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Protocol to Confirm Asbestos-Related Abnormalities

Pilot Study of Environmental Cases

Investigators:
Aubrey Miller, MD, MPH, Medical Officer,USPHS Region 8
Dan Middleton, MD, MPH, Medical Officer, ATSDR

October 12, 2000

ABSTRACT

Vermiculite was mined and processed in the Libby, Montana area from the 1920's to 1991. During this time miners, their household contacts, and other local area residents were exposed to varying concentrations of amphibole asbestos (actinolite-tremolite series) that was co-located with the vermiculite ore and mined incidentally to the vermiculite operations.

A pulmonologist in Spokane, Washington has evaluated over 200 patients from the Libby area for asbestos-related disease. Most of these patients are former employees of the mining operation or their household contacts, but several (10-20) cases are thought to have resulted from environmental (non-occupational) exposures. If these environmental cases are valid, the number of current and former Libby residents at risk may be much higher than previously thought. This case-series is proposed to review and confirm these cases of asbestos-related disease and clarify the source of their exposures. The experience that we gain in this review may also be useful as we prepare the protocol and data collection instruments for the larger case series (over 200 cases) that we plan to propose in a subsequent protocol.


I. INTRODUCTION

A pulmonologist in Spokane, Washington has evaluated over 200 patients from the Libby, Montana area for asbestos-related disease. Most of these patients were exposed while employed in the mining industry or while sharing a household with a mine employee (occupational exposure pathways), but several patients (10-20) did not report an association with the mining industry and appear to have been exposed through other (environmental) exposure pathways in Libby. If cases of asbestos-related disease have resulted solely from environmental pathways, the population at risk may be much larger than previously expected. During this initial case-series we will collect and evaluate information about the cases of asbestos-related disease who appear to have been exposed through environmental pathways.

History

Vermiculite mining at this site began in the 1920's and continued until 1991. The mine itself is located approximately 6 miles from the town of Libby. Vermiculite is used in agricultural products (e.g., potting soil, soil conditioner, and fertilizer) and construction materials (e.g., aggregates for plaster and concrete, home insulation). While the amphibole asbestos at this site was not mined for commercial purposes, mineral deposits were co-located with the vermiculite ore and were mined coincidentally to the vermiculite operations.

A transfer facility was located at the base of the mountain, approximately 3 miles from Libby. Over time, two expansion ("popping") facilities were located inside the Libby city limits; one of these facilities was located next to community baseball fields and readily accessible to area children. These plants heated vermiculite to approximately 600 degrees Fahrenheit in order to expand ("pop") the crystals. Asbestos fibers associated with the vermiculite may have been released into the ambient air during this process. Additionally, vermiculite was commonly used throughout the area as construction aggregate, soil additive in gardens, and insulation in homes.

While current airborne asbestos levels in Libby now appear to be low, ambient levels during the many decades that vermiculite was actively mined, processed, and shipped were certainly much higher. In fact, ambient air concentrations up to 15 times the current occupational limits were reported for downtown Libby in the past. A medical screening program is currently underway for residents who lived in Libby prior to January 1, 1991.

Community Concerns

Beginning in November 1999, a series of newspaper articles raised the Libby community's level of concern regarding the occurrence of asbestos-related disease among area residents, especially those with no former connection to the mining operations. There is a general understanding that exposed people may appear well, but be at increased risk for developing this disease in the future. This understanding is evidenced by the very high participation rate in the current medical testing program which started in mid-July. Some residents believe that anyone who has ever spent time in Libby is at risk for asbestos-related disease. In response to these concerns, there is an urgent need to validate the reports of asbestos-related disease among patients not associated with vermiculite mining and to identify important environmental exposure pathways.

Goals and Objectives

The reports of asbestos-related illnesses among residents with only environmental exposure pathways are of special concern. The following goals and objectives are proposed for this study:

Goal 1. Validate the reported cases of asbestos-related respiratory disease among the 10-20 patients who lived in Libby, but did not report an occupational exposure pathway.

Objectives:

1. Abstract information from the medical records.

  • Administer a questionnaire directly to each patient to systematically collect specific exposure and health-related information.
  • Confirm (with questionnaire data) the potential for environmental exposure and the absence of occupational exposure pathways (as a worker or household contact).
  • Confirm (by external expert review) than one (or more) CXRs or CT scans is consistent with asbestos-related pulmonary disease.

Goal 2. Identify environmental exposure pathways that may have contributed to disease among these 10-20 patients and may still be a risk factor for others in the community.

Objectives:

  • Review the case histories and administer questionnaires to collect information about environmental pathways that may have increased the risk for asbestos-related disease.
  • Analyze grouped data for commonalities of environmental exposure pathways and disease.

This protocol is solely for the pilot study (10-20 cases). In the future, we will develop a separate protocol for a large case series of Libby patients with asbestos-related diseases (approximately 200 cases).

II. BACKGROUND

Asbestos

The term "asbestos" actually refers to six naturally occurring fibrous minerals. Each asbestos-mineral contains a silicate unit combined with varying proportions of aluminum, calcium, iron, magnesium, and sodium.

The six types of asbestos are divided into to two morphologic classes:

(1) serpentine asbestos (chrysotile) with long and flexible fibers; and,

(2) amphibole asbestos (amosite, crocidolite, tremolite, anthophylite, and actinolite) with relatively brittle crystalline fibers.

Chrysotile asbestos makes up 90 to 95% of the asbestos produced for commercial use. Even though production has declined, asbestos released to the environment does not burn, dissolve, or evaporate and is not chemically reactive or biodegradable.

Previous Studies

Previous studies by researchers from NIOSH (1,2,3) and McGill University (4) found that former employees of the mine had substantial occupational exposure to asbestos associated with significantly increased pulmonary morbidity and mortality (i.e., asbestosis and lung cancer). Researchers at NIOSH studied the annual CXR's of mine and mill workers with at least 5 years tenure between 1975 and 1982. The researchers found an increased prevalence of parenchymal and pleural radiographic abnormalities. Logistic modeling of this data predicted a 1.3% increase in the odds ratio for small opacities per 5 additional fiber-years of exposure (3).

Recently, cases of asbestos-related pulmonary impairment have been reported among household contacts of former mine employees and others in the community with no connection to the mining operations.

Site-Related Environmental Contamination

Mining, handling, and processing of vermiculite has lead to widespread contamination of the area with mining waste. Residents may be at risk from previous (and possibly current) exposure to amphiboles that were mined and released into the environment. This case series is important in establishing (or refuting) the presence of asbostos-related disease among those without occupationally-related exposures.

Asbestos-Related Abnormalities

Pathophysiology

When airborne asbestos fibers enter the lungs, some are cleared by the lung's routine defense mechanisms. These defenses are less effective against fibrous particles. Unsuccessful attempts by macrophages to engulf asbestos fibers leads to tissue deposition of ferrous material as "asbestos bodies." Asbestos fibers can reach the lower lung, penetrate airway walls, and pass through lung parenchyma to the pleura.

Asbestos fibers initiate fibrosis by stimulating the persistent release of various inflammatory mediators and fibroblast growth factors. The resulting fibrous connective tissue causes pleural thickening and (frequently) the formation of calcified pleural plaques early in the disease process. Diffuse interstitial fibrosis results from a similar process in the lung parenchyma.

Diagnosis

The most common asbestos-related abnormalities seen on chest radiographs are pleural thickening and pleural plaques. Chest radiographs (posterior-anterior and lateral views) are routinely used to test for the pleural and parenchymal disease associated with asbestos exposure.

The International Labor Office has attempted to standardize the interpretation of chest radiographs used to identify abnormalities associated with dust exposure [ILO 1980]. NIOSH has published guidelines for obtaining the chest radiographs, as well as education and certification (B-reader) programs related to their interpretation. Even so, there is considerable variability among readers. The best chance for consistent interpretation is to use more than one experienced B-reader (preferably at least three) and look for agreement.

While cost and radiation make computerized tomography (CT undesirable as a screening tool, it is an effective tool in the clinical setting. For example, high resolution computerized tomography (HRCT) scans are more sensitive and specific in identifying and characterizing pleural changes than are chest radiographs. Unfortunately, there is no interpretation scheme comparable to the B-reader program for CT scans at this time. However, semi-quantitative schemes for evaluating asbestos disease on CT scans have been reported in the medical literature and similar approaches will be used in this study.

III. METHODS

Source and Selection of Cases for Review

Dr. Alan Whitehouse, a pulmonologist in private practice in Spokane, Washington, has 10-20 patients from the Libby area who have an asbestos-related diagnosis and did not report either occupational exposure or household contact with an exposed worker. He has agreed to make these medical records available to study investigators . Dr. Whitehouse will send eligible patients a letter (Attachment A) enclosing a written statement that describes the study (Attachment B). He will also enclose a medical release form to permit review of their medical records and direct contact by an interviewer (Attachment C). If the patient signs the release form and returns it, Dr. Whitehouse will make the patient's records available for review to PHS/ATSDR researchers in his medical office, however, all patient identifiers will be maintained by Dr. Whitehouse (see below, "privacy of medical information and data protection").

The patients ultimately selected as participants will meet the following criteria:

(1) have diagnosis of asbestos-related pulmonary disease;

(2) lived in the current study area used to qualify participants for the Libby medical testing program for 6 months prior to January 1, 1991 (within a circular radius 2 ½ miles of the town center or approximately 7 miles upstream along the Kootenai River, ½ mile on either side);

(3) did not report working at the vermiculite mine or any facility associated with it, OR be a direct household contact of any such worker;

(4) agree to participate and complete an interview regarding exposure and health; and,

(5) agree to release medical records (including chest radiographs and CT scans), without identifiers, to ATSDR/PHS researchers and sign the appropriate "Medical Release" form..

Dr. Whitehouse may not identify all of the patients whose asbestos-related pulmonary disease resulted from environmental exposure pathways in or near Libby, Montana. This will not invalidate any positive findings, because even one case of asbestos-related disease without an occupational pathway is so rare that it may have public health significance . We will track the response rate during this pilot study and record reasons for nonparticipation. If possible, changes will be made to address any issues affecting participation prior to initiating the larger study.

Collection of Additional Patient Health and Exposure History

A questionnaire (see Attachment D) to collect additional information concerning medical and exposure histories will be administered to each patient. This information will help us to understand each patients potential asbestos exposures and pertinent health information. Each participant will be questioned about current respiratory symptoms, (e.g., shortness of breath, pleuritic chest pain, and persistent cough), past medical history (including smoking history), occupational history, and potential pathways for exposure to vermiculite (e.g., as a worker, as a worker's household contact, or in certain recreational activities ("special pathways of exposure"). For example, it was common during the time period of interest for children to play in piles of vermiculite located at an expansion facility adjacent to their community baseball fields.

Patient identifiers ( name, current address) will not be on records maintained by ATSDR. A study identification number (ID) will be assigned to each patient. The master list associating patient identifiers with the corresponding ID numbers will be maintained in Dr. Whitehouse's office. The date of birth (DOB) will be coded as the year only.

The questionnaire will be administered via a programmed laptop computer by a trained interviewer currently working in Libby, as follows:

1st choice - interviewers will go to the home of the participant to administer the questionnaire; or,

2rd choice - interviewers may collect the information by telephone interview if the respondent no longer lives in the Libby area.

If the patient has already participated in the ongoing medical testing program in Libby and completed this questionnaire, they may consent to have this information transferred to the investigators in this case series (see consent form; Attachment C). After transfer to the case-series database, all identifying information will be re-coded as described above to ensure confidentiality.

Review and Abstraction of Medical Records

Patient medical records will be reviewed to evaluate the occurrence of asbestos-related pulmonary abnormalities and illness (i.e., cancer, asbestosis). All available medical information pertinent to asbestos-related abnormalities (i.e., physical findings, complications, symptoms, chest radiographs, CT scans, pulmonary function tests, and surgical reports) will be abstracted from each patient's medical records. Abstracted information will be collected on hard copies and then entered into a computer data-base. Also, we will refine the data abstraction forms for use in a more extensive case-series review to take place after this initial study. All patient identifiers will be removed or re-coded to ensure confidentiality.

External Case Review of X-rays and CT Scans

Chest X-rays

For each patient, copies of selected PA chest X-rays (without personal identifiers) will sent for review by an independent panel of three qualified B-readers. In general, films will be selected that supported the diagnosis of asbestos-related pulmonary disease. Additionally, several positive and negative control films will be sent for quality assurance/quality control purposes.

For study purposes, a case of asbestos-related disease is confirmed by radiograph if at least 2of the 3 experts agree that the participant has abnormalities that are "consistent" or "probably consistent" with asbestos-related changes, based on the presence of :

1) interstitial disease (irregular opacities with a profusion of 1/0 or greater); OR,

2) pleural disease (any combination of plaques, calcifications, or pleural thickening consistent with asbestos exposure).

CT Scans

For those patients with available CT scans, copies of selected CT scans (identifiers removed) will sent to an independent pulmonary radiologist for evaluation of asbestos-related abnormalities. For eligible participants, a case of asbestos-related disease is confirmed by CT scan if the reader's interpretation identifies either interstitial or pleural abnormalities that are "consistent with" asbestos-related changes." The extent of asbestos-related pleural and parenchymal disease will be also be graded using a semi-quantitative system similar to that described by Gamsu et. al. (5).

Case-Definition of Environmental Asbestos-related Pulmonary Disease

Medical information for each case will be reviewed to validate the occurrence of environmental asbestos-related pulmonary disease. In order to meet the case definition for environmental asbestos-related pulmonary disease, a study participant (eligible patient) must meet the following minimal criteria:

1) No significant history (by questionnaire) of occupational asbestos or verrmiculite exposure, or household contact with workers having such exposure; AND

2) evidence of abnormalities consistent with asbestos-related changes on a chest X-ray (by at least 2 of the 3 B-readers); OR evidence of abnormalities consistent with asbestos-related changes on an HRCT (by 1 expert reader during the pilot study).

Additional medical information, including physical findings, reported symptoms, pulmonary function testing, and oxygen diffusion capacity evaluations will be used to support the diagnosis and to characterize when possible (by comparison with normative guidelines) the functional severity of each case.

Reporting Results to Participants

Hardcopy results from each patient's expert review (CXR and CT scan) will be returned to Dr. Whitehouse. Copies of these results will also go to ATSDR/PHS researchers, but only Dr. Whitehouse will be able to match personal identifiers (e.g., names, current addresses, phone numbers) with the study ID numbers. These patients are already receiving medical care from Dr.Whitehouse, so it is appropriate for him to explain the clinical relevance of any new information. The results will be maintained with the patient's medical records and copies made available to participants directly from Dr. Whitehouse.

Specific responsibilities are summarized for key personnel in Attachment H.

Reimbursement for Participation

ATSDR's contractor will reimburse Dr. Whitehouse and his staff, within the modest limits established by the U.S. Government, for time and incidental expenses. ATSDR has not set aside money to reimburse participants.

Privacy of Medical Information and Data Protection

During this pilot study, the study investigators will have access to medical records as needed during the chart review process. However, each participant's records will be copied and abstracted without personal identifiers (i.e., name, exact date of birth, current address and telephone number, and social security number). Address information prior to 1991 will be abstracted, but deleted after recoding by geographic zones. ATSDR/PHS researchers will not record or maintain names of participants. Abstracted records and copies of X-rays or CT scans will be identified only by study ID number. Dr. Whitehouse and his staff (only) will maintain the list of patient names and study ID numbers in a confidential manner. The top of the list will be labeled in bold letters, "CONFIDENTIAL: NOT TO BE RELEASED FROM THIS MEDICAL OFFICE."

As federal public health agencies, the ATSDR and the USPHS are bound by federal law regarding the protection of confidential information. Under the Privacy Act of 1974 (5 U.S.C. Section 522a(e)), employees of federal agencies are responsible for protecting data collected on identifiable persons or organizations where the supplier of the information has not given the agency consent to make that data public. This responsibility for protection includes unauthorized visual observation of individually identified material, accidental loss, and theft of data.

While it is unlikely, sparse data could make it possible to identify addresses even after they are recoded as geographic zones; therefore, current addresses will not be coded intentionally (it could also be a pre-1991 address) and recoded addresses will be maintained as confidential information. All records will be maintained in compliance with the Privacy Act of 1974. No information with personal identifiers (name, current address, or social security number) will be released in the form of a report or publication. If ATSDR is required to release these data by the Freedom of Information Act, attention will be given to ensuring that participants cannot be identified.

REFERENCES

1. Amandus, H.E. Wheeler, P.E., Jankovic, J., and Tucker, J., (1987) The morbidity and mortality of vermiculite miners and millers exposed to tremolite-actinolite: Part I. Exposure estimates Am J of Ind. Med 11:1-14.

2. Amandus, H.E., and Wheeler, R. The morbidity and mortality of vermilite miners and millers exposed to tremolite-actinolite. Part II. mortality. Am Jof Ind Med 1987; 11:15-26.

3. Amandus, H.E., Althouse, R., Morgan, W.K.C., Sargent, E.N., and Jones, R. The morbidity and mortality of vermilite miners and millers exposed to tremolite-actinolite. Part III. radiographic findings. Am J of Ind Med 1987; 11:

4. McDonald JC, McDonald AD, Armstrong B, Sebastien P. Cohort Study of Mortality of Vermiculite Miners Exposed to Tremolite. British Journal of Industrial Medicine 1986; 43:436-444.

5. Gamsu G, Salmon CJ, Wamock ML, Blanc PD. CT quantification of interstitial fibrosis in patients with asbestosis: a comparison of two methods. Am J Rad 1995;164:63-68

ATTACHMENTS

Attachment A. Cover Letter for Forms Flesch-Kincaid Grade Level: 8.6

Note: to be on Dr. Whitehouse's stationary.

Date:

Dear_PATIENT NAME:_________________:

I am reviewing the records of my patients from Libby with an asbestos-related illness. Two public health physicians, Dr. Aubrey Miller and Dr. Dan Middleton, can assist in this review. We are asking for your help in learning more about these illnesses. As a first step, we would like to study patients who did not work at a vermiculite facility or live with someone who did. Your participation is voluntary.

If you choose to take part, your medical records will be copied. Your identity will be blacked out on the copies. Medical experts outside my practice will review copies of medical tests. An interviewer will contact you to ask questions about your health and exposure history. I take your privacy very seriously. I will do my utmost to ensure your confidentiality.

I want you to know that your choice to take part (or not) will not change our professional relationship. It is unlikely that the things we will learn will affect my recommendations for your medical treatment. We may be able to offer guidance to other doctors who treat patients from Libby. We may also be able to identify sources of asbestos that need attention.

Please read the attached "Consent Form" and "Release Form" carefully. If you agree to take part, please sign and date both forms and return them to me. A stamped, self-addressed envelope is enclosed for your convenience. If you have any questions, please feel free to call me at (509) 755-5864. You can also speak with either of these two public health physicians:

Dr. Aubrey Miller
Medical Coordinator Environmental Emergencies & Hazards
U.S. Public Health Service, Region 8
1-303-844-7857

or, Dr. Dan Middleton
Medical Officer
Division of Health Studies
Agency for Toxic Substances and Disease Registry
1-888-42-ATSDR (toll-free)

Sincerely,
Alan C. Whitehouse, MD

Enclosures

Attachment B: Consent Form

AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY
U.S. PUBLIC HEALTH SERVICE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

The Agency for Toxic Substances and Disease Registry (ATSDR) and the U.S. Public Health Service (PHS) are investigating the health effects of asbestos exposure in and around Libby, Montana. This initial study will focus on patients with asbestos-related illnesses who did not work at a local mining facility or live with someone working there. We will look at the results from all participants for research purposes. Taking part in this study is voluntary. What we learn may help us to identify exposures that need to be investigated. What we learn may also help us to guide doctors who evaluate and treat patients exposed to asbestos in the Libby area.

We will ask you questions and collect information from your existing medical records. You will not have any additional medical tests in this study. Taking part is not likely to lead to a change in your medical treatment. However, you should still be aware that ATSDR and the PHS cannot pay for any medical treatment. Participation could take up to 1 hour. This may be tiring, but the risk to you is very minimal.

Please read this consent form and the enclosed release form carefully. If you agree to take part, sign both forms and return them to Dr. Whitehouse. A stamped, self-addressed envelope is included for this purpose. After signing and returning these forms, the following things will occur:

(a) Dr. Whitehouse will allow two public health doctors (Dr. Miller and Dr. Middleton) to review your medical records.

(b) These public health doctors (or someone they choose) will copy the medical records about your respiratory illness. Your name, social security number, current address, phone number, and exact date of birth will be blacked out. A study identification number will be assigned to the copies.

 (c) Medical experts will be selected to review copies of your chest X-rays and CT scans. These experts will not know your identity.

 (d) You will be contacted by a professional interviewer. During the interview, you will be asked about your health and about possible exposures to vermiculite or asbestos. You will be asked about your work history and places you lived before 1991. This interview can be completed in-person or by telephone. It could take up to 1 hour to complete.

 (e) A copy your chest X-ray(s) will be evaluated by outside reviewers. A copy of your CT scan(s) will be evaluated by an outside reviewer. These reviewers will not know your identity. They will be looking for changes that can be caused by asbestos. Their opinions are not expected to lead to a change in your medical care. Dr. Whitehouse can explain their opinions to you.

 Financial Burden

ATSDR and the PHS will pay for all direct study expenses. The agencies have not set aside funds to compensate you for participating and cannot pay for your medical treatment.

  • Results

ATSDR and the PHS cannot provide the reviewers' opinions to you directly, because they will not keep your name or phone number. Dr. Whitehouse can explain the opinions given by outside reviewers and answer questions you may have.

  • Confidentiality

Your medical records are private and will be protected to the extent the law allows. People who work for Dr. Whitehouse will continue to see your medical records. The two public health doctors and people they choose to assist in the study will be able to identify you while collecting your information. After the copies are made and you have been interviewed, they will not keep a record of your name, social security number, current address, phone number, or exact date of birth. Only Dr. Whitehouse will be able to match you with your information. Your pre-1991 addresses will be plotted on a map after recoding them to further protect your identity.

Even though you are not identified, your information will be kept in locked file cabinets in locked rooms at ATSDR, in Atlanta, GA. Other local, state, or federal personnel may be allowed to see the records for public health or research purposes. No report will identify anyone in the study.

  • Rights and Questions

Taking part is voluntary. If you do not want to take part, there is no penalty. You may choose to stop at any time, even after signing this consent form. If you stop, there is no penalty. You will not lose any benefits to which you are now entitled. You may continue to see Dr. Whitehouse for medical care. Please contact Dr. Whitehouse if you have any questions about your medical care.

You will also be asked to sign a form to release your medical records to ATSDR and the PHS. Even after signing the release form, you may still choose not to take part in this study or you may stop at any time.

If you have any questions about this study, you can call, email, or write Dr. Aubrey Miller (PHS) or Dr. Dan Middleton (ATSDR) as follows:

Dr. Aubrey Miller
Medical Coordinator Environmental Emergencies & Hazards
Public Health Service (Region 8)
Denver, CO
Phone: (303) 844-7857
Email: amiller@hrsa.gov

Dan Middleton, M.D., MPH
Medical Officer
Division of Health Studies
Agency for Toxic Substances and Disease Registry
1600 Clifton Road MS E31
Atlanta, GA 30333
Phone: 1-888-42ATSDR (toll-free)
or 1-404-639-5142
Email: dcm2@cdc.gov

If you have any questions about your rights as a participant in a research study, you can call or write:

Brenda Weis, Ph.D.
Environmental Health Scientist
Office of Associate Administrator for Science
Agency for Toxic Substances and Disease Registry
1600 Clifton Road MS E28
Atlanta, GA 30333
Phone: 1-888-42ATSDR (toll-free)
or 1-404-639-0708

Directions:

Please contact Dr. Whitehouse or the study doctors (Dr. Miller or Dr. Middleton) to ask questions or if there is anything about this study you do not understand.

Consent to Participate

I have read the information above, and agree to take part in this study. I understand the purpose and intended use of the information I will provide. I know who will have access to this information. I know that taking part is voluntary. I can stop at any time, even after signing this consent form. I know what I have to do to take part in this study. I know that I will be able to ask any questions at any stage of the process. I know that taking part will not cost me anything. I understand that no treatment or ongoing care can be provided by study investigators (Dr. Miller and Dr. Middleton). I know that I will not lose any benefits or medical care that I now get if I decide not to be part of this study. I agree to take part in this study.

 Please print your name and mailing address:

Name: ________________________________________________

Address: ________________________________________________

________________________________________________

________________________________________________

Your Signature: ________________________________ Date: _______________

Attachment C: Release Form Flesch-Kincaid Grade Level: 8.5

Dr. Whitehouse,

I request that you give Dr. Miller and Dr. Middleton access to my medical records.

This includes copies of office and hospital notes and test results. This also includes copies of actual X-rays and CT scans. I understand that my name, social security number, current address, phone number, and exact date of birth will be removed from all copies that leave Dr. Whitehouse's office.

I know that providing this information will not cost me anything. I understand that I

will not receive any treatment or money as a part of this study. I understand that you (Dr. Whitehouse) will oversee this review of my medical records and take reasonable steps to protect my privacy.

I know that releasing this information is voluntary. I know that I will not loose any benefits or medical care I now get if I do not sign this form. I know that I can ask any questions I would like to ask. I know that I can change my mind, even after I sign this form.

I know that this information will be used for public health purposes. I know these agencies will take every reasonable step to make sure no information is released that could identify me. This request expires one year from the date I signed it. A copy of this document with my signature is as good as the original.

I agree to have my medical information released for review.

PARTICIPANT NAME (PLEASE PRINT):

SIGNATURE (INK):

DATE:

If you took part in the Libby medical testing program , please complete the following:

I took part in the Libby medical testing program sponsored by ATSDR and completed a face-to-face questionnaire. It is ok for ATSDR to share this information with Dr. Whitehouse and the public health researchers (Dr. Miller and Dr. Middleton):

Yes No (Circle one)

Your Signature:____________________________________ Date: ______________

 

ATTACHMENT D: Questionnaire (Computer Assisted Participant Interview)

For Office Use Only

Interviewer: _________________

Date: _______________

Start: _______________

Stop: _______________

DEMOGRAPHICS/RESIDENTIAL HISTORY

The following questions are about Demographic and Residential History . . .

1. Let me confirm that I have your name correctly. I have : (a) First _____________ (b) Middle _____________(c) Last ______________

Is that correct?

2. I have your date-of-birth as: (a) __________ Month (b) __________ Day (c) _________Year

Is that correct?

3. Sex (OBSERVED) __________________

4. Please tell me the addresses that you have lived at in the Libby area or Kootenai Valley beginning with your current address:

Address 1: (a) _______________________________________________________

Time Period: From __________ To __________

Address 2: (b) _______________________________________________________

Time Period: From __________ To __________

Address 3: (c) _______________________________________________________

Time Period: From __________ To __________

Address 4: (d) _______________________________________________________

Time Period: From __________ To __________

Address 5: (e) _______________________________________________________

Time Period: From __________ To __________

Did you live at any additional addresses in the Libby area or Kootenai Valley?

OCCUPATIONAL HISTORY

Now I am going to ask you some questions about your jobs and the jobs of people you lived with . . .

5. Were you ever employed for pay outside the home? Yes No

IF NO, PLEASE SKIP TO QUESTION 18

6. Did you ever work for W. R. Grace or Zonolite? Yes No

IF NO, PLEASE SKIP TO QUESTION 14

7. What year were you first employed by W.R. Grace or Zonolite?

 Year Started

8. What year were you last employed by W.R. Grace or Zonolite?

Year Ended

9. Please tell me the job titles you had and the departments you worked in while you worked at W.R. Grace or Zonolite. Start with the first job you held and end with the last job you held.

9a. Job Title

9b. What department was that in?

9c. What were your main activities or duties in this job?

9d. What year did you start?

9e. What year did you end?

10. How often did you use any type of respiratory protection (for example, a dust mask) while working at W.R. Grace or Zonolite? Never Sometimes Frequently

11. How often did you shower or change clothes before leaving work? Never Sometimes Frequently

12. How often did you wear your work clothes home from work? Never Sometimes Frequently

13. How often did you use the household car to go to and Never Sometimes Frequently from work?

14. Did you ever work as a secondary contractor to the mining Yes No or processing facilities for example, as a truck driver,, delivery person, or janitorial worker, etc?

IF NO, SKIP TO QUESTION 15

If YES, PLEASE LIST BELOW:

Pease tell me the job titles you had working as a secondary contractor to the mining or processing facilities. Start with the first job you held and end with the last job you held.

14a. Job Title

14b. What were your main activities or duties in this job?

14c. What year did you start?

14d. What year did you end?

15. Have you had jobs, not including ones at W.R. Grace or Zonolite, Yes No in which you were exposed to a lot of dust (for example, foundry work, mining, sandblasting)?

If NO, SKIP TO QUESTION 16

IF YES, PLEASE LIST BELOW:

Please tell me the job titles, not including W. R. Grace or Zonolite in which you were exposed to a lot of dust. Start with the first job you held and end with the last job you held.

15a. Job Title

15b. What were your main activities or duties in this job?

15c. What year did you start?

15d. What year did you end?

16. Have you had jobs, not including ones at W.R. Grace or Zonolite, Yes No in which you may have been exposed to vermiculite (for example, insulation installer, logger near the mine, etc)?

IF NO, SKIP TO QUESTION 17

IF YES, PLEASE LIST BELOW:

Please tell me the job titles, not including W. R. Grace or Zonolite in which you were exposed to a lot of vermiculite. Start with the first job you held and end with the last job you held.

16a. Job Title

16b. What were your main activities or duties in this job?

16c. What year did you start?

16d. What year did you end?

17. Have you had jobs, not including ones at W.R. Grace or Zonolite, in which you worked ....

17a. .... as a pipe or steam fitter? Yes No

17b. ..... as a plumber? Yes No

17c. ..... as a brake repair person? Yes No

17d. ..... as an insulator? Yes No

17e. ..... as a dry wall finisher? Yes No

17f. ..... as a carpenter? Yes No

17g. ..... as a roofer? Yes No

17h. ..... as an electrician? Yes No

17i. ...... as a welder? Yes No

17j. .....in a job where you mixed, cut, or sprayed asbestos material? Yes No

17k. ..... in a shipyard, or performed ship construction or repair? Yes No

17l. ..... in any job where you may have been exposed to asbestos? Yes No

17m. ..... around anyone performing one of the jobs above? Yes No

IF NO TO ANY OF THE ABOVE, SKIP TO QUESTION 18

IF YES TO ANY OF THE ABOVE, PLEASE LIST EACH JOB BELOW:

Please tell me the job titles. Start with the first job you held and end with the last job you held.

MILITARY SERVICE HISTORY

Next, I would like to ask you some questions about your Military Service History. . .

18. Were you ever in a military service? Yes No

IF NO, PLEASE SKIP TO QUESTION 19

18a. In the military, did you ever work on any kind of ship? Yes No

If YES, please describe your duties:______________________________________

18b. Are you aware of any exposure to asbestos during your military service? Yes No

If YES, please describe how you may have been exposed.____________________________

HOUSEHOLD CONTACT HISTORY

The next questions are about your household . . .

19. Did you ever live with someone while they worked for W.R. Grace or Zonolite? Yes No

IF NO, PLEASE SKIP TO QUESTION 29.

20a. Name: 20b. Name: 20c. Name:

21 What is (INSERT NAME) relationship to you?:

a. Relation b. Relation: c. Relation

22. How long did you live with (INSERT NAME)?:

a. Years: b. Years: c. Years:

23. How many of the years that you lived with (INSERT NAME) did ( INSERT NAME) work for W.R. Grace or Zonolite?

a. Years: b. Years: c. Years:

24. What job did (INSERT NAME) do at W.R. Grace or Zonolite?

a. Job: b. Job: c. Job:

25. How often did (INSERT NAME) wear his or her work clothes home?

  • Never Never Never
  • Sometimes Sometimes Sometimes
  • Always Always Always

26. How often did you do the laundry for (INSERT NAME)?

  • Never Never Never
  • Sometimes Sometimes Sometimes
  • Always Always Always

27. How often did you visit (INSERT NAME) while he/she was at work?

  • Never Never Never
  • Sometimes Sometimes Sometimes
  • Always Always Always

28. How often did (INSERT NAME) use the household car for work transportation?

  • Never Never Never
  • Sometimes Sometimes Sometimes
  • Always Always Always

Did you live with someone else while they worked for W.R. Grace or Zonolite?

POTENTIAL ENVIRONMENTAL EXPOSURES

(not occupational or household contact)

The following questions are about Potential Environmental Exposures . . .

29. To your knowledge, is vermiculite insulation Yes No present at any of the Lincoln County addresses you provided?

IF YES, please specify residence____________________________________________

30. Some products for the home, such as floor tiles, Yes No pipe insulation and siding can contain asbestos. Are you aware of any asbestos-containing products other than vermiculite that were present, or are still present, at any of the Lincoln County addresses you provided?

IF YES, please specify asbestos-containing product and residence ________________________________

31. Did you ever use vermiculite from the mine/plant for Yes No gardening?

IF YES, please specify residence _______________________________________________

32. Did you ever use vermiculite around one of the Yes No Lincoln County addresses you provided for any other purpose?

IF YES, please specify purpose and residence_______________ ____________________

33. Was your current home sampled for asbestos by the Yes No Environmental Protection Agency (EPA)?

34. How often did you handle vermiculite insulation? Never Sometimes Frequently

35. How often did you participate in recreational activities (hiking, hunting , etc) along Rainey Creek road? Never Sometimes Frequently

36. How often did you play at the ballfields near the expansion plant?  Never Sometimes Frequently

37. How often did you play in or around thevermiculite piles? Never Sometimes Frequently

IF YES, where were these piles located? _____________________________________________

38. How often did you heat vermiculite ore to make it expand or pop?

Never Sometimes Frequently

39. How often did you participate in activities where you came into contact with vermiculite insulation, products or ores not mentioned above?  Never Sometimes Frequently 

IF YES, Please Specify __________________________________

 

TOBACCO SMOKING

Now, I have a few questions about the use of tobacco products . . .

40. Have you ever smoked cigarettes (this means at least 400 cigarettes or Yes No 20 packs during your whole life)? IF NO, PLEASE SKIP TO QUESTION 46

Question 41-45

46. Do you or did you ever smoke cigars or a pipe regularly or frequently? Yes No

 47. Did any member of your family or household regularly smoke cigarettes inside the residence during the time that you lived together? Check yes or no for each person listed below.

IF YES, please indicate how many years you lived in the same household with them while they were smoking inside the residence?

  • Mother Yes No

___________________________________________________

 Years

 b. Father Yes No

___________________________________________________

 Years

 c. Spouse Yes No

___________________________________________________

 Years

 d. Other Yes No

___________________________________________________

 Years

 e. Other Yes No

___________________________________________________

 Years

 f. Other Yes No

___________________________________________________

 Years

 g. Are you currently living with someone who smokes inside the residence? Yes No

MEDICAL/SYMPTOM HISTORY

The next questions are about Medical Symptoms . . .

48. Do you have a regular doctor or clinic that you go to? Yes No

If YES, what is the name and address of the doctor or clinic?

Name (a) ________________________________________________

Address (b) ________________________________________________

___________________________________________________

49. Have you ever had tuberculosis? Yes No

50. Have you ever been hospitalized for pneumonia or pleurisy? Yes No

51. Have you ever had congestive heart failure or fluid on the lungs? Yes No

52. Have you ever had any other chest illness? Yes No

IF YES, please specify: _________________________________

53. Have you ever had a significant chest injury (such as a broken rib)? Yes No

54. Have you ever had chest surgery (open heart, chest drainage tube)? Yes No

55. Do you suffer from rheumatoid arthritis, scleroderma, or lupus? Yes No

56. Have you ever had or do you now have any type of cancer? Yes No

IF YES, please specify type of cancer

___________________________________________________

 (a)

 Cancer Type

IF YES, please specify year of diagnosis

___________________________________________________

 (b)

 Year Diagnosed

57. Have you ever had a chest X-ray? Yes No

58. Have you ever been told by a doctor that you have a lung disease or Yes No lung condition?

59. Have you coughed up phlegm (thick mucous) for 3 months of the year Yes No for the past 2 years?

For the next 3 questions, I will be asking you about conditions experienced in the past year.

60. Have you become hoarse or developed difficulty in swallowing in the last year? Yes No

61. In the past year, have you coughed up phlegm (thick mucous) Yes No that was bloody?

IF YES, SKIP QUESTION 64

62. In the past year, have you had periods of chest pain related to breathing? Yes No

63. Have you lost more than 15 pounds without dieting over the past 6 months? Yes No

64. Have you ever coughed up phlegm (thick mucous) that was bloody ? Yes No

65. Do you now have a cough on most days (at least 4 days out of the week)? Yes No

66. Are you now troubled by shortness of breath when walking up a slight Yes No hill or when hurrying on level ground?

IF NO, PLEASE SKIP TO QUESTION 67.

OTHER INFORMATION

 67. How concerned or worried are you that there is something in your neighborhood environment that may be harming your health?

  • Not at all
  • A little
  • Very

68. Are there any comments you would like to add or any important information you think we should know?

69. Interviewer Comments:

Thank you for participating.

 

Attachment E. Outcome form for chest X-ray reviewers

Study ID Number: |___| |___| |___| |___| |___| |___| |___| |___|

Please summarize each chest X-ray with attention to the presence of interstitial or pleural abnormalities.

1. Which best describes this CXR? abnormal (continue) normal (skip to END)

2. Is there evidence of interstitial abnormalities? yes no

If yes, choose the best category for the interstitial abnormalities from the following:

consistent with asbestos-related changes

not consistent with asbestos-related changes

cannot categorize regarding asbestos changes

3. Is there evidence of pleural abnormalities? yes no

If yes, choose the best category for these pleural abnormalities from the following:

consistent with asbestos-related changes

not consistent with asbestos-related changes

cannot categorize regarding asbestos changes

4. Is there evidence of other abnormalities on the CXR? yes no

If yes, describe:__________________________________________________

Comments/Notes: ___________________________________________________

Signature: __________________________________ Date:____________________

Attachment F. Summary form for HRCT Reader

Study ID Number: |___| |___| |___| |___| |___| |___| |___| |___|

 

Please summarize each HRCT scan with attention to the presence of interstitial or pleural abnormalities.

1. Which best describes this HRCT? abnormal (continue) normal (skip to END)

2. Is there evidence of interstitial abnormalities? yes no

If yes, choose the best category for the interstitial abnormalities from the following:

consistent with asbestos-related changes

not consistent with asbestos-related changes

cannot categorize regarding asbestos changes

3. Is there evidence of pleural abnormalities? yes no

If yes, choose the best category for these pleural abnormalities from the following:

consistent with asbestos-related changes

not consistent with asbestos-related changes

cannot categorize regarding asbestos changes

4. Is there evidence of other abnormalities on the HRCT? yes no

If yes, describe:

______________________________________________________

Comments/Notes: _______________________________________

Signature: __________________________________ Date:____________

ATTACHMENT G. PFT ABSTRACTION FORM

Study ID Number: |___| |___| |___| |___| |___| |___| |___| |___|

Note: Spirometry testing will follow American Thoracic Society guidelines and will be performed by a qualified technician. Established procedures will be followed to ensure correct technique, calibration methods, and maintenance. Qualified medical oversight will be established to monitor the test results, in order to ensure the quality of the results and validity of interpretations. The results will be compared to normative population data based on age, height, and sex..

T = total # of PFT tests on different days, and "n" varies from 1 to T

RESULT # n (n = 1, 2, ....T)

PARAMETER BEFORE ALBUTEROL AFTER ALBUTEROL

Date (day/mo/yr) _____________________

Height(ft_in) _____________________

Age (yrs) _____________________

Weight (lbs) _____________________

FVC best _____________________ ____________________

FVC pred _____________________ ____________________

FVC % pred _____________________ ____________________

 

FEV1 best _____________________ ____________________

FEV1 pred _____________________ ____________________

FEV1% pred _____________________ ____________________

FEV1/FVC _____________________ ____________________

FEV1/FVC pred ______________________ ____________________

FEV1/FVC% pred _____________________ ____________________

 

RV * _____________________ ____________________

RV pred _____________________ ____________________

RV% pred _____________________ ____________________

TLC * best _____________________ ____________________

TLC pred _____________________ ____________________

TLC% pred _____________________ ____________________

CLINICAL INTERPRETATION (as recorded on medical chart)

Normal Obstructive Restrictive Other

* The residual volume (RV) and total lung capacity (TLC) are not routinely measured.

 

ATTACHMENT H. CLINICAL ABSTRACTION FORM

Fill out one form per patient visit

Date of Patient Visit __ __/ __ __/__ __

 

CHECK ALL THAT APPLY:

Current Symptoms

Cough

Cough with phlegm

Describe nature and frequency of cough

Shortness of Breath

At rest During activities of daily living activities (e.g., dressing)

Walking on level ground Walking up stairs or hill

Other

Pleuritic Chest Pain (chest pain during breathing)

Date of onset __ __/ __ __/__ __

Date ended (if applicable) __ __/ __ __/__ __

Physical examination revealed...

Rales Wheezing Pleural Rub Other Describe_______________________________

 

Diagnoses by Pulmonary Specialist

Non-Malignant Asbestos-Related Pulmonary Disease

Asbestosis Date of diagnosis __ __/ __ __/__ __

Left pleural effusion Date of diagnosis __ __/ __ __/__ __

Right pleural effusion Date of diagnosis __ __/ __ __/__ __

Asbestos-Related Malignancy

Lung cancer Date of diagnosis __ __/ __ __/__ __

Mesothelioma Date of diagnosis __ __/ __ __/__ __

Other pulmonary diagnoses (not listed above)

Diagnosis Date __ __/ __ __/__ __

Diagnosis Date __ __/ __ __/__ __

Tests Performed at This Visit (Transcribe text of report for each test this visit)

Chest Radiograph

HRCT

PFTs

Diffusing Capacity

 

ATTACHMENT I. KEY PERSONNEL AND RESPONSIBILITIES

Personnel Title Org. Responsibilities
Aubrey Miller Co-Investigator PHS, Region 8
  • develops/implements plan
  • monitors work of the expert panel
  • develops form to abstract medical record
  • develops questionnaire for address
  • history and risk factor information
  • analyzes results
  • develops final summary report

Dan Middleton Co-Investigator ATSDR/DHS
  • develops/implements plan
  • monitors work of the expert panel
  • develops form to abstract medical record
  • develops questionnaire for address
  • history and risk factor information
  • analyzes results
  • develops final summary report

Dr. Alan Whitehouse Pulmonary Physician University Affiliation
  • sends initial letter to patients
  • collects consent and release forms
  • provides records to ATSDR
  • notifies patients of interpretations as requested (by expert panel).
  • answers questions about interpretations
  • consults for record review and abstraction,
  • Co-authors and reviews the final report
  • answers questions and discusses results (e.g., over the phone) for each patient

Dr. Jeff Lybarger Division Director, DHS ATSDR/DHS
  • provides general oversight of project; e.g., DHS assists with strategic decisions regarding protocol development and implementation, analysis and interpretation of final results, & preparation of final report
  • ensures necessary resources are available to complete the project

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