Smoking, smoking cessation and smoking relapse patterns: a web-based survey of current and former smokers in the US.

AIM: The aim of this study was to characterise the natural course of smoking cessation behaviour in a web-based survey of current and former cigarette smokers (CS and FS) in the United States. METHODS: A web-based survey of CS and FS was conducted in April 2009; demographic and socioeconomic characteristics and smoking history (including the number of lifetime and length of latest quit attempts, aids used and time to relapse) were collated. The surveyed cohort was selected from prescreened CS and FS panellists and matched for age, race and education, to be representative of the US population. Descriptive statistics and time-to-event analyses using Kaplan-Meier curves were applied in the analysis of this report. RESULTS: The final cohort comprised 512 CS and 566 FS (n = 1078). A larger proportion of FS than CS reported a longest smoke-free period of > 1 year (78.8% vs. 22.4%, respectively). As a greater variety of smoking cessation products became available over time, the proportion of unassisted quit attempts decreased from 76.1% prior to 1983 to 43.9% after 2006 for CS and from 79.3% to 50.3% for FS. The cumulative proportion of subjects relapsing was 31.3% by 1 week and 79.3% by 6 months. The estimated median time to next quit attempt was approximately 360 days. CONCLUSIONS: These data confirm that relapse is common and that as the variety of cessation modalities increase, the proportion of unassisted quit attempts decreases. Self-help or cold-turkey methods still provide significant alternatives even when pharmacotherapy is available. This study provides data related to the smoking history and smoking cessation patterns of a large, nationally representative sample of CS and FS.

Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making.

Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare.

Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa.

OBJECTIVES: Quality of life (QOL) data were used to evaluate the effects of self-administered intracavernosal injection of alprostadil for erectile dysfunction, when used for up to 18 months during a 13 country Phase III clinical trial. METHODS: The Duke Health Profile was used to measure patients' physical and psychosocial QOL at baseline, 3, 6, 12 and 18 months. Changes from baseline were measured using paired t-tests, with additional analyses by cause of dysfunction, starting dosage, and prior treatment. RESULTS: Patients displayed significant improvements in mental and social health and self-esteem at six months (P < 0.01, n = 570), with greater improvements at 12 and 18 months. Anxiety and depression measures also improved significantly at 12 and 18 months, as did the summary general health score. Worse pain scores were observed in the first year but not at 18 months. Those with a starting dosage of 10-20 micrograms, those with psychogenic causes of dysfunction, and those with no prior treatment for erectile dysfunction generally showed the greatest improvements. CONCLUSION: In this study, the clinical improvements in erectile function due to intracavernosal alprostadil therapy were complemented by QOL improvements, particularly in the mental health, of many patients.

Comparison of length of hospital stay for patients with known or suspected methicillin-resistant Staphylococcus species infections treated with linezolid or vancomycin: a randomized, multicenter trial.

STUDY OBJECTIVE: To compare hospital length of stay (LOS), weekly discharges, and days of antibiotic treatment with linezolid (intravenous with oral follow-up) and vancomycin (intravenous only). DESIGN: Multinational, randomized, phase III trial. SETTINGS: Hospitals in North America, Latin America, and Europe. PATIENTS: Four hundred sixty hospitalized patients with infections of known or suspected methicillin-resistant Staphylococcus species. INTERVENTION: Administration of linezolid or vancomycin. MEASUREMENTS AND MAIN RESULTS: For linezolid recipients, median LOS was 5 and 8 days shorter (p=0.05 and 0.003) in the complicated skin and soft tissue infection intent-to-treat (230 patients) and clinically evaluable (144) samples, and slightly but not significantly shorter in the overall intent-to-treat (460) and clinically evaluable (254) samples. In all samples, linezolid recipients had more discharges in the first week of treatment and fewer days of intravenous therapy than vancomycin recipients. CONCLUSION: Our results support linezolid's ability to reduce medical resource use.

The production of health care services and changing hospital reimbursement. The role of hospital-medical staff relationships.

The production of health care services has the unique feature that physicians do not face explicit costs for hospital inputs. This paper develops models of the production process given alternative hospital and medical staff relationships, and analyzes the impact of the change in hospital reimbursement under Medicare from a cost-based system to the Prospective Payment System (PPS). A basic theoretical result finds that the switch to PPS forces physicians to alter their input mix, changing both physician and hospital income. The effects of the introduction of PPS on hospital inputs, physician income, and hours of work are empirically examined.

Teaching hospital costs: the effects of medical staff characteristics.

This article examines the effect of medical staff behavior on the cost of hospital-based care and graduate medical education, and shows its implications for estimation of hospital costs. The empirical work brings a unique new data source for these characteristics to the estimation process. Our results indicate that there are important economies of scale and scope in hospital production, both for inpatient stays and for residency training. Controlling for medical staff characteristics significantly reduces the estimated costs of residency training. Staff characteristics may be capturing aspects of the quality of inpatient care and residency training provided by the hospital.

Young physicians most and least likely to have second thoughts about a career in medicine.

To identify factors associated with apparent disaffection with medicine as a career, the authors analyzed data for 4,931 young physicians surveyed in 1987. Using survey responses, the authors classified 932 of the physicians (18.9%) as most likely to have second thoughts about their career choices and 1,094 (22.2%) as least likely to have second thoughts. The group with the greatest reservations included significantly higher proportions of white women, blacks, and Hispanics. This group reported significantly lower incomes, higher educational debt, and more hours and patients' visits per week. Among employee physicians, those most disaffected were significantly more likely to report inappropriate use of tests and procedures and lack of autonomy in their practices. The authors conclude that it is important to reexamine the heavy reliance on debt financing of medical education, especially for minority students, and to explore the equality of career opportunities for women and minorities in medicine.

A comparison of preference assessment instruments used in a clinical trial: responses to the visual analog scale from the EuroQol EQ-5D and the Health Utilities Index.

OBJECTIVES: To compare preference assessments that were made by using the EuroQol EQ-5D and the Health Utilities Index Mark II. SUBJECTS: 561 patients in a randomized trial of tirilazad mesylate for aneurysmal subarachnoid hemorrhage. MEASURES: Three preference assessments (a value score for the EuroQol instrument and value and utility scores for the Health Utilities Index) made three months after randomization. The averages for each of the three scores, stratified by clinical outcomes and attributes of the Health Utilities Index health status classification system, were compared. To evaluate potential sources of difference between the instruments, the authors estimated two alternative Health Utilities Index scoring rules that were based on patient responses to the EuroQol instrument. RESULTS: Patients' ratings of their current health made by using the 100-point visual analog scale from the EuroQol instrument were more similar to the utility scores for the Health Utilities Index than they were to the value scores for the Health Utilities Index. The biggest differences between the visual analog scores for the EuroQol instrument and the utility scores for the Health Utilities index were seen at higher levels of functioning. CONCLUSION: For states representing higher levels of functioning, differences were seen between patients' self-ratings obtained by using the EuroQol instrument and the patients' utility scores on the Health Utilities Index; for states representing lower levels of functioning, substantial agreement was observed between these two scores. Differences observed at the higher levels of functioning suggest that further research is needed to determine whether the Health Utility Index's assignment of a score of 1.0 to the reference state representing being healthy is appropriate.

Patient acceptability and satisfaction with Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension).

The results from a User Satisfaction Questionnaire, Treatment Assessment Questionnaire, and Global Well-Being Schedule questionnaire administered to women participating in an open-labeled, nonrandomized, parallel, controlled study comparing a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C) (MPA/E2C) (Lunelle Monthly Contraceptive Injection) and a triphasic norethindrone (0.5, 0.75, 1.0 mg)/0.035 mg ethinyl estradiol (NET/EE) oral contraceptive (Ortho-Novum 7/7/7) are reviewed. Approximately 85% of all 1103 women enrolled in the comparative trial completed their initial and final questionnaires. To better assess the comparison of a new and extant method of contraception, outcome data were divided among MPA/E2C users and new and previous oral contraceptive (OC) users. Despite the inherent inequalities in comparing an injectable to an oral method of contraception, few treatment assessment and satisfaction outcomes were significantly different when comparing MPA/E2C users to new OC (NET/EE) users. More women in the MPA/E2C study group reported discomfort with their method than women in either NET/EE study group; however, only 19.4% of MPA/E2C users rated the administration of their contraceptive to be moderately uncomfortable or worse, compared to 11.7% of new NET/EE users and 13.4% of previous OC users. Among MPA/E2C users, 86.3% reported no interference with social activities compared with 90.4% of new NET/EE users. MPA/E2C and new NET/EE users were also similar in their responses recommending their respective contraceptive method to friends, with > 90% of both groups stating that they had a very favorable experience and would definitely recommend their method to a friend. In general, MPA/E2C was well accepted by women in the study group. Their attitudes and perceptions are similar to those of women who were starting OCs for the first time. These data support the premise that MPA/E2C may become a well accepted, first-line contraceptive option for women in the US.

PIP: The results of a user satisfaction questionnaire, treatment assessment questionnaire, and global well being schedule questionnaire administered to women participating in an open-labeled, nonrandomized, parallel, controlled study is reported in this paper. The study compared a new monthly injectable contraceptive containing 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate (E2C) with a triphasic norethindrone (0.5, 0.75, 1.0 mg)/0.035 mg ethinyl estradiol (NET/EE) oral contraceptive. Approximately 85% of 1103 women enrolled in the comparative trial completed their initial and final questionnaires. Despite the inherent inequalities in comparing an injectable to oral contraception, few treatment assessment and satisfaction outcomes were significantly different when comparing MPA/E2C users to new NET/EE users. More women in the MPA/E2C group reported discomfort with their method compared to the women in either the new or previous NET/EE user group. However, only 19.4% of MPA/E2C users rated the administration of their contraceptive to be moderately uncomfortable or worse, compared to 11.7% of new NET/EE users and 13.4% of previous NET/EE users. Among MPA/E2C users, 86.3% reported no interference with social activities compared with 90.4% of new NET/EE users. MPA/E2C and new NET/EE users were also similar in their responses recommending their respective contraceptive method to friends. These data support the premise that MPA/E2C may become the well-accepted, first-line contraceptive option for women in the US.

Young physicians and changes in medical practice characteristics between 1975 and 1987.

This article examines the proposition that an increasing representation in the total physician population has subjected young physicians to "baby boom" cohort effects seen in the general population. Analyzing comparative changes in income and other medical practice characteristics between 1975 and 1987, we find moderate evidence to support this proposition, particularly when specialty selection and changes in the income distribution are taken into account. Young male physicians experienced a significant income decline, as did certain specialties. Other characteristics also suggest that young physicians are working relatively harder now than a decade ago. However, the income decline for young physicians is smaller than for other baby boomers.

Physician-based measures of Medicare access.

Physician payment reforms implemented in January 1992 have dramatically changed the way payments for services are determined under the Medicare Part B program. This paper presents new measures of access using physician-level data that provide a baseline for monitoring changes in access that might occur as these payment reforms unfold and that allow us to examine recent access trends. Our results suggest that Medicare beneficiaries as a group currently have a high degree of access to care, and that access generally improved between 1986 and 1990.

Assessing the validity of the geographic practice cost indexes.

Data on physician practice inputs were used to test the degree to which the geographic practice cost indexes (GPCIs) of the Medicare physician payment schedule reflect geographic variation in input prices. For purposes of this study, input quantity information was collected through the American Medical Association's Socioeconomic Monitoring System survey in 1990 and 1991. These data, along with practice expense information, were used to construct unit input prices. The GPCIs were correlated with input prices; however, "real" or GPCI-adjusted prices varied significantly across locations. We conclude that the GPCIs are useful, but imperfect measures of geographic differences in physician practice input prices.

Comparative efficacy and effectiveness: an opportunity for clinical pharmacology.

Over the past 10 or more years, the drug development paradigm has shifted radically as a consequence of the availability of generic formulations for many important drugs and the growing influence of major payers in controlling reimbursement of new medicines. The demand for health care in an aging and increasingly information-seeking population is steadily outstripping society's ability to pay for all possible treatments. Regulatory approval of new drugs is necessary but no longer sufficient for market access in many countries, including the United States.

Practice mobility among young physicians.

This study examines practice mobility among young physicians, based on a large nationwide 1987 survey of physicians under age 40 years and in their second through fifth years of practice. Averaged across all physicians, there is a 10% to 12% chance of changing practices for each of the first 3 years, and about one in three physicians changes within the first 5 years. While the most common transition is from employee to self-employed practices, many practice changes are within employment type. Those starting in a self-employed solo practice are least likely to change practices, while those starting as HMO employees are most likely to change. Multinomial analysis of practice change choices reveals some specialty-specific differences in these choices, as well as the effects of experience, schooling, race, sex, debt, family constraints, and locational preferences. High debt is a factor in practice changes, but neither competition nor discrimination against minorities appear to play significant roles.

An international comparison of the reliability and responsiveness of the Duke Health Profile for measuring health-related quality of life of patients treated with alprostadil for erectile dysfunction.

OBJECTIVES: It is important that health measures are both reliable and responsive to clinical change. The aim of this study was to assess the reliability and responsiveness of the physical, mental, and social health scales of the Duke Health Profile (DUKE). METHODS: Impotent males self-administered the Duke Health Profile before and during treatment with alprostadil for erectile dysfunction during a 19-month period. Subjects were 490 patients in the United States and 583 patients in 12 other countries. Each of the three basic Duke Health Profile scales has only five items, and each is heterogeneous because each measures more than one health concept. RESULTS: Cronbach's alpha reliability estimates were: physical health, 0.68 for United States and 0.64 for other countries; mental health, 0.62 and 0.52, respectively; and social health, 0.53 and 0.47, respectively. Alprostadil was expected to improve mental health primarily, and results of the study were consistent with this hypothesis. For example, at approximately 14 months from therapy onset, mental health improved for patients both in the United States (standardized response mean, SRM, = 0.17) and other countries (mean SRM = 0.30), whereas physical health worsened in the United States and was unchanged in other countries, and social health was unchanged in the United States and improved in other countries. Maximum responsiveness was shown for mental health in the other countries, where the mean standardized response means at four follow-ups during a 19-month period were 0.11, 0.21, 0.30, and 0.36. CONCLUSIONS: This study provides support for the responsiveness of the Duke Health Profile mental health scale.

Physician contact with and attitudes toward HIV-seropositive patients. Results from a national survey.

The growing population of HIV-seropositives raises serious concerns about who will provide medical care to this group. This article presents the first national estimates of physician involvement in, and attitudes toward, the treatment of HIV-seropositive patients. Nearly 50% of the nonfederal patient care physicians in our nationally representative sample have treated at least one HIV patient, with an average of 6.7 such patients being treated per physician. Perceived responsibility to treat HIV-seropositive patients is uniformly strong across such physician and practice characteristics as specialty, years of experience, and practice type. However, there are pronounced differences in actual physician involvement along these dimensions.

Re-engineering drug development: integrating pharmacoeconomic research into the drug development process.

Pharmacoeconomic research will be an increasingly important aspect of drug development as providers, third-party payers, and worldwide government health agencies use cost-effectiveness and quality-of-life data to assist in making decisions on optimal pharmaceutical treatment protocols, formulary listings, and reimbursement. It is in the best interest of pharmaceutical companies to have an established, well-integrated pharmacoeconomic research program that can respond to the dynamic health-care environment and proactively plan a program to optimize patient care. The new paradigm for pharmacoeconomic research will require establishment and successful management of many internal and external customer relationships. This article discusses one company's organization of these relationships and how they are integrated into the drug development process during each stage of the product life cycle.

A comparison of scoring weights for the EuroQol derived from patients and the general public.

OBJECTIVE: General health state classification systems, such as the EuroQol instrument, have been developed to improve the systematic measurement and comparability of health state preferences. In this paper we generate valuations for EuroQol health states using responses to this instrument's visual analogue scale made by patients enrolled in a randomized clinical trial evaluating tirilazad mesylate, a new drug used to treat subarachnoid haemorrhage. We then compare these valuations derived from patients with published valuations derived from responses made by a sample from the general public. METHODS: The data were derived from two sources: (1) responses to the EuroQol instrument from 649 patients 3 months after enrollment in the clinical trial, and (2) from a published study reporting a scoring rule for the EuroQol instrument that was based upon responses made by the general public. We used a linear regression model to develop an additive scoring rule. This rule enables direct valuation of all 243 EuroQol health states using patients' scores for their own health states elicited using a visual analogue scale. We then compared predicted scores generated using our scoring rule with predicted scores derived from a sample from the general public. RESULTS: The predicted scores derived using the additive scoring rules met convergent validity criteria and explained a substantial amount of the variation in visual analogue scale scores (R(2)=0.57). In the pairwise comparison of the predicted scores derived from the study sample with those derived from the general public, we found that the former set of scores were higher for 223 of the 243 states. Despite the low level of correspondence in the pairwise comparison, the overall correlation between the two sets of scores was 87%. CONCLUSIONS: The model presented in this paper demonstrated that scoring weights for the EuroQol instrument can be derived directly from patient responses from a clinical trial and that these weights can explain a substantial amount of variation in health valuations. Scoring weights based on patient responses are significantly higher than those derived from the general public. Further research is required to understand the source of these differences.