follow-up started in 2011, 10-year follow-up in 2016 and 15-year follow-up in 2021. All measurements are web-based. Participants perform a speech-in-noise recognition test to measure hearing ability and fill out questionnaires about their hearing status, hearing aid use, self-reported hearing disability and coping, work status and work-related outcomes (work performance, need for recovery), physical and psychosocial health (depression, anxiety, distress, somatisation, loneliness), healthcare usage, lifestyle (smoking, alcohol), and technology use.Findings to dateThe NL-SH has shown the vast implications of reduced hearing ability for the quality of life and health of working-age adults. A selection of results published in 27 papers is presented. Age-related deterioration of hearing ability accelerates after the age of 50 years. Having a history of smoking is associated with a faster decline in hearing ability, but this relationship is not found for other cardiovascular risk factors. Poorer hearing ability is associated with increased distress, somatisation, depression and loneliness. Adults with impaired hearing ability are more likely to be unemployed or unfit for work, and need more time to recuperate from work effort.Future plansParticipant data will be linked to a national database to enable research on the association between hearing ability and mortality. Linking to environmental exposure data will facilitate insight in relations between environmental factors, hearing ability and psychosocial outcomes. The unique breadth of the NL-SH data will also allow for further research on other functional problems, for instance, hearing ability and fall risk.Trial registration numberNL12015.029.06.
Neutrophil activation in patients treated with endovascular therapy is associated with unfavorable outcomes and mitigated by intravenous thrombolysis
Authors: Maïer Benjamin , Di Meglio Lucas , Desilles Jean-Philippe , Solo Nomenjanahary Mialitiana , Delvoye François , Kyheng Maeva , Boursin Perrine , Ollivier Véronique , Dupont Sébastien , Rambaud Thomas , Hamdani Mylène , Labreuche Julien , Blanc Raphaël , Piotin Michel , Halimi Jean-Michel , Mazighi Mikaël , Ho-Tin-Noe Benoit 
Published: April 2023

BackgroundAccumulating evidence indicates that neutrophil activation (NA) contributes to microvascular thromboinflammation in acute ischemic stroke (AIS) due to a large vessel occlusion. Preclinical data have suggested that intravenous thrombolysis (IVT) before endovascular therapy (EVT) could dampen microvascular thromboinflammation. In this study we investigated the association between NA dynamics and stroke outcome, and the impact of IVT on NA in patients with AIS treated with EVT.MethodsA single-center prospective study was carried out, including patients treated with EVT for whom three blood samples (before, within 1 hour, 24 hours post-EVT) were drawn to measure plasma myeloperoxidase (MPO) concentration as a marker of NA. Unfavorable outcome was defined as a modified Rankin score of 3–6 at 3 months.ResultsBetween 2016 and 2020, 179 patients were included. The plasma MPO concentration peaked significantly 1 hour post-EVT (median increase 21.0 ng/mL (IQR −2.1–150)) and returned to pre-EVT baseline values 24 hours after EVT (median change from baseline −0.8 ng/mL (IQR −7.6–6.7)). This peak was strongly associated with unfavorable outcomes at 3 months (aOR 0.53 (95% CI 0.34 to 0.84), P=0.007). IVT before EVT abolished this 1 hour post-EVT MPO peak. Changes in plasma MPO concentration (baseline to 1 hour post-EVT) were associated with unfavorable outcomes only in patients not treated with IVT before EVT (aOR 0.54 (95% CI 0.33 to 0.88, P=0.013). However, we found no significant heterogeneity in the associations between changes in plasma MPO concentration and outcomes.ConclusionsA peak in plasma MPO concentration occurs early after EVT and is associated with unfavorable outcomes. IVT abolished the post-EVT MPO peak and may modulate the association between NA and outcomes.
Characteristics and outcomes of SARS-CoV-2 breakthrough infections among double-vaccinated and triple-vaccinated patients with inflammatory rheumatic diseases
Authors: Hasseli Rebecca , Richter Jutta G. , Hoyer Bimba Franziska , Lorenz Hanns-Martin , Pfeil Alexander , Regierer Anne Constanze , Schmeiser Tim , Strangfeld Anja , Voll Reinhard E , Krause Andreas , Reckert Sabine , Gräßler Anett , Saar Petra , Kapelle Andreas , Backhaus Marina , Blank Norbert , Henes Joerg , Osiek Silke , Knothe Anna , Hoese Guido , Brandt-Jürgens Jan , Maltzahn Anja , Specker Christof , Müller-Ladner Ulf , Schulze-Koops Hendrik 
Published: April 2023

ObjectiveTo analyse the clinical profile of SARS-CoV-2 breakthrough infections in at least double-vaccinated patients with inflammatory rheumatic diseases (IRDs).MethodsData from the physician-reported German COVID-19-IRD registry collected between February 2021 and July 2022 were analysed. SARS-CoV-2 cases were stratified according to patients’ vaccination status as being not vaccinated, double-vaccinated or triple-vaccinated prior to SARS-CoV-2 infection and descriptively compared. Independent associations between demographic and disease features and outcome of breakthrough infections were estimated by multivariable logistic regression.ResultsIn total, 2314 cases were included in the analysis (unvaccinated n=923, double-vaccinated n=551, triple-vaccinated n=803, quadruple-vaccinated n=37). SARS-CoV-2 infections occurred after a median of 151 (range 14–347) days in patients being double-vaccinated, and after 88 (range 14–270) days in those with a third vaccination. Hospitalisation was required in 15% of unvaccinated, 8% of double-vaccinated and 3% of triple-vaccinated/quadruple-vaccinated patients (p<0.001). Mortality was 2% in unvaccinated, 1.8% in the double-vaccinated and 0.6% in triple-vaccinated patients. Compared with unvaccinated patients, double-vaccinated (OR 0.43, 95% CI 0.29 to 0.62) and triple-vaccinated (OR 0.13, 95% CI 0.08 to 0.21) patients showed a significant lower risk of COVID-19-related hospitalisation. Using multivariable analysis, the third vaccination was significantly associated with a lower risk for COVID-19-related death (OR 0.26; 95% CI 0.01 to 0.73).ConclusionsOur cross-sectional data of COVID-19 infections in patients with IRD showed a significant reduction of hospitalisation due to infection in double-vaccinated or triple-vaccinated patients compared with those without vaccination and even a significant reduction of COVID-19-related deaths in triple-vaccinated patients. These data strongly support the beneficial effect of COVID-19 vaccination in patients with IRD.Trial registration numberEuDRACT 2020-001958-21.
Exploring Customers’ Feedback on the Technological and Operational Changes at the Departments of Motor Vehicles Due to Covid-19 Pandemic
Authors: Kutela Boniphace , Magehema Raynard Tom , Mwekh’iga Rafael 
Published: April 2023

In Early 2020, after COVID-19 was declared a pandemic, the Center for Disease Control and Prevention (CDC) provided guidelines to combat the spread of COVID-19. As a result, Departments of Motor Vehicles (DMVs) introduced several technological changes and modified operation protocols. This study explored the changes of customer feedback resulting from the changes in DMVs operations across the United States. A total of 24[Formula: see text]164 Google reviews were collected from 69 cities in 43 States. Sentiment analysis, text network, and logistic regression were applied to evaluate the changes of the feedback before and after the lockdown period. It was found that the post-lockdown reviews had higher positive polarity and low negative polarity than pre-lockdown reviews. Furthermore, positive feedback topics, such as excellent service and short waiting time, increased significantly during the post-lockdown era. Keywords that showed a higher likelihood of higher ratings include appointment, wait time, and minutes. Conversely, lower ratings were associated with keywords — customer services, hours, and people, among others. Further, the logistic regression showed that the odds of high ratings increased nearly three times when COVID-19-related keywords were mentioned. Several recommendations to improve operations are presented in this study. It is expected that the findings will benefit DMV operators and policymakers across the United States.