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DomainOutcomePreliminary DescriptionKarine Adel-PatientEmma CookKate KhalevaJennifer ProtudjerMichael GoldingAnita FossaluzzaDragan MijakoskiReviewerReviewerReviewerReviewerReviewerReviewerReviewerReviewerReviewerReviewerReviewerReviewerReviewer
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1.       Physiological/clinicalDesensitisation"Temporary state that allows a person to consume more of the food allergen than they
could prior to an intervention, but the underlying food allergy is still present so patients must still continue with strict allergen avoidance. Desensitisation requires the food allergen to be consumed regularly, without stopping, to maintain protection. Importantly, the level of protection is unstable so patients can react to their daily desensitisation treatment." This should be confirmed by oral food challenge (a medical procedure in which a food is eaten slowly, in gradually increasing amounts, under medical supervision, to accurately diagnose or rule out a true food allergy).		"strict allergen avaidance" is confusing considering desentisation must be pursued (thus the allergen consumed regularly, as mentionned just after)? I Don't really know if the outcome should be rather "success of desensitisation"?in response to Karine's comment, perhaps edit the sentence from : "so patients must still continue with strict allergen avoidance" to: "so patients must still continue with strict allergen avoidance in daily life" or "so patients must still continue with strict allergen avoidance outside of their intervention dose."Maybe "Success of desensitisation" is a good term for this outcome. Also, agree with Emma
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2.      Physiological/clinicalMaximum tolerated amount of allergenic foodChange in the tolerated (associated with the absence of symptoms) dose of food from the beginning to the end of the study, confirmed by oral food challenge (a medical procedure in which a food is eaten slowly, in gradually increasing amounts, under medical supervision, to accurately diagnose or rule out a true food allergy).outcome could be "change in maximum tolerated dose"?
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3.      Physiological/clinicalSustained unresponsivenessAbility of a person with food allergy to consume a larger amount of food than they could tolerate before an intervention without having an allergic reaction, after having paused treatment
for a period of several weeks. Typically, the person with food allergy is able to tolerate a standard serve or pass a diagnostic oral food challenge (a medical procedure in which a food is eaten slowly, in gradually increasing amounts, under medical supervision, to accurately diagnose or rule out a true food allergy) weeks after treatment discontinuation.		same comment as for outcome name / E2I would replace 'serve' with 'serving' in the description. Also, perhaps change the sentence from: "after having paused treatment for a period of several weeks." to: "after having paused treatment for a period of, at least, several weeks." ?Agree with Emma. I also wonder about the use of the term "standard serving" as this needs to be referenced against a person's age, and also approaches the medicalisation of food intake, which is what SU is, in fact, trying to minimise.I also agree with Emma.I agree with EmmaI agree with Jennifer. Just wondering, is "several weeks" enough for description or we should put exact number of weeks?
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4.      Physiological/clinicalSymptomsOccurrence and frequency of allergy-specific symptoms due to an intervention or accidental exposure (e.g. tingling or itching; a raised, itchy red rash (hives); swelling of the face, mouth (angioedema), throat or other areas of the body; difficulty swallowing; wheezing or shortness of breath; feeling dizzy and lightheaded; feeling sick (nausea) or vomiting; abdominal pain or diarrhoea; anaphylaxis; hay fever-like symptoms, such as sneezing or itchy eyes (allergic conjunctivitis) due to intervention or as a result of accidental exposure to food.outcome: occurence of undesired symptomes"?(response to Karine's comment - I think symptoms is more objective)"Allergy-specific symptoms" and then listing them (as is done) is fine. While there is the possiblity of subjectivity for some listed symptoms (e.g. nausea), taken in combination with other symptoms, they may be considered as allergy symptoms. It may be worth a peek at how these symptoms were operationalised in a large, Swedish cohort that captured such symptoms (e.g. PMID: 27846286) "Due to intervention or accidental exposure..." appears twice in the description. Should we delete one instance?I agree with Michael, but keep ...exposure to food.ffff
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5.      Physiological/clinicalImmune responseMeasurement of biological markers (e.g. IgE, IgG4, and IgA antibody levels to food protein, BAT test, MCAS test) or allergy tests (e.g. SPT), gut microbiome assessment.Gut microbiome is not really an immune response... maybe change as "biological markers", thus including immunological, microbiota, ... I suppose not all studies will mesure all these parameters, maybe should be more restrictive?
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6.      Physiological/clinicalAllergic comorbiditiesOccurrence of new cases of other allergic comorbidities (e.g. eosinophilic esophagitis, eczema, asthma, allergic rhintitis etc.) and the change of severity of previously existing comorbiditiesBurden of allergic (new/pre-existing) comorbidities ?Allergic comorbidities (prevalence, incidence, and remission), as well as severity thereofIf we analyse the comorbidities on a group level, we could refer to "new cases". Maybe is better to say: "Occurrence of newly manifested allergic comorbidities..."
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7.      FunctioningSatisfaction with interventionAnticipation of a person with food allergy and their carers that the intervention­­­­/services fulfils their health needs. "Anticipation of" was a little confusing for me as it suggests a measurement before the intervention (which seems to be outcome 8) whereas satisfaction suggests a measure during and at the end of an intervention. Perhaps change the description to something like: "Intervention/services fulfilled expectations of the person with food allergy and/or their carers."I agree with Emma. However, I would probably add "The degree to which...". For instance: The degree to which intervention/services fulfilled the expectations of the person with food allergy and/or their carersI agree with MichaelI agree with Michael
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8.      FunctioningMeet expectations from an interventionThe degree to which the expectation (anticipation or the belief) about what is to be encountered in an intervention or in the healthcare system will be met.Because of the wording of this outcome I thought it overlapped with outcome 7 (satisfaction with). I think this could be resolved by changing the outcome to something like: 'Initial expectations of intervention' or "Expectations of intervention"Should someone's initial expectations of a treatment or service be considered an outcome? I'm struggling to understand how it could be influenced by the treatment. If were talking about the degree to which expectations are met, however, is that any different then satisfaction?Similar reflection as Michael's
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9.      FunctioningFood-related psychological impactAnxiety  (including phobias), distress or worries related to food and symptoms caused by intervention and accidental exposure. I was wondering if we should add something that covers the psychological impact associated with the social consequences of food allergy (e.g., disappointment associated with missing out on shared meals).
For instance: "Anxiety (including phobias), distress or worries related to food, social impairments associated with food avoidance, and symptoms caused by intervention and accidental exposures. 		I agree with MichaelI agree with Michael
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10.   FunctioningFood allergy-related quality of life The effects of a food allergy and its consequent therapy upon a person with food allergy and their carers, as perceived by food allergic individual/carer (to add domains as examples)add domains : family, friends, professional environment ? overlap with 13 ?
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11.    FunctioningAdherenceThe extent to which a person's behaviour, taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider.Perhaps change to: The extent to which a person's behaviour (e.g., taking medication, following a diet, and/or executing lifestyle changes) corresponds with agreed recommendations from a health care provider.I agree with EmmaI agree with EmmaI agree with Emma
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12.   FunctioningSocial role-functioning and relationship problemsFood allergy impact on connecting with others, including family members and friends, maintaining and creating new friendships and personal/romantic relationship, social activities and travelsI think 'travel' in the description could potentially overlap with outcome 13 (e.g., travel as related to work / business trips or school trips (which are a big thing in Japan and as part of extracurricular club activities). Perhaps remove it from the description here?
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13.   FunctioningImpact on work, studies or extracurricular activitiesImpact of food allergy on work, study, attendance, engagement/ participation in extracurricular activities
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14.   FunctioningStigmaFear or experiences of being discriminated against, bullied, excluded from activities, ignored, including by employer/school/nursery/university, medical professionals, social groups, family/friends/neighbours, or othersI would remove this one I would keep this, or - at minimum - enmesh it wish social role functioning. FA-related bullying is reported to estimate 1 in 3, to 1 in 5 children. (These are the reported cases; the number could very well be higher.)I agree with Jennifer I would keep thisI agree with Jennifer
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15.    FunctioningFood allergy management behaviourDegree to which confidence, competence and motivation exists to manage food allergy.Perhaps we need to add something extra so it doesn't get confused with outcome 11: Adherence? Something along the lines of: "Degree to which confidence, competence and motivation exists to manage food allergy. For example, being able to communicate about allergies at restaurants, reliably carrying and using auto-injectors etc"Self management of food allergy?Self- or caregiver FA management Add in brackets the various areas (daily communication, restaurants, use and carrying auto-injector transport and others medicines (antihistamines, Ventolin, ...))
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16.   Resource useImpact on the householdThe way in which food allergy impacts people living with a person with food allergy.
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17.    Resource useEconomic impact Financial burden resulting from the costs of medications, food, and non-health related costs due to food allergy. Frequency of seeing healthcare professionals (e.g., doctor, physiotherapist, psychologist), taking rescue medications, returning to the hospital or emergency care, including complementary/alternative medicine (e.g., acupuncturists, naturopaths), medical devices/technologyPerhaps delete 'physiotherapist'? (or is this a typo? Should it read 'psychotherapist'?). I also wasn't sure what was meant by 'medical devices/technology' - perhaps add an example?Missing here are the indirect (time, opportunity costs) which must be considered in addition to, and in combination with direct costs. Costs also are intangible, but are covered above (Items 9-15). Would also add the costs to the healthcare system; there is a paucity of data on the economic impact of FA (see PMID: 35502316). That is, we need to consider the societal impact (e.g. the household, healthcare system, food industry, childcare/school)I would probably use the term impact rather than burden given that it is a bit more inclusive. Arguably food allergy has a financial impact on all families, but it can't always be considered a burden. For instance, wealthy families can easily absorb the additional direct costs food allergy and in some cases the indirect costs as well.

I agree we should add something about the time costs (indirect costs) of food allergy. 		Reality: for a family, the most important costs are related to food (special products), the frequency of medical consultations, the relatively high price of drugs to be renewed regularly, the choice of clothing (e.g. if allergy to latex), ...
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Maybe the patient / carer notation of a kind of risk/benefit (a global note, from his point of view, that will integrate all these points - then asessing theiur good correlation)?)?Should we consider adding 'TOLERANCE' and 'Adverse events' as outcome measures?
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