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Biomedical subjects

Frank A Chervenak

Publications and source records attributed to Frank A Chervenak.

At least 19 recordsLinked to original sources
PubMed2006

Ethics, a neglected dimension of power relationships of physician leaders.

OBJECTIVE: Physician leaders in obstetrics and gynecology find themselves in complex power relationships with administrative subordinates, administrative peers, and administrative superiors. The ethical dimensions of these power relationships have not been examined previously. STUDY DESIGN: The authors draw on the work of 3 major historic figures (John Gregory, Thomas Hobbes, and Friedrich Hoffmann) to identify for the first time 3 major types of power relationships and organizational cultures. Gregorian power relationships and organizational cultures are characterized by shared fiduciary responsibility that advances the core mission of a health care organization. Hobbesian power relationships and organizational cultures are characterized by relentless self-interest in a zero-sum game. Hoffmannian power relationships and organizational cultures are characterized by enlightened self-interest in a win-win game. RESULTS: The authors analyze the ethical dimensions of power relationships of physician leaders with subordinates, peers, and superiors and of organizational cultures. CONCLUSION: The authors support transformational leadership toward Gregorian power relationships and organizational cultures, using, when necessary, Hoffmannian power relationships and organizational cultures as a way station.

Administrative Personnel↗
PubMed2006

Preventive ethics for including women of childbearing potential in clinical trials.

OBJECTIVE: We present a preventive ethics approach for including women of childbearing potential in clinical trials. STUDY DESIGN: We explain the concept of preventive ethics and identify its implications for study design, the informed consent process, and study management. RESULTS: We identify and address ethically significant questions for investigators and institutional review boards to address, to responsibly enroll women of childbearing potential in clinical trials. These questions concern preventive ethics for study design, for the informed consent process, and for study management. Distinctive components of this preventive ethics approach include the distinction between directive and nondirective counseling, the recognition of the concept of moral risk for women as research subjects, and the distinction between professional and individual conscience. We identify ethical considerations for physicians considering referral of their patients to clinical trials. CONCLUSION: A comprehensive, preventive ethics approach to the ethical challenges in clinical trials related to the prevention and occurrence of pregnancy is essential for responsibly enrolling women of childbearing potential.

Adolescent↗
PubMed2006

Does a "vanishing twin" affect first-trimester biochemistry in Down syndrome risk assessment?

OBJECTIVE: The purpose of this study was to evaluate the impact of spontaneous reduction in multifetal pregnancy on first-trimester maternal serum biochemistry. STUDY DESIGN: We evaluated first-trimester pregnancy associated plasma protein-A (PAPP-A) and free beta-human chorionic gonadotropin levels in singleton euploid pregnancies. Biochemical values in pregnancies with evidence of spontaneous reduction were compared to other singleton pregnancies. Mann-Whitney U, Student t test, Fisher exact test, and logistic regression analysis were used for statistical comparison. RESULTS: There were 41 cases (0.9%) of spontaneous reduction. Though spontaneous reduction was not associated with different levels of either analyte, reduction within 4 weeks was associated with higher levels of both PAPP-A (1.79 vs 1.18; P = .002) and free beta-hCG (1.28 vs 0.96; P = .03) compared with other pregnancies. Spontaneous reduction was associated with a higher frequency of PAPP-A >95th %ile (17.1 vs 4.7%; P = .003) and free beta-hCG >95th %ile (17.1% vs 5.0%; P = .004). Logistic regression identified independent associations between spontaneous reduction and both high PAPP-A and high free beta-hCG. CONCLUSION: Recent spontaneous reduction is associated with higher values of PAPP-A and free beta-hCG. These differences have the potential to affect risk assessment for fetal aneuploidy.

Abortion, Spontaneous↗
PubMed2006

Clinical concepts of futility and ethically justified limits on neonatal care: a case presentation of an infant with Apgar scores of 0 at 1, 5, and 10 minutes.

Appropriate length of delivery room resuscitative efforts for infants born without signs of life is controversial. We present the case of a preterm infant with Apgar scores of 0 at 1, 5, and 10 minutes but with a recovered heartbeat at 15 minutes. Using the clinically relevant conceptions of the principle of futility, we examine the ethical justification for the successive decisions to initiate, continue, and ultimately limit care for this patient. This difficult case highlights the importance of understanding the ethical justification for clinical interventions that are made in the neonatal intensive care unit.

Apgar Score↗
PubMed2006

Clinical use of first-trimester aneuploidy screening in a United States population can replicate data from clinical trials.

OBJECTIVE: The clinical application of first-trimester aneuploidy screening remains controversial in the United States. The aim of our study was to evaluate the performance of maternal age, fetal nuchal translucency measurements, pregnancy-associated plasma protein A, and free beta-human chorionic gonadotrophin used in aneuploidy screening in a single institution outside of a clinical trial. STUDY DESIGN: Four thousand eight hundred eighty three patients underwent first-trimester aneuploidy screening at 11 to 13 6/7 weeks of gestation (fetal crown-rump length 45 mm to 84 mm) at our institution between January 2003 and September 2004. Measurement of nuchal translucency was performed according to the Fetal Medicine Foundation standards and was included in the overall risk assessment performed by NTD Laboratories. Measurement of pregnancy-associated plasma protein A and free beta-human chorionic gonadotrophin on maternal dried whole blood samples was conducted by NTD Laboratories and was reported as gestational-specific multiples of the median adjusted for ethnicity. Risk adjustment for trisomy 21 and trisomy 18 was done with a standard algorithm using maternal age, serum biochemistry, and nuchal translucency. Only singleton gestations (N = 4615) were included in the analysis. RESULTS: The median maternal age was 33.0 years (interquartile range 31.0 to 36.0) and the median crown-rump length was 61.2 mm (interquartile range 55.7 to 67.2) at the time of screening. There were a total of 22 fetuses diagnosed with trisomy 21 and 8 with trisomy 18. The detection rates for trisomy 21 for a 5% false-positive rate and 1% false-positive rate were 90.9% (20 of 22) and 77.3% (17 of 22), respectively. Similarly, the detection rates for trisomy 18 at a 5% false-positive rate and a 1% false-positive rate were 100% (8 of 8) and 100% (8 of 8), respectively. CONCLUSION: Non-investigational use of first-trimester aneuploidy screening for trisomy 21 and trisomy 18 can replicate results from investigational trials.

Aneuploidy↗
PubMed2006

Gestational age at abortion: the impact of first-trimester risk assessment for aneuploidy.

OBJECTIVE: The purpose of this study was to determine the impact of first-trimester risk assessment on gestational age at abortion for abnormal fetal karyotype. STUDY DESIGN: Women who had abortion for trisomies 21, 18, and 13, 45X, and Triploidy in our hospital from 1999 to 2005 were included. Data collected included gestational age at abortion, method of prenatal diagnosis, and whether or not first-trimester risk assessment was performed. Analysis was performed using Spearman Correlation, Chi-square for trend, Fisher exact test, and Mann-Whitney U test. RESULTS: One hundred forty-nine patients were included. There was an inverse correlation between year of abortion and gestational age (rho = -0.31; P < .001) coinciding with significant increases in the rates of first-trimester risk assessment and prenatal diagnosis by chronic villus sampling. CONCLUSION: First-trimester risk assessment is associated with earlier diagnosis of aneuploidy. In our institution, this has led to earlier abortions. Availability of quality first-trimester risk assessment can decrease the need for abortion later in pregnancy.

Abortion, Induced↗
PubMed2005

An ethical critique of boutique fetal imaging:a case for the medicalization of fetal imaging.

There has been a resurgence of boutique fetal imaging (non-diagnostic use of ultrasound scanning to make images of the fetus) after earlier efforts of this type were stopped by the Food and Drug Administration. Boutique fetal imaging is a logical extension of critiques of the medicalization of pregnancy and other aspects of our lives. We address the ethical issues that are involved in boutique fetal imaging, which include blanket prescriptions, psychosocial risks to pregnant women, the misleading label of "baby pictures," impact on decisions to terminate a pregnancy that was discovered later to be complicated by an anomaly, lack of adequate informed consent, medical cosmesis, and economic conflicts of interest. We argue for the medicalization of fetal imaging and that boutique fetal imaging is unjustified ethically.

Ethics, Medical↗
PubMed2005

Ultrasound evaluation of abnormal umbilical cord coiling in second trimester of gestation in association with adverse pregnancy outcome.

OBJECTIVE: The purpose of this study was to evaluate the antenatal umbilical cord coiling index obtained during the fetal anatomic survey in the second trimester as a predictor of adverse pregnancy outcome. STUDY DESIGN: Four hundred twenty-five consecutive women who had a fetal anatomic survey between 18 to 23 weeks of gestation were evaluated for umbilical cord coiling. The antenatal umbilical cord coiling index was calculated as a reciprocal value of the distance between a pair of coils (antenatal umbilical cord coiling index = 1/distance in cm) and was correlated with the following adverse pregnancy outcomes: (1) small for gestational age, (2) mode of delivery, (3) presence of meconium-stained amniotic fluid, (4) presence of nonreassuring fetal status in labor, and (5) Apgar scores at 1 and 5 minutes. RESULTS: A total of 294 patients had adequate ultrasound images and all antenatal and labor data to meet the study inclusion criteria. Abnormal coiling was associated significantly with small for gestational age neonates at birth (P = .043) and non-reassuring fetal status in labor (P = .007). Nine of 58 neonates (15.5%) with abnormal umbilical coiling were small for gestational age infants compared with 15 of 236 small for gestational age neonates (6.4%) who had normal cord coiling. A non-reassuring fetal status in labor was observed in 25.7% of fetuses (15/58 fetuses) with abnormal umbilical coiling compared with 11.0% of fetuses (26/236 fetuses) with normal cord coiling. In contrast, no statistical difference for Apgar scores at 1 and 5 minutes or higher prevalence of interventional deliveries and meconium-stained amniotic fluid in labor between the groups with normal and abnormal umbilical cord coiling was observed. CONCLUSION: Abnormal umbilical cord coiling that is detected at the fetal ultrasound anatomic survey in the second trimester is associated with a higher prevalence of small for gestational age neonates and non-reassuring fetal status in labor. This observation can be used potentially as a predictor of adverse antenatal or perinatal events in future studies.

Apgar Score↗
PubMed2005

Evidence-based obstetric ethics and informed decision-making by pregnant women about invasive diagnosis after first-trimester assessment of risk for trisomy 21.

OBJECTIVE: The purpose of this study was to determine the ability of pregnant women to incorporate sophisticated screening information about risk assessment into their decisions about invasive testing in an appropriate way. STUDY DESIGN: Assessment of risk for trisomy 21 was carried out by a combination of maternal age, fetal nuchal translucency (NT) thickness, and maternal serum free beta-human chorionic gonadotrophin (hCG) and pregnancy-associated plasma protein-A (PAPP-A) at 11 to 13+6 weeks. The patients were counseled with regards to their estimated risk, and were informed that the only way to know for sure whether or not the fetus has a chromosomal abnormality is by having an invasive test, but these tests carry a risk of miscarriage of about 1%. They were also informed that although a risk of 1 in 300 or more was generally considered to be high, it was up to them to decide in favor or against invasive testing. RESULTS: Assessment of risk was carried out in 30,564 singleton pregnancies with live fetuses at 11 to 13+6. The median maternal age was 34 (range 15-49) years and, in 14,816 (48.5%), the age was 35 years or greater. The rate of invasive testing increased exponentially with increasing estimated risk (r = 0.917, P < .0001). The estimated risk for trisomy 21 was 1 in 300 or more in 2565 (8.4%) women, and 1991 (77.6%) of these had invasive testing. The risk was less than 1 in 300 in 27,999 (91.6%) women, and 1286 (4.6%) of these had invasive testing. CONCLUSION: Pregnant women are able to use sophisticated screening information to make scientifically and ethically rational decisions about invasive testing for trisomy 21. These empiric data compliment the arguments of normative ethics to create evidence-based ethical standards for informed consent regarding invasive testing.

Adult↗
PubMed2005

Patient preference regarding first-trimester aneuploidy risk assessment.

OBJECTIVE: We assessed patient views regarding disclosure of first-trimester Down syndrome risk assessment results compared with withholding results until a single, more accurate second-trimester screening result is available. STUDY DESIGN: A prospective, institutional review board-approved, voluntary, anonymous survey was presented to patients with singleton pregnancies who were undergoing first-trimester nuchal translucency and biochemical screening at our institution. Options included immediate (sequential testing) or later disclosure (integrated testing). Descriptions and a comparison of the options were included in the survey. RESULTS: One hundred one women completed the questionnaires; 69.3% of the patients preferred sequential testing, compared with 30.7% of the patients who were either unsure or preferred integrated testing. Older patients and those patients with better background knowledge of screening tests preferred earlier disclosure of screening results (P = .035 and P = .026, respectively). Patients who preferred earlier disclosure also preferred termination of a Down syndrome pregnancy (P = .013). CONCLUSION: Older patients and those patients with a better understanding of screening tests preferred immediate disclosure of first-trimester risk assessment results; these women were more likely to prefer to terminate an affected pregnancy.

Adult↗
PubMed2005

Implementation of first-trimester risk assessment for trisomy 21: ethical considerations.

The performance and evaluation of first-trimester risk assessment should meet standards of scientific and ethical excellence. Scientific standards are well understood. Ethical standards are less well understood. On the basis of the ethical concept of the physician as fiduciary, and the ethical principles of respect for autonomy, beneficence, and justice, we show that the obstetrician has an ethical obligation to routinely offer pregnant women first-trimester risk assessment in high quality centers. On the basis of the professional virtues of integrity and self-sacrifice, we then show that both obstetricians and specialists in risk assessment have a strict ethical obligation to identify, responsibly manage, and disclose both economic and noneconomic conflicts of interests, especially when they are hidden. We conclude that ethics is an essential dimension of implementation of first-trimester risk assessment for trisomy 21.

Down Syndrome↗
PubMed2005

Obstetric outcomes after surgical abortion at > or = 20 weeks' gestation.

OBJECTIVE: The purpose of this study was to describe obstetric outcomes after surgical abortion at > or = 20 weeks, and to identify risk factors for subsequent spontaneous preterm birth. STUDY DESIGN: Patients who had surgical abortion at > or = 20 weeks' gestation from 1996 to 2003 and received subsequent prenatal care at The New York Weill Cornell Medical Center were identified. Indication for abortion, operative technique, and subsequent pregnancy outcomes were reviewed. Student t test, Fisher exact test, and Mann-Whitney U were used where appropriate. RESULTS: One hundred and twenty pregnancies in 89 women were identified. Thirteen (10.8%) ended with early miscarriage, and 5 were electively terminated. Of the remaining 102 pregnancies, 7 ended with spontaneous preterm birth. Those who experienced preterm birth were more likely to have undergone abortion due to cervical dilation and/or preterm premature rupture of membranes (PPROM) (27.3% vs 4.4%; P = .03). Those with a multifetal pregnancy in the subsequent pregnancy were more likely to have preterm birth (75.0% vs 4.3%; P < .001). In patients who underwent dilation and evacuation (D&E) for reasons other than cervical dilation and/or PPROM, rates of spontaneous preterm birth were identical between those who had intact dilation and extraction (D&X) and D&E using forceps (4.2% vs 4.5%; P = 1.0). CONCLUSION: In those who have undergone D&E at > or = 20 weeks, only a history of midtrimester cervical dilation and/or PPROM or a current multifetal pregnancy were associated with spontaneous preterm birth.

Abortion, Induced↗
PubMed2005

A comprehensive ethical framework for responsibly designing and conducting pharmacologic research that involves pregnant women.

OBJECTIVE: We present and defend ethically justified guidelines for pharmacologic research that involves pregnant women. STUDY DESIGN: We explain the ethical concept of the fetus as a patient and identify its ethical implications for the design and conduct of pharmacologic research that is intended to benefit pregnant women. RESULTS: This concept justifies criteria for the initiation of early-phase clinical investigation, the initiation of controlled trials, the use of placebo control subjects, the stopping of randomized controlled trials, the determination of when an experimental intervention should be regarded as standard of care, and research that involves adolescents. The informed consent process should be shaped by the pregnant patient's obligation to take in to account her beneficence-based obligations to a fetal patient. Selection criteria should not be based on abortion preference. And, physicians are justified ethically in referring pregnant women to trials. CONCLUSION: The concept of the fetus as a patient plays an essential role in the ethically justified design and conduct of pharmacologic research in pregnant women.

Abortion, Induced↗
PubMed2005

Clinical implications of the ethics of informed consent for first-trimester risk assessment for trisomy 21.

OBJECTIVE: We identify the clinical implications of the ethics of informed consent for risk assessment for trisomy 21. FINDING: Based on the ethics of informed consent, we find that routinely offering first-trimester risk assessment in centers qualified to provide it is ethically obligatory, and routinely withholding the results of first-trimester risk assessment is ethically unjustified. CONCLUSION: The ethics of informed consent is an essential dimension of first-trimester risk assessment for trisomy 21.

Down Syndrome↗
PubMed2005

Changes in fetal presentation in twin pregnancies.

OBJECTIVE: The aim of the study was to describe the occurrence of spontaneous version in twins in the third trimester, as well as the correlation between antepartum and birth presentation. METHODS: Twin pregnancies were divided into four gestational age intervals: 20-23; 24-27; 28-31; and 32-36 weeks. Fetal presentation was categorized as cephalic (C) or non-cephalic (NC). Hospital records were reviewed to determine demographic factors, including mode of conception. Chi-square was used to compare distributions of presentations, and Cramer's V measure of association was used to correlate presentations in individual pregnancies between antepartum intervals and birth. RESULTS: A total of 207 pregnancies were included. The distribution of fetal presentations changed significantly through gestational age intervals (p < 0.001), although they were similar between 32-36 weeks and birth (p = 0.75). Correlation between antepartum and birth presentation in individual pregnancies strengthened throughout the four intervals. No correlation was seen between parity, gender, birthweight, or in vitro fertilization and fetal presentation or rate of spontaneous version. CONCLUSION: Many twins undergo spontaneous version in the third trimester, though there is excellent correlation between presentation at 32-36 weeks and birth. A cephalic presenting twin at > or = 28 weeks is highly likely to be in cephalic presentation at delivery.

Chi-Square Distribution↗
PubMed2005

Responsibly managing the medical school--teaching hospital power relationship.

The relationship between medical schools and their teaching hospitals involves a complex and variable mixture of monopoly and monopsony power, which has not been previously been ethically analyzed. As a consequence, there is currently no ethical framework to guide leaders of both institutions in the responsible management of this complex power relationship. The authors define these two forms of power and, using economic concepts, analyze the nature of such power in the medical school-teaching hospital relationship, emphasizing the potential for exploitation. Using concepts from both business ethics and medical ethics, the authors analyze the nature of transparency and co-fiduciary responsibility in this relationship. On the basis of both rational self-interest, drawn from business ethics, and co-fiduciary responsibility, drawn from medical ethics, they argue for the centrality of transparency in the medical school-teaching hospital relationship. Understanding the ethics of monopoly and monopsony power is essential for the responsible management of the complex relationship between medical schools and their teaching hospitals and can assist the leadership of academic health centers in carrying out one of their major responsibilities: to prevent the exploitation of monopoly power and monopsony power in this relationship.

Academic Medical Centers↗