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Biomedical subjects

Margaret J Gunter

Publications and source records attributed to Margaret J Gunter.

15 recordsLinked to original sources

Laboratory monitoring of potassium and creatinine in ambulatory patients receiving angiotensin converting enzyme inhibitors and angiotensin receptor blockers.

PURPOSE: Serum potassium and creatinine monitoring is recommended for patients prescribed angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB). Much has been written about hyperkalemia associated with these drugs; little is known about laboratory monitoring patterns. The purpose of this retrospective cohort study was to assess creatinine and potassium monitoring and characteristics associated with monitoring among patients dispensed ACEi or ARB. METHODS: This study was conducted in 10 United States health maintenance organizations. Study patients (n = 52 906) were aged 18 or older with dispensings of ACEi or ARB for at least 1 year. Serum potassium and creatinine monitoring were assessed from administrative data and medical records. RESULTS: More than two-thirds (68.4%) of patients received laboratory monitoring. Likelihood of monitoring increased with age (adjusted odds ratio [OR] 2.10; 95% confidence interval [95%CI] 1.93, 2.28 [individuals >or= 80 compared to <50 years]), >9 outpatient visits (OR 1.46; 95%CI 1.39, 1.54), hospitalization (OR 1.15; 95%CI 1.06, 1.25), concomitant medications (potassium [OR 2.01; 95%CI 1.84, 2.20], diuretics [OR 1.54; 95%CI 1.47, 1.61], digoxin [OR 1.15; 95%CI 1.01, 1.30]), and comorbidities (diabetes [OR 1.68; 95%CI 1.61, 1.75], heart failure [OR 1.73; 95%CI 1.57, 1.90], chronic kidney disease [OR 2.95; 95%CI 2.48. 3.51]). CONCLUSIONS: Nearly one-third of patients dispensed ACEi or ARB did not undergo laboratory monitoring at least yearly. Though patients at increased risk of hyperkalemia were more likely to be monitored, many remained unmonitored.

Adult↗

Frequency of serum creatinine monitoring during allopurinol therapy in ambulatory patients.

BACKGROUND: Allopurinol dosage reduction is recommended in patients with renal dysfunction because drug toxicity risk is increased. Little information is available about serum creatinine (SCr) monitoring in ambulatory patients taking allopurinol. OBJECTIVE: To evaluate SCr monitoring among patients prescribed allopurinol, identify associated factors, and evaluate administrative data in assessing monitoring. METHODS: Information for this retrospective cohort study was drawn from a dataset of 2 020 037 individuals; approximately 200 000 members from each of 10 organizations. Study patients had received at least one year of ongoing allopurinol prescription dispensings. Patient variables analyzed included age, gender, chronic diseases, outpatient visits, hospitalizations, gout diagnosis, and SCr monitoring. A random sample of medical records was reviewed to assess the accuracy of the automated data. Statistical analysis included descriptive and logistic regression techniques. RESULTS: Overall, 1139 (26%) of 4357 patients did not have SCr monitoring. For individuals without recent hospitalization, factors protective against lack of monitoring were increasing age (OR 0.77 per 10 y; 95% CI 0.74 to 0.79), more chronic diseases (OR 0.81; 95% CI 0.78 to 0.83), more outpatient visits (OR 0.87 per 5 visits; 95% CI 0.83 to 0.91), and gout diagnosis (OR 0.74; 95% CI 0.65 to 0.85). The sensitivity and specificity of administrative data compared with medical records for SCr monitoring were 92% and 65%, respectively. CONCLUSIONS: More than one-fourth of patients dispensed allopurinol did not have SCr monitoring during one year of therapy. Lack of monitoring and lack of subsequent possible dosage adjustment put patients at increased risk of allopurinol toxicity.

Adolescent↗

Monitoring of drugs with a narrow therapeutic range in ambulatory care.

OBJECTIVES: To describe the proportion of patients receiving drugs with a narrow therapeutic range who lacked serum drug concentration monitoring during a 1-year period of therapy and to identify patient characteristics associated with lack of monitoring. STUDY DESIGN: Retrospective cohort. METHODS: Ambulatory patients (n = 17,748) at 10 health maintenance organizations who were receiving ongoing continuous drug therapy with digoxin, carbamazepine, divalproex sodium, lithium carbonate, lithium citrate, phenobarbital sodium, phenytoin, phenytoin sodium, primidone, quinidine gluconate, quinidine sulfate, procainamide hydrochloride, theophylline, theophylline sodium glycinate, tacrolimus, or cyclosporine for at least 12 months between January 1, 1999, and June 30, 2001, were identified. Serum drug concentration monitoring was assessed from administrative data and from medical record data. RESULTS: Fifty percent or more of patients receiving digoxin, theophylline, procainamide, quinidine, or primidone were not monitored, and 25% to 50% of patients receiving divalproex, carbamazepine, phenobarbital, phenytoin, or tacrolimus were not monitored. Younger age was associated with lack of monitoring for patients prescribed digoxin (adjusted odds ratio, 1.86; 95% confidence interval, 1.39-2.48) and theophylline (adjusted odds ratio, 1.58; 95% confidence interval, 1.23-2.04), while older age was associated with lack of monitoring for patients prescribed carbamazepine (adjusted odds ratio, 0.59; 95% confidence interval, 0.44-0.80) and divalproex (adjusted odds ratio, 0.50; 95% confidence interval, 0.38-0.66). Patients with fewer outpatient visits were also less likely to be monitored (P < .001). CONCLUSIONS: A substantial proportion of ambulatory patients receiving drugs with narrow intervals between doses resulting in beneficial and adverse effects did not have serum drug concentration monitoring during 1 year of use. Clinical implications of this finding need to be evaluated.

Ambulatory Care↗

Developing a computer algorithm to identify epilepsy cases in managed care organizations.

The goal of this study was to develop an algorithm for detecting epilepsy cases in managed care organizations (MCOs). A data set of potential epilepsy cases was constructed from an MCO's administrative data system for all health plan members continuously enrolled in the MCO for at least 1 year within the study period of July 1, 1996 through June 30, 1998. Epilepsy status was determined using medical record review for a sample of 617 cases. The best algorithm for detecting epilepsy cases was developed by examining combinations of diagnosis, diagnostic procedures, and medication use. The best algorithm derived in the exploratory phase was then applied to a new set of data from the same MCO covering the period of July 1, 1998 through June 30, 2000. A stratified sample based on ethnicity and age was drawn from the preliminary algorithm-identified epilepsy cases and non-cases. Medical record review was completed for 644 cases to determine the accuracy of the algorithm. Data from both phases were combined to permit refinement of logistic regression models and to provide more stable estimates of the parameters. The best model used diagnoses and antiepileptic drugs as predictors and had a positive predictive value of 84% (sensitivity 82%, specificity 94%). The best model correctly classified 90% of the cases. A stable algorithm that can be used to identify epilepsy patients within MCOs was developed. Implications for use of the algorithm in other health care settings are discussed.

Adult↗

Estimating prevalence, incidence, and disease-related mortality for patients with epilepsy in managed care organizations.

PURPOSE: The purpose of the present study was to apply computer algorithms to an administrative data set to identify the prevalence of epilepsy, incidence of epilepsy, and epilepsy-related mortality of patients in a managed care organization (MCO). METHODS: The study population consisted of members enrolled in Lovelace Health Plan, a component of Lovelace Health Systems, a statewide MCO headquartered in Albuquerque, New Mexico. Patient records were obtained from July 1996 to June 2001. Four logistic regression models with high sensitivity and specificity were applied to 1-, 3-, and 5-year time frames in which members were continuously enrolled in the MCO. Incidence was defined for patients who did not have an epilepsy-associated code in the 18 months before the first diagnosis entry. Mortality estimates in the population also were assessed by using a matched control group and linkage to a statewide death registry. RESULTS: The data yielded estimated prevalence rates of 7-10 per 1,000, depending on age, sex, ethnicity, and time interval. Annualized incidence was 47 per 100,000 for members continuously enrolled for 3 years and 71 per 100,000 for members continuously enrolled for 5 years. Crude mortality rates were 2-2.5 times higher for epilepsy patients identified with the algorithms than for the matched controls. Conditional logistic regression indicated that the odds of death for epilepsy patients as compared with controls ranged from 1.24 to 2.06. CONCLUSIONS: Accurate estimation of prevalence, incidence, and mortality rates for epilepsy is an essential component of disease management in MCOs. The algorithms in this project can be used to monitor trends in prevalence, incidence, and mortality to inform decisions critical to improving the health care needs and quality of life for patients with epilepsy.

Adult↗

Laboratory monitoring of drugs at initiation of therapy in ambulatory care.

BACKGROUND AND OBJECTIVES: Product labeling and published guidelines reflect the importance of monitoring laboratory parameters for drugs with a risk of organ system toxicity or electrolyte imbalance. Limited information exists about adherence to laboratory monitoring recommendations. The objective of this study was to describe laboratory monitoring among ambulatory patients dispensed medications for which laboratory testing is recommended at therapy initiation. DESIGN AND SUBJECTS: We conducted a retrospective cross-sectional analysis of patients in 10 geographically distributed health maintenance organizations who were newly prescribed medications with recommended laboratory test monitoring. The main outcome measure was the proportion of initial drug dispensing without recommended baseline laboratory monitoring for 35 newly initiated drugs or drug classes. RESULTS: One hundred seven thousand, seven hundred sixty-three of 279,354 (39%) initial drug dispensings occurred without recommended laboratory monitoring. Patients without monitoring were younger than patients who had monitoring (median 57 vs 61 years, P<.001). Thirty-two percent of dispensings where a serum creatinine was indicated did not have it evaluated (range across drugs, 12% to 61%); 39% did not have liver function testing (range 10% to 75%); 32% did not have hematologic monitoring (range 9% to 51%); and 34% did not have electrolyte monitoring (range 20% to 62%) (P<.001). CONCLUSIONS: Substantial opportunity exists to improve laboratory monitoring of drugs for which such monitoring is recommended. This study emphasizes the need for research to identify the clinical implications of not conducting recommended laboratory monitoring, existing barriers to monitoring, and methods to improve practice.

Ambulatory Care↗

Laboratory safety monitoring of chronic medications in ambulatory care settings.

OBJECTIVE: To evaluate laboratory safety monitoring in patients taking selected chronic prescription drugs. DESIGN: Retrospective study using 1999-2001 claims data to calculate rates of missed laboratory tests (potential laboratory monitoring errors). Eleven drugs/drug groups and 64 laboratory tests were evaluated. SETTING: Two staff/network model health maintenance organizations. PATIENTS: Continuously enrolled health plan members age> or =19 years taking > or =1 chronic medications. MEASUREMENTS AND MAIN RESULTS: Among patients taking chronic medications (N=29,823 in 1999, N=32,423 in 2000, and N=36,811 in 2001), 47.1% in 1999, 45.0% in 2000, and 44.0% in 2001 did not receive > or =1 test recommended for safety monitoring. Taking into account that patients were sometimes missing more than 1 test for a given drug and that patients were frequently taking multiple drugs, the rate of all potential laboratory monitoring errors was 849/1,000 patients/year in 1999, 810/1,000 patients/year in 2000, and 797/1,000 patients/year in 2001. Rates of potential laboratory monitoring errors varied considerably across individual drugs and laboratory tests. CONCLUSIONS: Lapses in laboratory monitoring of patients taking selected chronic medications were common. Further research is needed to determine whether, and to what extent, this failure to monitor patients is associated with adverse clinical outcomes.

Ambulatory Care↗

Health plan members' views on forgiving medical errors.

BACKGROUND: How patients respond to medical errors may influence how physicians approach disclosure of medical errors, but information on patients' responses is limited. Research is needed on how the circumstances that surround a medical error affect how patients respond. OBJECTIVE: To investigate whether patients' tendency to forgive a physician following a medical error varied under different circumstances. STUDY DESIGN: Cross-sectional survey. METHODS: We mailed a questionnaire to 1500 randomly selected health plan members; the response rate was 66%. Questionnaire items assessed the likelihood of forgiveness following a medical error under 12 circumstances drawn from a review of the literature. RESULTS: Respondents were most likely to forgive a physician if the patient failed to provide complete information (93% would or might forgive) and least likely to forgive if the error was due to efforts to keep costs down (11% would or might forgive). Most respondents would not forgive a physician when the physician was tired or distracted (68%), was incomplete in data collection (76%), lacked knowledge (78%), or failed to follow up (85%). Men were more likely to forgive than women; the most educated respondents were most likely to forgive. CONCLUSIONS: Our findings suggest that patients are not likely to forgive a physician in circumstances in which they suspect incompetence, inattention, or a lack of caring on the part of the physician involved. A more comprehensive understanding of forgiveness and the effect of forgiveness on the physician-patient relationship following a medical error is needed.

Cross-Sectional Studies↗

Management of epilepsy in adults. Diagnosis guidelines.

In this first of two articles on new epilepsy guidelines for primary care physicians, the authors present detailed algorithms for the diagnosis and classification of seizure disorders in adults. They discuss the differentiation between generalized and partial seizures and stress that accurate identification is especially important because the type of seizure determines the appropriate treatment. The second article (page 29) looks at the treatment portion of the new guidelines.

Adolescent↗

Management of epilepsy in adults. Treatment guidelines.

In this second of two articles on new epilepsy guidelines for primary care physicians, the authors discuss which treatments are the most effective in adults with this disease. They describe the antiepileptic drugs that are currently approved and elucidate the differences between established and newer options. Detailed algorithms cover pharmacotherapy, follow-up, and ongoing maintenance.

Adult↗

Health plan members' views about disclosure of medical errors.

BACKGROUND: Various authorities and national organizations encourage disclosing medical errors, but there is little information on how patients respond to disclosure. OBJECTIVE: To examine how the type of error, severity of adverse clinical outcome, and level of disclosure affect patients' responses to error and disclosure. DESIGN: Mail questionnaire survey (8 versions were developed) varying 3 factors in a completely crossed, randomized, factorial design. Each questionnaire included a vignette describing 1) a medical error (failure to check for penicillin allergy or inadequate monitoring of antiepileptic medication); 2) an associated clinical outcome (life-threatening or less serious); and 3) a physician-patient dialogue, with either full disclosure (acceptance of responsibility and an apology) or nondisclosure (expression of regret without acceptance of responsibility or an apology). SETTING: New England-based health plan. PARTICIPANTS: Random sample of 1500 adult members received the questionnaire, with a 66% response rate. MEASUREMENTS: Likelihood of changing physicians, likelihood of seeking legal advice, ratings of patient satisfaction, trust and emotional reaction in response to a vignette and dialogue, and views on medical error and disclosure. RESULTS: Full disclosure reduced the reported likelihood of changing physicians and increased patient satisfaction, trust, and positive emotional response. Full disclosure reduced the reported likelihood of seeking legal advice in only 1 error-and-outcome vignette. In the other vignettes, the percentage of patients indicating that they would seek legal advice was relatively high even with full disclosure. Almost all respondents (98.8%) wanted to be told of errors, most (83%) favored financial compensation if harm occurred, and few (12.7%) favored compensation if no harm occurred. LIMITATIONS: Since the study was done in the context of a managed care plan in one geographic area, it could not assess whether the results are generalizable to other populations. In addition, it could not determine whether responses to the simulated situations used predict responses to real situations. CONCLUSIONS: Patients will probably respond more favorably to physicians who fully disclose medical errors than to physicians who are less forthright, but the specifics of the case and the severity of the clinical outcome also affect patients' responses. In some circumstances, the desire to seek legal advice may not diminish despite full disclosure.

Adult↗

Impact of a seizure disorder disease management program on patient-reported quality of life.

The objective of this study was to evaluate the impact of a comprehensive, multifaceted disease management program on self-reported quality of life (QOL) for adult patients with epilepsy. The study (1996-2000) employed a quasi-experimental research design in which primary care clinics in a southwestern integrated delivery system were assigned to either the intervention or comparison group. The impact evaluation involved a comparison of responses to a validated QOL survey before and after a disease management intervention for adult health plan members with epilepsy. The intervention consisted of both formal provider training and associated tools and reinforcements as well as direct-to-patient interventions, including a comprehensive education booklet, a seizure diary, a patient education class, and a resource list. Pre-post analysis utilizing paired t-tests was conducted to identify any pre-post differences in QOL for both the intervention and comparison group patients, as measured by the seven specific domains of the epilepsy QOL instrument (QOLIE-31). The intervention group patients showed statistically significant positive changes in two QOL domains: Seizure Worry (p < 0.001) and Emotional Well-being (p < 0.05). One other domain, Overall Quality of Life, showed improvement in the intervention group that approached statistical significance (p < 0.06). There were no statistically significant changes for the comparison group. A well-designed, comprehensive disease management program can improve patient empowerment and coordination of care between the patient and provider, which resulted in an improvement in quality of life, one of the most central patient outcomes in this difficult disease.

Adolescent↗

Adequacy of glycemic, lipid, and blood pressure management for patients with diabetes in a managed care setting.

OBJECTIVE: We conducted a retrospective study to evaluate the adequacy of glycemic, lipid, and blood pressure (BP) management for diabetic patients in a managed care organization (MCO). RESEARCH DESIGN AND METHODS: Patients aged > or =18 years with diabetes (n=7,114) were retrospectively identified over a 2-year period from the MCO's administrative database based on the Health Plan Employer Data and Information Set 2000 selection criteria using pharmacy, laboratory, and encounter data. Analyses examined demographics and percentages of patients tested and meeting American Diabetes Association goals for HbA1c, lipids, and BP, both overall and for those receiving medication treatment versus no treatment. RESULTS: Testing rates for A1C, LDL cholesterol, and BP were 77, 54, and 95%, respectively. The percentage of patients tested who were at goal were 37% for A1C, 23% for LDL cholesterol, and 41% for systolic BP. Of the patients in our sample, 72% were treated for glycemic control, 64% were treated for BP control, and only 28% were treated for lipid control. Of the patients who received medication treatment, less than one-third were at goal for A1C (29%) and LDL cholesterol (32%), whereas 40% were at goal for systolic BP. CONCLUSIONS: We found that although a large percentage of diabetic patients were tested for A1C, LDL cholesterol, and systolic BP, a much smaller percentage had reached their respective goals. More aggressive glycemic, lipid, and BP management appears to be needed to improve care for these patients.

Adolescent↗

Measuring patient safety in ambulatory care: potential for identifying medical group drug-drug interaction rates using claims data.

OBJECTIVE: To evaluate the feasibility of using health-plan administrative data to measure potential drug-drug interaction (DDI) rates in the ambulatory setting at the medical-group level and to assess the potential use of DDI rates in performance measurement, quality improvement, and research in patient safety. STUDY DESIGN: We combined administrative and pharmacy claims data from 2 large health plans to calculate the rates at which member users of selected chronic medications were potentially exposed to a second drug known to pose a risk of harmful interactions. METHODS: We divided 44 medication combinations with risk of adverse interactions into those with DDIs of moderate/severe clinical significance and those with DDIs of mild significance. We then calculated yearly rates of potential DDIs in continuously enrolled members aged 19 and older from 1998 through 2001. Rates were calculated for all members, overall base-medication users, and, individual medical groups responsible for their care. RESULTS: The analytic data set included 756 047 patient-years of data and 110 to 123 medical groups per year. During the 4-year interval, one or more unique potential DDIs occurred in 6.2% to 6.7% of base-drug users and 2.0% to 2.3% of all adult health-plan members per year. Medical-group mean user rates were slightly lower (5.33%-5.81%), with wide variance (SD = 2.6%-3.1%) and high stability over time. CONCLUSION: Potential DDI rates calculated from health-plan data have promise for measurement in patient medication safety. This readily available and inexpensive evaluation tool has potential for monitoring, improvement, and research purposes if further studies validate their relationship to actual adverse events.

Adult↗

Management of osteoporosis in women aged 50 and older with osteoporosis-related fractures in a managed care population.

This study describes the pattern of evaluation and management of osteoporosis in women aged 50 and older following an osteoporosis-related fracture, conducted as a retrospective cohort study using the administrative claims database of a managed care organization. Subjects were women, aged 50 years and older, with at least one osteoporosis-related fracture in the years 1996-1998 who were continuously enrolled in the system's health plan for at least 6 months prior to and post-fracture. Bone mineral density (BMD) testing, diagnosis of osteoporosis, and treatment with any Food and Drug Administration-approved medication for osteoporosis were identified using CPT, ICD-9, and National Drug Codes for the 6-month post-fracture period. There were 658 women with an osteoporosis-related fracture: 189 (29%) hip fractures, 226 (34%) wrist fractures, 127 (19%) vertebral fractures, and 116 (18%) rib fractures. In the post-fracture period, 46 (7%) underwent BMD testing, 153 (23%) had a diagnosis of osteoporosis, and 220 (31%) were treated with a medication approved for the prevention or treatment of osteoporosis. Of the 220 women with medication claims, 124 (56%) were for estrogen, and 96 (44%) were for other antiresorptive agents. Of the 507 women who did not have medication claims during the 6 months prior to the fracture, only 17% had new fills after the fracture. Management of osteoporosis in women aged 50 and older with fractures was inadequate, despite the high risk of subsequent fractures and recommendations that osteoporosis be the presumptive diagnosis. Significant opportunity exists for improvement in assuring post-fracture followup care.

Aged↗