Ascertaining cause of death among men in the prostate cancer intervention versus observation trial.

BACKGROUND: The Prostate Cancer Intervention Versus Observation Trial (PIVOT) randomized 731 men with localized prostate cancer to radical prostatectomy or observation. PURPOSE: We describe the methods and results for cause-of-death assignments in PIVOT, and compare them to alternative strategies for ascertaining prostate cancer-specific mortality, as well as to the methods and results in the similar Scandinavian Prostate Cancer Group Study 4 (SPCG-4) trial. METHODS: Three PIVOT Endpoints Committee members, blinded to randomized treatment assignments, reviewed medical records and death certificates when available to assign a cause of death using a primary and a secondary adjudication question. Initial disagreements were resolved through discussion. The level of initial agreement among committee members was examined, as well as guesses at randomized treatment assignments for a convenience sample of cases. Final cause of death determinations were compared to death certificates. RESULTS: Complete agreement on cause of death by all three committee members before any discussion was achieved in 200/354 (56%) cases on the primary and 209/354 (59%) cases on the secondary. However, complete agreement on the primary rose to 306/354 (86%) when 'definite' and 'probably' categories were collapsed, as planned a priori. The three committee members' proportions of correct guesses of randomized treatment assignment were 82/121 (68%), 113/148 (76%), and 99/134 (74%). Using the committee's final adjudications as a gold standard, death certificates had suboptimal sensitivities, specificities, or predictive values depending on how they were used to determine cause of death. LIMITATIONS: There was no separate 'gold standard' by which to judge the accuracy of the final endpoints committee adjudications, and useful death certificates could not be obtained on about a third of PIVOT participants who died. CONCLUSIONS: The low level of initial agreement on cause of death among endpoint committee members and the potential for biased determinations due to partial unblinding to treatment assignment raise methodologic concerns about using prostate cancer mortality as an endpoint in clinical trials like PIVOT.

Dental restorations for dinka and nuer refugees: a confluence of culture and healing.

The Harvard Trauma Questionnaire, Hopkins Symptom Checklist-25, and the Self-reporting Questionnaire-24 were used to evaluate distress among 22 Dinka and Nuer refugees to the US before and after complete restoration of four to six lower front teeth that had been extracted during childhood in Sudan. Participants reported significant improvement in levels of distress following full restoration of missing teeth, including symptoms of PTSD. These results illustrate the value of incorporating community perspectives into the selection of health treatment options for newly arriving populations. But they also emphasize the unique situation faced by each refugee population as they embark on a wholly new cultural learning process.

The Mandinka nosological system in the context of post-trauma syndromes.

Preliminary studies of trauma and psychiatric sequelae among West African refugees have revealed the need to develop West African-sensitive assessment instruments. This article addresses the results of the first stage of such a process which involved two focus group discussions with nine traditional Mandinka practitioners. Various dimensions of the diagnoses required to adequately reflect the range of refugee experience are presented. Such dimensions include diagnostic labels, idioms of distress, causes, source, and seriousness. The findings of this pilot study suggest that the impact of trauma such as experienced by refugees is so complex that a unitary diagnostic label is insufficient.