bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and feasibility of a guided and tailored internet-based cognitive-behavioural intervention for kidney donors and kidney donor candidates
Authors: Wirken Lieke , van Middendorp Henriët , Hooghof Christina W , Bremer Tamara E , Hopman Sabine P F , van der Pant Karlijn A M I , Hoitsma Andries J , Hilbrands Luuk B , Evers Andrea W M 
Published: June 2018

ObjectivesLiving donor kidney transplantation is currently the preferred treatment for patients with end-stage renal disease. A subgroup of the kidney donor population experiences adjustment problems during or after the donation procedure (eg, anxiety or fatigue). There is a need for evidence-based interventions that decrease donation-related difficulties before or after donation. In the current study, a guided and tailored internet-based cognitive-behavioural therapy (ICBT) intervention for donors and donor candidates was developed and the feasibility and perceived effectiveness were evaluated.DesignPilot study including qualitative and quantitative research methods for intervention development and evaluation.SettingLiving kidney donor population of two Dutch transplantation centres.ParticipantsDonors and healthcare professionals participated in focus group interviews conducted to identify intervention themes and to map attitudes towards internet-based interventions. In a pilot feasibility study, 99 donors and donor candidates participated, of whom 38 completed the screening. Eight donors or donor candidates with a risk profile (ie, impaired mental health-related quality of life (HRQoL)) received and evaluated the intervention.InterventionsA guided and tailored ICBT intervention for donors and donor candidates was developed. Donation-related treatment modules, assignments and psychoeducation were integrated within an existing disease-generic ICBT intervention.Outcome measuresHRQoL, anxiety and depression were assessed before and after the ICBT intervention. Additional questionnaires were included to identify specific problem areas of donor functioning to tailor the ICBT intervention to the donor’s needs.ResultsDifferent intervention themes were derived from the focus group interviews (eg, physical limitations, and donation-specific emotional and social-relational problems). Participants were satisfied about the intervention content (7.7±0.8 on a 0–10 scale) and the therapeutic relationship (4.4±0.6 on a 1–5 scale), and indicated an improvement on domains of their treatment goals (3.2±0.7 on a 1–4 scale).ConclusionThis study showed positive evaluations concerning both feasibility and perceived effectiveness of the tailored ICBT intervention in kidney donors and donor candidates, in line with previous studies using comparable ICBT treatment protocols in other populations. Future research should examine the possibilities of integrating the intervention into psychosocial care for kidney donors.
Using electronic health records to quantify and stratify the severity of type 2 diabetes in primary care in England: rationale and cohort study design
Authors: Zghebi Salwa S , Rutter Martin K , Ashcroft Darren M , Salisbury Chris , Mallen Christian , Chew-Graham Carolyn A , Reeves David , van Marwijk Harm , Qureshi Nadeem , Weng Stephen , Peek Niels , Planner Claire , Nowakowska Magdalena , Mamas Mamas , Kontopantelis Evangelos 
Published: June 2018

IntroductionThe increasing prevalence of type 2 diabetes mellitus (T2DM) presents a significant burden on affected individuals and healthcare systems internationally. There is, however, no agreed validated measure to infer diabetes severity from electronic health records (EHRs). We aim to quantify T2DM severity and validate it using clinical adverse outcomes.Methods and analysisPrimary care data from the Clinical Practice Research Datalink, linked hospitalisation and mortality records between April 2007 and March 2017 for patients with T2DM in England will be used to develop a clinical algorithm to grade T2DM severity. The EHR-based algorithm will incorporate main risk factors (severity domains) for adverse outcomes to stratify T2DM cohorts by baseline and longitudinal severity scores. Provisionally, T2DM severity domains, identified through a systematic review and expert opinion, are: diabetes duration, glycated haemoglobin, microvascular complications, comorbidities and coprescribed treatments. Severity scores will be developed by two approaches: (1) calculating a count score of severity domains; (2) through hierarchical stratification of complications. Regression models estimates will be used to calculate domains weights. Survival analyses for the association between weighted severity scores and future outcomes—cardiovascular events, hospitalisation (diabetes-related, cardiovascular) and mortality (diabetes-related, cardiovascular, all-cause mortality)—will be performed as statistical validation. The proposed EHR-based approach will quantify the T2DM severity for primary care performance management and inform the methodology for measuring severity of other primary care-managed chronic conditions. We anticipate that the developed algorithm will be a practical tool for practitioners, aid clinical management decision-making, inform stratified medicine, support future clinical trials and contribute to more effective service planning and policy-making.Ethics and disseminationThe study protocol was approved by the Independent Scientific Advisory Committee. Some data were presented at the National Institute for Health Research School for Primary Care Research Showcase, September 2017, Oxford, UK and the Diabetes UK Professional Conference March 2018, London, UK. The study findings will be disseminated in relevant academic conferences and peer-reviewed journals.
Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study)
Authors: Hoffman Mariana , Van Hollebeke Marine , Clerckx Beatrix , Muller Johannes , Louvaris Zafeiris , Gosselink Rik , Hermans Greet , Langer Daniel 
Published: June 2018

IntroductionRespiratory muscle dysfunction has been associated with failure to wean from mechanical ventilation. It has therefore been hypothesised that these patients might benefit from inspiratory muscle training (IMT). Evidence, however, is thus far limited to data from small, single-centre studies with heterogeneity in inclusion criteria, training modalities and outcomes. The aim of this study is to evaluate the effects of a novel IMT method on weaning outcomes in selected patients with weaning difficulties.MethodsThis study is designed as a double-blind, parallel-group, randomised controlled superiority trial with 1:1 allocation ratio. Patients with weaning difficulties will be randomly allocated into either an IMT group (intervention) or a sham-IMT group (control). Ninetypatients (45 in each group) will be needed to detect a 28% difference in the proportion of weaning success between groups (estimated difference in primary outcome based on previous studies) with a risk for type I error (α) of 5% and statistical power (1-β) of 80%. Patients will perform four sets of 6–10 breaths daily against an external load using a tapered flow resistive loading device (POWERbreathe KH2, HaB International, UK). Training intensity in the intervention group will be adjusted to the highest tolerable load. The control group will train against a low resistance that will not be modified during the training period. Training will becontinued until patients are successfully weaned or for a maximum duration of 28 days. Pulmonary and respiratory muscle function, weaning duration, duration of mechanical ventilation, ventilator-free days and length of stay in the intensive care unit will be evaluated as secondary outcomes. Χ2 tests and analysis of covariance with adjustments for baseline values of respective outcomesas covariates will be used to compare results after the intervention period between groups.Ethics and disseminationEthics approval was obtained from the local ethical committee (Ethische Commissie Onderzoek UZ/KU Leuven protocol ID: S60516). Results from this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peerreviewed journals.Trial statusEnrolment into the study have started in August 2017. Data collection and data analysis are expected to be completed in September 2021.Trial registration numberNCT03240263.
Evaluation of published assessment tools for comorbidity in liver transplantation: a systematic review protocol
Authors: Qu Zhi , Gwiasda Jill , Schrem Harald , Kaltenborn Alexander , Harries Lena , Beneke Jan , Amelung Volker , Krauth Christian 
Published: June 2018

IntroductionLiver transplantation is considered the best therapy option for end-stage liver disease. Different factors including recipient comorbidity at time of transplantation are supposed to have substantial impact on outcomes. Although several studies have focused on comorbidity assessment indices for liver transplant recipients, there is no systematic review available on the methodological details and prognostic accuracy of these instruments. The aim of this study is to systematically review recipient comorbidity assessment indices in the context of liver transplantation.Methods and analysisPubMed, Embase, Web of Science and PsyINFO databases will be searched. Studies describing, using or evaluating specific assessment tools to predict the effect of comorbidity on clinical outcomes after liver transplantation will be included. The selection will be conducted independently by two reviewers. The study characteristics and methodological information on published comorbidity assessment tools will be extracted into a predefined structural table. This approach will be deployed to systematically extract information on the validity, reliability and practical feasibility of investigated comorbidity assessment tools for comparative evaluation. Narrative information synthesis will be conducted, and additional meta-analytical comparison will be performed, if appropriate.Ethics and disseminationAll data are collected from published literature. Thus, formal ethics review for the research is not required. The findings of this systematic review will be published in a peer-reviewed journal and presented at relevant conferences. The results of this systematic review will be highly relevant for further research on prognostic models, clinical decision making and optimisation of donor organ allocation.PROSPERO registration numberCRD42017074609.
Missing from the debate? A qualitative study exploring the role of communities within interventions to address female genital mutilation in Europe
Authors: Connelly Elaine , Murray Nina , Baillot Helen , Howard Natasha 
Published: June 2018

IntroductionPublic attention on female genital mutilation (FGM) in diaspora communities is increasing in Europe, as health and social welfare implications become better understood. This study explored the role of potentially affected communities within interventions to address FGM in Europe, examining current practices, promising interventions and remaining gaps.MethodsA qualitative study design incorporated 18 individual key informant interviews and five semistructured group interviews with policy-makers, service providers and community representatives. Data were analysed thematically, guided by the Scottish Government ‘4Ps’ framework for addressing violence against women and girls, that is, prevention, protection, provision of services and participation.ResultsParticipants emphasised both the importance of community participation and the lack of consistent engagement by policy-makers and practitioners. All indicated that communities had a key role, though most interventions focused on awareness-raising rather than community empowerment, behaviour change or influence on the design, delivery and/or evaluation of interventions.ConclusionsDespite clear consensus around the need to engage, support and empower potentially affected communities and several examples of meaningful community participation in addressing FGM (eg, REPLACE, REPLACE 2,Ketenaapak, Tackling FGM Initiative), the role of communities remains inconsistent and further engagement efforts are necessary.
Death within 1 year among emergency medical admissions to Scottish hospitals: incident cohort study
Authors: Moore Emily , Munoz-Arroyo Rosalia , Schofield Lauren , Radley Alice , Clark David , Isles Chris 
Published: June 2018

BackgroundIt is increasingly recognised that large numbers of hospital inpatients have entered the last year of their lives.AimTo establish the likelihood of death within 12 months of admission to hospital; to examine the influence on survival of a cancer diagnosis made within the previous 5 years; to assess whether previous emergency admissions influenced mortality; and to compare mortality with that of the wider Scottish population.DesignIncident cohort study.Setting22 hospitals in Scotland.ParticipantsThis study used routinely collected data from 10 477 inpatients admitted as an emergency to medicine in 22 Scottish hospitals between 18 and 31 March 2015. These data were linked to national death records and the Scottish Cancer Registry.Primary outcome measures1 year cohort mortality compared with that of the general Scottish population. Patient factors correlating with higher risk of mortality were identified using Cox regression.ResultsThere were 2346 (22.4%) deaths in the year following the census admission. Six hundred and ten patients died during that admission (5.8% of all admissions and 26% of all deaths) while 1736 died after the census admission (74% of all deaths). Malignant neoplasms (33.8%), circulatory diseases (22.5%) and respiratory disease (17.9%) accounted for almost three-quarters of all deaths. Mortality rose steeply with age and was five times higher at 1 year for patients aged 85 years and over compared with those who were under 60 years of age (41.9%vs7.9%) (p<0.001). Patients with cancer had a higher mortality rate than patients without a cancer diagnosis (55.6%vs16.6%) (p<0.001). Mortality was higher among patients with one or more emergency medical admissions in the previous year (30.1% v 15.1%) (p<0.001). Age/sex-standardised mortality was 110.4 (95% CI 104.4 to 116.5) for the cohort and 11.7 (95% CI 11.6 to 11.8) for the Scottish population, a 9.4-fold increase in risk.ConclusionThese data may help identify groups of patients admitted to hospital as medical emergencies who are at greatest risk of dying not only during admission but also in the following 12 months.
Prevalence of dyslipidaemia and awareness of blood cholesterol levels among community-living people: results from the Longevity check-up 7+ (Lookup 7+) cross-sectional survey
Authors: Marzetti Emanuele , Calvani Riccardo , Picca Anna , Sisto Alex , Tosato Matteo , Martone Anna Maria , Ortolani Elena , Salini Sara , Pafundi Teodosio , Santoliquido Angelo , Santoro Luca , Bernabei Roberto , Landi Francesco 
Published: June 2018

ObjectiveThe aim of the present study was to investigate the prevalence of abnormal cholesterol levels and to explore awareness of cholesterol values in an unselected sample of community-living adults.DesignCross-sectional survey.SettingExhibitions, malls and health promotion campaigns across Italy.Participants3535 community dwellers aged 18–98 years were enrolled between September 2016 and June 2017. Analyses were conducted in 3040 participants, after excluding 495 enrolees on cholesterol-lowering medications.Main outcome measuresTotal blood cholesterol levels and awareness of cholesterol values.ResultsAbnormal blood cholesterol values were found in 1961 (64.5%) of participants with no differences between genders (p=0.06). Among those who believed they had normal cholesterol levels, only 48% had values below 200 mg/dL. More than 40% had cholesterol values between 200 and 240 mg/dL, and around 10% had values >240 mg/dL. More than one-third of participants had not measured cholesterol in the last year. Among them, only 36% had normal cholesterol levels.ConclusionsAbnormal blood cholesterol is highly prevalent in our sample of Italian community dwellers, with less than half of participants being aware of their cholesterol levels.
Physiotherapy and Anterior Resection Syndrome (PARiS) trial: feasibility study protocol
Authors: Powell-Chandler Anna , Rees Buddug , Broad Carole , Torkington Jared , O’Neill Claire , Cornish Julie A 
Published: June 2018

IntroductionRectal cancer affects more than 600 patients per year in Wales, with a 5-year survival rate of around 60%. A recent report demonstrated that 19% of patients with bowel cancer had difficulty controlling their bowels after surgery, and these patients were twice as likely to report lower quality of life than those who had control. Nearly all patients will experience bowel dysfunction initially following surgery and up to 25% will experience severe bowel dysfunction on a long-term basis. The aim of this study is to test the feasibility of introducing a simple intervention in an attempt to improve bowel function following surgery for rectal cancer. We propose the introduction of an educational session from specialist nurses and physiotherapists prior to surgery and a subsequent physiotherapy programme for 3 months to teach patients how to strengthen their pelvic floor.Methods and analysisAll patients with rectal cancer planned to receive an anterior resection will be approached for the study. The study will take place in three centres over 12 months, and we expect to recruit 40 patients. The primary outcome measure is the proportion of eligible patients approached who consent to and attend the educational session. The secondary outcomes include patient compliance to the pelvic floor rehabilitation programme (assessed by patient paper or electronic diary), the acceptability of the intervention to the patient (assessed using qualitative interviews) and preoperative and postoperative pelvic floor tone (assessed using the Oxford Grading System and the International Continence Society Grading System), patient bowel function and patient quality of life (assessed using validated questionnaires).Ethics and disseminationEthics approval was granted. This feasibility study is in progress. If patients find the intervention acceptable, the next stage would be a trial comparing outcomes after anterior resection in those who have and do not have physiotherapy.Trial registration numberISRCTN77383505; Pre-results.
SMARTphone and social media-based Cardiac Rehabilitation and Secondary Prevention (SMART-CR/SP) for patients with coronary heart disease in China: a randomised controlled trial protocol
Authors: Dorje Tashi , Zhao Gang , Scheer Anna , Tsokey Lhamo , Wang Jing , Chen Yaolin , Tso Khandro , Tan B-K , Ge Junbo , Maiorana Andrew 
Published: June 2018

IntroductionThe burden of cardiovascular disease (CVD) is rapidly increasing in developing countries, however access to cardiac rehabilitation and secondary prevention (CR/SP) in these countries is limited. Alternative delivery models that are low-cost and easy to access are urgently needed to address this service gap. The objective of this study is to investigate whether a smartphone and social media-based (WeChat) home CR/SP programme can facilitate risk factor monitoring and modification to improve disease self-management and health outcomes in patients with coronary heart disease (CHD), after percutaneous coronary intervention (PCI) therapy.Methods and analysisWe propose a single-blind, randomised controlled trial of 300 patients post-PCI with follow-up over 12 months. The intervention group will receive a smartphone-based and WeChat-based CR/SP programme providing education and support for risk factor monitoring and modification. SMART-CR/SP incorporates core components of modern CR/SP: physical activity tracking with interactive feedback and goal setting; education modules addressing CHD understanding and self-management; remote blood pressure monitoring and strategies to improve medication adherence. Furthermore, a dedicated data portal and a CR/SP coach will facilitate individualised supervision and counselling. The control group will receive usual care but no formal CR/SP programme. The primary outcome is change in exercise capacity measured by 6 minute walk test distance. Secondary outcomes include knowledge and awareness of CHD, risk factor status, medication adherence, psychological well-being and quality of life, major cardiovascular events, re-hospitalisations and all-cause mortality. To assess the feasibility and patients’ acceptance of the intervention, a process evaluation will be performed at the conclusion of the study.Ethics and disseminationEthics approval was granted by both the Human Research Ethics Committee of Fudan University Zhongshan Hospital (HREC B2016-058) and Curtin University Human Research Ethics Office (HRE2016-0120). Results will be disseminated via peer-reviewed publications and presentations at conferences.Clinical trial registration numberChiCTR-INR-16009598; Pre-results.
How do iLead? Validation of a scale measuring active and passive implementation leadership in Swedish healthcare
Authors: Mosson Rebecca , von Thiele Schwarz Ulrica , Hasson Henna , Lundmark Robert , Richter Anne 
Published: June 2018

ObjectivesThis study aims to describe the creation of a scale—the iLead scale—through adaptations of existing domain-specific scales that measure active and passive implementation leadership, and to describe the psychometric properties of this scale.MethodsData collected from a leadership intervention were used in this validation study. Respondents were 336 healthcare professionals (90% female and 10% male; mean age 47 years) whose first-line and second-line managers participated in the intervention. The data were collected in the Stockholm regional healthcare organisation that offer primary, psychiatric, rehabilitation and acute hospital care, among other areas. The items for measuring implementation leadership were based on existent research and the full-range leadership model. Confirmatory factor analysis was performed to evaluate the dimensionality of the scale, followed by tests for reliability and convergent, discriminant and criterion-related validity using correlations and multilevel regression analyses.ResultsThe final scale consists of 16 items clustered into four subscales representing active implementation leadership, and one scale signifying passive implementation leadership. Findings showed that the hypothesised model had an acceptable model fit (χ2(99)=382.864**, Comparative Fit Index=0.935, Tucker-Lewis Index=0.911, root mean square error of approximation=0.059). The internal consistency and convergent, discriminant and criterion-related validity were all satisfactory.ConclusionsThe iLead scale is a valid measure of implementation leadership and is a tool for understanding how active and passive leader behaviours influence an implementation process. This brief scale may be particularly valuable to apply in training focusing on facilitating implementation, and in evaluating leader training. Moreover, the scale can be useful in evaluating various leader behaviours associated with implementation success or failure.