Potential therapeutic effects of contrast materials in hysterosalpingography: a prospective randomized clinical trial. Kaiser Permanente Infertility Work Group.

PURPOSE: To evaluate the influence of the contrast material used in hysterosalpingography (HSG) on subsequent reproductive success, independent of other therapeutic interventions. MATERIALS AND METHODS: In a prospective, multisite, randomized trial, 666 women who had been infertile for more than 1 year and were scheduled to undergo HSG as part of their evaluation were assigned to one of three groups: those receiving water-soluble contrast material (WSCM) (n = 260), those receiving oil-soluble contrast material (OSCM) (n = 273), and those receiving both OSCM and WSCM (n = 133). Possible causes of infertility and therapeutic interventions were abstracted from the medical records. Data on conception within 1 year and the outcome of conception were ascertained from multiple sources. RESULTS: Of 666 women, 204 (30.6%) had at least one pregnancy, and 136 (20.4%) had live births. The rates of live births were 20.4% (54 of 260) after HSG with WSCM, 19.4% (53 of 273) after HSG with OSCM, and 21.8% (29 of 133) after HSG with both WSCM and OSCM. Differences in reproductive outcome among contrast material groups were not statistically significant ((chi2)8 = 6.08, P = .64). Whatever the cause of infertility, the use of different contrast materials led to no significant differences in the rates of live births. CONCLUSION: There is no evidence to suggest that the choice of contrast material affects the rate of term pregnancy.

Deaths related to iodinated contrast media reported spontaneously to the U.S. Food and Drug Administration, 1978-1994: effect of the availability of low-osmolality contrast media.

PURPOSE: To determine whether reports of iodinated contrast medium-related deaths have decreased since low-osmolality contrast media (LOCM) became widely available in the United States. MATERIALS AND METHODS: With use of reports to the U.S. Food and Drug Administration Spontaneous Reporting System, data on iodinated contrast medium-related deaths after LOCM became available (1987-1994) were compared with data on deaths in the period before (1978-1986) and with data on deaths in an even earlier period (1967-1977). RESULTS: In 1967-1994, more than 1,000 contrast medium-related deaths were reported, 850 occurring during 1978-1994. Excluding 22 myelography-related deaths, 37% [corrected] more deaths were reported each year in 1987-1994 than in 1978-1986. Most of this increase was associated with the use of nonionic contrast media. In 1966-1977, 228 deaths were reported; in 1978-1986, 376; and in 1987-1994, 474. In 1987-1994, 220 deaths were associated with use of high-osmolality contrast media alone, 32 with ionic LOCM alone, 214 with nonionic LOCM alone, and eight with combinations of contrast media. CONCLUSION: Despite the availability of LOCM in the United States, data for 1978-1994 do not show a marked decrease in contrast medium-related deaths. Since 1990, more deaths have been associated with LOCM than with conventional contrast media. Although these data have substantial limitations, they shed some light on contrast medium use and safety.

Nonfatal adverse reactions to iodinated contrast media: spontaneous reporting to the U.S. Food and Drug Administration, 1978-1994.

PURPOSE: To identify any changes in the frequency of serious, nonfatal adverse drug events (ADEs) reported to the U.S. Food and Drug Administration in 1978-1994 since the introduction of low-osmolality contrast media (LOCM). MATERIALS AND METHODS: Reports of ADEs submitted were reviewed for use of iodinated contrast media. RESULTS: The estimated 170 million contrast medium-enhanced radiologic studies performed in 1978-1994 produced 22,785 reports of mild or moderate ADEs, 2,639 reports of serious but nonfatal ADEs, and 920 reports of death. The most common ADEs (urticaria, dyspnea, vomiting, pruritus, facial edema, and hypotension) ranked similarly for ionic and nonionic contrast media. High-osmolality contrast media were associated with 512 serious, nonfatal ADEs reported in 1978-1986; 1,068 were reported in 1987-1994. Nonionic LOCM were associated with 17 serious, nonfatal ADEs reported in 1978-1986; 609 were reported in 1987-1994. Intrathecal injection of nonionic contrast media was associated with 235 reported serious, nonfatal ADEs; intrathecal ionic [corrected] contrast media were associated with 14 such reported ADEs. CONCLUSION: Reports of serious, nonfatal ADEs are uncommon relative to the use of contrast media. The authors observed no decrease in the number of ADEs reported since the introduction of LOCM but did not consider marketing trends or secular reporting trends.

The radiographic preauricular groove: its non-relationship to past parity.

Deep preauricular sulci were identified on abdominal radiographs in 29 of 190 (15%) adult females and in none of 110 adult males. To assess the value of the deep preauricular sulcus as an index of past pregnancy, we examined gravidity and parity records of 190 women, using standard films that included the sacroiliac region. Deep, radiographic preauricular grooves were identified in 4 of 41 (10%) nulliparous women and in 25 of 149 (17%) women with positive pregnancy histories. We also examined radiographs obtained before and after pregnancy in six primigravidas. No evidence of radiographic changes in the preauricular grooves was seen in any of the six women. We conclude that the presence of a deep, radiographic preauricular sulcus is not necessarily an indication of past pregnancy.

Written informed consent for i.v. contrast-enhanced radiography: patients' attitudes and common limitations.

In a multiinstitutional study, we surveyed 902 patients who were undergoing IV contrast-enhanced CT or IV urography; the purpose of the study was to determine patients' reactions to being given a written description of some of the risks associated with radiographic contrast material just before undergoing the examination. Ninety percent of the patients who responded said they would rather receive this information than not receive it. Ten percent said they preferred not to be given the information. Limitations in obtaining a truly informed consent were not rare and occurred in patients with medical emergencies (3% of cases) and in those with a limited understanding of risk disclosure (11% of cases). Patients in the latter category included those who were comatose or semicomatose (2%), those with dementia (1%), those with aphasia (0.8%), those who had psychiatric problems (0.8%), those who were sedated (0.6%), those who were unable to read (2%), those who were unable to understand English (2%), and those who perceived the information as too technical (0.9%). Two percent of the patients were minors. Our survey shows that practical limitations in obtaining adequate risk disclosure are common, but most patients want and accept information about the risks of having IV contrast-enhanced CT or IV urography before undergoing the procedure.

Evaluating the success of mammography at the local level: how to conduct an audit of your practice.

Mammography is a single radiologic skill with a single goal, detection of a single disease, breast cancer. Periodic self-assessment of mammography interpretations strengthens patient care through allowing comparison with past performances and current national standards and enhancing mammographers' skills through review of proven cases. This article emphasizes five useful audit measurements for the success of a mammography program.

Radiology malpractice lawsuits: California jury verdicts.

In 1983, 16 out of every 100 U.S. physicians were sued for medical malpractice. The authors reviewed the courtroom results of all 144 lawsuits involving California radiologist defendants reported in Jury Verdicts Weekly (JVW) between 1971 and 1985. Almost half (66 of 144) of the lawsuits involved allegations of "failure to diagnose" (misinterpretations and oversights). About one third (45 of 144) involved procedure complications (angiography, 22; myelography, 11; intravenous contrast administration, 5; other, 7). About three fourths (93 of 127) of the verdicts favored the radiologist defendants. The authors' finding support the American College of Radiology Malpractice Awareness Task Force recommendations.

Spinal computed tomography and computed tomographic metrizamide myelography in the early diagnosis of metastatic disease.

New lesions were shown by Tc99m bone scans to have developed in sixty patients with known metastatic cancer or high-risk primary cancer and normal neurologic examinations; they were further evaluated with plain radiographs, spinal computed tomography (CT), and CT myelography (CT-M) according to an algorithm. Three groups were identified based on plain radiographs: group 1 (normal radiograph), group 2 (compression fracture as indicated by radiograph), group 3 (evidence of metastasis as indicated by radiograph). In group 1 (n = 18), spinal CT revealed that 33% of the patients had benign disease and 67%, metastases; epidural compression was seen in 25% of the patients with metastasis as indicated by CT-M. In group 2 (n = 26), CT-M disclosed that 38% had a benign compression fracture and 62% had metastases and that 63% of the patients with metastases had an epidural compression. In group 3 (n = 16), spinal CT revealed that 15 patients had metastases (one patient had benign disease). Epidural cord compression was seen in 47% of the patients with metastatic disease. In all groups, the presence of cortical bone discontinuity around the neural canal (seen in 31 patients) was highly associated with epidural compression (seen in 20 patients). Our approach allowed the early and accurate diagnosis of spinal metastasis and epidural tumor as well as the diagnosis of benign disease and was useful in planning optimal local therapy.

Renal oncocytoma followed for eighteen years without resection.

The natural history of unresected renal oncocytomas is unknown. We report a renal oncocytoma which was mistakenly diagnosed as benign renal cyst and followed up for eighteen years. We are unable to find other oncocytomas without resection which were followed up. The apparent lack of change in size over eighteen years supports the concept of slow growth. Malignant histologic characteristics confirm the potential for malignant degeneration in what is generally considered to be a benign lesion.

Radiologists and informed-consent lawsuits.

A national survey on informed-consent lawsuits that resulted from studies using contrast material revealed that 123 (8%) of 1,513 radiologists surveyed or others in their groups had been involved in informed-consent lawsuits. In response to a detailed follow-up questionnaire, 67 radiologists anonymously provided additional information regarding their lawsuits, which most often involved excretory urography (37%) or angiography (38%), with death or neurologic impairment the most common patient injuries. As a result of these lawsuits, many radiologists provide more detailed information to patients. In the United States, the total number of informed-consent lawsuits, however, was small in relation to the total number of studies done using contrast material.

Computed tomography of ileal loop urinary diversion in adults.

Surgically-placed urinary conduits remain the most common form of long-term, supravesical urinary drainage. We reviewed CT scans of 16 patients with ileal loops examined during a 3-year period to assess normal loop anatomy and associated pathological conditions. Computed tomography was indicated when conventional studies were considered inadequate. Indications for studies were suspected tumor recurrence in 12 (75%) and abscess localization in four (25%). The normal CT ileal loop lies medial to the cecum at the level of the sacral promontory. In 12 patients, CT identified abnormalities related to ileal loop diversion. Clinically unsuspected nontumorous complications (xanthogranulomatous pyelonephritis, pelvic abscess, and peristomal hernia) were detected by CT in patients with suspected tumor recurrence.

Informed consent for intravenous contrast-enhanced radiography: a national survey of practice and opinion.

A detailed questionnaire regarding the obtaining of patient consent for the administration of intravenous contrast agents was sent to 3845 radiologists in those hospitals across the United States having more than 100 beds. The results represent the current community practice and opinion of the 1547 radiologists (40%) who answered. They showed that 66% of respondents obtained no type of informed consent before injecting intravenous contrast agents. Half of those who did obtain consent did not inform their patients of possible specific major adverse reactions. Half of those who did not obtain consent believed the risk of adverse reaction was remote. Another 40% believed the consent procedure might heighten anxiety and, therefore, increase the risk of reaction. Obtaining informed consent, however, was not significantly associated with an increased incidence of major reactions. Since 8% of the respondents indicated some involvement in malpractice lawsuits regarding the question of informed consent for various procedures, the obtaining of informed consent might lessen the risk of exposure to malpractice litigation. Additional results showed that written consent did not appear to lessen the number of studies performed and that it offered more specific information to the patient regarding complications. Finally, most radiologists (80%) requested a specific policy regarding informed consent from at least one of the following organizations: the American College of Radiology (ACR) (96%), the Radiological Society of North America (RSNA) (26%), state chapters of the ACR (15%).

Spinal computed tomography scanning in the evaluation of metastatic disease.

Twenty patients with known metastatic cancer or high-risk primary cancer developed new lesions on Tc 99m bone scans and had normal plain radiographs. Spinal computed tomography (CT) was performed on all new bone-scan-positive lesions in minimal examination time. Fifteen patients had extensive metastatic vertebral disease and received local radiotherapy. One patient with new metastatic vertebral disease on CT was treated only with chemotherapy and developed acute spinal cord compression. Four patients had discogenic disease or degenerative disease but no evidence of metastases. Radionuclide bone scans are more sensitive but less specific than plain radiographs in detecting early bone metastases. Early and accurate diagnosis of metastasis is particularly important in the axial spine to prevent epidural compression and fracture. Spinal CT is valuable for identifying the presence and extent of vertebral metastases, as well as the presence of benign disease in cancer patients.

Primary cystic arthrosis of the hip.

Subchondral cysts can mimic the radiographic features of intra-osseous ganglia or a variety of neoplastic processes. This case demonstrates the development of a massive subarticular cyst in the supra-acetabular bone. The unique pathogenesis of subchondral cysts is illustrated by the evolution of radiographic features that may be useful in planning treatment.

Anatomy and pathology of the male pelvis by magnetic resonance imaging.

Magnetic resonance imaging (MRI) of the male pelvis was performed in 25 subjects: five normal volunteers; six patients with carcinoma of the bladder; nine with benign nodular hyperplasia (including five with concomitant bladder carcinoma); nine with prostatic carcinoma; and one with a lymphocele after radical prostatectomy. The display of normal anatomy is enhanced by the ability of the MRI device to provide images in direct transverse, sagittal, and coronal planes. Sessile and pedunculated types of bladder carcinoma are readily shown due to the superior ability of MRI for soft-tissue characterization. Direct sagittal scans are advantageous for evaluation of tumors at the bladder base, and by combining two different planes of images, the extent of the neoplasm is better delineated. In the analysis of the prostate, MRI displays the gland in three dimensions and therefore allows accurate volumetric measurements. The greatest potential of MRI seems to be its ability to detect pathology confined to the gland. However, it is not yet known if a neoplastic nodule can be differentiated from chronic prostatitis. Unlike x-ray CT, metallic clips produce no streaking artifacts, giving MRI a definite advantage in the evaluation of patients after radical surgery. These observations were made on a small number of patients. If the results are confirmed with a larger number of patients, MRI will assume a prominent role in the clinical evaluation of bladder and prostate cancer.