Study Preview
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? |
Primary Publication Information
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 | |
2 | Elective surgery | 2007 | |
3 | Elective surgery | 2008 | |
4 | Elective surgery | 2009 | |
5 | Elective surgery | 2010 | |
6 | Elective surgery | 2011 | |
7 | Elective surgery | 2012 | |
8 | Elective surgery | 2013 |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Specific KQ | KQ 4c: Surgery (recur prev) | ||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
KQ 4c: Surgery (recur prev) | |||
Study Design | Other single group study (for harms only) | ||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Other single group study (for harms only) | |||
Country | USA | ||
USA | |||
USA | |||
USA | |||
USA | |||
Funder | Not reported (or unclear) | ||
Study name | ACS-NSQIP 2005-13 | ||
Associated articles | 26116319, 20193685 | ||
ClinicalTrials.gov identifier | |||
Start and end years of the Study | 2005 | ||
2013 | |||
Inclusion criteria | Primary procedure CPT code or one of the secondary CPT codes (from the "other procedure" variables) was for partial colectomy or colostomy. | ||
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. | ||
if not an RCT, what was the directionality? | Retrospective | ||
Was diverticulitis diagnosed with CT? ... | Unclear/Multiple methods (explain) ... | NR | |
If NRCS, what analytic method was used to account for differences between study arms? | |||
How was diverticulitis diagnosed | Acute diverticulitis w/o hemorrhage or diverticulosis w/o hemorrhage by ICD-9 codes 562.11 and 562.1. | ||
Note/Comment about Design (or overall study) |
Baseline Characteristics
Question | Elective surgery | Elective surgery | Elective surgery | Elective surgery | Elective surgery | Elective surgery | Elective surgery | Elective surgery | Total | Comments | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-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 | |||
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 | |||||||||||
29.7 | 28.5 | 27.9 | 27.3 | 25.9 | 25.9 | 24.5 | 24.2 | ||||||||||||
65+ years | 65+ years | 65+ years | 65+ years | 65+ years | 65+ years | 65+ years | 65+ years | ||||||||||||
29.6 | 28.8 | 29 | 30 | 29.7 | 29.7 | 31.8 | 32.3 | ||||||||||||
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
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 |
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 |
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 |
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 |
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 |
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 | |||
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment | |||
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study | |||
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. | |||
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | |||
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data | No | No missing outcome data | |
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. | |
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. | |
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study? | |||
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains? | |||
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? | |||
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention? | |||
Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING | |||
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? | |||
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? | |||
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? | |||
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants? | |||
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? | |||
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY | |||
Q2: Did the study divide the follow up time of each individual participant into the different interventions? | |||
Q11: Did the start and follow up calendar years coincide for most participants in the study? | |||
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. | |||
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described? | Yes | ||
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population? | Yes | ||
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Yes |
Quality Rating
Guideline Used | Overall Rating |
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