NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY III Training Manual for Allergy Component Westat, Inc. 1650 Research Boulevard Rockville, MD 20850 (301) 251-1500 September 1988 Revised February 1989 TABLE OF CONTENTS Chapter Page 1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 1.1 Overview of the Allergy Component . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 1.2 General Overview of Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 2 EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 2.1 Description of Exam Room in MEC . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 2.2 Description of Equipment and Supplies . . . . . . . . . . . . . . . . . . . . . . . 2-1 2.2.1 Inventory of Supplies and Equipment . . . . . . . . . . . . . . . . . . 2-1 2.3 Equipment and Supply Setup Procedures . . . . . . . . . . . . . . . . . . . . . . 2-2 2.3.1 Start of Stand Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 2.3.2 Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 2.3.3 Daily Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 2.4 Care and Maintenance of Equipment and Supplies . . . . . . . . . . . . . . . . 2-3 2.5 End of Stand Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 2.5.1 Equipment Breakdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 2.5.2 Packing Supplies and Equipment . . . . . . . . . . . . . . . . . . . . . 2-3 3 EXAMINATION PROTOCOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 3.1 Eligibility Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 3.1.1 Sampling Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 3.1.2 Medical Exclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 3.2 Pre-Examination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 3.3 Examination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 3.3.1 Protocol Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 3.3.2 Examination Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 3.4 Postexamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15 4 LOGS AND RECORDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 4.1 Daily Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 iii TABLE OF CONTENTS (continued) Chapter Page 4.1.1 Automated System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 4.1.2 Hard Copy Daily Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 4.2 Calibration Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 4.3 Shipment of Forms and Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 5 QUALITY CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 6 SAFETY PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 6.1 Equipment and Supply Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 6.2 SP Movement and Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 6.3 Emergency Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 List of Appendices Appendix A User Documentation for Allergen Skin Test Screen . . . . . . . . . . . . . . . . . . . . . A-1 B Screen by Screen Instrucctions for the Allergy Component . . . . . . . . . . . . . . . . B-1 C NHANES III Allergy Component Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 D Spanish Version - Allergy Data Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 List of Exhibits Exhibit Page 3-1 Allergy Test Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 3-2 Schematic Diagram of Allergen Postions . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 3-3 Numbering the test sites (2 arms) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 3-4 Numbering the test sites (1 arm) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 3-5 Inserting the needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 3-6 Testing the skin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 3-7 Measuring flare and wheal reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12 3-8 Allergy test form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13 4-1 Allergy Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 iv 1. INTRODUCTION 1.1 Overview of the Allergy Component The allergy skin testing component of NHANES III has been developed by NCHS in collaboration with the Center for Biologics Evaluation and Research, Food and Drug Administration (CBER, FDA). This survey will help NCHS and CBER, FDA measure the prevalence of allergies in the United States and determine if the prevalence has changed since previous HANES surveys, which indicated that approximately 20 percent of the U.S. population is affected by allergic diseases. The Health Resources and Services Administration will use the data to measure the degree to which allergies in the population impact on health care delivery systems. The FDA will use the data on standardized allergens to assess their reactivity in the general population. The National Heart, Lung, and Blood Institute will use the allergy data in conjunction with other exam and interview data to increase our understanding of chronic obstructive lung disease. Data on allergies will be collected during interviews and examinations of SPs. During the interview, data will be collected on four main types of allergies: asthma, hayfever, eczema, and food and drug allergies. In addition, the questions will be designed to obtain information on trigger factors, severity, medication use, and hospitalizations. The examination component will consist of the application of 12 skin tests by the prick-puncture technique, and collection of blood for measurement of serum IgE (immunoglobin) levels. 1.2 General Overview of Procedures Allergens are extracts of certain foods, animal insects, pollen, or molds which are used to test a person for hypersensitivity to specific substances. The allergen skin tests administered in NHANES III are designed to minimize constitutional reactions necessitating the use of emergency medical procedures. Using the prick-puncture technique during each stand, approximately 134 SPs aged 1-1 6-59 will be tested for the following allergens and controls: 1 - Negative Control (glycerinated diluent) 7 - Peanut 2 - White oak 8 - Russian thistle 3 - Cat 9 - German cockroach 4 - Mite 10 - Bermuda grass 5 - Alternaria 11 - Ragweed 6 - Rye grass 12 - Positive control (histamine base) 1-2 2. EQUIPMENT 2.1 Description of Exam Room in MEC The allergy component takes place in the Body Measurement Room in the MEC. The technician and SP sit on either side of a table on which the SP's arm rests during the administration of the allergy tests and reading of the reactions. 2.2 Description of Equipment and Supplies 2.2.1 Inventory of Supplies and Equipment The following is a list of the supplies used in the allergy component: Cold box to store allergen vials during exam sessions Rack to hold allergen vials Timer with buzzer Lamp (with 75-watt incandescent bulb) Magnifying glass Clear plastic template to mark test sites (large, medium & small sizes) Metric ruler (plastic, transparent, flexible) Needle disposal box (biohazard container) Syringes to transfer solutions (1cc with 20 gauge needles 3/4" or 1/2") Black marking pen (fine, rolling writer, washable ink) Needles (BD 25 gauge, 5/8 inch) Alcohol sponge wipes Gloves Vials of allergen extracts Gauze pads 4x4's 2-1 2.3 Equipment and Supply Setup Procedures 2.3.1 Start of Stand Procedures Fresh solutions are used at the beginning of each stand. Check to make sure there is an adequate supply of all 12 extracts for the anticipated number of SPs to be tested for allergy during the stand. At the start of each stand, the freeze-dried extracts (cat hair, rye grass, russian thistle, short ragweed) must be reconstituted with diluent. To reconstitute each extract, you will need five (5) 1 ml. vials of the freeze-dried extracts; four (4) 5 ml. syringes; four (4) 20 gauge needles, 1" in length; and a 5 ml. dropper vial filled with diluent. Using an alcohol prep, wipe the tops of the 1 ml. vials containing the freeze-dried extract. Put a 20 gauge needle on the syringe. Draw up 5 ml. of diluent from the 5 ml. dropper vial. Inject 1 ml. of diluent into each vial. Shake well. When all the material has dissolved, withdraw the 1 ml. of reconstituted extract in each vial using the same syringe you used for injection into that vial. Finally, inject all 5 ml. of reconstituted extract into the 5 ml. dropper vial from which you originally withdrew the diluent. Label the dropper vial with the appropriate name and number. Treat the reconstituted solution as you would the other extracts. Repeat this procedure for each set of freeze-dried extracts. 2.3.2 Calibration Procedures There is no equipment to be calibrated. 2.3.3 Daily Procedures At the beginning of each session, remove the tray of vials from the refrigerator and place it in the exam room. At the end of the session, before refrigerating the tray of vials, make sure there is enough of each 2-2 solution to conduct allergy testing during the next session. Place the top of the cold box in the freezer. 2.4 Care and Maintenance of Equipment and Supplies To maintain the stability of the test allergens throughout a stand, allergen vials should be kept in the refrigerator when not in use; and in the cold box in the exam room when allergy testing is taking place. You should handle the allergen solutions with care, however they are not biohazardous. Thus, if an allergen solution spills on someone or on the floor or other object, merely wipe it with a damp cloth and throw it away. 2.5 End of Stand Procedures 2.5.1 Equipment Breakdown (There is no equipment to be broken down.) 2.5.2 Packing Supplies and Equipment Discard all open vials of allergens. Any unopened vials should be mailed back to Westat, on ice, via next day delivery. 2-3 3. EXAMINATION PROTOCOL 3.1 Eligibility Criteria 3.1.1 Sampling Procedures You will not need to conduct the sampling of appropriate SPs for allergy testing, but you should be aware of the procedure used. The sampling procedure to determine which examinees receive allergy testing (and which receive CNS) is as follows: Component SP Age Sample Allergy 6-19 years All 20-59 years 1/2 sample - even examinee number (CNS) 20-59 1/2 sample - odd examinee number The final digit of the Serial Number, not the check digit, should be used to determine the odd/even designation. 3.1.2 Medical Exclusion SPs with certain medical conditions will not be allowed to have the allergy skin tests. To determine which SPs are not eligible, the health technician should ask the questions as they appear on the screen or hard copy form (Exhibit 3-1). Question 1: "Are you now having problems breathing?" If the SP answers "No", you skip questions 2 and 3 which ask for additional information on breathing problems, and go on to question 4. If the SP answers "Yes", you continue on to question 2 for further questioning on breathing problems. 3-1 Exhibit 3-1 3-2