26 research outputs found

    SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires in the SUSPEND trial : a factorial design, randomised controlled trial

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    Acknowledgements SUSPEND was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project 80/71/01) and will be published in full in Health Technology Assessment. The Health Services Research Unit of the University of Aberdeen is funded in part by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Chief Scientist Office, HTA programme, NIHR, National Health Service, or Department of Health. The authors thank the SUSPEND staff and participants, without whom this study would not have been possible.Peer reviewedPublisher PD

    Decision aids for people considering taking part in clinical trials

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    The authors would like to thank the Cochrane Consumers and Communication Group editors and staff, in particular Sandy Oliver and John Kis‐Rigo, for their help and assistance with this review. We would also like to thank Cynthia Fraser, based at the Health Services Research Unit (University of Aberdeen), for help with development, refinement and running of the search strategies and Graeme MacLennan (also based at the Health Services Research Unit) for statistical advice. We would like to thank Muhammad Omar (Managing Editor of the Cochrane Incontinence Group) and Steven MacLennan (Academic Urology Unit, University of Aberdeen) for advice regarding RevMan and GRADE softwPeer reviewedPublisher PD

    The influence of early research experience in medical school on the decision to intercalate and future career in clinical academia : A questionnaire study

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    Funding for the study was made available from University academic development funds.Peer reviewedPublisher PD

    Estimating Site Performance (ESP) : can trial managers predict recruitment success at trial sites? An exploratory study

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    Availability of data and materials All quantitative data generated and analysed during this study are included in this published article [and its supplementary information files] Additional file 3. The dataset of predictions used and analysed during the current study are available from the corresponding author on reasonable request. The transcript of the group discussion generated and analysed during the current study is not publicly available due it containing information that could compromise research participant consent (it would be a relatively simple matter to identify trials and trial managers) but are available from the corresponding author on reasonable request.Peer reviewedPublisher PD

    A randomized trial comparing treatments for varicose veins

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    Supported by a grant from the Health Technology Assessment Programme of the National Institute for Health Research (06/45/02). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorate. We thank Janice Cruden for her secretarial support and data management; Gladys McPherson and the programming team at the Centre for Healthcare Randomised Trials; Tracey Davidson, Lynda Constable, Jackie Ellington, Laura Elliott, and Yvonne Fernie for help with scoring the Aberdeen Varicose Vein Questionnaire; Luke Vale and Laura Ternent, our original economists in the group; members of the Project Management Group for their ongoing advice and support of the trial; members of the study team (Graeme MacLennan, Maria Prior, and Denise Bolsover) who contributed to the behavioral recovery component of the trial; the independent members of the trial steering committee (Alun Davies [chair], Ian Loftus, and Jane Nixon) and the data and safety monitoring committee (Gerry Stansby [chair], Winston Banya, and Marcus Flather); and the staff members at recruitment sites (see the Supplementary Appendix) who facilitated recruitment, treatment, and follow-up of trial participants.Peer reviewedPublisher PD

    Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS)

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    Background: Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity, mortality and healthcare costs. Beta blockers are well-established drugs widely used to treat cardiovascular conditions. Observational studies consistently report that beta blocker use in people with COPD is associated with a reduced risk of COPD exacerbations. The bisoprolol in COPD study (BICS) investigates whether adding bisoprolol to routine COPD treatment has clinical and cost-effective benefits. A sub-study will risk stratify participants for heart failure to investigate whether any beneficial effect of bisoprolol is restricted to those with unrecognised heart disease. Methods: BICS is a pragmatic randomised parallel group double-blind placebo-controlled trial conducted in UK primary and secondary care sites. The major inclusion criteria are an established predominant respiratory diagnosis of COPD (post-bronchodilator FEV1 < 80% predicted, FEV1/FVC < 0.7), a self-reported history of ≥ 2 exacerbations requiring treatment with antibiotics and/or oral corticosteroids in a 12-month period since March 2019, age ≥ 40 years and a smoking history ≥ 10 pack years. A computerised randomisation system will allocate 1574 participants with equal probability to intervention or control groups, stratified by centre and recruitment in primary/secondary care. The intervention is bisoprolol (1.25 mg tablets) or identical placebo. The dose of bisoprolol/placebo is titrated up to a maximum of 4 tablets a day (5 mg bisoprolol) over 4–7 weeks depending on tolerance to up-dosing of bisoprolol/placebo—these titration assessments are completed by telephone or video call. Participants complete the remainder of the 52-week treatment period on the final titrated dose (1, 2, 3, 4 tablets) and during that time are followed up at 26 and 52 weeks by telephone or video call. The primary outcome is the total number of participant reported COPD exacerbations requiring oral corticosteroids and/or antibiotics during the 52-week treatment period. A sub-study will risk stratify participants for heart failure by echocardiography and measurement of blood biomarkers. Discussion: The demonstration that bisoprolol reduces the incidence of exacerbations would be relevant not only to patients and clinicians but also to healthcare providers, in the UK and globally. Trial registration: Current controlled trials ISRCTN10497306. Registered on 16 August 201
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