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Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial

IMPORTANCE: The factors associated with the failure of nonoperative management of appendicitis and the differences in patient-reported outcomes between successful and unsuccessful nonoperative management remain unknown. OBJECTIVES: To investigate factors associated with the failure of nonoperative m...

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Autores principales: Minneci, Peter C., Hade, Erinn M., Gil, Lindsay A., Metzger, Gregory A., Saito, Jacqueline M., Mak, Grace Z., Hirschl, Ronald B., Gadepalli, Samir, Helmrath, Michael A., Leys, Charles M., Sato, Thomas T., Lal, Dave R., Landman, Matthew P., Kabre, Rashmi, Fallat, Mary E., Cooper, Jennifer N., Deans, Katherine J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9062687/
https://www.ncbi.nlm.nih.gov/pubmed/35499827
http://dx.doi.org/10.1001/jamanetworkopen.2022.9712
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author Minneci, Peter C.
Hade, Erinn M.
Gil, Lindsay A.
Metzger, Gregory A.
Saito, Jacqueline M.
Mak, Grace Z.
Hirschl, Ronald B.
Gadepalli, Samir
Helmrath, Michael A.
Leys, Charles M.
Sato, Thomas T.
Lal, Dave R.
Landman, Matthew P.
Kabre, Rashmi
Fallat, Mary E.
Cooper, Jennifer N.
Deans, Katherine J.
author_facet Minneci, Peter C.
Hade, Erinn M.
Gil, Lindsay A.
Metzger, Gregory A.
Saito, Jacqueline M.
Mak, Grace Z.
Hirschl, Ronald B.
Gadepalli, Samir
Helmrath, Michael A.
Leys, Charles M.
Sato, Thomas T.
Lal, Dave R.
Landman, Matthew P.
Kabre, Rashmi
Fallat, Mary E.
Cooper, Jennifer N.
Deans, Katherine J.
author_sort Minneci, Peter C.
collection PubMed
description IMPORTANCE: The factors associated with the failure of nonoperative management of appendicitis and the differences in patient-reported outcomes between successful and unsuccessful nonoperative management remain unknown. OBJECTIVES: To investigate factors associated with the failure of nonoperative management of appendicitis and compare patient-reported outcomes between patients whose treatment succeeded and those whose treatment failed. DESIGN, SETTING, AND PARTICIPANTS: This study was a planned subgroup secondary analysis conducted in 10 children’s hospitals that included 370 children aged 7 to 17 years with uncomplicated appendicitis enrolled in a prospective, nonrandomized clinical trial between May 1, 2015, and October 31, 2018, with 1-year follow-up comparing nonoperative management with antibiotics vs surgery for uncomplicated appendicitis. Statistical analysis was performed from November 1, 2019, to February 12, 2022. INTERVENTIONS: Nonoperative management with antibiotics vs surgery. MAIN OUTCOMES AND MEASURES: Failure of nonoperative management and patient-reported outcomes. The relative risk (RR) of failure based on sociodemographic and clinical characteristics was calculated. Patient-reported outcomes were compared based on the success or failure of nonoperative management. RESULTS: Of 370 patients (34.6% of 1068 total patients; 229 boys [61.9%]; median age, 12.3 years [IQR, 10.0-14.6 years]) enrolled in the nonoperative group, treatment failure occurred for 125 patients (33.8%) at 1 year, with 53 patients (14.3%) undergoing appendectomy during initial hospitalization and 72 patients (19.5%) experiencing delayed treatment failure after hospital discharge. Higher patient-reported pain at presentation was associated with increased risk of in-hospital treatment failure (RR, 2.1 [95% CI, 1.0-4.4]) but not delayed treatment failure (RR, 1.3 [95% CI, 0.7-2.3]) or overall treatment failure at 1 year (RR, 1.5 [95% CI, 1.0-2.2]). Pain duration greater than 24 hours was associated with decreased risk of delayed treatment failure (RR, 0.3 [95% CI, 0.1-1.0]) but not in-hospital treatment failure (RR, 1.2 [95% CI, 0.5-2.7]) or treatment failure at 1 year (RR, 0.7 [95% CI, 0.4-1.2]). There was no increased risk of treatment failure associated with age, white blood cell count, sex, race, ethnicity, primary language, insurance status, transfer status, symptoms at presentation, or imaging results. Health care satisfaction at 30 days and patient-reported, health-related quality of life at 30 days and 1 year were not different. Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs 27.0; difference, 1.0 [95% CI, 0.01-2.0]) and 1 year (28.1 vs 27.0; difference, 1.1 [95% CI, 0.2-2.0]). CONCLUSIONS AND RELEVANCE: This analysis suggests that a higher pain level at presentation was associated with a higher risk of initial failure of nonoperative management and that a longer duration of pain was associated with lower risk of delayed treatment failure. Although satisfaction was high in both groups, satisfaction with the treatment decision was higher among patients with successful nonoperative management at 1 year. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02271932
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spelling pubmed-90626872022-05-18 Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial Minneci, Peter C. Hade, Erinn M. Gil, Lindsay A. Metzger, Gregory A. Saito, Jacqueline M. Mak, Grace Z. Hirschl, Ronald B. Gadepalli, Samir Helmrath, Michael A. Leys, Charles M. Sato, Thomas T. Lal, Dave R. Landman, Matthew P. Kabre, Rashmi Fallat, Mary E. Cooper, Jennifer N. Deans, Katherine J. JAMA Netw Open Original Investigation IMPORTANCE: The factors associated with the failure of nonoperative management of appendicitis and the differences in patient-reported outcomes between successful and unsuccessful nonoperative management remain unknown. OBJECTIVES: To investigate factors associated with the failure of nonoperative management of appendicitis and compare patient-reported outcomes between patients whose treatment succeeded and those whose treatment failed. DESIGN, SETTING, AND PARTICIPANTS: This study was a planned subgroup secondary analysis conducted in 10 children’s hospitals that included 370 children aged 7 to 17 years with uncomplicated appendicitis enrolled in a prospective, nonrandomized clinical trial between May 1, 2015, and October 31, 2018, with 1-year follow-up comparing nonoperative management with antibiotics vs surgery for uncomplicated appendicitis. Statistical analysis was performed from November 1, 2019, to February 12, 2022. INTERVENTIONS: Nonoperative management with antibiotics vs surgery. MAIN OUTCOMES AND MEASURES: Failure of nonoperative management and patient-reported outcomes. The relative risk (RR) of failure based on sociodemographic and clinical characteristics was calculated. Patient-reported outcomes were compared based on the success or failure of nonoperative management. RESULTS: Of 370 patients (34.6% of 1068 total patients; 229 boys [61.9%]; median age, 12.3 years [IQR, 10.0-14.6 years]) enrolled in the nonoperative group, treatment failure occurred for 125 patients (33.8%) at 1 year, with 53 patients (14.3%) undergoing appendectomy during initial hospitalization and 72 patients (19.5%) experiencing delayed treatment failure after hospital discharge. Higher patient-reported pain at presentation was associated with increased risk of in-hospital treatment failure (RR, 2.1 [95% CI, 1.0-4.4]) but not delayed treatment failure (RR, 1.3 [95% CI, 0.7-2.3]) or overall treatment failure at 1 year (RR, 1.5 [95% CI, 1.0-2.2]). Pain duration greater than 24 hours was associated with decreased risk of delayed treatment failure (RR, 0.3 [95% CI, 0.1-1.0]) but not in-hospital treatment failure (RR, 1.2 [95% CI, 0.5-2.7]) or treatment failure at 1 year (RR, 0.7 [95% CI, 0.4-1.2]). There was no increased risk of treatment failure associated with age, white blood cell count, sex, race, ethnicity, primary language, insurance status, transfer status, symptoms at presentation, or imaging results. Health care satisfaction at 30 days and patient-reported, health-related quality of life at 30 days and 1 year were not different. Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs 27.0; difference, 1.0 [95% CI, 0.01-2.0]) and 1 year (28.1 vs 27.0; difference, 1.1 [95% CI, 0.2-2.0]). CONCLUSIONS AND RELEVANCE: This analysis suggests that a higher pain level at presentation was associated with a higher risk of initial failure of nonoperative management and that a longer duration of pain was associated with lower risk of delayed treatment failure. Although satisfaction was high in both groups, satisfaction with the treatment decision was higher among patients with successful nonoperative management at 1 year. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02271932 American Medical Association 2022-05-02 /pmc/articles/PMC9062687/ /pubmed/35499827 http://dx.doi.org/10.1001/jamanetworkopen.2022.9712 Text en Copyright 2022 Minneci PC et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Minneci, Peter C.
Hade, Erinn M.
Gil, Lindsay A.
Metzger, Gregory A.
Saito, Jacqueline M.
Mak, Grace Z.
Hirschl, Ronald B.
Gadepalli, Samir
Helmrath, Michael A.
Leys, Charles M.
Sato, Thomas T.
Lal, Dave R.
Landman, Matthew P.
Kabre, Rashmi
Fallat, Mary E.
Cooper, Jennifer N.
Deans, Katherine J.
Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial
title Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial
title_full Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial
title_fullStr Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial
title_full_unstemmed Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial
title_short Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial
title_sort demographic and clinical characteristics associated with the failure of nonoperative management of uncomplicated appendicitis in children: secondary analysis of a nonrandomized clinical trial
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9062687/
https://www.ncbi.nlm.nih.gov/pubmed/35499827
http://dx.doi.org/10.1001/jamanetworkopen.2022.9712
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