Acknowledging the role of patient heterogeneity in hospital outcome reporting: Mortality after acute myocardial infarction in five European countries

Micaela Comendeiro-Maaløe; Francisco Estupiñán-Romero; Lau Caspar Thygesen; Céu Mateus; Juan Merlo; Enrique Bernal-Delgado; on behalf of the ECHO consortium

doi:10.1371/journal.pone.0228425

Peer Review History

Original SubmissionOctober 7, 2019
19 Nov 2019 Decision Letter - Timir Paul, Editor Transfer Alert This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present. PONE-D-19-28081 Acknowledging the role of patient heterogeneity in hospital outcomes reporting: mortality after acute myocardial infarction in five European countries. PLOS ONE Dear Dr. Comendeiro-Maaløe , 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. We would appreciate receiving your revised manuscript by 60 days. 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Thank you for stating in your Funding Statement: "The ECHO Project received funding from the 7th Framework Programme of the European Union (2010-2014) with Grant HEALTH-F3-2010-242189 and from the European Union’s Health Programme (2014-2020) with Grant 664691/BRIDGE Health. On the other hand, the authors Enrique Bernal-Delgado, Francisco Estupiñán-Romero and Micaela Comendeiro-Maaløe have been partially funded by the Institute for Health Carlos III through a public competitive grant (RD16/0001/0007) as part of the network for Health Services Research on Chronic Patients (REDISSEC) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." i) Please provide an amended statement that declares all the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now. Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement. ii) Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf. 6. Thank you for stating the following in the Acknowledgments Section of your manuscript: "The ECHO Project received funding from the 7th Framework Programme of the European Union (2010-2014) with grant HEALTH-F3-2010-242189 and from the European Union’s Health Programme (2014-2020) with grant 664691/BRIDGE Health." We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. * Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: "The ECHO Project received funding from the 7th Framework Programme of the European Union (2010-2014) with Grant HEALTH-F3-2010-242189 and from the European Union’s Health Programme (2014-2020) with Grant 664691/BRIDGE Health. On the other hand, the authors Enrique Bernal-Delgado, Francisco Estupiñán-Romero and Micaela Comendeiro-Maaløe have been partially funded by the Institute for Health Carlos III through a public competitive grant (RD16/0001/0007) as part of the network for Health Services Research on Chronic Patients (REDISSEC) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript". 7. 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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: The paper entitled “Acknowledging the role of patient heterogeneity in hospital outcomes reporting: mortality after acute myocardial infarction in five European countries.” by Comendeiro-Maaløe, et al. assesses the relevance of accounting for patients’ heterogeneity when reporting on hospitals’ performance. The present study suggests that accounting for patients’ heterogeneity is required to adequately characterize and report on hospitals performance. The topic of this manuscript is relevant to the field of this journal, and makes a significant contribution to this field. Tables are beautiful and easy to understand. This article is concise, well-written, and educational for readers of this journal. I would advise some minor changes: The introduction is difficult to follow and needs to be simplified for the average reader. For instance, Studies assessing the effect of Post MI heterogeneities have largely focused on mortality as the primary outcome. Differences in post MI survival can be explained by disparities in available resources and medical care. The manuscript is fraught with some minor grammatical errors and needs to be thoroughly proofread before submission. Flowchart of patient participation, exclusion and inclusion should be included in the manuscript if possible Reviewer #2: This is an observation study which evaluates the hospital effect in 107 hospitals from five different European countries in non-CHF AMI patients and AMI patients with CHF. Recognizing the importance of patient heterogeneity is important in reporting patient outcomes and assessing hospital performance. Different hospital vary in their underlying risk of any event. In this article by Comendeiro-Maaløe et al., multilevel regression model has been used for hospital-specific interpretations. The study assess two consecutive endpoints including variation in the hospital effect and level of agreement in hospital outcomes. They find that accounting for patients’ heterogeneity should be required to adequately characterize and report hospitals performance. Overall this paper is well written, tables and figures have been presented nicely. I would suggest editor accept this manuscript. ******** 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 [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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0228425.r001
Revision 1
14 Jan 2020 Author Response (Hereby we expose the same information included in the indexed document "response to reviewers") Ref: PONE-D-19-28081-R1 Responses to the first round of reviews Version 2020 01 10 Dear editor, Thank you very much for allowing us to submit a reviewed version of our manuscript. Please, find below our replies to your concerns and the first reviewer’s comments in a case-by-case manner. Those points that implied a change in the manuscript have been conveniently highlighted. Editor’s concerns and journal’s requirements: 2. 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. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent (We will update your Data Availability statement on your behalf to reflect the information you provide). Response: As required, we have added an informative paragraph in the revised cover letter as follows: “The access to pseudoanonimised patient-level administrative data (patient episodes: hospital admissions and discharges) supporting the manuscript findings is restricted to avoid data misuse in accordance with the System Level Security Policy of the Unit for Health Services and Policy Research at the Institute for Health Sciences in Aragon (IACS) (Available at: www.atlasvpm.org/grupo-coordinador/ARiHSPinformationsecuritypolicy) within the framework of the Spanish legal system, in particular, Regulation (EU) 2016/679, the Law 3/2018 on Personal Data Protection, the Law 14/2007 on Biomedical Research and the Law 37/2007 and Law 18/2015 on the Public Sector Information Reuse. Consequently, we have specified that only aggregated data may be accessed, upon request, throughout our data sharing agreement, by contacting the senior author of the manuscript Enrique Bernal-Delgado (ebernal.iacs@aragon.es) and/or the legal officer Ramón Launa-Garcés (rlaunag.iacs@aragon.es)” 5. Thank you for stating in your Funding Statement: "The ECHO Project received funding from the 7th Framework Programme of the European Union (2010-2014) with Grant HEALTH-F3-2010-242189 and from the European Union’s Health Programme (2014-2020) with Grant 664691/BRIDGE Health. On the other hand, the authors Enrique Bernal-Delgado, Francisco Estupiñán-Romero and Micaela Comendeiro-Maaløe have been partially funded by the Institute for Health Carlos III through a public competitive grant (RD16/0001/0007) as part of the network for Health Services Research on Chronic Patients (REDISSEC). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." i) Please provide an amended statement that declares all the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now. Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement. ii) Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf. Response: As required, we have added an amended statement in the revised cover letter as follows: “The ECHO Project received funding from the 7th Framework Programme of the European Union (2010-2014) with Grant HEALTH-F3-2010-242189 and from the European Union’s Health Programme (2014-2020) with Grant 664691/BRIDGE Health. Additionally, the authors Enrique Bernal-Delgado, Francisco Estupiñán-Romero and Micaela Comendeiro-Maaløe have been partially funded by the Institute for Health Carlos III through a public competitive grant (RD16/0001/0007) as part of the network for Health Services Research on Chronic Patients (REDISSEC). The funding sources received during this study played no role in the study design, data collection or the analysis, decision to publish, or preparation of the manuscript. There was no additional external funding received for this study” 6. Thank you for stating the following in the Acknowledgments Section of your manuscript: "The ECHO Project received funding from the 7th Framework Programme of the European Union (2010-2014) with grant HEALTH-F3-2010-242189 and from the European Union’s Health Programme (2014-2020) with grant 664691/BRIDGE Health." We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. * Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: "The ECHO Project received funding from the 7th Framework Programme of the European Union (2010-2014) with Grant HEALTH-F3-2010-242189 and from the European Union’s Health Programme (2014-2020) with Grant 664691/BRIDGE Health. On the other hand, the authors Enrique Bernal-Delgado, Francisco Estupiñán-Romero and Micaela Comendeiro-Maaløe have been partially funded by the Institute for Health Carlos III through a public competitive grant (RD16/0001/0007) as part of the network for Health Services Research on Chronic Patients (REDISSEC). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript". Response: all the funding information has been removed from the manuscript as required. The funding information has also been updated and included in the revised cover letter as required in point 5. Reviewer’s concerns: Reviewer #1 The introduction is difficult to follow and needs to be simplified for the average reader. For instance, Studies assessing the effect of Post MI heterogeneities have largely focused on mortality as the primary outcome. Differences in post MI survival can be explained by disparities in available resources and medical care. Response: Thank you for your suggestion, although we are afraid that by using other terms as you propose in your example, the meaning of the conceptualisation of what we methodologically develop later in the paper could be changed. Nevertheless, we believe that the corrections made in the introduction once the manuscript has been proofread by a native speaker, may ease comprehension. The manuscript is fraught with some minor grammatical errors and needs to be thoroughly proofread before submission. Response: thank you for the suggestion. As mentioned before, the manuscript has been proofread and corrected by a native speaker. Flowchart of patient participation, exclusion and inclusion should be included in the manuscript if possible Response: Thank you for the suggestion. A flowchart has been included at the beginning of the methods section, now named as figure 1. Attachments Attachment Submitted filename: PONE-D-19-28081R1_Response-to-reviewers_20200110.docx https://doi.org/10.1371/journal.pone.0228425.r002
15 Jan 2020 Decision Letter - Timir Paul, Editor Acknowledging the role of patient heterogeneity in hospital outcome reporting: mortality after acute myocardial infarction in five European countries. PONE-D-19-28081R1 Dear Dr. Enrique Bernal-Delgado, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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. With kind regards, Timir Paul Academic Editor PLOS ONE Additional Editor Comments (optional): All the reviewers' comments have been answered. Reviewers' comments: https://doi.org/10.1371/journal.pone.0228425.r003
Formally Accepted
21 Jan 2020 Acceptance Letter - Timir Paul, Editor PONE-D-19-28081R1 Acknowledging the role of patient heterogeneity in hospital outcome reporting: mortality after acute myocardial infarction in five European countries. Dear Dr. Bernal-Delgado: I am 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 notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Timir Paul Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0228425.r004

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