Systemic challenges in bipolar disorder management: A patient-centered approach.

Objectives: As part of a series of Patient-Centered Outcomes Research Institute-funded large-scale retrospective observational studies on bipolar disorder (BD) treatments and outcomes, we sought the input of patients with BD and their family members to develop research questions. We aimed to identify systemic root causes of patient-reported challenges with BD management in order to guide subsequent studies and initiatives.

Methods: Three focus groups were conducted where patients and their family members (total n = 34) formulated questions around the central theme, "What do you wish you had known in advance or over the course of treatment for BD?" In an affinity mapping exercise, participants clustered their questions and ranked the resulting categories by importance.

Local Control Strategy: Simple Analyses of Air Pollution Data Can Reveal Heterogeneity in Longevity Outcomes.

Claims from observational studies that use traditional model specification searches often fail to replicate, partially because the available data tend to be biased. There is an urgent need for an alternative statistical analysis strategy, that is not only simple and easily understood but also is more likely to give reliable insights when the available data have not been designed and balanced. The alternative strategy known as local control first generates local, nonparametric effect-size estimates (fair treatment comparisons) and only then asks whether the observed variation in these local estimates can be predicted from potential confounding factors.

Hypothyroidism risk compared among nine common bipolar disorder therapies in a large US cohort.

Objectives: Thyroid abnormalities in patients with bipolar disorder (BD) have been linked to lithium treatment for decades, yet other drugs have been less well studied. Our objective was to compare hypothyroidism risk for lithium versus the anticonvulsants and second-generation antipsychotics commonly prescribed for BD.

Methods: Administrative claims data on 24,574 patients with BD were analyzed with competing risk survival analysis.

Local control for identifying subgroups of interest in observational research: persistence of treatment for major depressive disorder.

Caregivers are regularly faced with decisions between competing treatments. Large observational health care databases provide a golden opportunity for research on heterogeneity in patient response to guide caregiver decisions, due to their sample size, diverse populations, and real-world setting. Local control is a promising tool for using observational data to detect patient subgroups with differential response on one treatment relative to another.

Item response analysis of the Positive and Negative Syndrome Scale.

Background: Statistical models based on item response theory were used to examine (a) the performance of individual Positive and Negative Syndrome Scale (PANSS) items and their options, (b) the effectiveness of various subscales to discriminate among individual differences in symptom severity, and (c) the appropriateness of cutoff scores recently recommended by Andreasen and her colleagues (2005) to establish symptom remission.

Methods: Option characteristic curves were estimated using a nonparametric item response model to examine the probability of endorsing each of 7 options within each of 30 PANSS items as a function of standardized, overall symptom severity. Our data were baseline PANSS scores from 9205 patients with schizophrenia or schizoaffective disorder who were enrolled between 1995 and 2003 in either a large, naturalistic, observational study or else in 1 of 12 randomized, double-blind, clinical trials comparing olanzapine to other antipsychotic drugs.

Higher costs and therapeutic factors associated with adherence to NCQA HEDIS antidepressant medication management measures: analysis of administrative claims.

Objective: To determine if the type of antidepressant drug is related to adherence to National Committee for Quality Assurance (NCQA) Antidepressant Medication Management (AMM) quality measures and to assess the 6-month health care costs among newly diagnosed depressed patients.

Methods: The MarketScan Commercial Claims and Encounter database for medical and pharmacy claims from January 2001 to September 2004 was used to assess adherence to the 3 AMM quality-of-care measures. AMM measures include (a) acute phase, the percentage of eligible members who remained on antidepressant medication continuously for 3 months after the initial diagnosis as determined by at least 84 days supply of antidepressant drugs during the first 114 days following receipt of the index antidepressant; (b) continuation phase, the percentage of eligible members who remained on antidepressant medication continuously for the 6 months after the initial diagnosis as determined by at least 180 days supply of antidepressants during the first 214 days following receipt of the index antidepressant; and (c) practitioner contacts, the percentage of members who received at least 3 follow-up office visits or telephone contacts with health care providers, including at least 1 contact with a practitioner licensed to prescribe (may not necessarily be the prescriber of the antidepressant).

Comparison of costs and utilization between users of insulin lispro versus users of regular insulin in a managed care setting.

Objective: To compare medical and pharmacy costs and utilization between patients with diabetes who received insulin lispro versus regular human insulin.

Methods: A retrospective analysis of medical and pharmacy claims was conducted among continuously enrolled users of insulin lispro or regular insulin during the identification period, March 1, 2000, through February 28, 2001, within a large managed care organization. This study improved upon the methodology used in previous studies by (a) stratifying (rather than 1:1 matching) individuals by their likelihood to use insulin lispro using the propensity score binning technique, and (b) refining the study inclusion criteria to include only patients with 3 or more fills of the insulin under study (lispro or regular) to exclude individuals who may have been on either product for a short time.

Cost-effectiveness inferences from bootstrap quadrant confidence levels: three degrees of dominance.

When with at least 95% confidence a new treatment is shown to be not only less costly (LC), but also more effective (ME), than a current treatment, that new treatment can be said to "strictly dominate" the current treatment statistically. But what can be said when head-to-head treatment comparisons turn out to be less clear-cut than this? Here, we propose two additional sets of specific LC and/or ME confidence thresholds to define the concepts of "some dominance" and "much dominance." Confidence levels associated with entire quadrants of the incremental cost-effectiveness (ICE) plane are easily computed using the same bootstrapping techniques used to estimate an "acceptability curve.

Cost and utilization comparisons among propensity score-matched insulin lispro and regular insulin users.

Objective: To compare cost and utilization among users of insulin lispro and regular (human) insulin.

Methods: This was a retrospective analysis using administrative claims data for continuously enrolled subjects using insulin lispro or regular insulin between January 1, 1998, and December 21, 1999. Subjects were matched 1 to 1 on the propensity to receive lispro versus regular insulin using a score estimated from baseline characteristics such as age, gender, comorbidities, and oral hypoglycemic use.

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.

Appropriateness of prescribing practices for serotonergic antidepressants.

Objective: Data from prescribing physicians were used to assess whether serotonergic antidepressants were used for appropriate indications and at appropriate initial dosages.

Methods: Data were derived from the confidential logs of psychiatrists and primary care physicians who provided prescription information from January 1, 1997, through June 30, 1999, as part of the National Disease and Therapeutic Index physician survey. The survey is not affiliated with a reimbursement system and therefore minimizes bias related to reimbursement.