Defining healthcare never events to effect system change: A protocol for systematic review

Joanna Zaslow; Jacqueline Fortier; Cara Bowman; Ria de Gorter; Ellen Tsai; Dennis Desai; Peter O’Neill; Richard Mimeault; Gary Garber

doi:10.1371/journal.pone.0279113

Peer Review History

Original SubmissionDecember 3, 2021
15 Aug 2022 Decision Letter - Alok Ranjan, Editor PONE-D-21-38367Defining healthcare never events to effect system change: A protocol for systematic reviewPLOS ONE Dear Dr. Zaslow, 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 the revised manuscript in the light of reviewer's comment. Please submit your revised manuscript by Sep 29 2022 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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If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Partly ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: No ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Thank you for the opportunity to review this paper. The authors describe a protocol for a systematic review on finding the most common list of never events, through looking at the academic and grey literature. The introduction justifies the need for this study, which nicely compliments Hegarty et al.’s systematic review of definitions of serious reportable events. Below are a few points for consideration to improve the strength of your protocol: • In the abstract you mention “to identify ‘core’ never events” – the addition of the term “core” gives the reader the sense that you are looking to focus in on a subset of the larger list of never events, so perhaps a clarification on this would be good. • On line 102, you mention “We will achieve this by performing a narrative synthesis of both peer-reviewed and grey literature for never events frameworks in order to identify those events which are consistently..”. It would be helpful to describe what never events “frameworks” refer to in this case – are these lists? • Is there a justification for excluding articles published before 2001? • The design section of the SPIDER framework includes national guidelines, national policy or national reporting systems. Would peer reviewed articles outside this criteria not be included in the study (i.e. single studies looking at a single never event)? If this is the case, it would be important to highlight within your objectives that your systematic is primarily focused on lists from these sources as it changes the scope of the review. • Since this is a protocol, it would be helpful to have a preliminary data extraction sheet in order to further help the reader understand what kind of data you are hoping to gather. • Within your discussion, you mention that “Identifying a core of never events can be a step towards making a singular list”. Perhaps a line or two on what would be the next steps (e.g. Delphi process?) ****** 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.0279113.r001
Revision 1
23 Sep 2022 Author Response Response to Reviewers: 1.In the abstract you mention “to identify ‘core’ never events” – the addition of the term “core” gives the reader the sense that you are looking to focus in on a subset of the larger list of never events, so perhaps a clarification on this would be good. We thank the reviewer for the comment and have added further detail into the abstract to clarify that our objective is to identify events that are consistently labelled as never events (lines 35-37). 2.On line 102, you mention “We will achieve this by performing a narrative synthesis of both peer-reviewed and grey literature for never events frameworks in order to identify those events which are consistently...” It would be helpful to describe what never events “frameworks” refer to in this case – are these lists? We have further clarified what our search strategy entailed (see lines 104-108). We have kept the word “framework” but have offered further explanation of what this entails – this means a list of never events along with a unique definition for never events and a unique purpose for tracking them. 3.Is there a justification for excluding articles published before 2001? We limited our search to articles published after 2001, as that is the year when the term was first introduced (see Table 1 and line 128). 4.The design section of the SPIDER framework includes national guidelines, national policy or national reporting systems? We have added further explanation in Table 1, where we have identified any study design (including peer-reviewed papers, regional/organizational guidelines, policies, or reporting papers) as meeting our inclusion criteria. 5. Would peer reviewed articles outside this criteria not be included in the study (i.e. single studies looking at a single never event)? If this is the case, it would be important to highlight within your objectives that your systematic is primarily focused on lists from these sources as it changes the scope of the review. We have added further explanation that we will be including single studies looking at a single never event (see line 102). 6. Since this is a protocol, it would be helpful to have a preliminary data extraction sheet in order to further help the reader understand what kind of data you are hoping to gather. We appreciate this suggestion and have attached a preliminary data extraction sheet to provide additional context to readers. 7. Within your discussion, you mention that “Identifying a core of never events can be a step towards making a singular list”. Perhaps a line or two on what would be the next steps (e.g. Delphi process?) We have added further detail about our next steps, including possible consultations with patient safety groups and health care organizations (see lines 191-193). We wish to thank the reviewer for their thoughtful comments and feedback. https://doi.org/10.1371/journal.pone.0279113.r002
1 Dec 2022 Decision Letter - Alok Ranjan, Editor Defining healthcare never events to effect system change: A protocol for systematic review PONE-D-21-38367R1 Dear Dr. Zaslow, 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, Alok Ranjan Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Thank you for addressing all the comments - the updated edits & data abstraction sheet make this protocol methodology sufficiently detailed. Good luck! ****** 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.0279113.r003
Formally Accepted
6 Dec 2022 Acceptance Letter - Alok Ranjan, Editor PONE-D-21-38367R1 Defining healthcare never events to effect system change: A protocol for systematic review Dear Dr. Zaslow: 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. Alok Ranjan Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0279113.r004

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