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CD: Quality of Life (2006)

Citation:

Lee A, Newman JM.  Celiac diet:  its impact on quality of life.  J Am Diet Assoc 2003; 103: 1533-1535.

PubMed ID: 14576723
 
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 determine the effects of a gluten-free diet, examining food consumption and limitations on quality of life for those with celiac disease.
Inclusion Criteria:
Members of Westchester Celiac Sprue Support Group.
Exclusion Criteria:
Excluded afterwards if under age 18.
Description of Study Protocol:

Recruitment

Mailed to members of Westchester Celiac Sprue Support Group.

Design

Cross-sectional Study.

Blinding used (if applicable)

Not applicable.

Intervention (if applicable)

Self-administered questionnaire.

Statistical Analysis

Descriptive statistics - frequencies and cross-tabulations.

Data Collection Summary:

Timing of Measurements

Self-administered questionnaire with 29 items, most using 3 or 5-point Likert scales.  Some items from Rand Survey.  2 celiac-disease health professionals and 2 leaders of support group reviewed questionnaire for content validity.

Dependent Variables

  • Quality of life taken from Rand Corporation 36-item International Health Survey (11 questions)

Independent Variables

  • Demographics (3 questions) 
  • Lifestyle (10 questions)
  • Food choices (7 questions)

Control Variables

 

Description of Actual Data Sample:

Initial N:  404 members of Westchester Celiac Sprue Support Group 

Attrition (final N):  274 responses (68% response rate), 253 usable (21 excluded since under age 18 and had not sought permission).  74% female, 26% male.

Age: 42% of respondents were 36 - 55 years old, 46% were 55+

Ethnicity:  Not mentioned 

Other relevant demographics:  Not mentioned. 

Anthropometrics (e.g., were groups same or different on important measures)

Location:  4 counties in New York State 

 

Summary of Results:

 

Has impact - Total (%) Has impact - Women (%) Has impact - Men (%) No impact - Total (%) No impact - Women (%) No impact - Men (%)
Dine out 86 65 20 14 12 2
Travel 82 64 18 18 14 4
Family 67 49 18

33

29

4

Career 41 26 15

59

50

9

Other Findings

90% of respondents perceived themselves as healthy and that their celiac disease had little effect on their quality of life.

Several areas of negative impact in maintaining a gluten-free diet.

86% reported difficulties in dining out.

82% reported difficulties with travel.

67% reported impact on family.

41% reported impact on career or work.

Results varied by gender:  more women reported that dining out (65%), travel (64%), and family (49%) were impacted by diet, although men reported less of an impact (20%, 18%, 18%, respectively).

Author Conclusion:
The gluten-free diet impacted various lifestyle aspects of the quality of life for individuals with celiac disease.  The results indicate a call to action for health professionals.  First, we need to be more aware of the prevalence of celiac disease in the US.  Second, there is a need for health professionals to be better educated about celiac disease, its varied symptoms, and the many intracacies of understanding the gluten-free diet.  Last, and probably most important, is the need for an increased sensitivity to the emotional and psychological impact that the diagnosis and treatment can have on an individual.
Funding Source:
Industry:
Unilever (Hamburg, Germany)
Food Company:
Reviewer Comments:
High response rate for survey.  Not necessarily generalizable findings.  Questionnaire tested for validity but not reliability.
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? ???
  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? ???
  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? ???
3. Were study groups comparable? N/A
  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? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? N/A
  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
  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? 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? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  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? N/A
  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? N/A
  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? N/A
  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? N/A
  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? N/A
  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