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Study Title and Description

Antibiotic treatment for uncomplicated and mild complicated diverticulitis: outpatient treatment for everyone.



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 Antibiotic treatment for uncomplicated and mild complicated diverticulitis: outpatient treatment for everyone.
Author Joliat GR., Emery J., Demartines N., Hübner M., Yersin B., Hahnloser D.
Country Department of Visceral Surgery, Lausanne University Hospital (CHUV), Rue du Bugnon 46, 1011, Lausanne, Switzerland.
Year 2017
Numbers Pubmed ID: 28664347

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 Setting: Inpatient management
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2 Setting: Outpatient management
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2a: Hospitalization (acute)
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KQ 2a: Hospitalization (acute)
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KQ 2a: Hospitalization (acute)
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KQ 2a: Hospitalization (acute)
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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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Nonrandomized comparative study (NRCS)
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Country ... Specify Other ... Switzerland
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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 2006
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2012
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Inclusion criteria uncomplicated or mild complicated diverticulitis, >18yo, CT based diagnosis of uD or mcD
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Exclusion criteria pts requiring an immediate (at admission) percutaneous drainage or surgery
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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? None. Crude; long term outcomes only
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How was diverticulitis diagnosed CT scan-based classification of Ambrosetti. Acute uD was defined as absence of the following: abscess, fistula, extraluminal contrast, pneumoperitoneum, and need for immediate percutaneous drainage/surgery. Acute mcD was defined as complicated diverticulitis with abscess <4 cm or pneumoperitoneum <2 cm.
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Note/Comment about Design (or overall study) Note, mixed uncomplicated with mild complicated pts. Also, # of prior diverticulitis episodes was not an exclusion criteria.
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Baseline Characteristics
Question Setting: Inpatient management Setting: Outpatient management Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 50 Male 64
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Participant Age - Continuous data (in years) Range 61 (50–72) Range 53 (44–64)
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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) 0 71 0 72
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History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Treatment failure      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure ERROR vs. ERROR


47 (29-74) for outpatient; 60 (34-82) for inpatient months

 N Analyzed 169 98 <0.001
Counts 54 10
P-Value
Outcome: Elective surgical treatment      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure Setting: Inpatient management vs. Setting: Outpatient management


47 (29-74) for outpatient; 60 (34-82) for inpatient N/A

 N Analyzed 169 98 0.497
Counts 30 14
P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure Setting: Inpatient management vs. Setting: Outpatient management


47 (29-74) for outpatient; 60 (34-82) for inpatient months

 N Analyzed 169 98 1
Counts 70 40


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 participants were aware of whether they were treated in hospital or as outpatients
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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 providers were aware of whether pts were treated in hospital or as outpatients
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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. Not Applicable
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data High outcomes based on surveys; incomplete response rate (44% non response for IT; 38% non response for OT)
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Unclear unclear if all survey outcomes are reported
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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.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? Y The decision of undertaking outpatient vs. inpatient approach was decided on a case by case basis by the surgeon or ER physician; differences between potential confounders noted (individuals treated as inpatient generally sicker)
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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? N
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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? NA
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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? N
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Serious
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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? PY outcomes based on responding to questionnaire. Questionnaire response (selection) may have been related to both the intervention and the outcome
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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? PY
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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? PY
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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? No No adjustment made to survey results for likely selection bias
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY Critical
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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? No No, retrospective cohort in 6 year span
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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. Yes patients were not blinded and self-reported outcomes; high risk
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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? No survey; no information on validation
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Quality Rating
Guideline Used Overall Rating