Biomedical subjects

Almut G Winterstein

Publications and source records attributed to Almut G Winterstein.

10 recordsLinked to original sources

PubMed2006

Automated medication error studies with audit supplementation were effectively designed and analyzed by time series.

BACKGROUND AND OBJECTIVE: To provide researchers with an efficient yet methodologically robust method to design and analyze studies of the effectiveness of quality improvement interventions targeted at medical errors. METHODS: An interrupted time-series design was chosen. Error rates of a preintervention observational period are compared to those of an intervention period (interrupted by a brief transitional period not used in the analysis). Potential errors are flagged by computerized analysis. The positive predictive value of this automated method is established by targeted expert review of random samples of monthly admissions with flagged errors. The lengths of the preintervention and intervention observational periods and number of audits per month are determined via power and type I error analysis. The setting was a future study of electronic alert systems for errors related to nephrotoxic agents in a medium-sized hospital. RESULTS: Based on these methods, a study was deemed feasible to be conducted over a 38-month period, auditing 40 potential errors per month. CONCLUSION: A logistic monthly error process model with independent variables (1) time in months (same slope pre vs. postintervention), and (2) a discrete jump postintervention to assess the effect size, offers a flexible, easy-to-interpret way to attack this problem.

Decision Support Systems, Clinical↗

PubMed2006

Medication safety infrastructure in critical-access hospitals in Florida.

PURPOSE: The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. METHODS: Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. RESULTS: The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. CONCLUSION: Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

Drug Compounding↗

PubMed2006

Effectiveness of nesiritide on dialysis or all-cause mortality in patients undergoing cardiothoracic surgery.

BACKGROUND: Natriuretic peptides have been shown to have favorable renal effects. However, recent evidence suggests potential renal side effects in patients with congestive heart failure. HYPOTHESIS: This study examined the effect of nesiritide (human B-type natriuretic peptide) on hemodialysis or death in patients undergoing cardiothoracic surgery. METHODS: This retrospective cohort study included patients (n = 940) undergoing nontransplant adult cardiothoracic surgery between July 2001 and February 2004. Patients receiving nesiritide within 3 days after and not before surgery (n = 151) were compared with those not given nesiritide (n = 789) for incidence of hemodialysis or in-hospital death by Day 21 (HD/death). Patients with preexisting dialysis and intraoperative deaths were excluded. Forward inclusion multiple logistic regression was used based on published risk factors for HD/death. RESULTS: Of 940 patients (318 coronary artery bypass graft, 348 valve, and 274 thoracic aorta), 36 required dialysis and 60 patients died (HD/death; n = 77). Adjusted for significant confounders (gender, age, procedure, intra-aortic balloon, baseline serum creatinine mg/dl [SCr], 1 day % SCr increase), nesiritide showed a statistically nonsignificant HD/death reduction (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.29-1.17; p = 0.129) in the group as a whole. When stratified by baseline SCr, a significant benefit was noted in patients with SCr > 1.0 (OR, 0.35; 95% CI 0.14-0.87; p = 0.024), while no significant effect was found in patients with SCr < 1.0 (OR, 1.55; 95% CI 0.48-5.07, p = 0.465). CONCLUSIONS: Nesiritide appears promising in reducing the risk of dialysis or death in patients with SCr > 1.0 undergoing cardiothoracic surgery; however, no effect was noted with SCr < 1.0. This study provides strong rationale for a randomized trial.

Acute Kidney Injury↗

PubMed2006

Pharmacoeconomic modeling of nesiritide versus dobutamine for decompensated heart failure.

STUDY OBJECTIVE: To model the cost-effectiveness of nesiritide compared with dobutamine in patients with decompensated heart failure. DESIGN: Cost-effectiveness analysis. MEASUREMENTS AND MAIN RESULTS: A decision tree model was derived from randomized clinical trial data and data from a previously published economic study. Four cost-effectiveness analyses were performed: analysis 1 -- full probabilistic analysis, repeatedly sampled probabilities for 6-month mortality and hospital readmission from distributions based on 95% confidence intervals (CIs); analysis 2 -- best-case nesiritide analysis, used the limiting values of the 95% CI favorable to nesiritide; analysis 3 -- best-case dobutamine analysis, used the limiting values of the 95% CI favorable to dobutamine; and analysis 4 -- replicated the previously published cost-effectiveness study and served as a methodologic control. Fifty-one consecutive Monte Carlo simulations for cohorts of 1000 hypothetical patients were performed for each analysis. Incremental cost, incremental effectiveness, and incremental cost-effectiveness ratios (ICERs) were calculated for nesiritide versus dobutamine. Analysis 1 showed a mean ICER of 767 US dollars/life-year gained for nesiritide versus dobutamine (incremental cost 251 US dollars +/- 290 US dollars, incremental effectiveness 0.33 +/- 0.22 yr). The 95% confidence region surrounding this point estimate spanned all four quadrants of the incremental cost-effectiveness scatterplot, suggesting inconclusive results. Nesiritide was the dominant treatment strategy in analysis 2 (incremental cost -734 US dollars+/- 106 US dollars, incremental effectiveness 1.19 +/- 0.07 yrs), whereas dobutamine was dominant in analysis 3 (incremental cost 1242 +/- 73 US dollars, incremental effectiveness -0.57 +/- 0.05 yr). Analysis 4 was comparable to the previously published cost-effectiveness analysis (incremental cost -77 +/- 87 US dollars, incremental effectiveness 0.48 +/- 0.05 yr). CONCLUSIONS: Based on available randomized clinical trial data, nesiritide did not exhibit robust economic superiority over dobutamine. When incorporating the uncertainty (i.e., 95% CIs) in clinical effectiveness as reported in available clinical trial data into the economic analysis, either nesiritide or dobutamine may be the dominant treatment (i.e., more effective at lower cost) for the studied population. Economic analyses of nesiritide and any comparator must account for uncertainty in estimates of cost as well as in clinical effectiveness.

Cardiotonic Agents↗

PubMed2005

Causes of hyperglycemia and hypoglycemia in adult inpatients.

PURPOSE: The underlying causes of hyperglycemia and hypoglycemia in adult medical and surgical inpatients were studied. METHODS: Hyperglycemic and hypoglycemic events occurring in adult medical and surgical patients admitted between February and July 2003 to a tertiary care hospital were identified prospectively from automated daily printouts of abnormal blood glucose levels generated by the hospital laboratory. Information on the causes of a random sample of events was ascertained within 24 hours through chart review and provider and patient interviews. Narratives were presented to an expert committee to assess the causes of each event and preventability. RESULTS: Eighteen of 24 hypoglycemic events and 26 of 26 hyperglycemic episodes were considered preventable. Failure to adjust antidiabetic drugs in response to decreases in oral intake and unexpected deviation from normal hospital routine were the most common factors contributing to hypoglycemia. Hyperglycemia was most often associated with an unwillingness of providers to take responsibility for diabetes management and the exclusive use of sliding-scale insulin regimens. CONCLUSION: Hyperglycemia and hypoglycemia in medical and surgical inpatients were mostly related to inadequate prescribing, monitoring, and communication practices.

Adult↗

PubMed2005

Pharmacy-specific quality indicators for asthma therapy.

BACKGROUND: Lack of appropriate drug therapy in asthma patients is a recognized quality problem leading to preventable emergency room visits, hospitalizations, or death. While indicators measuring pharmacotherapy quality on the level of prescribers and third party payers are widely used, no such indicators exist for pharmacies. OBJECTIVE: This study aimed to (1) develop quality indicators for asthma care applicable to retail pharmacies, (2) estimate the prevalence of inappropriate asthma drug therapy, and (3) explore variation in the quality of care across pharmacies. METHODS: We present a descriptive analysis of automated patient-specific dispensing data from February 1, 2000 to January 31, 2001 of beta-agonists and anti-inflammatory agents with a Food and Drug Administration-approved indication for asthma. Two quality indicators of potentially inappropriate drug therapy were applied: (1) the proportion of patients who obtained more than a 360-day supply (assuming maximum acceptable daily dose) of short-term beta-agonists (SABA) including all inhaler types, inhaler solutions, and syrups during the 12-month study and (2) the proportion of patients with 2 consecutive early refills of defined SABAs. Indicator values with 95% confidence intervals are reported for each pharmacy. RESULTS: Pharmacies had an average of 328 (range 169-534) patients who received SABAs. An average of 11 patients per pharmacy (3.4% of all patients who received SABAs) met the indicator 1 definition. The second indicator identified 8.2% (27) patients per pharmacy as short-term SABA overusers (range 3.9-11.9%). Of these, 48% did not receive any anti-inflammatory agents during the time frame when SABA overuse occurred. CONCLUSION: Application of drug therapy quality indicators at the level of individual pharmacies using dispensing data is feasible and identifies opportunities for quality improvement. Indicator 2 is most appropriate for daily practice, because it allows for timely identification of potentially uncontrolled patients, and offers a balance between indicator sensitivity and positive predictive value.

Adrenergic beta-Agonists↗

PubMed2004

Nature and causes of clinically significant medication errors in a tertiary care hospital.

PURPOSE: Medication errors identified through solicited error reports in general medicine and specialty units of a major tertiary care teaching hospital were studied to identify prevalent patterns and causes. METHODS: Medication error reports by a multidisciplinary team of eight clinicians at adult medical and surgical, hematology and oncology, bone marrow transplantation, and medical and cardiac intensive care units were collected prospectively over a three-month period. The reports were validated in terms of clinical significance, causality, and true presence of an error by two independent reviewers. Cluster analysis of valid reports (reports accepted by both reviewers) was used to identify prominent error patterns. RESULTS: Of 321 medication error reports, 240 were included in the analysis. Of these, 95 represented manifested errors and the rest near misses (not manifested [94] or averted [51]). Most manifested errors involved uncontrolled infections associated with prescribed underdoses of antiinfectives (23%), renal failure associated with prescribed overdoses of antiinfectives (4%), central-nervous-system drug intoxication following prescribed overdoses (4%), or uncontrolled pain associated with prescribed underdoses (4%). Most errors were initiated during prescribing (72%) and were associated with deficits in pharmacotherapy knowledge (39%) or with failure to consider critical patient information (18%). Errors initiated during dispensing and administration were mostly associated with performance deficits (e.g., accidental slips and lapses). CONCLUSION: A limited number of prevalent medication-error patterns described more than half of all reported errors in a hospital and suggested excellent areas for quality improvement. Error causes varied with the node of the medication-use process where they arose and suggested the need for tailored interventions to improve clinicians' performance.

Anti-Infective Agents↗

PubMed2003

Nature of preventable adverse drug events in hospitals: a literature review.

A literature review was conducted to identify the drug classes, types of errors, and types of adverse outcomes related to preventable adverse drug events (pADEs). Studies were identified by keyword search of MEDLINE and International Pharmaceutical Abstracts and by a manual search. The search was limited to peer-reviewed literature reporting pADEs in hospitalized patients and the frequencies of at least one pADE characteristic. The frequencies of pADEs and their characteristics were summarized using median and range. Ten studies published between 1994 and 2001 were included in the review. The reported median frequency of pADEs was 1.8% (range, 1.3-7.8%), and the median preventability rate of ADEs in the hospitals was 35.2% (range, 18.7-73.2%). Cardiovascular drugs were implicated for 17.9% of pADEs (range, 4.3-28.1%). Most pADEs occurred in the prescribing stage of the medication-use process and were dose related. Inappropriate prescribing decisions and patient monitoring were the most frequently identified causes of pADEs. The most common adverse outcomes were allergic reactions, hepatic or renal problems, cardiovascular problems, hematologic problems and bleeding, and central nervous system problems. Frequently reported examples of pADEs included antihypertensive overdose associated with bradycardia or hypotension, antiinfectives prescribed despite a history of allergy, warfarin overdose and inappropriate monitoring resulting in hemorrhage, and opioid overdose or underdose associated with respiratory depression or poor pain control, respectively. Despite the heterogeneity of pADEs, the results of this literature review suggest that a few types of drugs, errors, and adverse outcomes constitute a substantial proportion of pADEs. Targeting these high-priority areas could significantly reduce the overall frequency of pADEs.

Adverse Drug Reaction Reporting Systems↗

PubMed2002

Identifying clinically significant preventable adverse drug events through a hospital's database of adverse drug reaction reports.

The ability of a hospital's adverse drug reaction (ADR) database to identify common and repeated patterns of preventable adverse drug events (ADEs) was analyzed. ADR reports collected from 1994 through 2000 were extracted from a teaching hospital's ADR database. Reports were assessed concurrently in accordance with seven previously published explicit criteria for preventability. Only cases considered clinically significant were included in this analysis. Events that occurred in the ambulatory care setting were excluded. Preventable ADEs were categorized by drug or drug class, type of medication error, and the subsequent adverse outcome. Novel in this analysis was the linking of these three descriptors. Of the 2571 ADR reports assessed, 415 ADEs were deemed preventable. Of the preventable ADEs, 98 were not analyzed because they occurred in the ambulatory care setting, leaving 317 preventable ADEs in 275 inpatients (mean age +/- S.D., 48.5 +/- 23.9 years) for analysis. Although 93 drugs were associated with these ADEs, only 10 drugs accounted for more than 60% of the events. Analysis and categorization by type of error and outcome suggested that three high-priority preventable ADEs accounted for 50% of all reports: (1) overdoses of anticoagulants or insufficient monitoring and adjustments (according to laboratory test values) were associated with hemorrhagic events, (2) overdosing or failure to adjust for drug-drug interactions of opiate agonists was associated with somnolence and respiratory depression, and (3) inappropriate dosing or insufficient monitoring of insulins was associated with hypoglycemia. Analysis of a hospital ADR database identified prevalent and preventable clinically significant ADEs.

Adverse Drug Reaction Reporting Systems↗

PubMedDate not supplied

Preventable drug-related hospital admissions.

OBJECTIVE: To estimate the prevalence of preventable drug-related hospital admissions (PDRAs) and to explore if selected study characteristics affect prevalence estimates. METHODS: Keyword search of MEDLINE (1966-December 1999), International Pharmaceutical Abstracts (1970-December 1999), and hand search. Two reviewers independently selected studies published in peer-reviewed journals and extracted crude prevalence estimates and study characteristics. Trials had to specifically address consequences of drug therapy requiring hospital admission and include a quantitative preventability assessment. Stratified analysis and meta-regression were used to explore the association between study characteristics and prevalence estimates. DATA SYNTHESIS: Fifteen studies reported a median PDRA prevalence of 4.3% (interquartile range [IQR] 3.1-9.5%). The median preventability rate of drug-related admissions was 59% (IQR 50-73%). No evidence of publication bias related to study size could be determined. Because the individual study results were highly heterogeneous (Cochran's Q = 176, df = 14; p < 0.001), no meta-analytic summary estimate was computed. Stratified analysis suggested an association between prevalence estimates and 3 study characteristics: exclusion of first admissions (readmission studies: average PDRA prevalence of 14.0 %, estimated prevalence OR = 3.7); mean age of admissions >70 (OR = 2.1); and inclusion of "indirect" drug-related morbidity, such as omission errors or therapeutic failure (OR = 1.9). There was little evidence of other associations with prevalence estimates, such as selection of specific hospital units, exclusion/inclusion of planned admissions, country, and specified methods of PDRA case ascertainment. CONCLUSIONS: Drug-related morbidity is a significant healthcare problem, and a great proportion is preventable. Study methods in prevalence reports vary and should be considered when interpreting findings or planning future research.

Drug-Related Side Effects and Adverse Reactions↗