Paul A. Gluck

Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of teamwork training on the occurrence of adverse outcomes and process of care in labor and delivery. METHODS: A cluster-randomized controlled trial was conducted at seven intervention and eight control hospitals. The intervention was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at 20 weeks or more of gestation in which one or more adverse maternal or neonatal outcomes or both occurred (Adverse Outcome Index). Additional outcomes included 11 clinical process measures. RESULTS: A total of 1,307 personnel were trained and 28,536 deliveries analyzed. At baseline, there were no differences in demographic or delivery characteristics between the groups. The mean Adverse Outcome Index prevalence was similar in the control and intervention groups, both at baseline and after implementation of teamwork training (9.4% versus 9.0% and 7.2% versus 8.3%, respectively). The intracluster correlation coefficient was 0.015, with a resultant wide confidence interval for the difference in mean Adverse Outcome Index between groups (–5.6% to 3.2%). One process measure, the time from the decision to perform an immediate cesarean delivery to the incision, differed significantly after team training (33.3 minutes versus 21.2 minutes, P=.03). CONCLUSION: Training, as was conducted and implemented, did not transfer to a detectable impact in this study. The Adverse Outcome Index could be an important tool for comparing obstetric outcomes within and between institutions to help guide quality improvement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00381056 LEVEL OF EVIDENCE: I

Assessing Quality in Obstetrical Care: Development of Standardized Measures

BACKGROUND No nationally accepted set of quality indicators exists in obstetrics. A set of 10 outcome measures and three quality improvement tools was developed as part of a study evaluating the effects of teamwork on obstetric care in 15 institutions and > 28,000 patients. Each outcome was assigned a severity weighting score. MEASURES Three new obstetrical quality improvement outcome tools were developed. The Adverse Outcome Index (AOI) is the percent of deliveries with one or more adverse events. The average AOI during the pre-implementation data collection period of the teamwork study was 9.2% (range, 5.9%-16.6%). The Weighted Adverse Outcome Score (WAOS) describes the adverse event score per delivery. It is the sum of the points assigned to cases with adverse outcomes divided by the number of deliveries. The average WAOS for the preimplementation period was 3 points (range, 1.0-6.0). The Severity Index (SI) describes the severity of the outcomes. It is the sum of the adverse outcome scores divided by the number of deliveries with an identified adverse outcome. The average SI for the pre-implementation period was 31 points (range, 16-49). DISCUSSION The outcome measures and the AOI, WAOS, and SI can be used to benchmark ongoing care within and among organizations. These tools may be useful nationally for determining quality obstetric care.

A review of pregnancy outcomes after exposure to orally inhaled or intranasal budesonide

ABSTRACT Background: Inadequately controlled rhinitis is associated with worsening asthma, one of the most common potentially serious causes of pregnancy complications. Recent evidence-based guidelines now stress the importance of inhaled corticosteroids as first-line therapy in controlling asthma during pregnancy, with preference given to budesonide. Both inhaled and intranasal budesonide formulations are rated Pregnancy Category B; all other inhaled and intranasal corticosteroids are rated Pregnancy Category C. Objective: To review data from clinical and epidemiological studies investigating the effects of orally inhaled or intranasal budesonide on pregnancy outcomes. Methods: Clinical and epidemiological studies on the effects of maternal exposure to orally inhaled or intranasal budesonide were identified through searches of the literature indexed on Medline or the Developmental and Reproductive Toxicology (DART) database through January 2005. The search terms used were: ‘budesonide’ and ‘pregnancy’; ‘pregnancy complications’; ‘teratogens’; ‘fetus’; ‘embryo’; or ‘toxicology’. The search was limited to English-language articles and those evaluating humans. Pertinent abstracts were identified from recent US asthma and allergy meetings. Results: A total of five articles and three abstracts meeting the search criteria were identified. Retrospective epidemiological studies and a randomized, placebo-controlled, multicenter trial found no clinically or statistically significant effects on fetal outcomes among more than 6600 infants whose mothers were exposed to orally inhaled budesonide during pregnancy. Women who reported use of orally inhaled budesonide either during early pregnancy only or throughout pregnancy gave birth to infants of normal gestational age, birth weight, and length, with no increased rate of stillbirths, multiple births, or congenital malformations. In a retrospective case-control analysis, no association was found between inhaled budesonide or intranasal budesonide and the overall rate of infant cardiovascular defects. However, a marginally increased risk of less severe cardiovascular defects (odds ratio = 1.58, 95% confidence interval 1.02 to 2.46) was observed with intranasal budesonide in one analysis, possibly the result of a random association due to multiple testing or an unidentified confounder. Conclusion: Maternal exposure to orally inhaled budesonide during pregnancy is not associated with an increased risk of congenital malformations or other adverse fetal outcomes in studies of more than 6600 infants. Data on pregnancy outcomes after maternal exposure to intranasal budesonide are limited, but the totality of evidence, including pharmacological studies showing a much lower systemic exposure after intranasal administration, indicates its safety profile is at least comparable with that of orally inhaled budesonide.

Medical Error Theory

Some errors in health care are inevitable because of human fallibility and system complexity. To improve patient safety we must develop three strategies. First, prevent errors with forcing functions, reducing complexity and providing reminders at the point of care. Second, everyone working in health care should be alert to identify and eliminate latent (potential) errors before patients are harmed. Finally, we must establish defensive barriers that will intercept those errors that still occur and prevent them from causing patient injury. Only in this way can health care fulfill its potential and significantly reduce iatrogenic harm.

Medical liability and patient safety: Setting the proper course

There is genuine worry about and within our specialty. Rising malpractice premiums have resulted in early retirement, limited practices, geographic relocation, and diminished satisfaction among obstetricians and gynecologists. The liability insurance crisis has also contributed to a decreased interest among U.S. medical student graduates in obstetrics and gynecology. Efforts to preserve access to quality health care for women have begun. Furor over the liability crisis has resulted in policy makers introducing legislation to change our tort system. These efforts were supported, in part, by the Harvard Medical Practice Study, which demonstrated that only 17% of liability claims appear to have resulted from negligent injury. This information has been helpful in efforts to cap noneconomic damages in malpractice suits, which has led to stabilization in professional liability insurance rates in some states. That same study, however, revealed that only 2% of negligent injuries resulted in claims. Ultimately, efforts to fix a broken liability system do not address the more fundamental issue: How can we make medicine safer and reduce patient injury? Five years ago, the landmark Institute of Medicine report, To Err is Human, estimated that up to 100,000 people die each year in the United States as a result of medical error. Sadly, a recent report estimated that 195,000 die each year in U.S. hospitals, and “there is little evidence that patient safety has improved in the last 5 years.” These sobering facts, together with decreasing reimbursement, have created what some have called the “perfect storm” for our specialty. How should we reset the course to navigate our ship into safer waters? There appears to be cognitive dissonance as concerned physicians, nurses, hospital boards, policy makers, and patients try to reduce medical errors. On the one hand, a legal system that focuses on individual blame and punishment creates a wall of silence between doctor and patient and prevents meaningful analysis of the root cause(s) of an adverse outcome. On the other hand, the overarching principle behind improving safety is recognition that 90% of patient injuries result from bad systems, not bad people, and that we must make errors and near misses visible. This transparency should extend to patients who deserve a candid and compassionate explanation for adverse outcomes, and when appropriate, an apology. Both these conflicting approaches claim to make health care safer. We should continue our efforts to fix a broken legal system in which litigation does not always correlate with negligence and settlements are frequently capricious. However, we must not stop there. We must create a culture in obstetrics and gynecology in which patient safety is our core principle. Other high-risk industries, such as aviation and nuclear power, have transformed themselves by investing in systems that recognize the critical importance of “safety first,” and as a result, have achieved remarkable safety records. We can follow their lead by analyzing our errors, redesigning the system, and eliminating individual blame and retribution when they are not warMark D. Pearlman, MD

Factors impacting hand hygiene compliance among new interns: findings from a mandatory patient safety course.

BACKGROUND Residency is a critical transition during which individuals acquire lifelong behaviors important for professionalism and optimal patient care. One behavior is proper hand hygiene (HH), yet poor compliance with accepted HH practices remains a critical issue in many settings. This study explored the factors affecting hand hygiene compliance (HHC) in a diverse group of interns at the beginning of graduate training. METHODS During a required patient safety course, we observed HH behaviors using a standardized patient encounter. Interns were instructed to perform a focused exam in a simulated inpatient environment with HH products available and clearly visible. Participants were blinded to the HH component of the study. An auditory alert was triggered if participants failed to perform prepatient encounter HH. Compliance rates and the number of alerts were recorded. All encounters were videotaped. RESULTS The HHC among the 169 participants was 37.9% pre-encounter and was higher among female interns than males, although this difference was not statistically significant (41.6% versus 31.5%, P  =  .176). International medical graduates had significantly lower HHC compared with US graduates (23.2% versus 45.1%, P  =  .006). Most initially noncompliant participants performed HH after 1 alert (87.6%). DISCUSSION The initial low rate of HHC in our sample is comparable to other studies. Using direct video surveillance and auditory alarms, we improved our success rates for prepatient encounter HHC. Our study identified medical school origin as an important factor for HHC, and the significantly lower compliance for international medical graduates compared with US graduates has not been previously reported. These findings should be considered in designing interventions such as intern orientation and clinical education programs to improve HH behaviors.

Peer Review in Obstetrics and Gynecology by a National Medical Specialty Society

BACKGROUND Since 1986 the American College of Obstetricians and Gynecologists (ACOG) has offered a voluntary consultation service (Voluntary Review of Quality of Care [VRQC] program) to assist departments of obstetrics and gynecology in assessing their quality of care. HOW THE VQRC PROGRAM WORKS The VRQC program review team selects three to five topics for on-site medical record review to further investigate the care processes that may contribute to the perceived problems. Each chart is evaluated by a single reviewer with the use of worksheets with explicit, objective criteria that represent practice guidelines. In addition, key departmental and hospital personnel are interviewed on site to provide insight into the issues that prompted the request. EVALUATION OF THE VRQC PROGRAM The first 100 site visits took place in 29 states and represented a diverse geographic cohort of hospital departments of obstetrics and gynecology. Overall departmental and systemic deficiencies were significantly more common than clinical concerns. Obstetric issues were more prevalent than gynecologic issues. Induction and augmentation of labor was the most common deficiency, and the availability and quality of obstetric anesthesia was the second. CONCLUSION The VRQC program, as a voluntary consultative peer review program, addresses hospital-specific quality problems and also identifies common deficiencies across a diverse group of hospitals, which may warrant continuing education.

Quality and Safety in Women's Health

Designed for all providers of women’s healthcare including those undertaking Maintenance of Certification programs, trainees preparing for postgraduate examinations, and those initiating or growing a program of quality improvement and patient safety this practical manual guides those implementing QI and safety programs with specific emphasis on Obstetrics and Gynecology practice. The content contains a strong case-based element to improve accessibility and understanding. An introductory section covers core attributes needed by all physicians to build a culture of patient safety, including leadership, communication and QI skills. Core clinical skills are then reviewed in a variety of labor ward, office, operating room, and outpatient settings. Finally systems implications are highlighted, including information transparency and disclosure, training programs, and regulatory and legal implications. The editors are involved with national and international initiatives educating physicians in safety aspects of practice. The book is published in collaboration with the Foundation for EXXcellence. on this title

Effects of teamwork training on adverse outcomes and process of care in labor and delivery : A randomized controlled trial

ABSTRACT Reports from the Institute of Medicine propose that team training—and implementing team behaviors—can cut down on medical errors and enhance patient safety. The present investigators tested this idea in the area of obstetrics, a discipline that calls for intensive and error-free vigilance as well as effective communication between numerous disciplines. A cluster-randomized controlled trial was undertaken at 15 US hospitals: at seven a standardized teamwork training curriculum was introduced that focused on free communication and team structure. The remaining eight hospitals made up a control group. The curriculum (MedTeams Labor and Delivery Team Coordination Course) was based on care resource management, which attempts to utilize the ability of each team member to analyze and react to situations in ways that lessen the potential for error. A total of 1307 individuals were trained, and 28,536 deliveries were analyzed. Negative outcomes were quantified using an index outcome measure, the Adverse Outcome Index. The intervention and control groups were similar demographically and obstetrically at the outset. Adverse outcome indices also were comparable, and remained so after teamwork training was implemented. The only process measure that differed significantly after team training was in the interval from deciding to perform an immediate cesarean delivery to making the incision, which decreased from 33 to 21 minutes. There was considerable variability across hospitals in the commonest maternal outcome, a third- or fourth-degree perineal laceration following vaginal delivery, and also in the most prevalent neonatal outcome, unplanned admission to the neonatal intensive care unit. Postimplementation outcome measures did not differ significantly even after controlling for baseline differences. This study failed to show that teamwork training in obstetrical practices had any important clinical impact. Nevertheless, the Adverse Outcome Index might prove helpful when comparing obstetrical outcomes within and between institutions.

THE EFFECTS OF PREGNANCY ON ASTHMA: A PROSPECTIVE STUDY

Forty-seven pregnant asthmatics were studied in a prospective study. Maternal asthma was exacerbated in 43%, most often in the last trimester. Normal physiologic alterations of pregnancy are reviewed as plausable explanations for the course of asthmatic patients during pregnancy.