Tobacco Documents Online

40 t PROPOSAL TO REVIEW CLINICAL, S URGICAL AND AUTOPSY DIAGNOSIS OF LUNG CANCER 11 Recent autopsy studies have revealed evidence of both over and under diagnosis of lung cancer. The size of the reported diagnostic error has been surprisingly large despite the improvement in diagnostic techniques. Certain factors or a combination of factors may be influencing the clinical diag- nosis and could account for the wide range of errors that have been reported. It is proposed that a retrospective review of autopsy, surgical pathology and clinical records covering a 25-year . , period from 1948 to 1973 be made. Basically this review would include the following: 1. All autopsy and surgical pathology cases will be reviewed and selected information from these records will be recorded and computerized. This information will include the cited cause of death, autopsy and surgical pathology findings, da-te, etc. 2. Clinical records for those autopsy and surgical patients meeting certain selected requirements will be reviewed. 0 W ~ ~ A

li Specified information from these records will be recorded and computerized. Such information will include: (a) Admitting diagnosis and date. (b) Sign-out diagnosis (death certificate) and date (c) . Demographic information - age, sex, race, etc. (d) Past medical history. (e) Personal habits including alcohol, coffee, tobacco, etc. 3. The accuracy of lung cancer diagnosis will be examined. Admitting diagnosis and death certificate diagnosis will be com- pared with surgical pathology and/or autopsy findings. 4. The size or magnitude of the errors that are found will be determined. 5. The type of errors that have been made will be determined. 6. Possible factors which may explain the errors in diag- nosis will be examined. For example, a smoking history reported in the patient's clinical records may h ave influenced or may have been influenced by the diagnosis. It is suggested that the proposed study take place at the Lakeside Hospital (Western Reserve Medical School) in Cleveland,w . . ~. ~ OD -2-

` Ohio, a university center with a reputation for excellent medical practice. The hospital is located in a large metropolitan area that is subjected to industrial pollution. The population served is of broad ethnic background. Since the Lakeside Hospital is a teaching institution, approximately 70 percent of all deaths occurring in the institution are autopsied. During recent years between 80 and 90 percent of the death discharges of the thoracic surgery service have been autopsied. These high autopsy rate percentages allow for complete and accurate study results. Further, the addition of data concern- ing the results of surgical pathology examinations give the pro- posed study a dimension that is unique and not previously reported in the :Literature. Dr. John R. Carter, an outstanding pathologist, is a Professor of Pathology and Director of the Department of Pathology (see Curriculum Vitae attached). He will supervise this study, as well as select and work closely with the principal investigator. Under the supervision of Dr. Carter, Lakeside Hospital is presently undertaking to set up a computer-assisted storage and retrieval of autopsy and surgical pathology diagnoses. This -3-

c separately-funded program has begun to computerize current autopsy and surgical pathology diagnosis information starting with records dated January 1, 1973. Computer programs and record examination protocols have been or are presently being developed. The suggested retrospective study would benefit from the planning work for the prospective study and informa- tion gained from the prospective study would be available to Dr. Carter and the retrospective study's principal investigator. Dr. Carter has estimated that the retrospective study from 1948 to 1973 would require approximately two years. The ------~..~. ..~........._ .. _.-~._,. tentative budget estimate for professional and non-professional services to complete this study together with necessary computer time (including concluding analysis) is $100,000.00 to $110,000.00. ,~ . _. .~...............-_.. If the industry evidences interest in funding this research project„ Dr. Carter would then: 1. Interview and select a principal investigator. 2. After consultation with the principal investigator and other researchers, prepare a detailed study protocol for approval. 3. Determine specific cost figures.

Periodic reports will be given during the term of the study. Manuscripts for scientific publication will be prepared at the conclusion.of the proposed retrospective review.