A core outcome set for localised prostate cancer effectiveness trials

Abstract

We have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions that should be measured in all localised prostate cancer effectiveness trials.

EAU-EANM-ESTRO-ESUR-SIOG Prostate Cancer Guideline Panel Consensus Statements for Deferred Treatment with Curative Intent for Localised Prostate Cancer from an International Collaborative Study (DETECTIVE Study)

“…All other statements not falling in the above categories will be classified as equivocal. The decision to use 70% as a threshold was based on prior studies and consensus method research [10][11][12][13].…”

“…Both studies are complementary. MacLennan et al [12] used Delphi Disagree E U R O P E A N U R O L O G Y 7 6 ( 2 0 1 9 ) 7 9 0 -8 1 3 [12] core outcome set, providing confidence that men with localised prostate cancer and the HCPs who treat them, regarded the same outcomes as important in two separate samples. More recently, Merriel et al [17] published consensus statements on current best practice of active surveillance in the UK.…”

“…It may be argued that this is an arbitrary figure. However, our decision to use this threshold was informed by the methodological literature and through experience in previous consensus research conducted by members of the project steering group [12,13,18]. Many consensus projects define consensus as 70% of the participants choosing scores 7-9 and <15% choosing scores 1-3 (or vice versa) on a 9-point Likert scale, in order to account for the majority opinion whilst not dismissing divergent opinions [10,11,19].…”

How Do We Meet the Supportive Care and Information Needs of Those Living With and Beyond Bladder Cancer?

“…The focus of this has been on structure, process (key stakeholder behavior and interaction) and outcome (measurement and definition) of cancer care (10). This has included co-design work looking to address supportive care and information needs of those diagnosed with urological cancer (11), understanding how best to include the individual's voice in the design and delivery of care, and the language and measurement of care and outcomes e.g., clinical guidelines and core outcome sets [For more detail on individual projects see (1,(12)(13)(14)(15)(16)(17)(18)] (see Figure 1).…”

Key Steps in Conducting Systematic Reviews for Underpinning Clinical Practice Guidelines: Methodology of the European Association of Urology

“…This is crucial as many outcomes may be reported using multiple definitions (eg, biochemical recurrence after radical prostatectomy), measurement scales (eg, multiple urinary symptom questionnaires to access the severity of urinary incontinence), measurement method (eg, healthy parenchymal volume loss after partial nephrectomy measured by computed tomography volumetric analysis or estimated by surgeon), or different points in time (eg, cancer-specific survival at 1 yr, 5 yr, and 10 yr). Standardised sets of outcomes, known as "core outcome sets" represent the minimum that should be measured and reported in all clinical trials of a specific condition making it easier for the results of trials to be combined [17]. The numerical data required for MA are not always available and sometimes other statistics or graphical information can be collected and converted into the required format.…”