How patients interpret early signs of foot problems and reasons for delays in care: Findings from interviews with patients who have undergone toe amputations

Alyson J. Littman; Jessica Young; Megan Moldestad; Chin-Lin Tseng; Joseph R. Czerniecki; Gregory J. Landry; Jeffrey Robbins; Edward J. Boyko; Michael P. Dillon

doi:10.1371/journal.pone.0248310

Peer Review History

Original SubmissionNovember 22, 2020
13 Jan 2021 Decision Letter - Arezoo Eshraghi, Editor PONE-D-20-36785 How patients interpret early signs of foot problems and reasons for delays in care: findings from interviews with patients who have undergone toe amputations PLOS ONE Dear Dr. Littman, 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 Feb 27 2021 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. 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Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 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 ****** 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: Interesting qualitative study that was well designed. Generalizability is always an issue for these types of studies. As is common for this type of research a large number of potential subjects were not ultimately participants. Only men were interviewed. Need to be careful about the implication of using the term “large national sample”. While it is, this term usually implies that the sample is representative, and this is rarely true for a qualitative study including this one. It is interesting that patient understanding their medical condition was an issue for patients who are receiving education. This has been a common issue for educational programs and likely means we need to do a better job by maybe doing a “different” job. Reviewer #2: Very well presented! It is rare that the authors have paid attention to the details of manuscript preparation. Thank you for your work and growing the edge of knowledge with your work. I look forward to seeing this in print! Just an edit: Pg5 line 115 do you mean "inquiry" rather than "analysis" A pleasure to read! ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. 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Revision 1
8 Feb 2021 Author Response 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 Response: We have re-reviewed the style requirements and done our best to abide by them. 2. In the Methods section, please provide a copy of the interview guides as Supporting Information. Response: We inadvertently failed to include the Supplemental File with the first submission. We apologize. The interview guide is included as S1 File. Furthermore, When reporting the results of qualitative research, we suggest consulting the COREQ guidelines: http://intqhc.oxfordjournals.org/content/19/6/349. In this case, please provide additional information on how participants were approached for the interview, and where the interviews took place. Response: We appreciate the suggestion. We consulted the COREQ guidelines to ensure that we included the key information and presented it as clearly as possible; we made changes where we noticed opportunities to clarify our methods. We added a new subheading “Recruitment” where we detail how patients were approached. We state on line 127 that interviews were conducted over the telephone. 3. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. Response: We now specify that we obtained verbal consent and explain that we obtained a waiver of documentation of written informed consent in lines 114-115. Consent was verified at the start of the interview and recorded. 4. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Response: Due to legal and ethical restrictions, we are unable to share data publicly because the data contain potentially identifying and/or sensitive patient information. Data access requests will be reviewed by the IRB of the VA Puget Sound Health Care System (contact via Dr. Littman). Reviewer #1: Interesting qualitative study that was well designed. Generalizability is always an issue for these types of studies. As is common for this type of research a large number of potential subjects were not ultimately participants. Only men were interviewed. Need to be careful about the implication of using the term “large national sample”. While it is, this term usually implies that the sample is representative, and this is rarely true for a qualitative study including this one. Response: The reviewer makes a good point that our sample may not be representative. In line 405, we now state, “In interviews with a large sample of male patients from across the United States with diabetes who had undergone a toe amputation, delays in care were common.” We also include generalizability as a potential limitation in lines 444-445. It is interesting that patient understanding their medical condition was an issue for patients who are receiving education. This has been a common issue for educational programs and likely means we need to do a better job by maybe doing a “different” job. Response: We agree that it is interesting that patients understanding their medical condition was an issue for patients who (we believe) are receiving education. As noted by the reviewer, this has been a common issue for education programs and suggests that more research is needed to determine how to make educational programs more effective. Reviewer #2: Very well presented! It is rare that the authors have paid attention to the details of manuscript preparation. Thank you for your work and growing the edge of knowledge with your work. I look forward to seeing this in print! Just an edit: Pg5 line 115 do you mean "inquiry" rather than "analysis" A pleasure to read! Response: We are pleased that you appreciated our paper. In prior line 115 (current line 130), we have replaced the word “analysis” with “inquiry.” Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0248310.r002
24 Feb 2021 Decision Letter - Arezoo Eshraghi, Editor How patients interpret early signs of foot problems and reasons for delays in care: findings from interviews with patients who have undergone toe amputations PONE-D-20-36785R1 Dear Dr. Littman, 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, Arezoo Eshraghi, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0248310.r003
Formally Accepted
2 Mar 2021 Acceptance Letter - Arezoo Eshraghi, Editor PONE-D-20-36785R1 How patients interpret early signs of foot problems and reasons for delays in care: findings from interviews with patients who have undergone toe amputations Dear Dr. Littman: 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. Arezoo Eshraghi Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0248310.r004

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