bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adapting to ulcerative colitis to try to live a ‘normal’ life: a qualitative study of patients’ experiences in the Midlands region of England
Authors: McMullan Christel , Pinkney Thomas D , Jones Laura L , Magill Laura , Nepogodiev Dmitri , Pathmakanthan Shri , Cooney Rachel , Mathers Jonathan M 
Published: December 2018

ObjectiveTo provide a framework that is able to categorise whether patients are able to adapt to and lead a ‘normal’ life with ulcerative colitis (UC) and to detail the factors that influence this.DesignQualitative research study using in-depth semi-structured interviews.SettingFour clinical sites in the West and East Midlands regions of England.Participants28 adult patients diagnosed with UC for years between 1 and 22.ResultsMedication was rarely sufficient for patients to adapt to UC and live as ‘normal’ a life as possible. Virtually all patients tested and adopted non-medical adaptation methods to improve physical and psychological well-being, to help them carry on working and to prevent embarrassment. In addition, some patients benefited from outside support providing them with practical, emotional and/or financial help. In conjunction with adaptation strategies and the time to adapt, this meant that some patients with severe clinical disease were able to maintain a sense of normality in life. Patients reported that clinicians were not always receptive to discussion of the broader context of life with UC.ConclusionsPatients’ experience of UC and their ability to adapt in order to maintain a sense of normality in life is a complex interplay of symptoms, adaptation strategies and outside support. Over time patients test out a variety of non-medical adaptation strategies. Awareness of this may help clinicians and researchers to understand patients’ views on the role of medical and other therapies. Further research around the utility of this framework in clinical practice and research is now required.Trial registration numberISRCTN56523019, results.
Follow Your Virtual Trainer (FYVT): a randomised controlled trial protocol of IT-based lifestyle intervention programme to promote physical activity and health among middle-aged Hong Kong Chinese
Authors: Hui Stanley Sai-Chuen , Xie Yao Jie , Kwok Ron Chi-Wai , Tam Eric Wing-Cheung , Mak Winnie Wing Sze , Mo Phoenix Kit-Han 
Published: December 2018

IntroductionHong Kong is a highly urbanised city where many people work long hours. The limited time and lack of professional instruction are the typical barriers to exercise. The purpose of this study is to test the effectiveness of an information technology-based lifestyle intervention programme on improving physical activity (PA) level and health status in a sample of middle-aged Hong Kong adults.Methods and analysisA two-arm parallel randomised controlled trial named ‘Follow Your Virtual Trainer’ will be conducted among 200 physically inactive Chinese adults aged from 40 to 65 years. Those randomly allocated to an intervention group will be under the instruction of a web-based computer software termed ‘Virtual Trainer (VT)’ to conduct a 3-month self-planned PA programme. A series of online seminars with healthy lifestyle information will be released to the participants biweekly for 3 months. After that, 6 months observation will follow. Those in the control group will only receive a written advice of standard PA recommendation and the textual content of the seminars. The assessments will be implemented at baseline, the 3rd, 6th and 9th months. The primary outcome is PA measured by accelerometer and International Physical Activity Questionnaire. The secondary outcomes include cardiorespiratory fitness, resting energy expenditure, anthropometrics, body composition, blood pressure, health-related quality of life, sleep quality and quantity, fatigue, behaviour mediators and maintenance of PA. The main effectiveness of the intervention will be assessed by a linear mixed model that tests the random effect of treatment on outcomes at the 3rd, 6th and 9th months.Ethics and disseminationThis trial has been approved by the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (CRE 2015235). The study results will be presented at scientific conferences and published in peer-reviewed journals.Trial registration numberNCT02553980.
Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry)
Authors: Onorati Francesco , Gherli Riccardo , Mariscalco Giovanni , Girdauskas Evaldas , Quintana Eduardo , Santini Francesco , De Feo Marisa , Sponga Sandro , Tozzi Piergiorgio , Bashir Mohamad , Perrotti Andrea , Pappalardo Aniello , Ruggieri Vito Giovanni , Santarpino Giuseppe , Rinaldi Mauro , Ronaldo Silva , Nicolini Francesco 
Published: December 2018

IntroductionTraditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the ‘real clinical world’. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both ‘sutured’ and ‘sutureless’ valves) will provide a ‘real-world’ picture of available results of current surgical options and will help to clarify the ‘grey zones’ of current guidelines.Methods and analysisEuropean Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing ‘early’ 30-day all-cause and cardiovascular mortality, as well as major morbidity, and ‘late’ cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.Ethics and disseminationThe study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship.Trial registration numberNCT03143361; Pre-results.
Smartphone-Enhanced Low-Threshold Intervention for adolescents with Anorexia Nervosa (SELTIAN) waiting for outpatient psychotherapy: study protocol of a randomised controlled trial
Authors: Kolar David R , Hammerle Florian , Jenetzky Ekkehart , Huss Michael 
Published: December 2018

IntroductionAs smartphones are widely distributed nowadays, mental health apps seem to be a promising treatment tool. First self-help apps for eating disorders have been developed recently. However, studies assessing the efficacy of such apps are scarce. A smartphone app could prevent further weight reduction and increase commitment during waiting time for outpatient treatment, especially for adolescents with anorexia nervosa (AN). In this study protocol, a randomised controlled trial to assess the efficacy of a smartphone-enhanced low-threshold intervention for AN during waiting time is described.Methods and analysis30 adolescents with AN aged 12–19 years will be recruited at three child and adolescent psychiatry centres in Germany. All participants will be randomised to consultations only or consultations and the use of the Jourvie Research app. The app will be installed either on their own smartphone or on a research device. The participants will receive biweekly to monthly consultations for 3 months to review meal plans and weight management with a clinician. In addition, the Jourvie Research app for meal, behaviour and emotion protocolling will be provided to the intervention group. The protocols will be discussed with a clinician during the consultations. Dialectical behaviour therapy-informed skills for tension regulation to increase compliance with the meal plan will be taught in the intervention group and the app will remind the participant of a skill in a moment of need. The primary outcome is the age-adjusted and height-adjusted weight gain in standard deviation score after 3 months.Ethics and disseminationResults will be disseminated at conferences and through peer-reviewed publications. The trial was approved by the ethics review board of the local medical association, Mainz, Germany, under the reference number 837.338.15.Trial registration numberGerman clinical trials register, reference number DRKS00008946.
Compassionate care intervention for hospital nursing teams caring for older people: a pilot cluster randomised controlled trial
Authors: Gould Lisa Jane , Griffiths Peter , Barker Hannah Ruth , Libberton Paula , Mesa-Eguiagaray Ines , Pickering Ruth M , Shipway Lisa Jane , Bridges Jackie 
Published: December 2018

ObjectiveCompassionate care continues to be a focus for national and international attention, but the existing evidence base lacks the experimental methodology necessary to guide the selection of effective interventions for practice. This study aimed to evaluate the Creating Learning Environments for Compassionate Care (CLECC) intervention in improving compassionate care.SettingWard nursing teams (clusters) in two English National Health Service hospitals randomised to intervention (n=4) or control (n=2). Intervention wards comprised two medicines for older people (MOPs) wards and two medical/surgical wards. Control wards were both MOPs.ParticipantsData collected from 627 patients and 178 staff. Exclusion criteria: reverse barrier nursed, critically ill, palliative or non-English speaking. All other patients and all nursing staff and Health Care Assistant HCAs were invited to participant, agency and bank staff were excluded.InterventionCLECC, a workplace intervention focused on developing sustainable leadership and work-team practices to support the delivery of compassionate care. Control: No educational activity.Primary and secondary outcome measuresPrimary—Quality of Interaction Schedule (QuIS) for observed staff–patient interactions. Secondary—patient-reported evaluations of emotional care in hospital (PEECH); nurse-reported empathy (Jefferson Scale of Empathy).ResultsTrial proceeded as per protocol, randomisation was acceptable. Some but not all blinding strategies were successful. QuIS observations achieved 93% recruitment rate with 25% of patient sample cognitively impaired. At follow-up there were more total positive (78% vs 74%) and less total negative (8% vs 11%) QuIS ratings for intervention wards versus control wards. Sixty-three per cent of intervention ward patients scored lowest (ie, more negative) scores on PEECH connection subscale, versus 79% of control. This was not a statistically significant difference. No statistically significant differences in nursing empathy were observed.ConclusionsUse of experimental methods is feasible. The use of structured observation of staff–patient interaction quality is a promising outcome measure inclusive of hard to reach groups.Trial registration numberISRCTN16789770.
Comparison of hip function and quality of life of total hip arthroplasty and resurfacing arthroplasty in the treatment of young patients with arthritis of the hip joint at 5 years
Authors: Costa Matthew L , Achten Juul , Foguet Pedro , Parsons Nicholas R 
Published: December 2018

ObjectiveTo compare the medium-term clinical effectiveness of total hip arthroplasty and resurfacing arthroplasty.DesignSingle centre, two-arm, parallel group, assessor blinded, randomised controlled trial with 1:1 treatment allocation.SettingA large teaching hospital in England.Participants122 patients older than 18 years with severe arthritis of the hip joint, suitable for resurfacing arthroplasty of the hip. Patients were excluded if they were considered to be unable to adhere to trial procedures or complete questionnaires.InterventionsTotal hip arthroplasty (replacement of entire femoral head and neck); hip resurfacing arthroplasty (replacement of the articular surface of femoral head only, femoral neck remains intact). Both procedures replaced the articular surface of the acetabulum.OutcomesThe outcome measures were hip function assessed using the Oxford Hip Score (OHS) and health-related quality of life assessed using the EuroQol (EQ-5D). Patients were followed up annually for a minimum of 5 years. Outcome data were modelled using the generalised estimating equation methodology to explore temporal variations during follow-up.Results60 patients were randomly assigned to hip resurfacing arthroplasty and 62 to total hip arthroplasty. 95 (78%) of the 122 original study participants provided data at 5 years. There was a small decrease in both hip functions and quality of life in both groups of patients each year during the 5-year follow-up period. However, there was no evidence of a significant difference between treatments group in the OHS (P=0.333) or the EQ-5D (P=0.501).ConclusionsWe previously reported no difference in outcome in the first year after surgery. The current medium-term results also show no evidence of a difference in hip function or health-related quality of life in the 5 years following a total hip arthroplasty versus resurfacing arthroplasty.Trial registration numberISRCTN33354155. UKCRN 4093.
Hyponatraemia, hyperglycaemia and worsening renal function at first blood sample on emergency department admission as predictors of in-hospital death in patients with dyspnoea with suspected acute heart failure: retrospective observational analysis of the PARADISE cohort
Authors: Chouihed Tahar , Buessler Aurélien , Bassand Adrien , Jaeger Deborah , Virion Jean Marc , Nace Lionel , Barbé Françoise , Salignac Sylvain , Rossignol Patrick , Zannad Faiez , Girerd Nicolas 
Published: December 2018

ObjectivesTo assess the prognostic value of hyponatraemia, hyperglycaemia and impaired estimated glomerular filtration rate (eGFR) in predicting in-hospital death in patients with acute heart failure (AHF) admitted for acute dyspnoea in the emergency department.DesignRetrospective observational study.SettingEmergency Department of the University Hospital of Nancy. Data were collected from August 2013 to October 2015.ParticipantsThe analysis included 405 patients with AHF admitted for acute dyspnoea in an emergency department.ResultsThe population was elderly (mean age 82 years), 20.1% had hyponatraemia, 45.1% had hyperglycaemia and 48.6% had eGFR <50 mL/min/1.73 m2. Sixty-one patients (15.1%) died in hospital, mostly due to cardiac aetiology (58.3%). In multivariable analysis adjusted for key potential confounders, adjusted hyponatraemia (OR=2.40, (1.16 to 4.98), p=0.02), hyperglycaemia (OR=2.00, 1.06 to 3.76, p=0.03) and eGFR <50 mL/min/1.73 m2(OR=1.97 (1.00 to 3.80), p=0.04*) were all identified as significant independent predictors of in-hospital death.ConclusionsResults of basic routine laboratory tests (hyponatraemia, hyperglycaemia and impaired eGFR) performed on admission in the emergency department are independently associated with in-hospital death. These inexpensive tests, performed as early as patient admission in the emergency department, could allow the early identification of patients admitted for AHF who are at high risk of in-hospital death.Trial registration numberNCT02800122.
Impact of renin-angiotensin system inhibitors on clinical outcomes and ventricular remodelling after transcatheter aortic valve implantation: rationale and design of the RASTAVI randomised multicentre study
Authors: Amat-Santos Ignacio J , Catalá Pablo , Diez del Hoyo Felipe , Fernandez-Diaz Jose A , Alonso-Briales Juan H , Del Trigo María , Regueiro Ander , Juan-Salvadores Pablo , Serra Vicenç , Gutierrez-Ibanes Enrique , Muñoz-García Antonio J , Nombela-Franco Luis , Sabate Manel , Jimenez-Diaz Victor A , García del Blanco Bruno , López Javier , Varela-Falcón Luis H , Sevilla Teresa , Arnold Roman , Revilla Ana , San Roman J Alberto 
Published: December 2018

IntroductionTranscatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS) blockade has shown benefit in terms of adverse remodelling in severe AS and after surgical replacement.Methods and analysisThe RAS blockade after TAVI (RASTAVI) trial aims to detect if there is a benefit in clinical outcomes and ventricular remodelling with this therapeutic strategy following the TAVI procedure. The study has been designed as a randomised 1:1 open-label study that will be undertaken in 8 centres including 336 TAVI recipients. All patients will receive the standard treatment. The active treatment group will receive ramipril as well. Randomisation will be done before discharge, after signing informed consent. All patients will be followed up for 3 years. A cardiac magnetic resonance will be performed initially and at 1 year to assess ventricular remodelling, defined as ventricular dimensions, ejection fraction, ventricular mass and fibrosis. Recorded events will include cardiac death, admission due to heart failure and stroke. The RASTAVI Study will improve the management of patients after TAVI and may help to increase their quality of life, reduce readmissions and improve long-term survival in this scenario.Ethics and disseminationAll authors and local ethics committees have approved the study design. All patients will provide informed consent. Results will be published irrespective of whether the findings are positive or negative.Trial registration numberNCT03201185.
Factors influencing career progress for early stage clinician-scientists in emerging Asian academic medical centres: a qualitative study in Singapore
Authors: Yoon Sungwon , Koh Woon-Puay , Ong Marcus E H , Thumboo Julian 
Published: December 2018

ObjectivesTo explore the factors that influence career progress for early stage clinician-scientists and to identify ways to mitigate these factors in the context of emerging Asian academic medical centres (AMCs).DesignQualitative interviews and thematic data analysis based on grounded theory.Setting and participantsFive focus group interviews comprising 29 early career clinician-scientists who have received their first national-level career development award in Singapore.ResultsClinical priorities represented an overarching concern with many reporting the difficulty in delineating responsibilities between clinical care and research. Additionally, there was a prevailing perception of the lack of support for research at the institutional level. Participants tended to identify mentors through their own efforts in a relatively haphazard manner, often owing to the dearth of role models and perceived inadequacy of reward systems for mentoring. Support from mentors was thought to be limited in terms of targeted scientific guidance and long-term commitments to the relationship. Most of the participants expressed concerns about how they could secure the next level of funding with diminishing confidence. Notably, the work-life balance was neither conceptualised as a ‘barrier’ to successful pursuit of research career nor was it translated into the reason for leaving the dual clinical-research career pathway.ConclusionsResults revealed specific limitations presented by the research environment in newly emerging Asian AMCs. To retain a vibrant clinician-scientist workforce, additional measures are needed, aiming to improve institutional culture of research, build mentoring networks, adopt effective tools for tracking career progress and provide a clear and viable career progression path for clinician-scientist. Further research might explore the cross-cultural differences in managing work-life balance in academic medicine.
Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH) study: a protocol for an experimental interventional study
Authors: Minhas Jatinder S , Panerai Ronney B , Robinson Thompson G 
Published: December 2018

IntroductionCerebral autoregulation (CA) is impaired in a multitude of neurological conditions. Increasingly, clinical studies are correlating the nature of this impairment with prognostic markers. In acute intracerebral haemorrhage (ICH), impairment of CA has been associated with worsening clinical outcomes including poorer Glasgow Coma Score and larger haematoma volume. Hypocapnia has been shown to improve CA despite concerns over hypoperfusion and consequent ischaemic risks, and it is therefore hypothesised that hypocapnia (via hyperventilation) in acute ICH may improve CA and consequently clinical outcome. BREATHE-ICH is a CA-targeted interventional study in acute ICH utilising a simple bedside hyperventilatory manoeuvre.Methods and analysisPatients with acute ICH within 48 hours of onset will be included. The experimental set-up measures cerebral blood flow (cerebral blood velocity, transcranial Doppler), blood pressure (Finometer) and end tidal carbon dioxide (capnography) at baseline, and in response to hypocapnia (−5 mm and −10 mm Hg below baseline) achieved via a 90 s hyperventilatory manoeuvre. Autoregulation is evaluated with transfer function analysis and autoregulatory index calculations. Important classical endpoints associated with this before and after interventional study include death and disability at 14 days and the proportion of recruited individuals able to comply with the full measurement protocol.Ethics and disseminationA favourable opinion was granted by the East Midlands-Nottingham 1 Research Ethics Committee (17/EM/0283). It is anticipated that the results of this study will be presented at national and international meetings, with reports being published in journals during late 2018.Trial registration numberNCT03324321.