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BACK TO MAIN June 25,2001 Overview of the 3M Company Study "An Epidemiologic Analysis of Episodes of Care of 3M Decatur Chemical and Film Plant Employees, 1993-1998" The analysis of administrative databases, including health insurance claims data, have been infrequently reported in occupational epidemiologic research studies. Often reported are the results from traditional occupational retrospective cohort mortality studies. However if the outcomes in question do not lead to mortality, then such research has limited value. Morbidity studies circumvent the mortality issue. Frequently involving self-reported questionnaires, these morbidity studies, too, have limited value unless they involve the time-intensive review and validation of the reported health outcomes through medical record review. Recently, the advent of high-speed computers and aggregation of large databases have provided increasing opportunities for another avenue of morbidity research, that of analysis of administrative databases, including health insurance claims data. As Wong stated in his recent commentary in the Annals of Epidemiology (see July 2001, volume 11, pages 281-284), "the increasing use of personal identifiers to record everyday transactions and health-related events and the computerization and archive of these transactions and events, the possibility of record linkage in epidemiologic research is endless. In theory at least, linking existing administrative data to health records represents a fast and inexpensive approach to data Page 1 of 5 collection. In particular, routine analyses of such data will serve as an effective tool for surveillance or hypothesis generation. However, because these databases are set up and maintained for administrative and not scientific purposes, caution must be exercised in their use and their limitation must be recognized." The attached study entitled, "An Epidemiologic Analysis of Episodes of Care of 3M Decatur Chemical and Film Plant Employees, 1993-1998" utilizes a concept defined several decades ago, the 'episode of care' to examine an administrative health insurance claims database of 3M Decatur chemical and film plant employee and retiree records from January 1, 1993 through December 31, 1998. An episode of care is defined as a series of related health events with a beginning, an end and a course, all related to a particular health problem that exists continuously for a delineated period of time. Current commercialized computer software allows the stream of health claims data (e.g., inpatient, outpatient, pharmacy) to be examined in aggregate and categorized into episodes of care. The software code constructs an episode of a care around the indexeligible record by searching backward and forward in time for the health claims records that are related to the disease or condition on the index record. The index record consists of either procedure codes indicative of a face-to-face encounter or a pharmacy record for a delineating drug. More than 400 diseases and conditions were analyzed by the software (Clinical Care GroupsTMdeveloped by Ingenix Employer Group) used in this research study. An important limitation of an episode of care study is the fact that the concept does not translate: into well-defined epidemiologic endpoints as it may include incident cases, prevalent cases, tentatively diagnosed cases and misclassified cases that are the Page 2 of 5 routine consequence of the differential diagnoses that individuals may undergo in the course of disease diagnosis, treatment and management. Nevertheless, the episode of care concept may be a useful screening (i.e., surveillance) method for the potential risk of diseases and/or conditions that do not lead to traditional occupational epidemiologic study endpoints as stated previously. The purpose of this episode of care study was to compare the observed to expected episodes of care experience of 652 chemical employees to the observed to expected episode of care experience of 659 film plant employees at the 3M Decatur manufacturing site. Health claims data were not available prior to 1993. Because the local medical care delivery system has a large influence on diagnoses rendered and hospitalizations incurred, this study design was able to adjust for this issue by directly comparing the Decatur chemical plant population episode of care experience to the Decatur film plant population episode of care experience. For each plant population, an expected number was calculated based on the 3M Company's U.S. employee population experience using indirect standardization techniques talung into account age, gender and calendar time period. The ratio of these two ratios (chemical plant's observed to expected experience divided by the film plant's observed to expected experience) may then be considered a relative risk ratio under certain assumptions. Employee comparison groups within the chemical plant population were defined according to their potential workplace exposure to perfluooroctane sulfonyl fluoride (POSF) fluorochemical production. As Wong stated in his commentary (above), research studies such as this should be viewed as surveillance or hypothesis generating research endeavors. Based on a substantial body of literature including perfluorooctanesulfonate (PFOS) and Page 3 of 5 perfluorooctanoate (PFOA) toxicology and epidemiology research conducted, to date, the episodes of care that were considered a priori (i.e., surveillance) interests in this study were broadly defined to include liver and bladder cancer, endocrine disorders involving the thyroid gland and lipid metabolism, gastrointestinal disorders of the liver and biliary tract, and reproductive, pregnancy, congenital and perinatal disorders. In this regard, the episodes of care experience involving these outcomes was comparable between chemical and film plant employees. We did observe an association with cholelithiasis with acute cholecystitis but this was likely due to fewer expected number of episodes of care among the film plant employees rather than an excess of observed number of episodes of care among the chemical plant employees. It should be noted that other occupational epidemiologic research of medical surveillance data of the Decatur chemical plant employee population has not associated adverse clinical chemistry results with workplace exposure to POSF-based products. As can be expected when there are more than 400 diseases and conditions analyzed in an epidemiologic study, non a priori associations were also observed which included colorectal cancer, benign colonic polyps and benign neoplasms of the skin. We urge Considerable caution in the interpretation of these non a priori data as these associations were often the consequence of a few observed episodes of care reported among chemical plant employees and a fewer number of observed than expected episodes of care reported for film plant employees. Whether these non a priori findings have a biological rationale related to POSF-based exposure is doubtful as considerable toxicologic and epidemiologic research conducted, to date, does not provide support for these episode of care associations. Page 4 of 5 BACK TO MAIN 3M Company EPI-ooo4 Page 1 of 114 FINAL REPORT Epidemiology, 220-3W-05 Medical Department 3M Company St. Paul, MN 55144 Date:May 18,2001 Title: An Epidemiologic Analysis of Episodes of Care of 3M Decatur Chemical and Film Plant Employees, 1993-1998 Study Start Date: April 22, 1998 IRB Approval Date: April 22,1998 Protocol Number EPI-0004 IRB Approval Exempt Expedited X Principal Investigator: Co-investigators: Study Director: Geary W. Olsen, D.V.M., Ph.D.' Michele M. Burlew, M.S.' Brooks B. Hocking, B.A..* Julia C. Skratt, B.A.2 Jean M. Burris, R.N., M.P.H.' Jeffrey H. Mandel, M.D., M.P.H.' Jeffrey H. Mandel, M.D., M.P.H.' 1. 3M Company, Medical Department, Mail Stop 220-3W-05, St. Paul, MN 55144 2. Ingenix Employer Group, 157 Church Street, 25'h moor, New Haven, CT 065 10 i BACK TO MAIN ABSTRACT 3M Company EPI-OOO4 Page 2 of 114 A health care episode is defined as a series of related events with a beginning, an end, and a course, all related to a particular health problem that exists continuously for a delineated period of time. The episode of care concept does not translate into a well- defined epidemiologic endpoint as it may include incident cases, prevalent cases, tentatively diagnosed cases and misclassified cases that are the routine consequence of the differential diagnoses that individuals may undergo in the course of disease diagnosis, treatment and management. Nevertheless, the episode of care concept may be a useful screening method for the potential risk of diseases and/or conditions that do not lead to traditional occupational epidemiologic study endpoints such as mortality, or morbidity outcomes that would be difficult to assess without formal investigationsinvolving comprehensive medical record reviews to validate the diagnoses. The purpose of this study was to compare the observed to expected episodes of care experience of 652 chemical employees to the observed to expected episode of care experience of 659 film plant employees at the 3M Decatur manufacturing site. These employees worked between January 1,1993 and December 31,1998. We utilized the Clinical Care Groupsm (CCG) episode of care software developed by Ingenix Inc. to provide a comprehensive grouping of all visits (inpatient, outpatient), procedures, ancillary services and prescription drugs used in the diagnosis, treatment and management of more than 400 diseases or conditions. The software code constructs an episode of care around the index-eligible record by searching backward and forward in time for the health claims records that are related to the disease or condition on the index BACK TO MAIN 3M Company EPI-0004 Page 3 of 114 record. The index record consists of either procedure codes indicative of a face-to-face encounter or a pharmacy record for a delineating drug. Employee comparison groups were defined according to their potential workplace exposure to perfluorooctanesulfonyl fluoride (POSF) fluorochemical production. These comparison groups included those employees who only worked at the chemical or film plant, those employees who were consideredto have had a high exposurejob to POSFbased fluorochemicalsand those employeeswho had worked the 10 years prior to study onset in jobs with high potential for exposure to POSF-based fluorochemicals. These POSF-based fluorochemicalsmay transform metabolically, to an undetermined degree, to peffluorooctanesulfonate (PFOS). Industrial hygiene and biological monitoring at the Decatur plant had shown a strong correlation between employee serum levels with PFOS and peffluorooctanoate (PFOA). At Decatur, PFOA exposures may be the result of a byproduct of the electrolytic cell production, actual production of PFOA (began in 1998) or in its use as an elastomer in fluoropolymerproduction. The risk ratio episode of care ( R q C )provided the estimate of risk between the observed to expected episodes of care experienced among chemical plant employees compared to the observed to expected episodes of care experiencedamong film plant employees (nonexposed). In essence, R W C is a ratio of two indirect standardized ratios and is an unbiased estimator of the risk ratio if there are similar age- and genderspecific structuresbetween the two comparison populations. The expected number of episodes of care for the chemical and film plant populations was calculated from the health c1ain;S experience of the 3M U.S. manufacturing population. BACK TO MAIN 3M Company EPI-0004 Page 4 of 114 Based on a substantial body of literature including PFOS and PFOA toxicology and epidemiology research conducted, to date, the episodes of care that were considered a priori interests in this study included liver and bladder cancer, endocrine disorders involving the thyroid gland and lipid metabolism, gastrointestinal disorders of the liver and biliary tract, and reproductive, pregnancy, congenital and perinatal disorders. In our study, the overall episodes of care experiencewas comparablebetween chemical and film plant employeesfor most diseases and conditions.Of our a priori concerns, we observed only one liver cancer episode of care, which was from a film plant employee. Among all employees we did not observe W C s that excluded the null hypothesis ( R W C = 1.O)for a variety of liver disorders, thyroid and lipid metabolism disorders and reproductive, pregnancy, congenital and perinatal disorders. We did observe an associationwith cholelithiasis with acute cholecystitis( R W C = 8.6, 95% confidenceinterval 1.1-381); this may have been due, in part, to fewer expected number of episodes of care in the film plant. The RR$,C for other biliary tract disorders did not exclude the null hypothesisin the confidenceinterval. Because of a previously reported increased mortality risk for bladder cancer among the chemical plant employees, we focused particular attention on episodes of care which involved the urogenital tract. We found only one episode of care for bladder cancer reported for a film plant employee who had never worked in the chemical plant. We did observe a greater increased risk in episodes of care among chemical plant employeesfor lower urinary tract infections (R-C = 1.3,95%confidenceinterval 1.O- 1.6).Thisdncreasedrisk of episodesof care was greater among the long-term high exposurechemical plant workers ( R W C = 2.2,95%CI 1.4-3.3). There was also a BACK TO MAIN 3M Company EPI-OOO4 Page 5 of 114 greater percentage of these long-term high exposure chemical plant workers who had recurring lower urinary tract infections (59%)than film plant workers (3 1%). It is not known whether this reoccurrence is a result of occupational exposure(s)or nonoccupational-related factors. We do note that the prevalence of episodes of care for lower and unspecified urinary tract infections (number of unique individualsdivided by population at risk) was comparablebetween the chemical (9.5%)and film (9.9%)plant employees. Other associations observed, that were not a priori concerns, among all study subjects included increased R W C s for cancers and benign growths ( W C = 1.3,95% CI 1.1-1.6) that was contributed to by increased RRE&s (which did not exclude the null hypothesis) for benign colonic polyps ( R q C = 1.4,95%CI 0.9-2.1), malignant neoplasms of the colorectal tract ( R W C = 5.4,95%CI 0.5-265), malignant neoplasms of the rectum ( W C = 1.8,95%CI 0.3-12), malignantneoplasmsof the prostate ( W C = 7.7,95%CI 0.9-364) and benign neoplasms of the skin (=C = 1.3,95%CI 0.9- 1.7). We urge caution in the interpretation of our study data as these RRE@ represent the risk ratio orepisodes of care, not for disease incidence.Those R q C s with values greater than 2.0 were often the consequence of a few observed episodes of care reported among chemical plant employees and a greater number of expected than observed episodes of care reported for film plant employees. This led to wide confidence intervals as reported above for malignant neoplasms of the colorectal tract and prostate. Our analysis w i s limited by the study time period of six years. Health claims data were not availableprior to 1993. Whether our non a priori findings have a biological rationale BACK TO MAIN 3M Company EPI-ooo4 Page 6 of 1 14 related to POSF-based or PFOA exposure is doubtful as considerable toxicologic and epidemiologic research conducted, to date, does not provide support for these episode of care associations. INTRODUCTION 3M Perfluorooctanyl Chemistry. Toxicology and Epidemiology BACK TO MAIN 3M Company EPI-0004 Page 7 of I 14 Fluorinated organic compounds have been used for decades in a wide variety of industrial and commercial applications. The 3M company has produced fluorochemicals by an electrochemical process at its Decatur (Alabama) manufacturing facility that exchanges all of the hydrogen atoms of an organic feedstock with fluorine atoms from hydrogen fluoride [3M Company, 20001. The highest volume perfluorochemical produced in this way is perfluorooctane sulfonyl fluoride (POSF). Using POSF as a basic building block, unique chemistries can be created by further reaction with functionalized hydrocarbon molecules. These perfluorinated compounds are used in applications such as specialty lubricants, semiconductor manufacturing, protective barriers or coatings, surfactants, fire retardants and non-conductive coolants. Exposure to POSF-based fluorochemicals may transform metabolically, to an undetermined degree, to perfluorooctanesulfonate(PFOS; C8F17S0Y)as an end-stage metabolite. Information related to human and environmental exposures to PFOS have been developed providing evidence of widespread distribution in humans and the environment. A detailed description of industrial hygiene and biological monitoring of several fluorochemicals, including PFOS and perfluorooctanoate (PFOA, C,F&OO-), at the Decatur plant, has been reported [Logan et al, 2001; Olsen et al, 20011. At the Decatur site, PFOA exposures may be the result of it being produced as a by-product of the f- electrochemical cell production, of actual production of PFOA (which began in 1998)or of its use as an elastomer in fluoropolymer production. Employees may be exposed by BACK TO MAIN 3M Company EPI-0004 Page 8 of 114 one or all routes (i.e., inhalation, skin contact/absorption, and ingestion) to PFOS and PFOA. The primary route of exposure may be different for each employee and depends on several different factors such as: process conditions,job tasks, work location, personal hygiene, personal habits and general work practices [Logan et al, 20011 Inhalation was considered the primary route of exposure from POSF-based production processes and fugitive sources [Logan et al, 20011. Serum levels of PFOS from cell chemical operators engaged in POSF-based fluorochemicalproduction have averaged between 1 and 2 ppm with the highest values reported at 10 ppm. Employees engaged in indirect production activity, such as engineers and laboratory workers, had serum fluorochemical levels that averaged less than 0.5 ppm. At the Decatur site's film plant where nonfluorochemicalproduction occurs, located approximately300 yards from the chemical plant, employees' serum PFOS levels averaged 0.1 ppm. Although observed at slightly lower levels, the Decatur employees' serum PFOA levels correlated with their serum PFOS levels [Olsen et al, 20011. Unlike serum PFOS, serum PFOA levels did not exceed 5 ppm. Total serum organic fluorine was correlated with the organic fluorine calculated in employees' serum PFOS and PFOA levels. There is substantial toxicologic and epidemiologic literature regarding PFOA. Briefly, PFOA is a moderate inducer of peroxisome proliferation related to an increased incidenceof hepatic, pancreas, and Leydig cell adenomas in lifetime feeding bioassays of rats [Sibinski, 1987; Cook et al, 1994; Biegel et al, 1995, Obourn et al, 19971. Repeated daily expssure of cynomolgus primates to ammonium peffluorooctanoate for 26 weeks by gastric intubation resulted in severe toxicity among animals in the highest dose group BACK TO MAIN 3M Company EPI-OOO4 Page 9 of 114 (30 mg/kg/daysubsequentlyreduced to 20 mg/kg/day) during the course of the study [Butenhoff et al, 20011. Dose-related increased liver weights without macroscopicor microscopic changes occurred at the lowest dosage (3 mg/kg/day), which was associated with serum PFOA levels of approximately 50 ppm. Epidemiologic studies have not associatedclinical chemistries,hormones or mortality outcomes of workers with occupationalexposuresto PFOA [Gilliland and Mandel, 1993; 1996;Olsen et al, 1998; 2000; Alexander, 2001al. Several production employees at the 3M Cottage Grove plant, which manufactures ammonium perfluorooctanoate, have exceeded 30,ppm(range0.0 - 114 ppm) [Olsen et al, 19981. Regardingthe toxicology of PFOS, severalrepeat dose studies have consistently demonstratedthat the liver is the primary target organ [3M Company, 20001. Liver tissue response to high doses of PFOS included the enlargement of the liver and apparent alterations in metabolic processes with the reduction in serum cholesterol levels observed as the earliest clinical response to PFOS [Seacat et al, 2001al. These effects occurredin cynomolgusprimates at serum PFOS levels at 100ppm. Also at high doses, PFOS adversely affected survival of rat pups in the neonatal period of life as a result of maternal exposure during fetal development [3M Company, 20001. Reduced weight gain, absorptions and resorptions were observed at the higher dose groups tested (1.6 mg/kg/day and 3.2 mg/kg/day). There were no effects on post-natal neurological development or on fertility and estrous cycling in offspring in multi-generation studies. Multiple genotoxicityassays suggested PFOS does not present a hazard from interaction with genetfc material. Results from a two-year rat bioassay cancer study will be reported in 2001. a BACK TO MAIN 3M Company EPI-0004 Page 10 of 114 Serum PFOS levels in 3M's fluorochemical production workers have not been associated with abnormalities in clinical testing that included lipids, hematologic parameters and 1 1 different hormone values [Olsen et al, 19991.An update of a retrospective cohort mortality study of 2,083 Decatur chemical and film plant employees with at least one cumulative year of work experience was recently completed [Alexander, 2001bl. Standardizedmortality ratios (SMRs)were reported for three exposure subgroups: high exposure to POSF-based chemicals (e.g., cell and chemical operators), low exposureto POSF-based chemicals (engineers,laboratory workers in chemicalplant) and minimalhonexposure (film plant employees). The SMRs for total causes of death, all malignant neoplasms and all heart disease for each exposure sub-cohorts were lower than expected based on Alabama mortality rates. Two deaths from liver cancer were observed in the workers with at least one year of the combined employment in low and high exposure subcohorts ( S M R = 3.1,95% CI 0.4-11.1). Three bladder cancer deaths were reported among workers with at least one year of employmentin the high exposure subcohort ( S M R 16.1,95%CI 3.2-47.I). Two of these three employees had worked for extensiveperiods of time in both the chemical and film plants. It was not clear whether these employee bladder cancer deaths could be attributed to fluorochemical exposures, another bladder carcinogen(s) encountered during their Decatur or non-Decatur work history careers or other nonoccupational factors, including the unknown possibility of an increased risk for mortality but perhaps not incidence of bladder cancer in this worker population. A rhajor strength of a retrospective cohort mortality study is the fact that, if the complete study population is identified, a comprehensiveanalysis of the occupational BACK TO MAIN 3M Company EPI-OOO4 Page 1I of 114 cohort's death experience can be ascertained. However, if the occupational exposure is likely to lead to a non-mortality outcome, then the findings of the mortality study may be limited. Because the Decatur employees' PFOS serum levels were, on average, 2 orders of magnitude below the known earliest clinical effect (lowered serum cholesterol levels) in subchronic primate toxicity studies, it was not anticipated that disease outcomes would be associated with POSF-based fluorochemical exposures. Another reason for this epidemiologic investigation was to provide an additional perspective, that being morbidity of the Decatur chemical and film plant employees. Morbidity studies (whether prospective or retrospective,longitudinal or crosssectional) have their own important limitations. In particular,self-reportsof diseases or conditions without medical record confirmation may provide biased findings. Several important tasks must occur for medical record review to happen. First, patiendphysician confidentiality issues must be addressed in order to gain access to the records. Second, the medical records must then be found. Patients often visit multiple care givers and hospitalsklinics. Records may be lost or destroyed over time. Third, the medical records must be abstracted, coded and computerized for data analyses with subsequent quality assuranceprocesses in place. All of these are resource-intensive, time consuming tasks. Fourth, there may be potentially numerous a priori hypotheses to examine. Non a priori hypotheses simply may not be examined due to time and cost constraints. In order to minimize some of these limitations, we decided to examine what is refeired to as an "episodes of care" experience of Decatur chemical and film plant employee& An analysis of episodes of care should be considered a screeningstudy for BACK TO MAIN 3M Company EPI-0004 Page 12 of 114 morbidity outcomes. As this episode of care concept is not generally well-known and rarely reported in occupational epidemiologic research, a detailed description follows. Concept of an Episode of Care The health care episode concept was conceived less than forty years ago [Solon et a1 19673. A health care episode is defined as a series of related events with a beginning, an end, and a course, all related to a particular health problem that exists continuously for a delineated period of time [Hornbrook et al., 19851. An episode, as a measure of output, covers every service, and only those services, required to diagnose and treat each welldefined health problem. Hornbrook et a1 [19851 differentiated four types of health care episodes: illness (patient perspective), disease (provider perspective), episode of care (payer perspective) and health maintenance. An episode of illness was defined as a single, unbroken interval of time during which the patient suffers from a continuous series of signs andor symptoms that are perceived as ill-heath. An episode of disease begins with clinical specification that a disease is present and ends with specification that it is resolved. Episodes of disease may exist independent of episodes of illness. For example, although the illness symptoms may remain continuous, a physician may interpret the clinical evidence to reveal that the patient's initial disease has been superceded by another disease. Hornbrook et a1 [19851 defined an episode of care as a series of temporally continuous health care services related to treatment of a given illness or provided in response td a specific request by the patient. An episode of care is characterized by an onset, interim and a solution of the health problem for acute diseases and a resolution for BACK TO MAIN 3M Company EPI-ooo4 Page 13 of 114 chronic diseases. One specific episode of care may involve more than one episode of illness andor disease. The final type of episode Hornbrook et a1 [19851described was a health maintenance episode which incorporates a comprehensive scheme for categorizing reasons for a person's contact with the health care system which can include both nondisease (e.g., immunizations, birth control, preplacement exams, health promotion activity) as well as disease-related conditions. In general, it is much easier to measure episodes of care than episodes of illness or disease because medical records and insurance claims provide profiles of types and times of services more often than actual clinical data [Greene and Gunselman, 19841. Episodes of care can commence upon an appointment scheduled, first patient-provider encounter, establishment of a diagnosis, or patient history of a chronic illness that was diagnosed previously. An episode of care terminates upon evidence that the particular disease, illness or care process was completed. For acute diseases, this is fairly straightforward. For chronic diseases, there may be no resolution of the disease, multiple beginnings and endings of the illness, and possibly only one or multiple episodes of care. This depends upon how the algorithm is constructed for the episode of care. Because the episode of care can be measured (i.e., defined with a beginning, course, and end), several proprietary software products have been created which allow for the grouping of episodes of care via variable patient classification algorithms. Rosen and Mayer-Oake [19991 reviewed four of the most prominent first generation proprietary episode software products. Characteristics of these proprietary software products were the definiaibn of an episode, number of grouped categories, case-mix adjustment, comprehensiveness of the claims included, clinical flexibility, onset and resolution BACK TO MAIN 3M Company EPI-OOW Page 14 of 114 determinationsand time between episodes. The lack of readily availabledata has hindered some of the complex methodologicalproblems encountered when attempting to construct episode of care measures [Wingert et al, 19951. A variety of methodological issues need to be considered when using an episode of care software product. Most importantly, among the various software programs there is no uniform approach to the software construction(i.e., grouping) of an episode of care. Thus, types and counts of episodes of care may differ by the software used. An episode of care may begin with a clear diagnosis by a provider; some providers, however, base an initial diagnosis on the patient's signs and symptomswhereas others assign a diagnosis only after a confirmed procedure. It is possible that two different diagnosesmay be assigned to the same episode. A diagnosis that is categorized as confirmed, may in fact be tentative, or even incorrect (i.e., only a rule-out diagnosis). Thus, from an epidemiologic perspective an episode of care could represent any and all of the incident cases (newly diagnosed), prevalent cases (existing cases) and/or misclassifiedcases (both directions,false positive and false negative). Therefore, it is important that the term episode of care not be confused with incidenceor prevalence as it can be a measure of both and also have an undetermined degree of misclassification. It is best to view episodes of care as its own unique metric. Second, there is variability in the comprehensivenessof the services that are included in the construction of the health care episode. Generally inpatient and outpatient services are considered but other services including prescriptions and laboratory work-up may, or may not, be included. Third, the endpoint of an episode can also vary among these software programs. An endpoint can be a predetermined time period for a defined condition or it may be determined through BACK TO MAIN 3M Company EPI-0004 Page 15 of 114 the use of "clean periods" or "clean windows" which are defined as gaps in time between health care services necessary to separate possible recumng episodes. Finally, the clinical flexibility of the algorithm may differ depending upon the software program used [Cave 1995; Dang et al, 1996a; 1996b; Rosen and Mayer-Oakes, 19991. Studv Purpose The purpose of this study was to utilize Clinical Care GroupsTM(CCG) software, developed by Ingenix Employer Group (Ingenix) to analyze the episode of care experience among Decatur chemical and film plant employees. CCG represents state-ofthe-art episode of care methodology [Valdivia and Van Vorst; 20001. The overall methodologic strategy was to calculate, for more than 400 CCG disease and condition descriptions (defined in the Methods section), the risk ratio of the observed to expected episodes of care experience of Decatur chemical plant employees who worked between January 1,1993 and December 31,1998 compared to the observed to expected episodes of care experience of film plant employees who worked during the same time period. Based on toxicology and epidemiology research conducted, to date, on the PFOA and POSF-based chemistry, episodes of care that were considered a priori interests in this study included liver and bladder cancer, endocrine disorders involving the thyroid gland and lipid metabolism, gastrointestinal disorders of the liver and biliary tract, and reproductive, pregnancy, congenital and perinatal disorders. BACK TO MAIN METHODS 3M Company EPI-OOOQ Page 16 of 114 Presented below are detailed methodologic descriptions of the CCG software used in this study; the eligible Decatur employee study population; the databases used and data extraction techniques employed by Ingenix; and the statistical analyses that were used to construct the risk ratio episode of care. Specificsof CCG Software The CCG software involves a comprehensive grouping of all visits (inpatient, outpatient),procedures, ancillary services and prescription drugs used in the diagnosis treatment and management of more than 400 diseases or conditions. Within CCG, an episode of care is constructed by four main sections: episode initiation;incorporation of pharmacy claims; backward and forward searching; and claim record labeling. Unlike other episodes of care software, CCG pre-processes drug claims in an attempt to assign one or more diagnosis codes to each record based on diagnosis codes found in the patient's medical claims stream. This is called the Drug-Disease Matcher (DDMm). The software code (called a grouper by CCG) constructs an episode around the index-eligiblerecordby searchingbackward and forward in time for records that are related to the disease in question. Acute conditions have anterior and posterior clear windows which determine the number of days that can be searched prior to (anterior window) and after (posterior window) the index event. This window is reset if related claims are found. Because of their nature, chronic conditions do not have clear windows. Rather a piedetermined 999 day interval is set that can be reset 999 days from events that would be associated with the index event. BACK TO MAIN 3M Company EP1-m Page 17 of 114 The CCG grouper labels the claim records to one of the five following record types: index, associated, precursor, sign/symptom, and V-code. An index record consisted of either procedure codes indicative of a face-to-face encounter or a pharmacy record for a delineating drug (drugs that treat a specific disease, e.g., insulin for diabetes). Although claim records often list multiple diagnosis codes for a single encounter, the CCG program contained logic that determined the diagnosis code most likely the reason for the encounter. This primary diagnosis code on the index record determined which Class description (defined below) the record was assigned, thereby opening either a new episode of care or adding to an already existing episode. The other four claim record labels that the CCG software uses were: 1) precursor (contains one or more diagnosis codes representing a clinical precursor to the more clinically significant disease that had been episoded); 2) sigdsymptom (contains nonspecific diagnosis code that can be considered to part of a more specific disease); 3) V-code (supplementary factors that influenced health status but were not classified into more specific disease categories (e.g., alcoholism could refer to several different disease conditions)); and 4) associated records (non-index eligible procedure codes that occurred outside of a patient-provider encounter). The CCG software assigns an episode of care to a CCG Class description of a disease or condition. A CCG Class has several important qualities. It is: 1) clinically homogenous; 2) exhaustive; 3) part of a disease hierarchy; and 4)classified as a chronic or acute condition. Several CCG Classes may define a CCG Category. Several CCG Categoridconstitute a CCG Specialty Category. Altogether, the CCG grouper software BACK TO MAIN 3M Company EPI-OOO4 Page 18 of 114 allows for 20 Specialty Categoriesthat are subdivided into 103CCG Categories.The CCG Categories are then further subdivided into 442 CCG Class descriptions. The CCG software analysis provided a summary output file with one record per episode of care. For example, a claims stream for one patient that resulted in the primary diagnosis of acute myocardial infarction could have resulted in one Specialty Category episode (Disease of the Circulatory System), several CCG Categoryepisodes (e.g., atheroscleroticcoronary vascular disease, hypertension, disorders of heart valve) and many more CCG Class episodes within each CCG Category (e.g., the CCG Category atheroscleroticcoronary vascular disease may have shock, ischemic heart disease and acute myocardial infarction included as its CCG Class episodes of care). Ingenix Inc. has evaluated its CCG software performance against a sample of 450,000 members obtained from twelve health plans [Valdivia and Van Vorst, 20001. Of 2.3 million medical and pharmacy claim records, 84% were grouped into clinical care groups. The proportion grouped represented 90% of the total costs paid by the health plans. A greater percentage of the medical claims were grouped (91%) compared to pharmacy claims (72%)which represented93% and 77%of total costs for medical and pharmacy claims, respectively Decatur Study Population Although chemical production at Decatur began in 1961, our initial study population consisted of all full-time and inactive employees at the Decatur site as identified% the 3M Epidemiology's work history database for Decatur as of January 1, 1993. There was a one-year eligibilityemployment criterion to be included in this BACK TO MAIN 3M Company EPI-ooo4 Page 19 of 114 database. All employees hired subsequentlywere included in the study as long as they met the criterion to be eligible for this database. In other words, employees who worked for less than one year during the study time period were not included in this analysis. Employeeshired, terminated (voluntaryor involuntary termination)or died while employed from the company during the study (1/1/93 through 12/31/98) had their Decatur episodes of care experience limited to their Decatur time of employment. Fulltime active employees who retired during the study period continued to have their episodes of care experience examined through the end of study; Medlcare, however, becomes the employee's primary provider upon the employee's 65* birthday and thus Ingenix did not have most of these Medicare claims. Similarly, claim records for employees who went on long term disability (LTD) were covered primarily by Medicare after 18 months of LTD status. There were some employees (n c 40) who chose HMO coverage between 1996 and 1998. HMO records were not incorporated in the Ingenix database coveragefor the Decatur site. Altogether, there were 1,311 Decatur employees (97%)eligible for the episode of care analysis during the 1993 - 1998 time period. Analysis of the episode of care experience was examined by whether the employee was considered a chemical plant or film plant employee. Each employee's work history record was examined by the investigators(JMB, GWO, MMB) to determinewhether the employee: 1) ever worked in the chemical plant, film plant or both; 2) worked in the chemical plant, film plant or both during the study time period of January 1, 1993 through December 31, 1998; and 3) worked continuouslyin the chemical plant or fihn plant for the entire 10 years prior to the onset of the study time period, January 1, 1993 ('long-term' workers). For those employees who had work experiencein BACK TO MAIN 3M Company EPI-0004 Page 20 of 114 both the chemical and film plants, records were reviewed to identify which plant each employeeprimarily worked at in his or her career at the 3M Decatur site. Both chemical and film plant employees were categorized in the analyses as to whether they have, or have not, worked in both plants. The majority of film plant employees with prior work experience in the chemical plant worked at the chemical plant for a brief period of time (1 to 3 months) and this usually occurred during the first year of their employment. These employees were categorized as film plant employees. Likewise, the majority of chemical plant employees with prior work experience in the film plant worked at the film plant for a brief period of time and this usually occurred during the first year of their employment. These employees were categorized as chemical plant employees. Employees who had site-wideresponsibilities(those who may work daily in both chemical and film plants, such as environmental, health and safety specialists)were assigned to the chemical plant because of their greater likelihood of exposure to POSF-based chemicals than those employees who only worked in the film plant. Each employee was assigned a job title that describedthe person's usual job activity while a Decatur employee. Thesejob titles were: boiler operator, environmental health and safety specialist, engineer, mill operator, maintenance, office worker, operator (e.g., cell, chemical), quality control worker, shipping clerk and supervisor. Based on the findings from the Decatur serum fluorochemical assessment study [Olsen et al., 19991, three subcohort groups were categorized as to their potential for high, low and minimudnonexposed POSF-based exposure.. These were the same categorizationsused in the DectRur retrospectivecohort mortality study [Alexander,2001bl. For example, cell operators,chemical operators and maintenanceworkers at the chemical plant were BACK TO MAIN 3M Company FPI-OOO4 Page21 of 114 categorized as high exposure. Engineers and laboratory workers at the chemical plant were categorized as low exposure. Film plant workers were categorized as minimalhonexposed. Four study employee comparison groups were identified for the episodes of care analyses. The rationale for these four categorieswas to increase the likelihood of the chemical plant cohort to have long-term high fluorochemical exposurejobs. These four comparisons were: Group A Comparison: all chemical plant employeeswith or without prior film plant experience (n = 652) compared to all film plant employees with or without a prior chemical plant experience (n = 659). Group B Comparison: all chemical plant employees who never worked in the film plant (n = 388) compared to all film plant employees who never worked in the chemical plant (n =424). Group B is a subset of Group A. Group C Comparison: all high (defined above) fluorochemicalexposure chemical plant employees (n = 498) compared to theirjob counterparts(consideredleast exposed) in the film plant, (n = 490). Group C is a subset of Group A. BACK TO MAIN 3M Company EPI-0004 Page 22 of I14 Group D Cornoarison: all long-term (defined above), high fluorochemicai exposure chemical plant workers (n = 211)compared to their job counterparts (considered least exposed) in the film plant (n = 345). Group D is a subset of Group C, which is a subset of Group A . Ingenix Databases and Data Extraction Aside from developing the CCG product, Ingenix also provides data warehouse, reporting, consulting and analysis to 3M. On a quarterly basis, Ingenix receives member eligibility information, as well as, medical and prescription claim detail from each one of 3M's benefit plan vendors. Ingenix then uses this data to create the following databases: The Medical Focused Database provides access to the highest level of detail for both inpatient and outpatient data. The database is comprised of individual service records, meaning that every line item on each claim is broken out into its own individual record. This would allow you to drill down, for example, to a specific service provided by a specific physician for a specific patient on a specific day. The Monthlv Cost and Utilization(MCU)Database contains summarized claim data. Claims are aggregated in a fashion that allows a customer to easily report by grouping meaningful to the customer, such as by location or aggregations of location, by paid and incurred month, and by service categories. ' d BACK TO MAIN 3M Company EPI-OOO4 Page 23 of 114 The Inpatient ConfinementDatabase is the result of Ingenix methodology which links all services related to a hospital confinement and groups them into one record. The record contains a host of information necessary for analysis of inpatient services, including, but not limited to, length of stay, MDC, DRG, major specific diagnosis, surgery performed, and physician and facility provider. Prescription Drug Database is designed to capture drug specific details available from prescription mail order and drug card plans. The drug database includes claimant and expense information,prescription number, physician DEA number, pharmacy number and type, an indicator to identify how and why the drug was dispensed, and the National Drug Code (NDC). Additionally,Ingenix adds information specificto the particulardrug that was dispensed that is not supplied by the vendor. This informationis taken from First Databank's National Data File (NDDF), which includes: Blue Book Average Wholesale Price ( A m ) Federal Maximum Allowable cost (MAC Price) Controlled Substance Indicator BrandGeneric Indicator The Elinibilitv Database is derived from 3 M s enrollmentdata. The Eligibilitydatabase provides a routine way to access population, either on a summarized level or by indi'vidualmember. Furthermore,enrollment data can be used in conjunction with other Ingenix ddabases to produce information such as admission rates, services per employee or covered life, and average benefits per employeeor member. BACK TO MAIN 3M Company EPIboo4 Page 24 of 114 Extracts from the above medical and prescription drug databases were created for the entire 3M population (employee data and claim experience only). These extracts were tested against the source databases to ensure that the population subset for the extraction was correct. The testing method involved running various statistical reports (e.g. number of claimants, dollars paid, dates of service) from both the source and extracted data. Once the quality assurance checks had been satisfactorily completed, the extracted data was then run through the CCG grouping software to create the 3M specific episodes of care for the six-year study period. Data Analysis Because of confidentialityconcerns regarding employee medical information,the Ingenix investigatorswere the only researchers who knew the identification of the employees' episodes of care experience. Each study cohort's personal identifiers were provided to Ingenix for record linkage purposes to determine and extract the reported number of health claims per covered employee. For each person within each cohort (chemical or film, groups (A-D), Ingenix determined, based on the eligibility database described above, whether or not the person belonged to a 3M sponsored health plan that could result in the possibility of claims, regardless of type, for the 72 month study period (1993-1998). The actual number of days (i.e., time) in which an employee was enrolled within the company health plans was not known. We only knew whether employees were eligible on a month to month basis via the data available through the Ingenix Eligibilitflatabase. Therefore, we chose to examine the comparison of episodes of care experience between chemical and film plant to have a Poisson distribution and then BACK TO MAIN 3M Company EPI-0004 Page 25 of 114 subsequently compared the ratio of these two Poisson variables via the methods outlined by Ederer and Mantel [ 19741. The observed number of claims based on the CCG algorithm for the Specialty Category, Category and Class descriptions was compared to an expected value using indirect standardization methods [Tsai and Wen, 19861to adjust for three age categories (<40,40-49 and >=50 years) and gender (male, female). Two normative databases were used to calculate the expected number of claims: I) the entire U.S. 3M population health claims experience from 1993-1998 excluding the Cottage Grove and Cordova sites due to their fluorochemical production activities; and 2) the U.S. 3M population health claims experience from 1993-1998 excluding employees at the St. Paul, Woodbury, Cottage Grove, and Cordova sites. The latter database, hereafter called the 3M manufacturing plant normative database, provided a comparison database that was more representative of 3M manufacturing plant employees, in general, as it excluded the St. Paul 3M Center corporate and research employees. However, it also excluded the downtown St. Paul manufacturing plant as the 3M St. Paul manufacturing and corporate/research sites share identical location codes. [Note: A third normative database, which consisted of other companies that belong to the Ingenix aggregate database, was not considered appropriate because the different health insurance plans that these other companies use may greatly influence the type and degree of health care.] For each of the four comparison group's chemical and film plant populations, we calculated the observed and expected number of episodes of care experience for the CCG's Specialty Category, Category and Class descriptiws. BACK TO MAIN 3M Company EPI-ooo4 Page 26 of 114 A Standardized Episodes of Care Ratio (SE,CR) was calculated separately for the chemical and film plants for each respective cohort. That is, However, it is the ratio of the two plant indirect standardized ratios for each comparison group, which we defined as the Risk Ratio Episodes of Care (RRE&), provides the measure of risk between the two study populations. That is, This direct comparison of two indirect standardized ratios is an unbiased estimator of the risk ratio (i.e., relative risk) if there are similar age-specific structures between the two comparison populations [Tsai and Wen, 1986). Because the chemical and film plant cohorts had slightly different age structures used for the indirect standardization, the ratio of the two indirect standardized ratios for the chemical and film plant populations was not necessarily directly comparable. Therefore, we used the methods by Tsai and Wen [19861 to compare whether the ratio of two indirect standardized ratios, corrected for their age structure, was similar to an unadjusted ratio of 1. two indirect standardizedratios. That is, BACK TO MAIN 3M Company EPI-0004 Page 27 of 114 and The age- and gender- adjusted SEpCRchemical-correctedis the sum of the age-specific episodes of care for the chemical plant standardized to the sum of the chemical and film plant expected episodes of care. Likewise, the age- and gender-adjusted SE$CRfilm-corrstd c o ~ e c ~thi es sum of the age-specific episodes of care for the film plant standardized to the sum of the chemical and film plant expected episodes of care. It is important to note that each SE!&Rcommtedis not meaningful by itself, only their ratio, RREpCcomctdw, hich is an unbiased estimator of the relative risk [Tsia and Wen, 19861. Although Tsai and Wen [19861 suggestedthat a 95 percent confidenceinterval (95% CI) of R-Ccmected can be readily calculated using the procedures developedby Ederer and Mantel [19741 for the ratio of two Poisson variables, such methods, in fact, cannot be used without great difficulty. Unlike RRE& which is a ratio of two Poisson variables (x0bserv&hemicallxobservedfih)multiplied by a constant (~Expectea;,im/~xeCte4hemit~h~e,c),alculation of a confidenceinterval for BACK TO MAIN 3M Company EPI-OOOQ Page 28 of 114 RREpCcomected is not readily apparent as each ~ b S ~ ~ ~ d c o ~ e c t e d - c h e n J O b s e r V e d c o r r e c t e d - f i ~ m subgroup is not a Poisson variable and neither is their sum. Consequently,our analysis strategy was to calculate both a RREpCand a RREpCcomected. If the two risk ratios were comparable,which we suspected they would be given the fact that the chemical and film plant age structureswere not substantially different, then we assumed that RRE,C was a minimally biased risk ratio estimate and we calculatedthe 95% CI of R W C using the methods of Ederer and Mantel [19741. Cumulativebinomial tables [DocumentaGeigy, 19671were used to calculate the 95% CI when the number of total observations was less than 30. We used the normal approximation to the binomial when the total number of observationswas greater than or equal to 30. R W C and RR+C, were not calculatedwhen there were two or fewer total observed episodes of care for the chemical and film plants combined. RREpCmay be greater than the null hypothesis (as defined in this study as the exclusion of the null hypothesis value (1.0) from the 95%CI for three possible reasons. An increasedR W C may be due to: 1) a greater observedto expected episode of care experiencein the chemical plant (than-comparedto the film plant); 2) a greater expected than observedexperience in the film plant (than compared to the chemical plant) or 3) a combination of both 1 and 2. In other words, the first instance occurs when SEpCRcheficalis > 1.0 and SEpCRfilmis 21.0, but if SEpCRfihis > 1.0 it is still less than SEpCRchemical. The second instance occurs when SEpCRcheficalis 5 1.0 and SEpCRfihis < 1.0 ' but if SEpCRchhcails e 1.0it is still greater than SEpCRfil,. The potential for the greatest hgnification of the RRE,,C may occur in the third instance when SEpCRchemial is > 1.O and SEpCRfilmis c 1.O The RRE,,C that is increased in the first instancemight be BACK TO MAIN 3M Company EPI-ooo4 Page 29 of 114 attributed to the possibility of potential workplace exposure in the chemical plant whereas the RRE,C that is increased in the second instance may be due to an unexplained less than expected number of observed episodes of care in the film plant (and not as the possibility of potential workplace exposures in the chemical plant). The third instance may be the possibilityof either or both explanations. RESULTS Presented in Table 1 are the demographic characteristicsof the four study group comparisons. Among all 1,311 study subjects (study group A), 36 percent of the 659 film plant workers were 50 years of age or older comparedto 53 percent of the 659 chemical plant workers. Sixty percent of the employees had worked only in the chemical plant (n = 388) or only in the film plant (n = 424). This was defined as study comparison group B. Seventy-six percent (n = 498) of the 652 chemical plant employees worked in a job(s) with a high potential for POSF-based exposure. This defined study comparison group C. Among the 211 long-term high exposurechemical employees,comprisingstudy comparison group D, 61 percent had worked only in the chemical or film plant since 1983. Provided in Table 2 is the employment status at the beginning and end of study for comparison group A stratified by gender. For all 1,311 study subjects,3 1 percent of the chemical plant and 26 percent of the film plant employeeswere not yet hired as of the study onset (January 1, 1993). By the end of the study (December 31, 1998), 78 percent of the chhical plant employeeswere actively employed and 11 percent had retired. Among the film plant employees,71 percent were actively employed and 17 percent had BACK TO MAIN 3M Company EPI-OOO4 Page 30 of 114 retired. Percentages of inactive, terminated, deceased and transferred employees were comparablebetween the chemical and film plant employees. Provided in Tables 3 through 5 are similar percentages for the comparison groups B through D. Because of its definition of long-term workers since 1983, it is to be expected that comparison group D had the highest percentage (24 percent) of any comparison group for the number of retired employees at end of study. Presented in Appendix A is the employment status for each comparison group (A through D) by individual year (as of January 1'' ). The number of active chemical plant employeeswas relatively constant (i.e., never varied by more than 7 employeesbetween years) until 1997 when there was an increase of 83 employeesform January 1,1997 to January 1, 1998 (19 percent increase). During the six year study time period the number of film plant employees never varied by more than 30 employees between any two successive years. The ratio of total number of outpatient to inpatient claims per plant within each comparison group (A-D) was greater than 150 to 1 (Table 6). For each comparison group, the average number of outpatient claims per person per year was higher among film plant employees compared to chemical plant employees. The average number of inpatient claims was comparable. Provided in Tables 7 through 10 are the observed and expected numbers of episodes of care by plant for the CCG SpecialtyCategory,Category and Class descriptionsfor the four study comparison groups A through D, respectively. The expected esults were slightly higher when the 3M manufacturing population was used but this was true for both chemical and film plant populations; thus the RRE$ and BACK TO MAIN 3M Company EPI-OOO4 Page 31 of 114 RRE,C,, were similar regardless of which normative population was used. Therefore, for purposes of brevity we have only shown the analyses when the 3M manufacturing normative population was used. Presented in tables 7 through 10 are the number of unique individuals who constituted the total number of episodes of care for each CCG description. The RRE,C and RWC,, were comparable for most CCG descriptions and therefore the results will focus on the RRE& and its 95% CI. The CCG Specialty Categories are presented in a hierarchical order similar to ICD-9 codes, beginning with Infectious Diseases, then Cancers and Benign Growth, Endocrine Disorders, etc. Twenty Specialty Categories are presented (bold print) which are then subdivided into 97 Categories (directly under Specialty Category description) and these are further subdivided into Classes (indented under the Category description in the tables). For the Specialty Category of Cancers and Benign Growth, all Categories and Classes are presented. For the remaining Specialty Categories, all CCG Categories are presented but not all Class descriptions (although all Class descriptions provided by the CCG grouper were analyzed). In particular, Class descriptions were generally not provided under those Specialty Categories that had no a priori hypotheses (e.g., Psychiatric Disorders, Cardiovascular Disorders, Dermatologic Disorders, Musculoskeletal Disorders). RRE$ and RRE!&, were not calculated when there were two or fewer total observed episodes of care for the chemical and film plants combined. For study comparison group A (Table 7), there were 10,608 episodes of care (sum of the 20 Specialty Categories) for the 652 chemical plant employees during the six year study p e d d (average of 2.7 episodes of care per chemical plant employee per year). For BACK TO MAIN 3M Company EPI-OOO4 Page 32 of 114 the 659 film plant employees, they had 11,957 episodes of care (averageof 3.0 episodes of care per film plant employee per year). In Table 7, the Specialty Category of Cancers and Benign Growths had an RRE,C of 1.3 (95% CI 1.1-1.6). Within its Categories, neoplasms of the male reproductive system had an RRJ&C of 10.0 (95% CI 1.3 - 447). This RRE,C was the consequence of a disparity in observed to expected episodes of care of malignant neoplasms of the prostate in chemical and film plant employees. There were 5 observed versus 3.1 expected episodes of care of malignant neoplasms of the prostate among the chemical plant employees compared to 1 observed and 4.7 expected episodes of care in the film plant. The RRE& was 1.5 (95% CI 1.0-2.2) for neoplasms of the gastrointestinaltract (Table 7). More than eighty percent of these gastrointestinal tract episodes of care for both the chemical and film plant were for benign colonic polyps. There was an increased RR.E,,Cfor both malignant neoplasms of the colon (5.4,95% CI 0.5-265) and malignant neoplasms of rectum and anus (1.8, 95% CI 0.3-12.4). There was a total of 5 unique chemical plant employees who constituted the 8 episodes of care for these two conditions. Neoplasms of skin had an R q C of 1.3(95% CI 1.0-1.6). This increased RRE,,C was due to RR.E$s for malignant melanoma of the skin (>2.3,95% CI 1.0-63) and benign neoplasms of skin (1.3, 95% CI 0.9-1.7). Among the Specialty Category of Endocrine Disorders, the Category of diabetes Type I with complications had an RR.E,,Cof 5.1 (95% CI 0.5-247), which was due to the disparity of more observed than expected episodes of care in the chemical plant and vice versa in the film plant. However, the RRE,C for Diabetes Type I without complications BACK TO MAIN 3M Company EPI-0004 Page 33 of 114 was not elevated (1.O, 95% CI 0.4-2.6). There was no increased RRE,C found for the Categories of disorders of the thyroid (I. I, 95% CI 0.6-1A), lipid metabolism (1.O,95% CI 0.8-1.3) or other endocrine or nutritional disorders (1.0,95%CI 0.7-1.3). Although there were few episodes of care for disorders of the liver (Specialty Category is Gastrointestinal Disorders), there was an increased R R h C for cholelithiasis with acute cholecystitis (8.6,95%CI 1.1-380.7)under the Category of disorders of the biliary tract (1.7,95%CI 0.8 - 2.9). The elevated RRE& for cholelithiasis with acute cholecystitis was the consequence of observed to expected disparities between the chemical and film plant populations. No other class description regarding cholecystitis or chloelithiasis had an RRE& that excluded the null hypothesis. Episodes of care for acute pancreatitis was elevated among chemical plant employees (2.6,95%CI 0.6-16). All six episodes of care were from one unique individual. In Table 7, the Specialty Categories of CardiovascularDisorders, Pulmonary Disorders, Ear, Nose and Throat Disorders and Urologic Disorders did not have any RRE& with a 95%CI that excluded the null hypothesis. The highest RRE& was for the Category descriptions of disorders of renal function (3.1,95%CI 0.5-32.9) and disorders of renal parenchyma (3.7,95%CI 0.3-192). Again, these were based on a disparity of observed and expected values between the chemical and film plant populations. The Category of lower and unspecified urinary tract infections had an R-C of 1.3 (95% CI 1.0-1.6)with R W C s for the Class descriptions of cystitis of 1.5 (95%CI 1.0-2.2)and urin'ary tract, unspecified of 1.1 (95%CI (0.8-1.6). Whereas the prevalence of unique individuals'with an episode of care of cystitis was higher film plant employees (31/659 = 4.7 percent) compared to chemical plant employees (191652 = 2.9 percent), the BACK TO MAIN 3M Company EPI-0004 Page 34 of 114 recurrence of the episodes of care of cystitis was much higher among chemical plant employees(66%)compared to film plant employees (22%)and this was the result of a greater percentage of recurrence among female chemical plant employees. Of the 56 observed episodes of care for cystitis among chemical employees, 50 (89 percent) belonged to 14 (74 percent) female employees (data not shown) of the 19 total unique individuals who had such episodes of care. Of the 40 observed episodes of care for cystitis among the film plant employees, only 21 (52 percent) belonged to the 15 (48 percent) female employees (data not shown) of the 3 1 total unique individuals who had such episodes of care. The recurrence of the lower urinary tract, not specifiedinfections was comparablebetween chemical and film plant employeesas well as between female chemical and film plant employees. There was not an increased RRE& for calculi of the upper urinary tract (1.O, 95%CI 0.8-1.4). In Table 7, the SpecialtyCategories of Gynecologic and Reproductive Disorders, Pregnancy, Congenital Anomalies and Perinatal Disorders did not have any RRE& with a 95%CI that excluded the null hypothesis. The highest RRE,,C (3.6,95%CI 0.5-172) was for the Class description of pretenn labor (Category is complicatedpregnancy or delivery under the Specialty Category of Pregnancy). This RRE$ was the result of 7 episodes of care from 3 unique chemical plant employees. Among the Miscellaneous SpecialtyCategory in Table 7, there were no substantialdifferences for signs and symptoms(abdominal pain, chest pain, fever, headache with radiology, malaise, syncope, and ill-defined signs and symptoms) between episodes ofcare observed for the chemical and film plant employees. BACK TO MAIN 3M Company EPI-ooo4 Page 35 of 114 Comparable RRE,C results were observed when the entire study population was restricted to those employees who had only worked in either the chemical plant or film plant but not both (study comparison group B, Table 8). It should be noted that, unlike Table 7, the RRE& for lower and unspecified urinary tract infectionsexcluded the null hypothesis (1.5,95%CI 1.1-2.1).The percentage of chemical plant employeeswith recurrenceof episodes of care for cystitis was 72 percent comparedto 26 percent for film plant employees. Also observed was a higher R R h C for the Category of menopausal and menstrual disorders (2.0,95%CI 1.1-4.0). The episodes of care data presented in Table 9 are of those employees who were identifiedto have worked in high potential fluorochemicaljobs (e.g., cell operators, chemical operators)in the chemical plant and were compared to theirjob counterparts (film operators, process operators) in the film plant (i.e. study comparison group C). The RRE& for the Specialty Category of Cancers and Benign Growths was 1.8 (95%CI 1.23.0). CCG Categoriesthat contributedhigher R q C s included those reported previously in Tables 7 and 8: 1) neoplasms of the gastrointestinaltract (1.8,95%CI 1.2-3.0); neoplasms of the skin (1.1,95%CI 0.8-1.5);and neoplasms of the male reproductive tract (7.6,95%CI 0.9-359). Only one Class description,benign colonic polyps, had an RRE& which excluded the null hypothesis in its confidenceinterval (1.9,95%CI 1.13.2). Increased RREpCs that did not exclude the null hypothesis in the 95%CI included malignant neoplasms of colon (4.5,95%CI 0.4-238),malignant melanoma of the skin (>2.5,95%CI 0.8-51.0), malignant neoplasms of prostate (6.7,95%CI 0.6-325). and benign ovdrian cysts (2.6,95%CI 0.6-15.1). BACK TO MAIN 3M Company EPI-ooo4 Page 36 of 114 Of the non-cancer SpecialtyCategories presented in Table 9, only two contained a Category or Class description whose RRE,C excluded the null hypothesis in its 95% CI. In the SpecialtyCategory of Psychiatric Disorders, the Category of affectivedisorders had an RRE,C of 1.4(95%CI 1.1- 1.9). In the SpecialtyCategory of Gastrointestinal Disorders, the Class description of cholelithiasiswith acute cholecystitis had an R W C of 9.2 (95%CI 1.2-407). Again, this was the result of a greater number of observed episodes of care than expected among chemical plant employees(7 versus 2.5) compared to fewer observed than expected episodes of care (1 versus 3.2) among film plant employees. Unlike the results in Table 8, we did not observe an increased w C for the Category of menopausal and menstrual disorders (1.1,95%CI 0.7-2.0). Provided in Table 10 are the episodes of care analyses for those long-term high exposurejob employeesin the chemical plant along with their counterpartlong-term (least exposed) employees in the film plant (study comparison group D). The Specialty Categoryof Cancers and Benign Growths continuedto have an increasedw C which excludedthe null hypothesisin its 95%confidenceinterval (1.6,95%CI 1.2-2.1). As seen previously with the other study comparison groups (Tables 7-9), increased Category R W C s (under the Specialty Category of Cancers and Benign Growths) were observed for neoplasms of the gastrointestinal tract (2.9,95%CI 1.7-5.2),neoplasms of the male reproductive tract (9.7,95%CI 1.1-458),and neoplasms of skin (1.2, 95%CI 0.8-1.9). Increased Class R W C s were observed for malignant neoplasm of colon (>3.8,95%CI 0.9-60.0),malignant neoplasms of the rectum and anus (> 5.0,95%CI 0.9-62.0),benign colonic pdyps (2.4,95%CI 1.3-4.5),malignant melanomasof the skin (>3.0,95%CI 0.8-52) and malignant neoplasms of the prostate (8.2,95%CI 0.8-399). Except for BACK TO MAIN 3M Company EPI-OO04 Page 37 of 114 benign colonic polyps, these Classes had three or fewer episodes of care among chemical plant employees. Non-cancer Categorieswhich had a 95% CI that excluded the null hypothesis in Table 10 included disorders of the pancreas (6.4,95%CI 1.2-63),which was due to acute pancreatitis(5.5,95%CI 1.0-56). As mentioned previously, the six episodes of care for acute pancreatitis were from one individual. The Category of lower and unspecified urinary tract infections also excluded the null hypothesis (2.2,95%CI 1.4-3.3).Increased R W C were observed for both the episode of care described as cystitis (2.4,95%CI 1.24.8)and that of urinary tract infection, not specified (2.1,95%CI 1.2-3.5). The percentage of recurrence of cystitis was greater among chemical plant (61 percent) than film plant 24 percent) employees. Class descriptionsthat had a null hypothesisexcluded in the 95%CI of its RRE& were cholelithiasiswith acute cholecystitis(>4.0,95%CI 2.1-128) and abdominal pain (1.6,95%GI 1.2-2.1)under the Category of symptoms or signs (1.2,95%CI 1.1-1.4)of the Specialty Category described as Miscellaneous (1.2, 95%CI 1.1-1.4). All other Class descriptionsunder the Category symptoms or signs had RRE$Cs that were at or greater than the null hypothesis although none had 95%CISthat excluded the null hypothesis. Table 11 provides a summary of the SpecialtyCategories, Categories and Classes which had an R W C that excluded the null hypothesis in the 95%confidence interval for at least one of the four comparison groups, A through D, as discussed above in Tables 7 through 10. The only CCG description that had the null hypothesis excluded in all four comparisml'groupswas the CCG SpecialtyCategory of Cancers and Benign Growths. BACK TO MAIN DISCUSSION 3M Company EPI-ooo4 Page 38 of 114 The episode of care concept does not translate into a we1I-defined epidemiologic measure. An episode of care may include incident cases (i.e., newly diagnosed cases), prevalent cases (existing cases), tentatively diagnosed cases and misclassified cases that are the routine consequence of the differential diagnoses that individuals may undergo in the course of disease diagnosis, treatment and management. Acute episode of care conditions may include the same individual multiple times. Therefore a large R q C may not infer a high incidence risk. Likewise, a high RRE& could be masked as a consequence of a large observed to expected ratio in the film plant that is not the result of incident episodes of care although the numerator (chemical plant) is. The number of episodes of care can also be influenced by the practice patterns of the local medical community and the varying health plans available to members of the community. Episodes of care are hierarchical. Therefore, one person may contribute episodes of care to several Classes which represent fewer Categories of the same Specialty Category. All of these are constraints to the use of episodes of care methodology in occupational epidemiology investigations. On the other hand, episodes of care may be considered a reasonable screening method for the potential risk of diseases andor conditions when there are two study populations from the same company, covered by the same medical plan, who live within the same community, and who differ primarily only in their workplace exposure. This scenario existed with the employees at 3M's Decatur manufacturing site. Wdaddressed POSF-based workplace exposure with the construction of the four study comparison groups. We were able to subdivide the study population into those BACK TO MAIN 3M Company EPI-0004 Page 39 of 114 employees who were primarily in the chemical or film plants throughout their Decatur career (comparison group A), only in the chemical or film plants throughout their career (comparison group B), those who had worked in a high potential exposurejob (comparison group C), and those who had worked long-term (at least 10 years prior to the onset of the study) in a high potential exposurejob (comparison group D). Our study included individuals who were on long-term disability at the beginning and throughout the course of the study time period as well as those employees who retired subsequent to January 1, 1993. We recognize that neither of these groups provided a comprehensiveepisodes of care assessment due to the eligibilitycriteria for Medicare. Medicare does not cover employees' long term disability claims until 18 months after diagnosis. Thus, employees who went on long term disability during the course of the study would have had their initial disease or condition identifiedthrough company claims data. This may not be true, however, for the 20 chemical and 26 film plant employees who were already on long-term disability at the onset of the study (Table' 2). The majority of employees during the course of the study retired prior to age 65 and therefore their health claims would have been considered in the construction of the episodes of care through age 64. Our a priori interests included liver and bladder cancer, endocrine disorders involving the thyroid gland and lipid metabolism, gastrointestinal disorders of the liver and biliary tract, and reproductive, pregnancy, congenital and perinatal disorders. Because of the many multiple comparisons which were not of a priori interests, chance findings might arise, although this assumes the universal null hypothesis (Le,. that chance is the first-order explanation for all observed phenomenon) [Borak and Bidulescu, 2000; BACK TO MAIN 3M Company EPI-OOO4 Page 40 of I14 Rothman, 19921. We agree with Rothman's treatise [19901 that it is preferable not to provide adjustments for multiple comparisons in empirical research because it may lead to fewer errors of interpretationwhen the data are not random, but instead actual observations of nature. The intent of this study was to use the episodes of care methodology as a screen for morbidity outcomes associated with long-term high exposure to POSF-based production. An adjustment procedure would only increase the type I1error for those associationsthat are not null and thereby we could dismiss non a priori findings that should require further insight. A major a priori consideration was the bladder cancer association (3 observed 0.2 expected among a high POSF-exposed subcohort) reported in the Decatur retrospective cohort mortality study [Alexander, 2001bI. Two of these employees had also worked in the film plant during the course of their Decatur career. In our study, we observed no episodes of care for neoplasm of the bladder among chemical plant employees and one among the film plant employees. A review of the inpatient, outpatient and pharmacy claims confirmed this was a bladder cancer diagnosis during the course of the study. Because of confidentialityrequirements, we do not know the specificjobs this person performed although our data did provide this was a female employee not employed as a film plant production operator or maintenance worker since this episode of care of bladder cancer was not reported for comparison groups C or D. It is not possible for this episode of care of bladder cancer to be one of the three employees who had died from bladder cancer in the mortality study as-thesethree individuals had either quit or retired from the cdmpany prior to the onset of our study. BACK TO MAIN 3M Company EPI-OOO4 Page 41 of 114 Among the Specialty Category of Urologic Disorders, we did observe a higher RRE,C for disorders of renal function, renal parenchyma and lower and unspecified urinary tract infections. Among the latter, the percentage of episodes of care that represented recurrences was higher among all chemical plant employees (55 percent) compared to all film plant employees (38 percent). Among long-term high exposed employees, this recurrence percentage increased to 59 percent among the chemical plant employees with episodes of care for lower and urinary tract infections compared to 31 percent among film plant employees. Although the RRF$ was 2.2 (95% CI 1.4-3.3), the question then arises as to whether this two-fold increase is a result of non-related occupationalfactors associated with recurring lower urinary tract infections in the chemical plant employee population or as a consequence of an ongoing workplace exposure. Female chemical plant employeeshad a greater proportion of recurrencethan female film plant employees. Nevertheless, the prevalence of episodes of care of the Category defined as lower and unspecified urinary tract infectionswas comparablefor the unique long-term, high exposure chemical plant employees (20/211 = 9.5 percent) and the film plant employees (34/345 = 9.8 percent). There was no increased risk observed for upper urinary tract calculi. Laboratory results have not suggestedanimals were at increased risk for urinary tract infections in either a 2-year feeding study of rats or a 6-month feeding study of cynomolgus primates for PFOS [3M Company, 20001. A major exposureroute for serum PFOS levels assayed in Decatur employees,however, is the inhalation of POSF [Logan et al, 20011. To date, there is minimal information regarding thk toxicology of POSF via inhalation. Urinalysis findings have not been BACK TO MAIN 3M Company EPI-ooo4 Page 42 of 114 reported in previous medical surveillancereports on this plant population [Olsen et al, 19991. The increased RRE& for the Specialty Category of Cancers and Benign Growths was primarily attributedto neoplasms of the gastrointestinal tract and neoplasms of the skin. No episode of care of malignant neoplasm of the liver was reported among chemical plant employees compared to one episode of care in the film plant. Among all study subjects, the observed to expected number of benign colonic polyps was twice the expected for the chemical plant (48 versus 24.6) and forty percent higher than expected among film plant employees (47 versus 33.7). Whether this was the result of increased incidence, prevalence and/or that of heightened awareness through a screening program is not certain. We are aware that a chemical plant manager was diagnosed with colorectal cancer in 1997 and this may have heightened increased awareness among some employees for colorectal cancer screening in the latter two years of this study (Table 12). It should be noted that the for benign colonic polyps was increased for high exposure employees (1.9,95%CI 1.1-3.2) and for those long-term high exposure chemical plant employees (2.4,95%CI 1.3-4.5).The frequency of adenomatous polyps often parallels colorectal cancer incidence and colorectal cancer is generally not viewed as an occupationaldisease [Schottenfeld and Winawer, 19961. In the updated retrospective cohort mortality study of this Decatur workforce there were no observed colorectal cancer deaths compared to 1.6expected among employeesever employedin a high exposurejob, 1 colorectal cancer death compared to 0.8 expected among employees ever empidyed in a low exposurejob (but never a high exposurejob) and 0 colorectal cancer deaths comparedto 1.5 expected among employeeswho only worked in the film BACK TO MAIN 3M Company EPI-OOO4 Page 43 of 114 plant. There was no evidence reported of colorectal pathology in a six-month primate feeding study of PFOS [Seacat et al, 20011. Results from a two-year PFOS bioassay study in rats is pending [3M Company, 20001 but there was no pathology reported in the interim 14 week analysis[Seacat et al, 20011. The increased RRE,C observed for neoplasms of the skin were primarily attributed by malignant melanoma of the skin and benign neoplasms. Exposure to sunlight is considered a major cause of malignant melanoma in susceptible populations [Armstrongand English, 19961. There was no increased R W C for nonmalignant melanomas of the skin (Le., basal cell and squamous cell carcinomas). There was an increased RRE,C for benign neoplasm of the skin. However, histopathology was not available and thus these benign neoplasm findings are difficult to interpret. We did observe an increased W C for malignant neoplasm of the prostate among all subjects (10.0,95% CI 1.3-447). This increased RFU&C was largely due to a deficit of observed episodes of care among the film plant employees (1 observed versus 5.3 expected) rather than as a consequence of a large excess of observed episodes of care among the chemical plant employees (5 observed versus 3.1 expected). The total evidence suggests that a prior history of prostatic diseases may be associated with an increased risk of prostate cancer [Ross and Schottenfeld, 19961. In our study we did not observe an increased RRE& with prostatic hyperplasia nor for acute prostatitis. Among the long-term high exposure comparison population, the RRE& for prostatic hyperplasia was' 1.0(95% CI 0.6-1.5) and for acute prostatitis the R E & was 1.4 (95% CI 0.9-2.2). In addition:there were no observed deaths reported for prostate cancer in the 37 year follow-up of the retrospective cohort mortality study [Alexander, 2001bl at the Decatur BACK TO MAIN 3M Company EPI-OOOQ Page 44 of 114 site. Nor was there an increased SMR for prostate cancer mortality that was recently reported among Cottage Grove employees who historically have had the highest serum PFOA levels among the 3M fluorochemical manufacturing sites [Alexander, 2001al. Decreased cholesterol was the most sensitive clinical response, occurring only at serum PFOS levels > 100ppm, in a six month oral dosing study of cynomolgus primates [Seacat et al, 20011. Although there was no Specialty Category, Category or Class descriptions for hypolipidemia in our study, we did not observe any decreased R W C s for hyperlipidemia. Among long-term high exposed workers, the m C for hyperlipidemia was 0.9 (95%CI 0.7-1.3). A lack of an association was expected as serum PFOS levels in these Decatur chemical plant employees have not been found to be generally above 10 ppm [Olsen et al, 20011 nor associated with decreased serum cholesterol in biennial medical surveillance examinations [Olsen et al, 19991. Except for the episode of care described as cholelithiasis with acute cholecystitis, we observed no increased RRE$ for other disorders of the biliary tract or for disorders of the liver. This single association was due to a combination of increased observed to expected episodes of care among the chemical plant employees (7 versus 4.2) and the opposite occurrence among film plant employees (1 observed versus 5.2 expected). This magnitude of association for cholelithiasis with acute cholecystitis remained for longterm high exposed employees (RRE,C > 4.0,95%CI 2.1-128). Laboratory evidence is unlikely to provide substantial additional perspective. The biliary tract of the rat is substantially different than humans. At necropsy, there were no gallstones reported in a 6 month feeding study of cynomolgus primates [Seacat et al, 20011. BACK TO MAIN 3M Company EPI-ooo4 Page 45 of 114 There was minimal evidence for an increased risk of episodes of care among female chemical employees for pregnancy outcomes and complications, congenital anomalies and perinatal disorders. The RRE,C for preterm labor was 3.0 (95% CI 0.3144) based on 4 episodes of care. However, these 4 episodes of care arose from one employee. Although we observed an increased RRE,C for menopausal and menstrual disorders among those employees who only worked in the chemical plant compared to their film plant counterparts, this association was based on observed to expected ratios that were less than one for both plants. This finding was not replicated among the analyses for the high exposed and long-term high exposed comparison groups. Although we found no increased R q C for Parkinson's disease, we were perplexed by the large number of unique episodes of care reported (17 chemical employees, 19 film employees) as the prevalence in the general population is estimated at 0.1 percent [Tanner and Goldman, 19961. Our prevalence of episodes of care, based on these 36 unique episodes, was 2.8 percent. Further investigation revealed that the CCG grouping process for Parkinson's Disease took into account prescription drugs (via the CCG Drug Disease Matcher) as well as medical claims. An individual prescribed a drug that is considered a delineating drug for Parkinson's would be categorized as such in the episode of care algorithm although there was no ICD-9 code to substantiate a diagnosis. A review of the claims and pharmacy records of these 36 individuals revealed that only 5 individuals (3 chemical, 2 film) had outpatient claims with ICD-9 codes (332,333) that would be consistent with a diagnosis of Parlunson's Disease. However, two of these five individuals'(both with ICD-9 codes of 333 and not 332) only had one claim for a prescription in this six year time period Nineteen of the 36 individuals had their only BACK TO MAIN 3M Company EPI-OOO4 Page 46 of 114 episode of care as a prescription for amantadine hydrochloride. We suspect that these 19 were prescribed amantadine hydrochloride for its anti-influenzaA effects. There were, however, no ICD-9 codes for respiratory claims within the 30 day time period of the prescription. Therefore, we can only suspect that these prescriptions were done without a face-to-face encounter.No single physician was the predominant prescriber of these prescriptions. Of the remaining 12 individuals,only three had multiple prescriptions for SinemetTM.The remaining nine were also identified with single prescriptionsconsidered in the Drug Disease Matching program for Parkinson's Disease without any evidence of a face-to-face physician encounter. Therefore, we believe there was a minimum of 3 individuals (2 chemical, 1 film) and no more than 8 individuals (4 chemical, 4 film) that could have been diagnosed with Parkinson's Disease (4 chemical,4 film),amongthe 36 individuals (17 chemical, 19 film) who were identified by the CCG grouperto have episodes of care for Parkinson's Disease. This assumption would represent a study population prevalence of 0.2 and 0.6 percent, respectively for Parkinson's Disease. In summary, we conductedan analysis of the episodesof care of 652 chemical and 659 film plant employees at the Decatur manufacturing site from 1993-1998. Although the analyses of episodes of care does not translate into a well-defined epidemiologicmeasure, it can be used as a screeningmethod to determineif a study population could be at an increased risk for a disease or condition. Our analysis was further limited by the study time period of six years, 1993-1998. Further investigation would always be required to deteimine whether an increase in incidenceor prevalence actually edsts based on the episodes of care reported. In our study the overall episodes of care experience was comparable between chemical and film plant employees for most BACK TO MAIN 3M Company EPI-0004 Page 47 of 114 Specialty Categories, Categories and Class diseases and conditions. Where increased RRE,Cs were observed, they were often attributed to a deficit of observed episodes of care in the film plant as much as any observed excess of episodes of care in the chemical plant. These high RRE,C values often had very wide 95% confidence intervals which did not exclude, or barely excluded, the null value. Of our a priori concerns, we did not observe positive associations that excluded the null hypothesis for malignant neoplasm of the liver, liver disorders, thyroid and lipid metabolism disorders and reproductive, pregnancy, congenital and perinatal disorders. We did observe an association with cholelithiasiswith acute cholecystitis;this was due, in part, to a greater than expected number of episodes of care in the film plant. Other biliary tract disorders did not exclude the null hypothesis in the confidence interval. Because of the previously reported increased mortality risk for bladder cancer among the chemical plant employees, we focused particular attention on episodes of care which involved the urogenitaltract. We found one episodeof care for bladder cancer reported for a film plant employee who had never worked in the chemical plant. We did observe a greater increased risk in episodes of care among chemical plant employees for lower urinary.tractinfections but this was largely due to increasedpercentages of these employees having recurring episodes of care, rather than a greater prevalence of individuals having episodes of care. This increased risk of episodes of care was greater among the long-term high exposure chemical plant workers. It is not known whether this recurrence is a result of occupational exposure or nonoccupational-related factors. Other associatiorisobserved, that were not a priori concerns, included increased risk of episodes of care for benign colonic polyps and malignant neoplasms of the colorectal BACK TO MAIN 3M Company EPI-ooo4 Page 48 of 1I4 tract as well as malignant neoplasms of prostate. Whether these associations have a biological rationale is questionable as other toxicologic and epidemiologic research does not offer support in relation to the serum PFOS and/or PFOA levels measured in Decatur chemical plant employees. Acknowledgement The authors gratefully acknowledgethe assistance of Dr. Timothy Church. BACK TO MAIN REFERENCES 3M Company EPI-0004 Page 49 of 114 Alexander BH (2001a). Mortality study of workers employed at the 3M Cottage Grove facility. Minneapo1is:University of Minnesota (unpublished report) April 26,2001. Alexander BH (2001b). Mortality study of workers employed at the 3M Decatur facility. Minneapo1is:University of Minnesota (unpublished report) April 26,2001. Armstrong BK, English DR (1996). Cutaneous malignant melanoma. (In) Cancer Epidemiology and Prevention (second edition) , eds Schottenfeld D, Fraumeni JF. New York:Oxford University Press, pages 1282-1312. Borak J, Bidulescu A (2000). Some thoughts on multiple comparisons and their correction. OEM Report 14:65-7 1. Cook JC, Murray SM, Frame SR,Hurtt ME (1992). Induction of Leydig cell adenomas by ammonium perfluorooctanoate: a possible endocrine-related mechanism. Toxicol Appl Pharmacol 113:209-217. Biegel LG, Liu RCM, Hurtt ME, Cook JC (1995). Effects of ammonium perfluorooctanoate on Leydig cell function: in vitro, in vivo , and ex vivo studies. Toxicol Appl Pharmacol 134:18-25. Butenhoff J, Costa G, Clecombe C, Farrar D, Hansen K, Iwai H, Jung R, Kennedy G, Lieder P, Olsen G, Thomford P. Toxicity of ammonium perfluorooctanoate in cynomolgus monkeys after 26 weeks of oral dosing. St. Pauk3M Company (unpublished report). Cave DG (1995). Profiling physician practice patterns using diagnostic episode clusters. Med Care 35463-486. Dang DK, Pont JM, Portnoy MA (1996a). Episode treatment groups: an illness classification and episode building system. Part I. Med Int 1996 (March):ll8-122. Dang DK, Pont JM, Portnoy MA (1996b). Episode treatment groups: an illness classification and episode building system. Part 11. Med Int 1996 (April):122-128. Documenta Geigy Scientific Tables (1967). Seventh edition. Editors Diem K, Lenter K. Ciba-Geigy Limited; Basle, Switzerland. Ederer F, Mantel N (1974). Confidence limits on the ratio of two Poisson variables. Am J Epidemiol, 100:165-167. z Fetter R, Shin Y, Freemen J, Averill R, Thomspon J (1980). Case mix definition by diagnosis-related groups. Med Care 18(2 suppl): 1-53. BACK TO MAIN 3M Company EPI-0004 Page 50 of 114 Gilliland FD, Mandel JS (1993). Mortality among employees of a perfluorooctanoic acid production plant. J Occup Med 35950-954. Gilliland FD, Mandel JS (1996). Serum peffluorooctanoic acid and hepatic enzymes, lipoproteins and cholesterol: a study of occupationally exposed men. Am J Ind Med 129:560-568. Greene SB, Gunselman DL (1984). Conversion of claims files to an episode data base: a tool for management and research. Inquiry 21:189-194. Hornbrook MC, Hurtado A, Johnson R: Health care episodes: Definition, measurement and use. Med Care Rev 1985;42:163-218. Logan PW, Johnson TM, Olsen GW, Reagen WK, Mulhausen JR (2001). An industrial hygiene exposure assessment of a fluorochemical manufacturing plant. Am Ind Hyg Assoc J (submitted). Obourn JD, Frame SR, Bell RH, Longnecker DS, Elliott GS, Cook JC (1997). Mechanisms for the pancreatic oncogenic effects of the perixosme proliferator Wyeth14,643. Toxicol Appl Pharmacol 145425-436. Olsen GW, Gilliland FD, Burlew MM, Burris YM, Mandel JS, Mandel JH (1998). An epidemiologic investigation of reproductive hormones in men with occupational exposure to perfluorooctanoic acid J Occup Env Med 40:614-622. Olsen GW, Burris JM, Mandel JH, Zobel LR (1999). Serum perfluorooctane sulfonate and hepatic and lipid clinical chemistry tests in fluorochemical production employees. JOEM 41~799-806. Olsen GW, Burris JM, Burlew MM, Mandel JH (2000). Plasma cholecystokinin and hepatic enzymes, cholesterol and lipoproteins in ammonium perfluorooctanoate production workers. Drug Chem Toxicol23:603-620. Olsen GW, Logan PW, Hansen KJ, Simpson CA, Burris JM, Burlew MM, Vorarath SP, Venkateswarlu P, Schumpert JC, Mandel JH. Serum fluorochemicals in a random sample of production employees (2001). Am Ind Hyg Assoc J (submitted) Rosen AK, Mayer-Qakes A (1999). Episodes of Care: Theoretical frameworks versus current operational realities. J Quality Improvement25:111-128. Ross RK, Schottenfeld D (1996). Prostate Cancer. 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Investigation of the no observable effect level for perfluorooctanesulfonic acid potassium salt in cynomolgus monkeys after twenty-six weeks of oral dosing and one year of recovery. Toxicol Sciences (submitted). Seacat AM, Thomford PJ, Hansen KJ, Clemen LA, Case MT, Butenhoff JL (2001). Subchronic dietary toxicity of potassium perfluorooctanesulfonic acid in rats. Toxicol Sciences (submitted). Sibinski LJ (1987). Two-year oral (diet) toxicity/carcinogenicitystudy of fluorochemical FC-143 in rats. St. Pau1:Riker Laboratories. 3M Company (2000). SIDS Initial Assessment Report Pefluorooctane Sulfonic Acid and Its Salts. Minneapolis3M Company, Sept 20, 2000. Solon JA (1967). Delineating episodes of medical care. Am J Public Health 57:401-408. Tanner CM, Goldman SM (1996). Neuroepidemiology 14:317-335. Epidemiology of Parkinson's disease. Tsai SP, Wen CP (1986). A review of methodological issues of the standardized mortality ratio (SMR) in occupational cohort studies. Int J Epidemiol 158-21. Valdivia T, Van Vorst K (2000). 1ngenix:Minneapolis. Clinical Care Groupsm Methodology. Wingert TD, Kralewski JE,Lindquist TJ, Knutson DJ (1995). Constructing episodes of care from encounter and claims data: some methodological issues. Inquiry 32:430-443 (Winter 199996). J BACK TO MAIN Table 1 3M Company Demographic Characteristics of the Four Comparison Group Analysis Between Decatur Chemical and Film Plant Em-plo-yees EpI-OOO4 Page 52 of 114 Study Group 1 Study Group 3 Study Group 5 Study Group 6 Variable Chemical Film Chemical Film Chemical Film Chemical Film N 652 659 388 424 498 490 21 1 345 Male Female 530 (81) 122 (19) 558 (85) 101 (15) 311 (80) 77 (20) 364 (86) 60 (14) 423 (85) 75 (15) 425 (87) 65 (13) 196 (89) 15 (11) 308 (93) 37 (7) Age (end of study) < 30 30 - 39 40 - 49 50 - 59 2 60 59 (9) 124 (19) 238 (37) 182 (28) 49 (8) 36 (5) 82 (12) 194 (29) 267 (41) 80 (12) 51 (13) 83 (21) 118 (30) 107 (28) 29 (7) 34 (8) 62 (15) 149 (35) 152 (36) 27 (6) 43 (9) 104 (21) 194 (39) 122 (25) 35 (7) 19 (4) 65 (13) 151 (31) 194 (40) 61 (12) 0 (0) 1(0) 99 (47) 86 (41) 25 (12) 0 (0) 10 ( 3 ) 112 (32) 173 (50) 50 (15) Average Age (yrs) 45.1 48.6 44.0 46.3 44.5 49.0 50.7 52.3 Only worked in Chemical Plant High exposure job 388 (60) 498 (76) 424 (64) 508 (77) 388 (100) 424 (100) 298 (77) 322 (76) 298 (60) 322 (66) 498 (100) 490 (100) 128 (61) 212 (61) 211 (100) 345 (loo) Worked only in Chemical (or Film) Plant and, at least, from 1983- 1998 177 (27) 269 (41) 177 (46) 269 (63) 128 (26) 212 (43) 128 (61) 212 (61) BACK TO MAIN Table 2 3M Company EPI-OOO4 Page 53 of 114 EmploymentStatus by Gender and Plant of Study Comparison Group A, January 1, 1993 and December 31,1998 January 1, 1993 Active h a ctive Not yet hired Retired Terminated Deceased Transferred TOTAL Male 361 (68) 12 (2) 157 (30) 0 (0) 0 (0) 0 (0) 0 (0) 530 (100) Chemical Female 66 (54) 8 (7) 48 (39) 0 (0) 0 (0) 0 (0) 0 (0) 122 (100) Total 427 (65) 20 (3) 205 (31) 0 (0) 0 (0) 0 (0) 0 (0) 652 (100) Male Film Female Total 0 (0) - 558 (100) 0 (0) 101 (100) 0 (0) 659 (100) December 31,1998 Active Inactive Not yet hired Retired Terminated Deceased Transferred TOTAL 511 (78) 29 (4) 0 (0) 72 (11) 23 (4) 7 (1) 10 (2) 652 (100) BACK TO MAIN Table 3 3M Company EPI-OOO4 Page 54 of 114 Employment Status by Gender and Plant of Study Comparison Group B, January 1,1993 and December 31, 1998 January 1,1993 Active Inactive Not yet hired Retired Terminated Deceased Transferred TOTAL Male 169 (54) 8 (3) 134 (43) 0 (0) 0 (0) 0 (0) 0 (0) 311 (100) Chemical Female 33 (43) 3 (4) 41 (53) 0 (0) 0 (0) 0 (0) 0 (0) 77 (100) Total 202 (52) 11 (3) 175 (45) 0 (0) 0 (0) 0 (0) 0 (0) 388 (100) Male 260 (71) 12 (3) 92 (25) 0 (0) 0 (0) 0 (0) 0 (0) - 364 (100) Film Female 36 (60) 0 (0) 24 (40) 0 (0) 0 (0) 0 (0) 0 (0) 60 (100) Total 296 (70) 12 (3) 116 (27) 0 (0) 0 (0) 0 (0) 0 (0) 424 (100) December31, 1998 Active Inactive Not yet hired Retired Terminated Deceased Transferred TOTAL 243 (78) 12 (4) 0 (0) 37 (12) 11 (4) 2 (1) 6 (2) 311 (100) 58 (75) 7 (9) 0 (0) 8 (10) 2 (3) 0 (0) 2 (3) 77 (100) 301 (78) 19 (5) 0 (0) 45 (12) 13 (3) 2 (1) 8 (2) 388 (100) BACK TO MAIN Table 4 3M Company EPI-OOO4 Page 55 of 114 Employment Status by Gender and Plant Comparison Group C, January 1, 1993 and December 31,1998 January 1,1993 Active Inactive Not yet hired Retired Terminated Deceased Transferred TOTAL Male 273 (65) 11 (3) 139 (33) 0 (0) 0 (0) 0 (0) 0 (0) 423 (100) Chemical Female 35 (47) 7 (9) 33 (44) 0 (0) 0 (0) 0 (0) 0 (0) 75 (100) Total 308 (62) 18 (1) 172 (35) 0 (0) 0 (0) 0 (0) 0 (0) 490 (100) Male 323 (76) 20 (5) 82 (19) 0 (0) 0 (0) 0 (0) 0 (0) - 425 (100) Film Female 47 (72) 2 (3) 16 (25) 0 (0) 0 (0) 0 (0) 0 (0) 65 (100) Total 370 (76) 22 (4) 98 (20) 0 (0) 0 (0) 0 (0) 0 (0) 498 (100) December 3 1, 1998 Active Inactive Not yet hired Retired Terminated Deceased Transferred - TOTAL i BACK TO MAIN Table 5 3M Company EPI-OOO4 Page 56 of 114 Employment Status by Gender and Plant of Study Comparison Group D, January 1,1993 and December 31,1998 Transferred TOTAL 0 (0) 196 (100) 0 (0) 15 (100) 0 (0) 211 (100) 0 (0) 308 (100) 0 (0) 37 (100) 0 (0) 345 (100) Study Group A Study Group B Study Group C Study Group D \ Cohort Size 652 388 498 21 1 BACK TO MAIN Table 6 Number of Inpatient and Outpatient Claims by Plant by Four Study Groups 1993 - 1998 3M Company EPI-OOO4 Page 57 of 114 Chemical Plant Total Number of Claiins Inpatient Outpatient Average Personear Inpatient Outpatient 204 34,053 0.05 8.7 91 17,655 0.04 7.6 156 24,036 0.05 8.0 81 13,743 0.06 10.9 Cohort Size 659 424 490 345 Film Plant Total Number of Claims Inpatient Outpatient 237 40,174 152 24,05 1 183 30,010 131 23,572 Average PersodYear Inpatient Outpatient 0.06 10.2 0.06 9.5 0.06 10.2 0.06 11.4 Table 7 BACK TO MAIN 3M Company EPI-OOO4 Page 58 of 114 Observed, Expected and Unique Number of Individuals by Plant with Risk Ratios of Episode of Care (with and without correction factor) and 95% Confidence Interval of Risk Ratio (not corrected) for CCG Specialty Category, Category, and Class Descriptions Study Comparison Group A (All Employee Study Subjects) i CCG Specialty Category, Category and Class Description 1. Infectious Diseases Mycoses Septicemia Chemical Unique Number of Obs Exp Individuals (%) Film Unique Number of Obs Exp Individuals (%) RREDCcr m , c 95% CI 582 599.6 3 1.7 1 3.0 680 612.7 5 2.0 4 3.8 1 .o 0.9 - 0.8 1.0 0.7 0.7 0.1 - 3.6 0.3 0.3 0.0 - 3.2 Tuberculosis 1 1.2 1 1.3 HIV 0 0.6 0 0.6 Viral Infections, other Other infections 0 1.9 577 591.1 0 1.8 670 603.2 430 (64) 1.o 0.9 0.8 - 1.0 2. Cancers and Benign Growths 303 270.7 273 320.4 174 (64) 1.4 1.3 1.1 - 1.6 Neoplasms of the head and neck Neoplasms of the gastrointestinaltract 3 1.3 58 29.8 0 1.8 53 40.8 0 (-1 41 (77) > 2.3 1.6 > 2.3 1.5 0.6- lo00 1.0- 2.2 Malignant neoplasm of colon 4 1.8 Malignant neoplasm of liver 0 0.5 Malignant neoplasm of pancreas 1 0.4 Malignant neoplasm of rectum and anus 4 1.3 0 (-1 1 (loo) 4 1 2.4 1 0.6 0 0.6 3 1.8 1(1W 1 (loo) 0 (-) 3 (100) 6.5 5.4 0.5 - 265 - - 2.2 1.8 0.3 - 12.4 Carcinoma in situ, digestive tract 1 0.5 1 (loo) 1 0.7 1 (loo) Benign c I nic polyps 48 Neoplasms of the respiratory tract 2 Malignant tract f neo lasm of lower respiratory 2 Neoplasms of bones and connective tissue 1 Malignant neoplasm of bone 1 Neoplasms of skin 116 Malignant melanoma of skin 5 Malignant neoplasm of skin other than 17 melanoma Benign neoplasm of skin 94 Neoplasms of the breast and 33 female reproductive system Malignant neoplasm of female breast 2 Malignant neoplasm of body of uterus 1 Benign neoplasm of breast 10 Benign ovarian cyst 12 Benign neoplasm of ovary other than 1 cyst Uterine leiomyoma 7 Neoplasms of the urinary tract 0 Malignant neoplasm of bladder 0 Malignant neoplasm of kidney 0 24.6 2.5 2.1 0.6 0.6 97.9 2.2 23.8 71.9 40.8 3.5 0.4 16.8 8.6 0.9 9.7 1.8 1 .o 0.7 Table 7 (continued) BACK TO MAIN 47 33.7 1 3.3 1 2.8 0 0.8 0 0.8 108 114.1 0 2.6 26 31.6 82 79.8 24 41.6 0 4.0 0 0.4 10 17.6 5 7.7 0 0.8 9 10.1 2 2.4 1 1.5 1 0.9 3M Company EPI-OOOQ Page 59 of 114 1.5 3.3 3.3 1.3 > 2.3 0.9 1.3 1.4 I .4 2.6 2.7 1.3 > 2.3 0.9 I .3 1.4 0.9-2.1 0.1 - 155 0.1 - 158 - - 1.0 - 1.6 1.0-63 0.5 - 1.7 0.9- 1.7 0.8 - 2.5 1.1 1.1 0.4- 2.8 2.0 2.2 0.7 - 7.8 0.8 0.8 0.3- 2.4 0.0 0.0 - 0.0 7.2 Neoplasms of male reproductive system Malignant neoplasm of prostate Malignant neoplasm of testicle Neoplasms of the frervous system Malignant neoplasm of CNS, primary Neoplasmsof endocrineorgans Malignant neoplasm of thyroid Other neoplasms Malignant neoplasm, other Malignent neoplasm, unspecified and secondary Metastatic cancers other than lymph nodes Carcinoma in situ other than skin, respiratory or gastrointestinal Other benign or unspecified neoplasm Neoplasms of the hematologic system Leukemia, chronic Lymphoma Multiple myeloma Myeloproliferative syndrome 3. Endocrine Disorders Disorders of the thyroid 7 3.7 5 3.1 2 0.6 1 1.6 1 1.3 1 1.o 1 1.o 77 85.3 5 5.5 0 0.8 6 4.4 0 3.0 66 71.7 4 4.4 0 0.8 3 2.4 1 0.4 0 0.4 370 367.3 31 51.2 0 (-> 1 (loo) 0 (-) 224 (61) 22 (71) BACK TO MAIN 5.3 4.7 0.6 1.9 1.6 1.1 1.1 101.9 6.7 1.o 5.6 1 3.3 85.4 5.2 1.1. 2.8 1 0.5 2 0.4 453 438.8 33 57.1 3M Company EPI-OOOQ Page 60 of 114 10.1 10.0 1.3 -447 7.8 7.7 0.9-364 1.3 1.2 0.9 - 1.7 1.6 1.5 0.3 - 7.7 1.6 1.6 0.4 - 6.4 1.3 I .3 0.9 - 1.8 0.6 0.5 0.1 - 1.9 0.0 0.0 0.0 - 3.1 1.4 I .2 0.2 - 8.7 - 1 .o 1.o 0.9 - 1.1 1.1 1.1 0.6 - 1.8 Acquired hypothyroidism with surgery Hyperthyroidism other than in pregnancy Thyroid nodule, benign nontoxic t Thyroiditis ' Diabetes Diabetes Type I with complications Diabetes Type I without complications Diabetes Type I1 with complications Diabetes Type I1 without complications Disorders of lipid metabolism (hyperlipidemia) Fluid and electrolyte disorders Other endocrine or nutritional disorders Adrenal insufficiency Hyperparathyroidism Hypoglycemia Obesity Osteoporosis Other endocrine, nutritional and metabolic disorders 4. Hematologic Disorders Anemia, acquired 24 38.8 4 6.7 1 3.2 2 2.5 69 66.7 4 2.5 10 10.0 11 14.6 44 39.5 157 139.2 21 17.9 92 92.4 0 0.5 1 0.7 8 6.9 43 41.4 2 2.9 38 40.0 44 46.4 9 8.6 Table 7 (continued) 21 (88) 23 4 (loo) 5 BACK TO MAIN 43.4 23 (100) 7.5 5 (loo) 1(W 2 41 (59) 4 (loo) 10 (loo) 11 (100) 40 (91) 141 (90) 3 3.5 2 2.7 91 84.4 1 3.2 12 12.3 15 19.1 63 49.9 194 172.7 3 (10) 2 (100) 62 (68) l(1oo) 12 (100) 15 (100) 60 (95) 173 (89) 16 (76) 78 (85) 0 (-1 1 (1W 7 (88) 42 (98) 2 (100) 37 (97) 28 20.9 107 103.7 1 0.5 2 0.8 12 7.6 46 45.0 3 3.4 43 46.1 23 (82) 86 (80) 1 (loo) 2 (loo) 10 (75) 43 (93) 3 (loo) 41 (93) 36 (82) 9 (loo) 43 53.0 5 9.8 39 (91) 5 (1oO) 3M Company EPI-OOO4 Page 61 of 114 1.2 1.2 0.6 - 2.1 0.9 0.9 0.2 -4.1 0.4 0.4 0.0 - 4.6 1.o 1.1 0.1 - 15.1 1 .o 1 .o 0.7 - 1.3 5.8 5.1 0.5 - 247 1.1 1.o 0.4 - 2.6 1 .o 1.o 0.4 - 2.2 0.9 0.9 0.6 - 1.3 1.o 1.o 0.8 - 1.3 0.9 0.9 0.5 - 1.6 1.o 1.o 0.7 - 1.3 0.8 0.6 0.0- 12 0.8 0.7 0.3 - 2.0 1.1 1 .o 0.7 - 1.6 0.9 0.8 0.1 - 7.0 1.o 1.o 0.6 - 1.6 1.2 1.2 0.8 - 1.8 1.9 2.1 0.6 - 7.8 Disorders of hemostatic function Other hematologicdisorders 5. Psychiatric Disorders Affective disorders, Depression, major without psychotic behavior Depression, minor Dissociativeand personalitydisorders Neurotic disorders (anxiety disorders) Organic mental disorders Psychotic disorders Substance abuse 6a. Neurologic Disorders Congenitalor acquired central degenerative disorders Benign essential tremor Parkinson's disease Hemorrhage, cerebrovascular, or other major CNS disorders Other diseases of the nervous system Migraine Tension headache Peripheral neuromuscular disorders 2 0.9 33 36.7 389 398.4 138 150.8 81 60.3 47 76.8 3 4.0 45 55.4 1 2.2 0 3.2 201 178.8 186 211.4 19 13.3 2 1.9 17 9.1 18 18.3 86 94.3 42 37.1 6 10.4 63 82.4 Table 7 (continued) 1 (50) 30 (91) 218 (56) 105 (76) 77 (95) 0 38 ' 368 113 66 BACK TO MAIN 1.1 42.0 427.9 158.1 64.1 0 (-1 36 (95) 204 (55) 84 (74) 63 (95) 45 (96) 42 (93) 155 (77) 129 (69) 17 (89) 36 79.5 4.0 46 59.1 3 .O 3.4 200 196.3 236 236.9 22 14.9 34 (94) 3 (loo) 43 (93) 1 2 (100) 144 (72) 160 (68) 21 (95) 2.3 2 (100) 10.1 19 (100) 24 19 (73) 69 (80) 37 (88) 4 (67) 57 (90) 100 101.5 36 37.8 5 10.9 87 92.9 82 (82) 31 (86) 4 (80) 79 (91) 3M Company FiPI-OOO4 Page 62 of 114 0.2 - lo00 1.1 I .o 0.6 - 1.6 1.2 1.1 1.0- 1.3 * 1.4 1.3 1.0 - 1.7 1.4 1.3 0.9 - 1.8 1.5 1.4 0.9 - 2.1 1.1 I .o 0.1 - 7.4 1.1 1.o 0.7 - 1.6 - 1.2 1.1 0.9 - 1.4 0.9 0.9 0.7 - 1.1 1.o I .o 0.5 - 1.9 1.1 1.2 0.1 - 16.4 1.o 1 .o 0.5 - 2.0 1 .o 0.9 0.5 - 1.7 0.9 0.9 0.7 - 1.3 1.1 1.2 0.8 - 1.9 1.2 I .3 0.3 - 5.2 0.9 0.8 0.6- 1.1 Neuralgia, neuritis, radicolitis Carpal tunnel syndrome 6b. Opthamologic Disorders Disorders of the e$, Cataract Conjunctivitis, acute Glaucoma 7. Cardiovascular Disorders Hypertension Atherosclerotic coronary vascular disease and cardiac arrest Carditis and cardiomyopathy/C-IF Disorders of heart valves Dysrhythmia and conduction disorders Large arterial and peripheral vascular disorders Large vein thromboembolic disorders Minor venoudarterial disorders Other cardiovascular disorders 8a. Pulmonary Disorders Lower respiratory infections Obstructive pulmonary diseases 42 59.8 18 18.7 166 267.7 166 267.7 14 15.3 20 46.7 8 17.9 413 423 157 149.4 82 76.1 8 11.9 20 12.3 14 22.8 3 5.2 5 9.0 2 15.2 122 120.5 849 691.8 315 305.0 53 60.2 Table 7 (continued) 42 (100) 66 18 (100) 20 116 (70) 220 116 (70) 220 14 (100) 14 20 (loo) 31 8 (loo) 19 234 (57) 57 1 145 (92) 203 51 (62) 134 BACK TO MAIN 67.7 20.8 302.3 302.3 20.7 50.2 22.4 533 185.4 102.6 62 (94) 20 (100) 155 (70) 155 (70) 13 (93) 29 (94) 18 (95) 282 (49) 186 (92) 65 (49) 7 (88) 19 (95) 12 (86) 3 (100) 15 16.2 20 15.3 18 29.8 4 7.2 11 (73) 20 (100) 17 (94) 4 (100) 3 (60) 2 (1W 102 (84) 381 (45) 181 (57) 46 (87) 9 10.8 1 17.2 167 147.9 897 757.6 327 337.9 60 68.7 8 (89) 1 (100) 130 (78) 394 (44) 181 (55) 55 (92) 3M Company EPI-OOO4 Page 63 of 114 0.8 0.7 0.5- 1.1 1 .o 1 .o 0.5 - 2.0 0.9 0.9 0.7- 1.1 0.9 0.9 0.7 - 1.1 1.4 1.4 0.6 - 3.1 0.7 0.7 0.4 - 1.3 0.6 0.5 0.2 - 1.3 1 .o 0.9 0.8- 1.0 1 .o 1 .o 0.8 - 1.2 0.9 0.8 0.6 - 1.1 0.7 0.7 0.3 - 1.8 1.2 1.2 0.6 - 2.4 1.2 1.o 0.5 - 2.1 1.1 1.1 0.2 - 6.2 0.8 0.7 0.2 - 2.2 2.2 2.3 0.1 - 133 1.o 0.9 0.7 - 1.1 1.1 1.O 0.9 - 1.1 1.1 1.1 0.9 - 1.3 1.1 1 .o 0.7 - 1.5 Table 7 (continued) BACK TO MAIN Asthma Chronic obstructive puImonary disease Other pulmonary disorders \ Atelectasis Painful respiration Pleurisy with or without effusion Pulmonary eosinophilia Other disorders of the respiratory system Pulmonary edema Respiratory failure Sleep disorders 8b. Ear, Nose and Throat Disorders Disorders of the ear and vestibular apparatus Upper respiratory infections Pharyngitis, acute Sinusitis, acute Chronic sinusitis, with surgery Upper respiratory infection and common cold, acute Other upper respiratorydisorders 23 30 459 4 29 7 7 409 2 0 20 1443 233 1020 223 384 95 299 190 36.9 23.3 307.7 3.6 21.8 10.4 3.1 264.3 7.4 0.4 11.1 1347.3 267.3 888.1 212.2 27 1.9 82.2 302.5 191.8 22 (96) 30 (100) 329 (72) 4 (100) 21 (72) 3 (43) 7 (loo) 3 11 (76) 2 0 (-) 20 (100) 398 (28) 137 (59) 328 (32) 119 (53) 116 (43) 93 (98) 128 (43) 162 (85) 28 39.5 32 29.2 482 327.5 4 4.6 35 24.7 14 12.1 10 3.9 411 276.8 3 9.5 1 0.5 24 13.6 1620 1437.8 267 293.2 1116 940.1 202 215.8 426 290.2 108 89.0 368 326.8 237 204.4 27 (96) 31 (97) 344 (71) 4 (100) 33 (94) 9 (64) 10 (loo) 327 (80) 3 (loo) 1(10) 23 (96) 418 (26) 160 (60) 355 (32) 116 (57) 166 (39) 106 (98) 152 (41) 184 (78) 3M Company EPI-OoO4 Page 64of 114 1.o 0.9 0.5 - 1.6 1.2 1.2 0.7 - 2.0 1.1 1.o 0.9 - 1.2 1.2 1.3 0.2 -7.0 1.1 0.9 0.6 - 1.6 0.7 0.6 0.2 - 1.5 0.9 0.9 0.3- 2.6 1.1 1.o . 0.9- 1.2 0.8 0.9 0.1 - 7.4 1.1 1.o 0.5 - 1.9 1.o 1.o 0.9 - 1.0 1 .o I .o 0.8 - 1.2 1.o 1.o 0.9 - 1.1 1.2 1.1 0.9 - 1.4 1.o 1.o 0.8 - 1.1 1.1 1 .o 0.7 - 1.3 1 .o 0.9 0.8- 1.0 0.9 0.9 0.7 - 1.0 Table 7 (continued) BACK TO MAIN 3M Company EPI-OoO4 Page 65 of 114 Allergic rhinitis 9. Gastrointestinal Disorders Disorders of esophagus Disorders of stom&h and duodenum Disorders of the small intestine Hernias Inflammatory bowel disease Disorders of the large intestine Disorders of the liver Cihosis of liver without mention of alcohol 162 163.5 631 520.5 80 51.7 65 48.0 2 4.4 27 34.3 13 8.6 153 107.8 3 6.0 2 0.9 149 (92) 264 (42) 68 (85) 53 (82) 2 (loo) 23 (85) 193 173.3 755 604.3 109 61.2 112 55.7 4 4.6 59 42.0 7 9.6 176 129.9 3 6.9 0 1.1 170 (88) 306 (41) 89 (82) 75 (40) 3 (75) 49 (83) 7 (1co 121 (69) 3 (1W 0 (-1 0.9 0.9 0.7 - 1.1 1.o 1.o 0.9 - 1.1 0.9 0.9 0.6- 1.2 0.7 0.7 0.5 - 0.9 0.6 0.5 0.1 - 3.6 0.6 0.6 0.4 - 0.9 2.1 2. I 0.8 - 6.1 1.1 1.1 0.8 - 1.3 1.3 1.2 0.2 - 8.6 Hepatitis, acute alcoholic 0 0.3 1 0.4 Hepatitis, acute without hepatic coma 0 2.5 2 2.7 Hepatitis, chronic without hepatic coma 1 1.6 Disorders of the biliary tract 26 25.7 13 (50) 0 1.8 20 30.6 1.7 I .6 0.8 - 2.9 Cholecystitis without cholelithiasis, acute 1 2.2 2 2.7 0.7 0.6 0.0- 12 Cholecystitits without choleithiasis, chronic or other Cholelithiasiswith acute cholecystitits Cholelithiasis with chronic or unspecified cholecystitits 5 4.0 7 4.2 8 9.1 4 4.7 1 5.2 6 10.7 1.6 1.5 0.3 - 7.3 10.1 8.6 1.1 - 380.7 1.7 1.6 0.5 -5.5 Cholelithiasiswithout cholecystitis 5 6.1 7 7.3 0.9 0.9 0.2 - 3.1 Disorders of the pancreas Pancreatis, acute Pancreatis, chronic Other gastrointestibl disorders loa. UrologicDisorders Disorders of renal function Chronic renal failure Disorders of renal parenchyma Renal cyst Lower and unspecified urinary tract infections Cystitis Urinary tract, not specified Other disordersof the lower urinary tract Urethra stricture Other disorders of the upper urinary tract Calculus of urinary tract Other genitourinarydisorders Other diseases with surgery Upper urinary tract infections Acute pyelonephritis Disorders of the prostate 7 4.2 6 3.6 1 0.6 255 229.9 41 1 269.0 5 3.9 4 2.6 3 1.7 3 I .7 127 94.5 56 23.3 71 71.2 2 4.3 2 4.3 73 32.2 73 32.2 62 48.5 62 48.5 7 4.0 7 4.0 132 79.8 Table 7 (continued) 3 3 0 262 48 1 2 1 1 1 107 BACK TO MAIN 5.4 4.7 0.7 258.5 318.4 4.9 3.1 2.1 2.1 99.3 19 (34) 47 (66) 2 (W 2 (100) 34 (47) 34 (47) 60 (97) 60 (97) 6 (86) 6 (86) 83 (63) 40 24.3 67 75.1 15 4.9 15 4.9 85 38.9 85 38.9. 81 57.1 81 57.1 7 4.3 7 4.3 183 106.8 31 (78) 45 (67) 14 (93) 14 (93) 44 (52) 44 (52) 79 (98) 79 (98) 5 (71) 5 (71) 113 (62) 3M Company EPI-OOO4 Page 66 of 114 2.5 3 .O 0.7 - 18 2.1 2.6 0.6 - 15.8 - 1.2 1.1 0.9 - 1.3 1.1 1 .o 0.9 - 1.2 3.2 3.1 0.5 - 33 5.2 4.9 0.5 - 238 3.5 3.7 0.3 - 192 3.5 3.7 0.3 - 192 1.3 1.3 1.0 - 1.6 1.5 1.5 1.0-2.2 1.1 1.1 0.8 - 1.6 0.2 0.2 0.0 - 0.7 0.2 0.2 0.0 - 0.7 1.1 1.o 0.8 - 1.4 1.1 1.O 0.8 - 1.4 1.o 0.9 0.6 - 1.3 1 .O 0.9 0.6 - 1.3 1.1 1.1 0.3 - 3.5 1.1 1.1 0.3 - 3.5 1.o 1 .o 0.8 - 1.2 Table 7 (continued) BACK TO MAIN 3M Company EPI-OOO4 Page 67 of 114 Prostatic hyperplasia 59 40.6 Prostatitis, acute 73 39.2 lob. Gynecologic and Reproductive Disorders 354 378.4 53 (95) 55 (58) 182 (51) 83 58.1 100 48.7 323 374.1 1.o I .o 0.7 - 1.4 1 .o 0.9 0.7 - 1.2 1.2 1.1 0.9- 1.3 Disorders of the fefnale breast (nonmalignant) 32 29.8 28 (88) 21 31.3 1.6 1.6 0.9 - 2.9 Fibrocystic disease of breast Infections of the female genital tract 27 21.4 32 44.7 26 (96) 22 (69) 16 22.3 24 39.7 16 (100) 18 (75) 1.8 1.8 0.9 - 3.4 1.3 1.2 0.7 - 2.1 Menopausal and menstrual disorders 44 74.0 34 (77) 42 75.8 31 (74) 1.1 1.1 0.7 - 1.7 Other gynecologicdisorders 112 106.1 75 (67) 81 101.3 61 (75) 1.3 1.3 1.0- 1.8 Endometriosis Fertility and infertility management Contraceptiveor procreative management 11 6.1 134 123.8 41 51.8 11 (loo) 109 (81) 40 (98) 6 5.5 155 126.0 28 38.6 6 (100) 125 (81) 28 (100) 1.7 1.7 0.6 - 5.4 1 .o 0.9 0.7 - 1.1 1.1 1.1 0.7 - 1.8 Infertility female Impotence of organic origin 2 4.2 47 26.3 2 (100) 45 (96) 2 2.9 51 36.0 2 (100) 50 (98) 0.6 0.7 0.1 - 9.7 1.2 I .3 0.8 - 1.9 Other disorders of the male reproductive 44 41.6 system 42 (95) 74 48.5 71 (96) 0.8 0.7 0.5 - 1.0 11. Pregnancy Complicatedpregnancy or delivery 40 44.7 29 30.2 23 26.3, 16 18.6 1 .o I .o 0.6 - 1.8 1 .o 1.1 0.6 - 2.2 Diabetes, gestational 1 0.6 0 0.3 Multiple gestational 0.5 0 0.2 Postpartum hemorrhage 1.8 1 1.3 Pregnancy with abortion 2.8 1 1.8 1.5 1.9 0.2 - 101 Table 7 (continued) BACK TO MAIN 3M Company EPI-OOO4 Page 68 of 114 Pregnancy, ectopic 1 0.4 1 (loo) 0 0.2 Preterm labor 7 3.1 3 (43) 1 1.7 3.6 3.9 0.5 - 172 Other conditions during pregnancy Normal or unspecikd pregnancy and delivery 15 20.5 11 14.5 12 (80) 9 (82) 13 12.6 7 7.7 0.6 0.7 0.3.- 1.6 * 0.9 0.8 0.3 - 2.6 Spontaneous abortion Pregnancy 12. Dermatologic Disorders Dermatologic infections Disorders of the hair and nails 2 1.2 9 13.3 870 936.5 282 289.3 15 32.8 2 (loo) 9 (100) 351 (40) 164 (58) 13 (87) 0 0.7 7 7.0 929 1035.5 286 320.6 20 36.6 0 (-1 5 (71) 369 (40) 165 (58) 17 (85) 0.7 0.7 0.2 - 2.2 1.1 1.o 0.9- 1.1 1.2 1.1 0.9 - 1.3 1 .o 0.8 0.4 - 1.7 Immune mediated skin conditions Other dermatologic conditions 13. Musculoskeletal Disorders Acute or unspecified arthropathies and minor tendonitis 134 160.0 439 454.4 1396 1420.0 128 169.7 85 (63) 266 (61) 365 (26) 87 (68) 133 175.2 490 503.2 1741 1587.1 205 193.4 82 (62) 290 (59) 426 (24) 125 (61) 1.2 1.1 0.9 - 1.4 1.1 1.o 0.9- 1.1 1 .o 0.9 0.8 - 1.0 0.8 0.7 0.6 - 0.9 Crystalline arthritis 17 15.2 16 (94) 25 19.1 22 (88) 0.9 0.9 0.4 - 1.6 Degenerativejoint disorders,other than spine 65 80.8 50 (77) 115 96.6 97 (84) 0.7 0.7 0.5 - 0.9 Disorders of the spine 388 351.7 209 (54) 499 389.4 235 (47) 0.9 0.9 0.8 - 1.0 Vasculitis and connective tissue disorders Other 14. Congenital Anomalies Congenital Anomalies 13 9.5 785 793.2 25 28.4 25 28.4 13 (100) 295 (38) 25 (100) 25 (100) 18 11.1 879 877.5 27 31.2 27 31.2 16 (89) 340 (39) 26 (96) 26 (96) 0.9 0.9 0.4 - 1.8 1.1 1.o 0.9 - 1.1 1.1 1.o 0.6-1.8 1.1 1.o 0.6-1-8 Atrial septal defect Other cardiovascular'congenital abnormalities fB Other congeni 1 abnormalitieswith admittance '>. Other respiratory congenital abnormalities 15. Perinatal Disorders Conditionsoriginating in the perinatal period 16. Miscellaneous Other miscellaneousconditions Routine health care Symptomsor signs Abdominal pain Chest pain, unspecified Fever Headache with radiology Malaise and fatigue Syncope and collapse Symptoms,signs and ill - defined conditions 17. Injury and Poisoning Major traumatic injury Table 7 (continued) BACK TO MAIN 0 0.3 2 3.0 22 24.3 1 0.6 0 (-) 2 (loo) 22 (loo) 1(1oo) 1 0.4 5 3.8 20 26.2 1 0.7 2.7 2.7 1620 427 235 1193 199 186 20 130 65 19 574 1692.1 707.6 308.3 984.5 143.3 133.1 16.5 114.0 66.6 18.6 490.9 5 15 787.3 121 224.2 506 (31) 287 (67) 220 (94) 461 (39) 139 (70) 125 (67) 20 (loo) 76 (58) 55 (85) 15 (79) 409 (71) 259 (50) 85 (70) 4 2.6 1697 455 254 1242 180 209 28 120 66 19 620 1867.3 773.0 328.4 1094.3 159.9 162.3 18.2 120.2 73.4 22.0 536.3 616 844.5 140 241.0 525 (31) 319 (70) 233 (92) 480 (39) 127 (71) 132 (63) 28 (100) 70 (58) 57 (86) 15 (79) 431 (70) 294 (48) 106 (76) 3M Company EPI-OOO4 Page 69 of 114 0.6 0.5 0.1 -3.1 1.2 I .2 0.6 - 2.3 0.2 0.2 0.0- 2.4 0.2 0.2 0.0 - 2.4 1.1 1.1 1.0- 1.1 1.1 1.o 0.9 - 1.2 1.o 1 .o 0.8 - 1.2 1.1 1.1 1.0- 1.2 1.4 1.2 1.0 - 1.5 1.1 1.1 0.9 - 1.3 0.8 0.8 0.4 - 1.5 1.2 1.1 0.9 - 1.5 1.1 1.o 0.8 - 1.6 1.2 1.2 0.6 - 2.3 1.1 1.o 0.9 - 1.1 1 .o 0.9 0.8- 1.0 1.o 0.9 0.7- 1.2 Minor traumatic injury Other injury Table 7 (continued) BACK TO MAIN 3M Company EPI-OOO4 Page 70 of 114 284 445.1 110 118.1 178 (63) 97 (88) 363 473.4 113 130.1 219 (60) 94 (83) 0.9 0.8 0.7 - 1.0 1.2 1.1 0.8 - 1.4 Table 8 BACK TO MAIN 3M Company EPI-0004 Page 71 of 114 Observed, Expected and Unique Number of Individuals by Plant with Risk Ratios of Episode of Care (with and without correction factor) and 95% Confidence Interval of Risk Ratio (not corrected) for CCG Specialty Category, Category, and Class Descriptions Study Comparison Group B (Only Chemical or Only Film Employees) CCG Specialty Category, Category and Class Description 1. Infectious Diseases Mycoses Septicemia Tuberculosis HIV Viral infections, other Other infections 2. Cancers and Benign Growths Neoplasms of the head and neck Neoplasmsof the gastrointestinaltract Malignant neoplasm of colon Malignant neoplasm of liver Malignant neoplasm of pancreas Malignant neoplasm of rectum and anus Carcinoma in situ, digestive tract Chemical Unique Number of Obs Exp Individuals (%) 315 315.5 1 0.9 1 1.6 0 0.6 0 0.3 0 1.o 313 311.0 167 145.9 1 0.8 30 16.5 3 1.o 0 0.3 0 0.2 3 0.7 0 0.3 225 (71) 1 (100) 1 (100) 0 (-1 0 (-1 0 (-1 225 (72) 109 (65) 1 (100) 21 (70) 3 (100) 0 (-> 0 (-1 3 (100) 0 (-1 Film Unique Number of Obs Exp Individuals (%) RRE& 437 385.7 285 (65) 1.o 2 1.2 2 (1W 0.7 4 2.2 4 (100) 0.4 0 0.8 0 (-1 0 0.3 0 (-1 0 1.2 0 (-1 431 379.9 284 (66) 1.o 166 190.5 109 (66) 1.3 0 1.o 0 (-1 29 23.2 26 (90) I .5 0 1.5 0 (-1 >3.0 1 0.4 1 (100) 0 0.4 0 (-1 1 1.o l(lO0) 4.2 0 0.4 0 (-1 RRE& 0.9 0.6 0.3 0.9 1.3 1.5 3 .O 4.1 95% CI 0.8 - 1.0 0.0 - 12.4 0.0 - 3.5 0.8 - 1.0 1.1 - 1.6 0.9 - 2.5 0.6 - 43 0.3 - 217 Benign colonic polyps 24 13.6 Neoplasms of the respiratory tract 0 1.4 Malignant neoplasm of lower respiratory 0 1.1 tract Neoplasms of bones and connective tissue 0 0.3 Malignant neoplasm of bone 0 0.3 Neoplasms of skin 70 52.1 Malignant melanoma of skin 4 1.2 Malignant neoplasm of skin other than melanoma 10 13.0 Benign neoplasm of skin 56 37.9 Neoplasms of the breast and female reproductive system 16 22.1 Malignant neoplasm of female breast 2 1.9 Malignant neoplasm of body of uterus 0 0.2 Benign neoplasm of breast 7 9.1 Benign ovarian cyst 3 4.6 Benign neoplasm of ovary other than cyst 0 0.5 Uterine leiomyoma Neoplasms of the urinary tract 4 5.3 0 1.o Malignant neoplasm of bladder 0 0.6 Malignant neoplasm of kidney 0 0.4 Table 8 (continued) 27 0 0 BACK TO MAIN 19.2 24 (89) 1.3 1.9 0 (-1 1.4 0 (-1 0 0.4 0 0.4 65 69.9 0 1.7 13 18.5 0 (-1 0 (-> 57 (88) 0 (-1 11 (85) 1.4 > 3.3 1.1 52 49.8 50 (96) 1.4 13 23.6 13 (100) 1.4 0 2.2 0 (-) 0 0.2 0 (-1 5 10.0 5 (100) 1.7 2 4.5 2 (100) 1.3 0 0.5 0 (-) 6 5.7 6 (100) 0.7 2 1.4 2 (100) 1 0.8 1(100) 1 0.5 1 (100) 3M Company EPI-0004 Page 72 of 114 1.3 0.7 - 2.2 1.4 > 3.3 1.1 1.4 1.3 1.0 - 2.1 0.9 - 59 0.4 - 2.7 1.0 - 2.1 0.6 - 3.0 1.5 0.4 - 6.2 1.5 0.2 - 18 0.7 0.2 - 3.0 Neoplasms of male reproductive tract Malignant neoplasm of prostate Malignant neoplasm of testicle Neoplasms of the nervous system Malignant neoplasm of CNS, primary Neoplasms of endocrine organs Malignant neoplasm of thyroid Other neoplasms Malignant neoplasm, other Malignant neoplasm, unspecified and secondary Metastatic cancers other than lymph nodes Carcinoma in situ, other than skin, respiratory or gastrointestinal Other benign or unspecified neoplasm Neoplasms of the hematologic system Leukemia, chronic Lymphoma Multiple myeloma Myeloproliferative syndrome 3. Endocrine Disorders Disorders of the thyroid 4 2.1 3 1.8 1 0.3 1 0.9 1 0.7 0 0.5 0 0.5 41 45.9 3 3.0 0 0.4 0 2.4 0 1.6 38 38.4 4 2.3 0 0.4 3 1.2 1 0.2 0 0.2 194 197.0 18 27.5 BACK TO MAIN Table 8 (continued) 1 3.0 5.4 1 2.5 4.2 0 0.4 0 1.1 0 0.9 0 0.7 0 0.7 49 61.1 1.1 4 3.9 1.o 0 0.6 3 3.2 0.0 1 1.9 41 51.5 1.3 7 3.2 0.8 2 0.6 2 1.7 2.3 1 0.3 2 0.3 25 1 263.6 1.1 18 33.6 1.2 3M Company EPI-0004 Page 73 of 114 5.7 0.6 - 276 4.3 0.3 - 224 1.1 0.7 - 1.7 1.o 0.2 - 5.9 0.0 0.0 - 3.2 1.2 0.8 - 2.0 0.8 0.2-3.1 2.1 0.2 - 25.2 1.o 0.9 - 1.3 1.2 0.6 - 2.5 Acquired hypothyroidism with surgery Hyperthyroidism other than in pregnancy Thyroid nodule, benign nontoxic Thyroiditis Diabetes Diabetes Type I with complications Diabetes Type I without complications Diabetes Type I1 with complications Diabetes Type I1 without complications Disorders of lipid metabolism (hyperlipidemia) Fluid and electrolyte disorders Other endocrine or nutritional disorders Adrenal insufficiency Hyperparathyroidism Hypoglycemia Obesity Osteoporosis Other endocrine, nutritional and metabolic disorders 4. Hematologic Disorders Anemia, acquired 14 20.9 2 3.6 1 1.7 1 1.3 27 36.1 1 1.4 3 5.4 6 8.0 17 21.4 93 74.4 8 9.6 48 49.3 0 0.3 1 0.4 4 3.6 20 21.9 1 1.6 22 21.5 22 24.9 5 4.7 BACK TO MAIN Table 8 (continued) 12 (86) 2 (100) 13 25.5 13 (100) 1.3 2 4.4 2 (1W 1.1 1(W 1 2.1 1 (loo) 1 (100) 2 1.6 2 (100) 0.7 17 (63) 52 50.0 35 (67) 0.8 1(100) 0 1.9 0 (-1 3 7 7.5 7 (loo) 0.7 6 (loo) 7 11.1 7 (100) 1.3 16 (94) 38 29.6 35 (92) 0.6 83 (89) 104 105 92 (88) 1.3 4 (50) 43 (90) 0 (-1 1 (loo) 3 (79) 20 (100) 1 (100) 22 (100) 17 12.3 15 (88) 0.6 60 62.7 48 (80) 1.1 0 0.3 0 (-1 0 0.5 0 (-1 8 4.8 6 (75) 0.7 27 27.6 24 (89) 1.o 3 1.9 3 (100) 0.4 22 27.6 21 (95) 1.4 20 (91) 5 (100) 26 31.6 22 (85) 1.2 4 5.8 4 (100) 1.6 3M Company EPI-0004 Page 74 of 114 1.3 0.6 - 3.0 1.2 0.1 - 17 0.6 0.0 - 11.6 0.7 0.4 - 1.2 0.6 0.1 - 2.6 1.2 0.3 -4.1 0.6 0.3 - 1.1 1.3 0.9 - 1.7 0.6 0.2 - 1.5 1.o 0.7 - 1.5 0.7 0.2 - 2.5 0.9 0.5 - 1.7 0.4 0.0 - 5.0 1.3 0.7 - 2.4 1.1 0.6 - 2.0 1.6 0.3 - 7.8 Other hematologic disorders 5. Psychiatric Disorders Affective disorders Depression, major without psychotic behavior Depression, minor Dissociative and personality disorders Neurotic disorders (anxiety disorders) Organic mental disorders Psychotic disorders Substance abuse 6a. Neurologic Disorders Congenital or acquired central degenerative disorders Benign essential tremor Parkinson's disease Hemorrhage, cerebrovascular, or other major CNS disorders Other diseases of the nervous system Migraine Tension headache Peripheral neuromuscular disorders Neuralgia, neuritis, radiculitis 17 19.7 181 209.5 60 78.9 34 31.7 22 40.1 1 2.1 20 29.0 1 1.2 0 1.7 98 94.5 84 112.4 7 7.0 0 1.o 7 4.8 7 10.1 42 50.1 16 19.6 0 5 .O 28 43.5 17 31.6 BACK TO MAIN Table 8 (continued) 16 (94) 22 25.2 20 (91) 1.1 106 (59) 229 268.1 127 (55) 1.1 47 (78) 74 100.2 52 (70) 1.1 33 (97) 42 40.2 40 (95) 1.1 21 (95) 25 50.8 24 (96) 1.2 1(1W 2 2.6 2 (1W 0.5 19 (95) 29 37.4 26 (90) 0.9 1 1 1.7 1(1W 0 (-) 79 (81) 1 2.1 1(100) 120 121.4 87 (73) 1.1 59 (70) 136 144.5 90 (66) 0.8 7 (100) 13 9.2 13 (100) 0.7 1 (100) 7 (100) 7 (100) 34 (81) 15 (94) 0 (-> 25 (89) 17 (100) 1 1.4 1 (1oo) 12 6.3 12 (100) 0.8 19 13.8 13 (68) 0.5 54 62.0 43 (80) 1.o 22 23.3 19 (86) 0.8 4 6.0 3 (77) 0.0 50 57.5 43 (86) 0.7 38 41.9 35 (92) 0.6 3M Company EPI-0004 Page 75 of 114 1.o 0.5 - 1.9 1.o 0.8 - 1.2 1.o 0.7 - 1.5 1.o 0.6 - 1.7 1.1 0.6-2.1 0.6 0.0 - 12.2 0.9 0.5 - 1.6 1.1 0.8 - 1.4 0.8 0.6 - 1.1 0.7 0.2 - 1.9 0.8 0.3 - 2.1 0.5 0.2 - 1.2 1.o 0.6 - 1.5 0.9 0.4 - 1.7 0.0 0.0- 1.8 , 0.7 0.5 - 1.2 0.6 0.3 - 1.1 Carpel tunnel syndrome 6b. Opthamologic Disorders Disorders of the eye Cataract Conjunctivitis, acute Glaucoma 7. Cardiovascular Disorders Hypertension Atherosclerotic coronary vascular disease Carditis and cardiomyopathy/CHF Disorders of heart valves Dysrhythmia and conduction disorders Large arterial and peripheral vascular disorders Large vein thromboembolic disorders Minor venoudarterial disorders Other cardiovasculardisorders Sa. Pulmonary Disorders Lower respiratory infections Obstructivepulmonary diseases Asthma Chronic obstructive pulmonary disease 10 9.9 91 142.7 91 142.7 10 8.5 11 24.6 5 9.6 216 229.4 81 80.1 38 41.7 6 6.6 6 6.7 7 12.5 2 2.9 1 4.8 2 8.2 73 65.2 430 365.8 149 161.3 29 32.1 15 19.4 14 12.7 BACK TO MAIN Table 8 (continued) 10 (100) 12 12.7 12 (100) 1.1 64 (70) 120 184.0 95 (79) 1.o 64 (70) 120 184.0 95 (79) I .o 10 (100) 7 11.4 6 (86) 2.0 11 (100) 18 31.0 17 (94) 0.8 5 (1W 10 13.4 10 (100) 0.7 122 (56) 326 315.6 165 (51) 0.9 76 (94) 122 111.8 114 (93) 0.9 24 (63) 80 60.0 34 (43) 0.7 5 (83) 10 9.1 7 (70) 0.8 6 (100) 9 8.9 9 (loo) 0.9 6 (86) 8 17.3 8 (1W 1.2 2 (loo) 1 4.0 1 (loo) 2.8 l(lO0) 3 6.4 3 (10) 0.5 2 (loo) 0 10.1 0 (-) 61 (84) 93 87.3 73 (78) 1.1 202 (47) 524 468.6 240 (46) 1.1 91 (61) 196 208.5 114 (58) 1.o 25 (86) 39 41.7 34 (87) 1.1 15 (100) 14 24.6 13 (93) 1.5 14 (100) 25 17.1 24 (96) 0.8 3M Company EPI-0004 Page 76 of 114 1.1 0.4 - 2.7 1.o 0.7 - 1.3 1.o 0.7 - 1.3 1.9 0.7 - 5.9 0.8 0.3 - 1.7 0.7 0.2 - 2.2 0.9 0.8 - 1.1 0.9 0.7 - 1.2 0.7 0.5 - 1.0 0.8 0.3 - 2.5 0.9 0.3 - 2.8 1.2 0.4 - 3.8 2.8 0.1 - 162 0.4 0.0 - 5.5 1.1 0.8 - 1.4 1.1 0.9 - 1.2 1.o 0.8 - 1.2 1.o 0.6 - 1.6 1.4 0.6 - 3.0 0.8 0.4 - 1.5 Other pulmonary disorders Atelectasis Painful respiration Pleurisy with or without effusion Pulmonary eosinophilia Other disorders of the respiratory system Pulmonary edema Respiratory failure Sleep disorders 8b. Ear, Nose and Throat Disorders Disorders of the ear and vestibular apparatus Upper respiratory infections Pharyngitis, acute Sinusitis, acute Sinusitis, chronic with surgery Upper respiratory infection and common cold, acute Other upper respiratory disorders Allergic rhinitis 9. Gastrointestinal Disorders Disorders of esophagus 236 162.3 4 1.9 13 11.5 0 5.5 4 1.7 215 139.2 1 4.0 0 0.2 15 5.9 699 707.1 119 140.6 490 465.7 113 110.7 191 142.8 44 43.2 136 159.0 90 100.8 81 85.9 320 277.0 37 27.5 BACK TO MAIN Table 8 (continued) 170 (72) 275 204.1 198 (72) 1.2 4 (100) 9 (69) 3 2.7 3 (100) 2.2 18 15.2 16 (89) 1.o 0 (-1 8 7.3 5 (63) 0.0 4 (100) 5 2.3 5 (100) 1.2 163 (76) 240 173.3 190 (79) 1.2 l(lO0) 2 5.5 2 (100) 0.7 0 (-1 1 0.3 1(1W 15 (100) 11 8.4 10 (91) 2.0 221 (32) 941 906.1 256 (27) 1.o 72 (61) 150 184.1 95 (63) 1.1. 175 (36) 649 593.4 198 (31) 1.o 64 (57) 124 138.3 71 (57) 1.1 91 (48) 220 182.1 96 (44) 1.1 43 (98) 63 56.1 61 (97) 0.9 62 (46) 232 205.1 93 (40) 0.8 82 (91) 142 128.6 I12 (79) 0.8 77 (95) 116 109.0 102 (88) 0.9 139 (43) 467 369.6 187 (40) 1.o 34 (92) 61 37.5 53 (87) 0.8 3M Company EPI-0004 Page 77 of 114 1.1 0.9 - 1.3 1.9 0.3 - 12.6 1.0 0.4 - 2.0 0.0 0.0 - 0.8 1.1 0.2 - 5.0 1.1 0.9 - 1.4 0.7 0.0 - 13 2.0 0.8 - 4.7 1.o 0.9 - 1.1 1.o 0.8 - 1.3 1.o 0.9 - 1.1 1.1 0.9 - 1.5 1.1 0.9 - 1.4 0.9 0.6 - 1.4 0.8 0.6 - 0.9 0.8 0.6 - 1.1 0.9 0.7 - 1.2 0.9 0.8 - 1.1 0.8 0.5 - 1.3 Disorders of stomach and duodenum Disorders of the small intestine Hernias Inflammatory bowel disease Disorders of the large intestine Disorders of the liver Cirrhosis of liver without mention of alcohol Hepatitis, acute alcoholic Hepatitis, acute without hepatic coma Hepatitis, chronic without hepatic coma Disorders of the biliary tract Cholecystitis without cholelithiasis, acute Cholecystitis without cholelithiasis, chronic or other Cholelithiasis with acute cholecystitis Cholelithiasis with chronic or unspecified cholecystitis Cholelithiasis without cholecystitis Disorders of the pancreas Pancreatitis, acute Pancreatitis, chronic 31 25.5 1 2.3 15 18.3 3 4.5 77 57.8 3 3.1 2 0.5 0 0.2 0 1.3 1 0.9 18 13.9 0 1.2 3 2.2 6 2.3 5 4.9 4 3.3 7 2.3 6 2.0 1 0.3 BACK TO MAIN Table 8 (continued) 75 34.0 0.5 4 3.0 0.4 34 25.7 0.6 5 6.0 0.9 105 78.6 1.o 3 4.4 1.3 0 0.7 1 0.2 2 1.8 0 1.2 1 1 17.8 2.5 1 1.5 1 2.8 4.6 1 3.0 8.8 3 6.3 2.5 5 4.2 I .3 3 3.2 3.8 3 2.8 3.3 0 0.4 3M Company EPI-0004 Page 78 of 114 0.6 0.4 - 0.9 0.3 0.0 - 3.3 0.6 0.3 - 1.2 0.8 0.1 -4.1 1.o 0.7 - 1.4 1.4 0.2- 11 0.4 - 27.2 2.1 0.9 - 4.9 3.8 0.3 - 198 7.8 0.9 - 358 2.13 0.4 - 13.7 1.o 0.2 - 4.8 3.3 0.8 - 20 2.8 0.6 - 17.2 Other gastrointestinaldisorders loa. Urologic Disorders Disorders of renal function Chronic renal failure Disorders of renal parenchyma Renal cyst Lower and unspecified urinary tract infections Cystitis Urinary tract, not specified Other disorders of the lower urinary tract Urethral stricture Other disorders of the upper urinary tract Calculus of urinary tract Other genitourinarydisorders Other diseases with surgery Upper urinary tract infections Acute pyelonephritis Disorders of the prostate Prostatic hyperplasia Prostatitis, acute 128 121.8 273 144 4 2.1 3 1.4 1 0.9 1 0.9 96 50.7 47 12.5 49 38.1 1 2.3 1 2.3 51 17.0 51 17.0 34 25.9 34 25.9 4 2.2 4 2.2 82 43.3 29 22.6 53 20.7 BACK TO MAIN Table 8 (continued) 98 (77) 166 159.5 131 (79) 1.1 97 (36) 303 192.0 124 (41) 1.2 3 (75) 1 3.0 1(1W 5.8 3 (75) 1 1.9 1 (loo) 4.2 1 (10(3 1 1.3 1 (loo) 1 (loo) 1 1.3 1(100) 36 (38) 73 59.0 44 (60) 1.6 13 (28) 27 14.3 20 (74) 1.9 29 (59) 46 44.7 32 (70) 1.3 1 Uoo) 1 (100) 11 3.1 11 (100) 0.1 11 3.1 11 (100) 0.1 18 (35) 56 24.3 30 (54) 1.4 18 (35) 56 24.3 30 (54) 1.4 33 (97) 49 34.6 48 (98) 0.9 33 (97) 49 34.6 48 (98) 0.9 3 (75) 6 2.6 4 (67) 0.9 3 (75) 6 2.6 4 (67) 0.9 48 (59) 106 64.1 63 (59) 1.2 25 (86) 42 33.3 39 (93) 1.o 29 (55) 64 30.8 38 (59) 1.3 3M Company EPI-0004 Page 79 of 114 1.o 0.8 - 1.3 1.2 1.0 - 1.4 5.6 0.6 - 271 4.2 0.4 - 104 1.5 1.1 -2.1 2.0 1.2 - 3.3 1.3 0.8 - 1.9 0.1 0.0 - 0.9 0.1 0.0 - 0.9 1.3 0.9 - 1.9 1.3 0.9 - 1.9 0.9 0.6 - 1.5 0.9 0.6 - 1.5 0.8 0.2 - 3.4 0.8 0.2 - 3.4 1.1 0.9 - 1.5 1.o 0.6 - 1.7 1.2 0.8 - 1.8 lob. Gynecologicand ReproductiveDisorders Disorders of the female breast (non-malignant) Fibrocystic disease of breast Infections of the female genital tract Menopausal and menstrual disorders Other gynecologic disorders Endometriosis Fertility and infertility management Contraceptiveor procreative management Infertility female Impotence of organic origin Other disorders of the male reproductive system 11. Pregnancy Complicated pregnancy or delivery Diabetes, gestational Multiple gestational Postpartum hemorrhage Pregnancy with abortion Pregnancy, ectopic Preterm labor 187 203.1 18 16.1 15 11.6 18 24.2 29 40.1 60 57.3 6 3.3 62 65.4 23 27.1 1 2.3 20 14.4 18 21.7 25 24.1 19 16.3 1 0.3 1 0.3 1 1.o 2 1.5 1 0.2 4 1.7 BACK TO MAIN Table 8 (continued) 99 (53) 192 223.1 122 (64) 1.1 16 (89) 13 17.7 11 (85) 1.5 14 (93) 10 12.5 10 (100) 1.6 13 (72) 10 23.5 9 (90) 1.7 21 (72) 15 42.6 13 (87) 2.0 43 (55) 46 58.5 35 (76) 1.3 6 (loo) 3 3.2 3 1(@3 1.9 53 (85) 108 80.8 86 (80) 0.8 23 (100) 21 26.4 21 (100) 1.1 1(100) 19 (95) 17 (94) 2 2.0 2 (100) 0.4 32 21.3 31 (97) 0.9 53 31.1 50 (94) 0.5 22 18.5 0.8 15 12.9 0.9 0 0.2 0 0.2 1 0.9 1 1.2 1.4 0 0.2 1 1.3 2.8 3M Company EPI-0004 Page 80 of 114 1.1 0.9 - 1.3 1.5 0.7 - 3.3 1.6 0.7 - 4.1 1.7 0.8 - 4.2 2.0 1.1 -4.0 1.3 0.9 - 2.0 2.0 0.4 - 12.1 0.7 0.5 - 1.0 1.1 0.6 - 2.0 0.4 0.0 - 8.5 0.9 0.5 - 1.7 0.5 0.3 - 0.9 0.9 0.5 - 1.6 1.o 0.5-2.1 1.6 0.1 - 94 3.0 0.3 - 144 Other conditions during pregnancy Normal or unspecified pregnancy and delivery Spontaneous abortion Pregnancy 12. Dermatologic Disorders Dermatologic infections Disorders of the hair and nails Immune mediated skin conditions Other dermatologic conditions 13. Musculoskeletal Disorders Acute or unspecified arthropathies and minor tendonitis Crystalline arthritis Degenerativejoint disorders, other than spine Disorders of the spine Vasculitis and connective tissue disorders Other 14. Congenital Anomalies Congenital Anomalies Atrial septal defect 9 11.0 6 7.8 Table 8 (continued) 9 (100) 12 5 (83) 7 BACK TO MAIN 8.7 0.6 5.6 0.6 1 0.7 1 (100) 0 0.5 0 (-) 5 7.1 5 (100) 7 5.1 5 (71) 0.5 448 495.4 185 (41) 574 641.7 229 (40) 1.1 148 152.7 84 (57) 177 199.8 98 (55) 1.2 11 17.5 9 (82) 12 22.0 10 (83) 1.4 61 84.5 43 (70) 89 108.7 55 (62) 1.o 228 240.8 136 (60) 296 311.2 177 (60) 1.o 592 749.9 200 (34) 1099 981.7 260 (24) 0.8 70 89.5 48 (69) 131 119.8 79 (60) 0.7 14 8.1 39 43.5 13 (93) 31 (79) 13 11.8 12 (92) 1.5 63 57.0 54 (86) 0.9 180 184.8 101 (56) 305 244.0 150 (49) 0.8 5 5.1 5 11 6.6 10 (91) 0.6 284 418.9 149 (52) 576 542.5 207 (36) 0.7 11 15.0 11 (100) 19 19.3 19 (100) 0.8 11 15.0 11 (100) 19 19.3 19 (100) 0.8 0 0.2 0 (-1 1 0.2 1 (100) 3M Company EPI-0004 Page 81 of 114 0.6 0.2 - 1.5 0.6 0.2 - 2.2 0.5 0.1 - 1.9 1.o 0.9 - 1.2 1.1 0.9 - 1.4 1.2 0.5 - 2.9 0.9 0.6 - 1.2 1.o 0.8 - 1.2 0.7 0.6 - 0.8 0.7 0.5 - 1.0 1.6 0.7 - 3.6 0.8 0.5 - 1.2 0.8 0.7 - 0.9 0.6 0.2 - 1.9 0.6 0.6 - 0.7 0.8 0.3 - 1.7 0.8 0.3 - 1.7 Other cardiovascularcongenital abnormalities Other congenital abnormalities with admittance Other respiratory congenital abnormalities 15. Perinatal Disorders Disorders originating in the perinatal period 16. Miscellaneous Other miscellaneous conditions Routine health care Symptoms or signs Abdominal pain Chest pain, unspecified Fever Headache with radiology Malaise and fatigue Syncope and collapse Symptoms, signs and ill-defined conditions 17. Injury and Poisoning Major traumatic injury Minor traumatic injury 2 1.6 9 12.8 0 0.3 1 1.4 1 1.4 867 897.0 240 375.5 138 163.3 627 521.6 106 76.1 106 71.1 10 8.7 65 60.2 35 35.4 8 10.0 297 259.2 263 411.3 62 117.1 140 232.1 Table 8 (continued) 2 (100) 3 BACK TO MAIN 2.3 3 (loo) 1.o 9 (loo) 15 16.3 15 (100) 0.8 0 (-1 0 0.4 0 (-1 1 (100) 3 1.6 3 (1W 0.3 1 (100) 3 1.6 3 (loo) 0.3 279 (32) 1066 1151.8 333 (31) 1.1 160 (67) 286 476.4 203 (71) 1.1 130 (94) 160 203.8 149 (93) 1.1 251 (40) 780 675.3 302 (39) 1.1 72 (72) 113 98.0 78 (69) 1.3 67 (63) 130 98.5 81 (62) 1.2 10 (100) 15 11.4 15 (100) 1.o 38 (58) 80 74.2 46 (58) 1.1 28 (80) 35 44.8 33 (94) 1.3 6 (75) 10 13.3 8 (80) 1.o 221 (74) 397 333.9 269 (68) 1.o 126 (48) 381 536.4 176 (46) 1.o 38 (61) 85 153.2 64 (75) 1.o 86 (61) 226 301.9 136 (60) 0.9 3M Company EPI-0004 Page 82 of 114 0.9 0.1 - 8.0 0.8 0.3 - 1.9 0.4 0.0 - 4.7 0.4 0.0 - 4.7 1.o 1.0- 1.1 1.1 0.9 - 1.3 1.1 0.9 - 1.4 1.o 0.9 - 1.2 1.2 0.9 - 1.6 1.1 0.9 - 1.5 0.9 0.4-2.1 1.o 0.7 - 1.4 1.3 0.8-2.1 1.1 0.4 - 3.0 1.o 0.8 - 1.1 0.9 0.8 - 1.1 1.o 0.7 - 1.3 0.8 0.7 - 1.0 Other injury 61 62.1 BACK TO MAIN Table 8 (continued) 52 (85) 70 81.4 57 (81) 1.2 3M Company EPI-0004 Page 83 of 114 1.1 0.8 - 1.6 Table 9 BACK TO MAIN 3M Company EPI-0004 Page 84 of 114 Observed, Expected and Unique Number of Individuals by Plant with Risk Ratios of Episode of Care (with and without correction factor) and 95% Confidence Interval of Risk Ratio (not corrected) for CCG Specialty Category, Category, and Class Descriptions Study Comparison Group C (High Exposure Employees) CCG Specialty Category, Category and Class Description 1. Infectious Diseases Mycosis Septicemia Tuberculosis HIV Viral infections, other Other Infections 2. Cancers and Benign Growths Neoplasms of the head and neck Neoplasms of the gastrointestinal tract Malignant neoplasm of colon Malignant neoplasm of liver Malignant neoplasm of pancreas Malignant neoplasm of rectum and anus Carcinoma in situ, digestive tract Chemical Unique Number of Obs Exp Individuals (%) Film Unique Number of Obs Exp Individuals (%) 445 425.5 3 1.2 1 2.1 1 0.8 0 0.4 0 1.4 439 417.1 20 1 181.9 3 0.9 42 20.3 3 1.2 0 0.3 1 0.3 3 0.9 0 0.3 492 432.5 3 1.4 3 2.8 0 1.o 0 0.5 0 1.3 482 423.2 193 230.3 0 1.3 34 30.2 1 1.9 1 0.4 0 0.5 3 1.3 1 0.5 317 (64) 3 (1W 3 (100) 0 (-1 0 (-1 0 (-1 316 (65) 122 (63) 0 (-1 26 (76) 1(100) 1 (100) 0 (-1 3 (100) l(100) m,c, m, 95%CI 1.o 0.9 0.8 - 1.1 1.4 1.2 0.2 - 9.2 0.4 0.4 0.0 - 5.5 1.o 0.9 0.8 - 1.1 1.4 1.3 1.1 - 1.6 > 3.3 0.6 - > 150 2.0 1.8 1.2 - 3.0 5.5 4.5 0.4 - 238.4 1.8 1.5 0.2 - 11.4 Benign colonic polyps Neoplasms of the respiratory tract Malignant neoplasm of lower respiratory tract Neoplasms of bones and connective tissue Malignant neoplasm of bone Neoplasms of skin Malignant melanoma of skin Malignant neoplasm of skin other than melanoma Benign neoplasm of skin Neoplasms of the breast and female reproductive system Malignant neoplasm of female breast Malignant neoplasm of body of uterus Benign neoplasm of breast Benign ovarian cyst Benign neoplasm of ovary other than cyst Uterine leiomyoma Neoplasms of the urinary tract Malignant neoplasm of bladder Malignant neoplasm of kidney Neoplasms of male reproductive tract BACK TO MAIN Table 9 (continued) 35 16.8 28 25.0 2.0 1 1.6 1 2.4 1 1.2 1 1.9 0 0.4 0 0.4 75 68.8 4 1.6 11 16.6 0 0.6 0 0.6 81 82.8 0 1.9 22 23.4 0 (-1 0 (-1 67 (83) 0 (-) 18 (82) 1.1 > 2.5 0.8 60 50.6 21 22.9 59 57.4 56 (95) 1.1 18 27.4 16 (89) 1.3 1 1.9 0 2.7 1 0.2 0 0.3 7 9.4 8 11.7 1.0 8 5.1 3 4.9 3.1 0 0.5 0 4 5.3 7 6.6 0.7 0 1.2 1 1.8 0 0.7 0 1.1 0 0.5 1 0.7 5 2.6 1 4.0 8.6 3M Company EPI-0004 Page 85 of 114 1.9 1.1 - 3.2 1.1 > 2.5 0.7 0.8 - 1.5 0.8 - 51 0.3 - 1.5 1.2 0.8 - 1.7 1.4 0.7 - 2.74 1.1 0.3 - 1.5 2.6 0.6 - 15.1 0.7 0.2 - 2.8 7.6 0.9 - 359 BACK TO MAIN Table 9 (continued) Malignant neoplasm of prostate 4 2.1 1 3.5 7.3 Malignant neoplasm of testicle Neoplasms of the nervous system 1 0.5 1 1.o 0 0.4 1 1.4 Malignant neoplasm of CNS, primary 1 0.8 1 1.1 Neoplasms of endocrine organs 1 0.7 0 0.8 Malignant neoplasm of thyroid 1 0.7 0 0.8 Other neoplasms 50 58.4 49 73.8 1.3 Malignant neoplasm, other 2 3.7 3 4.8 0.9 Malignant neoplasm, unspecified and secondary 0 0.5 1 0.7 Metastatic cancers other than lymph nodes 5 2.8 3 4.1 2.4 Carcinoma in situ, other than skin, respiratory or gastrointestinal 0 1.9 0 2.2 Other benign or unspecified neoplasms 43 49.5 42 61.9 1.3 Neoplasms of the hematologic system 2 3.1 7 3.8 0.4 Leukemia, chronic Lymphoma 0 0.6 2 0.8 2 1.7 3 2.0 1.o Multiple myeloma 0 0.3 1 0.4 Myeloproliferative syndrome 0 0.3 1 0.3 3. Endocrine Disorders 256 249.2 344 317.1 1.o Disorders of the thyroid 17 32.0 25 39.8 0.8 Acquired hypothyroidism with surgery 15 24.2 17 30.2 1.1 3M Company EPI-0004 Page 86 of 114 6.7 0.7 - 325 1.3 0.9 - 2.0 0.9 0.1 - 7.7 2.4 0.5 - 15.5 1.3 0.8 - 2.0 0.4 0.0 - 1.9 0.8 0.1 - 6.9 1.o 0.8 - 1.1 0.8 0.4 - 1.6 1.1 0.5 - 2.3 BACK TO MAIN Table 9 (continued) Hyperthyroidism other than in pregnancy 1 4.3 l(lO0) 3 5.2 3 (100) 0.4 Thyroid nodule, benign nontoxic Thyroiditis Diabetes 0 2.0 0 (-1 3 2.4 3 (100) 0.0 1 1.6 1 (loo) 2 1.9 2 (loo) 0.4 57 46.2 36 (63) 78 62.0 54 (69) 1.o Diabetes Type I with complications 2 1.7 2 (100) 0 2.3 0 (-) Diabetes Type I without complications 8 7.1 8 (loo) 8 9.0 8 (loo) 1.3 Diabetes Type I1 with complication 8 10.1 8 (100) 14 14.1 14 (100) 0.8 Diabetes Type I1 without complications 39 27.3 35 (90) 56 36.5 53 (95) 1.o Disorders of lipid metabolism (hyperlipidemia) 109 97.7 99 (91) 144 126.9 127 (88) 1.o Fluid and electrolyte disorders 14 11.8 12 (86) 25 14.9 20 (80) 0.7 Other endocrine or nutritional disorders 59 61.4 51 (86) 72 73.5 58 (81) 1.o Adrenal insufficiency Hyperparathyroidism 0 0.3 0 (-1 0 0.4 0 (-) 1 0.4 2 0.6 1 Uoo) 2 (1W Hypoglycemia 4 4.8 4 (100) 7 5.5 6 (86) 0.7 Obesity 29 27.7 28 (97) 30 31.8 28 (93) 1.2 Osteoporosis Other endocrine, nutritional and metabolic disorders 1 1.6 1 (100) 3 2.4 3 (loo) 0.5 25 26.5 24 (96) 29 32.8 27 (93) 1.o 4. Hematologic Disorders Anemia, acquired Disorders of hemostatic function Other hematologic disorders 30 30.7 23 (77) 35 37.6 32 (91) 1.1 6 5.5 6 (loo) 5 6.9 5 (100) 1.2 2 0.6 1 (50) 0 0.8 0 (-1 22 24.5 19 (86) 30 30.0 29 (97) 1.o 3M Company EPI-0004 Page 87 of 114 0.4 0.0 - 5.1 0.0 0.0 - 3.0 0.6 0.0 - 11.5 1.o 0.7 - 1.4 1.3 0.4 - 3.9 0.8 0.3 - 2.0 0.9 0.6 - 1.4 1.o 0.8 - 1.3 0.7 0.4 - 1.4 I .o 0.7 - 1.4 0.7 0.1 - 2.5 1.1 0.7 - 1.9 0.5 0.0 - 6.1 1.1 0.6 - 1.9 1.1 0.6 - 1.8 1.5 0.4 - 6.3 0.9 0.5 - 1.6 5. Psychiatric Disorders Affective disorders Depression, major without psychotic behavior Depression, minor Dissociative and personality disorders Neurotic disorders (anxiety disorders) Organic mental disorders Psychotic disorders Substance abuse 6a. Neurologic Disorders Congenitalor acquired central degenerativedisorders Benign essential tremor Parkinson's disease Hemorrhage, cerebrovascular, or other major CNS disorders Other diseases of the nervous system Migraine Tension headache Peripheral neuromuscular disorders Neuralgia, neuritis, radiculitis Carpel Tunnel Syndrome BACK TO MAIN Table 9 (continued) 297 277.1 168 (57) 280 304.4 154 (55) 1.2 104 105.3 81 (78) 78 112.0 57 (73) 1.5 60 41.7 57 (95) 44 45.4 42 (95) 1.5 36 54.1 34 (94) 28 56.3 26 (93) 1.6 3 2.9 3 (100) 2 2.8 2 (100) 1.6 33 38.8 31 (94) 35 42.1 32 (91) 1.1 1 1.5 1 (100) 0 2.2 0 (-1 0 2.2 0 (-1 2 2.4 2 (lo(.)) 155 123.4 118 (76) 160 140.0 114 (71) 1.2 128 143.8 93 (73) 180 169.0 119 (66) 0.8 10 9.2 10 (100) 15 10.7 14 (93) 0.7 0 1.3 0 (-1 1 1.7 1 (100) 10 6.4 10 (100) 14 7.3 14 (100) 0.8 13 12.1 10 (77) 24 17.7 17 (71) 0.8 61 63.3 49 (80) 73 71.4 60 (82) 0.9 27 24.7 23 (85) 21 26.2 18 (86) 1.3 6 6.9 4 (67) 1 7.5 l(lO0) 5.6 44 56.9 41 (93) 68 66.7 62 (91) 0.8 29 41.7 29 (90) 50 48.8 47 (94) 0.7 13 12.4 13 (100) 17 14.8 17 (100) 0.9 3M Company EPI-0004 Page 88 of 114 1.2 1.0- 1.4 1.4 1.1- 1.9 1.5 1.0- 2.2 1.3 0.8 - 2.3 1.5 0.2 - 17.3 1.o 0.6 - 1.7 1.1 0.9 - 1.4 0.8 0.7 - 1.1 0.8 0.3 - 1.8 0.8 0.3 - 2.0 0.8 0.4 - 1.6 0.9 0.7 - 1.3 1.4 0.8 - 2.5 6.6 0.8 - 304 0.8 0.5 - 1.1 0.7 0.4 - 1.1 0.9 0.4 - 2.0 BACK TO MAIN Table 9 (continued) 6b. Opthamologic Disorders 118 185.3 80 (68) 153 216.8 108 (71) 0.9 Disorders of the eye Cataract 118 185.3 80 (68) 153 216.8 108 (71) 0.9 9 9.8 9 (loo) 13 15.1 12 (92) 1.o Conjunctivitis, acute 19 32.3 19 (100) 19 35.6 18 (95) 1.1 Glaucoma 7 12.3 7 (100) 12 16.4 12 (100) 0.8 7. Cardiovascular Disorders 322 290.2 175 (54) 4.43 390.5 222 (50) 1.o Hypertension 123 103.8 111 (90) 162 135.9 146 (90) 1.o Atheroscleroticcoronary vascular disease 67 53.3 39 (58) 106 76.3 50 (47) 1.o Carditis and cardiomyopathy/CHF Disorders of heart valves Dysrhythmia and conduction disorders 7 8.0 6 (86) 9 11.9 8 (89) 1.1 13 8.2 13 (100) 16 11.1 16 (100) 1.o 9 15.7 8 (89) 15 21.9 14 (93) 1.o Large arterial and peripheral vascular disorders 2 3.5 2 (loo) 3 5.3 3 (loo) 1.2 Large vein thromboembolicdisorders 3 6.0 2 (67) 6 7.8 6 (loo) 0.7 Minor venous/arterial disorders Other cardiovasculardisorders 0 9.6 0 (-1 0 12.1 0 (-1 98 81.3 81 (83) 126 107.2 100 (79) 1.1 Sa. Pulmonary Disorders 643 481.3 287 (45) 681 540.9 293 (43) 1.1 Lower respiratory infections 246 211.3 138 (56) 262 241.6 140 (53) 1.1 Obstructive pulmonary diseases 42 41.3 35 (83) 47 49.3 44 (94) 1.2 Asthma 18 25.6 17 (94) 21 28.0 20 (95) 1.1 Chronic obstructivepulmonary disease 24 15.7 24 (100) 26 21.2 26 (100) 1.3 Other pulmonary disorders 340 215.4 247 (73) 353 232.7 254 (72) 1.1 3M Company EPI-0004 Page 89 of 114 0.9 0.7 - 1.2 0.9 0.7 - 1.2 1.1 0.4 - 2.7 1.1 0.6 - 2.2 0.8 0.3 - 2.1 1.o 0.9 - 1.1 1.o 0.8 - 1.3 0.9 0.7 - 1.2 1.2 0.4 - 3.5 1.1 0.5 - 2.4 0.8 0.3 - 2.0 1.o 0.1 -9.0 0.7 0.1 - 3.1 1.o 0.8 - 1.4 1.1 1.0- 1.2 1.1 0.9 - 1.3 1.1 0.7 - 1.7 1.o 0.5 - 1.8 1.3 0.7 - 2.3 1.o 0.9 - 1.2 BACK TO MAIN Table 9 (continued) Atelectasis Painful respiration 4 2.4 4 (loo) 3 3.4 3 (loo) 1.5 20 15.1 15 (75) 27 17.7 26 (96) 1.o Pleurisy with or without effusion 2 7.1 2 (loo) 8 8.7 7 (88) 0.2 Pulmonary eosinophilia 7 2.1 7 (100) 8 2.8 8 (1W 1.2 Other disorders of the respiratory system 304 185.6 231 (76) 302 196.0 240 (79) 1.2 Pulmonary edema Respiratory failure 2 5.0 2 (loo) 2 6.9 2 (100) 1.1 0 0.3 0 (-1 1 0.3 1 (10(3 Sleep disorders 13 8.1 13 (100) 16 10.1 15 (94) 1.1 8b. Ear, Nose and Throat Disorders 1048 952.0 293 (28) 1134 1025.9 306 (27) 1.1 Disorders of the ear and vestibular apparatus 167 190.3 98 (59) 183 211.0 116 (63) 1.1 Upper respiratory infections 747 625.7 249 (33) 789 669.1 245 (31) 1.1 Pharyngitis, acute 164 151.9 89 (54) 139 152.9 80 (57) 1.3 Sinusitis, acute 287 189.6 129 (45) 313 206.3 124 (40) 1.o Sinusitis, chronic with surgery 69 58.2 68 (99) 79 63.8 77 (97) 1.1 Upper respiratory infection and common cold, acute 215 212.1 96 (45) 249 233.3 113 (45) 1.1 Other upper respiratory disorders Allergic rhinitis 9. GastrointestinalDisorders Disorders of esophagus Disorders of stomach and duodenum Disorders of the small intestine 134 136.0 113 (84) 162 145.9 129 (80) 0.9 110 115.4 102 (93) 128 123.4 117 (91) 0.9 455 363.1 192 (42) 541 437.3 231 (43) 1.1 54 36.1 44 (81) 75 44.5 63 (84) 0.9 47 33.2 37 (79) 75 40.2 51 (68) 0.8 2 3.2 2 (100) 2 3.3 2 (loo) 1.2 3M Company EPI-0004 Page 90 of 114 1.9 0.3 - 12.9 0.9 0.5 - 1.6 0.3 0.0 - 1.5 1.2 0.4 - 3.7 1.1 0.9 - 1.3 1.4 0.1 - 19.1 1.o 0.5 - 2.2 1.o 0.9 - 1.1 1.o 0.8 - 1.3 1.o 0.9 - 1.1 1.2 0.9 - 1.5 1.o 0.9 - 1.2 1.o 0.7 - 1.3 1.o 0.8 - 1.1 0.9 0.7 - 1.1 0.9 0.7 - 1.2 1.o 0.9 - 1.2 0.9 0.6 - 1.3 0.8 0.5 - 1.1 1.0 0.1 - 14 Hernias Inflammatory bowel disease Disorders of the large intestine Disorders of the liver Cirrhosis of the liver without mention of alcohol Hepatitis, acute alcoholic Hepatitis, acute without hepatic coma Hepatitis, chronic without hepatic coma Disorders of the biliary tract Cholecystitis without cholelithiasis, acute Cholecystitis without cholelithiasis, chronic or other Cholelithiasiswith acute cholecystitis. Cholelithiasis with chronic or unspecified cholecystitis Cholelithiasiswithout cholecystitis Disorders of the pancreas Pancreatitis, acute Pancreatitis. chronic Other gastrointestinal disorders loa. Urologic Disorders Disorders of renal function BACK TO MAIN Table 9 (continued) 19 24.5 17 (89) 42 31.0 0.6 8 6.0 8 (100) 7 7.0 1.3 106 75.5 79 (75) 122 94.7 1.2 3 4.3 3 (1W 2 5.0 2.0 2 0.6 2 (100) 0 0.8 0 0.3 0 (-1 1 0.3 1 (100) 0 1.8 0 (-1 1 2.0 l(100) 1 1.2 1 (100) 0 1.3 0 (-1 22 16.7 11 (50) 17 21.8 10 (59) 1.8 1 1.4 1 (100) 2 1.9 2 (100) 0.8 5 2.6 5 (1W 4 3:3 4 (100) 1.8 7 2.8 10.9 6 5.9 2.1 3 3.9 3 (100) 6 5.2 0.7 7 3.0 1(14) 2 4.0 3.3 6 2.6 1(17) 2 3.4 2.9 1 0.4 l(lO0) 0 0.5 187 160.5 145 (78) 197 185.9 1.2 288 185.6 114 (40) 331 230.4 1.1 4 2.8 3 (75) 2 3.6 2.6 3M Company EPI-0004 Page 91 of 114 0.6 0.3 - 1.0 1.3 0.4 - 4.2 1.1 0.8 - 1.4 1.8 0.2 - 21 1.7 0.9 - 3.3 0.7 0.0 - 13.1 1.6 0.3 - 8.0 9.3 1.2 -415 1.9 0.5 - 9.3 0.7 0.1 - 3.1 4.7 0.9 - 46 4.0 0.7 - 41 1.1 0.9 - 1.4 1.1 0.9 - 1.3 2.6 0.4 - 29 BACK TO MAIN Table 9 (continued) Chronic renal failure 3 1.8 3 (1W 1 2.3 1 (100) 4.0 Disorders of renal parenchyma 3 1.2 3 (loo) 1 1.5 1 (loo) 3.6 Renal cyst 3 1.2 3 (100) 1 1.5 1 3.6 Lower and unspecified urinary tract infections 83 59.3 38 (46) 73 68.1 48 (66) 1.4 Cystitis 29 14.4 15 (52) 25 16.5 18 (72) 1.4 Urinary tract, not specified 54 44.9 31 (57) 48 51.6 35 (73) 1.3 Other disorders of the lower urinary tract 2 3.0 2 (100) 13 3.6 12 (92) 0.2 Urethral stricture 2 3.0 2 (100) 13 3.6 12 (92) 0.2 Other disorders of the upper urinary tract 58 23.8 24 (41) 60 28.8 31 (52) 1.3 Calculus of urinary tract 58 23.8 24 (41) 60 28.8 31 (52) 1.3 Other genitourinary disorders 39 33.8 38 (97) 61 41.4 60 (98) 0.8 Other diseases with surgery 39 33.8 38 (97) 61 41.4 60 (98) 0.8 Upper urinary tract infections 7 2.7 6 (86) 6 3.0 4 (67) 1.3 Acute pyelonephritis 7 2.7 6 (86) 6 3.0 4 (67) 1.3 Disorders of the prostate 92 59.1 61 (66) 115 80.4 84 (73) 1.1 Prostatic hyperplasia 43 29.2 38 (88) 60 43.8 57 (95) 1.1 Prostatitis, acute 49 29.9 35 (71) 55 36.6 40 (73) 1.2 lob. Gynecologic and Reproductive Disorders 225 236.4 117 (52) 232 25 1.2 137 (59) 1.1 Disorders of the female breast (non-malignant) 22 16.7 19 (86) 15 20.8 14 (93) 1.8 Fibrocystic disease of breast Fertility and infertility management 18 11.7 17 (94) 11 14.7 11 (100) 2.0 88 91.6 71 (81) 109 89.8 88 (81) 0.9 3M Company EPI-0004 Page 92 of 114 3.8 0.3 - 200 3.9 0.3 - 202 3.8 0.3 - 202 1.3 0.9 - 1.8 1.3 0.8 - 2.4 1.3 0.9 - 1.9 0.2 0.0 - 0.8 0.2 0.0 - 0.8 1.2 0.8 - 1.7 1.2 0.8 - 1.7 0.8 0.5 - 1.2 0.8 0.5 - 1.2 1.3 0.4 - 4.6 1.3 0.4 - 4.6 1.1 0.8 - 1.4 1.1 0.7 - 1.6 1.1 0.7 - 1.6 1.o 0.9 - 1.2 1.8 0.9 - 3.7 2.1 0.9 - 4.8 0.8 0.6 - 1.1 Contraceptive or procreative management Infertility female Impotence of organic origin Other disorders of the male reproductive system Infections of the female genital tract Menopausal and menstrual disorders Other gynecologic disorders Endometriosis 11. Pregnancy Complicated pregnancy or delivery Diabetes, gestational Multiple gestational Postpartum hemorrhage Pregnancy with abortion Pregnancy, ectopic Preterm labor Other conditions during pregnancy Normal or unspecified pregnancy and delivery Spontaneous abortion Pregnancy BACK TO MAIN Table 9 (continued) 23 37.4 19 24.8 0.8 2 2.9 1 1.8 1.7 36 19.3 38 27.1 1.3 27 32.0 51 36.1 0.7 19 26.6 27 40.4 69 61.1 8 3.6 19 31.4 14 21.1 1 0.4 1 0.3 0 1.2 0 1.9 0 0.3 6 2.2 6 14.3 5 10.4 0 0.9 5 9.5 19 25.2 29 49.7 60 65.6 3 3.5 6 14.7 4 10.6 0 0.2 0 0.2 0 0.8 0 1.o 0 0.2 0 0.9 4 7.1 2 4.1 0 0.4 2 3.7 1.1 1.1 1.2 3.4 1.9 2.2 > 2.7 0.9 1.s 1.5 3M Company EPI-0004 Page 93 of 114 0.8 0.4 - 1.5 1.2 0.1 - 73 1.3 0.8 - 2.2 0.6 0.4 - 1.0 1.0 0.5 - 1.9 1.1 0.7 - 2.0 1.2 0.9 - 1.8 2.6 0.6 - 15.2 1.s 0.6 -4.5 1.8 0.6 - 7.4 > 2.7 0.5 - 27 0.8 0.2 - 3.6 1.o 0.2 - 10.4 1.o 0.2 - 10 BACK TO MAIN Table 9 (continued) 12. Dermatologic Disorders 605 658.4 252 (42) 682 743.0 265 (39) 1.1 Dermatologic infections 204 205.4 115 (56) 215 230.8 125 (58) 1.2 Disorders of the hair and nails Immune mediated skin conditions Other dermatologic conditions 13. Musculoskeletal Disorders Acute or unspecified arthropathies and minor tendonitis 9 21.9 8 (89) 19 26.0 16 (84) 0.6 94 111.4 60 (64) 108 125.1 63 (58) 1.o 298 319.7 194 (65) 340 361.1 200 (59) 1.1 1081 980.8 274 (25) 1357 1137.3 316 (23) 1.o 105 118.2 70 (67) 157 139.5 91 (58) 0.9 Crystalline arthritis Degenerativejoint disorders, other than spine 10 11.1 44 53.0 9 (90) 33 (75) 15 14.2 15 (100) 0.8 90 69.2 74 (82) 0.7 Disorders of the spine 300 246.9 166 (55) 389 279.8 178 (46) 0.9 Vasculitis and connective tissue disorders 10 6.1 10 (100) 12 7.9 11 (92) 1.2 Other 612 545.4 222 (36) 694 626.5 252 (36) 1.1 14. Congenital Anomalies 19 19.6 19 (100) 17 22.3 16 (94) 1.2 Congenital Anomalies 19 19.6 19 (100) 17 22.3 16 (94) I .2 Atrial septal defect Other cardiovascular congenital abnormalities 0 0.2 1 2.1 0 (-) 1 (100) 0 0.3 0 (-) 4 2.8 4 (loo) 0.4 Other congenital abnormalities with admittance 17 16.8 17 (100) 12 18.6 12 (100) 1.5 Other respiratory congenital abnormalities 1 0.4 1 (100) 1 0.5 1 (100) 3M Company EPI-0004 Page 94 of 114 1.o 0.9 - 1.1 1.1 0.9 - 1.3 0.6 0.2 - 1.3 1.o 0.7 - 1.3 1.0 0.8 - 1.2 0.9 0.9 - 1.0 0.8 0.6 - 1.0 0.9 0.3 - 2.0 0.6 0.4 - 0.9 0.9 0.8 - 1.0 1.1 0.4 - 2.7 1.o 0.9 - 1.1 1.3 0.6 - 2.6 1.3 0.6 - 2.6 0.4 0.0 - 3.4 1.6 0.7 - 3.6 15. Perinantal Disorders Conditions originating in the perinatal period 16. Miscellaneous Other miscellaneous conditions Routine health care Symptomsor signs Abdominal pain Chest pain, unspecified Fever Headache with radiology Malaise and fatigue Syncope and collapse Symptoms,signs and ill-defined conditions 17. Injury and Poisoning Major traumatic injury Minor traumatic injury Other injury Table 9 (continued) 1 1 BACK TO MAIN 3 (loo) 0.2 3 (100) 0.2 1196 1169.0 379 (32) 1234 1332.7 387 (31) 1.2 273 486.6 195 (71) 297 549.5 214 (72) 1.1 152 212.2 144 (95) 161 232.1 149 (93) 1.1 923 682.3 351 (38) 937 783.2 358 (38) 1.2 146 98.1 109 (75) 133 114.2 93 (70) 1.4 146 93.0 100 (68) 169 118.7 102 (59) 1.2 17 11.8 17 (100) 18 13.1 18 (100) 1.o 104 76.1 58 (56) 84 84.1 48 (57) 1.4 44 44.7 35 (80) 57 52.0 49 (86) 0.9 19 13.0 15 (88) 15 16.0 11 (61) 1.6 447 344.6 3 12 (70) 46 1 383.7 321 (70) 1.2 416 561.0 210 (50) 464 605.4 223 (48) 1.1 96 159.7 70 (73) 109 172.8 82 (75) 1.o 227 317.7 143 (63) 271 339.0 167 (62) 1.o 93 83.6 81 (87) 84 93.5 70 (83) 1.4 3M Company EPI-0004 Page 95 of 114 0.3 0.0 - 3.8 0.3 0.0 - 3.9 1.1 1.0 - 1.2 1.o 0.9 - 1.2 1.o 0.8 - 1.3 1.1 1.0- 1.2 1.3 1.0- 1.6 1.1 0.9 - 1.4 1.1 0.5 - 2.1 1.4 1.0 - 1.8 0.9 0.6 - 1.4 1.6 0.8 - 3.2 1.1 1.0 - 1.2 1.o 0.9 - 1.1 1.0 0.7 - 1.3 0.9 0.8 - 1.1 1.2 0.9 - 1.7 Table 10 BACK TO MAIN 3M Company EPI-0004 Page 96 of 114 Observed, Expected and Unique Number of Individuals by Plant with Risk Ratios of Episode of Care (with and without correction factor) and 95% Confidence Interval of Risk Ratio (not corrected) for CCG Specialty Category, Category, and Class Descriptions Study Comparison Group D (Long-Tern High Exposure Employees) CCG Specialty Category, Category and Class Description 1. Infectious Diseases Mycoses Septicemia Tuberculosis HIV Viral infections, other Other infections 2. Cancers and Benign Growths Neoplasms of the head and neck Neoplasms of the gastrointestinaltract Malignant neoplasm of colon Malignant neoplasm of liver Malignant neoplasm of pancreas Malignant neoplasm of rectum and anus Carcinoma in situ, digestive tract Chemical Unique Number of Obs Exp Individuals (%) 217 190.2 2 0.6 1 1.3 0 0.4 0 0.2 0 0.5 214 187.2 113 98.1 0 0.6 33 13.2 3 0.8 0 0.2 1 0.2 3 0.6 0 0.2 149 (70) 2 (100) 1 (100) 0 (-1 0 (-1 0 (-1 148 (69) 76 (67) 0 (-1 22 (67) 3 (100) 0 (-1 1 (100) 3 (100) 0 (-1 Obs Exp Film Unique Number of Individuals (%) m c c r RRE,c 380 332.3 2 1.2 1 2.3 0 0.8 0 0.4 0 0.9 377 326.7 137 189.1 0 1.1 22 25.9 0 1.6 1 0.4 0 0.4 0 1.1 0 0.4 235 (62) 2 (100) 1 (100) 0 (-1 0 (-1 0 (-1 235 (62) 89 (65) 0 (-1 19 (86) 0 (-) 1 (100) 0 (-1 0 (-> 0 (-1 1.o 1.o 1.6 1.9 1.o 1.o 1.6 1.6 3.2 2.9 > 3.8 > 3.8 > 5.0 > 5.0 95% CI 0.8 - 1.2 0.1 - 26.5 0.8 - 1.2 1.2 - 2.1 1.7 - 5 .2 0.9 - 60 0.9 - 62 Benign colonic polyps Neoplasms of the respiratory tract Malignant neoplasm of lower respiratory tract Neoplasms of bones and connective tissue Malignant neoplasm of bone Neoplasms of skin Malignant melanoma of skin Malignant neoplasm of skin other than melanoma Benign neoplasm of skin Neoplasms of the breast and female reproductive system Malignant neoplasm of female breast Malignant neoplasm of body of uterus Benign neoplasm of breast Benign ovarian cyst Benign neoplasm of ovary other than cyst Uterine leiomyoma Neoplasms of the urinary tract Malignant neoplasm of bladder Malignant neoplasm of kidney Neoplasms of male reproductive tract BACK TO MAIN Table 10 (continued) 26 11.0 1 1.o 1 0.8 21 21.4 0 2.0 0 1.6 0 0.2 0 0.2 41 38.1 3 1.o 7 10.7 0 0.5 0 0.5 60 68.1 0 1.6 16 20.1 0 (-1 0 (-1 49 (82) 0 (-1 14 (88) 31 26.5 4 7.3 44 46.4 11 20.7 42 (95) 10 (91) 1 0.7 0 0.1 2 3.3 0 1.2 0 0.1 1 1.7 0 0.8 0 0.5 0 0.3 5 1.8 0 2.1 0 0.2 4 8.9 2 3.5 0 0.4 5 5 .O 1 1.5 0 0.9 1 0.6 1 3.4 2.7 1.3 > 3.0 1.o 1.3 1.o 1.1 0.0 0.6 10.3 3M Company EPI-0004 Page 97 of 114 2.4 1.3 - 4.5 1.2 > 3.0 0.8 1.2 1.o 0.8 - 1.9 0.8 - 52 0.3 - 2.1 0.8 - 2.0 0.2 - 3.5 1.4 0.1 - 9.6 0.0 0.0 - 15 0.6 0.0 - 5.3 9.7 1.1 - 458 BACK TO MAIN Malignant neoplasm of prostate Malignant neoplasm of testicle Neoplasms of the nervous system Malignant neoplasm of CNS, primary Neoplasms of endocrine organs Malignant neoplasm of thyroid Other neoplasms Malignant neoplasm, other Malignant neoplasm, unspecified and secondary Metastatic cancers other than lymph nodes Carcinoma in situ, other than skin, respiratory or gastrointestinal Other benign or unspecified neoplasms Neoplasms of the hematologic system Leukemia, chronic Lymphoma Multiple myeloma Myeloproliferative syndrome 3. Endocrine Disorders Disorders of the thyroid Acquired hypothyroidism with surgery Table 10 (continued) 4 1.5 1 0.3 1 0.5 1 0.4 0 0.3 0 0.3 26 32.5 1 2.1 0 0.3 1 3.1 0 0.3 0 1.1 0 0.9 0 0.6 0 0.6 36 60.9 3 4.0 1 0.6 2 1.7 0 0.8 1 3.4 0 1.7 23 27.7 2 1.8 0 0.4 2 1.o 0 0.2 0 0.2 148 139.8 4 14.9 4 11.2 31 51.1 6 3.2 2 0.7 2 1.7 1 0.3 1 0.3 277 262.5 20 31.7 14 24.1 31 (100) 5 (83) 2 (100) 2 (100) 1 (100) 1 (100) 154 (56) 16 (80) 14 (100) 3M Company EPI-0004 Page 98 of 114 8.8 8.2 0.8 - 399 1.4 1.4 0.6 0.7 0.8 - 2.3 0.0 - 8.1 3.7 4.1 0.2 - 242 1.4 1.4 0.7 0.6 0.0 0.0 2.0 1.7 0.8 - 2.4 0.1 - 3.2 0.0 - 9.9 0.1 - 23 1.o 1.o 0.4 0.4 0.6 0.6 0.8 - 1.2 0.1 - 1.3 0.2 - 2.0 Hyperthyroidismother than in pregnancy Thyroid nodule, benign nontoxic Thyroiditis Diabetes Diabetes Type I with complications Diabetes Type I without complications Diabetes Type I1 with complications Diabetes Type I1 without complications Disorders of lipid metabolism (hyperlipidemia) Fluid and electrolyte disorders Other endocrine or nutritional disorders Adrenal insufficiency Hyperparathyroidism Hypoglycemia 0besity Osteoporosis Other endocrine, nutritional and metabolic disorders 4. Hematologic Disorders Anemia, acquired Disorders of hemostatic function BACK TO MAIN Table 10 (continued) 0 2.0 0 0.9 0 0.7 42 28.1 1 1.1 8 4.2 6 6.3 27 16.5 65 59.9 3 4.2 2 2.0 1 1.5 60 52.2 0 2.0 7 7.5 10 11.9 43 30.8 125 107.2 3 (100) 2 (100) 1(100) 41 (68) 0 (-1 7 (loo) 10 (100) 40 (93) 110 (88) 6 6.1 31 30.8 0 0.1 0 0.2 3 2.6 13 13.4 0 0.8 15 13.7 16 12.1 56 59.3 1 0.3 1 0.5 7 4.5 25 25.3 2 1.9 20 26.8 18 15.5 2 2.7 2 0.3 28 30.4 4 5.6 0 0.6 3M Company EPI-0004 Page 99 of 114 0.0 0.0 0.0 - 5.0 1.3 1.3 2.0 2.0 1.2 1.1 1.1 1.2 1.o 0.9 0.7 0.7 1.1 1.1 0.9 - 2.0 0.7 - 6.6 0.3 - 3.5 0.7 - 1.9 0.7 - 1.3 0.2 - 2.0 0.7 - 1.7 0.6 0.7 1.o 1.o 1.4 1.5 1.1 1.3 0.8 1.o 0.1 - 3.3 0.5 - 2.0 0.7 - 3.0 0.7 - 2.4 0.1 - 7.3 Other hematologic disorders 5. Psychiatric Disorders Affective disorders Depression, major without psychotic behavior Depression, minor Dissociative and personality disorders Neurotic disorders (anxiety disorders) Organic mental disorders Psychotic disorders Substance abuse 6a. Neurologic Disorders Congenitalor acquired central degenerativedisorders Benign essential tremor Parkinson's disease Hemorrhage, cerebrovascular, or other major CNS disorders Other diseases of the nervous system Migraine Tension headache Peripheral neuromuscular disorders Neuralgia, neuritis, radiculitis BACK TO MAIN Table 10 (continued) 14 12.5 144 136.5 40 50.6 24 20.2 11 (79) 79 (55) 28 (70) 22 (92) 24 24.2 206 242.2 56 88.4 28 36.0 23 (96) 116 (56) 38 (68) 29 (100) 12 25.8 0 1.4 16 19.3 1 1.o 0 1.1 87 61.9 60 73.2 6 4.9 11 (92) 0 (-1 15 (94) 1(1W 0 (-> 64 (74) 45 (75) 6 (100) 23 44.3 0 2.2 30 33.5 0 1.9 2 1.9 117 112.0 130 136.2 11 8.7 21 (91) 0 (-1 27 (90) 0 (-1 2 (100) 87 (74) 90 (69) 10 (100) 0 0.8 6 3.3 9 7.4 0 (-1 6 (100) 7 (78) 1 1.4 10 5.9 17 15.0 1(100) 10 (100) 13 (76) 25 29.7 9 10.5 4 3 .O 20 30.2 15 22.3 20 (80) 9 (100) 3 (75) 20 (100) 15 (100) 48 56.5 14 20.2 1 5.9 54 54.2 41 39.7 41 (85) 12 (86) 1 (100) 49 (91) 39 (95) 3M Company EPI-0004 Page 100 of 114 1.1 1.1 0.6 - 2.3 1.3 1.2 1.0 - 1.5 1.4 1.3 0.8 - 1.9 1.6 1.5 0.9 - 2.7 1.1 0.9 0.4 - 1.9 1.o 0.9 0.5 - 1.8 1.3 1.4 0.8 0.9 0.9 1.o 1.0- 1.8 0.6 - 1.2 0.3 - 2.9 1.o 1.1 1.o 1.1 0.9 1.o 1.1 1.2 5.5 7.9 0.7 0.7 0.7 0.7 0.3 - 3.2 0.4 - 2.5 0.6 - 1.6 0.5 - 3.1 0.8 - 384 0.4 - 1.1 0.3 - 1.2 Carpel Tunnel Syndrome Seizure disorders 6b. Opthamologic Disorders Disorders of the eye Cataract Conjunctivitis, acute Glaucoma 7. Cardiovascular Disorders Hypertension Atherosclerotic coronary vascular disease Carditis and cardiomyopathyKHF Disorders of heart valves Dysrhythmia and conduction disorders Large arterial and peripheral vascular disorders Large vein thromboembolicdisorders Minor venoudarterial disorders Other cardiovascular disorders Sa. Pulmonary Disorders Lower respiratory infections Obstructive pulmonary diseases Asthma BACK TO MAIN 4 6.3 0 0.9 72 94.9 72 94.9 7 6.0 12 15.5 6 7.4 205 174.5 73 62.9 50 35.3 2 5.0 5 4.6 7 9.7 2 2.2 Table 10 (continued) 4 (100) 0 (-1 46 (64) 46 (64) 7 (loo) 12 (100) 6 (100) 105 (51) 66 (90) 28 (56) 1 (50) 5 (100) 6 (86) 2 (loo) 12 11.9 0 1.5 124 174.3 124 174.3 9 12.7 14 28.0 10 13.8 355 328.3 134 114.3 84 65.7 2 10.1 16 9.2 12 18.5 2 4.6 12 (100) 0 (-1 84 (68) 84 (68) 8 (89) 13 (93) 10 (100) 182 (51) 122 (91) 40 (48) 2 (loo) 16 (100) 11 (92) 2 (loo) 1 3.3 0 4.7 65 46.3 314 239.8 110 107.4 20 21.6 6 12.4 1 (loo) 0 (-) 53 (82) 144 (46) 61 (55) 17 (85) 6 (loo) 4 6.4 0 9.7 101 89.0 515 431.0 191 193.7 37 39.9 17 22.1 4 (loo) 0 (-1 81 (80) 224 (43) 114 (60) 34 (92) 16 (94) 3M Company EPI-0004 Page 101of 114 0.6 0.6 0.2 - 2.1 1.1 1.1 1.1 1.1 1.5 1.7 1.6 1.6 1.1 1.1 1.1 1.1 1.o 1.o 1.1 1.1 2.0 2.0 0.6 0.6 1.2 1.1 2.3 2.0 0.5 0.5 0.8 - 1.4 0.8 - 1.4 0.5 - 5.0 0.7 - 3.6 0.3 - 3.4 0.9 - 1.3 0.7 - 1.3 0.8 - 1.6 0.2 - 28 0.2 - 1.8 0.4 - 3.1 0.2 - 28 0.0 - 4.9 1.2 1.2 0.9 - 1.7 1.1 1.1 1.0 - 1.3 1.o 1.o 0.8 - 1.3 1.o 1.o 0.6 - 1.8 0.7 0.6 0.2 - 1.7 Table 10 (continued) BACK TO MAIN 3M Company EPI-0004 Page 102 of 114 Chronic obstructivepulmonary disease 14 9.1 14 (100) 20 17.7 20 (100) 1.3 1.4 0.7 - 2.8 Other pulmonary disorders 175 102.8 125 (71) 275 182.9 195 (71) 1.1 1.1 0.9 - 1.4 Atelectasis Painful respiration Pleurisy with or without effusion Pulmonary eosinophilia Other disorders of the respiratory system 2 1.5 12 8.0 0 3.8 5 1.2 154 86.4 2 (100) 8 (67) 0 (-1 5 (100) 116 2 2.9 23 14.3 5 7.1 6 2.4 235 152.8 2 (10) 22 (96) 4 (80) 6 (1W 184 (78) 1.7 1.9 0.1 - 26.6 1.o 0.9 0.4 - 2.0 0.0 0.0 0.0 - 2.0 1.4 1.6 0.4 - 6.3 1.2 1.2 0.9 - 1.4 Pulmonary edema 1 3.0 1(100) 0 5.8 0 (-) Respiratory failure Sleep disorders 8b. Ear, Nose and Throat Disorders 0 0.2 8 5.0 499 468.0 0 (-1 8 (100) 130 (26) 0 0.3 12 8.5 891 811.9 0 (-) 11 (92) 230 (26) 1.4 1.1 0.4 - 3.0 1.o 1.o 0.9 - 1.1 Disorders of the ear and vestibular apparatus Upper respiratory infections Pharyngitis 94 98.1 339 303.6 63 69.9 52 (55) 111 (33) 38 (60) 133 169.2 640 527.7 112 118.0 86 (65) 189 (30) 67 (60) 1.3 1.2 0.9 - 1.6 1.o 0.9 0.8 - 1.1 1.1 1.o 0.7 - 1.3 Sinusitis, acute Sinusitis, chronic with surgery 137 92.5 33 29.4 62 (45) 32 (97) 262 163.3 60 50.9 95 (36) 56 (93) 0.9 0.9 0.8 - 1.1 1.o 1.o 0.6 - 1.5 Upper respiratory infection and Common cold, acute Other upper respiratory disorders Allergic rhinitis 106 106.0 66 66.3 54 55.6 43 (41) 53 (80) 49 (91) 200 186.0 118 115.0 95 97.0 88 (44) 94 (80) 86 (91) 0.9 0.9 0.7 - 1.2 0.9 1.o 0.7 - 1.3 0.9 1.o 0.7 - 1.4 9. Gastrointestinal Disorders Disorders of esophagus 254 198.8 27 20.6 94 (37) 23 (85) 426 358.2 63 36.9 181 (42) 53 (84) 1.1 1.1 0.9 - 1.3 0.8 0.8 0.5 - 1.2 Disorders of stomach and duodenum Disorders of the small intestine Hernias Inflammatory bowel disease Disorders of the large intestine Disorders of the liver Cirrhosis of liver without mention of alcohol Hepatitis, acute alcoholic Hepatitis, acute without hepatic coma Hepatitis, chronic without hepatic coma Disorders of the biliary tract Cholecystitis without cholelithiasis, acute Cholecystitis without cholelithiasis, chronic or other Cholelithiasis with acute cholecystitis Cholelithiasiswith chronicor unspecified cholecystitis Cholelithiasis without cholecystitis Disorders of the pancreas Pancreatitis, acute Pancreatitis, chronic Other gastrointestinal disorders BACK TO MAIN Table 10 (continued) 25 18.1 1 1.6 6 14.9 3 3.1 66 43.4 2 2.5 2 0.4 64 33.0 1 2.6 33 26.0 4 5.6 94 78.6 2 4.2 0 0.7 0 0.1 0 1.o 0 0.7 18 8.8 1 0.7 3 1.3 1 0.2 1 1.6 0 1.1 14 17.8 1 1.6 4 2.7 6 1.5 5 3.1 0 3.1 4 6.2 3 2.1 7 1.8 6 1.6 1 0.3 99 83.9 5 4.3 2 3.4 2 2.9 0 0.5 149 150.2 0.7 0.3 1.3 1.3 2.0 2.4 1.4 > 4.0 2.3 1.o 4.3 3.7 1.2 3M Company EPI-0004 Page 103 of 114 0.7 0.4 - 1.2 0.3 0.1 - 0.8 1.3 0.2 - 7.9 1.3 0.9 - 1.8 1.7 0.1 -23 2.6 1.2 - 5.5 1.5 > 4.0 2.5 1.2 6.4 5.5 0.2 - 9.0 2.1 - 128 0.5 - 12.7 0.2 - 6.2 1.2 - 63 1.0 - 56 1.2 0.9 - 1.5 Table 10 (continued) BACK TO MAIN 3M Company EPI-0004 Page 104 of 114 loa. Urologic Disorders 175 102.8 71 (41) 268 190.3 123 (46) 1.2 1.2 1.0 - 1.5 Disorders of the renal function 3 1.7 2 (67) 1 3.0 1 (loo) 5.3 5.5 0.4 - 287 Chronic renal failure Disorders of renal parenchyma Renal cyst Lower and unspecified urinary tract infections 2 1.1 2 0.7 2 0.7 49 24.5 2 (1W 2 (100) 2 (1W 20 (41) 0 1.9 1 1.3 1 1.3 49 53.1 1 (loo) 1 (1W 1(W 34 (69) 3.0 3.6 0.2 - 213 3.0 3.6 0.2-211 2.2 2.2 1.4 - 3.3 Cystitis 18 5.7 7 (39) 17 12.8 13 (76) 2.6 2.4 1.2 - 4.8 Urinary tract, not specified 31 18.8 16 (52) 32 40.4 25 (78) 2.0 2.1 1.2 - 3.5 Other disorders of the lower urinary tract Urethral stricture Other disorders of the upper urinary tract Calculus of urinary tract Other genitourinary disorders 1 1.7 1 1.7 30 14.5 30 14.5 21 18.7 1(100) 1(100) 15 (50) 15 (50) 20 (95) 13 2.9 13 2.9 50 24.2 50 24.2 49 34.0 12 (92) 12 (92) 24 (48) 24 (48) 48 (98) 0.2 0.1 0.0 - 0.9 0.2 0.1 0.0 - 0.9 1.o 1.o 0.6 - 1.6 1.o 1.o 0.6 - 1.6 0.8 0.8 0.5 - 1.3 Other diseases with surgery 21 18.7 20 (95) 49 34.0 48 (98) 0.8 0.8 0.5 - 1.3 Upper urinary tract infections Acute pyelonephritis 3 1.2 3 1.2 2 (67) 2 (67) 5 2.3 5 2.3 3 (60) 3 (60) 1.1 1.2 0.2 - 6.0 1.1 1.2 0.2 - 6.0 Disorders of the prostate Prostatic hyperplasia Prostatitis, acute 66 39.9 28 20.6 38 19.3 42 (64) 24 (86) 26 (68) 100 69.4 55 38.2 45 31.2 73 (73) 52 (95) 33 (73) 1.2 1.2 0.8 - 1.6 1.o 1.o 0.6 - 1.5 1.5 1.4 0.9 - 2.2 lob. Gynecologic and Reproductive Disorders Disorders of the female breast (non-malignant) 72 83.8 4 5.8 50 (69) 4 (100) 173 190.0 11 15.9 100 (58) 10 (91) 0.9 0.9 0.7 - 1.3 0.9 1.o 0.2 - 3.4 Table 10 (continued) BACK TO MAIN 3M Company EPI-0004 Page 105 of 114 Fibrocystic disease of breast Infections of the female genital tract Menopausal and menstrual disorders Other gynecologic disorders Endometriosis Fertility and infertility management Contraceptive or procreative management Infertility female Impotence of organic origin Other disorders of the male reproductive system 2 3.9 4 6.3 8 12.5 13 16.9 0 0.9 43 42.4 4 9.6 0 0.5 24 13.3 15 19.0 8 11.2 16 18.0 23 37.4 40 48.3 1 2.5 83 70.5 10 16.0 1 1.1 31 23.5 41 29.8 8 (100) 10 (63) 16 (70) 30 (75) 1(100) 66 (80) 10 (100) 1(100) 31 (100) 40 (98) 0.8 0.7 0.1 - 3.6 0.8 0.7 0.2 - 2.2 0.9 1.o 0.4 - 2.5 0.9 0.9 0.5 - 1.8 0.9 0.9 0.6 - 1.3 0.7 0.7 0.2 - 2.3 1.4 1.4 0.8 - 2.4 0.6 0.6 0.3 - 1.1 11. Pregnancy 0 3.5 2 7.9 Complicated pregnancy or delivery 0 2.6 2 6.0 Diabetes, gestational 0 0.0 0 0.1 Multiple gestational 0 0.0 0 0.1 Postpartum hemorrhage 0 0.3 0 0.5 Pregnancy with abortion 0 0.2 0 0.6 Pregnancy, ectopic 0 0.0 0 0.1 Preterm labor 0 0.2 0 0.5 Other conditions during pregnancy 0 1.8 2 4.0 Normal or unspecified pregnancy and delivery 0 0.9 0 1.9 Spontaneous abortion 0 0.1 0 0.2 Table 10 (continued) BACK TO MAIN 3M Company EPI-0004 Page 106 of 114 Pregnancy 12. Dermatologic Disorders Dermatologic infections Disorders of the hair and nails Immune mediated skin conditions Other dermatologic conditions 13. Musculoskeletal Disorders Acute or unspecified arthropathies and minor tendonitis Crystalline arthritis Degenerativejoint disorders, other than spine Disorders of the spine Vasculitis and connective tissue disorders Other 14. Congenital Anomalies Congenital Anomalies Atrial septal defect Other cardiovascular congenital abnormalities Other congenital abnormalities with admittance Other respiratory congenital abnormalities 0 0.8 296 335.7 105 106.3 6 10.7 43 55.9 142 162.8 489 510.6 47 64.2 8 7.1 27 28.9 161 129.4 4 3.3 242 277.7 9 9.9 9 9.9 0 0.1 0 1.3 9 8.3 0 0.2 0 (-1 123 (42) 59 (56) 5 (83) 28 (65) 89 (63) 135 (28) 37 (79) 7 (88) 22 (81) 83 (52) 4 (100) 112 (46) 9 (100) 9 (100) 0 (-1 0 (-1 9 (100) 0 (-1 0 1.7 535 595.3 179 185.3 16 20.6 85 99.9 255 289.5 1047 918.4 136 113.8 10 12.1 73 57.0 293 226.0 7 6.5 528 503.0 12 17.9 12 17.9 0 0.3 3 2.4 8 14.8 1 0.4 0 (-1 208 (39) 103 (58) 13 (81) 46 (54) 152 (60) 245 (23) 76 (56) 10 (100) 60 (82) 140 (48) 7 (100) 197 (37) 11 (92) 11 (92) 0 (-1 3 (100) 1.o 1.o 0.9 - 1.1 1.o 1.o 0.8 - 1.3 0.7 0.7 0.2 - 1.9 0.9 0.9 0.6 - 1.3 1.1 1.o 0.8 - 1.2 0.8 0.8 0.8 - 0.9 0.7 0.6 0.4 - 0.9 1.5 1.4 0.5 - 3.8 0.7 0.7 0.5 - 1.2 1.0 1.o 0.8 - 1.2 1.3 1.1 0.2 - 4.4 0.8 0.8 0.7 - 1.0 1.4 1.4 0.5 - 3.5 1.4 1.4 0.5 - 3.5 0.0 0.0 0.0 - 4.5 2.0 2.0 0.7 - 6.0 Table 10 (continued) BACK TO MAIN 3M Company EPI-0004 Page 107 of 114 15. Perinatal Disorders Conditions originating in the perinatal period 16. Miscellaneous Other miscellaneous conditions Routine health care Symptoms or signs Abdominal pain Chest pain, unspecified Fever Headache with radiology Malaise and fatigue Syncopeand collapse Symptoms, signs and ill-defined conditions 17. Injury and Poisoning Major traumatic injury Minor traumatic injury Other injury 0 0.7 0 0.6 644 589.3 147 239.9 84 100.8 497 349.4 93 50.0 93 55.2 8 6.2 48 35.0 22 22.1 7 7.2 226 173.3 191 283.1 39 81.1 108 158.9 44 43.2 0 (-1 0 (-) 189 (29) 98 (67) 77 (92) 181 (36) 64 (69) 61 (66) 8 (100) 25 (52) 16 (73) 6 (86) 160 (7 1) 102 (53) 30 (77) 70 (65) 40 (91) 1 1.3 1 1.o 952 1070.6 221 439.7 120 184.2 731 630.9 110 92.0 142 99.4 11 10.6 59 66.2 40 41.6 8 13.1 361 306.8 358 481.0 80 137.6 218 268.4 60 75.0 1 (100) 1(1W 294 (3 1) 156 (71) 112 (93) 275 (38) 75 (68) 85 (60) 11 (100) 37 (63) 37 (93) 7 (88) 247 (68) 170 (45) 61 (17) 128 (59) 54 (90) 1.2 1.2 1.1 - 1.4 1.3 1.2 1.0 - 1.5 1.3 1.3 1.0 - 1.7 1.2 1.2 1.1 - 1.4 1.6 1.6 1.2 - 2.1 1.2 1.2 0.9 - 1.6 1.2 1.3 0.4 - 3.4 1.5 1.5 1.0 - 2.3 1.o 1.o 0.6 - 1.8 1.7 1.6 0.5 - 5.0 1.1 1.1 0.9 - 1.3 1.o 1.o 0.8 - 1.1 0.9 0.8 0.6 - 1.2 0.9 0.8 0.7 - 1.1 1.4 1.3 0.9 - 1.9 BACK TO MAIN Table 11 Specialty Categories, Categories and Classes Which Had an RREpC that Excluded the Null Hypothesis in the 95% Confidence Interval for at Least One of the Four Comparison Groups A - D 3M Company EPI-0004 Page 108 of 114 CCG Description Comparison Group A RRE&C 95% CI Comparison Group B mC 95% CI Comparison Group C RREg 95% CI Comparison Group D mC 95% CI Specialty Categories Cancers and Benign Growths 1.3 1.1- 1.6 1.3 1.1 - 1.6 1.3 1.1- 1.6 1.6 1.2 - 2.1 Miscellaneous 1.0 1.0 - 1.1 1.0 1.0 - 1.1 1.1 1.0- 1.2 1.2 1.1- 1.4 Categories Neoplasm of gastrointestinal tract 1.5 1.0 - 2.2 1.5 0.9 - 2.5 1.8 1.2 - 3.0 2.9 1.7 - 5.2 Neoplasm of male reproductive 10.0 tract Affective disorders 1.3 Disorders of the biliary tract 1.6 1.3 - 447 1.0- 1.7 0.8 - 2.9 5.7 0.6 - 276 1 .o 0.7 - 1.5 2.1 0.9 - 4.9 7.6 0.9 - 359 1.4 1.1- 1.9 1.7 0.9 - 3.3 9.7 1.1 -458 1.3 0.8 - 1.9 2.6 1.2-55 Disorders of the pancreas Lower and unspecified urinary tract infections Menopausal and menstrual disorders Symptoms or signs Classes Benign colon polyps 3.0 0.7 - 18 1.3 1.0- 1.6 1.1 0.7 - 1.7 1.1 1.0- 1.2 1.4 0.9-2.1 3.3 0.8 - 20 1.5 1.1- 2.1 2.0 1.1-4.0 1 .o 0.9 - 1.2 1.3 0.7 - 2.2 4.7 0.9 - 46 1.3 0.9 - 1.8 1.1 0.7 - 2.0 1.1 1.0- 1.2 1.9 1.1 - 3.2 6.4 1.2-63 2.2 1.4 - 3.3 1 .o 0.4 - 2.5 1.2 1.1 - 1.4 2.4 1.3 - 4.5 Cholelithiasis with acute cholecystitis Cystitis Urinary tract infections not specified Abdominal pain Table 11(continued) 8.6 1.1- 381 7.8 0.9 - 358 1.5 1.0 - 2.2 1.1 0.8 - 1.6 2.0 1.2 - 3.3 1.3 0.8 - 1.9 1.2 1.0 - 1.5 1.2 0.9 - 1.6 BACK TO MAIN 9.2 1.2- 415 1.3 0.8 - 2.4 1.3 0.9 - 1.9 1.3 1.0 - 1.6 > 4.0 3M Company EPI-0004 Page 109 of 114 2.1 - 128 2.4 1.2- 4.8 2.1 1.2- 3.5 1.6 1.2- 2.1 BACK TO MAIN Chemical Plant Film Plant 1993 15 (31) 12 (26) Table 12 Number of Episodes of Care for Benign Colonic Polyps, By Plant and by Year (Percent in Parentheses) 1994 9 (19) 8 (17) 1995 6 (13) 6 (13) 1996 1 (2) 5 (11) 1997 8 (17) 7(15) 1998 9 (19) 9 (19) 3M Company EPI-0004 Page 110 of 114 Total 48 (100) 47 (100) Appendix A BACK TO MAIN 3M Company EPI-0004 Page 111 of 114 BACK TO MAIN I 3M Company I Appendix A Table 1 EPI-0004 Page 112 of 114 Employment Status by Gender and Plant of the Four Study Comparison Groups per Beginning of Each Study Year and End of Study January 1,1993 Active h a ctive Not yet hired Retired Terminated Deceased Transferred TOTAL Study Group A Chemical Film 427 (65) 20 (3) 205 (31) 0 (0) 0 (0) 0 (0) 0 (0) 652 (100) 502 (26) 26 (4) 131 (20) 0 (0) 0 (0) 0 (0) 0 (0) 659 (100) Study Group B Chemical Film 202 (52) 11 (3) 175 (45) 0 (0) 0 (0) 0 (0) 0 (0) 388 (100) 296 (70) 12 (3) 116 (27) 0 (0) 0 (0) 0 (0) 0 (0) 424 (100) Study Group C Chemical Film 308 (62) 18 (4) 172 (35) 0 (0) 0 (0) 0 (0) 0 (0) 498 (100) 370 (76) 22 (4) 98 (20) 0 (0) 0 (0) 0 (0) 0 (0) 490 (100) Study Group D Chemical Film 210 (100) 1(8) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 211 (100) 345 (100) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 345 (100) January 1,1995 Active h a ctive Not yet hired Retired Terminated Deceased Transferred TOTAL 469 (71) 32 (5) 111 (17) 33 (5) 5 (1) 2 (0) 6 (1) 659 (100) January 1,1996 Active Inactive Not yet hired Retired Terminated Deceased Transferred TOTAL January 1, 1997 Active Inactive Not yet hired Retired Terminated Deceased Transferred TOTAL January 1, 1998 Active Inactive Not yet hired Retired Terminated Deceased Transferred TOTAL BACK TO MAIN 3M Company EPI-0004 Page 113of 114 4 (1) 652 (100) 5 (1) 659 (100) 4 (1) 388 (100) 5 (1) 424 (100) 2 (0) 498 (100) 1 (0) 490 (100) 0 (0) 211 (100) 1 (0) 345 (100) 6 (1) 652 (100) 8 (1) 659 (100) 6 (2) 388 (100) 8 (2) 424 (100) 2 (0) 498 (100) 1 (0) 490 (100) 0 (0) 211 (100) 1 (0) 345 (100) December 31, 1998 Active BACK TO MAIN 3M Company EPI-0004 Page 114 of 114 Transferred TOTAL 10 (2) 652 (100) 8 (1) 659 (100) 8 (2) 388 (100) 8 (2) 424 (100) 2 (0) 498 (100 0 (0) 490 (100) 0 (0) 211 (100) 0 (0) 345 (100)