PONE-D-22-30497Italian cross-cultural adaptation of the Quality of Communication questionnaire and the 4-item Advance Care Planning Engagement questionnairePLOS ONE

Dear Dr. Giordano,

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Francesca Baratta, PharmD, PhD

Academic Editor

PLOS ONE

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"This research was funded by Fondazione Italiana Sclerosi Multipla (FISM; aism.fism.it), grant no. 2020/R-Multi/024 to A.S, and partially supported by the Italian Ministry of Health (RRC). R.L.S. is funded in part by the National Institute on Aging, National Institutes of Health (K24AG054415)."             

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"A.S. reports grants from the Italian Multiple Sclerosis Foundation (FISM) and the European Academy of Neurology, during the conduct of the study; she serves as board member for Merck Serono, and received personal fees from Almirall and Merck Serono, outside the submitted work."

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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: Yes

Reviewer #2: No

Reviewer #3: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: Yes

Reviewer #3: Yes

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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

Reviewer #2: Yes

Reviewer #3: Yes

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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: Yes

Reviewer #3: Yes

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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: At the end of your introduction, state the objective of your research instead of what is written in the last paragraph “ For each questionnaire, the linguistic validation encompasses two main actions: translation97 adaptation of the QOC and ACP-E inventories into Italian; psychometric validation. Here we report the results of the first action”.

The main aspect of the paper that can improve is the presentation of the cross-cultural adaptation (Results from page 9-12). Is it possible to create Tables to explain: what items were modified, why and how?

The conclusion should summarise your main results. Avoid citing references in your conclusion.

Reviewer #2: The authors translated and cross-culturally validated the Italian the Quality of Communication (QOC) and the 4-item ACP Engagement (4-item ACP-E). Their results in 14 subjects showed satisfactory semantic, conceptual and normative equivalence. Below my comments.

The authors report that “For each questionnaire, the linguistic validation encompasses two main actions: translation adaptation of the QOC and ACP-E inventories into Italian; psychometric validation”. But they claim to report only the first part (i.e. Translation and adaptation). Why did the authors decide not to report the results of the psychometric properties? Even if the questionnaire has been transculturally translated, if we do not know the psychometric properties (such as reliability and validity) we cannot use it with our patients and therefore the repercussions in clinical practice are very low. I highly recommend reporting the psychometric results as well. Furthermore, I have hardly read of papers reporting only the assessment of cross-cultural validity; these results are usually reported together with the validity and reliability results, to improve the application of the results in clinical practice.

The authors report that “the ACP-E is available in shorter versions (55-item, 34-item, 9-item, 4-item) … Specifically, we were interested in the 4-item version”. What are the reasons that led the authors to prefer the 4-item version? Why didn't they consider translating the entire completed questionnaire?

Information on the structure of the questionnaire is missing. For example, there is no information about the scores for each item and the calculation of the total score

The authors included only 14 patients in the cognitive de briefing. Typically, guidelines for cross-cultural validation suggest including 30 patients. Why did the authors only include 14 of them?

Reviewer #3: Peer-Review PONE-D-22-30497

Dear authors,

Thank you for submitting your manuscript to the journal PLOS ONE. This is a well-prepared and thorough investigation of the content validity of the Italian translations of two questionnaire relevant for supporting Advance Care Planning. I only have very minor comments below.

Clinical relevance of the questionnaires

In the introduction, you explain about ACP - what it is, its elements etc. You also specify that the two questionnaires be used for clinical and research purposes (page 4, line 82/83). I would recommend being a bit more specific regarding the use cases you envisage. Are you translating the questionnaires for evaluation purposes of ACP interventions? Or are you planning to bring them into clinical practice? If yes, in which setting? How is shared decision making going to happen with the aid of these questionnaires?

You can also specify this in the discussion section, not in the background section if you felt it would sit better there.

Methods

You are very comprehensive when it comes to explaining your methods. Although you specify the methods for cognitive interviewing and you also specify the analysis methods, I was missing the framework of Tourangeau being applied to the data. From the results and how they are reported, I would expect you probably used Tourangeau. It might be worth mentioning him and his framework.

Discussion/article

Your aim is the cross-cultural adaptation of the two ACP questionnaires. You do a very thorough translation process. However, although cultural issues are implicitly mentioned in the results, the discussion section then does not make them explicit. You present a lot of evidence in the background on the Italian's readiness to endorse ACP. You also describe the health care system's lack in responding to this need. You describe the "emotionally taxing" nature of some of the items. I was wondering whether it would be possible to explicitly discuss cultural issues and how they reflect on the construct ACP the questionnaire want to measure. After all, achieving translations that are faithful to the original definition and measurement of the construct is one of the aims of a cross-cultural adaptation. The other might be to learn more about once culture and, in reflection, about the construct under investigation. Results from cross-cultural adaptations of questionnaires can feed back into further develop the content validity of the questionnaires. I was missing a section in the discussion to do just that - a bit of reflection on the general content validity of the two questionnaires.

Minor comment

In the introduction section, you often speak of "his/her own personal values" or "his/her health". It is common to do a gender-neutral pronoun in plural in English in these situations (at least in publications, not in the actual questionnaires). Page 4, line 66 could better read as "ACP helps the patient to identify their own personal values and goals, understand their health..."

Otherwise, this was an engaging, clearly structured and methodologically thoroughly prepared study. What a pleasure to read!

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Reviewer #1: No

Reviewer #2: Yes: Leonardo Pellicciari

Reviewer #3: Yes: Christina Ramsenthaler

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Italian cross-cultural adaptation of the Quality of Communication questionnaire and the 4-item Advance Care Planning Engagement questionnaire

PONE-D-22-30497R1

Dear Dr. Giordano,

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.

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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,

Francesca Baratta, PharmD, PhD

Academic Editor

PLOS ONE

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 #2: All comments have been addressed

Reviewer #3: All comments have been addressed

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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 #2: Yes

Reviewer #3: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

Reviewer #3: N/A

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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 #2: Yes

Reviewer #3: Yes

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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 #2: Yes

Reviewer #3: Yes

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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 #2: I thank the authors for their efforts to answer my questions. I agree that the purpose of the paper is to describe the cross-cultural validation process. Unfortunately, in this form the results of this study have limited application in clinical practice. Having the validity and reliability data available allows clinicians to be able to use this tool. I hope these results will be available soon.

Reviewer #3: (No Response)

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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 #2: Yes: Leonardo Pellicciari

Reviewer #3: Yes: Christina Ramsenthaler

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