Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73).

Objective: To examine the traditional diet-heart hypothesis through recovery and analysis of previously unpublished data from the Minnesota Coronary Experiment (MCE) and to put findings in the context of existing diet-heart randomized controlled trials through a systematic review and meta-analysis.

Design: The MCE (1968-73) is a double blind randomized controlled trial designed to test whether replacement of saturated fat with vegetable oil rich in linoleic acid reduces coronary heart disease and death by lowering serum cholesterol. Recovered MCE unpublished documents and raw data were analyzed according to hypotheses prespecified by original investigators.

Randomized trial of a hearing conservation intervention for rural students: long-term outcomes.

Objectives: We had the rare opportunity to conduct a cluster-randomized controlled trial to observe the long-term (16-year) effects of a well-designed hearing conservation intervention for rural high school students. This trial assessed whether the intervention resulted in (1) reduced prevalence of noise-induced hearing loss (NIHL) assessed clinically and/or (2) sustained use of hearing protection devices.

Methods: In 1992-1996, 34 rural Wisconsin schools were recruited and 17 were assigned randomly to receive a comprehensive, 3-year, hearing conservation intervention.

Medical practice perspective: identification and mitigation of risk factors for mortality associated with intrathecal opioids for non-cancer pain.

Objective: The authors recently determined that early and longer term mortality after initiation or reinitiation of intrathecal opioid therapy is higher than previously appreciated: 0.088% within 3 days, 0.39% at 1 month, and 3.

Mortality associated with implantation and management of intrathecal opioid drug infusion systems to treat noncancer pain.

Background: In 2006, the authors observed a cluster of three deaths, which circumstances suggested were opioid-related, within 1 day after placement of intrathecal opioid pumps for noncancer pain. Further investigation suggested that mortality among such patients was higher than previously appreciated. The authors performed investigations to quantify that mortality and compare the results to control populations, including spinal cord stimulation and low back surgery.

Hearing conservation program for agricultural students: short-term outcomes from a cluster-randomized trial with planned long-term follow-up.

Objectives: (1) To conduct a contemporary analysis of historical data on short-term efficacy of a 3-year hearing conservation program conducted from 1992 to 1996 in Wisconsin, USA, with 753 high school students actively involved in farm work; (2) to establish procedures for assessment of hearing loss for use in a recently funded follow-up of this same hearing conservation program cohort.

Methods: We analyzed a pragmatic cluster-randomized controlled trial, with schools as the unit of randomization. Thirty-four rural schools were recruited and randomized to intervention or control.