EAL

CD: Quality of Life (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To describe and explore, using a qualitative approach, variations in the perception of health-related quality of life between men and women with long-standing celiac disease.

Inclusion Criteria:

Celiac patients on gluten-free diet for 10 years and who declared having no major concomitant disease.

Exclusion Criteria:

Excluded if not included above.

Description of Study Protocol:

Recruitment

Subjects recruited from previous study.

Design

Cross-Sectional, Descriptive

Blinding used (if applicable)

SF-36 scores not revealed to interviewers until after analysis.

Intervention (if applicable)

Gluten free diet for 10 years.

Statistical Analysis

Qualitative research. Triangulation of investigators used and focus group of 6 celiac patients employed for agreement in statements presented.

Data Collection Summary:

Timing of Measurements

Subjects had scored either high or low on the Short Form 36 Health Survey General Health and Vitality and were interviewed using phenomenography.

Dependent Variables

Appraisal of the phenomenon health-related quality of life, health-related quality of life when living with celiac disease, health-related quality of life in relation to coping with celiac disease and gender differences in perceptions of health-related quality of disease captured in 60 - 90 minute interviews by 2 practiced interviewers

Independent Variables

Gluten-free diet measured by self-rated compliance.

Control Variables

Description of Actual Data Sample:

Initial N: 10 celiac subjects.

Attrition (final N): See above.

Age: Mean age 57 years (range 35 - 73 years).

Ethnicity: Not mentioned.

Other relevant demographics: Not mentioned.

Anthropometrics

Location: Sweden

Summary of Results:

Other Findings

3 dimensions were revealed that pertained to the perception of health-related quality of life: bodily sensations, social consequences, and coping strategies.

Bodily sensations was based on the aspects of physical endurance and bowel symptoms. Most of the men described the physical consequences of celiac disease in terms of reduced physical endurance. Women experienced more bowel symptoms than men did, despite keeping to a strict diet. This item was the only one predicting the SF-36 scores.

Social consequences was based on the aspects of value of food, identification, and roles. The women considered celiac disease to be more socially inconvenient than the men did. The women described higher demands on themselves than the men did in various social roles, thus limiting their ability to take care of symptoms related to celiac disease.

Coping strategies was based on the aspects of acceptance and control. The celiac men took advantage of using a problem-oriented coping approach while the women seeking an emotionally oriented strategy showed less satisfaction with the outcome. The women expressed a lower degree of acceptance of living with celiac disease. For the women, the controlling of foods had social consequences as a result of feeling foced to plan every daily activity.

Author Conclusion:

We conclude that the intriguing difference in health-related quality of life between celiac men and women may have some of its origin in the way living with the disorder is conceptualized and coped with. The results imply that in the management of celiac patients, gender-related aspects need to be taken into account to improve treatment outcome. We believe our results may provide new insight into gener-related aspects of being celiac that could be useful to health professionals engaged in the lifelong care of these people.

Funding Source:

Government:

Medical Research Council of Southeast Sweden

Reviewer Comments:

Small sample size. Compliance was self-rated.

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?	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?	???
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)	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?	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.)	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?		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?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	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
	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?		???
	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?	N/A
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	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?	???
	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?	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?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	No
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	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)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
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