bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy
Authors: Trotta Francesco , Belleudi Valeria , Fusco Danilo , Amato Laura , Mecozzi Alessandra , Mayer Flavia , Sansone Massimo , Davoli Marina , Addis Antonio 
Published: March 2017

ObjectivesTo evaluate the benefit/risk profile of epoetin α biosimilar with the erythropoiesis-stimulating agents (ESAs) originators when administered to naïve patients from clinical practice.DesignPopulation-based observational cohort study.SettingAll residents in the Lazio Region, Italy, with chronic kidney disease (CKD) or cancer retrieved from the Electronic Therapeutic Plan (ETP) Register for ESA between 2012 and 2014.ParticipantsOverall, 13 470 incident ESA users were available for the analysis, 8161 in the CKD and 5309 in the oncology setting, respectively.InterventionsESAs identified through the ATC B03XA were divided into 3 groups: (1) biosimilars; (2) epoetin α originator and (3) other originators. Patients were exposed to ESAs from the date of activation of the ETP, until the end of a 6-month follow-up period.Outcome measuresEffectiveness (all-cause mortality and blood transfusion) and safety (major cardiovascular events, blood dyscrasia). A composite outcome including all-cause mortality, blood transfusion and major cardiovascular events was predefined. HRs of any outcome were estimated through Cox regression.ResultsWe found no differences between patients on biosimilars or all originators with regard to the risk estimates of all-cause mortality, blood transfusion, major cardiovascular events and blood dyscrasia in the CKD setting. The composite outcome confirmed these results (biosimilars vs epoetin α originators: adjusted HR=1.02, 95% CI 0.78 to 1.33; biosimilars vs other originators: adjusted HR=1.09, 95% CI 0.85 to 1.41). Comparable risk estimates were observed between biosimilars and all originators in the oncology setting.ConclusionsIn both settings, our findings are suggestive of no difference between biosimilars and originators on relevant effectiveness and safety outcomes. This study may contribute to settling future drug policy for the health services and provides reassurance on the approval pathway for biosimilars. The oncology setting merits further research, taking into account tumour types, tumour stage and anticancer chemotherapy administered.
QUIT EMR trial: a prospective, observational, multicentre study to evaluate quality and 24 hours post-transport morbidity of interhospital transportation of critically ill patients: study protocol
Authors: Strauch Ulrich , Bergmans Dennis C J J , Habers Joachim , Jansen Jochen , Winkens Bjorn , Veldman Dirk J , Roekaerts Paul M H J , Beckers Stefan K 
Published: March 2017

IntroductionIt is widely accepted that transportation of critically ill patients is high risk. Unfortunately, however, there are currently no evidence-based criteria with which to determine the quality of various interhospital transport systems and their impact on the outcomes for patients. We aim to rectify this by assessing 2 scores which were developed in our hospital in a prospective, observational study. Primarily, we will be examining the Quality of interhospital critical care transportation in the Euregion Meuse-Rhine (QUIT EMR) score, which focuses on the quality of the transport system, and secondarily the SEMROS (Simplified EMR outcome score) which detects changes in the patient's clinical condition in the 24 hours following their transportation.Methods and analysisA web-based application will be used to document around 150 pretransport, intratransport and post-transport items of each patient case.To be included, patients must be at least 18-years of age and should have been supervised by a physician during an interhospital transport which was started in the study region.The quality of the QUIT EMR score will be assessed by comparing 3 predefined levels of transport facilities: the high, medium and low standards. Subsequently, SEMROS will be used to determine the effect of transport quality on the morbidity 24 hours after transportation.It is estimated that there will be roughly 3000 appropriate cases suitable for inclusion in this study per year. Cases shall be collected from 1 April 2015 until 31 December 2017.Ethics and disseminationThis trial was approved by the Ethics committees of the university hospitals of Maastricht (Netherlands) and Aachen (Germany). The study results will be published in a peer reviewed journal. Results of this study will determine if a prospective randomised trial involving patients of various categories being randomly assigned to different levels of transportation system shall be conducted.Trial registration numberNTR4937.
From breathless to failure: symptom onset and diagnostic meaning in patients with heart failure—a qualitative study
Authors: Taylor C J , Hobbs F D R , Marshall T , Leyva-Leon F , Gale N 
Published: March 2017

ObjectivesTo explore 2 key points in the heart failure diagnostic pathway—symptom onset and diagnostic meaning—from the patient perspective.DesignQualitative interview study.SettingParticipants were recruited from a secondary care clinic in central England following referral from primary care.ParticipantsOver age 55 years with a recent (<1 year) diagnosis of heart failure confirmed by a cardiologist following initial presentation to primary care.MethodsSemistructured interviews were carried out with 16 participants (11 men and 5 women, median age 78.5 years) in their own homes. Data were audio-recorded and transcribed. Participants were asked to describe their diagnostic journey from when they first noticed something wrong up to and including the point of diagnosis. Data were analysed using the framework method.ResultsParticipants initially normalised symptoms and only sought medical help when daily activities were affected. Failure to realise that anything was wrong led to a delay in help-seeking. Participants' understanding of the term ‘heart failure’ was variable and 1 participant did not know he had the condition. The term itself caused great anxiety initially but participants learnt to cope with and accept their diagnosis over time.ConclusionsGreater public awareness of symptoms and adequate explanation of ‘heart failure’ as a diagnostic label, or reconsideration of its use, are potential areas of service improvement.
Quality of clinical practice guidelines in delirium: a systematic appraisal
Authors: Bush Shirley H , Marchington Katie L , Agar Meera , Davis Daniel H J , Sikora Lindsey , Tsang Tammy W Y 
Published: March 2017

ObjectiveTo determine the accessibility and currency of delirium guidelines, guideline summary papers and evaluation studies, and critically appraise guideline quality.DesignSystematic literature search for formal guidelines (in English or French) with focus on delirium assessment and/or management in adults (≥18 years), guideline summary papers and evaluation studies.Full appraisal of delirium guidelines published between 2008 and 2013 and obtaining a ‘Rigour of Development’ domain screening score cut-off of >40% using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument.Data sourcesMultiple bibliographic databases, guideline organisation databases, complemented by a grey literature search.Results3327 database citations and 83 grey literature links were identified. A total of 118 retrieved delirium guidelines and related documents underwent full-text screening. A final 21 delirium guidelines (with 10 being >5 years old), 12 guideline summary papers and 3 evaluation studies were included. For 11 delirium guidelines published between 2008 and 2013, the screening AGREE II ‘Rigour’ scores ranged from 3% to 91%, with seven meeting the cut-off score of >40%. Overall, the highest rating AGREE II domains were ‘Scope and Purpose’ (mean 80.1%, range 64–100%) and ‘Clarity and Presentation’ (mean 76.7%, range 38–97%). The lowest rating domains were ‘Applicability’ (mean 48.7%, range 8–81%) and ‘Editorial Independence’ (mean 53%, range 2–90%). The three highest rating guidelines in the ‘Applicability’ domain incorporated monitoring criteria or audit and costing templates, and/or implementation strategies.ConclusionsDelirium guidelines are best sourced by a systematic grey literature search. Delirium guideline quality varied across all six AGREE II domains, demonstrating the importance of using a formal appraisal tool prior to guideline adaptation and implementation into clinical settings. Adding more knowledge translation resources to guidelines may improve their practical application and effective monitoring. More delirium guideline evaluation studies are needed to determine their effect on clinical practice.
Maternal education, empowerment, economic status and child polio vaccination uptake in Pakistan: a population based cross sectional study
Authors: Khan Muhammad Tahir , Zaheer Sidra , Shafique Kashif 
Published: March 2017

ObjectivesTo explore the association of maternal education and empowerment with childhood polio vaccination using nationally representative data of Pakistani mothers in a reproductive age group.DesignCross-sectional.SettingSecondary analysis of Pakistan Demographic and Health Survey (PDHS), 2012–2013 data was performed.ParticipantsOf the 13 558 mothers included in the survey sample, 6982 mothers were able to provide information regarding polio vaccinations.Main outcome measuresPolio vaccination coverage among children aged up to 5 years was categorised as complete vaccination (all four oral polio vaccine (OPV) doses), incomplete vaccination, and no vaccination (zero OPV dose received). Mothers' empowerment status was assessed using standard ‘Measure DHS’ questions regarding their involvement in decision-making related to health, household possessions and visits among family and friends. Education was categorised as no education, primary, secondary and higher education. Results of multinomial regression analyses were reported as adjusted OR with 95% CI. We adjusted for age, wealth index, urban/rural residence, place of delivery, and antenatal and postnatal visits.ResultsOnly 56.4% (n=3936) of the children received complete polio vaccination. Women with no education had significantly higher odds of their child receiving no polio vaccination (OR 2.34, 95% CI 1.05 to 5.18; p<0.01) and incomplete vaccination (OR 1.40, 95% CI 1.04 to 1.87; p<0.01). Further, unempowered women also had significantly higher odds of not taking their child for any polio vaccination (OR 1.58, 95% CI 1.17 to 2.12; p<0.01) and incomplete vaccination (OR 1.18, 95% CI 1.00 to 1.41; p=0.04).ConclusionsIlliteracy, socioeconomic status and empowerment of women remained significant factors linked to poorer uptake of routine polio vaccination.
Implementation of ‘Goals of Patient Care’ medical treatment orders in residential aged care facilities: protocol for a randomised controlled trial
Authors: Martin Ruth S , Hayes Barbara J , Hutchinson Anastasia , Yates Paul , Lim Wen Kwang 
Published: March 2017

IntroductionSystematic reviews demonstrate that advance care planning (ACP) has many positive effects for residents of aged care facilities, including decreased hospitalisation. The proposed Residential Aged Care Facility (RACF) ‘Goals of Patient Care’ (GOPC) form incorporates a resident's prior advance care plan into medical treatment orders. Where none exists, it captures residents' preferences. This documentation helps guide healthcare decisions made at times of acute clinical deterioration.Methods and analysisThis is a mixed methods study. An unblinded cluster randomised controlled trial is proposed in three pairs of RACFs. In the intervention arm, GOPC forms will be completed by a doctor incorporating advance care plans or wishes. In the control arm, residents will have usual care which may include an advance care plan. The primary hypothesis is that the GOPC form is superior to standard ACP alone and will lead to decreased hospitalisation due to clearer documentation of residents' medical treatment plans. The primary outcome will be an analysis of the effect of the GOPC medical treatment orders on emergency department attendances and hospital admissions at 6 months. Secondary outcome measurements will include change in hospitalisation rates at 3 and 12 months, length of stay and external mortality rates among others. Qualitative interviews, 12 months post GOPC implementation, will be used for process evaluation of the GOPC and to evaluate staff perceptions of the form's usefulness for improving communication and medical decision-making at a time of deterioration.DisseminationThe results will be disseminated in peer review journals and research conferences. This robust randomised controlled trial will provide high-quality data about the influence of medical treatment orders that incorporate ACP or preferences adding to the current gap in knowledge and evidence in this area.Trial registration numberACTRN12615000298516, Results.
Factors influencing young men's decision to undergo health screening in Malaysia: a qualitative study
Authors: Teo Chin Hai , Ng Chirk Jenn , White Alan 
Published: March 2017

ObjectivesUptake of health screening is low in men, particularly among those aged <40 years. This study aimed to explore factors that influence health screening behaviour in younger men.DesignThis qualitative study employed an interpretive descriptive approach. Two trained researchers conducted in-depth interviews (IDIs) and focus group discussions (FGDs) using a semi-structured topic guide, which was developed based on literature review and behavioural theories. All IDIs and FGDs were audio-recorded and transcribed verbatim. Two researchers analysed the data independently using a thematic approach.Participants and settingMen working in a banking institution in Kuala Lumpur were recruited to the study. They were purposively sampled according to their ethnicity, job position, age and screening status in order to achieve maximal variation.ResultsEight IDIs and five FGDs were conducted (n=31) and six themes emerged from the analysis. (1) Young men did not consider screening as part of prevention and had low risk perception. (2) The younger generation was more receptive to health screening due to their exposure to health information through the internet. (3) Health screening was not a priority in young men except for those who were married. (4) Young men had limited income and would rather invest in health insurance than screening. (5) Young men tended to follow doctors' advice when it comes to screening and preferred doctors of the same gender and ethnicity. (6) Medical overuse was also raised where young men wanted more screening tests while doctors tended to promote unnecessary screening tests to them.ConclusionsThis study identified important factors that influenced young men's screening behaviour. Health authorities should address young men's misperceptions, promote the importance of early detection and develop a reasonable health screening strategy for them. Appropriate measures must be put in place to reduce low value screening practices.
Prevalence of latent TB infection and TB disease among adolescents in high TB burden countries in Africa: a systematic review protocol
Authors: Bunyasi Erick Wekesa , Schmidt Bey-Marrie , Abdullahi Leila Hussein , Mulenga Humphrey , Tameris Michele , Luabeya Angelique , Shenje Justin , Scriba Thomas , Geldenhuys Hennie , Wood Robin , Hatherill Mark 
Published: March 2017

IntroductionAlmost a third of the world population has latent tuberculosis (TB) infection (LTBI), ∼10 million of whom develop TB disease annually, despite existence of effective, but lengthy, preventive and curative drug regimens. Although adolescents appear to have a very high force of LTBI, their reported incidence of TB disease is less than that of their corresponding general population. The few available studies on adolescent TB infection and disease prevalence are not sufficient to address the apparent discordance between rates of infection and disease in high TB burden countries in Africa. Therefore, we aim to perform a systematic review to examine the relationship between adolescent LTBI and TB disease, benchmarked against national TB disease burden data.Methods and analysisA comprehensive literature search will be performed for cross-sectional studies and screening data in cohort studies to determine the prevalence of LTBI and TB disease among adolescents in high TB burden countries in Africa in the following databases:PubMed,Scopus,Cochrane library,Web of Science,Africa Wide,CINAHL and the Africa Index Medicus. This will be supplemented by a search of reference lists of selected articles for potentially relevant articles. We will restrict our search to articles published in the English language between 1990 and 2016 among adolescents in order to obtain estimates reflective of the mature HIV epidemic in most high TB burden countries in Africa that occurred over this critical period. Primary end points are: prevalence of LTBI and TB disease. We will use the random-effects or fixed-effects modelling for our meta-analysis based on heterogeneity estimates.Ethics and disseminationNo ethics approval is required given that this is a systematic review. Findings will be disseminated in a peer-reviewed journal in line with thePreferred Reporting Items for Systematic reviews and Meta-Analyses(PRISMA).Trial registration numberCRD42015023495.
Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: case study evaluation of adoption and maintenance of a complex intervention to reduce high-risk primary care prescribing
Authors: Grant Aileen , Dreischulte Tobias , Guthrie Bruce 
Published: March 2017

ObjectiveTo explore how different practices responded to the Data-driven Quality Improvement in Primary Care (DQIP) intervention in terms of their adoption of the work, reorganisation to deliver the intended change in care to patients, and whether implementation was sustained over time.DesignMixed-methods parallel process evaluation of a cluster trial, reporting the comparative case study of purposively selected practices.SettingTen (30%) primary care practices participating in the trial from Scotland, UK.ResultsFour practices were sampled because they had large rapid reductions in targeted prescribing. They all had internal agreement that the topic mattered, made early plans to implement including assigning responsibility for work and regularly evaluated progress. However, how they internally organised the work varied. Six practices were sampled because they had initial implementation failure. Implementation failure occurred at different stages depending on practice context, including internal disagreement about whether the work was worthwhile, and intention but lack of capacity to implement or sustain implementation due to unfilled posts or sickness. Practice context was not fixed, and most practices with initial failed implementation adapted to deliver at least some elements. All interviewed participants valued the intervention because it was an innovative way to address on an important aspect of safety (although one of the non-interviewed general practitioners in one practice disagreed with this). Participants felt that reviewing existing prescribing did influence their future initiation of targeted drugs, but raised concerns about sustainability.ConclusionsVariation in implementation and effectiveness was associated with differences in how practices valued, engaged with and sustained the work required. Initial implementation failure varied with practice context, but was not static, with most practices at least partially implementing by the end of the trial. Practices organised their delivery of changed care to patients in ways which suited their context, emphasising the importance of flexibility in any future widespread implementation.Trial registration numberNCT01425502.
Identifying, highlighting and reducing polypharmacy in a UK hospice inpatient unit using improvement Science methods
Authors: Phippen Alison , Pickard Jennie , Steinke Douglas , Cope Matt , Roberts Dai 
Published: March 2017

Polypharmacy, the concurrent use of multiple medications by one individual is a growing global issue driven by an ageing population and increasing prevalence of multi-morbidity[1]. Polypharmacy can be problematic: interactions between medications, reduced adherence to medication, burden of medication to patients, administration time, increased risk of errors and increased cost. Quality improvement methods were applied to identify and highlight polypharmacy patients with the aim of reducing their average number of regular tablets/capsules per day by 25%.The project was delivered within a UK based 27 bedded hospice inpatient unit. A series of PDSA cycles studied interventions focusing on the identification of patients with polypharmacy, the highlighting of these patients to prescribers for review and the views of patients about their medication. For the purposes of the study, polypharmacy was defined as greater than ten regular medicines and/or greater than twenty regular tablets/capsules each day. The interventions tested included patients on regular paracetamol and strong opioids being offered a trial without regular paracetamol, a constipation guide promoting the use of combination laxatives, education of prescribers around dose strengths, checklist of recommendations was placed in case notes and a sticker was used on the medicine chart to highlight patients in need of polypharmacy review.The introduction of a trial without paracetamol and a laxative guide led to reductions in polypharmacy. The sticker and checklist were successful interventions for highlighting patients with polypharmacy.Quality improvement methods were used to plan, try, test and implement simple interventions for patients on the hospice inpatient unit. This has led to a 25% reduction in the average regular tablet/capsules burden , a 16% reduction in the average number of regular medications and a 30% reduction in the average volume of liquid medication per patient without an increase in the use of ‘as required’ medication or length of stay.
Movement and physical demands of school and university rugby union match-play in England
Authors: Read Dale , Weaving Daniel , Phibbs Padraic , Darrall-Jones Joshua , Roe Gregory , Weakley Jonathon , Hendricks Sharief , Till Kevin , Jones Ben 
Published: March 2017

BackgroundIn England, rugby union is a popular sport and is widely played within schools. Despite the large participation numbers, the movement and physical demands of the sport and how they progress by age have not been explored.MethodNinety-six male rugby union players wore microtechnology devices during six rugby union matches within the education pathway to investigate the movement and physical demands of match-play. To quantify the positional differences and progression by age, data were obtained for participants at the under 16 (U16) (n=31 participants), under 18 (U18) (n=34 participants) and university (n=31 participants) levels. Players were further divided in forwards and backs. Data were analysed using magnitude-based inferences.ResultsFor the movement demands, U16 total distance and ‘striding’ was likely higher for forwards than backs, whereas at U18, unclear differences were observed and from university players the inverse was observed (very likely). In all age groups sprint distance was likely to very likely greater for backs than forwards. Forwards had greater physical demands than backs at all age groups. For consecutive age groups, U16 had a likely higher relative distance than U18, and U18 had a likely lower relative distance than university players. Physical demands were similar across age groups for forwards, and greater for backs at older age groups.ConclusionThe movement and physical demands of rugby union players participating in schools (U16 and U18), may not be as expected, however, the findings from university players show a similar pattern to the senior game.