https://orcid.org/0000-0003-0341-595X
Peer Review History
| Original SubmissionDecember 16, 2021 |
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PONE-D-21-36866Nepalese version of Douleur Neuropathique 4 ( DN4) questionnaire for assessment of neuropathic pain: a validation studyPLOS ONE Dear Dr. Shakya, 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 see the comments from the reviewers below. Although both reviewers request that you add more introductory material on neuropathic pain, it is not essential that you cite the papers on foot pain noted by the first reviewer. ============================== Please submit your revised manuscript by Sep 18 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. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Steve Zimmerman, PhD Associate Editor, PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. 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 Reviewer #2: Partly ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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: Yes Reviewer #2: 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 Reviewer #2: No ********** 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: I am grateful for the possibility to revise this research study. The assessment of neuropathic pain is a trend topic in the current research literature and may be a main focus of interest for readers. This is a well-written manuscript with an important clinical message, and should be of great interest to the journal readers. However, from my point of view, authors should include the following requeriments Introduction may be improved adding new information in order to provide an adequate state-of-the-art including some references. I suggest to include this references include in the attached to complete this requirement related to neuropathic Diabetic foot complications that authors do not included DOI 10.1111/iwj.13263 Methods are well-designed with relevant and complete information. Correct sample size calculations, good description of the properties of the outcome measurements as well as detailed statistical analyses were included. Discussion section is well structured with different sections. Authors manage well the discussion leading a good comparison with the showed references. However, author should discuss their results with regards other prior studies in validation and transcultural adaptation I suggest to include these references to attend this requeriment doi:10.3390/ijerph17176141 DOI: 10.18632/aging.202140 Reviewer #2: Thank you for the opportunity to review this interesting manuscript. Translation and cross-cultural adaptation of outcome measures are necessary and critical to advance research and clinical care. I congratulate authors on leading this for neuropathic pain. In general, paper is fairly written and meets a minimum criteria for an academic paper. However, several suggestions are provided below in order to improve the story on why this study is important, how to improve reporting of the Methods, Results and Discussion. Major criticisms: 1. The Introduction does not exactly cover why the study is needed. I would suggest the authors to include what is known about the topic in relation to Nepal, what the current gap is and how this paper addresses this major literature gap. You will see specific suggestions below. 2. Methods: Critical steps and items of validation studies are not covered. I would recommend authors to use COSMIN Checklist to report the current paper. https://www.cosmin.nl/wp-content/uploads/COSMIN-study-designing-checklist_final.pdf 3. Results: Also use COSMIN checklist to report results. 4. Discussion: It is quite vague and non-focused. I would recommend authors to rewrite the Discussion section to keep it more focused. Please focus on what key results were, whey they mean, how are the similar/different from other studies in the same country/region (or international literature if local/regional research is lacking), what are the implications, limitations, recommendations for the future studies. To write more focused Discussion section, authors may refer to a BMJ editorial, https://www.bmj.com/content/318/7193/1224 5. The authors state at the end of introduction "Once validated, this tool can be used as a screening tool by any health personnel for the diagnosis of neuropathic pain." In order to facilitate this more widely, I strongly recommend authors to upload Nepali DN4 as either appendix or supplementary online file to promote wide use of the scale in clinical practice or research. This aligns quite closely with ethos of PLOS ONE. I also recommend authors to share their data openly. 6. The authors indicate that DN4 is used to "diagnose neuropathic pain". Rather it is to identify signs and symptoms related to neuropathic pain. This is an important limitation of a self-reported measure and I request authors to change this consistently throughout the manuscript. Specific comments: INTRODUCTION: 1. Information presented in the Introduction is quite generic. I think authors should be more specific. Rather than only saying neuropathic pain is one of the prevalent conditions, also say what the prevalence is (Line 72); be specific on what other advanced investigations are and with citation please (line 71). 2. As above, Line 76: Rather than detection of neuropathic pain, it is the identification of the "neuropathic signs and symptoms". 3. When authors indicated the previous translation of pain related instruments in Nepali, I was hoping to see their use in the current study to assess construct validity of the scale, but this was lacking. It is the strength that authors have mentioned prior translation of numerical pain rating scale in Nepali. But what is missing is "what is known about Neuropathic pain" in Nepal and availability of other screening tools in Nepali. On a quick PubMed search, self-reported LANSS has been translated and validated in Nepali (https://pubmed.ncbi.nlm.nih.gov/34583020/). The Introduction would benefit by such review of literature and to highlight any advantages of availability of DN-4 in addition to self-reported LANSS and other instruments. METHODS: 4. could the authors add the name of the tertiary care hospital. 5. Line 105: I would suggest to use simple term such as "Nepali" than to refer to the language by "Nepalese language". 6. Line 106: Authors have provided comprehensive list of conditions which were excluded. It is unclear why these were excluded. Additionally, it is also important to know what are the types of chronic pain conditions that were included. 7. Line 123: Info about translation guideline belongs to the next paragraph on Phase 1: Translation and back translation. 8. It is surprising to see 6 forward translations of the scale, I am unclear of the rationale why. It seems like rather waste of Human Resources. The paper authors cited does seem to support this. 9: Please provide some info on why 25 patients were recruited for pre-testing. 10. Line 148: State in how many people was the translation of "cold pain" was tested. 11. Line 150: It was odd that content validity of the scale was discussed after pre-testing. Ideally it is performed before pre-testing. Only upon all experts agree on the prefinal version, it is subjected to pretesting. 12. Test methods: Please explicitly state what was the diagnostic criteria based on the IASP used in the current study. This is important for the internal validity of the study. 13. specify how test-retest reliability was assessed (agreement versus consistency)? Also specify Fleiss notation system (Shrout & Fleiss, 1979), which describes the type of ICC for example as ICC(2,1). 14. Line 178: Please describe the method how ROC curve was plotted and how AUC was derived. State what the scores of AUC mean. 15. Line 180: Explain what each of the parameters mean (sensitivity, specificity and liklihood ratios) with explanation on how these were computed. State what these scores mean. RESULTS: 16: The result would benefit with a flow diagram. How many patients were approached, how many recruited (and excluded), how many completed baseline survey, how many followed up at two weeks. 17. What was the mean duration of the follow up? 18. Could the authors provide any info on other sociodemographic variables such as ethnicity, education, occupation etc. These are important sociodemographic parameters that relates with the external validity and utility of the scale. 19. Table 4. Unclear what the ICC means in this Table. The results on ICC following this (text and Table 5) is quite high compared to what is presented in Table 4. Is it supposed to be pin prick? 20. Table 6 is an intense table. It should be simiplied so that it is self explanatory. DISCUSSION: see the major criticism comments above. 21. Limitations: An important aspect of construct validity, that is hypothesis testing is missing. That is testing strength and direction of association of the scale with other established scales (that is translated, cross-culturally adapted and validated scales) that assess the same or related constructs. This could be a recommendation for the future studies. 22. Limitations: Unclear who the study findings can be generalised to, because the full demographics of the study participants are unclear (e.g., sociocultural and economic positioning including education, ethnicity, occupation, income levels) CONCLUSIONS: As above, rather than predicting "neuropathic pain" it should be "identifying neuropathic pain signs and symptoms". ********** 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 Reviewer #2: 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. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. |
| Revision 1 |
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PONE-D-21-36866R1Nepalese version of Douleur Neuropathique 4 ( DN4) questionnaire for assessment of neuropathic pain: a validation studyPLOS ONE Dear Dr. Shakya, 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 Jan 01 2023 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. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Saurab Sharma, Ph.D. Guest Editor PLOS ONE Additional Editor Comments: Dear Dr Shakya and colleagues, Thank you for your patience related to the review process of this paper. I must acknowledge that I was one of the reviewers in the previous round of the review. The PLOS ONE editorial office requested me to serve as the associate editor for your paper. I accepted the request for two reasons: (1) I am familiar with this area of research very closely, both at the global and local context of Nepal, and (2) I wanted to help make an early decision as I know how frustrating this is to the authors, especially because the paper is under review for almost a year now. I should also mention that before accepting this request, I also declared to the editorial board that “I have published extensively in the area of pain in Nepal. The authors of this paper have not reviewed literature well and cited previous work appropriately. This bias will remain in me when making the decision.” The editorial decision is based on the assessment of your paper by the previous editor and reviewer and a new reviewer, in addition to my own assessment. In addition to the new reviewer’s feedback, please address my own concerns below. Please assist me in making an early decision, by responding to the reviewer’s and editor's comments fully. You are free to refuse any of the suggestions but fully justify this using credible references. Please write your responses in full, cite line numbers where changes were made, and also in your response letter, indicate what changes were made. That is, copy and paste key changes made in the manuscript into your response letter in order to assist the editor and reviewers. 1. The Introduction does not completely cover “what is known” and the need for the study or “what this study adds to what is known” at the time of writing the paper. Consistent with the comments in the previous round of review, the Introduction needs to cover relevant literature on (neuropathic) pain in Nepal. I appreciate you cited Sharma et al (2019) Pain Reports paper to identify gaps in the neuropathic literature. However, a paper published online in September 2021 (Journal of Pain; https://pubmed.ncbi.nlm.nih.gov/34583020/ ), identified the prevalence of neuropathic pain signs and symptoms as 12% in the general population and 23% in people with chronic pain. This is probably the only relevant publication on the topic in Nepal so far. The authors also indicated that the paper was published after they conceived the study, which is a fair point that this study couldn’t influence the conception and design of the current study (and therefore couldn’t be included in the current study). However, it is standard practice is to review relevant literature – at the time of manuscript writing – and include new papers to highlight “what is known”. A publication does not necessarily dismiss the need for another study (or a screening tool in this case). However, the authors should appreciate the literature published at the time of the writing and highlight what gap this current paper adds to what is known. The authors seem to have ignored the advancement in the assessment of neuropathic pain in Nepal (i.e., cross-cultural adaptation of the validation of the SLANSS, https://pubmed.ncbi.nlm.nih.gov/34583020/) in the Introduction and Discussion of the current paper. As I see it from my perspective the validation of DN4 in Nepali is an important step in the assessment of neuropathic pain in clinical populations whereas the SLASS was validated in a community sample with the intent for self-administration in community samples. These two measures complement each other and perhaps there is a nice opportunity to compare these two instruments in future research. For tips around writing clear Introduction in the field of Epidemiology, you may refer to https://pubmed.ncbi.nlm.nih.gov/23497856/. 2. Methods: Line 189, specify what criteria were considered for a probable diagnosis of neuropathic pain. Specify what patient’s history and clinical examination contributed to this decision. As indicated in the previous review, this is critical for the internal validity of the study. 3. Line 208, I would have thought ICC agreement is suitable rather than “consistency”. Justify the relevance of “consistency” over “agreement”. Similarly, why is it ICC(3,1) and not ICC(2,1)? 4. Results: Table 4. A follow-up clarification to the previous comment. Authors state that in their response to reviewers that “Table 4 shows the ICC of internal consistency reliability”. However, this ICC is used for test-retest reliability NOT for internal consistency. Cronbach’s alpha is used for internal consistency unless there is other credible evidence for this. Please add such references to justify your choices. 5. All results related to ICC and Cronbach’s alpha should be reported in decimals (report up to 3 digits after decimals). 6. The Discussion section still remains suboptimal (also corroborated by Reviewer 3). The authors also ignored the previous comments to adopt an established approach to reporting the Discussion section. In order to meet the requirements for the journal, please adopt PLOS’s recommendation on writing Discussion (see https://plos.org/resource/how-to-write-conclusions/). Lines 291-302 (of the track changed version of the manuscript) are not relevant to the Discussion section and should be deleted. Sections from lines 303 to 319 may be moved to Results but should be abbreviated by retaining “Results” aspects of the texts. This section needs restructuring and writing. 7. Limitations: authors seem to have ignored two of the previous comments related to the study limitations (also identified by Reviewer 3. First, the authors (all reasons considered), did not assess construct validity using hypothesis testing (see COSMIN guidance on its importance). This should be acknowledged as a limitation and could be promoted as a recommendation for future studies on DN4. 8. The authors did not assess education as their study variable but stated that both literate and illiterate patients were included in the study (lines 352-353). We cannot comment on something that wasn’t measured. Also in the previous response, the authors stated “Our study findings can be generalized to all those who can communicate in Nepali, irrespective of their demographics like education, ethnicity, occupation and income. We also mentioned in the discussion that we did not face any difficulty during data collection because of the difference in literacy level.” This is not true. If this was true, Nepali translation of DN4 wouldn’t be required provided it is shown to be valid in multiple other languages and socioeconomic groups. The study is only generalisable to the population on which they are tested. If the sample consisted of all participants with high levels of education, the study can’t be generalised to those who can’t read or write. Social determinants of health are important in research and health care, also endorsed by the World Health Organisation (https://www.who.int/health-topics/social-determinants-of-health#tab=tab_1). See more on social determinants of health here (https://pubmed.ncbi.nlm.nih.gov/24189091/ and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3863696/). Not assessing socioeconomic factors is an important limitation and future studies should consider assessing these. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #3: (No Response) ********** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. 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 #3: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: Yes ********** 4. 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 #3: Yes ********** 5. 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 #3: Yes ********** 6. 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 #3: It is my pleasure to review this manuscript that aimed to translate DN4 questionnaire into Nepalese and assess its psychometric properties. The manuscript is clear and well-written. The reviewer appreciates the excellent work of the authors. However, I have few comments for the authors. Abstract: “This study aimed to translate and validate DN4 questionnaire into Nepalese version.” The use of this phrase implies that “validate” is something you do to a test and that “validity” is a property of the test itself. “Tests do not have reliabilities and validities, only test responses do. This is an important point because test responses are a function not only of the items, tasks, or stimulus conditions but of the persons responding and the context of measurement.” SEE: Messick S. Validity. In: Linn RL, editor. Educational Measurement. 3rd ed. Phoenix: ORYZ Press; 1993. p. 14. Validity processes are aimed not at the integrity of the measures themselves, but about inferences that can be made about the people who complete those measures. I would suggest that the term “validate the measure (DN4 questionnaire)” be changed throughout the entire paper. For example, you may recast as: “This study aimed to translate the DN4 questionnaire into Nepalese and assess its psychometric properties.” Method: 1. Did you obtain permission to translate the DN4 questionnaire? 2. How did the authors handled missing data? 3. As far as the methodology is concern, no any form of validity test (i.e. content, structural and criterion validity) has been conducted even though the authors used the COSMIN checklist. With the study sample size, the authors could have at least assess structural validity of the Nepalese DN4 questionnaire 4. “The Area under the Curve (AUC) was considered as the area between the two episodes of the tests” What do you mean by two episodes? Are you referring to test and retest? If so, it sounds more appropriate to use the latter. 5. Discussion: I would suggest to the authors to rearrange the flow of the discussion as follows: a. Translation and cultural adaptation b. General characteristics including response of the questionnaire c. Responsiveness (sensitivity to change) d. Reliability e. Strengths and limitations f. Implication to clinical practice and research Good luck ********** 7. 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 #3: Yes: Dr. Aminu A Ibrahim ********** [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. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. |
| Revision 2 |
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PONE-D-21-36866R2Nepalese version of Douleur Neuropathique 4 (DN4) questionnaire for detection of neuropathic pain: translation and assessment of psychometric propertiesPLOS ONE Dear Dr. Shakya, 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 Apr 09 2023 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. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Saurab Sharma, Ph.D. Guest Editor PLOS ONE Additional Editor Comments (if provided): Dear authors, Thank you for making extensive revision on the paper and (partly) addressing reviewer’s and my comments. While some aspects of the manuscript have improved, some feedback remain unaddressed and new problems have been identified. During the resubmission, please check all files are uploaded and correct. These errors only delay the process and do not help any parties involved. Inability to address the comments adequately will lead to rejection of the paper as several issues remain, statistical analyses are questionnaire and manuscript writing quality is still suboptimal for PLOS One. Please read the feedback carefully and address them adequately. Take enough time to consult statisticians to correct the analyses and reporting of the analyses. Please have a native English speaker review the manuscript for grammar, flow and coherence. The manuscript is still hard to read and interpret even after 2nd round of revision. When you make changes, refer to page numbers and line numbers in the track changed version. If there are any questions, please feel free to write to me or organise a call to discuss the feedback. I want to be helpful. Methods: 1. Report completely the scoring of DN4 (that is 0 to 10) and “presence of neuropathic pain signs and symptoms” and “absence of neuropathic signs and symptoms” using a cut score of 4 if this is true. You also write later that cut off 4 yielded the highest sensitivity and specificity, I am unsure where that interpretation came from. 2. Explicitly say, which of these scorings were used for specific data analyses. Example, dichotomous scoring of “yes” or “no” for neuropathic pain for Kappa and 0 to 10 score for ICC (note both of these are reliability test). 3. Be specific with your statements. You write “Under descriptive statistics, mean, frequency and percentage were calculated.” Mean for which outcome or variable? Frequency for which? Etc…. 4. Cohen’s Kappa is used for test-retest reliability for dichotomous outcomes. You seem to have used it for diagnostic accuracy. See your text, “To compare the agreement between the score of DN4 questionnaire and the physician’s diagnosis of pain, Cohen’s kappa statistics was used”. This is incorrect but you are welcome to provide a rebuttal. If so, cite a credible reference to support this. 5. In response to my editor’s comment in the previous round, you declined the suggestion of ICC2,1 (2 way random model) and retained the use of ICC3,1 (2 way mixed model) without any convincing explanation. Your choice of ICC3,1 means that your analyses will not be generalisable to other clinicians using DN4 but is only valid for the clinicians in the study. This contradicts with your conclusion that “…it can now be used as a screening tool for ….” For more reading https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4913118/. 6. ROC: You say “We then derived Receiver Operating Characteristic (ROC) Curve for analyzing the discriminative ability of the test. The ROC curve was plotted for two episodes of the test, with sensitivity versus 1-specificity over all possible cutpoints.” Discriminatory ability of which test and against which test? Could you clarify what you mean by “two episodes of the test”. 7. What type of scoring of DN4 was used for ROC curve (dichotomous versus 0-10)? 8. You randomly introduce the use of Responsiveness as a title for a paragraph in Discussion. The study did not aim to assess responsiveness and is not applicable to this study. 9. “Similarly, different diagnostic values to detect neuropathic pain like sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ratio were calculated.” – Say how? 10. Use of 2x2 contingency table would be useful for the readers with diagnosis of neuropathic pain signs and symptoms by the index test (using DN4’s dichotomous categories) and reference test (doctor’s diagnosis). 11. You use PPV and NPV without spelling them out for the first time in the main text. Results: 12. Please upload PDF version of the Nepali DN4 instead of TIFF version. Make sure to refer ALL the Supplementary Tables and Figures in the Main text. 13. Table 2 reports comparison of frequency of items of DN4. But statistical tests used to for this is not presented in Methods section (name of the test in table legend does not suffice). Nor this was an aim of the study. Please list the complete aims of the study. In the same order, present the data analysis methods. Likewise, use the same order to present your results and discuss it. This logical order makes it easier for the readers to read and understand the findings. It is also easier for authors to write in this structure. 14. Tables 2 and 3 uses the diagnosis of pain as “nociceptive” for participants who were not categorised as having “neuropathic”. Not-being neuropathic does not automatically qualify as “nociceptive”. I recommend authors to use “non-neuropathic” instead. Please make sure to use this consistently and throughout the manuscript (like you use in Table 5). 15. Delete the use of “reliability” after “internal consistency” throughout the paper. 16. Line 348: use “Diagnostic accuracy of DN4” instead of ROC curve analysis as the heading. 17. Table 4, use the words and phrases exactly as they appear in the original DN4 questionnaire for ALL items. Eg Painful cold instead of cold pain, Pins and needles instead of Needle sensation. These may mean different things. 18. On line 353, Fig 1 is referred but it isn’t located in the main text. All figures referred to as Figures should be presented in the main text rather than in online supplement. 19. When you say the best sensitivity and specificity scores were identified for a cut off of 4. How was this determined? There is no information on the manuscript around this. 20. Line 355, “Similarly, other measures like Youden index, positive and negative predictive values were also calculated (Table 6).” This info is relevant for Methods section with more details on how to interpret them. There is no mention of Youden index in data analyses section. Discussion: 21. In paragraph 1, summarise the key results instead of just listing the aims and data analysis plan. 22. “DN4 questionnaire was first created by French neuropathic team and was originally in French language. Due to its simplistic nature, the questionnaire has been translated into various other languages. However, translation can be a complicated process. The major hurdle is the fact that every language has its own unique nuances, grammatical rules, vocabulary, and so on. Rendering ideas from one language to another while also keeping the essence intact is a difficult task with a simple translation” is background information and is not relevant for Discussion. Please remove it. Instead only discuss the results of the current study. 23. Line 399: “In the Hindi version of DN4 questionnaire also, cold pain was present in only 14% of patients with neuropathic pain [9]. In our study, only 17 % of patients with neuropathic pain had symptoms of cold pain.” This info does not fit under the heading of “translation…”. Only include issues related to translation here. 24. In this paragraph, you mention about “cold pain” only. How about other items on the scale? It was help readers with this info for their clinical practice. In our own previous study to identify how people describe their chronic pain, we found a lot of interesting words and phrases to describe pain by Nepali people with chronic pain (https://pubmed.ncbi.nlm.nih.gov/27895511/). If there were no problems with other items, please say so. 25. Line 439: as above, unsure how you concluded that 4/10 was the best cut off point. In fact this wasn’t the main your aim nor you tested this. I recommend you delete this throughout. 26. As above, replace responsiveness heading (line 441) with Diagnostic accuracy. Also, Kappa isn’t a measure for diagnostic accuracy but is for reliability. Your analyses should be revised and correct both for reliability and diagnostic accuracy. 27. Line 465 and 466, in the previous round of review, I pointed out that ICC values should be in decimal places, and your response was that this was corrected in all locations although it was’t. As an editor, it is frustrating when authors say the errors are corrected when they are not. It can be perceived as attempt to deceive. 28. Strengths and limitations: unsure how interviews minimize reliability and validity? Interviews in fact can lead to socially desirable response and interviewers can influence the responses affecting the validity of the responses. Also, DN4 has components that need clinical assessment unlike self-reported measures. So, this discussion point is irrelevant, and I recommend deleting. 29. Limitation 1: “The patients were first seen by a pain physician who was not involved in the interview.” This isn’t a limitation really but is in fact a strength. Ideally, the index test and the reference test should be conducted independently maintaining blinding by separate clinicians. This blinding ensures the robustness of the diagnostic accuracy tests. See QUADAS-2 tool for more details (https://pubmed.ncbi.nlm.nih.gov/22007046/). I also recommend using the terms such as index test and reference test to describe the tests as subheadings in Methods section. 30. The limitation here should be, in line with my comments in the previous round of review, “reference test for diagnosis of neuropathic signs and symptoms was performed by a pain physician using clinical examination alone” or something along this line. 31. Implication: while it is true that DN4 could be used in epidemiological studies, but it will demand enormous resources as it will require trained clinicians to perform physical examination increasing the costs of the study significantly as opposed to using self-reported tools alone. This further contradicts with authors’ point of its utility in “developing countries” which are resource limited. I would recommend authors to align the discussion around this or focus the implications around the clinical utility of DN4 rather than on epidemiological studies. Relevant to this, please change the use of “epidemiological” from conclusions of your abstract to “research settings” Other comments: 32. A general comment: as DN4 is a screening or diagnostic tool, test-retest reliability isn’t the primary concern here. Instead the focus should have been on inter- or intra-rater reliability. Test-retest reliability is critical for tests that are prognostic or that are used as outcome measures to track change within group or difference between groups. 33. Title: I recommend adding detection of neuropathic pain “signs and symptoms” in order to factor in its limitation of diagnostic accuracy in line with my feedback in the previous round of the review. 34. Abstract: Needs to be significantly revised in order to give it a structure that I was referring in above. Aims should include all aspects of measurement properties: internal consistency, test-retest reliability, diagnostic accuracy. In Methods, write how these were assessed in the same order. Results: report the results also in the exact same order. Unclear what “strength of test” means in line 45. It is confusing to read about AUC without any mention in Methods. Also, there was no mention of first and second test in the Methods. Good luck. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #3: All comments have been addressed ********** 2. Is the manuscript technically sound, and do the data support the conclusions? 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Nepalese version of Douleur Neuropathique 4 (DN4) questionnaire for detection of neuropathic pain signs and symptoms: translation and psychometric properties PONE-D-21-36866R3 Dear Dr. Shakya, 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, Saurab Sharma, Ph.D. Guest Editor PLOS ONE Additional Editor Comments (optional): Please note that several typographical errors still exist in the manuscript which I believe can be fixed at the typesetting and proofreading stages. Reviewers' comments: |
| Formally Accepted |
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PONE-D-21-36866R3 Nepalese version of Douleur Neuropathique 4 (DN4) questionnaire for detection of neuropathic pain signs and symptoms: translation and psychometric properties Dear Dr. Shakya: 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. Saurab Sharma Guest Editor PLOS ONE |
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