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Biomedical subjects

J A Shea

Publications and source records attributed to J A Shea.

At least 37 records · Page 2Linked to original sources
PubMed1998

Validation of cleaning procedures for highly potent drugs. II. Bisnafide.

The objective of this work was the development and validation of procedures designed to clean glass and stainless steel surfaces after exposure to the experimental anticancer drug, bisnafide. The cleaning procedures, using 5% acetic acid water, Alconox, and water, were validated using a wipe test and an HPLC method developed to quantitate low levels of bisnafide. The procedure developed for cleaning stainless steel is more stringent than that for glass because of the apparent greater affinity of bisnafide for stainless steel. The HPLC method is shown to be linear and reproducible (RSD 4.4% or less), with a detection limit of 4 ng/ml. Recoveries of 95.1, 83.5, and 70.0% were obtained from the wipe pads, glass plates, and stainless steel plates, respectively, at levels of approximately 0.7-1.7 ng/cm2. The cleaning procedures are shown to clean glass and stainless steel plates to less than 0.19 and 0.33 ng bisnafide/cm2, respectively. These results further demonstrate the need to fully characterize the recovery of drugs from surfaces and swabs in order to properly validate cleaning procedures. In addition, they demonstrate the potential need to develop surface-specific cleaning procedures.

Antineoplastic Agents↗
PubMed1997

What predicts gastroenterologists' and surgeons' diagnosis and management of common bile duct stones?

BACKGROUND: Because the literature suggests numerous indicators of common bile duct stones, we undertook a systematic assessment of physicians' judgments of the clinical utility of eight indicators: patient age, history of jaundice, history of pancreatitis, levels of serum alanine aminotransferase, alkaline phosphatase, amylase, and total bilirubin, and common bile duct diameter on ultrasonography. METHODS: Random samples of 1500 gastroenterologists and 1500 surgeons were sent a survey asking them to indicate the importance of each potential indicator of common bile duct stones, the likelihood of common bile duct stones for each of nine clinical vignettes, and whether they would order a preoperative ERCP. An abbreviated survey was sent to nonrespondents. RESULTS: Although there was substantial variation in the importances assigned to each indicator, the most important indicators were serum total bilirubin and diameter of common bile duct on ultrasound. The best predictors of the decision to order an ERCP were perceived likelihood of stones and specialty. The average threshold for ordering an ERCP was 37%. Respondents did not differ from nonrespondents in the perceived importance of the eight indicators. CONCLUSIONS: The substantial variation among gastroenterologists and surgeons regarding the optimal approach to common bile duct stones has clinical implications. Patients will receive varying recommendations for care, depending on whom they see.

Adult↗
PubMed1997

The limits of suffering: critical care nurses' views of hospital care at the end of life.

This study explores critical care nurses' beliefs, motivations, and experiences regarding end of life care. We performed a content analysis of the text comments provided by 468 U.S. critical care nurses in response to an anonymous mail survey about euthanasia. These comments reveal that these U.S. critical care nurses' feelings about issues surrounding the end of life are extremely complex. Eight themes emerged from 37 coded concepts, and the median number of themes volunteered per nurse was three. Among the most prevalent themes were patient concerns (53%), family concerns (33%), clinical circumstances (42%), the nurses' personal concerns (38%), and external or structural issues (68%). A profound sense of compassion and often conflicting forces were noted within and across themes. The nurses' comments offer a unique perspective on the care of critically ill patients and reveal much about that care that should be improved. In particular, (1) some nurses are frustrated about their limited role in the management of patients at the end of life, given their special understanding of these patients' experiences and wishes; (2) considerable confusion remains about the most appropriate way to care for these patients; and (3) the environment of some critical care setting may be unable to foster the compassion that many patients need.

Adult↗
PubMed1997

Performance of a new, HIV/AIDS-targeted quality of life (HAT-QoL) instrument in asymptomatic seropositive individuals.

OBJECTIVE: To evaluate the psychometric performance of a new human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS)-targeted quality of life (QoL) instrument in asymptomatic HIV-seropositive individuals. METHODS: 201 urban and rural, HIV-seropositive subjects were recruited to complete a 76-item pilot QoL measure developed using content provided in group process by seropositive individuals. Questionnaire responses from the full sample (n = 201) were used to identify dimensions and to reduce the number of items to 42. The responses to the retained items were then analysed for the asymptomatic subsample (n = 106). RESULTS: 9 multi-item dimensions were identified: overall function (OF), sexual function (SF), disclosure worries (DW), health worries (HW), financial worries (FW), HIV mastery (HM), life satisfaction (LS), medication concerns (MC) and provider trust (PT). The responses by asymptomatic subjects (74% male, 64% non-White and 63% homosexual/bisexual) revealed no substantial floor or ceiling effects, except for the PT dimension (where 44% were found to have scored the highest score). The internal consistency coefficients (Cronbach's alphas) were between 0.80 and 0.89 for six dimensions. The coefficients were lower for the SF (0.52), HM (0.67) and MC (0.48) dimensions. Construct validity assessments, using self-reported HIV disease-severity and sociodemographic variables, revealed some significant relationships (p < or = 0.05) for all dimensions except SF, MC and PT. CONCLUSIONS: The results suggested that five dimensions (OF, DW, HW, FW and LS) from the new instrument have good psychometric properties for asymptomatic HIV-seropositive individuals. These dimensions may be useful in the study of asymptomatic, seropositive individuals' QoL. Four dimensions (SF, HM, MC and PS) require additional refinement for this subpopulation.

Adult↗
PubMed1997

A new instrument for residency program evaluation.

The purpose of the study was to develop a comprehensive program evaluation instrument. Following pilot work with residents, a 69-item instrument consisting of statements with 5-point strongly agree to strongly disagree response options was distributed to 107 residents; 104 responded. Psychometric analyses revealed no ceiling or floor effects; 9 items were deleted. There were three subscales: workload (19 items; alpha = .76); educational environment (29 items; alpha = .72) and lifestyle issues (12 items; alpha = .62). Mean item scores were significantly higher for educational environment (3.53; SD 0.28) than for workload (2.78; SD 0.39) and lifestyle (2.96; SD 0.42). Items with the lowest scores reflected issues that were largely fixable. The 60-item instrument appears to be psychometrically sound, comprehensive, and exportable.

Adult↗
PubMed1997

Successful treatment of post-cholecystectomy bile leaks using nasobiliary tube drainage and sphincterotomy.

OBJECTIVE: Bile leaks are known complications of cholecystectomy. The combination of sphincterotomy and nasobiliary tube (NBT) drainage is effective for the immediate decompression of bile ducts and provides access for follow-up cholangiography. Our objective was to study, retrospectively, 19 patients who had undergone treatment for bile leaks with this combination between October 1991 and December 1995. METHODS: Nineteen patients (15 F, 4 M) ages 23-83 yr (mean 50 yr) presented with bile leaks secondary to open cholecystectomy (n = 1) and laparoscopic cholecystectomy (n = 18). All patients had sphincterotomy and NBT placement. Symptoms, findings at ERCP, and outcome were reviewed. RESULTS: Patients presented from 0 to 150 days after cholecystectomy (median = 2) with pain (n = 17), fever (n = 8), bile leakage in a surgical drain (n = 4), elevated liver tests (n = 8), and nausea and vomiting (n = 4). Fourteen patients had diagnostic imaging before endoscopic management. ERCP findings included cystic stump leak (n = 12), including one with a colocutaneous biliary fistula, gallbladder fossa leak (n = 3), right hepatic branch leak (n = 1), or no leak (n = 3). Three patients had choledocholithiasis. NBT drainage was used for a mean of 3.9 days (range 1-12 days). Fourteen patients had radiographic evidence of leak closure. One patient ultimately required surgical correction for a chronic colocutaneous biliary fistula. There were no early or late endoscopic complications. CONCLUSIONS: Endoscopic management with nasobiliary drainage and sphincterotomy is effective for acute uncomplicated bile leaks but may not be adequate for chronic fistulas. The advantages over endoprostheses include access for subsequent cholangiography, improved biliary decompression, and catheter removal without further endoscopy.

Adult↗
PubMed1996

The Functional Independence Measure: tests of scaling assumptions, structure, and reliability across 20 diverse impairment categories.

OBJECTIVE: The analysis presented here evaluated the psychometric properties of the Functional Independence Measure (FIM) as a summated rating scale within context of the 20 impairment categories of the FIM-Function Related Group (FIM-FRG) system. DESIGN: This study involved a cross-sectional analysis of patient records, utilizing factor analysis and techniques of multitrait scaling to verify the summative properties of the motor and cognitive dimensions of the FIM and to study the statistical properties of admission FIM scores. PATIENTS: Included were a total of 93.829 patients discharged from 252 freestanding rehabilitation hospitals and units during calendar year 1992. Cases were excluded that had missing or out-of-range values or atypical lengths of stay. These criteria were developed previously in conjunction with an expert clinical panel and confirmed through statistical analyses. RESULTS: Factor analyses supported the motor and cognitive dimensions across all 20 impairment categories. The resulting subscales exceeded minimum criteria for item internal consistency in 96.9% of tests and item discriminant validity in 100% of tests. Reliability coefficients for each impairment category for both subscales ranged from .86 to .97. There were no major ceiling effects, but patients in certain impairment categories were unable to climb stairs at admission. CONCLUSION: The psychometric properties of the summated FIM compare favorably to most standardized health measures used in medical practice. Findings provide support for the motor and cognitive subscales as used in the FIM-FRGs. As a unidimensional scale, the FIM quantifies care burden. Split into the motor and cognitive (as used in the FIM-FRGs) it distinguishes physical disabilities from those arising from communication or cognitive difficulties.

Activities of Daily Living↗
PubMed1996

Predictors of common bile duct stones prior to cholecystectomy: a meta-analysis.

BACKGROUND: The decision of whether or not to investigate for common bile duct stones before cholecystectomy utilizes clinical, laboratory, and radiologic information (indicators). There is tremendous individual variation among clinicians in the criteria used for making this decision. Our aim was to perform a meta-analysis of published data to estimate the performance characteristics of the most commonly used preoperative indicators of common bile duct stones. METHODS: Using predetermined exclusion criteria, we selected articles from a MEDLINE search and bibliographic review. Weighted averages were used to determine summary sensitivity, specificity, and positive and negative likelihood ratios for each indicator for stones. RESULTS: From 2221 citations identified, 22 studies met inclusion criteria. The 10 indicators examined were reported in a common fashion in three or more articles, and could be assessed preoperatively. Seven exhibited a specificity greater than 90%. Indicators with positive likelihood ratios of 10 or above were cholangitis, preoperative jaundice, and ultrasound evidence of common bile duct stones. Positive likelihood ratios for dilated common bile duct on ultrasound, hyperbilirubinemia, and jaundice ranged from almost 4 to almost 7. Elevated levels of alkaline phosphatase, pancreatitis, cholecystitis, and hyperamylasemia exhibited positive likelihood ratios of less than 3. CONCLUSIONS: This meta-analysis has identified indicators for duct stones and ranked them according to likelihood ratios. These findings can be applied as guidelines for whether to investigate for duct stones before cholecystectomy.

Cholecystectomy↗
PubMed1996

Mortality and complications associated with laparoscopic cholecystectomy. A meta-analysis.

OBJECTIVE: The purpose of this study was to perform a meta-analysis of large laparoscopic cholecystectomy case-series and compare results concerning complications, particularly bile duct injury, to those reported in open cholecystectomy case-series. SUMMARY BACKGROUND DATA: Since the introduction of laparoscopic cholecystectomy in the United States, hundreds of reports about the technique have been published, many including statements about the advantages of laparoscopic cholecystectomy compared with those of open cholecystectomy. There is an unevenness in scope and quality of the studies. Nevertheless, enough data have accumulated from large series to permit analyses of data regarding some of the most important issues. METHODS: Articles identified via a MEDLINE (the National Library of Medicine's computerized database) search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes of cholecystectomy were abstracted and summarized across studies. RESULTS: Outcomes of laparoscopic cholecystectomy are examined for 78,747 patients reported on in 98 studies and compared with outcomes of open cholecystectomy for 12,973 patients reported on in 28 studies. Laparoscopic cholecystectomy appears to have a higher common bile duct injury rate and a lower mortality rate. Estimated rates of other types of complications after laparoscopic cholecystectomy generally were low. Most conversions followed operative discoveries (e.g., dense adhesions) and were not the result of injury. CONCLUSIONS: There is wide variability in the amount and type of data reported within any single study, and patient populations may not be comparable across studies. Except for a higher common bile duct injury rate, laparoscopic cholecystectomy appears to be at least as safe a procedure as that of open cholecystectomy.

Cholecystectomy, Laparoscopic↗
PubMed1996

Validation of cleaning procedures for highly potent drugs. I. Losoxantrone.

The validation of a procedure designed to clean glass and stainless steel surfaces after exposure to the experimental anticancer drug losoxantrone is described. The cleaning procedure, using water and hypochlorite bleach, was validated using a wipe test and a high-performance liquid chromatography (HPLC) method developed to quantitate low levels of losoxantrone. The HPLC method is shown to be linear and reproducible (relative standard deviation (RSD): 7.1% or less), with a detection limit of 2 ng/ml. Recoveries of 71.0%, 50.1%, and 57.6% were reproducibly obtained from the wipe pads, glass plates, and stainless steel plates, respectively, at levels of 70-140 ng per 100 cm2. The cleaning procedure is shown to clean glass and stainless steel plates to less than 20 ng and 17 ng losoxantrone per 100 cm2, respectively. These results demonstrate the need to fully characterize the recovery of drugs from surfaces and swabs in order to properly validate cleaning procedures.

Anthraquinones↗
PubMed1995

Outcomes of open cholecystectomy in the elderly: a longitudinal analysis of 21,000 cases in the prelaparoscopic era.

OBJECTIVE: We sought to obtain unbiased estimates of open cholecystectomy outcomes in a population-based cohort of elderly patients during the immediate prelaparoscopic era. METHODS: Medicare claims data were used to identify 21,131 patients aged 65 years or more who underwent open cholecystectomy in Pennsylvania between 1986 and 1989 and to develop longitudinal histories of hospitalizations and physician services utilization for these patients. Study patients were divided into three groups: simple cholecystectomy, cholecystectomy with intraoperative cholangiography (IOC) alone, and cholecystectomy with common bile duct exploration (CBDE). Outcomes examined included 30- and 90-day postoperative mortality rates and postoperative complications. RESULTS: Postoperative mortality rates in all patients was 2.1% at 30 days and 3.6% at 90 days. Patients in the CBDE group had a significantly higher mortality rate than those in the simple cholecystectomy or IOC groups; adjusted for differences in case mix, the mortality rate in the CBDE group was 47% higher at 30 days and 29% higher at 90 days. Rates of retained or recurrent common duct stones, bile duct stricture, and recurrent biliary tract surgery by 42 to 60 months after cholecystectomy were 2.8%, 0.4%, and 1.0%, respectively. CBDE was a strong risk factor for these complications. In contrast, the IOC group had a significantly lower risk of having clinically manifest retained or recurrent common duct stones develop by 42 months after operation. CONCLUSIONS: This study provides an unbiased assessment of open cholecystectomy outcomes necessary for future comparisons of open and laparoscopic cholecystectomy in elderly patients. Estimates of the excess mortality rates associated with CBDE provide a benchmark for assessing the outcomes of alternative strategies for managing common duct stones during laparoscopic cholecystectomy. Findings regarding the rates of retained or recurrent common bile duct stones in patients undergoing simple cholecystectomy and IOC challenge widespread beliefs about the limited clinical importance of unsuspected common duct stones, at least in the elderly population, and are relevant to the debate about routine IOC.

Aged↗
PubMed1995

Diffusion of laparoscopic cholecystectomy among general surgeons in the United States.

Introduced in 1989, laparoscopic cholecystectomy has rapidly become the treatment of choice for symptomatic gallstones. This study describes the diffusion of laparoscopic cholecystectomy among general surgeons; assesses the importance of various reasons for surgeons adopting the procedure; and examine the influence of surgeon, practice, and health care market characteristics on the timing of adoption. The data were obtained from a survey of a national sample of surgeons. Most surgeons (81%) adopted laparoscopic cholecystectomy by early 1992. More than three fourths of adopters identified the desire to keep up with the state-of-the-art and improved patient outcomes as very or extremely important reasons for adoption. Results of proportional hazards regression analysis indicate that individual surgeons' adoption behavior generally was consistent with expected utility maximization in an uncertain new technological environment. Of particular interest, fee-for-service payment and more competitive practice settings and markets were associated with earlier adoption. These findings suggest that the "technological imperative" and surgeons' perception of the relative clinical and financial advantages of laparoscopic cholecystectomy were important reasons for the rapid diffusion of laparoscopic cholecystectomy. Policies that accelerate current trends toward payment of physicians based on salary or capitation and promote the growth of multispecialty group practice could slow the diffusion of new physician-based product innovations in health care.

Adult↗
PubMed1995

Morphine-augmented hepatobiliary scintigraphy: a meta-analysis.

The aim of this study was to compare the sensitivity and specificity of morphine-augmented hepatobiliary scintigraphy (MA-HBS) with that of conventional hepatobiliary scintigraphy (C-HBS) for acute cholecystitis. The results of most MA-HBS studies cannot be compared with C-HBS estimates, since articles describing C-HBS often include non-candidates for MA-HBS. However, using meta-analytic techniques to combine data from eligible studies (4 for C-HBS and 5 for MA-HBS), the specificity of MA-HBS (0.84; 95% CI = 0.75-0.94) was significantly greater (P = 0.008) than that of C-HBS (0.68; 95% CI = 0.61-0.75); there were no differences in sensitivity (MA-HBS; 0.96, 95% CI = 0.92-0.99; C-HBS: 0.97, 95% CI = 0.97-0.99).

Acute Disease↗
PubMed1994

Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease.

BACKGROUND: The purpose of this study was to estimate the sensitivity and specificity of diagnostic tests for gallstones and acute cholecystitis. METHODS: All English-language articles published from 1966 through 1992 about tests used in the diagnosis of biliary tract disease were identified through MEDLINE. From 1614 titles, 666 abstracts were examined and 322 articles were read to identify 61 articles with information about sensitivity and specificity. Application of exclusion criteria based on clinical and methodologic criteria left 30 articles for analysis. Cluster-sampling methods were adapted to obtain combined estimates of sensitivities and specificities. Adjustments were made to estimates that were biased because the gold standard was applied preferentially to patients with positive test results. RESULTS: Ultrasound has the best unadjusted sensitivity (0.97; 95% confidence interval, 0.95 to 0.99) and specificity (0.95; 95% confidence interval, 0.88 to 1.00) for evaluating patients with suspected gallstones. Adjusted values are 0.84 (0.76 to 0.92) and 0.99 (0.97 to 1.00), respectively. Adjusted and unadjusted results for oral cholecystogram were lower. Radionuclide scanning has the best sensitivity (0.97; 95% confidence interval, 0.96 to 0.98) and specificity (0.90; 95% confidence interval, 0.86 to 0.95) for evaluating patients with suspected acute cholecystitis; test performance is unaffected by delayed imaging. Unadjusted sensitivity and specificity of ultrasound in evaluating patients with suspected acute cholecystitis are 0.94 (0.92 to 0.96) and 0.78 (0.61 to 0.96); adjusted values are 0.88 (0.74 to 1.00) and 0.80 (0.62 to 0.98). CONCLUSIONS: Ultrasound is superior to oral cholecystogram for diagnosing cholelithiasis, and radionuclide scanning is the test of choice for acute cholecystitis. However, sensitivities and specificities are somewhat lower than commonly reported. We recommend estimates that are midway between the adjusted and unadjusted values.

Acute Disease↗
PubMed1993

Acute relapsing pancreatitis as a complication of papillary stenosis after endoscopic sphincterotomy.

Endoscopic sphincterotomy has proven to be a safe alternative to surgery for selected types of biliary disease. Despite a relatively low morbidity, postprocedure complications are well described. This report presents an experience with three patients in whom acute relapsing pancreatitis developed as a possible complication of papillary stenosis after endoscopic sphincterotomy. None of the patients had a previous history of elevations in serum amylase levels before endoscopic sphincterotomy. After procedure, pancreatitis and subsequently acute relapsing pancreatitis with documented stricture of the pancreatic duct orifice developed in all three patients. After surgical transduodenal sphincteroplasty, no new episodes of acute relapsing pancreatitis occurred.

Acute Disease↗