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31 ince its recent publication, the “American College of Radiology [ACR] White Paper on MR Safety” and its “ACR Magnetic Resonance [MR] Safe Practice Guidelines” [1] have met with a continually growing wave of support that has proven to be most gratifying to all involved in its creation. There has been widespread support for the concept of standardization of MR safety practices throughout the MR industry in clinical and research settings as a means of helping to decrease the incidence of those adverse MR-related events that are potentially avoidable. Generation of guidelines that would meet with universal approval would be difficult. Lenient guidelines result in criticism from those who believe that not enough is being done to protect patients and MR health care workers from potentially avoidable adverse events. Stringent recommendations might invoke protests against excessive external controls and the expense of implementation and restriction of the free practice of medicine and diagnostic radiology. Each of these potential concerns is valid in its own right. The “ACR Magnetic Resonance Safe Practice Guidelines” presented in the “American College of Radiology White Paper on MR Safety” attempt to balance these concerns yet accomplish the stated objective of improving the safety of MR examinations. It is for these reasons that the comments by our colleagues, Shellock and Crues [2], in their commentary are most appreciated. Unfortunately several misunderstandings in the commentary have introduced a note of confusion to some in our industry who wish to apply these guidelines to their own practices. It is the purpose of this response to clarify these issues.

he following is a report of the American College of Radiology Blue Ribbon Panel on MR Safety, chaired by Emanuel Kanal, MD, FACR, to the Task Force on Patient Safety, chaired by James P. Borgstede, MD, FACR. Under the auspices of the Task Force, the panel met in November 2001 consisting of the following members: A. James Barkovich, MD; Charlotte Bell, MD, (Anesthesia Patient Safety Foundation); James P. Borgstede, MD, FACR; William G. Bradley, MD, PhD, FACR; Joel Felmlee, PhD; Jerry W. Froelich, MD; Ellisa M. Kaminski, RTR, MR; Emanuel Kanal, MD, FACR; Elaine K. Keeler, PhD, (NEMA); James W. Lester, MD; Elizabeth Scoumis, RN, BSN; Loren A. Zaremba, PhD (FDA); and Marie D. Zinninger (American College of Radiology Staff). The following document is intended to be used as a template for MR facilities to follow in the development of an MR safety program. Recent articles in the medical literature and electronic/print media [1, 2] detailing Magnetic Resonance Imaging (MRI) adverse incidents involving patients, equipment, and personnel spotlighted the need for review. The Panel was charged with reviewing MR safety practices and guidelines and issuing new ones as appropriate for MR examinations and practices today [3–7]. The document restates existing practices and articulates new ones. This document will continue to evolve, as does the MRI field. There are potential risks in the MR environment, not only for the patient but also for the accompanying family members, attending health care professionals, and others who find themselves only occasionally or rarely in the magnetic fields of MR scanners, such as security or housekeeping personnel, firefighters, police, etc. These MR Safe Practices Guidelines have been developed to help guide MR practitioners regarding these issues and provide a basis for them to develop and implement their own MR policies and practices. It is intended that these MR Safe Practice Guidelines (and the policies and procedures to which they give rise) be reviewed and updated on a regular basis. It is the intent of the American College of Radiology (ACR) that these MR Safe Practice Guidelines will be helpful as the field of MR evolves and matures, providing patient MR services that are among the most powerful, yet safest, of all diagnostic procedures to be developed in the history of modern medicine.

A national task force consisting of members from the American College of Radiology, the American College of Surgeons, and the College of American Pathologists examined the issues surrounding stereotactic core-needle biopsy for occult breast lesions. Their report includes indications and contraindications, informed consent, specimen handling, and management of indeterminate, atypical, or discordant lesions.

This article discusses the background, goals, criteria, current results, impact, and future directions of the American College of Radiology's (ACR's) Mammography Accreditation Program. To date, approximately one half of the mammographic units in the United States have voluntarily applied for accreditation through the ACR program, with approximately one quarter of the units in the United States now accredited. Application rates have increased steadily since the start of the program in August 1987. The equipment performance criteria and professional criteria defined and employed in the ACR Mammography Accreditation Program have been adopted as standards for the performance of screening mammography by the ACR and have served as a basis for quality assurance standards in state and federal legislation on mammography.

The Radiation Therapy Oncology Group (RTOG) investigated the use of misonidazole as an hypoxic cell sensitizer in a Phase III prospective randomized trial employing radiotherapy, 600 cGy twice weekly to a total of 3600 cGy with and without misonidazole in the treatment of locally advanced non-metastatic squamous cell, adeno, or large cell carcinoma of the lung. Between January 1980 and July 1983, 117 patients from 21 institutions were enrolled. One-hundred eight patients were evaluable; 53 in the combined treatment arm and 55 in the radiation alone arm. Grade 3 or worse complications associated with radiation occurred in 17% of patients. Esophageal toxicity accounted for the majority of complications. Two (4%) patients in the radiotherapy plus misonidazole group experienced grade 3 peripheral neurotoxicity. Complete or partial responses were produced in 58% of the patients with radiotherapy alone and 36% of those treated with radiotherapy plus misonidazole (p = 0.08). At the time of first progression, over 50% of the patients had persistent local disease. Median survival was 7 months regardless of treatment. Misonidazole in the dose and schedule employed did not enhance the effect of radiotherapy on either local tumor control or overall survival in patients with advanced lung cancer.

The radiation therapy oncology group (RTOG) has conducted two studies testing the value of extended-versus limited-fields in carcinoma of the prostate. RTOG protocol 75-06 tests the value of paraaortic irradiation in patients with locally advanced tumors limited to the pelvis. RTOG protocol 77-06 tests the value of pelvic irradiation in patients with tumors limited to the prostate. Two hundred sixty-eight evaluable patients have been entered on RTOG 75-06, and 219 on RTOG 77-06 prior to 1981. This is a preliminary report on treatment-related morbidity in patients followed for a minimum of 1 year. Treatment-related morbidity has been classified according to a five-grade severity classification schema and correlated with the protocol option assignment in order to determine whether the use of extended fields had an effect on the incidence of side effects. Thirty-one percent of 268 patients on RTOG 75-06 and 34% of 219 patients on RTOG 77-06 had some form of treatment side effects. The majority (over 80%) of these were mild (grade 1 and 2) and by definition did not interfere with the patients' performance (life style). Only three patients on RTOG 75-06 and one on RTOG 77-06 had grade 4 complications (by definition requiring a surgical intervention). No fatal (grade 5) complications have been recorded so far. The use of paraaortic fields in RTOG 75-06 and pelvic fields in RTOG 77-06 have not resulted in a significant increase of GI or GU morbidity at this time. The only statistically significant trend was the incidence of postirradiation genital and lower extremity edema which strongly correlated with the extent of staging lymphadenectomy.

Treatment related morbidity, recorded in patients entered onto a RTOG phase III study (testing the value of periaortic irradiation in locally advanced carcinoma of the prostate), has been correlated with radiotherapeutic parameters to identify and quantify the relationship with treatment volumes, doses, and techniques. Between 1976 and 1983 a total of 526 analyzable cases were entered onto the study. The study design entailed randomization to either pelvic irradiation followed by a prostate boost or pelvic and periaortic irradiation followed by a prostate boost. Periaortic irradiation was not associated with a significantly increased incidence of bowel injuries manifested by diarrhea. No correlation between the total dose to the regional lymphatics (ranging from 4400 to 5100 cGy) and the incidence of bowel and bladder injuries could be established. Doses to the prostate in excess of 7000 cGy have not resulted in a significantly increased incidence of bladder injuries, but have been associated with a significant increase in the incidence of bowel injuries manifested by diarrhea. The techniques of pelvic irradiation did not seem to significantly influence the incidence of bowel or bladder complications. The technique of delivery of the prostatic boost did seem to influence the incidence of bowel injuries. This refers to the lateral boost technique and the perineal boost technique which have been associated with a higher incidence of diarrhea. All of the conclusions based on this analysis are applicable only to treatment volumes and dose ranges used in this study and to conventional fractionation of 180 to 200 cGy per day.

Four hundred and ninety-four patients with clinical Stage C carcinoma of the prostate, who were entered onto a phase III RTOG study, have been analyzed as to the potential effect of the pre-treatment transurethral resection (TUR) of the tumor. Treatment consisted of definitive irradiation to the prostate (6500–7000 cGy) and regional lymphatics (4500–5000 cGy). A total of 202 patients underwent pre-treatment TUR. This population was compared with the remaining 292 patients as to the rate of locoregional failure, incidence of distant metastases, disease-free survival, and survival. The TUR population fared significantly worse for all four end-points. To account for uneven distribution of recognized prognostic factors the results were then adjusted using stratified Mantel-Haenszel tests. The stratification process resulted in a reduced level of significance in the differences between the two populations. however, a trend toward a higher incidence of distant metastases could be observed within most strata. The trend was most pronounced in subpopulations characterized by Gleason score 6–7 and normal serum acid phosphatase (SAP). For the population characterized by Gleason score 6–10 and normal SAP, the differences in the incidence of distant metastases retained statistical significance. Whether these findings are secondary to tumor dissemination during TUR or are due to incompletely identified selection biases remains to be demonstrated in future (prospective) studies.

The incidence, severity, time of onset, and clinical course of complications of treatment have been reviewed in the RTOG studies of extended field irradiation in carcinoma of the prostate. A total of 526 patients, entered between 1976 and 1980 and followed for a minimum of 18 months, comprised the study population. In most instances of treatment-related morbidity, the symptoms were recorded during the first several months to 1 year following completion of treatment. Late occurrences, however, were not uncommon in certain types of radiation-produced injuries, such as proctitis, hematuria, and urethral strictures. Resolution of symptoms has been observed in a large proportion of patients including those with late occurrences of treatment-related morbidity, although the probability and the pattern of resolution differed considerably from one type of morbidity to another. Symptoms of cystitis are more likely to abate than those of proctitis. In patients who develop symptoms of proctitis the probability of persistence of symptoms beyond the second year following occurrence has been estimated at 20%–30%. Hematuria and symptoms secondary to urethral strictures seem to he even more likely to recur or persist, while genital and leg edema remain chronic in the majority of patients.

A total of 500 patients with extracapsular extension (clinical Stage C) carcinoma of the prostate received definitive radiotherapy directed to the prostate and the regional lymphatics. Pretreatment evaluation of the regional lymphatics was optional and was done in 245 patients who underwent either staging laparotomy or lymphangiography. The remaining 255 patients had no nodal evaluation. In 72 of the node-evaluated patients there was evidence of spread to the pelvic lymphatics and in 173 patients lymph nodes were negative. The three populations (lymph nodes-not evaluated, lymph nodes-involved, and lymph nodes-not involved) were analyzed as to the distribution of the recognized prognostic variables and compared as to the study end points (locoregional failure, incidence of distant metastases, disease free survival, and survival).

A total of 566 evaluable patients were accessioned to a phase III RTOG study of extended field irradiation in carcinoma of the prostate from 1976 to 1983. Eligible patients were those with locally advanced disease, either clinical Stage C or clinical Stage A 2 or B with pelvic lymph node involvement. The treatment consisted of irradiation of the regional lymphatics followed by a boost to the prostate. The data have been analyzed extensively to identify variables of potential prognostic significance. The assessed factors include tumor size, clinical stage, the degree of histological differentiation, nodal status, serum acid phosphatase status, hormonal management status, age, and race. These factors have been assessed as to their interdependence and correlation with the clinical course (study endpoints) using univariate analyses and Cox's Regression model. Significant interdependence of tumor size and Gleason score and tumor size and acid phosphatase was identified. The population receiving hormonal management either prior to or during radiotherapy had a significantly higher proportion of high grade tumors. Correlation of the assessed variables and the study endpoints (local control, incidence of distant metastases, NED survival, survival) singled out the degree of histological differentiation as the most powerful prognostic factor for all the endpoints. Age proved a useful predictor of local control (younger patients failed at a significantly higher rate), as did tumor size. Elevation of serum acid phosphatase correlated well with the incidence of metastatic disease but was not a useful predictor of survival. Tumor size and hormonal management status correlated well with the incidence of metastatic disease but only when analyzed separately from other factors. Their prognostic value was absent when Cox regression analysis was applied. Nodal status did not correlate well with any of the study endpoints, indicating then that in patients with clinical Stage C disease, treated with definitive radiotherapy to the prostate and regional lymphatics, this parameter may have limited prognostic usefulness. Although patients who received concomitant hormonal management had a significantly higher proportion of high grade lesions, their clinical course faired favorably in comparison with the population not receiving concomitant hormonal management. This may indicate a beneficial effect of adjuvant hormonal treatment which needs to be tested in a prospective study.

From 1976 to 1983 the Radiation Therapy Oncology Group conducted a study of extended field (periaortic) irradiation in carcinoma of the prostate. Eligible patients were those with clinical Stage C tumor with or without evidence of pelvic lymph node involvement and also those with Stage A-2 and B with evidence of pelvic lymph node involvement. The stratification criteria included histological grade, clinical stage, absence or presence of hormonal manipulation, and method of lymph node evaluation (lymphangiogram vs. laparotomy vs. no nodal evaluation). The patients were randomized to either receive pelvic irradiation followed by a boost to the prostate or pelvic and periaortic irradiation followed by a boost to the prostate. The prescribed daily dose was 180-200 rad to a total midplane dose to the regional lymphatics to 4000-4500 rad. The prostatic boost target volume was to receive additional 2000-2500 rad bringing the total dose to that area to a minimum of 6500 rad. A total of 523 analyzable patients have been accessioned to the protocol. Four hundred forty-eight of these are known to have received treatment per protocol. Median follow-up is 4 years and 3 months. The analyzable patients were evaluated for the incidence of distant metastases, NED survival and survival as a function of treatment arm. No statistically significant differences between the treatment arms could be documented. Similarly, no significant difference between treatment arms could be documented within a number of subpopulations such as those characterized by a particular grade, hormonal status, stage, age, acid phosphatase level, etc. The results of the study revealed no apparent benefit of elective periaortic irradiation in patients with detectable disease confined to the pelvis.

The Radiation Therapy Oncology Group (RTOG) investigated the use of misonidazole as an hypoxic cell sensitizer in a Phase III prospective randomized trial employing radiotherapy, 600 cGy twice weekly to a total of 3600 cGy with and without misonidazole in the treatment of locally advanced non-metastatic squamous cell, adeno, or large cell carcinoma of the lung. Between January 1980 and July 1983, 117 patients from 21 institutions were enrolled. One-hundred eight patients were evaluable; 53 in the combined treatment arm and 55 in the radiation alone arm. Grade 3 or worse complications associated with radiation occurred in 17% of patients. Esophageal toxicity accounted for the majority of complications. Two (4%) patients in the radiotherapy plus misonidazole group experienced grade 3 peripheral neurotoxicity. Complete or partial responses were produced in 58% of the patients with radiotherapy alone and 36% of those treated with radiotherapy plus misonidazole (p = 0.08). At the time of first progression, over 50% of the patients had persistent local disease. Median survival was 7 months regardless of treatment. Misonidazole in the dose and schedule employed did not enhance the effect of radiotherapy on either local tumor control or overall survival in patients with advanced lung cancer.

DURING the years 1935 to 1949 inclusive. 428 patients with acute perforated peptic ulcer were treated at the Cincinnati General Hospital. This report is concerned chiefly with the 128 patients who were seen during the past five years and who received penicillin as a part of their treatment. The other patients have been reported on previously and are used for comparison of the results of treatment.1The purpose of this analysis is, first, to determine whether immediate operative treatment of peptic ulcer, after the use of proper supportive measures, is justifiable in the face of the remarkable results which have been reported with the nonoperative method of treatment and, second, to consider briefly the question of immediate gastric resection in selected cases of perforated ulcer. The treatment of acute perforated ulcer at the Cincinnati General Hospital, as developed over the past fifteen to twenty years, has been operation, with

THE TECHNIC for partial duodenopancreatectomy described in 1935 by Whipple and his associates1has given impetus and encouragement for the radical treatment of tumors arising in a region previously considered inaccessible. Prior to this time, attempts had been made to resect ampullary tumors by a transduodenal approach; however, the results were by no means satisfactory, and the complications which arose in operating on jaundiced patients usually did not justify the procedures. It is hardly remarkable that before the advent of methods for controlling the tendency toward bleeding in the presence of jaundice palliative operations were usually performed. The use of vitamin K, a better understanding of the function of the liver and better preoperative preparation and postoperative management in conjunction with improved technical procedures have made possible wide excision of carcinoma of this region. During the past eleven years, some modifications of the original two stage operation as performed

Primary carcinoma of the bile ducts may be extrahepatic or intrahepatic in origin. The clinical and diagnostic features of the more prevalent extrahepatic forms are well known, but considerably less information is available for the intrahepatic variety. 1-5 Carcinomas arising from the mucosal cells of the finer radicles of the intrahepatic biliary tree are known as cholangiomas and are usually considered to be an uncommon form of primary neoplasm of the liver. 6 There is another unusual type of primary carcinoma of the intrahepatic ducts which is rarer and more difficult to recognize. This form arises from the major intrahepatic ducts near the hilus. Its insidious nature, the ease with which it mimics other biliary tract disorders, and its relative inaccessibility to surgical approach are factors which have made diagnosis very difficult, and frequently impossible until autopsy. 2-4 Since 1950, three patients with primary adenocarcinoma of the intrahepatic bile ducts have

IN TWO previous reports from this clinic, all cases of patients with appendicitis admitted to the Cincinnati General Hospital between 1915 and 1934 1 and 1934 and 1939 2 respectively were reviewed. The present study is a continuation of this series and will include all cases of patients with appendicitis treated between Jan. 1, 1939 and Jan. 1, 1944. In the preceding articles the general trend toward a reduced mortality rate from appendicitis as seen in this hospital was noted. This favorable trend was attributed to (1) the adoption of the McBurney incision in 1922 for appendectomy and (2) the intensive educational campaign concerning management of appendicitis directed toward physicians and the public. This campaign, fostered by the Public Health Federation and the Academy of Medicine of Cincinnati, is still in progress. The sustained and commendable improvement resulting from the campaign may be gaged by a comparison of certain phases

The operative treatment of penetrating wounds of the abdomen has changed but little in the past twenty years. Lower mortality has been attained chiefly by the introduction of improvements in anesthesia, by the more liberal use of blood and plasma transfusions, by the postoperative use of continuous gastric suction and by the use of the sulfonamide drugs. A patient presenting himself with a penetrating wound of the abdomen should be examined quickly but thoroughly to see, first, if he is in shock, second, the nature and extent of the external wound and evidence as to the direction of the stab or gunshot wound, and, third, for signs of peritoneal irritation. Local exploration of the wound, except under anesthesia, is usually not a wise policy, for it may spread infection to probe it and may lead to erroneous conclusions as to whether it penetrates the peritoneal cavity. In cases of doubt

Cystic enlargements of the common bile duct have been variously described as congenital, idiopathic and acquired. They have been called cysts, cystic dilatations and diverticulae of the duct. The etiology of the condition is obscure, and although many explanations have been offered, none of them seems to be completely satisfactory. Correct diagnosis before operation was apparently made only three times in the eighty-three cases recorded, and in many instances, the true condition was not recognized even at operation. Such errors will doubtless be repeated in the future, for few surgeons actually see a patient with this lesion. Therefore, unless the clinical picture is clear in the mind of the observer, it is unlikely that a correct preoperative diagnosis will be made. In contrast with this frequent failure in diagnosis, the methods of treatment have steadily improved, so that in the more recent cases, even when surgeons were not familiar with

IN MOST accounts of diverticula of the duodenum, it is argued that while diverticula are of relatively frequent occurrence, they seldom produce symptoms of any clinical significance and that most of them therefore may be disregarded so far as active surgical treatment is concerned. This conclusion is in accord with my own experience and belief, since I have had occasion to remove only three duodenal diverticula in a surgical experience of more than 25 years. On the other hand, it is incumbent to point out that at times diverticula in this position may account for persistent and distressing symptoms, and it is for this reason that the physician or surgeon should not disregard the fact that the presence of a diverticulum of the duodenum may be the sole cause of pain or vomiting. It is well established that the duodenum is one of the frequent sites for the occurrence of