Subclinical hypothyroidism in Wales from 2000 to 2021: A descriptive cohort study based on electronic health records

Brenda S. Bauer; Amaya Azcoaga-Lorenzo; Utkarsh Agrawal; Adeniyi Francis Fagbamigbe; Colin McCowan

doi:10.1371/journal.pone.0298871

Peer Review History

Original SubmissionOctober 6, 2023
1 Dec 2023 Decision Letter - Fateen Ata, Editor PONE-D-23-32464Subclinical hypothyroidism in Wales from 2000 to 2021: a descriptive cohort study based on electronic health recordsPLOS ONE Dear Dr. Bauer, 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 Jan 15 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. 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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 Additional Editor Comments: We have completed the peer-review process, and I'm writing to inform you that your submission has been evaluated as requiring major revisions. The reviewers have provided constructive feedback and identified key areas that need substantial revision. Their comments are aimed at enhancing the scientific rigor, clarity, and impact of your work. We believe your research will benefit from a revision, and we encourage you to revise the manuscript per the comments provided. Please find the reviewers' comments attached. [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: I Don't Know 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: The demographic and clinical characteristics of patients diagnosed with subclinical hypothyroidism in Wales between 2000 and 2021 are described in this study. Furthermore, the annual cumulative incidence during this period and the testing and treatment patterns linked to the disorders were investigated. Although the sample size of the study was relatively large and the results obtained in this study provided considerable significance for the assessment of subclinical hypothyroidism, the authors should address the following requirements. 1. Some of the tables need to be changed as bar graphs or pie charts. 2. There was too much redundancy in the conclusion section. The authors need to concisely summarize or itemize the results. Reviewer #2: In this article Brenda S Bauer and collegues report an discreptive study about the characterisation and the medication of SCH patients which covers almost the whole population of Wales spanning two decades, this study is of some interest,which indicates that more robust guidelines and recommendations are needed to ensure the consistent and appropriate clinical management of patients identified as having SCH. ****** 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: Yes: Ken-ichi Aihara 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. 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.0298871.r001
Revision 1
13 Jan 2024 Author Response Reviewer 1: We thank Reviewer 1 for their feedback on the manuscript. Because there are already five figures included in our original submission, we have limited scope to create additional figures. However, we have converted Table 3, which showed the frequency of abnormal tests before levothyroxine was initiated, to a bar graph – this is now included as Figure 5. The original length of the Conclusion section was 227 words – this has now been shortened to 210 words and rearranged to improve flow. It now reads: “This descriptive study on SCH in Wales shows an uneven rise in the overall number of patients, TFT and levothyroxine use between 2000 and 2021, with the highest annual cumulative incidence in 2012 at 502 cases per 100,000 people. Compared to patients who only had test results indicative of SCH, those with clinically recorded diagnoses were less likely to meet the 10mIU/L TSH cutoff for severe SCH but were also more likely to be offered treatment. In contrast, patients with mild SCH on their index test were less likely to receive levothyroxine. The clinical management of SCH was inconsistent with the recommendation to consider treatment only if a repeat test reveals TSH levels higher than 10mIU/L, considering that over a third of treated cases had only one prior abnormal test result. However, per the current NICE annual monitoring guidance, TFTs were ordered more frequently for treated than untreated patients. Our findings show that more robust guidelines are needed to ensure the appropriate clinical management of patients with SCH. Given the potential for a continued rise in patient numbers and conflicting evidence on the impact of SCH on patients’ long-term health, more research is needed to inform strategies to improve the use of TFTs and levothyroxine for managing this thyroid disorder.” Reviewer 2: We thank Reviewer 2 for their comments on the manuscript. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0298871.r002
1 Feb 2024 Decision Letter - Fateen Ata, Editor Subclinical hypothyroidism in Wales from 2000 to 2021: a descriptive cohort study based on electronic health records PONE-D-23-32464R1 Dear Dr. Bauer, 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, Fateen Ata, MD Academic Editor PLOS ONE Additional Editor Comments (optional): All comments have been addressed and manuscript is now suitable for publication. 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 #1: All comments have been addressed ******** 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 #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 #1: No ****** 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. 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: The authors have revised the manuscript after the first round review process. I have no further comment. ****** 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: Yes: Ken-ichi Aihara ******** https://doi.org/10.1371/journal.pone.0298871.r003
Formally Accepted
9 May 2024 Acceptance Letter - Fateen Ata, Editor PONE-D-23-32464R1 PLOS ONE Dear Dr. Bauer, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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. Fateen Ata Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0298871.r004

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