Descriptive study of the real-world, long-term cost estimates and duration of use for hormonal and nonhormonal intrauterine devices using US commercial insurance claims.

BACKGROUND: Intrauterine devices (IUDs) have comparable efficacy to permanent surgical contraceptive methods; however, long-term costs are infrequently considered. Existing estimates inconsistently account for costs outside of IUD insertion or removal, actual duration of use, or differences between hormonal and nonhormonal IUDs. OBJECTIVE: To describe health care resource utilization and commercial payer costs that arise throughout hormonal and nonhormonal IUD use. METHODS: In this retrospective cohort study, paid claims data (Merative, MarketScan) from a large US commercial claims database were evaluated between 2013 and 2019. Claims were included from individuals aged 12 to 45 years who had an IUD inserted in 2014, continuous insurance coverage for 1 year prior to insertion and throughout follow-up, and no insertion, removal, or reinsertion in the previous year. Procedures and services that could be IUD-related were identified using Current Procedural Terminology and International Classification of Diseases, Ninth and Tenth Edition codes. Duration of IUD use was evaluated by Kaplan-Meier analysis of time to IUD removal. Event rates were determined for identified procedures and services; costs were calculated as the sum of payer reimbursements per enrolled individual. All IUD types available during the study period were described: 2 hormonal IUDs (52-mg and 13.5-mg levonorgestrel-releasing [LNG]) and the nonhormonal (380-mm2 copper) IUD. RESULTS: Of 195,009 individuals meeting the age requirement and receiving an IUD in 2014, 63,386 met the inclusion criteria and 53,744 had their IUD type on record-42,777 (67.5%) 52-mg LNG, 2,932 (4.6%) 13.5-mg LNG, and 8,035 (12.7%) nonhormonal IUD users. Despite differences in their indicated duration (13.5-mg LNG, 3 years; 52-mg LNG, 5 years; and nonhormonal, 10 years), most individuals had their IUD removed before its indicated full duration of use (13.5-mg LNG, 56.1%; 52-mg LNG, 61.3%; nonhormonal [at 5 years], 54.6%). The event rate per 100 individuals during the follow-up period was highest for abnormal uterine bleeding (16.2), ovarian cysts (9.3), and surgical management of uterine perforations (4.5). IUD insertion costs (mean ± SE) per enrolled individual for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $931 ± $9, $1,107 ± $4, and $897 ± $6, respectively. Cumulative mean ± SE 5-year postinsertion costs for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $2,892 ± $232, $1,514 ± $31, and $1,389 ± $97, respectively, among the remaining enrolled individuals. CONCLUSIONS: In this descriptive study of commercially insured IUD users, at least half had their IUD removed before its indicated duration. IUD improvements that reduce the frequency of abnormal uterine bleeding, ovarian cysts, and uterine perforations may help reduce long-term IUD costs.

Estimated economic benefits from low-frequency administration of atypical antipsychotics in treatment of schizophrenia: a decision model.

The objective of this study was to quantify the direct medical resources used and the corresponding burden of disease in the treatment of patients with schizophrenia. Because low-frequency administration (LFA) of risperidone guarantees adherence during treatment intervals and offers fewer opportunities to discontinue, adherence and persistence were assumed to improve, thereby reducing relapses of major symptoms.A decision tree model including Markov processes with monthly cycles and a five-year maximum timeframe was constructed. Costs were adapted from the literature and discounted at a 3% annual rate. The population is a demographically homogeneous cohort of patients with schizophrenia, differentiated by initial disease severity (mildly ill, moderately ill, and severely ill). Treatment parameters are estimated using published information for once-daily risperidone standard oral therapy (RIS-SOT) and once-monthly risperidone long-acting injection (RIS-LAI) with LFA therapy characteristics derived from observed study trends. One-year and five-year results are expressed as discounted direct medical costs and mean number of relapses per patient (inpatient, outpatient, total) and are estimated for LFA therapies given at three, six, and nine month intervals.The one-year results show that LFA therapy every 3 months (LFA-3) ($6,088) is less costly than either RIS-SOT ($10,721) or RIS-LAI ($9,450) with similar trends in the 5-year results. Moreover, the model predicts that LFA-3 vs. RIS-SOT vs. RIS LAI therapy will reduce costly inpatient relapses (0.16 vs. 0.51 vs. 0.41). Extending the interval to six (LFA-6) and nine (LFA-9) months resulted in further reductions in relapse and costs.Limitations include the fact that LFA therapeutic options are hypothetical and do not yet exist and limited applicability to compare one antipsychotic agent versus another as only risperidone therapy is evaluated. However, study results have quantified the potential health state improvements and potential direct medical cost savings achievable with the development and use of LFA medication delivery technologies.

Economic impact of potential CYP450 pharmacokinetic drug-drug interactions among chronic low back pain patients taking opioids.

Chronic low back pain (cLBP) patients who take at least 1 CYP450-metabolized opioid analgesic agent concurrent with at least 1 other CYP450-metabolized medication experience a drug-drug exposure (DDE), which puts them at risk for a pharmacokinetic drug-drug interaction (PK DDI). This study compared utilization of healthcare resources and associated payments in cLBP patients with and without incident DDEs with the potential to cause PK DDIs. A retrospective database analysis examined the associated clinical events, healthcare utilization (measured in terms of claims for office visits, outpatient visits, emergency department visits, and hospitalization), and cost to the health plan, as defined as the sum of health plan payments for resources used. Patients were grouped into 2 cohorts by age (those under 65 and those 65 years and over). In the 6 months after exposure, total healthcare payments were significantly higher for DDE patients than those without DDEs (no-DDE), in both in the younger ($7,086, SD = $8,370) and $6,353, SD = $8,352, respectively, P < 0.001) and the older cohorts ($7,806 vs. $7,043, respectively, P = 0.013). Younger and older patients with DDE had significantly higher prescription payments than those without DDE ($2,041, SD = $2,706 vs. $1,565, SD = $2,349, respectively, P < 0.001 for younger and $2,482, SD = $2,481 vs. $2,286, SD = $2,521, respectively, P = 0.044 for older patients). Both older and younger patients with DDE had significantly more claims for office visits and higher associated payments than similar patients without DDE. Patients in the study who experienced DDEs that placed them at risk for PK DDIs had significantly greater utilization rates of healthcare resources and higher associated payments in the 6-month observation period following exposure.

Economic impact of potential drug-drug interactions among osteoarthritis patients taking opioids.

Patients with osteoarthritis (OA) taking at least one CYP450-metabolized opioid concurrently with another CYP450-metabolized medication experience a drug-drug exposure (DDE), which puts them at risk of a pharmacokinetic drug-drug interaction (PK DDI). This study compared patients with and without such an incident DDE to determine healthcare utilization and associated payments. Using a retrospective database analysis, the impact of DDEs was evaluated in terms of associated clinical events, healthcare services utilization (office visits, outpatient visits, ED visits, hospitalization), and payments in patient populations based on age (those under age 65 and those 65 years of age and older), during the 6 months after exposure. DDE patients had significantly more inpatient hospitalizations than no-DDE patients. Mean total payments at 6 months were significantly higher for both younger and older patients with DDE compared to similar patients without DDE ($9,469, SD = $12,192 vs. $8,382, SD = $14,078, respectively, for younger patients, resulting in a difference of $1,087, P < 0.004, and $9,829, SD = $11,721 vs. $8,622, SD = $10,131, respectively, for older patients, resulting in a difference of $1,207, P = 0.001). In both age groups, DDE patients had significantly higher payments for nonopioid prescription drugs ($1,824 SD = $2,420 vs. $1,362, SD = $1,891, respectively, for younger patients, resulting in a difference of $462, P < 0.001, and $2,197 SD = $2,332 vs. $2,013, SD = $2,437, respectively, for older patients, resulting in a difference of $184, P = 0.020). Overall, patients with OA who experienced DDEs had significantly greater utilization rates of healthcare resources and higher associated payments in the 6-month observation period following the exposure, compared to patients without DDEs, consistent with the risk of PK DDIs associated with DDEs.

Exposure to potential CYP450 pharmacokinetic drug-drug interactions among osteoarthritis patients: incremental risk of multiple prescriptions.

Patients taking more than one drug metabolized through the cytochrome P450 (CYP450) enzyme system experience a drug-drug exposure (DDE), which puts them at risk for a potential pharmacokinetic drug-drug interaction (DDI), defined as two or more drugs interacting in such a way that the effectiveness and/or toxicity of one or all drugs are changed. Any patient subjected to a DDE is at risk for a potentially serious DDI, the epidemiology of which has not been thoroughly studied. Many drugs are metabolized primarily via the CYP450 enzyme system, including certain opioids used to manage moderate to severe chronic pain. We conducted a retrospective analysis of a large commercial claims database and a Medicare database to assess the prevalence of DDEs among patients with osteoarthritis taking CYP450-metabolized opioids. The overall prevalence of DDEs in this population was 26%, with females more likely to experience DDEs than males (28.4% vs. 21.0%, respectively). The number of unique concurrent prescriptions at baseline, gender, age, and Charlson Comorbidity Index were statistically significant predictors of DDEs (P < 0.05). This study challenged previous assumptions about DDEs in that advanced age was not positively associated with the risk of DDE. However, the number of prescriptions the patient received in the 90-day window prior to the index date was a risk factor. For patients taking at least two medications in the 90-day period prior to the index date, every additional prescription taken increased their risk for a DDE during the observation period by 138% (on average). The risk of DDE during the study period was threefold greater for patients with one medication in the 90-day period before index date compared with similar patients with no prescriptions in that same period before the index date. DDEs are more common than may be generally believed in patients with osteoarthritis, regardless of age, and can occur even in patients taking few medications. When selecting an opioid analgesic to treat osteoarthritis, physicians should consider the potential for exposure of these patients to drugs that could interact unfavorably.

Prevalence of exposure to potential CYP450 pharmacokinetic drug-drug interactions among patients with chronic low back pain taking opioids.

Drug-drug interactions (DDIs) have been defined as two or more drugs interacting in such a way that the effectiveness and/or toxicity of one or all drugs are changed. Patients taking more than one drug metabolized through the cytochrome P450 (CYP450) enzyme system, including some, but not all, opioids experience a drug-drug exposure (DDE), which may result in a potentially dangerous DDI. Using a retrospective analysis of a large commercial claims database and a Medicare database, we evaluated DDEs that have the potential to cause DDIs among chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s). The overall prevalence of DDEs among cLBP patients was 27%. Women had a higher prevalence of DDEs (30.6% vs. 22% for men). Patients aged 45 to 55 and 56 to 64 years had the highest prevalence of DDEs (30.4% and 29.8%, respectively), followed by patients 34 to 45 years (27.9%). For patients>65 years, the prevalence of DDEs was 23.1%. In general, the prevalence of DDEs was fairly consistent across age ranges in this population. This study suggests that DDEs are common in the cLBP population. When selecting an opioid to treat cLBP, physicians should consider the potential for exposure of these patients to drugs that might unfavorably interact and, for that reason, the use of opioids that do not rely on the CYP450 system as their primary means of metabolism might be worthy of consideration.

Predicting EQ-5D utility scores from the 25-item National Eye Institute Vision Function Questionnaire (NEI-VFQ 25) in patients with age-related macular degeneration.

PURPOSE: In this study, we explored different statistical approaches to identify the best algorithm to predict EQ-5D utility scores from the NEI-VFQ 25 in patients with age-related macular degeneration (AMD). METHODS: Ordinary least squares (OLS), Tobit, and censored least absolute deviation (CLAD) approaches were compared using cross-sectional data (primary dataset, n = 151) at screening from a phase I/II clinical trial in patients with AMD. Three models were specified in this study: full (includes all 12 dimensions of the NEI-VFQ 25), short (includes only the general health dimension and the composite score), and reduced model (using stepwise regression). To evaluate the predictive accuracy of the models, the mean absolute prediction error (MAPE), mean error, and root means squared error were calculated using in-sample cross-validation (within the primary dataset) and out-of-sample validation using an independent dataset (n = 393). The model that provided the lowest prediction errors was chosen as the best model. RESULTS: In-sample cross-validation and out-of-sample validation consistently demonstrated that, compared to other approaches, heteroscedasticity-adjusted OLS produced the lowest MAPE (mean values were 0.1400, 0.1593, respectively) for the full model, while CLAD performed best for the short and reduced models (mean values were 0.1299, 0.1483, respectively). The normality and homoscedasticity assumptions of both OLS and Tobit were rejected. CLAD, however, can accommodate these particular violations. CONCLUSIONS: The CLAD-short model is recommended for producing the EQ-5D utility scores when only the NEI-VFQ 25 data are available.

A comparison of clinical practice guidelines in the initial pharmacological management of new-onset epilepsy in adults.

OBJECTIVE: Clinical practice guidelines (CPGs) are intended not only to provide supportive information for health care providers but also to act as a guide for health care policy decisions. However, extant CPGs do not always reach the same conclusions. The objective of this study was to compare recommendations for initial pharmacological treatment of new-onset epilepsy in adults as stated within published CPGs. METHODS: We performed a systematic review of CPGs, which were published by prominent national organizations between January 2000 and June 2005, regarding the initial pharmacological treatment of epilepsy in adults. RESULTS: Five CPGs and 1 evidence report were identified that focus on pharmaceutical management in epilepsy. The 3 guidelines most relevant to the question of new-onset epilepsy treatment in adults were developed by the American Academy of Neurology (AAN), Scottish Intercollegiate Guidelines Network (SIGN), and National Institute for Health and Clinical Excellence (NICE). AAN recommends the use of both recently introduced antiepileptic drugs (AEDs: gabapentin, lamotrigine, topiramate, and oxcarbazepine) and standard agents (carbamazepine, phenytoin, valproic acid/divalproex, and phenobarbital) in newly diagnosed epilepsy, i.e., a nontiered approach. Alternatively, NICE recommends using newer AEDs (lamotrigine, topiramate, and oxcarbazepine) only in patients who derive no benefit from older agents--a tiered approach. SIGN notes that all AEDs licensed for monotherapy have similar efficacy in newly diagnosed epilepsy--a recommendation for a nontiered approach. The newer AEDs (lamotrigine and oxcarbazepine) are recommended as first-line initial treatment as are standard agents (carbamazepine and valproic acid/divalproex). The NICE guideline includes economic and quality-of-life evidence in their recommendations while AAN and SIGN do not. In these regards, current data fails to show superiority for newer agents. CONCLUSION: In the past 5 years, several CPGs have been published in epilepsy management. Only 3 guidelines have explicit recommendations for initial pharmacological treatment of adults with epilepsy. With some variation regarding which medications are recommended from each group, all CPGs promote standard and newer AEDs as having similar clinical efficacy. Until efficacy, quality of life, or cost data for the newer agents demonstrates a superior outcome, older AEDs remain viable options as first-line for monotherapy in newly diagnosed patients and may provide cost benefits over newer agents.

Relationships between hyperglycemia and cognitive performance among adults with type 1 and type 2 diabetes.

OBJECTIVE: Hyperglycemia is a common event among patients with type 1 and type 2 diabetes. While the cognitive-motor slowing associated with hypoglycemia is well documented, the acute effects of hyperglycemia have not been studied extensively, despite patients' reports of negative effects. This study prospectively and objectively assessed the effects of hyperglycemia on cognitive-motor functioning in subjects' natural environment. RESEARCH DESIGN AND METHODS: Study 1 investigated 105 adults with type 1 diabetes (mean age 37 years and mean duration of diabetes 20 years), study 2 investigated 36 adults with type 2 diabetes (mean age 50 years and mean duration of diabetes 10 years), and study 3 investigated 91 adults with type 1 diabetes (mean age 39 years and mean duration of diabetes 20 years). Subjects used a hand-held computer for 70 trials over 4 weeks, which required them to complete various cognitive-motor tasks and then measure and enter their current blood glucose reading. RESULTS: Hyperglycemia (blood glucose >15 mmol/l) was associated with slowing of all cognitive performance tests (P < 0.02) and an increased number of mental subtraction errors for both type 1 and type 2 diabetic subjects. The effects of hyperglycemia were highly individualized, impacting approximately 50% of the subjects. CONCLUSIONS: Acute hyperglycemia is not a benign event for many individuals with diabetes, but it is associated with mild cognitive dysfunction.

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. Because the propensity score binning technique groups patients with similar baseline characteristics within strata (bins) and not among individual patients, almost the entire available sample is retained in the analysis, unlike propensity score matching, where large numbers of patients can be excluded depending on the matching scheme. Therefore, the propensity score binning technique, because it uses more complete information, is less likely to produce biased results. Patients were grouped into 5 bins (quintiles) based on their estimated likelihood to receive insulin lispro rather than regular insulin. The propensity score model used baseline characteristics of age, gender, comorbidities, use of oral antidiabetic medications, prescription copayment, and diabetes-related costs and utilization. Overall cost and utilization differences (lispro minus regular insulin) during the 12-month follow-up period were calculated using weights inversely proportional to variances of within-bin differences. RESULTS: Of 6,436 patients, 1,972 (30.6%) received insulin lispro and 4,464 (69.4%) received regular insulin. The propensity score estimation produced 5 bins, each containing between 1,287 and 1,288 patients, utilizing all patients in the analysis. Patients in the lower-numbered propensity score quintiles were older, more likely to use oral antidiabetic medications, and had more comorbidities than those in the higher-numbered quintiles. As quintile number increased, the percentage of insulin lispro users also increased. The weighted mean annual cost difference (lispro minus regular insulin) per patient was + USD 79 (P < 0.001) for diabetes-related pharmacy cost, + USD 212 (P < 0.001) for total pharmacy cost, USD 75 (P < 0.857) for diabetes-related medical cost, USD 2,286 (P <0.011) for nondiabetes medical cost, and USD 2,327 (P = 0.072) for total medical cost. CONCLUSIONS: Compared with regular insulin users, insulin lispro users incurred higher diabetes-related and total pharmacy costs but lower nondiabetes medical costs and similar total medical costs. Fewer hospitalizations among insulin lispro as compared with regular insulin users contributed to lower nondiabetes medical costs and similar total medical costs.

Outcomes of American Lung Association-Indiana Lung Centers asthma program.

The American Lung Association of Indiana (ALA-I), in conjunction with participating Indiana hospitals, developed the Lung Center concept as a mechanism to provide standardized delivery of lung health education. The goal of this pilot study was to evaluate initial experience with the Lung Center program "Overcoming Your Asthma," a two-session asthma education program, and identify areas needing improvement. A total of 305 participants responded to a 31-item questionnaire at baseline (immediately prior to program exposure) and again at 1 month (n = 75) and 6 months (n = 30) after participation. Overall, delivery of the ALA-I Lung Center asthma education program improved respondents' experience with asthma. At one month after the educational session, the program improved participant knowledge about asthma. This was associated with modest improvements in treatment behaviors, economic outcomes and asthma symptoms such as reduced breathing difficulties, wheezing and asthma exacerbations, and improvement in sleep. Improvements were not uniformly sustained at 6 months. In summary, the Lung Center asthma education program appears to benefit patients with asthma. The results provide preliminary evidence to support continued delivery of asthma education in Lung Centers. Future efforts should emphasize education to improve treatment attitudes and behaviors.

Diabetic retinopathy: contemporary prevalence in a well-controlled population.

OBJECTIVE: To measure the extent to which modern intensified risk factor control has lessened the duration-specific prevalence of diabetic retinopathy and, therefore, has decreased the risk of blindness in Americans with type 2 diabetes. RESEARCH DESIGN AND METHODS: Intensified control of blood glucose and blood pressure has prevented diabetic retinopathy in randomized controlled trials. There is as yet no confirmation that subsequent treatment intensification in the community has had the same result. We identified all 6993 members of a health maintenance organization, Kaiser Permanente Northwest (KPNW), who, in 1997-1998, had dilated retinal examinations and verifiable data of diagnosis of type 2 diabetes. We plotted prevalence by time since diagnosis for background diabetic retinopathy (BDR) and proliferative diabetic retinopathy (PDR) and compared these results to identically derived 1980-1982 results from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR). We estimated multivariate predictive models. RESULTS: Mean (+/- SD) HbA(1c) in KPNW was 7.84 +/- 1.26% versus 10.37% (standardized) in the WESDR. KPNW blood pressure averaged 138.6 +/- 13.8/79.5 +/- 7.4 mmHg compared with 147.0/79.0 in the WESDR. BDR was much less prevalent in KPNW, but PDR prevalence appeared unchanged. BDR preceded diagnosis in 20.8% of the WESDR subjects but only 2.0% of KPNW subjects. However, in both populations, the first cases of PDR appeared similarly, soon after diagnosis. CONCLUSIONS: Earlier diagnosis and more aggressive control of blood glucose and blood pressure decreased the duration-adjusted prevalence of background, but not of sight-threatening proliferative retinopathy. More population-based research is needed to replicate and explain this unexpected finding. Detecting and treating PDR should not be neglected on the assumption that risk-factor control has minimized its prevalence.

Productivity and medical costs of diabetes in a large employer population.

OBJECTIVE: The purpose of this study was to assess the economic burden of diabetes from an employer's perspective. We analyzed the costs of diabetes, using claims data for an employed population and the prevalence of selected comorbid conditions. RESEARCH DESIGN AND METHODS: The data source is a claims database from a national Fortune 100 manufacturer. It includes medical, pharmacy, and disability claims for all beneficiaries (n >100,000). Both medical and work productivity costs of diabetes patients are compared by age with those of matched control subjects from the overall beneficiary population. Out-of-pocket and intangible costs are excluded. RESULTS: In 1998, the employer's mean annual per capita costs were higher for all diabetes beneficiaries than for control subjects ($7,778 +/- 16,176 vs. $3,367 +/- 8,783; P < 0.0001), yielding an incremental cost of $4,410 +/- 18,407 associated with diabetes. The medical and productivity costs for employees with diabetes were significantly (P < 0.0008) higher than for control subjects. The incremental cost of diabetes among employees ranged from $4,671 (aged 18-35 years) to $4,369 (aged 56-64 years). CONCLUSIONS: Diabetes imposes a significant economic burden on employers, particularly when including productivity costs. Employers should select health plans that provide enriched benefits to diabetes patients, including ready access to medical and pharmacy services as well as aggressive diabetes management programs.

Preference for insulin delivery systems among current insulin users and nonusers.

BACKGROUND: It is not known whether preferences for the vial and syringe (VS) or the insulin injection pen device (IIPD) differ between current insulin users and nonusers. Additional benefits in treatment might be realized if preference were considered when discussing insulin use with patients initiating or changing insulin treatment. OBJECTIVE: The objective of this study was to examine respondent preferences for the VS and the IIPD between current insulin users and nonusers. METHODS: US residents with type 1 or 2 diabetes mellitus who responded to a year-2001 mail survey completed a 19-item self-administered questionnaire designed to assess respondents' expectations of attributes related to the VS and IIPD. Items were analyzed on a 5-point Likert-type scale with higher scores indicating greater agreement that attributes met expectations. Composite scores for ease of use, activity interference, and social acceptability were used to further examine differences between insulin users and nonusers regarding their preferences for the VS or IIPD. Observed differences in preferences were evaluated statistically using the chi-square test, paired Student t test, and regression analysis. RESULTS: Questionnaires were received from 302 respondents, producing an adjusted response rate of 20.8%. Respondents ranged in age from 18 to 83 years (mean [SD], 52.4 [13.2] years), with 62% reporting annual income above 25,000 US dollars. Of the 242 usable responses, 99 respondents were insulin users and 143 were not. Statistical evaluation using analysis of variance revealed significant regression coefficients (P < or = 0.001) for both insulin users and nonusers for each of the 3 dimensions (ease of use, activity interference, and social acceptability with respect to preference). CONCLUSIONS: Based on this survey analysis, overall preference for the IIPD appeared to be higher compared with the VS among both insulin users and nonusers. Social acceptability was the strongest predictor of preference for the IIPD. For current insulin users, social acceptability and ease of use were significant predictors of preference for the VS. For insulin nonusers, these results suggested that patient discussions about VS should emphasize activity interference and ease of use.

Development of an instrument to assess expectations of and preference for an insulin injection pen compared with the vial and syringe.

BACKGROUND: Before using a product, patients form expectations regarding the extent of a product's desirable attributes. These expectations can be used to understand their preference and anticipate potential satisfaction with the product. OBJECTIVE: The aim of this study was to produce a valid and reliable data collection instrument (the Insulin Injection Preference questionnaire [IIP-q]) to measure expectations of and preference for the insulin injection pen compared with the vial and syringe. METHODS: This study was initiated at the University of Mississippi (University, Mississippi). The IIP-q was developed to determine the extent to which respondents' prepurchase expectations of a product's attributes relate to preference for an insulin injection pen compared with the vial and syringe. Instrument development began with item generation related to product attributes important to patients who inject insulin. Items originated from an extensive search of the peer-reviewed Internet-based literature, marketing reports, clinical studies, and existing instruments. Content validity also was assessed using expert panel and focus group review. The resultant instrument (the IIP-q) was mailed to 1200 patients known to have type 1 or type 2 diabetes mellitus who either did or did not use insulin. Subscales were identified through exploratory factor analysis. Reliability and validity were assessed using Cronbach alpha for subscale items. Product-moment correlations between subscale dimensions and 2 global measures of preference were used to test the relationship between attribute expectations and preference. RESULTS: Seventeen of the questionnaires were returned as undeliverable, leaving 1183 in the sample population. Questionnaires were received from 302 individuals, 55 of whom failed to complete > or = 85% of the items and thus were not included in the final analysis. Of the 247 respondents (135 women, 112 men; mean [SD] age, 52.4 [13.2] years (range, 18-83 years]), 99 (40.1%) were current insulin users and 143 (57.9%) were not using insulin. Exploratory factor analysis resulted in a 13-item solution (Cronbach alpha = 0.92), accounting for 73.6% of the total explained variance. Ease of use, activity interference, and social acceptability emerged as expectation subscales from exploratory factor analysis. Cronbach alpha for items comprising the subscales ranged from 0.82 to 0.92. The 3 subscales were significantly correlated with patient preference (ease of use, r = 0.520, P < 0.001; activity interference, r = 0.570, p < 0.001; social acceptability, r = 0.602, p < 0.001). CONCLUSIONS: The results of the present study provide support for the IIP-q as a reliable and valid instrument to assess patient expectations of product attributes and preference. This instrument can be modified for use in clinical trials to determine the role of patient expectations and preference in their judgments regarding satisfaction with insulin delivery devices.

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. Once matched, 12 months of follow-up pharmacy and medical cost and utilization data (e.g. prescriptions, office visits, hospitalizations) from July 1,1997, through December 31, 2000, were analyzed using univariate statistics. RESULTS: Of 11,443 subjects, 3,341 (29.2%) had received a prescription for insulin lispro, while 8,102 (70.8%) had received a prescription for regular insulin. At baseline, lispro subjects tended to be younger, more often had type 1 diabetes and a history of insulin use, had fewer comorbidities, visited endocrinologists more often than family practice physicians, and had lower total costs. After matching on propensity score to within +/-0.01, 1,832 subject pairs were retained. On average, lispro subjects had significantly more office visits (P=0.0022) and pharmacy prescriptions (P=0.0165) but fewer inpatient hospital visits (P=0.0028)compared to regular insulin subjects. Cost results were similar, with insulin lispro subjects having significantly higher average office visit costs (P=0.0237) and pharmacy costs (P<0.0001) but lower inpatient hospital costs (P=0.0227). Total costs were not significantly different between treatment groups (P=0.5266). CONCLUSION: Total direct health care costs were not different between insulin lispro and regular insulin users. An association was observed between higher direct drug product cost and more intensive ambulatory care for insulin lispro users and lower inpatient hospital cost in the short-term.

Clinical practice guidelines on the initial assessment and treatment of urinary incontinence in women: a US focused review.

OBJECTIVE: To identify clinical practice guidelines from prominent US organizations for the initial management of urinary incontinence (UI) in women and compare them with recommendations from the International Consultation on Incontinence (ICI). The challenge of implementing guidelines in the US was also identified. METHODS: The medical literature was reviewed to identify relevant practice guidelines on the initial management of UI in community-dwelling women according to specific inclusion and exclusion criteria. Guidelines were compared with the ICI international gold standard relating to patient identification, initial therapy, and recommendation for specialist referral. Literature on programs to implement guidelines into clinical practice was reviewed. RESULTS: There is general agreement on how females with UI should be initially managed based on guidelines, monographs, and technical bulletins from prominent US organizations. Though these recommendations are more than 5 years old, they are fairly similar to the latest guidelines developed by the ICI in 2001. Minor discrepancies are mainly related to the lack of updating US guidelines based on most recent knowledge. Implementing existing guidelines into clinical practice presents a challenge. CONCLUSION: No evidence-based practice guidelines from prominent US organizations on the initial management of UI in women exist that are less than 5 years old, but the latest versions are in alignment with recent ICI/WHO guidelines. Although optimization of UI management may be the goal of guidances, the debate remains over whether these recommendations are actually effective in modifying practice. Simplifying and updating guidelines regularly may enhance adaptation in the initial management of UI in women.

The prevalence of opioid-related major potential drug-drug interactions and their impact on health care costs in chronic pain patients.

BACKGROUND: Literature has shown that chronic pain patients prescribed opioids are at an increased risk for experiencing drug-drug interactions as a result of polypharmacy. In addition, chronic, noncancer pain patients who experience drug-drug interactions have been shown to have greater health care utilization and costs. However, no study has focused on the health economics of major clinically significant drug-drug interactions associated with long-acting opioids. OBJECTIVES: To (a) estimate the prevalence of major drug-drug interactions among patients prescribed a long-acting opioid and (b) evaluate the potential impact of major drug-drug interactions on health care costs. METHODS: This study was a retrospective cohort analysis using claims data from the MarketScan Commercial Claims and Encounter Database between 2008 and 2010. Patients with at least 1 prescription for a long-acting opioid for ≥ 30 days were placed into cohorts according to the expected clinical impact of the potential drug-drug interaction: major versus none. Propensity score matching was used to mitigate differences in baseline characteristics between the cohorts. Health care costs were based on payments for all covered health care services, which consisted of inpatient and outpatient medical, emergency department, and outpatient prescription costs. RESULTS: Among 57,752 chronic, noncancer pain patients who met all inclusion and exclusion criteria, 5.7% (3,302) were exposed to a potential major drug-drug interaction. The costs associated with a potential interaction versus no potential interaction were significantly more after baseline characteristics of the cohorts were normalized by propensity score matching. Monthly health care costs in the 90-day post-index period were significantly greater ($3,366 vs. $2,757, a $609 difference) in patients exposed to a potential drug-drug interaction of major clinical significance, compared with those not exposed to a drug-drug interaction. The higher health care costs were mainly driven by outpatient and inpatient medical costs. CONCLUSIONS: Exposure to potential drug-drug interactions may result in unnecessary and unintended health care costs. Physicians should be made aware of commonly administered cytochrome P450 (CYP450) metabolized drugs in the chronic pain patient and consider prescribing non-CYP450 metabolized opioid and nonopioid analgesics. Managed care's use of utilization management tools to avoid these exposures may reduce costs.

Development of a questionnaire to assess the impact of chronic low back pain for use in regulated clinical trials.

BACKGROUND: Chronic low back pain (CLBP) is the most common chronic pain condition and is associated with clinical, economic, social, and public health impacts. The effect of CLBP on patients' health-related quality of life (HRQoL) is significant. The symptoms and impacts most often associated with CLBP include pain and disability; patients most affected are often crippled by the condition. CLBP also affects patients' mental, physical, and psychosocial well-being. A variety of self-report measures have been developed for the assessment of CLBP, such as the Roland Morris Disability Questionnaire (RMDQ); however, existing measures may not meet current regulatory expectation for the development, documentation, and use of patient-reported outcomes (PRO) questionnaires (U.S. Department of Health and Human Services, Food and Drug Administration, 2009). OBJECTIVES: This report describes the qualitative development of the Chronic Low Back Pain Impact Questionnaire (CLBP-IQ), created for use in clinical trials. METHODS: A total of 22 CLBP patients recruited by clinicians participated in concept elicitation interviews to identify target measurement concepts. An instrument development team generated the instructions, items, and response options guided by patient input. Cognitive debriefing interviews were conducted with 21 patients recruited by the same clinicians who recruited for concept elicitation interviews. During cognitive interviews, a draft instrument composed of 28 items was presented to individuals with CLBP to evaluate its readability and comprehensiveness. All research activities were conducted in the US. RESULTS: During concept elicitation interviews, participants reported a variety of physical, emotional, and social impacts associated with CLBP. Participants also reported CLBP impacts on sleep, energy, daily activities, work, household activities, leisure activities, cognition, self-care, and sex life. Impacts deemed simple, important, and relevant to CLBP patients became targets of measurement for the CLBP-IQ. During cognitive debriefing, seventeen items were interpreted as intended by at least 90 % of participants, and no items were interpreted incorrectly by more than five patients (24 %). Additionally, seventeen items were experienced by at least 90 % of participants, and no single item was experienced by less than 67 % of participants (n = 14). CONCLUSIONS: The CLBP-IQ was developed in accordance with current US Food and Drug Administration guidance on instrument development. Results from both concept elicitation and cognitive debriefing interviews support the content validity of the CLBP-IQ in patients with CLBP. Future development should proceed with psychometric evaluation.

Economic implications of potential drug-drug interactions in chronic pain patients.

Chronic pain patients may be subject to polypharmacy because of long-term pharmacological pain treatment and additional comorbidities. Many chronic pain patients expose themselves to potential drug-drug interactions (DDIs) and these interactions can have unintended and severe consequences. Prevalence and costs associated with DDIs are inconsistent and has led to an inadequate level of awareness among the medical community; therefore, it has become necessary to re-evaluate the rates of DDIs in chronic pain patients. Utilizing medical and prescription claims databases, five studies were conducted to assess the health care utilization of and associated financial payments for patients >18 years with chronic noncancer pain. The studies evaluated drug-drug exposures with the potential to cause DDIs specifically occurring through the CYP450 enzyme system. The studies reported that drug-drug exposures are prevalent, costly and can occur in any age group and that physicians should consider ways to limit their patients' exposure to potential DDIs.