Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time.

BACKGROUND: Pictorial cigarette warning labels are thought to increase risk knowledge, but experimental research has not examined longer-term effects on memory for health risks named in text. PURPOSE: To investigate memory-consolidation predictions that high- versus low-emotion warnings would support better long-term memory for named cigarette health risks and to test a mediational model of warning-label effects through memory on risk perceptions and quit intentions. METHODS: A combined sample of U.S.-representative adult smokers, U.S.-representative teen smokers/vulnerable smokers, and Appalachian-representative adult smokers were randomly assigned to a warning-label condition (High-emotion pictorial, Low-emotion pictorial, Text-only) in which they were exposed four times to nine warning labels and reported emotional reactions and elaboration. Memory of warning-label risk information, smoking risk perceptions, and quit intentions were assessed immediately after exposures or 6 weeks later. RESULTS: Recall of warning-label text was low across the samples and supported memory-consolidation predictions. Specifically, immediate recall was highest for Low-emotion warnings that elicited the least emotion, but recall also declined the most over time in this condition, leaving its 6-week recall lowest; 6-week recall was similar for High-emotion and Text-only warnings. Greater recall was associated with higher risk perceptions and greater quit intentions and mediated part of warning-label effects on these important smoking outcomes. High-emotion warnings had additional non-memory-related effects on risk perceptions and quit intentions that were superior to text-only warnings. CONCLUSIONS: High- but not Low-emotion pictorial warning labels may support the Food and Drug Administration's primary goal to "effectively convey the negative health consequences of smoking." CLINICALTRIALS.GOV IDENTIFIER: NCT03375840.

Effects of Pictorial Warning Labels for Cigarettes and Quit-Efficacy on Emotional Responses, Smoking Satisfaction, and Cigarette Consumption.

Background: Experimental research on pictorial warning labels for cigarettes has primarily examined immediate intentions to quit. Purpose: Here, we present the results of a clinical trial testing the impact on smoking during and after a 28-day period of naturalistic exposure to pictorial versus text-only warnings. Methods: Daily cigarette smokers (N = 244) at two sites in the USA were randomly assigned to receive their regular brand of cigarettes for 4 weeks with one of three warnings: (a) text-only, (b) pictures and text as proposed by FDA, or (c) the warnings proposed by FDA with additional text that elaborated on the risks of smoking. Analyses examined the effects of pictorial versus text-only warnings and self-efficacy for quitting on cigarette consumption during and 1 month after the trial as mediated by emotional and cognitive responses as well as satisfaction with smoking. Results: Stronger emotional responses to pictorial than text-only warnings predicted reduced satisfaction with smoking during the trial and lower cigarette consumption at follow-up among the majority of smokers who continued to smoke. Consistent with the efficacy-desire model, those with moderate efficacy reported the greatest reduction in consumption at follow-up. However, a small proportion of smokers (7%) who reported 7-day abstinence at follow-up did not exhibit a significant relation with self-efficacy. Conclusions: Pictorial warning labels proposed by FDA create unfavorable emotional reactions to smoking that predict reduced cigarette use compared to text alone, with even smokers low in self-efficacy exhibiting some reduction. Predictions that low self-efficacy smokers will respond unfavorably to warnings were not supported.

Cigarette Graphic Warning Labels Are Not Created Equal: They Can Increase or Decrease Smokers' Quit Intentions Relative to Text-Only Warnings.

INTRODUCTION: Cigarette graphic-warning labels elicit negative emotion. Research suggests negative emotion drives greater risk perceptions and quit intentions through multiple processes. The present research compares text-only warning effectiveness to that of graphic warnings eliciting more or less negative emotion. METHODS: Nationally representative online panels of 736 adult smokers and 469 teen smokers/vulnerable smokers were randomly assigned to view one of three warning types (text-only, text with low-emotion images, or text with high-emotion images) four times over 2 weeks. Participants recorded their emotional reaction to the warnings (measured as arousal), smoking risk perceptions, and quit intentions. Primary analyses used structural equation modeling. RESULTS: Participants in the high-emotion condition reported greater emotional reaction than text-only participants (bAdult = 0.21; bTeen = 0.27, p's < .004); those in the low-emotion condition reported lower emotional reaction than text-only participants (bAdult = -0.18; bTeen = -0.22, p's < .018). Stronger emotional reaction was associated with increased risk perceptions in both samples (bAdult = 0.66; bTeen = 0.85, p's < .001) and greater quit intentions among adults (bAdult = 1.00, p < .001). Compared to text-only warnings, low-emotion warnings were associated with reduced risk perceptions and quit intentions whereas high-emotion warnings were associated with increased risk perceptions and quit intentions. CONCLUSION: Warning labels with images that elicit more negative emotional reaction are associated with increased risk perceptions and quit intentions in adults and teens relative to text-only warnings. However, graphic warnings containing images which evoke little emotional reaction can backfire and reduce risk perceptions and quit intentions versus text-only warnings. IMPLICATIONS: This research is the first to directly manipulate two emotion levels in sets of nine cigarette graphic warning images and compare them with text-only warnings. Among adult and teen smokers, high-emotion graphic warnings were associated with increased risk perceptions and quit intentions versus text-only warnings. Low-emotion graphic warnings backfired and tended to reduce risk perceptions and quit intentions versus text-only warnings. Policy makers should be aware that merely placing images on cigarette packaging is insufficient to increase smokers' risk perceptions and quit intentions. Low-emotion graphic warnings will not necessarily produce desired population-level benefits relative to text-only or high-emotion warnings.

Deliberative disjunction: expert and public understanding of outcome uncertainty.

Many environmental and risk management decisions are made jointly by technical experts and members of the public. Frequently, their task is to select from among management alternatives whose outcomes are subject to varying degrees of uncertainty. Although it is recognized that how this uncertainty is interpreted can significantly affect decision-making processes and choices, little research has examined similarities and differences between expert and public understandings of uncertainty. We present results from a web-based survey that directly compares expert and lay interpretations and understandings of different expressions of uncertainty in the context of evaluating the consequences of proposed environmental management actions. Participants responded to two hypothetical but realistic scenarios involving trade-offs between environmental and other objectives and were asked a series of questions about their comprehension of the uncertainty information, their preferred choice among the alternatives, and the associated difficulty and amount of effort. Results demonstrate that experts and laypersons tend to use presentations of numerical ranges and evaluative labels differently; interestingly, the observed differences between the two groups were not explained by differences in numeracy or concerns for the predicted environmental losses. These findings question many of the usual presumptions about how uncertainty should be presented as part of deliberative risk- and environmental-management processes.

Development of the Patient Activation Measure for mental health.

Our objective was to adapt the physical health Patient Activation Measure (PAM) for use among people with mental health conditions (PAM-MH). Data came from three studies among people with chronic mental health conditions and were combined in Rasch analyses. The PAM-MH's psychometric properties equal those of the original 13-item PAM. Test-retest reliability and concurrent validity were good, and the PAM-MH showed sensitivity to change. The PAM-MH appears to be a reliable and valid measure of patient activation among individuals with mental health problems. It appears to have potential for use in assessing change in activation.

Does enrollment in a CDHP stimulate cost-effective utilization?

Consumer-driven health plans (CDHPs) are built on the assumption that with increased cost sharing consumers will select cost-effective evidence-based care. In this study, the authors explore whether patterns of utilization change after enrollment in a CDHP and whether the pattern reflects a shift toward evidence-based care. The study population is comprised of 18,025 employees and their adult dependents. The analysis uses a schema for categorizing claims data into high-priority (evidence-based care) and low-priority (limited or no evidence-based care) utilization. The findings indicate that enrollment in CDHPs resulted in a reduction of office visits in the 1st year of enrollment. These reductions in care appear to be indiscriminant, with patients cutting back in both high-and low-priority visits. The reductions in high- and low-priority visits were greater for employees with lower education and income.

Cigarette graphic warning labels increase both risk perceptions and smoking myth endorsement.

OBJECTIVE: Cigarette graphic warning labels elicit negative emotion, which increases risk perceptions through multiple processes. We examined whether this emotion simultaneously affects motivated cognitions like smoking myth endorsement (e.g. 'exercise can undo the negative effects of smoking') and perceptions of cigarette danger versus other products. DESIGN: 736 adult and 469 teen smokers/vulnerable smokers viewed one of three warning label types (text-only, low emotion graphic or high emotion graphic) four times over two weeks. MAIN OUTCOME MEASURES: Emotional reactions to the warnings were reported during the first and fourth exposures. Participants reported how often they considered the warnings, smoking myth endorsement, risk perceptions and perceptions of cigarette danger relative to smokeless tobacco and electronic cigarettes. RESULTS: In structural equation models, emotional reactions influenced risk perceptions and smoking myth endorsement through two processes. Emotion acted as information about risk, directly increasing smoking risk perceptions and decreasing smoking myth endorsement. Emotion also acted as a spotlight, motivating consideration of the warning information. Warning consideration increased risk perceptions, but also increased smoking myth endorsement. Emotional reactions to warnings decreased perceptions of cigarette danger relative to other products. CONCLUSIONS: Emotional reactions to cigarette warnings increase smoking risk perceptions, but also smoking myth endorsement and misperceptions that cigarettes are less dangerous than potentially harm-reducing tobacco products.

Consumer competencies and the use of comparative quality information: it isn't just about literacy.

While consumers are increasingly expected to use complex health care information to make informed decisions, it is unclear how many have the skills to do so. In this investigation we examine health literacy, numeracy, and patient activation, assessing the contribution of each to the comprehension of comparative health care performance reports and their use in making an informed choice. A convenience sample of 303 employed-age adults participated in the study. The findings indicate that numeracy skill is the strongest predictor of comprehension, followed by health literacy. Higher activation helps those low in literacy and numeracy compensate for their lower skills and achieve higher levels of comprehension. In addition, making good choices, when trade-offs are necessary, is related to activation separate from comprehension. This is important as many real-life choices involve trade-offs. Results indicate that choice is not just about literacy or comprehension, it also has to do with activation.

Do increases in patient activation result in improved self-management behaviors?

OBJECTIVE: The purpose of this study is to determine whether patient activation is a changing or changeable characteristic and to assess whether changes in activation also are accompanied by changes in health behavior. STUDY METHODS: To obtain variability in activation and self-management behavior, a controlled trial with chronic disease patients randomized into either intervention or control conditions was employed. In addition, changes in activation that occurred in the total sample were also examined for the study period. Using Mplus growth models, activation latent growth classes were identified and used in the analysis to predict changes in health behaviors and health outcomes. DATA SOURCES: Survey data from the 479 participants were collected at baseline, 6 weeks, and 6 months. PRINCIPAL FINDINGS: Positive change in activation is related to positive change in a variety of self-management behaviors. This is true even when the behavior in question is not being performed at baseline. When the behavior is already being performed at baseline, an increase in activation is related to maintaining a relatively high level of the behavior over time. The impact of the intervention, however, was less clear, as the increase in activation in the intervention group was matched by nearly equal increases in the control group. CONCLUSIONS: Results suggest that if activation is increased, a variety of improved behaviors will follow. The question still remains, however, as to what interventions will improve activation.

Assessing activation stage and employing a "next steps" approach to supporting patient self-management.

Current approaches to chronic illness care seek to engage the patient as part of the care team. Yet, finding effective ways to engage patients in their own care and support patient self-management has been challenging. Instead of pushing patients to immediately adopt all recommended behavioral changes, many programs encourage small steps while working toward a larger goal. A strategy that first assessed the level of mastery, and then encouraged "next step" behaviors, may be more effective as the recommended steps would be calibrated to the patient's level of competency. In this analysis, we build on the previous research to determine whether there are behaviors that are more or less likely to be adopted at different stages of activation.

Improving numeracy through values affirmation enhances decision and STEM outcomes.

Greater numeracy has been correlated with better health and financial outcomes in past studies, but causal effects in adults are unknown. In a 9-week longitudinal study, undergraduate students, all taking a psychology statistics course, were randomly assigned to a control condition or a values-affirmation manipulation intended to improve numeracy. By the final week in the course, the numeracy intervention (statistics-course enrollment combined with values affirmation) enhanced objective numeracy, subjective numeracy, and two decision-related outcomes (financial literacy and health-related behaviors). It also showed positive indirect-only effects on financial outcomes and a series of STEM-related outcomes (course grades, intentions to take more math-intensive courses, later math-intensive courses taken based on academic transcripts). All decision and STEM-related outcome effects were mediated by the changes in objective and/or subjective numeracy and demonstrated similar and robust enhancements. Improvements to abstract numeric reasoning can improve everyday outcomes.

Why worry? Worry, risk perceptions, and willingness to act to reduce medical errors.

Through the domain of medical errors, the role of worry and perceived risk in precautionary behaviors was examined in a convenience sample (N = 195, mean age = 42 years, 71% female). Worry was linked to fatality estimates. A model of the antecedents and consequences of worry also was tested. Risk characteristics such as dread and preventability, negative reactivity, and vulnerability to medical errors appeared to motivate worry about medical errors. Worry about medical errors was a better predictor of intentions to take precautionary actions than were risk perceptions. An understanding of how worry influences preventive efforts will help in building communication strategies to the public and in effectively engaging patients in the role of vigilant partner in care.

Hospital performance reports: impact on quality, market share, and reputation.

This study builds on earlier work by assessing the long-term impact of a public hospital performance report on both consumers and hospitals. In doing so, we shed light on the relative importance of alternative assumptions about what stimulates quality improvements. The findings indicate that making performance data public results in improvements in the clinical area reported upon. An earlier investigation indicated that hospitals included in the public report believed that the report would affect their public image. Indeed, consumer surveys suggest that inclusion did affect hospitals' reputations.

It isn't just about choice: the potential of a public performance report to affect the public image of hospitals.

Can a well-designed public performance report affect the public image of hospitals? Using a pre/postdesign and telephone interviews, consumer views and reports of their use of public hospital report are examined. The findings show that the report did influence consumer views about the quality of individual hospitals in the community 2 to 4 months after the release of the report.

Can patients be part of the solution? Views on their role in preventing medical errors.

Patients have the potential to play an important role in preventing medical errors. Yet little is known about how to effectively engage patients in this role as a "vigilant partner" in care. Respondents were asked to assess the perceived effectiveness of fourteen recommended actions for preventing medical errors. The findings indicate that most of the actions are viewed as effective. However, respondents also indicate that they are unlikely to engage in many of the recommended actions. Having a greater sense of self-efficacy in being able to prevent medical errors is significantly linked with a greater reported likelihood of engaging in preventive action.

Development and testing of a short form of the patient activation measure.

OBJECTIVE: The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. The measure was developed using Rasch analyses and is an interval level, unidimensional, Guttman-like measure. The current analysis is aimed at reducing the number of items in the measure while maintaining adequate precision. STUDY METHODS: We relied on an iterative use of Rasch analysis to identify items that could be eliminated without loss of significant precision and reliability. With each item deletion, the item scale locations were recalibrated and the person reliability evaluated to check if and how much of a decline in precision of measurement resulted from the deletion of the item. DATA SOURCES: The data used in the analysis were the same data used in the development of the original 22-item measure. These data were collected in 2003 via a telephone survey of 1,515 randomly selected adults. Principal Findings. The analysis yielded a 13-item measure that has psychometric properties similar to the original 22-item version. The scores for the 13-item measure range in value from 38.6 to 53.0 (on a theoretical 0-100 point scale). The range of values is essentially unchanged from the original 22-item version. Subgroup analysis suggests that there is a slight loss of precision with some subgroups. CONCLUSIONS: The results of the analysis indicate that the shortened 13-item version is both reliable and valid.

Presenting Numeric Information with Percentages and Descriptive Risk Labels: A Randomized Trial.

BACKGROUND: Previous research demonstrated that providing (v. not providing) numeric information about the adverse effects (AEs) of medications increased comprehension and willingness to use medication but left open the question about which numeric format is best. The objective was to determine which of 4 tested formats (percentage, frequency, percentage + risk label, frequency + risk label) maximizes comprehension and willingness to use medication across age and numeracy levels. METHODS: In a cross-sectional internet survey (N = 368; American Life Panel, 15 May 2008 to 18 June 2008), respondents were presented with a hypothetical prescription medication for high cholesterol. AE likelihoods were described using 1 of 4 tested formats. Main outcome measures were risk comprehension (ability to identify AE likelihood from a table) and willingness to use the medication (7-point scale; not likely = 0, very likely = 6). RESULTS: The percentage + risk label format resulted in the highest comprehension and willingness to use the medication compared with the other 3 formats (mean comprehension in percentage + risk label format = 95% v. mean across the other 3 formats = 81%; mean willingness = 3.3 v. 2.95, respectively). Comprehension differences between percentage and frequency formats were smaller among the less numerate. Willingness to use medication depended less on age and numeracy when labels were used. Generalizability is limited by the use of a sample that was older, more educated, and better off financially than national averages. CONCLUSIONS: Providing numeric AE-likelihood information in a percentage format with risk labels is likely to increase risk comprehension and willingness to use a medication compared with other numeric formats.

Does publicizing hospital performance stimulate quality improvement efforts?

This study evaluates the impact on quality improvement of reporting hospital performance publicly versus privately back to the hospital. Making performance information public appears to stimulate quality improvement activities in areas where performance is reported to be low. The findings from this Wisconsin-based study indicate that there is added value to making this information public.

Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers.

BACKGROUND: Controlling costs and achieving health care quality improvements require the participation of activated and informed consumers and patients. OBJECTIVES: We describe a process for conceptualizing and operationalizing what it means to be "activated" and delineate the process we used to develop a measure for assessing "activation," and the psychometric properties of that measure. METHODS: We used the convergence of the findings from a national expert consensus panel and patient focus groups to define the concept and identify the domains of activation. These domains were operationalized by constructing a large item pool. Items were pilot-tested and initial psychometric analysis performed using Rasch methodology. The third stage refined and extended the measure. The fourth stage used a national probability sample to assess the measure's psychometric performance overall and within different subpopulations. STUDY SAMPLE: Convenience samples of patients with and without chronic illness, and a national probability sample (N=1,515) are included at different stages in the research. CONCLUSIONS: The Patient Activation Measure is a valid, highly reliable, unidimensional, probabilistic Guttman-like scale that reflects a developmental model of activation. Activation appears to involve four stages: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. The measure has good psychometric properties indicating that it can be used at the individual patient level to tailor intervention and assess changes.

Numbers matter to informed patient choices: a randomized design across age and numeracy levels.

BACKGROUND: How drug adverse events (AEs) are communicated in the United States may mislead consumers and result in low adherence. Requiring written information to include numeric AE-likelihood information might lessen these effects, but providing numbers may disadvantage less skilled populations. The objective was to determine risk comprehension and willingness to use a medication when presented with numeric or nonnumeric AE-likelihood information across age, numeracy, and cholesterol-lowering drug-use groups. METHODS: In a cross-sectional Internet survey (N = 905; American Life Panel, 15 May 2008 to 18 June 2008), respondents were presented with a hypothetical prescription medication for high cholesterol. AE likelihoods were described using 1 of 6 formats (nonnumeric: consumer medication information (CMI)-like list, risk labels; numeric: percentage, frequency, risk labels + percentage, risk labels + frequency). Main outcome measures were risk comprehension (recoded to indicate presence/absence of risk overestimation and underestimation), willingness to use the medication (7-point scale; not likely = 0, very likely = 6), and main reason for willingness (chosen from 8 predefined reasons). RESULTS: Individuals given nonnumeric information were more likely to overestimate risk, were less willing to take the medication, and gave different reasons than those provided numeric information across numeracy and age groups (e.g., among the less numerate, 69% and 18% overestimated risks in nonnumeric and numeric formats, respectively; among the more numerate, these same proportions were 66% and 6%). Less numerate middle-aged and older adults, however, showed less influence of numeric format on willingness to take the medication. It is unclear whether differences are clinically meaningful, although some differences are large. CONCLUSIONS: Providing numeric AE-likelihood information (compared with nonnumeric) is likely to increase risk comprehension across numeracy and age levels. Its effects on uptake and adherence of prescribed drugs should be similar across the population, except perhaps in older, less numerate individuals.