Abstract
Introduction
Achieving health literacy is a primary goal of Healthy People 2030 due to the increasing recognition of its role to improve the health and well-being of all populations. Shared decision-making (SDM), a recognized process between patients and health care providers to discuss which health care decision is best for the patient considering the pros and cons, patient preferences, and circumstances, can improve health outcomes. Specifically, SDM can increase patient knowledge and the quality of decision-making, resulting in patients feeling more empowered, demonstrating less decisional regret, and more motivation. Yet, limited health literacy (LHL) can hinder a patient’s ability to engage in the SDM process. Patients’ ability to engage in SDM can be helped by improving health literacy levels, and by the suitability of the tools available to support them. Decision aids (DA) are educational tools that can help with SDM. SDM provides patients with the necessary skills, which, when paired with DAs designed with and for populations with LHL, can improve communication with health care providers.
Methods
Guided by elements of the Ottawa Decision Framework and principles of human-centered design, in this retrospective study we aimed to develop a novel and current brief colon cancer screening DA, “Making a Decision: Should I Stop or Continue Colon Cancer Screening – Ages 75-85,” based on feedback from adults ≥75 years at risk for LHL in two focus groups and a comprehensive health literacy demand assessment of the “Making a Decision About Colon Cancer Screening” using four tools to determine its readability, understandability, and actionability.
Results
Findings include a DA that was viewed favorably by older adult participants who were at risk for LHL.
Conclusions
With feedback from older adults at risk for LHL, we have developed a DA that can be tested in a larger randomized control trial.
Plain Language Summary
Shared decision-making discussions can be enhanced by patient decision aids. These tools provide balanced, evidence-based information to help patients think about which benefits and harms matter most to them. Limited heath literacy can be a barrier for patients to engage in shared decision-making. We aimed to develop a brief colon cancer decision aid based on an existing decision aid using feedback from adults >75 years at risk for limited health literacy along with four health literacy assessment tools to make sure the decision aid was readable, understandable and actionable. The new decision aid will now be tested in a larger sample of adults >75 years at risk for limited health literacy to determine if it is appropriate. When decision aids are designed with the target population, the goal is the older adults no matter what the literacy level can participate in shared decision making discussions around cancer screening.
Introduction
Achieving health literacy is a primary goal of Healthy People 2030 due to the increasing recognition of its role to improve the health and well-being of all populations. This goal is important since the last survey of American adults indicate that only 12% of Americans are considered proficient in their health literacy skills resulting in only a sufficient level of skill to navigate the health system, engage in complex medical discussions and fully participate in managing their health. 1 SDM is a process in where healthcare professionals and patients work together to make a health care decision that is based on clinical evidence, the patient’s values, and informed preferences2,3 and can improve health outcomes. 4 Specifically, SDM can increase patient knowledge5,6 and the quality of decision-making resulting in patients’ feeling more empowered, demonstrating less decisional regret and more motivation. 7 Yet, limited health literacy (LHL) can hinder a patient’s ability to engage in the SDM process. 7 Patients with LHL may not understand health information, be able to participate effectively in discussions, and make informed decisions about their care. 8 In fact, research suggests their ability to engage in SDM is determined largely by their health literacy skills and the quality and suitability of the tools and techniques available to support them.
Decision aids (DAs) are educational tools that can provide information on the benefits and harms of a decision and can increase SDM between patients and clinicians to help patients elicit their preferences and values. DAs have been shown to increase knowledge, clarity of personal values about the benefits and harms of decision options and patient participation in SDM and decrease decisional conflict (personal uncertainty about which course of action to take).5,9 SDM provides patients with the necessary skills, which when paired with DAs designed with and for populations with LHL,7,10 can improve communication with health care providers. Few DAs incorporate health literacy principles with a systematic review noting that only 12% of 213 patient DAs addressed the needs of populations with limited health literacy. 11
For this study, we focus on personal health literacy – the degree to which individuals have the ability to find, understand, and use information and services to inform health-related decisions and actions for themselves and others and its emphasis on people’s ability to use and understand health information to make “well-informed” decisions. 12 LHL is associated with adults ≥ 75 years, low educational attainment, racial and ethnic identity, and low income. 13 Low education is associated with lower health literacy among older adults 14 in part because older adults are less likely to have completed high school or college than other age groups. 15 Further, the physiological and psychological (including cognition) may affect the literacy levels of older adults. 16
Colon Cancer Screening Among Adults ≥ 75 years and Shared Decision-Making
Because of the uncertainty of the benefits of colon cancer screening for adults ≥ 75 years, national guidelines recommend that adults ≥ 75 years engage in SDM discussions with their health care providers around colon cancer screening.17,18 In making a decision and given the complexity of a decision to screen or not to screen for colon cancer, adults ≥ 75 years need to be informed of the benefits and harms of screening. The decision is complex because the benefits of screening are realized after 10 years and for populations with a <10 year life expectancy due to poor health, the harms (bleeding, perforation) of colon cancer screening which are immediate, may outweigh the chance of a future benefit. Traditionally the LHL older adult population has been under-screened and older LHL adults 76-85 who have never been screened for colon cancer screening are more likely to benefit, making the decision even more important. 19 In a SDM discussion, patients and their health care providers need to consider the patient’s overall health including life expectancy, prior screening history and preferences.
To support SDM among LHL populations, 20 we aimed to develop a novel and current brief colon cancer screening DA, “Making a Decision: Should I Stop or Continue Colon Cancer Screening – Ages 75-85,” (See Online Appendix) based on feedback from adults ≥75 years with LHL and a comprehensive health literacy demand assessment based on the “Making a Decision About Colon Cancer Screening” decision aid (See Online Appendix).21,22
Making a Decision About Colon Cancer Screening
“Making a Decision About Colon Cancer Screening” is a 20-page paper-based DA that targets patients of different sexes and of different age groups (70-74, 75-79, 80-84) resulting in six versions (70-74/Female; 70-74/Male; 75-79/Female; 75-79/Male; 80-84/Female; and 80-84/Male). The DA, first published in 2010, includes information about Fecal Occult Blood Test (FOBT), the potential harms, the need for individualized decision-making and a values clarification exercise.22-24 The DA uses pictograms to show rates of serious harms, benefits and risks of screening. It was written in large font to help patients with visual difficulties, takes between 5 and 15 minutes to read and targeted a seventh grade reading level; however, no formal reading assessment of this DA has previously been performed.
Conceptual Framework
This study was guided by elements of the Ottawa Decision Framework and Human Centered Design. The Ottawa Decision Framework 25 incorporates theories from psychology, decision sciences, and economics to 1. Help identify patients’ decision support needs and suboptimal determinants of decision-making (ie, inadequate knowledge); 2. Provide tailored decision support (eg, values clarification), and 3. Evaluate the decision-making process in the development of DAs. Human Centered Design 26 incorporates feedback to develop solutions that are important, effective, and can address problems for a target population. This study received Institutional Review Board approval from Simmons University (Study IRB#17-031; 9/8/2017).
Methods
Study Design
This two-part retrospective study involved two focus groups totaling 15 participants (n = 7 and n = 8) with no refusals or drop-outs providing feedback on “Making a Decision About Colon Cancer Screening” (Part 1) and a comprehensive health literacy assessment of the Making a Decision About Colon Cancer Screening DA and the newly developed colon cancer screening DA, “Making a Decision: Should I Stop or Continue Colon Cancer Screening – Ages 75-85” (Part 2). Using four health literacy assessment tools, we first assessed this DA for readability using the Simple Measure of Gobbledygook (SMOG), 27 followed by the Peter Mosenthal and Irwin Kirsch (PMOSE/KIRSCH), 28 for document complexity, the Patient Education Materials Assessment Tool (PEMAT),29,30 for understandability and actionability, and the Centers for Disease Control (CDC) Communication Index 31 for behavioral recommendations and risk communication.
Part 1
Participants were recruited using convenience sampling from community-based organizations in one urban area (Boston, MA) with the assistance of a community champion using flyers. Participants in the focus groups met the following inclusion criteria: • Between 75 and 85 years of age • No history of colon cancer • Had some college or less • Responded to a validated health literacy measure with a response of “somewhat to not at all” • Capacity to participate using the Orientation-Memory-Concentration Test Short Blessed Test (SDT) - cognitively oriented to time, place, and person
Based on previous studies,32,33 we learned that participants felt there was a stigma 34 about being considered “at risk” for LHL and thus being perceived as having low intelligence. 35 They indicated their reluctance to admit their discomfort with sharing concerns about understanding and using health information. 36 We found that using this question as our only condition for defining health literacy levels led us to initially exclude participants for whom the DA may have been useful. Therefore, we added educational attainment for our work going forward as part of the definition for defining health literacy. Furthermore, to ensure that we were reaching the intended populations, educational level was added based on research about the intersections that exist between educational attainment, age, racial and ethnic identity, socioeconomic status, and LHL.37-39 Given the intersection of these factors, it was important to use as many of those factors as possible to assess health literacy.
Each focus group was held at a community based organization, lasted one hour and was moderated by the first author (T.C.) who has a PhD and two Masters degrees in addition to extensive experience working with community organizations and developing health education materials. At the time of the study, the first author was a faculty member and identified as female. The community champion served as the notetaker with whom the faculty member had an existing relationship with whom helped with the first author establishing a relationship with participants. Each participant was consented prior to starting the focus groups. The focus groups were the first steps in revising the “Making a Decision About Colon Cancer Screening” DA. As part of the introduction, the first author explained her personal reasons for her interest in cancer screening and older adults. She explained to participants that in our first review of the DA, we thought there may need to be some changes, and we were interested in them providing specific feedback to determine if and what changes should be made. We explained to participants that the focus group would be a one-time interaction. We asked participants about their knowledge of colon cancer screening to open the discussion. Using the think aloud method, participants reviewed the DA with the facilitator. 40 This was adapted from a previous study conducted by authors. 32 We asked participants to review the DA in detail, going over each line, and to “think-aloud” about the content. We asked participants to say everything that passed through their mind as they read. Cognitive interviews using this think-aloud approach allow researchers to understand how patients perceive and interpret the information presented and to identify any potential problems in the material. 40 Consistent with the conceptual framework, we probed to learn about participants’ knowledge (ie, what they found confusing and what they did and did not understand about the DA), their values (what they liked and did not like about the DA), and their decision support needs (what resources would be helpful). Based on feedback from the first focus group and following the principle of human-centered design, we made changes to the DA after listening to the audiotapes and reviewing notes where participants expressed confusion with statements, such as “I am not sure what you are trying to say here,” or “What exactly do you mean? The team (T.C., R.H., M.S.) met to discuss what the concerns seem to mean and based on health literacy principles and research, provided suggestions to revise the DA for the second focus group. We followed a similar procedure after the second focus group in addition to coding to incorporate feedback into the new DA. We asked participants if they were interested in receiving a copy of the final DA when the study was completed.
Part 2
Previous studies have used SMOG, PMOSE/IKIRSCH, PEMAT, and CDC Index42,43 to assess readability, document complexity, understandability, actionability, behavioral recommendations and risk communications of patient education materials. The goal of these health literacy assessments is to assess materials for their reading grade levels, their understandability, actionability, behavioral recommendation and risk communication. Since adults 75 and older are more likely to have below basic or basic health literacy levels than those under 75,44,45 patient education materials need to be designed and written at the lowest possible reading grade levels with less complexity to ensure that older adults can understand and act on risks and behavioral recommendations. While each of these tools individually assess patient materials in a specific area; collectively, they provide a comprehensive view of health literacy demand assessment. 42
SMOG
The SMOG provides a reading grade level equivalency to a document. 27 The SMOG predicts 100% comprehension 46 and was validated against the McCall-Crabbs Standard Test Lessons (a standardized reading comprehension test) (r = .99). The inter-rater reliability of the SMOG has shown to be 100% for the assessment of Web-based information on mental health and is best suited for health care applications because of the consistency of results and use of more recent validation criteria for determining reading grade level estimates.47-49 See Online Appendix for details on scoring.
PMOSE/IKIRSCH
The PMOSE/IKIRSCH provides a measure of document complexity by examining the structure and density of tables, graphs and charts contained in materials. Assessment of document complexity involves identifying and scoring documents based on the complexity of their structure (eg, simple list, nested lists) and their density (eg, number of labels and items on the list). 28 Scoring on the PMOSE/IKIRSCH ranges from Level 1 proficiency – very low complexity (range including grade 4 equivalent to less than 8 years of schooling) to Level 5 proficiency – very high complexity (range including 16 years of schooling to more advanced postgraduate degree). Studies using PMOSE/IKIRSCH focus on applying it to evaluate materials, not on its psychometric properties.41,43 See Online Appendix for details on scoring.
PEMAT
The PEMAT provides a measure for understandability (e.g. when consumers of diverse backgrounds and varying levels of health literacy can process and explain key messages) and a measure of actionability (e.g. when consumers of diverse backgrounds and varying levels of health literacy can identify what they can do based on the information presented). The higher the score, the more understandable or actionable the material is.29,30 The PEMAT has good interrater reliability (.92 for understandability and .93 for actionability) and demonstrates strong internal consistency (α = .77 for understandability; α = .75 for actionability).30,50 See Online Appendix for details on scoring.
CDC Index
The CDC Index is a research-based assessment designed to ensure that materials are clear and easily understood with a focus on behavioral recommendations and risk communication. The CDC Index provides a measure of clarity of a document by examining 7 areas: main message and call to action, language, information design, state of the science, behavioral recommendations, numbers, and risk. Scores of >=90% indicate the materials are easy to understand and use. Lower scores indicate revisions are necessary. 31 See Online Appendix for details on scoring. The validity and reliability of the CCI utilized surveys to evaluate information clarity and audience comprehension of actual CDC material along with the same material redesigned to address the Index question and items. Respondents answered 10 questions about either an original health material or one redesigned with the CCI. For 9 out of 10 questions, the materials revised using the CCI were rated higher than the original materials. Regardless of education level, respondents rated the revised materials more favorably than the original materials. The results indicate that the CCI performed as intended and seemed more likely that audiences could correctly identify the intended main message and understand the words and numbers in the materials. Chi-squares were calculated to determine if differences in proportions between respondents who saw original materials vs respondents who saw revised materials were statistically significant at .05 or less with 7 out of the 10 questions statistically significant. 49
Data Analysis
Part 1
The focus groups were audio-taped and transcribed verbatim using an external professional transcription service. Qualitative analyses were conducted using an iterative process and following standard techniques. 51 There were a total of 5 coders. All coders have extensive training in qualitative analyses as they have worked on other projects together. Following the Consolidated criteria for reporting qualitative research, 52 the entire team participated in coding the transcripts. The primary and senior author reviewed both transcripts and field notes line by line in their entirety to identify comments related to the Ottawa Decision Framework. 25
To triangulate the data, 53 the primary and senior author identified a total of 5 codes that reflected the conceptual framework. The primary author along with the two other coders then independently reviewed, made observations, and coded each transcript, and met to review their findings. They first manually coded the transcripts, employing a provisional code list based on our theoretical framework first developed by the primary and senior author in their review of the transcripts. The provisional codes were refined and revised throughout the coding process. These first order codes were assigned operational definitions.51,53 Using observer triangulation, to minimize the potential biases related to the results, one team member recoded the transcripts using the predetermined codes using NVivo 12 qualitative data analysis software.51,53,54 To ensure trustworthiness in the coding process, the primary author and other team members then reviewed coding. Discrepancies in coding were resolved through consensus among all team members. The second order coding occurred as we reviewed the codes to identify semantic relationships in our findings, which were used to group them into three overall themes: 1. Lack of understanding/confusing; 2. Lack of diversity; and 3. Information overload.
Part 2
Two trained authors (M.H., Z.A.) independently scored the 2010 DA and the newly developed DA for each tool. The two coders resolved any discrepancies by talking through the scores; consensus was reached.
Results
Demographics
Demographics of Participants (n = 15)
Themes
Focus Group Feedback on Making a Decision About Colon Cancer Screening
Lack of Understanding/Confusing
As illustrated by the quotes (see Table 2), participants indicated they were confused about aspects of the DA and asked lots of questions for clarification to understand why they needed to make a decision and talk with their doctor, what poor health meant and what they had to do with colon cancer screening. They also did not understand the connection between screening and treatment. There was confusion about the point of the pictogram.
Lack of inclusion
Participants indicated that while it is important to learn about colon cancer screening, it is also important to present the information in a manner that is inclusive such that they can access the material, and attention-grabbing so that they want to pick up, read it and share it with someone. Specifically, there were concerns about the lack of 1. Diversity among the patients in the DA; 2. Pictures about the content and 3. White space.
Information overload
Overall, patients wanted the DA to be shorter and simpler. They felt there was too much information. Specifically, there was too much information and details, and the DA was geared towards college educated populations.
Part 2 Health Literacy Assessment
Assessment Tool Scores
aAssessed each question on the self health score calculation page as a list structure.
Making a Decision: Should I Stop or Continue Colon Cancer Screening – Ages 75-85
Concerns and Modification Made to Inform Novel DA
Discussion
This study aimed to develop a novel brief colon cancer screening DA, “Making a Decision: Should I Stop or Continue Colon Cancer Screening – Ages 75-85,” based on feedback from adults ≥75 years with LHL and a health literacy assessment of the “Making a Decision About Colon Cancer Screening.” As the US population continues to age, grow more diverse, and experience income disparities 55 along with medical advances, there are low-value services where the potential risk outweigh the potential benefits. 56 Based on national recommendations, colon cancer screening for adults between 75 and 85 without consideration for life expectancy and the risk for testing, overdiagnosis, and over treatment is a low-value service. 57 Shared decision making (SDM) is an intervention to help providers and patients determine whether to screen or not based on life expectancy and whether the risks outweigh the benefits. DAs such as the ones described here can complement the SDM intervention.
There are needs for DA tools in general and a stronger need for DA tools that intentionally incorporate the needs of populations experiencing low health literacy. Adapting a co-design process can help ensure that the DA is relevant and accessible to the target population.32,58,59 Attention to LHL principles including feedback from the target population, when developing materials such as is critical to ensure that adults ≥ 75 years are able to understand and use information to inform their colon cancer screening decisions. LHL principles include but are not limited to universal precautions (health care providers are treating all patients as if they are at risk of not understanding/acting on health information), using plain language (word choices), and discussing the most important information first. Formal reading assessments of DA’s are rarely conducted or reported. 11 Doing so may lead to tools that are easier to understand, access and use.
There are some limitations to this study worth noting. Not all of the health literacy assessment tools were validated although they have been utilized in studies. The sample size was small (n = 15) which could result in bias as participants self-selected to participate in the study. Further, despite efforts to minimize researcher bias through triangulation, researcher bias may be evident.
Conclusion
Given appropriate support, older adults of all literacy levels can increase their knowledge, increase their self-efficacy, and can participate in colon cancer screening decisions. 59 Thus, based on participant feedback on “Making a Decision about Colon Cancer Screening” we developed a new DA, “Deciding to Stop or Continue Colon Cancer Screening Ages 75-85” that was viewed favorably by participants. As part of the co-design process and to ensure that the DA meets the International DA standards, future work will be to conduct acceptability testing with older adults with low health literacy in another region of the US, their caregivers and health care providers, and to test its effect on colon cancer screening decisions.
Supplemental Material
Supplemental Material - Early Feedback for the Development of a Novel Brief Colon Cancer Screening Decision Aid for Adults > 75 years at Risk for Limited Health Literacy: A Pilot Study
Supplemental Material for Early Feedback for the Development of a Novel Brief Colon Cancer Screening Decision Aid for Adults
Supplemental Material
Supplemental Material - Early Feedback for the Development of a Novel Brief Colon Cancer Screening Decision Aid for Adults > 75 years at Risk for Limited Health Literacy: A Pilot Study
Supplemental Material for Early Feedback for the Development of a Novel Brief Colon Cancer Screening Decision Aid for Adults
Supplemental Material
Supplemental Material - Early Feedback for the Development of a Novel Brief Colon Cancer Screening Decision Aid for Adults > 75 years at Risk for Limited Health Literacy: A Pilot Study
Supplemental Material for Early Feedback for the Development of a Novel Brief Colon Cancer Screening Decision Aid for Adults
Footnotes
Acknowledgements
Latham, CE MS - School of Social Policy and Practice, University of Pennsylvania, Philadelphia, PA 19104; Editing and Reference Management
Ethical Considerations
This study received IRB approval from the Simmons College (University), Boston, MA, IRB#17-031 (9/8/2017). Participants were consented using an approved consent form.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study is supported by National Cancer Institute; K24 AG071906. National institute of aging; K23AG062795
Declaration of Conflicting Interests
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Cadet: NIH/NIA K23AG062795-01 Mentored Patient-Oriented Career Development Grant; Dr Schonberg: NIH/NIA K24 AG071906 Mid-Career Investigator Award. The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication
Supplemental Material
Supplemental material for this article is available online.
References
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