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Evaluation of procedural skills in gastroenterologists
GASTROENTEROLOGY
1987;92:254-7
EDITORIALS
Evaluation of Procedural Skills in Gastroenterologists Training of high quality is fundamental to the certification process. In 1977 the American Board of Internal Medicine published guidelines for the training of gastroenterologists as a measure of its interest in quality control (1,2). These recommendations became the basis for the development by another authority of the process of accreditation of training programs (3). The American Board of Internal Medicine and its Subspecialty Board on Gastroenterology now wish to extend the evaluation of essential clinical skills in gastroenterologists beyond the medical knowledge and clinical judgment tested on written examinations. These clinical skills include refined historytaking and physical examination skills, humanistic qualities, the abilities of a consultant to communicate and educate, and procedural skills. Many have used the Board’s certificate to convey clinical privileges to perform the procedures of the subspecialty, even though evaluation, documentation, and substantiation of these skills have not been systematically carried out. It is obvious that procedural skills should be directly observed and carefully assessed, both for certification and to document the basis for recommendations on behalf of former trainees seeking hospital privileges. As part of the overall assessment of clinical competence and as a new requirement for certification, program directors in gastroenterology will now be asked to verify certain procedural skills of their fellows. The Board defines these essential skills as the learned manual skills necessary to perform diagnostic and therapeutic procedures within the domain of the gastroenterologist. At the completion of 2 years of training, all fellows who are candidates for certification must present satisfactory skills in the indications, contraindications, performance, and interpretation of 1. upper 2. 3. 4. 5.
gastrointestinal
endoscopy,
including
bi-
opsy colonoscopy, including biopsy and polypectomy dilatation procedures for esophageal disease peroral small intestinal biopsy percutaneous aspiration liver biopsy. Additional
procedural
skills required
of a gastro-
enterologist will be determined by type of practice, personal preference, availability of other skilled professionals, and local delineation of privileges. For these reasons, the Board recognizes that fellowship training may include experience with procedures such as removal of foreign bodies, percutaneous endoscopic gastrostomy, cholangiopancreatography, dilatation procedures in the stomach and colon, laparoscopy, manometric studies, and secretory studies. Familiarity with the indications, contraindications, and interpretation of the results of these additional procedures is essential for all who seek certification. The Board does not dictate the number of times a procedure must be done to assure competency. Trainees’ manual dexterity and confidence vary, and procedures should be applied for the patient’s benefit and not to fulfill some arbitrary quota. Each trainee must maintain a formal log, listing all procedures performed-including indications, basic findings, complications, and pathology reports. This log should be reviewed by the program director and be made a permanent part of the trainee’s record in order to document satisfactory training in and achievement of technical skills. Specific methods for supervised training, observation, evaluation, and documentation of procedural skills will be left to the discretion of program directors. The Board recognizes that some candidates may be unable to fulfill this requirement because of physical handicap. For such individuals, the procedural skills requirements indicated above may be modified or waived. The American Board of Internal Medicine Subspecialty Board on Gastroenterology has learned that evaluation and documentation of procedural skills are already in place in many training programs. It will soon provide guidelines to gastroenterology program directors to facilitate the evaluation of essential skills and the development of local clinical competence programs. JR., M.D. SIDNEY COHEN, M.D. American Board of Internal Medicine
JOHN A. BENSON,
EDITORIALS
January 1987
References Benson JA Jr, Tyor MP. Quality control in training gastroenterologists. Gastroenterology 1977;73:395. Benson JA Jr, Tyor MP. Guidelines for the training of gastroenterologists from the American Board of Internal Medicine. Gastroenterology 1977;73:382-5. Special requirements for graduate education in the subspecial-
255
ties of internal medicine. Accreditation Council for Graduate Medical Education. 198611987 Directory of Residency Training Programs. Pages 38-40. Address requests for reprints to: John A. Benson, Jr., M.D., American Board of Internal Medicine, 200 S.W. Market Street, Portland, Oregon 97201. 0 1987 by the American Gastroenterological Association
Another Treatment for Primary Biliary Cirrhosis This year has witnessed a bull market in the treatment of primary biliary cirrhosis (PBC). After many years of disappointment, first with corticosteroids, then with azathioprine (1,2), and finally with Dpenicillamine (3-6), three drugs now appear to offer promise in the treatment of PBC: the recently resurrected azathioprine (7), colchicine (8),and now chlorambucil (9). Christensen et al. (7) continued their study of azathioprine versus placebo in PBC and reported that azathioprine prolonged survival and retarded the rate of clinical deterioration. Although their survival curves suggested that azathioprine had no beneficial effect on outcome, sophisticated biostatistical analysis using multiple regression analysis and the Cox proportional hazards model revised the apparently negative results and indicated that azathioprine improved survival by 20 months in their average patient with PBC. The strengths and weaknesses of this study have already been reviewed in GASTROENTEROLOGY by Roll (10).One can identify an additional concern: the failure of the authors to include any data concerning either biochemical tests of liver function or histologic changes related to azathioprine. These omissions make it difficult to evaluate the study fully. At the November 1985 meeting of the American Association for the Study of Liver Diseases we reported that colchicine improved serum bilirubin, albumin, aminotransferases, alkaline phosphatase, and cholesterol compared with placebo in 60 patients with PBC, and improved their survival after 4 years (8). It did not improve liver histology. Colchitine had no side effects other than easily reversible diarrhea in 14% of patients. Preliminary results of two other studies comparing colchicine with placebo also show favorable effects on survival and laboratory tests although the results are not statistically significant (11 ,l2). The colchicine data have been submitted for publication, but as yet are only published in abstract form.
The report by Hoofnagle et al. (9), in this issue of GASTROENTEROLOGY, of a randomized trial of chlorambucil for PBC provides even stronger evidence that effective medical treatment for this enigmatic disease may not be too far off. Twenty-four of 36 patients who were referred to the National Institutes of Health with a diagnosis of PBC were studied prospectively. There were valid reasons for excluding 12 patients and the exclusions do not detract from the study. Eleven patients were untreated. Thirteen patients received chlorambucil, 10 mg/day for 10 days, followed by a dosage of 2 mg/day. The dosage was further adjusted to keep the lymphocyte count at -50% of pretreatment levels. Chlorambucil dosage was halved if the white blood count fell below 3000/mm3 or the platelet count below 100,000. The drug was stopped if leukopenia or thrombocytopenia persisted with dosages of only 0.5 mg/day. The results are impressive despite the fact that only 24 patients were studied and the randomization was not perfect because a higher percentage of patients with histologically advanced disease were assigned to the no-treatment group. The two biochemical tests that are of greatest prognostic value in PBC, the serum bilirubin and albumin (73, were both improved by chlorambucil after 2 years. There were also significant decreases in immunoglobulin M and immunoglobulin G, as well as the expected lowering of the peripheral white blood count. There was a proportionately greater decrease in lymphocytes than polymorphonuclear leukocytes. Equally important, chlorambucil decreased hepatic inflammation, although there was no improvement in fibrosis or overall staging at 2 years. That serum alkaline phosphatase and aminotransferases were not greatly improved is of less importance. Neither test is a predictor of outcome. The authors interpret the results with appropriate caution. They recommend that chlorambucil not be given to patients with PBC except as part of future
1987;92:254-7
EDITORIALS
Evaluation of Procedural Skills in Gastroenterologists Training of high quality is fundamental to the certification process. In 1977 the American Board of Internal Medicine published guidelines for the training of gastroenterologists as a measure of its interest in quality control (1,2). These recommendations became the basis for the development by another authority of the process of accreditation of training programs (3). The American Board of Internal Medicine and its Subspecialty Board on Gastroenterology now wish to extend the evaluation of essential clinical skills in gastroenterologists beyond the medical knowledge and clinical judgment tested on written examinations. These clinical skills include refined historytaking and physical examination skills, humanistic qualities, the abilities of a consultant to communicate and educate, and procedural skills. Many have used the Board’s certificate to convey clinical privileges to perform the procedures of the subspecialty, even though evaluation, documentation, and substantiation of these skills have not been systematically carried out. It is obvious that procedural skills should be directly observed and carefully assessed, both for certification and to document the basis for recommendations on behalf of former trainees seeking hospital privileges. As part of the overall assessment of clinical competence and as a new requirement for certification, program directors in gastroenterology will now be asked to verify certain procedural skills of their fellows. The Board defines these essential skills as the learned manual skills necessary to perform diagnostic and therapeutic procedures within the domain of the gastroenterologist. At the completion of 2 years of training, all fellows who are candidates for certification must present satisfactory skills in the indications, contraindications, performance, and interpretation of 1. upper 2. 3. 4. 5.
gastrointestinal
endoscopy,
including
bi-
opsy colonoscopy, including biopsy and polypectomy dilatation procedures for esophageal disease peroral small intestinal biopsy percutaneous aspiration liver biopsy. Additional
procedural
skills required
of a gastro-
enterologist will be determined by type of practice, personal preference, availability of other skilled professionals, and local delineation of privileges. For these reasons, the Board recognizes that fellowship training may include experience with procedures such as removal of foreign bodies, percutaneous endoscopic gastrostomy, cholangiopancreatography, dilatation procedures in the stomach and colon, laparoscopy, manometric studies, and secretory studies. Familiarity with the indications, contraindications, and interpretation of the results of these additional procedures is essential for all who seek certification. The Board does not dictate the number of times a procedure must be done to assure competency. Trainees’ manual dexterity and confidence vary, and procedures should be applied for the patient’s benefit and not to fulfill some arbitrary quota. Each trainee must maintain a formal log, listing all procedures performed-including indications, basic findings, complications, and pathology reports. This log should be reviewed by the program director and be made a permanent part of the trainee’s record in order to document satisfactory training in and achievement of technical skills. Specific methods for supervised training, observation, evaluation, and documentation of procedural skills will be left to the discretion of program directors. The Board recognizes that some candidates may be unable to fulfill this requirement because of physical handicap. For such individuals, the procedural skills requirements indicated above may be modified or waived. The American Board of Internal Medicine Subspecialty Board on Gastroenterology has learned that evaluation and documentation of procedural skills are already in place in many training programs. It will soon provide guidelines to gastroenterology program directors to facilitate the evaluation of essential skills and the development of local clinical competence programs. JR., M.D. SIDNEY COHEN, M.D. American Board of Internal Medicine
JOHN A. BENSON,
EDITORIALS
January 1987
References Benson JA Jr, Tyor MP. Quality control in training gastroenterologists. Gastroenterology 1977;73:395. Benson JA Jr, Tyor MP. Guidelines for the training of gastroenterologists from the American Board of Internal Medicine. Gastroenterology 1977;73:382-5. Special requirements for graduate education in the subspecial-
255
ties of internal medicine. Accreditation Council for Graduate Medical Education. 198611987 Directory of Residency Training Programs. Pages 38-40. Address requests for reprints to: John A. Benson, Jr., M.D., American Board of Internal Medicine, 200 S.W. Market Street, Portland, Oregon 97201. 0 1987 by the American Gastroenterological Association
Another Treatment for Primary Biliary Cirrhosis This year has witnessed a bull market in the treatment of primary biliary cirrhosis (PBC). After many years of disappointment, first with corticosteroids, then with azathioprine (1,2), and finally with Dpenicillamine (3-6), three drugs now appear to offer promise in the treatment of PBC: the recently resurrected azathioprine (7), colchicine (8),and now chlorambucil (9). Christensen et al. (7) continued their study of azathioprine versus placebo in PBC and reported that azathioprine prolonged survival and retarded the rate of clinical deterioration. Although their survival curves suggested that azathioprine had no beneficial effect on outcome, sophisticated biostatistical analysis using multiple regression analysis and the Cox proportional hazards model revised the apparently negative results and indicated that azathioprine improved survival by 20 months in their average patient with PBC. The strengths and weaknesses of this study have already been reviewed in GASTROENTEROLOGY by Roll (10).One can identify an additional concern: the failure of the authors to include any data concerning either biochemical tests of liver function or histologic changes related to azathioprine. These omissions make it difficult to evaluate the study fully. At the November 1985 meeting of the American Association for the Study of Liver Diseases we reported that colchicine improved serum bilirubin, albumin, aminotransferases, alkaline phosphatase, and cholesterol compared with placebo in 60 patients with PBC, and improved their survival after 4 years (8). It did not improve liver histology. Colchitine had no side effects other than easily reversible diarrhea in 14% of patients. Preliminary results of two other studies comparing colchicine with placebo also show favorable effects on survival and laboratory tests although the results are not statistically significant (11 ,l2). The colchicine data have been submitted for publication, but as yet are only published in abstract form.
The report by Hoofnagle et al. (9), in this issue of GASTROENTEROLOGY, of a randomized trial of chlorambucil for PBC provides even stronger evidence that effective medical treatment for this enigmatic disease may not be too far off. Twenty-four of 36 patients who were referred to the National Institutes of Health with a diagnosis of PBC were studied prospectively. There were valid reasons for excluding 12 patients and the exclusions do not detract from the study. Eleven patients were untreated. Thirteen patients received chlorambucil, 10 mg/day for 10 days, followed by a dosage of 2 mg/day. The dosage was further adjusted to keep the lymphocyte count at -50% of pretreatment levels. Chlorambucil dosage was halved if the white blood count fell below 3000/mm3 or the platelet count below 100,000. The drug was stopped if leukopenia or thrombocytopenia persisted with dosages of only 0.5 mg/day. The results are impressive despite the fact that only 24 patients were studied and the randomization was not perfect because a higher percentage of patients with histologically advanced disease were assigned to the no-treatment group. The two biochemical tests that are of greatest prognostic value in PBC, the serum bilirubin and albumin (73, were both improved by chlorambucil after 2 years. There were also significant decreases in immunoglobulin M and immunoglobulin G, as well as the expected lowering of the peripheral white blood count. There was a proportionately greater decrease in lymphocytes than polymorphonuclear leukocytes. Equally important, chlorambucil decreased hepatic inflammation, although there was no improvement in fibrosis or overall staging at 2 years. That serum alkaline phosphatase and aminotransferases were not greatly improved is of less importance. Neither test is a predictor of outcome. The authors interpret the results with appropriate caution. They recommend that chlorambucil not be given to patients with PBC except as part of future