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Objective: To assess the effect of a research prioritization partnership that aimed to influence the research agenda relating to urinary incontinence (UI).Study Design and Setting: Research often neglects important gaps in existing evidence so that decisions must be made about treatments without reliable evidence of their effectiveness. In 2007-2009, a United Kingdom partnership of eight patient and 13 clinician organizations identified and prioritized gaps in the evidence that affect everyday decisions about treatment of UI. The top 10 prioritized research questions were published and reported to research funders in 2009. A year later, new research or funding applications relating to the prioritized topics were identified through reviews of research databases and consultation with funding organizations, elements of the research community, and organizations that participated in the partnership.Results: Since dissemination of the prioritized topics, five studies are known to have been funded, three in development; five new systematic reviews are under way, one is being updated; five questions are under consideration by a national research commissioning body.Conclusion: The partnership successfully developed and used a methodology for identification and prioritization of research needs through patient-clinician consensus. Prioritization through consensus can be effective in informing the development of clinically useful research. [ABSTRACT FROM AUTHOR]

Objective: To assess the effect of a research prioritization partnership that aimed to influence the research agenda relating to urinary incontinence (UI). Study Design and Setting: Research often neglects important gaps in existing evidence so that decisions must be made about treatments without reliable evidence of their effectiveness. In 2007-2009, a United Kingdom partnership of eight patient and 13 clinician organizations identified and prioritized gaps in the evidence that affect everyday decisions about treatment of UI. The top 10 prioritized research questions were published and reported to research funders in 2009. A year later, new research or funding applications relating to the prioritized topics were identified through reviews of research databases and consultation with funding organizations, elements of the research community, and organizations that participated in the partnership. Results: Since dissemination of the prioritized topics, five studies are known to have been funded, three in development; five new systematic reviews are under way, one is being updated; five questions are under consideration by a national research commissioning body. Conclusion: The partnership successfully developed and used a methodology for identification and prioritization of research needs through patienteclinician consensus. Prioritization through consensus can be effective in informing the development of clinically useful research. [ABSTRACT FROM AUTHOR]

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 ISRCTN15517O81. [ABSTRACT FROM AUTHOR]

Examines the impact third trimester placental grading by ultrasonography on fetal wellbeing in Great Britain. Evidence of reduced perinatal death; Use of the method in controlling infants mortality and morbidity; Unjustification of the study in routine scanning in late pregnancy.

The article discusses ways to manage neurogenic bladder dysfunction to prevent incontinence, urinary tract infections and improve patient quality of life. Neurogenic bladder dysfunction can be caused by spinal injury or neurological disorders. Management techniques can include catheterisation, stimulation of the sacral nerves and surgical methods such as urinary diversion and bladder augmentation. The authors note the possibility of urinary tract infections due to catheterisation and complications from surgery. They comment on the lack of clear best practices from randomised controlled trials.

Background: If the randomisation process within a trial is subverted, this can lead to selection bias that may invalidate the trial's result. To avoid this problem, it is recommended that some form of concealment should be put into place. Despite ongoing anecdotal concerns about their susceptibility to subversion, a surprising number of trials (over 10%) still use sealed opaque envelopes as the randomisation method of choice. This is likely due in part to the paucity of empirical data quantifying the potential effects of subversion. In this study we report a historical before and after study that compares the use of the sealed envelope method with a more secure centralised telephone allocation approach in order to provide such empirical evidence of the effects of subversion.Methods: This was an opportunistic before and after study set within a multi-centre surgical trial, which involved 654 patients from 28 clinicians from 23 centres in the UK and Ireland. Two methods of randomly allocating subjects to alternative treatments were adopted: (a) a sealed envelope system administered locally, and (b) a centralised telephone system administered by the trial co-ordination centre. Key prognostic variables were compared between randomisation methods: (a) age at trial entry, a key prognostic factor in the study, and (b) the order in which 'randomisation envelopes' were matched to subjects.Results: The median age of patients allocated to the experimental group with the sealed envelope system, was significantly lower both overall (59 vs 63 years, p < 0.01) and in particular for three clinicians (57 vs 72, p < 0.01; 33 vs 69, p < 0.001; 47 vs 72, p = 0.03). No differences in median age were found between the allocation groups for the centralised system.Conclusions: Due to inadequate allocation concealment with the sealed envelope system, the randomisation process was corrupted for patients recruited from three clinicians. Centralised randomisation ensures that treatment allocation is not only secure but seen to be secure. Where this proves to be impossible, allocation should at least be performed by an independent third party. Unless it is an absolute requirement, the use of sealed envelopes should be discontinued forthwith. [ABSTRACT FROM AUTHOR]

Background: Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods: Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results: The case study demonstrates that trials need various categories of people to buy in -- hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion: The performance of future clinical trials could be enhanced if trialists routinely considered these factors. [ABSTRACT FROM AUTHOR]

Objective To investigate the prevalence of persistent and long term postpartum urinary incontinence and associations with mode of first and subsequent delivery. Design Longitudinal study. Setting Maternity units in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand). Population Women (4214) who returned postal questionnaires three months and six years after the index birth. Methods Symptom data were obtained from both questionnaires and obstetric data from case-notes for the index birth and the second questionnaire for subsequent births. Logistic regression investigated the independent effects of mode of first delivery and delivery mode history. Main outcome measures Urinary incontinence—persistent (at three months and six years after index birth) and long term (at six years after index birth). Results The prevalence of persistent urinary incontinence was 24%. Delivering exclusively by caesarean section was associated with both less persistent (OR = 0.46, 95% CI 0.32–0.68) and long term urinary incontinence (OR = 0.50, 95% CI 0.40–0.63). Caesarean section birth in addition to vaginal delivery, however, was not associated with significantly less persistent incontinence (OR 0.93, 95% CI 0.67–1.29). There were no significant associations between persistent or long term urinary incontinence and forceps or vacuum extraction delivery. Other significantly associated factors were increasing number of births and older maternal age. Conclusions The risk of persistent and long term urinary incontinence is significantly lower following caesarean section deliveries but not if there is another vaginal birth. Even when delivering exclusively by caesarean section, the prevalence of persistent symptoms (14%) is still high. [ABSTRACT FROM AUTHOR]

Background: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme. Methods: The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. Results: Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. Conclusion: Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone. [ABSTRACT FROM AUTHOR]

Conclusions: A third of women may have some urinary incontinence three months after childbirth. Conservative management provided by nurses seems to reduce the likelihood of urinary and coexisting faecal incontinence persisting 12 months postpartum. Further trials for faecal incontinence are needed. [ABSTRACT FROM AUTHOR]