IMPLICATION OF ALTERNATIVE MINIMAL CLINICALLY IMPORTANT DIFFERENCE THRESHOLD ESTIMATION METHODS ON TECHNOLOGY ASSESSMENT.

OBJECTIVES: Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA). METHODS: Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information. Treatment effects were then compared with anchor-based MCID thresholds derived by Barnes et al. and thresholds obtained from an Agency for Healthcare Research and Quality (AHRQ) panel. RESULTS: The change in rTNSS score from baseline, represented as the average of the twice-daily recorded scores of the rTNSS, was -2.1 (p < .001) for azelastine hydrochloride 0.10%, 1.35 (p = .014) for ciclesonide, and -1.47 (p < .001) for fluticasone furoate. The change in the rTNSS score from baseline, represented by sum of the AM and PM score, was -2.7 for MP-AzeFlu (p < .001). The rTNSS change from baseline for each product was compared with anchor-based MCID threshold and the AHRQ panel estimates. Comparison of the observed treatment effect to the anchor-based and AHRQ panel MCID thresholds results in different conclusions, with clinically important differences being inferred when anchor-based estimates serve as the reference point. CONCLUSION: The AHRQ panel MCID threshold for the rTNSS was twelve times larger than the anchor-based estimates resulting in conflicting recommendations on whether different SAR treatments provide clinically meaningful benefit.

Meta-analysis of adverse events in recent randomized clinical trials for dimethyl fumarate, glatiramer acetate and teriflunomide for the treatment of relapsing forms of multiple sclerosis.

PURPOSE/AIM OF THE STUDY: Trials of dimethyl fumarate (DMF) and teriflunomide, two new oral therapies for relapsing-remitting multiple sclerosis (RRMS) were recently published [1, 2, 3]. A comparison of their safety against glatiramer acetate-a prevalent injectable treatment-is relevant to inform therapy-switching decisions. The study objective was to conduct a systematic review and mixed treatment comparison of total AEs in RCTs of dimethyl fumarate 240 mg bid (DMF2) or tid (DMF3), glatiramer acetate 20 mg injectable daily (GA), and teriflunomide 7 mg (TERI7) or 14 mg (TERI14) daily in RRMS patients. MATERIALS AND METHODS: Articles were selected following Cochrane guidelines. A network meta-analysis was used to compare the odds of patients experiencing at least one AE between drugs, using placebo as baseline. Drugs were compared using the odds ratio (OR), credible interval (CrI), and confidence in OR≥1 (PrOR). The mean rank (best=1) and corresponding Surface-Under-Cumulative-Ranking (SUCRA) (best=100%) were reported. RESULTS: 3737 patients from three RCTs were included for analysis. Patients receiving GA exhibited the lowest AEs (DMF2 [OR=2.67, PrOR=98.7%], DMF3 [OR=1.92, PrOR=95.3%], Teri7 [OR=2.74, PrOR=95.2%], Teri14 [OR=3.03, PrOR=96.4%]), and equivalent to PB (OR=1.60; PrOR=94.3%). No other significant differences were found. GA also ranked with the lowest AEs (rank=1.2, SUCRA=96.0%), whereas DMF2 and Teri14 ranked highest (rank=4.8). CONCLUSIONS: RRMS patients treated with glatiramer have the lowest odds of experiencing AEs, while patients taking DMF or teriflunomide have similar, higher odds of developing AEs, suggesting that patients treated with glatiramer may have higher QoL than patients under DMF or teriflunomide.

Updated cost-of-care estimates for commercially insured patients with multiple sclerosis: retrospective observational analysis of medical and pharmacy claims data.

BACKGROUND: For patients with multiple sclerosis (MS), previous research identified key disease sequelae as important cost drivers and suggested that among users of disease-modifying drugs (DMDs) in 2004, DMDs represented 73% of the total cost of care. More recent studies were limited to incident disease/treatment and/or excluded DMDs from cost estimates. To support contemporary pharmacoeconomic analyses, the present study was conducted to provide updated information about MS-related costs and cost drivers including DMDs. METHODS: For each of 2 years, 2006 and 2011, commercially insured, continuously eligible patients with ≥ 1 medical claim diagnosis of MS were sampled. MS-related charges were based on medical claims with MS diagnosis plus medical/pharmacy claims for DMDs. 2006 charges were adjusted to 2011 $ using the medical care component of the consumer price index (CPI). Subgroups of patients using DMDs (interferon [IFN] beta-1a intramuscular or subcutaneous, IFN beta-1b, glatiramer, natalizumab) in 2011 were identified. By-group differences were tested with bivariate statistics. RESULTS: Mean (standard deviation [SD]) age of 15,902 sample patients in 2011 was 47.6 (11.8) years, 76% female. Mean [SD] MS charges ($26,520 [$38,478] overall) were significantly (P < 0.001) higher for patients with common disease sequelae: malaise/fatigue (n = 2,235; $39,948 [$48,435]), paresthesia (n = 1,566; $33,648 [$45,273]), depression (n = 1,255; $42,831 [$51,693]), and abnormality of gait (n = 1,196; $48,361 [$55,472]). From 2006 to 2011, CPI-adjusted MS charges increased by 60%. Among patients treated with a single DMD in 2011, inpatient care was 6% of charges (range = 4%-8%; P = 0.155); outpatient care was 19% (range = 14%-20% except for natalizumab [29%]; P < 0.001); and DMDs were 75% (range = 67%-81%; P < 0.001). CONCLUSIONS: Common MS sequelae remain important cost drivers. Although MS treatment costs are increasing, the proportion of MS charges due to DMDs in 2011 is similar to that reported in 2004.

Healthcare costs among patients with excessive sleepiness associated with obstructive sleep apnea, shift work disorder, or narcolepsy.

BACKGROUND: Excessive daytime sleepiness affects nearly 20% of the general population and is associated with many medical conditions, including shift work disorder (SWD), obstructive sleep apnea (OSA), and narcolepsy. Excessive sleepiness imposes a significant clinical, quality-of-life, safety, and economic burden on society. OBJECTIVE: To compare healthcare costs for patients receiving initial therapy with armodafinil or with modafinil for the treatment of excessive sleepiness associated with OSA, SWD, or narcolepsy. METHODS: A retrospective cohort analysis of medical and pharmacy claims was conducted using the IMS LifeLink Health Plan Claims Database. Patients aged ≥18 years who had a pharmacy claim for armodafinil or for modafinil between June 1, 2009, and February 28, 2012, and had 6 months of continuous eligibility before the index prescription date, as well as International Classification of Diseases, Ninth Revision diagnosis for either OSA (327.23), SWD (327.36), or narcolepsy (347.0x) were included in the study. Patients were placed into 1 of 2 treatment cohorts based on their index prescription and followed for 1 month minimum and 34 months maximum. The annualized all-cause costs were calculated by multiplying the average per-month medical and pharmacy costs for each patient by 12 months. The daily average consumption (DACON) for armodafinil or for modafinil was calculated by dividing the total units dispensed of either drug by the prescription days supply. RESULTS: A total of 5693 patients receiving armodafinil and 9212 patients receiving modafinil were included in this study. A lower DACON was observed for armodafinil (1.04) compared with modafinil (1.47). The postindex mean medical costs were significantly lower for the armodafinil cohort compared with the modafinil cohort after adjusting for baseline differences ($11,363 vs $13,775, respectively; P = .005). The mean monthly drug-specific pharmacy costs were lower for the armodafinil cohort compared with the modafinil cohort ($166 vs $326, respectively; P <.001). In addition, lower total healthcare costs were observed for the armodafinil cohort compared with the modafinil cohort after correcting for baseline differences ($18,309 vs $23,530, respectively; P <.001). CONCLUSION: As shown in this analysis, armodafinil may have real-world DACON advantages and may be associated with lower overall healthcare costs compared with modafinil.

Using observational analysis of multiple sclerosis relapse to design outcomes-based contracts for disease-modifying drugs: a feasibility assessment.

OBJECTIVE: To assess predictors and costs of multiple sclerosis (MS) relapse, a potential outcome measure in payer-manufacturer risk-sharing agreements for disease-modifying drugs (DMDs). METHODS: A retrospective cohort analysis of medical/pharmacy claims was used. Study patients had ≥1 DMD (interferon beta, glatiramer, natalizumab) claim, without DMD claims in a 6-month pre-period before DMD initiation; were aged 18-64 years and continuously enrolled from the pre-period through a 24-month post-period; and had ≥2 MS medical claims during the 30-month study period. Post-period relapse cohorts included: (1) severe (hospitalization with MS diagnosis); (2) moderate (outpatient services including intravenous methylprednisolone); and (3) none. Poisson regression modeled severe relapse frequency, logistic regression modeled ≥1 severe relapse, and generalized linear modeling predicted healthcare costs. Tested predictors included demographics, insurance type, index DMD, pre-period health status, and DMD medication possession ratio (MPR). RESULTS: Severe relapse was experienced by 14.5% and moderate relapse by 13.8% of 2291 patients. In logistic regression, severe relapse was predicted by plan type; age (odds ratio [OR] = 1.018, 95% confidence interval [CI] = 1.005-1.031); pre-period Charlson Comorbidity Index (OR = 1.307, 95% CI = 1.166-1.464); pre-period proxy measure indicating impaired activities of daily living (OR = 1.470, 95% CI = 1.134-1.905); pre-period MS hospitalization (OR = 2.174, 95% CI = 1.537-3.074); and DMD non-adherence (MPR OR = 0.101, 95% CI = 0.068-0.151). Poisson regression results were similar. Predicted mean [standard deviation] all-cause healthcare expenditures were tripled for patients with severe compared with moderate relapse ($48,173 [$8665] and $13,334 [$1929], respectively). LIMITATIONS: Commercially insured patients from a single payer; use may have been inconsistent with approved indications; proxy relapse measure may have misclassified patients. CONCLUSIONS: Severe MS relapses requiring hospitalization, although affecting less than 15% of patients initiating DMD treatment, are associated with high medical costs. The only actionable predictor of severe relapse identified in observational analysis was MPR, raising questions about the feasibility of using observational data to guide outcomes-based contracting.

Assessing the role of patient support services on adherence rates in patients using glatiramer acetate for relapsing-remitting multiple sclerosis.

OBJECTIVE: To assess predictors of achievement of 80% Medication Possession Ratio (MPR) in patients receiving manufacturer-provided self-management services for relapsing-remitting multiple sclerosis (RRMS) patients taking glatiramer acetate (Copaxone). METHODS: De-identified patient records were selected for study inclusion if patients had been (1) continuously enrolled in one or more aspects of the self-management program for a minimum of 24 months and had adherence measured by MPR between the values of zero and one. Baseline patient univariate measures were assessed using chi-squared statistics for categorical variables and Analysis of Variance (ANOVA) for continuous variables. Bivariate logistic regression models were used to assess predictors of 80% MPR. RESULTS: A total of 5825 patients met the study inclusion criteria. About 70% of patients received manufacturer-provided injection training and 75% were eligible for, and utilized, copayment assistance; 74.3% of patients accessing sponsor provided support achieved a desired MPR of greater than or equal to 80%. Patients were 40% more likely to reach goal if injection training was provided by the manufacturer (OR = 1.435; 95% CI = 1.258-1.636) and were 30.6% more likely to achieve goal when eligible patients utilized copayment assistance programs (OR = 1.306; 95% CI = 1.109-1.570). Patients reinitiating treatment were at risk of lower adherence rates (OR = 0.605; CI = 0.476-0.769) compared to those who were new to therapy. CONCLUSIONS: Manufacturer-provided patient support programs improve adherence to glatiramer acetate therapy.

Differentiating the workplace needs of nurses by academic preparation and years in nursing.

Questions surrounding the optimal level of academic preparation for nurses entering the workforce appear to be nearing consensus. However, in most organizations, the existing nursing workforce includes nurses of various ages, amounts of experience, and levels of academic preparation. All nurses serve an important role in caring for patients. The objective of this study was to determine if differences in work environment perceptions exist for nurses with different levels of academic preparation but similar years of experience in nursing. Mean values of work environment perceptions were compared between associate degree nurses and bachelor of science nurses with equivalent years in clinical practice using univariate statistics. Bachelor of science nurses reported similar or more positive work environment perceptions across all levels of professional experience as compared with associate degree nurses. The largest difference in perceptions between the two groups was seen in nurses with more than 15 years of professional experience. In this group, bachelor of science nurses reported more positive perceptions of peer support, unit support, workload, and overall nursing satisfaction. Intent to stay was not different between the groups considered. The results of this study suggest that efforts to expand nurses' access to baccalaureate programs may have positive implications for professional nursing and the work environment.

Nursing support, workload, and intent to stay in Magnet, Magnet-aspiring, and non-Magnet hospitals.

This study examined the differences between nurses' (N = 3,337) scores on organizational support, workload, satisfaction, and intent to stay between Magnet, Magnet-aspiring, and non-Magnet hospitals. The study was conducted using the Individual Workload Perception Scale, a valid and reliable tool with 32 Likert scale items, with nurses from 11 states, 15 institutions, and 292 diverse units. Results indicate that nurses at Magnet hospitals had significantly better scores on all subscales. Furthermore, nurses from Magnet-aspiring hospitals had better scores than did nurses from non-Magnet facilities. Conclusions of the study indicate that the Magnet program is meeting its intended goal: to provide a professional practice environment for staff nurses. Nurse executives may consider using the Individual Workload Perception Scale as a way to assess their organization's culture as it relates to professional practice of the registered nurse.

United States operating room nurses: work environment perceptions.

Concerns about pending retirement of nurses working in the operating room (OR) are undeniable. The nurses' work environment and level of perceived support is part of the equation of why a nurse may choose to retire or stay in the workforce. This study compares nurses' perceptions of the work environment between OR nurses and nurses who work in other type units; and compares the work environment perceptions of OR nurses between institutions of two sizes (<300 beds and >300 beds). Findings include: OR nurses have better perceptions of their work environment than nurses in other type units and OR nurses in smaller hospitals are more satisfied with their work environment, workload and perceptions of organisational support. Implications for OR work environments are discussed.

Improving work environment perceptions for nurses employed in a rural setting.

CONTEXT: Effective recruitment and retention of professional nurses is a survival strategy for health care facilities, especially in rural areas. PURPOSE: This study examines the use of the Individual Workload Perception Scale to measure nurse satisfaction by a small rural hospital in order to make positive changes in the work environment for nurses. METHODS: Baseline work environment perceptions of nurses employed in a rural Kentucky hospital were assessed using the Individual Workload Perception Scale, a validated 38-item instrument. Nurses reviewed the results and brainstormed on potential interventions to address areas of concern. The 4 interventions selected for implementation by the nursing staff included (1) implementation of a shared decision making or governance model; (2) enhanced role of licensed practical nurses within the organization; (3) augmentation of administrative support on night and weekend shifts; and (4) utilization of wireless communication devices. After implementation of the interventions, staff nurse perceptions were reassessed using the same tool. FINDINGS: The follow-up survey revealed improvements in all areas measured by the Individual Workload Perception Scale, with the greatest improvement in the perception of the work environment noted among night nurses. The increase in positive work environment perception among these nurses, with greater than or equal to 11 years of professional experience, was statistically significant. CONCLUSIONS: Tools exist to support the development and evaluation of interventions to improve the work environment for nurses practicing in rural health care settings. By addressing issues of specific concern, both job satisfaction and retention of this talented pool of professionals can be enhanced.

Resource utilization and expenditures for overweight and obese children.

OBJECTIVES: To compare health care utilization and expenditures for healthy-weight patients, overweight patients, and patients with diagnosed and undiagnosed obesity and to examine factors associated with a diagnosis of obesity. DESIGN: Retrospective study using claims data from a large pediatric integrated delivery system. SETTING: An urban academic children's hospital. PARTICIPANTS: Children aged 5 to 18 years who presented to a primary care clinic for well-child care visits during the calendar years 2002 and 2003 and who were followed up for 12 months. MAIN OUTCOME MEASURES: Diagnosis of obesity, primary care visits, emergency department visits, laboratory use, and health care charges. RESULTS: Of 8404 patients, 57.9% were 10 years or older, 61.2% were African American, and 72.9% were insured by Medicaid. According to the criteria of body mass index (calculated as weight in kilograms divided by the square of height in meters), 17.8% were overweight and 21.9% were obese. Of the obese children, 42.9% had a diagnosis of obesity. Increased laboratory use was found in both children with diagnosed obesity (odds ratio [OR], 5.49; 95% confidence interval [CI], 4.65-6.48) and children with undiagnosed obesity (OR, 2.32; 95% CI, 1.97-2.74), relative to the healthy-weight group. Health care expenditures were significantly higher for children with diagnosed obesity (adjusted mean difference, $172; 95% CI, $138-$206) vs the healthy-weight group. Factors associated with the diagnosis of obesity were age 10 years and older (OR, 2.7; 95% CI, 2.0-3.4), female sex (OR, 1.5; 95% CI, 1.2-1.8), and having Medicaid (OR, 1.6; 95% CI, 1.1-2.3). CONCLUSIONS: Increased health care utilization and charges reported in obese adults are also present in obese children. Most children with obesity had not been diagnosed as having obesity in this administrative data set.

Work environment perceptions of pediatric nurses.

This study assessed whether pediatric nurse perceptions of the work environment differed (1) from nurses employed in nonpediatric settings, (2) by the type of pediatric practice setting, or (3) by year of birth. The results of the study suggested that pediatric nurses had more positive perceptions of unit support, workload, and overall nurse satisfaction than their colleagues working in nonpediatric facilities. Specific to pediatrics, younger nurses and those working in critical care settings seemed to be the happiest with their work environment.

Redesigning the health care system of the future.

The models outlined above represent alternative constructs for examining factors that may or may not influence human health in a positive manner. If the economic framework seems more theoretical than actionable, consider an alternative framework that has been advanced by the American Hospital Association and described in Table I. Regardless of the framework adopted, work to improve the health care system and its financing will be hard, irrespective of whether incremental or wholesale changes are made. What is important, however, is that a thoughtful approach be taken and the trade-offs of each decision carefully weighted. The health of the population of the state and the country depend on it.

Nurses' work environment perceptions when employed in states with and without mandatory staffing ratios and/or mandatory staffing plans.

Multiple stakeholders have sought regulatory and nonregulatory strategies to address nursing workforce and patient safety concerns. This study examines differences in nurses' work environment perceptions. Approximately 4,000 nurses employed in 10 states provided their perceptions of key characteristics of their work environment using the Individual Workload Perception Scale. Univariate statistics were used to characterize mean values of the nurses' work environment perceptions by state of employment and whether these perceptions changed if employed in states with versus without mandatory staffing ratios and/or mandatory staffing plans. This study provides preliminary evidence that mandatory staffing plan legislation may be linked with the most positive nurse work environment perceptions when compared with implementation of mandatory staffing ratios or no workforce regulation. Based on this preliminary observation, further analysis comparing the relative benefits and costs of workforce regulation may be warranted.

Comparing variations in labor costs for two vs. one full-time nurse manager.

Labor costs for two versus one full-time nurse manager were compared. Results revealed reductions in nursing costs per patient day. These results suggest that innovative models may hold promise as organizations struggle to retain nurses and decrease costs.

The impact of capitation on physician organizations' cost structures: an exploratory analysis.

This paper aims to evaluate the relationship between capitation payment methodology and the physician organization cost function. The paper provides evidence supporting a positive relationship between overhead rates and the level of capitation. Based on sample data, US medical practices whose net medical revenue consists of 11 percent or more capitation payments have significantly higher overhead costs per physician FTE.

Enhancing entrepreneurship and professionalism in medical informatics instruction: a collaborative training model.

This report describes an innovative training program designed to foster entrepreneurship and professionalism in students interested in the field of medical informatics. The course was developed through a private-public interinstitutional collaboration involving four academic institutions, one private firm specializing in health care information management systems, and a philanthropic organization. The program challenged students to serve in multiple roles on multidisciplinary teams and develop an innovative hand-held solution for drug information retrieval. Although the course was technically and behaviorally rigorous and required extensive hands-on experience in a nontraditional learning environment, both students and faculty responded positively.

Effects of changes in patient cost sharing and drug sample policies on prescription drug costs and utilization in a safety-net-provider setting.

PURPOSE: The impact of cost-containment strategies on prescription drug utilization and costs in an ambulatory care safety-net-provider setting was studied, along with the impact of these strategies on patient out-of-pocket expenditures. METHODS: Aggregate monthly prescription drug cost and utilization data were obtained from a health system's outpatient pharmacy computer system for the targeted clinic. The data represented approximately 42,000 patient visits over 38 months. Univariate and multivariate statistics were used to evaluate the influence of copayment increases and changes in prescription drug sample policies on prescription drug costs, prescription drug utilization, and patient expenditures. RESULTS: Prescription drug copayment increases were associated with significant decreases in prescription drug utilization and costs. An average per visit prescription drug copayment increase of $5 was associated with a significant reduction in prescription drug utilization per visit and a $26.07 reduction in prescription drug expenditures per visit per month. Removal of samples from the clinic did not result in a significant decrease in either prescription drug costs or utilization. The presence of samples, however, was associated with a significant reduction in per visit patient expenditures by an amount similar to the copayment for one brand-name prescription drug per visit. CONCLUSION: An increase in patient copayments was associated with reductions in a clinic's drug expenditures and prescription drug utilization per visit. Removal of prescription drug samples had no effect except increasing patients' out-of-pocket drug costs.