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Acknowledgements MDW, TA and AAS acknowledge support from the NIHR Newcastle Biomedical Research Centre. With thanks to NHS Scotland Support for Science for supporting the trial, and to the NIHR Ageing Clinical Research Network and the NIHR Primary Care Research Network for their assistance with site identification and participant recruitment. The authors of this manuscript certify that they comply with the ethical guidelines for authorship and publishing in the Journal of Cachexia, Sarcopenia and Muscle [28]. Funding The LACE trial (project reference 13/53/03) is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care. The Health Services Research Unit at the University of Aberdeen is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates ; Peer reviewed ; Publisher PDF

INTRODUCTION: The use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial. METHODS AND ANALYSIS: We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas 10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures. ETHICS AND DISSEMINATION: All participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858). TRIAL REGISTRATION DETAILS: The study has been registered with ClinicalTrials.gov under: NCT04049357.

Purpose– The purpose of this paper is to evaluate the effectiveness of a free book gifting programme, called "Bookstart+", in improving family reading outcomes.Design/methodology/approach– Bookstart+ consists of a pack of books and reading materials provided to families at their two-year-old child's statutory health visit. The pack is accompanied by a short priming demonstration, delivered by the health visitor, on shared reading. The evaluation took the form of a randomised controlled trial (RCT) with 460 families from the client lists of 115 health visitors.Findings– The study found evidence of: a positive significant effect on parents' attitudes to reading and books (Cohen'sd=+0.192,p=0.034); no significant effect on parental attitudes to their child reading (d=+0.085,p=0.279); and a negative effect, approaching significance, on public library usage (d=−0.160,p=0.055).Research limitations/implications– The attrition rate was high, with only 43.9 per cent of the target families completing all of the research. However, this level of attrition did not lead to any significant differences between the control and intervention groups on their pre-test measures.Practical implications– The study provides recommendations for free book gifting service provision in relation to pack contents and delivery.Originality/value– This paper contributes to the limited international RCT evidence on free book gifting programmes.

The aim of this study is to assess the efficacy of a restricted elimination diet in reducing symptoms in an unselected group of children with Attention deficit/hyperactivity disorder (ADHD). Dietary studies have already shown evidence of efficacy in selected subgroups. Twenty-seven children (mean age 6.2) who all met the DSM-IV criteria for ADHD, were assigned randomly to either an intervention group (15/27) or a waiting-list control group (12/27). Primary endpoint was the clinical response, i.e. a decrease in the symptom scores by 50% or more, at week 9 based on parent and teacher ratings on the abbreviated ten-item Conners Scale and the ADHD-DSM-IV Rating Scale. The intention-to-treat analysis showed that the number of clinical responders in the intervention group was significantly larger than that in the control group [parent ratings 11/15 (73%) versus 0/12 (0%); teacher ratings, 7/10 (70%) versus 0/7 (0%)]. The Number of ADHD criteria on the ADHD Rating Scale showed an effect size of 2.1 (cohen's d) and a scale reduction of 69.4%. Comorbid symptoms of oppositional defiant disorder also showed a significantly greater decrease in the intervention group than it did in the control group (cohens's d 1.1, scale reduction 45.3%). A strictly supervised elimination diet may be a valuable instrument in testing young children with ADHD on whether dietary factors may contribute to the manifestation of the disorder and may have a beneficial effect on the children's behaviour.

BACKGROUND: Successful implementation and long-term maintenance of healthy supermarkets initiatives are crucial to achieving potential population health benefits. Understanding barriers and enablers of implementation of real-world trials will enhance wide-scale implementation. This process evaluation of a healthy supermarket intervention sought to describe (i) customer, retailer and stakeholder perspectives on the intervention; (ii) intervention implementation; and (iii) implementation barriers and enablers. METHODS: Eat Well @ IGA was a 12-month randomised controlled trial conducted in 11 Independent Grocers of Australia (IGA) chain supermarkets in regional Victoria, Australia (5 intervention and 6 wait-listed control stores). Intervention components included trolley and basket signage, local area and in-store promotion, and shelf tags highlighting the healthiest packaged foods. A sequential mixed-methods process evaluation was undertaken. Customer exit surveys investigated demographics, and intervention recall and perceptions. Logistic mixed-models estimated associations between customer responses and demographics, with store as random effect. Supermarket staff surveys investigated staff demographics, interactions with customers, and intervention component feedback. Semi-structured stakeholder interviews with local government, retail and academic partners explored intervention perceptions, and factors which enabled or inhibited implementation, maintenance and scalability. Interviews were inductively coded to identify key themes. RESULTS: Of 500 customers surveyed, 33%[95%CI:23,44] recalled the Eat Well @ IGA brand and 97%[95%CI:93,99] agreed that IGA should continue its efforts to encourage healthy eating. The 82 staff surveyed demonstrated very favourable intervention perceptions. Themes from 19 interviews included that business models favour sales of unhealthy foods, and that stakeholder collaboration was crucial to intervention design and implementation. Staff surveys and interviews highlighted the need to ...

Funding: The project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 12/35/38). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. ; Objective : To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma. Design : Pragmatic multicentre randomised controlled trial. Setting : 27 secondary care glaucoma departments in the UK. Participants : 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017. Interventions : Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226). Main outcome measures : Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months. Secondary outcomes: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety. Results : At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval −1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference −2.8 (−3.8 to −1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare. Conclusion : Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication. ; Publisher PDF ; Peer reviewed

Background: Up to 50% of patients with schizophrenia are non-adherent with antipsychotic medication. Aims: To establish the efficacy of adherence therapy (AT) compared to treatment as usual (TAU) in improving clinical outcomes in patients with schizophrenia following an acute exacerbation of illness. Method: A parallel-group, single-blind, randomised controlled trial. Fieldwork was conducted in Thailand. Patients received eight weekly sessions of AT in addition to TAU. The primary outcome was improvement in psychopathology (measured using the Positive and Negative Syndrome Scale (PANSS)) at 26-week follow-up. Secondary outcomes included patient attitudes towards medication, global functioning and side-effects. Results: In total, 70 inpatients with schizophrenia were recruited to the trial. At 26-week follow-up, PANSS total scores improved in the AT compared to the TAU group by a mean of −3.94 points (effect size = 0.24). The number needed to treat (NNT) was 5. There was no significant effect on patients' attitudes towards treatment, functioning or medication side-effects. No treatment-related adverse effects were reported. Conclusion: AT improves psychopathology in Asian patients with schizophrenia following an acute exacerbation of illness.

Objectives: Strengths-based approaches to case management for people with mental illness have been widely used in Western countries. The aim of this study was to evaluate the effectiveness of Strengths Model Case Management (SMCM) among mental health clients in Hong Kong. Method: Two hundred and nine service clients were recruited from three Integrated Community Centres. Multiple measures related to recovery progress (e.g., Recovery Assessment Scale) were reported by both the clients and caseworkers before intervention and at 6 and12 months post-recruitment. Results and conclusion: Although there were no significant differences in improvement of most outcomes between the SMCM and control groups, the recovery scores of the SMCM group remained stable over time regardless of age, and also middle-aged participants (i.e., 40–59 years old) in the SMCM group achieved higher recovery scores over time than those in the control group. Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN) 12617001435370.

Funding: The project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 12/35/38). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no role in considering the study design or in the collection, analysis, or interpretation of data; writing the report; or the decision to submit the article for publication. The views expressed herein are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Acknowledgments Sponsor representative: Pauline Hyman-Taylor (from February 2019), Natalie McGregor (March 2015 to February 2019), Audrey Athlan (from July 2014 to March 2015), Joanne Thornhill (from 2013 to July 2014). Patient and public involvement representative: Rick Walsh, Russel Young. CHaRT Trial Office: Mark Forrest (from 2015), Gladys McPherson (until 2015). CHaRT Trial Office data coordinator: Pauline Garden. Health economists: Eoin Maloney (until 2015), Mehdi Javanbakht (until June 2019).All participants in the trial, staff, and members of the TAGS Investigator Group responsible for recruitment in the clinical centres. ; Peer reviewed ; Publisher PDF

Background: The aim of this trial was to compare a video- and a simulation-based teaching method to the conventional lecture-based method, hypothesizing that the video- and simulation-based teaching methods would lead to improved recognition of breathing patterns during cardiac arrest. Methods: In this Danish, investigator-initiated, stratified, randomised controlled trial, adult laypersons (university students, military conscripts and elderly retirees) participating in European Resuscitation Council Basic Life Support courses were randomised to receive teaching on how to recognise breathing patterns using a lecture- (usual practice), a video-, or a simulation-based teaching method. The primary outcome was recognition of breathing patterns in nine videos of actors simulating normal breathing, no breathing, and agonal breathing (three of each). We analysed outcomes using logistic regression models and present results as odds ratios (ORs) with 95% confidence intervals (CIs) and P-values from likelihood ratio tests. Results: One hundred fifty-three participants were included in the analyses from February 2, 2018 through May 21, 2019 and recognition of breathing patterns was statistically significantly different between the teaching methods (P = 0.013). Compared to lecture-based teaching (83% correct answers), both video- (90% correct answers; OR 1.77, 95% CI: 1.19–2.64) and simulation-based teaching (88% correct answers; OR 1.48; 95% CI: 1.01–2.17) led to significantly more correct answers. Video-based teaching was not statistically significantly different compared to simulation-based teaching (OR 1.20; 95% CI: 0.78–1.83). Conclusion: Video- and simulation-based teaching methods led to improved recognition of breathing patterns among laypersons participating in adult Basic Life Support courses compared to the conventional lecture-based teaching method.

Background: The aim of this trial was to compare a video- and a simulation-based teaching method to the conventional lecture-based method, hypothesizing that the video- and simulation-based teaching methods would lead to improved recognition of breathing patterns during cardiac arrest. Methods: In this Danish, investigator-initiated, stratified, randomised controlled trial, adult laypersons (university students, military conscripts and elderly retirees) participating in European Resuscitation Council Basic Life Support courses were randomised to receive teaching on how to recognise breathing patterns using a lecture- (usual practice), a video-, or a simulation-based teaching method. The primary outcome was recognition of breathing patterns in nine videos of actors simulating normal breathing, no breathing, and agonal breathing (three of each). We analysed outcomes using logistic regression models and present results as odds ratios (ORs) with 95% confidence intervals (CIs) and P-values from likelihood ratio tests. Results: One hundred fifty-three participants were included in the analyses from February 2, 2018 through May 21, 2019 and recognition of breathing patterns was statistically significantly different between the teaching methods (P = 0.013). Compared to lecture-based teaching (83% correct answers), both video- (90% correct answers; OR 1.77, 95% CI: 1.19–2.64) and simulation-based teaching (88% correct answers; OR 1.48; 95% CI: 1.01–2.17) led to significantly more correct answers. Video-based teaching was not statistically significantly different compared to simulation-based teaching (OR 1.20; 95% CI: 0.78–1.83). Conclusion: Video- and simulation-based teaching methods led to improved recognition of breathing patterns among laypersons participating in adult Basic Life Support courses compared to the conventional lecture-based teaching method.