EAL

CD: Gluten-free Diet (2021)

Author and Year:

Korpimaki S, Kaukinen K, et al, 2011

PubMed ID:

Article Title:

Gluten-sensitive hypertransaminasemia in celiac disease: an infrequent and often subclinical finding.

Authors:

Korpimäki S, Kaukinen K, Collin P, Haapala A, Holm P, Laurila K, Kurppa K, Saavalainen P, Haimila K, Partanen J, Mäki M, Lähdeaho M

Journal:

American Journal of Gastroenterology

Year of publication:

2011

Volume:

106

Issue:

Page numbers:

1689-1696

Study Design:

Prospective Cohort Study

Risk of Bias Assessment Rating:

Neutral

Inclusion Criteria:

Cross-sectional study: over 15 years old who participated in previous clinical trials undertaken by the Celiac Disease Study Group between the years 1995 and 2008 and for whom frozen stored sera were available for analysis. The untreated and treated celiac disease (CD) patients had the diagnosis of CD confirmed on small-bowel mucosal biopsy. Prospective study — gluten-free diet trial: newly diagnosed CD patients who followed a gluten-free diet for 1 year after diagnosis. Prospective study — gluten challenge trial: volunteer treated CD patients who had adhered to a strict gluten-free diet for at least 2 years, and were in clinical remission as judged by interview and clinical examination.

Exclusion Criteria:

Not reported

Research Purpose:

To verify the extent of liver involvement in celiac disease today, we first carried out a cross-sectional study and estimated the occurrence of hypertransaminasemia in a large cohort of untreated and treated celiac disease patients also diagnosed with minor or atypical symptoms and compared the findings with a non-celiac reference population. Second, to evaluate whether serum transaminase levels in celiac disease are gluten dependent, we determined liver enzyme levels in two prospective series comprising newly diagnosed celiac patients before and after 1 year on a gluten-free diet, and celiac patients in remission on a diet and after a gluten challenge.

Blinding efforts:

Not reported

Study Location:

Finland

Source(s) of Funding:

Government, University/Hospital, Not-for-profit

Please specify names of funders:

Tampere Hospital District, the Academy of Finland, the Sigrid Juselius Foundation, the Research Fund of the Finnish Celiac Society, and the Pediatric Research Foundation.

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?		Yes
	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?	Yes
	2.2.	Were criteria applied equally to all study groups?	N/A
	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?	???
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	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
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	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%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
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?	N/A
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
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	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?	Yes
	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?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
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