Samantha Wileman

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

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 ISRCTN15517081.

A Randomized Trial Comparing Treatments for Varicose Veins

BACKGROUND Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. METHODS In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. RESULTS After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001). CONCLUSIONS Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

Comparison of consultation rates in primary care attenders with and without seasonal affective disorder

BACKGROUND There is a lack of published information about the consultation patterns of patients with seasonal affective disorder (SAD) in primary care, when compared with non-seasonal controls (NSCs). METHODS Interview-confirmed SAD cases (n=90) were age- and sex-matched to two controls without significant seasonal morbidity on the Seasonal Pattern Assessment Questionnaire (SPAQ) (non-seasonal controls, NSCs). A comparison of their consultation rates was made using data abstracted from primary care records over 4 years. RESULTS The monthly rate of general practice consultations for SAD cases was significantly higher than that for NSCs. There was a significant difference in the median number of consultations in winter and autumn between the two groups. The matched multivariate analysis revealed that February and April were the independent months in which cases of SAD had significantly more consultations than NSCs. LIMITATIONS Optimal diagnostic criteria for SAD have not been determined and our criteria may have been over-inclusive. CONCLUSION In addition to a marked difference in monthly consultation rates between SAD cases and NSCs, the data demonstrate a difference in the pattern of seasonality of these rates. It is possible that increased frequency of consultation, in particular during the winter months (in patients who score as a case SPAQ), could be used as an indication of SAD in primary care.

Beliefs about surgery : Development and validation of an instrument to assess cognitive representations about surgery, in the context of a chronic illness

Objectives: Within a trial of medical and surgical treatments for gastro-esophageal reflux disease (GORD), involving randomised arms and preference arms, we tested the applicability of the Beliefs about Medicines Questionnaire (BMQ) and developed and tested the validity of a new Beliefs about Surgery Questionnaire (BSQ). Methods: Patients with GORD (N = 43) were interviewed to elicit their beliefs about medical and surgical treatments. These contributed to the development of BSQ items. The BMQ and BSQ were completed by trial participants at baseline (randomised trial: N = 325; preference trial: N = 414). Factor analysis and discriminant function analysis were used to assess validity. Results: Principal components analysis (PCA) largely replicated the four-factor BMQ structure. PCA of the combined BMQ/BSQ yielded six factors explaining 54.5% variance. BSQ items loaded onto distinct factors, demonstrating divergence from BMQ. As predicted, BMQ/BSQ scores enabled correct classification of 78.5% of participants to medication and surgery groups in the preference trial (χ2(6) = 205.9, p < 0.001) but only 54.5% (no better than chance) in the randomised trial (χ2(6) = 9.4, p = 0.154). Conclusions: The BSQ is a valid measure of perceptions about surgical treatments for GORD. With the BMQ, it provides information that may guide patients’ choices about treatment. This measure may be applicable to other conditions.

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

BackgroundStress 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/designMen 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.DiscussionA 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.Trial registrationInternational Standard Randomised Controlled Trial Registry: Number ISRCTN49212975. Registered on 22 July 2013. First patient randomised on 29 January 2014.

Overcoming a trial ‘adverse event’: impact and experiences of a temporary suspension of randomisation in clinical trials

A number of factors can result in the temporary suspension of randomisation in clinical trials, with the most common being safety, effectiveness and recruitment. However, external factors such as commercial, political, patient and media pressure can also have a significant impact on decisions to temporarily suspend randomisation. When the decision has been made to suspend randomisation, ethical considerations and future trial standing need to be addressed. This is not disputed when there is a clear and differential effect that needs to be reviewed. For example, a temporary suspension to evaluate unacceptable risks/undesirable consequences may be more ethical than continuing to recruit. However, imposing a temporary suspension of a trial too early may result in data that cannot be reliably interpreted. It may be more ethical to continue with the trial until this perceived effect is properly evaluated and interpreted. Information given to and the potential effect on all stakeholders (including patients and trial sites) should be considered as well as future recruitment, particularly where the decision is based on limited data. Results/reasons for a temporary trial suspension are not widely published (if at all), making it difficult to fully interpret any findings. The need to report the results or details of such a temporary suspension is arguably as important as the findings of completed studies. This presentation will discuss the implications, challenges and lessons learnt in delivering a trial following a temporary suspension of randomisation due to safety concerns.