Meteorological factors and timing of the initiating event of human parturition.

The aim of this study was to determine whether meteorological factors are associated with the timing of either onset of labor with intact membranes or rupture of membranes prior to labor-together referred to as 'the initiating event' of parturition. All patients delivering at Evanston Hospital after spontaneous labor or rupture of membranes at ≥20 weeks of gestation over a 6-month period were studied. Logistic regression models of the initiating event of parturition using clinical variables (maternal age, gestational age, parity, multiple gestation and intrauterine infection) with and without the addition of meteorological variables (barometric pressure, temperature and humidity) were compared. A total of 1,088 patients met the inclusion criteria. Gestational age, multiple gestation and chorioamnionitis were associated with timing of initiation of parturition (P < 0.01). The addition of meteorological to clinical variables generated a statistically significant improvement in prediction of the initiating event; however, the magnitude of this improvement was small (less than 2% difference in receiver-operating characteristic score). These observations held regardless of parity, fetal number and gestational age. Meteorological factors are associated with the timing of parturition, but the magnitude of this association is small.

Impact of mental disorders on cost and reimbursement for patients in inpatient rehabilitation facilities.

OBJECTIVE: To determine whether comorbid mental disorders affect inpatient rehabilitation facility (IRF) costs and to examine the extent to which Medicare's prospective payment system reimbursement sufficiently covers those costs. DESIGN: Secondary analysis of Medicare IRF Patient Assessment Instrument files and Medicare Provider and Review files. Payment was compared with costs for patients with and without reported mood, major depression, substance use, or anxiety disorders. The relationships among payment group assignment, comorbidity-related adjustments in payment, and the presence of mental disorders were estimated. SETTING: IRFs (N=1334) in the United States. PARTICIPANTS: Medicare fee-for-service beneficiaries (N=1,146,799) discharged from IRFs from 2002 to 2004. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: IRF costs. RESULTS: Mental disorders were reported for 13% of the Medicare fee-for-service beneficiaries. After controlling for payment group and comorbidity classifications, patients with mood, major depression, or anxiety disorders had significantly greater costs of $433, $1642, and $247 compared with patients without these disorders. The higher cost for patients with major depression (14.9% higher) is sufficient to justify a tier 2 comorbidity classification. CONCLUSIONS: A reimbursement adjustment for the presence of a major depressive disorder would bring Medicare reimbursement in line with facility costs. The failure to compensate facilities directly for providing care to patients with major depression may result in reduced access to care for these patients. It also may create a disincentive to meet mental health treatment needs during the rehabilitative episode. Further work is needed to compare costs between patients with and without confirmed mental health disorders, given concerns about the accurate reporting of mental health disorders.

Responding to a small-scale bioterrorist anthrax attack: cost-effectiveness analysis comparing preattack vaccination with postattack antibiotic treatment and vaccination.

BACKGROUND: In 2001, a small-scale bioterrorism-related anthrax attack was perpetrated via the US mail. The optimal future response may require strategies different from those required in a large-scale attack. METHODS: We conducted a cost-effectiveness analysis using Monte Carlo simulation during a 10-year time frame from a societal perspective to determine the optimal response strategy for a small-scale anthrax attack perpetrated against US Postal Service distribution centers in a large metropolitan area. Three strategies were compared: preattack vaccination of all US distribution center postal workers, postattack antibiotic therapy followed by vaccination of exposed personnel, and postattack antibiotic therapy without vaccination of exposed personnel. Outcome measures were costs, quality-adjusted life-years, and incremental cost-effectiveness. The probabilities for anthrax exposure and infection; vaccine and antibiotic benefits, risks, and costs; and associated clinical outcomes were derived from the medical literature and from bioterrorism experts. RESULTS: Postattack antibiotic therapy and vaccination of exposed postal workers is the most cost-effective response compared with other strategies. The incremental cost-effectiveness is $59 558 per quality-adjusted life-year compared with postattack antibiotic therapy alone. Preattack vaccination of all distribution center workers is less effective and more costly than the other 2 strategies. Assuming complete adherence to preattack vaccination, the incremental cost-effectiveness compared with postattack antibiotic therapy alone is almost $2.6 million per quality-adjusted life-year. CONCLUSION: Despite uncertainties about a future anthrax attack and exposure risk, postattack antibiotic therapy and vaccination of exposed personnel seems to be the optimal response to an attack perpetrated through the US Postal Service.

Trends in perinatal regionalization and the role of managed care.

OBJECTIVE: To describe trends in regionalization of perinatal care and identify factors that predict the extent of regionalization. METHODS: Data were drawn for four states for every year between 1989 and 1998. Panel data models estimated the effect of managed care enrollment on site of delivery for low, very low, and extremely low birth weight neonates. RESULTS: Strong evidence for regionalization over time was observed for North Carolina and Illinois, with little change in site of delivery in Washington. A shift from level III to level II hospitals was observed for low and very low birth weight neonates in California. Although managed care enrollment increased substantially in all four states, managed care had no effect on site of delivery; that is, the effect of managed care was near zero and not statistically significant in any state. CONCLUSION: Evidence supports the delivery of high-risk neonates at tertiary care centers. Despite changes in site of delivery, the percentages of very low birth weight neonates delivered at level III hospitals were substantially lower than the goal of 90% set by Healthy People 2010. Financial pressures introduced by managed care cannot be blamed for the failure to meet this goal. LEVEL OF EVIDENCE: II-2.

Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study.

PURPOSE: Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study. PATIENTS AND METHODS: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over. RESULTS: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P <.001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P <.001) differences were observed between patients who did and did not cross over in favor of imatinib. CONCLUSION: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.

Antidepressant treatment for depression: total charges and therapy duration*

BACKGROUND: The economic costs of depression are significant, both the direct medical costs of care and the indirect costs of lost productivity. Empirical studies of antidepressant cost-effectiveness suggest that the use of selective serotonin reuptake inhibitors (SSRIs) may be no more costly than tricyclic antidepressants (TCAs), will improve tolerability, and is associated with longer therapy duration. However the success of depression care usually involves multiple factors, including source of care, type of care, and patient characteristics, in addition to drug choice. The cost-effective mix of antidepressant therapy components is unclear. AIMS OF THE STUDY: Our study evaluates cost and antidepressant-continuity outcomes for depressed patients receiving antidepressant therapy. Specifically, we determined the impact of provider choice for initial care, concurrent psychotherapy, and choice of SSRI versus TCA-based pharmacotherapies on the joint outcome of low treatment cost and continuous antidepressant therapy. METHODS: A database of private health insurance claims identifies 2678 patients who received both a diagnosis of depression and a prescription for an antidepressant during 1990-1994. Patients each fall into one of four groups according to whether their health care charges are high versus low (using the median value as the break point) and by whether their antidepressant usage pattern is continuous versus having discontinued pharmacotherapy early (filling fewer than six prescriptions). A bivariate probit model controlling for patient characteristics, co-morbidities, type of depression and concurrent treatment is the primary multivariate statistical vehicle for the cost-effective treatment situation. RESULTS: SSRIs substantially reduce the incidence of patients discontinuing pharmacotherapy while leaving charges largely unchanged. The relative effectiveness of SSRIs in depression treatment is independent of the patient's personal characteristics and dominates the consequences of other treatment dimensions such as seeing a mental health specialist and receiving concurrent psychotherapy. Initial provider specialty is irrelevant to the continuity of pharmacotherapy, and concurrent psychotherapy creates a tradeoff through reduced pharmacotherapy interruption with higher costs. DISCUSSION: Longer therapy duration is associated with SSRI-based pharmacotherapy (relative to TCA-based pharmacotherapy) and with concurrent psychotherapy. High cost is associated with concurrent psychotherapy and choice of a specialty provider for initial care. In our study cost-effective care includes SSRI-based pharmacotherapy initiated with a non-specialty provider. Previous treatment history and other unobserved factors that might affect antidepressant choice are not included in our model. IMPLICATIONS FOR HEALTH CARE PROVISION: The decision to use an SSRI-based pharmacotherapy need not consider carefully the patient's personal characteristics. Shifting depressed patients' pharmacotherapy away from TCAs to SSRIs has the effect of improving outcomes by lowering the incidence of discontinuation of pharmacotherapy while leaving largely unchanged the likelihood of having high overall health care charges. Targeted use of concurrent psychotherapy may be additionally cost-effective. IMPLICATIONS FOR HEALTH POLICIES: The interaction of various components of depression care can alter the cost-effectiveness of antidepressant therapy. Our results demonstrate a role for the non-specialty provider in initiating care and support increased use of SSRIs as first-line therapy for depression as a way of providing cost-effective care that is consistent with APA guidelines for continuous antidepressant treatment. IMPLICATIONS FOR FURTHER RESEARCH: Further research that improves our understanding of how decisions regarding provider choice, concurrent psychotherapy, and drug choice are made will improve our understanding of the effects treatment choices on the cost-effectiveness of depression care. We have suggested that targeted concurrent psychotherapy may prove to be cost-effective; research to determine groups most likely to benefit from the additional treatment would further enable clinicians and healthcare policy makers to form a consensus regarding a model for treating depression.

Quality of life assessment for low literacy Latinos: a new multimedia program for self-administration.

Cancer patients who have limited literacy skills or English language proficiency are particularly vulnerable to receiving sub-optimal care. Outcome measurement in these patients may provide new insight into previously undetected problems. This report describes the development and testing of a Spanish language, multimedia program for quality of life (QOL) assessment. Pilot testing was conducted with 30 Latino cancer patients with a range of education levels and computer experience. Patients found the program easy to use and understand. The "Talking Touchscreen" is a practical, user-friendly method that provides greater opportunities to assess QOL in Spanish-speaking patients with a range of literacy skills.

Impact of Medicare's prospective payment system for inpatient rehabilitation facilities on stroke patient outcomes.

OBJECTIVE: To estimate the effect of Medicare's prospective payment system for inpatient rehabilitation facilities on discharge functional status, community discharge, and length of stay. DESIGN: Secondary analysis using data drawn from the American Medical Rehabilitation Providers Association subscription database. Eligible patients were Medicare and non-Medicare stroke patients discharged from inpatient rehabilitation facilities from 1998 through the first two quarters of 2006. Random effects panel data models were used to estimate the impact of prospective payment on motor and cognitive discharge function, the probability of discharge to the community and inpatient length of stay, controlling for patient, and facility characteristics. RESULTS: The introduction of prospective payment was associated with small, statistically significant reductions in Functional Independence Measure discharge motor (-1.10) and cognitive (-0.15) scores and in the probability of discharge to the community (adjusted odds ratio: 0.87) for Medicare fee-for-service patients. Length of stay was substantially lower for both Medicare (-1.86 days) and (-2.16) non-Medicare fee-for-service patients. CONCLUSIONS: Further research is needed to determine whether the small reductions in patient function are persistent over time. This short-term evaluation of prospective payment system suggests minimal negative impact on stroke patient function at discharge because of the change in Medicare reimbursement but a decrease in likelihood of discharge to the community.

Estimation of patient preference-based utility weights from the functional assessment of cancer therapy - general.

OBJECTIVE: The goal of this study was to estimate an algorithm to convert responses to the Functional Assessment of Cancer Therapy - General (FACT-G) to time trade-off (TTO) utilities based on utilities for current health elicited from cancer patients. METHODS: Data for 1433 cancer patients were randomly separated into construction and validation samples. Four FACT-G questions were selected for inclusion based on correlation with Eastern Clinical Oncology Group - Performance Status (ECOG-PS) scores and TTO utilities. Item response theory was used to collapse response categories. Ordinary least squares regression with the constant constrained to one was used to estimate the algorithm. RESULTS: The algorithm estimated mean utility for the full validation sample within three points of observed mean utility (0.805 vs. 0.832, P < 0.01). Mean utilities were well predicted (mean absolute difference < 0.03, P > 0.05) for most subgroups defined by ECOG-PS and Short Form-36 physical functioning scores, and responses to the FACT-G overall quality of life item. Nevertheless, the algorithm systematically overpredicted utilities for poorer health states. CONCLUSIONS: A FACT-G-based algorithm of cancer patient utilities was developed that estimates group mean utility scores with accuracy comparable to other indirect preference-based measures of health-related quality of life. Patient-based preferences for health outcomes of cancer treatment may be useful in multiple situations, such as managing resources within cancer centers and in understanding health states preferences among cancer experienced patients before and after treatment.

Cost-effectiveness analysis of anastrozole versus tamoxifen as primary adjuvant therapy for postmenopausal women with early breast cancer: a US healthcare system perspective. The 5-year completed treatment analysis of the ATAC ('Arimidex', Tamoxifen Alone or in Combination) trial.

BACKGROUND: This study evaluated the cost-effectiveness of anastrozole versus generic tamoxifen for primary adjuvant treatment of postmenopausal women with hormone receptor-positive (HR+) early breast cancer (EBC), from a US healthcare perspective. METHODS: A probabilistic Markov model was developed using the 5-year completed treatment analysis of the ATAC ('Arimidex', Tamoxifen Alone or in Combination) trial (ISRCTN 18233230) to project outcomes for anastrozole and tamoxifen to 25 years. Resource utilization data were obtained primarily from published literature and a physician survey (including expert opinion from ATAC Steering Committee members). Drug costs were taken from published wholesale acquisition costs (anastrozole $6.56/day, generic tamoxifen $1.33/day). Other unit costs ($US 2003-4) were from standard sources. Utility estimates of relevant health states, used to compute quality-adjusted life-years (QALYs), were collected using the standard gamble technique in a cross-sectional sample of 44 patients. Costs and benefits were discounted 3% annually. RESULTS: In a cohort of 1000 postmenopausal women with HR+ EBC, the model showed anastrozole treatment (versus tamoxifen) would lead to 257 QALYs gained (0.26 QALYs gained per patient), at an additional cost of $5.21 million over 25 years ($5,212 per patient). The estimated incremental cost-effectiveness ratio (ICER) of anastrozole compared with tamoxifen was $20,246 per QALY gained ($23,541 per life-year gained). Cost-effectiveness acceptability curves indicated a >90% probability that the cost per QALY gained with anastrozole would be <$50,000. Results were robust in a sensitivity analysis. CONCLUSION: Anastrozole is a cost-effective alternative to tamoxifen for the primary adjuvant treatment of postmenopausal women with HR+ EBC.

The impact of literacy on health-related quality of life measurement and outcomes in cancer outpatients.

BACKGROUND: Limited evidence exists regarding the relationship between literacy and health-related quality of life (HRQL). Research is needed to develop measurement techniques for low literacy populations and to evaluate potential literacy-related measurement bias. METHODS: A Talking Touchscreen (TT) was developed for an HRQL study. Low (n = 214) and high literacy (n = 201) adult cancer outpatients participated, 70% of whom were from racial/ethnic minorities. Patients completed three questionnaires by TT: FACT-G (cancer-specific), SF-36 (generic health status), and a standard gamble utility questionnaire. Measurement bias was evaluated using item response theory (IRT). Effects of literacy on HRQL were evaluated using regression models. RESULTS: Most (97%) patients rated the TT easy to use. In IRT analysis, 6/27 FACT-G and 12/31 SF-36 items demonstrated literacy bias; this was relatively balanced (10 items 'biased against' low literacy; 8 'biased against' high literacy). Mean literacy group differences were statistically and clinically non-significant for 9/14 HRQL outcomes. Adjustment for bias and/or covariates eliminated most remaining differences. CONCLUSIONS: The TT is valid and useful for HRQL assessment in low literacy populations. There appears to be no systematic literacy bias in reporting HRQL, and low literacy is not an independent risk factor for poorer HRQL.

Factors influencing the long-term success of periurethral collagen therapy in the office.

INTRODUCTION: Glutaraldehyde crosslinked bovine collagen has been used for periurethral bulking for the treatment of urodynamic stress incontinence since 1989 with variable success. A retrospective study was undertaken to evaluate the factors involved in the long-term success of glutaraldehyde crosslinked bovine collagen used for periurethral bulking in the office. METHODS: Patients were followed objectively with stress testing after receiving periurethral collagen injection in the office under local anesthesia. Repeat injections were done as necessary during their follow-up appointments. The "success" group was defined as those women who demonstrated negative stress tests for over 1 year following their first injection. RESULTS: Nineteen of 184 women (10.3%) demonstrated negative stress tests for over 1 year following only one initial injection of glutaraldehyde crosslinked collagen. Their success lasted a mean of 829 days up to the time of follow-up. CONCLUSION: Prior anti-incontinence surgery was the one factor analyzed that showed a trend toward this long lasting success. No other factors were predictive of negative stress tests for over 1 year. Prior anti-incontinence surgery seems to represent a factor involved in the long-term success of periurethral bulking in the office with glutaraldehyde crosslinked bovine collagen for the treatment of urodynamic stress incontinence.

Testing subject comprehension of utility questionnaires.

Utility questionnaires are often considered difficult for subjects to understand. Our study reports pilot testing of two subject comprehension tests to determine whether comprehension can be directly measured. Current health utilities were assessed using the standard gamble (SG), time trade-off (TTO), and visual analog scale. Subjects were randomized to one of two tests: (1) Logical consistency was tested by comparing rankings of two health states with an investigator-assigned a priori ranking; (2) Utility responses for two hypothetical respondents were presented; the subject was asked who had the better health. Thirty-one subjects completed the SG and TTO for two health states: being blind and wearing glasses. No subjects had inconsistent rankings. Post hoc analyses found that subjects reporting utilities below the first decile for the state, wearing glasses, had significantly lower current health utility than remaining subjects. Of the thirty subjects who evaluated the hypothetical respondents' utilities, five incorrectly judged the respondent with worse utility to have better health. Those subjects also reported current health utilities significantly lower than the remaining subjects. Our study findings suggest that a minority should be expected to have difficulty completing utility questionnaires. Comprehension checks may improve the reliability of utility data by enhancing training and by identifying subjects who may have misunderstood the utility questions.

The effect of prospective payment on rehabilitative care.

OBJECTIVES: To estimate the difference between cost and prospective payment system (PPS) reimbursements for rehabilitation care and to simulate potential consequences of cost-reducing strategies. DESIGN: A retrospective study to estimate costs and functional status at discharge from care. SETTING: An academic, urban, rehabilitation hospital. PARTICIPANTS: Stroke patients on their first admission to a rehabilitation hospital between 1994 and 1998. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Cost was estimated from billing databases. Function was measured using the motor and cognitive components of the FIM instrument. RESULTS: PPS reimbursements were 10,825 dollars (37%) lower than costs. No matter how much therapy was reduced, the costs were still greater than the mean PPS reimbursement. A reduction in length of stay by 9.6 days was required to bring costs in line with the PPS reimbursement, reducing discharge cognitive function by 1.1 points (P <.01). Use of group therapy brought costs close to PPS reimbursement amount and improved discharge cognitive function by 0.5 points (P <.10). CONCLUSIONS: Our study shows the large difference between costs and expected PPS reimbursements that would have been observed before the PPS. Institutions have many options that reduce costs, with little effect on function at discharge. Future studies should determine the impact of evolving reimbursement rules on facilities financial status, and on patient outcomes.

Paricalcitol-treated patients experience improved hospitalization outcomes compared with calcitriol-treated patients in real-world clinical settings.

BACKGROUND: Abnormalities of serum calcium, phosphorous and intact parathyroid hormone (PTH) are associated with morbidity and mortality in haemodialysis patients. Pharmacologic parenteral vitamin D administration is used to correct these abnormalities; however, the relationship between vitamin D therapies and hospitalizations has never been addressed. METHODS: Healthcare data from January 1999 to November 2001 were analysed for 11,443 adult haemodialysis patients who received at least 10 doses of vitamin D therapy. Multivariate models were used to evaluate the effects of vitamin D therapy on: (i) total number of hospitalizations, (ii) total number of hospital days and (iii) risk of first hospitalization after initiation of vitamin D therapy. RESULTS: When compared with the calcitriol group, the paricalcitol group had a lower risk of first all-cause hospitalization (14% less likely, P<0.0001), fewer hospitalizations per year (0.642 fewer, P<0.001) and fewer hospital days per year (6.84 fewer, P<0.001). In the paricalcitol and calcitriol groups, respectively, 5.6 and 41.3% patients switched to another vitamin D compound. For those patients who started and remained on the same vitamin D product, paricalcitol-treated patients experienced 0.846 fewer hospitalizations per year and 9.17 fewer hospital days per year, P<0.001 for both. The paricalcitol group also had a lower risk of first PTH-related hospitalizations, fewer PTH-related annual hospitalizations and fewer days per year. CONCLUSION: Paricalcitol-treated patients experienced fewer hospitalizations and hospital days per year when compared with calcitriol-treated patients. Initiating vitamin D therapy with paricalcitol may result in overall savings of approximately 7600-11,000 US dollars per patient per year. A randomized, controlled, blinded study would be valuable in confirming and understanding these results.

The talking touchscreen: a new approach to outcomes assessment in low literacy.

PURPOSE: Cancer patients who are deficient in literacy skills are particularly vulnerable to experiencing different outcomes due to disparities in care or barriers to care. Outcomes measurement in low literacy patients may provide new insight into problems previously undetected due to the challenges of completing paper-and-pencil forms. DESCRIPTION OF STUDY: A multimedia program was developed to provide a quality of life assessment platform that would be acceptable to patients with varying literacy skills and computer experience. One item at a time is presented on the computer touchscreen, accompanied by a recorded reading of the question. Various colors, fonts and graphic images are used to enhance visibility, and a small picture icon appears near each text element allowing patients to replay the sound as many times as they wish. Evaluation questions are presented to assess patient burden and preferences. RESULTS: An ethnically diverse group of 126 cancer patients with a range of literacy skills and computer experience reported that the 'talking touchscreen' (TT) was easy to use, and commented on the usefulness of the multimedia approach. CLINICAL IMPLICATIONS: The TT is a practical, user-friendly data acquisition method that provides greater opportunities to measure self-reported outcomes in patients with a range of literacy skills.