From guidelines to decision aids and adherence supports: Insights from the process of evidence translation.

OBJECTIVE: To explore the evidence-translator's experience of the expert-recommended process of translating guidelines into tools for decision making, action, and adherence with the goal of improvement. METHODS: A single reviewer dual reviewed the content, quality, certainty, and applicability of primary atherosclerotic cardiovascular prevention guidelines from the U.S. Preventive Services Task Force at the time of this work and used targeted searches of Medline to define the ideal structure and outcomes of tools; fill in gaps in guidelines; identify end-user needs; and choose and optimize existing tools in preparation for testing. RESULTS: Guidelines addressed screening, treatments, and/or supports, but never the combination of all three. None provided all of the information needed for evidence translation. Searches in Medline filled in some evidence gaps and provided key insights into end-user needs and effective tools. However, evidence translators are left with complicated decisions about how to use and align evidence. CONCLUSION: Guidelines provide some, but not all, of the evidence needed for evidence translation, requiring additional intensive work. Evidence gaps result in complicated decisions about how to use and align evidence and balance feasibility and rigor. PRACTICE IMPLICATIONS: Guidelines, standards groups, and researchers should work to better support the process of evidence translation.

Beginning with high value care in mind: A scoping review and toolkit to support the content, delivery, measurement, and sustainment of high value care.

OBJECTIVE: To create a shared vision for the content, delivery, measurement, and sustainment of patient-centered high value care. METHODS: We performed a scoping review and translated findings into toolkit for system leaders. For our scoping review, we searched Medline, 2005-November 2015, for literature on patient-centered care (PCC) and its relationship to a high value care change model. We supplemented searches with key author, Google Scholar, and key website searches. One author reviewed all titles, abstracts, and articles for inclusion; another reviewed a random 20%. To develop our toolkit, we translated evidence into simple, actionable briefs on key topics and added resources. We then iteratively circulated briefs and the overall toolkit to potential users, making updates as needed. RESULTS: In our scoping review, we found multiple interventions and measures to support the components of PCC and our change model. We found little on the overall effects of PCC or how PCC creates value. Potential users reported our toolkit was simple, understandable, thorough, timely, and likely to be globally useful. CONCLUSIONS: Considerable evidence supports patient-centered high value care and a toolkit garnered enthusiasm. PRACTICE IMPLICATIONS: The toolkit is ready for use, but needs comparison to other approaches.

Exploring factors that might influence primary-care provider discussion of and recommendation for prostate and colon cancer screening.

BACKGROUND: Primary-care providers may contribute to the use of low-value cancer screening. OBJECTIVE: We sought to examine circumstances under which primary-care providers would discuss and recommend two types of cancer screening services across a spectrum of net benefit and other factors known to influence screening. PATIENTS AND METHODS: This was a cross sectional survey of 126 primary-care providers in 24 primary-care clinics in the US. Participants completed surveys with two hypothetical screening scenarios for prostate or colorectal cancer (CRC). Patients in the scenarios varied by age and screening-request status. For each scenario, providers indicated whether they would discuss and recommend screening. Providers also reported on their screening attitudes and the influence of other factors known to affect screening (short patient visits, worry about lawsuits, clinical reminders/performance measures, and screening guidelines). We examined associations between providers' attitudes and their screening recommendations for hypothetical 90-year-olds (the lowest-value screening). RESULTS: Providers reported they would discuss cancer screening more often than they would recommend it (P<0.001). More providers would discuss and recommend screening for CRC than prostate cancer (P<0.001), for younger than older patients (P<0.001), and when the patient requested it than when not (P<0.001). For a 90-year-old patient, every point increase in cancer-specific screening attitude increased the likelihood of a screening recommendation (30% for prostate cancer and 30% for CRC). DISCUSSION: While most providers' reported practice patterns aligned with net benefit, some providers would discuss and recommend low-value cancer screening, particularly when faced with a patient request. CONCLUSION: More work appears to be needed to help providers to discuss and recommend screening that aligns with value.

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist.

BACKGROUND: Patient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs. METHODS: An international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases: (1) planning, (2) drafting and (3) consensus, which included a modified, two-stage, online international Delphi process. The work was conducted over 2 years with bimonthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist. RESULTS: The SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies. CONCLUSION: The SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the checklist.

A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial.

IMPORTANCE: Healthcare overuse, the delivery of low-value services, is increasingly recognized as a critical problem. However, little is known about the comparative effectiveness of alternate formats for presenting benefits and harms information to patients as a strategy to reduce overuse. OBJECTIVE: To examine the effect of different benefits and harms presentations on patients' intentions to accept low-value or potentially low-value screening services (prostate cancer screening in men ages 50-69 years; osteoporosis screening in low-risk women ages 50-64 years; or colorectal cancer screening in men and women ages 76-85 years). DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of 775 individuals eligible to receive information about any 1 of the 3 screening services and scheduled for a visit with their clinician. Participants were randomized to 1 of 4 intervention arms that differed in terms of presentation format: words, numbers, numbers plus narrative, and numbers plus framed presentation. The trial was conducted from September 2012 to June 2014 at 2 family medicine and 2 internal medicine practices affiliated with the Duke Primary Care Research Consortium. The data were analyzed between May and September of 2015. INTERVENTIONS: One-page evidence-based decision support sheets on each of the 3 screening services, with benefits and harms information presented in 1 of 4 formats: words, numbers, numbers plus narratives, or numbers plus a framed presentation. MAIN OUTCOMES AND MEASURES: The primary outcome was change in intention to accept screening (on a response scale from 1 to 5). Our secondary outcomes included general and disease-specific knowledge, perceived risk and consequences of disease, screening attitudes, perceived net benefit of screening, values clarity, and self-efficacy for screening. RESULTS: We enrolled and randomly allocated 775 individuals, aged 50 to 85 years, to 1 of 4 intervention arms: 195 to words, 192 to numbers, 196 to narrative, and 192 to framed formats. Intentions to accept screening were high before the intervention and change in intentions did not differ across intervention arms (words, -0.07; numbers, -0.05; numbers plus narrative, -0.12; numbers plus framed presentation, -0.02; P = .57 for all comparisons). Change in other outcomes also showed no difference across intervention arms. Results were similar when stratified by screening service. CONCLUSIONS AND RELEVANCE: Single, brief, written decision support interventions, such as the ones in this study, are unlikely to be sufficient to change intentions for screening. Alternate and additional interventions are needed to reduce overused screening services. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01694784.

Quantifying the utility of taking pills for preventing adverse health outcomes: a cross-sectional survey.

OBJECTIVES: The utility value attributed to taking pills for prevention can have a major effect on the cost-effectiveness of interventions, but few published studies have systematically quantified this value. We sought to quantify the utility value of taking pills used for prevention of cardiovascular disease (CVD). DESIGN: Cross-sectional survey. SETTING: Central North Carolina. PARTICIPANTS: 708 healthcare employees aged 18 years and older. PRIMARY AND SECONDARY OUTCOMES: Utility values for taking 1 pill/day, assessed using time trade-off, modified standard gamble and willingness-to-pay methods. RESULTS: Mean age of respondents was 43 years (19-74). The majority of the respondents were female (83%) and Caucasian (80%). Most (80%) took at least 2 pills/day. Mean utility values for taking 1 pill/day using the time trade-off method were: 0.9972 (95% CI 0.9962 to 0.9980). Values derived from the standard gamble and willingness-to-pay methods were 0.9967 (0.9954 to 0.9979) and 0.9989 (95% CI 0.9986 to 0.9991), respectively. Utility values varied little across characteristics such as age, sex, race, education level or number of pills taken per day. CONCLUSIONS: The utility value of taking pills daily in order to prevent an adverse CVD health outcome is approximately 0.997.

Different Measures, Different Outcomes? A Systematic Review of Performance-Based versus Self-Reported Measures of Health Literacy and Numeracy.

BACKGROUND: Health literacy (HL) and numeracy are measured by one of two methods: performance on objective tests or self-report of one's skills. Whether results from these methods differ in their relationship to health outcomes or use of health services is unknown. METHODS: We performed a systematic review to identify and evaluate articles that measured both performance-based and self-reported HL or numeracy and examined their relationship to health outcomes or health service use. To identify studies, we started with an AHRQ-funded systematic review of HL and health outcomes. We then looked for newer studies by searching MEDLINE from 1 February 2010 to 9 December 2014. We included English language studies meeting pre-specified criteria. Two reviewers independently assessed abstracts and studies for inclusion and graded study quality. One reviewer abstracted information from included studies while a second checked content for accuracy. RESULTS: We identified four "fair" quality studies that met inclusion criteria for our review. Two studies measuring HL found no differences between performance-based and self-reported HL for association with self-reported outcomes (including diabetes, stroke, hypertension) or a physician-completed rheumatoid arthritis disease activity score. However, HL measures were differentially related to a patient-completed health assessment questionnaire and to a patient's ability to interpret their prescription medication name and dose from a medication bottle. Only one study measured numeracy and found no difference between performance-based and self-reported measures of numeracy and colorectal cancer (CRC) screening utilization. However, in a moderator analysis from the same study, performance-based and self-reported numeracy were differentially related to CRC screening utilization when stratified by certain patient-provider communication behaviors (e.g., the chance to always ask questions and get the support that is needed). DISCUSSION: Most studies found no difference in the relationship between results of performance-based and self-reported measures and outcomes. However, we identified few studies using multiple instruments and/or objective outcomes.

Adult Patients' Perspectives on the Benefits and Harms of Overused Screening Tests: a Qualitative Study.

BACKGROUND: In recent years, there has been a growing interest in reducing the overuse of healthcare services. However, little is known about how patients conceptualize the benefits and harms of overused screening tests or how patients make decisions regarding these tests. OBJECTIVE: To determine how patients think about the harms and benefits of overused screening tests and how they consider these and other factors when making decisions. DESIGN: Semi-structured, qualitative interviews. PARTICIPANTS: The study comprised 50 patients, ages 50-84, who had previously received or not received any of four overused screening services: 1) prostate cancer screening (men ages 50-69), 2) colon cancer screening (men and women ages 76-85), 3) osteoporosis screening (low-risk women ages 50-64), or 4) cardiovascular disease screening (low-risk men and women ages 50-85). APPROACH: We conducted a thematic analysis, using a hybrid inductive-deductive approach. Two independent coders analyzed interview transcriptions to identify themes and exemplifying quotes. KEY RESULTS: Many patients could not name a harm of screening. When they did name harms, patients often focused on only the harms of the screening test itself and rarely mentioned harms further along the screening cascade (e.g., from follow-up testing and treatment). In contrast, patients could easily name benefits of screening, although many seemed to misunderstand or overestimate the magnitude of the benefits. Furthermore, patients described many additional factors they considered when making screening decisions, including their clinicians' recommendations, their age, family or friends' experiences with disease, and insurance coverage. CONCLUSIONS: This study highlights the need to help adults recognize and understand the benefits and harms of screening and make appropriate decisions about overused screening tests.

Quantifying the utility of taking pills for cardiovascular prevention.

BACKGROUND: The decrease in utility attributed to taking pills for cardiovascular prevention can have major effects on the cost-effectiveness of interventions but has not been well studied. We sought to measure the utility of daily pill-taking for cardiovascular prevention. METHODS AND RESULTS: We conducted a cross-sectional Internet-based survey of 1000 US residents aged ≥30 in March 2014. We calculated utility values, using time trade-off as our primary method and standard gamble and willingness-to-pay techniques as secondary analyses. Mean age of respondents was 50 years. Most were female (59%) and white (63%); 28% had less than a college degree; and 79% took ≥1 pills daily. Mean utility using the time trade-off method was 0.990 (95% confidence interval, 0.988-0.992), including ≈70% not willing to trade any amount of time to avoid taking a preventive pill daily. Using the standard gamble method, mean utility was 0.991 (0.989-0.993), with 62% not willing to risk any chance of death. Respondents were willing to pay an average of $1445 to avoid taking a pill daily, which translated to a mean utility of 0.994 (0.940-0.997), including 41% unwilling to pay any amount. Time trade-off-based utility varied by age (decreasing utility as age increased), sex, race, numeracy, difficulty with obtaining pills, and number of pills taken per day but did not vary by education level, literacy, or income. CONCLUSIONS: Mean utility for taking a pill daily for cardiovascular prevention is ≈0.990 to 0.994.

Clinicians' perceptions of the benefits and harms of prostate and colorectal cancer screening.

BACKGROUND: Clinicians' perceptions of screening benefits and harms influence their recommendations, which in turn shape patients' screening decisions. We sought to understand clinicians' perceptions of the benefits and harms of cancer screening by comparing 2 screening tests that differ in their balance of potential benefits to harms: colonoscopy, which results in net benefit for many adults, and prostate-specific antigen (PSA) testing, which may do more harm than good. METHODS: In this cross-sectional study, 126 clinicians at 24 family/internal medicine practices completed surveys in which they listed and rated the magnitude of colonoscopy and PSA testing benefits and harms for a hypothetical 70-year-old male patient and then estimated the likelihood that these tests would cause harm and lengthen the life of 100 similar men in the next 10 years. We tested the hypothesis that the availability heuristic would explain the association of screening test to perceived likelihood of benefit/harm and a competing hypothesis that clinicians' gist of screening tests as good or bad would mediate this association. RESULTS: Clinicians perceived PSA testing to have a greater likelihood of harm and a lower likelihood of lengthening life relative to colonoscopy. Consistent with our gist hypothesis, these associations were mediated by clinicians' gist of screening (balance of perceived benefits to perceived harms). LIMITATIONS: Generalizability beyond academic clinicians remains to be established. CONCLUSIONS: Targeting clinicians' gist of screening, for example through graphical displays that allow clinicians to make gist-based relative magnitude comparisons, may influence their risk perception and possibly reduce overrecommendation of screening.

The effect of numeracy level on completeness of home blood pressure monitoring.

Home blood pressure monitoring (HBPM) readings predict the increased risks of cardiovascular events and end-organ damage independent of office blood pressure (BP). Numeracy (the ability to handle numbers) may limit the feasibility of patients' performing HBPM. The authors analyzed data from 409 adults recruited from 12 North Carolina primary care clinics who completed a three-item numeracy assessment, the Rapid Estimate of Adult Literacy in Medicine-Short Form health literacy assessment, and HBPM over 2 weeks. Among the 409 participants, 73% were college graduates and 69% had adequate numeracy. Completion of HBPM was greater among those with adequate numeracy (96.2% vs 93.7%; P=.009) and did not correlate with health literacy scores. More participants with adequate numeracy reported completion of ≥85% of readings than those with low numeracy (95% vs 88%; P=.018). Adequate numeracy, but not high literacy, is associated with more complete HBPM reporting. Whether higher numeracy is associated with more accurate self-reported readings is an area of future research.

Have screening harms become newsworthy? News coverage of prostate and colorectal cancer screening since the 2008 USPSTF recommendation changes.

In 2008, the US Preventive Services Task Force updated its recommendations to discourage screening for prostate cancer in men over 75 and for colorectal cancer in adults over 85. We aimed to determine whether newspapers portrayed these screenings differently after these recommendation changes. A quantitative content analysis included articles on prostate-specific antigen (PSA) testing or colonoscopy in US newspapers from 2005 to 2012. Outcomes included the number of benefits and harms mentioned and the gist expert and lay readers might get from articles. Benefits in PSA articles (n = 222) and harms and benefits in colonoscopy articles (n = 65) did not change over time. Mentions of PSA harms increased after 2008 (p < .01). Expected expert gist of PSA articles became more negative after 2008 (p < .01). Expected lay gist was positive and did not change. News coverage of PSA testing harms increased without a decrease in the discussion of benefits. Consumers, especially lay consumers, are receiving unbalanced information on cancer screening.

A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.

IMPORTANCE: Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication (L&M) counseling to reduce coronary heart disease (CHD) risk. Thus, effective and feasible CHD prevention programs are needed for typical practice settings. OBJECTIVE: To assess the effectiveness, acceptability, and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats. DESIGN, SETTING, AND PARTICIPANTS: A comparative effectiveness trial in 5 diverse family medicine practices in North Carolina. Participants were established patients, aged 35 to 79 years, with no known cardiovascular disease, and at moderate to high risk for CHD (10-year Framingham Risk Score [FRS], ≥10%). INTERVENTIONS: Participants were randomized to counselor-delivered or web-based format, each including 4 intensive and 3 maintenance sessions. After randomization, both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies. Participants chose the risk-reducing strategies they wished to follow. MAIN OUTCOMES AND MEASURES: The primary outcome was within-group change in FRS at 4-month follow-up. Other measures included standardized assessments of blood pressure, blood lipid levels, lifestyle behaviors, and medication adherence. Acceptability and cost-effectiveness were also assessed. Outcomes were assessed at 4 and 12 months. RESULTS: Of 2274 screened patients, 385 were randomized (192 counselor; 193 web): mean age, 62 years; 24% African American; and mean FRS, 16.9%. Follow-up at 4 and 12 months included 91% and 87% of the randomized participants, respectively. There was a sustained reduction in FRS at both 4 months (primary outcome) and 12 months for both counselor-based (-2.3% [95% CI, -3.0% to -1.6%] and -1.9% [95% CI, -2.8% to -1.1%], respectively) and web-based groups (-1.5% [95% CI, -2.2% to -0.9%] and -1.7% [95% CI, -2.6% to -0.8%] respectively). At 4 months, the adjusted difference in FRS between groups was -1.0% (95% CI, -1.8% to -0.1%) (P = .03), and at 12 months, it was -0.6% (95% CI, -1.7% to 0.5%) (P = .30). The 12-month costs from the payer perspective were $207 and $110 per person for the counselor- and web-based interventions, respectively. CONCLUSIONS AND RELEVANCE: Both intervention formats reduced CHD risk through 12-month follow-up. The web format was less expensive. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01245686.

The effect of a decision aid intervention on decision making about coronary heart disease risk reduction: secondary analyses of a randomized trial.

BACKGROUND: Decision aids offer promise as a practical solution to improve patient decision making about coronary heart disease (CHD) prevention medications and help patients choose medications to which they are likely to adhere. However, little data is available on decision aids designed to promote adherence. METHODS: In this paper, we report on secondary analyses of a randomized trial of a CHD adherence intervention (second generation decision aid plus tailored messages) versus usual care in an effort to understand how the decision aid facilitates adherence. We focus on data collected from the primary study visit, when intervention participants presented 45 minutes early to a previously scheduled provider visit; viewed the decision aid, indicating their intent for CHD risk reduction after each decision aid component (individualized risk assessment and education, values clarification, and coaching); and filled out a post-decision aid survey assessing their knowledge, perceived risk, decisional conflict, and intent for CHD risk reduction. Control participants did not present early and received usual care from their provider. Following the provider visit, participants in both groups completed post-visit surveys assessing the number and quality of CHD discussions with their provider, their intent for CHD risk reduction, and their feelings about the decision aid. RESULTS: We enrolled 160 patients into our study (81 intervention, 79 control). Within the decision aid group, the decision aid significantly increased knowledge of effective CHD prevention strategies (+21 percentage points; adjusted p<.0001) and the accuracy of perceived CHD risk (+33 percentage points; adjusted p<.0001), and significantly decreased decisional conflict (-0.63; adjusted p<.0001). Comparing between study groups, the decision aid also significantly increased CHD prevention discussions with providers (+31 percentage points; adjusted p<.0001) and improved perceptions of some features of patient-provider interactions. Further, it increased participants' intentions for any effective CHD risk reducing strategies (+21 percentage points; 95% CI 5 to 37 percentage points), with a majority of the effect from the educational component of the decision aid. Ninety-nine percent of participants found the decision aid easy to understand and 93% felt it easy to use. CONCLUSIONS: Decision aids can play an important role in improving decisions about CHD prevention and increasing patient-provider discussions and intent to reduce CHD risk.

The harms of screening: a proposed taxonomy and application to lung cancer screening.

IMPORTANCE: Making rational decisions about screening requires information about its harms, but high-quality evidence is often either not available or not used. One reason may be that we lack a coherent framework, a taxonomy, for conceptualizing and studying these harms. OBJECTIVE: To create a taxonomy, we categorized harms from several sources: systematic reviews of screening, other published literature, and informal discussions with clinicians and patients. We used this information to develop an initial taxonomy and vetted it with local and national experts, making revisions as needed. RESULTS: We propose a taxonomy with 4 domains of harm from screening: physical effects, psychological effects, financial strain, and opportunity costs. Harms can occur at any step of the screening cascade. We provide definitions for each harm domain and illustrate the taxonomy using the example of screening for lung cancer. CONCLUSIONS AND RELEVANCE: The taxonomy provides a systematic way to conceptualize harms as experienced by patients. As shown in the lung cancer screening example, the taxonomy also makes clear where (which domains of harms and which parts of the screening cascade) we have useful information and where there are gaps in our knowledge. The taxonomy needs further testing and validation across a broad range of screening programs. We hope that further development of this taxonomy can improve our thinking about the harms of screening, thus informing our research, policy making, and decision making with patients about the wisdom of screening.

U.S. Preventive Services Task Force recommendations and cancer screening among female Medicare beneficiaries.

BACKGROUND: Medicare covers several cancer screening tests not currently recommended by the U.S. Preventive Services Task Force (Task Force). In September 2002, the Task Force relaxed the upper age limit of 70 years for breast cancer screening recommendations, and in March 2003 an upper age limit of 65 years was introduced for cervical cancer screening recommendations. We assessed whether mammogram and Pap test utilization among women with Medicare coverage is influenced by changes in the Task Force's recommendations for screening. METHODS: We identified female Medicare beneficiaries aged 66-80 years and used bivariate probit regression to examine the receipt of breast (mammogram) and cervical (Pap test) cancer screening reflecting changes in the Task Force recommendations. We analyzed 9,760 Medicare Current Beneficiary Survey responses from 2001 to 2007. RESULTS: More than two-thirds reported receiving a mammogram and more than one-third a Pap test in the previous 2 years. Lack of recommendation was given as a reason for not getting screened among the majority (51% for mammogram and 75% for Pap). After controlling for beneficiary-level socioeconomic characteristics and access to care factors, we did not observe a significant change in breast and cervical cancer screening patterns following the changes in Task Force recommendations. CONCLUSIONS: Although there is evidence that many Medicare beneficiaries adhere to screening guidelines, some women may be receiving non-recommended screening services covered by Medicare.

Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study.

BACKGROUND: Although lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial. METHODS: We conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35-79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up. RESULTS: We randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African-American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%. CONCLUSION: We have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention.

Kappa statistic for clustered dichotomous responses from physicians and patients.

The bootstrap method for estimating the standard error of the kappa statistic in the presence of clustered data is evaluated. Such data arise, for example, in assessing agreement between physicians and their patients regarding their understanding of the physician-patient interaction and discussions. We propose a computationally efficient procedure for generating correlated dichotomous responses for physicians and assigned patients for simulation studies. The simulation result demonstrates that the proposed bootstrap method produces better estimate of the standard error and better coverage performance compared with the asymptotic standard error estimate that ignores dependence among patients within physicians with at least a moderately large number of clusters. We present an example of an application to a coronary heart disease prevention study.