Yashdeep Gupta, DM Department of Medicine, Government Medical College and Hospital, Chandigarh, India Bharti Kalra, MS Bharti Hospital, Karnal, Haryana, India Rajiv Singla, DM Saket City Hospital, New Delhi, India Sanjay Kalra, DM Bharti Hospital, Karnal, Haryana, India
REFERENCES 1. Camelo Castillo W, Boggess K, Stürmer T, Brookhart MA, Benjamin DK Jr, Jonsson Funk M. Trends in glyburide compared with insulin use for gestational diabetes treatment in the United States, 2000–2011. Obstet Gynecol 2014;123: 1177–84. 2. Zeng YC, Li MJ, Chen Y, Jiang L, Wang SM, Mo XL, et al. The use of glyburide in the management of gestational diabetes mellitus: a meta-analysis. Adv Med Sci 2014;59:95–101. 3. Akcakus M, Koklu E, Baykan A, Yikilmaz A, Coskun A, Gunes T, et al. Macrosomic newborns of diabetic mothers are associated with increased aortic intima-media thickness and lipid concentrations. Horm Res 2007;67: 277–83. 4. Ryan EA, Al-Agha R. Glucose control during labor and delivery. Curr Diab Rep 2014;14:450. 5. Hung YC, Lin CC, Wang TY, Chang MP, Sung FC, Chen CC. Oral hypoglycaemic agents and the development of non-fatal cardiovascular events in patients with type 2 diabetes mellitus. Diabetes Metab Res Rev 2013;29: 673–9. Editor’s Note: Camelo Castillo et al declined to respond.
Facility-Based Identification of Women With Severe Maternal Morbidity: It is Time to Start To the Editor: I read with great interest the recent commentary by Callaghan and colleagues1 on their proposed approach for identifying severe maternal morbidity. However, the criterion identifying transfusion of 4 or more units of blood products may require some clarification. Does the authors’ criterion refer to 4 or more blood components2
634
Letters to the Editor
(to include red blood cells, plasma, platelets, and cryoprecipitate), or does the criterion refer to 4 or more red blood cell units? An additional consideration is whether the proposed criterion addresses total blood donor exposures as opposed to doses of blood components. If the criterion measures blood donor exposures, a parturient receiving a single platelet pool (comprised of 4–6 whole-blood derived platelet concentrate units) or a single cryoprecipitate pool (comprised of 4–10 cryoprecipitate units) would meet the proposed definition for severe maternal morbidity despite having received only one blood component dose. I congratulate the authors for their proposal; this holds promise as a practical system for tracking near-miss maternal morbidity events. However, that promise may be in jeopardy if readers superimpose their interpretation of “blood product” on the authors’ intent. Financial Disclosure: The author did not report any potential conflicts of interest.
Evelyn Lockhart, MD Department of Pathology, Duke University School of Medicine, Durham, North Carolina
REFERENCES 1. Callaghan WM, Grobman WA, Kilpatrick SJ, Main EK, D’Alton M. Facility-based identification of women with severe maternal morbidity. Obstet Gynecol 2014;123:978–81. 2. AABB. Circular of information for the use of human blood and blood components. Available at: http://www.aabb. org/tm/coi/Documents/coi1113.pdf. Retrieved July 17, 2014.
In Reply: We are grateful for Dr. Lockhart’s interest and close reading of our article proposing an approach for identifying severe maternal morbidity in birthing facilities.1 Dr. Lockhart raises an important point regarding transfusion of blood products, and we agree that this point requires clarification. The use of the term “blood products” could be confusing, especially when considering pooled blood components.
We would like to use this opportunity to clarify that for the purpose of facility-based review, “severe maternal morbidity” should be defined as women who are admitted to an intensive care unit, women who receive 4 or more units of blood (packed red blood cells or whole blood), or both. This definition will identify essentially the same women as would have been identified if other blood products also were included, but it would avoid potential confusion. For example, based on data used by You et al2 in their study of severe maternal morbidity, nearly all women who would have been identified as having had severe morbidity only because they received blood products other than packed cells or whole blood would have been identified anyway because they were admitted to an intensive care unit. Identification and review of severe maternal morbidity is an evolving process, and we acknowledge that institutions may elect to include criteria in addition to intensive care unit admission, transfusion of 4 or more units of blood, or both. We look forward to participating in ongoing discussions about review of severe maternal morbidity as a key component of quality improvement for maternity care, and we thank Dr. Lockhart for her insight regarding a potential point of confusion. Financial Disclosure: The authors did not report any potential conflicts of interest.
William M. Callaghan, MD, MPH Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, Georgia William A. Grobman, MD, MBA Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Sarah J. Kilpatrick, MD, PhD Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California Elliott K. Main, MD California Maternal Quality Care Collaborative, Palo Alto, California
OBSTETRICS & GYNECOLOGY
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
REFERENCES 1. Camelo Castillo W, Boggess K, Stürmer T, Brookhart MA, Benjamin DK Jr, Jonsson Funk M. Trends in glyburide compared with insulin use for gestational diabetes treatment in the United States, 2000–2011. Obstet Gynecol 2014;123: 1177–84. 2. Zeng YC, Li MJ, Chen Y, Jiang L, Wang SM, Mo XL, et al. The use of glyburide in the management of gestational diabetes mellitus: a meta-analysis. Adv Med Sci 2014;59:95–101. 3. Akcakus M, Koklu E, Baykan A, Yikilmaz A, Coskun A, Gunes T, et al. Macrosomic newborns of diabetic mothers are associated with increased aortic intima-media thickness and lipid concentrations. Horm Res 2007;67: 277–83. 4. Ryan EA, Al-Agha R. Glucose control during labor and delivery. Curr Diab Rep 2014;14:450. 5. Hung YC, Lin CC, Wang TY, Chang MP, Sung FC, Chen CC. Oral hypoglycaemic agents and the development of non-fatal cardiovascular events in patients with type 2 diabetes mellitus. Diabetes Metab Res Rev 2013;29: 673–9. Editor’s Note: Camelo Castillo et al declined to respond.
Facility-Based Identification of Women With Severe Maternal Morbidity: It is Time to Start To the Editor: I read with great interest the recent commentary by Callaghan and colleagues1 on their proposed approach for identifying severe maternal morbidity. However, the criterion identifying transfusion of 4 or more units of blood products may require some clarification. Does the authors’ criterion refer to 4 or more blood components2
634
Letters to the Editor
(to include red blood cells, plasma, platelets, and cryoprecipitate), or does the criterion refer to 4 or more red blood cell units? An additional consideration is whether the proposed criterion addresses total blood donor exposures as opposed to doses of blood components. If the criterion measures blood donor exposures, a parturient receiving a single platelet pool (comprised of 4–6 whole-blood derived platelet concentrate units) or a single cryoprecipitate pool (comprised of 4–10 cryoprecipitate units) would meet the proposed definition for severe maternal morbidity despite having received only one blood component dose. I congratulate the authors for their proposal; this holds promise as a practical system for tracking near-miss maternal morbidity events. However, that promise may be in jeopardy if readers superimpose their interpretation of “blood product” on the authors’ intent. Financial Disclosure: The author did not report any potential conflicts of interest.
Evelyn Lockhart, MD Department of Pathology, Duke University School of Medicine, Durham, North Carolina
REFERENCES 1. Callaghan WM, Grobman WA, Kilpatrick SJ, Main EK, D’Alton M. Facility-based identification of women with severe maternal morbidity. Obstet Gynecol 2014;123:978–81. 2. AABB. Circular of information for the use of human blood and blood components. Available at: http://www.aabb. org/tm/coi/Documents/coi1113.pdf. Retrieved July 17, 2014.
In Reply: We are grateful for Dr. Lockhart’s interest and close reading of our article proposing an approach for identifying severe maternal morbidity in birthing facilities.1 Dr. Lockhart raises an important point regarding transfusion of blood products, and we agree that this point requires clarification. The use of the term “blood products” could be confusing, especially when considering pooled blood components.
We would like to use this opportunity to clarify that for the purpose of facility-based review, “severe maternal morbidity” should be defined as women who are admitted to an intensive care unit, women who receive 4 or more units of blood (packed red blood cells or whole blood), or both. This definition will identify essentially the same women as would have been identified if other blood products also were included, but it would avoid potential confusion. For example, based on data used by You et al2 in their study of severe maternal morbidity, nearly all women who would have been identified as having had severe morbidity only because they received blood products other than packed cells or whole blood would have been identified anyway because they were admitted to an intensive care unit. Identification and review of severe maternal morbidity is an evolving process, and we acknowledge that institutions may elect to include criteria in addition to intensive care unit admission, transfusion of 4 or more units of blood, or both. We look forward to participating in ongoing discussions about review of severe maternal morbidity as a key component of quality improvement for maternity care, and we thank Dr. Lockhart for her insight regarding a potential point of confusion. Financial Disclosure: The authors did not report any potential conflicts of interest.
William M. Callaghan, MD, MPH Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, Georgia William A. Grobman, MD, MBA Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Sarah J. Kilpatrick, MD, PhD Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California Elliott K. Main, MD California Maternal Quality Care Collaborative, Palo Alto, California
OBSTETRICS & GYNECOLOGY
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
