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Open AccessDoes variation of surgical technique affect native tissue anterior pelvic organ prolapse repair outcomes?
The Variation in Surgical Technique study (VaST), demonstrated the large variation in surgical techniques used in native tissue (NT) anterior pelvic organ prolapse (POP) repairs. However, there are few compara...
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Open AccessPROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse
Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse.
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Open AccessClinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial
Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life....
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Open AccessThe TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation
Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to th...
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Article
Open AccessIt is unprecedented: trial management during the COVID-19 pandemic and beyond
The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporari...
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Open AccessHow to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt
Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequent...
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Article
Open AccessUsing systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project
Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavie...
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Open AccessVerifying participant-reported clinical outcomes: challenges and implications
Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the ‘accuracy’ of participant-reported clinical outcomes, ...
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Open AccessHEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial
Heavy menstrual bleeding (HMB) is a common problem affecting approximately 1.5 million women in England and Wales with a major impact on their physical, emotional, social and material quality of life. It is th...
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Open AccessA UK questionnaire survey of current techniques used to perform pelvic organ prolapse repair
Evidence-based medicine should result in better standardisation of practice. This study aims to evaluate whether there remains variation in surgical techniques in native tissue and graft/mesh repairs of pelvic...
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Open AccessTwo parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial
One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the origi...
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Open AccessThe importance of rapport and relationship building when recruiting to clinical trials: a qualitative investigation of trial recruitment consultations in a surgical RCT
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Article
Normative data for the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is widely used in both research and clinical contexts. However, UK normative data from HADS remain limited. In our recent review of the literature, only six rep...
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Open AccessTelephone calls to boost response rates in the collection of outcome data
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Open AccessPatient reported clinical outcomes: the challenges and implications for randomised controlled trials