Dr Audrey DunnGalvin PhD, Reg.Psychol PsSI,BPS. The consumer perspective : living with uncertainty
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1 Dr Audrey DunnGalvin PhD, Reg.Psychol PsSI,BPS. The consumer perspective : living with uncertainty
2 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? Family life can be difficult enough..but when you add food allergy to the mix those difficulties are multiplied Claire, mother of Becky, age 10, and Jane, age 13, U.S.
3 Living with labelling and thresholds means living with uncertainty THE PROBLEM
4 All Science involves making decisions based on the available data... 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 Janet, mother of Ciara, diagnosed with peanut and nut allergy at 3 years, Ireland.
5 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.
6 Food Challenge 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.
7 Labelling Robertson in press
8 Irish confectionery survey May Contain Shared equipment Shared facility Minor ingredient Total Baked Biscuits Cereal bars 2 1 (1) 1 4 (1) Chocolates 9 (1) 6 15 (1) Sports/ energy bars Total 22 (1) 1 3 (1) 8 38 (2) 1/22 may contain do contain 1/3 shared facility do contain 0/8 minor ingredient actually contain!!! Robertson in press
9 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 ****All doses 1 log lower that peanut ED5: 6mg Robertson in press
10 10 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.
11 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. Allergic reactions are perceived to be unpredictable Labelling is perceived to be unreliable Low perception of control and uncertainty A reduced public trust in safety of food labelling Increased Pyscho-Social Stress : Children, teens and parents anxious, avoidant or overprotective, frustrated, unsure, worried, stressed, angry... Low Confidence in coping and decision making Risk and vulnerability (emotional adjustment /safety)
12 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; 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): 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: 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 Jul;122(1):139-44, 144.e1-2.
13 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. 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 DunnGalvin et al. Cross-Cultural Comparison of the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) on four continents Mother of Sam, 13, UK
14 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, 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.
15 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). CASE STUDIES Emma & Peter
16 C A S E 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. S T U D Y 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. 1
17 C A S E S T U D Y 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. 2
18 THE SOLUTION?
19 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? Instead of dos and don ts how about some scientific facts so can make own judgement calls? John (16 years, US).
20 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)
21 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.
22 Feeling informed & in control of risk management Consumers understand that zero risk is not possible...but they do want more control Kate, Age 20, UK. A safe level to tell friends, you can t give a life time of knowledge in a hour The more precise and consistent information you have, the more informed the decisions you can make Isobel, Age 20, Ireland Dad of Jamie, Age 4, UK. You have to take risks but... this would be a calculated risk... which would give you a lot more control If the threshold at which he reacts could be used in a practical way, then far more helpful than the labelling we have now Mum of Caoimhe & Brian, Ireland I want to be in control of my health and wellness, to manage or improve it through making better choices 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 Andy, Age 30, US Helen, Mum of Daniel,US
23 Consumer
24 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? Roisin, Age 17., Ireland 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. Jake, Parent of Aine, 9 years. Ireland 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 Jenny, Parent of Sammy, Age 14, UK
25 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
26 ...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)
27 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.
28 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
29 So, to conclude...
30 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.
31 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): 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).
32 The validation of population thresholds can decrease the uncertainty of living with food allergy.
33 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.
34 Core theme..? Thresholds Acceptability
35 Core theme..? Thresholds Acceptability Joint Endeavour/Communication
36 If the whole process is communicated clearly then quality of life would be so much improved for allergic consumers Allergist, US 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. Parent, US
37 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 37
38 Thank you! 38
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