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Biomedical subjects

David W Bates

Publications and source records attributed to David W Bates.

At least 109 records · Page 6Linked to original sources

Monitoring amiodarone's toxicities: recommendations, evidence, and clinical practice.

OBJECTIVES: We sought to develop an explicit evidence-based model of medication monitoring and to evaluate monitoring practices and adverse drug events in patients taking amiodarone at one institution. METHODS: We searched MEDLINE (1966 through 2000) for English-language publications providing specific monitoring recommendations for amiodarone. A cross-sectional retrospective chart review of 99 outpatients receiving amiodarone therapy between Jan 1, 2000, and Jan 1, 2001, at a large tertiary-care hospital was performed to assess monitoring practices. Adverse drug events were identified by use of structured implicit reviews. The main outcome measure was the proportion of patients receiving the monitoring recommended in the literature and having amiodarone-related adverse drug events. RESULTS: Forty-three articles were identified that provided specific monitoring recommendations, although no studies were found that compared the outcomes of patients managed with different monitoring regimens. Overall, 70% of the recommended monitoring criteria were satisfied, although only 9 patients (9%; 95% confidence interval [95% CI], 3%-15%) received all of the recommended monitoring. Variability in monitoring practices was identified at all stages of the monitoring model. Of the patients, 52 (52%; 95% CI, 42%-62%) received minimum baseline evaluations, 22 (22%; 95% CI, 14%-31%) underwent ongoing surveillance, 75 (75%; 95% CI, 61%-89%) had appropriate responses to abnormal surveillance results, and 71 (71%; 95% CI, 62%-80%) had timely follow-up visits. Of the patients, 8 (8%; 95% CI, 3%-13%) had 9 amiodarone-related adverse drug events, of which 3 were judged to be preventable. Interrater agreement for monitoring processes (kappa = 0.83) and adverse drug events (kappa = 0.67) was good. CONCLUSIONS: Current standards for amiodarone toxicity monitoring are based on expert opinion with limited evidence to support most recommendations. Monitoring practices appear to vary significantly, with few patients receiving all of the recommended monitoring. Some amiodarone-related adverse drug events may be preventable and patient safety might be improved with a better understanding of monitoring processes.

Adult↗

Information technology and patient safety in nursing practice: an international perspective.

When people become patients, they place their trust in their health care providers. As providers assume responsibility for their diagnosis and treatment, patients have a right to expect that this will include responsibility for their safety during all aspects of care. However, increasing epidemiological data make it clear that patient safety is a global problem. Improved nursing care may prevent many adverse events, and nursing must take a stronger leadership role in this area. Although errors are almost inevitable, safety can be improved, and health care institutions are increasingly making safety a top priority. Information technology provides safety benefits by enhancing communication and delivering decision-support; its use will likely be a cornerstone for improving safety. This paper will discuss the status of patient safety from an international viewpoint, provide case studies from different countries, and discuss information technology solutions from a nursing perspective.

Humans↗

Validity of primary care patient self-report of abnormal (but not cancer) prostate biopsy results.

PURPOSE: We assessed the validity of patient self-report of abnormal (but not cancer) prostate biopsy results, ie, atypical cells or prostatic intraepithelial neoplasia. MATERIALS AND METHODS: We compared survey responses and pathology records for 156 men from a multicenter, prospective cohort study, which was designed to evaluate the impact of a suspicious prostate cancer screening test followed by benign prostate biopsy. RESULTS: Of the 156 subjects 45 (29%) reported having had atypical cells or prostatic intraepithelial neoplasia and 38 (24%) had a pathology report with atypia or prostate intraepithelial neoplasia. The sensitivity of the self-report was 87%, specificity was 90%, positive predictive value was 73% and negative predictive value was 95%. The kappa statistic was 0.7. CONCLUSIONS: Men in this study reported this complex result accurately. However, it was concerning that 5 men (13%) appeared unaware of an abnormal prostate biopsy result, especially given the substantial residual risk of prostate cancer conferred by this result.

Aged↗

An evaluation of the adequacy of outpatient monitoring of thyroid replacement therapy.

OBJECTIVES: Hypothyroid patients managed with excessive or insufficient thyroid replacement therapy are often difficult to clinically recognize. Monitoring may prevent or minimize the consequences of adverse drug events (ADEs). We sought to develop an explicit model of medication monitoring and to evaluate monitoring processes and ADEs in patients taking levothyroxine. METHODS: A retrospective chart review of 400 outpatients receiving levothyroxine therapy between 1 January 2000 and 1 January 2001 at a large North American tertiary care hospital. We measured the proportion of patients satisfying minimum monitoring criteria, experiencing specific monitoring errors and having levothyroxine-related ADEs. Explicit monitoring criteria were derived from the literature and through expert opinion. Adverse drug events were identified using structured implicit reviews. RESULTS: Overall, only 56% (95% confidence interval [95% CI] 51-62%) of the patients prescribed levothyroxine received the minimal recommended monitoring. Errors were identified at all stages of the monitoring model. Patients who received the recommended monitoring had fewer levothyroxine-related ADEs (1% vs. 6%, P=0.013) than those who did not. Minority status (white people 2% vs. black people 4% vs. Hispanics 14%, P=0.023) and primary language (English 3% vs. Non-English 20%, P=0.002) were the patient characteristics associated with levothyroxine-related ADEs. CONCLUSION: Only half of outpatients taking levothyroxine at one tertiary care hospital received the recommended monitoring during one year of follow-up. Levothyroxine-related ADEs were more frequent in patients with lower-quality monitoring and in minorities and non-English speakers.

Ambulatory Care↗

Patient satisfaction profiling of individual physicians: impact of panel status.

RATIONALE, AIMS AND OBJECTIVES: Evaluation of physician performance is increasingly based on patient satisfaction. However, few data are available regarding the extent to which individual physician profiles might be influenced by factors such as whether a physician's practice is open or closed. We evaluated whether panel status (whether or not a physician is accepting new patients) is associated with patient satisfaction with their primary care physician (PCP). METHODS: Cross-sectional analysis of patient satisfaction surveys. Surveys were available for 1,750 patients cared for by 69 PCPs. Patient satisfaction with their PCP was determined based on a composite of six questions derived from the Medical Outcomes Study. We used Generalized Estimating Equations to adjust for physician level variation. RESULTS: Patients of closed-panel physicians were more likely to rate their satisfaction with the provider as 'Excellent' or 'Very Good' compared to patients of open-panel physicians (78% vs. 69%, P <0.0001). After adjusting for satisfaction with the practice site, provider years in practice, managed care coverage, provider productivity, and patient race, the association between a closed panel and satisfaction remained significant (odds ratio 1.60, 95% confidence interval 1.10-2.31). CONCLUSIONS: Individual physicians' patient satisfaction data are confounded by factors not likely to be adjusted for in available profiles. After adjusting for other variables, physicians with closed panels still had better patient satisfaction compared to physicians with open panels. Further research is necessary to determine if panel status might also confound patient satisfaction.

Boston↗

An evaluation of risk factors for adverse drug events associated with angiotensin-converting enzyme inhibitors.

RATIONALE, AIMS AND OBJECTIVES: To identify potential factors leading to discontinuation of angiotensin-converting enzyme (ACE) inhibitors because of adverse drug events. METHODS: Retrospective cohort study was conducted at outpatient clinics affiliated with an urban tertiary care hospital. ACE inhibitors were administered to 2225 consecutive outpatients. RESULTS: In 19% of the total cohort, ACE inhibitors were discontinued because of adverse drug events. Cox proportional hazard model identified the following independent risk factors for discontinuation because of adverse drug events: age, female gender, ethnicity other than African American or Latino, no history of previous ACE inhibitor use, history of cough caused by another ACE inhibitor, hypertension, anxiety or depression, no hemodialysis, and elevated creatinine. History of smoking was shown to be a risk factor for cough [hazard ratio (HR): 2.5; 95% confidence interval (CI): 1.1-5.7], angioedema (HR: 2.7; 95% CI: 1.1-7.0), and hyperkalaemia (HR: 5.4; 95% CI: 1.3-23.2). History of ACE inhibitor-induced cough was not only a risk factor for cough (HR: 12.9; 95% CI: 7.5-22.3) but also for angioedema (HR: 9.1; 95% CI: 2.1-39.9). Patients with creatinine > or = 1.6 mg dL(-1) were likely to discontinue ACE inhibitors because of renal dysfunction (HR: 4.7; 95% CI: 1.5-12.7) and hyperkalaemia (HR: 10.9; 95% CI: 3.1-39.0). East Asians were more likely to develop cough (HR: 2.5; 95% CI: 1.1-5.7) and hyperkalaemia (HR: 80.3; 95% CI: 5.4-1190) and African Americans to develop angioedema (HR: 3.5; 95% CI: 1.3-8.9). CONCLUSIONS: Although further validation is necessary, these risk factors should help doctors identify patients with elevated risk for adverse drug events because of ACE inhibitors.

Angiotensin-Converting Enzyme Inhibitors↗

Development and validation of a clinical prediction rule for angiotensin-converting enzyme inhibitor-induced cough.

BACKGROUND: Angiotensin-converting enzyme inhibitors are effective for many cardiovascular diseases and are widely prescribed, but cough sometimes necessitates their withdrawal. OBJECTIVE: To develop and validate a model that predicts, by using information available at first prescription, whether a patient will develop cough within 6 months. DESIGN: Retrospective cohort study with derivation and validation sets. SETTING: Outpatient clinics affiliated with an urban tertiary care hospital. PATIENTS: Clinical data were collected from electronic charts. The derivation set included 1125 patients and the validation set included 567 patients. INTERVENTIONS: None. MEASUREMENTS: Angiotensin-converting enzyme inhibitor-induced cough assessed by predetermined criteria. RESULTS: In the total cohort, 12% of patients developed angiotensin-converting enzyme inhibitor-induced cough. Independent multivariate predictors of cough were older age, female gender, non-African American (with East Asian having highest risk), no history of previous angiotensin-converting enzyme inhibitor use, and history of cough due to another angiotensin-converting enzyme inhibitor. Patients with a history of angiotensin-converting enzyme inhibitor-induced cough were 29 times more likely to develop a cough than those without this history. These factors were used to develop a model stratifying patients into 4 risk groups. In the derivation set, low-risk, average-risk, intermediate-risk, and high-risk groups had a 6%, 9%, 22%, and 55% probability of cough, respectively. In the validation set, 4%, 14%, 20%, and 60% of patients in these 4 groups developed cough, respectively. CONCLUSIONS: This model may help clinicians predict the likelihood of a particular patient developing cough from an angiotensin-converting enzyme inhibitor at the time of prescribing, and may also assist with subsequent clinical decisions.

Angiotensin-Converting Enzyme Inhibitors↗

Communication factors in the follow-up of abnormal mammograms.

OBJECTIVE: To identify the communication factors that are significantly associated with appropriate short-term follow-up of abnormal mammograms. DESIGN: Prospective longitudinal study involving medical record review and patient survey. SETTING: Ten academically affiliated ambulatory medical practices in the Boston metropolitan area. PARTICIPANTS: One hundred twenty-six women with abnormal mammograms requiring short-term (6 months) follow-up imaging. MEASUREMENTS: Proportion of women in the study who received appropriate follow-up care. RESULTS: Eighty-one (64%) of the women with abnormal mammograms requiring short-term follow-up imaging received the appropriate follow-up care. After adjusting for patients' age and insurance status, 2 communication factors were found to be independently associated with the delivery of appropriate follow-up care: 1). physicians' documentation of a follow-up plan in the medical record (adjusted odds ratio, 2.79; 95% confidence interval, 1.11 to 6.98; P =.029); and 2). patients' understanding of the need for follow-up (adjusted odds ratio, 3.86; 95% confidence interval, 1.50 to 9.96; P =.006). None of the patients' clinical or psychological characteristics were associated with the delivery of appropriate follow-up care. CONCLUSIONS: Follow-up care for women with abnormal mammograms requiring short-term follow-up imaging is suboptimal. Documentation of the follow-up plan by the physician and understanding of the follow-up plan by the patient are important factors that are correlated with the receipt of appropriate follow-up care for these women. Interventions designed to improve the quality of result follow-up in the outpatient setting should address these issues in patient-doctor communication.

Breast Diseases↗

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. DESIGN: Nested case-control study. SETTING: Large multispecialty group practice in New England. PARTICIPANTS: All Medicare enrollees cared for by a multispecialty group practice during 1 year (N=30,397 person-years from July 1, 1999, through June 30, 2000). For each patient with an ADE, a control was randomly selected. MEASUREMENTS: Data were abstracted from medical records on age, sex, comorbidities, and medication use at the time of the event. RESULTS: ADEs were identified in 1,299 older adults. Independent risk factors included being female and aged 80 and older. There were dose-response associations with the Charlson Comorbidity Index and number of scheduled medications. Patients taking anticoagulants, antidepressants, antibiotics, cardiovascular drugs, diuretics, hormones, and corticosteroids were at increased risk. In the analysis of preventable ADEs, the dose-response relationship with comorbidity and number of medications remained. Patients taking nonopioid analgesics (predominantly nonsteroidal antiinflammatory drugs and acetaminophen), anticoagulants, diuretics, and anti-seizure medications were at increased risk. CONCLUSION: Prevention efforts to reduce ADEs should be targeted toward older adults with multiple medical conditions or taking multiple medications, nonopioid analgesics, anticoagulants, diuretics, and antiseizure medications.

Age Factors↗

Primary care physician attitudes towards using a secure web-based portal designed to facilitate electronic communication with patients.

BACKGROUND: Patient demand for email contact with physician practices is high. If physicians met this demand, improvements in communication, quality of care and patient satisfaction could result. However, physicians have typically been hesitant to communicate electronically with patients, largely due to concerns relating to workload, security and lack of compensation. GOAL: To assess physician attitudes towards electronic communication with patients six months after the implementation of an application called Patient Gateway. Patient Gateway allows patients to access an extract of their medical record and facilitates online communication with medical practices. METHODS: A paper-based survey was administered to the 43 primary care physicians in one integrated delivery system, with a 56% (24/43) response rate. RESULTS: Overall, physicians felt that Patient Gateway's impact on their practices was positive, especially in the areas of refill and referral request management and appointment scheduling. However, physicians are still hesitant to increase general electronic communication with patients; none opted to use Patient Gateway's general messaging function with patients, and those who had previously used outside systems to exchange emails with some patients continued to communicate with only a small proportion of their patient panel in this way. However, 38% of physicians already communicate with their own physicians via email, and another 19% would like to do so. CONCLUSIONS: Physicians' fears about being overwhelmed with messages were not realised. While physicians were generally enthusiastic about the application, none used it directly to communicate with patients. Over three-quarters of respondents indicated that they would be more enthusiastic about electronic communication with patients if this time were compensated.

Attitude of Health Personnel↗

Comprehensive computerised primary care records are an essential component of any national health information strategy: report from an international consensus conference.

In many countries, primary care informatics has developed to the point that it is recognised as an important enabler of quality improvement; this has not occurred to date in the United States. With this conference, we aimed to build an international consensus as to whether primary care has unique characteristics that require an informatics subspecialty; and, if so, to establish the role of primary care informatics in improving patient care, and to enable its recognition in the national strategy.The conference was organised by the primary care informatics working groups of AMIA, EFMI, IMIA and Wonca and took place at Medinfo 2004 in San Francisco. It consisted of two plenary lectures, two small-group work sessions and a panel discussion to summarise the day. It was attended by an international audience of 53 health informaticians, mostly working in primary care. There was consensus among the participants that primary care has many unique characteristics that justify the existence of an informatics subspecialty: primary care informatics (PCI). The conference identified principles and practical examples of: (1) the effective deployment of information technology to underpin the provision of records, communication and access to information; (2) the need to harness the extensive knowledge base about the practice of PCI; and (3) the contribution of the experimental work and theory that underpins the science of PCI. These principles and examples of their practical application were largely derived from the extensive knowledge base which has been built up in countries that have developed PCI over the last one to two decades.

Health Policy↗

A patient-controlled journal for an electronic medical record: issues and challenges.

Partners Healthcare System, Boston, MA, has developed a patient Web portal that features a patient-controlled electronic "journal" to allow patients to interact with their physician's electronic medical record. Patients can view and respond to health reminders, critique electronic chart information maintained by their doctor's office, enter additional clinical information, and prepare information summaries before an office visit. Creating shared information resources to support a collaborative care model required analysis of the business, architectural, and workflow requirements of the patient-controlled clinical portal and the physician-controlled electronic medical record system. In this paper we describe the challenges in aligning the two systems and serving the different user groups. Coupling the Patient Gateway system, serving over 8700 patients of 90 physicians as of September, 2003, with the Longitudinal Medical Record system, serving over 4000 physicians, has required a clear definition of user goals and workflow, well-defined interfaces, and careful consideration of system assumptions to succeed.

Ambulatory Care Information Systems↗

Safety of patients isolated for infection control.

CONTEXT: Hospital infection control policies that use patient isolation prevent nosocomial transmission of infectious diseases, but may inadvertently lead to patient neglect and errors. OBJECTIVE: To examine the quality of medical care received by patients isolated for infection control. DESIGN, SETTING, AND PATIENTS: We identified consecutive adults who were isolated for methicillin-resistant Staphylococcus aureus colonization or infection at 2 large North American teaching hospitals: a general cohort (patients admitted with all diagnoses between January 1, 1999, and January 1, 2000; n = 78); and a disease-specific cohort (patients admitted with a diagnosis of congestive heart failure between January 1, 1999, and July 1, 2002; n = 72). Two matched controls were selected for each isolated patient (n = 156 general cohort controls and n = 144 disease-specific cohort controls). MAIN OUTCOME MEASURES: Quality-of-care measures encompassing processes, outcomes, and satisfaction. Adjustments for study cohort and patient demographic, hospital, and clinical characteristics were conducted using multivariable regression. RESULTS: Isolated and control patients generally had similar baseline characteristics; however, isolated patients were twice as likely as control patients to experience adverse events during their hospitalization (31 vs 15 adverse events per 1000 days; P<.001). This difference in adverse events reflected preventable events (20 vs 3 adverse events per 1000 days; P<.001) as opposed to nonpreventable events (11 vs 12 adverse events per 1000 days; P =.98). Isolated patients were also more likely to formally complain to the hospital about their care than control patients (8% vs 1%; P<.001), to have their vital signs not recorded as ordered (51% vs 31%; P<.001), and more likely to have days with no physician progress note (26% vs 13%; P<.001). No differences in hospital mortality were observed for the 2 groups (17% vs 10%; P =.16). CONCLUSION: Compared with controls, patients isolated for infection control precautions experience more preventable adverse events, express greater dissatisfaction with their treatment, and have less documented care.

Canada↗

Ten commandments for effective clinical decision support: making the practice of evidence-based medicine a reality.

While evidence-based medicine has increasingly broad-based support in health care, it remains difficult to get physicians to actually practice it. Across most domains in medicine, practice has lagged behind knowledge by at least several years. The authors believe that the key tools for closing this gap will be information systems that provide decision support to users at the time they make decisions, which should result in improved quality of care. Furthermore, providers make many errors, and clinical decision support can be useful for finding and preventing such errors. Over the last eight years the authors have implemented and studied the impact of decision support across a broad array of domains and have found a number of common elements important to success. The goal of this report is to discuss these lessons learned in the interest of informing the efforts of others working to make the practice of evidence-based medicine a reality.

Decision Making, Computer-Assisted↗

Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review.

BACKGROUND: Iatrogenic injuries related to medications are common, costly, and clinically significant. Computerized physician order entry (CPOE) and clinical decision support systems (CDSSs) may reduce medication error rates. METHODS: We identified trials that evaluated the effects of CPOE and CDSSs on medication safety by electronically searching MEDLINE and the Cochrane Library and by manually searching the bibliographies of retrieved articles. Studies were included for systematic review if the design was a randomized controlled trial, a nonrandomized controlled trial, or an observational study with controls and if the measured outcomes were clinical (eg, adverse drug events) or surrogate (eg, medication errors) markers. Two reviewers extracted all the data. Discussion resolved any disagreements. RESULTS: Five trials assessing CPOE and 7 assessing isolated CDSSs met the criteria. Of the CPOE studies, 2 demonstrated a marked decrease in the serious medication error rate, 1 an improvement in corollary orders, 1 an improvement in 5 prescribing behaviors, and 1 an improvement in nephrotoxic drug dose and frequency. Of the 7 studies evaluating isolated CDSSs, 3 demonstrated statistically significant improvements in antibiotic-associated medication errors or adverse drug events and 1 an improvement in theophylline-associated medication errors. The remaining 3 studies had nonsignificant results. CONCLUSIONS: Use of CPOE and isolated CDSSs can substantially reduce medication error rates, but most studies have not been powered to detect differences in adverse drug events and have evaluated a small number of "homegrown" systems. Research is needed to evaluate commercial systems, to compare the various applications, to identify key components of applications, and to identify factors related to successful implementation of these systems.

Cost-Benefit Analysis↗

Linking laboratory and pharmacy: opportunities for reducing errors and improving care.

A myriad of errors and lost improvement opportunities result from failure of clinical laboratory and pharmacy information systems to effectively communicate. Pharmacotherapy could benefit from enhanced laboratory-pharmacy linkage with respect to (1) drug choice (laboratory-based indications and contraindications), (2) drug dosing (renal or hepatic, blood level-guided adjustments), (3) laboratory monitoring (laboratory signals of toxicity, baseline and ongoing monitoring), (4) laboratory result interpretation (drug interfering with test), and (5) broader quality improvement (surveillance for unrecognized toxicity, monitoring clinician response delays). Linkages can be retrospective or real-time. Many organizations could benefit now by linking existing pharmacy and laboratory data. Greater improvement is possible through implementation of electronic order entry with real-time decision support incorporating linked laboratory and pharmacy data. While many guidelines, admonitions, and rules exist regarding drugs and the laboratory, substantial new knowledge and evidence in this area are needed. Focusing on these unmet needs and accompanying logistical challenges is a priority.

Clinical Laboratory Information Systems↗