Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives.

Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials.

Can fish consumption advisories do better? Providing benefit and risk information to increase knowledge.

Humans exposed to methylmercury (MeHg) can suffer from adverse health impacts, e.g., serious neurological damage; however, fish is also a good source of omega-3 fish oils which promotes infants' neurological development. Because eating fish is the primary mechanism of MeHg exposure, federal and state agencies issue fish consumption advisories to inform the public about the risks of eating contaminated fish. An advisory's purpose is to provide information to consumers to increase their knowledge of specific product attributes; however, the difficulty in communicating both the risks and benefits of eating fish leads readers of fish advisories to over-restrict their fish consumption. Because the effectiveness of fish consumption advisories are not often evaluated by states, we help fill this gap by evaluating the effectiveness of Maine's fish consumption advisory in terms of improving knowledge. The results suggest the advisory successfully increased women's knowledge of both the benefits and risks of consuming fish while pregnant. The advisory also increased their ability to differentiate fish by their MeHg content, knowledge of both low and high-MeHg fish and knowledge of detailed attributes of seemingly substitutable goods, such as white tuna, light tuna and pre-packaged salmon. People who did not read the advisory lack the knowledge of how to identify fish that provide: health benefits like Omega-3 fatty acids, or health risks like MeHg; reading the advisory reduces this lack of knowledge. Readers increased ability to make specific substitutions to minimize risk while maintaining the benefits of fish eating suggests the advisory has the potential of reducing MeHg-related health risks while avoiding the drop in fish consumption show in other studies.

Plain language: a strategic response to the health literacy challenge.

Low health literacy is a major challenge confronting American and international health organizations. Research in the past decade has documented the prevalence of limited literacy and limited health literacy skills among adults worldwide. This creates a major policy challenge: how to create text-based health information - a common method of health communication - that is accessible to the public. Plain language is a logical, flexible response. While touted by American, Canadian, and European health policy makers, adoption and promotion of plain language standards and skills in health-focused organizations have lagged. Most text-based health information continues to be too hard for most adults to read. Barriers to more rapid diffusion of plain language are reflected in a set of myths perpetuated by critics. These myths are identified and refuted. While plain language is only one of many broad-based solutions needed to address low health literacy, the benefits to everyone demand increased use by health organizations.

Patient education materials about the treatment of early-stage prostate cancer: a critical review.

BACKGROUND: To ensure that patients make informed medical decisions, patient education materials must communicate treatment risks and benefits. OBJECTIVE: To survey publicly available patient education materials and assess their suitability to support informed decision making in early-stage prostate cancer. DESIGN: Cross-sectional review of Internet, print, and multimedia sources. SETTING: University data analysis laboratory. MEASUREMENTS: The content of 44 materials that described all standard treatment options was reviewed. Top-rated documents underwent plain-language review. Total score on 54 content items and accuracy, balance, and plain-language evaluation was measured. RESULTS: 502 of 546 patient education materials did not describe all standard treatments (watchful waiting, surgery, radiation, and hormone therapy). Eighty percent of the 44 materials that addressed standard treatments and underwent content review described anatomy, physiology, stage, and grade of cancer. Half of the materials fully described radical prostatectomy and radiation therapy. One third of the materials included risks and benefits of each treatment; none explicitly compared outcomes of all treatments in a single summary. Information was accurate and balanced but did not include key content for informed consent. LIMITATIONS: The search was restricted to publicly available materials and did not include books or materials written in languages other than English. The accuracy, balance, and plain-language reviews were evaluated by 1 reviewer. The criteria reflect the authors' focus on informed decision making. Other aspects of health education may require a different evaluation template. CONCLUSIONS: Currently available patient education materials on early-stage prostate cancer treatment do not contain comprehensive information about the risks and benefits of each treatment. To assist patients and physicians in choosing among prostate cancer treatment options, a new generation of materials is needed.

Evidence-based patient choice: a prostate cancer decision aid in plain language.

BACKGROUND: Decision aids (DA) to assist patients in evaluating treatment options and sharing in decision making have proliferated in recent years. Most require high literacy and do not use plain language principles. We describe one of the first attempts to design a decision aid using principles from reading research and document design. The plain language DA prototype addressed treatment decisions for localized prostate cancer. Evaluation assessed impact on knowledge, decisions, and discussions with doctors in men newly diagnosed with prostate cancer. METHODS: Document development steps included preparing an evidence-based DA in standard medical parlance, iteratively translating it to emphasize shared decision making and plain language in three formats (booklet, Internet, and audio-tape). Scientific review of medical content was integrated with expert health literacy review of document structure and design. Formative evaluation methods included focus groups (n = 4) and survey of a new sample of men newly diagnosed with prostate cancer (n = 60), compared with historical controls (n = 184). RESULTS: A transparent description of the development process and design elements is reported. Formative evaluation among newly diagnosed prostate cancer patients found the DA to be clear and useful in reaching a decision. Newly diagnosed patients reported more discussions with doctors about treatment options, and showed increases in knowledge of side effects of radiation therapy. CONCLUSION: The plain language DA presenting medical evidence in text and numerical formats appears acceptable and useful in decision-making about localized prostate cancer treatment. Further testing should evaluate the impact of all three media on decisions made and quality of life in the survivorship period, especially among very low literacy men.