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Study Title and Description

Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial).



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 Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial).
Author Biondo S., Golda T., Kreisler E., Espin E., Vallribera F., Oteiza F., Codina-Cazador A., Pujadas M., Flor B.
Country *Department of General and Digestive Surgery--Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain †Department of General and Digestive Surgery-Colorectal Unit, Vall d'Hebron University Hospital, Barcelona, Spain ‡Department of General and Digestive Surgery-Colorectal Unit, Virgen del Camino Hospital, Pamplona, Spain §Department of General and Digestive Surgery--Colorectal Unit, Josep Trueta University Hospital, Girona, Spain; and ‖Surgery-Colorectal Unit, Hospital Clinico Universitario, Valencia, Spain.
Year 2014
Numbers Pubmed ID: 23732265

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 Patients were admitted to the ward after given the first dose of antibiotic treatment intravenously in the emergency department
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2 Setting: Outpatient management Patients were discharged after given the first dose of antibiotic treatment intravenously in the emergency department
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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 RCT
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RCT
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RCT
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RCT
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Country ... Specify Other ... Spain
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Funder Non-industry (fully)
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Study name DIVER Trial
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2009
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2011
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Inclusion criteria older than 18 years of age + uncomplicated diverticulitis able to tolerate oral intake + good response to first treatment measures in emergency (improvement of pain and fever) + willing to continue treatment at home under supervision
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Exclusion criteria complicated colonic diverticulitis; maintenance of tenderness, fever, or/and persistence or worsening of acute pain after analgesic and first doses of antibiotics;pregnancy or breastfeeding; intake of antibiotic for colonic diverticulitis in the month previous to actual diagnosis; colorectal cancer suspicion at computed tomographic findings; concomitant unstable comorbid conditions; immunosuppression; cognitive, social, or psychiatric impairment; intolerance to oral intake and persisting vomiting
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Specific population? No (all comers) hospital-based sample
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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?
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How was diverticulitis diagnosed Uncomplicated diverticulitis was defined as pericolic phlegmon (grade Ia, modified Hinchey classification).
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Note/Comment about Design (or overall study)
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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 57.6 Male 51.5 Male 54.5
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Participant Age - Continuous data (in years) Mean 56.8 Mean 55.9 Mean 56.3
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SD 12.8 SD 13.4 SD 13.0
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Complicated diverticulitis 0 Complicated diverticulitis 0 Complicated diverticulitis 0
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Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) Other_1 (include definition in %) Mean (SD): 0.39 (1.0)
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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) Mean 0.39 Mean 0.47
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SD 1.0 SD 0.9
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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 Setting: Inpatient management vs. Setting: Outpatient management


2 months

 N Analyzed 66 66 0.619
Counts 4 3
Percentage 6.1 4.5
P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure Setting: Inpatient management vs. Setting: Outpatient management


2 months

 N Analyzed 66 66 0.590
Mean 49.6 50.3
SD 8.7 7.2
P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure Setting: Inpatient management vs. Setting: Outpatient management


2 months

 N Analyzed 66 66 0.989
Mean 52.6 53.0
SD 9.5 8.6


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 Low
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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 Low
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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. Low only 5 pts lost to f/u
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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 Unclear No protocol referenced; unclear if report includes all pre-specified outcomes
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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? Not Applicable
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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? Not Applicable
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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? Not Applicable
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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? Not Applicable
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Not Applicable
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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? Not Applicable
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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? Not Applicable
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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 Not Applicable
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Q2: Did the study divide the follow up time of each individual participant into the different interventions? Not Applicable
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Q11: Did the start and follow up calendar years coincide for most participants in the study? Not Applicable
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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. Low
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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
Guideline Used Overall Rating