Cross-Cultural Translation and Adaptation of the Consumer Ear Disease Risk Assessment (CEDRA) Questionnaire in Danish

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Dear authors,

 

Thank you for the interesting read of your manuscript. The study is intriguing as it emphasizes the need to integrate clinical assessment procedures to streamline certain healthcare processes. In this regard, it allows for the validation and potential practical use of a tool that is not currently available in Denmark, as the questionnaire had not been translated until now.

 

The work is generally well-written and clear in its objectives and methods. The section regarding the statistical analysis is well-described.

 

Here are some comments and suggestions for possible revisions:

 

Line 154: Reference is made to a sample consisting of 30 participants, representative of the target population of adults with subjective HL. What are the characteristics of this sample? It is recommended to describe it in this part of the article.

Throughout the paper, there is a reference to "targeted ear diseases (TEDs)" associated with HL. Given that the types of these diseases can be numerous, it might be helpful to provide the reader with some examples, perhaps those that occur more frequently.

Some of the characteristics of the sample of 600 participants included in the pilot testing phase are reported in the results chapter, but it would be better to describe this sample in the materials and methods section.

Lines 211-214: Mention is made of Item Response Theory (IRT). While it is stated that an IRT analysis fell outside the scope of the present study, this paragraph is somewhat unclear, so it might be better to provide slightly more detail and better explain what the authors are referring to.

Lines 227-229: So, in the end, how many valid questionnaires were considered in the reliability analysis phase? All 113? This information is mentioned in the results, but reading the methods chapter, it is not immediately clear, so it is better to explicitly state it here as well.

Lines 267-269: What were the changes made to the scoring method? Can some examples be provided?

Lines 277-280: There is a reference to a digital version of the questionnaire, which is also mentioned in the discussion chapter (line 368). However, in the methods and results chapters, the process of digitizing the questionnaire is not clear. Was it an initial objective, or did the need arise because some participants encountered difficulties due to the different instructions for completing the non-digital questionnaire?

Table 1: It is recommended to explicitly state in the caption that "CI" stands for confidence interval.

Line 292: It is reported that only 7% of the sample was diagnosed with one or more TEDs, which is a very low percentage. What is the prevalence of targeted ear diseases in the reference population? Is the percentage found consistent with the latter?

It is suggested to further delve into the discussion, especially regarding the practical application of a tool like the questionnaire under examination in conjunction with audiometric measures and visual images of the tympanic membrane.

Author Response

Dear Editor and Reviewers                                                                 

We write to address the recent review of our manuscript entitled “Cross-Cultural Translation and Adaptation of the Consumer Ear Disease Risk Assessment (CEDRA) Questionnaire in Danish” by Siggaard et al.

We wish to express our sincere appreciation for your time, constructive comments, and insightful suggestions, which have improved the quality and clarity of our manuscript.

We have taken all the comments into careful consideration and have accordingly implemented revisions to the manuscript. We trust that this response and the revised version align with your expectations and that our work is now suitable for reconsideration for publication.

We have provided detailed responses along with corresponding changes made in the manuscript in responses to the comments from Reviewer 1, 2 and 3. These responses are listed below each review comment in their original order.

We have uploaded the revised manuscript with all changes made visible through the Track Changes in Microsoft Word. For ease or reading, we have also provided a “clean” version of the revised manuscript that does not show visible changes.

We thank you again for your assistance and your constructive feedback, and eagerly anticipate your response.

On behalf of the author group,

Kind Regards,

Lene Dahl Siggaard, M.D., Ph.D. Fellow

Corresponding author

Email: [email protected]

 

 

 

 

 

 

 

In response to Reviewer 1

 

• Line 154: Reference is made to a sample consisting of 30 participants, representative of the target population of adults with subjective HL. What are the characteristics of this sample? It is recommended to describe it in this part of the article.

 

Author response: Thank you for highlighting this important aspect. The characteristics of the sample of 30 respondents have been incorporated into the revised Materials and Methods section (please see the modified paragraph below):

 

“The methodology of cognitive debriefing was employed to evaluate feasibility of the consensus version. This was tested on 30 respondents, comprising 55% males, with an average age of 64 years of which 55% were first time HA users. These respondents were representative of the target demographic of adults reporting subjective HL.” 

 

• Throughout the paper, there is a reference to "targeted ear diseases (TEDs)" associated with HL. Given that the types of these diseases can be numerous, it might be helpful to provide the reader with some examples, perhaps those that occur more frequently.

 

Author response: Thank you for this insightful aspect. As recommended, examples of TEDs have been incorporated in the revised Introduction section. Please refer to the modified paragraph below:

 

“Given the absence of direct patient-physician interaction in the RESA screening process, there was a need for an assessment tool capable of screening for a range of targeted ear diseases (TEDs) associated with HL. These included diseases related to the external auditory canal such as exostosis, otitis externa, cholesteatoma of the external auditory canal; conditions of the middle ear like cholesteatoma, otosclerosis, perforation or retraction of the tympanic membrane, infection, and otitis media; abnormalities in retro-cochlear structures such as vestibular schwannoma, tinnitus, and otogenic vertigo); and cerebral issues such as infection, tumor, head trauma, and vascular disorders or neurological disorders. The multi-complaint, 15-item Consumer Ear Disease Risk Assessment (CEDRA) questionnaire was identified as a suitable tool for this purpose, as it screens for 104 TEDs related to HL among potential first-time HA users and aligns well with the construct of interest. The types of TEDs identified in CEDRA encompassed conductive/middle ear or mastoid diseases, sensorineural or labyrinthine conditions, those related to the eight nerve, or those situated in the posterior fossa.”

 

• Some of the characteristics of the sample of 600 participants included in the pilot testing phase are reported in the results chapter, but it would be better to describe this sample in the materials and methods section.

 

Author response: Thank you for making this valid point. The characteristics of the 600 participants referenced have now been relocated to the Materials and Methods section, specifically under the

‘Pilot Testing’ subsection.

 

• Lines 211-214: Mention is made of Item Response Theory (IRT). While it is stated that an IRT analysis fell outside the scope of the present study, this paragraph is somewhat unclear, so it might be better to provide slightly more detail and better explain what the authors are referring to.

 

Author response: Thank you for pointing this out. Details to the paragraph regarding IRT are incorporated in the revised Materials and Methods section (see the modified paragraph below):

 

“In the case of a multidimensional questionnaire like CEDRA, Item Response Theory (IRT) analysis can provide a robust approach to its translational and cross-cultural adaptation. IRT’s capability to detect differential item functioning ensures that items maintain consistent meanings across varied cultural or linguistic backgrounds, thereby identifying potential cultural biases. The calibration properties of IRT allow for a comparative analysis of item behaviors across different cultures, shedding light on possible translation or interpretation discrepancies. This rigorous methodology aids in enhancing questionnaires by selecting items that are both culturally relevant and informative. Additionally, IRT enables the harmonization of various questionnaire versions or languages, guaranteeing that scores are comparable.”

 

• Lines 227-229: So, in the end, how many valid questionnaires were considered in the reliability analysis phase? All 113? This information is mentioned in the results, but reading the methods chapter, it is not immediately clear, so it is better to explicitly state it here as well.

 

Author response: Thank you for this valid point. The recommended modification has been incorporated in the revised Methods and Materials section under the ‘Reliability’ subsection (see the modified sentence below):

 

“In total, 113 test-retest questionnaires were completed and incorporated in the analysis.”

 

• Lines 267-269: What were the changes made to the scoring method? Can some examples be provided?

 

Author response: Thank you for making this point. The following clarifying sentence has been added to the revised Results section under the ‘Cognitive Debriefing’ subsection:

 

“The adjustments applied to the scoring instructions were primarily linguistic, intended to offer more detailed instructions for respondents to calculate their scores. Practically, this encompassed using more elaborate sentences and different words and phrasings to enhance comprehension.”

 

• Lines 277-280: There is a reference to a digital version of the questionnaire, which is also mentioned in the discussion chapter (line 368). However, in the methods and results chapters, the process of digitizing the questionnaire is not clear. Was it an initial objective, or did the need arise because some participants encountered difficulties due to the different instructions for completing the non-digital questionnaire?

 

Author response: Thank you for this keen observation. This issue has been clarified in the revised Materials and Methods section under the ‘Field Testing’ and ‘Cognitive Debriefing’ subsections (see the modification below):

 

“The objective of the present study was to offer the questionnaire in either a paper-based or digital format, or both, depending on the participants’ preference, and to streamline data collection. Both formats were considered beneficial for future use in comparable settings.”

 

• Table 1: It is recommended to explicitly state in the caption that "CI" stands for confidence interval.

 

Author response: Thank you for pointing this out. This issue has been clarified in Table 1 in the Results section.

 

• Line 292: It is reported that only 7% of the sample was diagnosed with one or more TEDs, which is a very low percentage. What is the prevalence of targeted ear diseases in the reference population? Is the percentage found consistent with the latter?

 

Author response: Thank you for this insightful comment. The following paragraph has been added to the revised Discussion section to discuss this matter:

“The 7% prevalence of TEDs observed in our sample of 600 participants appears to be somewhat consistent with the 5% TEDs prevalence estimated for Danish-speaking adults with HL, as reported by the Danish National Board of Social Services in 2010. While this comparison is discussed in other sources, more recent national statistics are not available.”

 

• It is suggested to further delve into the discussion, especially regarding the practical application of a tool like the questionnaire under examination in conjunction with audiometric measures and visual images of the tympanic membrane.

 

Author response: Thank you for highlighting this necessity. The concluding paragraph in the revised Discussion section has been expanded to emphasize the advantages of implementing RiHab within a remote ENT specialist assessment (RESA) context. Please find the revised paragraph provided below:

 

“The implementation of RESA screening for adult first-time HA users presents significant advantages for Denmark and other developed nations where standard diagnostic protocols necessitate in-person diagnostic process, mitigates extended diagnostic durations, and reduces treatment delays. Furthermore, it holds the potential to optimize socioeconomic resource distribution within the realm of hearing rehabilitation healthcare, all while maintaining patient safety and upholding current examination benchmarks. Nevertheless, the realization of these benefits hinges on the validation of both RiHab and the RESA screening model in a broader, more representative sample for a comprehensive evaluation of the model’s screening accuracy, as well as the efficacy and interrelationship of its constituent components.”

Reviewer 2 Report

Comments and Suggestions for Authors

Authors discuss about the avaliability of a new questionnaire for hearing impaired patients. 

The paper is well conducted and authors report every stage of the study. Nonetheless, the text sould be streamlined in order to facilitate the reading.

 

Comments on the Quality of English Language

The english language is well used and the reading is understandable.  Nonetheless, text and paragraphs sould be streamlined in order to more facilitate the reading.

Author Response

                                                                                                            

 

Dear Editor and Reviewers                                                                 

 

We write to address the recent review of our manuscript entitled “Cross-Cultural Translation and Adaptation of the Consumer Ear Disease Risk Assessment (CEDRA) Questionnaire in Danish” by Siggaard et al.

 

We wish to express our sincere appreciation for your time, constructive comments, and insightful suggestions, which have improved the quality and clarity of our manuscript.

 

We have taken all the comments into careful consideration and have accordingly implemented revisions to the manuscript. We trust that this response and the revised version align with your expectations and that our work is now suitable for reconsideration for publication.

 

We have provided detailed responses along with corresponding changes made in the manuscript in responses to the comments from Reviewer 1, 2 and 3. These responses are listed below each review comment in their original order.

 

We have uploaded the revised manuscript with all changes made visible through the Track Changes in Microsoft Word. For ease or reading, we have also provided a “clean” version of the revised manuscript that does not show visible changes.

 

We thank you again for your assistance and your constructive feedback, and eagerly anticipate your response.

 

On behalf of the author group,

 

Kind Regards,

 

Lene Dahl Siggaard, M.D., Ph.D. Fellow

Corresponding author

Email: [email protected]

 

 

 

 

 

 

 

In response to Reviewer 2

• The english language is well used and the reading is understandable.  Nonetheless, text and paragraphs sould be streamlined in order to more facilitate the reading.

Author response: Thank you for your feedback. Given the broad scope of your comment, we have diligently reviewed the manuscript to ensure consistent language use throughout. 

Reviewer 3 Report

Comments and Suggestions for Authors

I would like to thank the authors for their submission and allowing me to review their work.

This is an interesting study on an important topic. However, I would be grateful if you could add further explanations and changes on the following points:

1) ABSTRACT: Page 1, line 15

When was the study conducted?

2) INTRODUCTION: Page 2, line 61

Were acoustic reflex thresholds performed?

3) MATERIALS AND METHODS: Page 5, line 200

Were patients with unilateral hearing loss included in the study?

4) MATERIALS AND METHODS: Page 5, line 203

Were patients with malformations of the outer and middle ear excluded?

5) MATERIALS AND METHODS: Page 5, line 205

When was the study conducted?

6) RESULTS: Page 7, line 261

What about endolymphatic hydrops?  Endolymphatic hydrops may be present not only in Ménière's disease

7) DISCUSSION: Page 13, line 427

The “limitations section” should be expanded.

8) DISCUSSION: Page 13, line 444

Which are the future prospects of this study?

Comments on the Quality of English Language

Good

Author Response

                                                                                                            

 

Dear Editor and Reviewers                                                                 

 

We write to address the recent review of our manuscript entitled “Cross-Cultural Translation and Adaptation of the Consumer Ear Disease Risk Assessment (CEDRA) Questionnaire in Danish” by Siggaard et al.

 

We wish to express our sincere appreciation for your time, constructive comments, and insightful suggestions, which have improved the quality and clarity of our manuscript.

 

We have taken all the comments into careful consideration and have accordingly implemented revisions to the manuscript. We trust that this response and the revised version align with your expectations and that our work is now suitable for reconsideration for publication.

 

We have provided detailed responses along with corresponding changes made in the manuscript in responses to the comments from Reviewer 1, 2 and 3. These responses are listed below each review comment in their original order.

 

We have uploaded the revised manuscript with all changes made visible through the Track Changes in Microsoft Word. For ease or reading, we have also provided a “clean” version of the revised manuscript that does not show visible changes.

 

We thank you again for your assistance and your constructive feedback, and eagerly anticipate your response.

 

On behalf of the author group,

 

Kind Regards,

 

Lene Dahl Siggaard, M.D., Ph.D. Fellow

Corresponding author

Email: [email protected]

 

 

 

 

 

 

 

In response to Reviewer 3

• ABSTRACT: Page 1, line 15: When was the study conducted?

Author Response: The study was conducted between 2020-2022. This has been added to the revised Abstract.

• INTRODUCTION: Page 2, line 61: Were acoustic reflex thresholds performed?

Author response: Yes, acoustic reflex thresholds were performed. This has been clarified in the revised Introduction section. Please find the revision below:

“This examination encompassed a patient-reported medical history focused on ears and hearing, audiometric testing including air and bone conduction thresholds, a speech discrimination test, acoustic reflex tests, and a standard 226 Hz tympanometry, and the capture of still images of the tympanic membranes via video otoscopy”

• MATERIALS AND METHODS: Page 5, line 200: Were patients with unilateral hearing loss included in the study?

Author response: Yes. Patients with unilateral hearing loss were included. This is indicated by the description of the diagnostic groups of participants in the Materials and Methods section under the ‘Pilot testing’ subsection as highlighted below.

“The first diagnostic group comprised participants exhibiting either objectively normal hearing, characterized by an air conduction (AC) pure-tone average (AC-PTA) hearing level of 20 dB or better, or those with HL of varying magnitudes attributable to age or noise exposure. These ranged from mild HL (AC thresholds of 21-40 dB), moderate HL (AC thresholds of 41-60 dB), to severe or complicated HL exceeding AC thresholds of 61 dB and/or showcasing asymmetry in the average AC thresholds at frequencies of 500, 1000, 2000, and 4000 Hz (AC-PTA-4) greater than 30 dB between ears and/or a discrimination score (DS) of 20% or more between the two ears.”

• MATERIALS AND METHODS: Page 5, line 203: Were patients with malformations of the outer and middle ear excluded?

Author response: Thank you for this valid question. Patients with previously undiagnosed or unrecognized malformations of the middle ear were not excluded. Nonetheless, as specified in the inclusion criteria, participant were adults with subjective hearing loss who had no prior experience with hearing aids (as described in the text and inserted below). Thus, it is presumed that patients experiencing hearing loss due to congenital or acquired malformations of the outer ear would have undergone thorough evaluation and hearing rehabilitation in the past, thereby making them ineligible to participate in the present study.

”Inclusion criteria stipulated that participants be 18 years of age or older, report subjective HL, and have no prior experience with HAs. Exclusion criteria encompassed a lack of proficiency in the Danish language, the presence of severe dementia, or other cognitive impairments that could hinder informed consent and successful completion of the RiHab questionnaire.”

• MATERIALS AND METHODS: Page 5, line 205: When was the study conducted?

Author response: The study was conducted between 2020-2022. This information has been incorporated in the revised Materials and Methods section under the ‘Pilot Testing’ subsection.

• RESULTS: Page 7, line 261: What about endolymphatic hydrops?  Endolymphatic hydrops may be present not only in Ménière's disease.

Author response: While this is a valid observation, our team did not consider it within the questionnaire’s objective framework to query patients about their awareness or previous diagnosis of endolymphatic hydrops. Similarly, the authors of the original questionnaire, CEDRA, did not report any considerations in the matter.

• DISCUSSION: Page 13, line 427T: he “limitations section” should be expanded.

Author response: Thank you for your feedback. We have updated the limitations section within the revised Discussion. The ensuing paragraph addresses the study’s limitations in alignment with the points previously detailed in the text:

“While the translation and cross-cultural adaptation process followed field-specific guidelines, several potential limitations warrant attention. Direct translation of items might not always grasp the subtleties or cultural nuances of the original content. Additionally, certain concepts in the source culture might lack a direct counterpart in the target culture or may be interpreted differently. Such disparities can lead to variations in item interpretation between the CEDRA and RiHab versions, possibly introducing response biases. To mitigate this, we employed rigorous forward and back translations, coupled by cognitive interviews in 30 intended respondents and reviews by a diverse expert committee. Furthermore, as previously highlighted, incorporating an IRT analysis in future studies could further bolster the validity of the translation. Also, while pilot testing was conducted with 600 respondents, future studies might benefit from a larger sample size. This would account for the uncertain prevalence of TEDs in the target population, thereby enhancing the generalizability of our findings. “

• DISCUSSION: Page 13, line 444: Which are the future prospects of this study?

Author response: See our Author Response to Reviewer 1, point 10.