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1. Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis

Author

Thompson, Callie M, Voldal, Emily C, Davidson, Giana H, Sanchez, Sabrina E, Ayoung-Chee, Patricia, Victory, Jesse, Guiden, Mary, Bizzell, Bonnie, Glaser, Jacob, Hults, Christopher, Price, Thea P, Siparsky, Nicole, Ohe, Kristin, Mandell, Katherine A, DeUgarte, Daniel A, Kaji, Amy H, Uribe, Lisandra, Kao, Lillian S, Mueck, Krislynn M, Farjah, Farhood, Self, Wesley H, Clark, Sunday, Drake, F Thurston, Fischkoff, Katherine, Minko, Elizaveta, Cuschieri, Joseph, Faine, Brett, Skeete, Dionne A, Dhanani, Naila, Liang, Mike K, Krishnadasan, Anusha, Talan, David A, Fannon, Erin, Kessler, Larry G, Comstock, Bryan A, Heagerty, Patrick J, Monsell, Sarah E, Lawrence, Sarah O, Flum, David R, Lavallee, Danielle C, Parsons, Charles, Shapiro, Nathan I, Odom, Stephen R, Cooper, Randall, Tichter, Aleksandr, Hayward, Alyssa, Johnson, Jeffrey, Patton, Joe H, Hayes, Lillian Adrianna, Evans, Heather L, Arif, Hikmatullah, Hennessey, Laura, Fairfield, Cathy, Lew, Debbie, Bernardi, Karla, Olavarria, Oscar, Marquez, Stephanie, Ko, Tien C, McGrane, Karen, Sohn, Vance, Jones, Alan E, Patki, Deepti, Kutcher, Matthew E, Peacock, Rebekah K, Chung, Bruce, Carter, Damien W, MacKenzie, David, Burris, Debra, Mack, Joseph, Gerry, Terilee, Maggi, Jason, Pierce, Kristyn, Melis, Marcovalerio, Abouzeid, Mohamad, Shah, Paresh, Sinha, Prashant, Chiang, William, Rushing, Amy, Wisler, Jon, Steinberg, Steven, Tudor, Brandon, Foster, Careen S, Schaetzel, Shaina M, Morgan, Dayna, Tschirhart, John, Wallick, Julie, Martinez, Ryan, Wells, Sean, Ferrigno, Lisa, Salzberg, Matthew, Putnam, Brant, Kim, Dennis, Howell, Erin C, Spence, Lara H, Fleischman, Ross, Saltzman, Darin, Mireles, Debbie, Chen, Formosa, Moran, Gregory J, and Pathmarajah, Kavitha

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, patient-reported outcomes, appendicitis, appendectomy, antibiotics, sociodemographic factors, clinical factors, decisional regret, dissatisfaction with treatment, Comparison of Outcomes of antibiotic Drugs and Appendectomy, Writing Group for the CODA Collaborative:, Medical and Health Sciences, Surgery, Clinical sciences
Abstract

ObjectiveTo compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days.Summary background dataThe Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes.MethodsWe focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations.ResultsThe pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret.ConclusionsOverall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals.Trial registrationClinicaltrials.gov Identifier: NCT02800785.

Published
2023

2. Analysis of stepped wedge cluster randomized trials in the presence of a time-varying treatment effect

Author

Kenny, Avi, Voldal, Emily, Xia, Fan, Heagerty, Patrick J., and Hughes, James P.

Subjects
Statistics - Methodology
Abstract

Stepped wedge cluster randomized controlled trials are typically analyzed using models that assume the full effect of the treatment is achieved instantaneously. We provide an analytical framework for scenarios in which the treatment effect varies as a function of exposure time (time since the start of treatment) and define the "effect curve" as the magnitude of the treatment effect on the linear predictor scale as a function of exposure time. The "time-averaged treatment effect", (TATE) and "long-term treatment effect" (LTE) are summaries of this curve. We analytically derive the expectation of the estimator resulting from a model that assumes an immediate treatment effect and show that it can be expressed as a weighted sum of the time-specific treatment effects corresponding to the observed exposure times. Surprisingly, although the weights sum to one, some of the weights can be negative. This implies that the estimator may be severely misleading and can even converge to a value of the opposite sign of the true TATE or LTE. We describe several models that can be used to simultaneously estimate the entire effect curve, the TATE, and the LTE, some of which make assumptions about the shape of the effect curve. We evaluate these models in a simulation study to examine the operating characteristics of the resulting estimators and apply them to two real datasets.

Published
2021

4. Proceedings of the 14th International Newborn Brain Conference: Neonatal Neurocritical Care, seizures, and continuous aEEG and /or EEG monitoring

Author

MS Neonatologie, Brain, Child Health, Neurologen, Regenerative Medicine and Stem Cells, Circulatory Health, Arts-assistenten Kinderen, Abramsky, Ramy, Acun, Ceyda, Alt, Jesse, Aly, Hany, Arad, Noa, Baak, Lisanne M, Bakalar, Dana, Balasingham, Thameya, Bammler, Theo, Benders, Manon J N L, Benitez, Diana, Boni, Elisa, Boylan, Geraldine, Campbell, Ellie, Castri, Paola, Chandrashekar, Priyanka, Chavez-Valdez, Raul, Chen, May, Chiodin, Elisabetta, Comstock, Bryan, Damien, Janie, de Vries, Linda, Dickman, Jacky, Doucette, Leslie, Duckworth, Ellie, Echeverria-Palacio, Carlos, El Jalbout, Ramy, El-Dib, Mohamed, Elshibiny, Hoda, Flock, Debbie, Gallagher, Anne, Gasperoni, Enrica, Glass, Hannah, Harteman, Johanneke C, Harvey-Jones, Kelly, Hazan, Itay, Heagerty, Patrick, Inder, Terrie, Jantzie, Lauren, Juul, Sandra, Karnati, Sreenivas, Kute, Nazli, Lacaille, Helene, Lange, Frederic, Lemmers, Petra M A, Liu, Wei, Llaguno, Nathalie, Magalhães, Mauricio, Mambule, Ivan, Marandyuk, Bohdana, Marks, Kyla, Martin, Lee J, Massaro, An, Mathieson, Sean, McCaul, Melisa Carrasco, Meehan, Christopher, Meledin, Irina, Menna, Elisa, Menzato, Federica, Mintoft, Alison, Mitra, Subhabrata, Nakimuli, Annettee, Nanyunya, Carol, Norris, Georgina, Northington, Frances J, Numis, Adam, O'Reilly, Jiaqi J, Ortiz, Sandra, Padiyar, Swetha, Paquette, Natacha, Parmeggiani, Lucio, Patrizi, Silvia, Pavlidis, Elena, Pellegrin, Serena, Penn, Anna A, Petitpas, Laurence, Pinchefsky, Elana, Ponta, Alessandra, Puthuraya, Jacopo Proietti Subhash, Rais, Rana, Robertson, Nicola J, Rodrigues, Daniela, Salandin, Michela, Salzbank, Jacquelyn, Sánchez, Lilia, Schalij, Nienke, Serrano-Tabares, Carolina, Shany, Eilon, Staffler, Alex, Steggerda, Sylke, Tachtsidis, Ilias, Tann, Cally, Tataranno, Maria Luisa, Trabatti, Chiara, Tremblay, Julie, Tromp, Selma, Tucker, Katie, Turnbill, Victoria, Vacher, Claire-Marie, van Bel, Frank, van der Aa, Niek E, Van Meurs, Krisa, Van Steenis, Andrea, van Wyk, Linda, Vannasing, Phetsamone, Variane, Gabriel, Verma, Vinita, Voldal, Emily, Wagenaar, Nienke, Wu, Yvonne, Wustoff, Courtney, MS Neonatologie, Brain, Child Health, Neurologen, Regenerative Medicine and Stem Cells, Circulatory Health, Arts-assistenten Kinderen, Abramsky, Ramy, Acun, Ceyda, Alt, Jesse, Aly, Hany, Arad, Noa, Baak, Lisanne M, Bakalar, Dana, Balasingham, Thameya, Bammler, Theo, Benders, Manon J N L, Benitez, Diana, Boni, Elisa, Boylan, Geraldine, Campbell, Ellie, Castri, Paola, Chandrashekar, Priyanka, Chavez-Valdez, Raul, Chen, May, Chiodin, Elisabetta, Comstock, Bryan, Damien, Janie, de Vries, Linda, Dickman, Jacky, Doucette, Leslie, Duckworth, Ellie, Echeverria-Palacio, Carlos, El Jalbout, Ramy, El-Dib, Mohamed, Elshibiny, Hoda, Flock, Debbie, Gallagher, Anne, Gasperoni, Enrica, Glass, Hannah, Harteman, Johanneke C, Harvey-Jones, Kelly, Hazan, Itay, Heagerty, Patrick, Inder, Terrie, Jantzie, Lauren, Juul, Sandra, Karnati, Sreenivas, Kute, Nazli, Lacaille, Helene, Lange, Frederic, Lemmers, Petra M A, Liu, Wei, Llaguno, Nathalie, Magalhães, Mauricio, Mambule, Ivan, Marandyuk, Bohdana, Marks, Kyla, Martin, Lee J, Massaro, An, Mathieson, Sean, McCaul, Melisa Carrasco, Meehan, Christopher, Meledin, Irina, Menna, Elisa, Menzato, Federica, Mintoft, Alison, Mitra, Subhabrata, Nakimuli, Annettee, Nanyunya, Carol, Norris, Georgina, Northington, Frances J, Numis, Adam, O'Reilly, Jiaqi J, Ortiz, Sandra, Padiyar, Swetha, Paquette, Natacha, Parmeggiani, Lucio, Patrizi, Silvia, Pavlidis, Elena, Pellegrin, Serena, Penn, Anna A, Petitpas, Laurence, Pinchefsky, Elana, Ponta, Alessandra, Puthuraya, Jacopo Proietti Subhash, Rais, Rana, Robertson, Nicola J, Rodrigues, Daniela, Salandin, Michela, Salzbank, Jacquelyn, Sánchez, Lilia, Schalij, Nienke, Serrano-Tabares, Carolina, Shany, Eilon, Staffler, Alex, Steggerda, Sylke, Tachtsidis, Ilias, Tann, Cally, Tataranno, Maria Luisa, Trabatti, Chiara, Tremblay, Julie, Tromp, Selma, Tucker, Katie, Turnbill, Victoria, Vacher, Claire-Marie, van Bel, Frank, van der Aa, Niek E, Van Meurs, Krisa, Van Steenis, Andrea, van Wyk, Linda, Vannasing, Phetsamone, Variane, Gabriel, Verma, Vinita, Voldal, Emily, Wagenaar, Nienke, Wu, Yvonne, and Wustoff, Courtney

Published
2023

5. Self-selection vs Randomized Assignment of Treatment for Appendicitis

Author

Davidson, Giana H., Monsell, Sarah E., Evans, Heather, Voldal, Emily C., Fannon, Erin, Lawrence, Sarah O., Krishnadasan, Anusha, Talan, David A., Bizzell, Bonnie, Heagerty, Patrick J., Comstock, Bryan A., Lavallee, Danielle C., Villegas, Cassandra, Winchell, Robert, Thompson, Callie M., Self, Wesley H., Kao, Lillian S., Dodwad, Shah-Jahan, Sabbatini, Amber K., Droullard, David, Machado-Aranda, David, Gibbons, Melinda Maggard, Kaji, Amy H., DeUgarte, Daniel A., Ferrigno, Lisa, Salzberg, Matthew, Mandell, Katherine A., Siparsky, Nicole, Price, Thea P., Raman, Anooradha, Corsa, Joshua, Wisler, Jon, Ayoung-Chee, Patricia, Victory, Jesse, Jones, Alan, Kutcher, Matthew, McGrane, Karen, Holihan, Julie, Liang, Mike K., Cuschieri, Joseph, Johnson, Jeffrey, Fischkoff, Katherine, Drake, F. Thurston, Sanchez, Sabrina E., Odom, Stephen R., Kessler, Larry G., and Flum, David R.

Subjects
Treatment Outcome, Acute Disease, Appendectomy, Humans, Surgery, Appendicitis, Original Investigation, Anti-Bacterial Agents
Abstract

IMPORTANCE: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. OBJECTIVE: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. DESIGN, SETTING, AND PARTICIPANTS: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. INTERVENTIONS: Appendectomy vs antibiotics. MAIN OUTCOMES AND MEASURES: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. RESULTS: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, −1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. CONCLUSIONS AND RELEVANCE: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02800785

Published
2022

6. Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

Author

Thompson, Callie M, Thompson, Callie M, Voldal, Emily C, Davidson, Giana H, Sanchez, Sabrina E, Ayoung-Chee, Patricia, Victory, Jesse, Guiden, Mary, Bizzell, Bonnie, Glaser, Jacob, Hults, Christopher, Price, Thea P, Siparsky, Nicole, Ohe, Kristin, Mandell, Katherine A, DeUgarte, Daniel A, Kaji, Amy H, Uribe, Lisandra, Kao, Lillian S, Mueck, Krislynn M, Farjah, Farhood, Self, Wesley H, Clark, Sunday, Drake, F Thurston, Fischkoff, Katherine, Minko, Elizaveta, Cuschieri, Joseph, Faine, Brett, Skeete, Dionne A, Dhanani, Naila, Liang, Mike K, Krishnadasan, Anusha, Talan, David A, Fannon, Erin, Kessler, Larry G, Comstock, Bryan A, Heagerty, Patrick J, Monsell, Sarah E, Lawrence, Sarah O, Flum, David R, Lavallee, Danielle C, Writing Group for the CODA Collaborative, Thompson, Callie M, Thompson, Callie M, Voldal, Emily C, Davidson, Giana H, Sanchez, Sabrina E, Ayoung-Chee, Patricia, Victory, Jesse, Guiden, Mary, Bizzell, Bonnie, Glaser, Jacob, Hults, Christopher, Price, Thea P, Siparsky, Nicole, Ohe, Kristin, Mandell, Katherine A, DeUgarte, Daniel A, Kaji, Amy H, Uribe, Lisandra, Kao, Lillian S, Mueck, Krislynn M, Farjah, Farhood, Self, Wesley H, Clark, Sunday, Drake, F Thurston, Fischkoff, Katherine, Minko, Elizaveta, Cuschieri, Joseph, Faine, Brett, Skeete, Dionne A, Dhanani, Naila, Liang, Mike K, Krishnadasan, Anusha, Talan, David A, Fannon, Erin, Kessler, Larry G, Comstock, Bryan A, Heagerty, Patrick J, Monsell, Sarah E, Lawrence, Sarah O, Flum, David R, Lavallee, Danielle C, and Writing Group for the CODA Collaborative

Abstract

ObjectiveTo compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days.Summary background dataThe Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes.MethodsWe focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations.ResultsThe pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret.ConclusionsOverall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals.Trial registrationClinicaltrials.gov Identifier: NCT02800785.

Published
2022

8. Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis.

Author

Talan DA, Moran GJ, Krishnadasan A, Monsell SE, Faine BA, Uribe L, Kaji AH, DeUgarte DA, Self WH, Shapiro NI, Cuschieri J, Glaser J, Park PK, Price TP, Siparsky N, Sanchez SE, Machado-Aranda DA, Victory J, Ayoung-Chee P, Chiang W, Corsa J, Evans HL, Ferrigno L, Garcia L, Hatch Q, Horton MD, Johnson J, Jones A, Kao LS, Kelly A, Kim D, Kutcher ME, Liang MK, Maghami N, McGrane K, Minko E, Mohr C, Neufeld M, Patton JH, Rog C, Rushing A, Sabbatini AK, Salzberg M, Thompson CM, Tichter A, Wisler J, Bizzell B, Fannon E, Lawrence SO, Voldal EC, Lavallee DC, Comstock BA, Heagerty PJ, Davidson GH, Flum DR, and Kessler LG

Subjects
Acute Disease, Adult, Anti-Bacterial Agents therapeutic use, Appendectomy adverse effects, Cohort Studies, Female, Humans, Male, Outpatients, Appendicitis complications, Appendicitis surgery
Abstract

Importance: In the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs., Objective: To assess the use and safety of outpatient management of acute appendicitis., Design, Setting, and Participants: This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25 US hospitals from May 1, 2016, to February 28, 2020., Exposures: Participants randomized to antibiotics (intravenous then oral) could be discharged from the emergency department based on clinician judgment and prespecified criteria (hemodynamically stable, afebrile, oral intake tolerated, pain controlled, and follow-up confirmed). Outpatient management and hospitalization were defined as discharge within or after 24 hours, respectively., Main Outcomes and Measures: Outcomes compared among patients receiving outpatient vs inpatient care included serious adverse events (SAEs), appendectomies, health care encounters, satisfaction, missed workdays at 7 days, and EuroQol 5-dimension (EQ-5D) score at 30 days. In addition, appendectomy incidence among outpatients and inpatients, unadjusted and adjusted for illness severity, was compared., Results: Among 776 antibiotic-randomized participants, 42 (5.4%) underwent appendectomy within 24 hours and 8 (1.0%) did not receive their first antibiotic dose within 24 hours, leaving 726 (93.6%) comprising the study population (median age, 36 years; range, 18-86 years; 462 [63.6%] male; 437 [60.2%] White). Of these participants, 335 (46.1%; site range, 0-89.2%) were discharged within 24 hours, and 391 (53.9%) were discharged after 24 hours. Over 7 days, SAEs occurred in 0.9 (95% CI, 0.2-2.6) per 100 outpatients and 1.3 (95% CI, 0.4-2.9) per 100 inpatients; in the appendicolith subgroup, SAEs occurred in 2.3 (95% CI, 0.3-8.2) per 100 outpatients vs 2.8 (95% CI, 0.6-7.9) per 100 inpatients. During this period, appendectomy occurred in 9.9% (95% CI, 6.9%-13.7%) of outpatients and 14.1% (95% CI, 10.8%-18.0%) of inpatients; adjusted analysis demonstrated a similar difference in incidence (-4.0 percentage points; 95% CI, -8.7 to 0.6). At 30 days, appendectomies occurred in 12.6% (95% CI, 9.1%-16.7%) of outpatients and 19.0% (95% CI, 15.1%-23.4%) of inpatients. Outpatients missed fewer workdays (2.6 days; 95% CI, 2.3-2.9 days) than did inpatients (3.8 days; 95% CI, 3.4-4.3 days) and had similar frequency of return health care visits and high satisfaction and EQ-5D scores., Conclusions and Relevance: These findings support that outpatient antibiotic management is safe for selected adults with acute appendicitis, with no greater risk of complications or appendectomy than hospital care, and should be included in shared decision-making discussions of patient preferences for outcomes associated with nonoperative and operative care., Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Published
2022
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