A physician-based voluntary reporting system for adverse events and medical errors.

OBJECTIVE: To create a voluntary reporting method for identifying adverse events (AEs) and potential adverse events (PAEs) among medical inpatients. DESIGN: Medical house officers asked their peers about obstacles to care, injuries or extended hospitalizations, and problems with medications that affected their patients. Two independent reviewers coded event narratives for adverse outcomes, responsible parties, preventability, and process problems. We corroborated house officers' reports with hospital incident reports and conducted a retrospective chart review. SETTING: The cardiac step-down, oncology, and medical intensive care units of an urban teaching hospital. INTERVENTION: Structured confidential interviews by postgraduate year-2 and -3 medical residents of interns during work rounds. MEASUREMENTS AND MAIN RESULTS: Respondents reported 88 events over 3 months. AEs occurred among 5 patients (0.5% of admissions) and PAEs among 48 patients (4.9% of admissions). Delayed diagnoses and treatments figured prominently among PAEs (54%). Clinicians were responsible for the greatest number of incidents (55%), followed by workers in the laboratory (11%), radiology (15%), and pharmacy (3%). Respondents identified a variety of problematic processes of care, including problems with diagnosis (16%), therapy (26%), and failure to provide clinical and support services (29%). We corroborated 84% of reported events in the medical record. Participants found voluntary peer reporting of medical errors unobtrusive and agreed that it could be implemented on a regular basis. CONCLUSIONS: A physician-based voluntary reporting system for medical errors is feasible and acceptable to front-line clinicians.

Confidential clinician-reported surveillance of adverse events among medical inpatients.

BACKGROUND: Although iatrogenic injury poses a significant risk to hospitalized patients, detection of adverse events (AEs) is costly and difficult. METHODS: The authors developed a confidential reporting method for detecting AEs on a medicine unit of a teaching hospital. Adverse events were defined as patient injuries. Potential adverse events (PAEs) represented errors that could have, but did not result in harm. Investigators interviewed house officers during morning rounds and by e-mail, asking them to identify obstacles to high quality care and iatrogenic injuries. They compared house officer reports with hospital incident reports and patients' medical records. A multivariate regression model identified correlates of reporting. RESULTS: One hundred ten events occurred, affecting 84 patients. Queries by e-mail (incidence rate ratio [IRR] = 0.16; 95% confidence interval [95% CI], 0.05 to 0.49) and on days when house officers rotated to a new service (IRR = 0.12; 95% CI, 0.02 to 0.91) resulted in fewer reports. The most commonly reported process of care problems were inadequate evaluation of the patient (16.4%), failure to monitor or follow up (12.7%), and failure of the laboratory to perform a test (12.7%). Respondents identified 29 (26. 4%) AEs, 52 (47.3%) PAEs, and 29 (26.4%) other house officer-identified quality problems. An AE occurred in 2.6% of admissions. The hospital incident reporting system detected only one house officer-reported event. Chart review corroborated 72.9% of events. CONCLUSIONS: House officers detect many AEs among inpatients. Confidential peer interviews of front-line providers is a promising method for identifying medical errors and substandard quality.

Tumor microsatellite instability and clinical outcome in young patients with colorectal cancer.

BACKGROUND: Colorectal cancer can arise through two distinct mutational pathways: microsatellite instability or chromosomal instability. We tested the hypothesis that colorectal cancers arising from the microsatellite-instability pathway have distinctive clinical attributes that affect clinical outcome. METHODS: We tested specimens of colorectal cancer from a population-based series of 607 patients (50 years of age or younger at diagnosis) for microsatellite instability. We compared the clinical features and survival of patients who had colorectal cancer characterized by high-frequency microsatellite instability with these characteristics in patients who had colorectal cancers with microsatellite stability. RESULT: We found high-frequency microsatellite instability in 17 percent of the colorectal cancers in 607 patients, and in a multivariate analysis, microsatellite instability was associated with a significant survival advantage independently of all standard prognostic factors, including tumor stage (hazard ratio, 0.42; 95 percent confidence interval, 0.27 to 0.67; P< 0.001). Furthermore, regardless of the depth of tumor invasion, colorectal cancers with high-frequency microsatellite instability had a decreased likelihood of metastasizing to regional lymph nodes (odds ratio, 0.33; 95 percent confidence interval, 0.21 to 0.53; P< 0.001) or distant organs (odds ratio, 0.49; 95 percent confidence interval, 0.27 to 0.89; P=0.02). CONCLUSION: High-frequency microsatellite instability in colorectal cancer is independently predictive of a relatively favorable outcome and, in addition, reduces the likelihood of metastases.

Nonsteroidal anti-inflammatory drugs, traditional opioids, and tramadol: contrasting therapies for the treatment of chronic pain.

The treatment of chronic pain is an important function of physicians. In the United States, available drug treatments for chronic pain currently include simple analgesics such as acetaminophen, salicylates and other nonsteroidal anti-inflammatory drugs, traditional opioid drugs, and adjuvant agents (eg, antidepressants, anticonvulsants). Typically, the choice of a drug is made by balancing the indications for treatment, the clinical efficacy of the drug, and its toxicity. An understanding of the mechanism of action of these drugs helps to establish their role in therapy. Tramadol is an effective analgesic that works through a combined mechanism of weak mu receptor binding and the inhibition of serotonin and norepinephrine reuptake. Tramadol has a favorable adverse-effect profile and therefore is likely to have an important role in the management of chronic pain syndromes.

The use of cervical cytology to identify women at risk for chlamydial infection.

Testing asymptomatic women for chlamydial infection is advocated for high-risk populations, but testing criteria in low-risk settings are less clear. To determine whether findings from Papanicolaou (Pap) smears could identify women at risk for Chlamydia, we studied 512 women, 18 to 50 years of age, seeking routine gynecologic care. The prevalence of positive cultures for Chlamydia was 4.7%. Three cytologic findings were independently associated with Chlamydia on logistic regression: transformed lymphocytes, polymorphonuclear leukocytes, and squamous metaplasia. The sensitivity and the specificity of the presence of any two of these three findings were 75% and 73.6%, respectively. The prevalence of Chlamydia if two findings were present was 12.2%, nearly three times the population prevalence. Certain findings on cervical cytology may be useful as an adjunct in preventive care for chlamydial cervicitis.

The effect of cigarette smoking, Chlamydia trachomatis infection, and vaginal douching on ectopic pregnancy.

We conducted a case-control study of the relation between ectopic pregnancy and three exposures of interest: cigarette smoking, previous chlamydial infection, and vaginal douching. Cases were women with surgically confirmed tubal ectopic pregnancy; controls were women with intrauterine pregnancy at 14 weeks' gestation or less. All women were between the ages of 18-40 and were cared for at the same hospital. Sixty-nine case women and 101 controls were interviewed and underwent serologic tests for Chlamydia trachomatis exposure. Cases were more likely than controls to be nulliparous, non-white, and unmarried and to report a high school education or less (P less than .05). The proportions of cases and controls who reported smoking during the month of conception were 51 and 20%, respectively. The adjusted odds ratio for smoking was 2.4 (95% confidence interval 1.2-5.1) when current smokers were compared with former smokers and women who had never smoked. The proportions of women who had previous chlamydial infection (immunoglobulin G [IgG] greater than 1:64) among cases and controls were 35 and 20% (adjusted odds ratio 1.3, 95% confidence interval 0.6-3.0). Overall, 28% of cases and 19% of controls douched once or more per month (adjusted odds ratio 0.8, 95% confidence interval 0.3-2.2). We conclude that current cigarette smoking may be associated independently with ectopic pregnancy and that smoking cessation before the month of conception may reduce this risk. For these women, previous chlamydial infection and vaginal douching did not appear to increase significantly the risk of ectopic pregnancy.

Chlamydia trachomatis cervical infection in women seeking routine gynecologic care: criteria for selective testing.

PURPOSE: Chlamydia trachomatis infection is one of the most common sexually transmitted diseases. Developing methods to identify patients who are at higher risk would enable clinicians to perform selective testing for C. trachomatis infection, which may reduce morbidity, sequelae, and overall costs. Risk factors for C. trachomatis infection of the cervix in women seen for routine gynecologic care were therefore analyzed. PATIENTS AND METHODS: Extensive clinical data and cervical cultures were obtained from 1,141 women between the ages of 18 and 50. Multivariate techniques were used to develop and prospectively test a model to predict infection. RESULTS: In the model development series of 530 patients seen in a hospital-based practice, 24 (4.5%) had a positive culture result. In the validation series of 611 patients seen in private practice, 17 (2.8%) had positive culture results. The majority of infected patients (61%) were asymptomatic. For sexually active women 18 to 35 years of age, the optimal predictive model was based on three factors: level of education (high school or less), a sex partner with other partners during the prior three months, and endocervical bleeding induced by the initial swab. In the validation series, the prevalence of infection for women with one or more of these factors was 5.8% (95% confidence interval, 4.0 to 8.6) compared with 0.9% in patients without these factors (p = 0.005). CONCLUSION: Clinical information can be used in a low-prevalence population to predict a patient's risk for C. trachomatis infection and to select patients for testing.

Should women be tested for gonococcal infection of the cervix during routine gynecologic visits? An economic appraisal.

PURPOSE, PATIENTS, AND METHODS: We used decision analysis to calculate the economic implications of routine testing for Neisseria gonorrhoeae infection of the cervix. This study compared performing endocervical cultures in all women seeking routine gynecologic care to a no-test strategy. Estimates derived from the medical literature were varied in a sensitivity analysis, and a Monte Carlo technique was used to incorporate the estimates of experts into the analysis. RESULTS: We found that routinely testing for gonorrhea reduced overall medical costs when the prevalence of infection exceeded 1.5 percent. This result was most sensitive to variation in the cost of the culture and the assumption that treatment prevents adverse sequelae. Reducing the estimated cost of the culture from $9 to $5 decreased the threshold prevalence from 1.5 to 0.8 percent. When we considered the variation in estimates of experts, the threshold prevalence increased from 1.5 to 2.1 percent. CONCLUSION: We conclude that a strategy of testing and treating selected women with risk factors for gonorrhea will not only reduce the likelihood of the development of serious adverse sequelae but will also result in a reduction of medical costs.

Prevalence and recognition of alcohol abuse in a primary care population.

PURPOSE: The purpose of this study was to assess the prevalence, physician recognition, and treatment of alcohol abuse among patients of 19 senior medical residents practicing in a hospital-based, primary care setting. PATIENTS AND METHODS: Interviews of 242 outpatients were conducted, and alcohol abuse and dependence, as defined by the Diagnostic and Statistical Manual of Mental Disorders, third edition (DSM-III), were determined using the Diagnostic Interview Schedule. RESULTS: Twenty percent of the patients studied had abused or were dependent on alcohol at some time in their lives and 5 percent reported abuse or dependence within the last year. Of the techniques studied, a short screening questionnaire (Short Michigan Alcohol Screening Test [SMAST]) was the most accurate way of identifying patients who abused alcohol, and physician assessments were more accurate than laboratory tests. Although the physicians were aware of serious alcohol problems among 77 percent of their patients who met DSM-III criteria for alcohol abuse or dependence in the previous year, they identified only 36 percent of their patients with less serious problems or past alcohol abuse. They had only discussed alcohol abuse with 67 percent of the patients they identified as alcohol abusers. CONCLUSION: We conclude that a short screening questionnaire (SMAST) is an accurate means of identifying alcohol abuse. Despite the recognition of serious alcohol problems by the physicians, the problem is not addressed routinely even among patients that are recognized as alcoholic.

Gonorrhea in women seen for routine gynecologic care: criteria for testing.

PURPOSE: This study was initiated to determine risk factors for Neisseria gonorrhoeae infection of the cervix in women seen for routine care in a hospital-based obstetrics and gynecology practice. PATIENTS AND METHODS: Extensive clinical data and cervical culture specimens for N. gonorrhoeae were obtained prospectively from 1,441 women between the ages of 18 and 50. Fifty clinical factors were evaluated by multivariate analysis. RESULTS: Of the 1,441 patients tested, 25 (1.7 percent) had a positive culture result. The majority of infected women were asymptomatic. The following five factors were found to be associated independently with gonococcal infection: (1) sex with a partner who may have had gonorrhea or a urethral discharge within the prior three months, (2) endocervical bleeding induced by the initial swab, (3) age at first intercourse less than or equal to 16, (4) method of payment (Medicaid), and (5) low abdominal or pelvic pain. Race, a univariate risk factor, was not associated with gonorrhea when these other factors were considered. The risk of infection for women with none, one, two, or three or more of these multivariate risk factors was 0.2, 0.8, 2.9, and 9.8 percent, respectively. CONCLUSION: Clinical data are helpful in identifying women at risk for gonorrhea. If resources are insufficient to evaluate all sexually active women, we suggest routine testing based on the presence of the multivariate risk factors identified.

Fever in hospitalized medical patients: characteristics and significance.

The occurrence of fever and the clinical profile of febrile patients on the medical service of a teaching hospital were studied prospectively. Thirty-six per cent of 972 patients developed fever (temperature exceeding 38 degrees C). Their 13% mortality rate and 13.2-day average hospital stay exceeded the 3% mortality and seven-day hospitalization for afebrile patients (p less than 0.0001 for both). Most fever episodes occurred during the first two hospital days. Approximately 30% of first and subsequent fever episodes were caused by bacterial infections; illnesses involving tissue necrosis (e.g., stroke, myocardial infarction) accounted for 20%. Five conditions comprised 53% of diagnoses: respiratory and urinary tract infections, neoplasm, myocardial infarction, and drug reaction. Only one patient had a fever of uncertain origin. Several clinical clues used frequently to identify bacterial infections were reevaluated. Patients with bacterial infections had higher temperatures on the first febrile day (mean 38.9 degrees C) and were more likely to have had prior infections than those with other causes of fever (mean 38.3 degrees C, p less than 0.001). Older patients (greater than 75 years) had a lower febrile response to bacterial infections than younger patients. Fever in hospitalized medical patients is a common and important concomitant of increased mortality and length of hospitalization.

Use of a direct fluorescent antibody test for detecting Chlamydia trachomatis cervical infection in women seeking routine gynecologic care.

We determined the sensitivity, specificity, and predictive value of a direct fluorescence test for Chlamydia trachomatis infection compared with culture of the endocervix in women seeking routine gynecologic care. Of 527 patients seen in a hospital-based practice, 23 (4.4%) had a positive culture for C. trachomatis. The overall sensitivity of the direct test was 70%, and the specificity was 98%. When five or more endocervical cells were present on the direct test slide, the sensitivity increased to 92%, and the specificity decreased to 96% (P less than .05). When the presence of any columnar epithelial cells, five or more elementary bodies, or both was used as the criteria for accepting specimens, the sensitivity and specificity of the direct test were 80% and 96%, respectively. However, 44% of the specimens would be rejected if these criteria were used. The overall probability that an individual with a positive direct test would have a positive culture was 62%.

Febrile inpatients: house officers' use of blood cultures.

The so-called "fever work-up" is time-consuming and costly. The authors examined the practices of medical house officers in obtaining blood cultures, an important part of this evaluation, as well as the ability of these physicians to predict bacteremia in febrile patients. They studied all 344 medical inpatients who experienced episodes of fever during two 30-day periods, as well as all 50 cases of bacteremia detected during these and two additional 30-day periods. House officers drew blood for culture within one day after the onset of fever in 52% of fever episodes. In 20% of these episodes only one set of cultures (representing one venipuncture) was obtained. House officers estimated the likelihood of bacteremia to be 20% or less in 15 of 40 bacteremic patients. They failed to obtain blood cultures promptly in 10% of bacteremic episodes and in 27% of episodes where the cause of fever was a nonbacteremic bacterial infection. They obtained prompt blood cultures in only a bare majority of febrile episodes, frequently underestimated the likelihood of bacteremia, and inadequately sampled blood for bacteremia. In this study, clinical judgment was not an adequate substitute for routinely obtaining blood cultures for febrile medical inpatients.

Should tests for Chlamydia trachomatis cervical infection be done during routine gynecologic visits? An analysis of the costs of alternative strategies.

We used decision analysis to estimate the clinical and economic implications of testing for cervical infection caused by Chlamydia trachomatis in women during routine gynecologic visits. We compared a strategy of no routine testing with a strategy involving the use of routine cultures or the use of less expensive rapid tests for chlamydial infection (the direct fluorescent assay or the enzyme immunoassay). We used different assumptions for the costs and operating characteristics of the diagnostic tests, complications of undetected infection, and the cost of false-positive test results. We found that using one of the rapid tests would reduce overall costs if the prevalence of infection was 7% or greater. The use of routine cultures would reduce costs if the frequency of infection was 14% or greater. We conclude that testing for cervical infection with C. trachomatis in women seeking routine gynecologic care may reduce overall costs. The choice of diagnostic test should depend on the expected prevalence of infection, local cost considerations, and laboratory expertise in the execution of these tests.

Blood cultures.

We reviewed the literature on the performance of the blood culture as a diagnostic test and analyzed the data with Bayes' theorem to find the optimal number of cultures to draw. The blood culture is unusually dependent on physician behavior (use of sterile technique, the number and timing of cultures, volume of blood drawn) and on their clinical judgment (estimating the pretest probability of bacteremia, anticipating the causative pathogen, interpreting the results). Because there is no independent "gold-standard" procedure against which to evaluate this test, sensitivity and specificity can only be approximated. Sensitivity can be maximized by doing multiple cultures containing at least 10 mL of blood per set. Specificity can be maximized by adhering strictly to aseptic techniques and by requiring that multiple sets be positive for the series to be considered positive when the anticipated pathogens are also common contaminants. Two or three blood culture sets almost always suffice to establish or rule out bacteremia, although on some occasions obtaining more than three sets of cultures is indicated. One set is rarely, if ever, sufficient.