Bernard Ewigman

A randomized trial of prenatal ultrasonographic screening: Impact on the detection, management, and outcome of anomalous fetuses

OBJECTIVE The objective of this randomized clinical trial was to test the hypothesis that ultrasonographic screening would significantly alter perinatal outcome as a result of the antenatal detection of fetal congenital malformations. STUDY DESIGN Pregnant women without a specific indication for ultrasonography were randomly assigned to have either two screening sonograms (15 to 22 weeks and 31 to 35 weeks) or conventional obstetric care with ultrasonography used only as determined by the clinical judgment of the patients physician. The frequency of birth defect detection in the screened and control populations was compared, as was the impact of discovery on pregnancy outcome. RESULTS Major congenital malformations occurred in 2.3% of the 15,281 fetuses and infants in this study. Antenatal ultrasonography detected 35% of the anomalous fetuses in the screened group versus only 11% in the control population (relative detection rate 3.1; 95% confidence interval 2.0 to 5.1). Ultrasonography screening did not, however, significantly influence the management or outcome of pregnancies complicated by congenital malformations. Specifically, only 9 abortions were performed for anomalies among 7685 fetuses in the screened group whereas 4 pregnancies were terminated for fetal anomalies detected among 7596 control subjects. Ultrasonography screening also had no significant impact on survival rates among infants with potentially treatable, life-threatening anomalies despite the opportunity to take precautionary measures such as delivery in a tertiary center. CONCLUSIONS Ultrasonography screening in a low-risk pregnant population had no significant impact on the frequency of abortion for fetal anomalies. Survival rates for anomalous fetuses were also unaffected by screening.

Child Deaths Resulting From Inflicted Injuries: Household Risk Factors and Perpetrator Characteristics

Objective. To determine the role of household composition as an independent risk factor for fatal inflicted injuries among young children and describe perpetrator characteristics. Design, Setting, and Population. A population-based, case-control study of all children <5 years of age who died in Missouri between January 1, 1992, and December 31, 1999. Missouri Child Fatality Review Program data were analyzed. Cases all involved children with injuries inflicted by a parent or caregiver. Two age-matched controls per case child were selected randomly from children who died of natural causes. Main Outcome Measure. Inflicted-injury death. Household composition of case and control children was compared by using multivariate logistic regression. We hypothesized that children residing in households with adults unrelated to them are at higher risk of inflicted-injury death than children residing in households with 2 biological parents. Results. We identified 149 inflicted-injury deaths in our population during the 8-year study period. Children residing in households with unrelated adults were nearly 50 times as likely to die of inflicted injuries than children residing with 2 biological parents (adjusted odds ratio: 47.6; 95% confidence interval: 10.4–218). Children in households with a single parent and no other adults in residence had no increased risk of inflicted-injury death (adjusted odds ratio: 0.9; 95% confidence interval: 0.6–1.9). Perpetrators were identified in 132 (88.6%) of the cases. The majority of known perpetrators were male (71.2%), and most were the childs father (34.9%) or the boyfriend of the childs mother (24.2%). In households with unrelated adults, most perpetrators (83.9%) were the unrelated adult household member, and only 2 (6.5%) perpetrators were the biological parent of the child. Conclusions. Young children who reside in households with unrelated adults are at exceptionally high risk for inflicted-injury death. Most perpetrators are male, and most are residents of the decedent childs household at the time of injury.

Effect of physician profiling on utilization - Meta-analysis of randomized clinical trials

OBJECTIVES: An American Medical Association survey reported that more than half of physicians are subjects of either clinical or economic profiling. This multilevel meta-analysis was designed to assess the clinical effect of peer-comparison feedback intervention (profiles) in changing practice patterns.METHODS: Systematic computerized and manual searches were combined to retrieve articles on randomized controlled clinical trials testing profiling reports. Eligible studies were randomized, controlled clinical trials that tested peer-comparison feedback intervention and measured utilization of clinical procedures. To use all available information, data were abstracted and analyzed on three levels: (1) direction of effects, (2)p value from the statistical comparison, and (3) odds ratio (OR).MAIN RESULTS: In the 12 eligible trials, 553 physicians were profiled. The test result wasp<.05 for the vote-counting sign test of 12 studies (level 1) andp<.05 for the z-transformation test of 8 studies (level 2). There were 5 trials included in the OR analysis (level 3). The primary effect variable in two of the 5 trials had a nonsignificant OR. However, the overall OR calculated by the Mantel-Haenszel method was significant (1.091, confidence interval: 1.045 to 1.136).CONCLUSIONS: Profiling has a statistically significant, but minimal effect on the utilization of clinical procedures. The results of this study indicate a need for controlled clinical evaluations before subjecting large numbers of physicians to utilization management interventions.

A randomized trial of prenatal ultrasonographic screening: Impact on maternal management and outcome

OBJECTIVES This randomized clinical trial of 15,530 women was designed to test the hypothesis that screening ultrasonography in low-risk pregnancies would improve perinatal outcome. A secondary hypothesis addressed in this article was that screening ultrasonography would have a favorable impact on maternal management or outcome. STUDY DESIGN Pregnant women without a specific indication for ultrasonographic examination in early pregnancy were randomly assigned to have either two screening sonograms or conventional obstetric care. Pregnancy interventions and maternal outcomes were compared in the two groups. RESULTS No significant differences were found in maternal outcomes. Use of ultrasonography was markedly higher in the screened group. The rates of induced abortion, amniocentesis, tests of fetal well-being, external version, induction, and cesarean section and the distribution of total hospital days were similar in the two groups. Use of tocolytics and the rate of postdate pregnancy were both slightly lower in the screened group. CONCLUSION Screening ultrasonography resulted in no clinically significant benefit.

Practice-based research networks: the laboratories of primary care research.

Medical research has traditionally been based in academic centers, and the findings are frequently not applicable in community primary care settings. The result is a large gap between the possible and the practical in delivering high-quality primary medical care in the United States. Practice-based research networks (PBRNs), laboratories for primary care clinical research, are the appropriate vehicles for uniting the worlds of community primary care practice and clinical research. Although they have received little attention in the mainstream of clinical and health services research, PBRNs have already reported a variety of findings useful for primary care providers, and these networks have helped to identify key issues in healthcare delivery that affect important outcomes. In this report, we outline the rationale for and history of PBRNs. We describe the organization and work of several productive PBRNs, giving examples of their studies that have changed the standards of modern primary care practice. Finally, we describe a developing electronic process for identifying research questions obtained directly from primary care providers that can be used to focus the national primary care research agenda on questions of clinical relevance and importance. As electronic technologies are fully developed and tested, they will facilitate communication between clinicians and researchers, thereby improving the effectiveness and efficiency of practice-based research.

Child death review. The state of the nation.

BACKGROUND Child death review (CDR) is a mechanism to more accurately describe the causes and circumstances of death among children. The number of states performing CDR has more than doubled since 1992, but little is known about the characteristics of these programs. The purpose of this study was to describe the current status of CDR in the United States and to document variability in program purpose, scope, organization, and process. METHODS Investigators administered a written survey to CDR program representatives from 50 states and the District of Columbia (DC), followed by a telephone interview. RESULTS All 50 states and DC participated; 48 states and DC have an active CDR program. A total of 94% of programs agreed that identifying the cause of and preventing future deaths are important purposes of CDR. Assistance with child maltreatment prosecution was cited as an important purpose by only 13 states (27%). Twenty-two states (45%) review deaths from all causes, while six states (12%) review only deaths due to child maltreatment. CDR legislation exists in 33 states. Fifty-three percent of the CDR programs were implemented since 1996, and 59% report no or inadequate funding. CDR contributes to the death investigation process in seven states (14%), but the majority (59%) of reviews are retrospective, occurring months to years after the childs death. CONCLUSIONS CDR programs in the United States share commonalities in purpose and scope. Without national leadership, however, the wide variation in organization and process threatens to limit CDR effectiveness.

Racial/Ethnic Differences in Concerns About Current and Future Medications Among Patients With Type 2 Diabetes

OBJECTIVE—To evaluate ethnic differences in medication concerns (e.g., side effects and costs) that may contribute to ethnic differences in the adoption of and adherence to type 2 diabetes treatments. RESEARCH DESIGN AND METHODS—We conducted face-to-face interviews from May 2004 to May 2006 with type 2 diabetic patients ≥18 years of age (N = 676; 25% Latino, 34% non-Hispanic Caucasian, and 41% non-Hispanic African American) attending Chicago-area clinics. Primary outcomes of interest were concerns regarding medications and willingness to take additional medications. RESULTS—Latinos and African Americans had higher A1C levels than Caucasians (7.69 and 7.54% vs. 7.18%, respectively; P < 0.01). Latinos and African Americans were more likely than Caucasians to worry about drug side effects (66 and 49% vs. 39%, respectively) and medication dependency (65 and 52% vs. 39%, respectively; both P < 0.01). Ethnic minorities were also more likely to report reluctance to adding medications to their regimen (Latino 12%, African American 18%, and Caucasian 7%; P < 0.01). In analyses adjusted for demographics, income, education, and diabetes duration, current report of pain/discomfort with pills (odds ratio 2.43 [95% CI 1.39–4.27]), concern regarding disruption of daily routine (1.97 [1.14–3.42]), and African American ethnicity (2.48 [1.32–4.69]) emerged as major predictors of expressed reluctance to adding medications. CONCLUSIONS—Latinos and African Americans had significantly more concerns regarding the quality-of-life effects of diabetes-related medications than Caucasians. Whether these medication concerns contribute significantly to differences in treatment adoption and disparities in care deserves further exploration.

Methods of Randomized Controlled Clinical Trials in Health Services Research

The randomized controlled clinical trial is an increasingly used method in health services research. Analysis of methodology is needed to accelerate practical implementation of trial results, select trials for meta-analysis, and improve trial quality in health services research. The objectives of this study are to explore the methodology of health services research trials, create and validate a streamlined quality evaluation tool, and identify frequent quality defects and confounding effects on quality. The authors developed a quality questionnaire that contained 20 evaluation criteria for health services research trials. One hundred one trials from the Columbia Registry of Controlled Clinical Trials were evaluated using the new quality tool. The overall agreement between independent reviewers, Cohens kappa, was 0.94 (±0.01). Of a possible score of 100, the trials received an average score of 54.8 (±12.5). Five evaluation criteria indicated significant quality deficiencies (sample size, description of case selection, data on possible adverse effects, analysis of secondary effect variables, and retrospective analysis). The quality of study characteristics was significantly weaker than the quality of reporting characteristics (P <0.001). The total average scores of Medline-indexed journals were better than the non-Medline-indexed journals (P < 0.001). There was a positive correlation between the overall quality and year of publication (R = 0.21, P < 0.05). The authors conclude that the new quality evaluation tool leads to replicable results and there is an urgent need to improve several study characteristics of clinical trials. In comparison to drug trials, site selection, randomization, and blinding often require different approaches in health services research.

Epidemiologic predictors of cesarean section in nulliparous patients at low risk

OBJECTIVES We sought to determine whether certain maternal and fetal characteristics influenced the risk of maternal- and fetal-indicated cesarean sections in pregnant women at low risk for adverse perinatal outcomes. STUDY DESIGN From a cohort of 6393 low-risk nulliparous patients maternal and fetal indicated cesarean section rates with 95% confidence intervals were calculated and stratified by demographic, anthropometric, and clinical tests and measurements. The strongest risk factors were modeled by means of multiple logistic regression. RESULTS Few risk factors distinguished maternal from fetal characteristics preceding cesarean delivery. Maternal age was associated with increased cesarean section risk in the tallest group of women only, and cesarean section rates decreased with increasing height, increased with higher prepregnancy weights, and was highest in women carrying male fetuses. Higher first prenatal visit diastolic blood pressure, increasing numbers of nonstress tests, > or = 2+ prenatal urine protein, late sonograms, geographic region, and practice type were statistically significant risk factors as well. Interestingly, results of prenatal visit tests and measurements contributed less to the prevalence of cesarean section than did age, fetal sex, and anthropometric parameters. However, the generalizability of these results is limited to low-risk (predominantly white) populations. CONCLUSIONS Of the risk factors we were able to assess, a large proportion of the incidence of cesarean section in this population of nulliparous patients at low risk was attributable to age, sex of fetus, and anthropometric patient profiles.

Household Composition and Fatal Unintentional Injuries Related to Child Maltreatment

PURPOSE To determine if household composition is an independent risk factor for fatal unintentional injuries related to child maltreatment. DESIGN A population-based, case-control study using data from the Missouri Child Fatality Review Program for 1992-1999. METHODS Children under age five who died during the 8-year study period were eligible for study. Cases were defined as children who died of an unintentional injury that occurred when a parent or other adult caregiver: (a) was not present, (b) was present but not capable of protecting the child, (c) placed the child in an unsafe sleep environment, or (d) failed to use legally mandated safety devices. Controls were randomly selected from children who died of natural causes. Household composition was classified based on relationship of the adults living in the household to the deceased child. The five household composition categories were households with: (a) two biologic parents and no other adults, (b) one biologic parent and no other adults, (c) one or two biologic parents and another adult relative, (d) stepparents or foster parents, and (e) one or two biologic parents and another unrelated adult. Logistic regression analyses were conducted and odds ratios estimating the risk of maltreatment-related unintentional death associated with each household category compared to the reference households: those with two biologic parents and no other adults. FINDINGS Three hundred eighty children met the case definition. Children residing within households with adults unrelated to them had nearly six times the risk of dying of maltreatment-related unintentional injury (adjusted odds ratio [aOR] 5.9; 95% confidence interval [95% CI] 1.9-17.6). Children residing with step or foster parents and those living with other, related adults were also at increased risk of maltreatment death (aOR 2.6, 95% CI 1.0-6.5; and aOR 2.1, 95% CI 1.0-4.5, respectively). Risk was not elevated for children in households with a single biologic parent and no other adults in residence. CONCLUSIONS Young children residing in households with unrelated adults, step-parents, or foster parents are at increased risk of fatal unintentional injury related to maltreatment. Nurses can use the findings of this study to facilitate injury prevention by identifying families at risk for fatal unintentional injuries and providing these families with targeted education or referral.