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Study Title and Description

National Trends in Short-term Outcomes Following Non-emergent Surgery for Diverticular Disease.



Key Questions Addressed
4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title National Trends in Short-term Outcomes Following Non-emergent Surgery for Diverticular Disease.
Author Papageorge CM., Kennedy GD., Carchman EH.
Country Department of Surgery, Division of Colon and Rectal Surgery, University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, K4/730, Madison, WI, 53792-7375, USA.
Year 2016
Numbers Pubmed ID: 27120447

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 Elective surgery 2005/06
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2 Elective surgery 2007
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3 Elective surgery 2008
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4 Elective surgery 2009
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5 Elective surgery 2010
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6 Elective surgery 2011
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7 Elective surgery 2012
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8 Elective surgery 2013
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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KQ 4c: Surgery (recur prev)
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Study Design Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Other single group study (for harms only)
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Country USA
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USA
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USA
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USA
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USA
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Funder Not reported (or unclear)
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Study name ACS-NSQIP 2005-13
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Associated articles 26116319, 20193685
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ClinicalTrials.gov identifier
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Start and end years of the Study 2005
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2013
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Inclusion criteria Primary procedure CPT code or one of the secondary CPT codes (from the "other procedure" variables) was for partial colectomy or colostomy.
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Exclusion criteria Cases performed emergently, patients of ASA class 5 or unknown ASA class, cases performed by a surgical specialist in a field other than general surgery, presence of preoperative SIRS, sepsis or septic shock, and preoperative ventilator dependence.
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if not an RCT, what was the directionality? Retrospective
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Was diverticulitis diagnosed with CT? ... Unclear/Multiple methods (explain) ... NR
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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 Acute diverticulitis w/o hemorrhage or diverticulosis w/o hemorrhage by ICD-9 codes 562.11 and 562.1.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 48 Male 47.6 Male 46.8 Male 45 Male 44.6 Male 45.2 Male 46.2 Male 44.5
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Participant Age - Continuous data (in years) No data entered.
Participant Age - Categorical data <50 years <50 years <50 years <50 years <50 years <50 years <50 years <50 years
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29.7 28.5 27.9 27.3 25.9 25.9 24.5 24.2
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65+ years 65+ years 65+ years 65+ years 65+ years 65+ years 65+ years 65+ years
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29.6 28.8 29 30 29.7 29.7 31.8 32.3
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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 No data entered.
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
P-Value
Outcome: AE - 30 day mortality (post-surgical, CD V)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


30 days

N Analyzed 1660 2452 2973 3130 3654 4232 5489 6303 0.163
Percentage 0.5 0.6 0.3 0.5 0.4 0.4 0.3 0.3
P-Value
Outcome: AE - Sepsis (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


N/A N/A

N Analyzed 1660 2452 2973 3130 3654 4232 5489 6303 0.188
Percentage 4.1 2.7 2.7 3.1 3.0 3.0 2.9 2.8
P-Value
Outcome: AE - Major cardiac event (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


N/A N/A

N Analyzed 1660 2452 2973 3130 3654 4232 5489 6303 0.133
Percentage 0.1 0.2 0.1 0.4 0.2 0.4 0.3 0.2
P-Value
Outcome: AE - Major pulmonary event (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


N/A N/A

N Analyzed 1660 2452 2973 3130 3654 4232 5489 6303 0.411
Percentage 0.6 0.4 0.4 0.5 0.5 0.4 0.4 0.3
P-Value
Outcome: AE - Reintubation (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


N/A N/A

N Analyzed 1660 2452 2973 3130 3654 4232 5489 6303 0.009
Percentage 1.4 1.1 1 0.6 0.8 0.8 0.6 0.6
P-Value
Outcome: AE - Major cardiac event (CD IV)      Population: All Participants Between-Arm Comparisons
Time Point Measure Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Elective surgery Comparison Measure Elective surgery vs. Elective surgery


N/A N/A

N Analyzed 1660 2452 2973 3130 3654 4232 5489 6303 N/A
Percentage 0.2 0.2 0.1 0.2 0.2 0.2 0.1 0.1


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
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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
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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.
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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.
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data No No missing outcome data
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting No Study protocol is not available, but it appears study reported all outcomes of interest.
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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 Study appears to be free of other sources of bias.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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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?
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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?
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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?
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Q6: ROBINS-I - Risk of bias judgement for BIAS 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?
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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?
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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?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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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?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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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? 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