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Study Title and Description

Population-based study of outcomes following an initial acute diverticular abscess.



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 Population-based study of outcomes following an initial acute diverticular abscess.
Author Aquina CT., Becerra AZ., Xu Z., Justiniano CF., Noyes K., Monson JRT., Fleming FJ.
Country Surgical Health Outcomes and Research Enterprise (SHORE), Department of Surgery, University of Rochester Medical Center, Rochester, New York, USA.
Year 2019
Numbers Pubmed ID: 30335195

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 Elective surgery
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2 No intervention (non-placebo) Nonoperative management
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (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 USA
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USA
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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 2002
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2010
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Inclusion criteria at least 18 years, acute diverticular abscess
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Exclusion criteria laparotomy, laparoscopy, colectomy or stoma creation within 2 days of admission; concurrent diagnosis of colorectal cancer, cirrhosis, or ascites
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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? ... Unclear/Multiple methods (explain) ... Not reported
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If NRCS, what analytic method was used to account for differences between study arms? Multivariable analysis
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How was diverticulitis diagnosed NR
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery No intervention (non-placebo) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 51.8 Male 46.3 Not reported
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White 87.1 White 74.2
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Black 4.8 Black 11.9
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Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses Other...5.6 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses Other...11.1
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Other (or specific) race/ethnicity 2 - include race/ethnicity in parentheses Unknown...2.5 Other (or specific) race/ethnicity 2 - include race/ethnicity in parentheses Unknown...2.7
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Participant Age - Continuous data (in years) Median 56 Median 58 Not reported
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IQR 47, 66 IQR 47, 72
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Participant Age - Categorical data <=50 years <=50 years
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35.3 33.8
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51-65 years 51-65 years
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39.2 30.7
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>65 years >65 years
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25.5 35.6
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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) Other_1 (include definition in %) >=1... 16.3 Other_1 (include definition in %) >=1... 10.0 Not reported
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History of (Prior) Complicated Diverticulitis Not reported Not reported 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 Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Adverse events - Other      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


5 years

 N Analyzed 1660 5412 <0.001
Counts 166 309 1.88
Percentage 10.0 5.7 1.50
2.36
Outcome: Adverse events - Other      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


5 years

 N Analyzed 1660 5412
Counts 87 73
Percentage 5.2 1.3
Outcome: Adverse events - Other      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


5 years

 N Analyzed 1660 5412
Counts 80 243
Percentage 4.8 4.5
Outcome: Mortality - Diverticulitis-related      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


30 days

 N Analyzed 1660 5412
Counts 3 104
Percentage 0.2 1.9
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


5 years

 N Analyzed 1660 5412 <0.001
Counts 70 1340
Percentage 4.2 24.8
Outcome: Recurrence of diverticulitis      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


5 years

 N Analyzed 5412
Counts 398
Percentage 7.4
Outcome: Recurrence of diverticulitis      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


5 years

 N Analyzed 5412
Counts 735
Percentage 13.6
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


5 years

 N Analyzed 1660 5412 <0.001
Mean 8.0 4.6
SD 7.8 18.5
P-Value
Outcome: Resource use      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery No intervention (non-placebo) Comparison Measure Elective surgery vs. No intervention (non-placebo)


5 years

 N Analyzed 1660 5412 <0.001
Mean 70107 24490
SD 38832 95067
Outcome: Recurrence of diverticulitis      Population: All Participants
Time Point Measure Elective surgery No intervention (non-placebo)


5 years

 N Enrolled 5412
Median 278
25th Percentile 93.5
75th Percentile 707


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 No
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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
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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 Data
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No
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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. 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? No
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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? No
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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. No Data
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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.