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Study Title and Description

Prospective Creation and Validation of the PREVENTT (Prediction and Enaction of Prevention Treatments Trigger) Scale for Surgical Site Infections (SSIs) in Patients With Diverticulitis.



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 Prospective Creation and Validation of the PREVENTT (Prediction and Enaction of Prevention Treatments Trigger) Scale for Surgical Site Infections (SSIs) in Patients With Diverticulitis.
Author Bordeianou L., Cauley CE., Patel R., Bleday R., Mahmood S., Kennedy K., Ahmed KF., Yokoe D., Hooper D., Rubin M.
Country Department of General Surgery, Colorectal Surgery Center, Massachusetts General Hospital, Boston, MA.
Year 2019
Numbers Pubmed ID: 29916880

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
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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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Study Design 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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Funder Not reported (or unclear)
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Study name PREVENTT
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Associated articles
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ClinicalTrials.gov identifier
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Start and end years of the Study 2010
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2016
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Inclusion criteria underwent surgery for diverticulitis
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Exclusion criteria < 18 years of age, underwent a colectomy with a diagnosis of colon or rectal cancer or IBD.
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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? ... Unclear/Multiple methods (explain) ... not reported
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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 NR
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Elective surgery Total Comments
AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 43.6
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White 93.4
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Hispanic/Latino 3.2
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Participant Age - Continuous data (in years) Mean 59.9
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SD 12.7
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis Not reported 100
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Specific Complications of Diverticulitis 100
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Number of Prior Episodes of Diverticulitis (categorical) Other_1 (include definition in %) any previous episodes 50.1%
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History of (Prior) Complicated Diverticulitis Not reported
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KQ 4: Time Since Last Episode of Diverticulitis Not reported
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Note/Comment about baseline characteristics This is for the entire cohort, of which 87% had elective surgery
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Number of Prior Episodes of Diverticulitis (continuous) Not reported
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Results & Comparisons


Results Data
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


30 days

 N Analyzed 1506
Counts 284
Percentage 18.9
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


30 days

 N Analyzed 1506
Counts 73
Percentage 4.8
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


30 days

 N Analyzed 1506
Counts 13
Percentage 0.9
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Elective surgery


30 days

 N Analyzed 1506
Counts 224
Percentage 14.9


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 Low
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low
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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. Low
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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? No No definition of elective surgery
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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
No quality rating data was found.