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Item ID Number °1851 Author McKinlay, Sonja M. Corporate AllthOT New England Research Institute, Inc., Watertown, Mass RODOrt/ArtldB Tltlfl Women's Vietnam Veterans Health Study Protocol Development, Study Design and Protocol, Appendices, Deliverable D Journal/Book Title Year 000° Month/Day Color n Number of Images 253 DOSCrlptOn NOtBS Contract No. V101 (93)P-1138 Wednesday, July 11, 2001 Page 1852 of 1870 WOMEN VIETNAM VETERANS HEALTH STUDY PROTOCOL DEVELOPMENT CONTRACT NO. V101(93)P-1138 STUDY DESIGN AND PROTOCOL APPENDICES DELIVERABLE D SUBMITTED BY NEW ENGLAND RESEARCH INSTITUTE PRINCIPAL INVESTIGATOR SONJA M. MCKINLAY, PH.D NEW ENGLAND RESEARCH INSTITUTE, INC. 42 Pleasant Street Watertown, Massachusetts 02172 (617)923-7747 STUDY DESIGN PROTOCOL APPENDICES DELIVERABLE D 1. INFORMED CONSENT AND RELEASE FORMS 2. CONGENITAL ABNORMALITY CLASSIFICATION AND PEDIATRIC EXAMINATION 3. MYOCARDIAL INFARCTION, SUDDEN DEATH AND STROKE CLASSIFICATION 4. NEUROBEHAVIORAL TESTING PROTOCOL 5. SOFT TISSUE SARCOMA CLASSIFICATION 6. PROTOCOL FOR 2, 3, 7, 8 - TCDD BODY BURDEN DETERMINATION INFORMED CONSENT AND RELEASE FORMS WOMEN VETERANS HEALTH STUDY date Name Street Address City, State, Zip Dear As part of the "Women Veterans Health Study" sponsored by the Veterans Administration, we are interested in obtaining complete medical records on your hospitalizations which include some more technical information that is needed for the study. As we told you over the telephone, in order to do that we need to obtain a signed authorization form from you first. Could you please help us by signing the enclosed authorization form and returning it to us in the enclosed envelope as soon as possible. You may be assured that the information will be kept confidential and will be used only in completing the review of your record. We will be most grateful for your cooperation. Sincerely yours, Contractor WOMEN VETERANS HEALTH STUDY Written Release Format and Record Request AUTHORIZATION FOR DISCLOSURE OF MEDICAL INFORMATION Name: Hospital Number: Address: . Date of Birth: I hereby authorize the Hospital/Clinic to release information from my medical records to: CONTRACTOR ADDRESS This authorization covers all medical and/or psychiatric treatment, history of illness or related information. This authorization shall remain in effect as long as necessary (up to one year) to respond to the attached request. I also understand that I may revoke this authorization at any time. This authorization expires one year from date signed. Signature of Patient: Date: Authorization received by: Office: WOMEN VETERANS HEALTH STUDY 7/1/87 INFORMED CONSENT (PARTICIPANTS) As a participant in the "Women Veterans Health Study" I understand that I am eligible to participate in a follow-up study, on a subsample of individuals funded by the Veterans Administration. This follow-up is being conducted by (Contractor) in collaboration with the Red Cross. It includes collecting information on neuropsychological behavior, and physiological measurements. I understand that as a participant in this study, I will be asked to provide answers to some health-related questions, and participate in neurological testing which will be completed in a home visit, at my convenience, in about 3 hours. I understand that a visit to the nearest Red Cross Center will be scheduled for a blood sample to measure TCDD (dioxin) levels. Risks from the measurement made at the Red Cross Center includes slight discomfort at the insertion of the needle for the blood sample, and a small chance of bruising and infection. This procedure is similar to a donation of blood. The results of my measurements will be provided to me in a summary report about 3 months after the visit. At my request, a copy of this report will be sent to my physician. I also understand that these tests do not replace a physical examination by a physician, and in no way do they imply any form of medical treatment or diagnosis. I understand that all information I give is confidential and will be used for statistical purposes only. Each of these tests and procedures and their risks and discomforts have been explained to me and all of my questions about the study have been answered to my fullest satisfaction. (Respondent) Signature Examining Physician Signature Date WOMEN VETERANS HEALTH STUDY date Name Street Address City, State, Zip Dear As part of the "Women Veterans Health Study" sponsored by the Veterans Administration, we are interested in obtaining complete medical records on your child's hospitalizations which include some more technical information that is needed for the study. As we told you over the telephone, in order to do that we need to obtain a signed authorization form from you first. Could you please help us by signing the enclosed authorization form and returning it to us in the enclosed envelope as soon as possible. You may be assured that the information will be kept confidential and will be used only in completing the review of your child's record. We will be most grateful for your cooperation. Sincerely yours, Contractor WOMEN VETERANS HEALTH STUDY 7/1/87 INFORMED CONSENT (CHILDREN) As a participant in the "Women Veterans Health Study" I understand that my child is eligible to participate in a follow-up study, on a subsample of offspring funded by the Veterans Administration. This follow-up is being conducted by (Contractor) in collaboration with the Red Cross. It includes examination of my child by a physician specialist. I understand that as a participant in this study, my child will be given an examination. This will be completed in a home visit, at my and my child's convenience, in no more than 2 hours. The results of my child's exam will be provided to me in a summary report about 3 months after the visit. At my request, a copy of this report will be sent to my child's physician. I also understand that these tests do not replace a physical examination by a physician, and in no way do they imply any form of medical treatment or diagnosis. I understand that all information gathered is confidential and will be used for statistical purposes only. Each of these tests and procedures and their risks and discomforts have been explained to me and all of my questions about the study have been answered to my fullest satisfaction. I give my consent to have my child, (NAME) examined by Dr. (NAME). Parent (Guardian) Signature Date Examining Physician Signature Date WOMEN VETERANS HEALTH STUDY Written Release Format and Record Request For Child's Medical Records AUTHORIZATION FOR DISCLOSURE OF MEDICAL INFORMATION Name: Hospital Number: Address: , Date of Birth: I hereby authorize the Hospital/Clinic to release information from my child's medical records to: CONTRACTOR ADDRESS This authorization covers all medical and/or psychiatric treatment, history of illness or related information. This authorization shall remain in effect as long as necessary (up to one year) to respond to the attached request. I also understand that I may revoke this authorization at any time, This authorization expires one year from date signed. Signature of Parent: Date: Authorization received by: Office: CONGEN!TAL ABNORMALIT Y CLASSI FICATION AND PEDI ATRI C EXAMI NAT1 ON VERIFICATION OF CONGENITAL ABNORMALITY Currently the Ranch Hand II Study is relying on records and recoding of these records using modified ICD-9 CM classifications to verify congenital abnormalities detected up to the age of 18 years. Very few hospital records, from up to 18 years ago are unavailable. The following records are solicitied: • Birth Certificate; • Hospital Delivery Record; and • Records for any hospitalizations related to diagnoses of an anomaly. The modified ICD-9 CM classification which follows and the protocol for record abstraction used on Ranch Hand II are proposed for use in this study. BIRTH DEFECTS BRANCH SIX DIGIT CODE For Reportable Congenital Anomalies Based on B-P-A- Classification of Diseases (1979) and W.H-0. I-C-D.9 CM (197?) Code modifications developed by Birth Defects & Genetic Diseases Branch Center for Environmental Health Centers for Disease Control Atlanta, Georgia 30333 Doc. No. 6digit Version 05/87 INDEX TO 6-DIGIT CODE ICD-9 Ease. Code. Explanation to 6-Digit code i Anencephalus and similar anomalies 740 1 Spina bifida 741 2-3 Other congenital anomalies of 742 3-4 the brain and nervous system Congenital anomalies of the eye 743 5-6 Congenital anomalies of the ear, 744 7-8 face, and neck Bulbus cordis anomalies and anomalies 745 9-10 of cardiac septal closure Other congenital anomalies of 746 11-12 the heart Other congenital anomalies of 747 13-14 the circulatory system Congenital anomalies of the 748 15-16 respiratory system Cleft palate and cleft lip 749 17 Other congenital anomalies of the 750 18-19 upper alimentary tract Other congenital anomalies of 751 20-22 the digestive system Congenital anomalies o.f the 752 23-26 genital organs Congenital anomalies of the 753 27-28 urinary system INDEX (cont'd-) ICD-9 Certain corgenital musculo-skeletal 754 29 deformitj es ....... heac 29 ....... spire 29 ....... hip, legs, feet 29-30 ....... chest 30 Other congenital anomalies of limbs 755 31 ....... poljdactyly 31 ....... sync actyly 31 ....... reduction defects 32-33 ....... other anomalies, upper limbs 33 ....... other anomalies, lower limbs 34 Other musct.lo-skeletal anomalies 756 36 ....... of skull and face bones (craniosynostosis) 36 ....... of the spine and ribs 37 ....... spii.a bifida occulta 37 ....... choi.drodystrophy . 38 ....... oste odystrophies . 38 ....... of the diaphragm 39 ....... of 1 he abdominal wall 39 ....... other specif ied/unspec • • 39 Congenital anomalies of the integument 757 40 ....... skin 40 ....... hair, nails, other specified 41 Chromosomal anomalies 758 42-45 Other specified and unspecified 759 45 congenitj 1 anomalies ....... sple en 45 ...... -adrenal gland • 45 ......
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