Focus groups commenced approximately 4 months following the first public announcement of PCV in a rotavirus vaccine and approximately 2 months following the FDA recommendation to resume/continue rotavirus vaccinations. Results are presented in order of characteristics of the subjects, major respondent themes (pediatrician, parent, overarching), communication recommendations, and results of the pre-/post-focus group comparison of attitudes and opinions regarding rotavirus vaccines.
We conducted focus groups in three different regions of the United States (the West, Midwest, and Northeast). Table describes the characteristics of pediatricians (n = 45) (Table ) and mothers (n = 58) (Table ) participating in focus groups. Pediatricians had an average 15.4 years of experience (median = 15, range = 1-39) following residency, and most (62%) belonged to a private practice group. About one-third of the children enrolled by their pediatric offices were publicly insured and eligible for the Vaccines for Children Program, [19
] a federally-funded entitlement program providing vaccines at no cost to socioeconomically disadvantaged children. Most pediatricians solely administered RotaTeq™ (76%), compared with 4% who solely used Rotarix®
and 20% who reported using both vaccines.
Characteristics of pediatricians participating in focus groups by site.
Characteristics of mothers participating in focus groups by site.
More than 80% of pediatricians from all sites either strongly or somewhat agreed to the statement, "Before rotavirus vaccine was available, rotavirus was the most common cause of severe infectious diarrhea in children <2 years old in the US." About three-quarters (76%) strongly or somewhat agreed that rotavirus was responsible for more annual hospitalizations than influenza during the pre-vaccine era.
The average age for participating mothers was 33.2 years (median = 33.5, range = 21-44), and 76% had achieved more than a high school education. Most mothers (61%) reported being privately insured, compared with 33% having public insurance/Medicaid. The average household had 2.3 children, and most mothers (79%) had heard of rotavirus before the focus group.
Many pediatricians had negative memories of rotavirus infections and had observed a high burden of childhood disease from rotavirus gastroenteritis, as represented by common remarks included in Table . Those pediatricians who had the opportunity to observe rotavirus both during and after the pre-vaccine era understood firsthand the success of rotavirus vaccines in preventing severe pediatric acute gastroenteritis (Table ).
Examples of common comments from pediatricians regarding rotavirus disease.
Examples of comments from pediatricians regarding the post-licensure rotavirus vaccination period.
Overall, pediatricians reported that the mothers of their patients rarely hesitated to accept rotavirus vaccination. Specifically noted were reports that, "[Mothers] are willing to accept [rotavirus vaccine] when you say the virus gives horrible vomiting and diarrhea and it can last two weeks." As the vaccines are orally administered, pediatrician participants stated that many mothers do not count it among the injections recommended in the vaccination schedule.
At the time of the focus groups, most participating pediatricians had some prior knowledge that DNA material from PCV had been detected in rotavirus vaccines. When given detailed information on this topic, many seemed to intuitively measure the theoretical risks of PCV against the benefits they personally observed from rotavirus vaccination. Nearly every participating pediatrician expressed an opinion that the detection of DNA or DNA fragments from PCV in rotavirus vaccines was not clinically important, repeatedly using the term "non-issue." Particularly influential to this appraisal was that the published, large phase III randomized clinical trials that found both vaccines to be highly effective and safe were actually conducted with DNA material from PCV already in both vaccines. Respondents reported that, "Now I've learned that the particles have been there from day one, so if you believe the safety data on the vaccine itself then you believe that [the vaccine] is safe." Furthermore, many pediatricians found reassuring that PCV is not known to cause illness in humans, stating, "... [humans are] literally exposed to thousands of viruses every day and don't become ill." Since PCV material is likely consumed by many people in pork products without adverse consequences, many observed that, "...we are exposed to [PCV] in the pork we eat, and we're fine. So this is not our only exposure. It's not a new virus to us."
Given their general dismissal of any theoretical risk from DNA material from PCV in rotavirus vaccines, many pediatricians indicated that they would not devote time to explain the PCV finding, although many agreed that they would provide information to mothers who specifically queried them on the topic. Their general reluctance was rooted in three stated reasons: 1) DNA material from PCV in rotavirus vaccines did not constitute any risk, so the point was both moot and unduly alarming to the mothers, 2) discussion would be lengthy (and potentially non-reimbursable) and would compete with discussion of many other important clinically relevant topics, and, 3) many mothers would not fully understand the issue even with further elaboration.
While more than three-quarters of the participating mothers had at least some college education, many expressed a general lack of scientific and technical understanding of viruses, DNA, how vaccines are manufactured, and how vaccines work. Approximately one-fifth (21%) of the mothers reported unfamiliarity with the disease "rotavirus" and nearly none had prior knowledge of the PCV finding. One mother remarked, "I guess what all of this brings up for me is that I don't really understand what's in vaccines... it makes me feel like I want to understand more what a vaccine actually is, that this is what's happening... that there's a virus that somehow got in there that people didn't know about." Simplified information regarding PCV material in rotavirus vaccines seemed frightening, while detailed information was frequently overwhelming. "I don't know what the porcine circovirus is, so to me, this statement sounds like there's another virus present in the rotavirus vaccine. So, that would concern me." Stating that the vaccine was simply "safe" without providing evidence often brought further suspicion, exemplified by the comment, "When they say something is safe... well, it's the classic hedge. They don't have any evidence that it's not safe, which just means that they may not have studied it enough."
Mothers largely supported the ideal of transparency in being provided information regarding all vaccine risks and benefits. However, mothers often remarked that if they did not understand a medical or technical topic regarding their children's health they commonly relied on their pediatrician's guidance. Nonetheless, a few mothers mentioned that the detection of PCV material in rotavirus vaccines eroded their confidence in the vaccines (Table ).
Examples of comments from mothers regarding PCV materials found in rotavirus vaccines.
Many mothers and pediatricians expressed alarm that those who abstain from pork consumption for religious or personal reasons may have unsubstantiated fears that PCV is pig material (rather than the fact that PCV is a virus commonly found in pigs). Concern was most directed at whether parents of Jewish or Muslim faiths would reject the vaccines due to this misunderstanding. Some participants were similarly concerned that, due to its name, Porcine circovirus was somehow related to H1N1 influenza (a.k.a. swine flu) or illnesses of animal origin (e.g., bovine spongiform encephalopathy, a.k.a. mad cow disease) (Table ).
Examples of comments from pediatricians representing fears and concerns regarding PCV materials in rotavirus vaccines.
Pediatricians and some mothers cautioned that using the same acronym, PCV, for both Porcine circovirus and pneumococcal conjugate vaccine could cause confusion.
Vaccine Information Sheet (VIS) recommendations
Focus group participants indicated that a general statement should not replace further discussion between pediatrician and mother regarding the PCV finding. However, on the basis of themes elicited from focus group participants, the following paragraph was developed for the rotavirus vaccine information sheet (VIS) that is provided to all vaccinees:
"A virus (or parts of a virus) called porcine circovirus (PCV) is present in both rotavirus vaccines. There is no evidence that PCV is a safety risk or causes illness in humans, and these rotavirus vaccines have been shown to be safe and effective at preventing severe diarrhea. If you have questions, ask your doctor or visit http://www.cdc.gov/vaccines/vpd-vac/rotavirus
Nearly all pediatricians and mothers agreed that viewing VIS sheets for the first time during the office visit was inopportune. Some mothers acknowledged that the VIS was infrequently read at the health care visit, commonly stating, "By the time your kid actually gets the shot, you've waited in the waiting room, you've waited in the greeting room. You might have one, two, or three more older kids with you. They're all melting down, and of course, when they get their shots, then that's just horrible for everybody. So, how much of this [VIS] you might actually read right there, when you need to know it before you make a decision... not going to happen." Instead, being given this information in advance of the visit could provide mothers an opportunity to discuss the information with other caregivers and to research any concerns in advance of vaccination. Pediatricians generally remarked that they have limited time to discuss the vaccines or vaccine concerns at a well-child visit. Some pediatricians remarked that they proactively give VIS sheets as early as during the routine neonatal visits in order for parents to review future vaccinations in advance.
General communication perspectives
Mothers most frequently trusted the recommendations of their pediatricians. Pediatricians stated that they most trusted statements and medical alerts coming from the American Academy of Pediatrics (AAP).
Participants noted that websites of public health agencies and medical organizations should reflect relevant and updated information. Mothers emphasized that they should be referred to a specific webpage address with this information, not to a general agency or organizational home web address, to avoid difficulty in finding the correct material.
Several pediatricians using electronic medical records and automated information systems suggested that a few statements on the PCV finding be proposed that can be included in "dot phrase" information dissemination. "Dot phrases" are pieces of information that the health care provider can select to include in personalized information that can be provided during an office visit.
Results of Pre-/Post-test
Following the focus group discussion of rotavirus, rotavirus vaccines and PCV, pediatricians showed no statistically significant changes in their recommendation of rotavirus vaccines or in perceived barriers to vaccination. Nearly all pediatricians (98%) reported no change in their opinion to recommend the vaccines (P = 1.00). Also, no appreciable net change was observed among pediatricians who reported that parental concern with vaccine safety would be a barrier to rotavirus vaccination (26% reported vaccine safety to be an increased barrier, whereas 23% reported it to be a diminished barrier; P = 0.75). (Tables and )
Pre-focus group assessment results: Pediatricians and Mothers
Comparison of Pre- and Post-focus group questionnaires: Pediatricians and Mothers
Mothers, however, had more negative perceptions regarding the importance and safety of the vaccines and whether a subsequent baby would receive rotavirus vaccines. Roughly half of the participating mothers continued to feel confident that rotavirus vaccines are safe, while 37% changed their opinion to disagree with this statement. (P < 0.01) Following the focus group discussion, 16 of 52 mothers somewhat or strongly disagreed with the statement "If I had another baby, I would have that baby get rotavirus vaccine.", compared with 4 of 52 mothers stating this during the pre-focus group questionnaire. This indicates that 12 (23%) of 52 participating mothers changed their opinion on this issue following the focus group discussion. (P < 0.01) No significant change was observed regarding parental confidence that rotavirus vaccine prevents severe diarrhea (Tables and ).