bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of ABO isoagglutinin titres by three different methods in group O blood donors
Authors: Pandey Prashant , Setya Divya , Ranjan Shweta , Singh Mukesh Kumar , Singh Manish Kumar 
Published: November 2020

AbstractBackground and aimsAntibody titration by the manual method has certain limitations. The aim of this study was to compare the manual conventional test tube technique (CTT) with semi‐automated, column agglutination technique (CAT) and fully automated haemagglutination/solid‐phase red cell adherence (HA/SPRCA) technology in measuring antibody titres of anti‐A and anti‐B isoagglutinins of blood group O blood donors. The median IgM and IgG antibody titres with 1+, 2+ and 3+ end‐points were determined for each technology, and the agreement and correlation between results of the 3 technologies were evaluated.Materials and methodsThis was a prospective, observational study conducted from October 2018 to March 2020. All consecutive O group blood donors, who donated blood at the Department of Transfusion Medicine at a tertiary healthcare centre, were included in the study. All samples were consecutively tested by CTT, CAT and HA/SPRCA, and the results were recorded and compared.ResultsA total of 2005 donors were included. Inter‐observer variation was observed in 295 (14.71%) samples by the CTT and in 51 (2.54%) by the CAT. There was 43.4% and 40.3% agreement of anti‐A IgM and IgG titres between CAT (2+ strength) and CTT (1+ strength), respectively. The agreement for anti‐B IgM and IgG titres between CAT (2+ strength) and CTT (1+ strength) was 43.6% and 32%, respectively. While a strong correlation was found between CTT (1+ strength) and CAT (1+, 2+ strengths) for both IgM and IgG measurements of anti‐A and anti‐B isoagglutinins, the correlation between CTT (1+ strength) and HA/SPRCA (1+, 2+ strengths) was found to be weak. The median IgM titres for anti‐A and anti‐B were lower than the median IgG titres.ConclusionThe antibody titration levels were higher with CAT than with CTT, and those of HA/SPRCA were lower than those of CTT. Transfusion services need to decide which method would provide higher benefit to their patient population.
Study to evaluate the effectiveness and cost-effectiveness of different screening strategies for identifying undiagnosed COPD among residents (≥40 years) in four cities in China: protocol for a multicentre cross-sectional study on behalf of the Breathe Well group
Authors: Pan Zihan , Dickens Andrew P , Chi Chunhua , Kong Xia , Enocson Alexandra , Adab Peymane , Cheng Kar Keung , Sitch Alice J , Jowett Sue , Jordan Rachel 
Published: November 2020

IntroductionThe latest chronic obstructive pulmonary disease (COPD) epidemiology survey in China estimated that there were 99 million potential COPD patients in the country, the majority of whom are undiagnosed. Screening for COPD in primary care settings is of vital importance for China, but it is not known which strategy would be the most suitable for adoption in primary care. Studies have been conducted to test the accuracy of questionnaires, expiratory peak flow meters and microspirometers to screen for COPD, but no study has directly evaluated and compared the effectiveness and cost-effectiveness of these methods in the Chinese setting.Methods and analysisWe present the protocol for a multicentre cross-sectional study, to be conducted in eight community hospitals from four cities among Chinese adults aged 40 years or older to investigate the effectiveness and cost-effectiveness of different case-finding methods for COPD, and determine the test performance of individual and combinations of screening tests and strategies in comparison with quality diagnostic spirometry. Index tests are screening questionnaires (COPD Diagnostic Questionnaire (CDQ), COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk Questionnaire (CAPTURE), symptom-based questionnaire, COPD Screening Questionnaire (COPD-SQ)), microspirometer and peak flow. Each participant will complete all of these tests in one assessment. The primary analysis will compare the performance of a screening questionnaire with a handheld device. Secondary analyses will include the comparative performance of each index test, as well as a comparison of strategies where we use a screening questionnaire and a handheld device. Approximately 2000 participants will be recruited over 9 to 12 months.Ethics and disseminationThe study has been approved by Peking University Hospital and University of Birmingham. All study participants will provide written informed consent. Study results will be published in appropriate journal and presented at national and international conferences, as well as relevant social media and various community/stakeholder engagement activities.Trial registration numberISRCTN13357135.
Socioenvironmental criteria and postoperative complications in ambulatory surgery in a French university hospital: a prospective cross-sectional observational study
Authors: Mihailescu Sorina-Dana , Maréchal Isabelle , Thillard Denis , Gillibert André , Compère Vincent 
Published: November 2020

BackgroundAmbulatory surgery lowers hospitalisation costs, shortens the time to return to work but requires caution regarding socioenvironmental risk factors for complications and rehospitalisation.MethodsThis was a single-centre prospective cross-sectional observational study conducted in a university hospital centrein January 2017. The primary objective was to assess the rate of conversion from ambulatory surgery to conventional hospitalisation or emergency department visit within 30 days following discharge from ambulatory unit. Secondary objectives were to describe the socioenvironmental characteristics of outpatients and to identify risk factors for severe postoperative complications.Results598 outpatients were included. The most represented surgical specialties were ophthalmology (23.5%), gynaecology (19%) and orthopaedics (17.7%). Patients’ mean age was 50.8 years (SD, 19.8) and the male/female sex ratio was 0.68. There were 22 (3.68%, 95% CI 2.32% to 5.52%) severe complications, including 11 (1.84%, 95% CI 0.92% to 3.27%) conversions to conventional hospitalisation and 11 (1.84%) conversions to emergency department visit, 3 of which led to readmission. Regarding socioenvironmental characteristics, 116 outpatients (19.7%) lived alone but were not isolated and 15 (2.6%) lived alone and were socially isolated. Following ambulatory surgery, 9 outpatients (1.6%) returned home on foot, 20 (3.4%) by public transportation and 8 (1.4%) drove home; 133 outpatients (13.7%) were alone the first night following surgery. Severe complication rates were not significantly different according to socioenvironmental subgroups.ConclusionIn our study, the prevalence of severe complications was low, conforming to the literature. The study was underpowered to estimate the effect of socioenvironmental variables.
Effects of behavioural parent training for children with attention-deficit/hyperactivity disorder on parenting behaviour: a protocol for an individual participant data meta-analysis
Authors: Steenhuis Laura , Groenman Annabeth P , Hoekstra Pieter J , Hornstra Rianne , Luman Marjolein , van der Oord Saskia , van den Hoofdakker Barbara J 
Published: November 2020

IntroductionBehavioural parent training (BPT) is a well-established treatment for children with attention-deficit/hyperactivity disorder (ADHD). BPT is based on the hypothesis that improvements in parenting are mediators of improvements in children’s behaviours. However, meta-analyses show considerate heterogeneity in effects of BPT on child outcomes, and meta-analyses on parenting outcomes are scarce. Also, few studies have investigated parenting factors as mediators of child outcomes. This study aims to examine the effects and moderators of BPT on parenting outcomes and whether improvements in parenting mediate amelioration of behaviour and impairment in children with ADHD.Methods and analysesWe will conduct an individual participant data meta-analysis (IPDMA), making use of individual data of existing trials, and giving the opportunity for highly powered moderator analyses. This IPDMA will be performed by the Psychosocial ADHD INTervention (PAINT) collaboration. We will include randomised controlled trials of BPT, for individuals with ADHD below 18 years old. Systematic searches have been performed to locate relevant papers. Authors are currently contacted to share their data with the PAINT-IPDMA project. We will examine effects of BPT on parenting outcomes (eg, positive and negative parenting, management of affect, perceived parenting competence, parenting stress), moderators of these effects (eg, parental depression, parenting stress, severity of the child’s ADHD symptoms) and subsequently perform mediation analyses where parenting outcomes are modelled as mediators of child outcomes (eg, symptoms and severity of ADHD, comorbid psychopathology and impairment).Ethics and disseminationWe will include data from randomised control trials for which ethical approval has been received and consent forms have been signed. Deidentified data will be provided by the original investigators. We aim to disseminate our findings through peer-reviewed scientific journals, presentations at (inter)national scientific meetings, newsletters, the website of our project and the Dutch academic workspace ADHD.PROSPERO registration numberCRD42017069877.
3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial
Authors: Zhang Youyu , Liang Junyang , Xu Nanfang , Zeng Lin , Du Chaojun , Du Yaoxu , Zeng Yan , Yu Miao , Liu Zhongjun 
Published: November 2020

IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10–16 years) with Risser sign 0-II, Cobb angle of main curve of 20°−40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen’s design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.
External validation of the improving partial risk adjustment in surgery (PRAIS-2) model for 30-day mortality after paediatric cardiac surgery
Authors: Cocomello Lucia , Caputo Massimo , Cornish Rosie , Lawlor Deborah 
Published: November 2020

ObjectiveIndependent temporal external validation of the improving partial risk adjustment in surgery model (PRAIS-2) to predict 30-day mortality in patients undergoing paediatric cardiac surgery.DesignRetrospective analysis of prospectively collected data.SettingPaediatric cardiac surgery.InterventionPRAIS-2 validation was carried out using a two temporally different single centre (Bristol, UK) cohorts: Cohort 1 surgery undertaken from April 2004 to March 2009 and Cohort 2 from April 2015 to July 2019. For each subject PRAIS-2 score was calculated according to the original formula.ParticipantsA total of 1352 (2004-2009) and 1197 (2015-2019) paediatric cardiac surgical procedures were included in the Cohort 1 and Cohort 2, respectively (median age at the procedure 6.3 and 7.1 months).Primary and secondary outcome measuresPRAIS-2 performance was assessed in terms of discrimination by means of ROC (receiver operating characteristic) curve analysis and calibration by using the calibration belt method.ResultsPRAIS-2 score showed excellent discrimination for both cohorts (AUC 0.72 (95%CI: 0.65 to 0.80) and 0.88 (95%CI: 0.82 to 0.93), respectively). While PRAIS-2 was only marginally calibrated in Cohort 1, with a tendency to underestimate risk in lowrisk and overestimate risk in high risk procedures (P-value = 0.033), validation in Cohort 2 showed good calibration with the 95% confidence belt containing the bisector for predicted mortality (P-value = 0.143). We also observed good prediction accuracy in the non-elective procedures (N = 483;AUC 0.78 (95%CI 0.68 to 0.87); Calibration belt containing the bisector (P-value=0.589).ConclusionsIn a single centre UK-based cohort, PRAIS-2 showed excellent discrimination and calibration in predicting 30-day mortality in paediatric cardiac surgery including in those undergoing non-elective procedures. Our results support a wider adoption of PRAIS-2 score in the clinical practice.
Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion
Authors: Crowder Rebecca , Kityamuwesi Alex , Kiwanuka Noah , Lamunu Maureen , Namale Catherine , Tinka Lynn Kunihira , Nakate Agnes Sanyu , Ggita Joseph , Turimumahoro Patricia , Babirye Diana , Oyuku Denis , Berger Christopher Allen , Tucker Austin , Patel Devika , Sammann Amanda , Dowdy David , Stavia Turyahabwe , Cattamanchi Adithya , Katamba Achilles 
Published: November 2020

IntroductionLow-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The ‘DOT to DAT’ trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy.Methods and analysisThis is a pragmatic, stepped-wedge cluster randomised trial, with hybrid type 2 effectiveness-implementation design. The trial will include all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda. Three sites per month will switch from routine care (DOT) to the intervention (99DOTS-based treatment supervision) beginning in month 2, with the order determined randomly. 99DOTS enables patients to be monitored while self-administering TB medicines. Patients receive daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers. The primary effectiveness outcome is the proportion of patients completing TB treatment. With 18 clusters randomised into six steps and an average cluster size of 15 patients per month, the study will have 89% power to detect a 10% or greater increase in treatment completion between the routine care and intervention periods. Secondary outcomes include more proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention.Ethics and disseminationEthics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences and presentations to key stakeholders.Trial registration numberPACTR201808609844917.
Endovascular treatment versus standard medical treatment for acute basilar artery occlusion: protocol for a systematic review and meta-analysis
Authors: Bai Xuesong , Zhang Xiao , Li Long , Wang Tao , Dmytriw Adam Andrew , Feng Yao , Yang Kun , Wang Xue , Ma Yan , Jiao Liqun 
Published: November 2020

IntroductionAcute basilar artery occlusion (BAO) can cause posterior circulation stroke. There are two predominant therapies for BAO: standard medical treatment (SMT) and SMT plus endovascular thrombectomy (EVT). However, a conclusive systematic comparison of the safety and efficacy of SMT and those of SMT plus EVT for the treatment of BAO is lacking. Thus, a systematic review and meta-analysis is needed to evaluate the safety and efficacy of SMT and SMT plus EVT for the treatment of BAO.Methods and analysisThis protocol is drafted referring to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. We will search eligible studies from four main databases including MEDLINE, Web of Science, Cochrane Library and Embase. Randomised controlled trials (RCTs) and observational studies published before 1 October 2020 will be included. Two reviewers in our team will conduct the study selection and data extraction independently. Risk of bias will be assessed by Cochrane Collaboration criteria and the Newcastle-Ottawa scale for RCTs and observational studies, respectively. We will assess the good functional outcomes defining the modified Rankin scale score ≤2 at 90 days after treatment, short-term stroke severity as National Institutes of Health Stroke Scale score at 24 hours after intervention, and successful recanalisation as a modified Thrombolysis in Cerebral Infarction scale score of ≥2b after intervention. Also, safety outcomes will be assessed. The performance of this meta-analysis will depend on the quantity of included studies. The assessment of study heterogeneity will be performed by the I2 statistic. If there is mild heterogeneity (I2<20%) of intervention outcomes in included studies, the fixed-effect model will be applied; otherwise, the random-effect model will be performed. Subgroup analyses and an assessment of publication bias will also be conducted with sufficient data.Ethics and disseminationNo collection of primary data from patients is needed. Therefore, the ethical approval is unnecessary. The results may be presented in a peer-reviewed journal and related conferences.PROSPERO registration numberCRD42020176764.
Mask shortage during epidemics and pandemics: a scoping review of interventions to overcome limited supply
Authors: Kirubarajan Abirami , Khan Shawn , Got Tiffany , Yau Matthew , Bryan Jennifer M , Friedman Steven Marc 
Published: November 2020

ObjectiveTo characterise published evidence regarding preclinical and clinical interventions to overcome mask shortages during epidemics and pandemics.DesignSystematic scoping review.SettingsAll healthcare settings relevant to epidemics and pandemics.Search strategyEnglish peer-reviewed studies published from January 1995 to June 2020 were included. Literature was identified using four databases (Medline-OVID, EMBASE, CINAHL, Cochrane Library), forwards-and-backwards searching through Scopus and an extensive grey literature search. Assessment of study eligibility, data extraction and evidence appraisal were performed in duplicate by two independent reviewers.ResultsOf the 11 220 database citations, a total of 47 articles were included. These studies encompassed six broad categories of conservation strategies: decontamination, reusability of disposable masks and/or extended wear, layering, reusable respirators, non-traditional replacements or modifications and stockpiled masks. Promising strategies for mask conservation in the context of pandemics and epidemics include use of stockpiled masks, extended wear of disposable masks and decontamination.ConclusionThere are promising strategies for overcoming face mask shortages during epidemics and pandemics. Further research specific to practical considerations is required before implementation during the COVID-19 pandemic.
Dementias Platform UK Clinical Studies and Great Minds Register: protocol of a targeted brain health studies recontact database
Authors: Koychev Ivan , Young Simon , Holve Heather , Ben Yehuda Michael , Gallacher John 
Published: November 2020

IntroductionThe case for de-risking neurodegenerative research and development through highly informative experimental medicine studies early in the disease process is strong. Such studies depend on the availability of genetic as well as high-granularity, longitudinal, phenotypic data in healthy ageing individuals who can be recruited into early phase trials on the basis of their perceived dementia risk. Until now the creation of such research infrastructure has been hampered by the lack of expense and time required to gather the rich longitudinal data needed for adequate risk stratification. Dementias Platform UK (DPUK) is a public–private partnership that brings together data from over 40 cohorts in a standardised framework, which represent an until now unavailable opportunity to create such a resource through a streamlined brain health recontact platform based on existing cohorts, as well as prospectively collected data.Methods and analysisThe DPUK recontact platform consists of an opt-in (Great Minds, GM) and an opt-out component (Clinical Studies Register, CSR). GM requires invited DPUK cohort participants to consent to targeted recontact at the GM website and then to provide self-reported demographic and medical history information relevant to recruitment into clinical studies. Participants complete prospective browser-based and smartphone-based cognitive tests and are given the option for remote genetic and actigraphy testing. The GM data are linked to the retrospective DPUK cohort dataset, including genotypic and longitudinal phenotypic data. The CSR is a solution for cohorts explicitly allowing targeted recontact. Approved studies provide prescreening criteria on the basis of the CSR/GM dataset, and individuals meeting these criteria are offered participation directly (GM) or through the parent DPUK cohort (CSR). Descriptive statistics will be used to summarise the outcomes relevant to the number of participants engaged with the register. Its sample size is not defined but is limited by the size of the DPUK parent cohorts.Ethics and disseminationThe database was approved by the South Central–Oxford C Research Ethics Committee, reference 18/SC/0268 on the 27th of June 2018 and amended on the 1st of November 2019. The availability of the register to researchers will be disseminated through DPUK’s official communication channels as well as national and international scientific meetings.