Abstract
Coeliac disease (CD) is a chronic immune-mediated disease in genetically susceptible individuals, induced by ingested gluten. The treatment for CD is a lifelong gluten-free diet (GFD). The GFD involves restrictions in diet that may impact on a person’s Health-Related Quality of Life (HRQoL).
Aim
The aim of the present study was to develop the Coeliac Disease Quality of Life questionnaire (CDQL): a comprehensive CD-specific HRQoL measure that can be completed by children, adolescents, and adults or by proxy.
Methods
The questionnaire was developed in three phases. In phase 1, focus group methods and qualitative analysis of verbatim transcripts generated CD-specific items for a prototype instrument to sensitively captured patient concerns. In phase 2, CD patients completed the prototype CDQL. The questionnaire was refined through analysis of data and cognitive interviewing. In phase 3, the final version of the CDQL was answered by Danish respondents. The psychometric properties of the CDQL were assessed, and the HRQoL data were analyzed.
Results
The CDQL was completed by 422 respondents. The CDQL has 12 patient background items, 2 generic HRQoL items, and 30 CD-specific HRQoL item. The CD-specific HRQoL items were distributed on eight scales with acceptable to excellent reliability. Comprehensiveness and understandability was shown by feedback from cognitive interviewing from children, adolescents, and adults. Content validity was ensured by involving patients and clinicians in the development of the questionnaire. Sensitivity of the questionnaire was demonstrated in differences found between children, adolescents, and adult’s perception of their HRQoL in relation to having CD.
Conclusions
The CDQL comprehensively measures HRQoL in CD, and is psychometrically robust. The questionnaire may prove useful in tracking HRQoL in CD across age groups.
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Acknowledgements
We thank Ruth O Mahony for assisting the distributing of the questionnaire in Ireland during pilot testing. We thank the Danish Coeliac Society for feedback on the questionnaire and aid in recruiting participants. We thank all who participated in focus groups, interviews, and who answered the questionnaire.
Funding
This study was funded by The Danish Council for Strategic Research (J. No. 2009-38/23364-2). The authors did not receive any additional financial support for the research, authorship, and/or publication of this article.
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All authors declare that they have no conflict of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Appendices
Appendix: CDQL (Coeliac Disease Quality of Life questionnaire)
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This questionnaire is about the quality of life of people living with coeliac disease
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The questionnaire enquires as to how you feel about coeliac disease
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All responses are anonymous
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You may ask for assistance when answering the questionnaire
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It is important to us that you answer each question
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It takes about 5–10 minutes to complete the questionnaire
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Thank you for your participation! Feel free to post comments at the end of the questionnaire
Halfdan Skjerning
Audrey DunnGalvin
Steffen Husby
B11 If you eat something with gluten, do you experience any of these problems? | Extremely | A lot | Moderately | Slightly | Not at all | I don’t know | |
|---|---|---|---|---|---|---|---|
B11A | Abdominal pain | ||||||
B11B | Diarrhea | ||||||
B11C | Constipation | ||||||
B11D | Nausea | ||||||
B11E | Acid regurgitation | ||||||
B11F | Vomiting | ||||||
B11G | Feeling bloated | ||||||
B11H | Lack of appetite | ||||||
B11I | Fatigue | ||||||
B11J | Headache | ||||||
B11K | Sadness | ||||||
B11L | Mood swings | ||||||
B11M | Other (please state) ______________ | ||||||
B12 Have you experienced any of these problems associated with having coeliac disease the past two weeks? | All the time | Most of the time | Sometimes | Rarely | Never | |
|---|---|---|---|---|---|---|
B12A | Abdominal pain | |||||
B12B | Diarrhea | |||||
B12C | Constipation | |||||
B12D | Nausea | |||||
B12E | Acid regurgitation | |||||
B12F | Vomiting | |||||
B12G | Feeling bloated | |||||
B12H | Lack of appetite | |||||
B12I | Fatigue | |||||
B12J | Headache | |||||
B12K | Sadness | |||||
B12L | Mood swings | |||||
B12M | Other (please state) ______________ | |||||
Please keep in mind your standards, hopes, and concerns. We ask that you think about your life in the last two weeks.
Very poor | Poor | Neither poor nor good | Good | Very good | ||
|---|---|---|---|---|---|---|
GQ1 | How would you rate your quality of life? |
Very dissatisfied | Dissatisfied | Neither satisfied nor dissatisfied | Satisfied | Very satisfied | ||
|---|---|---|---|---|---|---|
GQ2 | How satisfied are you with your health? |
Very unwell |
Unwell |
Neutral |
Well |
Very well | I don’t know | ||
|---|---|---|---|---|---|---|---|
CQ1 | When I think of the time it took to be diagnosed with coeliac disease, I feel… | ||||||
CQ2 | When I think of the coeliac disease diagnostic process, I feel… | ||||||
CQ3 | When I think of attending an appointment for monitoring my coeliac disease, I feel… | ||||||
CQ4 | When I think of my knowledge of coeliac disease, I feel… | ||||||
CQ5 | When I think of what happens if I eat something with gluten, I feel… | ||||||
CQ6 | When I think of that I may eat something with gluten by accident, I feel… | ||||||
CQ7 | When I think of what it is like for me to follow a gluten-free diet, I feel… | ||||||
CQ8 | When I think of food containing gluten, which I cannot eat, I feel… | ||||||
CQ9 | When I think of trying to find out if there is gluten in the food, I feel… | ||||||
CQ10 | When I think of the labeling of gluten-free food, I feel… | ||||||
CQ11 | When I think of the availability of gluten-free food, I feel… | ||||||
CQ12 | When I think of the price of gluten-free food, I feel… | ||||||
CQ13 | When I think of the quality of gluten-free food, I feel… | ||||||
CQ14 | When I think of what it is like to be offered food that contains gluten, I feel… | ||||||
CQ15 | When I think of what it is like for me to be offered food which I am not sure contains gluten, I feel… | ||||||
CQ16 | When I think of asking whether there is gluten in the food, I feel… | ||||||
CQ17 | When I think of how others around me take notice of me in relation to gluten-free food, I feel… | ||||||
CQ18 | When I think of other people’s awareness about coeliac disease, I feel… | ||||||
CQ19 | When I think of how well other people can find out if there is gluten in a food, I feel… | ||||||
CQ20 | When I think of how it is for me to tell someone that I have coeliac disease, I feel… | ||||||
CQ21 | When I think of how it is for me to tell someone what I can eat and not eat, I feel… | ||||||
CQ22 | When I think of others’ reaction to gluten-free food, I feel… | ||||||
CQ23 | When I think of how it is for me to see others eating food that I cannot eat, I feel… | ||||||
CQ24 | When I think of how it is for me to stay on the gluten-free diet when I eat out, I feel… | ||||||
CQ25 | When I think of that there are not that many who have coeliac disease, I feel… | ||||||
CQ26 | When I think of the future with coeliac disease, I feel… | ||||||
CQ27 | When I think of that I cannot change that I have coeliac disease, I feel… | ||||||
CQ28 | When I think of my health as a whole in relation to coeliac disease, I feel… | ||||||
CQ29 | When I think of my life as compared to others all in all, in relation to coeliac disease, I feel… | ||||||
CQ30 | When I think of having coeliac disease, all in all, I feel… |
Thank you for your participation! Feel free to leave comments here:
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Scoring Procedure for the CDQL Scales
The scale ‘Worries-about-symptoms’ can be computed from items B11A to B11M by averaging the numeric values of the answered items.
The scale ‘Symptoms’ can be computed from items B12A to B12M by averaging the numeric values of the answered items.
The scale ‘Contacting health care’ can be computed by averaging the numeric values of the answered items: CQ1, CQ2, CQ3.
The scale ‘Having coeliac disease and following a gluten-free diet’ can be computed by averaging the numeric values of the answered items: CQ7, CQ8, CQ23, CQ24, CQ25, CQ26, CQ27.
The scale ‘Communicating about coeliac disease and gluten-free food’ can be computed by averaging the numeric values of the answered items: CQ16, CQ20, CQ21, CQ22.
The scale ‘Others’ handling my coeliac disease’ can be computed by averaging the numeric values of the answered items: CQ17, CQ18, CQ19.
The scale ‘Confronting gluten-containing food’ can be computed by averaging the numeric values of the answered items: CQ5, CQ6, CQ14, CQ15.
The scale ‘Knowing about coeliac disease and gluten-free food’ can be computed by averaging the numeric values of the answered items: CQ4, CQ9, CQ10.
The scale ‘Gluten-free food supply’ can be computed by averaging the numeric values of the answered items: CQ11, CQ12, CQ13.
The scale ‘Evaluating having coeliac disease in overall’ can be computed by averaging the numeric values of the answered items: CQ28, CQ29, CQ30.
Numeric values:
0 = Extremely (B11), All the time (B12), Very poor (GQ1), Very dissatisfied (GQ2), 
Very unwell (CQ)
1 = A lot (B11), Most of the time (B12), Poor (GQ1), Dissatisfied (GQ2), 
Unwell (CQ)
2 = Moderately (B11), Sometimes (B12), Neither poor nor good (GQ1), Neither satisfied nor dissatisfied (GQ2), 
Neutral (CQ)
3 = Slightly (B11), Rarely (B12), Good (GQ1), Satisfied (GQ2), 
Well (CQ)
4 = Not at all (B11), Never (B12), Very good (GQ1), Very satisfied (GQ2), 
Very well (CD)
‘I don’t know’ is treated as missing data.
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Skjerning, H., Hourihane, J., Husby, S. et al. A comprehensive questionnaire for the assessment of health-related quality of life in coeliac disease (CDQL). Qual Life Res 26, 2831–2850 (2017). https://doi.org/10.1007/s11136-017-1632-3
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DOI: https://doi.org/10.1007/s11136-017-1632-3