Gregory Reardon

Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review.

Purpose This study summarizes findings from objective assessments of compliance (or adherence) and persistence with ocular hypotensive agents in patients with glaucoma and ocular hypertension. Design Systematic literature review. Methods A PubMed and reference list search was conducted across publication years 1970–2010, using these terms and variants: “compliance,” the equivalent term “adherence,” and “persistence” in patients with these conditions and therapies. Summaries of selected studies were stratified by measurement method (electronic monitor, prescription fills review, medical chart review). Measures of central tendency across studies were calculated for commonly-reported compliance or persistence measures. Results Fifty-eight articles met all inclusion/exclusion criteria: measurement of compliance–electronic monitoring (seven studies reported in 14 articles), measurement of compliance/ persistence–prescription records (36 studies in 38 articles), and measurement of persistence– medical chart review (six studies in six articles). From electronic monitoring, most therapy-experienced patients took medication consistently, but ≥20% met criteria for poor compliance. From prescription records, only 56% (range 37%–92%) of the days in the first therapy year could be dosed with the medication supply dispensed over this period. At 12 months from therapy start, only 31% (range 10%–68%) of new therapy users had not discontinued, and 40% (range 14%–67%) had not discontinued or changed the initial therapy. From medical chart review, only 67% (range 62%–78%) of patients remained persistent 12 months after starting therapy. Conclusions Evidence provided by this review suggests that poor compliance and persistence has been and remains a common problem for many glaucoma patients, and is especially problematic for patients new to therapy. The direction of empirical research should shift toward a greater emphasis on understanding of root causes and identification and testing of solutions for this problem.

Use of warfarin in long-term care: a systematic review

BackgroundThe use of warfarin in older patients requires special consideration because of concerns with comorbidities, interacting medications, and the risk of bleeding. Several studies have suggested that warfarin may be underused or inconsistently prescribed in long-term care (LTC); no published systematic review has evaluated warfarin use for stroke prevention in this setting. This review was conducted to summarize the body of published original research regarding the use of warfarin in the LTC population.MethodsA systematic literature search of the PubMed, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library was conducted from January 1985 to August 2010 to identify studies that reported warfarin use in LTC. Studies were grouped by (1) rates of warfarin use and prescribing patterns, (2) association of resident and institutional characteristics with warfarin prescribing, (3) prescriber attitudes and concerns about warfarin use, (4) warfarin management and monitoring, and (5) warfarin-related adverse events. Summaries of study findings and quality assessments of each study were developed.ResultsTwenty-two studies met the inclusion criteria for this review. Atrial fibrillation (AF) was the most common indication for warfarin use in LTC and use of warfarin for stroke survivors was common. Rates of warfarin use in AF were low in 5 studies, ranging from 17% to 57%. These usage rates were low even among residents with high stroke risk and low bleeding risk. Scored bleeding risk had no apparent association with warfarin use in AF. In physician surveys, factors associated with not prescribing warfarin included risk of falls, dementia, short life expectancy, and history of bleeding. International normalized ratio was in the target range approximately half of the time. The combined overall rate of warfarin-related adverse events and potential events was 25.5 per 100 resident months on warfarin therapy.ConclusionsAmong residents with AF, use of warfarin and maintenance of INR levels to prevent stroke appear to be suboptimal. Among prescribers, perceived challenges associated with warfarin therapy often outweigh its benefits. Further research is needed to explicitly consider the appropriate balancing of risks and benefits in this frail patient population.

Study of anemia in long-term care (SALT): prevalence of anemia and its relationship with the risk of falls in nursing home residents

ABSTRACT Objective: The objectives of the current study were twofold. First, this study examined the prevalence of anemia in nursing home residents in the USA and its relationship with key resident characteristics and medical conditions. Second, the study explored whether an association between anemia and falls is evident in this same population. Research design and methods: Chart review was conducted in 40 nursing homes across the USA. Residents were randomly sampled and considered eligible if they: were ≥18 years of age; had ≥1 hemoglobin (Hb) level reported during the data uptake period of 1/1/04–2/1/05 (first occurrence defined as index Hb); had a recorded serum creatinine level; maintained residency in the facility; and did not receive dialysis during the 6-month post-index follow-up period. Resident demographics, laboratory values, comorbid conditions, medication regimens, falling events, physical functioning measures, and hospitalizations were obtained from chart data. The relationship between selected resident characteristics and comorbidities was explored with index Hb level, using multiple linear regression. Logistic regression was used to analyze the relationship between falling and recurrent falls with anemia (index Hb <13 g/dL and <12 g/dL in men and women ≥15 years, respectively) adjusting for selected variables presumed to be related to falls. Limitations: Study limitations include the retrospective design and limited follow-up, potential for biased selection of relevant covariates, gaps in time between index Hb levels and falling events, non-random selection of nursing homes, limits to quality and detail in data extracted from residents’ medical charts, and confounding of anemia therapy with index hemoglobin level. Results: A total of 564 sampled residents met the criteria for data completeness and were retained for analysis; of these, 70% were female. Mean age was 81 ± 12.3 years (±SD). Mean index Hb level was 11.9 ± 1.8 g/dL (12.2 ± 2.0 for males, 11.7 ± 1.6 for females). Of all residents studied, 56% were identified as anemic (64% males, 53% females) from index Hb level. In all, 53% of anemic residents were receiving an identified therapy, with 72% of these treated residents receiving iron. None received an erythropoietic-stimulating agent (ESA). For index Hb level, the regression coefficient was significant for female (p = 0.002), African-American race (p = 0.012), glomerular filtration rate (GFR) <60 mL/min/1.73 m2 (p < 0.001), diabetes (p = 0.004), cancer (p < 0.001), asthma (p = 0.002), GI bleeding (p = 0.012), and inflammatory disease (p = 0.039). Except for asthma, these factors were associated with a decrease in Hb. In the regression model for the dependent variable of falling, anemia (OR = 2.26, p < 0.001), psychoactive medication use (OR = 2.18, p = 0.001), and age 85+ years (OR = 2.08, p = 0.016) were associated with more than twice the risk of falling. Conclusions: Anemia in nursing home residents appears to be under-recognized. For residents over 70 years, the prevalence of anemia in both male and female residents was approximately four times the rate reported in a study of older community dwellers (Salive et al., 1992). Both anemia and the use of psychoactive medications are potentially modifiable factors strongly associated with falling. Since falls and related fractures are events associated with high morbidity and mortality, each of these factors deserves special consideration for potentially reducing the risk of such events in the nursing home.

Retrospective claims study of fluticasone propionate/salmeterol fixed-dose combination use as initial asthma controller therapy in children despite guideline recommendations

BACKGROUND According to current asthma treatment guidelines, single-entity inhaled corticosteroids (ICSs) should be used as initial controller therapy in children with mild to moderate persistent asthma. Long-acting beta(2)-agonists (LABAs) can be added to therapy for those patients whose asthma is not well controlled with a single-entity ICS. OBJECTIVES The goal of this study was to examine whether the claims history for children in a US insured population indicate proper fluticasone propionate/ salmeterol (FPS) fixed-dose combination use in accordance with recommended asthma guidelines and a US Food and Drug Administration (FDA) advisory and black box warning regarding LABA use. A comparison of study-drug charges was also conducted. METHODS Data from a US commercial insurance database were used in this retrospective study to evaluate pharmacy and medical claims for children between October 2004 and September 2006 (ie, the index period). An index date corresponding to the date of the first FPS claim was assigned to each patient. Eligible patients were aged 4 to 11 years and had >/=1 pharmacy claim for FPS during the index period. Those patients receiving 1 FPS prescription dose strength on the index date who were continuously enrolled for benefits during the preindex period (ie, the 365 days before the index date) were included in the study. Disease severity was assigned based on asthma-related pharmacy (frequency and/or incidence of oral corticosteroid, LABA, montelukast, and >365 doses of a short-acting beta(2)-agonist) and medical (asthma-related urgent care clinic or emergency department visits or hospitalizations) claim histories during the preindex period. RESULTS A total of 13,306 patients between the ages of 4 and 11 years on the index date were included in the study; their mean (SD) age was 8.9 (1.9) years. The majority of the patients were male (60.7%). Of the total FPS claims, 55.2% were for patients with no evidence of pharmacy or medical claims in the 365 days before the first FPS claim that would warrant ICS/LABA combination therapy according to asthma treatment guidelines. There were no large changes in preindex ICS claims over the course of the study in response to an FDA-issued advisory and black box warning regarding the use of LABAs. Median drug charges for single-entity ICS use were

Association of anemia with worsened activities of daily living and health-related quality of life scores derived from the Minimum Data Set in long-term care residents

98 compared with

Use of warfarin therapy among residents who developed venous thromboembolism in the nursing home.

168 for FPS therapy. CONCLUSIONS ICS/LABA combination treatment was used as initial therapy in 55.2% of children with mild to moderate asthma in this claims database population, contrary to the recommendations of current asthma treatment guidelines. The FDA advisory and black box warning for LABA use had little observed impact on the number of single-entity ICS claims.

Prevalence of Atrial Fibrillation in US Nursing Homes: Results from the National Nursing Home Survey, 1985–2004

BackgroundAmong long-term care (LTC) residents, we explored the association between anemia status and hemoglobin (Hb) level with Activities of Daily Living (ADL) functioning and health-related quality of life (HRQOL).MethodsData were derived from the AnalytiCare database, containing laboratory and Minimum Data Set (MDS) reports for 27 LTC facilities in Colorado. Study timeframe was 1/1/07-9/15/08. Patients were selected based on: residence in LTC >90 days, Hb and serum creatinine value within 90 days of the earliest non-admission (index) MDS. From the index MDS, the method of 1) Carpenter et al. [BMC Geriatrics 6:7(2006)] was used to derive a summary measure of ADL performance (the MDS-ADL score) and 2) Wodchis et al. [IJTAHC 19:3(2003)] was used to assign HRQOL scores (MDS items were mapped to the Health Utilities Index Mark 2 (HUI2) scoring function to create the MDS-HSI score). Anemia was defined as Hb <12 g/dL females and <13 g/dL males. Adjusted linear regression was used to evaluate the independent association of anemia and hemoglobin level on MDS-ADL and MDS-HSI scores.Results838 residents met all inclusion criteria; 46% of residents were anemic. Mean (SD) MDS-ADL score was 14.9 (7.5) [0–28 scale, where higher score indicates worse functioning]. In the adjusted model, anemia was associated with a significantly worse MDS-ADL score (+1.62 points, P=.001). Residents with Hb levels 10 to <11 g/dL had significantly worse ADL score (+2.06 points, P=.005) than the >13 g/dL reference. The mean MDS-HSI score was 0.431 (0.169) [range, where 0=dead to 1=perfect health]. Compared with non-anemic residents, in this adjusted model, residents with anemia had significantly worse MDS-HSI scores (−0.034 points, P=.005). Residents with hemoglobin levels <10 g/dL had significantly worse MDS-HSI scores (−0.058 points, P=.016) than the >13 g/dL reference.ConclusionsAfter adjusting for several covariates, LTC residents with anemia, and many of those with moderate to severe declines in Hb level, had significantly poorer outcomes in both ADL functioning and HRQOL. The association between Hb level and the HRQOL measure of MDS-HSI appears to be largely explained by the mobility domain of the HRQOL measure.

Validation of Stopwatch Measurements of Erection Duration against Responses to the Sexual Encounter Profile and International Index of Erectile Function in Patients Treated with a Phosphodiesterase Type 5 Inhibitor

BACKGROUND Treatment of venous thromboembolism (VTE) in long-term care (LTC) settings has received little empirical study. OBJECTIVE Among residents with VTE in nursing homes, this analysis evaluated frequency of anticoagulant use, the proportion of residents newly started on warfarin who persisted on therapy (≥3 months), and the association of key resident characteristics, including bleeding risk, with warfarin use and persistence. METHODS Using the AnalytiCare LTC database (US), eligible residents had deep vein thrombosis or pulmonary embolism coded in the Minimum Data Set (MDS) 2.0 during the uptake period April 1, 2007 through December 31, 2008 (earliest VTE was index date) and had 1 or more MDS assessment(s) over the 90-day preindex period, each negative for VTE. Logistic regression evaluated the association of resident characteristics with warfarin use. Cox regression evaluated persistence with warfarin therapy. RESULTS The median age of residents with VTE included in the analysis (N = 489) was 80 years; 73% received anticoagulant therapy and 66% were prescribed warfarin ±45 days of the index date. Multivariate logistic regression identified several factors significantly associated with warfarin use: location in South Central region (odds ratio [OR] = 1.94, P = 0.019) and the Western region (OR = 2.53, P = 0.005) [both vs reference South Atlantic]; body mass index categories normal (OR = 2.73, P = 0.045), overweight (OR = 4.21, P = 0.005), and obese (OR = 3.82, P = 0.010) (both vs reference underweight); Alzheimers/dementia (OR = 0.52, P = 0.024); cancer (OR = 0.39, P = 0.008); and moderate-dependent versus independent physical functioning (OR = 2.59, P = 0.003). Of residents newly started on warfarin therapy with no history of cancer (n = 149), 28% discontinued warfarin within 90 days of initiation. Peripheral vascular disease (PVD) (OR = 4.07, P < 0.001), Alzheimers disease/dementia (OR = 2.55, P = 0.046), and antipsychotic use (OR = 4.60, P < 0.001) were all significantly associated with discontinuation. CONCLUSIONS Patients in specific geographic regions who were underweight, had Alzheimers disease/dementia or cancer, or had independent physical functioning were less likely to receive warfarin. Nonpersistence of warfarin therapy was strongly related to antipsychotic use, presence of dementia, or PVD.

Falls in nursing home residents receiving pharmacotherapy for anemia

OBJECTIVES To evaluate the prevalence of atrial fibrillation (AFib) in US nursing homes from 1985 to 2004 and to project the prevalence of AFib to 2030. DESIGN This study is an analysis of cross-sectional data from the US National Nursing Home Survey, years 1985, 1995, 1997, 1999, and 2004. SETTING Randomly selected long term care facilities in the United States licensed by the state or certified for Medicaid/Medicare reimbursement. PARTICIPANTS Randomly selected residents within study facilities. MEASUREMENTS National Nursing Home Survey demographics and current medical conditions data were analyzed. Population estimates were calculated using National Nursing Home Survey sample weights. Absolute observed annual linear growth of the AFib prevalence rate was calculated using linear regression. Predictive margins were estimated using logistic regression models to evaluate effect of changes in resident case-mix over the survey years. Three estimation methods predicted the number residents having AFib in 2030. RESULTS The sample sizes of surveyed resident groups were as follows: n = 5238 (1985); n = 8056 (1995); n = 8138 (1997); n = 8215 (1999); and n = 13,507 (2004). Prevalence rates of AFib by year were 2.8% (95% confidence interval [CI]: 2.3-3.4%; 1985), 5.1% (95% CI: 4.6-5.6%; 1995), 5.8% (95% CI: 5.3-6.3%; 1997), 6.9% (95% CI: 6.3-7.4%; 1999), and 10.9% (95% CI: 10.2-11.5%; 2004). Population estimates of nursing home residents with AFib (in thousands) were 42.2 (95% CI: 34.1-50.3; 1985), 78.7 (95% CI: 70.8-86.7; 1995), 93.6 (95% CI: 84.9-102.3; 1997), 111.8 (95% CI: 102.1-121.5; 1999), and 162.1 (95% CI: 152.4-171.7; 2004). Absolute annual linear growth in the prevalence rate of AFib was +0.38% observed (P = .022), +0.39% using unadjusted predictive margins (P = .007), and +0.37% using adjusted predictive margins (P = .007). Projected estimates showed that 272,000 (95% CI: 197,000-347,000), 300,000, or 325,000 residents would have AFib in the year 2030. CONCLUSION The prevalence of AFib in US nursing home residents increased from 1985 to 2004 and is projected to grow substantially over the next 20 years, potentially resulting in an increased nursing home staff burden owing to increased stroke risk evaluations.

Usage of medications with high potential to interact with warfarin among atrial fibrillation residents in long-term care facilities

INTRODUCTION Although the Sexual Encounter Profile (SEP) and International Index of Erectile Function (IIEF) are frequently used to measure erectile dysfunction (ED) treatment outcomes, stopwatch-assessed duration of erection is a new, objective, and potentially useful endpoint of ED treatment effect. AIMS To assess the validity and reliability of stopwatch-assessed erection duration against responses to SEP items 2 (SEP-2) and 3 (SEP-3) and IIEF scale scores. METHODS Data were taken from a multi-center trial of vardenafil for the treatment of ED. Patients were randomized to vardenafil 10 mg or placebo for 4 weeks. After a 1-week washout period, patients received the alternate therapy for an additional 4 weeks. An electronic diary was used to record information about sexual attempts. The duration of erection was measured using a stopwatch and transcribed into the diary. The SEP was completed following each sexual attempt, and the IIEF was completed at the end of each treatment period. MAIN OUTCOME MEASURES Mean and median values of erection duration, mean SEP-2 and SEP-3 success rates, and scores for each of the 5 IIEF scales were calculated. RESULTS At baseline, correlations of median erection duration with the 5 IIEF scale scores ranged from 0.06 to 0.53, while correlations with mean SEP-2 and SEP-3 success rates were 0.66 and 0.49, respectively. Compared with the other measures, mean and median values of erection duration were less sensitive to differences between placebo- and vardenafil-treated patients and less responsive to clinical change associated with treatment crossover. However, mean erection duration exhibited a good level of reliability (intraclass correlation coefficient = 0.72, P < 0.001). CONCLUSIONS This study provides evidence for the validity and reliability of stopwatch-assessed duration of erection. Our findings suggest that erection duration is suitable for use as a unique endpoint in ED treatment-efficacy trials conducted for phosphodiesterase type 5 inhibitors.