Biopsy features are associated with primary symptoms in interstitial cystitis: results from the interstitial cystitis database study.

The purpose of this study was to investigate associations between bladder biopsy features and urinary symptoms for patients enrolled in the Interstitial Cystitis Database (ICDB) Study. Bladder biopsies were obtained during baseline screening in the ICDB Study and were evaluated for histopathologic features. Multivariable models for nighttime voiding frequency, urinary urgency, and pain were developed, incorporating biopsy features from the most diseased area of the bladder as predictors, adjusting for significant clinical factors, and clinical center variation. Among 204 interstitial cystitis (IC) patients providing biopsy specimens, cystoscopic pathology findings were not statistically associated (P >0.1) with primary IC symptoms, although the presence of Hunner's ulcer (n = 12) was suggestive of increased urinary frequency. Within a multivariable predictive model for nighttime voiding frequency, adjusting for age and minimum volume per void, 4 pathology features were noted: (1) mast cell count in lamina propria on tryptase stain; (2) complete loss of urothelium; (3) granulation tissue in lamina propria; and (4) vascular density in lamina propria on factor VIII (F8) stain were statistically significant (P <0.01). Similarly, in a multivariable model for urinary urgency, minimum volume, and percentage of submucosal granulation tissue remained statistically significant (P <0.01). Finally, the percentage of mucosa denuded of urothelium and the percentage of submucosal hemorrhage remained highly associated (P <0.01) with pain in a multivariable predictive model. The fact that the presence or severity of glomerulations was not selected for any of these predictive models suggests that cystoscopic findings of glomerulations are not predictive of IC symptoms. Furthermore, these results suggest an important role for certain pathologic features in the predictive modeling of IC symptoms.

CT percutaneous biopsy guns: comparison of end-cut and side-notch devices in cadaveric specimens.

OBJECTIVE: The purpose of this study was to compare the efficacies of four different types of end-cut biopsy guns with the side-notch Tru-cut biopsy gun. MATERIALS AND METHODS: A total of 25 liver, 15 kidney, 10 pancreas, and 15 breast biopsies were performed in the tissue from five autopsies with each of 12 different biopsy devices/biopsy depths. The tissue obtained was evaluated by an experienced cytopathologist who, not knowing which gun was used to obtain each specimen, used a predetermined grading scheme. RESULTS: When tissue was obtained, the end-cut biopsy guns performed equivalently to the side-notch biopsy gun in all four tissues. However, the end-cut guns had a significant number of "zero" biopsies (biopsy attempts during which no tissue was obtained). The proportion of zero biopsies with the end-cut guns ranged from up to 28% in the liver to 60% and 73% in the breast and kidney, respectively. CONCLUSION: The end-cut biopsy guns are easy to use and potentially can obtain high-quality specimens. However, the rate of zero biopsies during which no tissue is obtained is a serious deficiency. As a result, the use of the end-cut biopsy gun should be encouraged only for use with an introducer, with which multiple biopsy specimens can easily be obtained without additional needle punctures.

The effect of informed consent on the level of anxiety in patients given i.v. contrast material.

OBJECTIVE: A common reason given for not obtaining informed consent before the use of IV contrast material is that the anxiety created by informing patients of potential reactions will increase the possibility of their occurring. However, the idea that this is possible is debatable, and no study of this subject has used a standardized anxiety index. Accordingly, using the State-Trait Anxiety Inventory, we assessed the anxiety level among patients about to have an IV contrast procedure and measured the effect of informing them of the risks associated with the use of contrast material. SUBJECTS AND METHODS: Approximately 2050 adult outpatients at three separate medical centers were solicited for participation in this study. Each of the 1251 patients who volunteered to participate was placed into one of six groups. The majority were patients who were awaiting the injection of either ionic or nonionic contrast material and who were or were not informed of the risks associated with the use of IV contrast material. The last two groups were generally healthy outpatients reporting for routine X-rays who were not awaiting IV contrast administration but who were informed of the risks associated with the use of ionic and nonionic contrast material. Each patient informed of the risks was asked to read a standardized consent form, and all patients completed a standardized anxiety index. RESULTS: Patients who were informed of the risks associated with IV contrast material did not have measurably increased anxiety, and they did not have an increased prevalence of adverse reactions. Indeed, the only patients who had statistically significant increased anxiety compared with the other groups were among those awaiting the injection of ionic contrast material who were not informed of the risks (p = .04). The majority (51-78%) of patients in all six groups had measurable elevated anxiety scores. CONCLUSION: We conclude that it is not justified to fail to obtain informed consent in order to avoid anxiety-induced adverse reactions to IV contrast material. The majority of patients awaiting injection of IV contrast material have measurable increased anxiety levels regardless of whether they are informed of its risks.

Risks associated with the use of IV contrast material: analysis of patients' awareness.

OBJECTIVE: Opinions differ on the need to obtain informed consent for IV administration of contrast material. If the potential risks are common knowledge among most patients, the need for informed consent is reduced. The purpose of this study was to assess patients' baseline knowledge of the risks associated with use of IV contrast material. SUBJECTS AND METHODS: This study included 150 consecutive outpatients who had radiographic studies (CT or excretory urography) requiring use of IV contrast material. Before the procedure, patients were asked to complete a 10-question questionnaire assessing their understanding of the risks associated with the use of contrast material. Questions concerned the nature of their test and the reasons for and risks of contrast material. Analysis was done with Fisher's exact chi 2-test of association and Wilcoxon's two-sample test. RESULTS: On average, the patients performed significantly better on this questionnaire than if they had randomly picked each answer, indicating that the average patient has acquired some information about IV contrast material. However, the mean score was 51%, demonstrating that the average patient is not knowledgeable about all risks associated with the use of IV contrast material. We found no differences associated with sex or age. Patients with more than a high school level of education and who had previously received contrast material scored better, although they still correctly answered only 56% and 54% of the questions, respectively. CONCLUSION: Information about the risks associated with use of IV contrast material cannot be considered common knowledge among the general population of patients.

Secular trends in blood pressure among adult blacks and whites aged 18-34 years in two body mass index strata, United States, 1960-1980.

Secular trends in blood pressure among young adults reflect the proportion of the population at risk of developing hypertension and may be markers of progress in primary prevention. National health examination data from three successive surveys were analyzed to assess blood pressure trends for adult blacks and whites aged 18-34 years in two body mass index (BMI; weight (kg)/height (m)2) strata (< 25 or > or = 25). Blood pressure was categorized into a four-point ordinal scale using the weighted, within-sex 50th, 75th, and 90th percentiles for 18- to 24-year-old adults in the 1960-1962 survey. The effects were analyzed with cumulative logit models with alpha = 0.01. The systolic blood pressure decreased moderately for 25- to 34-year-old males and for females except those aged 25-34 years with a BMI of > or = 25. Diastolic blood pressure increased among males with a BMI of > or = 25 and among white males with a BMI of < 25, but did not show a significant overall trend among females. A BMI of > or = 25 was associated with substantially higher blood pressure in each survey, except for one age-sex-race subgroup. Racial differences within BMI were less consistent than the differences across BMI strata. In summary, the situation with respect to hypertension among females may have improved during this time period but for males may have worsened with respect to diastolic blood pressure. Data for both sexes support a need for population-wide obesity prevention to reduce the incidence of hypertension.

Blinded comparison of biopsy needles and automated devices in vitro: 1. Biopsy of diffuse hepatic disease.

OBJECTIVE: The purpose of this study was to compare several of the commonly used needles with several of the new automated biopsy devices (biopsy guns) for biopsy of diffuse hepatic disease. MATERIALS AND METHODS: Nine different biopsy needles or automated devices were each used to do three biopsies of 10 cadaveric livers. The specimens were reviewed in a blinded fashion by a pathologist who did not know which needle or device was used, and they were compared on the basis of a previously published histopathologic grading scale. RESULTS: The three conventional biopsy needles (16-gauge Jamshidi, 18-gauge Sure-Cut, and 14-gauge Tru-Cut) obtained a large amount of tissue with an average of 4.1 intact portal triads per biopsy. The 18-gauge Biopty gun obtained equivalent results. The 18-gauge Autovac gun with a 2-cm biopsy depth did not obtain any tissue in 18.5% of attempts. The 14- and 16-gauge Biopty guns and the 18-gauge Autovac gun with a 4-cm biopsy depth performed best with respect to fragment size and number of intact portal triads. CONCLUSION: Automated biopsy devices can provide more diagnostic specimens than can manual or conventional needles in biopsy for diffuse hepatic disease.

Blinded comparison of biopsy needles and automated devices in vitro: 2. Biopsy of medical renal disease.

OBJECTIVE: The purpose of this study was to compare several of the commonly used manual biopsy needles with several of the new automated biopsy devices (biopsy guns) for biopsy of medical renal disease. MATERIALS AND METHODS: Ten different biopsy needles or automated devices were each used to do two biopsies of 10 cadaveric kidneys. The specimens were reviewed in a blinded fashion by a pathologist using a previously published histopathologic scale. RESULTS: Of the four conventional biopsy needles tested (16-gauge Jamshidi, 18-gauge Sure-Cut, 14-gauge Tru-Cut, and 14-gauge Vim Silverman), the Jamshidi needle obtained the greatest average number of glomeruli (5.64). Results similar to those obtained with the conventional needles were obtained with the 16- and 18-gauge Biopty and Ultra-Cut biopsy guns. The 18-gauge Autovac gun with either a 2- or 4-cm depth of biopsy suffered from a significant number of biopsies from which no tissue was obtained. The 14-gauge Biopty gun was clearly superior, leading in all graded categories including the average number of glomeruli (8.11) per biopsy. CONCLUSION: The automated biopsy device, or biopsy gun, can provide more diagnostic specimens than can manual or conventional needles in biopsy for medical renal disease.

Automated biopsy devices: a blinded evaluation.

To evaluate 20 different automated biopsy devices with respect to the quality of tissue obtained for histopathologic analysis, a total of 1,470 18-gauge biopsy specimens were obtained from 10 fresh autopsy cases, including 30 liver, 20 kidney, 10 pancreas, and 10 psoas muscle biopsy specimens per device and per biopsy depth. There was no statistical difference in the performance of the long-throw Biopty, ASAP 18, 1.9-cm UltraCut, long-throw Monopty, and 2.5-cm ABS biopsy guns. All obtained a large amount of tissue with minimal fragmentation or crush artifact. Most of the short-throw biopsy guns (depth of biopsy < or = 1.1 cm) did not perform as well. Although the other guns performed adequately, less than optimal results were obtained with the Temno, Bio-Gun, Roth, Klear Kut, ABC, and Urocut biopsy guns. Most 18-gauge automated biopsy devices with a biopsy excursion of at least 2.0 cm provide a high-quality, diagnostically adequate specimen for histopathologic analysis.

Patient choice and nonionic contrast media.

RATIONALE AND OBJECTIVES: Because of the greatly increased cost of nonionic, low-osmolar contrast material, some practitioners reserve its use for patients at high risk for an adverse contrast reaction. The authors attempt to evaluate the proportion of low-risk outpatients--when offered a choice between the more expensive but lower-risk nonionic and the cheaper but higher-risk conventional ionic contrast material--that would choose the nonionic media. METHODS: Two hundred and fifty consecutive outpatients awaiting contrast-enhanced computed tomography were included in this study. Patients at increased risk for a contrast reaction were excluded. The remaining 162 patients were informed of the risks and told of the availability of nonionic contrast media with its up to six-fold decrease in serious complications. They were also informed that if they chose the lower-risk nonionic agent, they would likely have to pay the additional $100 to $150 in cost. RESULTS: Of the 162 low-risk patients surveyed, 48% selected nonionic contrast media, and 63% believed that all patients should be informed of the risks of contrast material and of the availability of nonionic contrast. CONCLUSIONS: The data support providing patients at low risk for an adverse reaction informed consent about the relative risks of ionic and nonionic contrast material.

Fine-needle aspiration biopsy for cytopathologic analysis: utility of syringe handles, automated guns, and the nonsuction method.

The performances of seven techniques and devices used with 22-gauge needles to obtain biopsy specimens for cytologic analysis were compared by means of single-blinded evaluation with an objective, previously published grading scheme. A total of 420 specimens were obtained from 10 fresh human cadavers (42 specimens per cadaver), including 30 hepatic, 20 renal, and 10 pancreatic specimens per technique or device. No statistical differences existed in the liver, kidney, or pancreas or in the combined data in the performance of the aspirator gun, syringe holders, vacuum needle, and end-cut gun versus the manual aspiration biopsy technique performed with a 22-gauge Chiba needle. However, nonaspiration, fine-needle capillary biopsy (FNCB) performed statistically significantly worse than any other technique or device in the kidney and pancreas and in comparison with the overall combined data. In the liver, no statistically significant difference existed in the overall performance of FNCB versus conventional aspiration biopsy, but the amount of cellular material obtained with FNCB was statistically significantly less.

Prognostic value of breast cancer aromatase.

The estrogen receptor, progesterone receptor, and intratumoral aromatase content of 127 breast carcinomas were determined. Patients whose tumor contained either estrogen or progesterone receptors had a longer disease-free interval, but no difference in survival was observed. Measurable aromatase activity was detected in 78 of 113 (69%) tumors. There was no relationship between aromatase activity and disease-free interval or survival.

Use of informed consent for ionic and nonionic contrast media.

The use of informed consent before intravenous administration of contrast material remains a controversial issue. It involves explaining the risks of intravenous contrast material and obtaining the patient's permission for its use. All physician groups who had billed Pennsylvania Blue Shield for at least three intravenous contrast material-enhanced procedures performed in 1989 were surveyed. Informed consent was obtained from at least some patients by about two-thirds of physician groups before using intravenous contrast material, regardless of whether it was ionic or nonionic. Nonradiologists were more likely to obtain informed consent before the use of ionic contrast material than radiologists. Regardless of specialty, practices associated with larger hospitals (greater than 250 beds), larger physician groups (greater than 10), or a university used informed consent less often than smaller physician groups or those associated with a smaller hospital or a private practice. Though results may be affected by regional variation or increased usage since previous surveys, the use of informed consent before the intravenous injection of contrast material is a common practice; it is obtained in the majority of patients.

Patients' attitudes toward informed consent for intravenous contrast media.

OBJECTIVES: To assess patient attitudes concerning informed consent and the risks of ionic and nonionic contrast material, 1,197 completed questionnaires were obtained from individuals either awaiting contrast injection or waiting for other services. METHODS: Six different questionnaire formats were administered, including two detailing the specific risks of ionic and nonionic contrast, respectively. Different questionnaire formats were used to assess whether the severity or the probability of adverse consequences had more influence on a patient's desire for information. Two questionnaires evaluated the effect of comparing medical risks to equivalent risks from everyday nonmedical activities. RESULTS AND CONCLUSIONS: Regardless of questionnaire format and the severity of potential risk, the large majority of individuals want some information before contrast injection, and approximately half view such information as essential. Individuals reacted more to the probability of a potential reaction than its severity, and to items ordered toward the end of a particular questionnaire than at the beginning.

Current usage of nonionic contrast.

All physicians who had billed Pennsylvania Blue Shield for at least three intravenous contrast studies during 1989 were surveyed on their use of nonionic versus ionic contrast. This surveyed group represents a diversity of hospital sizes, practice types, and group sizes. Of the 383 physician groups surveyed, responses were obtained from 285. The majority of the responding groups were radiologists (94.0%). Nonionic contrast is utilized in 41.3% of all intravenous studies. Radiologists use nonionic contrast in a much greater proportion than nonradiologists (P < 0.0001), with 17.6% of radiologists utilizing nonionic contrast in all of their patients. Conversely, 75% of nonradiologists utilize ionic contrast in all of their patients. For all physician groups surveyed, 40.3% utilize nonionic for at least 50%, while 27.6% use nonionics for more than 75% of their patients. The routine use of steroid premedication prior to the injection of ionic contrast is not a common practice. The increased utilization of nonionic contrast found in this survey may reflect the cross-section of physicians and practice types surveyed or may represent changing practice patterns among physicians utilizing contrast material.