Quality Measures Resources

OBJECTIVES: To use PERISTAT data on indicators of maternal mortality and morbidity to explore maternal health outcomes in Europe, and to discuss the implications of variations in the data sources for these indicators.
STUDY DESIGN: The PERISTAT feasibility study provides the source for this descriptive study, covering 15 European countries. Maternal mortality ratios are calculated, and data to describe maternal mortality by age, cause of death and mode of delivery are pooled for the countries that provided data.
RESULTS: Data presented show an increased risk of maternal death among older mothers and for caesarean sections compared with other modes of delivery, and the three most prevalent causes of maternal deaths reported were embolism, hypertensive diseases of pregnancy, and haemorrhage.
CONCLUSIONS: Variations in maternal mortality ratios reflect different data sources with varying levels of ascertainment in addition to differences in the number of maternal deaths. Further development is needed to construct comparable indicators of maternal morbidity.

Obstetric admissions are the leading cause of hospitalization for women in the United States, accounting for over 4 million hospital discharges each year. Measuring the quality of inpatient obstetrical care provided to these women is becoming increasingly important to patients, providers, and insurers. While numerous quality measures have been proposed, there is no agreement as to which measures should be used. An ideal quality measure for inpatient obstetrics would encompass 5 major characteristics: 1) association with meaningful maternal and neonatal outcomes, 2) relation to outcomes that are influenced by physician/health system behaviors, 3) affordability for application on a large scale basis, 4) acceptability to practicing obstetricians as a meaningful marker of quality, and 5) reliability/reproducibility. Traditional quality measurement tools such as maternal mortality, neonatal mortality and cesarean delivery rate are flawed measures. New measurements such as risk-adjusted primary cesarean rates, the nulliparous term singleton vertex cesarean birth (NTSV) rate, and the Adverse Outcomes Index (AOI) are currently being studied but these measures require further validation before widespread adoption.
TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians
LEARNING OBJECTIVES: After completion of this article, the reader should be able to summarize that quality measures of inpatient obstetrical care are numerous, explain that no one agrees on which measures should be used, and state that newer measures, once validated, should be considered.

The increasing trend of delivering at earlier gestational ages has raised concerns of the impact on maternal and infant health. The delicate balance of the risks and benefits associated with continuing a pregnancy versus delivering early remains challenging. Among singleton live births in the United States, the proportion of preterm births increased from 9.7% to 10.7% between 1996 and 2004. The increase in singleton preterm births occurred primarily among those delivered by cesarean section, with the largest percentage increase in late preterm births. For all maternal racial/ethnic groups, singleton cesarean section rates increased for each gestational age group. Singleton cesarean section rates for non-Hispanic black women increased at a faster pace among all preterm gestational age groups compared with non-Hispanic white and Hispanic women. Further research is needed to understand the underlying reasons for the increase in cesarean section deliveries resulting in preterm birth

Data limitations continue to pose challenges for efforts to identify racial and ethnic disparities in health and health care and analyze the underlying causes. Given budget constraints, the most feasible federal strategies to improve national data are those requiring only modest expenditures. Collaborations among private and public stakeholders hold promise for improving estimation methods and assessing disparities among small populations.

OBJECTIVE: To report the distribution and availability of the indicators describing the population of childbearing women in Europe and to assess the impact of the difference in the distribution of two of these indicators (age and multiple births) on some outcome indicators.
METHODS: The six PERISTAT indicators of population characteristics were computed using data from a survey of data providers in Europe. For maternal age and multiple births, the impact on health outcome was simulated for the extremes of the distribution using indirect standardised rates.
RESULTS: Data availability is good for basic demographic indicators (age, parity, multiple births), but less complete for indicators of social characteristics (education, smoking, country of birth). Further, common definitions are not used for the latter. Simulations of the impact of maternal age on health outcome found that variation in the maternal age distribution may cause trisomy 21 rates to differ by nearly 20% and maternal mortality ratios by nearly 50%.
CONCLUSION: Indicators of basic population characteristics are not collected routinely in every country. The crude distribution of these indicators is essential for international comparisons. Interpretation of comparative data would be improved by collection of health outcomes and service use by maternal characteristics.

OBJECTIVE: To assess the ability of the member states of the European Union to produce the indicators recommended by the PERISTAT project on perinatal health indicators and to provide an overview of fetal and infant health outcomes for these countries according to the information now available.
METHODS: We used data from the PERISTAT survey of data providers to compute PERISTAT indicators of fetal and infant health.
RESULTS: National data on fetal mortality are available for all countries, but vary in their definitions. To adjust for these differences in definition, PERISTAT recommends presenting rates by gestational age and birth weight. Not all countries can provide neonatal mortality data by gestational age, birth weight or plurality, as recommended by PERISTAT. Few countries in Europe can report infant mortality rates by birth weight and gestational age. The other recommended indicators are available to varying degrees.
CONCLUSIONS: This overview, which shows that Europe can produce a variety of indicators for monitoring the health of its new-borns, indicates that some key dimensions of perinatal health cannot now be measured with routine health statistics and reveals important disparities in health outcomes throughout Europe. For most indicators, the highest values are between 50 and 100% higher than the lowest values. The reasons for these variations and their importance for the surveillance of perinatal health are discussed.

OBJECTIVES: This study was undertaken to examine the national and regional rates of operative delivery among almost one quarter million births in a single year in the nation’s largest healthcare delivery system, using variation as an arbiter of the quality of decision making. STUDY DESIGN: We compared the variation in rates of primary cesarean and operative vaginal delivery in facilities of the Hospital Corporation of America during the year 2004. RESULTS: In 124 facilities representing almost 220,000 births during a 1-year period, the primary cesarean and operative vaginal delivery rates were 19%
5% (range 9-37) and 7%
4% (range 1-23). Within individual geographic regions, we consistently found variations of 200-300% in rates of primary cesarean delivery and variations approximating an order of magnitude for operative vaginal delivery. CONCLUSION: Within broad upper and lower limits, rates of operative delivery in the United States are highly variable and suggest a pattern of almost random decision making. This reflects a lack of sufficient reliable, outcomes-based data to guide clinical decision making. Key words: cesarean delivery, operative vaginal delivery, quality of care

OBJECTIVE: To quantify adverse neonatal and maternal outcomes associated with elective term delivery at less than 39 completed weeks of gestation.
STUDY DESIGN: Prospective observational study conducted in 27 hospitals over the course of 3 months in 2007.
RESULTS: Of 17,794 deliveries, 14,955 (84%) occurred at 37 weeks or greater. Of term deliveries, 6562 (44%) were planned, rather than spontaneous. Among the planned deliveries, 4645 (71%) were purely elective; 17.8% of infants delivered electively without medical indication at 37-38 weeks and 8% of those delivered electively at 38-39 weeks required admission to a newborn special care unit for an average of 4.5 days, compared with 4.6% of infants delivered at 39 weeks or beyond (P ! .001). Cesarean delivery rate in women undergoing induction of labor was not influenced by gestational age but was highly influenced by initial cervical dilatation and parity, ranging from 0% for parous women induced at 5 cm or greater to 50% for nulliparous women at 0 cm.
CONCLUSION: Elective delivery before 39 weeks’ gestation is associated with significant neonatal morbidity. Initial cervical dilatation is highly correlated with cesarean delivery among women undergoing induction of labor in both nulliparous and parous women. Elective delivery before 39 completed weeks’ gestation is inappropriate. Women contemplating elective induction at or beyond 39 weeks’ gestation with an unfavorable cervix should be counseled regarding an increased rate of cesarean delivery.

Oxytocin is the drug most commonly associated with preventable adverse perinatal outcomes and was recently added by the institute for Safe Medication Practices to a small list of medications "bearing a heightened risk of harm," which may "require special safeguards to reduce the risk of error." Current recommendations for the administration of this drug are vague with respect to indications, timing, dosage, and monitoring of maternal and fetal effects. A review of available clinical and pharmacologic data suggests that specific, evidence-based guidelines for the intrapartum administration of oxytocin may be derived from available data. If implemented, such practices may reduce the likelihood of patient harm. These suggested guidelines focus on limited elective administration of oxytocin, consideration of strategies that have been shown to decrease the need for indicated oxytocin use, reliance on low-dose oxytocin regimens, adherence to specific semiquantitative definitions of adequate and inadequate labor, and an acceptance that once adequate uterine activity has been achieved, more time rather than more oxytocin is generally preferable. The use of conservative, specific protocols for monitoring th effects of oxytocin on mother and fetus is likely not only to improve outcomes but also reduce conflict between members of the obstetric team. Implementation of these guidelines would seem appropriate in a culture increasingly focused on patient safety.

In today's healthcare environment, institutions are striving to streamline processes, reduce costs of healthcare, and establish best practice patterns while maintaining and improving the quality of care provided. Various healthcare delivery models are in use including case management and outcomes management. Various tools or structured-care methodologies (SCMs) are incorporated into these different models to support cost reduction and streamline processes while enhancing quality of care. This article discusses the tools frequently used, such as critical pathways, algorithms, and guidelines, as well as how these tools can be used in combination to support each other. This article also addresses the benefits of SCMs, how these tools are developed, and how the data obtained can be used in quality enhancement programs.

BACKGROUND: Previous reviews have shown inconsistent effects of publicly reported performance data on quality of care, but many new studies have become available in the 7 years since the last systematic review.
PURPOSE: To synthesize the evidence for using publicly reported performance data to improve quality.
DATA SOURCES: Web of Science, MEDLINE, EconLit, and Wilson Business Periodicals (1999-2006) and independent review of articles (1986-1999) identified in a previous systematic review. Only sources published in English were included.
STUDY SELECTION: Peer-reviewed articles assessing the effects of public release of performance data on selection of providers, quality improvement activity, clinical outcomes (effectiveness, patient safety, and patient-centeredness), and unintended consequences.
DATA EXTRACTION: Data on study participants, reporting system or level, study design, selection of providers, quality improvement activity, outcomes, and unintended consequences were extracted.
DATA SYNTHESIS: Forty-five articles published since 1986 (27 of which were published since 1999) evaluated the impact of public reporting on quality. Many focus on a select few reporting systems. Synthesis of data from 8 health plan-level studies suggests modest association between public reporting and plan selection. Synthesis of 11 studies, all hospital-level, suggests stimulation of quality improvement activity. Review of 9 hospital-level and 7 individual provider-level studies shows inconsistent association between public reporting and selection of hospitals and individual providers. Synthesis of 11 studies, primarily hospital-level, indicates inconsistent association between public reporting and improved effectiveness. Evidence on the impact of public reporting on patient safety and patient-centeredness is scant.
LIMITATIONS: Heterogeneity made comparisons across studies challenging. Only peer-reviewed, English-language articles were included.
CONCLUSION: Evidence is scant, particularly about individual providers and practices. Rigorous evaluation of many major public reporting systems is lacking. Evidence suggests that publicly releasing performance data stimulates quality improvement activity at the hospital level. The effect of public reporting on effectiveness, safety, and patient-centeredness remains uncertain.

A great essay on the history of the APGAR score and how obstetrics has changed with its focus on baby outcomes over the last generation. Atul Gawande's writing style works well for both lay and professional audiences.

Collaborative practice teams consist of interdisciplinary providers who are charged with the process of implementing and refining an outcomes management program within a targeted population. Collaborative practice teams work under the assumption that clinical quality enhancement through practice standardization decreases care fragmentation, resulting in improved physiologic, psychosocial, and financial outcomes. Collaborative practice team members identify best practice through the implementation and testing of interdisciplinary interventions. Represented on a critical pathway, these practices are evaluated toward achievement of defined population outcomes. In this article, the authors review the process of collaborative practice team formation, expected pitfalls and barriers to effective collaboration, and the work accomplished by a collaborative practice team.

The need to monitor progress in reducing maternal mortality has a long history, which can be traced back to the 1700s in some parts of the Western world. Today, however, this need is felt most acutely in developing countries, where the priority is to stimulate, evaluate and sustain action to prevent these essentially avoidable deaths. Over the last two decades, considerable efforts have been made to understand and overcome the measurement challenges of maternal mortality in the context of weak information systems, and new and enhanced methods and tools have emerged.

Crisis resource management (CRM) is a team-training program that teaches nontechnical skills such as: collaboration, communication, task management, teamwork, and leadership 1. The purpose of this study was to evaluate improvement in the nontechnical skills of a multidisciplinary team of pediatric residents, anesthesiology residents and pediatric nurses following participation in the CRM educational program. Self-efficacy theory guided the teaching method used in the CRM program. The Collaboration and Satisfaction about Care Decisions instrument 2 and the Anesthetists' Nontechnical Skills System 3 served as outcome measures. Seven multidisciplinary groups were studied with a total of 40 subjects. A significant increase was found in posttest scores for perceived collaboration and satisfaction with care and in numerical ratings of observed team skills following the CRM program. The results suggest multidisciplinary team participation in the CRM program increased perceived team collaboration, satisfaction with care, and observed teamwork skills.

The critical examination of clinical practice should be an integral part of patient care. It includes the development and implementation of guidelines, together with continuous evaluation of clinical process and outcomes to improve the quality of care provided. Clinical audit has not been successful in achieving this. The use of Integrated Care Pathways facilitates the introduction of guidelines and the continuous evaluation of clinical practice. Improvements are achieved by frequently revising the pathways to reflect current, local best practice. Integrated Care Pathways define the expected course of events in the care of a patient with a particular condition, within a set time-scale. A pathway is divided into time intervals during which specific goals and expected progress are defined, together with appropriate investigations and treatment. A pathway reflects the activities of a multidisciplinary team and can incorporate established guidelines and evidence-based medicine. It is usually unique to the institution in which it was developed. The pathway forms part of the clinical record of every patient. All variations from the pathway are documented, and the reasons for the variations analysed. Solutions are developed to address the causes of potentially avoidable variation, and the pathway is revised to incorporate these improvements. Integrated Care Pathways provide a powerful audit tool, as all aspects of the process and outcome of clinical practice can be constantly monitored. Variations from set standards are minimized, and improvements are rapidly incorporated into routine practice and subsequently re-evaluated.

BACKGROUND: In collaboration with the California Department of Health Maternal and Child Health Branch, the authors formed a Working Group to identify potential clinical indicators that could be used to inform decision making regarding maternal health care quality.
OBJECTIVE: To develop potential indicators for the assessment of maternal health care quality.
MATERIALS AND METHODS: A Working Group was convened to review information from the published literature and expert opinion. Selection of potential indicators was guided by the following goals: 1) To identify key areas for routine aggregate monitoring; 2) To include perspectives of relevant stakeholders in maternal health care services; 3) To include measures that are comprehensive and reflect a balance between maternal and fetal interests; and 4) To develop measures that would be valid, generalizable, mutable, and feasible.
RESULTS: Ninety potential indicators were identified. Each underwent a thorough review based on: its definition, objective, and validity; its contribution to innovation; the cost and timeliness of implementation; its feasibility, acceptability, and potential effectiveness; and its compatibility with ethics, values, and social policy. This process yielded 24 final indicators from the following categories: Health Status and Access (e.g., availability of 24 h inpatient anesthesia); Preconception and Interconception Care (e.g., Pap smear use); Antenatal Care (e.g., hospitalization for uncontrolled diabetes or pyelonephritis); Labor and Delivery Care (e.g., chorioamnionitis or obstetrical hemorrhage), and Postpartum Care (e.g., rate of postpartum visits).
CONCLUSIONS: These potential indicators, representative of the women's health continuum, can serve as a foundation to structure the development of consensus and methods for maternal health care quality assessment.

The main purpose of this article is to point out common pitfalls that can confuse comparative analyses of indicators of perinatal health and to discuss ways to overcome or minimize these difficulties. The challenge is to distinguish 'real' variations in the value of an indicator from variations due to differences in registration practices and definitions and from random variation. The first section presents the major properties that are desirable in indicators of perinatal health status and perinatal health care in Europe to be used for comparative purposes. The second section provides specific examples of the types of methodological difficulties encountered in European cross-country comparisons due to variations in the definition, measurement and construction of indicators. The conclusion discusses the PERISTAT project's responses to these difficulties and how these methodological constraints impact on the selection of an appropriate indicator set for Europe today.

With obstetrical delivery being the most frequent cause for hospital admissions, it is important to determine health- and patient-related characteristics affecting maternity length of stay (LOS). Although the average inpatient LOS has decreased steadily over the years, the issue of the appropriate LOS after delivery is complex and hotly debated, especially since the introduction of the mandatory minimum-stay legislation in the USA. The purpose of this paper is to identity factors associated with maternity LOS and to model variations in LOS. A Gamma mixture risk-adjusted model is proposed in order to analyze heterogeneity of maternity LOS within obstetrical Diagnosis Related Groups (DRGs). The determination of pertinent factors would benefit hospital administrators and clinicians to manage LOS and expenditures efficiently.

This paper uses the results of the PERISTAT feasibility study to assess the extent to which the participating countries of Europe were able to provide data to construct the core and recommended indicators of perinatal health defined in the project. After describing the approaches used for data collection in participating countries, this paper describes the extent to which they were able to provide the data requested to construct the indicators. It documents data sources within each country and their characteristics. The paper then discusses influences on the agenda, particularly the extent to which data collection occurs as a by-product of other processes such as civil registration and the administration of health care and how these processes can both enable and impede data collection. It closes by suggesting how data collection in Europe can be improved in order to widen the scope of the agenda for compiling perinatal indicators.

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.

Martin JA. United States vital statistics and the measurement of gestational age. Paediatric and Perinatal Epidemiology 2007; 21(Suppl. 2): 13–21. Estimates of the gestational age of the newborn based on US Birth Certificate data are extensively used to monitor trends in infant and maternal health and to improve our understanding of adverse pregnancy outcome. Two measures of gestational age, the ‘date of the last normal menses’ (LMP) and the ‘clinical estimate of gestation’ (CE), have been available from birth certificate data since 1989. Reporting irregularities with the LMP-based measure are well-documented, and important questions remain regarding the derivation of the CE. Changes in perinatal medicine and in vital statistics reporting in recent years may have importantly altered gestational age data based on vital statistics. This study describes how gestational age measures are collected and edited in US national vital statistics, and examines changes in the reporting of these measures by race and Hispanic origin between 1990 and 2002. Data are drawn from the National Center for Health Statistics’ restricted use US birth files for 1990–2002. Bivariable statistics are used. The percentage of records with missing LMP dates declined markedly over the study period, overall, and for each racial/Hispanic origin group studied. A marked shift in the distribution of the CE of gestational age was also observed, suggesting changes both in the true distribution of age at birth, and in the derivation of this measure. Agreement between the LMP-based and CE estimates increased over the study period, especially among preterm births. However, a high proportion of LMP dates continue to be missing or invalid and the derivation of the CE is still uncertain. In sum, although the reporting of gestational age measures in vital statistics appears to have improved between 1990 and 2002, substantial concerns with both the LMP-based and the CE persist. Efforts to identify approaches to further improve upon the quality of these data are needed.

Objective: To determine the effects of elective induction on the risk of cesarean delivery in a cohort of women with low-risk term pregnancies and to evaluate the costs of elective induction services within our hospital system. Methods: Records of 1135 eligible women with low-risk, singleton, vertex pregnancies at 38 – 41 weeks’ gestation who were eligible for vaginal delivery were analyzed retrospectively after elective induction (n 􏰆􏰆􏰆 263) or spontaneous labor (n 􏰆􏰆􏰆 872). Outcome measures included cesarean delivery and direct costs. Variables evaluated were parity, maternal age, estimated gestational age, birth weight, prior cesarean delivery, epidural anesthetic use, and provider category. Analysis was by univariable and multivariable regression modeling. Results: Elective induction placed nulliparas at a twofold higher risk for cesarean delivery (odds ratio 2.4, 95% confidence interval 1.2, 4.9) after adjustment for birth weight, maternal age, and gestational age. We found a significantly increased risk of cesarean delivery with increased birth weight for nulliparas (2– 66.7%). Increasing maternal age increased the risk of cesarean delivery in all parity groups (P <<< .05), but particularly among nulliparas (3–26.3%) (P <<< .001). Electively induced labors that ended in vaginal delivery cost $273 more and required an average of 4 hours more in the hospital before delivery than did noninduced vaginal deliveries (P <<< .001). Conclusion: Elective induction significantly increased the risk of cesarean delivery for nulliparas, and increased in-hospital predelivery time and costs. (Obstet Gynecol 2000; 95:917–22. © 2000 by The American College of Obstetri- cians and Gynecologists.)

OBJECTIVE: To establish whether the timing of delivery between 37 and 42 weeks gestation influences neonatal respiratory outcome and thus provide information which can be used to aid planning of elective delivery at term.
DESIGN: All cases of respiratory distress syndrome or transient tachypnoea at term requiring admission to the neonatal intensive care unit were recorded prospectively for nine years.
SETTING: Rosie Maternity Hospital, Cambridge.
SUBJECTS: During this time 33,289 deliveries occurred at or after 37 weeks of gestation.
MEASURES: This information enabled calculation of the relative risk of respiratory morbidity for respiratory distress syndrome or transient tachypnoea in relation to mode of delivery and onset of parturition for each week of gestation at term.
RESULTS: The incidence of respiratory distress syndrome at term was 2.2/ 1000 deliveries (95 % CI; 1.7-2.7). The incidence of transient tachypnoea was 5.7/1000 deliveries (95 % CI; 4.9-65). The incidence of respiratory morbidity was significantly higher for the group delivered by caesarean section before the onset of labour (35.5/ 1000) compared with caesarean section during labour (12.2/1000) (odds ratio, 2.9; 95% CI 1.9-4.4; P <0.001), and compared with vaginal delivery (5.3/1000) (odds ratio, 6.8; 95 % CI 52-8.9; P < 0.001). The relative risk of neonatal respiratory morbidity for delivery by caesarean section before the onset of labour during the week 37+0 to 37+6 compared with the week 38+0 to 38+6 was 1.74 (95 % CI 1.1 -2.8 ; P < 0.02) and during the week 38+O to 38+6 compared with the week 39+0 to 39+6 was 2.4 (95% CI 1.2-4.8; P < 0.02).
CONCLUSIONS: A significant reduction in neonatal respiratory morbidity would be obtained if elective caesarean section was performed in the week 39+0 to 39+6 of pregnancy.

The effect of medical errors and unsafe systems of care has had a profound effect on the practice of obstetrics and gynecology. From 1975 to 2000, medical malpractice costs for obstetrician– gynecologists have risen nearly four-fold higher than that of other medical costs. In addition, it has been estimated that defensive medicine may cost society $80 billion per year. Most importantly, many obstetrician– gynecologists are frustrated and seem to be abandoning the parts of their practice they perceive to put them at higher liability risk. This article discusses other medical specialty society efforts that have been successful in addressing the area of patient safety. Efforts to better track quality outcomes has been initiated by the American College of Surgeons through the National Surgical Quality Improvement Project, and the American Society of Anesthesiologists has demonstrated both dramatically improved outcomes and reduced liability costs through a concerted patient safety effort. The author proposes changes in four areas to specifically address patient safety in obstetrics and gynecology, including: the development of reliable and reproducible quality control measures (and a system to track them); national closed claim reviews to better understand and address the most important safety and liability areas for obstetrician– gynecologists; work prospectively with pharmaceutical and surgical device manufacturers to develop innovative new products that would increase the likelihood of safe outcomes; and create a culture of safety in obstetrics and gynecology by incorporating safety education into all levels of training. (Obstet Gynecol 2006;108:1266–71)

OBJECTIVE: Our goal was to lower unplanned primary cesarean deliveries by reducing elective inductions. STUDY DESIGN: To implement and sustain an induction management program, a committee of care providers reviewed induction rates. “Elective” and other categories were defined. An induction consent form was drafted. Consent compliance, induction rates, hours in labor and delivery and mode of delivery were evaluated. Outcomes were compared with historical data from 2 years earlier. RESULTS: A total of 10,166 nulliparas and 9869 multiparas attempted vaginal deliveries. Elective inductions decreased significantly, from 4.3% to 0.8% in nulliparas and from 13% to 9.5% in multiparas. A longer time to delivery was seen for both nulliparas (5.2 hours) and multiparas (4 hours) with elective inductions. Unplanned primary cesarean delivery rates are significantly lower in spontaneously laboring women, compared with those induced. CONCLUSION: A program aimed at reducing elective inductions was successfully implemented and sustained.

OBJECTIVE: To assess the validity of obstetric complications, including the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Core Measure on perineal lacerations, in the California Patient Discharge Data Set.
METHODS: We randomly sampled 1,611 deliveries from 52 of the 267 hospitals that performed more than 678 eligible deliveries in California in 1992-1993. We compared hospital-reported complications against our recoding of the same records.
RESULTS: Third- and fourth-degree perineal lacerations were reported accurately, with estimated sensitivities exceeding 90% and positive predictive values exceeding 65% (weighted to account for the stratified sampling design) or 85% (unweighted). Based on in-depth review of discrepant cases, we estimate the actual positive predictive value at over 90%. Most coding discrepancies were between no injury and first degree, or between first and second degree. Most postpartum complications, including urinary tract and wound infections, endometritis, anesthesia complications, and postpartum hemorrhage were reported with less than 70% sensitivity, but at least 80% positive predictive value. Composite measures from HealthGrades and Solucient, which include these complication codes, also suffer from high false-negative rates.
CONCLUSION: Third- and fourth-degree perineal lacerations are accurately reported on hospital discharge abstracts, confirming the validity of related quality indicators sponsored by the Agency for Healthcare Research and Quality and JCAHO. Administrative data seem less useful for monitoring other in-hospital postpartum complications.

Team performance measurement is a critical and frequently overlooked component of an effective simulation-based training system designed to build teamwork competencies. Quality team performance measurement is essential for systematically diagnosing team performance and subsequently making decisions concerning feedback and remediation. However, the complexities of team performance pose a challenge to effectively measuring team performance. This article synthesizes the scientific literature on this topic and provides a set of best practices for designing and implementing team performance measurement systems in simulation-based training.

In this article, the authors draw on the disciplines of sociology and environmental and social epidemiology to further understanding of mechanisms through which social factors contribute to disparate environmental exposures and health inequalities. They propose a conceptual framework for environmental health promotion that considers dynamic social processes through which social and environmental inequalities--and associated health disparities--are produced, reproduced, and potentially transformed. Using empirical evidence from the published literature, as well as their own practical experiences in conducting community-based participatory research in Detroit and Harlem, the authors examine health promotion interventions at various levels (community-wide, regional, and national) that aim to improve population health by addressing various aspects of social processes and/or physical environments. Finally, they recommend moving beyond environmental remediation strategies toward environmental health promotion efforts that are sustainable and explicitly designed to reduce social, environmental, and health inequalities.

OBJECTIVES: To review the standard of care in cases of maternal mortality due to hypertensive diseases in pregnancy and to make recommendations for its improvement.
DESIGN: Care given to women with hypertensive disease in pregnancy was audited and substandard care factors identified.
SETTING: Confidential enquiry by the Dutch Maternal Mortality Committee (MMC) from the Netherlands Society of Obstetrics and Gynaecology.
POPULATION: All maternal deaths reported to the MMC due to hypertensive disease in pregnancy in the Netherlands during the years 2000-04.
METHODS: Assessment for substandard care factors using a checklist based on the Dutch guideline of 'Hypertensive Disorders in Pregnancy'.
MAIN OUTCOME MEASURES: Substandard care in cases of maternal mortality due to hypertensive diseases in pregnancy.
RESULTS: A total of 27 cases of maternal death due to hypertensive disease in pregnancy were reported to the committee in the study period. In 26 cases (96%), substandard care factors were present, of which in 17 cases (63%), these were for more than five different items. In community midwifery care, the most frequent substandard care factor was no testing for proteinuria when clearly indicated (41%). In hospital care, the most frequent substandard care was related to insufficient diagnostic testing when indicated (41%), insufficient management of hypertension by obstetricians (85%), no use or inadequate use of magnesium sulphate (67%), inadequate stabilisation before transport to tertiary care centres and/or delivery (52%) and failure to consider timely delivery (44%).
CONCLUSIONS: Education of pregnant women concerning danger signs of hypertensive disease should be improved. Training of midwives and obstetricians should be improved in the following areas: performing basic diagnostic tests, adequate management of hypertension and eclampsia, with more attention to treatment of systolic blood pressure. This training should be guided by clear local protocols. Delivery should not be delayed in serious cases of hypertensive disease in pregnancy, not only after 32-34 weeks but also in early-onset pre-eclampsia as maternal risks often outweigh possible fetal benefits of temporising management.

Failure to rescue is an indicator that has been used to measure quality of care for surgical patients by evaluating the number of patients who die after developing postoperative complications. There are 2 key components of failure to rescue: (a) careful surveillance and timely identification of complications and (b) taking action by quickly initiating appropriate interventions and activating a team response. This concept has not been explored as a potential method to evaluate quality of intrapartum care. In obstetrics, complications leading to death are relatively rare because mothers and infants are generally healthy. Thus, there are not large numbers of maternal or infant deaths in individual hospitals or healthcare systems that allow the types of statistical analyses that have been previously used to measure failure to rescue rates. With modifications in the measurement process for failure to rescue in this population, there are direct implications for perinatal patient safety and lessons to be learned. A new use of the failure to rescue concept in a population not previously considered is proposed.

Methods to measure patient safety include structure, process and outcome measures, safety attitude and climate surveys, focus groups, storytelling, executive walk rounds, and external review. Ideally, measures of patient safety should be meaningful, science based, psychometrically sound, feasible, and actionable. Accurate and timely data feedback to caregivers is critical to effect required changes. A balanced set of patient safety measures provides valuable data to guide efforts to improve perinatal patient safety.

AIMS: 1. Ascertain antenatal and intrapartum risk factors for term neonates ventilated primarily for respiratory problems. 2. Describe the neonatal morbidity and mortality. Methods. Population-based case control cohort study. SETTING: Sydney and four large rural/urban Health Areas in New South Wales, 1996. SUBJECTS: Singleton term infants, no major congenital anomaly: subset of 99 infants ventilated primarily for respiratory problems from 182 cases admitted to a tertiary neonatal intensive care unit (NICU) for mechanical ventilation, and 550 randomly selected controls. OUTCOME: Risk factors for case status by maternal, antenatal, labor, delivery, and combined epochs, adjusted Odds Ratios (OR), 95 per cent Confidence Intervals (CI), p<0.05. RESULTS: Predictors of case status by multivariate epochs: mother’s age >35 years (1.9 (1.1, 3.2) p<0.03), primigravida (1.8 (1.1, 2.8) p<0.01), any antenatal complication (3.8 (2.4, 5.9) p<0.0001), birth weigh<3rd percentile (3.7 (1.5, 9.1) p<0.006), gestational diabetes (2.9 (1.3, 6.9) p<0.01), maternal pyrexia (6.5 (1.6, 27.2) p<0.01), birth weight >90th percentile (1.8 (1.01, 3.2) p<0.047), gestation 37–38 weeks (2.3 (1.5, 3.6) p<0.0004), forceps (4.4 (2.1, 9.1) p<0.0001), elective cesarean section (3.7 (2.0, 6.5) p<0.0001), emergency cesarean section (4.5 (2.4, 8.4) p<0.0001). Case mortality rate was 5 per cent. CONCLUSIONS: The pathways to neonatal respiratory morbidity in term infants are multifactorial. Several areas which warrant more in-depth study are: elective cesarean section at 37–38 weeks gestation, fetal growth restriction, macrosomia and the pattern of in-utero growth, maternal weight gain during pregnancy, gestational diabetes, pyrexia in labor and the role of chorioamnionitis.

Aims. 1. Ascertain antenatal and intrapartum risk factors for term neonates ventilated primarily for ‘perinatal asphyxia’. 2. Describe the neonatal morbidity and mortality. Methods. Population-based case control cohort study. Setting. Sydney and four large rural/urban health areas in New South Wales. Subjects. Singleton term infants, no major congenital anomaly: subset of 83 infants ventilated primarily for ‘asphyxia’ from 182 cases admitted to a tertiary neonatal intensive care unit (NICU) for mechanical ventilation, 550 randomly selected controls. Outcome. Risk factors for case status by maternal, antenatal, labor, delivery, and combined epochs, adjusted odds ratios (OR), 95 per cent confidence intervals (CI), p􏰁0.05. Results. Predictors of case status by multivariate epochs: Primigravida (1.8 [1.1, 2.8]), thyroid disease (7.8 [1.1, 57.0]), any antenatal complication (5.1 [3.0, 8.6]), growth restriction (4.2 [1.7, 10.4]), male gender (2.1 [1.3, 3.5]), gestational age 􏰂40 weeks (1.9 (1.1, 3.3)), prolonged rupture of membranes (9.7 [1.3, 72.5]), complicated labor (6.6 [3.7, 11.9]), induced labor (2.2 [1.3, 3.9]), prostaglandins 2.46 [1.23, 4.91]), maternal pyrexia (10.8 [2.8, 42.7]), placental hemorrhage in labor (OR 4.24 [1.45, 12.42]), forceps delivery (4.1 [1.9, 8.5]), emergency cesarean section (4.7 [2.6, 8.7]). Twenty case infants (24%) and no control infants died. Conclusions. This study has shown maternal and antepartum risk factors for severe neonatal morbidity in term infants. More centers need to become interested in the term baby, so that a larger multicenter study can further elucidate the heterogeneous causal pathways to term neonatal morbidity.

Background: Because of increased rates of respiratory complications, elective cesarean delivery is discouraged before 39 weeks of gestation unless there is evidence of fetal lung maturity. We assessed associations between elective cesarean delivery at term (37 weeks of gestation or longer) but before 39 weeks of gestation and neonatal outcomes. Methods: We studied a cohort of consecutive patients undergoing repeat cesarean sections performed at 19 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network from 1999 through 2002. Women with viable singleton pregnancies delivered electively (i.e., before the onset of labor and without any recognized indications for delivery before 39 weeks of gestation) were included. The primary outcome was the composite of neonatal death and any of several adverse events, including respiratory complications, treated hypoglycemia, newborn sepsis, and admission to the neonatal intensive care unit (ICU). Results:Of 24,077 repeat cesarean deliveries at term, 13,258 were performed electively; of these, 35.8% were performed before 39 completed weeks of gestation (6.3% at 37 weeks and 29.5% at 38 weeks) and 49.1% at 39 weeks of gestation. One neonatal death occurred. As compared with births at 39 weeks, births at 37 weeks and at 38 weeks were associated with an increased risk of the primary outcome (adjusted odds ratio for births at 37 weeks, 2.1; 95% confidence interval [CI], 1.7 to 2.5; adjusted odds ratio for births at 38 weeks, 1.5; 95% CI, 1.3 to 1.7; P for trend <0.001). The rates of adverse respiratory outcomes, mechanical ventilation, newborn sepsis, hypoglycemia, admission to the neonatal ICU, and hospitalization for 5 days or more were increased by a factor of 1.8 to 4.2 for births at 37 weeks and 1.3 to 2.1 for births at 38 weeks. Conclusions: Elective repeat cesarean delivery before 39 weeks of gestation is common and is associated with respiratory and other adverse neonatal outcomes.

OBJECTIVE: The objective was to develop, validate, and recommend a scaling model for a discriminative obstetric outcome measure named the Morbidity Assessment Index for Newborns. The purpose of this tool is to allow comparison of obstetric therapeutic strategies on neonatal morbidity, particularly in the mild to moderate morbidity range. STUDY DESIGN: A list of 66 check-mark (yes or no) items of readily available clinical and laboratory data from the early neonatal period was compiled by a panel of obstetric and neonatal experts. These data were collected on 411 neonates born at ≥28 weeks’ gestation and representing all grades of morbidity. Detailed psychometric testing included dimensionality testing and item analysis with the item response theory. The scores obtained with this new assessment tool were correlated with newborn and maternal disease conditions or events and with other measures of newborn morbidity. RESULTS: The Morbidity Assessment Index for Newborns is easy to apply in prospective or retrospective studies. Detailed psychometric evaluation resulted in modification of the list to 47 items, each item with a relative scale value according to severity of morbidity. The test was demonstrated to be a reliable and generalizable scaled index that performs optimally for the mild to moderate neonatal morbidity range. CONCLUSION: The Morbidity Assessment Index for Newborns is a validated outcome measurement scale of neonatal morbidity. This new tool may facilitate the conduct of obstetric clinical trials or epidemiologic population- based studies in obstetrics.

OBJECTIVES: To describe variation across Europe in PERISTAT indicators of health care in the perinatal period, and to assess the comparability of these indicators.
STUDY DESIGN: The PERISTAT feasibility study provides the source for this descriptive study, covering 15 European countries. Comparative analysis includes descriptions of births following management of sub-fertility, timing of first antenatal visit, onset of labour, mode of delivery, place of birth, preterm births in units without NICU, and breast-feeding uptake.
RESULTS: There is broad variation in the availability to provide data on perinatal indicators, and in perinatal health care across the European Union.
CONCLUSIONS: This paper describes the challenge of identifying indicators that are meaningful and robust for the full distribution of health care systems represented in the European Union. Further work is needed to ensure that the implementation of each indicator is comparable across member states.

OBJECTIVE: The objective of the study was to estimate the validity of obstetric procedures and diagnoses in California patient discharge data.
STUDY DESIGN: We randomly sampled 1611 deliveries from 52 of 267 California hospitals that performed more than 678 eligible deliveries in 1992 to 1993. We compared hospital-reported procedures and diagnoses against our recoding of the same records.
RESULTS: Cesarean, forceps, and vacuum delivery were accurately reported, with sensitivities and positive predictive values exceeding 90%. Episiotomy was underreported (70% sensitivity). Cesarean indications were reported with at least 60% sensitivity, except uterine inertia, herpes, and long labor. Among comorbidities, sensitivity exceeded 60% for chorioamnionitis, diabetes, premature labor, preeclampsia, and intrauterine death. Sensitivity was poor (less than 60%) for anemia, asthma, thyroid disorders, mental disorders, drug abuse, genitourinary infections, obesity, fibroids, excessive fetal growth, hypertension, premature rupture, polyhydramnios, and postdates.
CONCLUSION: The validity of hospital-reported obstetric procedures and diagnoses varies, with moderate to high accuracy for some codes but poor accuracy for others.

BACKGROUND: The PERISTAT project aimed to develop an indicator set for monitoring and describing perinatal health in Europe. The challenge was to define indicators that cover common concerns and have the same meaning within the different European health care systems.
METHODS: PERISTAT included i) a review of existing recommendations on perinatal health indicators, ii) a DELPHI consensus process with a scientific advisory committee composed of a clinician and an epidemiologist or statistician from each European member state as well as with a panel of midwives, and iii) a study of the availability of national statistics to construct recommended indicators. This article describes the first two components.
RESULTS: The review identified 10 international and 13 national recommended indicator sets. It also included indicators routinely compiled by WHO, EUROSTAT and OECD. Because of the methodological limits to using existing indicators for European comparisons, a high priority was placed on improving indicators already collected. Using the DELPHI method based on the results of the review, the scientific committee achieved a consensus on ten core and 23 recommended indicators, including 12 requiring further development.
CONCLUSIONS: The PERISTAT project was successful in identifying a set of indicators, which drew on and consolidated previous work. Consensus was not achieved on precise indicators in areas where uncertainty about appropriate indicators was high, although areas were targeted for future development. Finally, the feasibility study, which is in progress, is an essential part of the project, since it will enable member states to evaluate their capacity to produce these indicators.

The PERISTAT project was charged with developing an indicator set for monitoring and describing perinatal health in Europe as part of the European Commission's Health Monitoring Programme, run by the Directorate General for Health and Consumer Protection (DG-SANCO), which is working towards the establishment of a comprehensive health monitoring system at the community level. To develop its recommendations, the PERISTAT project carried out an extensive review of existing perinatal health indicators and then implemented a DELPHI consensus process with its scientific advisory committee, a panel composed of clinicians, epidemiologists and statisticians, as well as with a panel of midwives. Consensus was achieved on 10 core and 23 recommended indicators using methods that drew on and consolidated previous work in this field. Twelve of these indicators were targeted for further development and the other 21 for immediate implementation. A feasibility study, reported in the rest of this issue, was put into place to assess these recommendations.

Medical professionals and educators recognize that Simulation Based Medical Education (SBME) can contribute considerably to improving medical care by boosting medical professionals' performance and enhancing patient safety. A central characteristic of SBME is its unique approach to making (and learning from) mistakes, which is regarded as a powerful educational experience and as an opportunity for professional improvement. The basic assumption underlying SBME is that increased practice in learning from mistakes and in error management in a simulated environment will reduce occurrences of errors in real life and will provide professionals with the correct attitude and skills to cope competently with those mistakes that could not be prevented. The main message of the present paper is that this assumption, which serves as the driving force of SBME, should also serve as a starting point for critical thinking and questioning regarding the multiple aspects and components of SBME. These questions, in turn, should lead to empirical research that will provide feedback concerning changes that may be necessary in order to attain the goal of improving medical professionals' performance. Based on such research, SBME will be held accountable for its outcomes, i.e. whether its educational techniques indeed result in decreased occurrence of errors or not, and whether the ability to cope with the errors that do occur is significantly improved. The first of three issues that were addressed concerns individuals' experience of performing mistakes. It is suggested that in order to benefit fully from the experience of performing mistakes in a simulated context, medical educators should create a balance between the emotional load associated with the experience and the professional lessons that can be learned. Furthermore, research should focus on the long-term effects of the experience in changing professionals' attitudes and behaviour. The second question concerned the contribution of the different components of the educational experience to creating the desired changes in professionals' performance. Analysis of the teaching and learning involved in each stage of the educational event should serve as the basis for research that aims at identifying the unique contribution and efficiency of each element, and defining the essential core activities of a simulated experience. Finally, the need to define a newly emerging profession-SBME educator-was addressed. The professional qualifications are, clearly, multidisciplinary and should be based on the growing experience of medical educators in training students and professionals. Defining the profession is essential in order to create academic environments in which professionals will be trained to develop and implement new programmes, accompanied by research and assessment.

Reviews of perinatal care have consistently pointed to failures of communication among the care team and documentation of care as common factors in adverse events that occur in labor and delivery. They are also prime factors leading to malpractice claims. Idealized Design of Perinatal Care is an innovation project based on the principles of reliability science and the Institute for Healthcare Improvement’s (IHI’s) model for applying these principles to improve care. The Idealized Design model focuses on comprehensive redesign to enable a care system to perform substantially better in the future than the best it can do at present. The goal of Idealized Design of Perinatal Care is to achieve a new level of safer, more effective care and to minimize some of the risks identified in medical malpractice cases. The model described in this white paper, Idealized Design of Perinatal Care, represents the Institute for Healthcare Improvement’s best current assessment of the components of the safest and most reliable system of perinatal care. The four key components of the model are: The development of reliable clinical processes to manage labor and delivery The use of principles that improve safety (i.e., preventing, detecting, and mitigating errors) The establishment of prepared and activated care teams that communicate effectively with each other and with mothers and families A focus on mother and family as the locus of control during labor and delivery Two perinatal care "bundles" — a group of evidence-based interventions related to a disease or care process that, when executed together, result in better outcomes than when implemented individually — are being tested in this Idealized Design project: the Elective Induction Bundle and the Augmentation Bundle. The assumption of this innovation work is that reliably applying these evidence-based interventions in the delivery of perinatal care can dramatically improve outcomes. This white paper provides detail about the Idealized Design process and examines some of the initial work completed by teams in the innovation project.

DESCRIPTION: Patients with elective vaginal deliveries or elective cesarean sections at 37 to 39 weeks of gestation completed.
RATIONALE: For almost 3 decades, the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) have had in place a standard requiring 39 completed weeks gestation prior to ELECTIVE delivery, either vaginal or operative (ACOG, 1996). A survey conducted in 2007 of almost 20,000 births in HCA hospitals throughout the U.S. carried out in conjunction with the March of Dimes at the request of ACOG revealed that almost 1/3 of all babies delivered in the United States are electively delivered with 5% of all deliveries in the U.S. delivered in a manner violating ACOG/AAP guidelines. Most of these are for convenience, and result in significant short term neonatal morbidity (neonatal intensive care unit admission rates of 13- 21%) (Clark et al., 2009). According to Glantz (2005), compared to spontaneous labor, elective inductions result in more cesarean deliveries and longer maternal length of stay. The American Academy of Family Physicians (2000) also notes that elective induction doubles the cesarean delivery rate. Repeat elective cesarean sections before 39 weeks gestation also result in higher rates of adverse respiratory outcomes, mechanical ventilation, sepsis and hypoglycemia for the newborns (Tita et al., 2009).
TYPE: Process.
IMPROVEMENT: Decrease in the rate.
NUMERATOR: Patients with elective deliveries. Included Populations: ICD-9-CM Principal Procedure Code or ICD-9-CM Other Procedure Codes for one or more of the following: * Medical induction of labor as defined in Appendix A, Table 11.05 * Cesarean section as defined in Appendix A, Table 11.06 Excluded Populations: None. Data Elements: * ICD-9-CM Other Procedure Dates * ICD-9-CM Principal Procedure Code.
DENOMINATOR: Patients delivering newborns with 37 to 39 weeks of gestation completed Included Populations: Not applicable. Excluded Populations: * ICD-9-CM Principal Diagnosis Code or ICD-9-CM Other Diagnosis Codes for conditions justifying elective delivery as defined in Appendix A, Table 11.07 * Less than 8 years of age * Greather than or equal to 65 years of age * Length of stay > 120 days * Enrolled in clinical trials * Active Labor * Spontaneous Rupture of Membranes

DESCRIPTION: Nulliparous women with a term, singleton baby in a vertex position delivered by cesarean section.
RATIONALE: The removal of any pressure to not perform a cesarean birth has led to a skyrocketing of hospital, state and national cesarean section (CS) rates. Some hospitals now have CS rates over 50%. Hospitals with CS rates at 15-20% have infant outcomes that are just as good and better maternal outcomes (Gould et al., 2004). There are no data that higher rates improve any outcomes, yet the CS rates continue to rise. This measure seeks to focus attention on the most variable portion of the CS epidemic, the term labor CS in nulliparous women. This population segment accounts for the large majority of the variable portion of the CS rate, and is the area most affected by subjectivity. As compared to other CS measures, what is different about NTSV CS rate (Low-risk Primary CS in first births) is that there are clear cut quality improvement activities that can be done to address the differences. Main et al. (2006) found that over 60% of the variation among hospitals can be attributed to first birth labor induction rates and first birth early labor admission rates. The results showed if labor was forced when the cervix was not ready the outcomes were poorer. Alfirevic et al. (2004) also showed that labor and delivery guidelines can make a difference in labor outcomes. Many authors have shown that physician factors, rather than patient characteristics or obstetric diagnoses are the major driver for the difference in rates within a hospital (Berkowitz, et al., 1989; Goyert et al., 1989; Luthy et al., 2003). The dramatic variation in NTSV rates seen in all populations studied is striking according to Menacker (2006). Hospitals within a state (Coonrod et al., 2008; California Office of Statewide Hospital Planning and Development [OSHPD], 2007) and physicians within a hospital (Main, 1999) have rates with a 3-5 fold variation.
TYPE: Outcome.
IMPROVEMENT: Decrease in the rate.
NUMERATOR: Patients with cesarean sections Included Populations: ICD-9-CM Principal Procedure Code or ICD-9-CM Other Procedure Codes for cesarean section as defined in Appendix A, Table 11.06 Excluded Populations: None Data Elements: ICD-9-CM Other Procedure Codes ICD-9-CM Principal Procedure Code
DENOMINATOR: Nulliparous patients delivered of a live term singleton newborn in vertex presentation Included Populations: Nulliparous patients with ICD-9-CM Principal Diagnosis Code or ICD-9-CM Other Diagnosis Codes for outcome of delivery as defined in Appendix A, Table 11.08 and with a delivery of a newborn with 37 weeks or more of gestation completed Excluded Populations: * ICD-9-CM Principal Diagnosis Code or ICD-9-CM Other Diagnosis Codes, for contraindications to vaginal delivery as defined in Appendix A, Table 11.09 Less than 8 years of age Greater than or equal to 65 years of age Length of Stay >120 days Enrolled in clinical trials