bluuebunny/crossref_metadata_2025_split huggingface dataset:
Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill
Authors: Nickels Marc R , Aitken Leanne M , Walsham James , Barnett Adrian G , McPhail Steven M 
Published: October 2017

IntroductionIn-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown.Methods and analysisA single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) a usual care group or (2) a group that receives usual care and additional in-bed cycling sessions. The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire.Ethics and disseminationAppropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.Trial registration numberThis trial has been prospectively registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12616000948493); Pre-results.
A scoping review protocol on the roles and tasks of peer reviewers in the manuscript review process in biomedical journals
Authors: Glonti Ketevan , Cauchi Daniel , Cobo Erik , Boutron Isabelle , Moher David , Hren Darko 
Published: October 2017

IntroductionThe primary functions of peer reviewers are poorly defined. Thus far no body of literature has systematically identified the roles and tasks of peer reviewers of biomedical journals. A clear establishment of these can lead to improvements in the peer review process. The purpose of this scoping review is to determine what is known on the roles and tasks of peer reviewers.MethodsWe will use the methodological framework first proposed by Arksey and O’Malley and subsequently adapted by Levacet aland the Joanna Briggs Institute. The scoping review will include all study designs, as well as editorials, commentaries and grey literature. The following eight electronic databases will be searched (from inception to May 2017): Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, EMBASE, MEDLINE, PsycINFO, Scopus and Web of Science. Two reviewers will use inclusion and exclusion criteria based on the ‘Population–Concept–Context’ framework to independently screen titles and abstracts of articles considered for inclusion. Full-text screening of relevant eligible articles will also be carried out by two reviewers. The search strategy for grey literature will include searching in websites of existing networks, biomedical journal publishers and organisations that offer resources for peer reviewers. In addition we will review journal guidelines to peer reviewers on how to perform the manuscript review. Journals will be selected using the 2016 journal impact factor. We will identify and assess the top five, middle five and lowest-ranking five journals across all medical specialties.Ethics and disseminationThis scoping review will undertake a secondary analysis of data already collected and does not require ethical approval. The results will be disseminated through journals and conferences targeting stakeholders involved in peer review in biomedical research.
Identifying and sharing data for secondary data analysis of physical activity, sedentary behaviour and their determinants across the life course in Europe: general principles and an example from DEDIPAC
Authors: Lakerveld Jeroen , Loyen Anne , Ling Fiona Chun Man , De Craemer Marieke , van der Ploeg Hidde P , O’Gorman Donal J , Carlin Angela , Caprinica Laura , Kalter Joeri , Oppert Jean-Michel , Chastin Sebastian , Cardon Greet , Brug Johannes , MacDonncha Ciaran 
Published: October 2017

BackgroundThe utilisation of available cross-European data for secondary data analyses on physical activity, sedentary behaviours and their underlying determinants may benefit from the wide variation that exists across Europe in terms of these behaviours and their determinants. Such reuse of existing data for further research requires Findable; Accessible; Interoperable; Reusable (FAIR) data management and stewardship. We here describe the inventory and development of a comprehensive European dataset compendium and the process towards cross-European secondary data analyses of pooled data on physical activity, sedentary behaviour and their correlates across the life course.MethodsA five-step methodology was followed by the European Determinants of Diet and Physical Activity (DEDIPAC) Knowledge Hub, covering the (1) identification of relevant datasets across Europe, (2) development of a compendium including details on the design, study population, measures and level of accessibility of data from each study, (3) definition of key topics and approaches for secondary analyses, (4) process of gaining access to datasets and (5) pooling and harmonisation of the data and the development of a data harmonisation platform.ResultsA total of 114 unique datasets were found for inclusion within the DEDIPAC compendium. Of these datasets, 14 were eventually obtained and reused to address 10 exemplar research questions. The DEDIPAC data harmonisation platform proved to be useful for pooling, but in general, harmonisation was often restricted to just a few core (crude) outcome variables and some individual-level sociodemographic correlates of these behaviours.ConclusionsObtaining, pooling and harmonising data for secondary data analyses proved to be difficult and sometimes even impossible. Compliance to FAIR data management and stewardship principles currently appears to be limited for research in the field of physical activity and sedentary behaviour. We discuss some of the reasons why this might be the case and present recommendations based on our experience.
Future trends in the prevalence of severe activity limitations among older adults in Europe: a cross-national population study using EU-SILC
Authors: Scherbov Sergei , Weber Daniela 
Published: October 2017

ObjectiveTo project the proportion of population 65+ years with severe long-term activity limitations from 2017 to 2047.DesignLarge population study.SettingPopulation living in private households of the European Union (EU) and neighbouring countries.ParticipantsParticipants from the EU Statistics on Income and Living Conditions aged 55 years and older and living in one of 26 EU and neighbouring countries, who answered the health section of the questionnaire.Outcome measuresPrevalence of severe long-term activity limitations of particular subpopulations (ie, 55+, 65+, 75+ and 85+ years) by sex and country.ResultsWe find a huge variation in the prevalence of self-reported severe long-term limitations across Europe for both sexes. However, in 2017, about 20% of the female population aged 65 years and above and about 16% of their male counterparts are expected to report severe long-term activity limitations after accounting for differences in reporting. Accounting for cultural differences in reporting, we expect that European countries will have about 21% (decile 1: 19.5%; decile 9: 22.9%) of female and about 16.8% (decile 1: 15.4%; decile 9: 18.1%) of male 65+ years population with severe long-term activity limitations by 2047.ConclusionsOverall, despite the expected increase of life expectancy in European countries, our results suggest almost constant shares of older adults with severe long-term activity limitations within the next 30 years.
Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods
Authors: Thompson Rachel , Manski Ruth , Donnelly Kyla Z , Stevens Gabrielle , Agusti Daniela , Banach Michelle , Boardman Maureen B , Brady Pearl , Colón Bradt Christina , Foster Tina , Johnson Deborah J , Li Zhongze , Norsigian Judy , Nothnagle Melissa , Olson Ardis L , Shepherd Heather L , Stern Lisa F , Tosteson Tor D , Trevena Lyndal , Upadhya Krishna K , Elwyn Glyn 
Published: October 2017

IntroductionDespite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods.Methods and analysisWe will conduct a 2×2 factorial cluster randomised controlled trial with four arms: (1) video+prompt card, (2) decision aids+training, (3) video+prompt cardanddecision aids+training and (4) usual care. The clusters will be clinics in USA that deliver contraceptive care. The participants will be people who have completed a healthcare visit at a participating clinic, were assigned female sex at birth, are aged 15–49 years, are able to read and write English or Spanish and have not previously participated in the study. The primary outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the occurrence of a conversation about contraception in the healthcare visit, satisfaction with the conversation about contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy and unwelcome pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the healthcare visit, four weeks later and six months later.Ethics and disseminationWe will disseminate results via presentations at scientific and professional conferences, papers published in peer-reviewed, open-access journals and scientific and lay reports. We will also make an anonymised copy of the final participant-level dataset available to others for research purposes.Trial registration numberClinicalTrials.gov Identifier:NCT02759939.
A longitudinal study to assess the frequency and cost of antivascular endothelial therapy, and inequalities in access, in England between 2005 and 2015
Authors: Hollingworth William , Jones Tim , Reeves Barnaby C , Peto Tunde 
Published: October 2017

ObjectivesHigh-cost antivascular endothelial growth factor (anti-VEGF) medicines for eye disorders challenge ophthalmologists and policymakers to provide fair access for patients while minimising costs. We describe the growth in the use and costs of these medicines and measure inequalities in access.DesignLongitudinal study using Hospital Episode Statistics (2005/2006 to 2014/2015) and hospital prescribing cost reports (2008/2009 to 2015/2016). We used Poisson regression to estimate standardised rates and explore temporal and geographical variations.SettingNational Health Service (NHS) care in England.PopulationPatients receiving anti-VEGF injections for age-related macular degeneration, diabetic macular oedema and other eye disorders.InterventionsHigher-cost drugs (ranibizumab or aflibercept) recommended by the National Institute for Health and Care Excellence or lower-cost drug (bevacizumab) not licensed for eye disorders.Main outcome measuresNational procedure rates and variation between and within clinical commissioning groups (CCGs). Cost of ranibizumab and aflibercept prescribing.ResultsInjection procedures increased by 215% between 2010/2011 and 2014/2015. In 2014/2015 there were 388 031 procedures (714 per 100 000). There is no evidence that the dramatic growth in rates is slowing down. Since 2010/2011 the estimated cost of ranibizumab and aflibercept increased by 247% to £447 million in 2015/2016, equivalent to the entire annual budget of a CCG. There are large inequalities in access; in 2014/2015 procedure rates in a ‘high use’ CCG were 9.08 times higher than in a ‘low use’ CCG. In the South-West of England there was twofold variation in injections per patient per year (range 2.9 to 5.9).ConclusionsThe high and rising cost of anti-VEGF therapy affects the ability of the NHS to provide care for other patients. Current regulations encourage the increasing use of ranibizumab and aflibercept rather than bevacizumab, which evidence suggests is more cost-effective. NHS patients in England do not have equal access to the most cost-effective care.
Biopsychosocial Intervention for Stroke Carers (BISC): protocol for a feasibility randomised controlled trial (RCT)
Authors: Walker Marion F , Thomas Shirley A , Whitehead Phillip J , Condon Laura , Fisher Rebecca J , Kontou Eirini , Benford Penny , Cobley Christine 
Published: October 2017

IntroductionReducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers’ needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).Methods and analysisFeasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life.Ethics and disseminationFavourable ethical opinion was provided by East Midlands – Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.Trial registration numberISRCTN15643456; Pre-results.
Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis
Authors: Lexchin Joel 
Published: October 2017

ObjectivesInvestigate if the recommendations by the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR) to provincial, territorial and federal drug plans about whether to list non-oncology and oncology drug-indication combinations on their formularies are associated with whether the drug-indication combination was approved via the standard evidence pathway or the Notice of Compliance with conditions (NOC/c—limited evidence) pathway.DesignCohort study.Data sourcesWebsites of the CDR and pCODR up to the end of 31 March 2017; journal articles evaluating drugs approved through the NOC/c pathway, the NOC database, the NOC/c website and the Summary Basis of Decision website.InterventionsRecommendations by the CDR and pCODR.Primary and secondary outcome measuresAnalysis of the percent of drugs receiving positive listing recommendations from CDR and pCODR depending on the pathway used to approve the drug.ResultsThere were 310 recommendations for drug-indication combinations from the CDR and 79 from the pCODR. There was a statistically significant difference in the number of drug-indication combinations that received a list versus do not list recommendation from the CDR for those approved through the standard pathway compared with those approved through the NOC/c pathway (p=0.0407). A similar analysis for recommendations from the pCODR was not statistically significant.ConclusionFor non-oncology drug-indication combinations, the type of review appears to influence the recommendation regarding listing on public formularies. This difference may reflect the level of evidence about the efficacy and safety of the drug indication at the time the recommendation was made.
Factors associated with quality of life in elderly hospitalised patients undergoing post-acute rehabilitation: a cross-sectional analytical study in Switzerland
Authors: Bornet Marc-Antoine , Rubli Truchard Eve , Rochat Etienne , Pasquier Jérôme , Monod Stéfanie 
Published: October 2017

ObjectivesWe investigated whether biopsychosocial and spiritual factors and satisfaction with care were associated with patients’ perceived quality of life.DesignThis was a cross-sectional analytical study.SettingData were collected from inpatients at a postacute geriatric rehabilitation centre in a university hospital in Switzerland.ParticipantsParticipants aged 65 years and over were consecutively recruited from October 2014 to January 2016. Exclusion criteria included significant cognitive disorder and terminal illness. Of 227 eligible participants, complete data were collected from 167.Main outcome measuresPerceived quality of life was measured using WHO Quality of Life Questionnaire—version for older people. Predictive factors were age, sex, functional status at admission, comorbidities, cognitive status, depressive symptoms, living conditions and satisfaction with care. A secondary focus was the association between spiritual needs and quality of life.ResultsPatients undergoing geriatric rehabilitation experienced a good quality of life. Greater quality of life was significantly associated with higher functional status (rs=0.204, p=0.011), better cognitive status (rs=0.175, p=0.029) and greater satisfaction with care (rs=0.264, p=0.003). Poorer quality of life was significantly associated with comorbidities (rs=−.226, p=0.033), greater depressive symptoms (rs=−.379, p<0.001) and unmet spiritual needs (rs=−.211, p=0.049). Multivariate linear regression indicated that depressive symptoms (β=−0.961; 95% CIs −1.449 to 0.472; p<0.001) significantly predicted quality of life.ConclusionsPatient perceptions of quality of life were significantly associated with depression. More research is needed to assess whether considering quality of life could improve care plan creation.
Improving best possible medication history with vulnerable patients at an urban safety net academic hospital using pharmacy technicians
Authors: Sadasivaiah Shobha , Smith David E , Goldman Seth , Ratanawongsa Neda 
Published: October 2017

BackgroundBest possible medication history (BPMH) enhances the care of safety net patients, especially those with limited English proficiency and limited health literacy who are most vulnerable to medication error during the hospital admission process. Our large urban academic safety net centre faced numerous barriers to achieve BPMH among hospitalised patients including communication barriers that increase the time and complexity of eliciting BPMH, frequent provider turnover at our training institution and lack of an electronic health record (EHR) medication reconciliation tool to facilitate BPMH collection and monitoring.DesignLeveraging opportunities afforded by the US federal incentive EHR programme, our multidisciplinary team designed an EHR-facilitated medication reconciliation programme by which pharmacy technicians engaged newly admitted patients and their caregivers at the bedside to develop and electronically document the BPMH.StrategyPrior to this intervention, pharmacy technicians had no role in BPMH. Providers collected home medications documented on paper notes without a consistent methodology. With each plan–do–study–act (PDSA) cycle since the programme began, the goal was to increase the per cent of BPMH completed by a pharmacy technician. Individual PDSA cycles targeted either the pharmacy technicians by expanding their pool of eligible patients or provider engagement with the pharmacy technician workflow.ResultsBy optimising not only the health information technology platform but also the operational processes, the programme achieved a nearly 80% generation of BPMH completed by a highly trained pharmacy technician, surpassing its intended goal of 50% BPMH completion by a pharmacy technician on admission.ConclusionAn EHR-facilitated tool improved BPMH at an urban academic safety net hospital using pharmacy technicians.
Reducing radiation hazard opportunities in neonatal unit: quality improvement in radiation safety practices
Authors: Edison Priyantha , Chang Pi Sun , Toh Guan Hong , Lee Li Na , Sanamandra Sarat Kumar , Shah Varsha Atul 
Published: October 2017

AimGuided by the ALARA - "As Low As Reasonably Achievable" principle in radiation safety, a quality improvement project to optimise the bedside diagnostic imaging process to the best standards of care was conducted over a six month period. The goal was too reduce the radiation hazard opportunities in the neonatal intensive care unit by at least 75% from the existing level at Q2/2015, within 6 months.MethodsThe existing bedside imaging process was critically analysed and the following quality improvement initiatives were implemented namely , mandatory lead protective gear to healthcare staff, gonadal shield for neonates, guidelines for optimal collimation of X-ray beam and optimal positioning of neonates. Radiation dosimetry results, regular staff awareness sessions and strong collaboration between neonatologists, radiologists, radiographers and neonatal nurses helped to ensure compliance to the revised imaging process. Radiation hazard opportunities were measured by analysing all radiographs done during the period under baby exposure and healthcare staff exposure categories.Summary of resultsRadiation hazard opportunities were reduced by 100% to healthcare staff and 75% to neonates, and the overall reduction was 83%. The rate of discordance between radiograph request forms and images taken was measured as a surrogate marker for compliance to the project initiatives and it declined by 77%. Mandatory orientation of staff to the revised policy on the standardised diagnostic imaging process, regular radiation awareness talks and staff feedback sessions are among several measures taken to sustain the project.