Parental Perceptions of Penicillin Allergy Risk Stratification and Delabeling

Focus groups were conducted to ascertain themes from parental experiences with PCN allergies and their perceptions of the allergy risk stratification and delabeling process. Parents of children with a PCN allergy label discharged from a large academic children’s hospital between January 1, 2019, and April 15, 2020, were eligible for recruitment if they were English-speaking, had a child admitted to a Pediatric Hospital Medicine service, and were available to attend a focus group. Adolescent patients were encouraged to participate with their parents, when possible, to provide their own perspectives and experiences. Parents of children discharged from the hospital with PCN allergy were contacted by a research assistant to determine willingness to participate in the focus group. A sequential sampling strategy was used to recruit participants. Among participants in the focus groups, 1 parent had a child who underwent and passed an oral challenge during their hospitalization. Parents were encouraged to bring their children to the focus group for participation and children of appropriate age were assented. The study was approved by our Institutional Review Board (IRB #200251).

A master’s-level expert from the institution’s qualitative core, with training specific to focus groups and 1-on-1 interviews, was the focus group moderator. A moderator’s guide (Supplemental Fig 2) was developed and iteratively refined to include open-ended questions with prompts to stimulate further discussion. Brief information regarding penicillin allergies was presented. Initial questions consisted of past experiences with PCN allergies, allergy testing, and worries and concerns around antibiotic allergies. The moderator then presented general information on PCN allergies and the PCN delabeling process, including an amoxicillin oral challenge if the child screens as low-risk for true PCN allergy. This information is similar to that given to families when initiating the delabeling discussion in a clinical setting. The “invitation to delabel” was defined as a provider discussing the delabeling process with the family and contained information on the delabeling process, the PCN allergy risk-stratification questionnaire, and the delabeling setting options (outpatient clinic or hospital). Parents were informed the dose used and length of observation can also be varied. After viewing the presentation, parents were asked to discuss their impressions of the information and their willingness to have their child’s PCN allergy reevaluated. Participant recruitment was discontinued when thematic saturation was achieved, defined as consensus agreement of no new emerging themes during the focus group sessions. Thematic saturation was achieved after completion of 5 focus groups consisting of 21 parents and 2 adolescents. The adolescents were 12 and 16 years of age and did not contribute significantly to the discussion. For 1 focus group, only a single parent was able to participate. Because of the COVID-19 pandemic, focus groups were conducted and recorded using Zoom. Audio from the Zoom recordings was transcribed by an IRB-approved transcription service (Rev.com)

Qualitative data coding and analysis was managed by our institution’s Qualitative Research Core. A hierarchical coding system was developed and refined using the focus group moderator’s guide and a preliminary review of the transcripts (Supplemental Table 5). We identified 15 major categories (Supplemental Methods).

Two experienced qualitative data coders first established reliability of the coding system on 3 focus group transcripts. The results were compared, and any discrepancies were resolved through a reconciliation process. The coders then independently coded the remaining 2 transcripts. Each statement was treated as a separate quote and could be assigned up to 13 different codes. The coded transcripts were combined and sorted by code. All transcripts were managed with Excel 2016 and SPSS version 27.

Qualitative analysis was conducted using an iterative inductive and deductive approach, resulting in a theoretical framework (Fig 1).^9,10  Deductively, we were guided by Social Cognitive Theory and the Health Belief Model, as both help describe psychosocial behaviors, beliefs, and health decision-making.1,¹ –1 ⁴  Inductively, we sorted the quotes by coding category to identify higher-order themes and relationships between themes. The process was iterative in that the framework is theoretically informed, although the framework content is derived from the qualitative data.

Figure 1 presents the theoretical framework created from the qualitative analysis. There are 4 major interconnected themes represented in the framework: (1) family context, (2) invitation to delabel, (3) decision context, and (4) the decision outcome. This framework captured most of the discussion around the process of working with a family to undergo the process of delabeling a child who is found to be low risk for a true PCN allergy.

The framework demonstrates that the decision to engage in the delabeling evaluation is representative of the individual circumstances and perspectives of the family and programmatic context of the delabeling process.

The health history described the knowledge and past experiences of the parents regarding their child’s allergy label and their history with the health care system. Allergic reactions varied in frequency and severity. Parents had firm beliefs and expectations about the motives, trustworthiness, and competence of the healthcare system and providers. Most parents were convinced that their child had a past allergic reaction to penicillin. For example, “It’s not just 1 antibiotic, it’s several antibiotics. She has a horrible reaction; the rash is from any normal antibiotic” (Caregiver 3, Group 2). Some parents had previous positive experiences with allergy testing protocols. “We did it and were extremely happy we did do that” (Caregiver 2, Group 2) (see Table 1 for additional quotes).

When the invitation to delabel and delabeling protocol was presented, it was common for families to resist the idea of having their child tested for delabeling. For example, “Could it affect the breathing? That would be my first… If she has a reaction, could it affect her breathing?” (Caregiver 1, Group 3) (Table 2).

There were 2 subthemes identified during the invitation to delabel: patient education and overcoming resistance. The brief presentation given during the focus group was not sufficient to convince several parents that their child was eligible for a PCN allergy evaluation. Many parents believed their child’s PCN allergy to be permanent and did not know that you can “outgrow” an allergy. When presented this information, families were more open to PCN allergy evaluation. After hearing the presentation, one parent said, “Why would 95% of kids be flagged? … I would probably want to have an answer to that. But, are we willing to test for it? Yeah. I would, absolutely (Caregiver 1, Group 1).” Parents described experiences with shared decision making, reflected on ways they might agree to testing, and discussed including their child in shared decision making. For example, “I just want to do what’s best for her. And I’m always open to suggestions. … I’ll talk it over with the pediatrician” (Caregiver 1, Group 2). Table 3 provides quotes related to overcoming resistance.

The fourth major theme is the decision process (Table 4) and consisted of 3 main elements: attitudes and beliefs, perceived benefits, and thoughts and emotions. Specific parental attitudes and beliefs that may influence the decision to agree to allergy testing and delabeling included trust in the provider, sense of control, perceived severity of an allergic reaction, and the child’s perceived susceptibility for a reaction. For example, one parent talked about trust, “I trust that we have the information that we need and we have good doctors that help us make the best decisions and we trust them” (Caregiver 2, Group 2).

Parents also considered the anticipated benefits that might come from delabeling the child, which included less worry, more treatment options, improved quality of life, and lower cost: “It would be really nice to have that off of my list of worries, and it would also be nice for her to have a stronger option for when she does get ear infections or something” (Caregiver 1, Group 3).

There were both positive (relief) and negative (anxiety) emotions associated with the decision-making process. Anxiety about the child’s allergies or about the safety of the testing protocol make it harder for parents to choose to be tested. This parent voiced anxiety about her child’s allergies, “I would like it if she could take penicillin. I mean, it would make everything easier for her. I’m just so terrified, especially with her being so little” (Caregiver 1, Group 3). Another parent talked about feeling encouraged after her child was tested and delabeled, “Hey, this is a win. So, I remember just being encouraged by that” (Caregiver 1, Group 5).

One parent voiced general uncertainty about information from providers she did not know well, “I think that we live in a very confusing world when it comes to information, and that it is hard to trust things that you’re being told. Especially if they didn’t have a relationship with you previously” (Caregiver 1, Group 5). This mother had a child with complex medical needs and expressed a need to stay vigilant, “… because she’s so little. She doesn’t know what she’s allergic to, so you have to really be on your toes” (Caregiver 1, Group 3).

Finally, a family will decide whether to engage in the delabeling process and undergo an oral challenge. Several parents stated that they would need to have more information or their specific questions answered before they could commit to testing. For example, “And I think there’d have to be some good reasons to do it. I wouldn’t just do it for no reason because there’s plenty of antibiotics to choose from in this world and I don’t feel like in their situation that it’s really necessary” (Caregiver 2, Group 2). Others were convinced that testing was not worth the risks for their child. This parent was clear that testing was out of the question, “We just keep it marked as allergic, and they just try to avoid the conversation when I tell them, “We’re not attempting. There are no attempts” (Caregiver 2, Group 1). Additional relevant quotes are presented in Supplemental Table 6.

In our qualitative study of adolescents and parents of children with PCN allergy labels, we developed a theoretical framework with which to better understand parental perceptions of PCN allergies and the delabeling process. In general, we found that the presence of a prior perceived allergic reaction leads to a cycle of concern that is maintained by repeated interactions with the health system and the development of behaviors resistant to change. In response to a potential allergy evaluation to remove the PCN allergy label, there are factors that push parents to resist change as well as pivotal opportunities to pursue allergy testing and subsequent delabeling. Medical urgency, need for antibiotics, perceived benefits, and perceived harms of the allergy label are likely areas that can be targeted during implementation efforts to increase the frequency of amoxicillin oral challenges and delabeling in low-risk patients.

Some parents felt dismissed by the healthcare system when communicating about their child’s allergy symptoms and being told the symptoms were not an allergy or potentially not clinically serious. There was skepticism concerning the accuracy of, and reason to, undergo an allergy evaluation. Some parents expressed disbelief when informed that up to 95% of children with a PCN allergy label can safely take a PCN antibiotic, perhaps feeling like this information directly dismissed their experience. Further study will be critical to determining the optimal way to present allergy delabeling information to families.

Parents had strong feelings regarding which providers and healthcare settings they trusted to perform a PCN allergy evaluation. Some preferred their pediatrician or immunologist, whereas others preferred an emergency department physician because of their experience with medical emergencies. Although most PCN allergy evaluations are performed in the clinic setting, some parents felt the hospital would be a safer location. This finding supports ongoing efforts to buoy penicillin allergy delabeling efforts in children’s hospitals and also emphasizes that more work is needed to address parental concerns about PCN allergy testing and delabeling.^6,15 

We identified 2 important subthemes in overcoming resistance to PCN allergy evaluations and delabeling of low-risk patients that can be leveraged in future efforts to bolster PCN allergy delabeling: parent education and shared decision-making, in which parent and providers work together to potentially select a treatment plan. For example, our study found that many parents believed their child’s PCN allergy to be permanent and did not know an allergy could be “outgrown.”^16,17  When presented this information, families were more open to PCN allergy evaluation. Many participants were also not aware of the negative consequences of inaccurate labels and, when informed of higher healthcare costs and more resistant infections associated with PCN allergy labels, families were more open to PCN evaluation. Families were also open to PCN allergy evaluation when their medical condition necessitated PCN antibiotics and preferred a shared decision-making model when making antibiotic decisions. Parents of children with medical complexity were particularly open to shared decision-making and discussion with multiple providers, especially in the setting of immediate need for a PCN antibiotic. These findings are similar to survey studies in adults with PCN allergy labels, which also reveal that patient education can increase willingness to undergo an amoxicillin oral challenge.¹⁸  Although further study is needed to develop methods to best present allergy information to families, these findings suggest that improved parental education and shared decision-making of delabeling decisions are critical to creating buy-in from families.

Studies have demonstrated that a PCN allergy label is often added to a patient’s chart despite minimal or no exposure to a PCN antibiotic. For example, in one study, almost 10% of children were labeled as penicillin-allergic despite never receiving a PCN antibiotic and half of patients with a PCN allergy label had received 1 or fewer PCN prescriptions.²  In our study, we found a strong anchoring to the original allergy diagnosis and, subsequently, parental resistance to information about the accuracy of the PCN allergy label. Our finding that, even after passing an oral challenge some parents would continue to avoid PCN, highlights the deep imprinting that a negative PCN experience can have on a family. Future efforts may be wise to focus on labeling prevention in addition to removal.

One limitation of our study is that it was conducted at a single academic children’s hospital and results may not be transferrable to other settings. Another is the limited involvement of patients; our focus groups primarily consisted of parents with only 2 adolescents participating. It is possible that children and adolescents with PCN allergy labels may have differing viewpoints from their parents. Third, as we only included English-speaking patients in our study and did not collect demographic or allergy reaction information, there may be language or cultural factors that were not captured. Evaluation of trustworthiness across focus groups, such as performing member checking or triangulation, was not performed. Finally, we relied on parent memory of allergy reactions and emotions so findings may be subject to recall bias.

Despite these limitations, the parent and patient voices proved to be vital to the development of effective interventions aimed at safely removing inaccurate PCN allergy labels. Our theoretical framework highlights the key characteristics of parental perceptions and beliefs regarding PCN allergy in the delabeling process. These findings could inform future efforts to develop hospital-based delabeling interventions. Additional work is needed to prevent inaccurate index allergy labels and relabeling of allergies after the delabeling process.

Parents are amenable to hospital-based PCN allergy evaluation and delabeling, although PCN allergies remain a concern for some families even if their children pass an oral challenge. Further study is needed to develop methods to best present allergy information to families and implement safe and effective PCN allergy delabeling processes in the hospital setting.