EAACI Food Allergy and Anaphylaxis Guidelines

26 Instruments have been developed and validated for the measurement of health-related 27 quality of life in patients with food allergy. This guideline has been prepared by the European 28 Academy of Allergy and Clinical Immunology’s EAACI Guidelines for Food Allergy and 29 Anaphylaxis Group, and builds on a systematic review of the current literature on quality of 30 life instruments for food allergy. Guidance is provided on the use of such instruments in 31 research and the current limitations of their use in clinical practice is described. Gaps in 32 current knowledge as well as areas of future interest are described. This document is 33 relevant to health care workers dealing with food allergic patients, scientists engaging in 34 food allergy research and policy makers involved in regulatory aspects concerning food 35 allergy and safety. 36 37 Background 38 In recent decades, food allergy has become an important medical condition and there is 39 evidence that the prevalence may be increasing (1). As the medical morbidity and mortality 40 associated with food allergy is limited to symptoms resulting from incidental ingestions of 41 allergenic foods, conventional, symptom-based outcome measures fail to reflect the ongoing 42 burden of this condition to patients’ well being. Thus, although health-related quality of life 43 (HRQL)(Box 1) is an important outcome measure for many diseases, it is of particular 44 importance for food allergy because there are no alternatives of sufficient sensitivity for use 45 in most clinical situations. 46 A number of studies have been undertaken in the last decade which broadly address the 47 issue of quality of life in patients suffering from food allergy (2-8). Many of these studies 48 have employed questionnaires designed to illuminate some aspect of the experience of 49 patients with food allergy using both qualitative and quantitative approaches. This guideline 50 will focus on instruments designed to measure HRQL in a quantitative and disease-specific 51 fashion, and will, in particular, draw on a systematic review of existing instruments, one of 52 seven inter-linked evidence syntheses undertaken to provide a state-of-the-art synopsis of 53 the current evidence base in this area (9). That review included a comprehensive search and 54 quality assessment of instruments with special attention to the method of validation used. 55 This guideline will examine the possible applications of these instruments and provide advice 56 to clinicians and investigators on their proper use and the interpretation of results. Current 57 limitations will also be considered and unmet needs and areas of future interest identified. 58 59 Methods 60 This Guideline was produced using relevant principles detailed in the Appraisal of Guidelines 61 for Research & Evaluation (AGREE II) approach (10). This is in essence a structured approach 62 to guideline production that is designed to ensure appropriate representation of the full 63 range of stakeholders, a careful search for and critical appraisal of the relevant literature, a 64 systematic approach to the formulation and presentation of recommendations, and steps to 65 ensure that the risk of bias is minimized at each step of the process. We provide below an 66 overview of the approach used. 67 68 Clarifying the scope and purpose of the Guideline 69 In January 2012 the scope of the intended guidelines was agreed upon, including the: target 70 allergy conditions and population, the end-user group and allowing for adequate academic, 71 professional and lay presentation during guidelines development. 72 73 Ensuring appropriate stakeholder involvement 74 Participants represented a range of European countries, and academic and clinical 75 backgrounds (including medical secondary care, primary care and nursing), and patient 76 groups. The Food Allergy HRQL Taskforce continued to work together over the ensuing 18 77 months through email discussions, teleconferences and face-to-face meetings. 78 79 Systematic review of the evidence 80 The initial full range of questions that were considered important were rationalized through 81 several rounds of iteration to agree to a single key over-arching question – namely, ‘Which 82 disease-specific, validated instruments can be employed to enable assessment of the impact 83 of, and investigations and interventions for, food allergy on HRQL? ’ The answer to this was 84 then pursued through a formal systematic review of the evidence (9). 85 86 Formulating recommendations 87 The GRADE approach is a transparent, evidence-based approach to formulating 88 recommendations for interventions and diagnostic tests, but this is less suitable for use in 89 the context of recommendations on the use of which quality of life instruments to select or 90 how to use or interpret these. Therefore, following identification, critical appraisal and 91 synthesis of relevant data, members of the Taskforce developed draft consensus 92 recommendations on suitable validate instruments for use in the context of IgE-mediated 93 food allergy, and the use of these instruments and interpretation of data for: (a) clinical and 94 (b) research purposes. 95 96 Peer review 97 A draft of this guideline was externally peer-reviewed by experts from a range of 98 organizations, countries and professional backgrounds. All feedback was considered by the 99 Food Allergy HRQL Taskforce and, where appropriate, final revisions were made in the light 100 of the feedback received. We will be pleased to continue to receive feedback on this 101 guideline, which should be addressed to the corresponding author. 102