A. Russell Localio

Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I.

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.

The Impact of Placement Stability on Behavioral Well-Being for Children in Foster Care

OBJECTIVE. The problems children have upon entering foster care can potentially explain prior research findings that frequent placement changes are associated with poor outcomes. This study sought to disentangle this cascading relationship in order to identify the independent impact of placement stability on behavioral outcomes downstream. DESIGN/METHODS. Placement stability over the first 18 months in out-of-home care for 729 children from the National Survey of Child and Adolescent Well-being was categorized as early stability (stable placement within 45 days), late stability (stable placement beyond 45 days), or unstable (never achieving stability). Propensity scores predicting placement instability based on baseline attributes were divided into risk categories and added to a logistic regression model to examine the independent association between placement stability and behavioral well-being using the Child Behavior Checklist and temperament scores from the National Longitudinal Survey of Youth. RESULTS. Half (52%) of the children achieved early stability, 19% achieved later stability, and 28% remained unstable. Early stabilizers were more likely to be young, have normal baseline behavior, have no prior history with child welfare, and have birth parents without mental health problems. After accounting for baseline attributes, stability remained an important predictor of well-being at 18 months. Unstable children were more likely to have behavior problems than children who achieved early stability across every level of risk for instability. Among low-risk children, the probability of behavioral problems among early stabilizers was 22%, compared to 36% among unstable children, showing a 63% increase in behavior problems due to instability alone. CONCLUSIONS. Children in foster care experience placement instability unrelated to their baseline problems, and this instability has a significant impact on their behavioral well-being. This finding would support the development of interventions that promote placement stability as a means to improve outcomes among youth entering care.

Reliability and Validity of Estimating the NIH Stroke Scale Score from Medical Records

BACKGROUND AND PURPOSE The aim of our study was to determine whether the National Institutes of Health Stroke Scale (NIHSS) can be estimated retrospectively from medical records. The NIHSS is a quantitative measure of stroke-related neurological deficit with established reliability and validity for use in prospective clinical research. Recently, retrospective observational studies have estimated NIHSS scores from medical records for quantitative outcome analysis. The reliability and validity of estimation based on chart review has not been determined. METHODS Thirty-nine patients were selected because their NIHSS scores were formally measured at admission and discharge. Handwritten notes from medical records were abstracted and NIHSS scores were estimated by 6 raters who were blinded to the actual scores. Estimated scores were compared among raters and with the actual measured scores. RESULTS Interrater reliability was excellent, with an intraclass correlation coefficient of 0.82. Scores were well calibrated among the 6 raters. Estimated NIHSS scores closely approximated the actual scores, with a probability of 0.86 of correctly ranking a set of patients according to 5-point interval categories (as determined by the area under the receiver-operator characteristic curve). Patients with excellent outcomes (NIHSS score of </=5) could be identified with sensitivity of 0.72 and specificity of 0.89. There were no significant differences between these parameters at admission and discharge. CONCLUSIONS For the purposes of retrospective studies of acute stroke outcome, the NIHSS can be abstracted from medical records with a high degree of reliability and validity.

Clinical Risk Factors for Primary Graft Dysfunction after Lung Transplantation

RATIONALE Primary graft dysfunction (PGD) is the main cause of early morbidity and mortality after lung transplantation. Previous studies have yielded conflicting results for PGD risk factors. OBJECTIVES We sought to identify donor, recipient, and perioperative risk factors for PGD. METHODS We performed a 10-center prospective cohort study enrolled between March 2002 and December 2010 (the Lung Transplant Outcomes Group). The primary outcome was International Society for Heart and Lung Transplantation grade 3 PGD at 48 or 72 hours post-transplant. The association of potential risk factors with PGD was analyzed using multivariable conditional logistic regression. MEASUREMENTS AND MAIN RESULTS A total of 1,255 patients from 10 centers were enrolled; 211 subjects (16.8%) developed grade 3 PGD. In multivariable models, independent risk factors for PGD were any history of donor smoking (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2-2.6; P = 0.002); FiO2 during allograft reperfusion (OR, 1.1 per 10% increase in FiO2; 95% CI, 1.0-1.2; P = 0.01); single lung transplant (OR, 2; 95% CI, 1.2-3.3; P = 0.008); use of cardiopulmonary bypass (OR, 3.4; 95% CI, 2.2-5.3; P < 0.001); overweight (OR, 1.8; 95% CI, 1.2-2.7; P = 0.01) and obese (OR, 2.3; 95% CI, 1.3-3.9; P = 0.004) recipient body mass index; preoperative sarcoidosis (OR, 2.5; 95% CI, 1.1-5.6; P = 0.03) or pulmonary arterial hypertension (OR, 3.5; 95% CI, 1.6-7.7; P = 0.002); and mean pulmonary artery pressure (OR, 1.3 per 10 mm Hg increase; 95% CI, 1.1-1.5; P < 0.001). PGD was significantly associated with 90-day (relative risk, 4.8; absolute risk increase, 18%; P < 0.001) and 1-year (relative risk, 3; absolute risk increase, 23%; P < 0.001) mortality. CONCLUSIONS We identified grade 3 PGD risk factors, several of which are potentially modifiable and should be prioritized for future research aimed at preventative strategies. Clinical trial registered with www.clinicaltrials.gov (NCT 00552357).

The Adult Respiratory Distress Syndrome Cognitive Outcomes Study: Long-Term Neuropsychological Function in Survivors of Acute Lung Injury

RATIONALE Cognitive and psychiatric morbidity is common and potentially modifiable after acute lung injury (ALI). However, practical measures of neuropsychological function for use in multicenter trials are lacking. OBJECTIVES To determine whether a validated telephone-based neuropsychological test battery is feasible in a multicenter trial. To determine the frequency and risk factors for long-term neuropsychological impairment. METHODS As an adjunct study to the Acute Respiratory Distress Syndrome Clinical Trials Network Fluid and Catheter Treatment Trial, we assessed neuropsychological function at 2 and 12 months post-hospital discharge. MEASUREMENTS AND MAIN RESULTS Of 406 eligible survivors, we approached 261 to participate and 213 consented. We tested 122 subjects at least once, including 102 subjects at 12 months. Memory, verbal fluency, and executive function were impaired in 13% (12 of 92), 16% (15 of 96), and 49% (37 of 76) of long-term survivors. Long-term cognitive impairment was present in 41 of the 75 (55%) survivors who completed cognitive testing. Depression, post-traumatic stress disorder, or anxiety was present in 36% (37 of 102), 39% (40 of 102), and 62% (63 of 102) of long-term survivors. Enrollment in a conservative fluid-management strategy (P = 0.005) was associated with cognitive impairment and lower partial pressure of arterial oxygen during the trial was associated with cognitive (P = 0.02) and psychiatric impairment (P = 0.02). CONCLUSIONS Neuropsychological function can be assessed by telephone in a multicenter trial. Long-term neuropsychological impairment is common in survivors of ALI. Hypoxemia is a risk factor for long-term neuropsychological impairment. Fluid management strategy is a potential risk factor for long-term cognitive impairment; however, given the select population studied and an unclear mechanism, this finding requires confirmation.

Identification of Adverse Events Occurring during Hospitalization: A Cross-Sectional Study of Litigation, Quality Assurance, and Medical Records at Two Teaching Hospitals

STUDY OBJECTIVES To estimate the efficacy of a medical record review for identifying adverse events and negligent case suffered by hospitalized patients. DESIGN Cross-sectional study comparing an objective medical record review with information available from hospital quality assurance records as well as risk management and litigation records. SETTING Two metropolitan teaching hospitals in the northeastern United States. MEASUREMENTS AND MAIN RESULTS Using the litigation and risk management records as a criterion standard, we found that the medical record review had a sensitivity of 80% (93 of 116; 95% CI, 73% to 88%) for discovering adverse events and a sensitivity of 76% (51 of 67; 95% CI, 66% to 86%) for discovering negligent care. We estimated that record review of a random sample of hospitalizations across a geographic region would have even higher sensitivity (adverse-event sensitivity, 84%; negligence sensitivity, 80%). Moreover, we found that the adverse events we failed to discover led to less costly malpractice claims. A significant number of adverse events (20 of 172) among hospitalizations never gave rise to litigation or risk management investigation. Six of the twenty were due to negligent care. Quality assurance efforts at the level of the clinical departments in one hospital led to review of only 12 out of 82 risk management records. CONCLUSIONS The overwhelming majority of adverse events and episodes of negligent care are discoverable with the methods we used to evaluate medical records. Quality assurance efforts using similar record review methods should be further evaluated.

Identifying Adverse Events Caused by Medical Care: Degree of Physician Agreement in a Retrospective Chart Review

Retrospective case review has long been a main-stay of peer review. It supports scientific studies and medical audits as well as assessments of the appropriateness, effectiveness, and quality of health care provided by physicians, hospitals, or regions. As part of quality assurance, hospitals and clinics regularly use formal and informal case review. Insurers and managed care organizations rely on case review when making decisions about coverage. All forms of case review depend heavily on expert opinion. Case review also underlies current and proposed systems of compensating patients for injuries caused by medical care. Under the current litigation system, the patient must prove, with the support of expert medical opinion, that medical care contributed to the injury (causation) and fell below the standards of practice in the community (negligence). Under proposed no-fault alternatives to litigation, entitlement to compensation and liability for payment might also depend on an experts opinion as to whether the patients outcome was caused by medical care rather than by a preexisting disease or condition [1-4]. Critics have identified several problems with case review. First, experts cannot form a consensus about which outcomes are adverse. Second, medical technology changes rapidly and creates uncertainty about the appropriateness and effectiveness of practices. Third, administrative or transaction costs in making individualized determinations of causation might be high [5-8]. The American College of Physicians [9] and others [10] have called for further demonstration projects. Building on previous research on the reliability of clinical judgments, we used a large sample of physician reviews of medical records to estimate the degree of agreement on the cause of adverse patient outcomes. We also discuss the implications of the results for quality assurance, performance assessment, and proposals for no-fault patient compensation. Methods Cases were obtained from the Medical Practice Study, a project designed to estimate the rate of adverse events occurring among inpatients in a random sample of 31 429 medical records from 51 health care facilities in New York State. We defined an adverse event as an injury that 1) was caused at least in part by medical management and 2) required or prolonged hospitalization or led to disability after discharge. The injury could result from a providers action or inaction in either inpatient or outpatient settings or from a drug or medical device. The medical management did not have to be substandard or inappropriate; the injury could follow an unexpected complication. Adverse outcomes caused solely by underlying disease or by the intended consequences of treatment were not considered to be adverse events. For example, an injury to the recurrent laryngeal nerve during partial thyroidectomy (an unplanned and unintended but recognized complication) would be considered an adverse event, but the intentional destruction of the same nerve in a radical thyroid resection for cancer would not. A broken experimental balloon that led to an embolus and stroke during cardiac catheterization would, as a complication of treatment, also be an adverse event, especially if the patients risk was unknown. This result would apply even in a study approved by a Human Subjects Committee. Other aspects of the Medical Practice Study and the general methods have been widely reported [11-15]. The following methods are relevant to our report. Record Review Records were reviewed in two stages. In stage 1 (which is not the subject of this report), nurses and medical records administrators used a single review per case to screen the entire sample of records for the presence of 1 or more of 18 explicit criteria (Figure 2). These criteria were based primarily on previous research [16] and were revised by the physician investigators of the Medical Practice Study. Although explicit, the criteria were broad and open to interpretation. The nurses and records administrators received an extensive manual, which contained detailed examples of the criteria, and 2 hours of focused classroom training from team leaders chosen for this project. To increase the efficiency and accuracy of screening, the nurses and records administrators used preprinted forms generated by the project management team. Nurses were instructed to refer any questionable cases for stage 2 review. Questions of a more general nature were referred to supervisors and then to the project office for consistent responses. The estimated negative predictive value of the screening was 99.5% [17]. Figure 2. Screening Criteria Implemented at Stage 1 Review by Nurses and Medical Records Administrators. Judgments on adverse events by pairs of physician-reviewers and rate of agreement on occurrence of adverse events compared with extreme disagreement. If a = cases of extreme disagreement (one reviewer scored the outcome as 0 [no possible adverse event] and the other scored the case as 4, 5, or 6) and b = cases for which both reviewers found adverse events (both scored the case as 4, 5, or 6), then the reported rate of agreement = a/(a + b). Bars represent exact binomial 95% CIs. Numbers in parentheses are the population-weighted estimates of the number of cases in New York State in 1984 that are represented by the sampled cases reported in this figure. In stage 2, each record that had or may have had at least one criterion present was further analyzed by two physicians who worked independently. Physicians were recruited primarily from New York State through a network of personal contacts of the study investigators. The physicians could not review records at the hospitals in which they practiced. Most were board certified in surgery (23%) or internal medicine (68%); the remaining were certified in obstetrics and gynecology, family practice, pediatrics, urology, or emergency medicine. Eighty-five percent were male. Most physicians were in the early stage of their careers: Fifty-five percent had received board certification within the 10 years before the study began. All physicians had telephone access to a panel of experts. A separate manual and a structured abstraction form guided the stage 2 review. As described previously [17], both were revised repeatedly after extensive pilot testing. This 65-page manual included explicit instructions on several types of adverse events. According to the manual, for example, all surgical wound infections were almost invariably adverse events, as were all falls and all drug reactions that prolonged hospitalization or caused disability. A 14-page abstraction form first asked the physician reviewer to assess whether an adverse event might have occurred. If the physician found no possible adverse event, the review was stopped and the case received a score of 0. If an adverse event might have occurred, the reviewer considered a list of factors on the cause of the injury and rated his or her confidence about the occurrence of an adverse event on an interval scale of 1 to 6 (Figure 1). For a confidence score of 2 (slight to modest evidence of an adverse event) or greater, the reviewer indicated the type of event (fall, drug reaction, wound infection, error of omission, or failure to diagnose), the number of additional days of hospitalization (if applicable), and the degree of disability over and above the underlying disease. Finally, the reviewers considered whether the error amounted to negligence. Within this structure, however, the physician could be discreet in judging the cause of the injury, hospitalization, or disability (a structured implicit review). All physician reviewers identified themselves by number, with the understanding that their confidential opinions would not be used for quality assurance, peer review, or litigation. Copies of the abstraction booklet are available from the authors. Figure 1. Our report focuses on the two independent expert opinions obtained during stage 2 review as to whether an adverse outcome identified during stage 1 had been caused at least in part by medical management. Results of each assessment of causation were linked to the patients computerized discharge data summary to identify the patients age, diagnosis, and discharge status. Statistical Analysis Agreement between Reviewers We calculated a rate of agreement between the two physician reviewers in each pair on adverse events using a statistic described by Grant [18] for assessing agreement on abnormal tracings from electronic fetal monitoring. In our application, the numerator of this statistic was the number of cases in which both reviewers assessed their confidence in an adverse event as more likely than not or greater. This assessment corresponded to a score of 4, 5, or 6. The denominator was the sum of the numerator and the number of cases of extreme disagreement, for which one reviewer scored the case as 4, 5, or 6 and the other physician found no possible adverse event (a score of 0). The statistic therefore compared the number of cases with agreed-upon adverse events with the number of clear disagreements. This statistic does not include cases for which both physicians agreed that no adverse event had occurred. It recognizes that agreement about whether a patients condition is normal (no adverse event) is usually greater than agreement about whether a patient has disease or an abnormal condition [19-22]. The statistic is also not affected by the number of clearly normal cases in the samples of cases for review. In our study, the number of cases clearly without adverse events at stage 2 was influenced by the coarseness of the previous screening process. The stage 1 reviewers were cautioned to avoid false-negative determinations if they were in doubt, so that adverse events would not be overlooked. This statistic also facilitated comparisons of rates of agreement across subsets of such adverse events as drug reactions, which are

Hepatic Decompensation in Antiretroviral-Treated Patients Co-Infected With HIV and Hepatitis C Virus Compared With Hepatitis C Virus–Monoinfected Patients: A Cohort Study

Context Patients with HIV are often co-infected with hepatitis C virus (HCV). Whether treatment of HIV with antiretroviral therapy (ART) can improve HCV outcomes is a topic of interest. Contribution In a Veterans Affairs study, patients co-infected with HIV and HCV who had HIV RNA levels less than 1000 copies/mL had a lower rate of hepatic decompensation than those with less HIV suppression. However, the rate was still higher than that in HCV-monoinfected patients. Caution Few women were studied. Implication Patients co-infected with HIV and HCV remain at greater risk for poor outcomes from HCV infection than HCV-monoinfected patients despite viral suppression by ART. The Editors Co-infection with chronic hepatitis C virus (HCV) occurs in 10% to 30% of HIV-infected patients (14). The course of chronic HCV is accelerated in patients co-infected with HIV, with more rapid progression of liver fibrosis than in HCV-monoinfected patients (57). Consequently, HCV-related liver complications, particularly hepatic decompensation (defined by the presence of ascites, spontaneous bacterial peritonitis, variceal hemorrhage, or hepatic encephalopathy [8]), have emerged as important causes of illness in co-infected patients (9, 10). Despite the importance of HCV-related end-stage liver disease, few longitudinal studies have evaluated the incidence and determinants of hepatic decompensation among patients co-infected with HIV and HCV during the antiretroviral therapy (ART) era. Previous studies suggest that ART slows progression of HCV-associated liver fibrosis, possibly by reducing HIV-related inflammation and immune dysfunction and inhibiting the ability of HIV to directly infect hepatocytes (1013). However, whether rates of hepatic decompensation and other severe liver events (for example, hepatocellular carcinoma [HCC] or liver-related death) in co-infected patients receiving ART are similar to those in HCV-monoinfected patients remains unclear. Furthermore, the determinants of hepatic decompensation among co-infected patients receiving ART are unknown. Determination of these factors could help define the mechanisms of decompensation in co-infected patients and could suggest interventions to reduce the risk for end-stage liver disease in this population. We first compared the incidence of hepatic decompensation between antiretroviral-treated patients co-infected with HIV and HCV and HCV-monoinfected patients. We hypothesized that rates of decompensation would remain higher in co-infected patients despite ART. We then evaluated host and viral factors associated with decompensation among co-infected patients. Methods Study Design and Data Source We conducted a retrospective cohort study among antiretroviral-treated patients co-infected with HIV and HCV and HCV-monoinfected patients in the VACS-VC (Veterans Aging Cohort Study Virtual Cohort) between 1 January 1997 and 30 September 2010 (14). The VACS-VC consists of electronic medical record data from HIV-infected patients receiving care at Veterans Affairs (VA) medical facilities across the United States. Each HIV-infected patient is matched on age, sex, race/ethnicity, and site to 2 HIV-uninfected persons. Data include hospital and outpatient diagnoses (recorded using International Classification of Diseases, Ninth Revision [ICD-9], codes), procedures (recorded using CPT [Current Procedural Terminology] codes), laboratory results, and pharmacy data. Clinically confirmed cancer diagnoses are available from the VA Central Cancer Registry. Deaths are identified from the VA Vital Status file, which uses data from the Social Security Death Master File, Medicare Vital Status Files, and VA Beneficiary Identification and Records Locator Subsystem. For patients who died, principal cause of death can be determined by linkage with the National Death Index (15). In addition, U.S. Medicare and Medicaid claims data are available for veterans also enrolled in these programs and have been merged with VACS-VC data. Study Patients Co-infected patients were included if they had detectable HCV RNA, had recently initiated ART (defined as use of 3 antiretrovirals from 2 classes [16] or 3 nucleoside analogues [a previously accepted ART regimen] [17]) within the VA system, had an HIV RNA level greater than 500 copies/mL within 180 days before starting ART (to identify those who newly initiated ART [18]), and had been observed for at least 12 months in the VACS-VC after starting ART. Monoinfected patients had detectable HCV RNA, no recorded HIV ICD-9 diagnosis or antiretroviral prescriptions, and at least 12 months of observation in the VACS-VC. Patients were excluded if, during the baseline period (defined in the Statistical Analysis section), they had hepatic decompensation, HCC, or liver transplantation or received interferon-based HCV therapy (because treatment reduces the risk for hepatic decompensation [19, 20]). Study Outcomes The primary outcome was incident hepatic decompensation, which was defined by 1 ICD-9 diagnosis of ascites, spontaneous bacterial peritonitis, or esophageal variceal hemorrhage at hospital discharge or 2 such outpatient diagnoses in the VACS-VC (Supplement 1). A prior study validated this determination, with 91% of events confirmed by medical records (21). The requirement of 2 outpatient diagnoses aimed to exclude events that were suspected but not subsequently confirmed at follow-up visits. On the basis of the results of the prior validation study (21), we did not include ICD-9 diagnoses for hepatic encephalopathy and jaundice, which could indicate decompensation, because these diagnoses frequently were linked to unrelated conditions (for example, narcotic overuse, stroke recorded as encephalopathy, or biliary obstruction or atazanavir-associated hyperbilirubinemia recorded as jaundice). Date of decompensation was defined as the hospital discharge date (if identified by hospital diagnosis) or initial outpatient diagnosis date (if identified by outpatient diagnosis). Supplement 1. ICD-9, ICD-10, and CPT Codes Secondary outcomes included incident hepatic decompensation (determined by the aforementioned ICD-9based definition) within the VACS-VC, Medicare, or Medicaid data (to capture outcomes occurring at non-VA hospitals that did not result in transfer to a VA facility; this outcome was secondary because non-VA events have not been validated); HCC; and severe liver events, a composite outcome of hepatic decompensation within the VACS-VC, HCC, or liver-related death. Hepatocellular carcinoma was determined using the VA Central Cancer Registry, which confirmed diagnoses by histologic or cytologic evaluation or consistent radiography. We classified deaths as liver-related if the underlying cause from the National Death Index was recorded as hepatic decompensation, liver cancer, alcoholic liver disease, viral hepatitis, or nonalcoholic liver disease (Supplement 1) (15). Data Collection Baseline data (Table 1) included age, sex, race/ethnicity, VA center patient volume, body mass index (BMI), diabetes mellitus, alcohol dependence or abuse, injection or noninjection drug use, hepatitis B surface antigen status, HCV genotype, HCV RNA level, pre-ART CD4 cell count, pre-ART plasma HIV RNA level, and baseline antiretroviral regimen. Diabetes was defined as a random glucose level of at least 200 mg/dL or antidiabetic medication use (22, 23). Alcohol dependence or abuse (24) and injection or noninjection drug use (24, 25) were defined by previously validated ICD-9 diagnoses (Supplement 1). Baseline serum creatinine, hemoglobin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels and platelet count were collected from dates closest to but before the start of follow-up. Baseline FIB-4 score, a noninvasive measure of advanced hepatic fibrosis, was determined as follows: [age in yearsAST level in U/L] / [(platelet count in109/L)(ALT level in U/L)1/2] (26). Because liver fibrosis can progress by 1 stage as early as within 4 years for antiretroviral-treated patients co-infected with HIV and HCV (7) and within 5 years for HCV-monoinfected persons (27), we determined baseline FIB-4 scores by using ALT levels, AST levels, and platelet counts within a 2-year period around the start of follow-up. Scores less than 1.45 indicate no or minimal fibrosis, and scores greater than 3.25 indicate advanced hepatic fibrosis or cirrhosis in co-infected (26) and HCV-monoinfected patients (28). Table 1. Characteristics of the Study Cohorts Longitudinal data included hepatitis B surface antigen status, plasma HIV RNA level, diabetes, and liver transplantation (determined by diagnosis and procedural codes) (Supplement 1). Statistical Analysis The 12 months before the start of follow-up represented the baseline period for both cohorts. Follow-up began 12 months after ART initiation for co-infected patients and after 12 months in the VACS-VC for monoinfected patients. The rationale for defining the baseline period as the first year of receipt of ART for co-infected patients was that many of these patients initially entered care at the time of ART initiation, which was shortly after their HIV diagnosis. Follow-up continued until a study end point, death, initiation of HCV therapy, or the last visit before 30 September 2010, whichever came first. For descriptive purposes, we estimated incidence rates (events per 1000 person-years) of end points with 95% CIs, standardized by the age and race/ethnicity distribution of co-infected patients (29). We then used Cox models to estimate adjusted hazard ratios (HRs) for outcomes in co-infected compared with monoinfected patients (30). We controlled for all available clinically relevant variables in Table 1. The proportionality of hazards was evaluated by plots of Schoenfeld residuals (31). In a sensitivity analysis, we addressed the potential for informative censoring by using inverse probability of censoring weights and Cox regression (Supplement

Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians: a randomized trial.

IMPORTANCE Antimicrobial stewardship programs have been effective for inpatients, often through prescribing audit and feedback. However, most antimicrobial use occurs in outpatients with acute respiratory tract infections (ARTIs). OBJECTIVE To evaluate the effect of an antimicrobial stewardship intervention on antibiotic prescribing for pediatric outpatients. DESIGN Cluster randomized trial of outpatient antimicrobial stewardship comparing prescribing between intervention and control practices using a common electronic health record. After excluding children with chronic medical conditions, antibiotic allergies, and prior antibiotic use, we estimated prescribing rates for targeted ARTIs standardized for age, sex, race, and insurance from 20 months before the intervention to 12 months afterward (October 2008-June 2011). SETTING AND PARTICIPANTS A network of 25 pediatric primary care practices in Pennsylvania and New Jersey; 18 practices (162 clinicians) participated. INTERVENTIONS One 1-hour on-site clinician education session (June 2010) followed by 1 year of personalized, quarterly audit and feedback of prescribing for bacterial and viral ARTIs or usual practice. MAIN OUTCOMES AND MEASURES Rates of broad-spectrum (off-guideline) antibiotic prescribing for bacterial ARTIs and antibiotics for viral ARTIs for 1 year after the intervention. RESULTS Broad-spectrum antibiotic prescribing decreased from 26.8% to 14.3% (absolute difference, 12.5%) among intervention practices vs from 28.4% to 22.6% (absolute difference, 5.8%) in controls (difference of differences [DOD], 6.7%; P = .01 for differences in trajectories). Off-guideline prescribing for children with pneumonia decreased from 15.7% to 4.2% among intervention practices compared with 17.1% to 16.3% in controls (DOD, 10.7%; P < .001) and for acute sinusitis from 38.9% to 18.8% in intervention practices and from 40.0% to 33.9% in controls (DOD, 14.0%; P = .12). Off-guideline prescribing was uncommon at baseline and changed little for streptococcal pharyngitis (intervention, from 4.4% to 3.4%; control, from 5.6% to 3.5%; DOD, -1.1%; P = .82) and for viral infections (intervention, from 7.9% to 7.7%; control, from 6.4% to 4.5%; DOD, -1.7%; P = .93). CONCLUSIONS AND RELEVANCE In this large pediatric primary care network, clinician education coupled with audit and feedback, compared with usual practice, improved adherence to prescribing guidelines for common bacterial ARTIs, and the intervention did not affect antibiotic prescribing for viral infections. Future studies should examine the drivers of these effects, as well as the generalizability, sustainability, and clinical outcomes of outpatient antimicrobial stewardship. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01806103.

Association between primary care practice characteristics and emergency department use in a medicaid managed care organization.

Background:Many patients use emergency departments (EDs) for primary care. Previous studies have found that patient characteristics affect ED utilization. However, such studies have led to few policy changes. Objectives:We sought to determine whether Medicaid patients’ ED use is associated with characteristics of their primary care practices. Research Design:This was a cohort study. Subjects:A total of 57,850 patients, assigned to 353 primary care practices affiliated with a Medicaid HMO, were included. Measures:Predictor variables were characteristics of primary care practices, which were measured by visiting each practice. The outcome variable was ED use adjusted for patient characteristics. Results:On average, patients made 0.80 ED visits/person/yr. Patients from practices with more than 12 evening hours/wk used the ED 20% less than patients from practices without evening hours. A higher ratio of the number of active patients per clinician-hour of practice time was associated with more ED use. When more Medicaid patients were in a practice, these patients used the ED more frequently. Other factors associated with ED use included equipment for the care of asthma and presence of nurse practitioners and physician assistants. Discussion:Modifiable characteristics of primary care practices were associated with ED use. Because the observational design of this study does not allow definitive conclusions about causality, future studies should include intervention trials to determine whether changing practice characteristics can reduce ED use. Conclusions:Improving primary care access and scope of services may reduce ED use. Focusing on systems issues rather than patient characteristics may be a more productive strategy to improve appropriate use of emergency medical care.