Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> There are risks of adverse outcomes to patients in the course of health care management. A study was undertaken to measure these outcomes in California for 1974. Secondary benefits of the study include new insights into the types and sources of disabilities caused by health care management and the development of new methods for carrying out generic adverse-outcome monitoring. <s> BIB001 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> To provide information on the frequency of adverse drug reactions in ambulatory patients we used intensive telephone surveillance to detect suspected reactions in 1026 patients seen at an internal medicine group practice over a 1-year period. Two hundred and ninety-two suspected reactions were detected. The majority of suspected reactions were mild, causing predominantly worry or discomfort. We used a published algorithm to assess the suspected reactions for drug causation with the following results: 40 (14%) unlikely; 193 (66%) possible; 56 (19%) probable; and 3 (1%) definite. The rate of probable or definite reactions was 49/1026 (5%) per patient and 58/3330 (2%) per drug course. Surprisingly, neither the age of the patient nor the number of other drugs he was taking modified the risk of a reaction to an individual newly-started drug. Our data suggest that fear of adverse reaction should not usually be a major factor in therapeutic decision making for an ambulatory patient even when the patient is old or already on multiple drugs. <s> BIB002 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> BACKGROUND ::: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. ::: ::: ::: METHODS ::: We reviewed 30,121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. ::: ::: ::: RESULTS ::: Adverse events occurred in 3.7 percent of the hospitalizations (95 percent confidence interval, 3.2 to 4.2), and 27.6 percent of the adverse events were due to negligence (95 percent confidence interval, 22.5 to 32.6). Although 70.5 percent of the adverse events gave rise to disability lasting less than six months, 2.6 percent caused permanently disabling injuries and 13.6 percent led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi 2 = 21.04, P less than 0.0001). Using weighted totals, we estimated that among the 2,671,863 patients discharged from New York hospitals in 1984 there were 98,609 adverse events and 27,179 adverse events involving negligence. Rates of adverse events rose with age (P less than 0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (P less than 0.01). There were significant differences in rates of adverse events among categories of clinical specialties (P less than 0.0001), but no differences in the percentage due to negligence. ::: ::: ::: CONCLUSIONS ::: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care. <s> BIB003 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> OBJECTIVE ::: To describe the prevalence, types, and consequences of adverse drug events (ADEs) in older outpatients with polypharmacy. ::: ::: ::: DESIGN ::: A cohort study. ::: ::: ::: SETTING ::: General Medicine Clinic at the Durham Veterans Affairs Medical Center. ::: ::: ::: PATIENTS ::: A total of 167 high risk (taking > or = 5 scheduled medications) ambulatory older veterans who participated in a year long health service intervention trial. ::: ::: ::: MEASUREMENTS ::: Potential ADEs were identified by asking patients during closeout interviews whether, in the past year, they had experienced any side effects, unwanted reactions, or other problems from any medication. All reported medications and corresponding adverse experiences were assessed for plausibility by a research clinical pharmacist using two standard pharmacological textbooks and categorized by predictability, therapeutic class, and organ system. ::: ::: ::: RESULTS ::: Eighty self-reported ADEs involving 72 medications taken by 58 (35%) of 167 patients were textbook confirmed. Seventy-six of 80 (95%) ADEs were classified as Type A (predictable) reactions. Cardiovascular (33.3%) and central nervous system (27.8%) medication classes were most commonly implicated. Gastrointestinal (30%) and central nervous system (28.8%) ADE symptoms were common. Sixty-three percent of patients with ADEs required physician contacts, 10% emergency room visits, and 11% hospitalization. Twenty percent of medications implicated with ADEs required dosage adjustments, and 48% of ADE-related medications were discontinued. No significant differences (P > .05) were observed when ADE reporters (n = 58) and nonreporters (n = 109) were compared. ::: ::: ::: CONCLUSION ::: Predictable ADEs are common in high risk older outpatients, resulting in considerable medication modification and substantial healthcare utilization. <s> BIB004 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> A process for the preparation of R alpha -cyclopentenoids and then R alpha , R omega -cyclopentanoids is described. The process involves the reaction of a compound of the formula where X is halo, particularly Br or I and P is a protecting group with an alkylborane to produce the R alpha -cyclopentenone. The R alpha -cyclopentenone is reacted with a R omega cuprate to produce the R alpha , R omega -cyclopentenoid. The process is used for the preparation of prostaglandins which are known pharmaceutically active compounds. <s> BIB005 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> BACKGROUND ::: The ongoing debate on the incidence and types of iatrogenic injuries in American hospitals has been informed primarily by the Harvard Medical Practice Study, which analyzed hospitalizations in New York in 1984. The generalizability of these findings is unknown and has been questioned by other studies. ::: ::: ::: OBJECTIVE ::: We used methods similar to the Harvard Medical Practice Study to estimate the incidence and types of adverse events and negligent adverse events in Utah and Colorado in 1992. ::: ::: ::: DESIGN AND SUBJECTS ::: We selected a representative sample of hospitals from Utah and Colorado and then randomly sampled 15,000 nonpsychiatric 1992 discharges. Each record was screened by a trained nurse-reviewer for 1 of 18 criteria associated with adverse events. If > or =1 criteria were present, the record was reviewed by a trained physician to determine whether an adverse event or negligent adverse event occurred and to classify the type of adverse event. ::: ::: ::: MEASURES ::: The measures were adverse events and negligent adverse events. ::: ::: ::: RESULTS ::: Adverse events occurred in 2.9+/-0.2% (mean+/-SD) of hospitalizations in each state. In Utah, 32.6+/-4% of adverse events were due to negligence; in Colorado, 27.4+/-2.4%. Death occurred in 6.6+/-1.2% of adverse events and 8.8+/-2.5% of negligent adverse events. Operative adverse events comprised 44.9% of all adverse events; 16.9% were negligent, and 16.6% resulted in permanent disability. Adverse drug events were the leading cause of nonoperative adverse events (19.3% of all adverse events; 35.1% were negligent, and 9.7% caused permanent disability). Most adverse events were attributed to surgeons (46.1%, 22.3% negligent) and internists (23.2%, 44.9% negligent). ::: ::: ::: CONCLUSIONS ::: The incidence and types of adverse events in Utah and Colorado in 1992 were similar to those in New York State in 1984. Iatrogenic injury continues to be a significant public health problem. Improving systems of surgical care and drug delivery could substantially reduce the burden of iatrogenic injury. <s> BIB006 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> OBJECTIVE: Outpatient drug complications have not been well studied. We sought to assess the incidence and characteristics of outpatient drug complications, identify their clinical and nonclinical correlates, and evaluate their impact on patient satisfaction.DESIGN: Retrospective chart reviews and patient surveys.SETTING: Eleven Boston-area ambulatory clinics.PATIENTS: We randomly selected 2,248 outpatients, 20 to 75 years old.MEASUREMENTS AND MAIN RESULTS: Among 2,248 patients reporting prescription drug use, 394 (18%) reported a drug complication. In contrast, chart review revealed an adverse drug event in only 64 patients (3%). In univariate analyses, significant correlates of patient-reported drug complications were number of medical problems, number of medications, renal disease, failure to explain side effects before treatment, lower medication compliance, and primary language other than English or Spanish. In multivariate analysis, independent correlates were number of medical problems (odds ratio [OR] 1.17; 95% confidence interval [95% CI] 1.05 to 1.30), failure to explain side effects (OR 1.65; 95% CI, 1.16 to 2.35), and primary language other than English or Spanish (OR 1.40; 95% CI, 1.01 to 1.95). Patient satisfaction was lower among patients who reported drug complications (P < .0001). In addition, 48% of those reporting drug complications sought medical attention and 49% experienced worry or discomfort. On chart review, 3 (5%) of the patients with an adverse drug event required hospitalization and 8 (13%) had a documented previous reaction to the causative drug.CONCLUSIONS: Drug complications in the ambulatory setting were common, although most were not documented in the medical record. These complications increased use of the medical system and correlated with dissatisfaction with care. Our results indicate a need for better communication about potential side effects of medications, especially for patients with multiple medical problems. <s> BIB007 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> PURPOSE ::: Adverse drug events (ADEs), or injuries due to drugs, are common and often preventable. However, identifying ADEs, potential ADEs, and medication errors can be a major challenge. In this review, we describe methodologies that have been used to identify these events and give strategies for identification in non-study settings. ::: ::: ::: RESULTS ::: Methods such as voluntary reporting, chart review, and computerized monitoring for events have been most commonly used in studies of ADEs in inpatients. However, voluntary reporting, the method most hospitals currently use, has a very low yield of events. Chart review is much more sensitive but the costs are prohibitive. Computerized monitoring for ADEs (using rules or triggers) is a high yield and relatively inexpensive strategy that should be adopted by organizations. A limitation of this strategy, however, is that it identifies few medication errors and potential ADEs, which are also important. These can be captured through pharmacy logs, chart review, and direct observation. Once events have been identified, they can be classified by type of event, severity, and preventability. In non-study settings, the most practical method for identifying ADEs is computerized monitoring, and for identifying prescribing errors it is pharmacy logs of interventions. Once problems are found, a structure (either individual or committee) must be in place to classify them, identify opportunities for improvement, and carry out the necessary changes. ::: ::: ::: CONCLUSIONS ::: Health care organizations have the technology to significantly improve their detection of ADEs, medication errors, and potential ADEs. Identification and subsequent classification of events is crucial for quality efforts to improve patient safety. <s> BIB008 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> OBJECTIVE ::: To evaluate the use of a computer program to identify adverse drug events (ADEs) in the ambulatory setting and to evaluate the relative contribution of four computer search methods for identifying ADEs, including diagnosis codes, allergy rules, computer event monitoring rules, and text searching. ::: ::: ::: DESIGN ::: Retrospective analysis of one year of data from an electronic medical record, including records for 23,064 patients with a primary care physician, of whom 15,665 actually came for care. ::: ::: ::: MEASUREMENT ::: Presence of an ADE; sensitivity and specificity of computer searches for ADE. ::: ::: ::: RESULTS ::: The computer program identified 25,056 incidents, which were associated with an estimated 864 (95 percent confidence interval [CI], 750-978) ADES. Thus, the ADE rate was 5.5 (CI, 5.2-5.9) per 100 patients coming for care. Furthermore, in 79 (CI, 68-89) ADEs, the patient required hospitalization, resulting in an estimated rate of 3.4 (CI, 2.7-4.3) admissions per 1,000 patients. The sensitivity of the search methods for identifying ADEs was estimated to be 58 (CI, 18-98) percent, and the estimated specificity was 88 (CI, 87-88) percent. The positive predictive value was 7.5 (CI, 6.5-8.5) percent, and the negative predictive value was 99.2 (CI, 95.5-99.98) percent. Compared with age and gender-matched controls with no positive screen, patients with ADEs had twice as many outpatient visits and were taking nearly three times as many drugs. Antihypertensives, ACE-inhibitors, antibiotics, and diuretics were associated with 56 (CI, 47-65) percent of ADES. Among ADEs, 23 (CI, 16-32) percent were life-threatening or serious, and 38 (CI, 29-47) percent were judged preventable. ::: ::: ::: CONCLUSION ::: Computerized search programs can detect ADEs, and free-text searches were especially useful. Adverse drug events were frequent, and admissions were not rare, although most hospitals today do not identify them. Thus, such detection programs demonstrate "value-added" for the electronic record and may be useful for directing and assessing the impact of quality improvement efforts. <s> BIB009 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> BACKGROUND ::: Studies of hospitalized patients identify safety as a significant problem, but few data are available regarding injuries occurring after discharge. Patients may be vulnerable during this transition period. ::: ::: ::: OBJECTIVE ::: To describe the incidence, severity, preventability, and "ameliorability" of adverse events affecting patients after discharge from the hospital and to develop strategies for improving patient safety during this interval. ::: ::: ::: DESIGN ::: Prospective cohort study. ::: ::: ::: SETTING ::: A tertiary care academic hospital. ::: ::: ::: PATIENTS ::: 400 consecutive patients discharged home from the general medical service. ::: ::: ::: MEASUREMENTS ::: The three main outcomes were adverse events, defined as injuries occurring as a result of medical management; preventable adverse events, defined as adverse events judged to have been caused by an error; and ameliorable adverse events, defined as adverse events whose severity could have been decreased. Posthospital course was determined by performing a medical record review and a structured telephone interview approximately 3 weeks after each patient's discharge. Outcomes were determined by independent physician reviews. ::: ::: ::: RESULTS ::: Seventy-six patients had adverse events after discharge (19% [95% CI, 15% to 23%]). Of these, 23 had preventable adverse events (6% [CI, 4% to 9%]) and 24 had ameliorable adverse events (6% [CI, 4% to 9%]). Three percent of injuries were serious laboratory abnormalities, 65% were symptoms, 30% were symptoms associated with a nonpermanent disability, and 3% were permanent disabilities. Adverse drug events were the most common type of adverse event (66% [CI, 55% to 76%]), followed by procedure-related injuries (17% [CI, 8% to 26%]). Of the 25 adverse events resulting in at least a nonpermanent disability, 12 were preventable (48% [CI, 28% to 68%]) and 6 were ameliorable (24% [CI, 7% to 41%]). ::: ::: ::: CONCLUSION ::: Adverse events occurred frequently in the peridischarge period, and many could potentially have been prevented or ameliorated with simple strategies. <s> BIB010 </s> Detecting adverse events for patient safety research: a review of current methodologies <s> Introduction <s> OBJECTIVE: To evaluate the frequency of medication errors using a multidisciplinary approach, to classify these errors by type, and to determine how often medication errors are associated with adverse drug events (ADEs) and potential ADEs. <s> BIB011
Adverse events in health care appear to be responsible for 44,000 to 98,000 accidental deaths and over one million excess injuries each year BIB005  . Estimates of the prevalence of adverse events per hospital admission range from 2.9 to 16.6% BIB003 BIB006 BIB001  . While medical errors have not been as extensively studied in the outpatient setting, it is estimated that 3-35% of outpatients experience an adverse drug event BIB002 BIB004 BIB007 BIB009 and that 13% of all adverse events identified during hospitalizations occur during outpatient care BIB003 . In one study from a tertiary care center, 19% of patientÕs discharges from the hospital experienced an adverse event during the transition to outpatient care BIB010 . The pervasive problem of medical errors and adverse events in healthcare has made improving patient safety a national priority  . High quality evidence exists supporting many interventions designed to improve patient safety  , yet much work still remains. Researchers wishing to evaluate the effectiveness of patient safety interventions are faced with a daunting challenge. Identification of adverse events is critical for improving patient safety, yet medical errors and adverse events can be challenging to measure BIB008 . Efforts to overcome these problems have resulted in the development of several tools that researchers and increasingly clinical teams are using to detect adverse events. This paper reviews the methodologies that have been utilized for adverse event detection. For the purpose of this review, we have also included methods used to increase the reporting of adverse events within our definition of adverse event detection systems, as well as www.elsevier.com/locate/yjbin more recent approaches to the application of cognitive science principles to understanding and monitoring errors. We will begin with a brief description of both voluntary and involuntary manual methods for adverse event detection, then review combined modalities involving both electronic screening and manual review, and then describe fully automated methods for adverse event detection. We discuss the cognitive perspective in the final section. No universal definitions for descriptive terminology used within patient safety literature currently exist. This is one of the factors resulting in varying estimates of the prevalence of adverse events and medical errors. For the purposes of this paper, we will use the definitions presented by the Institute of Medicine (IOM) to define adverse events and medical errors. The IOM defined an adverse event as ''an injury caused by medical management rather than the underlying condition of the patient'' and a medical error as ''the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim'' BIB005 . A preventable adverse event is an adverse event that results from an error. It is important to note is that most adverse events do not result from an error, an example being a patient who experiences an anaphylactic reaction after their first exposure to a drug to which they had no prior allergic history, and also that most errors do not result in an adverse event, for example a ten-fold overdose order for a drug that gets intercepted and corrected by a pharmacist. Medical errors occur much more frequently than adverse events and medication errors outnumber adverse drug events by 100-1 BIB011 .