[show abstract][hide abstract] ABSTRACT: To investigate the psychological impact of prostate biopsy, including relationships between physical biopsy-related symptoms and anxiety and depression.
A prospective cohort of 1,147 men, nested within the Prostate Testing for Cancer and Treatment trial and recommended to receive prostate biopsy, completed questionnaires assessing physical and psychological harms after biopsy in the Prostate Biopsy Effects study. Psychological impact was measured using the Hospital Anxiety and Depression Scale, and scores were compared according to experiences of biopsy-related symptoms at biopsy, and at 7 and 35 days afterward, and in relation to biopsy results.
A total of 1,144 men (99.7%) returned questionnaires at biopsy, with 1,090 (95.0%) and 1,016 (88.6%) responding at 7 and 35 days postbiopsy. Most men experienced biopsy-related symptoms as no problem or a minor problem, and overall levels of anxiety and depression were low and similar to normative levels. Of men receiving a negative biopsy result (n = 471), anxiety was greater in those experiencing problematic biopsy-related symptoms compared with those experiencing nonproblematic symptoms at 7 days for the following symptoms: pain (P < .001), shivers, (P = .020), hematuria (P < .001), hematochezia (P < .001), and hemoejaculate (P < .001). Anxiety was reduced, although symptoms were not, after 35 days. Overall levels of anxiety were low across all time points except at the 35-day assessment among men who had received a cancer diagnosis.
Problematic postbiopsy symptoms can lead to increased anxiety, distinct from distress related to diagnosis of prostate cancer. Men and doctors need to consider these additional potential harms of biopsy when deciding whether to initiate prostate-specific antigen testing.
Journal of Clinical Oncology 10/2013; · 18.04 Impact Factor
[show abstract][hide abstract] ABSTRACT: Good clinical practice (GCP) guidelines emphasize trial site monitoring, although the implementation is unspecified and evidence for benefit is sparse. We aimed to develop a site monitoring process using peer reviewers to improve staff training, site performance, data collection, and GCP compliance.
The Peer Review Intervention for Monitoring and Evaluating sites (PRIME) team observed and gave feedback on trial recruitment and follow-up appointments, held staff meetings, and examined documentation during annual 2-day site visits. The intervention was evaluated in the ProtecT trial, a UK randomized controlled trial of localized prostate cancer treatments (ISRCTN20141297). The ProtecT coordinator and senior nurses conducted three monitoring rounds at eight sites (2004-2007). The process evaluation used PRIME report findings, trial databases, resource use, and a site nurse survey.
Adverse findings decreased across all sites from 44 in round 1 to 19 in round 3. Most findings related to protocol adherence or site organizational issues, including improvements in eligibility criteria application and data collection. Staff found site monitoring acceptable and made changes after reviews.
The PRIME process used observation by peer reviewers to improve protocol adherence and train site staff, which increased trial performance and consistency.
Journal of clinical epidemiology 01/2011; 64(6):628-36. · 2.96 Impact Factor