EAL

CD: Gluten-free Diet (2021)

Author and Year:

Koskinen O, Collin P, et al, 2010

PubMed ID:

19779364

Article Title:

Usefulness of small-bowel mucosal transglutaminase-2 specific autoantibody deposits in the diagnosis and follow-up of celiac disease.

Authors:

Koskinen O, Collin P, Lindfors K, Laurila K, Mäki M, Kaukinen K

Journal:

Journal of Clinical Gastroenterology

Year of publication:

2010

Volume:

Issue:

Page numbers:

483-488

Study Design:

Cross-Sectional Study

Risk of Bias Assessment Rating:

Neutral

Inclusion Criteria:

261 consecutive untreated celiac disease patients were enrolled in the study. All were found to have small-bowel mucosal villous atrophy with crypthyperplasia, thus fulfilling the current diagnostic criteria for the disease. A follow-up biopsy after 1 year on a gluten-free diet was taken from 71 of these patients (defined as the short-term treated group). The long-term group comprised 105 celiac patients maintaining a gluten-free diet for more than 2 years. The control group consisted of 78 nonceliac subjects who underwent endoscopy because of indigestion or suspicion of celiac disease, the condition being excluded by normal small-bowel mucosal villous architecture.

Exclusion Criteria:

Not reported

Research Purpose:

The aims of this study were first to assess systematically the presence of TG2-specific autoantibody deposits in a large cohort of untreated celiac disease patients, and second to establish whether and how fast the IgA deposits decline after initiation of a gluten-free diet. Furthermore, to validate the determination of intestinal IgA deposits as a future diagnostic tool for celiac disease, we compared the presence of intestinal IgA autoantibody deposits to conventional celiac serology, mucosal morphology and to the density of intraepithelial lymphocytes (IELs).

Blinding efforts:

All evaluations were carried out blindly without knowledge of disease history or laboratory findings.

Study Location:

Not reported - likely Finland due to author afilliations

Source(s) of Funding:

Government, University/Hospital, Not-for-profit

Please specify names of funders:

Research Council for Health, the Academy of Finland, the Pediatric Research Foundation, the Competitive Research Funding of the Pirkanmaa Hospital District, the Research Fund of the Finnish Celiac Society, the Sigrid Juselius Foundation and the European Commission

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		No
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	No
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
3.	Were study groups comparable?		No
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	No
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	Yes
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
4.	Was method of handling withdrawals described?		No
	4.1.	Were follow-up methods described and the same for all groups?	No
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
5.	Was blinding used to prevent introduction of bias?		Yes
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	Yes
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	???
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	N/A
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes