Abstract
Objective
Parents’ concerns about vaccine safety and side effects likely contribute to low rates of human papillomavirus (HPV) vaccination among adolescents. To facilitate parent-provider discussions about the HPV vaccine, we developed and tested the content of a clinical decision support application for implementation in pediatric clinical settings. This study sought to elicit perspectives of parents and providers on the best way to communicate information on vaccine side effects.
Methods
To understand the acceptability of the application’s content, we conducted focus groups with parents (n=11) and providers (n=9) at three primary care clinics. Focus groups transcriptions were analyzed using iterations of deductive and inductive coding, with independent coding by two trained reviewers to improve inter-rater reliability.
Results
Surprisingly, when parents reviewed screen shots of HPV vaccine safety and side effect messages, parents took exception to the expression “no evidence of serious side effects.” Parents wanted side effects listed explicitly so they could decide for themselves which side effects were “serious.” Parents also felt that the HPV vaccine did have serious side effects, and the wording undermined their trust in the vaccine messaging overall. Providers accepted the phrasing of side effects and did not express concerns that parents would object to the messaging.
Conclusions
Further research is needed to confirm parents’ concerns with the phrasing “no serious side effects” for the HPV vaccine and to assess the impact on HPV vaccination deferral or delay.
Significance
Parents’ concerns about vaccine side effects are important predictors of vaccinations, and likely contribute to low rates of human papillomavirus (HPV) vaccination. Vaccine Information Statements developed by the Centers for Disease Control and Prevention (CDC) include specific language for HPV vaccine side effects. However, less is known about parent acceptability and understanding of this communication strategy. This study found that parents of 11- to 12-year-olds considered language qualifying the severity of HPV vaccine side effects (e.g., “mild” and “severe”) to be unclear and potentially misleading. To encourage vaccine uptake, messaging of side effects should account for parents’ concerns and perspectives.
Keywords: human papillomavirus (HPV) vaccine, side effects, focus groups, communication
Introduction
In the United States, parents’ concerns about vaccine safety and side effects likely contribute to low human papillomavirus (HPV) vaccination rates: 40% of girls and 58% of boys 13 to 17 years old have not received any of the two to three recommended doses (Staras, Vadaparampil, Patel, & Shenkman, 2014; Walker et al., 2019). Although only 10% of parents delay or refuse any childhood vaccines, parents’ concerns about vaccine side effects are important predictors of vaccinations (Frew et al., 2016; Kennedy, LaVail, Nowak, Basket, & Landry, 2011; P. J. Smith, Humiston, Parnell, Vannice, & Salmon, 2010; Staras et al., 2014). The National Childhood Vaccine Injury Act of 1986 mandated that providers give parents the Vaccine Information Statements (VIS) from the Centers for Disease Control and Prevention (CDC) when administering vaccines to children to provide parents with accurate information about the risks and benefits of vaccines (M. H. Smith, 1988). Congress mandates specific content and review processes for the VISs and challenges exist in balancing the legal requirements and user preferences (U.S. Department of Health and Human Services, 2016). The VISs present side effects for most vaccines, including the HPV vaccine, as “mild,” “moderate,” or “serious”. (Centers for Disease Control, 2018). Specifically, the HPV VIS says: “Most people who get HPV vaccine do not have any serious problems with it.” Yet, parent acceptability and understanding of this communication strategy is unclear.
We developed an electronic parent and clinician decision support application (app) to help improve parent and provider communication about adolescent vaccinations. Our main objective is to increase the low rates of HPV vaccination among 11- to 12-year-olds. To understand the acceptability of our app’s content about the HPV vaccine, we shared selected screens from the app and elicited reactions from parents and providers of 11- to 12-year-old patients at three primary care clinics. While the study addressed many attributes of content and design, because of parents’strong and surprising perspectives, this paper focuses on parents’ and providers’ reactions to a statement adapted from the CDC VIS that the HPV vaccine has “no serious side effects.” Appreciation of parents’ interpretation of vaccine side effect messages, alongside clinicians’ perceptions of important information for parents, may facilitate development of more acceptable and effective vaccine messages.
Methods
We recruited six clinics from the OneFlorida Research Consortium to participate in a feasibility trial of our app. We focused recruitment on clinics that provided vaccinations in-house and had HPV vaccine initiation rates among 11- to 12-year-olds that were under the 2014 state average for 13-to 17-year-old girls (57.2%).(Reagan-Steiner et al., 2015) Stratifying by geographic area, we randomly assigned three clinics to immediate intervention and three to delayed intervention.
Between December 2016 and May 2017, we conducted parent and provider focus groups to evaluate the acceptability of the app’s content and design at the three clinics assigned to immediate intervention. All providers at each of the three clinics participated in Vaccines for Children – a federal program that funds vaccines for low-income children. In summer 2016, participating clinics reported that 14–90% of their patients received Medicaid insurance; between 300 and 600 11- to 12-year-olds visit the clinics annually; and 6–44% of 11- to 12-year-olds had received at least one dose of the HPV vaccine. Clinics were independent, affiliated with academic institutions, or integrated with health systems.
Because the app is targeted to all parents, any parent whose 11- to 12-year-old child had visited the clinic in the past year, regardless of vaccination history, was eligible to participate. We used two methods to recruit parent participants. First, as parents came for their child’s appointment, clinic staff gave parents a flyer and invited them to receive a follow-up call from study staff. Second, clinic staff called parents to explain that the clinic was conducting focus groups and asked permission to connect the parent to study staff. Parents who agreed were immediately connected to study staff who explained the purpose of the study and invited them to participate. All clinic providers who saw 11- to 12-year-olds were invited to participate. Participants received a meal and $20 cash. The Institutional Review Board approved this study.
During the focus groups, participants were shown select screens of the app and asked for their impressions following an interview guide administered by two trained moderators. All sessions were conducted in English. The app has separate parent and provider interfaces; thus, screens and moderator guides were different for parents and providers. In the first focus group, providers were guided through the app to the appropriate screens. Yet, because of the time spent on technical features (e.g., log-in, navigation), in all subsequent groups, we used paper screen shots to maximize the time spent discussing the app content and design. Each participant completed a demographic survey that did not include information on vaccinations.
Parent focus groups started with a video depicting a parent using the app in a clinic. After discussing overall impressions, parents were directed to a series of screen shots beginning with a list of reasons a parent may be hesitant about the HPV vaccine: safety, side effects, HPV infection risks, efficacy, and cost (Staras et al., 2014). For each topic, parents were shown a screen shot with educational information and navigation buttons to additional content. Screen shots included information on safe vaccine ingredients, frequency of mild and short-term effects, sometimes HPV infections cause cancer, vaccine protection lasts at least 10 years, HPV infections have decreased since the release of the vaccine, and HPV vaccine is free with health insurance and at some providers. Vaccine safety and side effect messages included the phrase “no serious side effects,” and did not list specific side effects (Figure 1). For each screen shot, parents were prompted to share their impressions overall and regarding clarity, content, and format.
Figure 1 top.
Parent Screen Shots including the phrase “no evidence of serious side effects”
Provider groups also started with a video of a parent using the app. Next, providers were shown screen shots of the app including tables of possible parent-selected topics with tailored discussion tips. The terminology “no serious side effects” was included in the discussion tips for vaccine safety (Figure 2). Providers were asked for their overall reaction, unhelpful tips, missing information, and formatting. At one clinic, the two providers were not available at the same time. Thus, these two providers completed semi-structured interviews.
Figure 2 top:
Provider Table Showing Parent Safety Hesitations and Discussion Tips
Sessions were audio recorded and transcribed for analysis with Nvivo 11. Two trained coders, with input from the principal investigator, reviewed transcripts and developed the codebook following iterations of deductive and inductive coding (Glaser & Strauss, 2017; Hsieh & Shannon, 2005). To improve inter-rater reliability, the coders met regularly to review coded transcripts and reach consensus on new codes and code definitions. Transcripts were back-coded to accommodate new themes that emerged during the course of coding.
Results
Across the three clinics, 165 parents were approached to participate, 71 refused, 68 were not reached, and 2 did not speak English. Among eligible parents who could be reached (N = 95), 24 agreed to attend the focus groups (25.3%) and 11 participated (11.6%). Participation rates were higher following phone calls (9/60 = 15%) than clinic visits (2/35 = 6%). At each of the three clinics, we conducted one parent focus group (group sizes = 3, 3, and 5) that lasted from 60 to 90 minutes. Among all focus groups, parents had either one or two children in their home who were 11 to 18 years old and were diverse by race/ethnicity, age, education, and marital status (Table 1). At each clinic, all providers participated in a focus group (group sizes = 3 and 4) lasting between 30 to 45 minutes or an individual semi-structured interview (n=2) lasting 15 minutes. Providers were female (100%), primarily pediatricians (60%), mostly between 30 and 50 years old (80%), and from diverse racial and ethnic backgrounds (30% Black, 20% White, 20% Asian, and 10% Hispanic).
Table.
Characteristics of parents participating in focus groups
| Number | Percentage | |
|---|---|---|
| Total | 11 | |
| Marital status | ||
| Married or living with partner | 6 | 54% |
| Single or never married | 5 | 45% |
| Highest level of school completed | ||
| Some high school | 1 | 9% |
| High school graduate or GED | 3 | 27% |
| Some college | 3 | 27% |
| College graduate or beyond | 4 | 36% |
| Age (years) | ||
| 30–33 | 3 | 27% |
| 34–37 | 2 | 18% |
| 38–40 | 1 | 9% |
| 41 or older | 5 | 45% |
| Number of 11- to 18-year-olds living in home | ||
| 1 | 6 | 54% |
| 2 | 5 | 45% |
| Gender of 11- to 18-year-olds living in home | ||
| Boys | 5 | 45% |
| Girls | 3 | 27% |
| One boy and one girl | 3 | 27% |
Surprisingly, while not specifically directed to the wording of side effects, when first shown the safety screen (Figure 1), parents in all three groups took strong exception to the expression “no evidence of serious side effects.” None of the parents responded positively to the side effect phrasing. Parents in all three groups stated they wanted side effects listed explicitly. Parents generally found the term “serious side effects” to be ambiguous, and preferred to decide for themselves which side effects are “serious.” One parent stated:
“Maybe list the side effects instead of saying ‘no serious side effects.’ List them and I can be the judge of what’s serious.”
Two themes emerged that may explain parents’ attitudes toward side effect wording. First, several participants remarked that the severity of side effects was relative to the needs of the individual child. What is a mild side effect for one child may be serious for another. For example, one parent noted that headaches would be a serious issue for his child:
“My son suffers from migraines. So, if I’m going to give him a vaccine that might cause mild headaches…. and then, if he was having a side effect from the vaccine… I’m thinking, ‘Oh, it’s just his migraines. His migraines have picked up.’ And I’m not putting it together.”
Second, participants in two parent focus groups questioned the trustworthiness of the statement “no evidence of serious side effects.” In one case, a parent felt the statement of “no evidence of serious side effects” was incorrect. She had researched the HPV vaccine online prior to participating in the focus group and cited a federal lawsuit that was filed because of “serious risks of this shot that weren’t disclosed to parents.”
“I feel like they’re lying to me, for lack of a better thing. Already I distrust them because there are serious side effects, and I should, as a parent, be able to make that decision. And to say there are no serious side effects, you’re taking that decision away from me. And so I would right away feel like nothing that I read here I can trust.”
Additionally, a few parents attributed their lack of trust to issues of data transparency. Parents expressed a preference for sources of information to improve the overall credibility. As one parent suggested:
“Just give us the wording, but give exactly where this information is coming from… Make us believe it.”
In contrast, there was limited discussion from providers on side effects wording as they were readily accepting of the supplied information and felt parents would be too. When prompted for feedback on the provider table (Figure 2), providers shared largely positive feedback on the content. Providers at two sites made comments directly relevant to the wording of side effects. One provider even highlighted the importance of mentioning there is no evidence of serious side effects to parents by saying:
“I would lose them probably after discussing serious side effects and saying there’s no evidence… Most parents I think would make their decision based on that.”
Discussion
Surprisingly, in focus groups reviewing parent-targeted messages about the HPV vaccine, parents of 11- to 12-year-olds had strong negative reactions to the phrasing of “no serious side effects.” In contrast, the providers at these same clinics readily accepted the phrasing “no serious side effects” and even highlighted it as important to parents. This strong negative parent reaction and the apparent lack of provider awareness of a potential issue with the message calls for additional research on parents’ reactions, the influence of these reactions on vaccination, and potentially alternative phrasing.
The parents’ expressed concerns with standard methods of communicating the side effects of vaccines is consistent with prior findings. Similar to a recent review for childhood vaccines (Ames, Glenton, & Lewin) parents wanted more information to personally weigh the benefits and harms and questioned the information’s trustworthiness. Additionally, our results complement a prior study that found parents were concerned about side effects considered mild by healthcare professionals (Shui, Kennedy, Wooten, Schwartz, & Gust, 2005).
The contrast between parents’ and health care providers’ reaction to the phrase “no serious side effects” is especially meaningful because providers play a major role in parents’ decisions to vaccinate (Gilkey et al., 2015; Philip J. Smith, Kennedy, Wooten, Gust, & Pickering, 2006), but understand vaccines through a different lens. Health care providers and medical organizations use the term “serious” to describe death, life threatening illness, hospitalization, disability or permanent damage, or other urgent conditions requiring medical intervention (U.S. Food & Drug Administration, 2016). Yet, parents appeared more likely to apply a non-medical definition of “important or dangerous,” and therefore, found the term “serious” ambiguous and less informative.
This study has important limitations. First, our assessment of thematic saturation was limited by the small number of participants (11 parents and 9 providers); a result of the pragmatic choice of one parent and one provider group at each of three clinics to aid development of a pilot intervention. Second, the interviews with individual providers may not have generated the same depth of qualitative data as the originally planned focus group since the interviews were of shorter average duration (15 minutes) than the provider focus groups (30–45 minutes).
Our focus on HPV vaccination messages in clinics with low rates of HPV vaccination is a strength of this study. While findings may not be applicable to other vaccines or to clinics with higher HPV vaccination rates, for qualitative inquiry the selection of clinics allowed us to explore perceptions of parents in depth.
While the statement “no serious side effects” is clinically meaningful, standardly used, and intended to alleviate parents’ fears, parents may interpret this statement as ambiguous and lacking in trustworthiness and transparency. Without further research, it is difficult to ascertain whether the participating parents’ opinions are widespread or modified by the social dynamics at play during focus groups.(Lehoux, Poland, & Daudelin, 2006) Yet, this hint of parents’ distaste for side effect severity qualifiers deserves further exploration into whether parents consider specific side effects serious and how influential vaccine side effect messaging is on vaccine receipt. Understanding the perspectives of parents in various contexts regarding new and existing vaccine resources is an essential component of effective vaccine communication. Parents’ trust of vaccine messages may be increased by rephrasing qualifiers of side-effect severity or only listing possible side effects.
Acknowledgements:
Research reported in this publication received financial support from the National Cancer Institute R21 CA202011 (S. Staras) and the OneFlorida Clinical Data Network, funded by the Patient-Centered Outcomes Research Institute #CDRN-1501–26692, in part by the OneFlorida Cancer Control Alliance (funded by the Florida Department of Health’s James and Esther King Biomedical Research Program #4KB16), and in part by the University of Florida Clinical and Translational Science Institute (supported in part by the NIH National Center for Advancing Translational Sciences under award number UL1TR001427). The content is solely the responsibility of the authors and does not necessarily represent the official views of any listed sponsor. The authors thank the focus group moderators: Mr. Esaa Samarah and the Florida State University Clinical Research Network team (Ms. Michelle Vinson, Ms. Lori Drum, and Ms. Jenn Mauck).
Footnotes
Publisher's Disclaimer: This Author Accepted Manuscript is a PDF file of an unedited peer-reviewed manuscript that has been accepted for publication but has not been copyedited or corrected. The official version of record that is published in the journal is kept up to date and so may therefore differ from this version.
The authors report no potential conflicts of interest.
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