Assessing Quality Of Life After Food Allergy Immunotherapy

While researchers are trying to understand how long-lasting protection against food allergies biologics can provide, another important question is how these treatments affect quality of life for the families and the children receiving treatment. As I mentioned above, having more “buffer” (or room for error) before having a severe reaction, feeling safer in typical situations (e.g. eating in a restaurant), and having fewer restrictions on activities because of a food allergy can all enhance quality of life. But, there are also clearly negative aspects of treatment that need to be weighed. Even with a promising approach like biologics and slow dose escalation to peanut protein, there are days of clinic visits to slowly increase dose, daily ingestion of medication, limitations to activities on the day of medication or after ingestion of treated food, and risk of a reaction to the treatment itself. To get at these trade-offs, we need to be measuring quality of life using both objective, patient-reported outcome measures and more practical measures of real-world effects. Challenge outcome and measures of dose of food in treated foods (e.g. peanut grams per ounce of peanut butter) are not enough.

Why It Matters

Our patients start on the Acupuncture treatment pathway for Health Reasons relating to Quality of Life issues.

While the rare serious reaction is the biggest risk for people with food allergy, the day-to-day challenges of living with food allergy may be greater. Food allergy sufferers must check food labels frequently, decline offers of food from unknown sources, ask waiters and waitresses about ingredients, always have ready access to their EpiPen or other emergency treatment, and be constantly on the lookout for hidden food. The impact of food allergy on sleep, school, work, travel, family meals and activities, and mental health is well recognised. Many people say that the fear of an accidental exposure influences almost every decision they make.

Immunotherapy is not meant to eliminate exposure to the allergenic substance that induces allergy symptoms. The goal is to increase the patient’s threshold of reaction, so that even if accidentally exposed to the substance, he or she is less likely to experience severe symptoms. For the millions of families with food allergies, even a small buffer zone that immunotherapy can create between accidental exposure and symptoms can translate to less stress and less anxiety, even if daily avoidance and epinephrine are still part of daily life.

A positive perspective on the value of employment support for people with mental health issues is argued, whilst acknowledging the difficulties of generating a positive account of the treatment process.

While exposing a dog with fear aggression to things that he fears can be stressful in the short term, the long term benefits of desensitization and counterconditioning make it all worthwhile. Gradually increasing the dose of things that a dog with fear aggression fears that he can tolerate is an important part of the training process. The dose of the things a dog with fear aggression fears (items on the list) needs to be increased gradually. Some programs are done in 10-15 minute segments, supervised or unsupervised, and others require many supervised sessions and monitoring of a dog’s behavior after increasing the dose. While families may work with a trainer or handler to learn how to gradually increase the dose of things that a dog fears, families are usually able to stick to a home dosing schedule very closely because there is careful planning that goes into administering a dose. There are some things that some dogs should avoid having doses administered while they are experiencing, such as exercise, taking a hot shower, or when they are ill. Other programs require families to plan their day around their dog’s meal times in order to administer doses. This can be especially difficult for some families (i.e., busy professionals, families with young children).

What about reactions that are anticipated but potentially erode a family’s sense of competence in caring for their child and themselves at home? Although unlikely to occur, common early reactions to treatment that could potentially occur include: a general itchy mouth feeling and occasional stomach discomfort. Although easily managed with an over-the-counter medication, such reactions can cause a child and family a lot of anxiety. There are some rare reactions to treatment that could potentially occur. Some of these could require immediate medical attention and potentially need emergency treatment which could also affect a family’s perception of how “safe” they are at home with this treatment.

Outcomes measuring quality of life may affect healthcare expenditures, medical access, and insurance coverage for treatments.

Payers and health systems are interested in the value of immunotherapy from a patient and family centered perspective outside of the clinical walls. What does it mean to a patient or family to be treated with immunotherapy for their cancer from a quality of life perspective? How does it allow a child to go to school for more days? Increase work productivity? Decrease the time a family member has to stay at home to care for a child during the day? Decrease emergency department use? These real-world outcomes will help shape the perceived value of this expensive treatment and make decisions on whether or not to expand and cover its use. A program that enables a child or adult to have better daily functioning, less family disruption, etc. will have different value than a program that simply changes a lab value.

Quality of life assessment can also guide the design of programs that help manage those domains that cause most burden to patients, through tailoring aspects of workflow, education, follow-up and support services. As more immunotherapy is delivered in community-based general oncology settings, there is a pressing need for practical strategies to improve quality of life.

It’s been a few years since I wrote my post on “better quality of life”, so it might be interesting to everyone to get a feel for what that all means in practice.

While Quality of Life improvements can be HUGE, they can also be very small and very concrete. Families feel less fearful when their child goes to school, less stressed during mealtimes, or more comfortable in a car when traveling to activities for soccer practice. Children feel less “other” when they are able to do things that their peers do, such as playing sports, riding bikes with friends, having a sleep over at a friend’s home, or participating in after school clubs like scouting, G/T, chorus, etc. Adults with ADHD feel comfortable eating in front of others at work, going out with friends to dinner or to a movie.

While most patients do very well on higher doses of clozapine, not all patients will show the same degree of response, and some may even get better after being on a maintenance dose or even after finishing treatment in the scheduled treatment phase. Some patients may even feel uncomfortable or even stressed during the dose escalations but show improvement later. Monitoring of the patient’s quality of life during different stages of treatment is important and the patient and their family should be involved in assessing whether treatment goals are being met.

Who It Affects

Children and caregivers

We must also consider the quality of life for caregivers and family members of children with food allergy symptoms. Parents are often responsible for numerous tasks such as grocery shopping and meal preparation, in addition to declaring foods and other allergens at school functions and other public gatherings. They will track and refill prescriptions for EpiPens, check expiration dates, and plan for worst case scenarios in which an EpiPen is needed. While immunotherapy for food allergy can reduce the anxiety of a child who has a food allergy, it is unlikely to add quality to the lives of those families. Rather, parents and children will assume new responsibilities to administer doses, monitor for symptoms of an allergic reaction, and treat reactions when they occur.

As a family, many of the routines and activities that parents typically manage (such as meal times and bedtime routines) need to be adapted in order to accommodate a treatment that will be required for several months or even years. For example, the time and planning needed to visit the clinic and/or administer medication multiple times a day might require organization around dosing time, trying to space out doses throughout the day, or limiting travel. This change can have an impact on siblings in the home. Stress on the caregiver can also have a significant effect on both adherence to treatment and overall satisfaction with the quality of that treatment.

Adolescents and young adults

For children and teenagers, nothing is more important than being able and allowed to do what their peers do, being independent and growing up as quickly and fully as possible. They want to play sports, go to restaurants with friends, go abroad on their own, or just go where and when they please. For the time being, this may be restricted by their allergy, but with proper immunotherapy, it is hoped that these restrictions will decrease over time. In the meantime, the teenager has to be able and willing to take responsibility for his or her own treatment, to report any occurring symptoms and to acknowledge the on-going risks of unintended ingestion of allergenic food.

Non-adherence can also occur among youth. For example, they may miss some doses of their medication or fail to inform their parents, caregivers or health care providers of changes in their medical, behavioral or high-risk sexual or drug using behaviours. An effective program for youth with diabetes includes teen-centered diabetes education, shared decision-making and realistic planning. Programs for youth with diabetes are generally more effective than mere punishment.

Adults with longstanding food allergy

While the major objectives of immunotherapy for honeybee sting allergy in adults are to remove the potential for life threatening reactions, there are also other goals. In addition to reducing fear of bees that interferes with work or leisure activities on the weekend or in their free time, adults with honeybee sting allergy may also have limitations in their normal activities due to occasion encounters with bees at places such as amusement parks, festivals, fairs or sporting events. Similar to children with honeybee sting allergy, many adults with this condition engage in avoidance of situations in which bees might be present and replacing this avoidance behavior with controlled exposures to bee venom can be a difficult process. The reasons for this difficulty can vary widely from person to person. Some people feel a significant burden relieved or improved by feeling protected from accidental stings and others have great stress and difficulty managing daily dosing.

Treatment and travel arrangements to and from hospital may limit the feasibility of aspects of care. For example, adults are less likely to be able to attend for frequent clinic appointments than families with children of the same age. This can make a big difference to quality of life and adults may want flexible arrangements for appointments as well as clear instructions on how to administer and schedule medication at home.

Clinicians, schools, and emergency responders

The child and their family need to understand what is realistic for treating their food allergy, and have a plan with the allergy specialist as to what the goals are, what the potential risks and benefits are. The specialist needs to work with the family to develop a dosing schedule and teach them how to read an EpiPen and what to do in case of an allergic reaction. The primary care physician/urgent care physician need to know what medications the child is on, and have documentation of the child’s dosing plan for their food allergy, as well as a plan for treating an allergic reaction, particularly when the child is on a dosing schedule at home.

As immunotherapy for food allergy emerges, schools and other child care facilities will continue to play important roles in the prevention and management of food allergy. Children with food allergy will need to avoid foods to which they are allergic and develop an action plan in case of an emergency. Parents and clinicians may feel increased confidence in the safety of such an approach and a changed threshold for tolerance of risk; it is therefore important that staff of schools and other child care facilities who care for food-allergic children understand what has changed and what has not.

Health systems and payers

Scaling up immunotherapy, particularly up-dosing, poses challenges to the clinical capacity and workforce, particularly in allergy clinics which may experience an increased demand for treatment. A hybrid model of specialist driven initiation of treatment in dedicated centres, followed by delivery in mainstream settings such as community based allergy clinics is proposed. Telehealth may also play a role.

Considerable evidence is generally required to determine the impact of a particular treatment in the clinical setting in which it would be used, and how it might affect quality of life and medical costs. This information can be useful for a number of areas of care, including education of patients and family members, laboratory monitoring, and follow-up visits to the clinician to assess the effect of the treatment on safety. Payers may then decide to cover all of the treatment, as both quality of life and indirect costs are favorable.

What Changes

1) Shared decision-making becomes the center of care

It is very important that treatment goals be compatible with those that the family has for the child’s life with this condition. For some, a major goal might be to avoid giving the child toxic oral medications and to be able to go out to eat or to visit with friends who are in town or on vacation. For others, the goal might be to occasionally go out to eat with town friends or occasionally to have a dinner guest. In a very small number of children, the goal could be remission with symptoms that last for many years, and this must be realistically defined and discussed prior to starting treatment.

I find that naming several of the key trade-offs between several options helps patients and families make a decision. These trade-offs can include issues such as depth of treatment, daily schedule of dosing, potential side effects, and level of emotional pain explored by the different options. Naming and discussing these trade-offs before starting treatment can really set up the patient and family for success, even with some of the more difficult treatment options. For example, differing trade-offs for watching a short clip versus avoiding the subject altogether.

Key questions to include in goal-setting

Unlike making long-term goals, making a treatment plan involves formulating specific, “practical” questions about the patient and family.

• How much does fear of accidental exposure affect school, work, or social life right now?
• What would a meaningful improvement look like in three months and in one year?
• Is the family ready for daily dosing routines and possible symptoms?
• What level of clinic visit frequency is realistic given travel and work constraints?

2) Care pathways need to expand and standardize

As immunotherapy becomes more mainstream and is prescribed for more children, it’s important that several systems be in place. First and foremost, there need to be clear criteria regarding who is eligible for immunotherapy. Families also need to receive some education about how immunotherapy works and the potential effects it can have. In addition, parents and children need to have a clear system of written dosing instructions for taking medication at home, an understanding of when they should stay home from school, from camp, from soccer, etc. for illness, and a plan for what to do in case of a missed dose.

Much about the care of children and young people with diabetes remains unchanged. However, the hybrid model may have a role in finding a balance between safety and workload. Specialist-led initiation and early escalation of care would remain at the core of diabetes management. However, longer term maintenance surveillance could be provided as a series of clinic sessions or as a remote service with patients seen at scheduled follow-ups.

This model is particularly useful for stable patients and their families allowing longer intervals between clinic visits. From a clinic perspective, by seeing families from rural areas at the same time, more patients can be seen in urban or resource-poor locations with less stretched resources.

Support systems that improve everyday experience

• Predictable appointment schedules and fast communication channels for symptom questions
• Clear written “sick day” rules and missed-dose plans
• Nutrition support to maintain balanced diets and reduce mealtime stress
• Mental health screening and referral pathways for anxiety and avoidance patterns

Addictions, depression, and chronic pain all make my regular reader list. Here are a few of the things I’m doing to make this site less painful to use.

3) Outcome measurement must go beyond clinical sensitivity

An increase in reaction threshold need not equate with improved quality of life. Monitoring and measuring of quality of life is therefore crucial. Patient-reported outcome measures and real-world clinical data should be used to monitor the quality of life of people with head and neck cancer. The use of validated questionnaires will help to avoid speculation and allow centres to compare their data with each other and with normative or comparison data.

What to measure and when

• Baseline: before starting treatment, to understand the starting burden
• Escalation phase: when visit frequency and symptoms may be highest
• Early maintenance: when routines stabilize but daily dosing continues
• Longer follow-up: to see whether benefits persist and whether burdens lessen

Quality of life changes in very different ways at different stages of life, both in degree and in kind.

Use both patient and caregiver perspectives where appropriate (e.g., use parent-proxy reporting to capture caregiver stress and disruption to family (family cohesion) versus child or teen self-report to capture social and emotional experiences from the child’s/teen’s perspective (social relationship, emotional/physical symptoms, recreational time)).

Real-world outcomes that reflect daily functioning

• School or work absences related to allergy or therapy
• Emergency visits and use of rescue medication
• Participation in social activities, travel, and school events
• Diet variety and confidence with food choices
• Caregiver time off work and out-of-pocket costs

Questionnaires can be used in conjunction with a set of clinical indicators that are meaningful to families.

4) Policy and reimbursement should reflect patient-centered value

Most models of disease burden concentrate on the health effects of disease. However, food allergy also has a significant impact on social and economic outcomes. As we strive to improve the coverage of care for children with food allergy, we need to consider how a system of care can help or hinder families who cannot afford the costs of traveling long distances and of seeing multiple specialists in different locations. We also need to consider how a system of care can help or hinder the burden on caregivers, the number of lost days of school, and poor mental health in these families.

Equity means that equity-focused cancer treatment and clinical trials are not only physically accessible but also linguistically and financially accessible. This means that programs and trials include language access, culturally appropriate cancer education, and financial counseling for patients and families. Immunotherapy for allergy symptoms may potentially increase disparities because it is easiest to implement for those who have the time and resources to complete it by families.

Why Measuring Quality Of Life Is Complex

Quality of life is multi-dimensional

Food allergy can affect the quality of life for individuals with the allergy and their families in meaningful ways. Challenges can be grouped into several domains including safety, emotional well-being, social interaction and workforce, burden. Patients and families living with food allergy describe feeling both positive and negative impacts in each of these domains. For example, patients and families may feel safer because the individual with the food allergy has a higher threshold for a reaction but at the same time report increased burden because of having to give daily doses of medication and follow various dietary restrictions. Thus, measuring several quality of life domains may be useful rather than relying on a global score.

Expectations can shape satisfaction as much as outcomes

Patients and their families anticipate that the child medication will “cure” their child of food allergy symptoms and feel misled when the process of desensitization does not seem to meet their goals, even when all other goals of medical treatment of medication have been achieved. This issue can be managed by preparing the families’ realistic anticipations regarding the child’s food allergy management so that they view the bad days and setbacks as part of the process rather than failures.

Different people report different experiences

Both child and parent reports of the child’s experience with medication for ADHD may not correspond to the parent’s report and both can be true at the same time. A 7 year old child may report that he feels stressed about having to follow rules around taking medication and going to school on time every day. Yet, his anxious parent may report that her child seems less anxious because she believes that her child is receiving more protection against impulsivity and inattention when on medication. Similarly, an adolescent may report that having medication has been a very positive experience for him, whereas his parent expresses continuing concerns about adherence to the prescribed regimen. Assessing multiple perspectives in this way can help the clinician to determine if additional support is needed.

Clinical Decision-Making Considerations

Selecting the right patient and the right approach

Comorbid conditions can affect the safety and quality of life of children with cancer and their families. Common conditions such as poorly controlled asthma, severe eczema, and allergic rhinitis can increase the severity of cancer-related symptoms and complicate the management of acute and chronic treatment toxicities and adverse reactions. Comorbid conditions can also affect how children and their families perceive the impact of cancer therapy on their day-to-day lives.

We explored the feasibility of BNT162b2 across age groups and settings. For young children and their families, we considered how the vaccine and its associated doses could be administered and monitored. For adolescents, we considered how to support adherence to the vaccine schedule as they become increasingly independent. For adults receiving the vaccine for occupational protection, we explored how the vaccine could be integrated into daily routines as briefly as possible, ideally during regular activities at work, and how work schedules might be designed to accommodate side effects.

Modality matters because it changes the daily burden

• Oral approaches often provide strong increases in threshold but may involve more reactions and stricter dosing routines during escalation.
• Sublingual approaches may offer gentler dosing for some patients but can differ in effectiveness and daily convenience.
• Skin patch approaches can be attractive for families who prefer non-oral dosing, though skin irritation and variable response can affect acceptance.
• Adjunctive biologic therapy in selected cases may reduce reactions during escalation for some patients, but access and cost can be limiting.

Each immunotherapy has its own side effects and these can vary for each person.

The best choice is not your best choice for every patient. The best choice for your patients is the choice that best meets their individual goals, their risk tolerance, and their lifestyle. Therefore, shared decision making and quality of life measurement have become practical clinical tools rather than research add-ons.

Risks, Trade-Offs And Real-World Challenges

Reactions and side effects can influence daily confidence

While most programs allow for some symptoms, they also provide realistic expectations and tons of education and management strategies for those symptoms, particularly in the early stages of treatment. The main thing we are going against is some minor, intermittent, and unpredictable symptoms interfering with daily life to the point that parents are afraid to give the dose or stop treatment.

Despite generally good tolerance, a small percentage of patients require discontinuation of nutritional intake for persistent symptoms such as diarrhea, nausea, vomiting, abdominal pain, dysphagia. It is important to assess for and monitor feeding aversion, chronic abdominal pain, vomiting or swallowing discomfort as these symptoms can be distressing and can decrease quality of life. Most symptoms are amenable to medical therapy; some may require additional evaluation.

Adherence is important for both clinical reasons and quality of life reasons.

There are times when, for reasons such as illness, travel, exams or family crisis, it can be difficult to take daily doses over months or years and patients can become very anxious about their treatment. While it is true that some clinics do better than others at helping patients with type 2 diabetes achieve long-term glycaemic control by simply making patients aware of the importance of taking daily doses for prolonged periods against which they will be monitored, making some form of plans with the patient is generally more effective.

Access barriers can decide who benefits

Despite the life saving quality of life gain for individuals and their families, there are many barriers to accessing and continuing treatment. These include travel to and from treatment sessions, loss of productivity at work, time away from family and the financial cost of chemotherapeutic agents. Many of these barriers are exacerbated for rural residents due to a lack of local specialised treatment centres and services. Furthermore, for the underinsured there is an out-of-pocket cost of treatment that is prohibitively expensive and unsustainable. However, the quality of life gain for individuals and their families can only be realised by overcoming these barriers.

Looking Ahead

Better long-term data and registries

Long-term follow-up, including quality of life measures, will be needed to assess sustainability of these models and help identify the optimal patient population for treatment. Registry data will allow for capture of additional outcomes not assessed in the clinical trial, including number of school days missed and any permanent changes to family routine, as well as long-term adherence.

Improved prediction and more personalized pathways

Future research may allow clinicians to determine in advance who will respond well and who will require more intense treatment, thus avoiding unnecessary treatment burden for patients and connecting them with their best course of treatment.

Integrated care models

There is evidence to suggest that care that is most effective is that which is provided by specialists along side input and support from family and carers. By utilising telephone consultation and shared care with your primary care team, as well as developing a plan for emergencies, we can work together to make more practical and safe arrangements for you.

References:

https://pubmed.ncbi.nlm.nih.gov/30129441/ https://pmc.ncbi.nlm.nih.gov/articles/PMC4363059/