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CD: Quality of Life (2006)

Citation:

Ciacci C, Iavarone A, Siniscalchi M, Romano R, De Rosa A. Psychological dimensions of celiac disease: toward an integrated approach. Dig Dis Sci. 2002; 47 (9): 2,082-2,087.

PubMed ID: 12353859
 
Study Design:
Cross-Sectional Study
Class:
D - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To evaluate the emotional impact of celiac disease diagnosis in adulthood, the patient-doctor relationship and the patients' cooperation with disease treatment and diet.

Inclusion Criteria:
  • All patients underwent a complete clinical evaluation, including laboratory findings
  • Endoscopy and jejunal biopsy were carried out and celiac disease diagnosis confirmed.
Exclusion Criteria:
All subjects free of psychotropic medication and no alcohol or substance abuse was reported.
Description of Study Protocol:

Recruitment

Patients consecutively seen at the Department of Gastroenterology.

Design

Cross-sectional study.

Statistical Analysis

  • Multiple-regression analyses performed to evaluate the effect of demographic variables on several dependent variables assessed by SAIC
  • The significance level was P=0.0167, based on a Bonferroni test considering an overall 0.05 level for each measure, divided by the three independent variables
  • A linear regression analysis was performed to check the effect of the duration of the disease on the intensity of the feelings at the time of diagnosis. The identification of psychological dimensions both at the time of diagnosis and at the present time was attempted by means of a factor analysis with varimax rotation. When scores derived from visual analog number lines were taken into account, correlations were analyzed by the Spearman rank test and paired comparisons by the T-test. Multiple comparisons and post-hoc evaluations were performed by one-way ANOVA and Scheffe test.
Data Collection Summary:

Timing of Measurements

  • Self-administered questionnaire: Self-Administered Inventory for Celiacs (SAIC)
  • 27 of 114 patients also answered an Illness Behavior Questionnaire to attempt to validate the SAIC, but the questions were not identical and there are no other questionnaires available for a complete comparison. 

Dependent Variables

  • Patient's level of knowledge of disease: Knowledge Rating Scale
  • Physical and emotional impact at diagnosis with visual analog scales 
  • Feelings during follow-up and coping mechanisms.

Independent Variables

Demographic variables (age, sex, socioeconomic level).

Description of Actual Data Sample:
  • Initial N: 114 adult celiac patients on a gluten-free diet (27 men, 87 women) and 25 untreated celiac patients
  • Attrition (final N): 114 on gluten-free diet and 25 untreated
  • Age: Age of patients on gluten-free diet, 29.62±11.18 years
  • Ethnicity: Not mentioned

Other Relevant Demographics

  • Age at diagnosis for patients on gluten-free diet: 20.43±15.04 years
  • Duration of gluten-free diet: 7.78±6.81 years 
  • Anthropometrics: Untreated celiac patients were sex- and age-matched
  • Location: Naples, Italy.
Summary of Results:

Other Findings

  • Celiac patients showed good knowledge of the disease, directly correlated to their socio-economic level (T=2.483, P=0.011). The newly diagnosed patients showed poorer knowledge of the disease (P=0.056), although the socio-economic variable was even more important in determining a good knowledge (P=0.001).
  • At diagnosis, "relief" was the most intense feeling (10.82±7.63), however the scores for this feeling were not significantly different from those of the other feelings except "sadness."  Demographics, time latency of diagnosis and duration of disease had no effect on the intensity of all feelings.
  • The scores of the self-rated emotions were entered into a principal component analysis that generated three factors:
    1. Fear, anger, anxiety and sadness
    2. Reassurance and resignation
    3. Relief.
  • In untreated patients, all analyses gave results not significantly different from the treated group
  • Patients judged the clinicians presenting the disease "in the right way" (F=33.279, P<0.0001), meaning without either dramatizing or underevaluating. The right way correlated with relief and reassurance (P=0.0009 and P=0.0008, respectively). Untreated patients were similar to those of treated patients.
  • At follow-up, anger was the predominant emotion that induced patients to transgress. The intensity of anger was significantly different as compared to those of other feelings, with exception of "avoiding feelings of being different."
  • The patients judged as moderate their difficulties when sitting down to dinner or when asking for gluten-free meals; the scores on these items were comparable to "feelings of being different," and a stroing interrelation was evident between all three items (P<0.0001)
  • A positive correlation was observed between "feelings of being different" and "sadness," "anger," "fear" and "anxiety" (P<0.0001) for all
  • Anger was inversely corelated with actual compliance to diet (P=0.0005).
Author Conclusion:
  • In conclusion, in adult patients, adaptive and psychological aspects must be taken into account to understand the celiac patient and for better clinical management
  • Further studies are needed and they will address a better definition of the psychological dimensions of patients suffering from celiac disease in prospective design, in order to contribute to an integrated approach in clinical management of celiac disease patients.
Funding Source:
Industry:
Nutrasweet
Food Company:
Reviewer Comments:

SAIC is new questionnaire and needs validation.

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) N/A
 
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? 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? ???
  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.) Yes
  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? N/A
  4.1. Were follow-up methods described and the same for all groups? N/A
  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? N/A
  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? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? N/A
  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
  6.6. Were extra or unplanned treatments described? N/A
  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? No
  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