Donald A. Goldmann

Temporal Trends in Rates of Patient Harm Resulting from Medical Care

BACKGROUND In the 10 years since publication of the Institute of Medicines report To Err Is Human, extensive efforts have been undertaken to improve patient safety. The success of these efforts remains unclear. METHODS We conducted a retrospective study of a stratified random sample of 10 hospitals in North Carolina. A total of 100 admissions per quarter from January 2002 through December 2007 were reviewed in random order by teams of nurse reviewers both within the hospitals (internal reviewers) and outside the hospitals (external reviewers) with the use of the Institute for Healthcare Improvements Global Trigger Tool for Measuring Adverse Events. Suspected harms that were identified on initial review were evaluated by two independent physician reviewers. We evaluated changes in the rates of harm, using a random-effects Poisson regression model with adjustment for hospital-level clustering, demographic characteristics of patients, hospital service, and high-risk conditions. RESULTS Among 2341 admissions, internal reviewers identified 588 harms (25.1 harms per 100 admissions; 95% confidence interval [CI], 23.1 to 27.2) [corrected]. Multivariate analyses of harms identified by internal reviewers showed no significant changes in the overall rate of harms per 1000 patient-days (reduction factor, 0.99 per year; 95% CI, 0.94 to 1.04; P=0.61) or the rate of preventable harms. There was a reduction in preventable harms identified by external reviewers that did not reach statistical significance (reduction factor, 0.92; 95% CI, 0.85 to 1.00; P=0.06), with no significant change in the overall rate of harms (reduction factor, 0.98; 95% CI, 0.93 to 1.04; P=0.47). CONCLUSIONS In a study of 10 North Carolina hospitals, we found that harms remain common, with little evidence of widespread improvement. Further efforts are needed to translate effective safety interventions into routine practice and to monitor health care safety over time. (Funded by the Rx Foundation.).

Recommendations for preventing the spread of vancomycin resistance: Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC)

A rapid increase in the incidence of infection and colonization with vancomycin-resistant enterococci (VRE) has been reported from U.S. hospitals in the last 5 years. This increase poses several problems, including a) the lack of available antimicrobials for therapy of infections due to VRE, since most VRE are also resistant to multiple other drugs, e.g., aminoglycosides and ampicillin, previously used for the treatment of infections due to these organisms, and b) the possibility that the vancomycin resistance genes present in VRE may be transferred to other gram-positive microorganisms such as Staphylococcus aureus. An increased risk of VRE infection and colonization has been associated with previous vancomycin and/or multi-antimicrobial therapy, severe underlying disease or immunosuppression, and intra-abdominal surgery. Because enterococci can be found in the normal gastrointestinal or female genital tract, most enterococcal infections have been attributed to endogenous sources within the individual patient. However, recent reports of outbreaks and endemic infections due to enterococci, including VRE, have shown that patient-to-patient transmission of the microorganisms can occur either via direct contact or indirectly via hands of personnel or contaminated patient-care equipment or environmental surfaces.(ABSTRACT TRUNCATED AT 250 WORDS)

Post-PCV7 Changes in Colonizing Pneumococcal Serotypes in 16 Massachusetts Communities, 2001 and 2004

Objective. The introduction of heptavalent conjugate pneumococcal vaccine (PCV7) has raised concerns for replacement with nonvaccine serotypes in both invasive disease and asymptomatic carriage. Analysis of colonizing serotypes among healthy children in the community provides critical data on such changes. Methods. Nasopharyngeal specimens were obtained from children who were younger than 7 years during well-child or sick visits in primary care practices in 16 Massachusetts communities during 2001 and 2004. Susceptibility testing and serotyping were performed on isolated Streptococcus pneumoniae strains. Vaccination history with PCV7 was abstracted from the medical record. Results. Among colonizing pneumococcal isolates, PCV7 serotypes decreased from 36% to 14%, and non-PCV7 serotypes increased from 34% to 55%. Overall carriage did not change (26% to 23%); neither did carriage of potentially cross-reactive serotypes (30% to 31%). The most common non-PCV7 serotypes were serotypes 11, 15, and 29. There was a substantial increase in penicillin nonsusceptibility from 8% to 25% in non-PCV7 serotypes; 35% were highly resistant to penicillin. Penicillin nonsusceptibility increased from 45% to 56% among PCV7 serotypes while remaining stable among PCV7 potentially cross-reactive strains (51% vs 54%). Conclusions. Pneumococcal colonization has changed after the introduction of PCV7, both in serotype distribution and in patterns of antibiotic resistance. The frequency of nonvaccine strains has increased, and the proportion of nonvaccine isolates that are not susceptible to penicillin has tripled. This shift toward increased carriage of nonvaccine serotypes warrants vigilance for changes in the epidemiology of invasive pneumococcal disease.

The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration

As the science of quality improvement in health care advances, the importance of sharing its accomplishments through the published literature increases. Current reporting of improvement work in health care varies widely in both content and quality. It is against this backdrop that a group of stakeholders from a variety of disciplines has created the Standards for QUality Improvement Reporting Excellence, which we refer to as the SQUIRE publication guidelines or SQUIRE statement. The SQUIRE statement consists of a checklist of 19 items that authors need to consider when writing articles that describe formal studies of quality improvement. Most of the items in the checklist are common to all scientific reporting, but virtually all of them have been modified to reflect the unique nature of medical improvement work. This “Explanation and Elaboration” document (E & E) is a companion to the SQUIRE statement. For each item in the SQUIRE guidelines the E & E document provides one or two examples from the published improvement literature, followed by an analysis of the ways in which the example expresses the intent of the guideline item. As with the E & E documents created to accompany other biomedical publication guidelines, the purpose of the SQUIRE E & E document is to assist authors along the path from completion of a quality improvement project to its publication. The SQUIRE statement itself, this E & E document, and additional information about reporting improvement work can be found at http://www.squire-statement.org.

Immunochemical Properties of the Staphylococcal Poly-N-Acetylglucosamine Surface Polysaccharide

ABSTRACT Staphylococcus aureus and Staphylococcus epidermidis often elaborate adherent biofilms, which contain the capsular polysaccharide-adhesin (PS/A) that mediates the initial cell adherence to biomaterials. Biofilm cells produce another antigen, termed polysaccharide intercellular adhesin (PIA), which is composed of a ∼28 kDa soluble linear β(1-6)-linked N-acetylglucosamine. We developed a new method to purify PS/A from S. aureus MN8m, a strain hyperproducing PS/A. Using multiple analytical techniques, we determined that the chemical structure of PS/A is also β(1-6)-N-acetylglucosamine (PNAG). We were unable to find N-succinylglucosamine residues in any of our preparations in contrast to previously reported findings (D. McKenney, K. Pouliot, Y. Wang, V. Murthy, M. Ulrich, G. Doring, J. C. Lee, D. A Goldmann, and G. B. Pier, Science 284:1523-1527, 1999). PNAG was produced with a wide range of molecular masses that could be divided into three major fractions with average molecular masses of 460 kDa (PNAG-I), 100 kDa (PNAG-II), and 21 kDa (PNAG-III). The purified antigens were not soluble at neutral pH unless first dissolved in 5 M HCl and then neutralized with 5 M NaOH. PNAG-I was very immunogenic in rabbits, but the responses of individual animals were variable. Immunization of mice with various doses (100, 50, or 10 μg) of PNAG-I, -II, and -III demonstrated that only PNAG-I was able to elicit an immunoglobulin G (IgG) immune response with the highest titers obtained with 100-μg dose. When we purified a small fraction of PNAG with a molecular mass of ∼780 kDa (PNAG-780) from PNAG-I, significantly higher IgG titers than those in mice immunized with the same doses of PNAG-I were obtained, suggesting the importance of the molecular mass of PNAG in the antibody response. These results further clarify the chemical structure of PS/A and help to differentiate it from PIA on the basis of immunogenicity, molecular size, and solubility.

Use of Confocal Microscopy To Analyze the Rate of Vancomycin Penetration through Staphylococcus aureus Biofilms

ABSTRACT When bacteria assume the biofilm mode of growth, they can tolerate levels of antimicrobial agents 10 to 1,000 times higher than the MICs of genetically equivalent planktonic bacteria. The properties of biofilms that give rise to antibiotic resistance are only partially understood. Inhibition of antibiotic penetration into the biofilm may play a role, but this has not been proven directly. In this report, penetration of the glycopeptide antibiotic vancomycin into viable Staphylococcus aureus biofilms was analyzed by confocal scanning laser microscopy using a fluorescently labeled derivative of the drug. We found that while vancomycin bound to free-floating bacteria in water within 5 min, it took more than 1 h to bind to cells within the deepest layers of a biofilm. These results indicate that the antibiotic is transported through the depth of the biofilm but that the rate is significantly reduced with respect to its transport through flowing water. This suggests that, whereas planktonic bacteria were rapidly exposed to a full bolus of vancomycin, the bacteria in the deeper layers of the biofilm were exposed to a gradually increasing dose of the drug due to its reduced rate of penetration. This gradual exposure may allow the biofilm bacteria to undergo stress-induced metabolic or transcriptional changes that increase resistance to the antibiotic. We also investigated the role of poly-N-acetylglucosamine, an important component of the S. aureus biofilm matrix, and found that its production was not involved in the observed decrease in the rate of vancomycin penetration.

Airborne Transmission of Chickenpox in a Hospital

The occurrence of chickenpox in pediatric hospitals disrupts routine care of immunologically normal patients and is potentially life-threatening to immunosuppressed patients.1 , 2 Guidelines for pr...

Microstream Capnography Improves Patient Monitoring During Moderate Sedation: A Randomized, Controlled Trial

BACKGROUND. Investigative efforts to improve monitoring during sedation for patients of all ages are part of a national agenda for patient safety. According to the Institute of Medicine, recent technological advances in patient monitoring have contributed to substantially decreased mortality for people receiving general anesthesia in operating room settings. Patient safety has not been similarly targeted for the several million children annually in the United States who receive moderate sedation without endotracheal intubation. Critical event analyses have documented that hypoxemia secondary to depressed respiratory activity is a principal risk factor for near misses and death in this population. Current guidelines for monitoring patient safety during moderate sedation in children call for continuous pulse oximetry and visual assessment, which may not detect alveolar hypoventilation until arterial oxygen desaturation has occurred. Microstream capnography may provide an “early warning system” by generating real-time waveforms of respiratory activity in nonintubated patients. OBJECTIVE. The aim of this study was to determine whether intervention based on capnography indications of alveolar hypoventilation reduces the incidence of arterial oxygen desaturation in nonintubated children receiving moderate sedation for nonsurgical procedures. PARTICIPANTS AND METHODS. We included 163 children undergoing 174 elective gastrointestinal procedures with moderate sedation in a pediatric endoscopy unit in a randomized, controlled trial. All of the patients received routine care, including 2-L supplemental oxygen via nasal cannula. Investigators, patients, and endoscopy staff were blinded to additional capnography monitoring. In the intervention arm, trained independent observers signaled to clinical staff if capnograms indicated alveolar hypoventilation for >15 seconds. In the control arm, observers signaled if capnograms indicated alveolar hypoventilation for >60 seconds. Endoscopy nurses responded to signals in both arms by encouraging patients to breathe deeply, even if routine patient monitoring did not indicate a change in respiratory status. OUTCOME MEASURES. Our primary outcome measure was patient arterial oxygen desaturation defined as a pulse oximetry reading of <95% for >5 seconds. Secondary outcome measures included documented assessments of abnormal ventilation, termination of the procedure secondary to concerns for patient safety, as well as other more rare adverse events including need for bag-mask ventilation, sedation reversal, or seizures. RESULTS. Children randomly assigned to the intervention arm were significantly less likely to experience arterial oxygen desaturation than children in the control arm. Two study patients had documented adverse events, with no procedures terminated for patient safety concerns. Intervention and control patients did not differ in baseline characteristics. Endoscopy staff documented poor ventilation in 3% of all procedures and no apnea. Capnography indicated alveolar hypoventilation during 56% of procedures and apnea during 24%. We found no change in magnitude or statistical significance of the intervention effect when we adjusted the analysis for age, sedative dose, or other covariates. CONCLUSIONS. The results of this controlled effectiveness trial support routine use of microstream capnography to detect alveolar hypoventilation and reduce hypoxemia during procedural sedation in children. In addition, capnography allowed early detection of arterial oxygen desaturation because of alveolar hypoventilation in the presence of supplemental oxygen. The current standard of care for monitoring all patients receiving sedation relies overtly on pulse oximetry, which does not measure ventilation. Most medical societies and regulatory organizations consider moderate sedation to be safe but also acknowledge serious associated risks, including suboptimal ventilation, airway obstruction, apnea, hypoxemia, hypoxia, and cardiopulmonary arrest. The results of this controlled trial suggest that microstream capnography improves the current standard of care for monitoring sedated children by allowing early detection of respiratory compromise, prompting intervention to minimize hypoxemia. Integrating capnography into patient monitoring protocols may ultimately improve the safety of nonintubated patients receiving moderate sedation.

Hospital Strategies Associated With 30-Day Readmission Rates for Patients With Heart Failure

Background—Reducing hospital readmission rates is a national priority; however, evidence about hospital strategies that are associated with lower readmission rates is limited. We sought to identify hospital strategies that were associated with lower readmission rates for patients with heart failure. Methods and Results—Using data from a Web-based survey of hospitals participating in national quality initiatives to reduce readmission (n=599; 91% response rate) during 2010–2011, we constructed a multivariable linear regression model, weighted by hospital volume, to determine strategies independently associated with risk-standardized 30-day readmission rates (RSRRs) adjusted for hospital teaching status, geographic location, and number of staffed beds. Strategies that were associated with lower hospital RSRRs included the following: (1) partnering with community physicians or physician groups to reduce readmission (0.33% percentage point lower RSRRs; P=0.017), (2) partnering with local hospitals to reduce readmissions (0.34 percentage point; P=0.020), (3) having nurses responsible for medication reconciliation (0.18 percentage point; P=0.002), (4) arranging follow-up appointments before discharge (0.19 percentage point; P=0.037), (5) having a process in place to send all discharge paper or electronic summaries directly to the patient’s primary physician (0.21 percentage point; P=0.004), and (6) assigning staff to follow up on test results that return after the patient is discharged (0.26 percentage point; P=0.049). Although statistically significant, the magnitude of the effects was modest with individual strategies associated with less than half a percentage point reduction in RSRRs; however, hospitals that implemented more strategies had significantly lower RSRRs (reduction of 0.34 percentage point for each additional strategy). Conclusions—Several strategies were associated with lower hospital RSRRs for patients with heart failure.

Pathogenesis of infections related to intravascular catheterization.

Over the past few decades, there have been major technological improvements in the manufacture of intravenous solutions and the manufacture and design of catheter materials. However, the risk of infection in patients receiving infusion therapy remains substantial, in part because of host factors (for example, increased use of immunosuppressive therapy, more aggressive surgery and life support, and improved survival at the extremes of life) and in part because of the availability of catheters that can be left in place for very long periods. Microbial components of normal skin flora, particularly coagulase-negative staphylococci, have emerged as the predominant pathogens in catheter-associated infections. Therefore, efforts to prevent skin microorganisms from entering the catheter wound (such as tunnelling of catheters and use of catheter cuffs and local antimicrobial agents) are logical and relatively effective. The specific properties of microorganisms that transform normally harmless commensals such as coagulase-negative staphylococci into formidable pathogens in the presence of a plastic foreign body are being explored. For example, Staphylococcus epidermidis elaborates a polysaccharide adhesin that also functions as a capsule and is a target for opsonic killing. However, the interactions between microorganism and catheter that lead to adherence, persistence, infection, and dissemination appear to be multifactorial. Images