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See detailCommunity- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda: the protocol of a mixed-methods study including a cluster randomised controlled trial (D²Rwanda)
Lygidakis, Charilaos UL; Uwizihiwe, JP; Kallestrup, P et al

in BMJ Open (2019), 9(7), 028427

Introduction In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has ... [more ▼]

Introduction In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients’ health behaviours and HBCPs’ work satisfaction. Methods and analysis This is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs’ programme; (2) HBCPs’ programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs’ programme. Under each hospital, administrative areas implementing the HBCPs’ programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs’ programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg. Ethics and dissemination Ethics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations. Trial registration number NCT03376607; Pre-results. [less ▲]

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See detailFamily Violence Curricula in Europe (FAVICUE): a cross-sectional descriptive study protocol
Gomez Bravo, Raquel UL; Lygidakis, Charilaos UL; Feder, Gene et al

in BMJ Open (2019), 9

Introduction. Family violence (FV) is a widespread public health problem of epidemic proportions and serious consequences. Doctors may be the first or only point of contact for victims who may be hesitant ... [more ▼]

Introduction. Family violence (FV) is a widespread public health problem of epidemic proportions and serious consequences. Doctors may be the first or only point of contact for victims who may be hesitant or unable to seek other sources of assistance, and they tend not to disclose abuse to doctors if not specifically asked. A comprehensive healthcare response is key to a coordinated community-wide approach to FV, but most of the practising physicians have received either no or insufficient education or training in any aspect of FV. Training of medical students concerning FV is often delivered in an inconsistent or ad hoc manner. The main aim of this project, Family Violence Curricula in Europe (FAVICUE), is to (1) describe current FV education delivery in European medical universities (undergraduate period) and during the specialist training in general practice (GP)/family medicine (FM) (postgraduate residency programme), and (2) compare it with WHO recommendations for FV curriculum. Methods and analysis. This is the protocol of a cross-sectional descriptive study consisting of two self-report online surveys (for undergraduate and postgraduate training, respectively) with 40 questions each. For both surveys, general practitioners, residents, medical students and professionals involved in their education from countries of the European region will be identified through the European Regional Branch of the World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (WONCA Europe) and will be invited to provide information regarding the training on FV. Descriptive tests will be carried out and a thematic analysis will be conducted on the open-ended questions. Ethics and dissemination Ethics approval has been obtained by the University of Luxembourg (ERP 17–015 FAVICUE). The results will provide important information concerning current curricula on FV, and can be used for mapping the educational needs and planning the implementation of future training interventions. They will be published and disseminated through WONCA Europe and its networks. [less ▲]

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See detailDifferent but Similar: Personality Traits of Surgeons and Internists. Results of a Cross-Sectional Observational Study
Stienen, Martin N.; Scholtes, Felix; Samuel, Robin UL et al

in BMJ Open (2018), 8(e02131),

Objectives: Medical practice may attract and possibly enhance distinct personality profiles. We set out to describe the personality profiles of surgical and medical specialties focusing on board-certified ... [more ▼]

Objectives: Medical practice may attract and possibly enhance distinct personality profiles. We set out to describe the personality profiles of surgical and medical specialties focusing on board-certified physicians. Design: Prospective, observational. Setting: Online survey containing the Ten-Item Personality Inventory (TIPI), an internationally validated measure of the Five Factor Model of personality dimensions, distributed to board-certified physicians, residents and medical students in several European countries and Canada. Differences in personality profiles were analyzed using MANOVA and Canonical Linear Discriminant Analysis on age- and sex-standardized z-scores of the personality traits. Single personality traits were analyzed using robust t-tests. Participants: The TIPI was completed by 2345 board-certified physicians, 1453 residents and 1350 medical students, who also provided demographic information. Interventions: None. Results: Normal population and board-certified physicians’ personality profiles differed (P<0.001). The latter scored higher on conscientiousness, extraversion, and agreeableness, but lower on neuroticism (all P<0.001). There was no difference in openness to experience. Board-certified surgical and medical doctors’ personality profiles were also different (P<0.001). Surgeons scored higher on extraversion (P=0.003) and openness to experience (P=0.002), but lower on neuroticism (P<0.001). There was no difference in agreeableness and conscientiousness. These differences in personality profiles were reproduced at other levels of training, i.e., in students and training physicians engaging in surgical versus medical practice. Conclusion: These results indicate the existence of a distinct and consistent average “physician personality”. Despite high variability within disciplines, there are moderate, but solid and reproducible differences between surgical and medical specialties. [less ▲]

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See detailRandomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website
Wallace, Paul; Struzzo, Pierliugi; Della Vedova, Roberto et al

in BMJ Open (2017), 7(11),

Background: Brief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application ... [more ▼]

Background: Brief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application offers a novel alternative to face-to-face intervention, but its relative effectiveness is unknown.Methods: Primary care-based, non-inferiority, randomised controlled trial comparing general practitioner (GP) facilitated access to an interactive alcohol reduction website (FA) with face-to-face BI for risky drinking. Patients screening positive on the short Alcohol Use Disorders Identification Test (AUDIT-C) were invited to participate in the trial. Assessment at baseline, 3 months and 12 months was carried out using AUDIT and EQ-5D-5L questionnaires. Findings: 58 participating GPs approached 9080 patients of whom 4529 (49.9%) logged on, 3841 (84.8%) undertook screening, 822 (21.4%) screened positive and 763 (19.9%) were recruited. 347 (45.5%) were allocated to FA and 416 (54.5%) to BI. At 3 months, subjects in FA group with an AUDIT score of ≥8 reduced from 95 (27.5%) to 85 (26.8%) while those in BI group increased from 123 (20.6%) to 141 (37%). Differences between groups were principally due to responses to AUDIT question 10. Analysis of primary outcome indicated non-inferiority of FA compared with BI, and prespecified subgroup analysis indicated benefits for older patients and those with higher levels of computer literacy and lower baseline severity. Additional analyses undertaken to take account of bias in response to AUDIT question 10 failed to support non-inferiority within the prespecified 10% boundary.Interpretation: Prespecified protocol-driven analyses of the trial indicate that FA is non-inferior to BI; however, identified bias in the outcome measure and further supportive analyses question the robustness of this finding. It is therefore not possible to draw firm conclusions from this trial, and further research is needed to determine whether the findings can be replicated using more robust outcome measures.Trial registration number NCT01638338; Results. [less ▲]

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See detailRandomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website: cost-effectiveness analysis
Hunter, Rachael; Wallace, Paul; Struzzo, Pierluigi et al

in BMJ Open (2017), 7(11),

Objectives To evaluate the 12-month costs and quality-adjusted life years (QALYs) gained to the Italian National Health Service of facilitated access to a website for hazardous drinkers compared with a ... [more ▼]

Objectives To evaluate the 12-month costs and quality-adjusted life years (QALYs) gained to the Italian National Health Service of facilitated access to a website for hazardous drinkers compared with a standard face-to-face brief intervention (BI). Design Randomised 1:1 non-inferiority trial. Setting Practices of 58 general practitioners (GPs) in Italy. Participants Of 9080 patients (>18 years old) approached to take part in the trial, 4529 (49·9%) logged on to the website and 3841 (84.8%) undertook online screening for hazardous drinking. 822 (21.4%) screened positive and 763 (19.9%) were recruited to the trial. Interventions Patients were randomised to receive either a face-to-face BI or access via a brochure from their GP to an alcohol reduction website (facilitated access). Primary and secondary outcome measures The primary outcome is the cost per QALY gained of facilitated access compared with face-to-face. A secondary analysis includes total costs and benefits per 100 patients, including number of hazardous drinkers prevented at 12 months. Results The average time required for the face-to-face BI was 8 min (95% CI 7.5 min to 8.6 min). Given the maximum time taken for facilitated access of 5 min, face-to-face is an additional 3 min: equivalent to having time for another GP appointment for every three patients referred to the website. Complete case analysis adjusting for baseline the difference in QALYs for facilitated access is 0.002 QALYs per patient (95% CI −0.007 to 0.011). Conclusions Facilitated access to a website to reduce hazardous drinking costs less than a face-to-face BI given by a GP with no worse outcomes. The lower cost of facilitated access, particularly in regards to investment of time, may facilitate the increase in provision of BIs for hazardous drinking. Trial registration number NCT01638338;Post-results. [less ▲]

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See detailCan health indicators and psychosocial characteristics predict attrition in youth with overweight and obesity seeking ambulatory treatment? Data from a retrospective longitudinal study in a paediatric clinic in Luxembourg.
Pit-Ten Cate, Ineke UL; Samouda, Hanen; Schierloh, Ulrike et al

in BMJ Open (2017), 7(9),

ABSTRACT Objectives: The current study aimed to identify factors that could predict attrition in youth starting ambulatory treatment to control or lose weight. Design: retrospective longitudinal study ... [more ▼]

ABSTRACT Objectives: The current study aimed to identify factors that could predict attrition in youth starting ambulatory treatment to control or lose weight. Design: retrospective longitudinal study Setting: paediatric clinic: ambulatory treatment program Patients and measures: A youth sample (N=191; 89 boys; age 7-17 years) completed measures of demographic characteristics, health and psychosocial traits before starting an ambulatory weight management program. Anthropometric and biological markers related to obesity were also obtained. Test of mean differences and regression analyses were used to investigate the relationship between these variables and attrition after one year. Results: Chi-square and t-test results showed both psychosocial and health indicators differentiated between participants who continued attending the treatment program and those that dropped out. More specifically, youth that dropped out of treatment were significantly older, had higher BMI-Z scores, higher levels of insulin, triglycerides and HOMA-IR, reported poorer health and more conduct problems, and were more dissatisfied with themselves and their bodies before starting treatment. Results of regression analyses revealed that weight status (anthropometric and biological markers), age and body dissatisfaction predict attrition (overall prediction success 73%; prediction success for continued attendance 90/91%; prediction success for dropout 42/44%). Conclusion: Attrition, but especially the continued attendance in treatment, can be successfully predicted by age, weight status and body dissatisfaction. For patients who present with one or more risk factors, careful consideration is needed to decide which (combination of) in- or outpatient program may facilitate prolonged engagement of the patient and hence may be most effective in establishing weight loss. [less ▲]

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See detailModelling the natural history of Huntingtons disease progression
Kuan, William; Kasis, Andrea; Yuan, Ye et al

in BMJ Open (2014)

Background: The lack of reliable biomarkers to track disease progression is a major problem in clinical research of chronic neurological disorders. Using Huntington’s disease (HD) as an example, we ... [more ▼]

Background: The lack of reliable biomarkers to track disease progression is a major problem in clinical research of chronic neurological disorders. Using Huntington’s disease (HD) as an example, we describe a novel approach to model HD and show that the progression of a neurological disorder can be predicted for individual patients. Methods : Starting with an initial cohort of 343 patients with HD that we have followed since 1995, we used data from 68 patients that satisfied our filtering criteria to model disease progression, based on the Unified Huntington’s Disease Rating Scale (UHDRS), a measure that is routinely used in HD clinics worldwide. Results : Our model was validated by: (A) extrapolating our equation to model the age of disease onset, (B) testing it on a second patient data set by loosening our filtering criteria, (C) cross-validating with a repeated random subsampling approach and (D) holdout validating with the latest clinical assessment data from the same cohort of patients. With UHDRS scores from the past four clinical visits (over a minimum span of 2 years), our model predicts disease progression of individual patients over the next 2 years with an accuracy of 89–91%. We have also provided evidence that patients with similar baseline clinical profiles can exhibit very different trajectories of disease progression. Conclusions : This new model therefore has important implications for HD research, most obviously in the development of potential disease-modifying therapies. We believe that a similar approach can also be adapted to model disease progression in other chronic neurological disorders. [less ▲]

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See detailA randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR-FVG): the study protocol.
Struzzo, Pierluigi; Scafato, Emanuele; McGregor, Richard et al

in BMJ open (2013), 3(2),

INTRODUCTION: There is a strong body of evidence demonstrating the effectiveness of brief interventions by primary care professionals for risky drinkers. However, implementation levels remain low because ... [more ▼]

INTRODUCTION: There is a strong body of evidence demonstrating the effectiveness of brief interventions by primary care professionals for risky drinkers. However, implementation levels remain low because of time constraints and other factors. Facilitated access to an alcohol reduction website offers primary care professionals a time-saving alternative to standard face-to-face intervention, but it is not known whether it is as effective. METHODS AND ANALYSIS: A randomised controlled non-inferiority trial for risky drinkers comparing facilitated access to a dedicated website with standard face-to-face brief intervention to be conducted in primary care settings in the Region of Friuli Giulia Venezia, Italy. Adult patients will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test (AUDIT-C) alcohol screening questionnaire. Screen positives will be requested to complete an online trial module including consent, baseline assessment and randomisation to either standard intervention by the practitioner or facilitated access to an alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 1 month, 3 months and 1 year using the full AUDIT questionnaire. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming a reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis. ETHICS AND DISSEMINATION: The protocol was approved by the Isontina Independent Local Ethics Committee on 14 June 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. REGISTRATION DETAILS: Trial registration number NCT: 01638338. [less ▲]

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