A core outcome set for localised prostate cancer effectiveness trials

Objective: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer. Background: Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio. This is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials. Subjects and methods: A list of 79 outcomes was derived from a systematic review of published localised prostate cancer effectiveness studies and semi-structured interviews with 15 prostate cancer patients. A two-stage consensus process involving 118 patients and 56 international healthcare professionals (HCPs) (cancer specialist nurses, urological surgeons and oncologists) was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and 8 patients. Results: The final COS included 19 outcomes. Twelve apply to all interventions: death from prostate cancer, death from any cause, local disease recurrence, distant disease recurrence/metastases, disease progression, need for salvage therapy, overall quality of life, stress urinary incontinence, urinary function, bowel function, faecal incontinence, sexual function. Seven were intervention-specific: perioperative deaths (surgery), positive surgical margin (surgery), thromboembolic disease (surgery), bothersome or symptomatic urethral or anastomotic stricture (surgery), need for curative treatment (active surveillance), treatment failure (ablative therapy), and side effects of hormonal therapy (hormone therapy). The UK-centric participants may limit the generalisability to other countries, but trialists should reason why the COS would not be applicable. The default position should not be that a COS developed in one country will automatically not be applicable elsewhere. Conclusion: We have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions which should be measured in all localised prostate cancer effectiveness trials

Urological cancer care pathways: development and use in the context of systematic reviews and clinical practice guidelines

Background: Making healthcare treatment decisions is a complex process involving a broad stakeholder base including patients, their families, health professionals, clinical practice guideline developers and funders of healthcare. Methods: This paper presents a review of a methodology for the development of urological cancer care pathways (UCAN care pathways), which reflects an appreciation of this broad stakeholder base. The methods section includes an overview of the steps in the development of the UCAN care pathways and engagement with clinical content experts and patient groups. Results: The development process is outlined, the uses of the urological cancer care pathways discussed and the implications for clinical practice highlighted. The full set of UCAN care pathways is published in this paper. These include care pathways on localised prostate cancer, locally advanced prostate cancer, metastatic prostate cancer, hormone-resistant prostate cancer, localised renal cell cancer, advanced renal cell cancer, testicular cancer, penile cancer, muscle invasive and metastatic bladder cancer and non-muscle invasive bladder cancer. Conclusion: The process provides a useful framework for improving urological cancer care through evidence synthesis, research prioritisation, stakeholder involvement and international collaboration. Although the focus of this work is urological cancers, the methodology can be applied to all aspects of urology and is transferable to other clinical specialties.11 page(s

The record of in-training assessments (RITAs) in urology: an evaluation of trainee perceptions.

AIMS: To evaluate the effect of the Calman reforms on SpRs in urology with respect to their educational goals, their experience of the RITA process and its value in preparing them for their chosen consultant careers. Participants and Methods: All urological trainees holding national training numbers who had completed at least one RITA review, but had not yet been awarded a CCST, were sampled. RESULTS: A total of 100 completed replies were received. Of those replying, 87% had an appointed educational supervisor with marked variation between regions. Training expectations in the four main categories of knowledge, vocational skills, operative competencies and personal development for each particular year of training were clear to only 40%, 35%, 44% and 60% of trainees, respectively. In general, trainee satisfaction with their most recent RITA review was fair with a mean of 6 (range, 4-8) on an arbitrary 10-point scale. Of the trainees, 83% felt that they would be adequately trained for consultant practice at the end of their training although this confidence varied between years of training. CONCLUSIONS: Unification in the registrar grade has initiated an improvement in urological education for SpRs. There has, however, been haphazard delivery of that education due to a lack of objectivity in definition and assessment of the educational goals in individual training years. The RITA process should be more prescriptive in its administration and the setting of annual targeted training objectives should help to optimise the training opportunities for individual SpRs