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Biomedical subjects

B L Strom

Publications and source records attributed to B L Strom.

At least 55 records · Page 3Linked to original sources
PubMed1999

Factors influencing the optimal control-to-case ratio in matched case-control studies.

Statistical power in matched case-control studies depends on both the correlation coefficient between cases and their matched controls (phi) and the prevalence of exposure among controls (P0). To examine the hypothesis that the value of increasing the control-to-case ratio beyond 5 varies with both phi and P0, the authors estimated statistical power for a hypothetical case-control study under different assumptions. The effect of increasing the control-to-case ratio depended on phi and, to a lesser extent, on P0. The results suggest that investigators consider including more than five controls per case when either phi is greater than about 0.2 or P, is less than about 0.15.

Bias↗
PubMed1999

Risk factors associated with the failure of a venous leg ulcer to heal.

BACKGROUND: Venous leg ulcers afflict a significant portion of the population. The most popular form of therapy for venous leg ulcers is a compression bandage (eg, Unna boot), a therapy that is frequently unsuccessful. OBJECTIVE: To describe risk factors associated with the failure of a wound to heal when treated with a limb-compression bandage for 24 weeks. DESIGN: A retrospective cohort study. SETTING: Single-center outpatient specialty clinic at an academic medical center. PARTICIPANTS: Two hundred sixty consecutive patients with chronic venous leg ulcers. MAIN OUTCOME MEASURE: The magnitude of the effect of a given risk factor on the probability that a wound will heal within 24 weeks of care. RESULTS: Based on an assessment of leg wounds during initial office visits, we observed that the failure of a wound to heal within 24 weeks was significantly associated with larger wound area, measured in square centimeters (odds ratio [OR], 1.19; 95% confidence interval [CI], 1.11-1.27), duration of the wound in months (OR, 1.09; 95% CI, 1.04-1.16), history of venous ligation or venous stripping (OR, 4.58; 95% CI, 1.84-11.36), history of hip or knee replacement surgery (OR, 3.52; 95% CI, 1.12-11.08), ankle brachial index of less than 0.80 (OR, 3.52; 95% CI, 1.12-11.08), and the presence of fibrin on more than 50% of the wound surface (OR, 3.42; 95% CI, 1.38-8.45). CONCLUSIONS: Several risk factors are associated with the failure of a patient's venous leg ulcer to heal while using limb-compression therapy. It is prudent to consider these factors when referring a patient to a wound care subspecialists or for alternative therapies.

Aged↗
PubMed1999

Potential utility of electronic drug compliance monitoring in measures of adverse outcomes associated with immunosuppressive agents.

Poor compliance with prescribed medications limits the effectiveness of many pharmacologic therapies and enhances their potential toxicities. Traditional methods of measuring drug-taking behavior, including direct observation, patient self-report, pill counts, and therapeutic drug level monitoring, all have well-described limitations in validity and interpretability. Electronic medication event monitoring has been used to assess compliance with therapies for hypertension, glaucoma, anemia, and epilepsy, overcoming many problems of traditional approaches. However, no published reports describe the use of electronic monitoring with immunosuppressive agents, despite their increasing use for non-life-threatening conditions and their many dose-dependent toxicities. Transplant recipients are thought to be at particular risk from noncompliance. Therefore, we undertook this study to assess the feasibility of electronically monitoring compliance with immunosuppressive drugs among renal allograft recipients. Twenty-five kidney transplant patients receiving immunosuppressive medications from a single pharmacy were enrolled. Each subject received electronic monitors with their immunosuppressive serum drug refills for cyclosporine and azathioprine. Each subject returned their monitors after the first month of this 2-month study for downloading data. The frequency distribution of interdose intervals were described. Two measures of average non-compliance were calculated for both drugs: the proportion of monitored days that had missed doses, and the proportion of missed doses. Once daily and twice daily regimens of cyclosporine were compared. Concordance in drug compliance between the two drugs was calculated for each subject and averaged over the study population. Twenty-two of 25 subjects missed one or more doses of cyclosporine or azathioprine. Seventeen (68%) subjects never missed four or more consecutive doses. Subjects were non-compliant with cyclosporine on 8.7% of monitored days, and non-compliance with azathioprine on 9.8% of monitored days. Subjects were non-compliant with 6.8% of their cyclosporine doses and 9.8% of their azathioprine doses. Patients were compliant with both drugs on 86.6% of days and were non-compliant with both drugs on 5.1% of days. Subjects were non-compliant with cyclosporine during 5% and 13.2% of monitored days for once and twice daily dosing regimens, respectively. Concordance analysis demonstrated that for 91.7% of days of monitoring, compliance information was identical for both drugs. This study demonstrated the feasibility of electronic medication event monitoring among kidney transplant patients. This methodology represents an important tool for monitoring compliance of immunosuppressive agents essential to their safe and effective use, and should be considered for use in future studies of these drugs and others with substantial dose-dependent toxicity.

Journal Article↗
PubMed1999

Risk of bleeding and hypoprothrombinaemia associated with NMTT side chain antibiotics: using cefoperazone as a test case.

A retrospective cohort study was performed to determine the incidence of hypoprothrombinaemia and bleeding in patients receiving cefoperazone, a third-generation cephalosporin that contains an NMTT side chain. 374 patients receiving cefoperazone from February 1983 to March 1986 at a teaching hospital in Philadelphia were compared with 497 patients receiving either ceftizoxime or cefotaxime during the same period, and with 476 patients receiving ceftazidime from April 1985 to December 1987. Adverse events (any bleeding episodes, decrease in haemoglobin, prolongation of prothrombin time (PT), and prolongation of partial thromboplastin times (PTT)) were evaluated, if occurring during the period from the start of cephalosporin therapy, or the start of therapy with one of the two control drugs, for 14 days after the last date of the first course of therapy were recorded. An increased risk of hypoprothrombinaemia was associated with the use of cefoperazone: the prothrombin time was prolonged by 5 s or more in 12.3% of patients receiving cefoperazone vs. 5.8% of patients receiving ceftizoxime or cefotaxime, and vs. 5.8% receiving ceftazidime; the adjusted odds ratios (95% CIs) were 3.6 (1.7-7.4) and 3.8 (1.8-7.8), respectively, and these increased at higher doses of cephalosporin. No protection was apparent from the administration of vitamin K prior to or during the course of cephalosporin. No overall increased risks were observed for bleeding (adjusted odds ratios (95% CIs) were 1.1 (0.8-1.4) vs. ceftizoxime or cefotaxime, and 0.9 (0.6-1.2) vs. ceftazidime), decrease in haemoglobin, or increased partial thromboplastin time. In subgroup analyses, increased risks of bleeding were observed with high dose cefoperazone use [2.8 (1.5-5.5) vs. ceftizoxime or cefotaxime, and 2.3 (1.1-4.6) vs. ceftazidime]. Patients receiving NMTT side chain antibiotics should be monitored for hypoprothrombinaemia, but any increase in bleeding is likely to be small, and prophylactic vitamin K is probably not warranted.

Journal Article↗
PubMed1999

The relationship of nonsteroidal anti-inflammatory drug use to the risk of breast cancer.

BACKGROUND: The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on the risk of breast cancer is unclear. We assessed the association in a hospital-based case-control study. METHODS: The cases (n = 6558) were compared with cancer controls (n = 3296) and noncancer controls admitted for trauma or acute infection (n = 2925). Odds ratios were estimated using multivariate logistic regression models. RESULTS: For women who used NSAIDs regularly beginning at least 1 year before admission, the odds ratios (OR) were 0.8 (95% CI 0.7, 1.0) with cancer controls and 0.7 (95% CI 0.6, 0.9) with noncancer controls. With noncancer controls, there was a statistically significant decreasing trend in the odds ratios as duration of use increased, whereas with cancer controls there was not. The reduction in risk for regular use was accounted for largely by a reduced odds ratio for one study center (Boston), which contributed 9% of the cases. CONCLUSIONS: The data are compatible with a small reduction in risk associated with regular NSAID use. However, inconsistencies in the data detract from a causal interpretation.

Adult↗
PubMed1999

A comparison of sensitivity analyses of the effect of wound duration on wound healing.

The effect of an unmeasured exposure on the association between an exposure and outcome can never be fully known in an observational study. The purpose of the current study was to evaluate the sensitivity to unmeasured confounding of the previously published association between wound duration and wound healing in a chronic venous leg ulcer. This was estimated using two methods of sensitivity analysis, called Rosenbaum's method and Greenland's external adjustment. The association between wound duration and wound healing was insensitive to confounding unless the odds ratio for the association between the confounder and a younger wound was almost nine (Rosenbaum). In fact, the association between this hypothetical confounder and healing must have an odds ratio of 100 to remove the effect of duration fully (Greenland). Both of these techniques provide useful and complementary information when assessing the effects of a potential unmeasured confounder.

Bandages↗
PubMed1999

Primary care physicians' decisions to perform flexible sigmoidoscopy.

OBJECTIVE: This study was designed to identify factors that influence primary care physicians' willingness to perform flexible sigmoidoscopy. MEASUREMENTS: Using a mailed questionnaire, we surveyed all 161 primary care physicians participating in a large health care system. We obtained information on training, current practice patterns, beliefs about screening for colorectal cancer, and the influence of various factors on their decision whether or not to perform flexible sigmoidoscopy in practice. MAIN RESULTS: Of the 131 physicians included in the analysis, 68 (52%) reported training in flexible sigmoidoscopy, of whom 36 (53%) were currently performing flexible sigmoidoscopy in practice. Time required to perform flexible sigmoidoscopy, availability of adequately trained staff, and availability of flexible sigmoidoscopy services provided by other clinicians were identified most often as reasons not to perform the procedure in practice. Male physicians were more likely than female physicians to report either performing flexible sigmoidoscopy or desiring to train to perform flexible sigmoidoscopy (odds ratio 2.61; 95% confidence interval 1.10, 6.23). This observed difference appears to be mediated through different weighting of decision criteria by male and female physicians. CONCLUSIONS: Approximately half of these primary care physicians trained in flexible sigmoidoscopy chose not to perform this procedure in practice. Self-perceived inefficiency in performing office-based flexible sigmoidoscopy deterred many of these physicians from providing this service for their patients.

Adult↗
PubMed1999

Screening for colorectal cancer and other GI cancers.

Most of the major advances in the screening for gastrointestinal cancers this year were in the area of colorectal cancer screening. Currently, screening is recommended for the prevention of colorectal cancer in average and high-risk populations. For average risk populations, large randomized trials support the use of screening fecal occult blood testing, and case-control studies support the use of screening sigmoidoscopy. This year, several investigators have addressed issues related to the probability of identifying advanced lesions in the proximal colon following a positive screening flexible sigmoidoscopy. Similarly, two studies identified that villous histology in an index polyp was associated with an increased risk of recurrent colonic polyps. Additionally, two large trials provided new insight about the prevalence of mutations in the MLH1 or MSH2 mismatch-repair genes among patients with colorectal cancer. Lastly, a case-control study from Sweden provided the best evidence to date that surveillance colonoscopies for patients with long-standing ulcerative colitis may reduce cancer-related mortality. Although further work is needed, these studies have served to advance our knowledge of colorectal cancer screening substantially.

Colorectal Neoplasms↗
PubMed1999

Effect of testosterone treatment on bone mineral density in men over 65 years of age.

As men age, their serum testosterone concentrations decrease, as do their bone densities. Because bone density is also low in hypogonadal men, we hypothesized that increasing the serum testosterone concentrations of men over 65 yr to those found in young men would increase their bone densities. We randomized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch double blindly for 36 months. We measured bone mineral density by dual energy x-ray absorptiometry before and during treatment. Ninety-six men completed the entire 36-month protocol. The mean serum testosterone concentration in the men treated with testosterone increased from 367 +/- 79 ng/dL (+/-SD; 12.7 +/- 2.7 nmol/L) before treatment to 625 +/- 249 ng/dL (21.7 +/- 8.6 nmol/L; P < 0.001) at 6 months of treatment and remained at that level for the duration of the study. The mean bone mineral density of the lumbar spine increased (P < 0.001) in both the placebo-treated (2.5 +/- 0.6%) and testosterone-treated (4.2 +/- 0.8%) groups, but the mean changes did not differ between the groups. Linear regression analysis, however, demonstrated that the lower the pretreatment serum testosterone concentration, the greater the effect of testosterone treatment on lumbar spine bone density from 0-36 months (P = 0.02). This analysis showed a minimal effect (0.9 +/- 1.0%) of testosterone treatment on bone mineral density for a pretreatment serum testosterone concentration of 400 ng/dL (13.9 nmol/L), but an increase of 5.9 +/- 2.2% for a pretreatment testosterone concentration of 200 ng/dL (6.9 nmol/L). Increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men did not increase lumbar spine bone density overall, but did increase it in those men with low pretreatment serum testosterone concentrations.

Administration, Cutaneous↗
PubMed1999

Effect of testosterone treatment on body composition and muscle strength in men over 65 years of age.

As men age, serum testosterone concentrations decrease, the percentage of body mass that is fat increases, the percentage of lean body mass decreases, and muscle strength decreases. Because these changes are similar to those that occur in hypogonadal men, we hypothesized that increasing the serum testosterone concentration of men over 65 yr of age to that in young men would decrease their fat mass, increase their lean mass, and increase their muscle strength. We randomized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch in a double blind study for 36 months. We measured body composition by dual energy x-ray absorptiometry and muscle strength by dynamometer before and during treatment. Ninety-six men completed the entire 36-month protocol. Fat mass decreased (-3.0+/-0.5 kg) in the testosterone-treated men during the 36 months of treatment, which was significantly different (P = 0.001) from the decrease (-0.7+/-0.5 kg) in the placebo-treated men. Lean mass increased (1.9+/-0.3 kg) in the testosterone-treated men, which was significantly different (P < 0.001) from that (0.2+/-0.2 kg) in the placebo-treated men. The decrease in fat mass in the testosterone-treated men was principally in the arms (-0.7+/-0.1 kg; P < 0.001 compared to the placebo group) and legs (-1.1+/-0.2 kg; P < 0.001), and the increase in lean mass was principally in the trunk (1.9+/-0.3 kg; P < 0.001). The change in strength of knee extension and flexion at 60 degrees and 180 degrees angular velocity during treatment, however, was not significantly different between the two groups. We conclude that increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men decreased fat mass, principally in the arms and legs, and increased lean mass, principally in the trunk, but did not increase the strength of knee extension and flexion, as measured by dynamometer.

Aged↗
PubMed1998

Dental and cardiac risk factors for infective endocarditis. A population-based, case-control study.

BACKGROUND: Although antibiotic prophylaxis against infective endocarditis is recommended, the true risk factors for infective endocarditis are unclear. OBJECTIVE: To quantitate the risk for endocarditis from dental treatment and cardiac abnormalities. DESIGN: Population-based, case-control study. SETTING: 54 hospitals in the Philadelphia area. PATIENTS: Persons with community-acquired infective endocarditis not associated with intravenous drug use were compared with community residents, matched by age, sex, and neighborhood of residence. MEASUREMENTS: Information on demographic characteristics, host risk factors, and dental treatment was obtained from structured telephone interviews, dental records, and medical records. RESULTS: During the preceding 3 months, dental treatment was no more frequent among case-patients than controls (adjusted odds ratio, 0.8 [95% CI, 0.4 to 1.5]). Of 273 case-patients, 104 (38%) knew of previous cardiac lesions compared with 17 controls (6%) (adjusted odds ratio, 16.7 [CI, 7.4 to 37.4]). Case-patients more often had a history of mitral valve prolapse (adjusted odds ratio, 19.4 [CI, 6.4 to 58.4]), congenital heart disease (adjusted odds ratio, 6.7 [CI, 2.3 to 19.4]), cardiac valvular surgery (adjusted odds ratio, 74.6 [CI, 12.5 to 447]), rheumatic fever (adjusted odds ratio, 13.4 [CI, 4.5 to 39.5]), and heart murmur without other known cardiac abnormalities (adjusted odds ratio, 4.2 [CI, 2.0 to 8.9]). Among case-patients with known cardiac lesions--the target of prophylaxis--dental therapy was significantly (P = 0.03) less common than among controls (adjusted odds ratio, 0.2 [CI, 0.04 to 0.7] over 3 months). Few participants received prophylactic antibiotics. CONCLUSIONS: Dental treatment does not seem to be a risk factor for infective endocarditis, even in patients with valvular abnormalities, but cardiac valvular abnormalities are strong risk factors. Few cases of infective endocarditis would be preventable with antibiotic prophylaxis, even with 100% effectiveness assumed. Current policies for prophylaxis should be reconsidered.

Adolescent↗
PubMed1998

Calcium channel blockers and the risk of cancer.

CONTEXT: Recent epidemiologic studies have raised the concern that calcium channel blocker use may increase the risk of cancer overall and of several specific cancers. OBJECTIVE: To assess whether calcium channel blocker use increases the risk of cancer overall and of specific cancers. DESIGN: Case-control drug surveillance study based on data collected from 1983 to 1996. SETTING: Hospitals in Baltimore, Md, New York, NY, and Philadelphia, Pa. PATIENTS: A total of 9513 patients aged 40 to 69 years with incident cancer of various sites and 6492 controls aged 40 to 69 years admitted for nonmalignant conditions. MAIN OUTCOME MEASURES: Incident cancer overall and 23 specific cancers. RESULTS: Calcium channel blocker use was unrelated to the risk of cancer overall (relative risk [RR], 1.1; 95% confidence interval [CI], 0.9-1.3). Use was not significantly associated with increased risks of individual cancers, including those previously implicated, except cancer of the kidney (RR, 1.8; 95% CI, 1.1 -2.7). Recent use, use for 5 or more years, and use of individual calcium channel blocker drugs were also not associated with cancer incidence. Use of beta-blockers and angiotensin-converting enzyme inhibitors was generally unrelated to cancer overall or individual cancers, but both were associated with kidney cancer (RR, 1.8; 95% CI, 1.3-2.5; and RR, 1.9; 95% CI, 1.2-3.0, respectively). CONCLUSIONS: The present study suggests that the use of calcium channel blockers is unrelated to an increase in the overall risk of cancer or of individual cancers, except kidney cancer, which has been associated with hypertension or drugs to treat hypertension in previous studies.

Adult↗
PubMed1998

Perioperative blood transfusion and postoperative mortality.

CONTEXT: The risks of blood transfusion have been studied extensively but the benefits and the hemoglobin concentration at which patients should receive a transfusion have not. OBJECTIVE: To determine the effect of perioperative transfusion on 30- and 90-day postoperative mortality. DESIGN: Retrospective cohort study. SETTING: A total of 20 US hospitals between 1983 and 1993. PARTICIPANTS: A total of 8787 consecutive hip fracture patients, aged 60 years or older, who underwent surgical repair. MAIN OUTCOME MEASURES: Primary outcome was 30-day postoperative mortality; secondary outcome was 90-day postoperative mortality. The "trigger" hemoglobin level was defined as the lowest hemoglobin level prior to the first transfusion during the time period or, for patients in the nontranfused group, as the lowest hemoglobin level during the time period. RESULTS: Overall 30-day mortality was 4.6% (n=402; 95% confidence interval [CI], 4.1%-5.0%); overall 90-day mortality was 9.0% (n=788; 95% CI, 8.4%-9.6%). A total of 42% of patients (n=3699) received a postoperative transfusion. Among patients with trigger hemoglobin levels between 80 and 100 g/L (8.0 and 10.0 g/dL), 55.6% received a transfusion, while 90.5% of patients with hemoglobin levels less than 80 g/L (8.0 g/dL) received postoperative transfusions. Postoperative transfusion did not influence 30- or 90-day mortality after adjusting for trigger hemoglobin level, cardiovascular disease, and other risk factors for death: for 30-day mortality, the adjusted odds ratio (OR) was 0.96 (95% CI, 0.74-1.26); for 90-day mortality, the adjusted hazard ratio was 1.08 (95% CI, 0.90-1.29). Similarly, 30-day mortality after surgery did not differ between those who received a preoperative transfusion and those who did not (adjusted OR, 1.23; 95% CI, 0.81-1.89). CONCLUSIONS: Perioperative transfusion in patients with hemoglobin levels 80 g/L (8.0 g/dL) or higher did not appear to influence the risk of 30- or 90-day mortality in this elderly population. At hemoglobin concentrations of less than 80 g/L (8.0 g/dL), 90.5% of patients received a transfusion, precluding further analysis of the association of transfusion and mortality.

Aged↗
PubMed1998

How you look determines what you find: severity of illness and variation in blood transfusion for hip fracture.

PURPOSE: Utilization report cards are commonly used to assess hospitals. However, in practice, they rarely account for differences in patient populations among hospitals. Our study questions were: (1) How does transfusion utilization for hip fracture patients vary among hospitals? (2) What patient characteristics are associated with transfusion and how do those characteristics vary among hospitals? (3) Is the apparent pattern of variation of utilization among hospitals altered by controlling for these patient characteristics? SUBJECTS AND METHODS: We included consecutive hip fracture patients aged 60 years or older who underwent surgical repair between 1982 and 1993 in 19 hospitals from four states, excluding those who refused blood transfusion, had multiple trauma, metastatic cancer, multiple myeloma, an above the knee amputation, or were paraplegic or quadriplegic. The outcome of interest was postoperative blood transfusion. "Trigger hemoglobin" was the lowest hemoglobin recorded before transfusion or recorded at any time during the week before or after surgery for patients who were not transfused. RESULTS: There was considerable variation in transfusion among hospitals postoperatively (range 31.2% to 54.0%, P = 0.001). Trigger hemoglobin also varied considerably among hospitals. In unadjusted analyses, four of nine teaching and two of nine nonteaching hospitals had postoperative transfusion rates significantly higher than the reference (teaching) hospital, while one nonteaching hospital had a lower rate. In an analysis controlling for trigger hemoglobin and multiple clinical variables, one of nine teaching and four of nine nonteaching hospitals had rates higher than the reference hospital, while four teaching hospitals and one nonteaching hospital had lower rates. CONCLUSIONS: The apparent pattern of variation of transfusion among hospitals varies according to how one adjusts for relevant patient characteristics. Utilization report cards that fail to adjust for these characteristics may be misleading.

Blood Transfusion↗
PubMed1998

Risk factors for clinically important adverse events after protamine administration following cardiopulmonary bypass.

OBJECTIVES: The purpose of this study was to determine risk factors for adverse events following protamine administration after cardiopulmonary bypass. BACKGROUND: Intravenous protamine administration is associated with a risk of severe systemic reactions. However, risk factors for these events have not been well delineated, thus hampering development of preventive strategies. METHODS: A case-control study nested within a cohort of consecutive patients undergoing surgery requiring cardiopulmonary bypass was performed. The primary case definition included those events (pulmonary hypertensive and systemic hypotensive) occurring within 10 min of protamine administration in the absence of other measurable causes of hemodynamic compromise. RESULTS: Comparing the 53 cases to the 223 control subjects, three risk factors were independently associated with events (multivariable odds ratio [95% confidence interval]): neutral protamine Hagedorn insulin use (8.18 [2.08, 32.2]); fish allergy (24.5 [1.24, 482.3]), and a history of nonprotamine medication allergy (2.97 [1.25, 7.07]). These risk factors demonstrated an increasingly strong association with progressively more specific case definitions. An estimated 39% of cardiopulmonary bypass patients had one or more of these risk factors. Prior intravenous protamine, central venous pressure prior to protamine, preoperative ejection fraction and the need for inotropes when coming off bypass did not exhibit statistically significant associations with events (all p > 0.15). Prior protamine allergy was associated specifically with an increased risk of pulmonary hypertension (multivariable odds ratio 189; 95% confidence interval 13, 2,856). CONCLUSIONS: Immunologic factors are important in predisposing individuals to protamine reactions, and a substantial proportion of patients are at considerably increased risk Strategies to reduce the risk of protamine-associated events are needed.

Cardiopulmonary Bypass↗
PubMed1998

Adverse events after protamine administration in patients undergoing cardiopulmonary bypass: risks and predictors of under-reporting.

A retrospective cohort study of patients undergoing cardiopulmonary bypass over 2 years at a single hospital was performed to determine the rate and predictors of attributing events to protamine and reporting them to a well-developed, hospital-based adverse drug reaction (ADR) program. Overall, 123 (12.9%) of 952 procedures were associated with an adverse event. Thirteen percent of these events were attributed to protamine in the medical record and 2.4% were reported to the ADR program. Only 19% of events attributed to protamine were reported. Even after excluding events with other measurable etiologies, the incidence of adverse events (2.6%) was still higher than that of attributed (0.8%) or reported (0.3%) events. Events that manifest as pulmonary hypertension occurred sooner after protamine, or were severe were significantly more likely to be attributed to protamine. These predictors demonstrated similar relationships with the probability of reporting events. Reliance on reporting of adverse events could not only underestimate the risk of these events, but might bias studies by identifying non-representative events.

Adverse Drug Reaction Reporting Systems↗
PubMed1998

Transitional cell cancer of the urinary tract and renal cell cancer in relation to acetaminophen use (United States).

Experimental and epidemiologic evidence have suggested that phenacetin use increases the risk of transitional cell cancers of the urinary tract. The drug is no longer marketed but a commonly used metabolite, acetaminophen, has been linked recently to an increased risk of renal cancer. We assessed the relation of acetaminophen use to the risk of transitional cell cancer of the urinary tract and of renal cell cancer with data from a hospital-based study of cancers and medication use conducted from 1976-96 in the eastern United States. We compared 498 cases of transitional cell cancer and 383 cases of renal cell cancer with 8,149 noncancer controls and 6,499 cancer controls and controlled confounding factors with logistic regression. For transitional cell cancer, the relative risk (RR) estimate for regular acetaminophen use that had begun at least a year before admission was 1.1 (95 percent confidence interval [CI] = 0.6-1.9) based on noncancer controls, and 0.9 (CI = 0.5-1.6) based on cancer controls. RR estimates for use that lasted at least five years, and for nonregular use, were also close to 1.0. For renal cell cancer, the corresponding estimates were again close to 1.0. Our results suggest that acetaminophen, as used in present study population, does not influence the risk of transitional cell cancer of the urinary tract or of renal cell cancer.

Acetaminophen↗