Critical appraisal:Kastelein F, Spaander MC, Steyerberg EW, Biermann K, Valkhoff VE, Kuipers EJ et al 2012 4

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Critical Appraisal

Article being appraised

Kastelein F, Spaander MC, Steyerberg EW, Biermann K, Valkhoff VE, Kuipers EJ et al. Proton Pump Inhibitors Reduce the Risk of Neoplastic Progression in Patients with Barrett's Esophagus. Clin Gastroenterol Hepatol 2012 Nov 27 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23200977.


Applicable clinical question

Key Facts

Study Design

cohort study, risk factors

Number of Patients:

540


Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
Moderate risk of bias Comments: Multi-institutional study from The Netherlands with prospective recruitment of study participants. Of 756 eligible patients, 216 dropped out for various reasons. Methods for exposures assessment, outcome assessment and analysis were excellent.

Risk of bias assessment: cohort study (risk factors)

Bias in selection of participants into study
Selection of the exposed and non-exposed cohorts
Drawn from the same population (low risk)
Bias due to error in exposure measurement
Measurement of exposure
Objective measurements from pre-existing records or <img alt="File:Jutta's info icon.png" src="/australiawiki_test/images/d/d9/Jutta%27s_info_icon.png" width="16" height="16"> baseline (Existing at or before baseline, where baseline is the time at which a participant is recorded to have entered the cohort or, if obtained after baseline, before onset of symptoms of the outcome or any likely effect of the developing outcome on the exposure) physical or biological assessment blind to outcome status (low risk)
Bias due to error in outcome measurement
Measurement of outcome
Outcome measurement unlikely to be influenced by exposure (low risk)
Was outcome of interest absent at the time to which the exposure refers?
Yes (low risk)
Was follow-up long enough for outcome to occur as a consequence of measured exposure? (Requires prior specification of a sufficient follow-up period)
Yes (low risk)
Bias due to non-participation
Participation rate in cohort
Participation rate in exposed cohort ≤10 percentage points different from non-exposed cohort OR exposed and non-exposed are from the same cohort (low risk)
Bias due to missing data
Completeness of follow-up of cohort
Active or passive follow-up with methods for ascertainment of one or more of outcome, death or emigration not described OR there was probably < 70% follow-up OR insufficient information to tell (high risk)
Accuracy of dates of outcome or censoring
Dates of outcome or censoring ascertained to within one year (low risk)
Difference in follow-up between exposed and non-exposed members of cohort
Follow-up methods are the same and likely to achieve the same completeness of follow-up in exposed and non-exposed participants (low risk)
Difference in missing data for exposure between those with or without the outcome
Difference in missing data for exposure ≥20 percentage points OR insufficient information to tell (high risk)
Bias due to confounding
Comparability of exposed and non-exposed cohorts with respect to potentially important confounding variables (Requires prior specification of potentially important confounders)
Age and other potentially important confounders measured and controlled by design or in analysis (low risk)
Analysis bias
Covariates are appropriately included in statistical analysis models
Variables measuring the same underlying concept or lying in the same causal pathway ARE NOT included together as covariates in statistical analysis models (low risk)
Size of effect
1 Reason for decision: Association between PPI use during follow-up and HGD/EAC



No REF
Yes 0.21 (0.07–0.66)

DURATION

0 Reference
0-2 y 3.46 (0.78–15.37)
2-4 y 0.44 (0.09–2.29)
>4 y 0.07 (0.02–0.26)

Relevance of evidence
1 Additional comments: This prospective cohort study constitutes level II evidence. The study incorporates clinically relevant outcomes.
Result of appraisal

Jutta's tick icon.png Included




Completed by

David Whiteman


Jutta's tick icon.png This appraisal has been completed.


Article
Kastelein F, Spaander MC, Steyerberg EW, Biermann K, Valkhoff VE, Kuipers EJ et al. Proton Pump Inhibitors Reduce the Risk of Neoplastic Progression in Patients with Barrett's Esophagus. Clin Gastroenterol Hepatol 2012 Nov 27 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23200977.
Assigned to
User:David.whiteman
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


Section below only relevant for Cancer Council Project Officer

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