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Obstetrician-gynecologists (ob-gyns) face similar types of biases in the workplace as any people in society. In this first of three articles exploring this issue, we present the stories from ob-gyns who describe their experiences dealing with these biases. These stories serve to personalize the issue and to encourage us to personally face bias in the workplace to build our own resilience and strength, to support those who are personally attacked or diminished, and to develop workplace cultures that are inclusive, diverse, and strong.

OBJECTIVE To evaluate observational research manuscripts submitted to Obstetrics & Gynecology to determine the level of adherence to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist and highlight specific areas that could be improved. METHODS A scoring system based on the STROBE checklist was developed and validated for consistency by volunteer medical students or doctors. Using this scoring system, we performed a cross-sectional analysis on 198 observational research manuscripts submitted to Obstetrics & Gynecology from 2008 to 2016. Each manuscript was given a score based on the STROBE checklist. Comparisons were made among acceptance status, country of origin, and study type. Descriptive statistics (means, medians, and frequencies) were calculated for each manuscript category. The t test or Wilcoxon rank-sum test was used to compare differences between two groups and analysis of variance or the Kruskal-Wallis test was used to compare differences among three or more groups. RESULTS There was a statistically significant difference between the mean score for accepted (23.2±2.7) compared with rejected (19.7±4.1) manuscripts (P

Cervical cancer disproportionately affects Latina women in the United States. This study evaluated the impact of patient navigation on cervical cancer prevention in Latinas.Between January 2004 and April 2011, 533 Latina women with an abnormal Pap smear requiring colposcopy received patient navigation from their healthcare center in Chelsea, Massachusetts, to the Massachusetts General Hospital (MGH). The comparison group comprised 253 non-navigated Latinas from other primary care practices at MGH referred to the same MGH colposcopy clinic. Primary outcomes were the percentage of missed colposcopy appointments, time to colposcopy, and changes in the severity of cervical pathology at colposcopy over two time periods, 2004-2007 and 2008-2011.The mean age in both groups was 35 years (range 22-86). Navigated women had fewer missed colposcopy appointments over time, with the average falling from 19.8% to 15.7% (p=0.024), compared with an insignificant increase in the no-show rates from 18.6% to 20.6% (p=0.454) in the comparison group. The difference in the no-show rate trend over time between the groups was significant (p0.001). The time to colposcopy did not change in either group, though trends over time demonstrated a shorter follow-up for navigated women (p=0.010). The grade of cervical abnormality among navigated women decreased from a numerical score of 2.03 to 1.83 (p=0.035) over the two time intervals, while the severity of pathological score in the non-navigated group did not change significantly from 1.83 to 1.92 (p=0.573) in the same interval. Comparison of trends in pathological score over time showed a decrease in the severity of cervical abnormality for navigated participants compared to the non-navigated group (p0.001).Patient navigation can prevent cervical cancer in Latina women by increasing colposcopy clinic attendance, shortening time to colposcopy, and decreasing severity of cervical abnormalities over time.

OBJECTIVE To evaluate whether quality of peer review and reviewer recommendation differ based on reviewer subspecialty in obstetrics and gynecology and to determine the role of experience on reviewer recommendation. METHODS We performed a retrospective cohort study of reviews submitted to Obstetrics & Gynecology between January 2010 and December 2014. Subspecialties were determined based on classification terms selected by each reviewer and included all major obstetrics and gynecology subspecialties, general obstetrics and gynecology, and nonobstetrics and gynecology categories. Review quality (graded on a 5-point Likert scale by the journal's editors) and reviewer recommendation of "reject" were compared across subspecialties using χ, analysis of variance, and multivariate logistic regression. RESULTS There were 20,027 reviews from 1,889 individual reviewers. Reviewers with family planning subspecialty provided higher-quality peer reviews compared with reviewers with gynecology only, reproductive endocrinology and infertility, gynecologic oncology, and general obstetrics and gynecology specialties (3.61±0.75 compared with 3.44±0.78, 3.42±0.72, 3.35±0.75, and 3.32±0.81, respectively, P

This article comments on the approaches to solving problems in the development of targeted drug therapies for cancer as outlined by expert collaborative panels and described in this issue by Amit et al., Abrams et al., and Clark et al.

BACKGROUND: The National Quality Forum recently endorsed the proportion of days covered (PDC)—a measure of medication adherence—as an indicator of quality in drug therapy management. OBJECTIVE: To inform initial efforts to improve the quality of drug therapy management, we compared PDC and persistence among new users of 6 commonly used chronic medication categories. METHODS: A retrospective analysis of pharmacy claims in a database of more than 64 million members enrolled in 100 health plans assessed persistence and adherence to drug therapy in 6 chronic conditions. Patients were included in the analysis if they initiated a prescription drug of interest in any of 6 drug classes—prostaglandin analogs, statins, bisphosphonates, oral antidiabetics, angiotensin II receptor blockers (ARBs), and overactive bladder (OAB) medications—between January 1 and December 31, 2005. The first claim for a drug of interest during this period was considered a patient’s index date. Patients were required to have a minimum of 12 months of continuous enrollment both preceding and following their index date. New users of a treatment were identified by excluding patients who filled a prescription for any drug in the same class during the previous 12 months and were followed for a minimum of 12 months. Nonpersistence was defined as discontinuation of the therapy class following an allowed gap between refills—30-, 60-, and 90-day refill gaps were used. Adherence was defined as a continuous measure of the proportion of days covered (PDC) during the 12-month post-index period. Logistic regression analyses predicted (a) nonpersistence during the 12-month post-index period and (b) adherence (PDC) of at least 80%, with drug class as the predictor variable of interest, controlling for demographic variables, insurance and plan type, history of hospitalization, Charlson comorbidity score, copayment for index medication, and number of medications at index. RESULTS: A total of 167,907 patients were identified across 6 cohorts. Using the 60-day gap, 6-month persistence rates were prostaglandin analogs 47%, statins 56%, bisphosphonates 56%, oral antidiabetics 66%, ARBs 63%, and OAB medications 28%. After the first 90 days of therapy, relative persistence was stable across cohorts, and rates declined consistently from 6 months post-index to study end. Logistic regression models showed that oral antidiabetic users had a 59%, 36%, 37%, and 79% decreased risk of nonpersistence in a 12-month follow-up period compared with patients taking prostaglandin analogs, statins, bisphosphonates, or OAB medications, respectively. Risk of nonpersistence decreased with increasing age. Mean (SD) 12-month adherence rates were: prostaglandin analogs 37% (26%), statins 61% (33%), bisphosphonates 60% (34%), oral antidiabetics 72% (32%), ARBs 66% (32%), and OAB medications 35% (32%). Logistic regression indicated that oral antidiabetic use was a significant predictor of adherence (PDC) of at least 80% compared with other therapy classes. Adjusted odds ratios for oral antidiabetics were 17.60 (95% confidence interval [CI] = 15.38-20.14) versus prostaglandin analogs, 2.06 (95% CI = 1.99-2.12) versus statins, 1.92 (95% CI = 1.83-2.02) versus bisphosphonates, 1.29 (95% CI = 1.24-1.34) versus ARBs, and 5.77 (95% CI = 5.38-6.19) versus OAB medications. CONCLUSION: This analysis of adherence (PDC) and persistence across a sample of 6 chronic therapies found variable but uniformly suboptimal medication use. Adherence to prostaglandin eye drops and OAB medications was lower than to cardiovascular, oral antidiabetic, and oral osteoporosis therapies. These findings provide useful baseline information for the development of initiatives to improve the quality of drug therapy management.

Objective We sought to determine lifetime costs, morbidity, and mortality associated with varying adherence to antihypertensive and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statin) therapy in a hypertensive population. Methods A model was constructed to compare costs and outcomes under three adherence scenarios: no treatment, ideal adherence, and real-world adherence. Simulated patients' characteristics matched those of participants in the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid-Lowering Arm and event probabilities were calculated with Framingham Heart Study risk equations. The real-world adherence scenario employed adherence data from an observational study of a US population; risk reductions at each level of adherence were based on linear extrapolations from clinical trials. Outputs included life expectancy, frequencies of primary and secondary coronary heart disease and stroke, and direct medical costs in 2006 US$. The incremental cost per life-year gained and incremental cost per event avoided were calculated comparing the three adherence scenarios. Results Mean life expectancy was 14.73 years (no-treatment scenario), 15.07 (real-world adherence), and 15.49 (ideal adherence). The average number of cardiovascular events per patients was 0.738 (no treatment), 0.610 (real-world adherence), and 0.441 (ideal adherence). The incremental cost of real-world adherence versus no treatment is $30,585 per life-year gained, and ideal adherence versus real-world adherence is $22,121 per life-year gained. Conclusions Hypertensive patients taking antihypertensive and statin therapy at real-world adherence levels can be expected to receive approximately 50% of the potential benefit seen in clinical trials. Depending on its cost, the incremental benefits of an effective adherence intervention program could make it an attractive value.

The study objective was to compare dose-equivalence, adherence and subsequent switch rates among patients recently switched from a branded to generic version of the same statin (generic substitution, GS) vs. those switched from branded statin to generic version of a different statin (therapeutic substitution, TS).In a retrospective cohort analysis among adult enrollees in over 90 US health plans, the authors identified adult patients who switched from a branded to generic statin from July-December 2006 (simvastatin became generic in June 2006). Patients were classified by type of statin switch: GS (e.g., branded simvastatin --generic simvastatin), and TS (e.g., branded atorvastatin --generic simvastatin). Demographic and clinical data were collected from claims before switch through 6 months follow-up. Separate outcomes of interest included proportion of patients that switched to a less potent daily dose, that switched back to previous branded statin after switch, and that were at least 80% adherent during the 6 months after initial switch. Significant predictors of each clinical outcome were identified using multivariable logistic regression models, adjusting for differences between groups in covariates and potential confounders.The 6-month TS (n = 3807) and GS (n = 40,165) groups were generally similar demographically. Compared to GS, TS patients were significantly more likely to be switched to a less potent dose (26.2% vs. 0.5%, adjusted odds ratio [AOR] in patients with high-potency index medication = 83.4, p0.0001); 33% less likely to be adherent in the 6 months after switch (67.7% vs. 75.9%, AOR in patients with no switch in first 6 months follow-up = 0.67, p0.0001); and four times more likely to switch back to previous branded statin (11.3% vs. 2.9%, AOR = 4.1, p0.0001).This study did not account for co-payment changes, lipid measurements, or changes in pill burden.While this study did not have data on why patients had TS (e.g., for cost or clinical reasons), TS was more likely to involve a subsequent disruption to statin therapy than GS. TS could potentially lead to adverse impacts on patients' outcomes, and should be studied further.

By almost any measure, the Medicare prescription drug benefit (Part D) is a resounding success. Twenty-five million Medicare beneficiaries enjoyed guaranteed access and choice of a drug benefit in 2008.1 Based on the bids submitted by Part D plans for 2009, the Centers for Medicare and Medicaid services (CMS) estimates that the average monthly premium for standard Part D coverage will be $28, an amount 37% lower than originally projected when the benefit was established in 2003.2 More than 85% of Medicare Part D beneficiaries report being satisfied with their drug benefit.3 Finally, the program has been far less costly to taxpayers than expected—now estimated to be 38.5% ($243.7 billion) less than the originally projected budget for the period 2004-2013.4 A key reason for the economic success of Part D is that it uses competition among Medicare prescription drug plans (PDPs) and pharmacies to control costs.4 The PDPs are free to use formularies and cost-sharing incentives (e.g., multi-tier copayment structures) to encourage use of generic medicines, preferred brands, and choice of pharmacies for long-term therapies. Plans negotiate rebates with manufacturers and reimbursement with pharmacies in order to offer competitive premiums to beneficiaries. To optimize the use of appropriate medicines, Part D also established a mechanism for enrollees with multiple chronic conditions and high drug costs (estimated to be 8%-14% of beneficiaries)5 to receive medication therapy management (MTM) services from health professionals, including pharmacists.

Aims: We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease (CHD) risk could lower patients' predicted Framingham CHD risk vs. usual care. Methods: The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospective, controlled, cluster-randomised trial in nine European countries, among patients at moderate cardiovascular risk. Following baseline assessments, physicians in the intervention group calculated patients' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme. Usual care physicians did not calculate patients' risk and provided usual care only. The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care. Results: Of 1103 patients across 100 sites, 524 patients receiving intervention, and 461 receiving usual care, were analysed for efficacy. After 6 months, mean predicted risks were 12.5% with intervention, and 13.7% with usual care [odds ratio = 0.896; p = 0.001, adjusted for risk at baseline (17.2% intervention; 16.9% usual care) and other covariates]. The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention (25.4%) than usual care (14.1%; p < 0.001), and 29.3% of smokers in the intervention group quit smoking vs. 21.4% of those receiving usual care (p = 0.04). Conclusions: A physician-implemented CHD risk evaluation/communication programme improved patients' modifiable risk factor profile, and lowered predicted CHD risk compared with usual care. By combining this strategy with more intensive treatment to reduce residual modifiable risk, we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice. (Less)

In clinical practice, persistence with statin therapy is poor. While little is known about relative persistence to specific statins, previous studies have observed greater persistence in patients who achieve greater degrees of lipid lowering. Identification of statin therapies which improve patient persistence has the potential to improve the quality of patient care and clinical outcomes. Therefore, we assessed patient persistence with atorvastatin and simvastatin in primary and secondary prevention patients enrolled in managed care.New statin users agedor =18 years, both with and without prior cardiovascular (CV) events within the 12 month pre-treatment period, were identified from a large national database of managed care patients. Patients initiated atorvastatin or simvastatin therapy from January 1, 2003 to September 30, 2005 and were continuously enrolled in a covered plan for at least 12 months before and after initiation of statin therapy. Subanalyses of patientsor =65 years were also conducted. Measures of interest included demographic and clinical characteristics of the study samples and persistence of statin utilization over the 1-year follow-up period. Persistence was defined as the number of days a patient remained on treatment in the first year following their index date, measured from the date of first fill to study end or the date of discontinuation.A total of 129 764 atorvastatin users and 45 558 simvastatin users without prior CV events were included in the study. For those patients with prior CV events, a total of 6888 atorvastatin users and 4443 simvastatin users were included in the study. Median persistence in patients without prior CV events was 50 days longer for patients initiating therapy with atorvastatin than simvastatin (207 vs. 157 days, p0.0001) and after adjusting for confounding factors, those treated with atorvastatin were 15% less likely to discontinue therapy during the first year than those treated with simvastatin (HR=0.85; 95% CI 0.84, 0.86; p0.001). In secondary prevention patients median persistence was 85 days longer in atorvastatin patients than simvastatin patients (266 vs. 181 days, p0.0001) and atorvastatin patients were 22% less likely to discontinue therapy (HR=0.78; 95% CI 0.75, 0.82; p0.001). Persistence was worse in the elderly patients, but the relative difference between atorvastatin and simvastatin was similar to the overall patient population.In patients with and without prior CV disease, persistence is generally poor, even worse in the elderly, but significantly better for atorvastatin patients than simvastatin patients (p0.001). Further studies are required to determine whether this is due to differences in cost, effectiveness, side-effects, or other attributes of the statins.Differences in persistence could be, in part, due to unmeasured confounders although all available variables were adjusted in multivariate analyses. Additionally, the claims database lacks some clinical data such as lipid levels, limiting assessments of statin efficacy, and does not include any reasons for discontinuation of therapy.

Background: Many older individuals have concomitant hypertension and dyslipidaemia — two conditions that, together with age, increase the risk of adverse cardiovascular events. Adherence to antihypertensive (AH) and lipid-lowering (LL) therapy is therefore particularly important in older patients with concomitant hypertension and dyslipidaemia. Objective: To determine patterns and predictors of adherence to concomitant AH and LL therapy among an older Medicare-eligible population. Methods: Enrolees (n = 4052) aged ≥65 years who initiated treatment with both AH and LL therapy within a 90-day period were studied in this retrospective cohort study conducted in a US managed care organization. Adherence to AH and LL medications was measured as the proportion of days covered by any AH and/or LL medication in each 3-month interval, from the start of concomitant therapy for up to 36 months (mean follow-up 19.5 months). In each interval, patients were considered ‘adherent’ to AH and LL therapy if they had filled prescriptions sufficient to cover ≥80% of days with both medication classes. A multivariable regression model evaluated potential predictors of adherence to concomitant therapy, including patient demographics, clinical characteristics and health services use patterns at baseline. Results: The percentage of patients adherent to both AH and LL therapy declined rapidly, before stabilizing, with 40.5%, 32.7% and 32.9% adherent at 3, 6 and 12 months, respectively. At each timepoint, an additional 27.8–35.0% of patients were adherent to either AH or LL therapy, but not both. Adherence was on average greater to AH than LL therapy. After adjusting for age, sex and other potential predictors, patients were more likely to be adherent if AH/LL therapies were initiated closer together in time (adjusted odds ratio [AOR] 1.13 for 0–30 days vs 61–90 days, p = 0.0563), had a history of cardiovascular disease (AOR 1.27, p = 0.0004), took fewer additional medications (AOR 0.43 for six or more medications vs zero or one medication, p < 0.0001) or had more outpatient physician visits in the prior year (AOR 1.26 for four to six visits vs zero to one visit, p < 0.0027). Conclusion: Adherence to concomitant AH and LL therapy among older adults is poor. Modifiable factors that may improve adherence in Medicare-eligible patients include initiating therapy concurrently and reducing patients’ overall pill burden.

Nonadherence with highly active antiretroviral therapy (HAART) is common in typical human immunodeficiency virus (HIV) patient care settings, but the consequences have not been well described. This study aimed to quantify the clinical and economic effects of nonadherence and estimate the cost-effectiveness of improving adherence in treatment-naive HIV patients.A Markov model was developed to project quality-adjusted life expectancy and direct medical costs for patients on an initial once-daily regimen of efavirenz, lamivudine, and stavudine XR. The model compared 2 adherence scenarios: "ideal" (based on clinical trials) and "typical" (based on observational studies in actual practice). Disease progression was a function of viral load, CD4 count, and adherence. Data on HIV natural history, treatment benefits, costs, and utilities were derived from the literature.With typical adherence, patients lose 1.2 quality-adjusted life years (QALYs) that could be gained with ideal adherence. Improving adherence to ideal levels is cost-effective at 29,400 US dollars/QALY gained. As much as 1,600 US dollars/y per patient could be spent on an intervention to improve adherence to ideal levels, and the incremental cost-effectiveness would remain less than 50,000 US dollars/QALY gained. A cost-effectiveness ratio of 50,000 US dollars/QALY is a commonly accepted minimum standard for cost-effective medical interventions in the United States, although many experts believe this standard has drifted upwards over time.Typical adherence with HAART reduces quality-adjusted life expectancy by 12% compared with ideal adherence. Interventions to improve adherence appear to be a highly cost-effective use of resources.

Background . Health state preferences can be a crucial component of cost-effectiveness analyses, but off-the-shelf health state utilities specifically for older people are not available. Objectives . Among participants in PROSPER, a trial of pravastatin in patients > 70 years, the authors assessed utilities for the health states that were relevant for the trial’s cost-utility analysis. Subjects and Methods . The authors cross-sectionally administered the Health Utilities Index, Mark 3 (HUI) to all PROSPER participants to assess each patient’s health state at the time of interview; they then used the scale’s multiattribute utility function to estimate the resulting utilities. The population was then stratified into 3 health states, and the mean utility function for each was calculated: recent myocardial infarction (MI, within 3 months), previous MI (> 3 months), or no prior MI. Linear and logistic regression were used to control for potential demographic and clinical characteristics. Results . Of the 5804 patients enrolled in the trial, 4677 were administered the HUI instrument. The likelihood of having a complete HUI response set decreased with higher age ( P < 0.001) but not with the other variables studied. A complete utility score could be calculated for 3390 participants. Of these, 2755 (81.3%) had no history of MI, 546 (16.1%) had an MI> 3 months previously, and 89 (2.6%) had an MI within 3 months. The mean (median) utilities were virtually identical for these states: 0.75 (0.84), 0.74 (0.84), and 0.74 (0.84), respectively. From multivariate analyses, utilities decreased with higher age and the presence of several other comorbidities (diabetes, stroke, peripheral vascular disease); women had lower utilities than men (all P < 0.01). Conclusions . In this large implementation of the HUI in elderly patients, the instrument did not detect any differences in estimated utilities related to having a MI. Potential causes of nondiscrimination for MI include the possibility that competing comorbidities may reduce the impact of MI on quality of life in this age group, as well as the possibility that a standard instrument derived from and validated in younger populations may not perform as well in elderly people.

Summary The MEDLINE database was searched from 1972 to June 2002 to identify studies of interventions designed to improve compliance with antihypertensive or lipid-lowering medications. Studies were required to employ a controlled design, follow patients for ≥6 months and measure compliance by a method other than patient self-report. The literature review yielded 62 studies describing 79 interventions. Overall, 56% of interventions were reported to improve patient compliance. When only those studies meeting minimum criteria for methodological quality were considered, 22 interventions remained and 12 were recommended, because they demonstrated a significant improvement in compliance. Recommended interventions included fixed-dose combination drugs, once-daily or once-weekly dosing schedules, unit-dose packaging, educational counselling by telephone, case management by pharmacists, treatment in pharmacist- or nurse-operated disease management clinics, mailed refill reminders, self-monitoring, dose-tailoring, rewards and various combination strategies. Personalised, patient-focused programs that involved frequent contact with health professionals or a combination of interventions were the most effective at improving compliance. Less-intensive strategies, such as prescribing products that simplify the medication regimen or sending refill reminders, achieved smaller improvements in compliance but may be cost-effective due to their low cost.

Purpose. The relationship between low-density lipoprotein (LDL) cholesterol reduction in the first 3 months of statin therapy and medication adherence during a 33-month follow-up period was studied. Methods. A retrospective cohort study was conducted among enrollees in a Southeastern managed care plan who started therapy with atorvastatin, fluvastatin, lovastatin, pravastatin, or simvastatin between October 1999 and August 2001, were enrolled for ≥12 months before and ≥6 months after treatment initiation, and had at least one LDL cholesterol measurement in the year before and 4–12 weeks after the start of therapy. Patients were followed up via electronic pharmacy and medical records for up to 33 more months. The follow-up period was divided into 3-month intervals; patients were considered adherent if statin therapy was available ≥80% of the time. A generalized linear model for repeated measures quantified the association between change in LDL cholesterol at 4–12 weeks and medication adherence in subsequent intervals, adjusting for demographic, clinical, and health-service-use variables. Results. The final sample consisted of 9510 patients. Medication adherence decreased significantly over time: 59%, 40%, 34%, and 21% of patients were adherent at 3, 6, 12, and 36 months, respectively. Mean ± S.D. LDL cholesterol reduction at 12 weeks was 28.9% ± 19.9%. The relative LDL cholesterol reduction at 12 weeks was significantly and independently associated with subsequent medication adherence: Compared with subjects in the first quartile of LDL cholesterol reduction, those in quartiles 2, 3, and 4 were more likely to be adherent in any subsequent interval (adjusted odds ratio [95% confidence interval], 1.26 [1.12–1.42], 1.25 [1.11–1.40], and 1.15 [1.02–1.29], respectively). Other independent predictors of adherence in months 4–36 included adherence during the initial three months of therapy, age, and recent history of coronary revascularization. Conclusion. Greater reduction in LDL cholesterol levels during the first three months of statin therapy was associated with greater adherence to lipid-lowering drug therapy.

Introduction and Objective: The National Cholesterol Education Program recommends regular physician follow-up and lipid testing to promote adherence with lipidlowering medications. The objective of this study was to determine whether lipid tests and physician visits after treatment initiation are indeed associated with adherence to statin therapy. Subjects and Methods: A retrospective cohort study was conducted among 19 422 enrolees in a US managed care plan who initiated treatment with a statin between October 1999 and August 2001. Computerised pharmacy, medical and laboratory records were used to study the patterns and predictors of adherence with lipid-lowering therapy for up to 3 years. Adherence was assessed in 3-month intervals with patients considered ‘adherent’ if ≥80% of days were covered by lipid-lowering therapy. Results: In the first 3 months, 40% of patients had follow-up lipid tests and only 21% had dyslipidaemia visits (14% had both). Those receiving such care were substantially more likely to be adherent in subsequent intervals. Compared with those without follow-up, the relative odds of adherence were 1.42 and 1.27 for patients with one or more lipid test and one or more dyslipidaemia visit, respectively (95% confidence intervals [CI] 1.33, 1.50 and 1.16, 1.39). Patients who received a followup visit and lipid test were 45% more likely to be adherent (95% CI 1.34, 1.55). Similar associations were observed when lipid tests and dyslipidaemia visits occurred later in therapy. Conclusion: Early and frequent follow-up by physicians — especially lipid testing — was associated with improved adherence to lipid-lowering therapy. A randomised prospective study is needed to determine whether this relationship is causal.

Solutions to challenges like the one described have come from collaborations involving secondary and postsecondary institutions. Partnerships between colleges and high schools have produced excellent avenues for increased student learning (Greenberg, 1991; Kelter et al., 1992; Rhoton, 1994). While the primary goal of such partnerships has generally been to provide science content instruction for high school students, anecdotal evidence suggested to us that carefully designed partnerships may result in additional perhaps unanticipated positive outcomes. Documentation of these student and teacher outcomes may further guide the formation of effective collaborations and partnerships. The purpose of SHARON FELDSTEIN is a Graduate Assistant in the Science Education and Literacy Center (Rider SELECT) at Rider University, Lawrenceville, NJ 08648; and MICHAEL S. BENNER,fOrmer Director of Rider SELECT, is at the AEE Program at Milton Hershey School, Hershey, PA 17033; e-mail: bennerm@mhs-pa.or

Purpose To address poor patient compliance with antihypertensives, clinicians and researchers need accurate measures of adherence with prescribed regimens. Although self-reports are often the only means available in routine practice, their accuracy and agreement with other data sources remain questionable. Methods A telephone survey was conducted on 200 hypertensive patients treated with a single antihypertensive agent in a large health maintenance organization (HMO) or a Veterans Affairs medical center (VAMC) to obtain self-reports of the frequency of missing antihypertensive therapy. We then analyzed records of all filled prescriptions to calculate the number of days that patients actually had antihypertensive medications available for use. Agreement between the two data sources was measured with correlation coefficients and kappa statistics. Logistic regression models were used to identify demographic, clinical and psychosocial correlates of overstating compliance. Results There was very poor agreement between self-reported compliance and days actually covered by filled prescriptions (Spearman correlation coefficient = 0.15; 95%CI: 0.01, 0.28). Very poor agreement was also observed between a categorical measure of self-reported compliance (ever vs. never missing a dose) and categories of actual compliance defined by filled prescriptions ( 80% of days covered; kappa = 0.12, 95%CI: −0.02, 0.26). Surprisingly, few factors were associated with inaccurate self-reporting in either crude or adjusted analyses; fewer visits to health care providers was significantly associated with overstating compliance. Conclusions Compliance was markedly overstated in this sample of patients and few characteristics identified those who reported more versus less accurately. Clinicians and researchers who rely on self-reports should be aware of these limits and should take steps to enhance their accuracy. Copyright © 2003 John Wiley & Sons, Ltd.

Analysis of claims data from 46,076 diabetic patients without cardiovascular disease initiating atorvastatin or simvastatin therapy suggested that, after adjusting for demographic and clinical confounders, use of atorvastatin was associated with fewer cardiovascular events versus simvastatin at doses of similar potency (HR 0.88, 95% CI 0.80–0.97, P =0.01).

Buried low-dimensional integrated dot and wire structures fabricated by masked implantation enhanced intermixing are compared directly. Using high excitation and transient spectroscopy hot carrier effects as well as phase-space filling in the low-dimensional structures are observed. The carrier cooling curves of the wires and dots show a bend at about 350 ps which may be an indication of two dominant relaxation mechanisms. The influences of the carrier capture in low-dimensional systems and the relaxation on the carrier temperature are separated by measurements with different excitation wavelengths

PURPOSE We conducted a phase II study to determine the response to and toxicity of docetaxel (Taxotere; Rhône-Poulenc Rorer Pharmaceuticals, Inc, Collegeville, PA) in patients with advanced non-small-cell lung cancer refractory to prior platinum-containing chemotherapy (PCC) regimens. PATIENTS AND METHODS Forty-four patients with stage IIIb or IV platinum-refractory non-small-cell lung cancer were treated with 100 mg/m2 of docetaxel intravenously over 1 hour every 3 weeks. The responses of 42 of 44 patients were assessable. Most patients had a Zubrod performance status of 1; the predominant histologic type was adenocarcinoma (61%), and 91% of patients had stage IV disease. RESULTS Nine of 42 assessable patients (21%) achieved a partial response to treatment. The median response duration (from response to progression) was 17 weeks, and the projected median survival duration of all patients is 42 weeks (51 weeks for adenocarcinoma and 22 weeks for nonadenocarcinoma). Grade 3/4 neutropenia occurred in 85% of patients and was associated with fever that required intravenous antibiotics in 16% of patients (3% of cycles). Other acute side effects included easily treated hypersensitivity reactions and dermatitis. Cumulative side effects included fluid retention and neuropathy. CONCLUSION Docetaxel administered at 100 mg/m2 intravenously every 3 weeks has notable activity against platinum-refractory non-small-cell lung cancer, with a 21% major response rate. Primary side effects were neutropenia, hypersensitivity, and fluid retention.

PURPOSE We conducted a phase II study to determine the response and toxicity of docetaxel (Taxotere; Rhône-Poulenc Rorer Pharmaceuticals, Inc, Collegeville, PA) in chemotherapy-naive patients with advanced non-small-cell lung cancer. PATIENTS AND METHODS We treated 41 chemotherapy-naive patients who had stage IIIb or IV non-small-cell lung cancer with 100 mg/m2 of docetaxel intravenously over 1 hour every 3 weeks. Responses were assessed after every one to two treatment courses. Responses of 39 of 41 patients were assessable. The patient's median age was 63 years; 90% of patients had a Zubrod performance status of 0 or 1. The predominant histology was adenocarcinoma (54%), and 90% of patients had stage IV disease. RESULTS Thirteen patients (33%) achieved a partial response to treatment, and the median response duration was 14 weeks. Grade 3 or 4 neutropenia occurred in 97% of patient; this was usually of brief duration and was associated with serious infection in 17% of patients. Other acute toxic effects included easily treated hypersensitivity reactions (36% of patients) and dermatitis (74%). We also observed fluid retention (with peripheral edema or pleural effusion or both) in 54% of patients. This was a cumulative side effect that generally occurred late in treatment. CONCLUSION Docetaxel administered at 100 mg/m2 intravenously every 3 weeks has significant activity against non-small-cell lung cancer, with a 33% major response rate. Primary toxicities were neutropenia, hypersensitivity, and fluid retention.

At the 2010 Conference on Clinical Cancer Research, held on October 20, 2010, in Washington, DC, co-convened by Friends of Cancer Research and the Engelberg Center for Health Care Reform at the Brookings Institution, participants explored 4 pressing challenges in the field. Articles summarizing the

A well-defined pathway for the accelerated development and approval of targeted cancer therapies and companion diagnostics would reduce uncertainty, improve efficiency in development and provide an effective incentive for developers.

The American Recovery and Reinvestment Act of 2009 included new funding for developing better evidence about health interventions, with a down payment of $1.1 billion for comparative effectiveness research. Our analysis of funds allocated in the legislation found that nearly 90 percent of the $1.1 billion will eventually be spent on two main types of activity: developing and synthesizing comparative effectiveness evidence, and improving the capacity to conduct comparative effectiveness research. Based on our analysis, priorities for the new funding should include greater emphasis on experimental research; evaluation of reforms at the health system level; identification of effects on subgroups of patients; inclusion of understudied groups of patients; and dissemination of results.

Reports indicate that there are gender-based differences in aspects of the peer-review process.This is an analysis of editorial board members' reviews of original research submissions based on gender using the web-based management program, Editorial Manager, from January 1, 2002, through December 31, 2008. We evaluated recommendations of editorial board members for acceptance/rejection using a four-tier system, agreement with editor's final decision, turnaround time from review request to submission, and editors' grades of reviews on a 5-point scale. We evaluated the performance of editorial board members with advancing tenure, seeking trends in recommendations over time.We included 6062 manuscript reviews representing 5958 manuscripts; 67% were assigned to male editorial board members and 33% to females. There were 38 editorial board members (25 men, 13 women) with tenure duration from 2 to 4.9 years, and 3 editors (2 men, 1 woman) serving 7, 7, and 6 years, respectively. Women were less likely to accept or accept with minor revisions than men (p0.003). Median turnaround times were 14 (0-55) days for women and 10 (0-33) days for men (p0.001). The editors' grades assigned to women were more often than men's grades in the very good to exceptional category (p0.0001). There was no difference based on gender, with approximately 73% decision congruence overall with the editors' final decisions. Men rejected more manuscripts than did women with advancing tenure on the editorial board (p0.0001).There are differences based on gender of editorial board members' recommendations about manuscript triage, turnaround time, and editors' grades assigned. Overall, however, these differences do not affect editors' ultimate decisions about manuscript publication.

Comparative effectiveness research (CER) has received substantial attention as a potential approach for improving health outcomes while lowering costs of care, and for improving the relevance and quality of clinical and health services research. The Institute of Medicine defines CER as 'the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.' Improving the methods and infrastructure for CER will require sustained attention to the following issues: (1) Meaningful involvement of patients, consumers, clinicians, payers, and policymakers in key phases of CER study design and implementation; (2) Development of methodological 'best practices' for the design of CER studies that reflect decision-maker needs and balance internal validity with relevance, feasibility and timeliness; and (3) Improvements in research infrastructure to enhance the validity and efficiency with which CER studies are implemented. The approach to addressing each of these issues should be informed by the understanding that the primary purpose of CER is to help health care decision makers make informed clinical and health policy decisions.

A previous study in 4703 patients suggested that a single-pill combination of amlodipine and atorvastatin is associated with greater adherence to therapy than a two-pill calcium channel antagonist (calcium channel blocker [CCB]) and HMG-CoA reductase inhibitor (statin) regimen. However, the impact of prior medication use on the potential adherence benefits of single-pill amlodipine/atorvastatin has not been studied.To compare adherence to single-pill amlodipine/atorvastatin versus two-pill CCB + statin regimens in a large managed care population, stratified according to prior CCB and statin use.This retrospective study was conducted among managed care enrolees in the US. Patients included in the analysis had to have a pharmacy claim for single-pill amlodipine/atorvastatin or claims for both a CCB and a statin within any 30-day window between April 2004 and April 2005. Adherence was measured over 6 months following the index date (the date of the first single-pill amlodipine/atorvastatin claim or of the claim for the second medication class for any two-pill CCB + statin regimen) as the proportion of days covered (PDC) by both CCB and statin therapy; patients were considered 'adherent' if PDC wasor =80%. Patients were divided into four cohorts based on pre-index CCB and statin use: (i) naive (CCB)/naive (statin); (ii) experienced (CCB)/naive (statin); (iii) naive (CCB)/experienced (statin); and (iv) experienced (CCB)/experienced (statin). Within each cohort, adherence was compared for patients receiving single-pill amlodipine/atorvastatin versus two-pill amlodipine + atorvastatin or other two-pill CCB + statin regimens (including amlodipine or atorvastatin but not both) at index. Multivariable logistic regression with propensity score weighting was used to adjust for covariates, including age, sex and co-morbidities.In total, 35,430 patients were included in the analysis. At month 6 (after adjusting for covariates), patients in the experienced (CCB)/naive (statin) cohort receiving single-pill amlodipine/atorvastatin were more than twice as likely to be adherent as those receiving two-pill amlodipine + atorvastatin (odds ratio [OR] 2.20; p0.0001) or other two-pill CCB + statin regimens (OR 2.75; p0.0001). Similarly, patients in the naive (CCB)/experienced (statin) cohort receiving single-pill amlodipine/atorvastatin were more likely to be adherent than those receiving two-pill amlodipine + atorvastatin (OR 1.72; p0.0001) or other two-pill CCB + statin regimens (OR 2.81; p0.0001). In contrast, in the naive (CCB)/naive (statin) cohort there was no significant difference in adherence between patients receiving single-pill amlodipine/atorvastatin versus two-pill amlodipine + atorvastatin (OR 1.00), although patients receiving single-pill amlodipine/atorvastatin were slightly more likely to be adherent than those receiving other two-pill CCB + statin regimens (OR 1.29; p0.01). In the experienced (CCB)/experienced (statin) cohort there was also no significant difference between patients receiving single-pill amlodipine/atorvastatin versus two-pill amlodipine + atorvastatin (OR 1.08), and only a slightly greater likelihood of achieving adherence to single-pill amlodipine/atorvastatin versus other two-pill CCB + statin regimens (OR 1.19; p0.01).This large retrospective study confirms previous observations that single-pill amlodipine/atorvastatin can help improve adherence versus two-pill CCB + statin regimens. However, greater improvements in adherence are likely to be observed in patients with prior experience of either CCB or statin therapy than in those either naive to, or experienced with, both therapies.

The objective of this study was to examine whether differences in effectiveness exist between statins in hypertensive patients seen in clinical practice. We assessed cardiovascular (CV) outcomes in hypertensive patients without cardiovascular disease who began therapy with atorvastatin (10 or 20 mg/d) or simvastatin (20 or 40 mg/d) between January 1, 2003, and September 30, 2005, using claims data from 92 US managed care plans in the PharMetrics database. A total of 98,471 hypertensive patients were identified, comprising 74,685 atorvastatin users (mean dose 13.6 mg/d) and 23,786 simvastatin users (mean dose 28.6 mg/d), and followed a median 1.5 years for the occurrence of a first CV event. The crude CV event rates were 2.81 and 3.92 per 100 person-years for atorvastatin and simvastatin, respectively [unadjusted hazard ratio (HR): 0.73; 95% confidence interval (CI): 0.68-0.78, P < 0.001]. After adjusting for clinical and demographic confounders, use of atorvastatin was associated with fewer CV events compared with simvastatin (HR: 0.91; 95% CI: 0.84-0.98, P = 0.009). However, the lipid-lowering efficacy of the 2 statins could not be assessed as patient lipid data were unavailable. In conclusion, hypertensive patients without cardiovascular disease who initiated atorvastatin (10 or 20 mg/d) had a significantly lower risk of subsequent CV events compared with those who initiated simvastatin at doses of similar potency (20 or 40 mg/d). As with all observational studies, the study is subject to certain limitations, and the findings should be regarded as hypothesis generating.

This retrospective cohort analysis demonstrates the application of propensity score methods in the Be In Charge (BIC) program, a drug therapy management program for patients with hepatitis C. Data were drawn from BIC participant records and program utilization and from a longitudinal database of administrative claims for pharmacy and medical services. Eligible patients must have received peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin, but analyses evaluated only PEG-IFN alfa-2b use; BIC enrollees were matched with patients not enrolled in BIC (controls). Adherence was measured on the basis of the number of injections dispensed and the proportion of patients for whom an average of at least 1 injection per week was dispensed during follow-up. BIC subjects refilled 1.2 more injections than did controls (P < .001) within 12 weeks, 2.7 more (P < .001) within 24 weeks, and 6.7 more (P < .001) within 48 weeks. BIC enrollees were more likely than controls to refill the indicated dose (1 injection per week) within 12 weeks (72% vs 64%, P < .001), 24 weeks (52% vs 41%, P < .001), and 48 weeks (22% vs 13%, P = .002) of initiation. These data suggest that the BIC program may significantly improve adherence to PEG-IFN alfa-2b.

Study Type – Symptom prevalence (prospective cohort) Level of Evidence 1b OBJECTIVE To evaluate patient-reported reasons for discontinuing antimuscarinic prescription medications for overactive bladder (OAB). PATIENTS AND METHODS A phase 1 screening survey was sent to a representative sample of 260 000 households in the USA to identify patients using antimuscarinic agents for OAB. A detailed phase-2 follow-up survey was sent to 6577 respondents with one or more antimuscarinic prescriptions for OAB in the 12 months before the phase 1 survey. The follow-up survey included questions about demographics, clinical characteristics, antimuscarinic use, beliefs about OAB, treatment expectations, OAB symptom bother, and pre-coded reasons for discontinuation. Patients who reported discontinuing one or more OAB medication during the 12 months before phase 2 were grouped by reason, using latent class analysis (LCA); the Lo-Mendell-Rubin likelihood statistical test was used to determine the number of classes. Conditional probabilities of reasons for discontinuation were calculated for each class. Multivariable logistic regression was used to assess the influence of demographic and clinical characteristics on class assignment. RESULTS In all, 162 906 (63%) and 5392 (82%) useable responses were returned in phases 1 and 2, respectively; the demographics were similar in respondents and nonrespondents in both phases. In all, 1322 phase 2 respondents (24.5%) reported discontinuing one or more antimuscarinic drugs during the 12 months before phase 2. LCA identified two classes (Lo-Mendell-Rubin statistic, P = 0.01) based on reasons for discontinuation. Most respondents (89%) reported discontinuing OAB medication primarily due to unmet treatment expectations and/or tolerability; many respondents in this class switched to a new antimuscarinic agent. A smaller group (11%) indicated a general aversion to taking medication. Age, sex, race, income, and history of incontinence were not predictive of class assignment. CONCLUSIONS Expectations about treatment efficacy and side-effects are the most important considerations in discontinuing OAB medications for most patients. Interventions to promote realistic expectations about treatment efficacy and side-effects might enhance adherence.

Study Type – Symptom prevalence (prospective cohort) Level of Evidence 1b OBJECTIVE To identify predictors of self-reported discontinuation of overactive bladder (OAB) medication using a three-phase survey. PATIENTS AND METHODS In January 2005, a phase 1 survey was sent to 260 000 households in the USA to assess the prevalence of OAB symptom bother, treatment patterns and healthcare consulting behaviour. In July 2005, a detailed phase 2 follow-up survey was sent to 6577 phase 1 respondents who had used one or more OAB medications within the 12 months before phase 1; the phase 2 survey included questions about respondents’ sociodemographic characteristics, general health status, OAB symptom bother, healthcare consulting behaviour, beliefs about OAB and treatment options, and medication usage. Six months later, a phase 3 survey was sent to 3387 phase-2 respondents who were persistent with OAB medication or had discontinued within

Treatment guidelines for dyslipidemic patients have focused on lipid levels and risk assessments. However, normolipidemic patients who have multiple risk factors for cardiovascular disease may also benefit from HMG-CoA reductase inhibitor (statin) therapy.We examined the frequency of statin prescriptions in patients initiating antihypertensive drug treatment in a US managed-care setting. STUDY DESIGN AND PATIENT: This retrospective cohort study used the PharMetrics' Patient-Centric Database to identify enrollees initiating antihypertensive treatment (September 2001 to February 2004). Patients newly treated with antihypertensives and with various levels of coronary heart disease (CHD) risk (including dyslipidemia, established CHD, type 2 diabetes mellitus, and no CHD but three or more cardiovascular risk factors) were included in the study.Cumulative probability of receiving statin therapy each month after antihypertensive initiation. Multivariable logistic regression was used to identify factors associated with receiving concomitant statin therapy.Of 142 389 patients (mean age 51.7 years) newly treated with antihypertensives, 32 056 (22.5%) were prescribed statins within 1 year. The cumulative probability of being prescribed a statin increased with increasing numbers of CHD risk factors, irrespective of dyslipidemia status. After adjusting for age, sex, and other potential predictors, patients were more likely to receive statin therapy if they had a history of dyslipidemia (adjusted odds ratio [AOR] 5.68 [95% CI 5.52, 5.85]), established CHD/congestive heart failure (AOR 3.39 [95% CI 3.16, 3.63]), or three or more additional cardiovascular risk factors but no CHD (AOR 3.01 [95% CI 2.74, 3.30]).Among patients beginning antihypertensive treatment, those with established CHD or CHD risk factors were more likely to receive statins, but a substantial fraction did not fill any statin prescription. The increased use of statin therapy could benefit many hypertensive patients with additional CHD risk factors.

Purpose. The association between prescription burden and medication adherence in patients initiating antihypertensive and lipid-lowering therapy was studied. Methods. Patients enrolled in managed care organizations who initiated antihypertensive therapy coincident with lipid-lowering therapy (no more than 90 days apart) between January 1, 1997, and April 30, 2000, were eligible for inclusion. Analysis was limited to new users of antihypertensive and lipid-lowering therapy. The proportion of days covered (PDC) by antihypertensive and lipid-lowering therapy was calculated for the first year after therapy initiation; patients with a PDC of ≥80% for both drug classes were considered adherent. Prescription burden was defined as the number of prescription medications taken in the year prior to starting antihypertensive and lipid-lowering therapy. Demographic, clinical, and health-service-use variables associated with both prescription burden and medication adherence were measured using medical and pharmacy claims data from the year before initiation of antihypertensive and lipid-lowering therapy. Results. Among 5759 patients, the mean ± S.D. prescription burden was 3.6 ± 3.7 (median, 3) medications, and the mean ± S.D. PDC with antihypertensive and lipid-lowering therapy was 53.9% ± 31.9% (median, 58.5%). Among patients with 0, 1, and 2 prior medications, 41%, 35%, and 30% of patients were adherent, respectively, to antihypertensive and lipid-lowering therapy. Among patients with 10 or more prior medications, 20% were adherent. Conclusion. Among patients in a managed care database taking antihypertensive and lipid-lowering medications, adherence to those regimens became less likely as the number of prescription medications increased. The reduction in adherence with additional prescription medications was greatest in patients with the fewest preexisting prescriptions.

In a congressionally mandated effort to improve postmarketing safety surveillance, the FDA is seeking to develop the Sentinel Network to link vast amounts of data on patients, medication use, and a...

The 7th conference of the American College of Chest Physicians (ACCP7) provides recommendations on the type, dose, and duration of thromboprophylaxis in hospitalized patients at risk of venous thromboembolism (VTE), but the extent to which hospitals follow these criteria has not been well studied. Discharge and billing records for patients admitted to any of 16 acute-care hospitals from January 2005 to December 2006 were obtained. Patients 18 years or older who had an inpatient stayor=2 days and no apparent contraindications for thromboprophylaxis were grouped into the categories of critical care, surgery and medically ill before being assessed for additional VTE risk factors based on the diagnostic criteria outlined in ACCP7. For patients at risk, the recommended type (mechanical or pharmacologic), dose, and duration of thromboprophylaxis was identified based on the guidelines and compared to the regimen actually received, if any. Among the 258,556 hospitalized patients, 68,278 (26.4%) were determined to be at risk of VTE without apparent contraindications for thromboprophylaxis. The proportions of patients who received the appropriate type, dose, and duration of thromboprophylaxis were 10.5, 9.8, and 17.9% for critical care, medical, and surgical patients, respectively. Of those at risk, 36.8% received no thromboprophylaxis and an additional 50.2% received thromboprophylaxis deemed inappropriate for one or more reasons. The implementation of ACCP7 guidelines for type, dosage, and duration of thromboprophylaxis is low in patients at risk of VTE. There is a need for physicians and health systems to improve awareness and implementation of recommended thromboprophylaxis.

INTRODUCTION Between 1990 and 2005, 920 cancer compounds underwent clinical trials, yet only 32 were approved [1]. The uncertain fate of products in the pipeline for new oncology treatments and the apparent opportunities for improving its productivity are sources of frustration for everyone in the cancer community. The current situation doesn’t reflect a lack of effort. The average amount of time spent in development and approval for those 32 therapies was 9.1 years [1], but the development process is not focused on treatments that actually work: half of the cancer therapies that ultimately failed reached expensive and time-consuming late-stage clinical testing before being abandoned [2]. At the U.S. Food and Drug Administration (FDA), new oncology treatments represent a disproportionately high share of priority reviews, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the agency’s expedited access programs. But while FDA approval times are 6 months shorter for oncology drugs than for other categories on average, clinical development times are 1.5 years longer than for other therapies. The problems of inefficient and uncertain development are not new, but they have become more urgent in an era that should be defined by clinically meaningful advances in genomics and proteomics and the promise of personalized cancer therapy. With more effective ways to predict and demonstrate the safety and effectiveness of such targeted therapies, this new era of cancer therapy could arrive much sooner. To identify some promising and concrete actions that could address the productivity challenge in the clinical development of cancer therapies, the Engelberg Center for Health Care Reform at the Brookings Institution hosted a Conference on Clinical Cancer Research, with support from Friends of Cancer Research, the American Society of Clinical Oncology (ASCO), and the American Association for Cancer Research (AACR). The September 26 meeting convened cancer experts from academia, the National Cancer Institute (NCI), the FDA, patient advocacy groups, and the medical products industry with the aim of identifying consensus-driven solutions to critical questions regarding the future of clinical cancer research. Thanks to the efforts of four expert collaborative panels and a room of more than 150 thought leaders who joined in the discussion, a set of concrete steps emerged to help usher in 21st century care for patients with cancer. The shared vision, as articulated by John Niederhuber of the NCI and others, is for a more quantitative and systematic process for determining the safety and efficacy of cancer therapies, linked to more comprehensive and consistent evidence from collaborative trials and clinical practice. By combin

We measured patient reported bother due to overactive bladder syndrome, patterns of physician consultation and prescription medication use for overactive bladder symptoms in adults in the United States.A survey sample was derived from a consumer panel of 600,000 American households developed to match the United States Census of 260,000 adults. The survey included the Overactive Bladder-Validated 8 awareness tool, which includes 8 questions that measure the degree of bother due to specific bladder symptoms. A score of 8 or greater denotes probable overactive bladder. Additional questions probed treatment patterns, health care consultation, overactive bladder diagnosis, treatment type and prescription treatment used. A nonrespondent telephone survey in 1,004 participants was done to evaluate differences between mail survey respondents and nonrespondents.The response rate was 63% (162,906 respondents). Women represented 55.1% of the sample and 21.8% of respondents were 65 years old or older. Symptom bother, as determined by an Overactive Bladder-Validated 8 score of 8 or greater, was reported by 26.6% of the total sample, including 23.7% of men and 28.9% of women. The percent of men and women reporting bother increased with age. Of respondents with probable overactive bladder only 45.7% had discussed the symptoms with a medical provider, 22.5% had previously used prescription medication for overactive bladder, 13.5% had used overactive bladder medication in the last 12 months and 8.1% were currently on treatment.A substantial proportion of adults in the United States reported some degree of bother due to overactive bladder symptoms. The degree of bother was associated with age and gender. Overall less than half of patients with probable overactive bladder discussed the symptoms with a health care provider. A small proportion was prescribed medication and an even smaller proportion was currently on treatment.

While the results of randomized clinical trials have indicated that statins improve outcomes in patients without cardiovascular disease (CVD), it remains uncertain whether there are differences in efficacy between statins, particularly in clinical practice, where the public health implications could be substantial.We assessed cardiovascular (CV) outcomes among primary-prevention patients newly initiating therapy with atorvastatin or simvastatin.Using claims data from 92 US managed care plans, we identified new statin users without CVD who initiated atorvastatin (10 or 20 mg) or simvastatin (20 or 40 mg) from January 2003 to September 2005 and were continuously enrolled in a covered plan foror = 12 months before andor = 1 month after the initiation of statin therapy. The main outcome was the time to the first CV event (hospitalization related to myocardial infarction, angina, or coronary artery disease; stroke; amaurosis fugax; transient ischemic attack; peripheral or central nervous system vascular disease; or revascularization). Persistence with treatment was calculated in terms of the number of days during follow-up that a patient remained on statin treatment, starting from the date of the first prescription fill to the end of the study or the date at which therapy was discontinued.A total of 168,973 patients initiating atorvastatin (mean dose, 13.5 mg) and 50,658 patients initiating simvastatin (mean dose, 28.5 mg) were followed for a median of 1.5 years. Atorvastatin patients were significantly more persistent with treatment than simvastatin patients (median treatment duration, 158 vs 124 days, respectively; P0.001). After adjustment for age, sex, type of health plan, payer type, geographic region, calendar year of statin initiation, physician specialty, comorbidities, concomitant therapies, and total direct health care costs in the year before statin initiation, use of atorvastatin was associated with significantly fewer CV events compared with use of simvastatin (hazard ratio = 0.88; 95% CI, 0.83-0.93; P0.001).In these patients without CVD, atorvastatin 10 or 20 mg was associated with a significantly lower risk of CV events compared with simvastatin 20 or 40 mg. Further studies are required to determine whether differences in persistence, achieved low-density lipoprotein cholesterol levels, or other factors contribute to these differences in outcomes.

This study determined the prevalence of primary prevention patients aged 40 to 79 years with uncontrolled hypertension (HTN) and low/moderate cholesterol levels, and the clinical and economic consequences of their cardiovascular risk levels stratified by additional cardiovascular risk factors. Prevalence was estimated from the 1999 to 2002 National Health and Nutrition Examination Survey (NHANES) datasets. Framingham risk equations were used to calculate the 4-year risk of coronary heart disease (CHD). HTN and cholesterol levels were then statistically "controlled" to ideal levels and risks were recalculated. Prevalence of uncontrolled hypertension was 15.2 million cases (13.7%). Of those, 12.9 million (84.8%) had low/moderate cholesterol levels, and 2.2 million (16.7%) had >/=3 additional risk factors with no history of CHD. Nearly 200,000 coronary events are expected to occur within 4 years, incurring over $2.5 billion in direct medical costs. Statistical estimation suggests that 64% of 4-year risk was attributable to uncontrolled blood pressure and lipids. The large number and high cost of CHD events expected to occur within the next 4 years in primary prevention patients with uncontrolled hypertension and >/=3 additional risk factors justifies aggressive screening to ensure that these patients are identified and properly managed.

Objective To test the primary study hypothesis that a physician-delivered coronary heart disease risk evaluation and communication program can lower patients' predicted 10-year risk of myocardial infarction or death due to coronary heart disease by 10% within 6 months compared to usual care. Design Prospective, parallel group, open-label, controlled, cluster-randomized multinational trial; the study site is the unit of randomization. Setting Patients were recruited from 106 general practices located in nine European countries. Patients Men and women aged 45 to 64 (N = 1500) with a documented history of hypertension (treated or untreated), systolic blood pressure ≥ 140 mmHg (or ≥ 130 mmHg in the presence of renal or kidney disease), no history of cardiovascular disease, and a predicted 10-year risk of myocardial infarction or death due to coronary heart disease ≥ 10%. Intervention Sites were randomized to deliver a physician-directed coronary heart disease risk communication and education program or usual care. The intervention program included informing patients of their 10-year risk of myocardial infarction or death due to coronary heart disease, educating patients about modifiable risk factors and their control, and three follow-up phone calls by a physician or study nurse. Main outcome measure Predicted 10-year risk of myocardial infarction or death due to coronary heart disease at 6 months. Conclusions REACH OUT will evaluate a novel, patient-focused, physician-implemented application of coronary heart disease risk equations. Results of the study will be of practical relevance to physicians, health care organizations, and those who issue clinical guidelines for the reduction of cardiovascular risk.