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Study Title and Description

Determinants of treatment and outcomes of diverticular abscesses.



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 Determinants of treatment and outcomes of diverticular abscesses.
Author Mali J., Mentula P., Leppäniemi A., Sallinen V.
Country 1Department of Abdominal Surgery, University of Helsinki and HUS Helsinki University Hospital, Haartmaninkatu 4, 00029 HUS, Helsinki, Finland.
Year 2019
Numbers Pubmed ID: 31320921

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 IR: Percutaneous drainage
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2 Antibiotics: Multiple (discretionary or undefined)
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2c: Interventional radiology (acute)
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Study Design Nonrandomized comparative study (NRCS)
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Country ... Specify Other ... Finland
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Funder Non-industry (fully)
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Study name Helsinki University Hospital 2016-13
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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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2013
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Inclusion criteria Abscess size >40mm,
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Exclusion criteria Colon cancer mimicking diverticulitis
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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? multivariable logistic regression
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How was diverticulitis diagnosed CT
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 61 Male 39 Not reported
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Participant Age - Continuous data (in years) Median 60 Median 67 Not reported
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IQR 50, 69 IQR 55, 78
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 100 Complicated diverticulitis 100 Not reported
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Specific Complications of Diverticulitis Abscess ≥ 40mm Abscess ≥ 40mm
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100 100
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Number of Prior Episodes of Diverticulitis (categorical) Other_1 (include definition in %) >=1...44% Other_1 (include definition in %) >=1...33% Not reported
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History of (Prior) Complicated Diverticulitis Yes 44 Yes 33 Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Not reported Not reported Not reported
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) Not reported Not reported Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: Mortality - Diverticulitis-related      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


30 days

N Analyzed 18 18 1
Counts 1 1
Percentage 6 6
P-Value
Outcome: Treatment failure      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


30 days

N Analyzed 18 18 0.49
Counts 6 8
Percentage 33 44
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


30 days

N Analyzed 12 12 1
Counts 1 2
Percentage 8 17
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. IR: Percutaneous drainage


30 days

N Analyzed 12 12 1
Counts 1 1
Percentage 8 8
P-Value
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


30 days

N Analyzed 18 18 1
Counts 2 3
Percentage 11 17
P-Value P-Value
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


During initial admission N/A

N Analyzed 18 18 1
Counts 5 5
Percentage 28 28


>30 days

N Analyzed 18 18 1
Counts 9 8
Percentage 50 44
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


30 days

N Analyzed 12 12 1
Counts 1 2
Percentage 8 17
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


30 days

N Analyzed 12 12 1
Counts 1 1
Percentage 8 8
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure IR: Percutaneous drainage Antibiotics: Multiple (discretionary or undefined) Comparison Measure IR: Percutaneous drainage vs. Antibiotics: Multiple (discretionary or undefined)


30 days

N Analyzed 18 18 0.73
Median 6 6
25th Percentile 3 3
75th Percentile 12 10


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 High
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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. High
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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. High
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
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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. Low
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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
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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? 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
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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. High
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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
No quality rating data was found.