Reliability, validity, and responsiveness of the Thai version of the Dry Eye-Related Quality-of-Life Score questionnaire

Napaporn Tananuvat; Sasiwimon Tansanguan; Nahathai Wongpakaran; Tinakon Wongpakaran

doi:10.1371/journal.pone.0271228

Peer Review History

Original SubmissionJanuary 10, 2022
18 May 2022 Decision Letter - Adrienne Csutak, Editor PONE-D-22-00892Reliability, validity, and responsiveness of the Thai version of the Dry Eye-Related Quality-of-Life Score questionnairePLOS ONE Dear Dr. Tananuvat, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jun 26 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Review The manuscript reports on a follow-up investigation of the author’s previous article on the Dry Eye-related Quality-of-life Score (DEQS) questionnaire translated to the Thai language, DEQS-Th, for use in Thailand. They have used statistical methods for producing quantitative measures of the effectiveness of the questionnaire for screening patients with suspected dry eye disease (DED). They compared DEQS-Th with other DED tests and evaluated reliability, internal consistency, test-retest correlation, responsiveness, and accuracy of the DEQS-Th. The authors report cut-off scores to be used for screening and detecting DED using the DEQS-Th. Inconsistencies between the Abstract, Results and Discussion are noted below. However, there is a fundamental issue relative to the cut-off scores that should be addressed. The DEQS-Th cut-off scores are reported as “>X” for diagnostic tests and “>Y” for ocular symptoms. As can be seen from the Supplemental Tables S1 and S2, as the score rises, the sensitivity of the test decreases while the specificity increases. This is a standard property of Receiver Operator Characteristic (ROC) curves (Fig. 1). Is it preferable to have a higher cut-off with decreased sensitivity (fewer cases of DED detected) and increased specificity (fewer false positives)? Or is it better to have a lower cut-off with increased sensitivity (more cases of DED detected) and decreased specificity (more false positives)? The authors should acknowledge that using a cut-off value represents a trade-off between sensitivity and specificity. If they recommend using “>” with the cut-off, they should justify the choice being made between sensitivity and specificity. Some specific comments: Lines 30-31, 281-282, 344: The cut-off scores, “>18.33“ and “>19”, for rating the DEQ-Th diagnostic tests are not equivalent. As can be seen in the Supplementary S1 Table, there is a difference between a cut-off of 18.33 and any other cut-off value. Only 18.33 gives the sensitivity of 90 and specificity of 76.67. For any other cut-off number, the sensitivity and specificity will be different. To report a cut-off of 19, the authors should recalculate the sensitivity and specificity corresponding to the cut-off and report those results in lines 281-282. In any event, the reported cut-off, sensitivity and specificity in the Abstract (lines 30-31) and the cut-off in the Discussion (line 344) need to be changed to be consistent with the results reported in the Results on lines 281-282. In addition, “>” is inappropriate if the reported cut-off is supposed to represent a particular sensitivity and specificity. Lines 31-32, 283-284, 350: The cut-off scores, “>3” and “>4”, for rating the DEQ-Th using subscale ocular symptoms for DED screening are not equal. As can be seen in the Supplementary S2 Table, there is a difference between a cut-off of 3 and a cut-off of 4. A cut-off of 3 gives the sensitivity equal to 93.00 and specificity equal to 63.33, while a cut-off of 4 gives a sensitivity of 86.00 and a specificity of 66.67. The cut-off, sensitivity and specificity given in the Abstract (lines 31-32) and the cut-off in the Discussion (line 350) need to be consistent with the cut-off, sensitivity and specificity given in the Results in lines 283-284. As noted above, here too, “>” is inappropriate if the reported cut-off is supposed to represent a particular sensitivity and specificity. Lines 73: The DEQS was developed in 2013, not 2014. Lines 148-154: For the OSDI, the patients use a 5-point scale, 0-4. Need to specify how this is translated to a 0-100 scale – to obtain the total OSDI score, calculate the sum of scores of all questions answered times 25 divided by total number of questions answered, giving the OSDI a scale from 0-100. Lines 209, 220, 226: none-DED should be non-DED Lines 421-423: Add the date of the FDA document, December 2009, to Ref 17 and update the availability date from 2021 to be current in 2022. Supplementary Material: The results presented in this manuscript, Tables 2-7 and S1 and S2, are based on data collected in the course of this research. The data have not been made available with this submission. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. 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Revision 1
24 May 2022 Author Response Response to Reviewers Dear Reviewer, We greatly appreciate your time for your kind review and constructive comments on the manuscript entitled “Reliability, validity, and responsiveness of the Thai version of the Dry Eye-Related Quality-of-Life Score questionnaire” (Submission ID PONE-D-22-00892). We have carefully studied your comments and made corrections as suggested. Please find enclosed the revised version of our manuscript highlighted in yellow and the detailed point-by-point response to the comments raised by the reviewer. We hope that our responses would be satisfactory. Sincerely yours, Napaporn Tananuvat, M.D. (On behalf of the co-authors) Reviewer #1: Review The manuscript reports on a follow-up investigation of the author’s previous article on the Dry Eye-related Quality-of-life Score (DEQS) questionnaire translated to the Thai language, DEQS-Th, for use in Thailand. They have used statistical methods for producing quantitative measures of the effectiveness of the questionnaire for screening patients with suspected dry eye disease (DED). They compared DEQS-Th with other DED tests and evaluated reliability, internal consistency, test-retest correlation, responsiveness, and accuracy of the DEQS-Th. The authors report cut-off scores to be used for screening and detecting DED using the DEQS-Th. Inconsistencies between the Abstract, Results and Discussion are noted below. However, there is a fundamental issue relative to the cut-off scores that should be addressed. The DEQS-Th cut-off scores are reported as “>X” for diagnostic tests and “>Y” for ocular symptoms. As can be seen from the Supplemental Tables S1 and S2, as the score rises, the sensitivity of the test decreases while the specificity increases. This is a standard property of Receiver Operator Characteristic (ROC) curves (Fig. 1). Is it preferable to have a higher cut-off with decreased sensitivity (fewer cases of DED detected) and increased specificity (fewer false positives)? Or is it better to have a lower cut-off with increased sensitivity (more cases of DED detected) and decreased specificity (more false positives)? The authors should acknowledge that using a cut-off value represents a trade-off between sensitivity and specificity. If they recommend using “>” with the cut-off, they should justify the choice being made between sensitivity and specificity. Response: Thank you for your comments and suggestions. We apologize for the inconsistencies. The data are now corrected. We strongly agree with you that there is a trade-off between sensitivity and specificity using the different cut-off scores. That’s why we use a cut-off of ≥18.33 that yields a sensitivity of 90.00% and a specificity of 76.67%. This optimal criterion also provides the lowest cost (0.131) when the cost estimation is taken into account. In the revised manuscript, we apply “≥” for the criterion values in both Supplement S1 Table and S2 Table as suggested. Some specific comments: Lines 30-31, 281-282, 344: The cut-off scores, “>18.33“ and “>19”, for rating the DEQ-Th diagnostic tests are not equivalent. As can be seen in the Supplementary S1 Table, there is a difference between a cut-off of 18.33 and any other cut-off value. Only 18.33 gives the sensitivity of 90 and specificity of 76.67. For any other cut-off number, the sensitivity and specificity will be different. To report a cut-off of 19, the authors should recalculate the sensitivity and specificity corresponding to the cut-off and report those results in lines 281-282. In any event, the reported cut-off, sensitivity and specificity in the Abstract (lines 30-31) and the cut-off in the Discussion (line 344) need to be changed to be consistent with the results reported in the Results on lines 281-282. In addition, “>” is inappropriate if the reported cut-off is supposed to represent a particular sensitivity and specificity. Response: Thank you for your careful review. In the revised manuscript, the cut-off score of ≥ 18.33 was used consistently in the Abstract, the Results, and the Discussion part. Practically, we suggest a cut-off score of ≥ 18 for simple use of the DEQS-TH questionnaire even though the exact sensitivity and specificity may be slightly changed from the original 18.33. This statement is added in the Discussion part (lines 346-347). Lines 31-32, 283-284, 350: The cut-off scores, “>3” and “>4”, for rating the DEQ-Th using subscale ocular symptoms for DED screening are not equal. As can be seen in the Supplementary S2 Table, there is a difference between a cut-off of 3 and a cut-off of 4. A cut-off of 3 gives the sensitivity equal to 93.00 and specificity equal to 63.33, while a cut-off of 4 gives a sensitivity of 86.00 and a specificity of 66.67. The cut-off, sensitivity and specificity given in the Abstract (lines 31-32) and the cut-off in the Discussion (line 350) need to be consistent with the cut-off, sensitivity and specificity given in the Results in lines 283-284. As noted above, here too, “>” is inappropriate if the reported cut-off is supposed to represent a particular sensitivity and specificity. Response: Thanks again for your comment. The cut-off score ≥ 3 was used consistently in the revised manuscript. Lines 73: The DEQS was developed in 2013, not 2014. Response: Thank you for the correction. The year of the DEQS development is changed to be… “2013” (line 73). Lines 148-154: For the OSDI, the patients use a 5-point scale, 0-4. Need to specify how this is translated to a 0-100 scale – to obtain the total OSDI score, calculate the sum of scores of all questions answered times 25 divided by total number of questions answered, giving the OSDI a scale from 0-100. Response: The calculation of the OSDI total score is added up as suggested as… “The OSDI total score was obtained by multiplying the sum scores of all questions answered by 25 and dividing by the total number of questions answered, giving the OSDI a scale from 0-100 with higher scores reflecting greater disability” (Lines 150-152). Lines 209, 220, 226: none-DED should be non-DED Response: Thanks for your careful review. These typing errors are corrected. We also re-check thorough the manuscript for any other mistakes. Lines 421-423: Add the date of the FDA document, December 2009, to Ref 17 and update the availability date from 2021 to be current in 2022. Response: Thank you for the suggestion. This reference is edited as suggested (line 425). Supplementary Material: The results presented in this manuscript, Tables 2-7 and S1 and S2, are based on data collected in the course of this research. The data have not been made available with this submission. Response: We believe that all relevant data are within the paper. However, the data are enclosed with this revision. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0271228.r002
27 Jun 2022 Decision Letter - Adrienne Csutak, Editor Reliability, validity, and responsiveness of the Thai version of the Dry Eye-Related Quality-of-Life Score questionnaire PONE-D-22-00892R1 Dear Dr. Tananuvat, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Adrienne Csutak, MD, PhD, MSc Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0271228.r003
Formally Accepted
11 Jul 2022 Acceptance Letter - Adrienne Csutak, Editor PONE-D-22-00892R1 Reliability, validity, and responsiveness of the Thai version of the Dry Eye-Related Quality-of-Life Score questionnaire Dear Dr. Tananuvat: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Adrienne Csutak Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0271228.r004

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