Further Validation of the Crohn’s and Ulcerative Colitis Questionnaire-32 (CUCQ-32) to Measure the Quality of Life in Patients Treated with Biologics Therapy

Round 1

Reviewer 1 Report

The authors have constructed a shortened version of the CUCQ-32 by condensing it to 12 questions and then also adding 5 questions specific to individuals with a stoma (the CUCQ+). They validated the questionnaire on 484 patients and assessed correlation with the EQ5D and clinical disease activity scores for UC and Crohn’s disease. They found correlation with the EQ5D as well as clinical activity scores. This provides an alternative to the sIBDQ questionnaire and would be a useful tool given the longer tools are time consuming. The authors had previously validated a CUC-8 as well. The addition of the stoma specific questions is also useful but further details on how these measures were arrived at are needed. I have the following suggestions:

 

• The surveyed group was mainly patients with Crohn’s disease (382/484) as was the stoma cohort – were there differences in the correlations between patients with UC and CD? Do you think this may have impacted on the results and that the stoma results would be reflective of patients with UC as well? This should be addressed in the discussion and the number of patients with UC/ Crohn’s participating should be added in the abstract
• What value does the CUCQ12 add to the CUCQ8 you had previously published?
• Adding new questions to the survey for patients with a stoma should require more details of the process and how these were assessed in relation to quality-of-life measures. How was this process completed or was this just generated by expert consensus?

 

Minor points:

 

Page 3, line 71 – “cognitive interviews ? And” – please explain what is involved in this process and remove the question mark and capital letter for and

 

Page 5, line 107 – please define what you mean by no change in bowel condition – is it exactly the same clinical disease activity score or was some discrepancy allowed?

 

Page 8, line 165 avoid using “very well” to describe a correlation r value of 0.59 and consider using “weak correlation” instead 

Author Response

Dear respected reviewer

Re: Manuscript ID: clinpract-1724342

On behalf of my co-authors, I would like to thank you for reviewing our manuscript (Further validation of the Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) to measure the Quality of Life in patients treated with biologics therapy).  We also greatly appreciate your comments and thoughtful suggestions that add substantial depth and impact to our findings. Please find below point-by-point responses to your concerns.  

We have considered your comments and uploaded the revised version of the manuscript with tracked changes. We hope that you find our responses satisfactory and that the manuscript is now acceptable for publication.

Comments:

• The surveyed group was mainly patients with Crohn’s disease (382/484) as was the stoma cohort – were there differences in the correlations between patients with UC and CD? Do you think this may have impacted the results and that the stoma results would be reflective of patients with UC as well? This should be addressed in the discussion and the number of patients with UC/ Crohn’s participating should be added in the abstract

Response: Thank you for this comment. We did a sub-analysis for CD and UC. The correlation remained good at disease-specific levels ( r = 0.51 in CD, r = 0.56 in UC  p < 0.05) but was slightly low in IBD-U ( r = 0.303) with p = 0.151. This has been added to the results.

The point raised regarding the validity in UC patients with a stoma is valid. The sample size of patients with a stoma was not large enough to allow separate analysis. Validation is an ongoing process, we are currently in the process of writing up a separate study on the validation of the stoma extension in patients with a stoma on a separate cohort of patients who had surgery for UC.

This limitation was acknowledged in the discussion.

The numbers of patients with UC/CD were mentioned in the abstract as highlighted by the respected reviewer.

 

• What value does the CUCQ12 add to the CUCQ8 you had previously published?

Response: We propose the use of CUCQ-12 plus as a quick and novel quality of life measurement tool for symptoms of patients with IBD as well as assessment including supplementary questions for the stoma. CUCQ-8 questionnaire does not include supplementary questions for the stoma. We, therefore, suggest using CUCQ-12 plus in routine clinical settings as a quick QoL questionnaire as well as in research, registries or clinical trials.

 

• Adding new questions to the survey for patients with a stoma should require more details of the process and how these were assessed in relation to quality-of-life measures. How was this process completed or was this just generated by expert consensus?

Response: Thank you. A semi-structured approach using the “think aloud” technique was followed to encourage patients to participate and identify items to be included in the stoma specific questionnaire. The patients were shown the questionnaires at each session and asked to contribute ideas and preferences about the questions' format, layout and response categories. This was done to ensure the questions addressed all IBD-related issues that are considered necessary by patients and provide feedback regarding the content of the shortened CUCQ and its stoma-specific supplementary questions. 

 

Minor points:

• Page 3, line 71 – “cognitive interviews ? And” – please explain what is involved in this process and remove the question mark and capital letter for and

Response. This is now added as above and the necessary changes was made.

• Page 5, line 107 – please define what you mean by no change in bowel condition – is it exactly the same clinical disease activity score or was some discrepancy allowed?

Response: The anchor question meant to ask about IBD condition and symptoms on a 100-point scale. Patients with changes of less than 10 scores compared to the first visit were included in the reproducibility analysis. This further clarification was added to the manuscript.

• Page 8, line 165 avoid using “very well” to describe a correlation r value of 0.59 and consider using “weak correlation” instead 

Response: thanks this is now changed.

We hope the above appropriately address all reviewers’ comments.

 

Looking forward to hearing from you soon

 

Best regards

Dr Laith Alrubaiy

On behalf of co-authors

 

Reviewer 2 Report

This study investigated the validation of Crohn’s and Ulcerative Colitis Questionnaire-32 (CUCQ-32) to measure the quality of life in patients treated with biologics therapy. This study is interesting, but has some problems.

 

Major comments;

#. In Tables 2 and 3, the total number of cases does not match in several items. For example, in GENDER, the total number of patients with Crohn's disease does not match. Also, in SMOKING, the total number of patients with ulcerative colitis does not match. "Had a postgraduate degree or qualification" also does not match the total number of UC patients. If the patient background table is not credible, the study results cannot be believed.

 

Minor comments;

#1. Abbreviations should be listed after the full spelling. Please double-check the order of abbreviations and full spellings. HRQoL does not indicate abbreviations.

 

#2. It would be better to show the full spelling of the abbreviation shown in the Table outside the column.

 

#3. Table 2 shows 'Male (%), Female (%)', but no percentages are given. Please confirm it.

Author Response

Dear Respected reviewer

Re: Manuscript ID: clinpract-1724342

 

On behalf of my co-authors, I would like to thank you for reviewing our manuscript (Further validation of the Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) to measure the Quality of Life in patients treated with biologics therapy).  We also greatly appreciate your comments and thoughtful suggestions that add substantial depth and impact to our findings. Please find below point-by-point responses to your comments and concerns.  

We have considered your respected reviewers’ comments and uploaded the revised version of the manuscript with tracked changes. We hope that you find our responses satisfactory and that the manuscript is now acceptable for publication.

Reviewer 2:

In Tables 2 and 3, the total number of cases does not match in several items. For example, in GENDER, the total number of patients with Crohn's disease does not match. Also, in SMOKING, the total number of patients with ulcerative colitis does not match. "Had a postgraduate degree or qualification" also does not match the total number of UC patients. If the patient background table is not credible, the study results cannot be believed.

 

Response: Thank you. This is now corrected.

Minor comments;

#1. Abbreviations should be listed after the full spelling. Please double-check the order of abbreviations and full spellings. HRQoL does not indicate abbreviations.

Response: Done

 

#2. It would be better to show the full spelling of the abbreviation shown in the Table outside the column.

Response: Thank you this has now been changed to make it clear.

 

#3. Table 2 shows 'Male (%), Female (%)', but no percentages are given. Please confirm it.

Response. This is now done.

 

We hope the above appropriately addresses all your comments.

Best regards

Dr Laith Alrubaiy

On behalf of co-authors

 

 

Reviewer 3 Report

Thank you for this paper. I find this topic very important, and overall clinically useful. This topic is generally neglected in IBD, and can be very useful. I like the idea of implementing questions on stoma and sexuality, which is of key importance for patient's quality of life.

Although this is not deeply scientific paper it relates to one of the most important questions for the patients and this topic should be even more addressed since it is neglected by medical providers.

Strenghts are multicentric approach and adequate statistical approach, and therefore I believe it will find it's audience and validation in other countries.

Of course, there is always ways to improve but for now this is wide and pragmatic questionnaire that could find it's clinical use very fast.

 

 

Author Response

Dear respected reviewer,

Re: Manuscript ID: clinpract-1724342

On behalf of my co-authors, I would like to thank you for reviewing our manuscript (Further validation of the Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) to measure the Quality of Life in patients treated with biologics therapy).  We also greatly appreciate your complimentary comments and thoughtful suggestions that add substantial depth and impact to our findings.

We have considered the respected reviewers’ comments and uploaded the revised version of the manuscript with tracked changes. We hope that you find our responses satisfactory and that the manuscript is now acceptable for publication.

Looking forward to hearing from you soon

Best regards

Dr Laith Alrubaiy

On behalf of co-authors

Round 2

Reviewer 1 Report

The authors have addressed all of the suggested comments appropriately and improved the manuscript.