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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
5
Key words: adults, children, EAACI, food allergy, health-related-quality-of-life, infants 6
7
8
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
22
23
Words: approximately 4371 (Max. 4500) 24
25
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 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
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 differences or changes in groups where these are 142
expected. It is often assessed in patients whose HRQL is expected to change (e.g. those 143
who have experienced food allergic reactions or relevant interventions). 144
Interpretability ensures that the relevance or clinical significance of measurements is 145
apparent. This is ascertained by calculating the minimal clinical important difference 146
(MCID), or the smallest change in HRQL score associated with a significant change in a 147
global rating reported by patients. 148
All of these properties were examined in the systematic review (9) Particular emphasis was 149
given to establishment of validity, which is of fundamental importance to proper instrument 150
development. 151
Twenty studies were quality appraised in the systematic review (9) and seven disease-152
specific HRQL instruments were identified as fulfilling the criteria described above (2-7;11-153
13). These included instruments for children, adolescents, adults and parent or caregiver, 154
and were either self-reported or proxy-reported (see Table 1 below). The FAQLQ (CF, TF, AF 155
and PF) instruments have undergone the most thorough validation process, including 156
assessment of their psychometric properties. 157
These instruments are all available free of charge and several are available in multiple 158
languages. They may be downloaded from the following website: www.future FA-159
HRQLsite.EAACI.org 160
161
162
Table 1. Summary of food allergy specific health related quality of life instruments 163
164
165
166
167
168
169
170
171
172
173
174
175
Abbreviation
(where
stated)
Key
references
Full name Target population
(age range in years)
Respondent
FAQLQ-CF
3 Food Allergy Quality of Life Questionnaire Child Form
Children (8 to 12)
Children (8 to 12)
FAQLQ-TF 4 Food Allergy Quality of Life Questionnaire Teenager Form
Adolescents (13 to 18)
Adolescents (13 to 18)
FAQL-teen 12 Food Allergy Quality of Life Assessment Tool For Adolescents
Adolescents (13 to 18)
Adolescents (13 to 18)
You and Your Food Allergy
13 You and Your Food Allergy Adolescents (13 to 18)
Adolescents (13 to 18)
FAQLQ-AF 5 Food Allergy Quality of Life Questionnaire Adult Form
Adults (>18)
Adults (>18)
FAQL-PB 11 Food Allergy Quality-of-Life Parental Burden
Parents Parents
FAQLQ-PF 6 Food Allergy Quality of Life Questionnaire Parent Form
Children (0 to 12)
Parents
Choosing an instrument 176
If HRQL instruments are to yield useful information in patients with food allergy, it is 177
important to choose a tool that is appropriate for the setting, diagnosis and age of the 178
patient (2, 14). FAQLQ questionnaires (Table 1) have been developed and validated for 179
patients with IgE-mediated allergies (excluding Oral Allergy/Pollen Food Syndrome) and are 180
therefore not suitable for non-IgE mediated food allergies (2-7). The food allergy-specific 181
HRQL instruments have been designed to detect clinically important differences and changes 182
in the disease-specific quality of life of patients with food allergy. As they are specific for IgE-183
mediated food allergy, they do not allow for comparison with other disorders. 184
185
The choice of food allergy-specific HRQL instrument should primarily be determined by the 186
age of the patients, as highlighted in Table 1. In young children (i.e. those ≤8 years), a parent 187
proxy questionnaire (which can be used up to the age of 12 years) is required (6-7) whereas 188
patient-administered instruments are appropriate for older children (> 8 years), adolescents 189
and adults, as they can express their own social/emotional and physical well-being (5). 190
Language may also impact on the choice of instrument, not only because of differences 191
between languages, but also because of cultural differences in various areas where the same 192
language is spoken. The FAQLQ-AF has now been validated in several European countries 193
and is available in English, French, Spanish, Italian, Polish, Greek, Dutch and Icelandic (15-16) 194
The FAQLQ-PF (6-7, 17) has been validated in French, Spanish, German, Dutch, Danish and 195
Mandarin, although only the data on the first has been published in a full length paper to 196
date. Although the FAQLQ-CF has also been translated into a number of different languages, 197
the data on validity and consistency in those languages has not yet been published. Figure 1 198
provides an algorithm guiding the appropriate use of FAQLQ and key factors to take into 199
account are listed in Box 2. 200
201
Currently, there are no tools that can be used to gain insight on the contribution of the 202
parent-child relationship on the HRQL of a food allergic child. There is some evidence that 203
comparison of patient reported HRQL to parent (proxy) reported HRQL using the FAQLQs 204
can offer some insights in this area. For example, an optional section in the FAQLQ-PF 205
evaluates the amount of stress felt my mother, father, and family as a result of food allergy 206
Self-report level of stress been found to correlate significantly with parent rated HRQL for 207
the child (18-19). A parent (proxy) reported instrument is currently being developed for 208
adolescents with food allergy which may increase our knowledge of the role that adolescent-209
parent relationships play in teenagers with food allergy. Finally, the dynamics of a family 210
with a food allergic child may also be informed by assessing the parental burden using the 211
FAQL-PB (11). 212
213
Currently, the FAQLQs have only been used in the research setting to provide quantitative 214
information on the HRQL of patients with IgE-mediated food allergy to assess the effect of 215
interventions and determine outcomes (14). If they are to be used in clinic, the question 216
arises to whether they are a valid measure of HRQL at the level of individual patients to 217
guide clinical practice. Methods to assess individual validity and patient acceptability of 218
HRQL have been used in other diseases (20-21). In essence, to be useful in clinical practice, 219
reproducibility of the HRQLQ is required to be high and sensitive enough to detect 220
differences in allergy management, and the information the instrument provides must be 221
shown to affect patient management. Although the instruments described in this guideline 222
have characteristics suggesting they may be capable of providing valid HRQL assessments at 223
the level of individual patients, more studies are required in this area. One recent study (22) 224
evaluated the effectiveness of a developmentally appropriate Cognitive Behavioural Therapy 225
(CBT) intervention specifically developed to improve HRQL for children and teenagers with 226
IgE mediated food allergy. The FAQLQ-PF, CF, and TF were used and the results showed that 227
the measures were sensitive enough to detect improvement in HRQL in individual patients 228
relative to a control group. 229
230
For patients with food allergy outside the remit of current validated FAQLQ questionnaires 231
(e.g. those with non-IgE mediated food allergy) validated, generic HRQL may be considered. 232
However, these have not been designed to detect HRQL issues specific to food allergy and so 233
are unlikely to be sensitive to small but potentially important differences or changes in food 234
allergy HRQL and will be affected by any existing comorbid disorders. 235
236
237
238
239
Figure 1: Choosing an appropriate Food Allergy HRQLQ 240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
Box 2. Summary box of factors to take into account when choosing a HRQLQ for food 266
allergy 267
type of food allergy (IgE mediated or not, food-pollen syndrome) 268
research or clinical application 269
inclusion or exclusion of effects of co-morbidities 270
patient age 271
language and cultural availability/appropriateness 272
preferred respondent: parent/caregiver as proxy, or child 273
target population/individual: parent/caregiver or child 274
275
276
277
278
279
HRQLQ
Research (Group Setting) Clinical (Individual Setting)
IgE Mediated Non-IgE
Mediated
No validated tool OAS FAQLQ
Adult Consider generic validated HRQL
instruments (not all tools validated for individiual use)
Child (0-18)
FAQLQ 13-18 years 0-12 years
>8 years
FAQLQ-PF
FAQLQ-CF
FAQLQ-TF
FAQL-teen
You and Your Allergy
< 8 years
FAQLQ-PF
Care-giver
FAQLQ-PB
Using an instrument 280
Ideally, HRQL instruments should be used in the setting (language, culture and age group) in 281
which it was developed. In practice, instruments must often negotiate differences between 282
the setting of their development and their ultimate application. It is thus often advisable to 283
include an independent measure such as the FAIM in the study in the new setting in order to 284
differentiate between negative study outcomes due to lack of changes in HRQL from those 285
due to loss of validity of the HRQL measure in the new setting. 286
287
HRQL measurements are imminently suited to determine whether interventions offer a 288
benefit increment to patients which they find meaningful. In order to demonstrate this, the 289
minimally clinical important difference (MCID) for the instrument used must be determined. 290
The MCID is the smallest increment of difference or change in HRQL score which patients 291
find clinically meaningful. Currently, none of the food allergy instruments have provided a 292
MCID. This is thus an unmet need in this area, as it will allow interventions to be assessed 293
quantitatively by permitting calculation of numbers needed to treat (NNT) resulting from the 294
intervention being studied. 295
296
Pharmaco-economic research on is mostly used to identify, measure, and compare the costs, 297
risks, and benefits of programs, services, or therapies and determine which alternative 298
produces the best health outcome for the resources invested. Validated HRQL instruments 299
for food allergy can be of value because they are able to measure the benefits of health care 300
interventions from a patient perspective and ascertain whether the benefit of a particular 301
intervention. Such measurements may be expressed as Quality (of life)-Adjusted Life Years 302
(QALYs) which captures both the HRQL lost or gained and the time to which this change 303
pertains. Such information is essential to cost-utility analysis which may be important to 304
policy makers. 305
306
307
Aside from the FAIM or similar independent measure and a global assessment, many other 308
psychometric tools may be used concomitantly to gain insight into the patient experience of 309
disease and treatment. Of these, the burden of treatment (BoT) measurement deserves 310
special mention, as it allows the evaluation of disease and treatment by asking patients to 311
weigh these entities in their overall assessment of the benefits of a particular intervention. 312
Together with HRQL, this can offer a comprehensive evaluation of the net benefits of an 313
intervention. 314
315
Gaps in the evidence and recommendations 316
The development of the above described suite of high quality food allergy-specific HRQL 317
instruments is a welcome advance in helping to assess the impact of IgE-mediated food 318
allergy on patients’ quality of life. That said, it is important to note that there remain a 319
number of important research gaps in order to have a comprehensive set of tools for use in 320
the everyday management of patients with food allergy across Europe. These are 321
summarized below. 322
323
First, the MCID of existing instruments needs to be determined. This is essential to allow for 324
calculation of NNTs for clinical care and pharmaco-economic analysis. 325
326
Second, there are at present no tools for assessing HRQL in those with non-IgE-mediated 327
food allergy or in those with oral allergy/pollen food syndrome. Given that these 328
manifestations of food allergy can have a substantial impact on the quality of life of patients 329
and carers, there is a pressing need to develop appropriate instruments. 330
331
Third, the tools available for assessing HRQL in those with IgE-mediated food allergy are still 332
only available in a fraction of the languages spoken across Europe. Given that food allergy 333
affects people throughout Europe (1), formal validational work needs to be undertaken to 334
make these instruments available across the full spectrum of relevant languages. 335
336
Fourth, it should be noted that the available instruments have primarily been developed for 337
use in research contexts. Using instruments in routine clinical contexts is potentially very 338
valuable and is hence on the policy agendas of some European countries, but this does 339
require the MCID of the instruments to be established in order to assess the impact of 340
interventions/care provision on individual (rather than groups of) patients. Furthermore, in 341
order to facilitate implementation in routine care contexts, it is important that these tools 342
are validated for use across a range of platforms – for example, completion on patient 343
portals, mobile phones, tablets, and personal computers. Given the increasing move to 344
electronic health records across Europe, electronic data capture will also facilitate seamless 345
transfer into patient records. 346
347
How best to assess HRQL in the many patients with co-existent allergic problems is another 348
related clinically important consideration. The main options are to either use an 349
accompanying generic instrument (e.g. the EuroQol) or to add in additional disease specific 350
instruments for each co-morbidity. Whilst the latter approach may be feasible in those with 351
one co-morbdity (e.g. atopic eczema/dermatitis), it is likely to prove much more challenging 352
in those with multiple co-morbdities (e.g. atopic eczema/dermatitis, allergic rhinitis and 353
asthma). 354
355
Finally, there is a need to identify relevant thresholds for costs per QALY and how these 356
might vary across Europe in order to help inform policy considerations. In this respect, it is 357
important that individual, family and societal perspectives are considered. 358
359
Based on the systematic review of HRQL instruments for IgE mediated food allergy, and the 360
identification of needs and gaps in clinical practice and research, we make the following 361
recommendations. These can be divided into general recommendations (Box 3), 362
recommendations for clinicians (Box 4) and recommendations for researchers (Box 5). 363
364
365
Box 3. General Recommendations 366
1. Only validated instruments as identified by this systematic review should be used to 367
measure HRQL in food allergic subjects. 368
2. An independent measure (e.g. FAIM) should be used simultaneously as a correlating 369
measure. 370
3. An established approach should be used when the validated questionnaires are 371
translated into other languages, e.g. back translation and validation in the local language 372
– there may be important linguistic or cultural issues that invalidate the tool in other 373
countries. 374
4. To date, the FAQLQ (AF, TF, CF and PF) and FAQL-PB instruments and the You and Your 375
Food Allergy instrument are the only tools sufficiently well-validated to be used in 376
research contexts. The appropriate questionnaire will depend on the age of the patient. 377
5. Alterations to questions in the instrument are strongly discouraged, as these may 378
compromise validity. If alterations are made, the instrument requires re-validation. 379
6. The instruments recommended in this review are specific to IgE-mediated food allergy 380
and are not suited for use in patients with non-IgE mediated disease or oral allergy 381
syndrome. Furthermore, for patients where measurement of HRQL due to comorbid 382
conditions is desireable, appropriate disease-specific and/or a generic instrument may be 383
required. 384
385
Box 4. Recommendations for Clinicians 386
387
1. To date, the use of food-allergy specific HRQL tools in clinical practice has been little 388
documented. Clinicians should be aware of this and be cautious when using HRQL 389
measurements to guide mangement decisions. 390
2. There is currently also no information on the use of HRQL measurements as a form of 391
bench-marking in food allergy. 392
393
394
Box 5. Recommendations for Research 395
396
1. Research is needed on optimum methods of administration (e.g. paper, online, phone 397
etc.), procedures (e.g. frequency) and interpretation (e.g. MCID). 398
2. Research is needed on which HRQL measures (if any) are valid at the level of individual 399
patients to guide clinical practice. 400
3. Research is needed on the efficacy of disease specific HRQL instruments in the evaluation 401
of medical and technological advances, patient satisfaction and quality of care and health 402
and regulatory policy 403
4. The inclusion of HRQL in models to explain different pathways in the development, 404
expression, and impact of chronic diseases. 405
5. Norms for age, gender, and country/culture need to be developed. 406
6. Research on the relationship between responses to both proxy and self-report HRQL 407
measures. 408
7. Research on optimum methods (clinical and statistical) for evaluating HRQL in patients 409
with co-morbid conditions. 410
8. Further work is needed to see how quality adjusted life years (QALYs) for food allergy can 411
be developed, to help inform policy. 412
413
Where next with HRQL instruments? 414
The healthcare system has traditionally focused on treating disease at point of failure, such 415
as life-saving surgery or intensive medical therapy. In the case of food allergy, this occurs 416
with accidental reactions or anaphylaxis. With healthcare professionals and governments 417
now placing more of an emphasis on prevention, a different patient management model is 418
required to assess cost-effectiveness within the continuum of care. Clinically, standardized 419
HRQL measures can enhance screening patients for burdens associated with even 420
asymptomatic periods of food allergy and can be used to monitor changes . 421
Another important issue for policy makers is how HRQL can aid policy decisions in allocating 422
healthcare resources. Efforts to link quality of life gains and optimal resource allocation has 423
proved challenging in many areas of healthcare. Decisions are often taken based on the 424
outcomes of an evaluation expressed as incremental costs per QALY gained, or disability 425
adjusted life years (DALY). Measuring HRQL in economic or monetary terms has not been 426
attempted to date in the area of food allergy. Since QALYs need to be measured against 427
some threshold (usually the monetary or consumption value of QALY gains), disease-specific, 428
meaningful estimates of the value of QALY gains in food allergy need to be developed. 429
Disease specific HRQL measures can be a key tool in such a development. 430
How best to develop an efficient and integrated method of assessment and monitoring of 431
HRQL in patients with co-existent allergic problems has been a matter of recent debate. In 432
order to retain the advantages of a disease specific instrument, the use of communications 433
technology may be an option. Unlike a paper questionnaire, electronic questionnaires can be 434
developed that consist of a subgroup of questions from a much larger collection to provide 435
personalised instruments that, for example, cater for type of allergy, multiple allergy, 436
distance from medical centre, co-morbid condition. Where appropriate, section(s) on coping, 437
anxiety, risk, reactions, and management style could also be included. A further advantage 438
of an electronic system would be the ease with which a detailed database could be 439
generated for health status of individual patients on a longitudinal basis. This would allow 440
healthcare providers to target additional input to individual patients or families experiencing 441
impaired HRQL due to particular circumstances. 442
Some questions remain that impact on the future potential value of HRQL measures in 443
allergy. Firstly, what are the correlates of HRQL in food allergy (e.g. anxiety, health beliefs, 444
risk perception, information processing, coping behaviours) and how do they impact on the 445
likelihood of adverse reactions and management? Which of these variables are causally 446
related to HRQL status, and which variables are the effect of HRQL status? Lastly, as HRQL 447
depends on subjective perception of the burden of food allergy, what are the underlying 448
neuropsychological mechanisms? These questions have particular relevance for the 449
interpretation and usefulness of HRQL measures in clinical practice. As our knowledge base 450
grows, clarity will evolve about how HRQL relates to other variables. However, it is 451
important that we design studies that help to clarify the mechanisms of effect predictors and 452
outcomes. Studies must be theory driven, well designed, multi-site, and build on previous 453
work. Models should allow for bidirectional causal pathways linking health to health related 454
quality of life (including all significant variables and their weights) . For example, if the flow 455
is bi-directional for some of the components, this has profound implications in terms of 456
interpretation and application of HRQL results.The mechanisms responsible for any 457
associations should be evaluated. Such models may be seen as a blueprint for exploration as 458
well as a summary of available evidence. 459
Since the developmental process plays an important role in shaping and determining 460
physical and psychological health and HRQL, an attempt to delineate a developmental 461
pathway is also vital. Life transitions provide a naturalistic research opportunity to 462
investigate adaptability to a diagnosis of food allergy and the link to health outcomes and 463
HRQL.The pathway should take account of sensitive transition points when the interaction of 464
biopsychosocial factors may create an increased vulnerability in terms of health and well-465
being (8,23). 466
In addition to providing a meaningful way to assess the end results of health care services, 467
including clinical and therapeutic interventions, and policy, HRQL measures can allow health 468
professionals to pinpoint the time when both parents and children may need further support 469
on issues such as diet, auto-injectors, risk management, managing anxiety, and changing 470
developmental and practical challenges. It can also help us to identify unintended impacts 471
of potential management options. The use of HRQL measures cross-culturally and across 472
countries can delineate similarities, differences, and dynamic factors. Taken together, such 473
findings, combined with research on variables related to HRQL, can provides a broader view 474
on the impact of food allergy and on outcomes. 475
476
477
Acknowledgements 478
479
480
Authors’ contribution 481
482
483
Conflicts of interest 484
485
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