Streamlining the study start up process

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The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux Questionnaire.

INTRODUCTION This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS. Method Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD. The final measure consisted of 31 items covering 7 categories (Heartburn; Acid reflux; Wind; Eating and swallowing; Bowel movements; Sleep; Work, physical and social activities). The measure produced two outputs: a quality of life score (RQLS) and five Reflux symptom scores. Reliability (internal consistency), criterion validity with the SF-36 and, sensitivity to change in terms of relationship with reported change in prescribed medication were assessed amongst a sample of 794 patients recruited into the trial. RESULTS The measure was shown to be internally consistent, to show criterion validity with the SF-36 and sensitive to changes in patients use of prescribed medication at baseline and 3 month follow-up. DISCUSSION The Reflux questionnaire is a new self-administered questionnaire for use amongst patients with GORD. Initial findings suggest that the new measure is valid, reliable, acceptable to respondents and simple to administer in both a clinical and research context

Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease : UK collaborative randomised trial

ABSTRACT Objective To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Multicentre, pragmatic randomised trial (with parallel preference groups). Setting 21 hospitals in the United Kingdom. Participants 357 randomised participants (178 surgical,179 medical) and 453 preference participants (261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for >12 months. Intervention The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care. Main outcome measures The disease specific REFLUX quality of life score (primary outcome), SF-36, EQ-5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications. Main results Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 (62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% (59/154) randomised to surgery (14% (14/104) among those who had fundoplication) were taking reflux medication versus 90% (147/164) randomised medical management. The REFLUX score favoured the randomised surgical group (14.0, 95% confidence interval 9.6 to 18.4; P<0.001). Differences of a third to half of 1 SD in other health status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group. Conclusion At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD. Trial registration ISRCTN15517081This study was funded by the NIHR Health Technology Assessment Programme (as part of project no. 97/10/99) and the full project report is published in Health Technology Assessment 2008;12:1/181. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorates.Peer reviewe

Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH) : a parallel-group, open-label, randomised controlled trial

UK National Institute for Health Research Health Technology Assessment Programme. Acknowledgments We thank the women who participated in the HEALTH study. We also thank Angela Hyde (Vice Chair of the Royal College of Obstetricians and Gynaecologists Women's Network until September, 2015, and co-applicant on the original grant application until October, 2016) for her contribution to the design of the participant facing documents and participation in trial meetings from the perspective of a patient, Jonathan Cook (statistician and co-applicant on the original grant application until April, 2014) for his contributions to the study design, Rebecca Bruce for her secretarial support and data management, members of the project management group for their ongoing advice and support of the trial, plus the independent members of the trial steering committee (Henry Kitchener [Chair], Patrick Chien, Barbara Farrell, and Isobel Montgomery) and data monitoring committee (Jane Norman [Chair], Peter O'Donovan, and Andy Vail), and the staff at the recruitment sites who facilitated recruitment, treatment, and follow-up of trial participants. The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number 12/35/23). The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views expressed herein are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care.Peer reviewedPublisher PD

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial) : pragmatic, multicentre randomised controlled trial

Acknowledgments This project will be published in full in the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme series. Data monitoring committee: Catherine Hewitt (University of York), Jonathan Lund (University of Nottingham), Tim McAdam (Belfast Health and Social Care Trust), and Amir Nisar (Maidstone and Tunbridge Wells NHS Trust). Trial steering group: David Beard (University of Oxford), Ian Beckingham (Nottingham University Hospitals NHS Trust), John Leeds (Newcastle Hospitals NHS Foundation Trust), and Dee McDonald (patient representative). Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme (project No 14/192/71). The Health Services Research Unit of the University of Aberdeen is funded in part by the chief scientist’s office of the Scottish government’s health and social care directorates. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the chief scientist’s office, HTA programme, NIHR, NHS, or Department of Health. The funder had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.Peer reviewedPublisher PD

Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding:the HEALTH RCT

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Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): Study protocol for a randomised controlled trial

© 2018 The Author(s). Background: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Methods/design: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. Discussion: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS

HEALTH:laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

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