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1.  Addressing overdiagnosis and overtreatment in cancer: a prescription for change 
The Lancet. Oncology  2014;15(6):e234-e242.
A vast range of disorders—from indolent to fast-growing lesions—are labelled as cancer. Therefore, we believe that several changes should be made to the approach to cancer screening and care, such as use of new terminology for indolent and precancerous disorders. We propose the term indolent lesion of epithelial origin, or IDLE, for those lesions (currently labelled as cancers) and their precursors that are unlikely to cause harm if they are left untreated. Furthermore, precursors of cancer or high-risk disorders should not have the term cancer in them. The rationale for this change in approach is that indolent lesions with low malignant potential are common, and screening brings indolent lesions and their precursors to clinical attention, which leads to overdiagnosis and, if unrecognised, possible overtreatment. To minimise that potential, new strategies should be adopted to better define and manage IDLEs. Screening guidelines should be revised to lower the chance of detection of minimal-risk IDLEs and inconsequential cancers with the same energy traditionally used to increase the sensitivity of screening tests. Changing the terminology for some of the lesions currently referred to as cancer will allow physicians to shift medicolegal notions and perceived risk to reflect the evolving understanding of biology, be more judicious about when a biopsy should be done, and organise studies and registries that offer observation or less invasive approaches for indolent disease. Emphasis on avoidance of harm while assuring benefit will improve screening and treatment of patients and will be equally effective in the prevention of death from cancer.
doi:10.1016/S1470-2045(13)70598-9
PMCID: PMC4322920  PMID: 24807866
2.  Geographic Variation in Diagnosis Frequency and Risk of Death Among Medicare Beneficiaries 
Context
Because diagnosis is typically thought of as purely a patient attribute, it is considered a critical factor in risk-adjustment policies designed to reward efficient and high-quality care.
Objective
To determine the association between frequency of diagnoses for chronic conditions in geographic areas and case-fatality rate among Medicare beneficiaries.
Design, Setting, and Participants
Cross-sectional analysis of the mean number of 9 serious chronic conditions (cancer, chronic obstructive pulmonary disease, coronary artery disease, congestive heart failure, peripheral artery disease, severe liver disease, diabetes with end-organ disease, chronic renal failure, and dementia) diagnosed in 306 hospital referral regions (HRRs) in the United States; HRRs were divided into quintiles of diagnosis frequency. Participants were 5 153 877 fee-for-service Medicare beneficiaries in 2007.
Main Outcome Measures
Age/sex/race–adjusted case-fatality rates.
Results
Diagnosis frequency ranged across HRRs from 0.58 chronic conditions in Grand Junction, Colorado, to 1.23 in Miami, Florida (mean, 0.90 [95% confidence interval {CI}, 0.89–0.91]; median, 0.87 [interquartile range, 0.80–0.96]). The number of conditions diagnosed was related to risk of death: among patients diagnosed with 0, 1, 2, and 3 conditions the case-fatality rate was 16, 45, 93, and 154 per 1000, respectively. As regional diagnosis frequency increased, however, the case fatality associated with a chronic condition became progressively less. Among patients diagnosed with 1 condition, the case-fatality rate decreased in a stepwise fashion across quintiles of diagnosis frequency, from 51 per 1000 in the lowest quintile to 38 per 1000 in the highest quintile (relative rate, 0.74 [95% CI, 0.72–0.76]). For patients diagnosed with 3 conditions, the corresponding case-fatality rates were 168 and 137 per 1000 (relative rate, 0.81 [95% CI, 0.79–0.84]).
Conclusion
Among fee-for-service Medicare beneficiaries, there is an inverse relationship between the regional frequency of diagnoses and the case-fatality rate for chronic conditions.
doi:10.1001/jama.2011.307
PMCID: PMC3071496  PMID: 21406648
3.  Prostate Cancer Diagnosis and Treatment After the Introduction of Prostate-Specific Antigen Screening: 1986–2005 
Background
Although there is uncertainty about the effect of prostate-specific antigen (PSA) screening on the rate of prostate cancer death, there is little uncertainty about its effect on the rate of prostate cancer diagnosis. Systematic estimates of the number of men affected, however, to our knowledge, do not exist.
Methods
We obtained data on age-specific incidence and initial course of therapy from the National Cancer Institute's Surveillance, Epidemiology, and End Results program. We then used age-specific male population estimates from the US Census to determine the excess (or deficit) in the number of men diagnosed and treated in each year after 1986—the year before PSA screening was introduced.
Results
Overall incidence of prostate cancer rose rapidly after 1986, peaked in 1992, and then declined, albeit to levels considerably higher than those in 1986. Overall incidence, however, obscured distinct age-specific patterns: The relative incidence rate (2005 relative to 1986) was 0.56 in men aged 80 years and older, 1.09 in men aged 70–79 years, 1.91 in men aged 60–69 years, 3.64 in men aged 50–59 years, and 7.23 in men younger than 50 years. Since 1986, an estimated additional 1 305 600 men were diagnosed with prostate cancer, 1 004 800 of whom were definitively treated for the disease. Using the most optimistic assumption about the benefit of screening—that the entire decline in prostate cancer mortality observed during this period is attributable to this additional diagnosis—we estimated that, for each man who experienced the presumed benefit, more than 20 had to be diagnosed with prostate cancer.
Conclusions
The introduction of PSA screening has resulted in more than 1 million additional men being diagnosed and treated for prostate cancer in the United States. The growth is particularly dramatic for younger men. Given the considerable time that has passed since PSA screening began, most of this excess incidence must represent overdiagnosis.
doi:10.1093/jnci/djp278
PMCID: PMC2758309  PMID: 19720969
4.  Skin biopsy rates and incidence of melanoma: population based ecological study 
BMJ : British Medical Journal  2005;331(7515):481.
Objectives To describe changes in skin biopsy rates and to determine their relation with changes in the incidence of melanoma.
Design Population based ecological study.
Setting Nine geographical areas of the United States.
Participants Participants of the Surveillance Epidemiology and End Results (SEER) programme aged 65 and older.
Main outcome measures For the period 1986 to 2001, annual skin biopsy rates for each surveillance area from Medicare claims and incidence rates for melanoma for the same population.
Results Between 1986 and 2001 the average biopsy rate across the nine participating areas increased 2.5-fold among people aged 65 and older (2847 to 7222 per 100 000 population). Over the same period the average incidence of melanoma increased 2.4-fold (45 to 108 per 100 000 population). Assuming that the occurrence of true disease was constant, the extra number of melanoma cases that were diagnosed after carrying out 1000 additional biopsies was 12.6 (95% confidence interval 11.2 to 14.0). After controlling for a potential increase in the true occurrence of disease, 1000 additional biopsies were still associated with 6.9 (3.1 to 10.8) extra melanoma cases diagnosed. Stage specific analyses suggested that 1000 biopsies were associated with 4.4 (2.1 to 6.8) extra cases of in situ melanoma diagnosed and 2.3 (0.0 to 4.6) extra cases of local melanoma, but not with the incidence of advanced melanoma. Mortality from melanoma changed little during the period.
Conclusion The incidence of melanoma is associated with biopsy rates. That the extra cases diagnosed were confined to early stage cancer while mortality remained stable suggests overdiagnosis—the increased incidence being largely the result of increased diagnostic scrutiny and not an increase in the incidence of disease.
doi:10.1136/bmj.38516.649537.E0
PMCID: PMC1199022  PMID: 16081427
7.  Impact of Diastolic and Systolic Blood Pressure on Mortality: Implications for the Definition of “Normal” 
ABSTRACT
BACKGROUND
The National Heart, Lung and Blood Institute currently defines a blood pressure under 120/80 as “normal.”
OBJECTIVE
To examine the independent effects of diastolic (DBP) and systolic blood pressure (SBP) on mortality and to estimate the number of Americans affected by accounting for these effects in the definition of “normal.”
DESIGN, PARTICIPANTS AND MEASURES
Data on adults (age 25–75) collected in the early 1970s in the first National Health and Nutrition Examination Survey were linked to vital status data through 1992 (N = 13,792) to model the relationship between blood pressure and mortality rate adjusting for age, sex, race, smoking status, BMI, cholesterol, education and income. To estimate the number of Americans in each blood pressure category, nationally representative data collected in the early 1960s (as a proxy for the underlying distribution of untreated blood pressure) were combined with 2008 population estimates from the US Census.
RESULTS
The mortality rate for individuals over age 50 began to increase in a stepwise fashion with increasing DBP levels of over 90. However, adjusting for SBP made the relationship disappear. For individuals over 50, the mortality rate began to significantly increase at a SBP ≥140 independent of DBP. In individuals ≤50 years of age, the situation was reversed; DBP was the more important predictor of mortality. Using these data to redefine a normal blood pressure as one that does not confer an increased mortality risk would reduce the number of American adults currently labeled as abnormal by about 100 million.
CONCLUSIONS
DBP provides relatively little independent mortality risk information in adults over 50, but is an important predictor of mortality in younger adults. Conversely, SBP is more important in older adults than in younger adults. Accounting for these relationships in the definition of normal would avoid unnecessarily labeling millions of Americans as abnormal.
doi:10.1007/s11606-011-1660-6
PMCID: PMC3138604  PMID: 21404131
blood pressure; hypertension; guidelines; mortality
8.  Population-based risk of complications following transthoracic needle lung biopsy of a pulmonary nodule 
Annals of internal medicine  2011;155(3):137-144.
Background
Because pulmonary nodules are found in up to 25% of patients undergoing chest computed tomography, the question of whether to biopsy is becoming increasingly common. Data on complications following transthoracic needle lung biopsy are limited to case series from selected institutions.
Objective
To determine population-based estimates of risks of complications following transthoracic needle biopsy of a pulmonary nodule.
Design
Cross-sectional analysis.
Setting
The 2006 Healthcare Cost and Utilization Project’s State Ambulatory Surgery Databases and State Inpatient Databases for California, Florida, Michigan, and New York.
Patients
15,865 adults who underwent transthoracic needle biopsy of a pulmonary nodule.
Measurements
Percent of biopsies complicated by hemorrhage, any pneumothorax, and pneumothorax requiring chest tube, and adjusted odds ratios for these complications associated with various biopsy characteristics, calculated using multivariable population-averaged generalized estimating equations.
Results
Although hemorrhage was rare, complicating 1.0% (95% CI 0.9-1.2%) of biopsies, 17.8% (95% CI 11.8-23.8%) of patients with hemorrhage required a blood transfusion. By contrast, the risk of any pneumothorax was 15.0% (95% CI 14.0-16.0%), and 6.6% (95% CI 6.0-7.2%) of all biopsies resulted in a pneumothorax requiring chest tube. Compared to patients without complications, those who experienced hemorrhage or pneumothorax requiring chest tube had longer lengths of stay (p<0.001) and were more likely to develop respiratory failure requiring mechanical ventilation (p=0.02). Patients aged 60-69 years (as opposed to younger or older patients), smokers, and those with chronic obstructive pulmonary disease had higher risk of complications.
Limitations
Estimated risks may be inaccurate if coding of complications is incomplete. The databases analyzed contain little clinical detail (e.g., nodule characteristics, biopsy pathology) and cannot determine whether biopsies produced useful information.
Conclusion
While hemorrhage is an infrequent complication of transthoracic needle lung biopsy, pneumothorax is common and often necessitates chest tube placement. These population-based data should help patients and doctors make a more informed choice on whether to biopsy a pulmonary nodule.
Primary Funding Source
Department of Veterans Affairs and National Cancer Institute K07 CA 138772
doi:10.1059/0003-4819-155-3-201108020-00003
PMCID: PMC3150964  PMID: 21810706
9.  Estimated Risk of Advanced and Multiple Adenomas Based On the Results of Two Prior Colonoscopies 
Annals of internal medicine  2009;151(2):103-109.
Background
Suggested intervals for postpolypectomy surveillance colonoscopy are currently based upon the adenoma findings from the most recent exam.
Objective
Determine the risk of clinically significant adenoma recurrence based upon the results of two prior colonoscopies.
Design
Prospective cohort
Setting
Academic and private centers in North America
Patients
Subjects in an adenoma chemoprevention trial in which all subjects had ≥ 1 adenoma at the time of a complete colonoscopy at entry. For this analysis, we included only subjects whose qualifying adenoma was their first. All subjects then had second and third study colonoscopy at roughly 3-year intervals.
Measurements
Proportion of patients developing high-risk findings at the third study colonoscopy: either at least one advanced (≥1cm or advanced histology) adenoma or multiple (≥ 3) adenomas.
Results
Fifty-eight of 564 subjects (10%) had high-risk findings at the third study exam. If the second exam showed high-risk findings, then results from the first exam added no significant information about the probability of detecting high-risk findings on the third exam (18.2% if the first exam had high-risk findings vs. 20% if the first exam had low-risk findings (P=0.78). If the second exam showed no adenomas, then the results from the first exam added significant information about the probability of detecting high-risk findings on the third exam (12.3% if the first exam had high-risk findings vs. 4.9% if the first exam had low-risk findings (P=0.015)
Limitations
This observational study cannot specifically examine adenoma recurrence risk at intervals suggested for low risk adenoma patients (e.g. 5 vs. 10 years).
Conclusions
Information from two prior exams may help identify low-risk populations that benefit little from intense surveillance. Surveillance guidelines might be tailored in selected subjects to use information from two prior exams, not just the most recent one.
Funding
Dr Robertson’s work is supported by a VA HSR&D Career Development Award. The parent study was supported by grant R01 CA 59005 from the National Institutes of Health.
PMCID: PMC2779048  PMID: 19620162
10.  The Risk of Death by Age, Sex, and Smoking Status in the United States: Putting Health Risks in Context 
Background
To make sense of the disease risks they face, people need basic facts about the magnitude of a particular risk and how one risk compares with other risks. Unfortunately, this fundamental information is not readily available to patients or physicians. We created simple one-page charts that present the 10-year chance of dying from various causes according to age, sex, and smoking status.
Methods
We used the National Center for Health Statistics Multiple Cause of Death Public Use File for 2004 and data from the 2004 US Census to calculate age- and sex-specific death rates for various causes of death. We then combined data on smoking prevalence (from the National Health Interview Survey) and the relative risks of death from various causes for smokers vs never smokers (from the American Cancer Society’s Cancer Prevention Study-II) to determine age-, sex-, and smoking-specific death rates. Finally, we accumulated these risks for various starting ages in a series of 10-year life tables. The charts present the 10-year risks of dying from heart disease; stroke; lung, colon, breast, cervical, ovarian, and prostate cancer; pneumonia; influenza; AIDS; chronic obstructive pulmonary disease; accidents; and all causes.
Results
At all ages, the 10-year risk of death from all causes combined is higher for men than women. The effect of smoking on the chance of dying is similar to the effect of adding 5 to 10 years of age: for example, a 55-year-old man who smokes has about the same 10-year risk of death from all causes as a 65-year-old man who never smoked (ie, 178 vs 176 of 1000 men, respectively). For men who never smoked, heart disease death represents the single largest cause of death from age 50 on and the chance of dying from heart disease exceeds the chances of dying from lung, colon, and prostate cancers combined at every age. For men who currently smoke, the chance of dying from lung cancer is of the same order of magnitude as the chance dying from heart disease and after age 50 it is about 10 times greater than the chance of dying from prostate or colon cancer. For women who have never smoked, the magnitudes of the 10-year risks of death from breast cancer and heart disease are similar until age 60; from this age on, heart disease represents the single largest cause of death. For women who currently smoke, the chance of dying from heart disease or lung cancer exceeds the chance of dying from breast cancer from age 40 on (and does so by at least a factor of 5 after age 55).
Conclusion
The availability of simple charts with consistent data presentations of important causes of death may facilitate discussion about disease risk between physicians and their patients and help highlight the dangers of smoking.
doi:10.1093/jnci/djn124
PMCID: PMC3298961  PMID: 18544745
11.  Estimating the Impact of Adding C-Reactive Protein as a Criterion for Lipid Lowering Treatment in the United States 
Background
There is growing interest in using C-reactive protein (CRP) levels to help select patients for lipid lowering therapy—although this practice is not yet supported by evidence of benefit in a randomized trial.
Objective
To estimate the number of Americans potentially affected if a CRP criteria were adopted as an additional indication for lipid lowering therapy. To provide context, we also determined how well current lipid lowering guidelines are being implemented.
Methods
We analyzed nationally representative data to determine how many Americans age 35 and older meet current National Cholesterol Education Program (NCEP) treatment criteria (a combination of risk factors and their Framingham risk score). We then determined how many of the remaining individuals would meet criteria for treatment using 2 different CRP-based strategies: (1) narrow: treat individuals at intermediate risk (i.e., 2 or more risk factors and an estimated 10–20% risk of coronary artery disease over the next 10 years) with CRP > 3 mg/L and (2) broad: treat all individuals with CRP > 3 mg/L.
Data source
Analyses are based on the 2,778 individuals participating in the 1999–2002 National Health and Nutrition Examination Survey with complete data on cardiac risk factors, fasting lipid levels, CRP, and use of lipid lowering agents.
Main measures
The estimated number and proportion of American adults meeting NCEP criteria who take lipid-lowering drugs, and the additional number who would be eligible based on CRP testing.
Results
About 53 of the 153 million Americans aged 35 and older meet current NCEP criteria (that do not involve CRP) for lipid-lowering treatment. Sixty-five percent, however, are not currently being treated, even among those at highest risk (i.e., patients with established heart disease or its risk equivalent)—62% are untreated. Adopting the narrow and broad CRP strategies would make an additional 2.1 and 25.3 million Americans eligible for treatment, respectively. The latter strategy would make over half the adults age 35 and older eligible for lipid-lowering therapy, with most of the additionally eligible (57%) coming from the lowest NCEP heart risk category (i.e., 0–1 risk factors).
Conclusion
There is substantial underuse of lipid lowering therapy for American adults at high risk for coronary disease. Rather than adopting CRP-based strategies, which would make millions more lower risk patients eligible for treatment (and for whom treatment benefit has not yet been demonstrated in a randomized trial), we should ensure the treatment of currently defined high-risk patients for whom the benefit of therapy is established.
doi:10.1007/s11606-006-0033-z
PMCID: PMC1824732  PMID: 17356986
coronary disease; risk assessment; C-reactive protein; antilipemic agents; guideline adherence
12.  Estimating the Impact of Adding C-Reactive Protein as a Criterion for Lipid Lowering Treatment in the United States 
Background
There is growing interest in using C-reactive protein (CRP) levels to help select patients for lipid lowering therapy—although this practice is not yet supported by evidence of benefit in a randomized trial.
Objective
To estimate the number of Americans potentially affected if a CRP criteria were adopted as an additional indication for lipid lowering therapy. To provide context, we also determined how well current lipid lowering guidelines are being implemented.
Methods
We analyzed nationally representative data to determine how many Americans age 35 and older meet current National Cholesterol Education Program (NCEP) treatment criteria (a combination of risk factors and their Framingham risk score). We then determined how many of the remaining individuals would meet criteria for treatment using 2 different CRP-based strategies: (1) narrow: treat individuals at intermediate risk (i.e., 2 or more risk factors and an estimated 10–20% risk of coronary artery disease over the next 10 years) with CRP > 3 mg/L and (2) broad: treat all individuals with CRP > 3 mg/L.
Data source
Analyses are based on the 2,778 individuals participating in the 1999–2002 National Health and Nutrition Examination Survey with complete data on cardiac risk factors, fasting lipid levels, CRP, and use of lipid lowering agents.
Main measures
The estimated number and proportion of American adults meeting NCEP criteria who take lipid-lowering drugs, and the additional number who would be eligible based on CRP testing.
Results
About 53 of the 153 million Americans aged 35 and older meet current NCEP criteria (that do not involve CRP) for lipid-lowering treatment. Sixty-five percent, however, are not currently being treated, even among those at highest risk (i.e., patients with established heart disease or its risk equivalent)—62% are untreated. Adopting the narrow and broad CRP strategies would make an additional 2.1 and 25.3 million Americans eligible for treatment, respectively. The latter strategy would make over half the adults age 35 and older eligible for lipid-lowering therapy, with most of the additionally eligible (57%) coming from the lowest NCEP heart risk category (i.e., 0–1 risk factors).
Conclusion
There is substantial underuse of lipid lowering therapy for American adults at high risk for coronary disease. Rather than adopting CRP-based strategies, which would make millions more lower risk patients eligible for treatment (and for whom treatment benefit has not yet been demonstrated in a randomized trial), we should ensure the treatment of currently defined high-risk patients for whom the benefit of therapy is established.
doi:10.1007/s11606-006-0033-z
PMCID: PMC1824732  PMID: 17356986
coronary disease; risk assessment; C-reactive protein; antilipemic agents; guideline adherence
13.  Ratio measures in leading medical journals: structured review of accessibility of underlying absolute risks 
BMJ : British Medical Journal  2006;333(7581):1248.
Objective To examine the accessibility of absolute risk in articles reporting ratio measures in leading medical journals.
Design Structured review of abstracts presenting ratio measures.
Setting Articles published between 1 June 2003 and 1 May 2004 in Annals of Internal Medicine, BMJ, Journal of the American Medical Association, Journal of the National Cancer Institute, Lancet, and New England Journal of Medicine.
Participants 222 articles based on study designs in which absolute risks were directly calculable (61 randomised trials, 161 cohort studies).
Main outcome measure Accessibility of the absolute risks underlying the first ratio measure in the abstract.
Results 68% of articles (150/222) failed to report the underlying absolute risks for the first ratio measure in the abstract (range 55−81% across the journals). Among these articles, about half did report the underlying absolute risks elsewhere in the article (text, table, or figure) but half did not report them anywhere. Absolute risks were more likely to be reported in the abstract for randomised trials compared with cohort studies (62% v 21%; relative risk 3.0, 95% confidence interval 2.1 to 4.2) and for studies reporting crude compared with adjusted ratio measures (62% v 21%; relative risk 3.0, 2.1 to 4.3).
Conclusion Absolute risks are often not easily accessible in articles reporting ratio measures and sometimes are missing altogether—this lack of accessibility can easily exaggerate readers' perceptions of benefit or harm.
doi:10.1136/bmj.38985.564317.7C
PMCID: PMC1702463  PMID: 17060338
14.  Patients and Medical Statistics 
Journal of General Internal Medicine  2005;20(11):996-1000.
BACKGROUND
People are increasingly presented with medical statistics. There are no existing measures to assess their level of interest or confidence in using medical statistics.
OBJECTIVE
To develop 2 new measures, the STAT-interest and STAT-confidence scales, and assess their reliability and validity.
DESIGN
Survey with retest after approximately 2 weeks.
SUBJECTS
Two hundred and twenty-four people were recruited from advertisements in local newspapers, an outpatient clinic waiting area, and a hospital open house.
MEASURES
We developed and revised 5 items on interest in medical statistics and 3 on confidence understanding statistics.
RESULTS
Study participants were mostly college graduates (52%); 25% had a high school education or less. The mean age was 53 (range 20 to 84) years. Most paid attention to medical statistics (6% paid no attention). The mean (SD) STAT-interest score was 68 (17) and ranged from 15 to 100. Confidence in using statistics was also high: the mean (SD) STAT-confidence score was 65 (19) and ranged from 11 to 100. STAT-interest and STAT-confidence scores were moderately correlated (r=.36, P<.001). Both scales demonstrated good test–retest repeatability (r=.60, .62, respectively), internal consistency reliability (Cronbach's α=0.70 and 0.78), and usability (individual item nonresponse ranged from 0% to 1.3%). Scale scores correlated only weakly with scores on a medical data interpretation test (r=.15 and .26, respectively).
CONCLUSION
The STAT-interest and STAT-confidence scales are usable and reliable. Interest and confidence were only weakly related to the ability to actually use data.
doi:10.1111/j.1525-1497.2005.00179.x
PMCID: PMC1490265  PMID: 16307623
decision making; patient education; statistic
16.  The Frequency of Pap Smear Screening in the United States 
BACKGROUND
U.S. professional medical societies and the national health systems of all other industrialized nations recommend that most women need not undergo Papanicolaou (Pap) smear screening annually. There are no data, however, regarding the frequency at which women actually undergo screening.
OBJECTIVE
To describe the frequency of cervical cancer screening in the United States.
DESIGN
National Health Interview Survey, a cross-sectional population-based telephone survey conducted by the National Center for Health Statistics.
PARTICIPANTS
Representative sample of U.S. women age 21 and older who denied a history of cancer (N = 16,467).
MEASUREMENTS
Pap smear screening frequency, categorized as no regular screening or screening at 1 of 3 discrete screening intervals (every year, every 2 years, or every 3 years) based on each woman's reported number of Pap smears in the previous 6 years.
RESULTS
The vast majority (93%) of American women report having had at least one Pap smear in their lifetime. Among women with no history of abnormal smears, 55% undergo Pap smear screening annually, 17% report a 2-year screening interval, 16% report being screened every 3 years, and 11% are not being screened regularly. Even the very elderly report frequent screening—38% of women age 75 to 84 and 20% of women age 85 and older reported annual Pap smears. Overall, 20% of women reported having had at least one abnormal Pap smear. Among these women, rates of frequent Pap smear screening are considerably higher—80% undergo annual screening, with only a modest decline in screening frequency with increasing age.
CONCLUSIONS
The majority of American women report being screened for cervical cancer more frequently than recommended. Lengthening the screening interval would not only reduce the volume of specimens that cytotechnologists are required to read, but would also reduce the follow-up testing after abnormal smears.
doi:10.1111/j.1525-1497.2004.21107.x
PMCID: PMC1492158  PMID: 15009779
cervical cancer screening; Pap smear; test frequency; overutilization
17.  US women's attitudes to false-positive mammography results and detection of ductal carcinoma in situ 
Western Journal of Medicine  2000;173(5):307-312.
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.
PMCID: PMC1071147  PMID: 11069862
18.  US women's attitudes to false positive mammography results and detection of ductal carcinoma in situ: cross sectional survey 
BMJ : British Medical Journal  2000;320(7250):1635-1640.
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.
PMCID: PMC27408  PMID: 10856064
19.  The Role of Patients and Providers in the Timing of Follow-up Visits 
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.
POPULATON/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 (≤2 weeks) was recommended were excluded.
MEASUREMENTS
Mean revisit interval was adjusted for patient factors using a regression model that accounted for patients being nested within providers and providers being nested within sites. Four patient-level variable blocks (illness burden–patient, travel time, illness burden–physician, and prior utilization) were sequentially entered into a linear model to determine their role in explaining the variance in revisit intervals. Physician identity was also entered after four blocks.
MAIN RESULTS
Recommended revisit intervals ranged from 1 month to over 1 year with the most common recommended intervals being 2, 3, or 6 months. About 10% of the variance in revisit interval was explained by illness measures independent of provider (e.g., general health perception) and travel time. Adding other illness measures (e.g., diagnoses, medications) and prior utilization (e.g., clinic visits) doubled the variance explained (R2= .21). Finally, the identification of individual provider doubled the explained variance again (R2= .45). After adjusting for patient factors, the average revisit interval for individual providers ranged from 8 to 26 weeks (8 to 19 weeks when restricted to the 16 staff physicians). There were also substantial differences across the three sites (adjusted means: 14, 17, and 11 weeks).
CONCLUSIONS
Even after adjusting for a detailed array of patient-level data, primary care providers have different practice styles regarding the timing of return visits. These may, in turn, reflect the local “culture” in which they practice. How many patients providers are able to care for may be determined by the providers’ inclinations toward the timing of follow-up visits.
doi:10.1046/j.1525-1497.1999.00321.x
PMCID: PMC1496567  PMID: 10203634
outpatients; follow-up visits; revisit interval
20.  Setting the Revisit Interval in Primary Care 
OBJECTIVE
Although longitudinal care constitutes the bulk of primary care, physicians receive little guidance on the fundamental question of how to time follow-up visits. We sought to identify important predictors of the revisit interval and to describe the variability in how physicians set these intervals when caring for patients with common medical conditions.
DESIGN
Cross-sectional survey of physicians performed at the end of office visits for consecutive patients with hypertension, angina, diabetes, or musculoskeletal pain.
PARTICIPANTS/SETTING
One hundred sixty-four patients under the care of 11 primary care physicians in the Dartmouth Primary Care Cooperative Research Network.
MEASUREMENTS
The main outcome measures were the variability in mean revisit intervals across physicians and the proportion of explained variance by potential determinants of revisit intervals. We assessed the relation between the revisit interval (dependent variable) and three groups of independent variables, patient characteristics (e.g., age, physician perception of patient health), identification of individual physician, and physician characterization of the visit (e.g., routine visit, visit requiring a change in management, or visit occurring on a “hectic” day), using multiple regression that accounted for the natural grouping of patients within physician.
MAIN RESULTS
Revisit intervals ranged from 1 week to over 1 year. The most common intervals were 12 and 16 weeks. Physicians’ perception of fair-poor health status and visits involving a change in management were most strongly related to shorter revisit intervals. In multivariate analyses, patient characteristics explained about 18% of the variance in revisit intervals, and adding identification of the individual provider doubled the explained variance to about 40%. Physician characterization of the visit increased explained variance to 57%. The average revisit interval adjusted for patient characteristics for each of the 11 physicians varied from 4 to 20 weeks. Although all physicians lengthened revisit intervals for routine visits and shortened them when changing management, the relative ranking of mean revisit intervals for each physician changed little for different visit characterizations—some physicians were consistently long and others were consistently short.
CONCLUSION
Physicians vary widely in their recommendations for office revisits. Patient factors accounted for only a small part of this variation. Although physicians responded to visits in predictable ways, each physician appeared to have a unique set point for the length of the revisits interval.
doi:10.1046/j.1525-1497.1999.00322.x
PMCID: PMC1496560  PMID: 10203635
follow-up; revisit interval
21.  The Effectiveness of Cost-Effectiveness Analysis in Containing Costs 
OBJECTIVE
Although cost-effectiveness analyses (CEAs) have been advocated as a tool to critically appraise the value of health expenditures, it has been widely hoped that they might also help contain health care costs. To determine how often they discourage additional expenditures, we reviewed the conclusions of recently published CEAs.
DATA SOURCES
A search of the Abridged Index Medicus (a subset of MEDLINE designed to afford rapid access to the literature of “immediate interest” to the practicing physician) between 1990 and 1996.
STUDY SELECTION
We only included articles that reported an explicit cost-effectiveness (CE) ratio (a cost for some given health effect) in the abstract.
DATA ABSTRACTION
From each abstract, we collected the value for the incremental CE ratio and the measure of health effect (life-years, quality-adjusted life-years [QALYs], other). We then categorized the authors' conclusion into one of three categories: supports strategy requiring additional expenditure, no firm conclusion, and supports low-cost alternative. Finally, we obtained the article and collected information on funding source.
DATA SYNTHESIS
Among the 109 eligible articles, the authors' conclusion supported strategies requiring additional expenditure in 58 (53%) and supported the low-cost alternative in 28 (26%). We then focused on the 65 articles reporting either life-years or QALYs. Cost-effectiveness ratios ranged from $400 to $166,000 (per life-year or QALY) in the 39 articles (60%) in which authors supported additional expenditure, and ranged from $61,500 to $11,600,000 in the 13 articles (20%) in which authors supported the low-cost alternative. Despite identifying similar CE ratios, authors arrived at different conclusions in the overlapping range ($61,500 to $166,000). Of the 10 articles acknowledging industry funding, 9 supported a strategy requiring additional expenditure (p = .01 as compared with those without such funding).
CONCLUSIONS
Authors of CEAs are more likely to support strategies requiring additional expenditure than the low-cost alternative. There is no obvious consensus about how small the CE ratio should be to warrant additional expenditure. Finally, concerns about funding source seem to be warranted.
doi:10.1046/j.1525-1497.1998.00201.x
PMCID: PMC1500894  PMID: 9798812
cost-effectiveness analyses; health cost containment; life-years; quality-adjusted life-years
22.  Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews 
BMJ : British Medical Journal  1998;317(7161):771-775.
Objective: To determine how patients with lung cancer value the trade off between the survival benefit of chemotherapy and its toxicities.
Design: Scripted interviews that included three hypothetical scenarios. Each scenario described the same patient with metastatic non-small cell lung cancer with an expected survival of 4 months without treatment. Subjects were asked to indicate the minimum survival benefit required to accept the side effects of chemotherapy in the first two scenarios (mild toxicity and severe toxicity). In the third scenario, subjects were asked to choose between chemotherapy and supportive care when the benefit of chemotherapy was either to prolong life by 3 months or to palliate symptoms.
Subjects: 81 patients previously treated with cis-platinum based chemotherapy for advanced non-small cell lung cancer.
Main outcome measure: Survival threshold for accepting chemotherapy.
Results: The minimum survival threshold for accepting the toxicity of chemotherapy varied widely in patients. Several patients would accept chemotherapy for a survival benefit of 1 week, while others would not choose chemotherapy even for a survival benefit of 24 months. The median survival threshold for accepting chemotherapy was 4.5 months for mild toxicity and 9 months for severe toxicity. When given the choice between supportive care and chemotherapy only 18 (22%) patients chose chemotherapy for a survival benefit of 3 months; 55 (68%) patients chose chemotherapy if it substantially reduced symptoms without prolonging life.
Conclusions: Patients’ willingness to accept chemotherapy for the treatment of metastatic lung cancer varies widely. Many would not choose chemotherapy for its likely survival benefit of 3 months but would if it improved quality of life. The conflict between these patients’ preferences and the care they previously received has several explanations, one being that some patients had not received the treatment they would have chosen had they been fully informed.
Key messagesThe median survival of patients with metastatic non-small cell lung cancer is improved by about 3 months with the addition of chemotherapyLung cancer patients who had had chemotherapy were interviewed in this study to learn about their treatment preferences with a range of survival benefitsSeveral patients would choose chemotherapy for a survival benefit of as little as 1 week, while others would not choose chemotherapy even when offered a survival benefit of 24 monthsMost patients would not choose chemotherapy for its likely survival benefit of 3 months, but would if it improved quality of lifeSome patients with lung cancer may not be getting the treatment they would choose were they fully informed
PMCID: PMC28665  PMID: 9740561
23.  Is Language a Barrier to the Use of Preventive Services? 
OBJECTIVE
To isolate the effect of spoken language from financial barriers to care, we examined the relation of language to use of preventive services in a system with universal access.
DESIGN
Cross-sectional survey.
SETTING
Household population of women living in Ontario, Canada, in 1990.
PARTICIPANTS
Subjects were 22,448 women completing the 1990 Ontario Health Survey, a population-based random sample of households.
MEASUREMENTS AND MAIN RESULTS
We defined language as the language spoken in the home and assessed self-reported receipt of breast examination, mammogram and Pap testing. We used logistic regression to calculate odds ratios for each service adjusting for potential sources of confounding: socioeconomic characteristics, contact with the health care system, and measures reflecting culture. Ten percent of the women spoke a non-English language at home (4% French, 6% other). After adjustment, compared with English speakers, French-speaking women were significantly less likely to receive breast exams or mammography, and other language speakers were less likely to receive Pap testing.
CONCLUSIONS
Women whose main spoken language was not English were less likely to receive important preventive services. Improving communication with patients with limited English may enhance participation in screening programs.
doi:10.1046/j.1525-1497.1997.00085.x
PMCID: PMC1497155  PMID: 9276652
language; preventive health services; accessibility of health services; communication barriers
24.  Evaluating Randomized Trials of Screening 
doi:10.1046/j.1525-1497.1997.00017.x
PMCID: PMC1497070  PMID: 9051562
25.  Observational intensity bias associated with illness adjustment: cross sectional analysis of insurance claims 
Objective To determine the bias associated with frequency of visits by physicians in adjusting for illness, using diagnoses recorded in administrative databases.
Setting Claims data from the US Medicare program for services provided in 2007 among 306 US hospital referral regions.
Design Cross sectional analysis.
Participants 20% sample of fee for service Medicare beneficiaries residing in the United States in 2007 (n=5 153 877).
Main outcome measures The effect of illness adjustment on regional mortality and spending rates using standard and visit corrected illness methods for adjustment. The standard method adjusts using comorbidity measures based on diagnoses listed in administrative databases; the modified method corrects these measures for the frequency of visits by physicians. Three conventions for measuring comorbidity are used: the Charlson comorbidity index, Iezzoni chronic conditions, and hierarchical condition categories risk scores.
Results The visit corrected Charlson comorbidity index explained more of the variation in age, sex, and race mortality across the 306 hospital referral regions than did the standard index (R2=0.21 v 0.11, P<0.001) and, compared with sex and race adjusted mortality, reduced regional variation, whereas adjustment using the standard Charlson comorbidity index increased it. Although visit corrected and age, sex, and race adjusted mortality rates were similar in hospital referral regions with the highest and lowest fifths of visits, adjustment using the standard index resulted in a rate that was 18% lower in the highest fifth (46.4 v 56.3 deaths per 1000, P<0.001). Age, sex, and race adjusted spending as well as visit corrected spending was more than 30% greater in the highest fifth of visits than in the lowest fifth, but only 12% greater after adjustment using the standard index. Similar results were obtained using the Iezzoni and the hierarchical condition categories conventions for measuring comorbidity.
Conclusion The rates of visits by physicians introduce substantial bias when regional mortality and spending rates are adjusted for illness using comorbidity measures based on the observed number of diagnoses recorded in Medicare’s administrative database. Adjusting without correction for regional variation in visit rates tends to make regions with high rates of visits seem to have lower mortality and lower costs, and vice versa. Visit corrected comorbidity measures better explain variation in age, sex, and race mortality than observed measures, and reduce observational intensity bias.
doi:10.1136/bmj.f549
PMCID: PMC3578417  PMID: 23430282

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