Extraction Form Preview:
Extraction Form for KQs 2 and 4
Arm Name Suggestions
| Arm Title | Arm Description | User Note |
|---|---|---|
| Setting: Inpatient management | ||
| Setting: Outpatient management | ||
| Antibiotics: Multiple (discretionary or undefined) | ||
| Antibiotics: Amoxicillin + Clavulanate | ||
| Antibiotics: Cephalosporin + Metronidazole | ||
| Antibiotics: Ciprofloxacin | ||
| IR: Percutaneous drainage | ||
| IR: No percutaneous drainage | ||
| Pharm: 5-ASA | AKA mesalazine, mesalamine | |
| Pharm: Probiotics | ||
| Non-pharm: Dietary modification | ||
| Elective surgery | ||
| Placebo | ||
| No intervention (non-placebo) |
Arm Details
Design Details and Enrollment
Baseline Characteristics Fields
Outcome Name Suggestions
| Outcome Title | Note |
|---|---|
| Resolution of diverticulitis | |
| Return to normal bowel function | |
| Length of hospital (or intensive care unit) stay | |
| Interventional radiology procedure for diverticulitis (avoidance) | |
| Conversion to (or occurrence of) complicated diverticulitis | |
| Surgery for diverticulitis, including colostomy (avoidance) | |
| Hospitalization (or re-hospitalization) for diverticulitis (avoidance) | |
| Quality of life | |
| Functional outcomes | |
| Resource use | |
| Missed work/school | |
| Mortality - Diverticulitis-related | |
| Mortality - All-cause (non-AE) | |
| Recurrence of diverticulitis | |
| Opioid misuse | |
| AE - Infection requiring Abx (CD II) | |
| AE - Clostridioides difficile (C diff) infection | |
| AE - Antibiotic resistance | |
| AE - Bleed requiring transfusion (CD II) | |
| AE - Return to OR or unplanned procedure (CD III) | |
| AE - Allergic reaction (major) | |
| AE - Serious (SAE) | |
| AE - Unplanned ICU admission (CD IV) | |
| AE - Unplanned (re)hospitalization (CD IV) | |
| AE - Stroke (CD IV) | |
| AE - Major cardiac event (CD IV) | |
| AE - Major pulmonary event (CD IV) | |
| AE - Sepsis (CD IV) | |
| AE - 30 day mortality (post-surgical, CD V) | |
| AE - AE resulting in treatment discontinuation | |
| AE - DVT |
Outcome Details
Quality Dimension Fields
| Quality Dimension | Value | Notes |
|---|---|---|
| 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 | ||
| 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. | ||
| Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | ||
| Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | ||
| Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting | ||
| Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. | ||
| Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? | ||
| Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | ||
| 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? | ||
| Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | ||
| Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | ||
| 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? | ||
| 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? | ||
| 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? | ||
| Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? | ||
| 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? | ||
| Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY | ||
| Q2: Did the study divide the follow up time of each individual participant into the different interventions? | ||
| Q11: Did the start and follow up calendar years coincide for most participants in the study? | ||
| Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | ||
| Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | ||
| Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | ||
| Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? |
Overall Rating of Study:
Quality Guideline Used in Assessment:
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