LETTER TO THE EDITOR Outpatient Versus Hospitalization Management for Uncomplicated Diverticulitis
REFERENCE 1. Biondo S, Golda T, Kreisler E, Espin E, et al. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER trial). Ann Surg. 2014;259:38–44.
Reply:
W
Michael A. Kohn, MD, MPP University of California, San Francisco Millbrae, CA [email protected]
e thank the authors for their letter on the article “Outpatient Versus Hospitalization Management for Uncomplicated Diverticulitis: A Prospective, Multicenter Randomized Clinical Trial (DIVER Trial).”1 We are sorry if some statement and results could have been the reason of confusion for the reader. We want to remark that in all the series of the study, death occurred only in one patient and not in 2 patients as the authors of the letter state. We agree with the comment that one of the criteria for treatment failure was hospital readmission or mortality during the first 60 days after discharge. On the basis of this last criterion, we should have stated “readmission during the first 60 days or mortality with a causal relationship with the treatment after discharge.” According to this definition, the patient in the outpatient group who suffered bacteremia and pulmonary embolism was considered as a readmission and she was 1 of the 3 patients with readmission in this group. This patient survived complications and did not die as the authors have commented in the letter. The patient who died as a consequence of acute myocardial infarction was not included among patients with treatment failure because when he suffered the myocardial infarction, he was diverticulitis symptom free since several days from discharge and we did
Disclosure: The author declares no conflicts of interest. C 2014 Wolters Kluwer Health, Inc. All Copyright rights reserved. ISSN: 0003-4932/14/26202-e0086 DOI: 10.1097/SLA.0000000000000633
Disclosure: The authors declare no conflicts of interest. 10.1097/SLA.0000000000000634
To the Editor: iondo et al1 report the results of a randomized trial comparing inpatient with outpatient treatment of computed tomography– proven left colonic diverticulitis. The patients all had computed tomographic findings with confined pericolic phlegmon (“Hinchey stage Ia). The total sample size was 132, with 66 patients in each treatment group. The authors reported 4 (6.1%) treatment failures (hospital readmission) in the inpatient group and 3 (4.5%) treatment failures in the outpatient group. So, the risk of treatment failure was actually lower in the outpatient group. However, they did not count 2 deaths in the outpatient group as treatment failures. (One of the deaths was due to bacteremia and pulmonary embolism, and the other was due to acute myocardial infarction.) In their “Methods” section, the authors define treatment failure as including “mortality during the first 60 days after discharge.” By calculating an outpatient treatment failure rate of 3 of 66 (4.5%) instead of 5 of 66 (7.6%), the authors did more than omit the 2 deaths from the treatment failures; they actually counted them as successful treatments.
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e86 | www.annalsofsurgery.com
not relate the adverse event with diverticulitis and treatment. When death occurred, the diagnosis of diverticular disease had already been confirmed by colonoscopy. Maybe, the fact that this patient was not included among patients with treatment failure could be considered as a misinterpretation. In any case, even if this patient had been considered as a case of failure, the percentage would be 6.1%, similar to that of the inpatient group (P = 1.000), and the confidence interval of difference (−9.3% to 9.3%) did not exceed the limit of no inferiority. We also want to stress that the hypothesis of the study was that outpatient care of patients with uncomplicated diverticulitis would be as safe and effective as hospitalization. A small difference in the percentage of readmission between the groups was observed in the study and weighted against the hospitalization treatment, as the risk of treatment failure was lower in the outpatient group. However, no management relevance is given to that observation except for emphasizing the safety of outpatient treatment. Sebastiano Biondo, MD, PhD Esther Kreisler, MD, PhD Thomas Golda, MD, PhD Colorectal Unit Department of General and Digestive Surgery Bellvitge University Hospital University of Barcelona Barcelona, Spain [email protected]
REFERENCE 1. Biondo S, Golda T, Kreisler E, et al. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial). Ann Surg. 2014;259:38–44.
Annals of Surgery r Volume 262, Number 2, August 2015
Copyright © 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
REFERENCE 1. Biondo S, Golda T, Kreisler E, Espin E, et al. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER trial). Ann Surg. 2014;259:38–44.
Reply:
W
Michael A. Kohn, MD, MPP University of California, San Francisco Millbrae, CA [email protected]
e thank the authors for their letter on the article “Outpatient Versus Hospitalization Management for Uncomplicated Diverticulitis: A Prospective, Multicenter Randomized Clinical Trial (DIVER Trial).”1 We are sorry if some statement and results could have been the reason of confusion for the reader. We want to remark that in all the series of the study, death occurred only in one patient and not in 2 patients as the authors of the letter state. We agree with the comment that one of the criteria for treatment failure was hospital readmission or mortality during the first 60 days after discharge. On the basis of this last criterion, we should have stated “readmission during the first 60 days or mortality with a causal relationship with the treatment after discharge.” According to this definition, the patient in the outpatient group who suffered bacteremia and pulmonary embolism was considered as a readmission and she was 1 of the 3 patients with readmission in this group. This patient survived complications and did not die as the authors have commented in the letter. The patient who died as a consequence of acute myocardial infarction was not included among patients with treatment failure because when he suffered the myocardial infarction, he was diverticulitis symptom free since several days from discharge and we did
Disclosure: The author declares no conflicts of interest. C 2014 Wolters Kluwer Health, Inc. All Copyright rights reserved. ISSN: 0003-4932/14/26202-e0086 DOI: 10.1097/SLA.0000000000000633
Disclosure: The authors declare no conflicts of interest. 10.1097/SLA.0000000000000634
To the Editor: iondo et al1 report the results of a randomized trial comparing inpatient with outpatient treatment of computed tomography– proven left colonic diverticulitis. The patients all had computed tomographic findings with confined pericolic phlegmon (“Hinchey stage Ia). The total sample size was 132, with 66 patients in each treatment group. The authors reported 4 (6.1%) treatment failures (hospital readmission) in the inpatient group and 3 (4.5%) treatment failures in the outpatient group. So, the risk of treatment failure was actually lower in the outpatient group. However, they did not count 2 deaths in the outpatient group as treatment failures. (One of the deaths was due to bacteremia and pulmonary embolism, and the other was due to acute myocardial infarction.) In their “Methods” section, the authors define treatment failure as including “mortality during the first 60 days after discharge.” By calculating an outpatient treatment failure rate of 3 of 66 (4.5%) instead of 5 of 66 (7.6%), the authors did more than omit the 2 deaths from the treatment failures; they actually counted them as successful treatments.
B
e86 | www.annalsofsurgery.com
not relate the adverse event with diverticulitis and treatment. When death occurred, the diagnosis of diverticular disease had already been confirmed by colonoscopy. Maybe, the fact that this patient was not included among patients with treatment failure could be considered as a misinterpretation. In any case, even if this patient had been considered as a case of failure, the percentage would be 6.1%, similar to that of the inpatient group (P = 1.000), and the confidence interval of difference (−9.3% to 9.3%) did not exceed the limit of no inferiority. We also want to stress that the hypothesis of the study was that outpatient care of patients with uncomplicated diverticulitis would be as safe and effective as hospitalization. A small difference in the percentage of readmission between the groups was observed in the study and weighted against the hospitalization treatment, as the risk of treatment failure was lower in the outpatient group. However, no management relevance is given to that observation except for emphasizing the safety of outpatient treatment. Sebastiano Biondo, MD, PhD Esther Kreisler, MD, PhD Thomas Golda, MD, PhD Colorectal Unit Department of General and Digestive Surgery Bellvitge University Hospital University of Barcelona Barcelona, Spain [email protected]
REFERENCE 1. Biondo S, Golda T, Kreisler E, et al. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial). Ann Surg. 2014;259:38–44.
Annals of Surgery r Volume 262, Number 2, August 2015
Copyright © 2014 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
