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Study Title and Description

Treatment of acute uncomplicated diverticulitis without antibiotics: risk factors for treatment failure.



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 Treatment of acute uncomplicated diverticulitis without antibiotics: risk factors for treatment failure.
Author Bolkenstein HE., Draaisma WA., van de Wall B., Consten E., Broeders I.
Country Department of Surgery, Meander Medical Centre, 3800 BM, Amersfoort, The Netherlands. he.bolkenstein@meandermc.nl.
Year 2018
Numbers Pubmed ID: 29679152

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: Outpatient management
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2 Setting: Inpatient 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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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 2005
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2017
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Inclusion criteria adults presenting to ED 1st episode acute UD; CT confirmed
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Exclusion criteria Immunocompromised, signs of sepsis
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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? logistic regression
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How was diverticulitis diagnosed A specific diagnostic code was used for pts meeting UD 1st episode criteria. UD was defined as the absence of perforation (extravasation of contrast on CT), abscess, bleeding, or signs of peritonitis, which cor- responds to the modified Hinchey classification 1A
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Note/Comment about Design (or overall study) The aim of the current study is to assess the clinical course of UD patients who were initially treated without antibiotics and to identify risk factors for treatment failure in this patient group.
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Baseline Characteristics
Question Setting: Outpatient management Setting: Inpatient management Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 40
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Not reported
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Participant Age - Continuous data (in years) Mean 58
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SD 13
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Uncomplicated diverticulitis 100
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Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 0 100
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History of (Prior) Complicated Diverticulitis No 100
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KQ 4: Time Since Last Episode of Diverticulitis No data entered.
Note/Comment about baseline characteristics Provided baseline information about how pts presented to hospital "Patients who were admitted to the hospital within 24 h after presentation presented more often with nausea (43 vs 34%), vomiting (12 vs 5%), and active muscle resistance at physical examination (19 vs 12%) compared to patients who were treated as outpatients. Temperature (mean 37.4 vs 37.2 °C), leucocytes (mean 12.3 × 109/L vs 11.3 × 109/L), and C-reactive protein (CRP) level (mean 104 vs 84 mg/L) were also higher at presentation in patients admitted to the hospital."
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Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high Adj. P-Value Adjusted For: Enter a Title Here
Outcome: Treatment failure      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Outpatient management Setting: Inpatient management Comparison Measure All Arms (ANOVA)


30 days

N Analyzed 264 301 2.44
Counts 12 34 1.21
4.90
0.01
female gender, age, ASA score > 2, no rebound tenderness, CRP (mg/L)
beta-coefficient: 0.89


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
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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 Patients admitted to hospital were sicker than those treated as outpatients (more nausea, vomiting, higher temp, CRP, etc)
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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 composite outcome, many of which could have been influenced by known assignment to inpatient vs. outpatient care
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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. High retrospective study
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low Some missing data for predictors in multiple regression, but low (1-7%); in total 304 data items (7% of data) were imputed.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low Appear to have followed a pre-specified approach to selecting and including model parameters in final multivariable model
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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. No
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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 admit a patient to the hospital was made by the attending physician based on individual patient characteristics
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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 multivariable regression with univariate predictors of treatment failure included
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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 age (Y); gender (Y); (absence of) rebound tenderness (unclear/N), CRP level (unclear/Y). No info reported on methods used to guide physical examination and validity of assessment for rebound tenderness or more objective CRP lab assessment.
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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
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING Serious Although some factors are adjusted for, the validity of measurement of these confounders is uncertain and the list of confounders is likely incomplete. Effect is likely still biased due to confounding.
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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
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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 From index ED visit to within 30 days of visit
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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 do not believe selection bias was at play in this this study
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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 Various - retrospective review of all patients meeting eligibility within 12 year period
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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.
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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? Unsure Inpatient vs. outpatient (how actually treated in both) not clearly described, esp. compared to other study protocols
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? No No information
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Quality Rating
No quality rating data was found.