Do parents really understand what they read when they are given a Vaccine Information Statement (VIS)? Can they even read it?
According to Pediatrics in 1996:
(Parent comprehension of polio vaccine information pamphlets.) *bolding ours
BACKGROUND. Medical information pamphlets often are written using language that requires a reading level higher than parents of many pediatric patients have achieved. Anecdotal reports suggest that many parents may not readily understand the federally mandated Public Health Service vaccine information pamphlets prepared by the Centers for Disease Control and Prevention (CDC) in 1991. The level at which the pamphlets need to be written for low-reading-level parents is undetermined, as is whether parents reading at higher levels will accept low-reading-level materials.
CONCLUSIONS. A short, simply written pamphlet with instructional graphics was preferred by high- and low-income parents seen in private and public clinics. The sixth grade reading level appears to be too high for many parents in public clinics; new materials aimed at third to fourth grade levels may be required. The new 1994 CDC immunization materials, written at the eighth grade level, may still be inappropriately high. The American medical community should adopt available techniques for the development of more effective patient-parent education materials.
Then in 1998 according to Patient Education and Counseling:
(A polio immunization pamphlet with increased appeal and simplified language does not improve comprehension to an acceptable level.)*bolding ours
We used a randomized trial to compare two polio vaccine pamphlets written on a sixth grade level–the vaccine information statement prepared by the Centers for Disease Control (CDC) and an easy-to-read pamphlet we developed (LSU)–for reading ability, comprehension and preference among 610 parents with a broad range of demographic characteristics. Parents at all reading levels and incomes preferred LSU (76% vs. 21%, P < 0.001). Although readers of LSU achieved significantly higher comprehension (65% vs. 60%, P < 0.05) this difference may not be clinically significant. The information items presented with instructional graphics were the only items on which differences in comprehension levels achieved both clinical and statistical significance. Comprehension was lowest for the CDC mandated information on risks and the National Injury Compensation. Our findings demonstrate that simplifying written immunization material and making it more suitable will increase appeal, but such modification may not raise comprehension to an acceptable level without use of instructional graphics. Health education materials intended for general parent populations, which are written on a sixth grade reading level, may not adequately educate parents or prepare them for a discussion with their physicians.
Examples of current VIS’s are here. Most have been rewritten in the last year. In my opinion, they appear to be written at or just below the 6th grade reading level. Essentially, it appears nothing has changed.
Again, I must ask the question; are these truly informed consent? Take a look at this newer Vis on multiple vaccines. The VIS describes the diseases and the individual vaccines, but does not go in depth into the multiple vaccine brand given and what the ramifications of what EACH of those multiple vaccines could be, and they ARE different. Pentacel is not Pediarix and can not be assumed to have the same adverse reaction(s).
I must also address the following excerpt stated in Pediatrics. (Parent comprehension of polio vaccine information pamphlets, 1996 Jun; 97(6 Pt 1):804-10, pg.809.) *bolding ours
“Pamphlet authors should determine the key points that the patient (or parent) needs to know to achieve the behavioural objective. Non-essential concepts can then be deleted. The key is to write for the desired health behaviour, rather than for high-level knowledge.”
How is that true informed consent if they are leaving out key points that people SHOULD know about? This excerpt alone shows you how the medical establishment is not going to give patients all the information needed to assess whether vaccination is in the best interest of the individual. Vaccine Information Sheets have simply become a manipulation tool to get patients to do what the medical establishments want.
Also see:
Tips for creating easy- to- read print materials your audience will want to read and use
Informed Consent For Clinical Trials
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Vaccine Information Statements-True Informed Consent or Something Else?
