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Study Title and Description

Outpatient treatment of acute diverticulitis: rates and predictors of failure.



Key Questions Addressed
2 KEY QUESTION 2 KQ 2: What are the benefits and harms of various treatment options for the treatment of acute diverticulitis? KQ 2a. For patients with acute uncomplicated diverticulitis, what are the effectiveness and harms of hospitalization versus outpatient management of the acute episode? • Do the effects and harms vary by patient characteristics, presentation or course of illness, or other factors? KQ 2b. For patients with acute uncomplicated or complicated diverticulitis, what are the effects, comparative effects, and harms of antibiotics? • Do the effects and harms vary between patients with complicated or uncomplicated diverticulitis? • Do the (comparative) effects and harms vary by route of administration of antibiotics, type of antibiotic, and duration of course of antibiotics? • Do the (comparative) effects and harms vary by patient characteristics, presentation or course of illness, or other factors? KQ 2c. For patients with acute complicated diverticulitis, what are the effects and harms of interventional radiology procedures compared with conservative management? • Do the effects and harms vary by patient characteristics, presentation or course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Outpatient treatment of acute diverticulitis: rates and predictors of failure.
Author Etzioni DA., Chiu VY., Cannom RR., Burchette RJ., Haigh PI., Abbas MA.
Country Department of Colorectal Surgery, University of Southern California, Los Angeles, California 90033, USA. Etzioni.david@gmail.com
Year 2010
Numbers Pubmed ID: 20484998

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction Form for KQs 2 and 4
Arms
Number Title Description Comments
1 Antibiotics: Fluoroquinolone+metronidazole
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2 Antibiotics: Multiple (discretionary or undefined) Other
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3 Antibiotic duration: <10 days
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4 Antibiotic duration: 10-13 days
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5 Antibiotic duration: 14+ days
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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Study Design Nonrandomized comparative study (NRCS)
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Country USA
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Funder Not reported (or unclear)
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Study name
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2006
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2007
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Inclusion criteria evaluated in Kaiser Permanente ED for a primary assigned diagnosis of acute diverticulitis, continuously enrolled as a member in Kaiser Permanente system before the index treatment episode,
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Exclusion criteria admitted for inpatient treatment, prior diagnosis of diverticulitis, colorectal cancer, inflammatory bowel disease, did not have CT within 1 year of ED evaluation
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if not an RCT, what was the directionality? Retrospective
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Specific population? ... Population specified... ... We analyzed any patient who was evaluated in a KPSC emergency department (ED) for a primary assigned diagnosis of acute diverticulitis, as defined by International Classification of Disease (ICD)
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Was diverticulitis diagnosed with CT? CT
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If NRCS, what analytic method was used to account for differences between study arms?
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How was diverticulitis diagnosed ICD codes
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Antibiotics: Fluoroquinolone+metronidazole Antibiotics: Multiple (discretionary or undefined) Antibiotic duration: <10 days Antibiotic duration: 10-13 days Antibiotic duration: 14+ days Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 46
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Participant Age - Continuous data (in years) Mean 58.5
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis No data entered.
Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) No data entered.
History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotics: Fluoroquinolone+metronidazole Antibiotics: Multiple (discretionary or undefined) Antibiotic duration: <10 days Antibiotic duration: 10-13 days Antibiotic duration: 14+ days Comparison Measure Antibiotics: Fluoroquinolone+metronidazole vs. Antibiotics: Multiple (discretionary or undefined) Antibiotic duration: <10 days vs. Antibiotic duration: 10-13 days Antibiotic duration: <10 days vs. Antibiotic duration: 14+ days


Enter a numeric value or title (required) years

 N Analyzed 589 104 107 485 101 1.05 0.72 0.68
Counts 34 5 7 27 5 0.38 0.29 0.20
Percentage 5.8 4.8 6.5 5.6 5 2.92 1.78 2.35


Quality Dimensions
Dimension Value Notes Comments
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study No
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. No
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Unsure
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting No
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. No
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? Yes
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? Yes Multivariable logistic regression adjusting for age, sex, race/ethnicity, Charlson score, CT scan findings (presence/absence of abscess, phlegmon, perforation, and free fluid), WBC count, and antibiotic used/duration of use
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study? Yes
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? No
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Low
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention? No
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention? No
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome? No
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? Yes
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases? Not Applicable
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY Low
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Q2: Did the study divide the follow up time of each individual participant into the different interventions? No
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Q11: Did the start and follow up calendar years coincide for most participants in the study? Yes
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Not Applicable
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? No
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? Yes
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Quality Rating
No quality rating data was found.