Health-related quality of life with pembrolizumab monotherapy in patients with previously treated advanced microsatellite instability high/mismatch repair deficient endometrial cancer in the KEYNOTE-158 study.

OBJECTIVE: Pembrolizumab demonstrated a clinically meaningful objective response rate in patients with previously treated, advanced MSI-H/dMMR endometrial cancer in the multicohort phase 2 KEYNOTE-158 study (ClinicalTrials.gov, NCT02628067). We present health-related quality of life (HRQoL) results for these patients. METHODS: This analysis included patients from cohorts D (endometrial cancer with any MSI status) and K (any MSI-H/dMMR solid tumor except colorectal) who had previously treated, advanced MSI-H/dMMR endometrial cancer. Patients received pembrolizumab 200 mg Q3W for 35 cycles. EORTC QLQ-C30 and EQ-5D-3L questionnaires were administered at baseline, at regular intervals during treatment, and 30 days after treatment discontinuation. Pre-specified exploratory analyses included changes from baseline to week 9 in QLQ-C30 global health status (GHS)/QoL and EQ-5D-3L visual analog scale (VAS) score for all patients and by best overall response. RESULTS: 84 of 90 enrolled patients completed ≥1 HRQoL questionnaire and were included in the analysis. QLQ-C30 and EQ-5D-3L compliance rates were 90% and 94%, respectively, at baseline, and 92% and 93% at week 9. Mean (95% CI) QLQ-C30 GHS/QoL scores improved from baseline to week 9 by 6.08 (0.71-11.46) points in the overall population, with greater improvement in patients who achieved complete or partial response (11.67 [5.33-18.00]-point increase). Mean (95% CI) EQ-5D-3L VAS scores improved by 6.00 (2.25-9.75) points in the overall population and 9.11 (5.24-12.98) points in patients with CR/PR. CONCLUSIONS: Pembrolizumab maintained or improved HRQoL in patients with previously treated, advanced MSI-H/dMMR endometrial cancer, further supporting efficacy and safety results from KEYNOTE-158 and pembrolizumab use in this setting.

Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine.

BACKGROUND: In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P < 0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial. METHODS: The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. RESULTS: For DTIC, all functional dimensions except role dimension worsened from baseline at follow-up. For dabrafenib, all functionality dimensions remained stable relative to baseline or improved at week 6; mean change in seven symptom dimensions improved from baseline, with appetite loss, insomnia, nausea and vomiting, and pain showing the greatest improvement. In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting. Mixed-model-repeated measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements from baseline in favor of dabrafenib for emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia at weeks 6 and/or 12. After crossing over to dabrafenib upon progression (n = 35), improvements in all QoL dimensions were evident after receiving dabrafenib for 6 (n = 31) to 12 (n = 25) weeks. CONCLUSIONS: This first reported QoL analysis for a BRAF inhibitor in metastatic melanoma demonstrates that the high tumor response rates and PFS superiority of dabrafenib over DTIC is not only a theoretical advantage, but also transforms in a rapid functional and symptomatic benefit for the patient. ClinicalTrials.gov Identifier: NCT01227889.

Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study.

BACKGROUND: In a randomized phase III study, trametinib prolonged progression-free survival and improved overall survival versus chemotherapy in patients with BRAF V600 mutation-positive melanoma. PATIENTS AND METHODS: Patients' quality of life (QOL) was assessed at baseline and follow-up visits using the European Organisation for Research and Treatment of Cancer Core QOL questionnaire. RESULTS: In the primary efficacy population (BRAF V600E+, no brain metastases) from baseline to weeks 6 and 12, patients' global health status scores worsened by 4-5 points with chemotherapy but improved by 2-3 points with trametinib. Rapid and substantive reductions in QOL functionality (e.g. role functioning, 8-11 points at weeks 6 and 12) and symptom exacerbation (e.g. fatigue, 4-8 points; nausea and vomiting, 5 points, both at weeks 6 and 12) were observed in chemotherapy-treated patients. In contrast, trametinib-treated patients reported small improvements or slight worsening from baseline at week 12, depending on the functional dimension and symptom. The mean symptom-scale scores for chemotherapy-treated patients increased from baseline (symptoms worsened) for seven of eight symptoms at week 6 (except insomnia) and six of eight symptoms at week 12 (except dyspnea and insomnia). In contrast, at weeks 6 and 12, the mean symptom-scale scores for trametinib decreased from baseline (symptoms improved) for pain (11-12 points), insomnia (10-12 points), and appetite loss (1-5 points), whereas those for diarrhea worsened (15-16 points). Mixed-model repeated-measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements (small to moderate) from baseline in favor of trametinib for global health; physical, role, and social functioning; fatigue; pain; insomnia; nausea and vomiting; constipation; dyspnea; and appetite at weeks 6 and/or 12. QOL results for the intent-to-treat population were consistent. CONCLUSIONS: This first QOL assessment for a MEK inhibitor in metastatic melanoma demonstrated that trametinib was associated with less functional impairment, smaller declines in health status, and less exacerbation of symptoms versus chemotherapy.

Cost-effectiveness of lapatinib plus letrozole in her2-positive, hormone receptor-positive metastatic breast cancer in Canada.

BACKGROUND: The cost-effectiveness of first-line treatment with lapatinib plus letrozole for postmenopausal women with hormone receptor-positive (hr+), human epidermal growth factor receptor 2-positive (her2+) metastatic breast cancer (mbc) has not been assessed from the Canadian health care system and societal perspectives. METHODS: A partitioned survival analysis model with 3 health states (alive, pre-progression; alive, post-progression; dead) was developed to estimate direct and indirect costs and quality-adjusted life years (qalys) with lapatinib-letrozole, letrozole, anastrozole, or trastuzumab-anastrozole as first-line treatment. Clinical inputs for lapatinib-letrozole and letrozole were taken from the EGF30008 trial (NCT00073528). Clinical inputs for anastrozole and trastuzumab-anastrozole were taken from a network meta-analysis of published studies. Drug costs were obtained from the manufacturer's price list, the Quebec list of medications, and imsBrogan. Other costs were taken from the Ontario Health Insurance Plan's Schedule of Benefits and Fees and published studies. A 10-year time horizon was used. Costs and qalys were discounted at 5% annually. Deterministic and probabilistic sensitivity analyses were performed to assess the effects of changes in model parameters. RESULTS: Quality-adjusted life years gained with lapatinib-letrozole were 0.236 compared with trastuzumab-anastrozole, 0.440 compared with letrozole, and 0.568 compared with anastrozole. Assuming a health care system perspective, incremental costs were $5,805, $67,029, and $67,472 respectively. Given a cost per qaly threshold of $100,000, the probability that lapatinib-letrozole is preferred was 21% compared with letrozole, 36% compared with anastrozole, and 68% compared with trastuzumab-anastrozole. Results from the societal perspective were similar. CONCLUSIONS: In postmenopausal women with hr+/her2+ mbc receiving first-line treatment, lapatinib-letrozole may not be cost-effective compared with letrozole or anastrozole, but may be cost-effective compared with trastuzumab-anastrozole.

Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer.

BACKGROUND: Progression-free survival (PFS) was significantly longer for the lapatinib plus trastuzumab (L+T) arm than for L alone in a phase III, randomized, open-label study of women with human epidermal growth factor receptor 2 positive metastatic breast cancer who had documented progression on at least one T-containing regimen in the metastatic setting. This analysis focused on impact of treatments on health-related quality of life (HRQOL). METHODS: HRQOL was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Changes from baseline and time to deterioration were analyzed in the intent-to-treat population. RESULTS: Differences between the treatment arms in adjusted mean change from baseline favored the L+T arm, ranging from 0.0 to 4.1 (FACT-B), 1.0-4.0 [Functional Assessment of Cancer Therapy-General (FACT-G)], and 0.5-2.7 (Trial Outcome Index). Most differences were not statistically significant, except for FACT-G at week 12 (delta = 4.0, P = 0.037). Similar results were found in a sensitivity analysis that included HRQOL records up to patient withdrawal from original randomized treatment. The longer time to HRQOL deterioration in the L+T arm was not statistically significant (FACT-B hazard ratio, 0.82; 95% confidence interval 0.56-1.20). CONCLUSION: The addition of lapatinib to trastuzumab prolonged PFS while improving or maintaining near-term HRQOL, suggesting a meaningful clinical benefit to patients.

Systematic review of aromatase inhibitors in the first-line treatment for hormone sensitive advanced or metastatic breast cancer.

To undertake a systematic review of three first-line treatments (letrozole, anastrozole and exemestane) for hormone sensitive advanced or metastatic breast cancer (MBC) in post-menopausal women. We searched six databases from inception up to January 2009 for relevant trials regardless of language or publication status. Randomised controlled clinical trials assessing the safety and efficacy of first-line AIs for post-menopausal women with hormone receptor-positive (HR+, i.e. ER+ and/or PgR+) with or without ErbB2 (HER2)-positive MBC, who have not received prior therapy for advanced or metastatic disease were included. Where meta-analysis using direct or indirect comparisons was considered unsuitable for some or all of the data, we employed a narrative synthesis method. Four studies (25 papers) met the inclusion criteria. From the available evidence, it was possible to directly compare the three AIs with tamoxifen. In addition, by using a network meta-analysis it was possible to compare the three AIs with each other. Based on direct evidence, letrozole seemed to be significantly better than tamoxifen in terms of time-to-progression (TTP) (HR = 0.70 (95% CI: 0.60, 0.82)), objective response rate (RR = 0.65 (95% CI: 0.52, 0.82)) and quality-adjusted time without symptoms or toxicity (Q-Twist difference = 1.5; P < 0.001). Exemestane seemed significantly superior to tamoxifen in terms of objective response rate (RR = 0.68 (95% CI: 0.53, 0.89)). Anastrozole seemed significantly superior to tamoxifen in terms of TTP in one trial (HR = 1.42 (95% CI: 1.15, NR)), but not in the other (HR = 1.01 (95% CI: 0.87, NR)). In terms of adverse events, no significant differences were found between letrozole and tamoxifen. Tamoxifen was associated with significantly more serious adverse events in comparison with exemestane (OR = 0.61 (95% CI: 0.38, 0.97)); while exemestane was associated with significantly more arthralgia in comparison with tamoxifen (OR = 2.33 (95% CI: 1.07, 5.11)). Anastrozole was associated with significantly more total adverse events (OR = 1.04 (95% CI: 1.00, 1.09)) and hot flushes (OR = 1.39 (95% CI: 1.03, 1.89)) in comparison with tamoxifen in one trial; however, the other trial showed no significant differences in adverse events between anastrozole and tamoxifen. The indirect comparison of AIs with each other in women with post-menopausal, hormone sensitive advanced or MBC showed that letrozole and exemestane were better in terms of objective response rate than anastrozole; while the more clinically relevant outcomes overall survival (OS) and progression-free survival (PFS) showed no significant differences between AIs. OS and PFS showed no significant differences between AIs and hence based on these results a class effect for all AIs is possible. However, these results are based on indirect comparisons and a network analysis for which the basic assumptions of homogeneity, similarity and consistency were not fulfilled. Therefore, despite the fact that these are the best available data, the results need to be interpreted with appropriate caution. Head-to-head comparisons between letrozole, anastrozole and exemestane in the first-line MBC setting are warranted.

Impact of lapatinib monotherapy on QOL and pain symptoms in patients with HER2+ relapsed or refractory inflammatory breast cancer.

OBJECTIVE: EGF103009 (ClinicalTrials.gov identifier: NCT00105950) was a phase 2, open-label, multicenter study that showed lapatinib monotherapy to be clinically active in women with relapsed or refractory HER2+ (ErbB2+) inflammatory breast cancer that progressed following prior therapy with anthracyclines, taxanes, and trastuzumab. The objective of the present study was to assess the impact of lapatinib on quality of life (QOL) and pain symptoms in these patients. RESEARCH DESIGN AND METHODS: QOL and pain assessments were added during a study amendment and hence only 33 of 126 HER2+ patients were available for baseline assessment. QOL and pain were assessed using the EORTC QLQ-C30 and Brief Pain Inventory-Short Form (BPI-SF) questionnaires, respectively. Both questionnaires were completed at baseline and every 4 weeks thereafter. Change from baseline in QOL and pain scores were summarized by visit. In a post hoc analysis, scores were compared between patients with different clinical response status. RESULTS: Over 60% of the 33 HER2+ patients with the baseline assessments completed the first three postbaseline assessments (week 4, n = 26; week 8, n = 21; week 12, n = 20). At week 8, improvement from baseline in mean EORTC QLQ-C30 scores was observed for global QOL (delta = 14.5; 95% CI: 4.0, 25.0), role functioning (delta = 15; 95% CI: 0.9, 29.1), social functioning (delta = 14.9; 95% CI: -0.5, 30.3), and physical functioning subscales (delta = 9.0; 95% CI: 1.2, 16.8). All symptom scales (except diarrhea) improved from baseline at most scheduled visits during the 20-week follow-up period. Mean scores for all four BPI-SF summary pain scores at week 8 suggested improvement in pain severity and pain interference. Clinical responders had improved scores on most aspects of QOL, compared with declining scores among nonresponders to treatment. CONCLUSIONS: The QOL improvement among the small number of patients with QOL data indicates that lapatinib monotherapy may improve level of functioning/QOL and provide relief from symptoms, including pain, in the short term. These QOL benefits add to the clinical improvement associated with lapatinib therapy in heavily pretreated patients with an aggressive form of breast cancer.

Relationship between effects on time-to-disease progression and overall survival in studies of metastatic breast cancer.

The relationship between overall survival (OS) and disease progression end points has been demonstrated in colorectal, colon, and non-small cell lung cancers. We assessed the association between OS and time-to-progression (TTP) or progression-free survival (PFS) in metastatic breast cancer (MBC) studies. A literature search retrieved all randomised controlled trials since 1994 in patients with MBC in which OS and either TTP or PFS were reported. Summary data on trial and patient characteristics were abstracted. Study effect sizes were derived as the ratio of median progression (or survival) times, which approximates the hazard ratio. Effects were centred at zero for regression analyses weighted by sample size. Numerous treatments were represented in 67 studies (17 081 patients). Modeling showed a positive association between outcomes for progression and survival (R(2)=0.30) with a slope of 0.32 (P<0.001) and a non-significant intercept. Thus, a treatment effect on TTP/PFS translated into a concordant effect on OS, but with attenuated effect size. Similar results were found in models of subsets and sensitivity analyses. These results demonstrate that treatment effects on progression end points in MBC trials are expected to result in treatment differences on OS that are smaller yet consistently in the same direction.

Q-TWiST analysis of lapatinib combined with capecitabine for the treatment of metastatic breast cancer.

The addition of lapatinib (Tykerb/Tyverb) to capecitabine (Xeloda) delays disease progression more effectively than capecitabine monotherapy in women with previously treated HER2+ metastatic breast cancer (MBC). The quality-adjusted time without symptoms of disease or toxicity of treatment (Q-TWiST) method was used to compare treatments. The area under survival curves was partitioned into health states: toxicity (TOX), time without symptoms of disease progression or toxicity (TWiST), and relapse period until death or end of follow-up (REL). Average times spent in each state, weighted by utility, were derived and comparisons of Q-TWiST between groups performed with varying combinations of the utility weights. Utility weights of 0.5 for both TOX and REL, that is, counting 2 days of TOX or REL as 1 day of TWiST, resulted in a 7-week difference in quality-adjusted survival favouring combination therapy (P=0.0013). The Q-TWiST difference is clinically meaningful and was statistically significant across an entire matrix of possible utility weights. Results were robust in sensitivity analyses. An analysis with utilities based on EQ-5D scores was consistent with the above findings. Combination therapy of lapatinib with capecitabine resulted in greater quality-adjusted survival than capecitabine monotherapy in trastuzumab-refractory MBC patients.

Impact of compliance and persistence with bisphosphonate therapy on health care costs and utilization.

UNLABELLED: The impact of persistence and compliance with bisphosphonate therapy on health care costs and utilization was examined in women newly prescribed bisphosphonates. At 3 years, women who were persistent and compliant with bisphosphonate therapy had lower total costs compared with non-persistent and non-compliant women, after controlling for relevant risk factors. INTRODUCTION: The impact of persistence and compliance with bisphosphonate therapy on health care costs and utilization was examined in bisphosphonate-naïve women. METHODS: Two claims databases were used to identify women > or = 45 years of age and who filled a new bisphosphonate prescription during 2000-2002. Persistence and compliance were evaluated over 3 years. Compliance was defined as a medication possession ratio (days of bisphosphonate supply/days of follow-up) > or = 0.80; persistence was defined as no refill gaps > or = 30 days. Multivariate models accounted for potential confounders. RESULTS: This analysis included 32,944 women (mean age, 64 years) who filled a new prescription for daily or weekly alendronate (n = 26,581) or risedronate (n = 6,363). At 3 years, 37% of women were compliant and 21% of women were persistent. Unadjusted total mean health care costs were lower for the compliant vs. non-compliant and persistent vs. non-persistent cohorts. After adjusting for potential confounders, total health care costs were reduced by 8.9% for persistent patients (p < 0.001) and 3.5% for compliant patients (p = 0.014). Persistence decreased the likelihood of inpatient admission by 47%. CONCLUSION: At 3 years, women who were persistent and compliant with bisphosphonate therapy had lower total costs compared with non-persistent and non-compliant women, after controlling for relevant risk factors.

Cost-effectiveness of bisphosphonate therapies for women with postmenopausal osteoporosis: implications of improved persistence with less frequently administered oral bisphosphonates.

OBJECTIVE: Studies have shown that weekly bisphosphonate dosing results in improved persistence compared to daily dosing among patients with postmenopausal osteoporosis, yet more than 50% of patients discontinue therapy within a year. An oral, less frequent administration bisphosphonate provides an opportunity to improve persistence, a parameter not well modeled in previous cost-effectiveness analyses of osteoporosis therapies. RESEARCH DESIGN AND METHODS: We developed a Markov model to estimate the effect of improved persistence on the cost-effectiveness of bisphosphonates among postmenopausal women with established osteoporosis (vertebral fracture and bone mineral density T-score

Obesity and health-related quality of life: a cross-sectional analysis of the US population.

OBJECTIVE: To examine the relationship between body mass index (BMI) and health-related quality-of-life (HRQL), in the presence of dietary controls and/or exercise in a national sample in the United States. METHODS: BMI and its association with HRQL domains (physical, mental and activity limitations) were examined using the Centers' for Disease Control and Prevention's 2000 Behavioral Risk Factor Surveillence System (BRFSS) data, after adjusting for various sociodemographic factors, self-reported health-status, and diet/exercise behavior. RESULTS: Based on World Health Organization's (WHO) classification of obesity, the study sample (N=182 372) included approximately 43.7% nonoverweight, 36% overweight, 14% obese, and 7% severely obese respondents. Exercise and dietary modifications were used by 17.5% of overweight, 15.2% of obese, and 12.5% of severely obese individuals. Logistic regression results using nonoverweight BMI as the reference category showed that severely obese (OR=1.87, 95% CI 1.64-2.12) and obese (OR=1.21, 95% CI 1.09-1.33) were more likely to experience greater than 14 unhealthy days affecting the physical health domain. Severely obese (OR=1.41, 95% CI 1.26-1.59) and obese (OR=1.17, 95% CI 1.07-1.28) were also more likely to experience greater than 14 unhealthy days affecting the mental health domain. Similarly, severely obese (OR=1.73, 95% CI 1.50-1.99) and obese (OR=1.22, 95% CI 1.08-1.37) were more likely to experience greater than 14 days with activity limitations. Exercise and dietary controls were associated with better HRQL across all three domains. CONCLUSION: The study highlights the relationship between BMI and HRQL in the United States. The study also underlines the positive correlation of exercise and dietary modifications with HRQL.

Pharmacists' preferences for continuing education and certificate programs.

OBJECTIVE: To conduct an assessment of the needs and interests of West Virginia pharmacists with respect to continuing education (CE) and certificate programs (CP) versus a nontraditional PharmD program (NTP). METHODS: A cross-sectional study was conducted. The survey was mailed to 2800 West Virginia University School of Pharmacy alumni and West Virginia licensed pharmacists. The survey collected data pertaining to pharmacists' perceptions for the needs of CE, CP, and the NTP program; the optimal structuring of these programs; and the demographics of participants. RESULTS: A 24% (674) usable response rate was achieved from two mailings. Respondents were asked to address all areas of interest: approximately 75% showed interest in enrolling in CE, 45% in CP, and 40% in the NTP program. Interest levels varied across demographic and practice characteristics. Seven methods of instruction were evaluated by pharmacists, with live lectures being the most preferred for both CE and CP. Interest for specific content areas and topics for CE workshops and CP were identified. The type and amount of employer support and willingness to pay for enrollment in the two types of programs were obtained. Markets' needs for CE and CP were identified for five typical pharmacists' profiles (e.g., staff pharmacists in community practice). CONCLUSIONS: Results can be used by CE providers to develop CE and CP programs of most interest to pharmacists and target them to appropriate demographic segments in order to be cost-effective.

Pharmacists and immunizations: a national survey.

OBJECTIVES: To obtain information about pharmacists' current involvement in and willingness to provide immunization services, and to assess perceived barriers to providing immunization services. DESIGN: Cross-sectional mail survey. SETTING: National. PATIENTS OR OTHER PARTICIPANTS: Random sample of 5,342 pharmacists from chain, independent, mass merchandiser/grocery, primary care clinic, and health maintenance organization settings. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Responses to survey on pharmacy-based immunization services--current involvement, willingness to get involved, perceived obstacles, and patients' interest. RESULTS: Three mailings yielded a response rate of 25.3% (1,348 responses). Only 53.1% of respondents knew correctly whether their state allowed pharmacists to administer immunizations. Although a significant number of pharmacists were involved in immunization activities, such as counseling and promotion, only 2.2% and 0.9% of respondents were involved in actual administration of adult and childhood immunizations, respectively. In general, men, independents, owners/partners, and pharmacists who had attended immunization-related educational programs were more willing to provide immunization services than were women, chain and staff pharmacists, and educational program nonattendees. Pharmacists who had attended immunization-related educational programs also perceived pharmacist- and patient-related factors as less problematic for pharmacy-based immunization services than did nonattendees. CONCLUSION: This survey provides a baseline measure of the nature and extent of pharmacist involvement in immunizations that can be used now and in future years. The profession can use the findings on pharmacists' willingness to provide immunization services and their perception of obstacles to such services as a basis for targeted educational and promotional programs and materials.

Assessing managed care's role in promoting preventive care.

The current trend of managed health care systems opens the door to more effective control of chronic diseases through preventive care. The goal of this study was to assess managed care's role in promoting preventive care. A mail survey was conducted of a national sample of 1,200 directors, associated with preventive care, in managed care organizations (MCOs) in the U.S. Data was obtained on perceived effectiveness, degree of importance, and likelihood of support for implementation of strategies recommended (case management, utilization review programs, selective contracting, and cost sharing) for ensuring appropriate utilization of preventive services. Also, information was collected on interventions perceived effective in encouraging plan members to utilize and providers to offer preventive services. Response rate was 17.3%. Case management and prospective and concurrent utilization review programs were perceived most effective, important, and likely to receive support for implementation while cost sharing (using deductibles and coinsurance) and retrospective utilization review programs ranked low on all dimensions. Plan member-directed interventions perceived effective in encouraging utilization of preventive services included telephone and mail reminders while computer-generated reminders and medical record audits with feedback were perceived effective in encouraging providers to offer such services. Results identified preferred MCO strategies and interventions for ensuring appropriate utilization of preventive services. Further research is needed to develop methods to encourage people at high risk for chronic diseases not currently utilizing preventive services to receive such services.

Barriers and facilitators to providing common preventive screening services in managed care settings.

Despite increasing emphasis on disease prevention and health promotion, and ample evidence demonstrating the effectiveness of preventive services, such services are underutilized in the United States. The current trend of health care toward health maintenance organizations and other managed care systems opens the door, perhaps to more effective control of heart disease, cancers and other chronic diseases through preventive care. This warrants attention to the barriers/facilitators to the provision/utilization of preventive screening services in such settings. Overall goal of this study was to assess barriers/facilitators to the provision/utilization of preventive services in managed care organizations (MCOs). This was accomplished by a) identifying barriers/facilitators to the provision/utilization of three common preventive screening services (cholesterol screenings, mammograms, and Pap smears); and b) profiling typical MCO recipients of these three preventive screening services. A self-administered, mail questionnaire was used to obtain information from a national sample of 1,200 Directors of MCOs associated with preventive care. A total of 175 usable responses were received resulting in a 17.3 percent net response rate. The strongest barrier to the provision of all three screening services is the inability of them to generate short term savings for the MCO. Other barriers include high disenrollment rates, conflicting recommendations about effectiveness (for mammograms and cholesterol screenings), and patients' fears of getting a positive result (for mammograms and Pap smears). The improved health status as a result of early intervention, high consumer awareness (for mammograms and Pap smears), and long term savings are important facilitators to the provision/utilization of these screening services. Comparing barriers and facilitators across the three services shows the stronger barriers affecting the provision/utilization of mammograms. For all three screening services, typical managed care recipients are those in the high income groups with greater education levels. However, with the increasing enrollment of Medicaid beneficiaries into managed care, MCOs may find themselves selectively targeting these high risk low income and less educated individuals to receive the preventive screening services. Study findings should be useful to health planners, policymakers and researchers at all levels in their efforts to encourage and promote healthier lifestyle choices among U.S. residents. Future studies should address receipt of preventive services by Medicaid and Medicare beneficiaries in managed care settings.

The gift relationship between pharmaceutical companies and physicians: an exploratory survey of physicians.

The purpose of this exploratory study was to survey physicians' attitudes surrounding the 'gift relationship' between pharmaceutical companies and physicians. A survey was mailed to 1000 randomly selected West Virginia physicians, of which 283 (28.3%) responses were received. The most commonly received gifts reported by the study physicians were trinkets (77.4%), followed by books (41.7%) and meals (41%). Principal component analysis and varimax rotation identified seven physician belief constructs. The mean ratings of the constructs indicated that the physicians slightly agreed that pharmaceutical companies give gifts to physicians to influence their prescribing, moderately disagreed that they do so as a form of professional recognition of physicians, and strongly disagreed that their prescribing behaviour could be influenced by the gifts they receive. Physicians slightly disagreed that pharmaceutical companies' sponsoring of CME programmes are only promotional gimmicks. Although the study physicians slightly disagreed that it may be inappropriate for them to accept gifts from pharmaceutical companies, they seemed slightly averse to having 'gift relationships' between pharmaceutical companies and physicians made public. Correlation analysis suggested that physicians who have a large number of patients in their practice, see a larger number of patients per day, or write a large number of prescriptions per day are more likely to be offered gifts by pharmaceutical companies, and they are also more likely to condone the practice of gift giving and receiving.