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1. Can a simulation-based training program impact the use of evidence based routine practices at birth? Results of a hospital-based cluster randomized trial in Mexico

Author

Fritz, Jimena, Walker, Dilys M, Cohen, Susanna, Angeles, Gustavo, and Lamadrid-Figueroa, Hector

Subjects
Reproductive Medicine, Health Services and Systems, Biomedical and Clinical Sciences, Health Sciences, Clinical Research, Clinical Trials and Supportive Activities, Pediatric, 8.1 Organisation and delivery of services, Health and social care services research, Autonomic Fibers, Preganglionic, Delivery, Obstetric, Emergency Medical Services, Evidence-Based Practice, Health Personnel, Hospitals, Humans, Intensive Care, Neonatal, Mexico, Patient Care Team, Quality Improvement, General Science & Technology
Abstract

BackgroundIn Mexico, although the majority of births are attended in hospitals, reports have emerged of obstetric violence, use of unsafe practices, and failure to employ evidence-based practices (EBP). Recent attention has refocused global efforts towards provision of quality care that is both patient-centered and evidence-based. Scaling up of local interventions should rely on strong evidence of effectiveness.ObjectiveTo perform a secondary analysis to evaluate the impact of a simulation and team-training program (PRONTO) on the performance of EBP in normal births.MethodsA pair-matched cluster randomized controlled trial of the intervention was designed to measure the impact of the program (PRONTO intervention) on a sample of 24 hospitals (12 hospitals received the PRONTO training and 12 served as controls) in the states of Chiapas, Guerrero, and Mexico. We estimated the impact of receiving the intervention on the probability of birth practices performance in a sample of 641 observed births of which 318 occurred in the treated hospitals and 323 occurred in control hospitals. Data was collected at 4 time points (baseline, 4th, 8th and 12th months after the training). Women were blinded to treatment allocation but observers and providers were not. Estimates were obtained by fitting difference-in-differences logistic regression models considering confounding variables. The trial is registered at clinicaltrials.gov: # NCT01477554.ResultsSignificant changes were found following the intervention. At 4 months post-intervention an increase of 20 percentage points (p.p.) for complete Active Management of Third Stage of Labor (AMTSL) (p = 0.044), and 16 p.p. increase for Skin-to-Skin Contact (p = 0.067); at 12 months a 25 p.p. increase of the 1st step of AMTSL (p = 0.026) and a 42 p.p. increase of Delayed Cord Clamping (p = 0.004); at 4 months a 30 (p = 0.001) and at 8 months a 22 (p = 0.010) p.p. decrease for Uterine Sweeping.ConclusionsThe intervention has an impact on adopting EBP at birth, contributing to an increased quality of care. Long lasting impacts on these practices are possible if there were to be a widespread adoption of the training techniques including simulation, team-training and facilitated discussions regarding routine care.

Published
2017

2. Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design

Author

Horwitz, Leora I., primary, Thaweethai, Tanayott, additional, Brosnahan, Shari B., additional, Cicek, Mine S., additional, Fitzgerald, Megan L., additional, Goldman, Jason D., additional, Hess, Rachel, additional, Hodder, S. L., additional, Jacoby, Vanessa L., additional, Jordan, Michael R., additional, Krishnan, Jerry A., additional, Laiyemo, Adeyinka O., additional, Metz, Torri D., additional, Nichols, Lauren, additional, Patzer, Rachel E., additional, Sekar, Anisha, additional, Singer, Nora G., additional, Stiles, Lauren E., additional, Taylor, Barbara S., additional, Ahmed, Shifa, additional, Algren, Heather A., additional, Anglin, Khamal, additional, Aponte-Soto, Lisa, additional, Ashktorab, Hassan, additional, Bassett, Ingrid V., additional, Bedi, Brahmchetna, additional, Bhadelia, Nahid, additional, Bime, Christian, additional, Bind, Marie-Abele C., additional, Black, Lora J., additional, Blomkalns, Andra L., additional, Brim, Hassan, additional, Castro, Mario, additional, Chan, James, additional, Charney, Alexander W., additional, Chen, Benjamin K., additional, Chen, Li Qing, additional, Chen, Peter, additional, Chestek, David, additional, Chibnik, Lori B., additional, Chow, Dominic C., additional, Chu, Helen Y., additional, Clifton, Rebecca G., additional, Collins, Shelby, additional, Costantine, Maged M., additional, Cribbs, Sushma K., additional, Deeks, Steven G., additional, Dickinson, John D., additional, Donohue, Sarah E., additional, Durstenfeld, Matthew S., additional, Emery, Ivette F., additional, Erlandson, Kristine M., additional, Facelli, Julio C., additional, Farah-Abraham, Rachael, additional, Finn, Aloke V., additional, Fischer, Melinda S., additional, Flaherman, Valerie J., additional, Fleurimont, Judes, additional, Fonseca, Vivian, additional, Gallagher, Emily J., additional, Gander, Jennifer C., additional, Gennaro, Maria Laura, additional, Gibson, Kelly S., additional, Go, Minjoung, additional, Goodman, Steven N., additional, Granger, Joey P., additional, Greenway, Frank L., additional, Hafner, John W., additional, Han, Jenny E., additional, Harkins, Michelle S., additional, Hauser, Kristine S. P., additional, Heath, James R., additional, Hernandez, Carla R., additional, Ho, On, additional, Hoffman, Matthew K., additional, Hoover, Susan E., additional, Horowitz, Carol R., additional, Hsu, Harvey, additional, Hsue, Priscilla Y., additional, Hughes, Brenna L., additional, Jagannathan, Prasanna, additional, James, Judith A., additional, John, Janice, additional, Jolley, Sarah, additional, Judd, S. E., additional, Juskowich, Joy J., additional, Kanjilal, Diane G., additional, Karlson, Elizabeth W., additional, Katz, Stuart D., additional, Kelly, J. Daniel, additional, Kelly, Sara W., additional, Kim, Arthur Y., additional, Kirwan, John P., additional, Knox, Kenneth S., additional, Kumar, Andre, additional, Lamendola-Essel, Michelle F., additional, Lanca, Margaret, additional, Lee-lannotti, Joyce K., additional, Lefebvre, R. Craig, additional, Levy, Bruce D., additional, Lin, Janet Y., additional, Logarbo, Brian P., additional, Logue, Jennifer K., additional, Longo, Michele T., additional, Luciano, Carlos A., additional, Lutrick, Karen, additional, Malakooti, Shahdi K., additional, Mallett, Gail, additional, Maranga, Gabrielle, additional, Marathe, Jai G., additional, Marconi, Vincent C., additional, Marshall, Gailen D., additional, Martin, Christopher F., additional, Martin, Jeffrey N., additional, May, Heidi T., additional, McComsey, Grace A., additional, McDonald, Dylan, additional, Mendez-Figueroa, Hector, additional, Miele, Lucio, additional, Mittleman, Murray A., additional, Mohandas, Sindhu, additional, Mouchati, Christian, additional, Mullington, Janet M., additional, Nadkarni, Girish N., additional, Nahin, Erica R., additional, Neuman, Robert B., additional, Newman, Lisa T., additional, Nguyen, Amber, additional, Nikolich, Janko Z., additional, Ofotokun, Igho, additional, Ogbogu, Princess U., additional, Palatnik, Anna, additional, Palomares, Kristy T. S., additional, Parimon, Tanyalak, additional, Parry, Samuel, additional, Parthasarathy, Sairam, additional, Patterson, Thomas F., additional, Pearman, Ann, additional, Peluso, Michael J., additional, Pemu, Priscilla, additional, Pettker, Christian M., additional, Plunkett, Beth A., additional, Pogreba-Brown, Kristen, additional, Poppas, Athena, additional, Porterfield, J. Zachary, additional, Quigley, John G., additional, Quinn, Davin K., additional, Raissy, Hengameh, additional, Rebello, Candida J., additional, Reddy, Uma M., additional, Reece, Rebecca, additional, Reeder, Harrison T., additional, Rischard, Franz P., additional, Rosas, Johana M., additional, Rosen, Clifford J., additional, Rouphael, Nadine G., additional, Rouse, Dwight J., additional, Ruff, Adam M., additional, Saint Jean, Christina, additional, Sandoval, Grecio J., additional, Santana, Jorge L., additional, Schlater, Shannon M., additional, Sciurba, Frank C., additional, Selvaggi, Caitlin, additional, Seshadri, Sudha, additional, Sesso, Howard D., additional, Shah, Dimpy P., additional, Shemesh, Eyal, additional, Sherif, Zaki A., additional, Shinnick, Daniel J., additional, Simhan, Hyagriv N., additional, Singh, Upinder, additional, Sowles, Amber, additional, Subbian, Vignesh, additional, Sun, Jun, additional, Suthar, Mehul S., additional, Teunis, Larissa J., additional, Thorp, John M., additional, Ticotsky, Amberly, additional, Tita, Alan T. N., additional, Tragus, Robin, additional, Tuttle, Katherine R., additional, Urdaneta, Alfredo E., additional, Utz, P. J., additional, VanWagoner, Timothy M., additional, Vasey, Andrew, additional, Vernon, Suzanne D., additional, Vidal, Crystal, additional, Walker, Tiffany, additional, Ward, Honorine D., additional, Warren, David E., additional, Weeks, Ryan M., additional, Weiner, Steven J., additional, Weyer, Jordan C., additional, Wheeler, Jennifer L., additional, Whiteheart, Sidney W., additional, Wiley, Zanthia, additional, Williams, Natasha J., additional, Wisnivesky, Juan P., additional, Wood, John C., additional, Yee, Lynn M., additional, Young, Natalie M., additional, Zisis, Sokratis N., additional, and Foulkes, Andrea S., additional

Published
2023
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6. Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

Author

Metz TD, Clifton RG, Gallagher R, Gross RS, Horwitz LI, Jacoby VL, Martin-Herz SP, Peralta-Carcelen M, Reeder HT, Beamon CJ, Chan J, Chang AA, Costantine MM, Fitzgerald ML, Foulkes AS, Gibson KS, Güthe N, Habli M, Hackney DN, Hoffman MK, Hoffman MC, Hughes BL, Katz SD, Laleau V, Mallett G, Mendez-Figueroa H, Monzon V, Palatnik A, Palomares KTS, Parry S, Pettker CM, Plunkett BA, Poppas A, Reddy UM, Rouse DJ, Saade GR, Sandoval GJ, Schlater SM, Sciurba FC, Simhan HN, Skupski DW, Sowles A, Thaweethai T, Thomas GL, Thorp JM Jr, Tita AT, Weiner SJ, Weigand S, Yee LM, and Flaherman VJ

Subjects
Adult, Female, Humans, Pregnancy, Pandemics prevention & control, Post-Acute COVID-19 Syndrome, Prospective Studies, Retrospective Studies, SARS-CoV-2, COVID-19 epidemiology
Abstract

Importance: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads., Methods: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators., Discussion: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero., Clinical Trials.gov Identifier: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Metz reports personal fees from Pfizer for her role as a medical consultant for a SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for RSV vaccination in pregnancy study, and grants from Gestvision for role as a site PI for a preeclampsia study outside the submitted work. Dr. Horwitz reported serving as a member of the National Academy of Medicine Committee on the Long-Term Health Effects Stemming from COVID-19 and Implications for the Social Security Administration. Dr. Costantine reported receiving grant support for work not related to this paper from Baxter International and Siemens Healthcare and personal consulting fees not related to this paper from Progenity and Siemens Healthcare. These disclosures do not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Metz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2023
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