Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks

Background  

The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks.     

The universe of developmental care: a new conceptual model for application in the neonatal intensive care unit.

Developmental care for high-risk infants is practiced in most neonatal units around the world. Despite its wide acceptance, inconsistency in its definition and application has resulted in criticism regarding its scientific merit. The universe of developmental care model proposed in this article is the first major reformulation of neonatal developmental care theory since Als' synactive theory. Neither the developing brain nor the environment exists in isolation, and therefore are dependent on each other for all caregiving activities. Central to this model is the concept of a shared surface, manifested most obviously by the skin that forms the critical link between the body/organism and environment and becomes the focal point for human interactions. The components of the model and its theoretical underpinnings, its practical application and direction for future clinical practice, education, and research are presented.     

Interstitial thermoradiotherapy

The more recent engineering and clinical aspects of interstitial hyperthermia are reviewed. The advantages and difficulties of microwave, radiofrequency, and ferromagnetic seeds are evaluated and some future directions for improvements are outlined.     

An empirical study of the use of living versus deceased study subjects: associations with liver cancer in the selected cancers study.

PURPOSE: In case-control studies, the issue of whether living or deceased controls should be used for deceased cases has been controversial. METHODS: Using data from a study of cancer among men that selected both live (n = 1910) and deceased controls (n = 596) for cases of liver cancer (109 deceased, 59 living), we examined the effects of using information from proxy respondents (cases and controls) and from live cases and controls on associations between liver cancer and known risk factors. Cases diagnosed between 1984 and 1988 were selected from eight population-based cancer registries. Live controls were recruited by random digit dialing, deceased controls from death certificate files. Controls were matched to cases on geographic area, year-of-birth, and race. RESULTS: Adjusted odds ratios (OR) calculated for deceased cases and controls, when compared to odds ratios for live cases and controls, were attenuated towards the null value for history of hepatitis (4.7 vs. 14.9), blood transfusions (1.1 vs. 7.8), and cirrhosis (9.3 vs. 51.1). When all cases and living controls were used, odds ratios did not differ substantially from those for living cases and controls except for cirrhosis (OR = 154.2). For smoking, the odds ratios were similar in all analyses. Adjustment for type of interview (self, proxy) did not eliminate differences between results for living and deceased subjects; significant interactions were found between type of interview and hepatitis, cirrhosis, and blood transfusions. CONCLUSIONS: Selection of live controls for deceased cases is recommended to decrease misclassification in measures of exposure.     

An emergency department shooting of a prisoner/patient under guard: lessons learned

When an ED prisoner/patient was shot, the unfortunate incident offered a number of lessons, even for a busy, seasoned emergency department with good security. These lessons, not the least of which was to think twice before removing both handcuffs, are worth sharing.     

A randomized, double-blind, parallel-group study comparing the analgesic effect of etoricoxib to placebo, naproxen sodium, and acetaminophen with codeine using the dental impaction pain model

OBJECTIVE: To compare the overall analgesic effect, including time to onset, peak and duration of effect for etoricoxib 120 mg, a new COX-2 selective inhibitor, in patients with acute pain to that of placebo. Naproxen sodium 550 mg and acetaminophen/codeine 600/60 mg were the active comparators. METHODS: A total of 201 patients with moderate to severe pain following surgical extraction of > or = 2 third molars, of which at least the mandibular tooth was impacted, were randomly allocated to receive single oral doses of placebo (n = 50), etoricoxib 120 mg (n = 50), naproxen sodium 550 mg (n = 51), or acetaminophen/codeine 600/60 mg (n = 50). The endpoints included total pain relief over 8 hours (TOPAR8, primary end point), sum of pain intensity difference over 8 hours, patient's global evaluation, onset, peak, and duration of analgesia. RESULTS: Etoricoxib 120 mg had a significantly greater least squares (LS) mean TOPAR8 score than placebo (20.9 vs 5.4; P < 0.001) and acetaminophen/codeine 600/60 mg (20.9 vs 11.5; P < 0.001), and a similar LS mean TOPAR8 score to naproxen sodium 550 mg (20.9 vs 21.3). All three active treatments had rapid onset of analgesia, median time approximately 30 minutes. The duration of analgesic effect, defined as median time to rescue medication use, was >24 hours for etoricoxib, 20.8 hours for naproxen sodium, 3.6 hours for acetaminophen/codeine, and 1.6 hours for placebo. DISCUSSION: Etoricoxib is a new COX-2 selective inhibitor under development for treatment of osteoarthritis, rheumatoid arthritis, and acute pain. In this study, etoricoxib 120 mg provided rapid and long-lasting pain relief to patients with moderate-to-severe postdental surgery pain. Etoricoxib was generally well tolerated.     

Advancing Uterine Cancer Survivorship Among African American Women

Background

Few studies have examined health behavior interventions for African American women who are uterine cancer survivors. Black-white differences in uterine cancer survival suggest that there are unmet needs among these survivors.