EAL

CD: Neurological Outcomes (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To explore the relevance of depressive symptoms in a cohort of adult celiac patients.

Inclusion Criteria:

Consecutive patients with celiac disease seen at the Dept of Gastroenterology. All patients underwent complete clinical evaluation including laboratory findings, endoscopy and jejunal biopsy. Second group of hepatitis-C virus-related chronic persistent hepatitis served as chronic condition control. Normal control subjects were recruited from hospital staff and their relatives.

Exclusion Criteria:

Free of psychotropic medication and no reported alcohol / substance abuse.

Description of Study Protocol:

Recruitment

Celiac disease patients recruited from Dept of Gastroenterology, controls recruited from hospital staff and their relatives.

Design

Cohort Study.

Blinding used (if applicable)

Not applicable.

Intervention (if applicable)

Anonymous, self-administered questionnaire.

Statistical Analysis

Comparison between groups performed with one-way ANOVA and Scheffe post hoc test. The effect of demographic variables on the scale scores was checked with multiple regression analysis and non-parametric Kendall correlation rank test. Significance level was fixed at P = 0.0167 or P = 0.0125, decided on a Bonferroni basis. The characterization of depression subtypes in celiac disease patients was attempted through factor analysis.

Data Collection Summary:

Timing of Measurements

Anonymous, self-administered questionnaire.

Dependent Variables

Depressive symptoms measured through modified version of Zung Self-Rating Depression Scale (M-SDS), gastrointestinal items removed
Knowledge of celiac disease measured through Knowledge Rating Scale

Independent Variables

Gluten free diet and dietary compliance measured through Dietetic Restriction Compliance visual analog scale

Control Variables

Demographic variables: age, sex, socioeconomic level

Description of Actual Data Sample:

Initial N: 92 adult celiacs (22 men, 70 women), 100 normal controls (29 men, 71 women) and 48 patients with chronic persistent hepatitis (14 men, 34 women)

Attrition (final N): See above

Age: Celiac patients: 29.36 +/- 11.28 years, Hepatitis patients: 31.83 +/- 11.01 years, Controls: 30.04 +/- 12.32 years

Ethnicity: Not mentioned

Other relevant demographics: Mean age at time of diagnosis was 20.56 +/- 15.35 years in celiac disease patients and 24.08 +/- 9.65 in hepatitis patients, differences were not significant. Mean duration of gluten-free diet was 7.9 years.

Anthropometrics: Demographic variables were comparable across the 3 groups

Location: Naples, Italy

Summary of Results:

	Mean +/- SD	Range
Celiac Disease - M-SDS	31.81 +/- 7.84	18 - 50
Hepatitis - M-SDS	28.73 +/- 7.09	18 - 45
Controls - M-SDS	27.14 +/- 5.26	19 - 38
Celiac Disease - KRS	20.73 +/- 5.07	1 - 25
Celiac Disease - DRC	16.17 +/- 4.20	0 - 20

Other Findings

The Self-Rating Depression Scale scores differentiated celiac disease patients from controls. Both "psychologic" and "biologic" scores were different between groups (F = 14.166, P = 0.0002 for psychologic scores, F = 26.465, P < 0.0001 for biologic scores).

Demographic variables did not influence the M-SDS and DRC scores, while the socioeconomic variable had an effect on knowledge scores (t = 2.338, P = 0.0163) with the celac disease patients in higher socioeconomic levels having a better knowledge of the disease.

Age at diagnosis and duration of and compliance with gluten-free diet did not correlate with depression.

3 main factors could be identified through the Self-Rating Depression Scale: reactiveness (referred depression, tendency to cry, decreased energy, restlessness, and irritability), pessimism (hope about the future, ability to make decisions, sense of usefulness, and feeling full of life), and anhedonic-asthenic (sexual interest, sense of clear mind, and facility in doing things).

Author Conclusion:

In conclusion, the results of the present study highlight the relevance of depressive symptoms among celiac patients; this interpretation is consistent with the co-occurrence of biologic and psychologic mechanisms, the last probably being, in our sample, predominant. This should encourage clinicians to pay attention to psychiatric and psychologic evaluation in managing care of these patients.

Funding Source:

University/Hospital:

University of Naples (Italy)

Reviewer Comments:

Gastrointestinal items removed from Self-Rating Depression Scale to avoid bias. Not sure where hepatitis patients were recruited from or why there were only 48 subjects. Unclear as to whether the questionnaires were tested for reliability and validity.

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?	Yes
	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?	Yes
3.	Were study groups comparable?		???
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	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?	???
	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.)	???
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
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%.)	Yes
	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
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		N/A
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	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.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	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?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		???
	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?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	???
	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)?	Yes
	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