Angela Diaz, MD, PhD, MPH1,2; Jeffrey W. Hutchinson, MD3,4
doi : 10.1001/jamapediatrics.2020.3220
JAMA Pediatr. 2021;175(3):227-228
Two recent reports, The Promise of Adolescence: Realizing Opportunity for All Youth (Promise)1 and Promoting Positive Adolescent Health Behaviors and Outcomes: Thriving in the 21st Century (Promoting),2 from the National Academies of Sciences, Engineering, and Medicine (National Academies) conclude that adolescence is a developmental period full of opportunity for extraordinary learning and growth. The dramatic plasticity and malleability during this period prime adolescents to explore new environments, practice decision-making skills, and develop the healthy behaviors that are foundational for long-term well-being.
Jasmyne Jackson, MD, MBA1,2
doi : 10.1001/jamapediatrics.2020.3607
JAMA Pediatr. 2021;175(3):228-230
Chants of “love wins” ricocheted from the concrete streets of New York City up to my window. On June 26, 2015, the US Supreme Court narrowly ruled in Obergefell v Hodges that the Fourteenth Amendment requires all states to grant same-sex marriage licenses. With my identity tucked safely under the guise of an ally, I went out to the streets to celebrate, surrounded by posters, glitter, hope, and pride. I was handed a newspaper with the front page featuring the day’s slogan printed over a rainbow-filled crowd. I took 2. I purposely saved a copy to take with me back to Michigan, where I was not yet out to my medical school or family. But that landmark decision helped me decide that my time in the closet was up and that it was time to throw out cloaks of isolation, fear, and resentment. My eyes welled—love could look like me.
Elizabeth R. Wolf, MD, MPH1; Alex H. Krist, MD, MPH2; Alan R. Schroeder, MD3
doi : 10.1001/jamapediatrics.2020.4681
JAMA Pediatr. 2021;175(3):230-232
The 20th century heralded major advancements in pediatric health care including vaccinations, antibiotics, and sophisticated radiographic studies. These interventions led to substantial improvements in child mortality. Yet, as medical interventions became more commonplace, concerns about negative health effects developed. As a result, many of the changes to pediatric practice in the 21st century have actually involved deimplementation, the process of reducing care that is harmful, ineffective, overused, or not cost-effective. Despite this progress, many practices persist that are not supported by evidence. This Viewpoint explores the historical drivers of deimplementation and proposes ways to further reduce the amount of low-value care delivered to children.
Tracy A. Lieu, MD, MPH1; Elio Gizzi, MD1; Edward R. Lee, MD1
doi : 10.1001/jamapediatrics.2020.4684
JAMA Pediatr. 2021;175(3):232-234
The coronavirus disease 2019 (COVID-19) pandemic has heightened the need for video medical visits, launching US pediatricians on a steep learning curve. In 2016, just 15% of US pediatricians were using telehealth modalities,1 but pressure to adopt them has been increasing owing to interest from parents and expansion in telehealth visits by stand-alone health care professionals linked to corporations and other entities.2 Financial barriers to telehealth were quickly reduced early in the pandemic as states issued new guidance and payers updated reimbursement policies.3
Sherif Emil, MD, CM1
doi : 10.1001/jamapediatrics.2020.5269
JAMA Pediatr. 2021;175(3):235
I was in a busy nursing station, steps away from where I had last seen her. “She rested. I’m here if you need me,” I replied. I clenched my teeth, hurriedly completed my note, and raced back to my office before losing composure. I had anticipated this message for weeks but also wished that it would never come. I hoped and prayed for a miracle, a miracle that we could explain through a target pill or a bizarre remission but that I would recognize as a miracle. I had lived such miracles before. They were as real as they were rare.
Mohan Pammi, MD, PhD1; Steven L. Clark, MD2; Alireza A. Shamshirsaz, MD2
doi : 10.1001/jamapediatrics.2020.5363
JAMA Pediatr. 2021;175(3):236-237
It has been estimated that 2 of 3 women in labor in the US receive oxygen supplementation for nonreassuring fetal heart rate patterns at some point during labor.1 During the course of labor, maternal-fetal oxygen delivery is interrupted by uterine contractions and ceases when the contractions exceed 40 mm Hg in intensity, a level typically exceeded many times before delivery. This hypoxic stress results in the development of significant metabolic acidemia even under normal conditions, with the umbilical artery pH decreasing from a prelabor mean of approximately 7.38 to a mean pH of 7.25 at the time of delivery.2 These changes occur despite numerous mechanisms that serve to mitigate the degree of tissue hypoxia and associated metabolic acidemia resulting from the process of labor, including a relatively high fetal hemoglobin level, enhanced oxygen-carrying capacity and tissue delivery by hemoglobin F, and high levels of fetal 2,3-disphosphoglycerate.
Tracy K. Richmond, MD, MPH1,2; Idia B. Thurston, PhD3; Kendrin R. Sonneville, ScD, RD4
doi : 10.1001/jamapediatrics.2020.4777
JAMA Pediatr. 2021;175(3):238-239
Concern regarding childhood obesity remains a primary focus of public health officials, clinicians, individuals, and families in the United States. Accordingly, numerous weight-focused public health interventions, such as school-based body mass index (BMI) screenings and report cards sent home to notify parents of their child’s weight status, have been developed. Although the goal of these interventions is to reduce obesity, the percentage of youths with elevated BMIs has continued to grow,1 and, correspondingly, so too has the percentage of youths experiencing weight stigma and body dissatisfaction.2
David A. Kaufman, MD1,2; Karen M. Puopolo, MD, PhD3,4,5
doi : 10.1001/jamapediatrics.2020.5100
JAMA Pediatr. 2021;175(3):240-242
Gail J. Demmler-Harrison, MD1
doi : 10.1001/jamapediatrics.2020.5445
JAMA Pediatr. 2021;175(3):e205445
In the article by Dollard et al,1 the preliminary results of a sentinel newborn screening program for congenital cytomegalovirus (CMV) comparing detection of CMV DNA in newborn dried blood spots (NBDBS) using enhanced, more sensitive DNA extraction and polymerase chain reaction (PCR) methods are reported. They compared NBDBS testing with CMV DNA detection in saliva swabs in a newborn screening study involving more than 12?000 newborns of a projected 25?000 enrolled in a multicenter Minnesota study. In this study, Dollard et al1 demonstrate a prevalence of 0.45% of congenital CMV and show high analytical sensitivity (combined: sensitivity, 85.7%; 95% CI, 74.3%-92.6%; University of Minnesota laboratory: sensitivity, 73.2%; 95% CI, 60.4%-83.0%; US Centers for Disease Control and Prevention laboratory: sensitivity, 76.8%; 95% CI, 64.2%-85.9%) for NBDBS CMV DNA detection. Prior studies involving retrospective diagnosis of symptomatic newborns have shown a similar sensitivity of 62% to 95%, but when NBDBS were used for large-scale, prospective newborn screening for congenital CMV, similar to the study by Dollard et al,1 sensitivities as low as 37% were reported.2,3 By using enhanced PCR methods, Dollard et al1 have rekindled the hope that NBDBS testing may be a viable method for large-scale, universal newborn screening for congenital CMV.
S?ren Dalsgaard, MD, PhD1,2
doi : 10.1001/jamapediatrics.2020.5502
JAMA Pediatr. 2021;175(3):e205502
The evidence for bidirectional links between the immune system and the central nervous system has accumulated over the last few decades. One important area within this field of research is the association between maternal autoimmune diseases and mental disorders. Several previous epidemiologic studies have found autoimmune diseases to be associated with mental disorders, with the largest evidence base being for associations with schizophrenia,1 bipolar disorder,2 depression,3 and autism spectrum disorder,4 and much fewer studies having examined associations with attention-deficit/hyperactivity disorder (ADHD),5 tic disorders,6 and obsessive-compulsive disorder.7 Multiple potential mechanisms have been proposed for the association between maternal autoimmune diseases and mental disorders,8 and the article by Nielsen et al9 sums up the literature on this. Overall, these mechanisms are thought to include shared genetic and environmental risk factors or direct effects of maternal autoantibodies or cytokines crossing the placenta and altering the fetal immune response, which in turns leads to changes in the central nervous system.
Emily Feinberg, ScD, CPNP1,2; Marilyn Augustyn, MD3,4; Sarabeth Broder-Fingert, MD, MPH1,4; Amanda Bennett, MD, MPH5; Carol Weitzman, MD6,7; Jocelyn Kuhn, PhD1,4; Emily Hickey, PhD4,8; Andrea Chu, MPH4; Julia Levinson, MSc4; Jenna Sandler Eilenberg, MA, MPH9; Michael Silverstein, MD, MPH1,4; Howard J. Cabral, PhD10; Gregory Patts, MPH11; Yaminette Diaz-Linhart, MSW, MPH12; Ivys Fernandez-Pastrana, JD4; Jessica Rosenberg, MPH4; Judith S. Miller, PhD13; James P. Guevara, MD, MPH14,15; Ada M. Fenick, MD6; Nathan J. Blum, MD13
doi : 10.1001/jamapediatrics.2020.5218
JAMA Pediatr. 2021;175(3):243-250
Importance Early identification of autism spectrum disorder (ASD) is associated with improved cognitive and behavioral outcomes. Targeted strategies are needed to support equitable access to diagnostic services to ensure that children from low-income and racial/ethnic minority families receive the benefits of early ASD identification and treatment.
Kristine A. Madsen, MD, MPH1; Hannah R. Thompson, PhD, MPH2; Jennifer Linchey, MPH2; Lorrene D. Ritchie, PhD, RD3; Shalika Gupta, MA2; Dianne Neumark-Sztainer, MPH, PhD4; Patricia B. Crawford, RD, DrPH3; Charles E. McCulloch, PhD5; Ana Ibarra-Castro, BA2
doi : 10.1001/jamapediatrics.2020.4768
JAMA Pediatr. 2021;175(3):251-259
Importance Annually, US schools screen millions of students’ body mass index (BMI) and report the results to parents, with little experimental evidence on potential benefits and harms.
Andrea Ronchi, MD1; Carlo Pietrasanta, MD1,2; Maurizio Zavattoni, MD3; Martina Saruggia, MD4; Federico Schena, MD1; Maria Teresa Sinelli, MD5; Massimo Agosti, MD6,7; Chryssoula Tzialla, MD8; Felicia Filomena Varsalone, MD9; Lea Testa, MD1; Claudia Ballerini, MD1; Stefania Ferrari, MD4; Giovanna Mangili, MD4; Maria Luisa Ventura, MD5; Simona Perniciaro, MD6; Elena Spada, PhD1; Giovanna Lunghi, MD10; Antonio Piralla, PhD3; Fausto Baldanti, MD3,11; Fabio Mosca, MD1,2; Lorenza Pugni, MD1
doi : 10.1001/jamapediatrics.2020.5086
JAMA Pediatr. 2021;175(3):260-266
Importance The management of mother-infant dyads during the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic constitutes a major issue for neonatologists. In mothers with SARS-CoV-2 infection, current recommendations suggest either to separate the dyad or encourage protected rooming-in under appropriate precautions. No data are available regarding the risk of mother-to-infant transmission of SARS-CoV-2 during rooming-in.
Francesca Solmi, PhD1; Helen Sharpe, PhD2; Suzanne H. Gage, PhD3; Jane Maddock, PhD4; Glyn Lewis, PhD1; Praveetha Patalay, PhD5
doi : 10.1001/jamapediatrics.2020.4746
JAMA Pediatr. 2021;175(3):267-275
Importance In the context of the growing prevalence of childhood obesity, behaviors aimed at weight loss and their psychological burden might be increasing.
Lilly Shanahan, PhD1,2; Sherika N. Hill, PhD3; Laura Bechtiger, MSc1; Annekatrin Steinhoff, PhD1; Jennifer Godwin, PhD4; Lauren M. Gaydosh, PhD5; Kathleen Mullan Harris, PhD6; Kenneth A. Dodge, PhD4,7; William E. Copeland, PhD8
doi : 10.1001/jamapediatrics.2020.5205
JAMA Pediatr. 2021;175(3):276-285
Importance Opioid use disorder and opioid deaths have increased dramatically in young adults in the US, but the age-related course or precursors to opioid use among young people are not fully understood.
Alex Kresovich, MA1; Meredith K. Reffner Collins, MA1; Daniel Riffe, PhD1; Francesca R. Dillman Carpentier, PhD1
doi : 10.1001/jamapediatrics.2020.5155
JAMA Pediatr. 2021;175(3):286-292
Importance Rap artists are among the most recognizable celebrities in the US, serving as role models to an increasingly diverse audience of listeners. Through their lyrics, these artists have the potential to shape mental health discourse and reduce stigma.
Sheila C. Dollard, PhD1; Maggie Dreon, MS2; Nelmary Hernandez-Alvarado, MS3; Minal M. Amin, MPH1; Phili Wong, MS1; Tatiana M. Lanzieri, MD, MPH1; Erin A. Osterholm, MD4; Abbey Sidebottom, PhD5; Sondra Rosendahl, MS2; Mark T. McCann, BA2; Mark R. Schleiss, MD3
doi : 10.1001/jamapediatrics.2020.5441
JAMA Pediatr. 2021;175(3):e205441
Importance The sensitivity of dried blood spots (DBS) to identify newborns with congenital cytomegalovirus (cCMV) infection has not been evaluated in screening studies using the current, higher-sensitivity methods for DBS processing.
Timothy C. Nielsen, MPH1; Natasha Nassar, PhD1; Antonia W. Shand, MMed1,2; Hannah Jones, MBChB1; Adam J. Guastella, PhD1; Russell C. Dale, PhD1; Samantha J. Lain, PhD1
doi : 10.1001/jamapediatrics.2020.5487
JAMA Pediatr. 2021;175(3):e205487
Importance Maternal autoimmune disease has been associated with increased risk of neurodevelopmental disorders in offspring, but few studies have assessed the association with attention-deficit/hyperactivity disorder (ADHD).
Ryan W. Morgan, MD, MTR1,2; Matthew P. Kirschen, MD, PhD1,2; Todd J. Kilbaugh, MD1,2; Robert M. Sutton, MD, MSCE1,2; Alexis A. Topjian, MD, MSCE1,2
doi : 10.1001/jamapediatrics.2020.5039
JAMA Pediatr. 2021;175(3):293-302
Importance Pediatric in-hospital cardiac arrest (IHCA) occurs frequently and is associated with high morbidity and mortality. The objective of this narrative review is to summarize the current knowledge and recommendations regarding pediatric IHCA and cardiopulmonary resuscitation (CPR).
Alexandra Byrne, MD1; Melanie Gross Hagen, MD2; Lindsay Thompson, MD, MS1,3
doi : 10.1001/jamapediatrics.2020.5989
JAMA Pediatr. 2021;175(3):332
Christina S. Kim, MD1; Nicole Grady, MD1; Matthew Derrick, MD1; Yueyue Yu, MS1; Kaitlyn Oliphant, PhD1; Jing Lu, PhD1; Erika C. Claud, MD1
doi : 10.1001/jamapediatrics.2020.4916
JAMA Pediatr. 2021;175(3):303-305
There is increasing concern regarding antibiotics and the developing infant microbiome. We conducted what is, to our knowledge, the first randomized, double-blinded placebo-controlled trial to test the hypothesis that withholding the standard 48 hours of intravenous empirical antibiotics immediately after birth in preterm infants protects the developing microbiome and improves clinical outcomes.
Sean T. O’Leary, MD, MPH1; Lynnsay Trefren, MSN, RN2; Heather Roth, MA2; Angela Moss, MS3; Rachel Severson, MS2; Allison Kempe, MD, MPH1
doi : 10.1001/jamapediatrics.2020.4733
JAMA Pediatr. 2021;175(3):305-307
Thomas K. Hagerman, BS1; Amy J. Houtrow, MD, MPH, PhD2,3
doi : 10.1001/jamapediatrics.2020.5073
JAMA Pediatr. 2021;175(3):307-310
Accurate identification of children with disabilities is clearly a priority in multiple contexts, including measurement of health care inequities, programmatic planning, and addressing resource allocation. Yet the definitions of disability used in research, clinical, and policy-making settings vary substantially by how disability is conceptualized.1 There is a paucity of information regarding how prevalence estimates compare by disability definition and how these definitions may be inadvertently biased in their inclusion or exclusion of specific groups of children. In this study, we aimed to compare the prevalence of disability and sociodemographic differences among children using 5 different disability definitions.
William Sullivan, BS1; Benjamin C. Reeves, BA1; Phan Q. Duy, BS1; Carol Nelson-Williams, MA2; Weilai Dong, BS2; Sheng Chih Jin, PhD3; Kristopher T. Kahle, MD, PhD1
doi : 10.1001/jamapediatrics.2020.4878
JAMA Pediatr. 2021;175(3):310-313
Congenital hydrocephalus (CH) affects 1 in 1000 births, is a major cause of morbidity, and costs the US health care system $2 billion annually.1 More than 40% of CH cases are thought to have a genetic etiology. However, only less than 5% of CH cases are associated with a defined gene mutation,1 limiting the utility of genetic testing with targeted approaches and underscoring the need for CH gene discovery. The X-linked recessive form of hydrocephalus associated with aqueductal stenosis (OMIM #307000) owing to mutation of L1 cell adhesion molecule (L1CAM) is the most common form of CH (approximately 3% of total cases),1 and variably presents in male patients with mental retardation, spastic paraparesis, and adducted thumbs as part of L1 syndrome.2 Currently, L1CAM is the only gene for which targeted screening is advised and routinely clinically available for CH; however, there is little consensus on testing criteria or methods.3 Moreover, patients with no family history who present with perinatal CH are most commonly assessed, if at all, by karyotype or microarray analysis aimed at detecting chromosomal abnormalities or copy number variants but unable to identify de novo or inherited rare mutations.4
Wei Li, PhD1; Yuxin Zhang, MD2; Jiwei Wang, PhD2; Akihiko Ozaki, MD, PhD3; Qingxiao Wang, MD1; Yue Chen, PhD4; Qingwu Jiang, MSc2
doi : 10.1001/jamapediatrics.2020.5499
JAMA Pediatr. 2021;175(3):313-316
Alfredo Tagarro, PhD, MD1,2; Cristina Epalza, PhD, MD2,3; Mar Santos, PhD, MD4; Francisco José Sanz-Santaeufemia, PhD, MD5; Enrique Otheo, PhD, MD6; Cinta Moraleda, PhD, MD2,3; Cristina Calvo, PhD, MD7
doi : 10.1001/jamapediatrics.2020.1346
JAMA Pediatr. 2021;175(3):316-317
Pedro de la Oliva, MD, PhD1; Miguel Rodriguez-Rubio, MD1; Julio Garc?a-Rodr?guez, MD, PhD2
doi : 10.1001/jamapediatrics.2020.2925
JAMA Pediatr. 2021;175(3):318
Alfredo Tagarro, MD, PhD1,2,3; Cinta Moraleda, MD, PhD2,3,4; Cristina Calvo, MD, PhD3,5
doi : 10.1001/jamapediatrics.2020.2937
JAMA Pediatr. 2021;175(3):318-319
Sixiang Liang, MD1; Qianqian Zeng, MD2
doi : 10.1001/jamapediatrics.2020.4933
JAMA Pediatr. 2021;175(3):319-320
Xinyan Xie, BA1; Jiajia Zhang, PhD, MS2; Ranran Song, PhD, MS1
doi : 10.1001/jamapediatrics.2020.4936
JAMA Pediatr. 2021;175(3):320
Chika Uzoigwe, MA1; Omer Ali, MBBS2
doi : 10.1001/jamapediatrics.2020.5077
JAMA Pediatr. 2021;175(3):320-321
Souhail Alouini, MD, PhD1; Goda Venslauskaite, MPh2
doi : 10.1001/jamapediatrics.2020.5080
JAMA Pediatr. 2021;175(3):321-322
Tracey A. Wilkinson, MD, MPH1; Melissa J. Kottke, MD, MPH, MBA2; Elise D. Berlan, MD, MPH3
doi : 10.1001/jamapediatrics.2020.5091
JAMA Pediatr. 2021;175(3):322
Alessandro Perri, MD1; Maria Letizia Patti, MD1; Giovanni Vento, MD2
doi : 10.1001/jamapediatrics.2020.5083
JAMA Pediatr. 2021;175(3):322-323
To the Editor We read with great interest the Viewpoint by Dani and Corsini,1 in which they underline the limits of applicability of guidelines of pediatric scientific societies (the Pediatric Endocrine Society and American Academy of Pediatrics) about threshold values defining neonatal hypoglycemia. The authors state that the cutoff for detection of hypoglycaemia set at 45 mg/dL (blood sample; to convert glucose to millimoles per liter, multiply by 0.0555), even after 24 hours of life, is reasonably safe for healthy term infants.
Carlo Dani, MD1,2; Iuri Corsini, MD1
doi : 10.1001/jamapediatrics.2020.5094
JAMA Pediatr. 2021;175(3):323-324
In Reply We thank Perri et al for their valuable remarks on our Viewpoint on guidelines for management of neonatal hypoglycemia.1 They suggest that a glucose plasma level of 60 mg/dL (to convert glucose to millimoles per liter, multiply by 0.0555) after 48 hours of life might be used as cutoff value for deciding of starting/not discontinuing glucose monitoring in hospitalized infants in whom hypoglycemia is suspected. In fact, this cutoff value allowed them to diagnose 3 cases of persistent hyperinsulinemic hypoglycemia.
Chiara Rogantini, MD1; Livio Provenzi, PhD2; Martina Maria Mensi, MD, PhD2
doi : 10.1001/jamapediatrics.2020.5161
JAMA Pediatr. 2021;175(3):324
To the Editor The Biel et al article1 published in JAMA Pediatrics adds to the growing literature suggesting that a family-centered approach is necessary to address pediatric mental health care. We wholeheartedly agree with the authors about the urgent need to implement family-based models in pediatric psychiatry by focusing on parenting skills and family conflict as integrant part of comprehensive treatment plans for children mental health.1
Matthew G. Biel, MD, MSc1; Michael H. Tang, MD, MBA2; Barry Zuckerman, MD3
doi : 10.1001/jamapediatrics.2020.5164
JAMA Pediatr. 2021;175(3):324-325
In Reply We are grateful for the letter from Rogantini et al in response to our Viewpoint, “Pediatric Mental Health Must Be Family Mental Health Care.”1 We wholeheartedly agree with their strong recommendation to prioritize family-centered approaches to assessment and treatment for children and adolescents with eating disorders. Indeed, there is compelling evidence that eating disorders very often emerge in the context of problematic family relationships and that treatment outcomes and long-term prognosis improve when these relationship factors are actively addressed in treatment.
Matthew A. Rysavy, MD, PhD1; Marlyse F. Haward, MD2
doi : 10.1001/jamapediatrics.2020.5167
JAMA Pediatr. 2021;175(3):325
To the Editor We read with interest the article by Kidszun et al,1 which reported a clinical trial randomizing expectant mothers to higher (60%) vs lower (30%) numerical estimates of survival for a hypothetical infant born at a periviable gestation. The authors showed that the primary outcome, the mothers’ expressed preference for life-sustaining treatment or comfort care, did not depend on the numerical estimate provided.1 We would like to raise 2 points with respect to interpreting the authors’ findings.
André Kidszun, MD, MA1; Julia Inthorn, PhD2
doi : 10.1001/jamapediatrics.2020.5170
JAMA Pediatr. 2021;175(3):325-326
In Reply We thank Rysavy and Haward for their interest in our study1 and their important comments. They raise 2 critical points: the effects of message framing and the question whether, in general, providing neonatal outcome estimates is a valuable intervention.
Faizan Mazhar, PhD1; Vera Battini, PharmaD1; Carla Carnovale, PharmaD1
doi : 10.1001/jamapediatrics.2020.5173
JAMA Pediatr. 2021;175(3):326-327
To the Editor We read with interest the Viewpoint by Huybrechts et al1 concerning the safety of medical therapies during pregnancy, commonly prescribed for off-label use. Because of obvious ethical concerns, pregnant individuals are excluded from randomized clinical trials looking at reproductive outcomes following drug exposures; thus, pregnancy exposure data must be obtained from indirect sources, mostly represented by cohort studies and pregnancy registries. However, there is a considerable lag between the time of drug approval and obtaining sufficient numbers of first-trimester exposures in the pregnancy registries to be able to rule out an increase in overall and rare birth defects. The unfortunate reality is that we learned the most about teratogenic effects only after a drug has been marketed. The well-known historical examples are of thalidomide, diethylstilboestrol, and more recently, dolutegravir.
Krista F. Huybrechts, MS, PhD1; Sonia Hern?ndez-D?az, MD, DrPH2; Brian T. Bateman, MD, MS3
doi : 10.1001/jamapediatrics.2020.5177
JAMA Pediatr. 2021;175(3):327-328
In Reply Recognizing that preapproval randomized clinical trials typically exclude pregnant individuals and that the evidence on pregnancy safety required for drug labels must come from postapproval studies,1 Mazhar et al make the case for spontaneous reporting system databases, such as the US Food and Drug Administration Adverse Event Reporting System, as a highly valuable source of information about a drug’s safety and efficacy profile, particularly in frail populations.
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