Biomedical subjects

Joyce A Cramer

Publications and source records attributed to Joyce A Cramer.

At least 19 recordsLinked to original sources

PubMed2006

Persistence with bisphosphonate treatment for osteoporosis: finding the root of the problem.

Poor compliance and persistence are among the most significant reasons for failed pharmacotherapy encountered in clinical practice. Consequences of poor compliance range from minor to serious, depending on drug characteristics, disease state, and severity of disease. Compliance and persistence are particular problems for patients with a disorder such as osteoporosis, which remains asymptomatic for long periods. Poor compliance with bisphosphonate therapy for osteoporosis has been associated with a smaller decrease in the rate of bone turnover and smaller improvements in bone mineral density, and may potentially result in a higher risk of fracture and disability. The compliance problem is additive; complex dosing guidelines may contribute to poor compliance with therapy, and the failure to follow these guidelines may result in treatment-related adverse events that further reduce compliance. In the long term, these issues often result in nonpersistence with treatment. In addition to direct consequences for the patient, poor compliance is associated with significant healthcare costs. Studies suggest that less-frequent dosing regimens improve compliance; however, even among patients receiving weekly bisphosphonates, persistence may remain suboptimal. Several strategies are available to improve compliance and persistence with osteoporosis therapies. Good communication between the healthcare provider and the patient--with continuous reinforcement of the importance of treatment--is a key approach to improving persistence. Patients should receive feedback to confirm that their treatment is having an effect, and individualized reminder systems should be recommended to help the patient adhere to the treatment plan. Potentially, every patient is liable to discontinue treatment even after a long period of regular dosing. It should be assumed that every patient receiving therapy for osteoporosis needs regular reinforcement of the importance of continuing therapy.

Bone Density↗

PubMed2006

The effect of dosing frequency on compliance and persistence with bisphosphonate therapy in postmenopausal women: a comparison of studies in the United States, the United Kingdom, and France.

OBJECTIVES: The aim of this study was to determine the effect of dose frequency on compliance and persistence with bisphosphonate therapy in postmenopausal women and to compare findings from 3 different health care systems. METHODS: Three independently performed retrospective cohort analyses were performed using observational data sources. In the United States, bisphosphonate-naive postmenopausal women were identified from a database providing information on health plan prescription drug claims; in the United Kingdom and France, bisphosphonate-naive postmenopausal women were identified from a database of medical records supplied by general practice physicians. The women were grouped into 2 cohorts: those who were initiated on a weekly regimen of alendronate 70 mg or risedronate 35 mg and those initiated on a daily regimen of alendronate 5 or 10 mg or risedronate 5 mg. Compliance was measured in terms of the medication possession ratio (MPR), which was defined as the proportion of days in the 12-month follow-up period for which patients were covered by prescriptions for bisphosphonates. Persistence was measured as the number of days from the date of the index prescription to the last day of prescription coverage within the followup period. Women were classified as nonpersistent if the gap between prescriptions was > 30 days. RESULTS: The study included 2741 postmenopausal women with osteoporosis from the United States, 7567 from the United Kingdom, and 5332 from France. The mean (SD) age of the women was 73.0, 71.7, and 69.7 years in the 3 countries, respectively. The overall MPR was 61% in the United States, 74% in the United Kingdom, and 58% in France. In all 3 countries, women on a weekly regimen had a significantly greater MPR than women on a daily regimen (69% vs 58%, respectively, in the United States; 76% vs 64% in the United Kingdom; and 59% vs 53% in France; all, P < 0.001). Women on a weekly regimen of bisphosphonates persisted with treatment significantly longer than women on a daily regimen (227 vs 185 days, respectively, in the United States; 249 vs 208 in the United Kingdom; and 179 vs 155 in France; all, P < 0.001). A significantly greater proportion of the women on a weekly regimen persisted with treatment for 12 months compared with those on a daily regimen (44% vs 32%, respectively, in the United States; 52% vs 40% in the United Kingdom; and 51% vs 44% in France; all, P < 0.001). CONCLUSIONS: In all 3 countries, postmenopausal women prescribed a weekly regimen of bisphosphonates had significantly greater rates of compliance than women prescribed a daily regimen, and they persisted longer with treatment. However, compliance and persistence rates were suboptimal for both regimens.

Cohort Studies↗

PubMed2005

Differentiating anxiety and depression symptoms in patients with partial epilepsy.

Anxiety and depression are separate psychiatric conditions that are often interrelated. This study examines whether they exist independently in this population of patients with partial epilepsy and if they affect all quality-of-life domains. Adult epilepsy patients taking two or more antiepileptic drugs completed a health status survey including demographic items, the Hospital Anxiety and Depression Scale, and the Quality of Life in Epilepsy-10 (QOLIE-10). The questionnaire was completed by 201 epilepsy patients. Symptom prevalences of anxiety (52% none, 25% mild, 16% moderate, 7% severe) and depression (62% none, 20% mild, 14% moderate, 4% severe) were high. All health-related quality-of-life (HRQOL) domains worsened significantly with increasing levels of anxiety and depression: Total QOLIE-10 scores decreased from 72+/-18 in patients with no anxiety to 54+/-13 in those with mild, 48+/-18 in those with moderate, and 40+/-23 in those with severe anxiety (P<0.0001). Total QOLIE-10 scores decreased from 70+/-16 in patients with no depression to 50+/-16 in those with mild, 45+/-16 in those with moderate, and 24+/-21 in those with severe depression (P<0.0001). No significant difference in anxiety scores was observed controlling for seizure frequency or epilepsy duration. Regression analyses showed that anxiety and depression account for different proportions of variance as predictors of HRQOL (R2=0.337 (anxiety) and 0.511 (depression)). The data suggest that patients may benefit from increased attention to the role of anxiety separately from depression.

Adult↗

PubMed2005

Brief report: a quality of life instrument for adolescents with growth disorders.

This study assessed the psychometric properties of a recently developed health-related quality of life (HRQOL) instrument (Vécu et Santé Perçue de l'Adolescent -Malade, VSP-AM) in 172 adolescents receiving growth hormone. The VSP-AM was cross-culturally adapted into English and tested for internal consistency (alpha=0.78-0.89 subscales, 0.74 Summary Score), construct and criterion validity, and responsiveness. Correlations with other scales demonstrated convergent validity. Adolescents who reported HRQOL as high or low had significantly different scores (all p<0.001). Adolescents receiving growth hormone therapy differed significantly from adolescents with medical, surgical or psychiatric disorders. The VSP-AM shows reliability and validity for HRQOL measurement in adolescents with growth disorders.

Adolescent↗

PubMed2005

The impact of epilepsy on health status among younger and older adults.

PURPOSE: The incidence of epilepsy is highest among the elderly, yet our understanding of the impact of epilepsy is based predominantly on inferences from studies of younger adults. This study examines the impact of epilepsy on patients' subjective health status in a population that includes both younger and older adults. METHODS: We used national administrative and survey databases from the Veterans Health Administration to examine health status as measured by a modification of the SF-36 (RV-36) in patients from three age cohorts: young adults (18-40 years), middle-aged adults (41-64 years), and older adults (65 years and older). Because chronicity of epilepsy may influence these outcomes, we compared scores for patients with new-onset epilepsy, chronic epilepsy, and no epilepsy by using analysis of covariance, controlling for patient demographic and clinical characteristics that may also affect health status. RESULTS: With the exception of physical status measures, older adults appeared to cope better with their epilepsy than did middle-aged patients. Young adults with new-onset epilepsy reported poor general health and worse mental health, but high levels of physical function and physical activity. Middle-aged patients with new-onset epilepsy scored lowest in all domains, and their peers with chronic epilepsy also reported poor general physical health and emotional functioning. CONCLUSIONS: Although having fewer physiologic reserves, older adults appeared most resilient in facing this chronic illness, and middle-aged adults fared the worst. Interventions to improve quality of life among patients with epilepsy should be tailored to age and epilepsy chronicity.

Adolescent↗

PubMed2005

Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis.

OBJECTIVE: Poor compliance and persistence with bisphosphonates is a concern in postmenopausal osteoporosis due to its negative impact on fracture risk and healthcare costs as well as quality of life. Reducing oral bisphosphonate dosing frequency is one measure available to increase therapy convenience and practicality, with the hope of improving compliance and persistence. This study compared compliance and persistence with weekly and daily bisphosphonate regimens for postmenopausal osteoporosis. METHODS: Administrative claims data (1997-2002) from 30 health plans were used to identify postmenopausal women (> 45 years) with osteoporosis, who had been newly prescribed a once-weekly (QW alendronate 35 mg or 70 mg) or once-daily (QD alendronate 5 mg or 10 mg or risedronate 5 mg) bisphosphonate. QW and QD cohorts were followed for 12 months from initial prescription. Medication possession ratios (MPRs) measured refill compliance during follow-up. Persistence was calculated as the number of days from the initial prescription to a lapse of > 30 days after completion of the previous refill. RESULTS: Data were available for 2741 women (QW, N = 731, QD, N = 2010). QW users had significantly higher medication compliance than QD users (69.2% vs. 57.6% MPR, p < or = 0.0001). QW users persisted with therapy significantly longer than QD users (p < 0.0001) and had higher rates of retention on treatment at 12 months than QD users (44.2% QW; 31.7% QD). Dosing frequency was the strongest predictor of time to discontinuation (p < 0.0001). CONCLUSIONS: Postmenopausal women prescribed a weekly bisphosphonate had significantly better compliance and persistence than those taking more frequent, daily bisphosphonate doses. However, compliance and persistence rates for both regimens were suboptimal, suggesting that less frequent dosing intervals may provide an opportunity to further improve the consistent use of bisphosphonate therapy.

Age Factors↗

PubMed2005

The influence of insulin use on glycemic control: How well do adults follow prescriptions for insulin?

OBJECTIVE: The purposes of this study were to determine the relationship between insulin self-management and glycemic control and to identify patient characteristics associated with better control. RESEARCH DESIGN AND METHODS: A Department of Veterans Affairs regional database was used to identify patients with diabetes on chronic insulin therapy (n = 6,222) with dose defined as number of units and doses. The rate of insulin use during a 2-year period was calculated using pharmacy data. Regression analyses were used 1) to predict compliance with prescribed insulin regimens using demographic variables, HbA1c levels, and a measure of diabetes management intensity and 2) to predict HbA1c levels using demographic variables and rates of insulin use. RESULTS: Insulin use was 77.44 +/- 17% of prescribed amounts, including wastage; HbA1c levels were 7.98 +/- 1.66%. Concomitant oral hypoglycemic agent use (84.89 +/- 16%) was higher than insulin use (P < 0.0001) but correlated with insulin use (r = 0.189, P < 0.0001). Ordinary least-squares regression showed that race, HbA1c levels, and intensity of diabetes management were significant predictors of insulin use. Age, race, and insulin use were significant predictors of HbA1c levels. CONCLUSIONS: Adults prescribed a specific insulin regimen averaged using 77% of prescribed doses, demonstrating good intention to follow the prescription. However, HbA1c higher than the recommended level suggested that the rate of insulin use, the prescribed regimen, or both were inadequate to achieve good glycemic control in patients with long-term insulin use.

Administration, Oral↗

PubMed2004

Quality of life improvement with conversion to lamotrigine monotherapy.

This report describes the effect on patient-reported quality of life (QOL) after reduction from two drugs to monotherapy with lamotrigine. Patients taking lamotrigine (LTG) with an enzyme-inducing drug were converted to LTG monotherapy for a 12-week follow-up. Changes in QOLIE-31 between baseline and follow-up were compared with physicians' global change ratings and patient-reported health status. Total QOLIE-31 scores increased 10.7 points for patients rated by physicians as having mild improvement, and 17 points for those reported as having moderate to marked improvement. Subscale scores also increased by minimum important change (MIC) amounts (> or = 11.76), with the largest change in Cognition, Energy, Medication Effects, and Seizure Worry subscales. The data also support > or = 11 MIC as a clinically important change in total score for the QOLIE-31. Exploratory analyses also provide information about MIC for individual subscales (8-18 for physician rated global change, 10-26 for patient-rated global health status change). This study demonstrates the value of reduction to monotherapy from the patients' and physicians' perspectives.

Adolescent↗

PubMed2004

The impact of comorbid depression on health resource utilization in a community sample of people with epilepsy.

This study assessed the impact of comorbid depression on health care utilization and health care coverage by people with epilepsy in US communities using a postal survey questionnaire. People with untreated depression used significantly more health resources of all types assessed with and without adjustment for seizure type, seizure recency, and days with epilepsy symptoms. The number of visits to medical doctors and psychiatrists differed significantly among people with no (N = 443), mild to moderate (N = 58), and severe (N = 148) symptoms of depression who were not receiving antidepressant treatment (all P < 0.001). People with current symptoms treated with antidepressants had more medical visits than people with no current symptoms ( P=0.016 ). People with current symptoms but not treated for depression had more medical and psychiatric visits than people with no current symptoms (both P = 0.001). These data highlight the impact of comorbid depression on health care utilization by people with epilepsy.

Adult↗

PubMed2004

Improved mood states with lamotrigine in patients with epilepsy.

Lamotrigine (LTG) was added to other antiepileptic drugs (AEDs) in a study of adjunctive therapy. In addition to seizure control and adverse effects, patients were evaluated for changes in mood states and quality of life. The Profile of Mood States (POMS) and 31-item Quality of Life in Epilepsy (QOLIE-31) instruments were administered at baseline (N=196), after addition of LTG as adjunctive treatment (N=155), and after withdrawal of other drugs to LTG monotherapy (N=51). POMS scores correlated highly with the QOLIE-31 Emotional Well-Being subscale, a known measure of mood. All POMS subscales were significantly improved (all P<0.0001) at the end of the adjunctive therapy phase. POMS scores remained significantly better than baseline among patients completing the conversion to monotherapy (all P<0.003). Minimal clinically important changes were determined for POMS scores. These data indicate that LTG improves mood states to a clinically important degree, even in the presence of other AEDs. The improvement likely was not a synergy but attributable only to LTG because it remained stable after withdrawal of the other AEDs.

Adult↗

PubMed2004

Electronic monitoring and counseling to improve medication adherence.

Electronic caps, pill caps that record the date and time of pill bottle opening provide an objective measure of adherence to prescribed medication. A promising intervention to improve adherence, cue-dose training, involves reviewing patients' pill cap-generated reports concerning their medication-taking and offering individualized recommendations for remembering to take medications at specific times of day. In this preliminary study, 79 patients prescribed the antihyperglycemic medication metformin had adherence assessed during a 4-week baseline period. Adherence, defined as proportion of prescribed doses taken within a predetermined 4-h window, was measured using electronic MEMS caps. Those who had less than 80% baseline adherence (n = 33) were randomly assigned to either receive 4 months of cue-dose training (n = 16) or to a control group (n = 17). Cue-dose training was associated with significantly better adherence to metformin (mean improvement of 15%). The effects of cue-dose training on adherence to other antihyperglycemic medication did not reach statistical significance. Glycosylated hemoglobin (a measure of blood sugar control) did not differ between groups. Data from nine patients who reviewed pill cap-generated data with their primary care providers suggested that both patients and providers found the discussion moderately helpful and not at all uncomfortable.

Cues↗

PubMed2004

Results of a naturalistic study of treatment options: switching atypical antipsychotic drugs or augmenting with valproate.

BACKGROUND: Combination therapy with atypical antipsychotic agents has not been well studied. Duration of persistence with a prescribed treatment regimen can be used to estimate overall treatment success. OBJECTIVE: The aim of this study was to determine whether valproate augmentation improved treatment efficacy (ie, persistence with the prescribed regimen) and efficacy (ie, reduction of antipsychotic dose) with atypical antipsychotic drugs for older and younger patients, using a retrospective database analysis. METHODS: Prescription refill data for atypical antipsychotics during calendar-year 2001 from a national pharmacy chain was used for longitudinal analyses. The database was used to identify patients aged 15 to 64 years and > or =65 years taking risperidone, quetiapine, or olanzapine (but not valproate). Patients who switched to another atypical antipsychotic (group A) or added valproate (group B) were followed after the index prescription to determine the duration of persistence with the treatment regimen and dose changes. RESULTS: We identified 10,262 patients who were prescribed an atypical antipsychotic, of whom 1022 patients switched to an alternative atypical and 1651 added valproate to the index atypical. The addition of valproate provided significantly longer duration of treatment regimen (mean, 155-159 days) than switching from any atypical antipsychotic drug (mean, 127-130 days) for patients aged 15 to 64 years or > or =65 years (all P<0.001). Atypical antipsychotic doses did not change significantly from baseline to final prescription in groups A or B. The final mean (SD) dose of valproate added to risperidone (389.1 [130.7] mg/d) was significantly lower than valproate added to quetiapine (424.6 [117.1] mg/d; P=0.002) or olanzapine (411.6 [122.8] mg/d; P=0.007). CONCLUSIONS: In this naturalistic study, the addition of valproate to an atypical antipsychotic increased the duration of treatment compared with switching among atypical antipsychotics. Valproate augmentation may be a good treatment strategy for patients whose atypical antipsychotic monotherapy is inadequate.

Adolescent↗

PubMed2004

Development of a growth hormone injection questionnaire for adolescents.

We developed an instrument to assess feelings about self-injection of growth hormone (GH) in adolescents with growth disorders. Summary scores did not differ significantly by cohort, age, gender, or diagnosis. Adolescents who were more comfortable with GH injections had higher health-related quality of life, functional capacity, and self-control.

Adolescent↗

PubMed2004

A systematic review of adherence with medications for diabetes.

OBJECTIVE: The purpose of this study was to determine the extent to which patients omit doses of medications prescribed for diabetes. RESEARCH DESIGN AND METHODS: A literature search (1966-2003) was performed to identify reports with quantitative data on adherence with oral hypoglycemic agents (OHAs) and insulin and correlations between adherence rates and glycemic control. Adequate documentation of adherence was found in 15 retrospective studies of OHA prescription refill rates, 5 prospective electronic monitoring OHA studies, and 3 retrospective insulin studies. RESULTS: Retrospective analyses showed that adherence to OHA therapy ranged from 36 to 93% in patients remaining on treatment for 6-24 months. Prospective electronic monitoring studies documented that patients took 67-85% of OHA doses as prescribed. Electronic monitoring identified poor compliers for interventions that improved adherence (61-79%; P < 0.05). Young patients filled prescriptions for one-third of prescribed insulin doses. Insulin adherence among patients with type 2 diabetes was 62-64%. CONCLUSIONS: This review confirms that many patients for whom diabetes medication was prescribed were poor compliers with treatment, including both OHAs and insulin. However, electronic monitoring systems were useful in improving adherence for individual patients. Similar electronic monitoring systems for insulin administration could help healthcare providers determine patients needing additional support.

Diabetes Mellitus↗

PubMed2003

Tolerability of levetiracetam in elderly patients with CNS disorders.

The purpose of this analysis was to compare treatment-emergent adverse events (TEAE) related to use of levetiracetam (LEV) reported by young and elderly patients with anxiety and cognitive disorders, and young epilepsy patients. The LEV database includes reports of TEAE from trials of patients with diagnoses of a cognitive disorder (N=719), an anxiety disorder (N=1510), or localization-related epilepsy (N=1023) who participated in clinical trials lasting up to 16 weeks. Patients were grouped as young (<65 years) or elderly (> or = 65 years). The most common TEAE occurring most frequently in the LEV-treated groups were abdominal pain, asthenia, headache, anorexia, weight loss, dizziness, insomnia, somnolence, and tremor. The only significant differences in TEAE were seen between young and elderly groups with anxiety disorders (>3% higher for LEV than for placebo-treated patients) in headache (5.2% elderly, -0.9% young, P=0.041), and tremor (5.2 and -0.5%, respectively, P=0.022) and between young anxiety patients and young epilepsy patients for somnolence (-0.7 and 5.4%, respectively, P=0.036). For the other TEAEs there was no evidence for consistent differences between young and elderly patients and between patients with different CNS disorders. Overall, LEV was well tolerated by all patient groups. The favorable adverse event profile suggests that LEV might be suitable for use by elderly patients.

Adolescent↗

PubMed2003

The influence of comorbid depression on quality of life for people with epilepsy.

The impact of depression on health-related quality of life (HRQOL) for people with epilepsy was evaluated using a postal survey that assessed HRQOL, depression, and seizure severity (N=501). QOLIE-89 scores were significantly reduced by comorbid depression (all P<0.0001) for all types of seizures. People with predominantly major, partial, and minor seizures had significantly poorer HRQOL if they had mild-moderate or major depression (all P<0.0001). People with any type of recent seizure had significantly poorer HRQOL in all domains than people who were seizure-free for 3 months. Differences between groups by depression category were clinically significant (>12 points). Depression (r=-0.72), seizure bothersomeness (r=-0.54), seizure severity (r=-0.37), and days disabled with seizures (r=-0.65) were significantly correlated with poorer HRQOL in all domains than found for nondepressed patients (all subscales P<0.0001). Clinical depression is significantly associated with poorer HRQOL among people with all types of seizures.

Adult↗

PubMed2003

Maintenance of improvement in health-related quality of life during long-term treatment with levetiracetam.

Health-related quality of life (HRQOL) of patients taking levetiracetam (LEV) was evaluated in long-term follow-up. Short-term assessments compared LEV and placebo add-on therapy in an 18-week clinical trial, with long-term follow-up for a mean of 4.1 years. The QOLIE-31 was expanded to assess distress associated with each domain, change, and priority of importance of each domain. Significant improvements were observed at short-term in patients starting with LEV (N=66), whereas patients initially randomized to placebo (N=35) were unchanged. Improvement observed in LEV starters remained stable long-term. Placebo starters reached the same level of improvement in HRQOL at long-term. Correlations between the QOLIE-31-P distress items and domain items indicated that distress was significantly lower when HRQOL was better (P<0.0001, all domains). At long-term, highest-priority QOLIE-31-P domains were Social Functioning, Cognitive Function, and Overall QOL. Thus, gains in HRQOL were maintained during long-term LEV treatment, whether LEV was initiated early or late. Patient distress and importance of domains are useful data in determining how treatments impact on HRQOL.

Adolescent↗

PubMed2003

A systematic review of the behavioral effects of levetiracetam in adults with epilepsy, cognitive disorders, or an anxiety disorder during clinical trials.

This report reviews behavioral adverse events occurring among adults receiving levetiracetam (LEV) or placebo who participated in short-term, placebo-controlled studies in epilepsy (1023), cognitive disorders (719), or anxiety disorders (1510) and epilepsy patients (1393) observed in long-term trials. Behavioral events (affective, psychotic, and suicidal symptoms) were significantly more common among epilepsy patients than cognition or anxiety patients treated with LEV for similar durations (P=0.022). Affective symptoms occurring at 1% or more often in epilepsy placebo-controlled trials included depression (3.8% LEV-2.1% placebo), nervousness (3.8%-1.8%), hostility (2.3%-0.9%), anxiety (1.8%-1.1%), and emotional lability (1.7%-0.2%). Patients with cognitive and anxiety disorders had lower incidences of these symptoms. The incidence of behavioral events in LEV-treated epilepsy patients was lower than rates reported for some other antiepileptic drugs. These data support the hypothesis that some feature related to epilepsy is the cause of many behavioral events rather than the addition of a specific antiepileptic drug.

Humans↗