bluuebunny/crossref_metadata_2025_split huggingface dataset:
Which outcomes should be used in future bronchiolitis trials? Developing a bronchiolitis core outcome set using a systematic review, Delphi survey and a consensus workshop
Authors: Rosala-Hallas A , Jones Ashley P , Williamson Paula R , Bedson Emma , Compton Vanessa , Fernandes Ricardo M , Lacy David , Lyttle Mark David , Peak Matthew , Thorburn Kentigern , Woolfall Kerry , Van Miert Clare , McNamara Paul S 
Published: March 2022

ObjectivesThe objective of this study was to develop a core outcome set (COS) for use in future clinical trials in bronchiolitis. We wanted to find out which outcomes are important to healthcare professionals (HCPs) and to parents and which outcomes should be prioritised for use in future clinical trials.Design and settingThe study used a systematic review, workshops and interviews, a Delphi survey and a final consensus workshop.ResultsThirteen parents and 45 HCPs took part in 5 workshops; 15 other parents were also separately interviewed. Fifty-six items were identified from the systematic review, workshops and interviews. Rounds one and two of the Delphi survey involved 299 and 194 participants, respectively. Sixteen outcomes met the criteria for inclusion within the COS. The consensus meeting was attended by 10 participants, with representation from all three stakeholder groups. Nine outcomes were added, totalling 25 outcomes to be included in the COS.ConclusionWe have developed the first parent and HCP consensus on a COS for bronchiolitis in a hospital setting. The use of this COS will ensure outcomes in future bronchiolitis trials are important and relevant, and will enable the trial results to be compared and combined.Trial registration numberISRCTN75766048.
Disease knowledge, medical experience, health-related quality of life and health-care costs among patients with advanced colorectal cancer in China: protocol for a nationwide multicentre survey
Authors: Liu Yin , Xu Hui-Fang , Zhang Xi , Yu Yan-Qin , Zhao Yu-Qian , Zhang Shao-Kai , Qiao You-Lin 
Published: March 2022

BackgroundColorectal cancer (CRC) is one of the most common cancers in China. Most patients have developed advanced stage at diagnosis, leading to a low 5-year survival rate. To optimise prevention strategies, we planned a survey to evaluate the disease knowledge, medical experience and health-related quality of life (HRQOL) before and after the treatment of CRC, and healthcare costs among patients with advanced CRC in China.Methods and analysisThis is a nationwide, hospital-based, multicentre survey. Nineteen hospitals in seven cities were selected by multistage stratified sampling. Mainland China is divided into seven regions according to the traditional administrative district definition; two cities of each region were selected through simple random sampling, and then one tertiary cancer hospital and one general hospital were selected for each city. More than 4445 patients with CRC in the selected hospitals with stage III or IV will be enrolled in this study. The trained interviewers will collect information through patients’ self-report and/or medical records, including demographics and medical history; knowledge about CRC high-risk factors, screening procedure and treatment methods; medical experience on CRC screening, diagnosis and treatment; HRQOL before and after CRC treatment; and costs of CRC. All data will be input by two independent staff and verified using Epidata V.3.1 software. Data validation plan will be made to guide data checking. All statistical analyses will be conducted using SAS V.9.4 and SPSS V.24.0 software.Ethics and disseminationThe study was approved by the ethics committees of Henan Cancer Hospital, the leading participant hospital. Findings of this study will be disseminated through peer-reviewed open-access journals and presented as posters and/or oral sections in national and international conferences. Results will also be popularised to the public via media or the internet.
Effectiveness of posture-correction interventions for mechanical neck pain and posture among people with forward head posture: protocol for a systematic review
Authors: Balthillaya Ganesh M , Parsekar Shradha S , Gangavelli Ranganath , Prabhu Narayan , Bhat Shyamasunder N , Rao Bhamini Krishna 
Published: March 2022

IntroductionForward head posture (FHP) is the most common postural deviation of the upper back. It is believed to be one of the predisposing factors for the development of mechanical neck pain (MNP). We propose doing a systematic review to find the effectiveness of interventions targeted on FHP with MNP and assess implementation fidelity associated with these interventions.Methods and analysisMedline (PubMed), Web of Science (Social Science Citation Index), EMBASE, Scopus, PEDro and CINAHL databases will be searched for studies published in English from their inception. Forward and backward citations of the included studies will be investigated for identifying additional records. We will include randomised controlled trials and non/quasi-experimental studies with two groups assessing the effectiveness of interventions targeted on FHP with MNP. Observational studies, non-randomised studies with single group and reviews will be excluded. We will consider the following outcome measures: postural variables of FHP, neck pain, performance-based functional disability scores of the neck, quality of life, basic activities of daily living and work-related outcomes. The unique citations will be screened by titles/abstracts and full texts, independently. The Cochrane Risk of Bias 2 tool will be used to critically appraise the included studies. The risk of bias and data abstraction of included studies will be undertaken independently. A qualitative synthesis will be conducted and, if sufficient studies with comparable outcome measures are available, we will statistically pool the result.Ethics and disseminationWe will undertake a systematic review of primary studies, and will not directly recruit participants hence, ethical clearance is not applicable. We will aim to present the findings of the completed systematic review at an international conference and subsequently submit the manuscript in a peer-reviewed journal for publication.PROSPERO registration numberCRD42021250310.
Partner’s characteristics and adolescent motherhood among married adolescent girls in 48 low-income and middle-income countries: a population-based study
Authors: Huda M Mamun , O'Flaherty Martin , Finlay Jocelyn Edwina , Edmed Shannon , Mamun Abdullah Al 
Published: March 2022

ObjectivesThe objective of this study was to examine the prevalence of adolescent motherhood among married adolescent girls and its associations with their partners’ characteristics in low-income and middle-income countries (LMICs).DesignPopulation-based study.Participants54 285 ever married (or lived with a partner) adolescent girls (15–19 years old) were including in prevalence analysis. However, partner characteristics were assessed in a subsample of 24 433 adolescent girls who were married (or living with a partner) at the time of interview.SettingsData from the latest available Demographic and Health Survey round during 2010–2018 in 48 LMICs across different geographic regions.ResultsThe overall prevalence of adolescent motherhood was 73.98% (95% CI 70.96 to 78.10) among married adolescent girls in this study. In the pooled analysis, statistically significant and positive associations were observed between adolescent motherhood and partners’ desire for more children (adjusted marginal effect (AME): 2.34, 95% CI 1.21 to 3.47) and spousal age gap (AME: 1.67, 95% CI 0.30 to 3.04 for three plus age gap). However, no statistically significant association was observed between adolescent motherhood and partners’ education (AME: −0.36, 95% CI −1.77 to 1.05 for primary education) and partners’ agricultural occupation (AME: 1.07, 95% CI −0.17 to 2.32). Overall, there was significant variation in the associations across countries; however, the positive associations persisted between adolescent motherhood and partners’ desire for more children and spousal age gap in most of the studied countries.ConclusionsOur findings may inform policymakers about the importance of incorporating partners of married adolescent girls into the existing birth control programmes to delay age at first birth among married adolescents in LMICs. More attention should be given to the married adolescent girls who have older partners, and efforts to discourage marriages with much older partners may have a secondary benefit of reducing adolescent motherhood in LMICs.
Telerehabilitation for lower extremity recovery poststroke: a systematic review and meta-analysis protocol
Authors: Park Sarah , Tang Ada , Pollock Courtney , Sakakibara Brodie M 
Published: March 2022

IntroductionApproximately 30% of individuals with stroke report unmet lower extremity recovery needs after formal hospital-based rehabilitation programmes have ended. Telerehabilitation can mitigate issues surrounding accessibility of rehabilitation services by providing ongoing support to promote recovery, however, no review exists that is specific to telerehabilitation for lower extremity recovery. This paper describes the protocol of a systematic review and meta-analysis that aims to describe and evaluate the effectiveness of lower extremity-focused telerehabilitation interventions on clinical outcomes poststroke.Methods and analysisA systematic review of relevant electronic databases (MEDLINE, Embase, CINAHL, PsycINFO, Web of Science, Google Scholar, PEDro, PubMed and Cochrane Library) between inception and February 2022 will be undertaken to identify eligible interventional studies published in English that compared telerehabilitation focusing on lower extremity recovery to another intervention or usual care for individuals living in the community with stroke. Clinical outcomes examined will include those related to physical function and impairment, activities and participation that are typically assessed in clinical practice and research. Two reviewers will independently screen results, identify studies to be included for review, extract data and assess risk of bias. Meta-analyses will be performed if sufficient data exist. Sensitivity analyses will be performed by removing studies with low methodological quality, and subgroup analyses will be performed if data allow by stratifying papers based on salient demographic or stroke factors and comparing results. The reporting of the review will follow the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The quality of evidence regarding various outcomes for telerehabilitation for lower extremity recovery poststroke will be assessed according to the Grading of Recommendation, Assessment, Development and Evaluation approach.Ethics and disseminationNo ethical approval or informed consent is needed for this systematic review. The findings of this review will be disseminated via peer-reviewed publications and conference presentations.PROSPERO registration numberCRD42021246886.
Ferritin-guided iron supplementation in whole blood donors: optimal dosage, donor response, return and efficacy (FORTE)—a randomised controlled trial protocol
Authors: Karregat Jan , Sweegers Maike G , Quee Franke A , Weekamp Henriëtte H , Swinkels Dorine W , Novotny Vĕra M J , Zaaijer Hans L , van den Hurk Katja 
Published: March 2022

BackgroundFrequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation.MethodsTwelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire.Ethics and disseminationThis study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels.Trial registration numberNL8590; The Dutch trial registry.
Prevalence of depression in China during the early stage of the COVID-19 pandemic: a cross-sectional study in an online survey sample
Authors: Liu Weina , Yu Fengyun , Geldsetzer Pascal , Yang Juntao , Wang Zhuoran , Golden Todd , Jiao Lirui , Chen Qiushi , Liu Haitao , Wu Peixin , Wang Chen , Bärnighausen Till , Chen Simiao 
Published: March 2022

ObjectivesWe aimed to determine (1) the prevalence of depression during the COVID-19 pandemic among Chinese adults and (2) how depression prevalence varied by province and sociodemographic characteristics.DesignCross-sectional study.SettingNational online survey in China.ParticipantsWe conducted a cross-sectional online survey among adults registered with the survey company KuRunData from 8 May 2020 to 8 June 2020. We aimed to recruit 300–360 adults per province (n=14 493), with a similar distribution by sex and rural-urban residency as the general population within each of these provinces.Primary outcomeParticipants completed the Patient Health Questionaire-9 (PHQ-9). We calculated the prevalence of depression (defined as a PHQ-9 score ≥10) nationally and separately for each province.AnalysisCovariate-unadjusted and covariate-adjusted logistic regression models were used to examine how the prevalence of depression varied by adults’ sociodemographic characteristics. All analyses used survey sampling weights.ResultsThe survey was initiated by 14 493 participants, with 10 000 completing all survey questions and included in the analysis. The prevalence of depression in the national sample was 6.3% (95% CI 5.7% to 6.8%). A higher odds of depression was associated with living in an urban area (OR 1.50; 95% CI 1.18 to 1.90) and working as a nurse (OR 3.06; 95% CI 1.41 to 6.66). A lower odds of depression was associated with participants who had accurate knowledge of COVID-19 transmission prevention actions (OR 0.71; 95% CI 0.51 to 0.98), the knowledge that saliva is a main transmission route (OR 0.80; 95% CI 0.64 to 0.99) and awareness of COVID-19 symptoms (OR, 0.82; 95% CI 0.68 to 1.00).ConclusionAround one in 20 adults in our online survey sample had a PHQ-9 score suggestive of depression. Interventions and policies to prevent and treat depression during the COVID-19 pandemic in China may be particularly needed for nurses and those living in urban areas.
Assessing quality of older persons’ emergency transitions between long-term and acute care settings: a proof-of-concept study
Authors: Tate Kaitlyn , McLane Patrick , Reid Colin , Rowe Brian H , Cummings Garnet , Estabrooks Carole A , Cummings Greta 
Published: March 2022

BackgroundLong-term care (LTC) residents frequently experience transitions in the location of more advanced care delivery, including receiving emergency department (ED) care. In this proof-of-concept study, we aimed to determine if we could identify measures in quality of care across transitions from LTC to the ED, via emergency medical services and back, by applying Institute of Medicine (IOM) Quality of Care Domains to an existing dataset.MethodsIn the Older Persons’ Transitions in Care (OPTIC) study, we collected information on residents’ transitions in two Western Canadian cities. We applied the IOM’s Quality of Care Domains to the OPTIC data to create binary measures of transition quality. We report the median (MED) per cent and IQR of measures met within each domain of quality.ResultsWe tracked 637 transitions over a 12-month period, with data collected from each setting. We developed 19 safety measures, 20 measures of resident-centred care, 3 measures of timely care and 5 measures of effective care. We were unable to develop measures for equitable care at an individual transfer level. Domain scores varied across individual transitions, with the highest scores in safety (MED 79%, IQR: 63–95), efficiency (66%; IQR: 66–99), and resident-centred (45%; IQR: 25–65), followed by effectiveness (36%; IQR: 16–56), and timeliness (0%; IQR: 0–50).ConclusionsOur results show variation in scores across the domains of quality suggesting that it is possible to track quality of transitions for individuals across all settings, and not only within settings. We recommend that future work in tracking quality of care be performed at several levels (LTC, region, health authority, province). Such tracking is necessary to evaluate and improve overall quality of care.
Evaluation of the Post-COVID-19 Functional Status (PCFS) Scale in a cohort of patients recovering from hypoxemic SARS-CoV-2 pneumonia
Authors: Benkalfate Naïla , Eschapasse Emmanuel , Georges Thomas , Leblanc Camille , Dirou Stephanie , Melscoet Lise , Chéné Anne-Laure , Horeau-Langlard Delphine , Bry Charlotte , Chambellan Arnaud , Nicolas Aymeric , Claire Defrance , Liberge Renan , Karakachoff Matilde , Hardouin Jean-Benoit , Blanc François-Xavier , Lemarchand Patricia 
Published: March 2022

IntroductionCOVID-19 sequelae are numerous and multisystemic, and how to evaluate those symptomatic patients is a timely issue. Kloket alproposed the Post-COVID-19 Functional Status (PCFS) Scale as an easy tool to evaluate limitations related to persistent symptoms. Our aim was to analyse PCFS Scale ability to detect functional limitations and its correlation with quality of life in a cohort of patients, 2–9 months after hospitalisation for COVID-19 hypoxemic pneumonia.MethodsPCFS Scale was evaluated in 121 patients together with quality of life and dyspnoea questionnaires, pulmonary function tests and CT scans.ResultsWe observed a high correlation with multiple questionnaires (Short Form-36, Hospital Anxiety and Depression Scale, modified Medical Research Council, end Borg Six-Minute Walk Test), making the PCFS Scale a quick and global tool to evaluate functional limitations related to various persistent symptoms following COVID-19 pneumonia.DiscussionThe PCFS Scale seems to be a suitable instrument to screen for patients who will require careful follow-up after COVID-19 hypoxemic pneumonia even in the absence of pulmonary sequelae.
Phase IB study of ziv-aflibercept plus pembrolizumab in patients with advanced solid tumors
Authors: Rahma Osama E , Tyan Kevin , Giobbie-Hurder Anita , Brohl Andrew S , Bedard Philippe L , Renouf Daniel J , Sharon Elad , Streicher Howard , Hathaway Emma , Cunningham Rachel , Manos Michael , Severgnini Mariano , Rodig Scott , Stephen Hodi F 
Published: March 2022

BackgroundThe combination of antiangiogenic agents with immune checkpoint inhibitors could potentially overcome immune suppression driven by tumor angiogenesis. We report results from a phase IB study of ziv-aflibercept plus pembrolizumab in patients with advanced solid tumors.MethodsThis is a multicenter phase IB dose-escalation study of the combination of ziv-aflibercept (at 2–4 mg/kg) plus pembrolizumab (at 2 mg/kg) administered intravenously every 2 weeks with expansion cohorts in programmed cell death protein 1 (PD-1)/programmed death-ligand 1(PD-L1)-naïve melanoma, renal cell carcinoma (RCC), microsatellite stable colorectal cancer (CRC), and ovarian cancer. The primary objective was to determine maximum tolerated dose (MTD) and recommended dose of the combination. Secondary endpoints included overall response rate (ORR) and overall survival (OS). Exploratory objectives included correlation of clinical efficacy with tumor and peripheral immune population densities.ResultsOverall, 33 patients were enrolled during dose escalation (n=3) and dose expansion (n=30). No dose-limiting toxicities were reported in the initial dose level. Ziv-aflibercept 4 mg/kg plus pembrolizumab 2 mg/kg every 2 weeks was established as the MTD. Grade ≥3 adverse events occurred in 19/33 patients (58%), the most common being hypertension (36%) and proteinuria (18%). ORR in the dose-expansion cohort was 16.7% (5/30, 90% CI 7% to 32%). Complete responses occurred in melanoma (n=2); partial responses occurred in RCC (n=1), mesothelioma (n=1), and melanoma (n=1). Median OS was as follows: melanoma, not reached (NR); RCC, 15.7 months (90% CI 2.5 to 15.7); CRC, 3.3 months (90% CI 0.6 to 3.4); ovarian, 12.5 months (90% CI 3.8 to 13.6); other solid tumors, NR. Activated tumor-infiltrating CD8 T cells at baseline (CD8+PD1+), high CD40L expression, and increased peripheral memory CD8 T cells correlated with clinical response.ConclusionThe combination of ziv-aflibercept and pembrolizumab demonstrated an acceptable safety profile with antitumor activity in solid tumors. The combination is currently being studied in sarcoma and anti-PD-1-resistant melanoma.Trial registration numberNCT02298959.