Study Preview
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? |
Primary Publication Information
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 | ||
2 | No intervention (non-placebo) | Nonoperative management |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4c: Surgery (recur prev) | ||
KQ 4c: Surgery (recur prev) | |||
Study Design | Nonrandomized comparative study (NRCS) | ||
Nonrandomized comparative study (NRCS) | |||
Country | USA | ||
USA | |||
Funder | Not reported (or unclear) | ||
Study name | |||
Associated articles | |||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2002 | ||
2010 | |||
Inclusion criteria | at least 18 years, acute diverticular abscess | ||
Exclusion criteria | laparotomy, laparoscopy, colectomy or stoma creation within 2 days of admission; concurrent diagnosis of colorectal cancer, cirrhosis, or ascites | ||
if not an RCT, what was the directionality? | Retrospective | ||
Specific population? | No (all comers) | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | Not reported | |
If NRCS, what analytic method was used to account for differences between study arms? | Multivariable analysis | ||
How was diverticulitis diagnosed | NR | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Elective surgery | No intervention (non-placebo) | Total | Comments | |||
---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
Participant race/ethnicity characteristics | Male | 51.8 | Male | 46.3 | Not reported | ||
White | 87.1 | White | 74.2 | ||||
Black | 4.8 | Black | 11.9 | ||||
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 | ||||
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 | ||||
Participant Age - Continuous data (in years) | Median | 56 | Median | 58 | Not reported | ||
IQR | 47, 66 | IQR | 47, 72 | ||||
Participant Age - Categorical data | <=50 years | <=50 years | |||||
35.3 | 33.8 | ||||||
51-65 years | 51-65 years | ||||||
39.2 | 30.7 | ||||||
>65 years | >65 years | ||||||
25.5 | 35.6 | ||||||
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 | ||
History of (Prior) Complicated Diverticulitis | Not reported | Not reported | Not reported | ||||
KQ 4: Time Since Last Episode of Diverticulitis | Not reported | Not reported | Not reported | ||||
Note/Comment about baseline characteristics | No data entered. | ||||||
Number of Prior Episodes of Diverticulitis (continuous) | Not reported | Not reported | Not reported |
Results & Comparisons
Results Data
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 |
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 |
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 |
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 | |||
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | |||
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | No | ||
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 | ||
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 | ||
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | No | ||
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | No | ||
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | Low | ||
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? | Yes | ||
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | Yes | ||
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 | ||
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | No | ||
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | Low | ||
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 | ||
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 | ||
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 | ||
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? | Yes | ||
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 | Low | ||
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? | Yes | ||
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 | ||
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
No quality rating data was found.