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Study Title and Description

Conservative treatment of acute colonic diverticulitis: are antibiotics always mandatory?



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 Conservative treatment of acute colonic diverticulitis: are antibiotics always mandatory?
Author Hjern F., Josephson T., Altman D., Holmström B., Mellgren A., Pollack J., Johansson C.
Country Division of Surgery, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden. fredrik.hjern@ds.se
Year 2007
Numbers Pubmed ID: 17190761

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 No intervention (non-placebo)
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2 Antibiotics: Cephalosporin + Metronidazole
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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Study Design Nonrandomized comparative study (NRCS)
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Country ... Specify Other ... Sweden
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Funder Non-industry (fully)
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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 2000
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2002
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Inclusion criteria Clinical diagnosis of Acute Diverticulitis confirmed by CT
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Exclusion criteria Diagnoses only based on clinical findings, operated immediately following admission because of clinical signs of peritonitis, perforated AD confirmed by CT
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if not an RCT, what was the directionality? Prospective
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Specific population? ... Population specified... ... People hospitalized with a diagnosis of Acute diverticulitis from the hospital computerized registry
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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? Univariate analysis for the data of patient groups treated with or without antibiotics. Multivariate logistic regression model to evaluate risk for further events during follow up.
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How was diverticulitis diagnosed Clinical diagnosis of Acute Diverticulitis confirmed by CT
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question No intervention (non-placebo) Antibiotics: Cephalosporin + Metronidazole Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 35 Male 37 Male 36
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Participant Age - Continuous data (in years) Mean 59 Mean 60
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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) No data entered.
History of (Prior) Complicated Diverticulitis Yes 30 Yes 25
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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
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: All Participants
Time Point Measure No intervention (non-placebo) Antibiotics: Cephalosporin + Metronidazole


Baseline N/A

N Analyzed 193 118
Counts 0 3
Percentage 0 3
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants
Time Point Measure No intervention (non-placebo) Antibiotics: Cephalosporin + Metronidazole


Baseline N/A

N Analyzed 186 115
Counts 51 32
Percentage 27.4 27.8
Outcome: Resolution of diverticulitis      Population: All Participants
Time Point Measure No intervention (non-placebo) Antibiotics: Cephalosporin + Metronidazole


<1 weeks

N Analyzed 153 83
Counts 78 34
Percentage 51 41


1-4 weeks

N Analyzed 153 83
Counts 52 33
Percentage 34 40


>4 weeks

N Analyzed 153 83
Counts 23 16
Percentage 15 19
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants
Time Point Measure No intervention (non-placebo) Antibiotics: Cephalosporin + Metronidazole


Baseline N/A

N Analyzed 193 118
Mean 3 5
Max 15 22
Min 1 1


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 Not Applicable not RCT
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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 Not Applicable not RCT
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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 Yes no blinding of patients; high risk of bias
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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. Yes no blinding of personnel; high risk of bias
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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. Yes no blinding of outcome assessors; high risk of bias
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No minimum loss to f/u (see Figure 1); low risk of bias
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Unsure Unclear what outcomes may have been assessed by not 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? Yes Decision to tx w/ or w/out Abs at treating surgeon's discretion. State standard care was to NOT prescribe and that clinical factors were considered in decision-making. Bias due to confounding is high
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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? Yes MV regression
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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? Unsure Clinical characteristics noted in charts. Potential for error or bias.
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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? No No, used baseline variables
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Yes Likely bias due to measured or unmeasured confounding, even with regression analysis
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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? No Selection into study based on diagnosis as determined from retrospective review of charts
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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? 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 No
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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. Yes no blinding of outcome assessors; high risk of bias
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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? No Not all pts received the same antibiotic regimen; though on average most received cephalosporine and metronidazole by iv and then quinolene and metronidazole
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? No failure of treatment (need for surgery or need for antibiotics b/c of symptoms) was somewhat subjective and could have been biased by previous knowledge of treatment.
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Quality Rating
Guideline Used Overall Rating