bluuebunny/crossref_metadata_2025_split huggingface dataset:
Targeted therapies for previously treated advanced or metastatic renal cell carcinoma: systematic review and network meta-analysis
Authors: Karner Charlotta , Kew Kayleigh , Wakefield Victoria , Masento Natalie , Edwards Steven J 
Published: March 2019

ObjectiveTo compare the effectiveness and safety of treatments for advanced or metastatic renal cell carcinoma (amRCC) after treatment with vascular endothelial growth factor (VEGF)-targeted treatment.DesignSystematic review and network meta-analysis of randomised controlled trials (RCTs) and comparative observational studies. MEDLINE, EMBASE and Cochrane Library were searched up to January 2018.ParticipantsPeople with amRCC requiring treatment after VEGF-targeted treatment.InterventionsAxitinib, cabozantinib, everolimus, lenvatinib with everolimus, nivolumab, sorafenib and best supportive care (BSC).OutcomesPrimary outcomes were overall survival (OS) and progression-free survival (PFS); secondary outcomes were objective response rate (ORR), adverse events, and health-related quality of life (HRQoL).ResultsTwelve studies were included (n=5144): five RCTs and seven observational studies. Lenvatinib with everolimus significantly increased OS and PFS over everolimus (HR 0.61, 95% Credible Interval [95%CrI]: 0.36 to 0.96 and 0.47, 95%CrI: 0.26 to 0.77, respectively) as did cabozantinib (HR 0.66, 95%CrI: 0.53 to 0.82 and 0.51, 95%CrI: 0.41 to 0.63, respectively). This remained the case when observational evidence was included. Nivolumab also significantly improved OS versus everolimus (HR 0.74, 95%CrI: 0.57 to 0.93). OS sensitivity analysis, including observational studies, indicates everolimus being more effective than axitinib and sorafenib. However, inconsistency was identified in the OS sensitivity analysis. PFS sensitivity analysis suggests axitinib is more effective than everolimus, which may be more effective than sorafenib. The results for ORR supported the OS and PFS analyses. Nivolumab is associated with fewer grade 3 or grade 4 adverse events than lenvatinib with everolimus or cabozantinib. HRQoL could not be analysed due to differences in tools used.ConclusionsLenvatinib with everolimus, cabozantinib and nivolumab are effective in prolonging the survival for people with amRCC subsequent to VEGF-targeted treatment, but there is considerable uncertainty about how they compare to each other and how much better they are than axitinib and sorafenib.PROSPERO registrationnumberCRD42017071540.
Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors
Authors: Krusche Adele , Bradbury Katherine , Corbett Teresa , Barnett Jane , Stuart Beth , Yao Guiqing Lily , Bacon Roger , Böhning Dankmar , Cheetham-Blake Tara , Eccles Diana , Foster Claire , Geraghty Adam William Alfred , Leydon Geraldine , Müller Andre , Neal Richard D , Osborne Richard , Rathod Shanaya , Richardson Alison , Sharman Geoffrey , Summers Kevin , Watson Eila , Wilde Laura , Wilkinson Clare , Yardley Lucy , Little Paul 
Published: March 2019

IntroductionLow quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysisA randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and disseminationThe trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN96374224; Pre-results.
Development of a core outcome set for behavioural weight management programmes for adults with overweight and obesity: protocol for obtaining expert consensus using Delphi methodology
Authors: Mackenzie Ruth M , Ells Louisa J , Simpson Sharon Anne , Logue Jennifer 
Published: March 2019

IntroductionWeight management interventions in research studies and in clinical practice differ in length, advice, frequency of meetings, staff and cost. Very few real-world programmes have published patient-related outcomes, and those that have published used different ways of reporting the information, making it impossible to compare interventions and further develop the evidence base. Developing a core outcome set for behavioural weight management programmes (BWMPs) for adults with overweight and obesity will allow different BWMPs to be compared and reveal which interventions work best for which members of the population.Methods and analysisAn expert group, comprised of 40 people who work in, refer to, or attend BWMPs for adults with overweight and obesity, will be asked to decide which outcomes services should report. An online Delphi process will be employed to help the group reach consensus as to which outcomes should be measured and reported, and which definitions/instruments should be used in order to do so. The first stage of the Delphi process (three rounds of questionnaires) will focus on outcomes while the second stage (three additional rounds of questionnaires) will focus on definition/instrument selection.Ethics and disseminationEthical approval for this study has been received from the University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee. With regard to disseminating results, a report will be submitted to our funding body, the Chief Scientist Office of the Scottish Government Health Department. In addition, early findings will be shared with Public Health England and Health Scotland, and results communicated via conference presentations, peer review publication and our institutions’ social media platforms.
Crew resource management training in healthcare: a systematic review of intervention design, training conditions and evaluation
Authors: Gross Benedict , Rusin Leonie , Kiesewetter Jan , Zottmann Jan M , Fischer Martin R , Prückner Stephan , Zech Alexandra 
Published: March 2019

ObjectivesCrew resource management (CRM) training formats have become a popular method to increase patient safety by consideration of the role that human factors play in healthcare delivery. The purposes of this review were to identify what is subsumed under the label of CRM in a healthcare context and to determine how such training is delivered and evaluated.DesignSystematic review of published literature.Data sourcesPubMed, PsycINFO and ERIC were searched through 8 October 2018.Eligibility criteria for selecting studiesIndividually constructed interventions for healthcare staff that were labelled as CRM training, or described as based on CRM principles or on aviation-derived human factors training. Only studies reporting both an intervention and results were included.Data extraction and synthesisThe studies were examined and coded for relevant passages. Characteristics regarding intervention design, training conditions and evaluation methods were analysed and summarised both qualitatively and quantitatively.ResultsSixty-one interventions were included. 48% did not explain any keyword of their CRM intervention to a reproducible detail. Operating room teams and surgery, emergency medicine, intensive care unit staff and anaesthesiology came in contact most with a majority of the CRM interventions delivered in a 1-day or half-day format. Trainer qualification is reported seldomly. Evaluation methods and levels display strong variation.ConclusionsCritical topics were identified for the CRM training community and include the following: the need to agree on common terms and definitions for CRM in healthcare, standards of good practice for reporting CRM interventions and their effects, as well as the need for more research to establish non-educational criteria for success in the implementation of CRM in healthcare organisations.
Application of speCtraL computed tomogrAphy to impRove specIficity of cardiac compuTed tomographY (CLARITY study): rationale and design
Authors: van Hamersvelt Robbert Willem , Išgum Ivana , de Jong Pim A , Cramer Maarten Jan Maria , Leenders Geert E H , Willemink Martin J , Voskuil Michiel , Leiner Tim 
Published: March 2019

IntroductionAnatomic stenosis evaluation on coronary CT angiography (CCTA) lacks specificity in indicating the functional significance of a stenosis. Recent developments in CT techniques (including dual-layer spectral detector CT [SDCT] and static stress CT perfusion [CTP]) and image analyses (including fractional flow reserve [FFR] derived from CCTA images [FFRCT] and deep learning analysis [DL]) are potential strategies to increase the specificity of CCTA by combining both anatomical and functional information in one investigation. The aim of the current study is to assess the diagnostic performance of (combinations of) SDCT, CTP, FFRCTand DL for the identification of functionally significant coronary artery stenosis.Methods and analysisSeventy-five patients aged 18 years and older with stable angina and known coronary artery disease and scheduled to undergo clinically indicated invasive FFR will be enrolled. All subjects will undergo the following SDCT scans: coronary calcium scoring, static stress CTP, rest CCTA and if indicated (history of myocardial infarction) a delayed enhancement acquisition. Invasive FFR of ≤0.80, measured within 30 days after the SDCT scans, will be used as reference to indicate a functionally significant stenosis. The primary study endpoint is the diagnostic performance of SDCT (including CTP) for the identification of functionally significant coronary artery stenosis. Secondary study endpoint is the diagnostic performance of SDCT, CTP, FFRCTand DL separately and combined for the identification of functionally significant coronary artery stenosis.Ethics and disseminationEthical approval was obtained. All subjects will provide written informed consent. Study findings will be disseminated through peer-reviewed conference presentations and journal publications.Trial registration numberNCT03139006; Pre-results.
Treatment patterns, persistence and adherence rates in patients with type 2 diabetes mellitus in Japan: a claims-based cohort study
Authors: Nishimura Rimei , Kato Haruka , Kisanuki Koichi , Oh Akinori , Hiroi Shinzo , Onishi Yoshie , Guelfucci Florent , Shimasaki Yukio 
Published: March 2019

ObjectiveTo determine real-world trends in antidiabetic drug use, and persistence and adherence, in Japanese patients with type 2 diabetes mellitus (T2DM).DesignRetrospective evaluation of administrative claims data (2011–2015) using the Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases.SettingAnalysis of two administrative claims databases for Japanese patients with T2DM.ParticipantsAdults (aged ≥18 years) with an International Classification of Diseases, 10th Revision code of T2DM and at least one antidiabetic drug prescription.Main outcome measuresTreatment patterns in untreated (UT) or previously treated (PT) patients receiving antidiabetic therapy; persistence with treatment at 12 months; adherence to treatment at 12 months.Results40 908 and 90 421 patients were included from the JMDC and MDV databases, respectively. The most frequently prescribed therapy at the index (first prescription) date was dipeptidyl peptidase-4 inhibitor (DPP-4i) in UT patients (JMDC: 44.0%, MDV: 54.8%) and combination therapy in PT patients (74.6%, 81.1%). Most common combinations were DPP-4i plus: biguanide (BG; 11.4%, 10.9%), sulfonylurea (SU; 8.4%, 11.0%) or BG+SU (7.8%, 9.1%). In UT or PT patients from either database whose index prescription was for any antidiabetic drug class(es) other than DPP-4i, the most frequent add-on or switch was to DPP-4i. 12-month persistence with index monotherapy was highest with DPP-4i and BG. Adherence was high (≥80%) for all monotherapy schedules, except insulin and glucagon-like peptide-1 agonist, and for the five most frequent two-drug and three-drug combinations. Persistence was greater in elderly UT patients and in those receiving ≤5 medications, but comparatively worse in UT patients with ≥3 index antidiabetic drug classes.ConclusionsThe findings indicate that DPP-4i is the most commonly used antidiabetic drug class in Japanese patients with T2DM, and persistence and adherence to this antidiabetic drug class are high.
Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study
Authors: Blencowe Natalie S , Skilton Anni , Gaunt Daisy , Brierley Rachel , Hollowood Andrew , Dwerryhouse Simon , Higgs Simon , Robb William , Boddy Alex , Hanna George , Barham C Paul , Blazeby Jane 
Published: March 2019

IntroductionRandomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in ‘real world’ settings), compared with explanatory trials (which are smaller and more tightly controlled).ObjectiveThis protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.Methods and analysisWe have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity.Ethics and disseminationEthics approval was obtained (NRES Committee South West—Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal.Trial registration numberISRCTN59036820,ISRCTN10386621.
Cohort study of healthcare use, costs and diagnoses from onset to 6 months after discharge for takotsubo syndrome in Sweden
Authors: Wallström Sara , Ekman Inger , Omerovic Elmir , Ulin Kerstin , Gyllensten Hanna 
Published: March 2019

ObjectiveLittle is known about the economic impact of takotsubo syndrome (TS) for patients and the health system after initial discharge from hospital. Therefore, the aim of this study was to describe the healthcare resource use and calculate direct healthcare costs for TS, from hospitalisation to 6 months after discharge, and explore the distribution of costs between TS and other diagnoses among patients with TS.Method, participants and settingCohort study investigating direct healthcare costs from hospitalisation, open specialised outpatient and primary care. Healthcare resource use during 6 months after diagnosis with TS was collected for 58 consecutive patients from the Regional Patient Register. Incidence-based direct healthcare costs, in 2015 values, were calculated using diagnosis-related group weights and unit costs from national statistics on healthcare costs.ResultsThe mean length of hospital stay was 10.2 days, index 6.4 and re-admissions 3.8 days. The mean number of follow-up encounters per patient was 15.6, of which two-thirds was specialised outpatient and one-third was primary care. This resulted in an average cost of €10 360. Of this, costs of €8026 (77.5%) occurred during encounters for which at least one of the registered conditions was cardiovascular. Costs differed little according to background characteristics.ConclusionThis study shows that patients utilise hospital, specialised outpatient and primary care after discharge for TS. Most direct healthcare costs relate to cardiac diagnoses. Patients with TS would probably benefit from a supportive follow-up programme after discharge from hospital.
Implementing a quality improvement initiative for the management of chronic obstructive pulmonary disease in rural Nepal
Authors: Mehanni Stephen , Jha Dhiraj , Kumar Anirudh , Choudhury Nandini , Dangal Binod , Deukmedjian Grace , Dhungana Santosh Kumar , Gauchan Bikash , Gupta Tula Krishna , Halliday Scott , Kalaunee S P , Mahar Ramesh , Poudel Sanjaya , Raut Anant , Schwarz Ryan , Singh Dipendra Raman , Thapa Aradhana , Thapa Roshan , Wong Lena , Maru Duncan , Schwarz Dan 
Published: March 2019

BackgroundChronic obstructive pulmonary disease accounts for a significant portion of the world’s morbidity and mortality, and disproportionately affects low/middle-income countries. Chronic obstructive pulmonary disease management in low-resource settings is suboptimal with diagnostics, medications and high-quality, evidence-based care largely unavailable or unaffordable for most people. In early 2016, we aimed to improve the quality of chronic obstructive pulmonary disease management at Bayalpata Hospital in rural Achham, Nepal. Given that quality improvement infrastructure is limited in our setting, we also aimed to model the use of an electronic health record system for quality improvement, and to build local quality improvement capacity.DesignUsing international chronic obstructive pulmonary disease guidelines, the quality improvement team designed a locally adapted chronic obstructive pulmonary disease protocol which was subsequently converted into an electronic health record template. Over several Plan-Do-Study-Act cycles, the team rolled out a multifaceted intervention including educational sessions, reminders, as well as audits and feedback.ResultsThe rate of oral corticosteroid prescriptions for acute exacerbations of chronic obstructive pulmonary disease increased from 14% at baseline to >60% by month 7, with the mean monthly rate maintained above this level for the remainder of the initiative. The process measure of chronic obstructive pulmonary disease template completion rate increased from 44% at baseline to >60% by month 2 and remained between 50% and 70% for the remainder of the initiative.ConclusionThis case study demonstrates the feasibility of robust quality improvement programmes in rural settings and the essential role of capacity building in ensuring sustainability. It also highlights how individual quality improvement initiatives can catalyse systems-level improvements, which in turn create a stronger foundation for continuous quality improvement and healthcare system strengthening.
Reducing inappropriately suspended VTE prophylaxis through a multidisciplinary shared learning programme and electronic prompting
Authors: Brewer Christopher Felix , Ip Dorothy , Drasar Emma , Aghakhani Poureya 
Published: March 2019

BackgroundVenous thromboembolism (VTE) is a major cause of preventable hospital death, accounting for up to 10% of inpatient mortality. National guidelines recommend that all patients should be regularly assessed for VTE risk, and prescribed mechanical and pharmacological prophylaxis accordingly. While previous studies have focused on improving prescription uptake on admission, there has been relatively little emphasis on the inappropriate suspension of prophylaxis during inpatient stay.ObjectiveThe purpose of this project was to identify the reasons and scale of inappropriate suspension of pharmacological VTE prophylaxis for medical inpatients. We subsequently planned to introduce a number of interventions in order to reduce inappropriate suspension.MethodsAn initial audit of all medical inpatients was carried out to establish the number with inappropriately suspended pharmacological prophylaxis. We then designed a series of educational meetings and electronic prompting interventions to alert prescribers to these errors, followed by re-audit to assess their efficacy.ResultsThe number of patients with inappropriately suspended VTE prophylaxis was significantly reduced following introduction of our intervention strategy.ConclusionsCombined education and electronic email prompts are an effective way of alerting practitioners to reduce inappropriate suspension of VTE prophylaxis. With ongoing teaching and integration of prescribing software alerts, this reduction in VTE prescribing errors could be sustained.
Health examinations of child migrants in Europe: screening or assessment of healthcare needs?
Authors: Hjern Anders , Stubbe Østergaard Liv , Nörredam Marie-Louise 
Published: March 2019

BackgroundMore than 800 000 asylum-seeking children were registered in Europe during 2015–2017. Many of them arrived with accumulated needs of healthcare. In this study, we examined the legislation for health examinations on arrival for migrant children in the EU/EAA area.MethodsWe did a survey to child health professionals within the EU-funded MOCHA project, supplemented by desktop research of official documents.ResultsIn all but three surveyed countries in the EU/EEA, there were systematic health examinations of newly settled migrant children. In most eastern European countries and Germany, this health examination was mandatory; while in the rest of western and northern Europe it was mostly voluntary. All countries that had a mandatory policy of health examinations screened for communicable diseases to protect the host population. Almost all countries with a voluntary policy also aimed to assess a child’s individual healthcare needs, but this was rarely the case in countries with a mandatory policy.ConclusionSystematic health examinations of migrant children are routinely performed in most countries in the EU/EEA; but in many countries, it could be improved considerably by extending the focus from screening for communicable diseases to assessing and addressing individual needs of healthcare.