bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of “JolinchenKids—Fit and Healthy in Daycare” on Children’s Objectively Measured Physical Activity: A Cluster-Controlled Study
Authors: Brandes Berit , Buck Christoph , Wright Marvin N. , Pischke Claudia R. , Brandes Mirko 
Published: August 2020

Background:To evaluate a multicomponent health promotion program targeting preschoolers’ physical activity (PA).Methods:PA of children from 23 German daycare facilities (DFs; 13 intervention DFs, 10 control DFs) was measured via accelerometry at baseline and after 12 months. Children’s sedentary time, light PA, and moderate to vigorous PA were estimated. Adherence was tracked with paper-and-pencil calendars. Mixed-model regression analyses were used to assess intervention effects.Results:PA data were analyzed from 183 (4.2 [0.8] y, 48.1% boys) children. At follow-up, children in DF groups with more than 50% adherence to PA intervention components showed an increase of 9 minutes of moderate to vigorous PA per day (β = 9.28; 95% confidence interval [CI], −0.16 to 18.72) and a 19-minute decrease in sedentary time (β = −19.25; 95% CI, −43.66 to 5.16) compared with the control group, whereas children’s PA of those who were exposed to no or less than 50% adherence remained unchanged (moderate to vigorous PA: β = 0.34; 95% CI, −13.73 to 14.41; sedentary time: β = 1.78; 95% CI, −26.54 to 30.09). Notable effects were found in children with migration background.Conclusions:Only small benefits in PA outcomes were observed after 1 year. A minimum of 50% adherence to the intervention seems to be crucial for facilitating intervention effects.
Effects of preconditioning by nasal splint and mouth breathing on emergence delirium after functional endoscopic sinus surgery in Chinese adults: a study protocol for a randomised controlled trial
Authors: Xu Hongjiao , Li Xiang , Yang Bin , Shen Zhenyuan , Li Weiwen , Zhou Yachun , Jiang Jihong , Chen Xia , Gu Yuyu , Pei Zhi , Li Jinbao 
Published: August 2020

IntroductionEmergence delirium (ED) is a common adverse manifestation after general anaesthesia and may result in undesirable consequences. Its causes and mechanisms are diverse and complex, and it is still unavoidable in clinical work. There is a high incidence of ED after otorhinolaryngology surgery, which may result from the sudden loss of functional senses and discomfort of surgical organs. This study aims to test a non-invasive, non-drug treatment modality of nose clamping and mouth-breathing training before surgery to reduce ED.Methods and analysisThis prospective randomised controlled trial (RCT) will include 200 patients who undergo functional endoscopic sinus surgery (FESS) at Shanghai General Hospital, China. Study participants will be randomly assigned in two groups with a 1:1 ratio. The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme. After surgery, we will perform a single-blinded assessment of ED occurrence with stratification. IBM SPSS Statistics V.20 statistical software will be used for statistical analyses. A X2 test will be used to compare the two groups, and t-tests will determine the statistical significance of continuous variables.Ethics and disseminationThis RCT was designed in accordance with the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Shanghai General Hospital, ID: 2019KY039.We expect to release the original data in February 2022 on the ResMan original data sharing platform (IPD sharing platform) of the China clinical trial registry, which can be viewed at the following website:http://www.medresman.org.cn/pub/cn/proj/projectshow.aspx?proj=6293.Trial registration numberChiCTR1900024925
What is the optimum systemic treatment for advanced/metastatic renal cell carcinoma of favourable, intermediate and poor risk, respectively? A systematic review and network meta-analysis
Authors: Cao Guanghui , Wu Xiaoqiang , Wang Zhiwei , Tian Xiangyong , Zhang Chan , Wu Xuan , Zhang Haotian , Jing Gaopeng , Yan Tianzhong 
Published: August 2020

PurposeThe optimum systemic therapies for advanced/metastatic renal cell carcinoma (RCC) of favourable, intermediate and poor risk have not been established. We aimed to compare and rank the effects associated with systemic therapies in the first-line setting.MethodsWe searched PubMed, Cochrane databases, Web of Science and ClinicalTrials.gov for randomised controlled trials (RCT) published up to February 2020 of all available treatments for advanced/metastatic RCC. Analysis was done on a Bayesian framework.Results15 unique RCTs including 8995 patients were identified. For advanced/metastatic RCC of favourable risk, avelumab plus axitinib was associated with a significantly higher improvement in progression-free survival (PFS) than sunitinib (HR 0.57, 95% CI 0.34 to 0.96). For intermediate-risk patients, cabozantinib, nivolumab plus ipilimumab, pembrolizumab plus axitinib and avelumab plus axitinib were associated with significantly higher improvement in PFS than sunitinib (HR 0.63, 95% CI 0.44 to 0.97; HR 0.66, 95% CI 0.53 to 0.81; HR 0.58, 95% CI 0.44 to 0.80; HR 0.62, 95% CI 0.47 to 0.83, respectively); pembrolizumab plus axitinib and nivolumab plus ipilimumab were associated with significantly higher improvement in overall survival (OS) than sunitinib (HR 0.53, 95% CI 0.34 to 0.81; HR 0.66, 95% CI 0.50 to 0.87, respectively). For poor-risk patients, nivolumab plus ipilimumab and pembrolizumab plus axitinib were associated with significantly higher improvement in PFS than sunitinib (HR 0.57, 95% CI 0.43 to 0.76; HR 0.48, 95% CI 0.30 to 0.82, respectively); nivolumab plus ipilimumab and pembrolizumab plus axitinib were significantly more efficacious for OS than sunitinib (HR 0.57, 95% CI 0.39 to 0.883; HR 0.43, 95% CI 0.23 to 0.80, respectively). For OS, there were 81% and 78% probabilities that pembrolizumab plus axitinib was the best option for intermediate-risk and poor-risk patients, respectively.ConclusionAvelumab plus axitinib might be the optimum treatment for advanced/metastatic RCC of favourable risk. Pembrolizumab plus axitinib might be the optimum treatment for intermediate-risk and poor-risk patients.
The economic burden of infections following intramedullary nailing for a tibial shaft fracture in England
Authors: Galvain Thibaut , Chitnis Abhishek , Paparouni Konstantina , Tong Cindy , Holy Chantal E , Giannoudis Peter V 
Published: August 2020

ObjectivesDetermine the impact of infections on direct costs and healthcare resource use in England for patients undergoing intramedullary nailing (IMN) for tibial shaft fractures.DesignNon-concurrent cohort based on retrospectively collected data with 2-year follow-up.SettingEngland.ParticipantsThe study population included adult patients (≥18 years) in England with a diagnosis of tibial shaft fracture (International Classification of Diseases-10, S822) in the inpatient setting between May 2003 and June 2017 followed by a procedure for IMN for tibial shaft fracture within 30 days. Patient data were derived from the Clinical Practice Research Datalink linked to National Health Service Hospital Episode Statistics datasets.Primary independent variableInfection.Primary and secondary outcome measuresThe primary outcome was total inpatient costs from index stay admission through 1 year of follow-up. Secondary outcome included cumulative total healthcare costs, and resource utilisation at 30 days, 90 days, 1 year and 2 years.ResultsOverall, 805 patients met the inclusion criteria. At index inpatient stay, 3.7% had a post-IMN infection, rising to 11.7% at 1 year. One-year inpatient costs were 80% higher for patients with infection (p<0.001). Total costs were estimated to be £14 756 (95% CI £13 123 to £16 593) for patients with infection versus £8279 (95% CI £7946 to £8626). Length of stay (LOS), readmission and reoperation were the key drivers of healthcare costs (all p<0.001). After adjustment, LOS was higher by 109% (95% CI 62% to 169%), from 10.5 days to 21.9 days, for patients with infection. The odds of being readmitted or requiring reoperation were higher by 5.18 times (95% CI 3.01 to 9.13) and 2.47 times (95% CI 1.48 to 4.09), respectively, for patients with infection versus those without infection.ConclusionsPost-IMN infection significantly increases inpatient costs, LOS, readmissions and reoperations associated with tibial fracture fixation. Healthcare burden could be reduced through novel surgical site infection prevention strategies.
Factors affecting mothers’ intentions to visit healthcare facilities before hospitalisation of children with pneumonia in Biliran province, Philippines: a qualitative study
Authors: Sato Mari , Oshitani Hitoshi , Tamaki Raita , Oyamada Nobuko , Sato Kineko , Nadra Alkaff Raihana , Landicho Jhoys , Alday Portia P , Lupisan Socorro P , Tallo Veronica L 
Published: August 2020

Background and objectivesDespite a substantial reduction in the mortality rate of children under 5 years in the past 25 years, pneumonia remains the single-largest infectious cause of child deaths worldwide. This study explored the chronological order of visited healthcare facilities and practitioners, and the factors affecting mothers’ intention to seek care before the hospitalisation of children with pneumonia.Methods and analysisA qualitative research design was employed using theory of planned behaviour as a framework for the analysis. Using purposive sampling technique, 11 mothers, whose children under 5 years old were hospitalised with severe pneumonia, were recruited for individual semi-structured interviews. Their socio-demographic information was analysed using descriptive statistics.ResultsMothers brought their sick children to multiple facilities, and 1 to 19 days had passed before hospitalisation. We identified four major factors determining mothers’ intentions: (1) doing something useful for the sick child, (2) expecting the child to receive the necessary assessment and treatment, (3) accepting advice to visit a healthcare facility and be referred to a hospital and (4) considering issues and benefits associated with hospitalisation. Mothers noticed their children’s unusual symptoms and monitored them while applying home remedies. They also took their children to traditional healers despite knowing that the treatments were not necessarily effective. Mothers expected children to be checked by health professionals and listened to advice from family members regarding the facilities to visit, and from healthcare staff to be referred to a hospital. Financial issues and the double burden of housework and caring for the hospitalised child were mothers’ major concerns about hospitalisation.ConclusionChildren were hospitalised after several days because they visited multiple healthcare facilities, including traditional healers. Improving care quality at healthcare facilities and reducing financial and mothers’ burden may reduce the hospitalisation delay for children with pneumonia.
Adaptive design methods in dialysis clinical trials: a systematic review protocol
Authors: Judge Conor , Murphy Robert P , Cormican Sarah , Smyth Andrew , O'Halloran Martin , O'Donnell Martin 
Published: August 2020

IntroductionAdaptive design methods are a potential solution to improve efficiency of clinical trials but their uptake in dialysis is unknown. We aim to investigate the use of adaptive design methods in dialysis clinical trials and to cultivate further adoption of adaptive design methods by the nephrology community.Methods and analysisWe will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and the Cochrane Collaboration Handbook. We will perform a literature search through MEDLINE (PubMed), EMBASE and CENTRAL, a detailed data extraction of trial characteristics and a narrative synthesis of the data. There will be no language restrictions. We will estimate the percentage of adaptive clinical trials per year in dialysis. Subgroup analysis will be performed by dialysis modality, funder and geographical location.Ethics and disseminationEthical approval will not be required for this study as data will be obtained from publicly available clinical trials. We will disseminate our results in a peer-reviewed publication.PROSPERO registration number
Evaluation of propensity score used in cardiovascular research: a cross-sectional survey and guidance document
Authors: Samuel Michelle , Batomen Brice , Rouette Julie , Kim Joanne , Platt Robert W , Brophy James M , Kaufman Jay S 
Published: August 2020

BackgroundPropensity score (PS) methods are frequently used in cardiovascular clinical research. Previous evaluations revealed poor reporting of PS methods, however a comprehensive and current evaluation of PS use and reporting is lacking. The objectives of the present survey were to (1) evaluate the quality of PS methods in cardiovascular publications, (2) summarise PS methods and (3) propose key reporting elements for PS publications.MethodsA PubMed search for cardiovascular PS articles published between 2010 and 2017 in high-impact general medical (top five by impact factor) and cardiovascular (top three by impact factor) journals was performed. Articles were evaluated for the reporting of PS techniques and methods. Data extraction elements were identified from the PS literature and extraction forms were pilot tested.ResultsOf the 306 PS articles identified, most were published inJournal of the American College of Cardiology(29%; n=88), andCirculation(27%, n=81), followed byEuropean Heart Journal(15%; n=47). PS matching was performed most often, followed by direct adjustment, inverse probability of treatment weighting and stratification. Most studies (77%; n=193) selected variables to include in the PS model a priori. A total of 38% (n=116) of studies did not report standardised mean differences, but instead relied on hypothesis testing. For matching, 92% (n=193) of articles presented the balance of covariates. Overall, interpretations of the effect estimates corresponded to the PS method conducted or described in 49% (n=150) of the reviewed articles.DiscussionAlthough PS methods are frequently used in high-impact medical journals, reporting of methodological details has been inconsistent. Improved reporting of PS results is warranted and these proposals should aid both researchers and consumers in the presentation and interpretation of PS methods.
Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease
Authors: Gao Lan , Maddison Ralph , Rawstorn Jonathan , Ball Kylie , Oldenburg Brian , Chow Clara , McNaughton Sarah , Lamb Karen , Amerena John , Nadurata Voltaire , Neil Christopher , Cameron Stuart , Moodie Marj 
Published: August 2020

IntroductionIt is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia.Methods and analysisThe within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO2max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020.Ethics and disseminationThe study protocol has been approved under Australia’s National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001458224).
Sudden death in individuals with obstructive sleep apnoea: protocol for a systematic review and meta-analysis
Authors: Heilbrunn Emily , Ssentongo Paddy , Chinchilli Vernon M , Ssentongo Anna E 
Published: August 2020

IntroductionObstructive sleep apnoea (OSA) is a form of sleep-disordered breathing, characterised by blockage of the airway, snoring, gasping for air during sleep, daytime sleepiness and fatigue. OSA is associated with increased risk of cardiovascular and cerebrovascular morbidity and mortality, and sudden cardiac death (SCD). The magnitude of this risk varies in the literature and therefore we aim to systematically assess this risk. This study protocol proposes a meta-analysis and systematic review aimed to estimate the magnitude of the association between OSA, ‘sudden death’ and cardiovascular death.MethodsWe will conduct a systematic review and meta-analysis of studies published from the inception of each database, which report the risk of ‘sudden death’ or cardiovascular death (including SCD) in individuals diagnosed with OSA versus persons without OSA. The primary outcome of interest in this study will be the relative risk of ‘sudden death’ in patients diagnosed with OSA in comparison to those without an OSA diagnosis. We will search the following electronic research databases: PubMed (MEDLINE), Cochrane, OVID (Healthstar), OVID (Medline), Scopus and Joana Briggs Institute EBP Database. This protocol was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines. The checklist for this document is included in the supplemental material. Two reviewers will screen articles for inclusion criteria, extracting appropriate data and evaluating the quality of the included studies. The methodological quality of studies will be appraised using an appropriate tool. Funnel plots and the Egger’s test will be employed to evaluate potential publication bias. We will fit random-effects model with inverse-variance methods for the pooling effect estimates. We will conduct a meta-regression analysis, using numerous variables of interest including age, gender, race, body mass index, hypertension and diabetes, to explore sources of study heterogeneity.PROSPERO registration numberCRD42020164941.Ethics and disseminationNo ethics clearance was required for this protocol, for no primary data are being collected on research subjects. Only secondary analysis of pre-existing data in scientific databases will be evaluated. The findings of this meta-analysis will be published in a peer-reviewed journal and presented at scientific conferences. These results may assist professionals in the prevention and management of OSA and SCD.
‘I’m praying for a miracle’: characteristics of spiritual statements in paediatric intensive care unit care conferences
Authors: Gradick Katie , October Tessie , Pascoe David , Fleming Jeff , Moore Dominic 
Published: August 2020

ContextSupporting spiritual needs is a well-established aspect of palliative care, but no data exist regarding how physicians engage with patients and families around spirituality during care conferences in paediatric intensive care units (PICU).ObjectivesTo assess the frequency and characteristics of family and physician spiritual statements in PICU care conferences.MethodsWe performed qualitative analysis of 71 transcripts from PICU conferences, audio-recorded at an urban, quaternary medical centre. Transcripts were derived from a single-centre, cross-sectional, qualitative study.ResultsWe identified spiritual language in 46% (33/71) of PICU care conferences. Spiritual statements were divided relatively evenly between family member (51%, 67/131) and physician statements (49%, 64/131). Physician responses to families’ spiritual statements were coded as supportive (46%, 31/67), deferred (30%, 20/67), indifferent (24%, 16/67) or exploratory (0/67).ConclusionsIn this single-centre PICU, spiritual statements were present 46% of the time during high stakes decision-making conferences, but there was little evidence of spiritual care best practices, such as offering chaplain support and performing open-ended spiritual assessments. PICU clinicians should expect spiritual statements in care conferences and be prepared to respond.
Women, older age, faster cycling speed and increased wind speeds are independent risk factors for acute injury-related medical encounters during a 109 km mass community-based participation cycling event: a 3-year study in 102251 race starters—SAFER XII
Authors: Killops Jannelene , Sewry Nicola Ann , Schwellnus Martin , Swanevelder Sonja , Janse van Rensburg Dina , Jordaan Esme 
Published: August 2020

BackgroundThere are limited data on acute injury-related medical encounters (injuries) in endurance cycling events.ObjectiveTo determine the risk factors for injuries during a mass community-based endurance cycling event.DesignRetrospective, cross-sectional study.SettingCape Town Cycle Tour (109 km), South Africa.Participants102 251 race starters.MethodsAll injuries for 3 years were recorded by race medical doctors and nurses. Injuries were grouped into main anatomical area of injury, and a Poisson regression model was used to determine the risk factors associated with injuries.ResultsThe four injury risk factors associated with all injuries during an endurance cycling event were sex (women vs men, p<0.0001), older age (p=0.0005), faster cycling speed (p<0.0001) and higher average individualised Wind Speed (aiWindSpeed, p<0.0001). The only risk factor for serious/life-threatening injuries was women (p=0.0413). For specific main anatomical areas: head/neck (women), upper limb (women, older age, faster cyclists), trunk (women, higher aiWindSpeed), and lower limb (higher aiWindSpeed).ConclusionWomen, older age, faster cycling speed and higher aiWindSpeed were all risk factors for acute injuries during a mass community-based endurance cycling event. These risk factors should help inform race organisers and medical teams on race day to ensure the best medical care is given, and effective acute injury prevention programmes are disseminated.