Bulletin of the NYU hospital for joint diseases
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Bull NYU Hosp Jt Dis · Jan 2009
Safety reporting in randomized clinical trials - a need for improvement.
The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs.
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Bull NYU Hosp Jt Dis · Jan 2009
Long-term functional outcome and donor-site morbidity associated with autogenous iliac crest bone grafts utilizing a modified anterior approach.
Prior studies and techniques for harvesting iliac crest bone have shown significant postoperative pain, disability, and poor cosmesis. This retrospective study was conducted to examine bone graft donor-site morbidity by evaluating functional outcomes in patients who have undergone a modified anterior harvesting approach. The medical charts and hospital records of 43 patients were retrospectively reviewed over a 6-year period. ⋯ SMFA scores demonstrated a mean dysfunction score of 48.5 (range, 41.8 to 71.1) and a bother index of mean 47.9 (range, 42.6 to 73.9). Utilizing the anterior approach in iliac crest bone harvesting provides an abundant supply of both cortical and cancellous bone, an aesthetically favorable scar, and decreased postoperative donor-site pain. There were very few complications seen in our cohort as compared to previous studies with very good long-term functional outcomes.
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Bull NYU Hosp Jt Dis · Jan 2008
ReviewOrthopaedic anesthesia - part 1. Commonly used anesthetic agents in orthopaedics.
Anesthesia is a broad discipline; for orthopaedic applications, the type and location of the planned orthopaedic procedure is important in the selection of the most appropriate anesthetic agent and technique. The purpose of this overview is to: 1. highlight the role of several anesthetic agents commonly used in an orthopaedic setting and 2. to familiarize the orthopaedist with those techniques of regional anesthesia that have implications for emergency rooms and other ambulatory settings. Because the subject matter is expansive in scope, it is necessary to address each of the above objectives separately, in two different articles. Part 1 describes anesthetic agents, whereas Part 2 encompasses techniques of administering regional anesthesia.
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Bull NYU Hosp Jt Dis · Jan 2008
The effects of alcohol on in-hospital mortality in drivers admitted after motor vehicle accidents.
The effects of alcohol on morbidity and mortality following motor vehicle accidents (MVAs) are controversial. This study was performed to address the effect of alcohol on in-hospital mortality for drivers in MVAs admitted to a trauma center before and after controlling for injury severity, safety device use, and patient demographics. ⋯ These results suggest the importance of carefully considering the consequences that falsely inlated ISS scores might have for patients with alcohol present. Future work should evaluate the possible inlation of ISS and attempt to reconcile different interpreta- tions of the effects that the presence of alcohol may have on MVA mortality based by jointly considering crash site and in-hospital data.
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Bull NYU Hosp Jt Dis · Jan 2008
Some concerns about adverse event reporting in randomized clinical trials.
Reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking and with limited application in the real world, as RCTs are of short duration, include small numbers of patients, and are selective for subjects lacking in comorbid conditions. It is not surprising that new and unexpected safety concerns emerge with any new drug after it has been launched and used by many more patients. ⋯ This article focuses on some of the shortcomings of AE reporting in RCTs, especially those involving tumor necrosis factor (TNF) inhibitors. Discussion focuses on reporting of "time-to-event" issues, use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient-years" when reporting AEs, and the problem of adequate sample size and power calculations that are lacking in safety outcome data trials.