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Study Title and Description

Long-term safety of once-daily multimatrix mesalazine: A pooled clinical trials analysis



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 Long-term safety of once-daily multimatrix mesalazine: A pooled clinical trials analysis
Author Silva Sanchez SD, H Wan, P Streck, D Willshire, JB Raskin
Country
Year 2014
Numbers

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: 5-ASA (4.8 g/d)
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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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Study Design Nonrandomized comparative study (NRCS)
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Nonrandomized comparative study (NRCS)
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Nonrandomized comparative study (NRCS)
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Country Not reported
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Not reported
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Not reported
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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 NCT00545740, NCT00545103
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Start and end years of the Study
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Inclusion criteria
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Exclusion criteria
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if not an RCT, what was the directionality? Unclear
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Specific population? Not reported
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If NRCS, what analytic method was used to account for differences between study arms? NR
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How was diverticulitis diagnosed
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Note/Comment about Design (or overall study) Missing information due to publication type: abstract
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Baseline Characteristics
Question Pharm: 5-ASA (4.8 g/d) Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics No data entered.
Participant Age - Continuous data (in years) No data entered.
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 Missing information due to publication type: abstract Missing information due to publication type: abstract
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Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
Outcome: Adverse event - any      Population: All Participants
Time Point Measure Pharm: 5-ASA (4.8 g/d)


Enter a numeric value or title (required) years

N Analyzed 299
Counts 211
Percentage 71
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Pharm: 5-ASA (4.8 g/d)


Enter a numeric value or title (required) years

N Analyzed 299
Counts
Percentage 6
Outcome: Adverse event - headache      Population: All Participants
Time Point Measure Pharm: 5-ASA (4.8 g/d)


Enter a numeric value or title (required) years

N Analyzed 299
Counts
Percentage 9


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
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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.
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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.
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No Data Abstract does not provide this information.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting No Data Abstract does not provide this information.
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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 Data Abstract does not provide this information.
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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.
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? No Data Abstract does not provide this information.
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? No Data Abstract does not provide this information.
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? No Data Abstract does not provide this information.
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Quality Rating
No quality rating data was found.