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1. Patient and Process Outcomes among Pediatric Patients Undergoing Appendectomy during the COVID-19 Pandemic: An International Retrospective Cohort Study

Author

Matava, Clyde T, Tighe, Nathaniel TG, Baertschiger, Reto, Wilder, Robert T, Correll, Lynnie, Staffa, Steven J, Zurakowski, David, Kato, Meredith A, Meier, Petra M, Raman, Vidya, Reddy, Srijaya K, Roque, Remigio A, Peterson, Melissa Brooks, Zhong, John, Edala, Thejovathi, Greer, Timothy J, von Ungern-Sternberg, Britta S, Cravero, Joseph, Simpao, Allan F, Ali, Anita Akbar, Al-Rabbat, Mohamad F, Brzenski, Alyssa B, Casey, William F, Chhabada, Surendrasingh, Collin, Michael, Dhumak, Vipul J, D’Mello, Ajay, Echeverry, Piedad C, Ellison, Pavithra R, Fernandez, Allison M, Fisher, Jake A, Fuller, Clinton L, Glover, Chris D, Guruswamy, Velu, Hesselink, Emily B, Hunyady, Agnes I, Lorinc, Amanda N, King, Michael, Mihaila, Lavinia, Nelson, Jonathon H, Ng, Ann S, Ramjist, Joshua K, Ravula, Nirop R, Beel, Elizabeth Rossmann, Rugnathx, Rahil, Shaw, Robert E, Sheth, Michelle M, Sinha, Tripiti, Sommerfield, Aine, Soneru, Codruta, Templeton, Thomas W, and Williams, RJ

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Pediatric, Patient Safety, Prevention, Good Health and Well Being, Humans, Child, COVID-19, Retrospective Studies, Pandemics, Appendicitis, Appendectomy, COVID-19 Testing, Postoperative Complications, SARS-CoV-2, Length of Stay, PEACOC Collaborators, Anesthesiology, Clinical sciences
Abstract

BackgroundCOVID-19 forced healthcare systems to make unprecedented changes in clinical care processes. The authors hypothesized that the COVID-19 pandemic adversely impacted timely access to care, perioperative processes, and clinical outcomes for pediatric patients undergoing primary appendectomy.MethodsA retrospective, international, multicenter study was conducted using matched cohorts within participating centers of the international PEdiatric Anesthesia COVID-19 Collaborative (PEACOC). Patients younger than 18 yr old were matched using age, American Society of Anesthesiologists Physical Status, and sex. The primary outcome was the difference in hospital length of stay of patients undergoing primary appendectomy during a 2-month period early in the COVID-19 pandemic (April to May 2020) compared with prepandemic (April to May 2019). Secondary outcomes included time to appendectomy and the incidence of complicated appendicitis.ResultsA total of 3,351 cases from 28 institutions were available with 1,684 cases in the prepandemic cohort matched to 1,618 in the pandemic cohort. Hospital length of stay was statistically significantly different between the two groups: 29 h (interquartile range: 18 to 79) in the pandemic cohort versus 28 h (interquartile range: 18 to 67) in the prepandemic cohort (adjusted coefficient, 1 [95% CI, 0.39 to 1.61]; P < 0.001), but this difference was small. Eight centers demonstrated a statistically significantly longer hospital length of stay in the pandemic period than in the prepandemic period, while 13 were shorter and 7 did not observe a statistically significant difference. During the pandemic period, there was a greater occurrence of complicated appendicitis, prepandemic 313 (18.6%) versus pandemic 389 (24.1%), an absolute difference of 5.5% (adjusted odds ratio, 1.32 [95% CI, 1.1 to 1.59]; P = 0.003). Preoperative SARS-CoV-2 testing was associated with significantly longer time-to-appendectomy, 720 min (interquartile range: 430 to 1,112) with testing versus 414 min (interquartile range: 231 to 770) without testing, adjusted coefficient, 306 min (95% CI, 241 to 371; P < 0.001), and longer hospital length of stay, 31 h (interquartile range: 20 to 83) with testing versus 24 h (interquartile range: 14 to 68) without testing, adjusted coefficient, 7.0 (95% CI, 2.7 to 11.3; P = 0.002).ConclusionsFor children undergoing appendectomy, the COVID-19 pandemic did not significantly impact hospital length of stay.Editor’s perspective

Published
2023

2. A survey of the global impact of COVID‐19 on the practice of pediatric anesthesia: A study from the pediatric anesthesia COVID‐19 Collaborative Group

Author

Soneru, Codruta N, Fernandez, Allison M, Bradford, Victoria, Staffa, Steven J, Raman, Vidya T, Cravero, Joseph, Zurakowski, David, Meier, Petra M, Balakrishnan, Sindu, Bansal, Vipin, Torres, Angela Becerra, Beethe, Amy, Benzon, Hubert A, Bhandari, Angelina, Bocanegra, Ashley, Bould, Dylan, Peterson, Melissa Brooks, Brzenski, Alyssa, Busso, Veronica, Cain, James G, Cassidy, Myles, Cheon, Eric C, Chhabada, Surendrasingh, Correll, Lynnie R, Dalesio, Nicholas M, Davidson, Andrew, Derderian, Courtney, Dhumak, Vipul, Disma, Nicola, D'Mello, Ajay, Echeverry, Piedad, Ellison, Pavithra R, Erb, Thomas, Fajardo, Angelica, Falcon, Ricardo J, Frugoni, Brian, García, Javier, Giraldo, Olga Lucía, Glover, Chris D, Goeller, Jessica, Goobie, Susan M, Gooch, Ingrid, Granados, Lina Maria, Grivoyannis, Anastasia, Guruswamy, Velu, Hesselink, Emily, Hobbs, Jill, Hunyady, Agnes, Jain, Ranu, Jorge‐Reynolds, Lydia, Kato, Meredith A, King, Michael R, Kitzman, Jamie, Koh, Jeffrey, Lester, Andy, Lorinc, Amanda, Lozano, Constanza, Manupipatpong, Katherine, Matava, Clyde, McLuckie, Duncan, Merchant, Kanwal, Levy, Heather Mitzel, Muldowney, Bridget L, Navarro, Julian Andres, Nelson, Jonathon, Patel, Amish, Patel, Roshan, Ravula, Niroop, Reddy, Desigen, Reddy, Srijaya K, McCormick, Megan Rodgers, Roque, Remigio, Rosen, David, Beel, Elizabeth Rossmann, Rothschild, Leelach, Sarmiento, Lina, Shadrina, Anna, Shaw, Robert, Sheth, Michelle, Simpao, Allan F, Singh, Neeta, Smith, Timothy E, Soria, Claire, Szmuk, Peter, Taicher, Brad M, Tan, Gee Mei, Teng, Howard, Edala, Thejovathi, Tighe, Nathaniel, Tom, Simon, Trujillo, Alexander, Vishneski, Susan R, Vivas, Juan Pablo, Von Samek, Adam, von Ungern‐Sternberg, Britta S, Whyte, Simon, and Wilder, Robert T

Subjects
Clinical Research, Patient Safety, Pediatric, Generic health relevance, Good Health and Well Being, Anesthesia, Anesthesiologists, Anesthesiology, COVID-19, COVID-19 Testing, Child, Humans, Pandemics, Pediatricians, Pediatrics, Personal Protective Equipment, Practice Guidelines as Topic, Practice Patterns, Physicians', SARS-CoV-2, Societies, Medical, Surveys and Questionnaires, United States, hospital economics, pediatric anesthesia, personal protective equipment, preoperative testing, simulation, Pediatric Anesthesia COVID-19 Collaborative, Paediatrics and Reproductive Medicine
Abstract

BackgroundPediatric anesthesiology has been greatly impacted by COVID-19 in the delivery of care to patients and to the individual providers. With this study, we sought to survey pediatric centers and highlight the variations in care related to perioperative medicine during the COVID-19 pandemic, including the availability of protective equipment, the practice of pediatric anesthesia, and economic impact.AimThe aim of the survey was to determine how COVID-19 directly impacted pediatric anesthesia practices during the study period.MethodsA survey concerning four major domains (testing, safety, clinical management/policy, economics) was developed. It was pilot tested for clarity and content by members of the Pediatric Anesthesia COVID-19 Collaborative. The survey was administered by email to all Pediatric Anesthesia COVID-19 Collaborative members on September 1, 2020. Respondents had six weeks to complete the survey and were instructed to answer the questions based on their institution's practice during September 1 - October 13, 2020.ResultsSixty-three institutions (100% response rate) participated in the COVID-19 Pediatric Anesthesia Survey. Forty-one hospitals (65%) were from the United States, and 35% included other countries. N95 masks were available to anesthesia teams at 91% of institutions (n = 57) (95% CI: 80%-96%). COVID-19 testing criteria of anesthesia staff and guidelines to return to work varied by institution. Structured simulation training aimed at improving COVID-19 safety and patient care occurred at 62% of institutions (n = 39). Pediatric anesthesiologists were economically affected by a reduction in their employer benefits and restriction of travel due to employer imposed quarantine regulations.ConclusionOur data indicate that the COVID-19 pandemic has impacted the testing, safety, clinical management, and economics of pediatric anesthesia practice. Further investigation into the long-term consequences for the specialty is indicated.

Published
2021

4. Perioperative Management and In-Hospital Outcomes After Minimally Invasive Repair of Pectus Excavatum: A Multicenter Registry Report From the Society for Pediatric Anesthesia Improvement Network

Author

Muhly, Wallis T., Beltran, Ralph J., Bielsky, Alan, Bryskin, Robert B., Chinn, Christopher, Choudhry, Dinesh K., Cucchiaro, Giovanni, Fernandez, Allison, Glover, Chris D., Haile, Dawit T., Kost-Byerly, Sabine, Schnepper, Gregory D., Zurakowski, David, Agarwal, Rita, Bhalla, Tarun, Eisdorfer, Seth, Huang, Henry, Maxwell, Lynne G., Thomas, James J., Tjia, Imelda, Wilder, Robert T., and Cravero, Joseph P.

Published
2019
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12. Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

Author

Davidson, Andrew J., Morton, Neil S., Arnup, Sarah J., De Graaff, Jurgen C., Disma, Nicola, Withington, Davinia E., Frawley, Geoff, Hunt, Rodney W., Hardy, Pollyanna, Khotcholava, Magda, Von Ungern Sternberg, Britta S., Wilton, Niall, Tuo, Pietro, Salvo, Ida, Ormond, Gillian, Stargatt, Robyn, Locatelli, Bruno Guido, McCann, Mary Ellen, Lee, Katherine, Sheppard, Suzette, Hartmann, Penelope, Ragg, Philip, Backstrom, Marie, Costi, David, Von Ungern-Sternberg, Britta S., Knottenbelt, Graham, Montobbio, Giovanni, Mameli, Leila, Giribaldi, Gaia, Prato, Alessio Pini, Mattioli, Girolamo, Wolfler, Andrea, Izzo, Francesca, Sonzogni, Valter, Van Gool, Jose T D G, Numan, Sandra C., Kalkman, Cor J., Hagenaars, J. H M, Absalom, Anthony R., Hoekstra, Frouckje M., Volkers, Martin J., Furue, Koto, Gaudreault, Josee, Berde, Charles, Soriano, Sulpicio, Young, Vanessa, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph P., Bellinger, David, Marmor, Jacki, Lynn, Anne, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Meuller, Martin, Haret, Denisa, Szmuk, Peter, Steiner, Jeffery, Kravitz, Brian, Suresh, Santhanam, Hays, Stephen R., Taenzer, Andreas H., Maxwell, Lynne G., Williams, Robert K., Bell, Graham T., Dorris, Liam, Adey, Claire, Bagshaw, Oliver, Chisakuta, Anthony, Eissa, Ayman, Stoddart, Peter, Davis, Annette, Myles, Paul, Wolf, Andy, McIntosh, Neil, Carlin, John, Leslie, Kate, De Lima, Jonathan, Hammer, Greg, Field, David, Gebski, Val, and Tibboel, Dick

Subjects
Male, Internationality, Spinal, Apnea, Research Support, U.S. Gov't, P.H.S, Child Development, Postoperative Complications, Research Support, N.I.H., Extramural, Risk Factors, Journal Article, Humans, Comparative Study, Anesthesia, Wakefulness, General, Anesthesia, General, Anesthesia, Spinal, Female, Follow-Up Studies, Infant, Infant, Newborn, Treatment Outcome, Anesthesiology and Pain Medicine, Research Support, Non-U.S. Gov't, Newborn, Multicenter Study, Randomized Controlled Trial
Abstract

Background: Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. Methods: Infants aged 60 weeks or younger, postmenstrual age scheduled for inguinal herniorrhaphy, were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation. The primary outcome of this analysis was any observed apnea up to 12 h postoperatively. Apnea assessment was unblinded. Results: Three hundred sixty-three patients were assigned to RA and 359 to GA. Overall, the incidence of apnea (0 to 12 h) was similar between arms (3% in RA and 4% in GA arms; odds ratio [OR], 0.63; 95% CI, 0.31 to 1.30, P = 0.2133); however, the incidence of early apnea (0 to 30 min) was lower in the RA arm (1 vs. 3%; OR, 0.20; 95% CI, 0.05 to 0.91; P = 0.0367). The incidence of late apnea (30 min to 12 h) was 2% in both RA and GA arms (OR, 1.17; 95% CI, 0.41 to 3.33; P = 0.7688). The strongest predictor of apnea was prematurity (OR, 21.87; 95% CI, 4.38 to 109.24), and 96% of infants with apnea were premature. Conclusions: RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period. Cardiorespiratory monitoring should be used for all ex-premature infants.

Published
2015

13. Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes

Author

Frawley, Geoff, Bell, Graham, Disma, NICOLA MASSIMO, Withington, Davinia E., De Graaff, Jurgen C., Morton, Neil S., Mccann, Mary Ellen, Arnup, Sarah J., Bagshaw, Oliver, Wolfler, Andrea, Bellinger, David, Davidson, Andrew J., Hardy, Pollyanna, Hunt, Rodney W., Stargatt, Robyn, Ormond, Gillian, Hartmann, Penelope, Ragg, Philip, Backstrom, Marie, Costi, David, Von Ungern Sternberg, Britta S., Wilton, Niall, Knottenbelt, Graham, Montobbio, Giovanni, Mameli, Leila, Tuo, Pietro, Giribaldi, Gaia, Prato, Alessio Pini, Mattioli, Girolamo, Izzo, Francesca, Salvo, Ida, Sonzogni, Valter, Locatelli, Bruno Guido, Khotcholava, Magda, Van Gool, Jose T. D. G., Numan, Sandra C., Kalkman, Cor J., Hagenaars, J. H. M., Absalom, Anthony R., Hoekstra, Frouckje M., Volkers, Martin J., Furue, Koto, Gaudreault, Josee, Berde, Charles, Soriano, Sulpicio, Young, Vanessa, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph P., Marmor, Jacki, Lynn, Anne, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Meuller, Martin, Haret, Denisa, Suresh, Santhanam, Hays, Stephen R., Taenzer, Andreas H., Maxwell, Lynne G., Williams, Robert K., Bell, Graham T., Dorris, Liam, Adey, Claire, Chisakuta, Anthony, Eissa, Ayman, Stoddart, Peter, Davis, Annette, Myles, Paul, Wolf, Andy, Carlin, John, Leslie, Kate, De Lima, Jonathan, Field, David, Gebski, Val, Tibboel, Dick, Szmuk, Peter, Steiner, Jeffery, and Kravitz, Brian

Subjects
Male, Hernia, Internationality, Spinal, Apnea, Hernia, Inguinal, Anesthesia, Conduction, Anesthesia, General, Anesthesia, Spinal, Child Development, Cohort Studies, Female, Humans, Infant, Infant, Newborn, Predictive Value of Tests, Prospective Studies, Single-Blind Method, Treatment Failure, Treatment Outcome, Anesthesiology and Pain Medicine, Conduction, Article, Anesthesia, General, Newborn, Inguinal
Abstract

Awake regional anesthesia (RA) is a viable alternative to general anesthesia (GA) for infants undergoing lower abdominal surgery. Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes. The General Anesthesia compared to Spinal anesthesia study compares neurodevelopmental outcomes after awake RA or GA in otherwise healthy infants. The aim of the study is to describe success and failure rates of RA and report factors associated with failure.This was a nested cohort study within a prospective, randomized, controlled, observer-blind, equivalence trial. Seven hundred twenty-two infants 60 weeks or less postmenstrual age scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA (spinal, caudal epidural, or combined spinal caudal anesthetic) or GA with sevoflurane. The data of 339 infants, where spinal or combined spinal caudal anesthetic was attempted, were analyzed. Possible predictors of failure were assessed including patient factors, technique, experience of site and anesthetist, and type of local anesthetic.RA was sufficient for the completion of surgery in 83.2% of patients. Spinal anesthesia was successful in 86.9% of cases and combined spinal caudal anesthetic in 76.1%. Thirty-four patients required conversion to GA, and an additional 23 patients (6.8%) required brief sedation. Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure (odds ratio = 2.46).The failure rate of spinal anesthesia was low. Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone.

Published
2015

14. In Reply

Author

Beach, Michael L., primary, Cohen, Daniel M., additional, Gallagher, Susan M., additional, and Cravero, Joseph P., additional

Published
2016
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16. Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

Author

Medische staf Anesthesiologie, Circulatory Health, Brain, Davidson, Andrew J., Morton, Neil S., Arnup, Sarah J., De Graaff, Jurgen C., Disma, Nicola, Withington, Davinia E., Frawley, Geoff, Hunt, Rodney W., Hardy, Pollyanna, Khotcholava, Magda, Von Ungern Sternberg, Britta S., Wilton, Niall, Tuo, Pietro, Salvo, Ida, Ormond, Gillian, Stargatt, Robyn, Locatelli, Bruno Guido, McCann, Mary Ellen, Lee, Katherine, Sheppard, Suzette, Hartmann, Penelope, Ragg, Philip, Backstrom, Marie, Costi, David, Von Ungern-Sternberg, Britta S., Knottenbelt, Graham, Montobbio, Giovanni, Mameli, Leila, Giribaldi, Gaia, Prato, Alessio Pini, Mattioli, Girolamo, Wolfler, Andrea, Izzo, Francesca, Sonzogni, Valter, Van Gool, Jose T D G, Numan, Sandra C., Kalkman, Cor J., Hagenaars, J. H M, Absalom, Anthony R., Hoekstra, Frouckje M., Volkers, Martin J., Furue, Koto, Gaudreault, Josee, Berde, Charles, Soriano, Sulpicio, Young, Vanessa, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph P., Bellinger, David, Marmor, Jacki, Lynn, Anne, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Meuller, Martin, Haret, Denisa, Szmuk, Peter, Steiner, Jeffery, Kravitz, Brian, Suresh, Santhanam, Hays, Stephen R., Taenzer, Andreas H., Maxwell, Lynne G., Williams, Robert K., Bell, Graham T., Dorris, Liam, Adey, Claire, Bagshaw, Oliver, Chisakuta, Anthony, Eissa, Ayman, Stoddart, Peter, Davis, Annette, Myles, Paul, Wolf, Andy, McIntosh, Neil, Carlin, John, Leslie, Kate, De Lima, Jonathan, Hammer, Greg, Field, David, Gebski, Val, Tibboel, Dick, Medische staf Anesthesiologie, Circulatory Health, Brain, Davidson, Andrew J., Morton, Neil S., Arnup, Sarah J., De Graaff, Jurgen C., Disma, Nicola, Withington, Davinia E., Frawley, Geoff, Hunt, Rodney W., Hardy, Pollyanna, Khotcholava, Magda, Von Ungern Sternberg, Britta S., Wilton, Niall, Tuo, Pietro, Salvo, Ida, Ormond, Gillian, Stargatt, Robyn, Locatelli, Bruno Guido, McCann, Mary Ellen, Lee, Katherine, Sheppard, Suzette, Hartmann, Penelope, Ragg, Philip, Backstrom, Marie, Costi, David, Von Ungern-Sternberg, Britta S., Knottenbelt, Graham, Montobbio, Giovanni, Mameli, Leila, Giribaldi, Gaia, Prato, Alessio Pini, Mattioli, Girolamo, Wolfler, Andrea, Izzo, Francesca, Sonzogni, Valter, Van Gool, Jose T D G, Numan, Sandra C., Kalkman, Cor J., Hagenaars, J. H M, Absalom, Anthony R., Hoekstra, Frouckje M., Volkers, Martin J., Furue, Koto, Gaudreault, Josee, Berde, Charles, Soriano, Sulpicio, Young, Vanessa, Sethna, Navil, Kovatsis, Pete, Cravero, Joseph P., Bellinger, David, Marmor, Jacki, Lynn, Anne, Ivanova, Iskra, Hunyady, Agnes, Verma, Shilpa, Polaner, David, Thomas, Joss, Meuller, Martin, Haret, Denisa, Szmuk, Peter, Steiner, Jeffery, Kravitz, Brian, Suresh, Santhanam, Hays, Stephen R., Taenzer, Andreas H., Maxwell, Lynne G., Williams, Robert K., Bell, Graham T., Dorris, Liam, Adey, Claire, Bagshaw, Oliver, Chisakuta, Anthony, Eissa, Ayman, Stoddart, Peter, Davis, Annette, Myles, Paul, Wolf, Andy, McIntosh, Neil, Carlin, John, Leslie, Kate, De Lima, Jonathan, Hammer, Greg, Field, David, Gebski, Val, and Tibboel, Dick

Published
2015

17. Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations

Author

Ward, Denham S., Williams, Mark R., Berkenbosch, John W., Bhatt, Maala, Carlson, Douglas, Chappell, Phillip, Clark, Randall M., Constant, Isabelle, Conway, Aaron, Cravero, Joseph, Dahan, Albert, Dexter, Franklin, Dionne, Raymond, Dworkin, Robert H., Gan, Tong J., Gozal, David, Green, Steven, Irwin, Michael G., Karan, Suzanne, Kochman, Michael, Lerman, Jerrold, Lightdale, Jenifer R., Litman, Ronald S., Mason, Keira P., Miner, James, O’Connor, Robert E., Pandharipande, Pratik, Riker, Richard R., Roback, Mark G., Sessler, Daniel I., Sexton, Anne, Tobin, Joseph R., Turk, Dennis C., Twersky, Rebecca S., Urman, Richard D., Weiss, Mark, Wunsch, Hannah, and Zhao-Wong, Anna

Abstract

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public–private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as “the avoidance of physical or psychological harm.” A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Published
2018
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18. Efficacy Outcome Measures for Pediatric Procedural Sedation Clinical Trials: An ACTTION Systematic Review

Author

Williams, Mark R., Nayshtut, Michael, Hoefnagel, Amie, McKeown, Andrew, Carlson, Douglas W., Cravero, Joseph, Lightdale, Jenifer, Mason, Keira P., Wilson, Stephen, Turk, Dennis C., Dworkin, Robert H., and Ward, Denham S.

Abstract

Objective evaluations comparing different techniques and approaches to pediatric procedural sedation studies have been limited by a lack of consistency among the outcome measures used in assessment. This study reviewed those existing measures, which have undergone psychometric analysis in a pediatric procedural sedation setting, to determine to what extent and in what circumstances their use is justified across the spectrum of procedures, age groups, and techniques. The results of our study suggest that a wide range of measures has been used to assess the efficacy and effectiveness of pediatric procedural sedation. Most lack the evidence of validity and reliability that is necessary to facilitate rigorous clinical trial design, as well as the evaluation of new drugs and devices. A set of core pediatric sedation outcome domains and outcome measures can be developed on the basis of our findings. We believe that consensus among all stakeholders regarding appropriate domains and measures to evaluate pediatric procedural sedation is possible and that widespread implementation of such recommendations should be pursued.

Published
2018
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19. Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations

Author

Williams, Mark R., Ward, Denham S., Carlson, Douglas, Cravero, Joseph, Dexter, Franklin, Lightdale, Jenifer R., Mason, Keira P., Miner, James, Vargo, John J., Berkenbosch, John W., Clark, Randall M., Constant, Isabelle, Dionne, Raymond, Dworkin, Robert H., Gozal, David, Grayzel, David, Irwin, Michael G., Lerman, Jerrold, O’Connor, Robert E., Pandharipande, Pratik, Rappaport, Bob A., Riker, Richard R., Tobin, Joseph R., Turk, Dennis C., Twersky, Rebecca S., and Sessler, Daniel I.

Abstract

Published ahead of print September 12, 2016.The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public–private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, (2) efficacy, (3) patient-centered and/or family-centered outcomes, and (4) efficiency. This meeting identified core outcome measures within the efficacy and patient-centered and/or family-centered domains. Safety will be addressed in a subsequent meeting, and efficiency will not be addressed at this time. These measures encompass depth and levels of sedation, proceduralist and patient satisfaction, patient recall, and degree of pain experienced. Consistent use of the recommended outcome measures will facilitate the comprehensive reporting across sedation trials, along with meaningful comparisons among studies and interventions in systematic reviews and meta-analyses.

Published
2017
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