Study protocol for a non-randomised controlled trial: Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI)

Marco Antonio Raya-Ruiz; María Rodríguez-Bailón; Beatriz Castaño-Monsalve; Laura Vidaña-Moya; Ana Judit Fernández-Solano; José Antonio Merchán-Baeza

doi:10.1371/journal.pone.0274193

Peer Review History

Original SubmissionSeptember 28, 2021
10 Jun 2022 Decision Letter - Vanessa Carels, Editor PONE-D-21-30716Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI): Study protocol for a non-randomised controlled trialPLOS ONE Dear Dr. Merchán-Baeza, 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 Jul 24 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: 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, Vanessa Carels Staff 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 https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. 2. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Partly ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Partly ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: No ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 ****** 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 ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The manuscript entitled ‘Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI): Study protocol for non-randomized controlled Trial’ The manuscript requires further improvement based on the following comments. The title requires revision e.g. to begin with ‘Study protocol for a non-randomized controlled trial…….. Abstract Page 2, the sentence ‘intervention based on MOHO and developed in a home setting’ requires revision. The comparative group is to be clearly stated. The abstract requires English editing, Materials and methods Page 6, typo etc.)). Page 6, the numbering item A, B, C could be replaced with, (i), (ii), (iii) or (a), (b), (c). This applies to other sections of the manuscript. Recruitment of subjects Page 7, more information on how the subjects were allocated to intervention and control groups, who allocate/placed the subjects into the groups and collect the data to be clearly stated. Page 7, how long is the estimated waiting list in the control group to be clearly stated. Page 9, the objectives to be placed after introduction before materials and methods section. The objectives require English editing. ‘developed in a home setting’ not clear. The words 'meaningful occupation' and ‘ to know the contribution’ are to be revised. Meaningful occupation to be replaced with meaningful activities. Page 8 Figure 1, more information/important point(s) on what was received by intervention and control group to be clearly stated in the figure. Intervention Page 11, the sentence ‘which has as one of its main objectives the facilitation of participation in occupations in people with severe volitional difficulties’ to be revised. All inventories/questionnaires whether all are Spanish versions to be indicated. Sample size calculation One or two-tailed test and the attrition rate to be stated. Beta=0.20 and Power=1-0.20=0.80 Statistical analysis A write-up on possible missing data and methods of handling missing data is to be added. Page 20 Paragraph 2 Line 5, for the statement ‘In model 2, the variable satisfaction with the occupation (collected by SDO-OB) will be added’ to state clearly whether variables in model 1 are included in model 2 as well. ****** 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 #1: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. 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. https://doi.org/10.1371/journal.pone.0274193.r001
Revision 1
17 Jun 2022 Author Response RESPONSE TO REVIEWERS - PONE-D-21-30716 Note: author uses red for responses under the original comment 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Partly ________________________________________ 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Partly ________________________________________ 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: No Response to question 1, 2 and 3: Since some time has passed since our manuscript proposal and, after reading the reviewer's comments, we have revised most of the sections to bring them more in line with what was suggested. In this regard, we expect this sections to be considerably improved. Thank you for the comments. ________________________________________ 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 ________________________________________ 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 ________________________________________ 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The manuscript entitled ‘Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI): Study protocol for non-randomized controlled Trial’ The manuscript requires further improvement based on the following comments. The title requires revision e.g. to begin with ‘Study protocol for a non-randomized controlled trial…….. Response: Thank you for the suggestion. Change has been made Abstract Page 2, the sentence ‘intervention based on MOHO and developed in a home setting’ requires revision. The comparative group is to be clearly stated. The abstract requires English editing. Response: Thank you for the suggestion. Changes have been made and, in general, an official translation service (PRS) has been used. Materials and methods Page 6, typo etc.)). Response: Fixed, thank you. Page 6, the numbering item A, B, C could be replaced with, (i), (ii), (iii) or (a), (b), (c). This applies to other sections of the manuscript. Response: Changes had been made plus best definition of inclusion/exclusion criteria Recruitment of subjects Page 7, more information on how the subjects were allocated to intervention and control groups, who allocate/placed the subjects into the groups and collect the data to be clearly stated. Page 7, how long is the estimated waiting list in the control group to be clearly stated. Response: Thanks for the comments, we have improved the definition of this section and we hope that it will further clarify the procedure. Page 9, the objectives to be placed after introduction before materials and methods section. The objectives require English editing. ‘developed in a home setting’ not clear. The words 'meaningful occupation' and ‘ to know the contribution’ are to be revised. Meaningful occupation to be replaced with meaningful activities. Response: Thanks for the suggestion. We have changed the concept of home-setting to community-based, for being more complete. We have also corrected the phrasing of the objectives. Regarding the change from meaningful occupation to meaningful activity, we agree with your suggestion, also in line with articles such as Eakman (2013). Page 8 Figure 1, more information/important point(s) on what was received by intervention and control group to be clearly stated in the figure. Response: on the basis of your suggestion, we have changed the figure to add this issue. Intervention Page 11, the sentence ‘which has as one of its main objectives the facilitation of participation in occupations in people with severe volitional difficulties’ to be revised. Response: revision done, thanks for the comment. All inventories/questionnaires whether all are Spanish versions to be indicated. Response: changes have been made. Sample size calculation One or two-tailed test and the attrition rate to be stated. Beta=0.20 and Power=1-0.20=0.80. Response: thank you very much for the comment, we have made changes in this aspect, adding the consideration of the two tails, also in the calculation of the power size. Statistical analysis A write-up on possible missing data and methods of handling missing data is to be added. Response: thank you so much for the suggestion. We have added a clarification in this respect, using the multiple imputation method. Page 20 Paragraph 2 Line 5, for the statement ‘In model 2, the variable satisfaction with the occupation (collected by SDO-OB) will be added’ to state clearly whether variables in model 1 are included in model 2 as well. Response: thanks for the comment, we have better clarified that sentence. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0274193.r002
12 Jul 2022 Decision Letter - Thomas Tischer, Editor PONE-D-21-30716R1Study protocol for a non-randomised controlled trial: Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI)PLOS ONE Dear Dr. Merchán-Baeza, 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 address the points that the reviewer noted and see the "additional Editor comments" section below. Please submit your revised manuscript by Aug 26 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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, Thomas Tischer Staff Editor PLOS ONE Additional Editor Comments (if provided): We noticed that specifically the abstract needs some copy editing. PLOS ONE does not provide copy editing services, please ensure the use proper English language and grammar throughout the manuscript. We noticed that the sample size of your study has increased from 106 to 134. This does not agree with the registered trial protocol NCT04586842. Please comment on this and seek out advise if an amendment is required. If an amendment is required, please ensure it is granted before the manuscript is resubmitted. If no amendment is required please explain why. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Partly ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 ****** 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 ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The authors have put in a great effort to address the comments. Minor comments Line 358 - Typo error 'anaylisis' Line 128-133 - Objectives to be placed at Line 127 (before Materials and Methods section) ****** 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 #1: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. 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. https://doi.org/10.1371/journal.pone.0274193.r003
Revision 2
27 Jul 2022 Author Response Thank you so much for your feedback. We believe that this project is useful for the population profile for which it is designed, so we are enthusiastic with the opportunity to publish it Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0274193.r004
24 Aug 2022 Decision Letter - George Vousden, Editor Study protocol for a non-randomised controlled trial: Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI) PONE-D-21-30716R2 Dear Dr. Merchán-Baeza, 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, George Vousden Staff Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0274193.r005
Formally Accepted
29 Sep 2022 Acceptance Letter - George Vousden, Editor PONE-D-21-30716R2 Study protocol for a non-randomised controlled trial: Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI) Dear Dr. Merchán-Baeza: 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. George Vousden Staff Editor PLOS ONE https://doi.org/10.1371/journal.pone.0274193.r006

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