Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis.

PURPOSE: To analyze the frequency, rationale and determinants of attending physicians requesting that their eligible patients not be approached for participation in a thromboprophylaxis trial. METHODS: Research personnel in 67 centers prospectively documented eligible non-randomized patients due to physicians declining to allow their patients to be approached. RESULTS: In 67 centers, 3,764 patients were enrolled, but 1,460 eligible patients had no consent encounter. For 218 (14.9 %) of these, attending physicians requested that their patients not be approached. The most common reasons included a high risk of bleeding (31.2 %) related to fear of heparin bioaccumulation in renal failure, the presence of an epidural catheter, peri-operative status or other factors; specific preferences for thromboprophylaxis (12.4 %); morbid obesity (9.6 %); uncertain prognosis (6.4 %); general discomfort with research (3.7 %) and unclear reasons (17.0 %). Physicians were more likely to decline when approached by less experienced research personnel; considering those with[10 years of experience as the reference category, the odds ratios (OR) for physician refusals to personnel without trial experience was 10.47 [95 % confidence interval (CI) 2.19-50.02] and those with less than 10 years experience was 1.72 (95 % CI 0.61-4.84). Physicians in open rather than closed units were more likely to decline (OR 4.26; 95 % CI 1.27-14.34). Refusals decreased each year of enrollment compared to the pilot phase. CONCLUSIONS: Tracking, analyzing, interpreting and reporting the rates and reasons for physicians declining to allow their patients to be approached for enrollment provides insights into clinicians' concerns and attitudes to trials. This information can encourage physician communication and education, and potentially enhance efficient recruitment.

Clinical experience with severe 2009 H1N1 influenza in the intensive care unit at King Saud Medical City, Saudi Arabia.

PURPOSE: The objective of this study was to describe the epidemiological characteristics, clinical features, treatment, and outcome of 2009 H1N1-infected patients who were admitted to the intensive care unit (ICU) at King Saud Medical City (KSMC) in Riyadh, Kingdom of Saudi Arabia. METHODS: Retrospectively, we collected demographic data as well as data on the clinical presentation and risk factors for 86 patients who were admitted to the ICU with H1N1 influenza A. The APACHE IV System was used to assess the severity of the illness. The overall hospital mortality was calculated and correlated with the use of steroids and the time of oseltamivir administration. RESULTS: The mean age of the patients was 40.8 years. Mortality increased steadily with increasing APACHE IV score. Patients who received steroids had a mortality rate of 47% compared with 23% for patients who were not treated with steroids; this difference was significant, with a P value of <0.01. The late administration of oseltamivir was associated with a mortality rate of 82% compared with 28% in the context of early oseltamivir administration; this difference was significant, with a P value of <0.01. CONCLUSIONS: Patients who were admitted to the ICU with severe 2009 H1N1 infection were young and had a relatively high severity-of-illness score. The late administration of oseltamivir was associated with a 12-fold increase in mortality. Steroid use was associated with a 3-fold increase in mortality.