This is a protocol of a systematic review

Foster, Margaret

Heavener, Trace

Memon, Ahmed

Meyer, Chase

Vassar, Matt

Wayant, Cole

English

Texas A&amp;M Repository

 PROSPEROInternational prospective register of systematic reviews Do non-steroidal anti-inflammatory drugs provide a protective effect on developingBarrett’s esophagus and esophageal cancer? A systematic review and meta-analysisTrace Heavener, Cole Wayant, Ahmed Memon, Chase Meyer, Margaret Foster, Matt Vassar CitationTrace Heavener, Cole Wayant, Ahmed Memon, Chase Meyer, Margaret Foster, Matt Vassar. Donon-steroidal anti-inflammatory drugs provide a protective effect on developing Barrett’sesophagus and esophageal cancer? A systematic review and meta-analysis. PROSPERO 2018CRD42018118489 Available from: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018118489 Review questionTo determine if NSAIDs have a protective effect of developing Barrett’s esophagus or esophageal cancer. SearchesAn electronic literature search will be conducted on MEDLINE (Ovid), EMBASE (Ovid), and the CochraneCentral Register of Controlled Trials (CENTRAL) from inception to November 2018. Concepts included in thesearch are NSAIDs and esophageal cancer. Language and year will not be restricted. Full reports andabstracts (if able to obtain sufficient data) irrespective of language will be included. A manual search usingreference lists of pertinent publications and conference presentation will be included.Keywords include: 1) “anti-inflammatory agent,” “aspirin,” “acetylsalicylic acid,” “non-steroidal anti-inflammatory drug,” “COX,” or “cyclooxygenase,”; 2) combined with “esophageal cancer,” “oesophagealcancer,” “esophageal adenocarcinoma,” “neoplasm,” “esophageal carcinoma,” “squamous cell carcinomaof the esophagus” or “Barrett’s esophagus”. Types of study to be includedObservational studies (such as case control and cohort) Condition or domain being studiedNon-steroidal anti-inflammatory drugs provide a protective effect on developing Barrett’s esophagus andesophageal cancer. Participants/populationAdults (18 years of age or greater) with exposure to NSAIDs, aspirin, or both who have measuredoccurrence of esophageal cancer diagnosis or death from esophageal cancer. Intervention(s), exposure(s)Use of NSAIDs (salicylates such as aspirin, selective COX-2 inhibitors such as celecoxib, and non-selectiveCOX-2 inhibitors such as meloxicam, ibuprofen, and indomethacin). Comparator(s)/controlNo use of NSAIDs ContextInclusion criteria: observational studies (such as case control and cohort); adults (18 years of age or greater);exposure to NSAIDs, aspirin, or both; measured occurrence of esophageal cancer diagnosis or death fromesophageal cancer; and reported a relative risk (RR) or odds ratios (ORs) with confidence intervals, orsufficient data to permit their calculation.Exclusion criteria: case reports, case seriesIn situations where multiple publications were from the same trial, data will be used from the publication withthe longest follow up.                               Page: 1 / 4 PROSPEROInternational prospective register of systematic reviews Main outcome(s)Development of Barrett’s esophagus, esophageal adenocarcinoma, or squamous cell carcinoma of theesophagus Additional outcome(s)Frequency and type of adverse effects Data extraction (selection and coding)After final selection of studies for the quantitative analysis, a pilot test of data extraction will be completed.Two authors (A.M., C.W.) will then independently extract the following data points: type of study, status oftrial, type of intervention, gender, ethnicity, age, Barrett’s esophagus, outcome assessment, exposureascertainment, sample size, lost to follow-up, location of study and disclosed conflict of interests in astandardized data collection form.All citations identified from the literature search will be merged, de-duplicated and stored in the referencemanager database, Rayyan (https://rayyan.qcri.org/). A data collection form will be created using Googleforms and all extracted data will be stored in Google drive will all authors having access. Following pilottesting, two authors (A.M., C.W.) will independently review all citations by title and abstract for a list ofpotential articles. Following title and abstract screening, a comparison of the selections from the tworeviewers will be performed, and disagreements will be settled by a third author (T.H.). At this point, the fulltext of remaining articles will be retrieved and pilot test screening will be conducted by two authors (A.M.,C.W.). They will then independently assess all papers to determine the final selection (dependent oneligibility) of relevant studies for inclusion in the review. An unweighted kappa score will be calculated toensure agreement between the two reviewers for inter-rater concordance. A flow diagram will be created andincluded in the published results.  Risk of bias (quality) assessmentTwo authors (A.M., C.W.) will independently assess each study for its risk of bias using the Risk Of Bias InNon-Randomized Studies - of Interventions (ROBINS-I)(https://sites.google.com/site/riskofbiastool/welcome/home/current-version-of-robins-i/robins-i-tool-2016) atthe study level. Strategy for data synthesisIf possible, a meta-analysis will be conducted with the following considerations. Meta-analysis will beassessed using random effects model according to Dersimonian and Laird method to account for expectedclinical heterogeneity between studies. The corresponding fixed-effects analysis will also be provided.Summary effects will be calculated as risk ratios with 95% confidence interval with a prespecified alpha levelof 0.05 for significance. Heterogeneity will be assessed with Cochran Q and I² method with 0.1 to representsignificance. The number needed to treat with corresponding confidence intervals will be presented. Allstatistical analysis will be carried out using Stata (version 15.1) software. Analysis of subgroups or subsetsA priori subgroup analyses include: Gender (female vs. male); Ethnicity (Asian vs. Western populations,based on study location); Age; Risk of bias (High versus low). The following prespecified criteria will beperformed as sensitivity analysis: (1) each study omitted in turn with recalculation of summary of effects; (2)removal of those with high risk of bias, (3) removal of unpublished studies, (4) removal of studies thatimputed missing data (if applicable). Contact details for further informationTrace Heavenertrace.heavener@bswhealth.org Organisational affiliation of the reviewBaylor Scott and White Healthcare Review team members and their organisational affiliationsDr Trace Heavener. Baylor Scott and White HealthcareMr Cole Wayant. Oklahoma State University Center for Health Sciences                               Page: 2 / 4 PROSPEROInternational prospective register of systematic reviewsMr Ahmed Memon. Texas A&M College of MedicineMr Chase Meyer. Oklahoma State University Center for Health SciencesMrs Margaret Foster. Texas A&M UniversityDr Matt Vassar. Oklahoma State University Center for Health Sciences Anticipated or actual start date03 December 2018 Anticipated completion date03 June 2019 Funding sources/sponsorsNone Conflicts of interest LanguageEnglish CountryUnited States of America Stage of reviewReview_Ongoing Subject index terms statusSubject indexing assigned by CRD Subject index termsAnti-Inflammatory Agents, Non-Steroidal; Barrett Esophagus; Esophageal Neoplasms; Humans Date of registration in PROSPERO20 December 2018 Date of publication of this version20 December 2018 Details of any existing review of the same topic by the same authors Stage of review at time of this submissionThe review has not started Stage Started CompletedPreliminary searches No NoPiloting of the study selection process No NoFormal screening of search results against eligibility criteria No NoData extraction No NoRisk of bias (quality) assessment No NoData analysis No No Versions20 December 2018                               Page: 3 / 4 PROSPEROInternational prospective register of systematic reviewsPROSPEROThis information has been provided by the named contact for this review. CRD has accepted this information in goodfaith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registrationrecord, any associated files or external websites. Powered by TCPDF (www.tcpdf.org)                               Page: 4 / 4

Do non-steroidal anti-inflammatory drugs provide a protective effect on developing Barrett’s esophagus and esophageal cancer? A systematic review and meta-analysis

Texas A&M University

 PROSPERO
International prospective register of systematic reviews
 Do non-steroidal anti-inflammatory drugs provide a protective effect on developing
Barrett’s esophagus and esophageal cancer? A systematic review and meta-analysis
Trace Heavener, Cole Wayant, Ahmed Memon, Chase Meyer, Margaret Foster, Matt Vassar
 
Citation
Trace Heavener, Cole Wayant, Ahmed Memon, Chase Meyer, Margaret Foster, Matt Vassar. Do
non-steroidal anti-inflammatory drugs provide a protective effect on developing Barrett’s
esophagus and esophageal cancer? A systematic review and meta-analysis. PROSPERO 2018
CRD42018118489 Available from: 
http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018118489
 
Review question
To determine if NSAIDs have a protective effect of developing Barrett’s esophagus or esophageal cancer.
 
Searches
An electronic literature search will be conducted on MEDLINE (Ovid), EMBASE (Ovid), and the Cochrane
Central Register of Controlled Trials (CENTRAL) from inception to November 2018. Concepts included in the
search are NSAIDs and esophageal cancer. Language and year will not be restricted. Full reports and
abstracts (if able to obtain sufficient data) irrespective of language will be included. A manual search using
reference lists of pertinent publications and conference presentation will be included.
Keywords include: 1) “anti-inflammatory agent,” “aspirin,” “acetylsalicylic acid,” “non-steroidal anti-
inflammatory drug,” “COX,” or “cyclooxygenase,”; 2) combined with “esophageal cancer,” “oesophageal
cancer,” “esophageal adenocarcinoma,” “neoplasm,” “esophageal carcinoma,” “squamous cell carcinoma
of the esophagus” or “Barrett’s esophagus”.
 
Types of study to be included
Observational studies (such as case control and cohort)
 
Condition or domain being studied
Non-steroidal anti-inflammatory drugs provide a protective effect on developing Barrett’s esophagus and
esophageal cancer.
 
Participants/population
Adults (18 years of age or greater) with exposure to NSAIDs, aspirin, or both who have measured
occurrence of esophageal cancer diagnosis or death from esophageal cancer.
 
Intervention(s), exposure(s)
Use of NSAIDs (salicylates such as aspirin, selective COX-2 inhibitors such as celecoxib, and non-selective
COX-2 inhibitors such as meloxicam, ibuprofen, and indomethacin).
 
Comparator(s)/control
No use of NSAIDs
 
Context
Inclusion criteria: observational studies (such as case control and cohort); adults (18 years of age or greater);
exposure to NSAIDs, aspirin, or both; measured occurrence of esophageal cancer diagnosis or death from
esophageal cancer; and reported a relative risk (RR) or odds ratios (ORs) with confidence intervals, or
sufficient data to permit their calculation.
Exclusion criteria: case reports, case series
In situations where multiple publications were from the same trial, data will be used from the publication with
the longest follow up.
                               Page: 1 / 4
 PROSPERO
International prospective register of systematic reviews
 
Main outcome(s)
Development of Barrett’s esophagus, esophageal adenocarcinoma, or squamous cell carcinoma of the
esophagus
 
Additional outcome(s)
Frequency and type of adverse effects
 
Data extraction (selection and coding)
After final selection of studies for the quantitative analysis, a pilot test of data extraction will be completed.
Two authors (A.M., C.W.) will then independently extract the following data points: type of study, status of
trial, type of intervention, gender, ethnicity, age, Barrett’s esophagus, outcome assessment, exposure
ascertainment, sample size, lost to follow-up, location of study and disclosed conflict of interests in a
standardized data collection form.
All citations identified from the literature search will be merged, de-duplicated and stored in the reference
manager database, Rayyan (https://rayyan.qcri.org/). A data collection form will be created using Google
forms and all extracted data will be stored in Google drive will all authors having access. Following pilot
testing, two authors (A.M., C.W.) will independently review all citations by title and abstract for a list of
potential articles. Following title and abstract screening, a comparison of the selections from the two
reviewers will be performed, and disagreements will be settled by a third author (T.H.). At this point, the full
text of remaining articles will be retrieved and pilot test screening will be conducted by two authors (A.M.,
C.W.). They will then independently assess all papers to determine the final selection (dependent on
eligibility) of relevant studies for inclusion in the review. An unweighted kappa score will be calculated to
ensure agreement between the two reviewers for inter-rater concordance. A flow diagram will be created and
included in the published results. 
 
Risk of bias (quality) assessment
Two authors (A.M., C.W.) will independently assess each study for its risk of bias using the Risk Of Bias In
Non-Randomized Studies - of Interventions (ROBINS-I)
(https://sites.google.com/site/riskofbiastool/welcome/home/current-version-of-robins-i/robins-i-tool-2016) at
the study level.
 
Strategy for data synthesis
If possible, a meta-analysis will be conducted with the following considerations. Meta-analysis will be
assessed using random effects model according to Dersimonian and Laird method to account for expected
clinical heterogeneity between studies. The corresponding fixed-effects analysis will also be provided.
Summary effects will be calculated as risk ratios with 95% confidence interval with a prespecified alpha level
of 0.05 for significance. Heterogeneity will be assessed with Cochran Q and I² method with 0.1 to represent
significance. The number needed to treat with corresponding confidence intervals will be presented. All
statistical analysis will be carried out using Stata (version 15.1) software.
 
Analysis of subgroups or subsets
A priori subgroup analyses include: Gender (female vs. male); Ethnicity (Asian vs. Western populations,
based on study location); Age; Risk of bias (High versus low). The following prespecified criteria will be
performed as sensitivity analysis: (1) each study omitted in turn with recalculation of summary of effects; (2)
removal of those with high risk of bias, (3) removal of unpublished studies, (4) removal of studies that
imputed missing data (if applicable).
 
Contact details for further information
Trace Heavener
trace.heavener@bswhealth.org
 
Organisational affiliation of the review
Baylor Scott and White Healthcare
 
Review team members and their organisational affiliations
Dr Trace Heavener. Baylor Scott and White Healthcare
Mr Cole Wayant. Oklahoma State University Center for Health Sciences
                               Page: 2 / 4
 PROSPERO
International prospective register of systematic reviews
Mr Ahmed Memon. Texas A&M College of Medicine
Mr Chase Meyer. Oklahoma State University Center for Health Sciences
Mrs Margaret Foster. Texas A&M University
Dr Matt Vassar. Oklahoma State University Center for Health Sciences
 
Anticipated or actual start date
03 December 2018
 
Anticipated completion date
03 June 2019
 
Funding sources/sponsors
None
 
Conflicts of interest
 
Language
English
 
Country
United States of America
 
Stage of review
Review_Ongoing
 
Subject index terms status
Subject indexing assigned by CRD
 
Subject index terms
Anti-Inflammatory Agents, Non-Steroidal; Barrett Esophagus; Esophageal Neoplasms; Humans
 
Date of registration in PROSPERO
20 December 2018
 
Date of publication of this version
20 December 2018
 
Details of any existing review of the same topic by the same authors
 
Stage of review at time of this submission
The review has not started
 
Stage Started Completed
Preliminary searches No No
Piloting of the study selection process No No
Formal screening of search results against eligibility criteria No No
Data extraction No No
Risk of bias (quality) assessment No No
Data analysis No No
 
Versions
20 December 2018
                               Page: 3 / 4
 PROSPERO
International prospective register of systematic reviews
PROSPERO
This information has been provided by the named contact for this review. CRD has accepted this information in good
faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration
record, any associated files or external websites. 
Powered by TCPDF (www.tcpdf.org)
                               Page: 4 / 4


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Do non-steroidal anti-inflammatory drugs provide a protective effect on developing Barrett’s esophagus and esophageal cancer? A systematic review and meta-analysis

Abstract

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Texas A&M Repository

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Do non-steroidal anti-inflammatory drugs provide a protective effect on developing Barrett’s esophagus and esophageal cancer? A systematic review and meta-analysis

Abstract

Similar works

Full text

Available Versions

Texas A&amp;M Repository

Texas A&M University

Texas A&M Repository