bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol for a prospective cohort study: Prevention of Transmissions by Effective Colonisation Tracking in Neonates (PROTECT-Neo)
Authors: Götting Tim , Reuter Sandra , Jonas Daniel , Hentschel Roland , Henneke Philipp , Klotz Daniel , Hock Simone , Wolkewitz Martin , Blümel Benjamin , Häcker Georg , Grundmann Hajo , Mutters Nico 
Published: September 2020

IntroductionTransmissions of opportunistic bacterial pathogens between neonates increase the risk of infections with negative repercussions, including higher mortality, morbidity and permanent disabilities. The probability of transmissions between patients is contingent on a set of intrinsic (patient-related) and extrinsic (ward-related) risk factors that are not clearly quantified. It is the dual objective of the Prevention of Transmissions by Effective Colonisation Tracking-Neo study to determine the density of transmission events in a level III neonatal intensive care unit (NICU) and to identify risk factors that may be causally associated with transmission events.Methods and analysisA full cohort of patients treated in a 17-bed level III NICU will be prospectively followed and transmission events between two or more patients will be documented. A transmission event occurs when isogenic isolates from two different patients can be identified. Isolates will be obtained by routine weekly screening. Isogenicity will be determined by whole-genome sequencing. During the study, relevant intrinsic and extrinsic risk factors will be recorded. Specimen and data will be collected for 1 year. We postulate that transmission density increases during episodes when demand for intensive care cannot be met by existing staff, and that threshold dynamics have a bearing on cohorting and hand hygiene performance. Poisson logistic regression, proportional hazard and multilevel competing risk models will be used to estimate the effect of explanatory variables.Ethics and disseminationThis study has been approved by the local ethics committee (study ID 287/18). The results will be published in peer-reviewed medical journals, communicated to participants, the general public and all relevant stakeholders.Trial registration numberThe German Clinical Trials Registry (DRKS00017733); Pre-results.
Antibiotic-induced changes in the human gut microbiota for the most commonly prescribed antibiotics in primary care in the UK: a systematic review
Authors: Elvers Karen T , Wilson Victoria J , Hammond Ashley , Duncan Lorna , Huntley Alyson L , Hay Alastair D , van der Werf Esther T 
Published: September 2020

ObjectiveThe gut microbiota influences many aspects of human health. We investigated the magnitude and duration of changes in gut microbiota in response to antibiotics commonly prescribed in UK primary care.MethodsWe searched MEDLINE, EMBASE and AMED, all years up to May 2020 including all study designs, collecting and analysing data on the effect of antibiotics prescribed for respiratory and urinary tract infections. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane standard methods. Risk of bias was evaluated using the Critical Appraisal Skills Programme. Narrative synthesis was used to report the themes emerging from the data.Main outcome measuresPrimary outcomes were antibiotic-induced changes in the composition and/or diversity of the gut microbiota. Secondary outcome was the time for the microbiota to return to baseline.ResultsThirty-one articles with low or unclear risk of bias showed that antibiotics impact the gut microbiota by causing rapid and diminished levels of bacterial diversity and changes in relative abundances. After cessation of treatment, gut bacteria recover, in most individuals, to their baseline state within a few weeks. Some studies suggested longer term effects from 2 to 6 months. Considerable heterogeneity in methodology makes the studies prone to biases and other confounding factors. Doxycycline was associated with a marked short-term decrease inBifidobacteriumdiversity. Clarithromycin decreased the populations of Enterobacteria, and the anaerobic bacteriaBifidobacteriumsp andLactobacillussp in numbers and diversity for up to 5 weeks. Phenoxymethylpenicillin, nitrofurantoin and amoxicillin had very little effect on the gut microbiome.ConclusionsDespite substantial heterogeneity of the studies and small sample sizes, there is evidence that antibiotics commonly used in primary care influence the composition of the gastrointestinal microbiota. Larger population-based studies are needed to fully understand how antibiotics modulate the microbiota, and to determine if these are associated with (longer term) health consequences.PROSPERO registration numberCRD42017073750.
Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol
Authors: Mazza Danielle , Amos Natalie , Watson Cathy J , McGeechan Kevin , Haas Marion , Peipert Jeffrey F , Lucke Jayne , Taft Angela , McNamee Kathleen , Black Kirsten I 
Published: September 2020

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more ‘mainstream’ strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.
Overcoming barriers to engagement and adherence to a home-based physical activity intervention for patients with heart failure: a qualitative focus group study
Authors: Okwose Nduka C , O'Brien Nicola , Charman Sarah , Cassidy Sophie , Brodie David , Bailey Kristian , MacGowan Guy A , Jakovljevic Djordje G , Avery Leah 
Published: September 2020

ObjectivesClinical guidelines recommend regular physical activity for patients with heart failure to improve functional capacity and symptoms and to reduce hospitalisation. Cardiac rehabilitation programmes have demonstrated success in this regard; however, uptake and adherence are suboptimal. Home-based physical activity programmes have gained popularity to address these issues, although it is acknowledged that their ability to provide personalised support will impact on their effectiveness. This study aimed to identify barriers and facilitators to engagement and adherence to a home-based physical activity programme, and to identify ways in which it could be integrated into the care pathway for patients with heart failure.DesignA qualitative focus group study was conducted. Data were analysed using thematic analysis.ParticipantsA purposive sample of 16 patients, 82% male, aged 68±7 years, with heart failure duration of 10±9 years were recruited.InterventionA 12-week behavioural intervention targeting physical activity was delivered once per week by telephone.ResultsTen main themes were generated that provided a comprehensive overview of the active ingredients of the intervention in terms of engagement and adherence. Fear of undertaking physical activity was reported to be a significant barrier to engagement. Influences of family members were both barriers and facilitators to engagement and adherence. Facilitators included endorsement of the intervention by clinicians knowledgeable about physical activity in the context of heart failure; ongoing support and personalised feedback from team members, including tailoring to meet individual needs, overcome barriers and increase confidence.ConclusionsEndorsement of interventions by clinicians to reduce patients’ fear of undertaking physical activity and individual tailoring to overcome barriers are necessary for long-term adherence. Encouraging family members to attend consultations to address misconceptions and fear about the contraindications of physical activity in the context of heart failure should be considered for adherence, and peer-support for long-term maintenance.Trial registration numberNCT03677271.
Nurse-led patient-centred intervention to increase written advance directives for outpatients in early-stage palliative care: study protocol for a randomised controlled trial with an embedded explanatory qualitative study
Authors: Iglesias Katia , Busnel Catherine , Dufour Florian , Pautex Sophie , Séchaud Laurence 
Published: September 2020

IntroductionDiscussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals. Helping people discuss and formalise their preferences in end-of-life care, as planned in the Go Wish intervention, could reduce health-related anxiety in the advance care planning (ACP) and advance directive (AD) process. The aims of this study are (1) to test the effectiveness of the Go Wish intervention among outpatients in early-stage palliative care and (2) to understand the role of defence mechanisms in end-of-life discussions among nurses, patients and relatives.Methods and analysisA mixed-methods study will be performed. A cluster randomised controlled trials with three parallel arms will be conducted with 45 patients with chronic progressive diseases impacting life expectancy in each group: (1) Group A, Go Wish intervention for patients and their relatives; (2) Group A, Go Wish intervention for patients alone and (3) Group B, for patients (with a waiting list), who will receive the standardised information on ADs (usual care). Randomisation will be at the nurse level as each patient is referred to one of the 20 participating nurses (convenience sample of 20 nurses). A qualitative study will be conducted to understand the cognitive and emotional processes and experiences of nurses, patients and relatives confronted with end-of-life discussions. The outcome measurements include the completion of ADs (yes/no), anxiety, quality of communication about end-of-life care, empowerment, quality of life and attitudes towards ADs.Ethics and disseminationThe study protocol has been approved by the Human Research Ethics Committee of the Canton of Geneva, Switzerland (no. 2019–00922). The findings will be disseminated to practice (nurses, patients and relatives), to national and international scientific conferences, and peer-reviewed journals covering nursing science, psychology and medicine.Trial registration numberNCT04065685.
Is it necessary for children to receive professional fluoride in addition to regular fluoride toothpaste? Protocol for a systematic review
Authors: Yu Lintong , Yu Xueqian , Li Yueyang , Li Jun , Hua Fang , Song Guangtai 
Published: September 2020

IntroductionRegular toothbrushing with fluoride toothpaste is a fundamental intervention for caries prevention. Professional fluoride application (PFA) is widely considered a beneficial supplement to the routine use of fluoride toothpaste. However, some recent studies have failed to demonstrate the preventive effect of PFA. In addition, an increasing number of studies have highlighted the potential adverse effects of fluoride. However, little information exists on the effectiveness of additional PFA. The objective of this review is to systematically analyse the efficacy of PFA in addition to regular fluoride toothpaste among children under the age of 16.Method and analysisWe will search the PubMed, Embase, Google Scholar and Cochrane Central Register of Controlled Trials databases for randomised controlled trials without language or publication date restrictions. Additional studies will be identified by manually searching the reference lists of the included studies and relevant reviews. At least two authors will carry out the selection of studies independently and in duplicate. The Cochrane Risk of Bias tool will be used to assess the risk of bias of the included studies. The random effects model will be used for meta-analyses. The data synthesis will be conducted using Review Manager software (RevMan V.5.3). The Grading of Recommendation, Assessment, Development and Evaluation will be used to assess the quality of supporting evidence for each major comparison.Ethics and disseminationThere is no need for ethical approval. The results of this review will be disseminated through peer-reviewed publications and social networks.PROSPERO registration numberCRD42020165270
Variation in changes in the incidence of colorectal cancer by age and association with screening uptake: an observational study
Authors: Clark Gavin RC , Anderson Annie S , Godfrey Thomas G , Strachan Judith A , Fraser Callum G , Steele Robert JC 
Published: September 2020

ObjectivesIn developed countries, the incidence of colorectal cancer (CRC) has declined in the over 50 years age group but increased in younger people. We studied CRC incidence by age and the influence of screening uptake.DesignAge-standardised and sex-standardised incidences for CRC from 1997 to 2017 were obtained from the Scottish Cancer Registry (SCR). In addition, linkage between the Scottish Bowel Screening Database and the SCR allowed investigation of any association between screening participation and CRC incidence.SettingScotland and the Scottish Bowel Screening Programme, in which guaiac faecal occult blood test screening was piloted from March 2000 and fully rolled by December 2009.ParticipantsFrom the introduction of screening in 2000 through to 2017, 2 395 172 were invited to participate, of whom 1 487 999 participated at least once.Main outcome measuresIncidence of CRC.ResultsIn the screening age range (50–74 years), CRC incidence peaked at 156.5 cases per 100 000 in 2010 after full roll-out of screening across Scotland but fell to 123.9 per 100 000 in 2017. However, under 50 years, there was a rise from 5.3 cases per 100 000 in 2000 to 6.8 per 100 000 in 2017. When CRC incidence was examined in those who had been offered screening, incidence fell in the participant group more than in the non-participant group after roll-out of screening was complete. Analysis of cumulative incidence demonstrated that CRC incidence in the participant group remained consistently below that of the non-participant from around 7 years of follow-up.ConclusionsThe incidence of CRC in Scotland has declined in the over 50 years age group but increased in younger people. It is likely that population screening has contributed to the reduction in CRC incidence in the over 50 years age group.
Ability of fabric face mask materials to filter ultrafine particles at coughing velocity
Authors: O'Kelly Eugenia , Pirog Sophia , Ward James , Clarkson P John 
Published: September 2020

ObjectiveWe examined the ability of fabrics which might be used to create home-made face masks to filter out ultrafine (0.02–0.1 µm) particles at the velocity of adult human coughing.MethodsTwenty commonly available fabrics and materials were evaluated for their ability to reduce air concentrations of ultrafine particles at coughing face velocities. Further assessment was made on the filtration ability of selected fabrics while damp and of fabric combinations which might be used to construct home-made masks.ResultsSingle fabric layers blocked a range of ultrafine particles. When fabrics were layered, a higher percentage of ultrafine particles were filtered. The average filtration efficiency of single layer fabrics and of layered combination was found to be 35% and 45%, respectively. Non-woven fusible interfacing, when combined with other fabrics, could add up to 11% additional filtration efficiency. However, fabric and fabric combinations were more difficult to breathe through than N95 masks.ConclusionsThe current coronavirus pandemic has left many communities without access to N95 face masks. Our findings suggest that face masks made from layered common fabric can help filter ultrafine particles and provide some protection for the wearer when commercial face masks are unavailable.
Evaluating level of adherence to nicotine replacement therapy and its impact on smoking cessation: a protocol for systematic review and meta-analysis
Authors: Mersha Amanual Getnet , Eftekhari Parivash , Bovill Michelle , Tollosa Daniel Nigusse , Gould Gillian Sandra 
Published: September 2020

IntroductionNicotine replacement therapy (NRT) has proven effective for smoking cessation in clinical trials, however it was found less effective in population-based studies, potentially due to inconsistent or incorrect use of NRT. The aim of this paper is to describe a systematic review protocol to evaluate level of adherence to NRT; the discrepancy of adherence to NRT in clinical and population-based studies and degree of association between level of adherence and success of smoking cessation.Methods and analysisLiterature search will use five databases (Medline, Scopus, Embase, CINAHL and PsycINFO). Studies will be appraised for methodological quality using National Institutes of Health Quality Assessment Tool. To reduce heterogeneity, we will analyse clinical trials and population-based studies separately; pooled analyses will be done among studies that used similar measurements. Heterogeneity of studies will be assessed by Higgins’ I2 statistical test. When studies are adequately homogeneous, results will be pooled using random-effects model with proportion and ORs with 95% CIs and p values for each outcome. We will explain sources of heterogeneity by subgroup analysis or sensitivity analysis. Funnel plots and Egger’s regression asymmetry test with p<0.05 will be used as a cut-off point to affirm presence of statistically significant publication bias. Statistical analyses will be carried out using Stata V.16 software. Only studies reporting a valid strategy to control for reverse causality will be included.DiscussionThis review will provide evidence to support the importance of adherence on rate of smoking cessation and level of adherence to NRT. The findings will be used to inform smoking cessation interventions, researchers and policymakers.Ethics and disseminationAs a systematic literature review, this protocol does not require ethics approval. Research outcomes will be presented at relevant conferences and findings will be published in a relevant peer-reviewed journal.PROSPERO registration numberCRD42020176749.
Effectiveness of non-pharmacological interventions to decrease fatigue in people living with HIV/AIDS: a protocol of systematic review and meta-analysis
Authors: Xiao Xueling , Reynolds Nancy R , Saligan Leorey , Lei Yunxiao , Wang Min , Wang Honghong 
Published: September 2020

IntroductionFatigue is a common symptom among people living with HIV (PLWH). It has a substantial adverse impact on functional status and the ability to conduct activities of daily living. Identifying effective strategies to prevent or reduce fatigue is significant to promote the quality of life of this vulnerable population. The purpose of this review is to synthesise the non-pharmacological evidence and assess the effects of interventions on reducing HIV-related fatigue among PLWH.Methods and analysisWe will comprehensively search literature available up to 30 June 2020, in the following databases: PubMed, Embase, CINAHL, Cochrane Library, Web of Science and PsycINFO. The reference list of selected studies and relevant published reviews will also be screened to retrieve potential articles. Two reviewers will identify the eligible articles, extract data and identify the biases in the selected studies. Any disagreements will be referred to a third reviewer. We will qualitatively synthesise the evidence and pool data with meta-analysis according to the heterogeneity of different studies.Ethics and disseminationThis systematic review will not raise any ethical issues since it is a secondary data collection and analysis. The results will inform effective strategies to reduce fatigue among PLWH. The final report will be published in a peer-reviewed journal and academic conferences.PROSPERO registration numberCRD42020153715.
Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults
Authors: Ader Florence 
Published: September 2020

IntroductionTo find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.Methods and analysisDisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β−1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included.Ethics and disseminationInserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04315948 Eudra-CT 2020-000936-23.