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Study Title and Description

Outpatient treatment for acute uncomplicated diverticulitis.



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 treatment for acute uncomplicated diverticulitis.
Author Ünlü Ç., Gunadi PM., Gerhards MF., Boermeester MA., Vrouenraets BC.
Country aDepartment of Surgery, Sint Lucas Andreas Hospital bDepartment of Surgery, Onze Lieve Vrouwe Gasthuis cDepartment of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Year 2013
Numbers Pubmed ID: 23636075

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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Country ... Specify Other ... The Netherlands
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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 2004
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2012
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Inclusion criteria ICD-9 codes for diverticulitis
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Exclusion criteria recurrent diverticulitis, complicated diverticulitis (Hinchey stages 2, 3, and 4), and right-sided diverticulitis
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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) ...
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If NRCS, what analytic method was used to account for differences between study arms? crude; no adjustment
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How was diverticulitis diagnosed first made on the basis of symptoms, physical examination, blood tests, and blood culture results. In patients suspected of having diverticulitis, the diagnosis was confirmed by ultrasonography (US), computed tomography (CT), or in rare cases by colonoscopy if patients were referred directly to the gastroenterologist by the family practitioner in the case of longer existing pain in the lower left abdominal quadrant.
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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 37.1 Male 42.4
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Participant Age - Continuous data (in years) Mean 59.3 Mean 54.5
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SD 14.6 SD 11.1
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) No data entered.
History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics "we found significant differences in baseline characteristics" (inpatient older and sicker)
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Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure


mean 48 (SD 26.4) months

N Analyzed 194 118
Counts 52 22
Outcome: Elective surgical treatment      Population: All Participants
Time Point Measure Setting: Inpatient management Setting: Outpatient management


mean 48 (SD 26.4) months

N Analyzed 194 118
Counts 8 3
Outcome: Diverticulitis-related morbidities      Population: All Participants
Time Point Measure Setting: Inpatient management Setting: Outpatient management


mean 48 (SD 26.4) months

N Analyzed 194 118
Counts 1 0


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 High no randomization
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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 High no randomization
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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 no blinding
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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 no blinding
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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 no blinding
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low appear to have lost 3% from screened sample (before eligibility criteria applied) because of death
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Unclear Unclear if other outcomes were explored in retrospective analysis
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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? Yes patient factors definitely influenced treatment (by design, and demonstrated in regression - inpatient were 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? No only crude numbers
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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 not Y/PY to 1.4
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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 only crude numbers
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Critical
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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? N
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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? NA
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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? NA
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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? No
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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
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? Yes all patients w/ ICD 9 code to present to hospital in timeframe
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? No just inpatient and outpatient; no information on treatment protocols
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? No treatment failure and recurrence - lot of subjectivity in decision making to admit and pursue treatments that were defined in composite outcome
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Quality Rating
No quality rating data was found.