Patterns and predictors of adherence to follow-up health guidance invitations in a general health check-up program in Japan: A cohort study with an employer-sponsored insurer database

Yuichiro Mori; Kunihiro Matsushita; Kosuke Inoue; Shingo Fukuma

doi:10.1371/journal.pone.0286317

Peer Review History

Original SubmissionNovember 23, 2022
7 Feb 2023 Decision Letter - Fred Nuwaha, Editor PONE-D-22-26592Patterns and predictors of adherence to follow-up health guidance invitations in a general health check-up program in Japan: a nationwide cohort studyPLOS ONE Dear Dr. Shingo Fukuma 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 Mar 24 2023 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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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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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 ****** 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 authors describe adherence to a health screening programme among individuals at high risk of CVD in a nation-wide survey in Japan based on analysis of an insurance database. In summary, 71.7% of eligible individuals attended a health check-up, 23.2% of them with high CVD risk and not on medication were invited for health guidance, and only 35.2% of them received health guidance. Older age, concerns regarding HTN, DM, and dyslipidemia, and self-reported motivation for lifestyle change were associated with improved adherence to health guidance invitation. Comments: 1. Title: The study is not of the general population in Japan, but of a selected group of individuals (employees in architecture or civil engineering companies and their family members). The data source is an insurer database. The title needs to reflect these. 2. Why was an insurer database for employees in architecture or civil engineering companies and their family members selected? Why were other employment categories not included? This needs discussion/ justification. 3. High CVD risk was defined as obesity PLUS hypertension, diabetes/pre-diabetes, and high TG or low HDL. Elevated LDL was not considered as a high-risk indicator – why? People with low or normal BMI were excluded, and many of them may have had other CVD risk factors such as HT, DM, DL. This needs discussion/ justification. 4. Many other population-based studies and/or screening programmes use risk scores from a risk prediction tool (such as the Framingham score) to identify individuals at high CVD risk. How does the method used for detecting high risk individuals in the present study compare with these methods? Please discuss. 5. This data is unlikely to be representative of the Japanese population at large due to several reasons: 90% of study population were men; only one selected category of employees/ professionals (this is addressed by the authors); data source was the database of one main insurer, and there is no data on individuals with other insurers. How many of the Japanese population are registered with this insurer? These limitations need to be discussed. 6. Adherence to health guidance was ascertained from records of lifestyle consultation or clinic visit on the insurer database. There was no direct ascertainment from individuals. This is a limitation that can affect the accuracy of the findings. Needs discussion. 7. There is no discussion on how these findings compare with studies done elsewhere. The discussion needs to be expanded with references to such findings. 8. What are the strengths of the study, that would warrant its publication? Minor comments: Results: Pg 9: Line 245; says ‘….97.5% (n = 30,979) were followed up for 365 days …’. Is this correct? Or should it say (n = 30,194)? Please check. ****** 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 ******** [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.0286317.r001
Revision 1
26 Apr 2023 Author Response Our responses are provided, along with comments from editors and reviewers. 1. Title: The study is not of the general population in Japan, but of a selected group of individuals (employees in architecture or civil engineering companies and their family members). The data source is an insurer database. The title needs to reflect these. We appreciate the reasonable suggestion. We have modified the title accordingly. The revised title is "Patterns and predictors of adherence to follow-up health guidance invitations in a general health check-up program in Japan: a cohort study with an employer-sponsored insurer database". 2. Why was an insurer database for employees in architecture or civil engineering companies and their family members selected? Why were other employment categories not included? This needs discussion/ justification. We appreciate the comment which clarifies the reason for the data source selection. We selected this insurer for the analysis because it is one of the largest employer-sponsored health insurers in Japan, covering 400 thousand of individuals. In addition, the wording and design for the health guidance invitation remained consistent throughout the study period. Therefore, we included this explanation in the Data source section in Methods. "... This database includes information on employees in architecture or civil engineering companies and their family members who other insurers do not cover. We selected this insurer for the analysis because it is one of the largest employer-sponsored health insurers in Japan, covering 400 thousand of individuals. In addition, the wording and design for the health guidance invitation remained consistent throughout the study period. The database contains demographic characteristics, medical history, …" 3. High CVD risk was defined as obesity PLUS hypertension, diabetes/pre-diabetes, and high TG or low HDL. Elevated LDL was not considered as a high-risk indicator – why? People with low or normal BMI were excluded, and many of them may have had other CVD risk factors such as HT, DM, DL. This needs discussion/ justification. We agree that the comment is a reasonable criticism of Japan's general health check-up program. However, the government has defined the definition of high CVD risk from the beginning of the program. Therefore, the definition was not under our control. Given the discrepancy between the cutoffs to predict high CVD risk between the program and commonly used prediction tools, we modified the limitation paragraph to reflect this issue. Please refer to the answer to comment 4. 4. Many other population-based studies and/or screening programmes use risk scores from a risk prediction tool (such as the Framingham score) to identify individuals at high CVD risk. How does the method used for detecting high risk individuals in the present study compare with these methods? Please discuss. As per the answer to comment 3, the criteria to define high CVD risk significantly differ from other commonly used prediction tools. This difference may limit the generalizability of our findings to individuals identified as high-risk using other risk prediction tools. We edited the limitation paragraph to reflect this issue. ". Third, the definition of the high CVD risk in Japan's health check-up program, which emphasizes waist circumference, significantly differs from other commonly used risk prediction tools. This difference may limit the generalizability of our findings to individuals identified as high-risk using other risk prediction tools. Fourth, …" 5. This data is unlikely to be representative of the Japanese population at large due to several reasons: 90% of study population were men; only one selected category of employees/ professionals (this is addressed by the authors); data source was the database of one main insurer, and there is no data on individuals with other insurers. How many of the Japanese population are registered with this insurer? These limitations need to be discussed. We appreciate the suggestion that the deviation of our cohort from the general population should be discussed. We want to note that the proportion of males in those who attended health check-ups was 58%, much closer to the general population than 90%. Therefore, we suggest that the main source of the deviation would be the definition of high CVD risk rather than population characteristics. We additionally discussed this issue in the limitation paragraph. "… Fourth, the study found a male predominance (90%) among those invited for health guidance, in contrast to the 58% male attendance at health check-ups. This deviation would also be attributed to the health check-up program's definition of high CVD risk. …" 6. Adherence to health guidance was ascertained from records of lifestyle consultation or clinic visit on the insurer database. There was no direct ascertainment from individuals. This is a limitation that can affect the accuracy of the findings. Needs discussion. We agree there would be misclassifications in the ascertained clinic visits in response to health guidance invitations. Therefore, we also have included this point in the limitation paragraph. "Second, reflecting the nature of administrative data, there remains the possibility of misclassification of the study variables. For example, the observed clinic visits with relevant disease codes might not be in response to the health guidance invitation." 7. There is no discussion on how these findings compare with studies done elsewhere. The discussion needs to be expanded with references to such findings. While there have been several studies on the predictors of receiving health check-ups, this study is the first, to our knowledge, to investigate the predictors of attending follow-up risk-stratified interventions after health check-ups. In light of this, we have revised the fourth paragraph of the discussion section to provide a comparison of our findings with previous research on predictors of receiving health check-ups. We acknowledge the valuable feedback received, which has enabled us to make our discussion more informative and precise. "The more concerning results regarding HTN, DM, or dyslipidemia were another predictor of improved adherence. This finding contrasts with previous research that identified good health status as a predictor of receiving health check-ups (3). Both numeric information on those risk factors (e.g., blood pressure or laboratory test results) and the intensity of recommendation procedures (e.g., specific letter design and employer involvement) would have contributed to better adherence in individuals with more concerning results. …" 8. What are the strengths of the study, that would warrant its publication? To our best knowledge, this study first examined adherence patterns and predictors of attending follow-up risk-stratified interventions after health check-ups. These findings have important implications for healthcare providers designing follow-up interventions after health check-ups, particularly for individuals with chronic conditions. Minor comments: Results: Pg 9: Line 245; says '….97.5% (n = 30,979) were followed up for 365 days …'. Is this correct? Or should it say (n = 30,194)? Please check. Thank you for the correction. As the comment indicates, 97.5% (n = 30,194) were followed up for 365 days. We corrected the paragraph as suggested. The revised version of the paragraph is shown below. The number "35.2%" did not need correction as 10,614/30,194 equals to 35.15…, which can be rounded to 35.2. "In 2017, 71.7% of the population (133,573/ 186,316) attended a health check-up (Figure 2). Among those 133,573 individuals, 25.7% (n = 34,294) were taking prescribed medication for HTN, DM, or dyslipidemia, and 23.2% (n = 30,979) were invited for health guidance as having a high CVD risk and without such medications; of these 30,979 invited for health guidance, 97.5% (n = 30,194) were followed up for 365 days from their check-ups. Of these 30,194 individuals, 35.2% (n = 10,614) received health guidance within 365 days." Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0286317.r002
8 May 2023 Decision Letter - Fred Nuwaha, Editor PONE-D-22-26592R1Patterns and predictors of adherence to follow-up health guidance invitations in a general health check-up program in Japan: a cohort study with an employer-sponsored insurer databasePLOS ONE Dear Dr. Fukuma, 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 Jun 22 2023 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, Fred Nuwaha 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. Additional Editor Comments: Please revise manuscript according to reviewers comments. [Note: HTML markup is below. Please do not edit.] 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: (No Response) ******** 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: 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. 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 addressed most of the comments. They have partly discussed the limitations of the high CVD screening strategy used, but Comment 3 has not been specifically addressed in the discussion. Suggest add the following to the discussion as limitations of the screening strategy – (1) Elevated LDL was not considered a high-risk indicator; (2) People with low or normal BMI were excluded, and many of them may have had other CVD risk factors such as HT, DM, DL. Minor comment: Line 147 - suggest “ .. over 400,000…” instead of “… 400 thousand …” ****** 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.0286317.r003
Revision 2
9 May 2023 Author Response 1. They have partly discussed the limitations of the high CVD screening strategy used, but Comment 3 has not been specifically addressed in the discussion. Suggest add the following to the discussion as limitations of the screening strategy – (1) Elevated LDL was not considered a high-risk indicator; (2) People with low or normal BMI were excluded, and many of them may have had other CVD risk factors such as HT, DM, DL. We appreciate the comment which clarifies the limitation of our manuscript. We modified the limitation paragraph reflecting the suggestion. "... Third, the definition of the high CVD risk in Japan’s health check-up program, which emphasizes waist circumference, significantly differs from other commonly used risk prediction tools. For example, elevated low density lipoprotein cholesterol was not considered a high-risk indicator; and people with low or normal BMI with normal waist circumflex were excluded, though many of them may have had other CVD risk factors such as HT, DM, and dyslipidemia. This difference may limit the generalizability of our findings to individuals identified as high-risk using other risk prediction tools. …" 2. Line 147 - suggest “ .. over 400,000…” instead of “… 400 thousand …” We appreciate the suggestion that enhances the readability of our manuscript. We edited the line accordingly. “… We selected this insurer for the analysis because it is one of the largest employer-sponsored health insurers in Japan, covering over 400,000 individuals. In addition, the wording and design for the health guidance invitation remained consistent throughout the study period. …” (Data source paragraph in Methods) Attachments Attachment Submitted filename: Response to Reviewers (1).docx https://doi.org/10.1371/journal.pone.0286317.r004
15 May 2023 Decision Letter - Fred Nuwaha, Editor Patterns and predictors of adherence to follow-up health guidance invitations in a general health check-up program in Japan: a cohort study with an employer-sponsored insurer database PONE-D-22-26592R2 Dear Dr. Shingo, 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, Fred Nuwaha Academic Editor PLOS ONE Additional Editor Comments (optional): 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: I Don't Know ****** 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 satisfactorily addressed the review comments. I have no further revisions to suggest. ****** 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 ******** https://doi.org/10.1371/journal.pone.0286317.r005
Formally Accepted
17 May 2023 Acceptance Letter - Fred Nuwaha, Editor PONE-D-22-26592R2 Patterns and predictors of adherence to follow-up health guidance invitations in a general health check-up program in Japan: A cohort study with an employer-sponsored insurer database Dear Dr. Fukuma: 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. Fred Nuwaha Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0286317.r006

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