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Biomedical subjects

Richard Platt

Publications and source records attributed to Richard Platt.

At least 19 recordsLinked to original sources

Multivariate scan statistics for disease surveillance.

In disease surveillance, there are often many different data sets or data groupings for which we wish to do surveillance. If each data set is analysed separately rather than combined, the statistical power to detect an outbreak that is present in all data sets may suffer due to low numbers in each. On the other hand, if the data sets are added by taking the sum of the counts, then a signal that is primarily present in one data set may be hidden due to random noise in the other data sets. In this paper, we present an extension of the spatial and space-time scan statistic that simultaneously incorporates multiple data sets into a single likelihood function, so that a signal is generated whether it occurs in only one or in multiple data sets. This is done by defining the combined log likelihood as the sum of the individual log likelihoods for those data sets for which the observed case count is more than the expected. We also present another extension, where the concept of combining likelihoods from different data sets is used to adjust for covariates. Using data from the National Bioterrorism Syndromic Surveillance Demonstration Project, we illustrate the new method using physician telephone calls, regular physician visits and urgent care visits by Harvard Pilgrim Health Care members cared for by Harvard Vanguard Medical Associates, a large multi-specialty group practice in Massachusetts. For upper and lower gastrointestinal (GI) illness, there were on average 20 telephone calls, nine urgent care visits and 22 regular physician visits per day. The strongest signal was generated by a single data set and due to a familial outbreak of pinworm disease. The second and third strongest signals were generated by the combined strength of two of the three data sets.

Boston↗

Estimation of the period prevalence of inflammatory bowel disease among nine health plans using computerized diagnoses and outpatient pharmacy dispensings.

BACKGROUND: There are few contemporary estimates of prevalence rates for inflammatory bowel disease (IBD) in diverse North American communities. METHODS: We estimated the period prevalence of IBD for January 1, 1999, through June 30, 2001, among 1.8 million randomly sampled members of nine integrated healthcare organizations in the US using computerized diagnoses and outpatient pharmaceutical dispensing. We also assessed the positive predictive value (PPV) and sensitivities of 1) the case-finding algorithm, and 2) the 30-month sampling period using medical chart review and linkage to a 78-month dataset, respectively. RESULTS: The PPV of the case-finding algorithm was 81% (95% confidence interval [CI], 78-87) and 84% (95% CI, 79-89) in two different organizations. In both, the sensitivity of the optimal algorithm, compared with the most inclusive, exceeded 90%. The sensitivity of the 30-month sampling period compared with 78 months was 61% (95% CI, 57-64) in one organization. Applying a slightly more sensitive case-finding algorithm, the average period prevalence of IBD across the nine organizations, standardized to the age- and gender-distribution of the US population, 2000 census, was 388 cases (95% CI, 378-397) per 100,000 persons (range 209-784 per 100,000; average follow-up 26 months). The prevalence of Crohn's disease, ulcerative colitis, and unspecified IBD was 129, 191, and 69 per 100,000, respectively. CONCLUSIONS: The observed average prevalence was similar to prevalence proportions reported for other North American populations (369-408 per 100,000). Additional research is needed to understand differences in the occurrence of IBD among diverse populations as well as practice variation in diagnosis and treatment of IBD.

Adolescent↗

Laboratory monitoring of potassium and creatinine in ambulatory patients receiving angiotensin converting enzyme inhibitors and angiotensin receptor blockers.

PURPOSE: Serum potassium and creatinine monitoring is recommended for patients prescribed angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB). Much has been written about hyperkalemia associated with these drugs; little is known about laboratory monitoring patterns. The purpose of this retrospective cohort study was to assess creatinine and potassium monitoring and characteristics associated with monitoring among patients dispensed ACEi or ARB. METHODS: This study was conducted in 10 United States health maintenance organizations. Study patients (n = 52 906) were aged 18 or older with dispensings of ACEi or ARB for at least 1 year. Serum potassium and creatinine monitoring were assessed from administrative data and medical records. RESULTS: More than two-thirds (68.4%) of patients received laboratory monitoring. Likelihood of monitoring increased with age (adjusted odds ratio [OR] 2.10; 95% confidence interval [95%CI] 1.93, 2.28 [individuals >or= 80 compared to <50 years]), >9 outpatient visits (OR 1.46; 95%CI 1.39, 1.54), hospitalization (OR 1.15; 95%CI 1.06, 1.25), concomitant medications (potassium [OR 2.01; 95%CI 1.84, 2.20], diuretics [OR 1.54; 95%CI 1.47, 1.61], digoxin [OR 1.15; 95%CI 1.01, 1.30]), and comorbidities (diabetes [OR 1.68; 95%CI 1.61, 1.75], heart failure [OR 1.73; 95%CI 1.57, 1.90], chronic kidney disease [OR 2.95; 95%CI 2.48. 3.51]). CONCLUSIONS: Nearly one-third of patients dispensed ACEi or ARB did not undergo laboratory monitoring at least yearly. Though patients at increased risk of hyperkalemia were more likely to be monitored, many remained unmonitored.

Adult↗

Risk factors for statin-associated rhabdomyolysis.

PURPOSE: To identify and characterize risk factors for rhabdomyolysis in patients prescribed statin monotherapy or statin plus fibrate therapy. METHODS: A nested case-control study was conducted within a cohort of 252,460 new users of lipid-lowering medications across 11 geographically dispersed U.S. health plans. Twenty-one cases of rhabdomyolysis confirmed by medical record review were compared to 200 individually matched controls without rhabdomyolysis. A conditional logistic regression model was applied to evaluate the effects of age, gender, comorbidities, concurrent medication use, dosage, and duration of statin use on the development of rhabdomyolysis. RESULTS: Statin users 65 years of age and older have four times the risk of hospitalization for rhabdomyolysis than those under age 65 (odds ratio (OR) = 4.36, 95% confidence interval (CI): 1.5,14.1). We also observed a joint effect of high statin dosage and renal disease (p = 0.022). When these two variables were added to the model with age, we obtained an OR of 5.73 for dosage (95%CI: 0.63, 52.6) and 6.26 for renal disease (95%CI: 0.46, 63.38). Although not statistically significant, we did observe a greater than twofold increase in risk for rhabdomyolysis among females (OR = 2.53, 95%CI: 0.91, 7.32). CONCLUSIONS: Findings of this study indicate that older age is a risk factor for rhabdomyolysis among statin users. Although the evidence is not as strong, high statin dosage, renal disease, and female gender may be additional risk factors. Patients at higher risk of developing rhabdomyolysis should be closely monitored for signs and symptoms of the disease.

Adult↗

Asthma drug use and the development of Churg-Strauss syndrome (CSS).

PURPOSE: Case reports suggest that leukotriene modifier use may be associated with the onset of Churg-Strauss syndrome (CSS). Using pooled data from two nested case-control studies, we examined the association between asthma drug use and the development of CSS. METHODS: The study was performed in three US managed care organizations and a US national health plan with chart access and complete electronic pharmacy data, with a covered population of 13.9 million. There were 47 cases of possible or definite CSS and 4700 asthma drug user controls identified between January 1, 1995 and December 31, 2002. We examined exposure to asthma drugs in cases and controls, including leukotriene modifiers (6 cases and 202 controls), in the two to 6 months prior to the onset of adjudicated CSS. RESULTS: While the crude association between use of leukotriene modifiers and CSS was strong (odds ratio (OR) 4.00, 95% confidence interval (CI): 1.49-10.60), in a multivariable analysis controlling for use of oral corticosteroids, inhaled corticosteroids, and number of categories of asthma drugs dispensed, there was no significant association (OR 1.32, 95% CI: 0.44-3.96). Use of inhaled and oral corticosteroids, evaluated as markers of asthma severity, were associated with CSS (OR 3.07, 95% CI: 1.34-7.03 and OR 5.36, 95% CI: 2.51-11.45, respectively). CONCLUSIONS: No association was found between CSS and leukotriene modifiers after controlling for asthma drug use However, it is not possible to rule out modest associations with asthma treatments given CSS is so rare and so highly correlated with asthma severity, suggesting further investigation is warranted.

Adolescent↗

Improving methicillin-resistant Staphylococcus aureus surveillance and reporting in intensive care units.

BACKGROUND: Routine culturing of patients in intensive care units (ICUs) for methicillin-resistant Staphylococcus aureus (MRSA) identifies unrecognized carriers and facilitates timely isolation. However, the benefit of surveillance in detecting prevalent and incident carriers likely varies among ICUs. In addition, many assessments underestimate the incidence of acquisition by including prevalent carriers in the at-risk population. METHODS: We performed a retrospective cohort study using accurate at-risk populations to evaluate the range of benefit of admission and weekly surveillance cultures in detecting otherwise unrecognized MRSA in 12 ICUs in 5 states. RESULTS: We assessed 142 ICU-months. Among the 12 ICUs, the admission prevalence of imported MRSA was 5%-21%, with admission surveillance providing 30%-135% increases in rates of detection. The monthly hospital-associated incidence was 2%-6%, with weekly surveillance providing 7%-157% increases in detection. The common practice of reporting incidence using the total number of patients or total patient-days underestimated incidence by one-third. Surgical ICUs had lower MRSA importation but higher MRSA incidence. Overall, routine surveillance prevented the misclassification of 17% (unit range, 11%-29%) of "incident" carriers, compared with clinical cultures, and increased precaution days by 18% (unit range, 11%-91%). CONCLUSIONS: Routine surveillance significantly increases the detection of MRSA, but this benefit is not uniform across ICUs, even with high compliance and the use of correct denominators.

Academic Medical Centers↗

Improving the assessment of vancomycin-resistant enterococci by routine screening.

BACKGROUND: As infection with vancomycin-resistant enterococci (VRE) increases in hospitals, knowledge about VRE reservoirs and improved accuracy of epidemiologic measures are needed. Many assessments underestimate incidence by including prevalent carriers in at-risk populations. Routine surveillance cultures can substantially improve prevalence and incidence estimates, and assessing the range of improvement across diverse units is important. METHODS: We performed a retrospective cohort study using accurate at-risk populations to evaluate the range of benefit of admission and weekly surveillance cultures in detecting unrecognized VRE in 14 patient-care units. RESULTS: We assessed 165 unit-months. The admission prevalence of VRE was 2.2%-27.2%, with admission surveillance providing 2.2-17-fold increased detection. Medical units were significantly more likely to admit VRE carriers than were surgical units. Monthly incidence was 0.8%-9.7%, with weekly surveillance providing 3.3-15.4-fold increased detection. The common practice of reporting incidence using the total number of patients, rather than patients at risk, underestimated incidence by one-third. Overall, routine surveillance prevented the misclassification of 43.0% (unit range, 0%-85.7%) of "incident" carriers on the basis of clinical cultures alone and increased VRE precaution days by 2.4-fold (unit range, 2.0-2.6-fold). CONCLUSIONS: Routine surveillance markedly increases the detection of VRE, despite variability across patient-care units. Correct denominators prevent the substantial underestimation of incidence.

Academic Medical Centers↗

Risk of acquiring antibiotic-resistant bacteria from prior room occupants.

BACKGROUND: Environmental contamination with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) occurs during the care of patients harboring these organisms and may increase the risk of transmission to subsequent room occupants. METHODS: Twenty-month retrospective cohort study of patients admitted to 8 intensive care units performing routine admission and weekly screening for MRSA and VRE. We assessed the relative odds of acquisition among patients admitted to rooms in which the most recent occupants were MRSA positive or VRE positive, compared with patients admitted to other rooms. RESULTS: Of 11 528 intensive care unit room stays, 10 151 occupants were eligible to acquire MRSA, and 10 349 were eligible to acquire VRE. Among patients whose prior room occupant was MRSA positive, 3.9% acquired MRSA, compared with 2.9% of patients whose prior room occupant was MRSA negative (adjusted odds ratio, 1.4; P = .04). VRE, Among patients whose prior room occupant was VRE positive, these values were 4.5% and 2.8% respectively (adjusted odds ratio, 1.4; P = .02). These excess risks accounted for 5.1% of all incident MRSA cases and 6.8% of all incident VRE cases, with a population attributable risk among exposed patients of less than 2% for either organism. Acquisition was significantly associated with longer post-intensive care unit length of stay. CONCLUSIONS: Admission to a room previously occupied by an MRSA-positive patient or a VRE-positive patient significantly increased the odds of acquisition for MRSA and VRE. However, this route of transmission was a minor contributor to overall transmission. The effect of current cleaning practices in reducing the risk to the observed levels and the potential for further reduction are unknown.

Boston↗

Distributed data processing for public health surveillance.

BACKGROUND: Many systems for routine public health surveillance rely on centralized collection of potentially identifiable, individual, identifiable personal health information (PHI) records. Although individual, identifiable patient records are essential for conditions for which there is mandated reporting, such as tuberculosis or sexually transmitted diseases, they are not routinely required for effective syndromic surveillance. Public concern about the routine collection of large quantities of PHI to support non-traditional public health functions may make alternative surveillance methods that do not rely on centralized identifiable PHI databases increasingly desirable. METHODS: The National Bioterrorism Syndromic Surveillance Demonstration Program (NDP) is an example of one alternative model. All PHI in this system is initially processed within the secured infrastructure of the health care provider that collects and holds the data, using uniform software distributed and supported by the NDP. Only highly aggregated count data is transferred to the datacenter for statistical processing and display. RESULTS: Detailed, patient level information is readily available to the health care provider to elucidate signals observed in the aggregated data, or for ad hoc queries. We briefly describe the benefits and disadvantages associated with this distributed processing model for routine automated syndromic surveillance. CONCLUSION: For well-defined surveillance requirements, the model can be successfully deployed with very low risk of inadvertent disclosure of PHI--a feature that may make participation in surveillance systems more feasible for organizations and more appealing to the individuals whose PHI they hold. It is possible to design and implement distributed systems to support non-routine public health needs if required.

Bioterrorism↗

Impact of routine intensive care unit surveillance cultures and resultant barrier precautions on hospital-wide methicillin-resistant Staphylococcus aureus bacteremia.

BACKGROUND: Serial interventions are often used to reduce the risk of health care-associated methicillin-resistant Staphylococcus aureus (MRSA) infections. To our knowledge, the relative impact of these interventions has not previously been ascertained. METHODS: We conducted a retrospective study of 4 major infection control interventions using an interrupted time series design to evaluate their impact on MRSA bacteremia in an 800-bed hospital with 8 intensive care units (ICUs). Interventions were introduced 1 at a time during a 9-year period and involved the promotion of compliance with maximal sterile barrier precautions during central venous catheter placement, the institution of alcohol-based hand rubs for hand disinfection, the introduction of a hand hygiene campaign, and the institution of routine nares surveillance cultures for MRSA in all ICUs for patients on ICU admission and weekly thereafter while in the ICU. Positive cultures resulted in the initiation of contact isolation precautions. Using segmented regression analyses, we evaluated changes in monthly incidence and prevalence of MRSA bacteremia from their predicted values. Methicillin-susceptible Staphylococcus aureus bacteremia was monitored as a control. RESULTS: Routine surveillance cultures and subsequent contact isolation precautions resulted in substantial reductions in MRSA bacteremia in both ICUs and non-ICUs. In 16 months, the incidence density of MRSA bacteremia decreased by 75% in ICUs (P=.007) and by 40% in non-ICUs (P=.008), leading to a 67% hospital-wide reduction in the incidence density of MRSA bacteremia (P=.002). Methicillin-susceptible S. aureus bacteremia rates remained stable during this time. The other interventions were not associated with a statistically significant change in MRSA bacteremia. CONCLUSIONS: Routine surveillance for MRSA in ICUs allowed earlier initiation of contact isolation precautions and was associated with large and statistically significant reductions in the incidence of MRSA bacteremia in the ICUs and hospital wide. In contrast, no similar decrease was attributable to the other infection control interventions.

Bacteremia↗

The impact of prescribing safety alerts for elderly persons in an electronic medical record: an interrupted time series evaluation.

BACKGROUND: Considerable effort and attention have focused on medication safety in elderly persons; one approach that has been understudied in the outpatient environment is the use of computerized provider order entry with clinical decision support. The objective of this study was to examine the effects of computerized provider order entry with clinical decision support in reducing the use of potentially contraindicated agents in elderly persons. METHODS: With data from a 39-month period of a natural experiment, we evaluated changes in medication dispensing using interrupted time series analysis to estimate changes, controlling for prealert prescribing trends. The setting was a large health maintenance organization in the Pacific Northwest. All adult enrollees of the health plan participated. The intervention was computerized alerts cautioning against using certain medications in elderly persons. The main outcome measure was dispensing per 10,000 members per month. RESULTS: Following the implementation of the drug-specific alerts, a large and persistent reduction (5.1 prescriptions per 10,000, P=.004), a 22% relative decrease from the month before alert implementation, in the exposure of elderly patients to nonpreferred medications was observed. We found no evidence of a decrease in use of nonpreferred agents for nonelderly patients. The reduction seen in use of nonpreferred agents for elderly persons was driven primarily by decreases in dispensing for tertiary tricyclic agents. CONCLUSIONS: We found that alerts in an outpatient electronic medical record aimed at decreasing prescribing of medication use in elderly persons may be an effective method of reducing prescribing of contraindicated medications. The effect of the alerts on patient outcomes is less certain and deserves further investigation.

Adult↗

Reducing warfarin medication interactions: an interrupted time series evaluation.

BACKGROUND: Computerized decision support reduces medication errors in inpatients, but limited evidence supports its effectiveness in reducing the coprescribing of interacting medications, especially in the outpatient setting. The usefulness of academic detailing to enhance the effectiveness of medication interaction alerts also is uncertain. METHODS: This study used an interrupted time series design. In a health maintenance organization with an electronic medical record, we evaluated the effectiveness of electronic medical record alerts and group academic detailing to reduce the coprescribing of warfarin and interacting medications. Participants were 239 primary care providers at 15 primary care clinics and 9910 patients taking warfarin. All 15 clinics received electronic medical record alerts for the coprescription of warfarin and 5 interacting medications: acetaminophen, nonsteroidal anti-inflammatory medications, fluconazole, metronidazole, and sulfamethoxazole. Seven clinics were randomly assigned to receive group academic detailing. The primary outcome, the interacting prescription rate (ie, the number of coprescriptions of warfarin-interacting medications per 10 000 warfarin users per month), was analyzed with segmented regression models, controlling for preintervention trends. RESULTS: At baseline, nearly a third of patients had an interacting prescription. Coinciding with the alerts, there was an immediate and continued reduction in the warfarin-interacting medication prescription rate (from 3294.0 to 2804.2), resulting in a 14.9% relative reduction (95% confidence interval, -19.5 to -10.2) at 12 months. Group academic detailing did not enhance alert effectiveness. CONCLUSIONS: This study, using a strong and quasi-experimental design in ambulatory care, found that medication interaction alerts modestly reduced the frequency of coprescribing of interacting medications. Additional efforts will be required to further reduce rates of inappropriate prescribing of warfarin with interacting drugs.

Acetaminophen↗

Evaluating spatial surveillance: detection of known outbreaks in real data.

Since the anthrax attacks of October 2001 and the SARS outbreaks of recent years, there has been an increasing interest in developing surveillance systems to aid in the early detection of such illness. Systems have been established which do this is by monitoring primary health-care visits, pharmacy sales, absenteeism records, and other non-traditional sources of data. While many resources have been invested in establishing such systems, relatively little effort has as yet been expended in evaluating their performance. One way to evaluate a given surveillance system is to compare the signals it generates with known outbreaks identified in other systems. In public health practice, for example, public health departments investigate reports of illness and sometimes track hospital admissions. Comparison of new systems with extant systems cannot generate estimates of test characteristics such as sensitivity and specificity, since the actual number of positives and negatives cannot be known. However, the comparison can reveal whether a new or proposed system's signals match outbreaks detected by the existing system. This could help support or reject the new system as an alternative or complement to the extant system. We propose three methods to test the null hypothesis that the new system does not signal true outbreaks more often than would be expected by chance. The methods differ in the restrictiveness of the assumptions required. Each test may detect weaknesses in the new system, depending on the distribution of outbreaks and can be used to construct confidence limits on the agreement between the new system's signals and the outbreaks, given the distribution of the signals. They can be used to assess whether the new system works in that it detects the outbreaks better than chance would suggest and can also determine if the new systems' signals are generated earlier than an extant system.

Data Interpretation, Statistical↗

Frequency of serum creatinine monitoring during allopurinol therapy in ambulatory patients.

BACKGROUND: Allopurinol dosage reduction is recommended in patients with renal dysfunction because drug toxicity risk is increased. Little information is available about serum creatinine (SCr) monitoring in ambulatory patients taking allopurinol. OBJECTIVE: To evaluate SCr monitoring among patients prescribed allopurinol, identify associated factors, and evaluate administrative data in assessing monitoring. METHODS: Information for this retrospective cohort study was drawn from a dataset of 2 020 037 individuals; approximately 200 000 members from each of 10 organizations. Study patients had received at least one year of ongoing allopurinol prescription dispensings. Patient variables analyzed included age, gender, chronic diseases, outpatient visits, hospitalizations, gout diagnosis, and SCr monitoring. A random sample of medical records was reviewed to assess the accuracy of the automated data. Statistical analysis included descriptive and logistic regression techniques. RESULTS: Overall, 1139 (26%) of 4357 patients did not have SCr monitoring. For individuals without recent hospitalization, factors protective against lack of monitoring were increasing age (OR 0.77 per 10 y; 95% CI 0.74 to 0.79), more chronic diseases (OR 0.81; 95% CI 0.78 to 0.83), more outpatient visits (OR 0.87 per 5 visits; 95% CI 0.83 to 0.91), and gout diagnosis (OR 0.74; 95% CI 0.65 to 0.85). The sensitivity and specificity of administrative data compared with medical records for SCr monitoring were 92% and 65%, respectively. CONCLUSIONS: More than one-fourth of patients dispensed allopurinol did not have SCr monitoring during one year of therapy. Lack of monitoring and lack of subsequent possible dosage adjustment put patients at increased risk of allopurinol toxicity.

Adolescent↗

Frequency of high-risk use of QT-prolonging medications.

PURPOSE: Prolongation of the QT interval has been associated with increased risk of torsades de pointes and death. Concurrent use of more than one QT-prolonging drug or a QT-prolonging drug with a drug that alters its pharmacokinetic profile is an important risk factor for adverse outcomes. METHODS: Using a representative sample of 2 million health plan members from 10 health maintenance organizations with pharmacy benefits between January 1999 and July 2001, we identified potential drug interactions involving QT-prolonging medications. Prescription claims overlapping by at least 7 days for either 2 or more QT-prolonging drugs or a QT-prolonging drug with a drug that alters its clearance were considered potential drug interactions. We determined the number of drug interactions overall and the number of these interactions involving patients with other risk factors for torsades de pointes. RESULTS: A total of 48 465 potential drug interactions were identified in 10 415 (4.6%) of the 228 550 patients with at least one prescription for a QT-prolonging drug. Amitriptyline was involved in 37 859 (78.1%) of the drug interactions. Of all potential drug interactions, 43 689 (90.1%) occurred in patients with at least one other risk factor for torsades de pointes, and 1053 (2.2%) were listed as a contraindicated combination in product labeling. CONCLUSION: Potential drug interactions involving currently marketed QT-prolonging drugs occurred in 4.6% of patients who had a prescription for a QT-prolonging medication. The findings suggest several areas for targeted interventions to decrease the potential risk from QT-prolonging medications.

Age Factors↗

FDA drug prescribing warnings: is the black box half empty or half full?

PURPOSE: Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high-risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings. The purpose of the present study was to assess the frequency of use of BBW medications in ambulatory care and prescribing compliance with BBW recommendations. METHODS: This retrospective study used automated claims data of 929 958 enrollees in 10 geographically diverse health plans in the United States to estimate frequency of use in ambulatory care of 216 BBW drugs/drug groups between 1/1/99 and 31/6/01. We assessed dispensing compliance with the BBW requirements for selected drugs. RESULTS: During a 30-month period, more than 40% of enrollees received at least one medication that carried a BBW that could potentially apply to them. We found few instances of prescribing during pregnancy of BBW drugs absolutely contra-indicated in pregnancy. There was almost no co-prescribing of contra-indicated drugs with the two QT-interval-prolonging BBW drugs evaluated. Most non-compliance occurred with recommendations for baseline laboratory monitoring (49.6% of all therapy initiations that should have been accompanied by baseline laboratory monitoring were not). CONCLUSIONS: Many individuals receive drugs considered to carry the potential for serious risk. For some of these drugs, use is largely consistent with their BBW, while for others it is not. Since it will not be possible to avoid certain drug- associated risks, it will be important to develop effective methods to use BBWs and other methods to minimize risks.

Adolescent↗

Use of prescription medications with a potential for fetal harm among pregnant women.

PURPOSE: To estimate the prevalence of use of prescription drugs with a potential for fetal harm among pregnant women in the United States. METHODS: A retrospective study was conducted using the automated databases of eight health maintenance organizations involved in the HMO Research Network Center for Education and Research on Therapeutics (CERT). Women who delivered an infant from January 1996 to December 2000 were identified. The frequency of use of prescription drugs with a potential for fetal harm was based upon the expert review of a clinical teratologist and the U.S. Food and Drug Administration (FDA) risk classification system, assuming a gestational duration of 270 days. RESULTS: Among the 114 165 women with no documentation of a diagnosis suggesting potential pre-term birth or dispensing of ovulation stimulants in the 270 days before delivery, 1305 (1.1%) received a teratogenic drug during the 270 days before delivery, based upon the expert review of a clinical teratologist. A larger proportion of women received U.S. FDA category D or X drugs (5.8%; N = 6600). However, the general patterns of use were similar, with higher use in early pregnancy compared to later trimesters. The proportion of women dispensed a teratogen during pregnancy was substantially higher among women who received a teratogen in the 90 days before pregnancy compared to women who did not (adjusted RR = 38.9, 95%CI, 33.5, 45.3). CONCLUSIONS: Our results suggest that further efforts directed at physicians to counsel women or at the women themselves about the potential risks of particular medications appear warranted.

Drug Prescriptions↗

Monitoring patient safety in health care: building the case for surrogate measures.

BACKGROUND: Objective measurements are notably lacking for many adverse events in health care. A new approach to monitoring such events is based on the experience in measuring hospital-associated infections. DEVELOPING OBJECTIVE AND UNIVERSAL MEASURES: An essential tenet of the current goal of surveillance-focusing only on rigorously confirmed adverse events-is neither necessary nor achievable across the entire health care system. Efforts should be directed instead to creating objective measures of quality of care and of outcomes that can be used by all health care facilities. Adopting objective measures would be easier if health care was open to surrogate measures of important outcomes. Surrogate measures of interest for infection surveillance are used to identify objective, readily ascertained events that are sufficiently correlated with infections to provide useful information about organizations' infection rates. For example, the surgical site infection rate following coronary artery bypass appears to correlate closely enough with the proportion of patients who receive extended courses of inpatient antibiotics to be a useful indicator of a hospital's outcomes for the procedure. CONCLUSION: Developing clinically relevant process or surrogate measures that clinicians would use to improve patient outcomes is essential. These measures could be relevant not only to hospital-acquired infections but other health care-related adverse events that are relatively common yet require substantial resources to identify.

Centers for Disease Control and Prevention, U.S.↗