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BACKGROUND: Pharmaceutical companies spent US$1.8 billion on direct-to-consumer advertisements for prescription drugs in 1999. Our aim was to establish what messages are being communicated to the public by these advertisements. METHODS: We investigated the content of advertisements, which appeared in ten magazines in the USA. We examined seven issues of each of these published between July, 1998, and July, 1999. FINDINGS: 67 advertisements appeared a total of 211 times during our study. Of these, 133 (63%) were for drugs to ameliorate symptoms, 54 (26%) to treat disease, and 23 (11%) to prevent illness. In the 67 unique advertisements, promotional techniques used included emotional appeals (45, 67%) and encouragement of consumers to consider medical causes for their experiences (26, 39%). More advertisements described the benefit of medication with vague, qualitative terms (58, 87%), than with data (9, 13%). However, half the advertisements used data to describe side-effects, typically with lists of side-effects that generally occurred infrequently. None mentioned cost. INTERPRETATION: Provision of complete information about the benefit of prescription drugs in advertisements would serve the interests of physicians and the public.

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BACKGROUND: Patients' values are fundamental to decision models, cost-effectiveness analyses, and pharmacoeconomic analyses. The standard methods used to assess how patients value different health states are inherently quantitative. People without strong quantitative skills (i.e., low numeracy) may not be able to complete these tasks in a meaningful way. METHODS: To determine whether the validity of utility assessments depends on the respondent's level of numeracy, the authors conducted in-person interviews and written surveys and assessed utility for the current health for 96 women volunteers. Numeracy was measured using a previously validated 3-item scale. The authors examined the correlation between self-reported health and utility for current health (assessed using the standard gamble, time trade-off, and visual analog techniques) across levels of numeracy. For half of the women, the authors also assessed standard gamble utility for 3 imagined health states (breast cancer, heart disease, and osteoporosis) and asked how much the women feared each disease. RESULTS: Respondent ages ranged from 50 to 79 years (mean = 63), all were high school graduates, and 52% had a college or postgraduate degree. Twenty-six percent answered 0 or only 1 of the numeracy questions correctly, 37% answered 2 correctly, and 37% answered all 3 correctly. Among women with the lowest level of numeracy, the correlation between utility for current health and self-reported health was in the wrong direction (i.e., worse health valued higher than better health): for standard gamble, Spearman r=-0.16, P = 0.44;for time trade-off, Spearman r=-0.13, P=0.54. Among the most numerate women, the authors observed a fair to moderate positive correlation with both standard gamble (Spearman r=0.22, P=0.19) and time trade-off (Spearman r=0.50, P=0.002). In contrast, using the visual analog scale, the authors observed a substantial correlation in the expected direction at all levels of numeracy (Spearman r= 0.82, 0.50, and 0.60 for women answering 0-1, 2, and 3 numeracy questions, respectively; all Ps < or = 0.003). With regard to the imagined health states, the most feared disease had the lowest utility for 35% of the women with the lowest numeracy compared to 76% of the women with the highest numeracy (P=0.03). CONCLUSIONS: The validity of standard utility assessments is related to the subject's facility with numbers. Limited numeracy may be an important barrier to meaningfully assessing patients' values using the standard gamble and time trade-off techniques.

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BACKGROUND: To promote informed decision making about mammography, clinicians are urged to present women with complete, relevant information about breast cancer and screening. Understanding women's current beliefs may help guide such efforts by uncovering misunderstandings, conceptual gaps, and areas of concern. OBJECTIVE: The authors sought to learn how women view breast cancer, their personal risk of breast cancer, and how screening mammography affects that risk. METHODS: Forty-one open-ended semistructured telephone interviews with women selected from a national database by quota sampling to ensure a wide range in demographics of the participants. RESULTS: Almost all respondents viewed breast cancer as a uniformly progressive disease that begins in a silent curable form (typically found by mammograms) and, unless treated early, invariably grows, spreads, and kills. Some women felt that any abnormality found must be treated, even if it was not malignant. None had heard of potentially nonprogressive cancers, and when informed, most felt that the uncertain prognosis of such lesions reinforced the need to find and treat disease as soon as possible. Women expressed a wide range of views about their personal risk of breast cancer. Although some saw breast cancer as a central threat to their health, many others cited heart disease, other cancers, violence, and trauma as greater concerns. Most recognized the importance of "uncontrollable" factors for breast cancer such as age, sex, family history, and genetics. However, other "controllable" factors with little or no demonstrated link to breast cancer (e.g., smoking, diet, toxic exposures, "bad attitudes") were given equal or greater prominence, suggesting that many women feel considerable personal responsibility for their level of breast cancer risk. Similarly, although women recognized that mammography was not perfect, almost all believed that failure to have mammograms put one at risk for premature and preventable death. When asked how mammography worked, almost all repeated the message that "early detection saves lives," suggesting that advanced cancer (and perhaps most cancer deaths) reflected a failure of early detection. The belief in the benefit of early detection was so strong that some women advocated scaring other women into getting mammograms because it is "better to be safe than sorry." CONCLUSIONS: Women view breast cancer as a uniformly progressive disease rarely curable unless caught early. The exaggerated importance many attribute to a variety of controllable factors in modifying personal risk and the "danger" seen in failing to have mammograms may lead women diagnosed with breast cancer to blame themselves.

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OBJECTIVE: To determine women's attitudes and knowledge of both false-positive mammography results and the detection of ductal carcinoma in situ after screening mammography. DESIGN: Cross-sectional survey. SETTING: United States. PARTICIPANTS: A total of 479 women aged 18 to 97 years who did not report a history of breast cancer. Main outcome measures Attitudes and knowledge about false-positive results and the detection of ductal carcinoma in situ after screening mammography. RESULTS: Women were aware that false-positive results do occur. Their median estimate of the false-positive rate for 10 years of annual screening was 20% (25th percentile estimate, 10%; 75th percentile estimate, 45%). The women were highly tolerant of false-positive results: 63% thought that 500 or more false-positives per life saved was reasonable, and 37% would tolerate a rate of 10,000 or more. Women who had had a false-positive result (n = 76) expressed the same high tolerance: 30 (39%) would tolerate 10,000 or more false-positives. In all, 62% of women did not want to take false-positive results into account when deciding about screening. Only 8% of women thought that mammography could harm a woman without breast cancer, and 94% doubted the possibility of nonprogressive breast cancers. Few had heard of ductal carcinoma in situ, a cancer that may not progress, but when informed, 60% of women wanted to take into account the possibility of it being detected when deciding about screening. CONCLUSIONS: Women are aware of false-positive results and seem to view them as an acceptable consequence of screening mammography. In contrast, most women are unaware that screening can detect cancers that may never progress but think that such information would be relevant. Education should perhaps focus less on false-positive results and more on the less-familiar outcome of the detection of ductal carcinoma in situ.

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BACKGROUND: Clinicians and researchers often wish to know how patients perceive the likelihoods of health risks. Little work has been done to develop and validate scales and formats to measure perceptions of event probabilities, particularly low probabilities (i.e., <1%). OBJECTIVE: To compare a new visual analog scale with three benchmarks in terms of validity and reliability. DESIGN: Survey with retest after approximately two weeks. Respondents estimated the probabilities of six events with the new scale, which featured a "magnifying glass" to represent probabilities between 0 and 1% on a logarithmic scale. Participants estimated the same probabilities on three benchmarks: two linear visual analog scales (one labeled with words, one with numbers) and a "1 in x" scale. SUBJECTS: 100 veterans and family members and 107 university faculty and students. MEASURES: For each scale, the authors assessed: 1) validity-the correlation between participants' direct rankings (i.e., numbering them from 1 to 6) and scale-derived rankings of the relative probabilities of six events; 2) test-retest reliability-the correlation of responses from test to retest two weeks later; 3) usability (missing/ incorrect responses, participant evaluation). RESULTS: Both the magnifier and the two linear scales outperformed the "1 in x" scale on all criteria. The magnifier scale performed about as well as the two linear visual analog scales for validity (correlation between direct and scale-derived rankings = 0.72), reliability (test-retest correlation = 0.55), and usability (2% missing or incorrect responses, 65% rated it easy to use). 62% felt the magnifier scale was a "very good or good" indicator of their feelings about chance. The magnifier scale facilitated expression of low-probability judgments. For example, the estimated chance of parenting sextuplets was orders of magnitude lower on the magnifier scale (median perceived chance 10(-5)) than on its linear counterpart (10(-2)). Participants' assessments of high-probability events (e.g., chance of catching a cold in the next year) were not affected by the presence of the magnifier. CONCLUSIONS: The "1 in x" scale performs poorly and is very difficult for people to use. The magnifier scale and the linear number scale are similar in validity, reliability, and usability. However, only the magnifier scale makes it possible to elicit perceptions in the low-probability range (<1%).

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BACKGROUND: This study examined age-, sex-, and race- related increases in body iron stores that have been implicated in disease and the relative utility of the serum ferritin versus the percentage of transferrin saturation for population-based estimation of iron status. METHODS AND RESULTS: Serum ferritin levels were examined by age, sex, and race, and values were compared with the percent transferrin saturation in 20,040 individuals >17 years of age from the third National Health and Nutrition Examination Survey (NHANES III) database. Body iron stores reflected by serum ferritin levels rose in the late teens in men and after menopause in women. This rise was more rapid and maximum ferritin levels were greater for blacks than whites and Hispanics of comparable age and sex. The distribution of values for the serum ferritin differed from the percent transferrin saturation. CONCLUSIONS: Different patterns of iron accumulation exist according to age, sex, and race. Serum ferritin levels reflect graded, population-based differences in body iron stores, but the percentage of transferrin saturation does not. The hypothesis that iron accumulation may contribute to higher morbidity and mortality rates can be tested in clinical trials of calibrated reduction of body iron stores in defined disease settings.

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CONTEXT: Increased 5-year survival for cancer patients is generally inferred to mean that cancer treatment has improved and that fewer patients die of cancer. Increased 5-year survival, however, may also reflect changes in diagnosis: finding more people with early-stage cancer, including some who would never have become symptomatic from their cancer. OBJECTIVE: To determine the relationship over time between 5-year cancer survival and 2 other measures of cancer burden, mortality and incidence. DESIGN AND SETTING: Using population-based statistics reported by the National Cancer Institute Surveillance, Epidemiology, and End Results Program, we calculated the change in 5-year survival from 1950 to 1995 for the 20 most common solid tumor types. Using the tumor as the unit of analysis, we correlated changes in 5-year survival with changes in mortality and incidence. MAIN OUTCOME MEASURE: The association between changes in 5-year survival and changes in mortality and incidence measured using simple correlation coefficients (Pearson and Spearman). RESULTS: From 1950 to 1995, there was an increase in 5-year survival for each of the 20 tumor types. The absolute increase in 5-year survival ranged from 3% (pancreatic cancer) to 50% (prostate cancer). During the same period, mortality rates declined for 12 types of cancer and increased for the remaining 8 types. There was little correlation between the change in 5-year survival for a specific tumor and the change in tumor-related mortality (Pearson r=.00; Spearman r=-.07). On the other hand, the change in 5-year survival was positively correlated with the change in the tumor incidence rate (Pearson r=+. 49; Spearman r=+.37). CONCLUSION: Although 5-year survival is a valid measure for comparing cancer therapies in a randomized trial, our analysis shows that changes in 5-year survival over time bear little relationship to changes in cancer mortality. Instead, they appear primarily related to changing patterns of diagnosis. JAMA. 2000.

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OBJECTIVE: To determine women's attitudes to and knowledge of both false positive mammography results and the detection of ductal carcinoma in situ after screening mammography. DESIGN: Cross sectional survey. SETTING: United States. PARTICIPANTS: 479 women aged 18-97 years who did not report a history of breast cancer. MAIN OUTCOME MEASURES: Attitudes to and knowledge of false positive results and the detection of ductal carcinoma in situ after screening mammography. RESULTS: Women were aware that false positive results do occur. Their median estimate of the false positive rate for 10 years of annual screening was 20% (25th percentile estimate, 10%; 75th percentile estimate, 45%). The women were highly tolerant of false positives: 63% thought that 500 or more false positives per life saved was reasonable and 37% would tolerate 10 000 or more. Women who had had a false positive result (n=76) expressed the same high tolerance: 39% would tolerate 10 000 or more false positives. 62% of women did not want to take false positive results into account when deciding about screening. Only 8% of women thought that mammography could harm a woman without breast cancer, and 94% doubted the possibility of non-progressive breast cancers. Few had heard about ductal carcinoma in situ, a cancer that may not progress, but when informed, 60% of women wanted to take into account the possibility of it being detected when deciding about screening. CONCLUSIONS: Women are aware of false positives and seem to view them as an acceptable consequence of screening mammography. In contrast, most women are unaware that screening can detect cancers that may never progress but feel that such information would be relevant. Education should perhaps focus less on false positives and more on the less familiar outcome of detection of ductal carcinoma in situ.

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BACKGROUND: The fractious public debate over mammography screening recommendations for women aged 40 to 49 years has received extensive attention in medical journals and in the press. OBJECTIVE: To learn how women interpret the mammography screening debate. METHODS: We mailed a survey to a random sample of American women 18 years and older, oversampling women of screening age (40-70 years). Sixty-six percent of women completed the survey (n = 503). MAIN OUTCOME MEASURES: The main outcome measures were women's reactions to the debate, their suggestion for the starting age for mammography screening, and their understanding of the source of the debate. RESULTS: Almost all women (95%) said that they had paid some attention to the recent discussion about mammography screening. Only 24% said the discussion had improved their understanding of mammography, while 50% reported being upset by the public disagreement among screening experts. Women's beliefs about mammography differed from those articulated by experts in the debate. Eighty-three percent believed that mammography had proven benefit for women aged 40 to 49 years, and 38% believed that benefit was proven for women younger than 40 years. Most women suggested that mammography screening should begin before age 40 years, while only 5% suggested a first mammogram should be performed at 50 years or older. In response to an open-ended question about why mammography has been controversial, 15% cited concerns about the potential harms of radiation and another 12% cited questions about efficacy. Nearly half (49%), however, identified costs as the major source of debate (eg, "Health maintenance organizations [HMOs] don't want to pay for mammography"). CONCLUSIONS: Most women paid attention to the recent debate about routine mammography screening for women aged 40 to 49 years, but many believed the debate was about money rather than the question of benefit. Policy makers issuing recommendations about implementation of large-scale mammography screening services need to consider how to effectively disseminate their message.

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CONTEXT: The Institute of Medicine (IOM) report on medical errors created an intense public response by stating that between 44,000 and 98,000 hospitalized Americans die each year as a result of preventable medical errors. OBJECTIVE: To determine how well the IOM committee documented its estimates and how valid they were. METHODS: We reviewed the studies cited in the IOM committee's report and related published articles. RESULTS: The two studies cited by the IOM committee substantiate its statement that adverse events occur in 2.9% to 3.7% of hospital admissions. Supporting data for the assertion that about half of these adverse events are preventable are less clear. In fact, the original studies cited did not define preventable adverse events, and the reliability of subjective judgments about preventability was not formally assessed. The committee's estimate of the number of preventable deaths due to medical errors is least substantiated. The methods used to estimate the upper bound of the estimate (98,000 preventable deaths) were highly subjective, and their reliability and reproducibility are unknown, as are the methods used to estimate the lower bound (44,000 deaths). CONCLUSION: Using the published literature, we could not confirm the Institute of Medicine's reported number of deaths due to medical errors. Due to the potential impact of this number on policy, it is unfortunate that the IOM's estimate is not well substantiated.

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CONTEXT: In the hope of extending treatment benefits to patients with early disease, various professional societies have recommended changing several common disease definitions by lowering the threshold value for diagnosis. COUNT: Number of Americans labeled "diseased" under new definitions for diabetes, hypertension, hypercholesterolemia, and being overweight. CALCULATION: [symbol: see text] DATA SOURCE: Adult participants (age > 17 years) in the Third National Health and Nutrition Examination Survey (1988-1994). RESULTS: Adopting the new definitions would dramatically inflate disease prevalence. Changing the threshold for diabetes from a fasting glucose level of > or = 140 mg/dL to > or = 126 mg/dL would result in 1.7 million new cases. Redefining hypertension as systolic blood pressure > or = 140 mm Hg instead of > or = 160 mm Hg or diastolic blood pressure > or = 90 mm Hg instead of > or = 100 mm Hg would create 13 million new hypertensive patients. For hypercholesterolemia (a cholesterol level of > or = 200 mg/dL instead of > or = 240 mg/dL) and being overweight (body mass index > or = 25 kg/m2 instead of > or = 27 kg/m2), the number of new cases would be 42 million and 29 million, respectively. The new definitions ultimately label 75% of the adult U.S. population as diseased. CONCLUSIONS: If these modest changes in disease definition were adopted, great numbers of people would be considered diseased. The extent to which new "patients" would ultimately benefit from early detection and treatment of these conditions is unknown. Whether they would experience important physical or psychological harm is an open question.

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CONTEXT: Information is a basic prerequisite to informed medical decision making. GENERAL QUESTION: How can we help people interpret the quantitative data they need to make informed decisions? SPECIFIC RESEARCH CHALLENGE: To develop and evaluate interventions that will help people make sense of the quantitative data relevant to their health care decisions. STANDARD APPROACH: Traditional patient education interventions focus on providing disease-specific information (e.g., educational brochures about a single disease). POTENTIAL DIFFICULTIES: Interventions that focus on content--the provision of facts--may not be sufficient help for people facing medical decisions. Training that prepares people to make sense of the facts that they are given may be necessary. ALTERNATE APPROACH: We propose developing a generic (i.e., not disease-specific) tutorial to prepare people to better understand and more critically evaluate data on disease risk and the benefits and harms of treatment. This tutorial aims to improve critical reading skills by teaching people about risk (e.g., probability and rates) and showing them what to look for in statements about risk (e.g., time frame), how to put disease risk and treatment benefit in context (e.g., evaluating competing risks), how to interpret changes in risk, and whether to believe the statements about changes in risk.

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BACKGROUND: Some studies suggest that women dramatically overestimate the risk of having breast cancer while others conclude that they underestimate it. To understand better how women perceive the chance of getting breast cancer, the authors asked women to estimate the risk in several ways. Each woman's answer was related to her actual risk. METHODS: Women were randomly selected from a registry of female veterans in New England. A mailed questionnaire asked each woman to estimate her ten-year risk of dying from breast cancer as a number out of 1,000 ("___ in 1,000" perceived risk) and whether this risk was higher than, the same as, or lower than that of an average woman her age (comparative perceived risk). The woman was also asked to compare her risk of dying from breast cancer with her risk of dying from heart disease. Risk-factor data were collected so that each woman's actual risk of breast cancer death could be estimated (actual risk). RESULTS: 201 women had complete data. The median age of the respondents was 62 years (range 27-80), and 98% were high school graduates. Most women (98%) overestimated the "___ in 1,000" risk of breast cancer death-half by eightfold or more (interquartile range, 4-36-fold overestimates). In contrast, only 10% of these women thought that they were at higher risk than an average woman their age. Most correctly thought that their risk of dying from breast cancer was lower than their risk of dying from heart disease. The women's "____in 1,000" perceived risks of breast cancer death were unrelated to their actual risks and had no significant agreement with an external bench-mark of importantly "high risk" (i.e., met risk criteria for the Tamoxifen primary prevention trial). In contrast, the women's comparative perceptions of being at low, average or high risk were related to actual risks and significantly agreed with the "high risk" benchmark. Most women not at importantly "high risk" correctly classified themselves; however, almost two thirds of "high risk" women misclassified themselves as "average or lower than average risk." CONCLUSIONS: The method used to elicit perceptions of risk matters. These women's responses to the comparative questions showed that they "knew more" about their actual risks than their open-ended numeric responses suggested.

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OBJECTIVE: Although the decision about how frequently to see outpatients has a direct impact on a provider's workload and may impact health care costs, revisit intervals have rarely been a topic of investigation. To begin to understand what factors are correlated with this decision, we examined baseline data from a Department of Veterans Affairs (VA) Cooperative Study designed to evaluate telephone care. DESIGN: Observational study based on extensive patient data collected during enrollment into the randomized trial. Providers were required to recommend a revisit interval (e.g., "return visit in 3 months") for each patient before randomization, under the assumption that the patient would be receiving clinic visits as usual. POPULATION/SETTING: Five hundred seventy-one patients over age 55 cared for by one of the 30 providers working in three VA general medical clinics. Patients for whom immediate follow-up (

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