Outline EAACI Guidelines QoL Measures

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  • EAACI Food Allergy and Anaphylaxis Guidelines 1

    Food Allergy HRQL Measures 2

    3

    Short title: EAACI Food Allergy HRQL Measures Guideline 4

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    Key words: adults, children, EAACI, food allergy, health-related-quality-of-life, infants 6

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    Abbreviations: 9

    AGREE II appraisal of guidelines for research & evaluation 10

    BoT burden of treatment 11

    CBT cognitive behavioural therapy 12

    DALY disability adjusted life years 13

    EAACI European Academy of Allergy and Clinical Immunology 14

    FAIM food allergy independent measure 15

    GRADE Grading of Recommendations, Assessment, Development and Evaluation 16

    HRQL Health related quality of life 17

    IM independent measures 18

    MCID minimal clinical important difference 19

    NNT numbers needed to treat 20

    QALY quality adjusted life years 21

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    Words: approximately 4371 (Max. 4500) 24

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  • Abstract 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 Immunologys - 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

    103

    Identification of evidence gaps 104

    The process of developing this guideline has identified a number of evidence gaps and we 105

    plan in future to prioritize the questions that the Food Allergy HRQL Taskforce believes 106

    should be most urgently addressed through formal consensus building techniques. We plan 107

    furthermore to draft outline research briefs that funders can use to commission research on 108

    these questions. 109

    110

    Editorial independence and managing conflict of interests 111

    The production of this guideline was funded and supported by EAACI. The funders did not 112

    have any influence on the guideline production process, its contents or on the decision to 113

    publish. Conflicts of interest statements were completed by all members of the Taskforce 114

    and these were taken into account by the Food Allergy HRQL Taskforce chair as 115

    recommendations were formulated. 116

    117

    Review of Guideline 118

  • The guidelines will be reviewed in 2017 and updated accordingly. However important 119

    advances will be incorporated prior to this date if required. 120

    121

    Results 122

    The development of instruments used to measure HRQL should follow a specific 123

    methodology to ensure their validity, reproducibility, responsiveness (or sensitivity) and 124

    interpretability (2) (Box 1). 125

    126

    127

  • Box 1. Key terms 128

    Health-related quality of life (HRQL): that part of quality of life affected by disease and its 129 treatment 130

    Validity ensures that only that part of quality of life is being measured which is related to 131 or driven by the disease in question. It is established by correlating measurements to one 132 or more independent measures (IM) of the disease which provide an estimation of the 133 extent and severity of patients food allergy. An exact correlation is not expected as the 134 HRQL instrument will not be measuring the same dimensions as the IM. 135

    Reproducibility ensures that measurements taken under identical conditions are 136 equivalent, and may be assessed by test re-test analysis. It is generally assessed by asking 137 patients to complete the HRQL instrument twice, a few weeks apart, during a period 138 when the is no change expected in their HRQL (e.g. when they have not experienced any 139 food allergic reactions or received any relevant interventions). 140

    Responsiveness ensures that differences or changes of potential importance are not 141 missed, and is examined by measuring differ