A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes.

OBJECTIVES: We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program (DPP) lifestyle intervention. METHODS: Between July 2008 and November 2010, we individually randomized 509 overweight or obese, low-income, nondiabetic adults with elevated blood glucose in Indianapolis, Indiana, to receive standard care plus brief lifestyle counseling or be offered a group-based YMCA adaptation of the DPP (YDPP). Primary outcome was mean weight loss difference at 12 months. In our intention-to-treat analyses, we used longitudinal linear or logistic regression, multiply imputing missing observations. We used instrumental variables regression to estimate weight loss effectiveness among participants completing 9 or more intervention lessons. RESULTS: In the YDPP arm, 161 (62.6%) participants attended ≥ 1 lesson and 103 (40.0%) completed 9 or more lessons. In intention-to-treat analysis, mean 12-month weight loss was 2.3 kilograms (95% confidence interval [CI] = 1.1, 3.4 kg) more for the YDPP arm than for standard care participants. In instrumental variable analyses, persons attending 9 or more lessons had a 5.3-kilogram (95% CI = 2.8, 7.9 kg) greater weight loss than did those with standard care alone. CONCLUSIONS: The YMCA model for DPP delivery achieves meaningful weight loss at 12 months among low-income adults.

Discordant Care and Decision Quality: Patients' Reasons for Not Receiving Their Initial Test of Choice in Colorectal Cancer Screening.

BACKGROUND: Concordance between a person's values and the test or treatment they ultimately receive is widely considered to be an essential outcome for good decision quality. There is little research, however, on why patients receive "discordant" care. A large, randomized trial of decision aids for colorectal cancer (CRC) screening provided an opportunity to assess why some patients received a different test than the one they preferred at an earlier time point. METHODS: Of 688 patients who participated in the trial, 43 received a different CRC screening test than the one they selected after viewing a decision aid 6 mo prior. These patients answered 2 brief, open-ended questions about the reasons for this discordance. The research team analyzed their answers using qualitative description. RESULTS: Patient responses reflected 6 major categories: barriers or risks of initially favored test, benefits of alternative test, costs or health insurance coverage, discussion with family or friends, provider factors or recommendation, and health issues. CONCLUSIONS: Some of the patients' explanations fit well with the informed concordance approach, which infers poor decision quality from the existence of discordant care, since in these cases it appears that the patient's values and preferences were not adequately respected. Other statements suggest that the patient had an informed rationale for changing their mind about which test to undergo. These cases may reflect high-quality decision making, despite the existence of discordance as measured in the trial. This analysis highlights a major challenge to a popular approach for assessing decision quality, the difficulty of normatively assessing the quality of decision making when apparent discordant care has been provided, and the need to assess patient values and preference over time. HIGHLIGHTS: Value-choice concordance is an accepted measure for assessing decision quality in decision aid trials, but greater exploration of apparently discordant care challenges key assumptions of this method; this study provides evidence that discordance as typically measured may not always reflect low-quality patient decision making.Researchers evaluating decision aids and assessing decision quality should consider the use of qualitative methods to supplement measures of decision quality and consider assessing patient preferences at multiple time points.

Patient understanding of pharmacogenomic test results in clinical care.

OBJECTIVE: Previous research has not objectively assessed patients' comprehension of their pharmacogenomic test results. In this study we assessed understanding of patients who had undergone cytochrome P450 2C19 (CYP2C19) pharmacogenomic testing. METHODS: 31 semi-structured interviews with patients who underwent CYP2C19 testing after cardiac catheterization and had been sent a brochure, letter, and wallet card explaining their results. Answers to Likert and binary questions were summarized with descriptive statistics. Qualitative data were analyzed using a grounded theory approach, with particular focus on categorization. RESULTS: No participants knew the name of the gene tested or their metabolizer status. Seven participants (23%) knew whether the testing identified any medications that would have lower effectiveness or increased adverse effects for them at standard doses ("Adequate Understanding"). Four participants (13%) read their results from the letter or wallet card they received but had no independent understanding ("Reliant on Written Materials"). Ten participants remembered receiving the written materials (32%). CONCLUSION: A majority of participants who had undergone CYP2C19 PGx testing did not understand their results at even a minimal level and would be unable to communicate them to future providers. PRACTICE IMPLICATIONS: Further research is necessary to improve patient understanding of PGx testing and their results, potentially through improving patient-provider communication.

Biobank Participants' Attitudes toward Requiring Understanding for Biobank Consent.

Biobank participants often do not understand the information they are provided during the informed consent process. Ethicists and other stakeholders have disagreed, however, on the appropriate response to these failures in understanding. This paper describes an attempt to address this issue by conducting knowledge tests with 22 recent biobank enrollees, followed by in-depth, semistructured interviews about the goal of understanding in biobank consent. The interviews revealed that while biobank enrollees thought the information on the knowledge test was important, they did not think that performance on the test should affect whether individuals are permitted to enroll in a biobank. Three main themes emerged from the interviews: helping others by contributing to research is more important than understanding consent forms, less understanding is required because biobank-based research is low risk, and only a small amount of information in the consent form is really essential. These perspectives should be considered in discussing the ethics and governance of biobank consent processes.

Measuring the Impact of Quantitative Information on Patient Understanding: Approaches for Assessing the Adequacy of Patient Knowledge about Colorectal Cancer Screening.

Background. Guidelines recommend that decision aids disclose quantitative information to patients considering colorectal cancer (CRC) screening, but the impact on patient knowledge and decision making is limited. An important challenge for assessing any disclosure involves determining when an individual has "adequate knowledge" to make a decision. Methods. We analyzed data from a trial that randomized 213 patients to view a decision aid about CRC screening that contained verbal information (qualitative arm) versus one containing verbal plus quantitative information (quantitative arm). We analyzed participants' answers to 8 "qualitative knowledge" questions, which did not cover the quantitative information, at baseline (T0) and after viewing the decision aid (T1). We introduce a novel approach that defines adequate knowledge as correctly answering all of a subset of questions that are particularly relevant because of the participant's test choice ("Choice-Based Knowledge Assessment"). Results. Participants in the quantitative arm answered a higher mean number of knowledge questions correctly at T1 than did participants in the qualitative arm (7.3 v. 6.9, P < 0.05), and they more frequently had adequate knowledge at T1 based on a cutoff of 6 or 7 correct out of 8 (94% v. 83%, P < 0.05, and 86% v. 71%, P < 0.05, respectively). Members of the quantitative group also more frequently had adequate knowledge at T1 when assessed by Choice-Based Knowledge Assessment (87% v. 76%, P < 0.05). Conclusions. Patients who viewed quantitative information in addition to verbal information had greater qualitative knowledge and more frequently had adequate knowledge compared with those who viewed verbal information alone, according to most ways of defining adequate knowledge. Quantitative information may have helped participants better understand qualitative or gist concepts. Trial Registration: ClinicalTrials.gov ID# NCT01415479. Highlights: Patients who viewed quantitative information in a decision aid about colorectal cancer screening were more knowledgeable about nonquantitative information and were more likely to have adequate knowledge according to a variety of approaches for assessing that, compared with individuals who viewed only qualitative information. This result supports the inclusion of quantitative information in decision aids.Researchers assessing patient understanding should consider a variety of ways to define adequate knowledge when assessing decision quality.

Layperson Views about the Design and Evaluation of Decision Aids: A Public Deliberation.

PURPOSE: We carried out the first public deliberation to elicit lay input regarding guidelines for the design and evaluation of decision aids, focusing on the example of colorectal ("colon") cancer screening. METHODS: A random, demographically stratified sample of 28 laypeople convened for 4 days, during which they were informed about key issues regarding colon cancer, screening tests, risk communication, and decision aids. Participants then deliberated in small and large group sessions about the following: 1) What information should be included in all decision aids for colon screening? 2) What risk information should be in a decision aid and how should risk information be presented? 3) What makes a screening decision a good one (reasonable or legitimate)? 4) What makes a decision aid and the advice it provides trustworthy? With the help of a trained facilitator, the deliberants formulated recommendations, and a vote was held on each to identify support and alternative views. RESULTS: Twenty-one recommendations ("deliberative conclusions") were strongly supported. Some conclusions matched current recommendations, such as that decision aids should be available for use with and without providers present (conclusions 1-4) and should support informed choice (conclusion 9). Some conclusions differed from current recommendations, at least in emphasis-for example, that decision aids should disclose cost of screening (conclusion 11) and should be kept simple and understandable (conclusion 14). Deliberants recommended that decision aids should disclose the baseline risk of getting colon cancer (conclusions 15, 17). LIMITATIONS: Single location and medical decision. CONCLUSIONS: Guidelines for design of decision aids should consider putting a greater focus on disclosing cost and keeping decision aids simple, and they possibly should recommend disclosing less extensive amounts of quantitative information than currently recommended.

Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding.

BACKGROUND: Biobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees' comprehension under an "integrated consent" process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how much patients understand after enrolling under these conditions. Methods: We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants. Results: Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% "I don't know." In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% "I don't know." Participants scored particularly poorly on questions about data sharing and accessing medical records. Conclusions: Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank.

An arts-based educational exhibit on menopausal hot flashes.

OBJECTIVE: The aim of this study was to describe the development process, science, and symbolism of an arts-based educational exhibit designed to address myths, misinformation, negative imagery, and use of unproven treatments related to menopausal hot flashes. METHODS: The development process included iterative and informal feedback from a variety of individuals, a partnership with an experienced exhibit designer, and collaborations between artists and scientists. RESULTS: The resulting exhibit creates an environment where the public is immersed in accurate information about hot flashes. Although based on an iterative process, the resulting exhibit content reflects an estimated 500+ scientific studies, including those referenced in The North American Menopause Society position statements on hormone and nonhormone management of hot flashes. The seven main exhibit pieces convey scientific information and symbolize various aspects of women's experiences. CONCLUSIONS: This innovative exhibit has high potential to be a disruptive innovation to address the preponderance of myths, misinformation, and negative imagery surrounding menopausal hot flashes and potentially decrease the use of unproven therapies.

Focus group reactions to an arts-based educational exhibit on menopausal hot flashes.

OBJECTIVE: To assess public reactions to an arts-based educational exhibit designed to immerse and engage people in scientific facts to increase their conceptual understanding of hot flashes. Our ultimate goals were to stimulate learning and conversations about menopausal hot flashes to change interactions between menopausal women and providers, and menopausal women and other people (family, friends, etc). Focus groups reacted to the concept art (graphics, miniaturized model); and a questionnaire for quickly assessing reactions. METHODS: Using a qualitative descriptive methodology, six focus groups of diverse people (n = 50) aged 13 to 64 years described their reactions to the art and questionnaire. Recruitment methods were word of mouth, advertisements on university websites, and a university-based participant registry. Data were analyzed using qualitative content analysis and inductively derived codes. RESULTS: Reactions to the concept art were generally favorable. Participants remarked on appealing and less appealing aspects and age appropriateness. Appealing aspects were resonance with women's experiences, clear information, use of symbolism, and overall design. Less appealing aspects lacked resonance, contained confusing information, or unappealing design elements. Participants felt the exhibit should be open to all ages. The final questionnaire reflected participants' descriptions of the art's ability to stimulate learning, dispel myths, spur dialog, and increase empathy. CONCLUSIONS: The concept art is an appropriate tool for improving knowledge and communication about hot flashes. Displaying the concept art and/or future full-scale exhibit in healthcare settings or public venues may facilitate learning and communication among three groups-menopausal women, healthcare providers, and others.

Public survey reactions to an arts-based educational menopausal hot flash exhibit.

OBJECTIVE: The aim of this study was to obtain public survey reactions to concept art for an exhibit about menopausal hot flashes designed to stimulate learning, dispel myths, spur dialogue, and increase empathy. METHODS: Immediately before viewing the art, participants provided demographic information and answered one open-ended question. Immediately after viewing the art, participants answered the same open-ended question, one additional open-ended question, and completed quantitative survey questions. RESULTS: Overall, public reactions to the concept art were positive. Qualitative and quantitative data indicated that the public thought the exhibit was appealing, stimulated learning, dispelled myths, spurred desire to have conversations about hot flashes, and increased empathy for women with menopausal hot flashes. CONCLUSIONS: The exhibit concept art was appealing and was reported to have a positive impact on the public. Study findings provide support for building the exhibit full-scale as a traveling educational resource that might change public discourse around menopausal hot flashes.

Impact of including quantitative information in a decision aid for colorectal cancer screening: A randomized controlled trial.

OBJECTIVE: Guidelines recommend that decision aids provide quantitative information about risks and benefits of available options. Impact of providing this information is unknown. METHODS: Randomized trial comparing two decision aids about colorectal cancer (CRC) screening with colonoscopy or fecal immunochemical test (FIT). 688 primary care patients due for CRC screening viewed a decision aid that uses words only (Verbal arm) vs. one that provides quantitative information (Quantitative arm). Main outcomes included perceived CRC risk, intent to be screened, and test preference, measured before and after viewing decision aid, and screening uptake at six months. Analyses were performed with ANCOVA and logistic regression. RESULTS: Compared to the Verbal arm, those in the Quantitative arm had a larger increase in intent to undergo FIT (p = 0.011) and were more likely to switch their preferred test from non-FIT to FIT (28% vs. 19%, p = .010). There were decreases in perceived risk in the Verbal Arm but not the Quantitative Arm (p = 0.004). There was no difference in screening uptake. Numeracy did not moderate any effects. CONCLUSIONS: Quantitative information had relatively minor impact and no clearly negative effects, such as reducing uptake. PRACTICE IMPLICATIONS: Quantitative information may be useful but not essential for patients viewing decision aids.

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial.

BACKGROUND: Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a "nudge" towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge. METHODS: Primary care patients (n = 213) eligible for colorectal cancer screening viewed basic screening information and were randomized to view (a) quantitative information (quantitative module), (b) a nudge towards stool testing with the fecal immunochemical test (FIT) (nudge module), (c) neither a nor b, or (d) both a and b. Outcome measures were perceived colorectal cancer risk, screening intent, preferred test, and decision conflict, measured before and after viewing the decision aid, and screening behavior at 6 months. RESULTS: Patients viewing the quantitative module were more likely to be screened than those who did not ( P = 0.012). Patients viewing the nudge module had a greater increase in perceived colorectal cancer risk than those who did not ( P = 0.041). Those viewing the quantitative module had a smaller increase in perceived risk than those who did not ( P = 0.046), and the effect was moderated by numeracy. Among patients with high numeracy who did not view the nudge module, those who viewed the quantitative module had a greater increase in intent to undergo FIT ( P = 0.028) than did those who did not. LIMITATIONS: The limitations of this study were the limited sample size and single healthcare system. CONCLUSIONS: Adding quantitative information to a decision aid increased uptake of colorectal cancer screening, while adding a nudge to undergo FIT did not increase uptake. Further research on quantitative information in decision aids is warranted.

Retention strategies in longitudinal studies with emerging adults.

PURPOSE/OBJECTIVES: The purpose of this report was to describe retention strategies that were useful and those that were not in a longitudinal study of emerging adults. BACKGROUND: A longitudinal study examining the transition to young adulthood among emerging adults with type 1 diabetes, which had success in retention, provided the context for describing retention strategies. RATIONALE: A challenge in longitudinally designed studies is retention of participants because the loss decreases power for statistical analysis. Given that emerging adulthood is a period of instability, retention is particularly challenging among this population. However, longitudinal studies are the best way to understand developmental changes, and it is also important to increase our knowledge of health outcomes during emerging adulthood. DESCRIPTION: Retention strategies used in the study are described, including promoting a positive relationship with participants, maintaining contact with participants, having a study staff with good interpersonal skills, using incentives, conveying respect for participants, and using user-friendly data collection. OUTCOMES: Useful strategies to promote a positive relationship included sending cards and newsletters to participants, maintaining consistency of contact person, and expressing appreciation for participant's time and effort. Useful strategies for maintaining contact with participants included obtaining contact information at every data collection point, maintaining birth dates and chart numbers in tracking databases, monitoring returned mail, and using Web search engines. Other useful strategies were providing incentives to participants, employing staff with good interpersonal skills, providing participants with choices when appropriate, and using user-friendly data collection. One strategy, using contests, was not found useful. CONCLUSIONS: Despite the challenges of conducting longitudinally designed studies with emerging adults, multiple retention strategies can be used that are useful to retention. IMPLICATIONS: It is feasible to conduct longitudinal studies with emerging adults despite the challenges.

Rationale, design, and baseline characteristics of a community-based comparative effectiveness trial to prevent type 2 diabetes in economically disadvantaged adults: the RAPID Study.

Reaching Out and Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA. RAPID enrolled adult primary care patients, with BMI 24 kg/m(2) or higher and abnormal glucose metabolism (HbA1c 5.7-6.9% or fasting plasma glucose 100-125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period. At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 lbs, and BMI of 36.9 ± 8.6 kg/m(2). 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥130 mmHg, 33.1% had a total blood cholesterol exceeding 200mg/dL, and 74% reported a household income of <$25,000. The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes.

Discussions of life expectancy moderate relationships between prognosis and anxiety or depression in men with advanced cancer.

PURPOSE: Oncologists avoid prognostic discussions due to concerns about increasing patients' anxiety or depression. We sought to determine if perceived prognosis or extent of prognostic discussions predicted anxiety or depression and whether prognostic discussions moderated the relationship between prognosis and anxiety or depression. METHODS: Men with advanced cancer and their oncologists estimated the likelihood of survival at 6 months and reported extent of prognostic discussions. Anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS). RESULTS: Men who died within 6 months reported higher scores on depression but not anxiety. Men who estimated a lower (10%-75%) likelihood of surviving at least 6 months were more depressed and anxious than men who estimated a higher (>90%) likelihood of survival. A similar relationship was seen with oncologists' prognostications. Men who reported having had full prognostic discussions with their oncologist had less depression compared with men who reported having had brief or no discussions. Men for whom the oncologists reported a full discussion had greater anxiety. The relationships between patient-perceived prognosis and depression or anxiety were moderated by extent of prognostic discussions as reported by the patient or oncologist, respectively. CONCLUSION: Full prognostic discussions are associated with less depression among men who perceive a poor prognosis. Anxiety is increased in men if the oncologists report a full discussion. Oncologists should engage in prognostic discussions but assess for increased anxiety to facilitate coping with advanced cancer.