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Study Title and Description

Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute 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 Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis.
Author Daniels L., Ünlü Ç., de Korte N., van Dieren S., Stockmann HB., Vrouenraets BC., Consten EC., van der Hoeven JA., Eijsbouts QA., Faneyte IF., Bemelman WA., Dijkgraaf MG., Boermeester MA.
Country Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Year 2017
Numbers Pubmed ID: 27686365

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 No intervention (non-placebo) No antibiotic
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2 Antibiotics: Amoxicillin + Clavulanate IV amoxicillin–clavulanic acid was chosen as broad-spectrum antibiotic treatment of choice. Was switched to oral administration after 10 days if tolerated. In the event of allergy, a switch was made to the combination of Ciprofloxacin and Metronidazole.
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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KQ 2b: Antibiotics (acute)
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Study Design RCT
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RCT
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RCT
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RCT
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RCT
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Country ... Specify Other ... Sweden
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Funder Non-industry (fully)
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Study name DIABOLO
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Associated articles 30807455, 28241291, 29700480
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ClinicalTrials.gov identifier NCT01111253
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Start and end years of the Study 2010
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2012
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Inclusion criteria Left sided uncomplicated acute diverticulitis, clinical and diagnostic (ultrasound or CT) proven, modified Hinchey stages 1a-b (abscess size up to 5 cm) and Ambrosetti's 'mild' diverticulitis stage included.
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Exclusion criteria Previous radiologically proven diverticulitis, higher modified Hinchey stages or Ambrosetti's 'severe' diverticulitis stage, sepsis, antibiotic use in the previous 4 weeks.
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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?
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How was diverticulitis diagnosed Patients were eligible if they had a first episode of left-sided, uncomplicated, acute diverticulitis, confirmed within 24 h by CT.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 51.5 Male 49.6 Male 50.6
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Participant Age - Continuous data (in years) Mean 57.4
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Participant Age - Categorical data No data entered.
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: Return to normal bowel function      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.183
Counts 234 248
Percentage 89.3 93.2
P-Value
Outcome: Hospitalization (or re-hospitalization) for diverticulitis (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.148
N Enrolled
Percentage 17.6 12
Counts 46 32
P-Value P-Value
Outcome: Hospitalization (or re-hospitalization) for diverticulitis or diverticulitis-related complications      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

N Analyzed 262 266
Counts 66 35


24 months

Counts 0.403
Counts
Counts 11 8
N Analyzed 227 241
Percentage 4.8 3.3
P-Value
Outcome: Time outside hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

Proportion 0.989 0.983 0.006
Max 0.978 0.978
Min 0.994 0.989
N Analyzed 262 266
P-Value
Outcome: Ongoing Diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.183
Counts 19 11
Percentage 7.3 4.1
P-Value P-Value
Outcome: Recurrence of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.494
Counts 9 8
Percentage 3.4 3.0


24 months

Counts 0.885
Counts
Counts 35 36
N Analyzed 227 241
Percentage 15.4 14.9
P-Value
Outcome: Surgery for diverticulitis, including colostomy (avoidance)      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.254
Counts 8 3
Percentage 3.1 1.1
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

N Analyzed 262 266 0.221
Counts 127 145
Percentage 48.5 54.5
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

N Analyzed 262 266 0.086
Counts 89 114
Percentage 34 42.9
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

N Analyzed 262 266 0.345
Counts 69 61
Percentage 26.3 22.9
P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

N Analyzed 262 266 0.006
Counts 1 22
Percentage 0.4 8.3
P-Value
Outcome: Mortality - Diverticulitis-related      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

N Analyzed 262 266 0.432
Counts 3 1
Percentage 1.1 0.4
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.682
Percentage 0.8 0.8
Counts 2 2


24 months

Counts
Counts
Counts 2 3
N Analyzed 227 241
Percentage 0.9 1.2
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.678
Percentage 1.1 1.1
Counts 3 3


24 months

Counts
Counts
Counts 5 2
N Analyzed 227 241
Percentage 2.2 0.8
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.448
Proportion 1.5 0.8
Counts 4 2


24 months

Counts
Counts
Counts 4 2
N Analyzed 227 241
Percentage 1.8 0.8
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.553
Counts 1 0
Percentage 0.4 0


24 months

Counts
Counts
Counts 1 1
N Analyzed 227 241
Percentage 0.4 0.4
P-Value P-Value
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

N Analyzed 262 266 0.390
Percentage 0.8 0
Counts 2 0


24 months

Counts
Counts
Counts 3 0
N Analyzed 227 241
Percentage 1.3 0
Adj. Odds Ratio (OR) Adj. 95% CI low Adj. 95% CI high
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


12 months

Counts 63 83 0.65
Counts 0.40
Counts 1.04
Percentage 33.3 43
N Analyzed 189 193
Odds Ratio (OR) 95% CI low 95% CI high
Outcome: Diverticulitis-related morbidities      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


12 months

Counts 75 79 0.99
Counts 0.6
Counts 1.46
Percentage 35.7 36.1
N Analyzed 210 219
Outcome: Failure of treatment      Population: All Participants
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate


Baseline N/A

Counts
Counts
Counts
Percentage
N Analyzed
P-Value
Outcome: Failure of treatment      Population: Hinchey 1A, pericolic extraluminal air Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Counts 0 1 0.44
Counts
Counts
Percentage 0 6
N Analyzed 22 17
95% CI low P-Value 95% CI high HR
Outcome: Resolution of diverticulitis      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

Max 35 30 0.78
Min 6 7 0.151
Median 14 12 NR
0.91
95% CI low Hazard Ration (HR) P-Value
Outcome: Resolution of diverticulitis      Population: Patients with Hinchey 1a disease Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


6 months

Max 35 28 0.77
Min 6 6 0.90
Median 14 12 0.118
P-Value
Outcome: Length of hospital (or intensive care unit) stay      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

N Analyzed 262 266 0.006
Max 3 3
Min 1 2
N Enrolled 2 3
P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Mean
Median 60 60
25th Percentile 24.5 20
N Analyzed 237 240


3 months

N Enrolled
Mean
Median
25th Percentile


6 months

N Enrolled
Mean
Median
25th Percentile


12 months

Mean
Median 80 80
25th Percentile 20 22.3
N Analyzed 191 202


24 months

N Enrolled
Mean
Median
25th Percentile


Mean estimated scores over 3, 6, 12, 24 months, with adjustment for baseline scores N/A

Mean 77.2 76.4 0.323
N Enrolled
Median
25th Percentile
P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Mean
N Enrolled 242 232
Median 39.1 41.6
25th Percentile 13.5 12.5


3 months

Mean
N Enrolled
Median
25th Percentile


6 months

Mean
N Enrolled
Median
25th Percentile


12 months

Mean
N Enrolled 188 195
Median 49.4 48.1
25th Percentile 16.1 17.8


24 months

Mean
N Enrolled
Median
25th Percentile


Mean estimated scores over 3, 6, 12, 24 months, with adjustment for baseline scores N/A

Mean 47.2 46.5 0.193
N Enrolled
Median
25th Percentile
P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Mean
N Enrolled 234 232
Median 54.4 54.8
25th Percentile 14.6 14.2


3 months

Mean
N Enrolled
Median
25th Percentile


6 months

Mean
N Enrolled
Median
25th Percentile


12 months

Mean
N Enrolled 188 195
Median 55 54.6
25th Percentile 8.7 10.6


24 months

Mean
N Enrolled
Median
25th Percentile


Mean estimated scores over 3, 6, 12, 24 months, with adjustment for baseline scores N/A

Mean 50.4 49.9 0.485
N Enrolled
Median
25th Percentile
P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Mean
N Enrolled 236 240
Median 17 18
25th Percentile 8 8


3 months

Mean
N Enrolled
Median
25th Percentile


6 months

Mean
N Enrolled
Median
25th Percentile


12 months

Mean
N Enrolled 192 201
Median 22 22
25th Percentile 7 8


24 months

Mean
N Enrolled
Median
25th Percentile


Mean estimated scores over 3, 6, 12, 24 months, with adjustment for baseline scores N/A

Mean 20.7 20.7 0.914
N Enrolled
Median
25th Percentile
P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Mean
N Enrolled 236 240
Median 55 56
25th Percentile 14 15


3 months

Mean
N Enrolled
Median
25th Percentile


6 months

Mean
N Enrolled
Median
25th Percentile


12 months

Mean
N Enrolled 192 201
Median 65 66
25th Percentile 13 15.5


24 months

Mean
N Enrolled
Median
25th Percentile


Mean estimated scores over 3, 6, 12, 24 months, with adjustment for baseline scores N/A

Mean 62.6 62.9 0.564
N Enrolled
Median
25th Percentile
P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Mean
N Enrolled 236 240
Median 100 15
25th Percentile 28 5


3 months

Mean
N Enrolled
Median
25th Percentile


6 months

Mean
N Enrolled
Median
25th Percentile


12 months

Mean
N Enrolled 192 201
Median 18 18
25th Percentile 4 4


24 months

Mean
N Enrolled
Median
25th Percentile


Mean estimated scores over 3, 6, 12, 24 months, with adjustment for baseline scores N/A

Mean 16.5 16.5 0.893
N Enrolled
Median
25th Percentile
P-Value P-Value P-Value P-Value P-Value P-Value
Outcome: Quality of life      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention (non-placebo) Antibiotics: Amoxicillin + Clavulanate Comparison Measure Antibiotics: Amoxicillin + Clavulanate vs. No intervention (non-placebo)


Baseline N/A

Mean
N Enrolled 236 240
Median 12 12
25th Percentile 6 7


3 months

Mean
N Enrolled
Median
25th Percentile


6 months

Mean
N Enrolled
Median
25th Percentile


12 months

Mean
N Enrolled 236 201
Median 19 18
25th Percentile 6 6


24 months

Mean
N Enrolled
Median
25th Percentile


Mean estimated scores over 3, 6, 12, 24 months, with adjustment for baseline scores N/A

Mean 16.6 16.5 0.694
N Enrolled
Median
25th Percentile


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 Low
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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 Low
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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
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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
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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. Low
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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. Low
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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
No quality rating data was found.