Mary D’Alton, MD Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, New york
REFERENCES 1. Callaghan WM, Grobman WA, Kilpatrick SJ, Main EK, D’Alton M. Facility-based identification of women with severe maternal morbidity. It is time to start. Obstet Gynecol 2014;123: 978–81. 2. You WB, Chandrasekaran S, Sullivan J, Grobman W. Validation of a scoring system to identify women with near-miss maternal morbidity. Am J Perinatol 2013; 30:21–4.
Periviable Birth: Executive Summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists To the Editor: We read with concern the Executive Summary of the Joint Workshop on Periviable Birth and find the recommendations in Table 3 particularly troubling.1 The omission of a parent representative group, a critical stakeholder who should have been part of any consensus statement, is particularly glaring. Many organizations have adopted GRADE (Grading of Recommendations Assessment, Development and Evaluation), a consensus process rating quality of evidence and strength of recommendations, as the framework for developing evidence-based recommendations.2–4 Evidence is classified as high, moderate, low, and very low quality and involves consideration of five domains including risk of bias for each outcome (methodologic quality), directness of evidence, heterogeneity, precision of effect estimates, and publication bias.2–4 All studies referenced raise serious concerns for risk of bias
VOL. 124, NO. 3, SEPTEMBER 2014
for all outcomes, and evidence would have been categorized as low quality and an unlikely substrate for a strong recommendation.1 Importantly, guideline users have to determine how much they can trust that a recommendation will produce more favorable rather than unfavorable consequences.5 Several factors influence strength of a recommendation, including risk– benefit balance, quality of evidence, and patient values and preferences.2–4 Importantly, parents of a fetus at 23 to 23 6/7 weeks of gestation often have different opinions about outcome and treatment options. Moreover, a health care professional’s opinion may differ from that of the parents. Thus, parental values and preferences must be paramount when grading the strength of a recommendation of a periviable fetus. Table 3 provides recommendations for 23 0/7 weeks and more. We find this troubling, because fetal outcomes at 23 to 23 6/7 weeks are distinctly different from those of larger fetuses. We suggest two possible recommendations. First option, we recommend against the routine administration of all interventions for neonates born between 23 and 23 6/7 weeks of estimated gestational age. However, under special circumstances (parental preferences), these interventions could be considered. Alternative option, we suggest (weak recommendation) that all interventions may be considered (low quality of evidence) in accordance with parent preferences. To conclude, we strongly suggest that the authors consider undertaking a re-evaluation of the literature and making a recommendation based on the explicit and transparent processes espoused by the GRADE approach rather than expert opinion. Financial Disclosure: The author did not report any potential conflicts of interest.
Jeffrey Perlman, MB, ChB Department of Pediatrics, Division of Newborn Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York, New York
REFERENCES 1. Raju TN, Mercer BM, Burchfield DJ, Joseph GF. Periviable birth: executive summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute
of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol 2014; 123;1083–96. 2. Cuello Garcia CA, Pacheco Alvarado KP, Perez Gaxiola G. Grading recommendations in clinical practice guidelines: randomised experimental evaluation of four different systems. Arch Dis Child 2011;96:723–8. 3. Schünemann H, Brozek J, Oxman A, eds. GRADE handbook for grading quality of evidence and strength of recommendation. Version 3.2 [updated March 2009]. The GRADE Working Group; 2009. Available at: http://ims. cochrane.org/gradepro. Retrieved June 27, 2014. 4. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction—GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011;64:383–94. 5. Institute of Medicine. Clinical practice guidelines we can trust. Report brief. Institute of Medicine; 2011. Available at: http: //www.iom.edu/Reports/2011/ClinicalPractice-Guidelines-We-Can-Trust.aspx. Retrieved June 27, 2014.
In Reply: We appreciate Dr. Perlman’s interest in the Executive Summary of the Joint Workshop on Periviable Birth.1 His concerns reflect issues that were raised during the workshop and in development of the consensus statement, both of which included parents of preterm children in addition to experts in obstetrics, neonatal care, and ethics. In our deliberations and document, we have specifically addressed the understanding that parents’ views will reflect their own interpretation of the circumstances and information provided to them and that they should be actively involved in the decision-making process. We have provided currently available outcome information regarding survival across the spectrum of periviable birth, focusing on those studies that included liveborn, resuscitated neonates born in the past decade (see Table 1 in our article1). As we addressed in Table 2, a number of factors are potentially responsible for the broad range of published outcomes for any given week of gestation. Dr. Perlman’s opinion regarding treatment of those born at 23 to 23 6/7 weeks of gestation reflects a previously held assumption that these neonates are distinctly different from those born at 24 weeks of gestation. The reported
Letters to the Editor
635
frequency of survival has ranged from 26–76% among neonates born at 23 weeks of gestation, whereas those born at 24 weeks of gestation have a reported survival rate of 55–87%. The majority of survivors born at the periviable stage will incur major morbidities, regardless of gestational age at birth. Although survival is less frequent at 23 than at 24 weeks of gestation, 23 weeks of gestation is not an inflection point for futility. The suggestion that the survival and intact survival rates at 23 weeks of gestation are insufficient to warrant intervention, but that outcomes at 24 weeks of gestation are sufficient, is an opinion that has been held in the past for neonates born at 24–26 weeks of gestation. Where data exist, we encourage counseling based on available information rather than opinion. Where data are lacking, we stress the importance of an objective review of available information in a manner preferred by the family. We encourage close, perhaps repeated interactions with the family while making the difficult decisions regarding treatment issues. We strongly believe that such counseling should not be biased by the preconceived opinions of caregivers. Financial Disclosure: The authors did not report any potential conflicts of interest. The opinions expressed here do not necessarily reflect those of the National Institutes of Health, Department of Health and Human Services, or that of the United States Federal Government, or those of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, or American Academy of Pediatrics. Gerald R. Joseph Jr is an employee of the American College of Obstetricians and Gynecologists (the College). All opinions expressed in this article are the authors’ and do not necessarily reflect the policies and views of the College. Any remuneration that the authors receive from the College is unrelated to the content of this article.
Brian M. Mercer, MD Society for Maternal-Fetal Medicine and Case Western Reserve University– MetroHealth Medical Center, Cleveland, Ohio Tonse N.K. Raju, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland David J. Burchfield, MD American Academy of Pediatrics and University of Florida, Gainesville, Florida
636
Letters to the Editor
Gerald F. Joseph, Jr, MD American College of Obstetricians and Gynecologists, Washington DC
REFERENCE 1. Raju TN, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal Fetal Medicine, American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists. Obstet Gynecol 2014;123:1083–96.
Adding Injury to Injury: Ethical Implications of the Medicaid Sterilization Consent Regulations To the Editor: I completely agree that the current waiting period regulations for sterilization are unethical and do more harm than good,1 and I have not met an obstetrician–gynecologist or midwife who believes otherwise. As regulations, not laws, they can be changed after a period of public commentary and review by the Department of Health and Human Services. The burning question is how to start the process. Since 2011, I have written four times to Department of Health and Human Services, twice with supporting letters from members of the Massachusetts Congressional Delegation, requesting action. Most recently, in 2014, I also included a supporting letter from District I of the American College of Obstetricians and Gynecologists, which additionally referenced the recently reaffirmed concurring opinion of the American Medical Association.2 The Department of Health and Human Services responded only once, in December 2011, when the Deputy Assistant Secretary for Population Affairs replied that these “concerns are valid, and will be taken into consideration when the regulations are next reviewed within HHS.” I inquired when that would be (no response), and now, going on 3 years later, there is still no review process scheduled. Do the authors have ideas or plans to elicit action from the Department of Health and Human Services? Equal
access to sterilization should be a priority in reproductive health care. Financial Disclosure: The author did not report any potential conflicts of interest.
Sylvia Fine, MD Cambridge, Massachusetts
REFERENCE 1. Brown BP, Chor J. Adding injury to injury: ethical implications of the Medicaid sterilization consent regulations. Obstet Gynecol 2014;123:1348–51. 2. http://www.ama-assn.org/resources/doc/ img/i13-summary-of-actions.pdf. Retrieved July 17, 2014.
In Reply: We agree with Dr. Fine that physician advocacy is an excellent first step toward addressing this barrier to care. Unfortunately, as her experience illustrates, individual doctors often hold little sway with large bureaucracies— even when they are backed by legislators or local professional societies. A coordinated advocacy effort by the American College of Obstetricians and Gynecologists (the College), at the regional and national level, supported by other national organizations likely will be necessary to effect change in these rules. We would like to see federal sterilization regulations become a higher lobbying priority for the College. Specifically, the College should call for revised consent guidelines that apply to all women (not just to those who are federally insured) and that do away with the 30-day waiting period and the proscription on obtaining consent in labor while providing safeguards to ensure that no woman is coerced into undergoing a tubal ligation. Financial Disclosure: The authors did not report any potential conflicts of interest.
Benjamin P. Brown, MD Department of Obstetrics and Gynecology, University of Chicago Medical Center, Chicago, Illinois Julie Chor, MD, MPH Department of Obstetrics and Gynecology, University of Chicago Medical Center and, MacLean Center for Clinical Medical Ethics, Chicago, Illinois
OBSTETRICS & GYNECOLOGY
REFERENCES 1. Callaghan WM, Grobman WA, Kilpatrick SJ, Main EK, D’Alton M. Facility-based identification of women with severe maternal morbidity. It is time to start. Obstet Gynecol 2014;123: 978–81. 2. You WB, Chandrasekaran S, Sullivan J, Grobman W. Validation of a scoring system to identify women with near-miss maternal morbidity. Am J Perinatol 2013; 30:21–4.
Periviable Birth: Executive Summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists To the Editor: We read with concern the Executive Summary of the Joint Workshop on Periviable Birth and find the recommendations in Table 3 particularly troubling.1 The omission of a parent representative group, a critical stakeholder who should have been part of any consensus statement, is particularly glaring. Many organizations have adopted GRADE (Grading of Recommendations Assessment, Development and Evaluation), a consensus process rating quality of evidence and strength of recommendations, as the framework for developing evidence-based recommendations.2–4 Evidence is classified as high, moderate, low, and very low quality and involves consideration of five domains including risk of bias for each outcome (methodologic quality), directness of evidence, heterogeneity, precision of effect estimates, and publication bias.2–4 All studies referenced raise serious concerns for risk of bias
VOL. 124, NO. 3, SEPTEMBER 2014
for all outcomes, and evidence would have been categorized as low quality and an unlikely substrate for a strong recommendation.1 Importantly, guideline users have to determine how much they can trust that a recommendation will produce more favorable rather than unfavorable consequences.5 Several factors influence strength of a recommendation, including risk– benefit balance, quality of evidence, and patient values and preferences.2–4 Importantly, parents of a fetus at 23 to 23 6/7 weeks of gestation often have different opinions about outcome and treatment options. Moreover, a health care professional’s opinion may differ from that of the parents. Thus, parental values and preferences must be paramount when grading the strength of a recommendation of a periviable fetus. Table 3 provides recommendations for 23 0/7 weeks and more. We find this troubling, because fetal outcomes at 23 to 23 6/7 weeks are distinctly different from those of larger fetuses. We suggest two possible recommendations. First option, we recommend against the routine administration of all interventions for neonates born between 23 and 23 6/7 weeks of estimated gestational age. However, under special circumstances (parental preferences), these interventions could be considered. Alternative option, we suggest (weak recommendation) that all interventions may be considered (low quality of evidence) in accordance with parent preferences. To conclude, we strongly suggest that the authors consider undertaking a re-evaluation of the literature and making a recommendation based on the explicit and transparent processes espoused by the GRADE approach rather than expert opinion. Financial Disclosure: The author did not report any potential conflicts of interest.
Jeffrey Perlman, MB, ChB Department of Pediatrics, Division of Newborn Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York, New York
REFERENCES 1. Raju TN, Mercer BM, Burchfield DJ, Joseph GF. Periviable birth: executive summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute
of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol 2014; 123;1083–96. 2. Cuello Garcia CA, Pacheco Alvarado KP, Perez Gaxiola G. Grading recommendations in clinical practice guidelines: randomised experimental evaluation of four different systems. Arch Dis Child 2011;96:723–8. 3. Schünemann H, Brozek J, Oxman A, eds. GRADE handbook for grading quality of evidence and strength of recommendation. Version 3.2 [updated March 2009]. The GRADE Working Group; 2009. Available at: http://ims. cochrane.org/gradepro. Retrieved June 27, 2014. 4. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction—GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011;64:383–94. 5. Institute of Medicine. Clinical practice guidelines we can trust. Report brief. Institute of Medicine; 2011. Available at: http: //www.iom.edu/Reports/2011/ClinicalPractice-Guidelines-We-Can-Trust.aspx. Retrieved June 27, 2014.
In Reply: We appreciate Dr. Perlman’s interest in the Executive Summary of the Joint Workshop on Periviable Birth.1 His concerns reflect issues that were raised during the workshop and in development of the consensus statement, both of which included parents of preterm children in addition to experts in obstetrics, neonatal care, and ethics. In our deliberations and document, we have specifically addressed the understanding that parents’ views will reflect their own interpretation of the circumstances and information provided to them and that they should be actively involved in the decision-making process. We have provided currently available outcome information regarding survival across the spectrum of periviable birth, focusing on those studies that included liveborn, resuscitated neonates born in the past decade (see Table 1 in our article1). As we addressed in Table 2, a number of factors are potentially responsible for the broad range of published outcomes for any given week of gestation. Dr. Perlman’s opinion regarding treatment of those born at 23 to 23 6/7 weeks of gestation reflects a previously held assumption that these neonates are distinctly different from those born at 24 weeks of gestation. The reported
Letters to the Editor
635
frequency of survival has ranged from 26–76% among neonates born at 23 weeks of gestation, whereas those born at 24 weeks of gestation have a reported survival rate of 55–87%. The majority of survivors born at the periviable stage will incur major morbidities, regardless of gestational age at birth. Although survival is less frequent at 23 than at 24 weeks of gestation, 23 weeks of gestation is not an inflection point for futility. The suggestion that the survival and intact survival rates at 23 weeks of gestation are insufficient to warrant intervention, but that outcomes at 24 weeks of gestation are sufficient, is an opinion that has been held in the past for neonates born at 24–26 weeks of gestation. Where data exist, we encourage counseling based on available information rather than opinion. Where data are lacking, we stress the importance of an objective review of available information in a manner preferred by the family. We encourage close, perhaps repeated interactions with the family while making the difficult decisions regarding treatment issues. We strongly believe that such counseling should not be biased by the preconceived opinions of caregivers. Financial Disclosure: The authors did not report any potential conflicts of interest. The opinions expressed here do not necessarily reflect those of the National Institutes of Health, Department of Health and Human Services, or that of the United States Federal Government, or those of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, or American Academy of Pediatrics. Gerald R. Joseph Jr is an employee of the American College of Obstetricians and Gynecologists (the College). All opinions expressed in this article are the authors’ and do not necessarily reflect the policies and views of the College. Any remuneration that the authors receive from the College is unrelated to the content of this article.
Brian M. Mercer, MD Society for Maternal-Fetal Medicine and Case Western Reserve University– MetroHealth Medical Center, Cleveland, Ohio Tonse N.K. Raju, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland David J. Burchfield, MD American Academy of Pediatrics and University of Florida, Gainesville, Florida
636
Letters to the Editor
Gerald F. Joseph, Jr, MD American College of Obstetricians and Gynecologists, Washington DC
REFERENCE 1. Raju TN, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal Fetal Medicine, American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists. Obstet Gynecol 2014;123:1083–96.
Adding Injury to Injury: Ethical Implications of the Medicaid Sterilization Consent Regulations To the Editor: I completely agree that the current waiting period regulations for sterilization are unethical and do more harm than good,1 and I have not met an obstetrician–gynecologist or midwife who believes otherwise. As regulations, not laws, they can be changed after a period of public commentary and review by the Department of Health and Human Services. The burning question is how to start the process. Since 2011, I have written four times to Department of Health and Human Services, twice with supporting letters from members of the Massachusetts Congressional Delegation, requesting action. Most recently, in 2014, I also included a supporting letter from District I of the American College of Obstetricians and Gynecologists, which additionally referenced the recently reaffirmed concurring opinion of the American Medical Association.2 The Department of Health and Human Services responded only once, in December 2011, when the Deputy Assistant Secretary for Population Affairs replied that these “concerns are valid, and will be taken into consideration when the regulations are next reviewed within HHS.” I inquired when that would be (no response), and now, going on 3 years later, there is still no review process scheduled. Do the authors have ideas or plans to elicit action from the Department of Health and Human Services? Equal
access to sterilization should be a priority in reproductive health care. Financial Disclosure: The author did not report any potential conflicts of interest.
Sylvia Fine, MD Cambridge, Massachusetts
REFERENCE 1. Brown BP, Chor J. Adding injury to injury: ethical implications of the Medicaid sterilization consent regulations. Obstet Gynecol 2014;123:1348–51. 2. http://www.ama-assn.org/resources/doc/ img/i13-summary-of-actions.pdf. Retrieved July 17, 2014.
In Reply: We agree with Dr. Fine that physician advocacy is an excellent first step toward addressing this barrier to care. Unfortunately, as her experience illustrates, individual doctors often hold little sway with large bureaucracies— even when they are backed by legislators or local professional societies. A coordinated advocacy effort by the American College of Obstetricians and Gynecologists (the College), at the regional and national level, supported by other national organizations likely will be necessary to effect change in these rules. We would like to see federal sterilization regulations become a higher lobbying priority for the College. Specifically, the College should call for revised consent guidelines that apply to all women (not just to those who are federally insured) and that do away with the 30-day waiting period and the proscription on obtaining consent in labor while providing safeguards to ensure that no woman is coerced into undergoing a tubal ligation. Financial Disclosure: The authors did not report any potential conflicts of interest.
Benjamin P. Brown, MD Department of Obstetrics and Gynecology, University of Chicago Medical Center, Chicago, Illinois Julie Chor, MD, MPH Department of Obstetrics and Gynecology, University of Chicago Medical Center and, MacLean Center for Clinical Medical Ethics, Chicago, Illinois
OBSTETRICS & GYNECOLOGY
