Quantitative study designs used in quality improvement and assessment.

This article describes common quantitative design techniques that can be used to collect and analyze quality data. An understanding of the differences between these design techniques can help healthcare quality professionals make the most efficient use of their time, energies, and resources. To evaluate the advantages and disadvantages of these various study designs, it is necessary to assess factors that threaten the degree with which quality professionals may infer a cause-and-effect relationship from the data collected. Processes, the conduits of organizational function, often can be assessed by methods that do not take into account confounding and compromising circumstances that affect the outcomes of their analyses. An assumption that the implementation of process improvements may cause real change is incomplete without a consideration of other factors that might also have caused the same result. It is only through the identification, assessment, and exclusion of these alternative factors that administrators and healthcare quality professionals can assess the degree to which true process improvement or compliance has occurred. This article describes the advantages and disadvantages of common quantitative design techniques and reviews the corresponding threats to the interpretability of data obtained from their use.

Organochlorine pesticides and heavy metals in muscle and ovaries of Gulf coast striped bass (Morone saxatilis) from the Apalachicola River, Florida, USA.

Eight female Gulf coast striped bass (Morone saxatilis) broodfish collected for induced spawning from the Apalachicola River below the Jim Woodruff Lock and Dam were analyzed for organochlorine pesticides (OCs) and metals in muscle and ovarian tissues. Chemical analyses revealed that muscle and ovaries contained detectable amounts of OCs and metals. Concentrations of p,p'-DDE, a derivative of the pesticide DDT, in muscle and ovary (0.54 and 0.65 microg/g, respectively) were significantly higher than alpha-chlordane, dieldrin, and p,p'-DDD. The presence of p,p'-DDE, an antiandrogenic compound, in females suggests that the compound also may be present in male striped bass. Concentrations of Cr, Hg, Mg, and Mn were higher in muscle than in ovarian tissues. Concentrations of Hg have almost doubled in muscle tissues (0.85 microg/g) and tripled in ovaries (0. 15 microg/g) in our samples, compared with the data from 1986 to 1989. Organochlorine pesticides and metal contaminants were present in muscle and ovarian tissues of adult females and may have been retarding development of eggs leading to low hatching rates.

Organochlorine, PCB, PAH, and metal concentrations in eggs of loggerhead sea turtles (Caretta caretta) from northwest Florida, USA.

Composite samples of unhatched and physically unaltered loggerhead sea turtle, Caretta caretta, eggs collected from 20 nests along northwest Florida were analyzed for organochlorine pesticides (OCPs), polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAHs), and metals. Chemical analyses revealed that turtle eggs contained detectable amounts of metals, PAHs, and PCBs. Only one OCP, p,p'-DDD, was detected, and its presence was restricted to eggs from two nesting sites. None of the PCB concentrations exceeded the Food and Drug Administration's (FDA) action limit. Concentrations of dioxin-like PCB congeners, 105, 118, and 126, and total PCBs were also detected and are contributors to the toxic burden of loggerhead sea turtle eggs. Concentrations of PAHs, 1,2,5,6-dibenzanthracene, 1-methyl naphthalene, C1-naphthalene and naphthalene were variable at nesting sites. Comparison of mean metal burdens in eggs from different beaches suggested that no uniform geographic gradients exist. Presence of OCPs, PCBs, PAHs and metals and their additive or synergistic toxicity is a concern to loggerhead sea turtle eggs; however, additive or synergistic impacts for loggerhead sea turtles are largely undocumented.

Chymodiactin in patients with herniated lumbar intervertebral disc(s). An open-label, multicenter study.

To extent the safety information for Chymodiactin (chymopapain for injection), 37 neurologic and orthopedic surgeons conducted an open-label, multicenter, phase 3 clinical study. A total of 1,498 patients with one or two herniated lumbar intervertebral discs were enrolled. Therapeutic results were generally favorable, with the percentages of patients achieving either excellent or good (or successful) results ranging from 79.6% to 88.9%, depending on criteria employed in the tabulation. There were 13 cases of anaphylaxis, and 2 of these patients died of complications of anaphylaxis. Two additional patients experienced serious neurologic problems. The first of these two patients developed transverse myelitis and paraplegia approximately 3 weeks following chemonucleolysis. Transdural discograms at three levels had been done approximately 2 days prior to chemonucleolysis, in violation of the protocol. The second patient developed acute cauda equina syndrome, and, despite emergency laminectomy, had permanent neurologic sequelae. Back spasm and stiffness/soreness were the most frequently encountered adverse experiences.

Chymodiactin postmarketing surveillance. Demographic and adverse experience data in 29,075 patients.

Postmarketing surveillance data on 29,075 patients who received Chymodiactin (Smith Laboratories' formulation of chymopapain) intradiscal injections for a herniated lumbar intervertebral disc are summarized and tabulated. The serious adverse reactions reported include death, anaphylaxis, paraplegia, and discitis. Similar problems also have been reported for Discase (Baxter-Travenol's formulation of chymopapain). Of 11 deaths reported following Chymodiactin administration, only 3 appear to be related to the drug or procedure. Two of these three were due to anaphylaxis and the third to bacterial discitis with resultant meningitis. Paraplegia appeared to be primarily due to needle trauma or injection of contrast agent and enzyme into the subarachnoid space. Careful patient selection and needle placement are essential for avoiding serious problems.