The consumer perspective :

living with uncertainty

Dr Audrey DunnGalvin PhD, Reg.Psychol PsSI,BPS.

Growing up with food allergy : impact on psycho-social development.

Living with uncertainty

Labelling

Thresholds What can we do to decrease uncertainty and improve quality of life

for consumers?

Claire, mother of Becky, age 10, and Jane, age 13, U.S.

Family life can be difficult enough..but

when you add food allergy to the mix

those difficulties are multiplied’

THE PROBLEM

Living with ‘labelling’ and ‘thresholds’ means ‘living with uncertainty’

All Science involves making decisions

based on the available data....

Janet, mother of Ciara, diagnosed with peanut and nut allergy at 3

years, Ireland.

‘I was shocked when Ciara was diagnosed and I seemed to be given a list

of rules based on complete avoidance.......but what about the evidence for

that...it seems conflicting and confusing ....I would like to make more

informed choices’

‘Uncertainty’ constitutes a major obstacle to

constructive decision making in human beings of all

ages.

DunnGalvin, & Hourihane, Developmental aspects of HRQL in food related chronic disease (2011) The International Handbook of Behaviour, Diet and Nutrition ; Springer, US.

Today your child has tolerated a food challenge to a very low trace dose of peanut. What does this mean? This suggests that if your child eats a food product which contains precautionary labelling (e.g. ‘may contain traces of nuts’ statements) in the future, he/she is at extremely low, but not zero, risk of having an allergic reaction. As usual, any packaged good can be accidentally contaminated with larger amounts of peanut protein, and hence an unpredictable allergic reaction to such foods can occur.

Food Challenge

Labelling

Robertson in press

Irish confectionery survey

“May Contain”

“Shared equipment”

“Shared facility”

“Minor ingredient”

Total

Baked 2 1 3

Biscuits 6 1 1 1 9

Cereal bars 2 1 (1) 1 4 (1)

Chocolates 9 (1) 6 15 (1)

Sports/ energy bars

5 2 7

Total 22 (1) 1 3 (1) 8 38 (2)

Robertson in press 1/22 “may contain” do contain 1/3 “shared facility” do contain 0/8 “minor ingredient” actually contain!!!

Irish confectionery survey

Label Number tested

Concentration Dose per serving

Chocolate “May contain peanut”

3 1 positive

25.8mcg/g BLD BLD

0.52mg <0.05mg <0.05mg

Cereal bar “Shared facility” 4 4 positive

3.0 mcg/g 2.8 mcg/g 7.4 mcg/g 6.2 mcg/g

0.14mg 0.13mg 0.33mg 0.28mg

Robertson in press

****All doses 1 log lower that peanut ED5: 6mg

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Precautionary labelling – paradoxically - can lead to

both increased anxiety and/or risk

DunnGalvin, A & Hourihane, J O’B. Developmental aspects of HRQL in food related

chronic disease (2011) The International Handbook of Behaviour, Diet and

Nutrition ; Springer, US.

Children, teens and parents need to cope

with normal developmental changes

Children, teens and parents need

to cope with Constant vigilance

May contain used as a ‘safety net’ Food challenge as diagnosis vs safe level

Confusion how much allergen is required to cause a

reaction, and how severe this reaction might be.

Labelling is perceived to be unreliable

Allergic reactions are perceived to be

unpredictable

A reduced public trust in safety of food

labelling

Low perception of control and uncertainty

Increased Pyscho-Social Stress : Children, teens and parents anxious,

avoidant or overprotective, frustrated, unsure, worried, stressed, angry ...

Risk and vulnerability (emotional adjustment /safety)

Low Confidence in coping and decision making

Quality of Life

It is not surprising, therefore, that food allergy (and it’s management)

has a large impact on development and on quality of life in

psychological, emotional and social domains.

DunnGalvin A, & Hourihane JO’B. Developmental trajectories in allergic diseases: A review. Advances in Food and Nutrition

Research, 2009 Volume 56 Elsevier Inc.

DunnGalvin, A.,de Blok, B.M.J. Dubois, A., Hourihane, J.O’B (2008). Development and Validation of the Food Allergy Quality of

Life – Parent Administered Questionnaire(FAQLQ-PF) for food allergic children aged 0-12 years. Clinical and Experimental

Allergy, 38; 977-986

DunnGalvin, A Cullinane , C Daly, D Flokstra-de Blok BMJDubois AEJ, Hourihane JO’B..Longitudinal validity and

responsiveness of the Food Allergy Quality of Life Questionnaire – Parent Form (FAQLQ-PF) in children 0-12 years

following positive and negative food challenges. Clin Exp Allergy.2010 Mar;40(3):476-85

Flokstra-de Blok BMJ, DunnGalvin A, Vlieg-Boersta BJ, Oude Elberink JNG, Duiverman EJ, Hourihane JO, Dubois AEJ.

Development and validation of a self-administered Food Allergy Quality of Life Questionnaire for children. Clin Exp Allergy

2009;39:127-137.

Flokstra-de Blok BMJ, DunnGalvin A, Vlieg-Boerstra BJ, Oude Elberink JNG, Duiverman EJ, Hourihane JO, Dubois AEJ.

Development and validation of the self-administered Food Allergy Quality of Life Questionnaire for adolescents. J Allergy

Clin Immunol. 2008 Jul;122(1):139-44, 144.e1-2.

Quality of Life in Food Allergy

(Europrevall, FP6)

Similar patterns of responses

across countries at 12 months

Highest impact in items relating to

social and dietary restrictions,

including fear of new foods, new

people and new places.

DunnGalvin et al. Cross-Cultural Comparison of the Food Allergy

Quality of Life Questionnaire (FAQLQ-PF) on four continents

‘I made up reasons for him not to be out and I was very very

protective of him and wouldn’t let him have the freedom, I

was so paranoid that something was going to happen to him’

Mother of Sam, 13, UK

Living and coping with food allergy.....

………. is a cumulative history of interactive processes (both age and disease specific) that are embedded in a child’s developmental pathway, therefore...

Growing up with ‘uncertainty’ has a profound and longterm impact.

DunnGalvin, A & Hourihane, J O’B. Developmental aspects of HRQL in food related chronic

disease (2011) The International Handbook of Behaviour, Diet and Nutrition ; Springer, US.

DunnGalvin A, Gaffney A, Hourihane JO’B. Developmental pathways in food allergy : a new theoretical model Allergy, 2009; 64, 560-568

DunnGalvin A, Burks, WJ, Dubois AEJ, Chang WC, Hourihane JO’B. Profiling Families Enrolled in Food Allergy Immunotherapy Studies, Pediatrics 2009;124 e503-e509

DunnGalvin A, & Hourihane JO’B. Developmental trajectories in allergic diseases: A review. Advances in Food and Nutrition Research, 2009 Volume 56 Elsevier Inc.

CASE STUDIES

Emma & Peter

‘Food Allergy Matters’ : Evidence-based efficacy of an intervention developed to

moderate the psychological impact of food allergy, using a controlled design.

DunnGalvin & Hourihane (submitted).

• Emma (6 years) presented as an anxious child, who was very

dependent on Mum.

• She was emotionally mature for her age, in her manner and thought processes. Mum

scored Emma very highly on the ‘Food anxiety’ subscale of the FAQLQ-PF (6 out of

7). She was highly fearful of anaphylaxis and would interpret many social situations

(e.g. going to the cinema) as ‘scary’. She would also ask Mum again and again to check

if packaging contained peanuts.

• We describe Emma as ‘anxious/avoidant ‘ and the emotions and behaviours

associated with being careful about food were now generalising to all life situations,

so that she was fearful of any ‘new’ people and places. Both Mum and Emma cried

as they described what it was like to live with food allergy. Neither felt that they

were ‘in control’ of the everyday management of allergy.

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Peter (12 years) presented as a confident and articulate child. ◦ He has had experienced anaphylaxis twice in the relatively recent past, and Mum

was very worried. Peter scored highly (5.2) on the third subscale of the FAQLQ-PF impact of ‘social and dietary restrictions’.

Peter, thinks wishfully of food he would like to eat and/or being no longer allergic.

He is very frustrated by the ‘rules’ feels that they ‘are pointless’ because of the uncertainty of allergic reactions, labelling of ingredients, and low awareness. He compares his life very unfavourably with other children and he expects a negative reaction if he tells peers of his allergy.

He has begun to take risks (such as not reading labels, not telling

others of his allergies). ◦ As his way to try and exert control over uncertain conditions. He resents

parental protection which he regards as ‘nagging’ and sometimes ‘forgets’ his pen.

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THE SOLUTION ?

• Current risk hazard approaches perpetuate uncertainty and studies have shown that consumers, clinicians, regulators and food industry want a ‘better’ way of risk assessment and management.

Therefore ... ... ... • Can we translate the science on thresholds into meaningful

strategies (labelling of allergens, or to communicating information) in order to reduce uncertainty and improve quality of life ?

John (16 years, US).

‘Instead of ‘dos and don’ts’ – how about some scientific facts so can make

own judgement calls ?’

We consulted over 600 participants (Europe & UK) in focus

groups, interviews and via an online survey

With the aim of integrating perspectives from clinicians, industry,

and consumers on labelling and thresholds and

To identify concerns which must be addressed in order to

develop harmonised approaches and strategies ... ...

... that actually work,

... that will be accepted,

... and that can be communicated clearly.

Translating science into meaningful strategies for consumers, clinicians and industry. DunnGalvin,

Baumert, Taylor, (in preparation)

The qualitative analysis revealed 4

main themes :

1. ‘The reality of living with risk’

1. ‘Maintaining a balance’

1. ‘Feeling informed and in control of risk management’

1. ‘Communicating thresholds’.

‘Feeling informed & in control of risk

management’

Consumers understand that zero risk is not possible...but they do want

more control

‘A safe level to tell friends, you

can’t give a life time of knowledge

in a hour’

‘You have to take risks but ... this would be a

calculated risk ... which would give you a lot more

control’

‘The more precise and consistent information you have, the

more informed the decisions you can make’

‘I want to be in control of

my health and wellness, to

manage or improve it

through making better

choices’

‘If the threshold at

which he reacts

could be used in a

practical way, then

far more helpful

than the labelling

we have now’

Isobel, Age 20, Ireland Dad of Jamie,

Age 4, UK.

Kate, Age 20, UK.

Mum of Caoimhe &

Brian, Ireland

Andy, Age 30, US

‘When I first thought about the whole concept, I said, ‘oh no’ but I am really

coming round to it...it’s quite an easily understandable idea really when you

explain it, and it’s what we do ourselves anyway alot of the time’

Helen, Mum of Daniel,US

Consumer

‘Communicating thresholds’

‘Why can’t we be involved ...we’re the ones

buying and eating it, we know what we

want, what would work...not just me, but all

of us, why don’t they ask us ?’ ‘Even if we disagreed, we would surely find a

consensus, and at least people would know

that everyone had been involved in making

that decision .

‘You would have to understand it … how they developed it ,

what’s the evidence behind it. We’re not stupid, we will get it ... if

it’s communicated properly’

Roisin, Age 17., Ireland

Jake, Parent of Aine, 9

years. Ireland

Jenny, Parent of

Sammy, Age 14, UK

Most popular/frequent suggestions from all age

groups, including parents

1. Maximum/minimum levels

2. Including ‘confidence’ levels

3. Link to eating out/restaurants

4. Bar code link (shopping/eating out)

5. Clinical interview

6. Agreed and consistent terminology

.........An ideal label???

• This product has been produced in a manufacturing

facility where the likelihood of any product containing

any peanut is <5%. The maximum detected amount of

peanut has been Xmg/serving. This amount is known

to be safe for 95% of peanut allergic consumers and

to date it has not been shown to cause a severe

allergic reaction in allergist supervised tests.

• Hourihane (EAACI Milan, 2013)

Today your child has tolerated a food challenge to a very low trace

dose of peanut.

What does this mean?

This suggests that if your child eats a food product which contains

precautionary labelling (e.g. ‘may contain traces of nuts’ statements) in

the future, he/she is at extremely low, but not zero, risk of having an

allergic reaction.

As usual, any packaged good can be accidentally contaminated with

larger amounts of peanut protein, and hence an unpredictable allergic

reaction to such foods can occur.

Today your child has tolerated a food challenge to a very low trace dose of

peanut.

What are our recommendations?

We recommend ongoing care and caution. However, for most children with

peanut allergy, parents may now decide that their child can start (or continue)

eating foods which such contain precautionary labelling. If such foods are

consumed, a reaction is still possible, but exceedingly unlikely to occur.

For some children, including but not limited to those who have a

history of more severe anaphylaxis to peanut or unstable asthma,

this should be discussed with your allergy specialist and

a decision is made on a case-by-case basis.

K Allen

So, to conclude...

Uncertainty has a profound psychological

impact on children, teens, young people

and families growing up and living with

food allergy.

However, practical interventions can

reduce this uncertainty and improve

quality of life.

For example, through reducing uncertainty...

Routine oral food challenge improves Quality of Life

◦ DunnGalvin A, Cullinane C, Daly D A, Flokstra-de Blok B M J, Dubois A E J, Hourihane J O'B (2010). Longitudinal validity and responsiveness of the Food Allergy Quality of Life Questionnaire - Parent Form in children 0-12 years following positive and negative food challenges. Clinical & Experimental Allergy; 40(3):476-85.

Good communication and clinical support improves Quality of life and

confidence in decision making and management

◦ Kelleher MM, Hourihane JO’B, Dunngalvin A, Cullinane C, Fitzsimons J, Sheikh A (2012). A 24-h helpline for access to expert management advice for food allergy-related anaphylaxis in children: protocol for a pragmatic randomised controlled trial. BMJ 2(4).

Learning to cope constructively with food allergy improves perception

of control and Quality of life

◦ ‘Food Allergy Matters’ : Evidence-based efficacy of an intervention developed to moderate the psychological impact of food allergy, using a controlled design. DunnGalvin & Hourihane (submitted).

The validation of population thresholds

can decrease the uncertainty of living with

food allergy.

Acceptability ?

• The acceptability of thresholds can be increased through the

implementation of certain linked strategies,

clearer, trustworthy,and consistent labelling,

increased understanding and awareness about thresholds,

a stronger link between individual and population thresholds

• leading to FA consumers accepting a perceived ‘higher level of risk’ if

they are able to feel more in control of their lives and their allergy.

Core theme ..?

Thresholds Acceptability

Thresholds Acceptability

Joint Endeavour/Communication

Core theme ..?

‘If the whole process is communicated

clearly– then quality of life would be so

much improved for allergic consumers’

‘Life is long. I hope my child lives longer as

a adult than a child. If there were a safe

min level on shared equipment, it would

open up a universe of food for her. ‘

Allergist, US

Parent, US

acknowledgements

Jonathan O’B.Hourihane, University College Cork

Europrevall Birth Cohort Group (Italy, Netherlands, UK, Iceland, Spain, Germany)

Aziz Sheik & Allison Worth, University of Edinburgh

Hazel Gowland. AllergyAction, UK

Anaphylaxis Ireland.

Steve Taylor, Joe Baumert, FARRP, University of Nebraska

Antonella Muraro & Laura Polloni ,Padua University.

Jennifer LeBovidge, Harvard Children’s Hospital, Harvard University, US

Wesley Burks, Duke University

Katie Allen, Nadine Bertelli, Royal Children’s Hospital, Melbourne, Australia

Wen Chin, Women & Children’s Hospital, Singapore

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Thank you ! a.dunngalvin@ucc.ie

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