https://orcid.org/0000-0003-3455-598X
Peer Review History
| Original SubmissionJune 5, 2023 |
|---|
|
PONE-D-23-17224Regulation of Medical Devices in Zimbabwe: A qualitative study with key stakeholdersPLOS ONE Dear Dr. Chiku, 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.br /> Please submit your revised manuscript by Oct 02 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:
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, Adetayo Olorunlana, Ph.D. Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. 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 2. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. "Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. [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: N/A Reviewer #2: N/A ********** 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: No 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: This is a very thorough, well-executed and thoughtful study. General •This is simply too long. Without tables it’s 10593 words for a qualitative survey of 14 people. No one is going to read that. The authors are strongly advised to cut the text length in half. •The authors could reduce some length and ease the reader through making use of an additional graphic and table. See below. Abstract: •Methods: oSurveys (how many?) and semi-structured interviews (12) in Zimbabwe regulators oAlso interviewed (how many?) South African Health Products Regulatory Authority, Tanzania, and WHO to learn about “best practices in transitioning to medical device regulations” oHow was survey developed, tested, how were respondents identified and survey distributed? How many sent? How many received? How were interviewees identified? •Conclusion: oAccessibility not the same concept as safety Introduction •Lines 40-46, are confusing and confused. These lines should be omitted, and making clear that the focus is on device manufacturer safeguards. •Lines 72-74. I like how the authors describe overall regulatory deficiencies and that Zimbabwe is inclusive. I like how they review other literature exploring this. It would be quite helpful to precede this with an explanation of what the different Zimbabwean regulatory offices/bodies are, before delving into their deficiencies. •Lines 75-76, the authors jump into describing stakeholder findings, before describing their research methods. This is out of place. •Lines 80-83, the authors go from substandard and falsified medical devices, to manufacturer burden which are two separate concepts. The former is of primary responsibility, and the latter is of secondary interest. Further, I think a country with fewer regulations/oversight should not be equated with greater regulator burden for manufacturers. •Line 87: I don’t think the authors are focused only on IVDs, are they? Methods •Line 103, Rugera requires a formal citation. •How were respondents identified? How contacted? By whom? •Line 113, “one staff member completed questionnaires…” goes in the results section •Line 124: I don’t know what this means, as it is all about regulations. •Line 142: how many representatives were selected? •134-144, very confusing. Would help readers to draw a flow map or a table with all the different regulatory agencies (without and outside of Zimbabwe), and what their regulatory purview is, such as pre-market, post-market etc. (which may have to go in the results section but can be referenced here.). There are so many acronyms in the paper, it’s very tedious to read without a visual aid. •184-185, who is the research team? How many designed, how many conducted, how many coded, how analyzed results? Results •Line 226, what’s the difference between a “participant “and a “critical stakeholder’ Discussion •lines 604-606. This is the first mention of classification schema. Would help to introduce this earlier than the discussion section. •Lines 694-707 should go into a table, along with other terms, to ease the readers. •Lines 760-180 should go into a table. •Line 814 “the main out of this study is a roadmap”. Where is it? Put it ino a visual, please. The text is too tedious. Reviewer #2: General Comments This relevant and timely study sheds light on the medical device regulatory landscape in a low-income country. The regulation of medical devices is critical to improving access to safe and reliable health products. The insights from key informants from the Medicines Control Authority, the Medical Laboratory and Clinical Scientists Council and the National Microbiology Reference Laboratory reveal both a lack of regulation as well as fragmented oversight involving these three agencies in Zimbabwe. This paper could potentially serve as a catalyst to improve engagement and communication between the three national institutions to create more robust and streamlined regulation of medical devices. The “best practice” perspectives from South Africa, Tanzania and the WHO highlight key enabling factors or facilitators towards developing a legislative framework for medical devices and for the successful implementation of medical device regulation. The study design, sampling, data collection and data analysis methods are all suitable to address the research questions, although in some cases more detail is required to ensure transparency and reproducibility. Additionally, mechanisms for ensuring accuracy should be adequately explained. The manuscript is generally well written, however, a number of language and typographical errors were found throughout the manuscript (e.g. line 157-159, line 165-166, line 240, line 496-498, line 816). The in-text citations should also be checked against the final list of references. Introduction It would be useful to provide an overview of the maturity levels of medicines regulatory authorities in African countries, including Zimbabwe to get a general sense of the regulatory capacity. Line 62: What is meant by “no data”? Please clarify. Line 82: Provide necessary references to support statements - unless the entire paragraph is entirely derived from reference 6? Methods It appears that no aspect of the methodology was piloted; is there a particular reason for this? Line 99: Is there a particular reason why a legal expert from the medicines regulatory authority was not identified as a key informant? I imagine that the expert, technical knowledge of such a person would have been salient? Line 103: Was the data collection tool validated for this setting? If not, an explanation of why this may not have been necessary should be included. Line 113: It is not clear if one staff member from each of the three institutions was approached or whether all were approached and only three responded? If the former is correct, what was the rationale for including only one staff member from each agency and what was the basis for selecting these individuals? Were there any efforts to triangulate findings if only one participant was included from each institution? Were the questionnaires self-administered or researcher-administered? Also, were the surveys completed electronically, telephonically or in-person? Line 100: Technically, the sampling approach combined a purposive and snowball method, correct? This should be clearly reflected. Line 130: Is there a particular reason why the “GBT+Medical Devices” was not employed as the standard from which to develop the data collection tool? Please check the two references for the GBT as they appear to be incorrect. Line 134-135: These acronyms were introduced previously and there is no need to write them out in full again. Line 162: Is there a reference to support the medical device advancements in SA and Tanzania? Table 1: Refer to comment for line 113. Additionally, were there only 12 participants who were approached for interviews or did some decline to be interviewed? There should be some indication of the response rate for the survey and for the interviews in paragraph where reference is made to Table 1. Line 185: Were the same researchers involved in interviews and transcribing? If not, what mechanisms were introduced to ensure accuracy of the transcripts? Line 191: Which coding frame was used for deductive coding? Elaborate on the manner in which inductive and deductive coding was used in tandem. This will enhance the reproducibility of the coding process. Line 193: The coding was not done in duplicate, correct? What then was the process for achieving consensus? Line 203: It makes sense to keep the interviewee’s identity anonymous but why/how was the “interview content” kept anonymous? Results The configuration of the results should be reconsidered since there appears to be repetition of the same quotes – sometimes up to three times in results (table and text) and discussion (text). Consider summarising findings in the table and only presenting quotes in the results. P12: The theme of limited regulatory capacity fails to mention essential capacity issues that would generally plague a low-income country such as lack of technical expertise, infrastructure and funding. These challenges feature under a different theme , namely, the “improvements to the system” theme on P15, but should also feature under capacity constraints. Again, if the findings in the table are summarised, as opposed to presenting selected quotes, this could provide a more complete picture and prevent repetition. P23-24: Formatting corrections are required in the table to align quotes with correct the correct interviewee. Discussion Line 597: Clarify the type of dossiers referred to in this sentence. Is it for condoms and gloves? Line 694-708: It is important to reconcile this theory to the study findings in a short preface to this paragraph. Line 716-717: Italicise for consistency Line 740: Was this “study” also initiated by the Tanzanian NRA? If so, perhaps make this explicit. Figure 1: Provide a citation for this figure Figure 2: Is the roadmap novel in any way or is it adopted entirely from literature? If the latter, there should be a reference provided for the figure. Overall, the paper's insights into the regulatory challenges and stakeholder perceptions in a resource-limited setting have the potential to resonate with a wide range of individuals and organizations involved in healthcare, policy, research, and advocacy on a global scale. Addressing these weaknesses alluded to above could enhance the overall quality, rigor, and clarity of the report, making it more robust and impactful in contributing to the understanding of medical device regulation in resource-limited settings like Zimbabwe. Thank you for the opportunity to review this paper. ********** 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 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.
|
| Revision 1 |
|
PONE-D-23-17224R1Regulation of medical devices in zimbabwe: a qualitative study with key stakeholdersPLOS ONE Dear Dr. Chiku, 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 03 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. Please include the following items when submitting your revised 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, Adetayo Olorunlana, Ph.D. Academic Editor PLOS ONE [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 #3: (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 #3: Partly ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: 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 #3: 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 #3: No ********** 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 #3: This is an important paper but does require some major revisions. overall the paper should be carefully read by all co-authors and someone not listed as an author for copy editing and improved writing style. Introduction: - line 114- what is 'this advice' given to Zimbabwe? Methods: - line 130- yes/no questionnaire needs more explanation. is it to understand opinions or is about existing structures/systems? - line 134- interviews seem to be 2 types- those with KIIs in Zimbabwe and those outside Zimbabwe. Were different interview guides used for each type of KII? What was the purpose of each and what were the broad themes/topics covered for each? Results seem to indicate that interviews in Zimbabwe were to understand the current context, experiences, challenges, opportunities etc while those internationally were to understand best practices, frameworks, recommendations. The methods need to be clear to understand and align with the results. - line 166- suggested rewording- "Purposive and snowball sampling was used to select participants, ... " - line 205- one does not transcribe TO identify themes and concepts. These are 2 seperate steps that are not linked. - line 206- reference for Rugera et al - line 207-210- reword this to reflect the process of analysis and synthesis of qualitative data - line 213- "Participants were assigned anonymous codes ... " suggest using IDs instead of codes to not confuse with coding of data. And this sentence should be moved to the 'ethical considerations' section. - line 219- HOW were identities protected? - Ethical considerations section- reorder, reword for improved readability - line 211- 3 themes mentioned are not aligning with how themes/results presented in results section. There seems to be 3 different analyses done- describe each separately (1) yes/no questionnaire, (2) KIIs within Zimbabwe, (3) KIIs outside Zimbabwe. Was Rugger's frame used for both types of interviews Results: - line 224- results and discussion are 2 very seperate broad sections. - include a few lines before presenting results to describe how the results are being presented, (1) yes/no questionnaire, (2) KIIs within Zimbabwe, (3) KIIs outside Zimbabwe. - Present the Y/N questionnaire results in a table - Table 2- Themes listed here to not align with themes described in line 211- acts, regulations and guidelines. The way the theme is named is presenting the result (ie. deleted limited and just have legal framework and regulatory capacity; delete 'the needs to improve the' and just leave it as medical devices regulatory system.Correct this in the subheadings of themes as well as in the table. Delete 'Stakeholders agree that' - lines 259-264- restructure for improved readability - line 268- reword "At the time of the interviews, ... " - line 278-279- the quote is not adding anything more than what is said at line 275 - section on 'medical devices regulatory system' needs descriptive text to summary the findings on this theme and not just rely on quotes. First quote on line 305 needs the pt ID included. - Table 4- are these themes or seemingly more of recommendations which are useful but suggest they be listed in a table of recommendations or summary of findings - headings at lines 336 and 344- combine into one subheading of 'international standards/tools' - line 358- correct rep to be representative Discussion: - there are alot of results presented in the discussion. This needs to be reviewed to restructure so that it is discussing rather than presenting results and in particular quotes (data) should not be in a discussion. Many are good quotes and better presented in the results. To improve the structure of the discussion, consider subheadings. - references are missing at lines 486/487, 491 - lines 403-412- this section repeats itself (methodological difference) and would benefit from some editing to improve readability - lines 439- 441- - Table 5 has important elements to consider but rather than laying out the table from Systems Thinking in Tobacco control, apply this to how it is or can be used in a system for regulation of medical devices in Zimbabwe. This has been done in Figure 2. Focus on describing figure 2 and table 5 is not necessary. - lines 575-580- line 578 is repeating line 576. could this roadmap be introduced earlier in discussion to describe the challenges and opportunities based on this roadmap - line 593- is data saturation necessary in a study of KIs/stakeholders describing the current context of a legal framework? Conclusion: -edit to improve readability. Currently reads like a bullet point list ********** 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 #3: 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. |
| Revision 2 |
|
PONE-D-23-17224R2Regulation of medical devices in Zimbabwe: a qualitative study with key stakeholdersPLOS ONE Dear Dr. Chiku, 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 Feb 01 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. Please include the following items when submitting your revised 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, Adetayo Olorunlana, Ph.D. Academic Editor PLOS ONE [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 #3: (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 #3: Partly ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: N/A ********** 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 #3: 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 #3: No ********** 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 #3: (line numbers refer to version with track changes) Abstract - Intro is 2 sentences. Need an additional 1-2 sentence to give background. - It needs to be clear that different methods employed- a questionnaire and KIIs. - Analysis of questionnaires in main paper is descriptive analysis but not reflected in abstract. - Abstract is too long and needs revision- consider condensing the conclusion as a start. Intro - Line 139- who recommended member states in the SADC region...? - Line 169- how was it sent back to researcher? “... and emailed back to the researcher”? - Line 170- “study’s standardize scope prevented triangulation”- belongs in limitations section Methods - Line 208-211. Inset that these are based in Zimbabwe to make it clear. - Line 216- separate paragraph when talking about interviews done outside Zimbabwe - Line 240- move to study procedures in first section of methods. How were data recorded? Audio recordings, notes... ? - Lines 252-244 are not part of analysis. This is describing study procedures and should be moved to that section of the methods. - Line 258-9- transcription and identifying themes and concepts are not interrelated. Move transcription to how data collected and processed. Then lines 257-260 should be restructured for improved readability and avoid repetition. - Line 267-271 talks about development of themes but its stated that themes come from Rugera’s themes. This needs to be clarified. Findings - Survey results- A table of what exists and does not exist in the regulatory bodies would be beneficial. - Table 2- no need to include the study duration in the title - Line 436- italicize the quote - Line 459 saying the same thing as previous sentence. - Line 460-462 should be moved to analysis section of methods. - Table 4- no need to include dates in the title - Line 481- ‘tolls’- should this be ‘tools’? - Line 510- is this the first time these 3 acronyms used?- need to write them out in full. - Line 573, “despite...” this sentence is incomplete. Rephrase. - Line 589- what is meant by ‘work’? be more specific. - Line 638-9- rewrite for improved readability - Line 657- “this finding is similar...” this can be merged into previous sentence to for improved readability. - Lines 659 and 664 can be rewritten to merge and improve readability. - Line 712- its not clear what this caption credit is for. Is it a reference for the requirements for effective regulation? If so cite it as any other reference. - Line 734- “Table 6...” reword to be more clear. “...indicates gaps in MASCA identified from the South Africa and Tanzania experiences.” - Line 742-755 is giving a lot of results rather then discussing. - Line 773- “This framework covers...”- remove this. It’s a repeat of line 770 Conclusion - This is very long. Lines 797-836- are these another summary of what is in the discussion? Suggest to remove this while assuring that its already covered in the results/discussion. Double check that ALL acronyms are described in full the first time they are used This is valuable research and worthy of publication. But I strongly recommend the manuscript be read and edited by someone else to check its well organized and written clearly. ********** 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 #3: 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. |
| Revision 3 |
|
PONE-D-23-17224R3Navigating Regulatory Landscape: A Qualitative Exploration of Medical Devices and In Vitro Diagnostic Medical Devices Oversight in Zimbabwe through Key Stakeholder PerspectivesPLOS ONE Dear Dr. Chiku, 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 Apr 11 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. Please include the following items when submitting your revised manuscript:
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, Adetayo Olorunlana, Ph.D. 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. [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 #3: (No Response) Reviewer #4: (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 #3: Yes Reviewer #4: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: Yes Reviewer #4: 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 #3: Yes Reviewer #4: 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 #3: (No Response) Reviewer #4: 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 #3: Abstract- this is still very long and needs to be shortened line 40- remove 'global average' line 42- "opacity that is opaque"- this is not clear. consider rewording line 43- "it is unclear if medical devices..." this is a repeat of previous sentence. suggest this sentence be removed line 46- incomplete sentence. add, "Additionally we aimed, to learn..." line 49- 3 pts from 3 organisations is 9 people. Line 53 says 12 pts. Please double check these numbers line 58- "thematic approach" sentence needs to be restructured. "Using a common coding framework, we used thematic analysis for interviews conduced in Zimbabwe and with international regulators." Methods: Table 1 goes in results line 255- NVivo does not analyse. It is used top code and organise data. Move mention of its use in line 258, "Coding of data... and selective coding, using NVivo 12." line 276- you discuss anonymity yet the participants organisation and their job roles is listed. This is very identifying. In line 282 its say removing job titles from data. Yet job title is in tables 1 and 4. Please address this important ethical issue. Results: Table 2- shorten the questions to be key phrases/points Discussion: line 568- i believe this is first time RLS is used. write it out in full in the section 'exploring opportunities for improvement' there are still results presented in the form of quotes. This discussion needs to be more tidy by summarising and discussing results rather than presenting them. I recommend that authors have someone external to the project review this paper in detail. There is still some room for improvement in the writing style to be more concise and scientific. Reviewer #4: Thank you for the opportunity to review this interesting article which looks at medical device regulations in Zimbabwe and Tanzania. The article includes recommendations for further maturity of regulations and regulatory structures in these countries, and potentially these are applicable more widely in similar settings. Firstly, I would like to check with the authors that they have explicit consent for the details on job title used here and especially in table 4 this is quite an identifying characteristic (just short of naming participants in many cases). I have a number of other, minor comments, with the hope to improve readability and therefore bring forward the main learning of this manuscript. Introduction Line 82: “It also includes products…” what is “it” referring to? Line 104: please introduce the IMDRF acronym here and remove full name from line 109. Line 114: I have not seen the African region referred to as the “Afro” region – is this common? Perhaps use “African region” instead Line 119-120: Reference for this? Methods General – authors state that COREQ is used for reporting however several things are left out: what are the interviewers' experience and training? what is the relationship, if any, between the interviewer and the participants? Any prior knowledge? Line 143-145: The sentence that begins with “However, our study…” belongs in limitations section. Also I don’t fully understand this, please rephrase for clarity. Medical devices and IVD regulatory system Line 392 – 394 – regarding the sentence that begins “However, it is reactive…” I see that the further text below is an example of what you mean by this so perhaps you don't need this sentence? If you do decide to keep it, please rephrase to add clarity. International standards and tools Line 442 – On first reading I was wondering what the participant mean that the model was updated? Now I see there is a section currently in the discussion (Line 630 – 659 and table 5), which if it is indeed part of what you found in the study, is results and should be moved up here specifically as it helps to explain this paragraph and statement by the participant. The transition period to implement new regulations Line 489: what does “rely on the status” mean? Line 491-2: Please clarify whose statement is this - the authors of this manuscript or the participants. If this is the authors’ statement it belongs in the discussion. Discussion Line 630 – 659 and table 5 – I think this belongs in the results section. Line 638 – “Table 6” is below labelled table 5. ********** 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 #3: No Reviewer #4: Yes: Sebastian S Fuller ********** [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. |
| Revision 4 |
|
Navigating Regulatory Landscape: A Qualitative Exploration of Medical Devices and In Vitro Diagnostic Medical Devices Oversight in Zimbabwe through Key Stakeholder Perspectives PONE-D-23-17224R4 Dear Dr. Chiku, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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, Adetayo Olorunlana, Ph.D. 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 #4: 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 #4: (No Response) ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #4: (No Response) ********** 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 #4: (No Response) ********** 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 #4: (No Response) ********** 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 #4: (No Response) ********** 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 #4: No ********** |
| Formally Accepted |
|
PONE-D-23-17224R4 PLOS ONE Dear Dr. Chiku, 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 Associate Professor Adetayo Olorunlana Academic Editor PLOS ONE |
Open letter on the publication of peer review reports
PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.
We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.
Learn more at ASAPbio .