UDHQ Project Overview and Update 7 May 2012

Transcription

1 Introduction Organ, tissue, and eye (OTE) donation and transplantation professionals have long understood the value of collecting medical and behavioral history information on potential donors to assess infectious disease risk as well as determine factors that can affect quality of organ function or tissue utility. Testing today is greatly improved and valuable, both for detecting infectious diseases and understanding expected organ function, however, gaps remain (i.e., testing window periods, health history that assists with predicting organ functionality) that can be filled by collecting accurate information from the deceased donor s proxy historian. OTE donor medical and behavioral risk questionnaires have never been studied to assess comprehension or the formats being used, and they are known to be the root cause of mistakes. After reports of the successful development of a qualified blood donor questionnaire, the OTE donation community started the UDHQ-OTE Project to develop similar tools for screening donors for transplantation. The first drafts of interview questionnaires were developed by a multi-organizational Task Force that incorporated lessons learned from the blood donation community s experiences and from our own professionals involved with interviewing bereaved donor family members or others in close relationship to the donor. Two draft questionnaires were issued in December 2010 for public consultation and more than 500 comments were received. Evaluation of each comment was performed by a stakeholder review group with a final version for a donor >12 years old submitted to NCHS in late April The National Center for Health Statistics (NCHS) will evaluate the questions using cognitive interviewing techniques and field testing. The use of these forms will become widespread and training programs will be developed for those who use them. Project Overview The UDHQ-OTE Project is an acronym for the development of a Uniform Donor History Questionnaire for Organ, Tissue, and Eye donors that began, as a concept, in This project has been a major effort involving experienced professionals from organ, tissue, and ocular donation organizations and professional associations, as well as government agencies. Its purpose is to create qualified uniform donor history questionnaires, one for child donors and one for adult donors, with supporting documents for use by organ, tissue, and eye (OTE) donation professionals when screening for risk and determining suitability. Questionnaires currently used to screen OTE donors in the United States and Canada have problems similar to those identified by blood donation professionals. These include: content and formats have never been formally evaluated for effectiveness; use of questions that are not necessary and can be distracters; incorporation of many long, often compound, questions; inclusion of terminology and word phrases that the general public may not comprehend; and lack of standardization among organizations, which affects tissue and eye bank quality program review processes and interpretation of answers by organ transplant professionals. 1

2 Additionally, the Project takes into account special needs of the bereaved historian of a deceased donor. Primary aims are to reduce the complexity of the questionnaire while concurrently providing education to the historian to facilitate comprehension and to obtain accurate responses to risk assessment questioning by using more effective wording. Development During 2007, a multi-organizational 1 Uniform Donor History Questionnaire (UDHQ) Task Force was formed to begin work on a consensus questionnaire based on screening requirements of regulations and professional standards, best practices from the vast amount of experiences of members, and new concepts learned from the development of a universal blood donor questionnaire, as well as one for cellular therapy product donors, in the United States [1,2,3,4,5]. This new Task Force met periodically by conference call over the next 3 years. In November 2010, the development and subsequent validation of the UDHQ for transplant purposes was recognized and unanimously supported by an Advisory Committee to the Secretary of Health and Human Services (HHS): the Advisory Committee on Blood Safety and Availability (ACBSA). After discussion of transplant-related disease transmission events, this Committee determined there remain gaps in identifying the risk of disease involving donors of organs and tissues. To address it, the Committee recommended the Secretary support development and validation of a uniform donor health history, screening questionnaire. The Committee additionally recommended the development of a uniform questionnaire for donor screening to optimize patient safety. On December 1, 2010 the multi-organizational Uniform Donor History Questionnaire (UDHQ) Task Force released a draft version of a questionnaire to be used for an organ, tissue, or eye donor >12 years old, as well as one for a child donor, and requested constructive comments from professionals and the public. Incorporation of these questionnaires will prove to streamline this critical donor risk assessment process and increase satisfaction of all stakeholders involved in providing donor information (proxy historians), those administering the interviews, and those who review the answers to the donor risk assessment questions. These tools are expected to: optimize identification of suitable donors; minimize donor loss due to inappropriate rule out; and accurately identify an organ donor risk designation. Important background information was also provided and, before sending comments, submitters were directed to read it to gain a better understanding of the reasoning behind the order and construction of the questions (see Significant Notes: Questionnaire Structure and Content below). Through mid-january 2011, more than 500 comments were collected via a web link provided on the homepage of the American Association of Tissue Banks ( as well as by letters and . 1 The UDHQ-OTE Task Force included 70 members from organ procurement organizations, eye banks, tissue banks, non-transplant anatomical donation organizations, software companies, and representatives of the following: AATB, AOPO, CDC, EBAA, FDA/CBER, Health Canada, HRSA, NATCO, NHS/Scotland, and the NY State DoH. Twenty-five members regularly attended conference call discussions over a 3-year period. 2

3 In April 2011, a steering committee, the UDHQ Stakeholder Review Group, was formed to review these comments and finalize the forms. This included representatives from appropriate government agencies such as FDA/CBER, HRSA, CDC, and NCHS, as well as two OPTN/UNOS committees (DTAC, and the OPO Committee), and professional societies such as the AATB, AOPO, EBAA, NATCO, AST, and ASTS. A few members of the UDHQ Task Force comprise the remainder of this review group. They finalized a version of the Donor Risk Assessment Interview form for donors >12 years old after careful consideration of all the comments received. Officials from FDA/CBER offered a few final comments for improvement that were incorporated so the form was sure to meet federal expectations when screening donors of cells and/or tissues. The questions are designed to meet all requirements, which means compliance to requirements of regulations, laws and standards. The concepts surrounding how this can be done is optimized by use of broad-based capture questions, a process that assists with a respondent s understanding of questions asked. Further questioning to identify specific risks is only used when indicated. The DRAI form for donors> 12 years old will be further scrutinized by the foremost authority regarding development of effective, public health and behavioral history surveys. In Phase 1 during 2012, which is now being organized, the CDC s National Center for Health Statistics (NCHS) plans to perform a series of cognitive interviewing studies using the final version of the adult questionnaire. This is a qualitative evaluation of the questions and has been funded via an Interagency Agreement by the Office of Blood, Organ and Other Tissue Safety at CDC. Phase II is planned for 2013 and will comprise of field testing to obtain quantitative evaluation of the questions, however, funding sources for this phase remain to be identified. Significant Notes: Questionnaire Structure and Content This background information was provided during the on-line, public consultation period: Question order has been evaluated many times during development. The Task Force believes related risk assessments have been properly grouped and the concept of arranging them to place less recall stress on the donor s historian has been applied. Mental time travel starts with the present and flows backward sequentially through certain risk assessment time periods, ending with history ever. To reduce the number of time periods, some risk periods were expanded to allow grouping. In these cases, if a yes response to a capture question is received, the interviewer is reminded of the risk time period that applies and to ask more questions only if indicated. Although kept to a minimum, there is a question or two where risk screening redundancy occurs; entirely restricting screening for risk to one possible chance does not always occur (i.e., risks related to travel) and this is deliberate. Questions are constructed to be as short as possible but also gather necessary information to cover established national, state and association (standards) requirements; if your requirements are more stringent than these, re-evaluating the efficacy of requiring more 3

4 information should be pursued at your establishment. If differences in risk assessment continue, the process uniformity stakeholders have agreed upon will be in jeopardy. Use of she/he* in the questions appears awkward and this is on purpose. This consistently reminds the interviewer to mix the appropriate pronoun with other terms with which the historian can relate such as: the donor s given name; their nickname; or, by inserting your father, mother, husband, wife, sister, brother, daughter, son, or child (as indicated). By using this approach, the interviewer is afforded real-time instructions throughout administration of the questionnaire, versus simply using the donor or the deceased during the interview. A few questions include examples to educate the donor s historian regarding risk being assessed. For instance, in communication with federal authorities, defining sexual activity is expected if a capture question is used to initially assess this risk. The Task Force has developed an acceptable approach while also considering the sensitive nature of the topic. Additionally, providing examples van result in reducing the number of questions. The Risk Assessment Interview Questionnaire for a child donor was developed in response to numerous requests to develop one tailored to this unique donor population. It s intended for use for a donor who is 12 years of age or younger. Questionnaire versions (child and adult ) issued for comment were formatted to utilize a documentation method to circle responses. Checkbox versions of these questionnaires were also developed, and it is understood that electronic versions could additionally be formulated that offer another documentation method. Practice regarding the best documentation method to use was a topic that was further evaluated and the checkbox method is used in the final version. National training courses are planned to educate stakeholders regarding the background and rationale supporting the format and risk being assessed by asking each question. Additionally, work continues on: a User Instructions document that outlines expectations for the interviewer; easy to follow flowcharts for each question; and finalization of a DRAI for CHILD donors. References 1 Beatty P, Interview Evaluation of the Blood Donor History Screening Questionnaire, Results of a study conducted August-December, 2001, National Center for Health Statistics, Centers for Disease Control and Prevention %20Cognitive%20Evaluation%20final%20report%20NCHS%20v2.pdf 2 Orton S, Virvis V, Summary of Focus Group Discussions of Donor Screening Questions for Structure, Content and Comprehension, March %20UDHQ%20TF%20Focus%20Group%20Summary%20Final.pdf 4

5 3 Williams A, et al., Estimates of Infectious Disease Risk Factors in US Blood Donors, JAMA. 1997;277(12): Prepared by Scott A. Brubaker, CTBS UDHQ-OTE Project Chairperson May 7,