Terry S. Field

Incidence and preventability of adverse drug events in nursing homes

PURPOSE Adverse drug events, especially those that may have been preventable, are among the most serious concerns about medication use in nursing homes. We studied the incidence and preventability of adverse drug events and potential adverse drug events in nursing homes. METHODS We performed a cohort study of all long-term care residents of 18 community-based nursing homes in Massachusetts during a 12-month observation period. Potential drug-related incidents were detected by stimulated self-report by nursing home staff and by periodic review of the records of nursing home residents by trained nurse and pharmacist investigators. Each incident was classified by 2 independent physician-reviewers, using a structured implicit review process, by whether or not it constituted an adverse drug event or potential adverse drug event (those that may have caused harm, but did not because of chance or because they were detected), by the severity of the event (significant, serious, life-threatening, or fatal), and by whether it was preventable. Examples of significant events included nonurticarial rashes, falls without associated fracture, hemorrhage not requiring transfusion or hospitalization, and oversedation; examples of serious events included urticaria, falls with fracture, hemorrhage requiring transfusion or hospitalization, and delirium. RESULTS During 28,839 nursing home resident-months of observation in the 18 participating nursing homes, 546 adverse drug events (1.89 per 100 resident-months) and 188 potential adverse drug events (0.65 per 100 resident-months) were identified. Of the adverse drug events, 1 was fatal, 31 (6%) were life-threatening, 206 (38%) were serious, and 308 (56%) were significant. Overall, 51% of the adverse drug events were judged to be preventable, including 171 (72%) of the 238 fatal, life-threatening, or serious events and 105 (34%) of the 308 significant events (P < 0.001). Errors resulting in preventable adverse drug events occurred most often at the stages of ordering and monitoring; errors in transcription, dispensing, and administration were less commonly identified. Psychoactive medications (antipsychotics, antidepressants, and sedatives/hypnotics) and anticoagulants were the most common medications associated with preventable adverse drug events. Neuropsychiatric events were the most common types of preventable adverse drug events. CONCLUSIONS Adverse drug events are common and often preventable in nursing homes. More serious adverse drug events are more likely to be preventable. Prevention strategies should target the ordering and monitoring stages of pharmaceutical care.

Vitamin E and vitamin C supplement use and risk of incident Alzheimer disease.

Oxidative stress may play a role in neurologic disease. The present study examined the relation between use of vitamin E and vitamin C and incident Alzheimer disease in a prospective study of 633 persons 65 years and older. A stratified random sample was selected from a disease-free population. At baseline, all vitamin supplements taken in the previous 2 weeks were identified by direct inspection. After an average follow-up period of 4.3 years, 91 of the sample participants with vitamin information met accepted criteria for the clinical diagnosis of Alzheimer disease. None of the 27 vitamin E supplement users had Alzheimer disease compared with 3.9 predicted based on the crude observed incidence among nonusers (p = 0.04) and 2.5 predicted based on age, sex, years of education, and length of follow-up interval (p = 0.23). None of the 23 vitamin C supplement users had Alzheimer disease compared with 3.3 predicted based on the crude observed incidence among nonusers (p = 0.10) and 3.2 predicted adjusted for age, sex, education, and follow-up interval (p = 0.04). There was no relation between Alzheimer disease and use of multivitamins. These data suggest that use of the higher-dose vitamin E and vitamin C supplements may lower the risk of Alzheimer disease.

The effect of computerized physician order entry with clinical decision support on the rates of adverse drug events: a systematic review

ContextComputerized physician order entry (CPOE) with clinical decision support (CDS) has been promoted as an effective strategy to prevent the development of a drug injury defined as an adverse drug event (ADE).ObjectiveTo systematically review studies evaluating the effects of CPOE with CDS on the development of an ADE as an outcome measure.Data SourcesPUBMED versions of MEDLINE (from inception through March 2007) were searched to identify relevant studies. Reference lists of included studies were also searched.MethodsWe searched for original investigations, randomized and nonrandomized clinical trials, and observational studies that evaluated the effect of CPOE with CDS on the rates of ADEs. The studies identified were assessed to determine the type of computer system used, drug categories being evaluated, types of ADEs measured, and clinical outcomes assessed.ResultsOf the 543 citations identified, 10 studies met our inclusion criteria. These studies were grouped into categories based on their setting: hospital or ambulatory; no studies related to the long-term care setting were identified. CPOE with CDS contributed to a statistically significant (P ≤ .05) decrease in ADEs in 5 (50.0%) of the 10 studies. Four studies (40.0%) reported a nonstatistically significant reduction in ADE rates, and 1 study (10.0%) demonstrated no change in ADE rates.ConclusionsFew studies have measured the effect of CPOE with CDS on the rates of ADEs, and none were randomized controlled trials. Further research is needed to evaluate the efficacy of CPOE with CDS across the various clinical settings.

Predictors of Tamoxifen Discontinuation Among Older Women With Estrogen Receptor–Positive Breast Cancer

PURPOSE Five years of adjuvant tamoxifen therapy for estrogen receptor (ER) -positive breast cancer is more effective than 2 years of use. However, information on tamoxifen discontinuation is scanty. We sought to identify predictors of tamoxifen discontinuation among older women with breast cancer. PATIENTS AND METHODS Within six health care delivery systems, we identified women >or= 65 years old diagnosed with stage I to IIB ER-positive or indeterminant breast cancer between 1990 and 1994 who had filled a prescription for adjuvant tamoxifen. We observed them for 5 years after initial tamoxifen prescription. We used automated pharmacy records to validate tamoxifen prescription information abstracted from medical records. The primary end point was tamoxifen discontinuation, operationalized as ever discontinuing tamoxifen during 5 years of follow-up. We used Cox proportional hazards to identify predictors of tamoxifen discontinuation. RESULTS Of 961 women who were prescribed tamoxifen, 49% discontinued tamoxifen before the completion of 5 years. Discontinuers were more likely to be aged 75 to less than 80 years (v < 70 years; hazard ratio [HR] = 1.41; 95% CI, 1.06 to 1.87), be aged >or= 80 years (HR = 2.02; 95% CI, 1.53 to 2.66), have an increase in Charlson Comorbidity Index at 3 years from diagnosis (HR = 1.52; 95% CI, 1.18 to 1.95), have an increase in the number of cardiopulmonary comorbidities at 3 years (HR = 1.75; 95% CI, 1.34 to 2.28), have indeterminant ER status (v ER-positive status; HR = 1.36; 95% CI, 1.00 to 1.85), and have received breast-conserving surgery (BCS) without radiotherapy (v mastectomy; HR = 1.62; 95% CI, 1.18 to 2.22). CONCLUSION Attention to nonadherence among older women at risk of discontinuation, particularly those receiving BCS without radiotherapy, might improve breast cancer outcomes for these women.

Risk Factors for Adverse Drug Events Among Older Adults in the Ambulatory Setting

Objectives: To gather information on patient‐level factors associated with risk of adverse drug events (ADEs) that may allow focus of prevention efforts on patients at high risk.

Knowledge, Patterns of Care, and Outcomes of Care for Generalists and Specialists

OBJECTIVE: To critically evaluate the differences between generalist physicians and specialists in terms of knowledge, patterns of care, and clinical outcomes of care.METHODS: English-language articles (January 1981 to January 1998) were identified through a Medline search and examination of bibliographies of identified articles. Systematic evaluation of articles relevant to adult medicine that had a direct comparison between generalist physicians and specialists in terms of knowledge relative to widely accepted standards of care, patterns of care (including use of medications, ancillary services, procedures, and resource utilization), and outcomes of care was performed.MAIN RESULTS: In many survey studies, specialists were reported to be more knowledgeable about conditions encompassed within their specialty. In terms of overall practice patterns, specialists practicing in their area of expertise were more likely to use medications associated with improved survival and to comply with routine health maintenance screening guidelines; they used more resources including diagnostic tests, procedures, and longer hospital stays. In the limited number of studies examining the care of patients with acute myocardial infarction, acute nonhemorrhagic stroke, and asthma, specialists had superior outcomes compared with generalists.CONCLUSIONS: There is evidence in the literature suggesting differences between specialists and generalists in terms of knowledge, patterns of care, and clinical outcomes of care for a broad range of diseases. In published studies, specialists were generally more knowledgeable about their area of expertise and quicker to adopt new and effective treatments than generalists. More research is needed to examine whether these patterns of care translate into superior outcomes for patients. Further work is also needed to delineate the components of care for which generalists and specialists should be responsible, in order to provide the highest quality of care to patients while most effectively utilizing existing physician manpower.

Evidence for a positive linear relation between blood pressure and mortality in elderly people

Many studies of blood pressure in the elderly have found higher death rates in groups with the lowest blood pressure than in those with intermediate values. In a large community study, we examined whether these findings are real or artifacts of short follow-up, co-morbidity, or low blood pressure in people near death. In 1982-83, we assessed drug use, medical history, disability, physical function, and blood pressure in 3657 residents of East Boston, Massachusetts, aged 65 and older. We identified all deaths (1709) up to 1992 and followed up survivors for an average of 10.5 (range 9.5-11.0) years. After adjustment for confounding variables (including frailty and disorders such as congestive heart failure and myocardial infarction) and exclusion of deaths within the first 3 years of follow-up, higher systolic pressure predicted linear increases in cardiovascular (p < 0.0001) and total (p < 0.0007) mortality. Higher diastolic pressure predicted increases in cardiovascular (p = 0.006) but not total (p = 0.48) mortality. These results differed from those for the first 3 years, during which groups with the lowest systolic and diastolic pressures had the highest death rates. In the long term, lower blood pressure in old age, as in middle age, is associated with better survival. Short-term findings may differ because of associations of co-morbidity and frailty with blood pressure near death. Overall, the findings support recommendations to treat high blood pressure in elderly people.

Unexplained Variation Across US Nursing Homes in Antipsychotic Prescribing Rates

BACKGROUND Serious safety concerns related to the use of antipsychotics have not decreased the prescribing of these agents to nursing home (NH) residents. We assessed the extent to which resident clinical characteristics and institutional prescribing practice were associated with antipsychotic prescribing. METHODS Antipsychotic prescribing was assessed for a nationwide, cross-sectional population of 16 586 newly admitted NH residents in 2006. We computed facility-level antipsychotic rates based on the previous years (2005) prescribing patterns. Poisson regressions with generalized estimating equations were used to identify the likelihood of resident-level antipsychotic medication use in 2006, given 2005 facility-level prescribing pattern and NH resident indication for antipsychotic therapy (psychosis, dementia, and behavioral disturbance). RESULTS More than 29% (n = 4818) of study residents received at least 1 antipsychotic medication in 2006. Of the antipsychotic medication users, 32% (n = 1545) had no identified clinical indication for this therapy. Residents entering NHs with the highest facility-level antipsychotic rates were 1.37 times more likely to receive antipsychotics relative to those entering the lowest prescribing rate NHs, after adjusting for potential clinical indications (risk ratio [RR], 1.37; 95% confidence interval [CI], 1.24-1.51). The elevated risk associated with facility-level prescribing rates was apparent for only NH residents with dementia but no psychosis (RR, 1.40; 95% CI, 1.23-1.59) and residents without dementia or psychosis (RR, 1.54; 95% CI, 1.24-1.91). CONCLUSIONS The NH antipsychotic prescribing rate was independently associated with the use of antipsychotics in NH residents. Future research is needed to determine why such a prescribing culture exists and whether it could result in adverse health consequences.

A demonstration of the impact of response bias on the results of patient satisfaction surveys

OBJECTIVES The purposes of the present study were to examine patient satisfaction survey data for evidence of response bias, and to demonstrate, using simulated data, how response bias may impact interpretation of results. DATA SOURCES Patient satisfaction ratings of primary care providers (family practitioners and general internists) practicing in the context of a group-model health maintenance organization and simulated data generated to be comparable to the actual data. STUDY DESIGN Correlational analysis of actual patient satisfaction data, followed by a simulation study where response bias was modeled, with comparison of results from biased and unbiased samples. PRINCIPAL FINDINGS A positive correlation was found between mean patient satisfaction rating and response rate in the actual patient satisfaction data. Simulation results suggest response bias could lead to overestimation of patient satisfaction overall, with this effect greatest for physicians with the lowest satisfaction scores. CONCLUSIONS Findings suggest that response bias may significantly impact the results of patient satisfaction surveys, leading to overestimation of the level of satisfaction in the patient population overall. Estimates of satisfaction may be most inflated for providers with the least satisfied patients, thereby threatening the validity of provider-level comparisons.

Surveying physicians: do components of the "Total Design Approach" to optimizing survey response rates apply to physicians?

Background. Surveys serve essential roles in clinical epidemiology and health services research. However, physician surveys frequently encounter problems achieving adequate response rates. Research on enhancing response rates to surveys of the general public has led to the development of Dillman’s “Total Design Approach“ to the design and conduct of surveys. The impact of this approach on response rates among physicians is uncertain. Objective. To determine the extent to which the components of the total design approach have been found to be effective in physician surveys. Design. A systematic review. Results. The effectiveness of prepaid financial incentives, special contacts, and personalization to enhance response rates in surveys of physicians have been confirmed by the existing research. There is suggestive evidence supporting the use of first class stamps on return envelopes and multiple contacts. The optimum amount for incentives and the number of contacts necessary have not been established. Details of questionnaire design and their impact on response rates have received almost no attention from researchers. Few studies have assessed the usefulness of combinations of components of the total design approach. Conclusions. Despite the number of surveys conducted among physicians, their cost, the level of interest in their findings, and in spite of inadequate response rates, there have been few randomized trials conducted on important aspects of enhancing response in this population. Until this gap has been filled, researchers conducting surveys of physicians should consider including all components of the total design approach whenever feasible.