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Study Title and Description

Applicability, safety and efficiency of outpatient treatment in 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 Applicability, safety and efficiency of outpatient treatment in uncomplicated diverticulitis.
Author Moya P., Arroyo A., Pérez-Legaz J., Serrano P., Candela F., Soriano-Irigaray L., Calpena R.
Country Department of Surgery, University General Hospital of Elche, Alicante, Spain. pedromoyaforcen@gmail.com
Year 2012
Numbers Pubmed ID: 22706731

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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Study Design Nonrandomized comparative study (NRCS)
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Country ... Specify Other ... Spain
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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 2007
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2009
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Inclusion criteria admitted to ED w/ diagnosis of AUD based on medical history, physical examination, and CT scan; <90yo, immunocompetent, tolerated oral intake, adequate family and social support network
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Exclusion criteria signs of severe sepsis; complicated AD
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if not an RCT, what was the directionality? Prospective
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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? only compared groups using Student t test
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How was diverticulitis diagnosed edical history, physical examination and abdominopelvic computed tomography (CT) scanning. The diagnostic criteria for acute diverticulitis in the abdomino- pelvic CT scan were, according to the classification by Ambrosetti/Doringer-Neff [5, 6] (Table 2), presence of diverticula, colonic wall thickening ([4 mm) and/or soft tissue stranding of the pericolic fat. Those patients with abundant free fluid, intra-abdominal abscess or pneumo-peritoneum were diagnosed with complicated acute diverticulitis and were excluded from the study.
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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 45 Male 50
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Participant Age - Continuous data (in years) Mean 59.65 Mean 56.06
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Range 36–84 Range 32–83
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100 Uncomplicated diverticulitis 100
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Specific Complications of Diverticulitis 0
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0
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0
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NR
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NR
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NR
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Number of Prior Episodes of Diverticulitis (categorical) 0 82 0 84
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>=2 18 >=2 16
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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
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Note/Comment about baseline characteristics despite NRCS, table 1 characteristics well balanced.
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Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
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


9 +/- 18 (hospital); 7 +/- 9 months (outpatient) months

 N Analyzed 44 32 0.86
Counts 3 2
Percentage 6.81 6.25
P-Value
Outcome: Surgical treatment for further episodes      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure Setting: Inpatient management vs. Setting: Outpatient management


9 +/- 18 (hospital); 7 +/- 9 months (outpatient) months

 N Analyzed 44 32 0.76
Counts 2 1
Percentage 4.5 3.12
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


9 +/- 18 (hospital); 7 +/- 9 months (outpatient) months

 N Analyzed 44 32 0.76
Counts 2 1
Percentage 4.5 3.12
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure Setting: Inpatient management Setting: Outpatient management Comparison Measure Setting: Inpatient management vs. Setting: Outpatient management


9 +/- 18 (hospital); 7 +/- 9 months (outpatient) months

 N Analyzed 44 32 <0.05
Mean 5.8 0.28
SD
SE
Max 5 0
Min 11 5


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 Yes participants not blinded; yes to 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 personnel not blinded; yes to 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. Unsure possible personnel may have treated differently depending on knowledge of intervention or access to patients (inpatient get more?)
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No 2 protocol exclusions, but no apparent loss to f/u
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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 and possibly 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 While the ITS appeared to result in balanced clinical features and radiologic findings, they did not do any analyses to account for these variables (or others)
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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 No adjusted analyses reported
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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 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? 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
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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 there was high risk of selection bias in the study
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Q2: Did the study divide the follow up time of each individual participant into the different interventions? Yes yes, protocol 1 (inpatient) was delivered to all eligible pts first, then protocol 2 (outpatient) was delivered to all eligible pts
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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. Unsure possible personnel may have treated differently depending on knowledge of intervention or access to patients (inpatient get more?)
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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 largely clinical; criteria and methods not described in detail
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Quality Rating
Guideline Used Overall Rating