Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes

Weiqin Li; Cuiping Zhang; Junhong Leng; Ping Shao; Huiguang Tian; Fuxia Zhang; Ling Dong; Zhijie Yu; Juliana C. N. Chan; Gang Hu; Ping Zhang; Xilin Yang

doi:10.1371/journal.pone.0237738

Peer Review History

Original SubmissionApril 27, 2020
19 May 2020 Decision Letter - Linglin Xie, Editor PONE-D-20-12277 Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes PLOS ONE Dear Dr. Li, 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 hat addresses the points raised during the review process. We would appreciate receiving your revised manuscript by 07/18/2020. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. 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Thank you also for including your funding statement; "This project was supported by the National Key Research and Development Program of China (Grants No: 2018YFC1313900, 2018YFC1313903, 2016YFC1300101 and 2016YFC0900602), and BRIDGES (Project No: LT09-227). BRIDGES is an International Diabetes Federation program supported by an educational grant from Lilly Diabetes." Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." If this statement is not correct you must amend it as needed. Please include this amended Role of Funder and Competing Interests statement in your cover letter; we will change the online submission form on your behalf. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests [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: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes 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: Major comment: 1. Could you provide more details about how you randomly assigned the women into SC or UC group? Or provide some statistics to show no other factors would cause the differences regarding the pregnancy outcomes between two groups. Minor comment: 1. Some numbers in table 3 are not correct. 2. What are the p-values of : macrosomia [the SC group vs. the UC group: 11.2% (38/339) vs. 17.5% (63/361)] and LGA [the SC group vs. the UC group: 13.0% (44/339) vs. 19.9% (72/361)] Reviewer #2: Based on the data from one of the biggest city in CHINA, the authors evaluated the cost-effectiveness of lifestyle intervention in women with GDM and found that lifestyle intervention cost less than ¥33,000 for prevention of a macrosomia/LGA infant in China, so intensive lifestyle intervention may be an efficient use of health care resources in China. Although this paper provides potentially interesting new observations, there are some significant issues that need to be addressed for it to be suitable for publication. Major point: 1. Only 339 from the SC and 361 from UC are availabel finally, its a very important information , should be shown in the abstract. 2. The p value need to be shown in the first paragraph of the results between different groups, without that how to say "the SC significantly reduced the rates of macrosomia....." Minor point: 3. The unit in the sentence ‘35 kcal/day/kg for one kilogram body weight per day for those with BMI at <18.5 kg/m2; 30–35 kcal/day for those with BMI at 18.5-23.9 kg/m2; 25-30 kcal/day/kg for those with BMI at 24.0-27.9 kg/m2; 25 kcal/day/kg for those BMI at 28.0 kg/m2 and more” is not clear. 4. macrosomia should be a special kind of LGA, so the defination of LGA need to exclude macrosomia. 5. the language of this manuscript need to be improved. ****** 6. 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Revision 1
17 Jul 2020 Author Response PONE-D-20-12277 Response to Reviewer #1 Reviewer #1: Major comment: 1. Could you provide more details about how you randomly assigned the women into SC or UC group? Or provide some statistics to show no other factors would cause the differences regarding the pregnancy outcomes between two groups. Response: Thank you for your comment. Details of the randomization were described in our previous publication. Following the suggestion, we now added more details of randomization as follows: “A simple randomization procedure without replacement (i.e., by the time sequence of visits to the clinic and a list of priori computer-generated random assignment status by X.Y.) was used to perform the random assignment by the intervention team members.” We also added a sentence to show no significant differences regarding the pregnancy outcomes between two groups as “There were no significant differences between the two groups for the baseline clinical and biochemical characteristics.”. Minor comment: 1. Some numbers in table 3 are not correct. Response: Thank you for the careful reading . We have corrected the error. . 2. What are the p-values of : macrosomia [the SC group vs. the UC group: 11.2% (38/339) vs. 17.5% (63/361)] and LGA [the SC group vs. the UC group: 13.0% (44/339) vs. 19.9% (72/361)] Response: We have added the p values in the first paragraph of the results. Response to Reviewer #2 Reviewer #2: Based on the data from one of the biggest city in CHINA, the authors evaluated the cost-effectiveness of lifestyle intervention in women with GDM and found that lifestyle intervention cost less than ¥33,000 for prevention of a macrosomia/LGA infant in China, so intensive lifestyle intervention may be an efficient use of health care resources in China. Although this paper provides potentially interesting new observations, there are some significant issues that need to be addressed for it to be suitable for publication. Major point: 1. Only 339 from the SC and 361 from UC are availabel finally, its a very important information , should be shown in the abstract. Response: Thank you for your comment. We have added this information in the abstract. 2. The p value need to be shown in the first paragraph of the results between different groups, without that how to say "the SC significantly reduced the rates of macrosomia....." Response: Thank you for your comment. We have added the p values in the first paragraph of the results. Minor point: 3. The unit in the sentence ‘35 kcal/day/kg for one kilogram body weight per day for those with BMI at <18.5 kg/m2; 30–35 kcal/day for those with BMI at 18.5-23.9 kg/m2; 25-30 kcal/day/kg for those with BMI at 24.0-27.9 kg/m2; 25 kcal/day/kg for those BMI at 28.0 kg/m2 and more” is not clear. Response: Thank you for your comment. We have revised this sentence. Now it reads as “35 kcal per day for one kilogram of body weight (35 kcal/day/kg) for women with BMI at <18.5 kg/m2; 30–35 kcal/day/kg for women with BMI at 18.5-23.9 kg/m2; 25-30 kcal/day/kg for women with BMI at 24.0-27.9 kg/m2; 25 kcal/day/kg for women with BMI at 28.0 kg/m2 and more” 4. macrosomia should be a special kind of LGA, so the defination of LGA need to exclude macrosomia. Response: We thank the reviewer for this insight. We agree that macrosomia is a special kind of LGA. However, in our original RCT design, we used the two outcomes as sperate outcome measures for the trial. We defined LGA as birth weight above the gender- and gestational age- specific 90th percentiles using the Tianjin local references, while macrosomia as birth weight ≥4,000 gram. The two measures were both prior defined primary endpoints for our RCT. We reported the effectiveness of intervention using both endpoints in our previous published main analysis. So we preferred not to exclude macrosomia from LGA to keep consistency with the main report. 5. the language of this manuscript need to be improved. Response: Thank you for your comment. Now, a native English editor has copyedited the paper. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0237738.r002
3 Aug 2020 Decision Letter - Linglin Xie, Editor Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes PONE-D-20-12277R1 Dear Dr. Li 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, Linglin Xie 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 Reviewer #2: 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 Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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 Reviewer #2: 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 Reviewer #2: 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: (No Response) Reviewer #2: My commets to author has been responsed in the new version this time, not only the data but also the statistical analysis been performed appropriately, the language also been improved, its valuable to be published. ****** 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 Reviewer #2: No https://doi.org/10.1371/journal.pone.0237738.r003
Formally Accepted
10 Aug 2020 Acceptance Letter - Linglin Xie, Editor PONE-D-20-12277R1 Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes Dear Dr. Li: 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. Linglin Xie Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0237738.r004

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