65 research outputs found

    Data entry checking - is it necessary?

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    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

    Clinical trials software: commercial system or build your own?

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    Simple imputation methods were inadequate for missing not at random (MNAR) quality of life data

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    Acknowledgements We thank the patients who took part in the RECORD study, without whose help this study would not have been possible. The MRC funded the central organisation of RECORD, and Shire Pharmaceuticals Group plc funded the drugs, which were manufactured by Nycomed Ltd. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorate. Shona Fielding is also currently funded by the Chief Scientist Office on a Research Training Fellowship (CZF/1/31). The views expressed are, however, not necessarily those of the funding body.Peer reviewedPublisher PD

    Individualised pelvic floor muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial

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    <br>Background: Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women with prolapsed are often advised to do pelvic floor muscle exercises, but supporting evidence is limited. Our aim was to establish if one-to-one individualised pelvic floor muscle training (PFMT) is effective in reducing prolapse symptoms.</br> <br>Methods: A parallel‐group multicentre randomised controlled trial (ISRCTN35911035) in female outpatients with newly-diagnosed, symptomatic stage I, II or III prolapse, comparing five PFMT appointments over 16 weeks (n=225) versus a lifestyle advice leaflet (n=222). Treatment allocation was by remote computer allocation using minimisation. Our primary endpoint was participants’ self-report of prolapsed symptoms at 12 months. Group assignment was masked from outcome assessors. We compared outcomes between trial groups in an intention-to-treat analysis. The cost of PFMT and savings on subsequent treatments were calculated to estimate cost-effectiveness.</br> <br>Findings: Compared to the control group, the intervention group reported fewer prolapse symptoms at 12 months (mean difference between groups in change score 1.52, 95% CI [0.46, 2.59], p=0.0053); reported their prolapse to be “better” more often (57.2% versus 44.7%, difference 12.6%, 95% CI [1.1%, 24.1%], p=0.0336); and had an increased but non-significant odds of having less severe stage of prolapse at their 6-month clinical examination, (OR 1.47, 95% CI [0.97, 2.27], p=0.07). The control group had a greater uptake of other prolapse treatment (49.6% versus 24.1%, difference 25.5%, 95% CI [14.5%, 36.0%], p <0.0001). Findings were robust to missing data. The net cost of the 25 intervention was £131.61 per woman and the cost per one-point reduction in the symptom score was £86.59, 95% CI [£50.81, £286.11]. </br&gt
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