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Study Title and Description

Retrospective comparison of long-term ten-day/month rifaximin or mesalazine in prevention of relapse in acute diverticulitis.



Key Questions Addressed
4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Retrospective comparison of long-term ten-day/month rifaximin or mesalazine in prevention of relapse in acute diverticulitis.
Author Festa V., Spila Alegiani S., Chiesara F., Moretti A., Bianchi M., Dezi A., Traversa G., Koch M.
Country Gastroenterology and Liver Unit, S. Filippo Neri General Hospital, Rome, Italy. virginia.festa@asl-rme.it.
Year 2017
Numbers Pubmed ID: 28387885

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 Pharm: rifaximin
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2 Pharm: 5-ASA AKA mesalazine, mesalamine
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4a: Pharmacologic (recur prev)
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KQ 4a: Pharmacologic (recur prev)
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Study Design Nonrandomized comparative study (NRCS)
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Nonrandomized comparative study (NRCS)
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Country ... Specify Other ... Italy
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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 2010
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2014
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Inclusion criteria ≥18 yrs, with ≥1 documented episode of acute diverticulitis in the previous 24 months that resolved w/o surgery
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Exclusion criteria Previous abdominal surgery (except appendectomy and hernia repair), history of IBD or cancer, active psychiatric disease.
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if not an RCT, what was the directionality? Retrospective
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Specific population? No (all comers)
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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? The initial model included potential confounders.
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How was diverticulitis diagnosed CT scan of the abdomen/pelvis, elevated WBC count, elevated C-reactive protein, and abdominal pain.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Pharm: rifaximin Pharm: 5-ASA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 47.2 Male 42.3
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Participant Age - Continuous data (in years) No data entered.
Participant Age - Categorical data <= 65 years <= 65 years
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45.8 51.9
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>65 years >65 years
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54.2 48.1
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Participants with Un/Complicated Diverticulitis No data entered.
Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 1 86.1 1 90.4
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>=2 13.9 >=2 9.6
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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. Hazard Ratio (HR) Adj. 95% CI low Adj. 95% CI high
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Pharm: rifaximin Pharm: 5-ASA Comparison Measure Pharm: 5-ASA vs. Pharm: rifaximin


15 months

N Analyzed 72 52 0.27
Counts 7 14 0.10
Percentage 9.7 26.9 0.72
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: All Participants
Time Point Measure Pharm: rifaximin Pharm: 5-ASA


15 months

N Analyzed 72 52
Counts 2 2
Percentage
Outcome: Adverse event - any      Population: All Participants
Time Point Measure Pharm: rifaximin Pharm: 5-ASA


15 months

N Analyzed 72 52
Counts 0 1
Percentage
Outcome: Resolution of diverticulitis      Population: All Participants
Time Point Measure Pharm: rifaximin Pharm: 5-ASA


24 months

N Analyzed 72 52
Counts
Percentage 83.3 71.1


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 Not Applicable
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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 Not Applicable
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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 Yes Participants were not blinded to the drug they were receiving; potential high risk of bias (although the drugs were believed to be equivalent in efficacy as described by the study)
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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. Yes Care providers were not blinded to the drug. Selection of drug up to 2 treating physicians; potential high risk of bias (although the drugs were believed to be equivalent in efficacy as described by the study)
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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. Yes Outcome assessors were not blinded to the drug patients received; potential high risk of bias (although the drugs were believed to be equivalent in efficacy as described by the study)
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Yes
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Yes Unclear if additional outcomes were studied and not reported
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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.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? Yes Used MV Cox regression analysis with important confounders. Kept only significant predictors using stepwise backward approach. Possible confounding from eliminated predictors and confounders not observed and included in the model
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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 MV Cox regression analysis
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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? Unsure Demographic and clinical characteristics extracted from charts
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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 Baseline variables
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Yes
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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 Retrospective, but selection based on established diagnosis of diverticular disease from chart w/ previous episode of AD (prior to treatment)
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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? Not Applicable
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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? Not Applicable
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? Yes Patients were treated after index treatment (although not definitely defined)
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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 No Assess there to be low risk of bias for the selection of participants into the study
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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? No Retrospective cohort of pts meeting eligibility criteria 2010-14
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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 Outcome assessors were not blinded to the drug patients received; potential high risk of bias (although the drugs were believed to be equivalent in efficacy as described by the study) (NB: no apparent subjective outcomes reported; domain NA)
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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? Yes
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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
Guideline Used Overall Rating