2012 UPDATED CHAPTER J:ADDRESSING HEALTH LITERACY(Original Title: Using Plain Language)

SECTION 1:
AUTHORS/AFFILIATIONS
Kirsten McCaffery (co-lead)

University of Sydney

Australia

Stacey Sheridan (co-lead)

University of North Carolina

USA

Don Nutbeam (co-lead)

University of Southampton

UK

Marla Clayman

Northwestern University

USA

Karen Kelly-Blake

Michigan State University

USA

Margaret Rovner

Michigan State University

USA

David Rovner

Michigan State University

USA

Sian Smith

University of Sydney

Australia

Mike Wolf

Northwestern University

USA

NOTE
The original title for this dimension (“Using Plain Language”) is now considered inadequate tocapture the interface between health literacy and decision aids. While plain language
presentations of the information within decision aids is still critical, skills-based conceptions ofhealth literacy provide important insight into the need for decision aids to address individuals’
variable cognitive and social skills as they clarify values and interact with the health system toachieve the best health outcomes.
Therefore, this updated dimension chapter presents entirely new sections regarding definition,
theoretical rationale, evidence base, and references.
The original dimension chapter is included here as an Appendix.

Suggested citation:
McCaffery K, Sheridan S, Nutbeam D, Clayman M, Kelly‐Blake K, Rovner M, Rovner D, Smith S, Wolf M. (2012) Addressing Health
Literacy. In Volk R & Llewellyn‐Thomas H (editors). 2012 Update of the International Patient Decision Aids Standards (IPDAS)
Collaboration’s Background Document. Chapter J. http://ipdas.ohri.ca/resources.html.

Addressing Health Literacy
SECTION 2:
CHAPTER SUMMARY
What is this quality dimension?
Health literacy is at its simplest the “capacity to obtain, process and understand basic
health information and services needed to make appropriate health decisions”. Broader
definitions extend beyond reading and writing skills (functional health literacy) to include
communicative and social skills (interactive/communicative health literacy) and advanced
literacy, cognitive and social skills to analyze information and make informed decisions (critical
health literacy). We propose that each of these forms of health literacy is required for patients toeffectively use decision aids. Attending to these levels of health literacy in decision aid design,and supporting consumers not only to read and understand decision aids but also to have theconfidence to communicate with health professionals and their families, to negotiate decisions,and to think critically in order to make an informed decision, is an important objective in PtDA
development.
What is the theoretical rationale for including this quality dimension?
A large proportion of people living in developed countries have inadequate healthliteracy. It is particularly common among the elderly, ethnic minorities, and sociallydisadvantaged populations. These same populations experience higher rates of preventabledisease and poorly managed chronic disease and engage frequently with the health system.
Lower health literacy is independently associated with poor health across a wide range ofoutcomes. Health information including PtDAs needs to be designed so that it is appropriate forthe health literacy levels of the majority of consumers for whom it is prepared. A person’s ability
to effectively use a PtDA will be determined both by their health literacy skills and the quality
and suitability of the PtDA.
What is the evidence to support including or excluding this quality dimension?
We reviewed several sets of evidence related to this dimension: 1) evidence on the effectsof health literacy on decision making outcomes, including knowledge, values clarity, and patient
involvement; 2) evidence on the effects of interventions designed to mitigate the effect of low
health literacy on decision making outcomes; and 3) evidence on whether decision aids address
low health literacy and are tested in low literacy populations.
In an existing systematic review, we found evidence from 14 out of 16 trials that lower
health literacy is associated with lower patient health knowledge. In a review that we conducted,
no studies reported on values clarity per se, but two reasonable-quality studies showed that low
health literacy is related to higher decisional uncertainty and regret. Three studies showed thatlower health literacy was associated with lower desire for involvement in decision making, 2
showed it was related to lower question asking, and 3 with adjusted analyses found that it was
related to a lower patient centered communication process. The effects of low health literacy onother measures of patient involvement (e.g., perceptions of interaction and receipt of
information) were mixed.
In an existing review, fourteen studies reported practical design strategies to improveknowledge for lower health literacy patients. These strategies include presenting essential
information only or first, presenting information in tables or pictographs rather than text,
presenting numerical information so that the higher number is better, using the same2

Addressing Health Literacy
denominators to present treatment benefit information, presenting numerical information as
frequencies for conditional probabilities, and adding video to verbal narrative to improve thesalience of information. In a review we conducted, a single pre-post study also found that video
that improved the salience of information also reduced decisional uncertainty. No studies ofinterventions addressed outcomes related to patient involvement.
In our review of the 97 trials of PtDAs, we found only 3 PtDAs which addressed theneeds of lower literacy or education audiences. In 90% of trials neither the readability of thePtDA or health literacy of the audience were reported. However, in the studies where literacy or
education were addressed, results were encouraging, suggesting increases in knowledge andinformed choice.
To ensure equity in access to decision aids, developers need to ensure that tools areappropriate for lower as well as higher health literacy consumers. In doing so, developers need
to attend not only to issues of comprehension (functional health literacy); they also need to foster
insight into one’s attitudes towards the pros and cons of different health care options (values
clarification), as well as foster the processes (communicative and critical literacy) involved in thedecision making encounter itself, in order to support shared decision making.
SECTION 3:
DEFINITION (CONCEPTUAL/OPERATIONAL) OF THIS QUALITY DIMENSIONa)
Original Definition
No explicit definition of “health literacy” was provided in the original chapter, which focused on“plain language”.
b)Updated Definition

Literacy
Literacy is a complex concept with two distinctive elements – those that are task-based (e.g.,
reading and writing basic text) and those that are skills-based (the knowledge and skills required
to perform key literacy tasks, ranging from word recognition to drawing inference from text) (1).
Literacy can be measured in absolute terms by distinguishing between those who can read andwrite and those who cannot, and in relative terms by assessing the skill differences between
adults who are able to perform relatively challenging literacy tasks and those who are not. Even
the most basic functional literacy skills enable people to better develop their knowledge andimprove their potential to achieve goals.
Health Literacy
Health literacy can be considered as a “domain” of literacy. Health literacy is commonly definedas ‘the capacity to obtain, process, and understand basic health information and services needed
to make appropriate health decisions’ (2, 3).
Broader definitions encompass a wider range of cognitive and social skills that enable people tofeel empowered to take control and improve their health (4, 5). According to Nutbeam (6, 7),
health literacy comprises three levels:3

Addressing Health Literacy
1. Functional health literacy – basic reading comprehension and writing skills to understandhealth information/messages, together with knowledge of health conditions, services, andsystems.
2. Interactive health literacy – higher level communicative and social skills required to
extract and discuss information with others.
3. Critical health literacy skills – advanced literacy, cognitive, and social skills to analyze
information and make informed decisions.
One could argue that these levels correspond with the skills required to effectively use patients’decision aids (PtDAs) and to engage in shared decision making.
Furthermore, health literacy is both context- and content-specific; different health care contexts
require specific content knowledge and skills (7). This means that even those with higher literacy
skills may have difficulties in novel health care environments (7).
c)

Emerging Issues/Research Areas in Definition

See Section 6.

SECTION 4:
THEORETICAL RATIONALE FOR INCLUDING THIS QUALITY DIMENSIONa)

Original Theoretical Rationale

No explicit theoretical rationale about “addressing health literacy” was provided in the original
chapter, which focused on “using plain language”.
b)Updated Theoretical Rationale

BackgroundA large proportion of people living in developed nations have difficulties performing everyday
literacy tasks. National adult literacy surveys conducted across Organization for Economic Cooperation and Development (OECD) countries indicate that between 16% and 48% of thegeneral population (depending on the definitions and measures used) have inadequate functional
literacy skills (8-11).
Furthermore, although methods of assessment vary, data indicate that inadequate health literacy
is common, particularly among elderly, ethnic minority, and socially disadvantaged populations.
These same populations generally experience higher rates of preventable disease and poorly
managed chronic disease. In the US, approximately 80 million adults (36%) were described ashaving “basic” or “below basic” health literacy (1); in Australia, 9 million adults (60% ) were
found to lack basic health literacy skills (8). This is problematic, since there is now moderate tostrong evidence that lower health literacy is independently associated with a range of outcomes,
including increased mortality, reduced overall health status, and a poorer ability to takemedication appropriately and interpret health messages (12, 13).
4

Addressing Health Literacy

In addition, numeracy skills (“the ability to understand and use numbers in daily life”), which aresometimes conceptualized a sub-component of health literacy, also influence how well people
can read and interpret health information and make informed health decisions (14). Up to 50% of
adults have been shown to possess basic or below numeracy skills and would therefore
experience difficulties performing tasks, such as reading nutrition information, measuring
medication dosages, and understanding risk information about benefits and harms of medical
treatments (9, 10, 15).

Health Literacy and the Design of Patients’ Decision Aids
Taken together, the results of these surveys provide a sharp reminder of the need to provide
health information in a form that is appropriate for the literacy and numeracy levels of the
majority of adults for whom it is prepared.
Therefore, since a person’s ability to effectively use a PtDA will be determined by both theirhealth literacy skills and the quality and suitability of the PtDA (16), designers of PtDAs need toensure that these tools can be accessed and understood by adults across all health literacy levels,
including those with lower health literacy, and can support decisions that are informed andbehaviorally implemented. This background chapter examines existing reviews and theoretical
literature in order to extract basic principles that could guide PtDA developers towards thisobjective.
c)

Emerging Issues/Research Areas in Rationale

See Section 6.

SECTION 5:
EVIDENCE BASE UNDERLYING THIS QUALITY DIMENSIONa)

Summary of the Original Evidence Base

The original chapter focused on the evidence base relevant to “plain language”, rather than theevidence about “health literacy”.
b)Updated Evidence Base

The overall aim of our literature review was two-fold:I. To review evidence for the effects of health literacy and numeracy on decision making
outcomes including knowledge, values clarity, and patient involvement andcommunication.
II. To review the trials of PtDAs to date, with respect to their attention to a) accounting for
health literacy, and b) testing with low literacy populations.

5Addressing Health Literacy
I. Decision Making Among Consumers With Lower Health Literacy, Literacy, orNumeracy: Review of Evidence
Background
This first aspect of our review was guided by two questions: 1) What is known about how healthliteracy affects decision-making outcomes? and 2) What is known about interventions’ ability to
mitigate the effects of lower health literacy on decision making outcomes?
SourceTo answer our questions, we took two approaches. First, we searched 2004 and 2011 systematic
reviews on Health Literacy Interventions and Outcomes (13, 17) for answers and, if available,summarized their results. Second, when questions were not answered, we performed our own
systematic review and data synthesis.
Methods
Full details of our systematic review methods are available elsewhere (18). In brief, to identify
relevant articles on health literacy and decision making, we searched articles included in 2004
and 2011 systematic reviews performed for the U.S. Agency for Healthcare Research andQuality (AHRQ). These reviews examined health literacy (including numeracy) interventions
and outcomes. We also searched the titles and abstracts of articles that were excluded from the
AHRQ 2011 review to identify articles reporting on decision making outcomes andinterventions. These articles had been excluded from the 2011 review either because 1) they did
not use a quantitative measure of health literacy or 2) they used a quantitative measure of healthliteracy, but reported only on decision making outcomes (such as values clarity, decisional
confidence or uncertainty, decision satisfaction or regret, patient desire for involvement, actual
patient involvement, and communication quality) (17). To ensure that we had identified all
relevant literature, we also reviewed the bibliographies of narrative reviews on health literacy
and shared decision making(19) and communication(20), systematic reviews on PtDAs (21),question asking (22), and patient centred care (23), and we queried experts for missing studies.
Inclusion criteria for this review mirrored the AHRQ criteria; however, these criteria wereextended to include articles that included individual-level self-reported assessments of healthliteracy. We additionally required intervention studies to either stratify results by health literacy
level or be performed in a lower literacy-only population. We followed standard systematic
review procedures to identify articles, to abstract evidence, and to rate the quality of included
articles. We included all fair- or good-quality studies in our review.

6

Addressing Health Literacy
Results
The results of this aspect of our literature review are structured according to the following
general functional goals of PtDAs (21):
1. PtDA Goal 1: To support users to understand health information relevant to their decision.
To achieve this goal, PtDAs provide evidence-based information about a health condition,
the options, associated benefits, harms, probabilities and scientific uncertainties.
2. PtDA Goal 2: To support users to clarify their values.
To achieve this goal, PtDAs help patients to recognize the values-sensitive nature of thedecision, and to clarify--either implicitly or explicitly--the value they place on the options’benefits, harms, and scientific uncertainties.
3. PtDA Goal 3: To support users to be actively involved in decision making and tocommunicate with others.
To achieve this goal, PtDAs provide structured guidance in the steps of decision making andcommunication of their informed values with others involved in the decision (e.g., clinician,family, friends).
PtDA Goal 1:
To support users to understand health information relevant to their decision.
Relationship between Health Literacy and Knowledge, Comprehension, and Accuracy of Risk
Perception
A 2004 systematic review conducted for the AHRQ found that low health literacy (measured
predominantly by the Rapid Estimate of Adult Literacy in Medicine (REALM) or Test of
Functional Health Literacy in Adults (TOFHLA)) was related to patient knowledge in 14 of 16
studies dating from 1980 through 2003 (13). Of the two studies that did not show a relationship,
one was clearly underpowered. Therefore, investigators concluded that the relationship was soclear that additional examination of this relationship was not necessary during a 2011 update.
In 2011, AHRQ-funded investigators assessed the effect of numeracy on knowledge andaccuracy of risk perception from 1966 to February 2011 (17). In four studies with a quantitative
measure of numeracy, investigators found mixed effects of numeracy on general and disease
specific knowledge. Additionally, in five studies with a quantitative measure of numeracy,
investigators found mixed effects of numeracy on the accuracy of perception of risk andtreatment benefit, with notable variation by task and measured outcomes (i.e. disparities inaccuracy were even greater for participants when stating verbatim versus gist risk).

7

Addressing Health Literacy
Effect of Health Literacy Interventions on Knowledge, Comprehension, or Accuracy of Risk
Perception
A paper published from the 2011 AHRQ review that included an updated search (24) identified
38 studies published between 1966 and February 2011 that met the following criteria: theyexamined the effect of single or multiple literacy-directed strategies on knowledge orcomprehension; they quantitatively assessed participants’ health literacy or numeracy; and theystratified analyses by health literacy level.
Fourteen of these studies (13 RCTs and 1 non-randomized controlled trial) specifically examinedthe effects of single strategies that might be useful in PtDA design. Among these 14 studies(which were reported in 12 articles) (25-32), investigators found multiple discrete design featuresthat improved comprehension for low health literacy individuals in at least one study. These aresummarized in Table 1 below.
Of the remaining 24 studies that reported on interventions using a mixture of literacy-directedstrategies, only one reported on a PtDA intervention (33). While this pre-post study of a prostatecancer PtDA reported improved knowledge among individuals in all health literacy subgroups(adequate health literacy: + 1.27 points of 10 point scale, adjusted p <0.01; inadequate healthliteracy +2.05 points, adjusted p <0.01; p for interaction not reported), it did not report its
literacy-directed strategies in sufficient detail to allow literacy-directed recommendations to be
derived.
Table 1. Design Features that Improved Comprehension for Lower Literacy Individuals in
at Least One Study








Design Features
Presenting essential information by itself or first (29)
Presenting numerical information in tables or pictographs rather than text (26, 30)
Presenting numerical information so that the higher number is better (i.e. “nurses
per patient”(more is better) rather than “patients per nurse” (less is better)) (29)
Presenting numerical information with the same denominator(26)Using natural frequencies to help individuals understand the probability of disease
following testing (26)
Adding video to verbal narratives to improve the salience of information (31)8

Addressing Health Literacy
PtDA Goal 2:
To support users to clarify their values.
We addressed the effect of health literacy and numeracy on values clarity outcomes andinterventions through our own systematic review. (See Table 2).
The Relationship between Health Literacy and Values Clarity
We found no studies that examined the relationship between health literacy and values clarity perse. However, four cross-sectional studies (34-37) investigated the relationships between healthliteracy and decision uncertainty, decisional regret, and decision confidence. In the two studies
that performed adjusted analyses, lower health literacy increased both decision uncertainty (34)and decision regret (36). The effect of health literacy on decision confidence is less clear, with
two unadjusted analyses showing mixed results (38, 39).
Interventions Designed to Help Low Literacy Individuals Clarify Values
In the single intervention study in this group (37), Volandes et al. found that a PtDA using video
images to help elucidate the salience of various health states reduced decision uncertainty among
all patients, with the greatest reduction found among patients with lower health literacy.
PtDA Goal 3:
To support users to be actively involved in decision making
and to communicate with others.
The Relationship Between Health Literacy And Patient Involvement And Communication
Thirteen studies reviewed the relationship between health literacy level and various aspects ofthe decision making encounter, such as: patient activation and desire for participation; question
asking; broader participation; and communication quality (see Table 2). Three studies, including
two that adjusted for confounders, reported that adults with lower health literacy were less likely
to want to be involved in decision making compared to those with higher literacy (40-42). A
fourth showed that patient activation was associated with numeracy, but not health literacy inunadjusted correlational analysis (29).
Two papers addressed the relationship between literacy and question asking (43, 44). One (43)found that both level and type of health literacy (functional, communicative, or critical)
influenced question asking, with lower levels of communicative health literacy associated withless question asking. The other (44) found that lower literacy patients were less likely to ask
questions overall (although this just failed to reach statistical significance). Of the questions
asked, lower literacy patients asked significantly fewer medical and lifestyle questions and moreclarification questions suggesting lack of understanding.
Two papers addressed patient involvement more broadly. One study reported (43) patients withlower “communicative” health literacy perceived they had less involvement in clinicalconsultations (although this just failed to achieve statistical significance likely due to the small

9Addressing Health Literacy
sample size). Arthur et al. (45) reported a trend toward less “mutuality” among US diabetes
patients with limited health literacy.
Of the eight studies examining communication quality, three large well done studies withadjusted analyses reported lower patient-centered communication across several communication
outcomes among those with lower health literacy. Communication was not specific to decision
making and the effect varied by outcome (46-48). A fourth study found that ratings of patientcentered communication varied by measurement of numeracy. Patients with low objective
numeracy reported more favorable communication and those with low subjective numeracy
reported less favorable communication (49). One unadjusted analysis found no difference
between lower and higher health literacy patients’ perceptions that doctors facilitated theirinvolvement in diabetes care (40).
Results of the remaining studies varied by outcome. One study found that parents with lower
health literacy reported more favorable interactions with their child’s healthcare provider (50).
Another found poorer decision satisfaction about breast cancer treatment among those with lower
health literacy (34). Finally, one study (43) found that those with low critical health literacy
were more likely to report adequate information when more information was given (whereas
those with high literacy did not), offering a potential explanation for the contrasting findings
above.
Interventions Designed to Help in The Communication Encounter
We identified no papers that tested interventions, although one reported baseline data from acluster randomized trial (51).

10Addressing Health Literacy
Table 2. Summary of Findings for PtDA Goals 1 and 2: Supporting Values Clarification,
Patient Involvement and Communication Among Lower Literacy Consumers
PtDA Goal
2

OutcomeNo of Studies

Summary of findings

Decisional uncertainty

2 (34, 36)

Lower HL associated with higher uncertainty anddecisional regret.

Confidence in DM

2 (38, 39)

Effect unclear.

Intervention studies: toassist values
clarification

1 (37)

Video images to increase the salience of healthstates reduced decisional uncertainty withstrongest effect in lower HL patients.

Preferences forparticipation in DM /patient activation

3 (40-42)

Lower preference for involvement among lower
HL patients.

(29)

Patient activation associated with lower numeracy
not HL.

Question asking

2 (43, 44)Less question asking among those with lower
communicative HL. More clarification questions
asked (indicating lack of understanding)

Level of involvement

2 (43, 45)

Patients with lower ‘communicative’ HL reported
less involvement.

Decisional regret

3Less ‘mutuality’ observed between Drs and lower
HL patient
Communication quality/ Patient centred care
(PCC)

Intervention studies:

5 (40, 47, 49,
50, 52)Less PCC among lower HL patients in 3 studies
with adjusted analyses. 1 study reported effects
varied by how numeracy is measured.

3 (34, 43, 50)

Effects varied

None

N/A

HL - health literacy DM - decision making

Discussion
Limitations
There are some limitations to this aspect of our review. A single reviewer reviewed articles to
exclude those unrelated to the topic of our review. Although the articles closest in subject to ourreview’s purposes were assessed by two reviewers, it is possible that some relevant studies were
missed. Other limitations are the inherent potential for publication bias, the diversity of measuresused for similar outcomes, and the small number of physicians (despite adequate numbers ofpatients) that were included in studies of health literacy and communication. Although not a11

Addressing Health Literacy
specific limitation of our reviews, one additional issue is that we excluded studies stratifying
analyses by education. We made this choice because our search was not designed to pick up
education as a proxy for literacy and we likely would have missed many relevant studies. It
should be noted, however, that important information may be learned from such studies (53, 54).
Interpretations
Overall, this aspect of our review suggests that consumers’ health literacy levels are likely to
influence aspects of PtDAs and the shared decision making process: knowledge andunderstanding of the disease/condition, treatment options and outcomes; values clarification withrespect to feelings of uncertainty and decisional regret; and the desire and ability to participate indecision making (communicate with and ask questions of health professionals). Patients withlower health literacy in general had poorer outcomes across most of the measures examined (e.g.,
lower knowledge, higher uncertainty, poorer communication, and less patient centered-care). If
PtDAs are to be helpful in structuring and guiding decision making, they must address healthliteracy issues related to these critical processes. Intervention research relating to values
clarification and the decision-making encounter (goals 2 and 3) are extremely limited withalmost no intervention studies available to guide PtDA developers. More research here isespecially needed to understand potential differential effects of interventions by literacy level.
However, there is evidence to support improving the design and content of PtDAs—assummarized in Table 1—to facilitate comprehension among lower health literacy patients. The
use of these strategies is recommended for the development of PtDAs for lower health literacy
consumers.
II.

Attention Paid to Health Literacy in PtDA Trials: Review of Evidence

Background
This second aspect of our review was guided by the question: What level of attention is paid toliteracy in trials of PtDAs to date?
SourceThe latest available Cochrane Collaboration’s systematic review of randomized controlled trialsof PtDAs (21), updated (using the same search strategy) to identify new trials published in 2010.
Methods
For full details, see (18). In brief, the evaluative criteria for this review were based on the
published 2006 IPDAS health literacy criteria (55), which recommend that PtDAs should be:
1. Written at a level that can be understood by those in the target group;
2. Written at a grade 8 equivalent or lower on a readability score such as SMOG or FRY;
3. Presented using media other than reading (audio, video, in-person).
These three published criteria constituted the core criteria that astute DA developers should meet
(55).
12

Addressing Health Literacy

Five additional criteria were used in this review, in order to assess internet-based PtDAs and thebasic adequacy of the trial design for evaluating PtDA effectiveness in low literacy populations.
The five new criteria addressed whether the PtDA study:
4. Provided PtDAs by internet;
5. Stratified by health literacy / literacy;
6. Stratified by education as a proxy for health literacy;
7. Had adequate power to analyze lower literacy samples;
8. Addressed health literacy in the conclusions.
Each study was graded using these eight evaluation criteria. Criteria were coded aspresent/absent/unknown. Lack of indication of IPDAS criteria and lack of mention of literacy at
all were coded as “absent”. If articles made a global reference to the IPDAS criteria, but made no
specific mention of the criteria addressed, they were scored as “unknown”.
Results
The total number of PtDA trials in the latest Cochrane Collaboration’s update was 87. Ten moretrials were identified in the updated search up to and including 2010, so that the total set of PtDA
trials evaluated was 97 (21). Table 3 below lists the percentages and absolute numbers ofindividual studies that were evaluated according to our literacy criteria.
Table 3: Attention Paid to Health Literacy in PtDA Trials: Percentages (and Absolute
Numbers)
Criteria Used to Evaluate PtDA Trial

Present
AbsentUnknown
On Web
Total
Trials≤ Grade Media
Literacy
Literacyother
8Stratified Stratified
Addressed
Level
Reading than Webby
byAdequate
in
Ϯ
Age
Power
Conclusion
StatedTextϮϮ Based Literacy Education
4
5
68
6
2
0
2
3
(4)
(5)
(67)
(6)
(2)
(0)
(2)
(3)
93
92
30
90
98
100
98
96
(91)
(89)
(29)
(87)
(95)
(97)
(95)
(94)
1
3
1
1
0
0
0
0
(2)
(3)
(1)
(1)
(0)
(0)
(0)
(0)
NA
NA
NA
3
NA
NA
NA
NA
(3)
100%
100%
100% 100%
100%
100%
100%
100%
(97)
(97)
(97)
(97)
(97)
(97)
(97)
(97)

Ϯ Most trials did not identify the literacy level of the intended audience. We operationalized this criterion to code‘present’ if the research sample group’s literacy requirements were stated.

13Addressing Health Literacy

ϮϮ If the PtDA was text based, but included graphics of frequencies and other numeric data, these were considered

to be text. This criterion was meant to provide for alternative media for non-readers such as pictures, video
explanations of data, voice-over narration, etc.

Five percent of all RCTs (56-60) reported the PtDA reading level as grade 8 or below. Two trial
reports (61, 62) stated that IPDAS criteria were followed but made no reference to which specificcriteria. Many PtDAs used media other than pure text, including interactive video and audio
tape, although it was not clear whether these modalities were used specifically to address issuesof literacy. There were eight web-based PtDAs (63-70), though in many the presence or absenceof content other than straight text could not be determined.
The following studies recruited patients presumed to have lower health literacy based on theireducational status and reported conclusions about health literacy (54, 57, 61, 71 , 72-74). Threerandomized trials compared lower health literacy or education groups to higher health literacy
groups. Two Australian studies developed PtDAs for bowel cancer screening, one specificallydesigned for a lower health literacy audience (61, 74). One US study additionally addressed
prostate cancer screening through a comparison ‘edutainment’ PtDA and a paper PtDA (54). All
three of these PtDAs appear to have adhered to the IPDAS criteria and included quantitative
outcome data and explaining technical terms. One PtDA was paper-based (74); the remaining
two focused on either audio or multi-media.
Two of three studies showed that PtDAs increased knowledge in samples presumed to havelower health literacy based on their educational status. Trevena et al (74) found a significant
increase in knowledge in both low and highly educated participants in the DA arm. Smith et al.
(75) reported a 38% increase in knowledge and a 22% increase in informed choice (adequate
knowledge and consistent attitudes and behaviour) in low education adults who received theliteracy-sensitive PtDA compared with those who received standard information. The third study
on prostate cancer screening, which also used education as a proxy for health literacy, found nodifference in knowledge between the ‘edutainment’ and an audio-booklet presentation containing
the same information (54). However, the entertainment-based aid was associated with lower
decisional conflict and greater self-advocacy when compared to “low health literacy” patients
given the audio booklet. No differences between aids were observed for “high health literacy”
patients.
Discussion
Limitations
The small number of PtDA RCTs that addressed health literacy suggests neglect of thisimportant area in the field. Health literacy was not directly measured in any study. Proxy
measures were used in three studies that reported having recruited individuals with unspecified
deficits in education and health literacy. A limitation of our review of the attention paid toliteracy in DAs is that we have not included the background articles that describe thedevelopment of PtDAs (e.g., (61)) tested in the trials. Adding these may provide greater insight
into how literacy was addressed. It does not, however, address the lack of attention to literacy inthe trials and in identification of research questions. A related limitation is that we included only14

Addressing Health Literacy
RCTs. Other studies of PtDAs that used different research designs may have included PtDAs that
addressed low health literacy. We also note that there is now mixed evidence regarding thebenefit of alternate media on improving outcomes for lower literacy patients (24), thus criteria
may need to be revised for future reviews.
Interpretations
Overall, very little attention was paid to literacy concerns in the PtDA RCTs reviewed. Only 3
out of 97 PtDA trials included adults with low education or literacy or used PtDAs designed
explicitly to address low literacy audiences. In 90% or more of the trials, the reading needs of theparticipants and the reading level of the PtDAs were not reported. A clear bottom line is that
PtDAs are rarely developed with low literacy populations in mind, despite the observations that:in many developed countries only half the population has more than basic reading skills (1); andhealth information developed for adults at a grade 9 reading level is widely accepted by moreeducated as well as less educated users (76, 77). However, importantly in PtDA studies in which
education and literacy were addressed, results across literacy groups are encouraging in that
increases in knowledge and in informed choice have been reported.

SECTION 6:
EVIDENCE-BASED PRINCIPLES AND EMERGING ISSUES
Overall Conclusions
Lower health literacy groups tend to have the lowest levels of knowledge and involvement inhealth care, and some of the poorest health outcomes. The consistent observation that patientswith lower health literacy desire less involvement in decision making may be a consequence of alack of awareness that they can be involved (61) and a lack of confidence in sharing the decision
process with health care providers. In patients with higher health literacy, desire for involvement
has been found to increase when patients are shown the PtDA tools that are available (78).
Accordingly, in order to ensure equity in access to PtDA resources and shared decision making,developers of PtDAs need to ensure that these tools are accessible to lower as well as higher
health literacy consumers, and that lower health literacy groups are better equipped andsupported to utilize PtDAs.
Some principles for PtDAs can be derived from our current review-based and expert-opinionbased evidence about the health literacy needs of consumers. There are also large areas in which
there is scant research about important health literacy issues in the field of PtDAs. Below, wehighlight some of those relatively established principles and relatively unexplored issues.

15Addressing Health Literacy
Principles for the Design, Development, Testing, and Implementation of PtDAs for Lower
Health Literacy Consumers
Review-Based Principles
The reviewed literature reports the results of direct tests of ways to enhance understanding of
PtDA-provided information among lower health literacy consumers. Here, we summarize thatliterature’s “take home” messages for PtDA developers:
1. Present essential information by itself or first. See Chapter B: Presenting Information about
Options for further guidance on the presentation of information.
2. Present numerical information in tables and/or pictographs rather than in text only.
3. Present numerical information so that the higher number is “better”. For instance, present“nurses per patient” (higher number better) rather than “patient per nurse” (lower number
better).
4. Use a consistent denominator for numerical information (e.g. 1 out of 1000, 500 out of1000). See Chapter C: Presenting Probabilities for further guidance on the presentation ofnumerical/probabilistic information.
5. If possible, add video to verbal narratives to improve the salience of information about
unfamiliar health states. See Chapter E: Using Personal Stories for further guidance on theuse of narratives.
We emphasize that these principles are based on the available literature to date, which derives
from a small number of studies. Further direct tests of ways to enhance understanding of PtDAprovided information are needed in the field of health literacy; such studies may generate
different results in different populations.
Expert Opinion-Based Principles Emerging from The Broader Literature
Based on systematic reviews of the broader health literacy literature, the authors of this chapter
believe that particular principles can be tentatively applied to the design, development, testing,and implementation of PtDAs for lower health literacy consumers. (For example, the AHRQ
systematic review (24)-- although not specific to PtDAs -- identified a number of features thatappear to improve the effectiveness of interventions for lower health literacy populations.)Use high intensity interventions. In the broader health literacy literature, successfulinterventions combine multiple literacy-directed strategies. Thus, designing decision aids that
support knowledge acquisition and understanding (through plain language, simple numbers,
and a range of visual and linguistic techniques) generally would be expected to produce
better outcomes. Multiple reinforcing contacts following delivery of the decision aid would
also generally be expected to support active decision making.

16Addressing Health LiteracyUse theory-based interventions when appropriate. In the broader health literacy literature,
successful interventions are theory-based. Thus, theory might be used to maximize theimpact of decision aids. For instance, there are well-established behavioral andcommunication theories that might be applied in decision aids to motivate engagement withthe decision aid or, if appropriate, engagement in specific behaviors (e.g., colon cancer
screening).



Pilot testing before full implementation. In the broader health literacy literature, successfulinterventions have been pilot-tested prior to implementation. Patient decision aids that haveworked successfully with higher literacy populations cannot be assumed to be useful withlower literacy groups. Pilot testing is needed to examine the information needs andcommunication preferences of lower literacy populations and should examine the wholeprocess of decision making among lower health literacy consumers. This means checking
not only understanding of the language and content but also whether the PtDA helps users toclarify values, communicate with health professionals, and implement a decision.



Increased emphasis on skill building among lower health literacy consumers. In the broader
health literacy literature, successful low literacy interventions help with skill building. Thissuggests that demonstrating and modeling values clarification and physician interactions indecision aids may improve outcomes among low literacy users of decision aids.



Delivery of the intervention to lower health literacy consumers by a health professional (e.g.,
pharmacist, health educator, nurse practitioner, physician). In the broader low health literacy
literature, the most successful low literacy interventions are delivered by a healthprofessional rather than by non-clinicians. This suggests that delivery of decision aids in thecontext of clinical care might result in the best outcomes.

Research Gaps in the Design, Development, Testing, and Implementation of PtDAs for
Lower Health Literacy Consumers
Research addressing health literacy in PtDAs is in its infancy. To date, not enough attention has
been paid to the needs of lower literacy consumers in PtDA research. There are important
deficits in the extent to which attention has been paid to health literacy in PtDA development andevaluation. (For example, the application of the IPDAS 2006 (79) health literacy criteria to thedevelopment of PtDAs has not been systematically investigated). And much work is still needed
to develop and test strategies to help adults with lower health literacy to gain key literacy skills,
to engage in the values clarification process, and to be involved in doctor-patientcommunication.
These research gaps could be closed if PtDA developers used systematic study methods andreporting strategies such as:
1. Assessing literacy/health literacy and/or numeracy levels in study samples by:a) directly measuring functional health literacy and/ or numeracy among a representative
sample of the target sample of consumers, using a recognized measure such as
TOFHLA, REALM, or Newest Vital Signs (NVS); and17

Addressing Health Literacyb) using a self-report health literacy and/or numeracy measure to assess perceived skills(e.g., (80, 81) – bearing in mind that there are well-recognized limitations to selfreported health literacy/numeracy measures.
2. Selecting a measurable strategy to ensure that the language of the PtDA is written at a levelthat is understood by the majority of the target audience (e.g., Flesch-Kincaid, Simple
Measure Of Gobbledegook (SMOG), Fry Readability Formula (or Fry Readability Graph), or
other accepted approaches; see http://www.nlm.nih.gov/medlineplus/etr.html), Suitability
Assessment of Materials (SAM) or Systemic Functional Linguistics [74].
3. Stating how the PtDA accommodated health literacy or numeracy requirements identified in
the population.
4. Stating that good health literacy principles were followed in the PtDA development (e.g., 83,
84-88).
5. Recruiting, where possible, adequate numbers of low health literacy/numeracy individuals toevaluate effectiveness specifically in this population through stratified analysis. If fullinclusion is not possible, reporting results of pilot studies among lower health literacy
consumers.
Other research gaps include the need to identify the characteristics of PtDAs that are universally
acceptable and helpful, and those characteristics that are particularly effective at enhancing
shared decision making among people with lower health literacy/numeracy. Ultimately, thisfuture research will contribute in important ways towards understanding the effects of PtDAs on
health inequalities and towards ensuring that lower literacy/numeracy groups are notdisadvantaged.

18Addressing Health Literacy
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24Addressing Health Literacy
APPENDIX
Original Chapter J: Using Plain Language
Margaret HolmesRovner (lead)
Angie Fagerlin

Michigan State University

USA

University of Michigan

USA

Kirsten McCaffery

University of Sydney

Australia

Lisa Schwartz

USA

Stacey Sheridan

Dartmouth Medical School, Dartmouth College, New
Hampshire
University of North Carolina

USA

Sue Stableford

University of New EnglandUSA

Original Rationale/Theory
Patient decision aids are designed to present medical evidence that assists patients to identify
screening, diagnostic testing, and treatment options, to determine their values associated with thepotential harms and benefits of these options, and to participate in medical decisions. It istherefore, crucial that the text and graphics used to present this information are written inlanguage that is easily understood. Ideally, patient decision aids should be comprehensible toeveryone in the target audience, regardless of literacy level. However, medical detail required todescribe harms and benefits is, by definition, technical language that is more challenging forreaders to understand and particularly difficult for readers with limited literacy skills. Thesetypes of resources can be improved by applying the principles of plain language to a document.’sdesign, and by measuring readability.
Plain Language
There is no gold standard for what constitutes plain language, although there is wide agreement
about many attributes, based on research evidence, about reading, cognitive
psychology, social marketing, usability, and document design. The 3 major categories of
attributes are: 1) the use of everyday language and other clear writing styles; 2) well-structured,
logically sequenced, and focused information; and 3) effective document design. When these
attributes are used, even good readers have demonstrated improvements in speed and accuracy ofreading. As well, in medical situations many adults lack the context necessary to understand andapply the information which further impairs the use of new information. Finally, patients facedwith health decisions frequently experience heightened emotional stress which interferes withcognitive abilities. Therefore, developing patient decision aids using attributes of plain language
is important for patients of all literacy levels.
Readability
The most valid and reliable measure of the level of a text’s comprehension difficulty is its
readability. Patient decision aids need to be as transparent as possible in describing the literacy
25Addressing Health Literacy
level required to read or listen to the information provided. The majority (50% or more) of “thetarget population” should be able to understand the patient decision aid.
Therefore, in general, the readability of patient decision aids should be at the level equivalent tograde 7 or 8 in the US. However, when patient decision aids are specifically targeted to lower
literacy populations, the readability level should be adjusted accordingly. Finally, the method
used to assess readability should be reported with the readability levels.
Original Evidence
Literacy Rates
According to the 1992 National Adult Literacy survey, about half of US adults read at or below
the 7-8th grade level. The issue of literacy is of ongoing concern across many countries that
include Australia, Canada, Germany, New Zealand, Sweden, the United Kingdom, and the US.
Plain Language
There is some evidence that increasing reading ease improves comprehension, and emerging
evidence of the effect on health outcomes. Poor literacy has been found to be related to lack ofpreventive health behaviors (e.g., cervical and breast cancer screening, influenza andpneumococcal immunization), increased risk of hospitalization, decreased ability to follow
medical instructions (e.g., use of inhaler), and less control of chronic illness (e.g., glycemic
control). However, several studies have shown that health outcomes can be responsive tointerventions designed to improve the readability of materials. While the evidence is weak, and it
is unclear whether interventions directed at improving readability will lead to better
health outcomes, low literacy may be part of a complex of problems relating to poor healthoutcomes. A recent review identified 24 studies that examined interventions to improve healthfor persons with low literacy. These studies found mixed results about the interventions’ ability
to affect knowledge, intermediate markers of disease, disease prevalence and incidence, healthbehaviors, and use of health services. Few studies examined each type of literacy intervention(text, videotape, computer, oral presentation), therefore it is not clear which types of tools aremost effective. Additional limitations included variability in the study designs, the interventions
tested, and the outcomes assessed.
Readability Measurement
There are well-validated tools for readability (e.g. SMOG, Fry). However, the easily accessible
readability measures in word processing software are not very accurate or acceptable.
Readability measures focus on the text, while more recent work on health literacy has focused on
the abilities of the persons reading the text. Despite their limitations, these existing tools arehelpful to good document design and should be used; in the meantime, investigators should revalidate them with various populations and develop more sensitive and specific tools to predict
informed decision-making and health outcomes.

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Inventory of Available Patient Decision Aids
There is no evidence found on the assessment of readability of patient decision aids and theirsuitability for particular audiences. Most of the 131 patient decision aids, in the Cochrane review
inventory, were developed for general audiences (O’Connor et al., 2003). Further researchshould focus on: a) demonstrating which characteristics of patient decision aids enhancereadability and improve comprehension resulting in better health outcomes; b) examining the useof patient decision aids in both low and high literacy groups to determine whether theintervention ameliorates differences according to literacy status; and c) determining whether
interventions work directly to improve patients.’ knowledge and understanding or indirectly
through other mechanisms.
Current Initiatives
The research agenda in health literacy should be enhanced by the work of the Institute ofMedicine in this field. The Institute of Medicine's report Health Literacy: A Prescription to End
Confusion, released in April 2004, highlights the scope of the problem and outlines a researchand policy agenda with key recommendations.
Original References
Importance of Health Literacy Generally
IOM report on Health Literacy (pending)
IOM report: Speaking of Health: Assessing health communication strategies for diverse populations.
National Academies Press, Washington DC, 2002.
Williams MV, Davis T, Parker RM, et al. The role of health literacy in patient-physician communication.
Communicating with Special Populations 2002; 34(5):383-389.
Parker RM: Health Literacy: a challenge for American patients and their health care providers. Health
Promotion International 2000; 15(4):277-283.
Gazmararian JA, Williams MV, Peel J, et al. Health literacy and knowledge of chronic disease. Patient
Education and Counseling 2003; 51:267-275.
Linking Reading And Other Research to Plain Language Criteria
Felder D, et al. (Eds) Document Design: A Review of the Relevant Research. Washington DC: Document
Design Center, American Institutes for Research, National Institute of Education, DHEW. April 1980.
Reprinted 1989.
Felder D, Pickering F, Charrow V, et al. Guidelines for Document Designers. Washington DC: Document
Design Center, American Institutes for Research, November 1981.
Spyridakis J, Wenger M. Writing for human performance: relating reading research to document design.
Technical Communication. 1991; 202-215 (second quarter).

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Addressing Health Literacy
Hibbard J, Peters E. Supporting informed consumer health care decisions: data presentation approaches
that facilitate the use of information in choice. Annual Review of Public Health 2003; 24:413-433
Linking Plain Language With Increased Comprehension (Selected Sample)
Baker GC, Newton DE, Bergstresser PR. Increased readability improves the comprehension of written
information for patients with skin disease. Journal American Academy Dermatology 1988;19:1135-41.
Davis T, Bocchini JA Jr, Fredrickson D, et al. Parent comprehension of polio vaccine information
pamphlets. Pediatrics 1996; 97:804-810.
Jolly B, Scott JL, Sanford SM. Simplification of emergency department discharge instructions improves
patient comprehension. Annals of Emergency Medicine 1995; 26:443-446.
Meade C, Byrd J, Lee M. Improving patient comprehension of literature on smoking. American Journalof Public Health 1989;79:1411-1412.
Effects of Literacy on Health Outcomes
DeWalt DA, Berkman N, Sheridan SL, et al. Literacy and health outcomes: a systematic review of theliterature (personal communication).
Pignone MP, DeWalt DA, Sheridan SL, et al. Interventions to improve health outcomes for patients withlow literacy: systematic review (personal communication).
Measures of Readability And Suitability: Description And Validation
Chall J, Dale E. Readability revisited: The new Dale-Chall Readability Formula. Brookline Books, 1995.
Fry, EB. Readability Scale. Providence, RI, Jamestown Publishers, 1976.
Mailloux S, Johnson ME, Fisher DG, et al. How reliable is computerized assessment of readability?
Computers in Nursing 1995; 13(5):221-225.
Ley P, Florio T. The use of readability formulas in health care. Psychology, Health & Medicine 1996;
1(1):7-28.
Computerized readability software. Available at www.micropowerandlight.com
Doak C, Doak L, Root J. Teaching Patients with Low Literacy Skills (2nd ed). Philadelphia: Lippincott,
1996.
SMOG scoring directions: Harvard School of Public Health website. Available at:www.hsph.harvard.edu/healthliteracy
Literacy Status of Populations
National Assessment of Adult Literacy 2003 (NAAL) project will produce several published reports that
address the status of literacy among adults in the U.S. and literacy trends over time. The working title ofthe principal NAAL 2003 national and state reports is: Literacy Skills of America's Adults in Workplace,
Family, and Community Settings. Available at: http://nces.ed.gov/naal/

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ABS (Australian Bureau of Statistics), Aspects of Literacy: assessed skill levels in Australia 1996. 1997,
Canberra: Australian Government Publishing Service.
Literacy in the Information Age: Final Report of the International Adult Literacy Survey OECD, Parisand the Minister of Industry, Canada, 2000.
National Needs and Impact Survey of Literacy, Numeracy and ICT Skills, October 2003. Department for
Education and Skills, DfES Research Report 490. HMSO.

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Original AppendicesMeasuring Readability
Using a readability formula is a good first evaluation of any patient decision aid. The result,usually expressed in a grade level, gives an estimate of the level of reading difficulty. The
formulas (e.g., SMOG, Fry) are generally valid within 1-2 grade levels and have good interformula correlation. Variation is largely due to different assumptions about level of reader
comprehension. All formulas, however, are just indicators of reading ease or difficulty andshould be used within a larger context of using plain language writing and design techniques.
Directions for using the SMOG are at this Harvard School of Public Health website:www.hsph.harvard.edu/healthliteracy. Directions for using the Fry are in “Doak, Doak, and Root
(1996). Teaching Patients with Low Literacy Skills”.
If developers of patient decision aids want to use their computers to assess readability, they needto purchase software designed especially for this purpose (see references). The assessment
software built into MS Word is not accurate and the Flesch-Kincaid formula as programmed in
the software does not report a grade level above grade 12.
If using a computer program, the document must be “cleaned up” prior to running the readability
analysis program. This includes deleting all titles and subtitles, extraneous periods (for example,
after “Dr..”), and all bulleted lists. There may be other software instructions to follow as well.
Resources For Plain Language Writing
The following are several governmental and not-for-profit organizations’ guidelines for plain
language that would be helpful to patient decision aid developers:
 www.plainlanguagenetwork.org
 www.plainlanugage.gov
 www.cdc.gov/publications.htm (publication at end of list titled .“Simply Put.” for CDC
standards)
 http://oc.nci.nih.gov/services/Clear_and_Simple/HOME.HTM (These are NIH guidelines)
 www.usability.gov/guidelines/usability/guidelines.pdf (federal standards for website
usability)
 www.discern.org.uk
 www.clear.nald.ca

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