Study Preview
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? |
Primary Publication Information
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 | ||
2 | Pharm: 5-ASA | AKA mesalazine, mesalamine |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4a: Pharmacologic (recur prev) | ||
KQ 4a: Pharmacologic (recur prev) | |||
Study Design | Nonrandomized comparative study (NRCS) | ||
Nonrandomized comparative study (NRCS) | |||
Country ... Specify | Other ... | Italy | |
Funder | Not reported (or unclear) | ||
Study name | |||
Associated articles | |||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2010 | ||
2014 | |||
Inclusion criteria | ≥18 yrs, with ≥1 documented episode of acute diverticulitis in the previous 24 months that resolved w/o surgery | ||
Exclusion criteria | Previous abdominal surgery (except appendectomy and hernia repair), history of IBD or cancer, active psychiatric disease. | ||
if not an RCT, what was the directionality? | Retrospective | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? | CT | ||
If NRCS, what analytic method was used to account for differences between study arms? | The initial model included potential confounders. | ||
How was diverticulitis diagnosed | CT scan of the abdomen/pelvis, elevated WBC count, elevated C-reactive protein, and abdominal pain. | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Pharm: rifaximin | Pharm: 5-ASA | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 47.2 | Male | 42.3 | |||
Participant Age - Continuous data (in years) | No data entered. | ||||||
Participant Age - Categorical data | <= 65 years | <= 65 years | |||||
45.8 | 51.9 | ||||||
>65 years | >65 years | ||||||
54.2 | 48.1 | ||||||
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 | |||
>=2 | 13.9 | >=2 | 9.6 | ||||
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
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 | ||
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | Not Applicable | ||
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) | |
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) | |
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) | |
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | Yes | ||
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | Yes | Unclear if additional outcomes were studied and not reported | |
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | |||
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 | |
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 | |
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 | |
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 | |
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | Yes | ||
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) | |
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 | ||
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 | ||
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) | |
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 | ||
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 | |
Q2: Did the study divide the follow up time of each individual participant into the different interventions? | No | ||
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 | |
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) | |
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | Yes | ||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | Yes | ||
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Yes |
Quality Rating
Guideline Used | Overall Rating |
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