PONE-D-23-24670Developing a multimedia patient-reported outcomes measure for low literacy patientsPLOS ONE

Dear Dr. Giladi,

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 by the two reviewers during the review process.

Please submit your revised manuscript by Jan 01 2024 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
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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,

Xiaodan Tang

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript adhere to the experimental procedures and analyses described in the Registered Report Protocol?

If the manuscript reports any deviations from the planned experimental procedures and analyses, those must be reasonable and adequately justified.

Reviewer #1: Yes

Reviewer #2: Yes

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2. If the manuscript reports exploratory analyses or experimental procedures not outlined in the original Registered Report Protocol, are these reasonable, justified and methodologically sound?

A Registered Report may include valid exploratory analyses not previously outlined in the Registered Report Protocol, as long as they are described as such.

Reviewer #1: Yes

Reviewer #2: Yes

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3. Are the conclusions supported by the data and do they address the research question presented in the Registered Report Protocol?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. The conclusions must be drawn appropriately based on the research question(s) outlined in the Registered Report Protocol and on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

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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 #1: Yes

Reviewer #2: 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 #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This report describes the development of an English language multimedia version of the PROMIS-UE. The project implemented rigorous methodology, consisting of seven phases, and feedback from a community advisory board, patients, caregivers, and clinic staff. Future research will include back adaptation, usability testing via qualitative evaluation, and psychometric validation of the mPROMIS-UE. If successful, this multimedia instrument would be a useful addition to collecting patient-reported outcomes in diverse literacy populations.

There are only a few issues that need some additional details:

1. There is no description of the patient population, other than to state that they had “a hand and upper extremity condition.” It is not clear what this means. Also, how large is this population in the U.S.?

2. What mode and method of administration were used for the direct observation phase of PROM administration and completion in the clinic’s waiting and check-in areas?

3. The author chose the Patient Reported Outcomes Measurement Information System Upper Extremity Short Form 7a (PROMIS-UE). A definition of this measure is needed.

Reviewer #2: This well-written paper essentially describes a human-centered design process. On the whole, it is overly focused on methods (HCD) and not focused enough on results. In the abstract, the first five sentences of "results" belong with the methods. The development of the mPROMIS-UE prototype is the result - not the "identification" of personas. ("Identification" seems an overly strong word choice. My impression is that your observations and interviews informed the profiles and personas that you used to develop the modified tool.)

I have a parallel comment for the body of the paper. I recommend reflecting on what is "methods" and what is "results," and how to shift to a more appropriate balance. I imagine that you're hoping to convey to readers the fruit of your effort, rather than the process of developing it.

In your introduction, you write that your first goal was to create the mPROMIS-UE, and the second goal was to assess its acceptability. Were those the goals of this paper, or the project overall? If the former, check to ensure that the paper's focus is on these objectives.

Your community advisory board does not have very many members. It may be helpful to contextualize its size with reference to work by others, and to consider listing as a limitation that your user feedback came from a relatively small number of users.

What is the relevance for low-literacy populations outside of the US? Could your tool be employed elsewhere, or just with the population for which it was designed through HCD?

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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.

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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

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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.

PONE-D-23-24670R1Developing a multimedia patient-reported outcomes measure for low literacy patientsPLOS ONE

Dear Dr. Giladi,

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 11 2024 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled '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,

Xiaodan Tang

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript adhere to the experimental procedures and analyses described in the Registered Report Protocol?

If the manuscript reports any deviations from the planned experimental procedures and analyses, those must be reasonable and adequately justified.

Reviewer #2: Yes

Reviewer #3: Partly

**********

2. If the manuscript reports exploratory analyses or experimental procedures not outlined in the original Registered Report Protocol, are these reasonable, justified and methodologically sound?

A Registered Report may include valid exploratory analyses not previously outlined in the Registered Report Protocol, as long as they are described as such.

Reviewer #2: Yes

Reviewer #3: Partly

**********

3. Are the conclusions supported by the data and do they address the research question presented in the Registered Report Protocol?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. The conclusions must be drawn appropriately based on the research question(s) outlined in the Registered Report Protocol and on the data presented.

Reviewer #2: Yes

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 #2: Yes

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 #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: Thank you for your edits to strengthen the manuscript. It is much better than your last version. Thank you for your responses to my observations and recommendations.

I appreciate that you changed some instances of persona development to “…our interviews revealed two distinct user personas…” I would call attention to the reality that your abstract still retains the use of “identify,” asserting that you “identified two distinct user personas…” As in my last review, I find this word choice to be overly strong, since another HCD process could conceivably reveal alternative personas. In keeping with the qualitative nature of this undertaking, I wonder if you would please locate continued uses of “identify” in relation to personas and change to a different verb.

I have no additional comments.

Reviewer #3: Thank you for the opportunity to review this manuscript, which describes and important development in the field of patient-reported outcomes measurement. I hope the following comments will help to further improve the manuscript. I organized the comments by section and, where applicable, line numbers.

ABSTRACT

28: The authors may wish to instead refer to their previously published Multimedia Adaptation Protocol.

53-54: In the abstract, the authors refer to “feasibility of adapting PROMs to multimedia versions”. As I read the manuscript, I understand this to be the primary goal. Please consider clarifying the goal in the manuscript.

57: Please delete the term “reliably”. The results do not provide any evidence of reliability and reliability is not discussed in the manuscript.

INTRODUCTION

60-61: Given the broad readership, it is important to explain what PROs are. Please provide a definition so readers can understand what kind of outcomes this refers to.

76: “to accurately capture PROs”. Is accuracy the main goal? The study seems to focus more on accessibility, appropriateness, and feasiblity, which are important goals from an equity point of view. Please consider clarifying this here.

77: The specific focus on “hand and upper extremity patient population” comes as a surprise, given the flow of the argument in the discussion. Please explain in the introduction why you are focusing on this particular measure and patient population. If the intent is for this to serve as a context for demonstrating the application of the protocol, please say so. Or, else, provide another rationale for this specific focus.

Additionally, given the broad readership of this journal, please describe further in the introduction what is meant by "hand and upper extremity patients" and provide some description of how PROMs are being used in this context (e.g., To determine the best treatment options? Or to evaluate the outcomes of surgical or medical interventions?).

81: “MAP is an innovative protocol for adaptation”. This reads rather repetitive, stating the obvious. Please consider revising.

METHODS

Overall comment: Please refer to the journal's guidelines on reporting of qualitative research. A few key points are identified in my comments above. https://journals.plos.org/plosone/s/submission-guidelines#loc-guidelines-for-specific-study-types: "Qualitative research studies should be reported in accordance to the Consolidated criteria for reporting qualitative research (COREQ) checklist or Standards for reporting qualitative research (SRQR) checklist."

Study setting (101): To address my comment above, please explain how PRO data are currently being used in this clinic. What are the purposes for collecting the PRO data?

Instrument selection (113): Please provide further description of the items and measurement validity evidence. Given the focus of this manuscript, it is important to fully understand what is being measured and what the validity evidence of the original instrument is.

Study design

141: Please provide a reference to participant observation methods.

149: Please define what this means. How is this different from regular thematic analysis? The description of the results reflect a more general content analysis approach. Please describe how the data were analyzed to arrive at themes. Or, if content analysis was used, please indicate this. Either way, please provide a suitable reference for the approach that was used.

Discovery interviews: Some inclusion criteria are described, but the sampling approach is unclear. Please describe how participants were selected and the type of sampling method used (e.g., purposive, convenience, consecutive, snowball). Did any of the approached people refuse to participate? If so, is anything known about the reasons for non-participation?

171: Please indicate here that the CLA was the interviewer and describe the nature of the relationship of CLA with the interview participants. Is it possible that he results may have been influenced by the relationship.

172: Please provide further description of the interview guides (e.g., provide examples of questions asked or include the guides as an appendix).

178: Was CLA the only person doing the analyses, or were others involved in the analysis as well? Please describe.

179: Please provide a reference to the thematic analysis approach that was used (given that there are different methodological approaches - see above comment). Please also indicate whether any software was used to assist with the analysis.

Ideation workshop: It seems that patients were not included in this phase. Is that correct? Please make this explicit, as this could be viewed as a limitation.

RESULTS

Direct observation: See comment above regarding content vs. thematic analysis. The results, as presented here, seem to be more representative of a type of content analysis. It is unclear what the inductive themes might be. Please revise or clarify.

Ideation workshop: It is unclear what all the idea names in Table 3 refer to. Please provide further description in the text or a footnote to this table.

Prototyping: Based on the MAP approach, I understand that the prototype should be informed by the results of the prior phases (B, C and D). However, this is currently not clear. Please expand the text, or in the table, to more explicitly demonstrate how the prototype was developed based on the results reported above.

DISCUSSION

It would be helpful, and conventional, to first describe a summary of the overall result of your study.

365: Please discuss what you consider to be the key recommendations for advancing this approach to PRO data capture.

It is critically important to indicate the need for further research on validity evidence. The authors correctly refer to this in the abstract, when they state: "“Future research will include back adaptation, usability testing via qualitative evaluation, and psychometric validation of the mPROMIS-UE”. Please elaborate on this in the discussion section of the manuscript.

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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: No

Reviewer #3: 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.

PONE-D-23-24670R2Developing a multimedia patient-reported outcomes measure for low literacy patients with a human-centered design approachPLOS ONE

Dear Dr. Giladi,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, I think there are still some minor revisions (see below) needed before it can be accepted for publication.  1. The first mention of PROMIS needs to include a trademark, PROMIS®

2. PROMIS UE is not disease-specific. It is a generic measure that can be used across all diseases and conditions. Please revise accordingly in the "Instrument selection" section.3. In the "Implications" section, the authors stated that "as the mPROMIS-UE could replace the current PROMIS instrument rather than being an additional instrument to be administered to certain segments of the clinic population." This statement was not supported by the evidence provided in this paper, as no thorough psychometric analysis has been conducted for mPROMIS-UE. 

Please submit your revised manuscript by May 30 2024 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled '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,

Xiaodan Tang

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

[Note: HTML markup is below. Please do not edit.]

[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.

Developing a multimedia patient-reported outcomes measure for low literacy patients with a human-centered design approach

PONE-D-23-24670R3

Dear Dr. Giladi,

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,

Xiaodan Tang

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: