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Study Title and Description

A randomized controlled study of mesalamine after acute diverticulitis: results of the DIVA trial.



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 A randomized controlled study of mesalamine after acute diverticulitis: results of the DIVA trial.
Author Stollman N., Magowan S., Shanahan F., Quigley EM.
Country Division of Gastroenterology, Department of Medicine, University of California San Francisco, Oakland, CA, USA. neil@stollman.com
Year 2013
Numbers Pubmed ID: 23426454

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 Placebo
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2 Pharm: 5-ASA AKA mesalazine, mesalamine
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3 Pharm: Mesalamine + Probiotic
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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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KQ 4a: Pharmacologic (recur prev)
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KQ 4a: Pharmacologic (recur prev)
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Study Design RCT
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RCT
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RCT
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RCT
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Country USA
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USA
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USA
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USA
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Funder Industry (fully or in part)
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Study name DIVA
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Associated articles
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ClinicalTrials.gov identifier NCT00554099
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Start and end years of the Study 2007
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2010
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Inclusion criteria 35-85 years, diagnosis of acute diverticulitis (first, second, or third attack) confirmed by CT scan, a global symptom score >=12 at baseline, including an abdominal pain assessment score >2. Female patients had to be postmenopausal, surgically sterile, or have a negative pregnancy test and practice acceptable contraception.
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Exclusion criteria Complications of diverticulitis (abscess, perforation), IBS, fulfilling ROME criteria before their attack of diverticulitis; active or recent peptic ulcer; history of major abdominal or recent GI surgery; conditions causing malabsorption, chronic abdominal pain, GI motility disorder, or short bowel syndrome; C. Diff., bacterial pathogens, or ova and parasites
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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?
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How was diverticulitis diagnosed CT scan (radiographically judged to be consistent with acute diverticulitis)
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Note/Comment about Design (or overall study) Patients initially enrolled with acute diverticulitis, but randomization occurred after resolution, up to 14 days later
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Baseline Characteristics
Question Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 53.7 Male 42.5 Male 47.2
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White 95.1 White 97.5 White 91.7
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Black 4.9 Black 0 Black 5.6
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Hispanic/Latino 9.8 Hispanic/Latino 5 Hispanic/Latino 11.1
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Asian 0 Asian 0 Asian 2.8
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Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses Multiracial: 0 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses Multiracial: 2.5 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses Multiracial: 0
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Participant Age - Continuous data (in years) Mean 56.1 Mean 57.7 Mean 59.1
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SD 11.1 SD 12.8 SD 10.1
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Range 39, 79 Range 35, 83 Range 35, 75
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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) 0 51.2 0 45 0 52.8 0 49.6
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1 34.1 1 35 1 22.2 1 30.8
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2 14.6 2 20 2 25 2 19.7
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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
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic Comparison Measure


12 weeks

N Analyzed 41 40 36
Counts 8 5 4.248
Percentage 20 12.5 11.8


52 weeks

N Analyzed 29 32 27
Counts 9 9 10
Percentage 31 28.1 37
Outcome: Adverse event - any      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


12 weeks

N Analyzed 41 40 36
Counts
Percentage 41.5 47.5 38.9
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


12 weeks

N Analyzed 41 40 36
Counts 3 2 0
Percentage 7.3 5 0
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Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


12 weeks

N Analyzed 41 40 36
Counts 1 2 0
Percentage 2.4 5.0 0
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


12 weeks

N Analyzed 41 40 36
Counts 0 1 1
Percentage 0 2.5 2.78
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Outcome: Adverse event - headache      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


12 weeks

N Analyzed 41 41 36
Counts 0 0 1
Percentage 0 0 2.8
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Outcome: Adverse events - GI disorders      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


12 weeks

N Analyzed 41 40 36
Counts 10 11 6
Percentage 24.4 27.5 16.7
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Outcome: Global Symptom Score (GSS)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


52 weeks

N Analyzed 29 32 27
Counts 15 21 8
Percentage 50 66.7 29.2
note self-calculated the counts self-calculated the counts self-calculated the counts
P-Value
Outcome: Global Symptom Score (GSS)      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic Comparison Measure Pharm: 5-ASA vs. Placebo


52 weeks

N Analyzed 29 32 27 0.0452
Counts 5 12 2
Percentage 18.2 40.7 8.3
note self-calculated the counts self-calculated the counts self-calculated the counts
P-Value
Outcome: Time to recurrence      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic Comparison Measure ERROR vs. ERROR


52 weeks

N Analyzed 29 32 27 NS (across arms)
Mean 100.1 308.7 280.7
SD
SE
Outcome: Global Symptom Score (GSS)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: Mesalamine + Probiotic


Baseline N/A

N Analyzed 41 40 36
Mean 23.5 22
SD 9.1 8.6
Median 19.4


52 weeks

N Analyzed 41 40 36
Mean
SD
Median 5 1 4.4


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 No The investigator or designated repre- sentative called an Interactive Voice Response System for patient randomization and allocation of study medication.
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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 No The investigator or designated repre- sentative called an Interactive Voice Response System for patient randomization and allocation of study medication.
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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 Triple-blinded. Participant, Care Provider, Investigator (NCT)
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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 Triple-blinded. Participant, Care Provider, Investigator (NCT)
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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. No
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Yes Follow up on only the 75% who completed the 12-week course
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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?
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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?
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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?
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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?
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
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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?
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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?
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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?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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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?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN 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?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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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. No
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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Quality Rating
No quality rating data was found.