Patient and Physician Preferences for Antibiotics in Acute Uncomplicated Diverticulitis: A Delphi Consensus Process to Generate Noninferiority Margins.
Acute Disease
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents
/ therapeutic use
Attitude of Health Personnel
Conservative Treatment
Delphi Technique
Diverticulitis, Colonic
/ drug therapy
Female
Humans
Male
Middle Aged
Patient Education as Topic
Patient Preference
/ psychology
Physicians
/ psychology
Risk Assessment
Journal
Diseases of the colon and rectum
ISSN: 1530-0358
Titre abrégé: Dis Colon Rectum
Pays: United States
ID NLM: 0372764
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
pubmed:
24
10
2020
medline:
23
4
2021
entrez:
23
10
2020
Statut:
ppublish
Résumé
Despite the existing evidence, the omission of antibiotics in the management of acute uncomplicated diverticulitis has not gained widespread acceptance. This study aims to incorporate the input of both patients and physicians on the omission of antibiotics in uncomplicated diverticulitis to generate noninferiority margins for 3 outcomes. This was a mixed-methods study, including in-person interviews with patients and a Delphi process with physicians. North American patients and physicians participated. Consecutive patients undergoing colonoscopy, 40% of whom had a previous history of diverticulitis, were selected. Informational video (for patients) and evidence summaries (for physicians) regarding antibiotics in diverticulitis were reviewed. Noninferiority margins were generated for time to reach full recovery, persistent diverticulitis, and progression to complicated diverticulitis in the context of a nonantibiotic strategy. Consensus was defined as an interquartile range <2.5. Fifty patients participated in this study. To avoid antibiotics, patients were willing to accept up to 5.0 (3.0-7.0) days longer to reach full recovery, up to an absolute increase of 4.0% (4.0-6.0) in the risk of developing persistent diverticulitis, and up to an absolute increase of 2.0% (0-3.8) in the risk of progressing to complicated diverticulitis. A total of 55 physicians participated in the Delphi (round 1 response rate = 94.8%; round 2 response rate = 100%). Consensus noninferiority margins were generated for persistent diverticulitis (4.0%, 4.0-5.0) and progression to complicated diverticulitis (3.0%, 2.0-3.0), but could not be generated for time to reach full recovery (5.0 days, 3.5-7.0). Patients were recruited from a single institution, and Delphi participants were invited and not randomly selected. Noninferiority margins were generated for 3 important outcomes after the treatment of acute uncomplicated diverticulitis in the context of a nonantibiotic strategy.
Sections du résumé
BACKGROUND
Despite the existing evidence, the omission of antibiotics in the management of acute uncomplicated diverticulitis has not gained widespread acceptance.
OBJECTIVE
This study aims to incorporate the input of both patients and physicians on the omission of antibiotics in uncomplicated diverticulitis to generate noninferiority margins for 3 outcomes.
DESIGN
This was a mixed-methods study, including in-person interviews with patients and a Delphi process with physicians.
SETTINGS
North American patients and physicians participated.
PATIENTS
Consecutive patients undergoing colonoscopy, 40% of whom had a previous history of diverticulitis, were selected.
INTERVENTIONS
Informational video (for patients) and evidence summaries (for physicians) regarding antibiotics in diverticulitis were reviewed.
MAIN OUTCOMES MEASURES
Noninferiority margins were generated for time to reach full recovery, persistent diverticulitis, and progression to complicated diverticulitis in the context of a nonantibiotic strategy. Consensus was defined as an interquartile range <2.5.
RESULTS
Fifty patients participated in this study. To avoid antibiotics, patients were willing to accept up to 5.0 (3.0-7.0) days longer to reach full recovery, up to an absolute increase of 4.0% (4.0-6.0) in the risk of developing persistent diverticulitis, and up to an absolute increase of 2.0% (0-3.8) in the risk of progressing to complicated diverticulitis. A total of 55 physicians participated in the Delphi (round 1 response rate = 94.8%; round 2 response rate = 100%). Consensus noninferiority margins were generated for persistent diverticulitis (4.0%, 4.0-5.0) and progression to complicated diverticulitis (3.0%, 2.0-3.0), but could not be generated for time to reach full recovery (5.0 days, 3.5-7.0).
LIMITATIONS
Patients were recruited from a single institution, and Delphi participants were invited and not randomly selected.
CONCLUSION
Noninferiority margins were generated for 3 important outcomes after the treatment of acute uncomplicated diverticulitis in the context of a nonantibiotic strategy.
Identifiants
pubmed: 33093297
doi: 10.1097/DCR.0000000000001815
pii: 00003453-202101000-00020
doi:
Substances chimiques
Anti-Bacterial Agents
0
Types de publication
Consensus Development Conference
Journal Article
Video-Audio Media
Langues
eng
Sous-ensembles de citation
IM
Pagination
119-127Références
Strate LL, Morris AM. Epidemiology, pathophysiology, and treatment of diverticulitis. Gastroenterology. 2019; 156:1282–1298.e1
Tursi A, Brandimarte G, Giorgetti G, Elisei W, Maiorano M, Aiello F. The clinical picture of uncomplicated versus complicated diverticulitis of the colon. Dig Dis Sci. 2008; 53:2474–2479
Floch MH. A hypothesis: is diverticulitis a type of inflammatory bowel disease? J Clin Gastroenterol. 2006; 40suppl 3S121–S125
Isacson D, Andreasson K, Nikberg M, Smedh K, Chabok A. No antibiotics in acute uncomplicated diverticulitis: does it work? Scand J Gastroenterol. 2014; 49:1441–1446
Mali JP, Mentula PJ, Leppäniemi AK, Sallinen VJ. Symptomatic treatment for uncomplicated acute diverticulitis: a prospective cohort study. Dis Colon Rectum. 2016; 59:529–534
Brochmann ND, Schultz JK, Jakobsen GS, Øresland T. Management of acute uncomplicated diverticulitis without antibiotics: a single-centre cohort study. Colorectal Dis. 2016; 18:1101–1107
de Korte N, Kuyvenhoven JP, van der Peet DL, Felt-Bersma RJ, Cuesta MA, Stockmann HB. Mild colonic diverticulitis can be treated without antibiotics. A case-control study. Colorectal Dis. 2012; 14:325–330
Ünlü Ç, Gunadi PM, Gerhards MF, Boermeester MA, Vrouenraets BC. Outpatient treatment for acute uncomplicated diverticulitis. Eur J Gastroenterol Hepatol. 2013; 25:1038–1043
Hjern F, Josephson T, Altman D, et al. Conservative treatment of acute colonic diverticulitis: are antibiotics always mandatory? Scand J Gastroenterol. 2007; 42:41–47
Chabok A, Påhlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012; 99:532–539
Daniels L, Ünlü Ç, de Korte N, et al.; Dutch Diverticular Disease (3D) Collaborative Study Group. Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis. Br J Surg. 2017; 104:52–61
Francis NK, Sylla P, Abou-Khalil M, et al. EAES and SAGES 2018 consensus conference on acute diverticulitis management: evidence-based recommendations for clinical practice. Surg Endosc. 2019; 33:2726–2741
Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the management of acute diverticulitis. Gastroenterology. 2015; 149:1944–1949
Feingold D, Steele SR, Lee S, et al. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014; 57:284–294
Mauri L, D’Agostino RB Sr. Challenges in the design and interpretation of noninferiority trials. N Engl J Med. 2017; 377:1357–1367
Treadwell JR, Uhl S, Tipton K, et al. Assessing equivalence and noninferiority. J Clin Epidemiol. 2012; 65:1144–1149
Kennedy ED, Borowiec AM, Schmocker S, et al. Patient and physician preferences for nonoperative management for low rectal cancer: is it a reasonable treatment option? Dis Colon Rectum. 2018; 61:1281–1289
Acuna SA, Chesney TR, Amarasekera ST, Baxter NN. Defining non-inferiority margins for quality of surgical resection for rectal cancer: a Delphi consensus study. Ann Surg Oncol. 2018; 25:3171–3178
Lee AC, Cousens S, Darmstadt GL, et al. Care during labor and birth for the prevention of intrapartum-related neonatal deaths: a systematic review and Delphi estimation of mortality effect. BMC Public Health. 2011; 11suppl 3S10
Acuna SA, Chesney TR, Baxter NN. Incorporating patient preferences in noninferiority trials [published online ahead of print June 24, 2019].. JAMA. doi: 10.1001/jama.2019.7059
doi: 10.1001/jama.2019.7059
Montgomery AA, Fahey T. How do patients’ treatment preferences compare with those of clinicians? Qual Health Care. 2001; 10suppl 1i39–i43
Rehal S, Morris TP, Fielding K, Carpenter JR, Phillips PP. Non-inferiority trials: are they inferior? A systematic review of reporting in major medical journals. BMJ Open. 2016; 6:e012594
Acuna SA, Chesney TR, Ramjist JK, Shah PS, Kennedy ED, Baxter NN. Laparoscopic versus open resection for rectal cancer: a noninferiority meta-analysis of quality of surgical resection outcomes. Ann Surg. 2019; 269:849–855
Garfinkle R, Boutros M. Recurrent versus persistent diverticulitis: an important distinction. Dis Colon Rectum. 2016; 59:e437
Gervaz P, Ambrosetti P. Time for a (re) definition of (recurrent) sigmoid diverticulitis? Ann Surg. 2011; 254:1076–1077