Summary of Focus Group Discussions of Donor Screening Questions for Structure, Content and Comprehension. Sharyn L. Orton, Ph.D.

Transcription

1 Summary of Focus Group Discussions of Donor Screening Questions for Structure, Content and Comprehension. Sharyn L. Orton, Ph.D., Scientist Holland Laboratory, Transmissible Diseases Laboratory and Victoria J. Virvos, M.Ed., Consultant Enlightening Enterprises, Richmond, VA

2 Table of Contents Background Page 2 Materials and Methods Page 3 Results Page 5 Specific questions: History of/contact with hepatitis Page 6, 7 Tattoo, piercing, acupuncture, etc. Page 7, 8 Chagas disease/babesiosis Page 8 Cancer Page 8-10 CJD risk Page 9 Travel to the UK Page 9 Bovine insulin Page 10 Heart or lung diseases Page 10 Bleeding disorder/blood disease Page 10 Transplant/graft Page 10,11 User of needles (intravenous)/sex with Page 11 Travel to Africa Page 11, 12 Jail or prison Page 12 Other risks associated with sexual behavior; MSM Page 12, 13 Human growth hormone Page 14 New vcjd risk-related travel Page Capture travel questions Page 17 Conclusion Page 19 Focus group participant demographics Page References Page 24 1

3 Background As a result of continuing efforts to improve the safety of the blood supply, infectious disease testing has improved in sensitivity and specificity over time. There is still concern about donations from individuals who may be in the window period of infectivity, as well as individuals who may be infected with other potentially transfusiontransmissible diseases for which licensed tests for donor testing are not available. In an effort to reduce the potential risk, donor educational materials and donor history questionnaires have been modified over time to include questions regarding risk behavior or exposures as recommended or required by the Food and Drug Administration (FDA). The format of the questionnaire has been modified to include direct and oral questioning regarding a variety of behaviors 1-3 in addition to self-administered portions of the questions. Studies of donors in the late 1980 s have shown that culturally sensitive predonation educational materials needed to be developed and distributed prior to the screening process, as opposed to the actual interview questions which needed to be broadly based and directed at the general community. In a study designed to maximize the screening efficacy of donors for the human immunodeficiency virus (HIV) risk, different methods of intervention were used. 4 Based on the results of this study, the FDA concluded that donors with high-risk behavior were more likely to be deferred from donation when asked specific oral questions. By 1992, a list of sample direct questions had been developed, modified and published. Also in 1992, the American Association of Blood Banks (AABB) endorsed, and the FDA approved, a Uniform Donor History Questionnaire (UDHQ). 5 The original document that was submitted to the AABB for review was developed by a committee of the Blood Centers of California, which collected and collated questions used by member institutions. Focused attention was given to ensure regulatory compliance in the language used. Questions were reviewed and a master list was developed. 6 However, as with other questionnaires in use, individual questions, developed either by the AABB or the FDA, were not validated at a population level of potential donors. In fact, very little can be found in the literature regarding validation of donor history questions. In standardized survey research it is known that the wording of questions directly affects the quality of the answers. The question becomes a source of error if it is poorly understood, the information cannot be recalled, the respondent is unwilling to answer or if the question does not evoke the required information. 7 Multiple questions within a question, poorly defined terms and other design flaws are common errors. Lengthy questions asked directly by the interviewer may contain too much information to be recalled quickly. When these types of questions are self-administered, the individual may scan the first few lines, rather than read the entire question thoroughly. 7 A good question is understood, answered consistently and answered in a way that is consistent with the information one is trying to obtain. The question should be worded so that every individual is answering the same question and the respondents can understand the meaning. To stimulate recall, the time frame of the question should be specified first, followed by the response task or variable. If questions are to be asked orally, it is important that the questions be adequately scripted for oral administration. Important areas to cover are whether (1) the questions appropriately cover the material, 2

4 (2) the respondents are willing and able to recall, and (3) the questions convey consistent understandable meaning. 8 Questions should be designed as precise measurement tools. Ideas regarding the design of questions can be obtained through focus groups of users that evaluate whether the questions asked are clear, concise and understandable. Focus groups should include a sample of the potential donor population, including participants from different ethnic, age, educational groups and settings. The diversity of the participants may be as important, if not more so, than selecting individuals that are considered representative. 9 Several small groups of people are adequate to discuss terms and concepts that need definition, and make assumptions about how respondents behave or think about the material covered. Cognitive research techniques have identified the usefulness of think aloud interview processes where individuals go through a pretest version of the survey instrument and then discuss ambiguities and difficulties in responding. 9 Focus groups were conducted as part of a multiple study evaluation process, and each series is described in the Methods section. The object of these focus groups was to target question wording and comprehension in a targeted sample of potential or past blood donors. MATERIALS AND METHODS Evaluation process Focus groups were held in three settings to evaluate: Selected American Red Cross (ARC) questions Uniform Donor History Questionnaire questions New, FDA-proposed European travel questions (related to vcjd risk). The first series of focus groups was conducted at the ARC between 1998 and Because certain donor screening topics are sometimes remembered after the donation process (donor callback or post-donation information ) or at a subsequent donation, leading to blood component recalls/market withdrawals, seven questions were evaluated as part of a Recall/Market Withdrawal study. 10 In addition, the questions from the FDA Final Guidance; Revised Precautionary Measures to Reduce the Possible Risk of Transmission of CJD and nvcjd by Blood and Blood Products were evaluated. In the next series (2001), as part of the Uniform Donor History Questionnaire (UDHQ) Task Force, additional questions on the current AABB Uniform Donor History Questionnaire were evaluated using the same technique. Finally, recommended questions from the FDA Draft Guidance; Revised Measures to Reduce the Possible Risk of Transmission of CJD and vcjd by Blood and Blood Products, were also evaluated for the UDHQ Task Force. For this group of questions, participants were also asked to state their preference for the UDHQ or FDA wording. Population sample and demographics For the ARC study, an ARC Donor Resources volunteer familiar with donor groups in the Baltimore/Washington area recruited the participants. For the initial discussion, six separate groups were held with individuals recruited from a church, a business, a high school/college, and individuals selected randomly from the general population. Men and women of various age and racial groups were represented. The 3

5 participants were either from the Baltimore/Washington or Richmond, Virginia areas. For individuals to participate in the initial focus group, they must have (1) never been a blood donor but, (2) to the best of their knowledge been eligible to do so. The demographic characteristics of these participants are presented in Table 1. After revision of the questions, three additional focus groups were held to discuss the revised questions. These participants included both individuals who had and had not previously donated. The demographics of these participants are presented in Table 2. For the UDHQ Task Force, the majority of participants were from the groups noted above, but also included a group from the military to more thoroughly evaluate the European travel questions. All participants were from the Baltimore/Washington area. Criteria for individuals to participate in the focus group included, to the best of their knowledge, being eligible to donate. Current or past donors were not excluded. The demographic characteristics of these participants are presented in Tables 3 and 4. Participants in all groups (with the exception of the military) received $50 as reimbursement for their time and travel expenses. Site Participants were asked to come to the ARC Jerome H. Holland Laboratory in Rockville, Maryland, on a specified date for the focus group discussion. If the Rockville location was not convenient, an alternative more convenient site was selected. Two of the initial and one follow-up focus group were held in Richmond, Virginia. The focus group was scheduled for 2-3 hours. Facilitators Two facilitators were present for the group discussion. The first, an independent consultant whose background is in education and special education, led the discussion group as a layperson. The second, an epidemiologist (with experience as a medical technologist), was present to provide scientific background and information on regulatory requirements when needed. Focus group discussion protocol Individuals were first introduced to the facilitators. The purpose of the focus group discussion was described and the expectations for the participants were outlined. It was stressed that the discussion was not intended to determine why an individual did not donate or to elicit an actual response to the questions being discussed. For non-donors, the donor process from arrival through donation completion was described. Descriptions were provided of the possible environment, pre-donation information, medical exam and history, donation process, confidential unit exclusion, callback number and type of testing performed on each donation. For the ARC study a, What you must know before giving blood, pre-donation information sheet was provided for the participants to read, and each was shown a Blood Donation Record (questionnaire). For each question evaluated, a facilitator read the question aloud. Then the question was provided to the participants on a flip chart, for 4

6 referral during the discussion. For subsequent UDHQ focus groups, written copies of the questions were provided while the facilitator read the questions. The following list of questions was either posted or presented as topics to be considered: 1. What is the question asking? Participants first discussed what the question seemed to be asking them, prior to the facilitators disclosing what the FDA and/or the AABB required, recommended or intended. 2. Are all of the terms and question format clear? 3. If not, would you ask for more information? 4. Is there a better way of asking the question? Participants were told that group consensus did not need to be reached and that all ideas would be recorded. 5. If additional information should be given, where/how should it be provided? As the discussion progressed, explanations regarding FDA regulations, AABB standards and recommendations, and information related to these questions (currently available in the scientific literature) were provided as needed by the facilitators. RESULTS For the first series of focus groups, the seven ARC questions in use at the time (and discussed by the focus groups) are noted, followed in parenthesis by the corresponding wording of the question from the current AABB UDHQ (noted as AABB ). The same groups also discussed the original UK travel and bovine insulin questions. Prior to focus group discussions being conducted for the UDHQ Task Force, the task force members discussed and made revisions to the wording of some of the AABB UDHQ questions. For these questions, the wording below is either the current AABB wording, or that recommended by the UDHQ Task Force, but is noted as UDHQ. For the new recommended vcjd related travel questions, the focus groups were also asked to comment on their preference of FDA or UDHQ Task Force revised wording. Therefore, the UDHQ Task Force revised wording is noted as UDHQ, followed by the FDA wording in parenthesis. In addition, a discussion of capture question development for all travel questions was conducted. Each question is accompanied by a summary of the unanimous or majority opinions of the groups. If participants recommendations were the same, or virtually the same, one recommendation is noted. Otherwise, all recommendations are noted. Some general comments consistent with all the focus groups conducted included the following: General: 1. Question length: Participants noted that some of the questions are too long to only be read orally. However, if a donor is able to read the questions themselves, most of the questions do not appear to be too long. The notable exception is complex compound 5

7 questions, including some of the travel questions related to vcjd risk, which are discussed in more detail below. 2. Content: Some of the recommendations involve removing one or two words (as either unnecessary or redundant), with the intent of even further simplifying the questions. 3. The term "sex": After discussing the term "sex or sexual contact", participants recommended the following: a. That a wall chart be used that has a list of all possible situations that are considered "sexual contact." (Ultimately, the Task Force chose the pre-donation educational materials as the venue for describing sexual contact and sex ) b. For oral questions, that this list be read to the donor (breaking eye contact) at the first question that contains "sexual contact," and just be referred to at each additional question. All groups recommended that any sexual practice considered to be risky be clearly defined. This was particularly true of the high school students because: (a) most considered only vaginal sex as "sex," (b) most did not know that anal sex was associated with increased risk for infectious diseases, and (c) none considered oral sex as "sex," nor did they think that it put them at risk for any infectious disease. Note: The number before each question listed below does not correspond to the actual question number on the new, revised Uniform Donor History Questionnaire. Note: # 1 9 were conducted with the groups characterized in Table 1. Follow-up to # 1 7 was conducted with groups described in Table 2. # 1 and 2: ARC: Since the age of 11, have you had yellow jaundice, liver disease or hepatitis? and Have you ever tested positive for hepatitis? (AABB: Have you ever had yellow jaundice, liver disease, viral hepatitis, or a positive test for hepatitis? ) Focus group discussion: Participants felt that many people would have a hard time remembering since the age of 11, and questions should be specific to hepatitis viruses. In addition, they thought that the use of the terms liver disease and yellow jaundice were vague, unnecessary, and this entire area should be covered by one question. Participant recommendation: Have you ever had hepatitis or tested positive for hepatitis? 6

8 # 3: ARC: In the past 12 months, have you been in close contact with anyone having yellow jaundice or hepatitis, or have you received Hepatitis B Immune Globulin (HBIg)? (AABB: In the past 12 months, have you been in close contact with anyone having yellow jaundice or hepatitis, or have you received Hepatitis B Immune Globulin (HBIg)? ) Focus group discussion: All participants again agreed that phrase yellow jaundice not be used, and that close contact should be defined in pre-donation information. A small wall poster should be provided, listing the types of close contact that would be included. This information should be pointed out and read aloud the first time that the term close contact occurs in a question. Thereafter, it should just be pointed out. They also noted that it should be explained that it HBIg is not the Hepatitis B vaccine, and that this topic would best be covered by two separate questions. (Ultimately, the Task Force embedded activities that constitute close contact in specific questions in the revised questionnaire) Participant recommendation: In the past 12 months have you been in close contact (with above explanation) with anyone having hepatitis? and as a separate question, In the past 12 months have you received Hepatitis B Immune Globulin (HBIG)? This is not the Hepatitis B vaccine. # 4: ARC: In the past 12 months, have you had a tattoo, an accidental needlestick, or nonsterile acupuncture, ear, skin, or body piercing, or have you come in contact with someone else s blood? (AABB: In the past 12 months, have you had a tattoo applied, ear or skin piercing, nonsterile acupuncture, an accidental needle-stick, or have you come in contact with someone else s blood? ) Focus group discussion: All participants agreed that there was too much information for one question and that it was quite believable that this is the most common source of post donation information. Most thought that if a donor were to hear an item that really stands out as drastic or severe, he or she might focus on that word and not hear any of the other choices. All agreed that first choices might be forgotten by the time the last choice was presented. It was recommended that the question be split, and noted that the order of the choices was important, and the terms needlestick and non-sterile needed definition. A recommendation for needlestick was to qualify it as a medical needle, or a description of exactly what type(s) of needle would qualify for deferral. The recommendation for nonsterile was to qualify it as not medically sterile. Participant recommendation: In the past 12 months have you been in contact with someone else s blood or had an accidental needlestick with a medical needle (or appropriate definition)?, and 7

9 In the past 12 months have you had ear, body piercing or acupuncture with equipment that was not medically sterilized? AND In the past 12 months have you had a tattoo? Another possibility was to preface this section of questioning with Now I am going to ask you some questions about things that you may have done in the past 12 months. Have you: Been in contact with someone else s blood? Yes or No, and Had an accidental needlestick with a medical needle? Yes or No, and Also in the last 12 months, have you had any of the following done with equipment that was not medically sterilized : Your ears pierced? Yes or No Acupuncture? Yes or No, Body piercing? Yes or No And finally, in the past 12 months have you had a tattoo? Yes or No. Exact wording varied somewhat between groups and 2 groups put contact with someone else s blood and accidental needlestick last. However, all groups agreed that the order should be: ears pierced, acupuncture, body piercing and tattoo. # 5: ARC: Have you ever had Chagas disease or babesiosis? (AABB: Have you ever had malaria, Chagas disease, or babesiosis? ). Focus group discussion: No participant had heard of either Chagas disease or babesiosis. After an explanation, all individuals agreed that if a physician told you that you had either of these, you would probably remember it. They also noted that without a scientific lecture being provided, there was no recommendation for a change to this question. Participant recommendation: No change. # 6: ARC: Have you ever had cancer (except non-melanoma skin cancer or cervical carcinoma in situ? (AABB: Have you ever had cancer, a blood disease, or a bleeding problem? ) Focus group discussion: Participants felt that individuals who have had cervical cancer in situ would probably know what that was and that the use of the term non-melanoma may be confusing. Their concern was that, when hearing the melanoma portion, the donor may think that it is okay to donate even having had a history of melanoma. 8

10 Participant recommendation: Have you ever had cancer? If yes, what type? The interviewer would document this and allow individuals with non-melanoma skin cancer or cervical cancer in situ to donate. (This recommendation is a capture question, and was not implemented.) # 7: ARC: Have you or any blood relative had Creutzfeldt-Jakob Disease, have you ever been told that your family is at increased risk for Creutzfeldt-Jakob Disease, or have you ever had a dura mater (or brain covering) transplant during head or brain injury? (AABB: Have you received a dura mater (or brain covering) graft? and Have you or any of your blood relatives had Creutzfeldt-Jakob Disease or have you ever been told that your family is at an increased risk for Creutzfeldt-Jakob Disease? ) Focus group discussion: No individuals had heard of CJD. After an explanation, all participants felt that asking if you had been diagnosed with CJD was ridiculous ; a person would be too ill to donate. It was suggested that, after first saying Creutzfeldt- Jakob Disease, the interviewer should state, also known as CJD and use CJD later. Focus group participants asked if an individual would be told by a physician that they were at risk, if a family member were diagnosed with the disease. If so, it was suggested that asking both parts of the question might be redundant. All agreed that the question was too long and should be split into two separate questions. Regarding dura mater transplants, it was suggested that the question be worded, brain covering, also known as dura mater. Participant recommendation: Has a blood relative ever had Creutzfeldt-Jakob disease, also known as CJD? (if necessary, leave as part..or have you been told that your family is at increased risk for CJD? ), and as a separate question, Have you ever had a brain covering (or dura mater) transplant during head or brain surgery? For # 1-7, follow-up focus groups had no additional recommendations. # 8: ARC: During 1980 through 1996, have you spent 6 months or more in the United Kingdom? (England, Northern Ireland, Scotland, Wales, Isle of Man, Channel Islands)? Focus group discussion: Participants felt that if this question was asked orally, the countries should be listed on a visual aid. In addition, the additive time should be clearer. Participant recommendation: Between 1980 through 1996, did you spend time in the United Kingdom that adds up to 6 months or more? (England, Northern Ireland, Scotland, Wales, Isle of Man, Channel Islands)? (Note : between does not include 1980; change to from is addressed in the General section prior to question 24). 9

11 # 9: ARC: Have you been injected with bovine insulin? Focus group discussion: One participant who was a diabetic stated that it was unlikely that a diabetic would remember over a long time period. Participant recommendation: No change. Note: # were conducted with groups 1, 2 and 4 characterized in Table 3. #10: UDHQ: "Have you ever had cancer or any problem with your heart or lungs?" Focus group discussion: Some participants from one group questioned whether leukemia should be included here. They felt that a person who had had leukemia would know that it was a cancer. (It was explained that leukemia is included in a later question.) They also felt that this wording effectively covers a wide variety of diseases, including things like asthma. They did not have any recommendations for revising this question. Two groups felt that this was a run on sentence, and that cancer should not be included with heart or lung problems. They recommended that this be split into 2 questions: Participant recommendation: "Have you ever had cancer?" and "Have you ever had any problem with your heart and/or lungs?" # 11: UDHQ: "Have you ever had a bleeding disorder or a blood disease, including leukemia?" Focus group discussion: Participants felt that leukemia should be dropped as it is considered cancer. The predominantly African-American group was concerned with the word disorder had too negative a connotation. They preferred the use of the word "problem." There was discussion around whether "problem" would invoke affirmative responses for simple bleeding episodes. However, they felt that "problem" was a term that minorities (who are more likely to have hemoglobinopathies) would better identify with. Conversely, one group thought that "disorder" sounded appropriately like a medical diagnosis. Participant recommendation: "Have you ever had a bleeding disorder (or problem) or a blood disease?" # 12: UDHQ: "In the past 12 months, have you had a transplant or graft such as organ, tissue, bone or skin?" 10

12 Focus group discussion: One group thought this question was clear. One group thought that bone marrow transplant should be included, but that adding this to the question would make it too long. In addition, they stated that "transplant" and "graft" are associated with very specific things, and that the question should be split into two. The third group thought this question would be clear even without the "such as...", because it may not be all inclusive (e.g., bone marrow). All thought that someone who had had a transplant or a graft would probably know it. Participant recommendation: One group: No change. One group: "In the past 12 months, have you had a transplant such as organ, tissue or bone marrow?" and "In the past 12 months, have you had a bone or skin graft?" One group: "In the past 12 months, have you had a transplant or graft?" Note: Later focus group discussion of the addition of human and such as, as required by the FDA, indicated that this language was not problematic, but would preclude using one question. # 13: UDHQ: "Have you ever used needles to take drugs or steroids not prescribed by your doctor?" Focus group discussion: All 3 groups asked whether the interest was in the use of drugs or steroids, or in the use of the needle. Concern was raised about missing the use of injected vitamins or diet supplements as well. Participant recommendation: "Have you ever used needles to inject (or alternatively "take") anything not prescribed by your doctor?" # 14: UDHQ: "In the past 12 months, have you had sex with anyone who has ever used needles to take drugs or steroids not prescribed by their doctor?" Focus group discussion: Participants from previous focus groups reiterated their concerns and recommendations about the term "sex", as did all new participants. Participants would make the previous recommendation regarding the term sex to this question, as well. Participant recommendation: No other change. # 15: UDHQ: If yes to travel to Africa: "Did you receive a blood transfusion or any other medical treatment with a product made from blood? " 11

13 Focus group discussion: Participants were not sure what "other medical treatment with a product made from blood" meant. They were unsure if it included ritualistic medical treatments. If so, it needed to be clearer. They had several questions: 1. Would "medical treatment" only include visiting a physician or medical facility? 2. How would someone know if a product was made from blood? 3. What are the types of products made from blood? 4. Are you only including human blood? Participant recommendation: No group was sure how to word "other medical treatment with a product made from blood" so that it would be clear. All 3 groups recommended that the question start with "While you were there " # 16: UDHQ: "In the past 12 months, have you been in jail or prison? " Focus group discussion: Participants gave some thought to changing to "incarcerated in jail or in prisons," to clarify residence. The high school age participants wanted to know if this included county lock-up and/or juvenile hall (because exposure risk can occur there as well). All participants wanted to know if this was for a specific time frame. They were informed of the 72 hour limit. Their recommendations were (1) add lock-up and/or juvenile hall, and (2) add the time period to the end of the question (although there was some concern about the length of the question). Participant recommendation (HS group): " In the past 12 months, have you been in juvenile hall, lock-up, jail or prison?" or, "In the past 12 months, have you been in juvenile hall, lock-up, jail or prison for more than 72 hours?" Note: # were conducted with groups 1, 3 and 4 characterized in Table 3. # 17: UDHQ: "In the past 12 months, have you had sex with a prostitute or someone else who takes money or drugs or other payment for sex?" Focus group discussion: Participants thought that the word "prostitute" was redundant, and somewhat inflammatory. In addition, some thought that using "anyone" instead of "someone" was more powerful. There was discussion regarding changing "takes" to "accepts," although this wasn't considered a major issue. Participant recommendation (with the same issues about the word sex previously noted): "In the past 12 months, have you had sex with anyone who accepts (or takes) money, drugs or other payment for sex?" 12

14 # 18: UDHQ: "At any time since 1977, have you received money, drugs, or other payment for sex? " Focus group discussion: Participants debated whether "at any time" was necessary. Some thought it was not; others thought it made the statement more powerful. Otherwise, they did not have any recommendations for revising this question. Participant recommendation: No change. # 19: UDHQ: Males: "Have you ever had sex with another male, even once, since 1977?" Focus group discussion: Male participants thought that "even once" should be understood, but agreed that including it does accent it, although some felt that ever and even once was redundant. For consistency with the other questions, they felt that "since 1977" should be at the front of the question. Participant recommendation: Males: "Since 1977, have you ever had sex with another male, even once?" # 20: UDHQ: Females: "In the past 12 months, have you had sex with a male who has ever had sex with another male?" Focus group discussion: Female participants in one group discussed changing "ever" to "even once," but decided that it was too confusing. Participant recommendation: No change. # 21: UDHQ: "In the past 12 months, have you had sex with anyone who has a bleeding problem, such as hemophilia?" Focus group discussion: One group wanted to know why hemophilia was not included in the question about having bleeding disorders, and why the word "problem" is used here, but "disorder" is used on the other question. To make the question less confusing, they discussed using "or hemophilia" rather than "such as". One group had no recommendations. The last group suggested changing "problem" to "condition" on all questions for consistency. Participant recommendation: "In the past 12 months, have you had sex with a hemophiliac, or anyone who has a bleeding problem (or condition)?" 13

15 # 22: UDHQ: "Have you had sex with anyone who was born in or lived in Africa?" Focus group discussion: Participants were interested in whether travel, specifically extended travel, would also be considered a risk. Their thought was that business people, students, Peace Corp workers, etc., might spend months at a time in an African country, and not consider it having lived there. If so, they recommended including it in the question. They also wanted to know what the time frame would be for "lived in." One group wanted to know why some questions related to sex ask "ever" and some do not. Participant recommendation: "Have you had sex with anyone who was born or lived in Africa?" or (If travel should be included): "Have you had sex with anyone who was born, lived in or traveled to Africa?" Note: # were conducted with groups characterized in Table 4. # 23: UDHQ: Have you ever received growth hormone from human pituitary glands? Focus group discussion: All three groups agreed on simplification of the question. One group also noted that individuals who received this would probably know it. Participant recommendation: Have you ever received human growth hormone? # pertain to the new vcjd risk-related travel questions General 1. Three groups preferred the question structure to be the year(s), the countries, and then the cumulative time required. The 4 th group, (military) all of whom were regular travelers, preferred the year(s), the cumulative time requirement and then the countries, if they knew up front that the question was related to travel. 2. All 4 groups recommended the following standard wording: From 1980 through 1996 and From 1980 to the present. They pointed out that between 1980 and 1996 does not include 1980 or # 24: Issue: Should the question regarding transfusion in the UK follow the travel question (so the countries do not need to be re-stated); is the difference in time periods clear? UDHQ: From 1980 through 1996, did you spend time in the United Kingdom that adds up to 3 months or more? (England, Northern Ireland, Scotland, Wales, the Isle of Man, 14

16 the Channel Islands, Gibraltar, or the Falkland Islands) followed by the new question: Between 1980 and the present, have you received a transfusion of blood, platelets or plasma in the United Kingdom? Focus group discussion: Three of the 4 groups felt that an individual who answered no to the travel question might skip over the transfusion question without realizing the time period difference. All 4 groups recommended bolding 1980 through 1996 in the first question and 1980 and the present in the second question. If this could not be done, all 4 groups recommended that the questions be separated. One group recommended that if United Kingdom could be described as a definition, that the wording be changed to England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar or the Falkland Islands (the United Kingdom) Participant recommendation: From 1980 through 1996 (note bold), did you spend time in England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar, or the Falkland Islands (the United Kingdom) that adds up to 3 months or more? Followed by, Between 1980 and the present, have you received a transfusion of blood, platelets or plasma in the United Kingdom? # 25: UDHQ: Since 1980 have you spent time in France that adds up to 5 years or more? (FDA: Have you visited or lived in France since 1980? If so, have you spent a total time of 5 years or more, between 1980 and the present? ) Focus group discussion: All 4 groups preferred the UDHQTF wording due to simplicity, and recommended no change. Participant recommendation: No change. # 26: UDHQ: Are you a current or former member of The US military, a civilian military employee, or a dependent? - If yes, between 1980 and 1996 have you been stationed for 6 months or more in a BSE risk country? (list of countries will be provided) (FDA proposed questions: As a current or former member of the US military, a civilian military employee, or a dependent, have you been stationed in Belgium, the Netherlands, or Germany for 6 months or more, between 1980 and 1990? and, As a current or former member of the US military, a civilian military employee, or a dependent, have you been stationed in Spain, Portugal, Italy, Turkey or Greece for 6 months or more, between 1980 and 1996? ) Focus group discussion: Two groups (including the military) thought BSE risk country was confusing, and noted that we don t have a question that specifically states malaria risk country. 15

17 Two groups, (including the military), thought that not putting the time period in the first question will confuse what time period applies to former member. (Example, a child of a WWII vet; one a former dependent, one a former member of the military.) The military group also noted the following: Current or former members of the US military, a civilian military employee, or a dependent and stationed might not capture all individuals who are at risk. Independent contractors may not consider themselves civilian military employees and contractors plus military staff only temporarily on assignment may not consider themselves stationed. However, they would very likely eat on base. Also, all 4 groups noted that between 1980 and 1996 does not accurately capture the time period (noted above). All 4 groups preferred the UDHQ wording due to simplicity, but with revision. Participant recommendation: From 1980 through 1996, were you employed by the Department of Defense, or a dependent? - If yes, did you spend a total time of 6 months or more in any of these countries? (list of countries will be provided) # 27: UDHQ: Since 1980 have you spent time that adds up to 5 years or more in BSE risk countries? (includes time in the United Kingdom) (FDA: Have you visited or lived in Europe between 1980 and the present? If so, have you spent a total of 5 years of more in BSE risk countries of Europe between 1980 and the present? (Please include time spent in the UK). Focus group discussion: There was similar discussion about BSE risk country noted above. All 4 groups preferred the UDHQ wording due to simplicity. Participant recommendation: Since 1980 have you spent time that adds up to 5 years or more in any of these countries, including the United Kingdom? (list of countries to be provided) 16

18 Capture travel question: The groups characterized in Table 4 also spent a great deal of time discussing whether a capture question for travel would be appropriate. The following is a compilation of the recommendations for a capture question. The groups suggested that the questions be ordered so that you start with the question that defers the most people, (i.e., travel to locales where malaria is endemic) to minimize the number of questions each donor needs to answer. However, the UDHQ Task Force preferred asking permanent deferral questions first. Participant recommendation: 1. Have you traveled outside of the US or Canada? If no, the donor moves to the next set of questions. If yes, Was it in the past 3 years? If no, go to 1.a If yes, Where? Interviewer will check the CDC Health Information for International Travels also known as the yellow book. If not deferred, go to 1.a a. From 1980 through 1996, did you spend time in England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar, or the Falkland Islands (the United Kingdom) that adds up to 3 months or more? If no, go to 1.b b. Since 1980, have you spent time that adds up to 5 years or more in these countries (include time in the UK)? (BSE risk country list would be provided) Note: currently this question would be France rather than these countries. If no, go to 1.c c. From 1980 through 1996, were you employed by the Department of Defense, or a dependent? If no, go to 1.d If yes, did you spend time that adds up to 6 months or more in these countries? (a BSE risk country list would be provided) If no, go to 1.d d. Were you ever transfused with blood, platelets or plasma in the UK or Africa? If no, go to next set questions. If yes, Where? If UK, Was it since 1980? If no, go to next set of questions. 17

19 UDHQ Task Force preferred algorithm: Have you ever traveled outside of the US or Canada? If no, the donor moves to the next set of questions. If yes: (the questions that would result in a permanent deferral would be asked first, from most likely to least likely to be affirmative) A. From 1980 through 1996, did you spend time in England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar, or the Falkland Islands (the United Kingdom) that adds up to 3 months or more? If no, go to B. B. Since 1980, have you spent time that adds up to 5 years or more in these countries (include time in the UK)? (BSE risk country list would be provided) Note: currently this question would be France rather than these countries If no, go to C. C. From 1980 through 1996 were you employed by the Department of Defense, or were you a dependent of someone employed by the DoD? If no, go to D. If yes, did you spend time that adds up to 6 months or more in these countries? (a BSE risk country list would be provided) If no, go to D. D. Were you ever transfused with blood, platelets or plasma in the UK or Africa? If no, go to E. If yes, Where? If UK, Was it since 1980? If no, go to E. E. Was your travel in the past 3 years? If no, go to next set of questions. If yes, Where? Interviewer will check the CDC Health Information for International Travelers, also known as the yellow book. If not deferred, go to next set of questions 18

20 CONCLUSION Comments and recommendations were substantive and were often very similar between groups. These focus group discussions provided recommendations for clarification of terms and rewording of questions to enhance donor comprehension. Importantly, however, the recommendations presented might not be appropriate in all confines of current regulatory requirements or recommendations. Even with explanations of the FDA and AABB requirements/recommendations, some participant recommendations may miss the intent of the requirement. For example, while the focus group participants recommended a simplified CJD question, the FDA Guidance for Industry specifically recommends redundancy in the questioning to maximize collection of information regarding CJD risk. Information obtained from conducting these focus groups contributed valuable information and suggestions regarding wording of targeted donor history questions for better donor comprehension. 19

21 Age Gender Education Race Ethnicity Table 1. Age, sex, educational level, race and ethnicity: initial ARC focus groups 1 High school n=6 2 Church n=5 Group type** 3 Business n=4 4 Random n=3 5 Random n=3 6 Random n= > 70 Male Female < 12 th grade 1 12 th grade; no diploma 5 HS grad or equivalent Some college, technical 2 or trade school Associate s degree Bachelor s degree Master s degree 2 Professional degree or 2 doctorate White Black 4 Other 2* Non-Hispanic Hispanic * one Asian, one American Indian ** no previous donors 20

22 Age Sex Table 2. Age, sex, educational level, race and ethnicity: follow-up ARC focus groups Education Race Ethnicity 1 Random n=4 Group type 2 Business n=4 3 Random n= > 70 Male Female 3 4 < 12 th grade 12 th grade; no diploma HS grad or equivalent Some college, technical or trade school Associate s degree 1 Bachelor s degree 1 Master s degree Professional degree or doctorate White Black 1 Other Non-Hispanic Hispanic 1 Yes 4 (all > * years ago (8 yrs ago) No 3 3 * one regular apheresis donor, one whole blood 8 months ago, one whole blood > 10 years ago Previous donation 21

23 Age Gender Table 3. Age, sex, educational level, race and ethnicity: UDHQ focus groups Education Race 1 Business n=4 2 Random n=7 3 Random n=6 4 High school n=5 < > 70 Male Female < 12 th grade 5 12 th grade; no 1 diploma HS grad or 1 2 equivalent Some college, technical or trade school Associate s degree 1 1 Bachelor s degree 4 Master s degree Professional degree or doctorate White Black 5 2 Ethnicity Other Non-Hispanic Previous Hispanic No donation Yes

24 Age Table 4. Age, sex, educational level, race and ethnicity: UDHQ focus groups for revised travel deferral Gender Education Race 1 Business n=4 2 Minority n=5 3 Military n=4 4 High school n=4 < > 70 Male Female < 12 th grade 1 12 th grade; no 1 3 diploma HS grad or 1 equivalent Some college, 2 3 technical or trade school Associate s degree Bachelor s degree 2 Master s degree 4 Professional degree or doctorate White Black 5 2 Ethnicity Other Non-Hispanic Previous Hispanic No donation Yes

25 References 1. Galea G. The role of personal interviews by direct questioning on blood donors with particular reference to prevention of transfusion-related infections: a Scottish perspective. Transfusion Medicine, 1997, 7: Silvergleid AJ, Leparc GF, Schmidt PJ. Impact of explicit questions about highrisk activities on donor attitudes and donor deferral patterns. Results in two community blood centers. Transfusion, 1989, 29;4: Gimble JG, Friedman LI. Effects of oral donor questioning about high-risk behaviors for human immunodeficiency virus infection. Transfusion, 1992, 32;5: Mayo DJ, Rose AM, Matchett SE, et al. Screening potential blood donors at risk for human immunodeficiency virus. Transfusion, 1991, 31: Silvergleid AJ. Donor Screening: Selected Topics in Transfusion Medicine. Clinics in Laboratory Medicine, 1992, 12; 4: Kolins J, Silvergleid AJ. Creating a Uniform Donor Medical History Questionnaire. Transfusion, 1991, 31;4: Fowler FJ. Survey Research Methods, 2 nd edition. Applied Social Research Methods Series, Volume Edited by Tara S. Mead, Sage Publications. 8.. Fowler FJ, Mangione TW. Standardized Survey Interviewing: Minimizing Interviewer-Related Error. Applied Social Research Methods Series, Volume Edited by Leonard Bickman and Debra Rog, Sage Publications. 9. Fowler FJ. Improving Survey Questions: Design and Evaluation. Applied Social Research Methods Series, Volume Edited by Susan McElroy, Sage Publications. 10. Orton SL, Virvos VJ, Williams AE. Validation of donor-screening questions: structure, content, and comprehension. Transfusion, 2000, 40: