Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification

Sara Begg; Alex Wright; Graham Small; Matt Kirby; Sarah Moore; Ben Koudou; William Kisinza; Diabate Abdoulaye; Jason Moore; Robert Malima; Patrick Kija; Frank Mosha; Constant Edi; Imelda Bates

doi:10.1371/journal.pone.0259849

Peer Review History

Original SubmissionMarch 24, 2021
6 Jul 2021 Decision Letter - Ramzi Mansour, Editor PONE-D-21-09716 Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification PLOS ONE Dear Dr. Begg, 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 30 July 2021. 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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Please include a copy of the interview guides used as a Supporting Information file. 4. This is a qualitative study , as such, we do not feel that any conclusions on the effectiveness of the test facilities using their own internal resources to address high-control factors may be supported; thus, we ask that you revise the text (especially, but no limited to, the aims and Conclusions) to avoid unsupported statements. 5. During our internal checks, the in-house editorial staff noted that you conducted research or obtained samples in another country, specifically Burkina Faso. Please check the relevant national regulations and laws applying to foreign researchers and state whether you obtained the required permits and approvals. Please address this in your ethics statement in both the manuscript and submission information. 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We will update your Data Availability statement on your behalf to reflect the information you provide. [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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? 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Reviewer #1: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Excellent contribution, I am pleased to see this type of study in a serious journal. Withholding transcripts of interviews seems appropriate to me. I would like to see more on the method for analysing the findings revealed through interviews, probably in section 2.3. Were the researchers looking for low, medium and high control from the start, or was that the criteria that emerged from the study? Any other references that you can add on that methodology of a largely qualitative approach? Also, please add a sentence about why you did not consider it worth running any statistical on the results, in 2.5. Please reword sentence line 546-547. Line 580 repeats so possibly say, Expanding on the observation noted above (or correct repetition). Typo line 574. Table 1, is IRSS private? explain if it is a private lab within a government entity. ABSTRACT - talks about data for regulatory entities but this is never expanded on and who are 'these' is not clear. Is this a key point? If so, clarify better in the intro. At least describe the type of regulators (e.g. which Ministry). Or cite refs to say it is important. Otherwise, it seems a bit undeveloped. ****** 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: Yes:** M. Megan Quinlan [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.0259849.r001
Revision 1
18 Oct 2021 Author Response Editor comments 1. Please ensure that your manuscript meets PLOS ONE's style requirements This has been updated. 2. Please include your tables as part of your main manuscript and remove the individual files These have been added. 3. Please include a copy of the interview guides used as a Supporting Information file. These have been added. 4. This is a qualitative study, as such, we do not feel that any conclusions on the effectiveness of the test facilities using their own internal resources to address high-control factors may be supported References to effectiveness have been removed, and simplified to clarify that test facilities can mobilise their own internal resources to address high control factors (without claiming that this work was effective): “For partnership and consortia models of research capacity strengthening, test facilities can use their own internal resources to address identified high-control factors.” 5. During our internal checks, the in-house editorial staff noted that you conducted research or obtained samples in another country, specifically Burkina Faso. Please check the relevant national regulations and laws applying to foreign researchers and state whether you obtained the required permits and approvals. We have clarified that: “In line with LSTM’s guidance on Network and Capacity Strengthening Studies, senior management at the IHI (Tanzania) and IRSS (Burkina Faso) test facilities provided an institutional approval document to confirm willingness to participate and that the research did not require in-country approval.” Please find text from this LSTM guidance here: In-Country REC Exemption Criteria 1. Research on aspects of a Network of academics or professionals, where all participants are members of the Network 2. Capacity strengthening research, including facility assessments and interviews focussed on work-based matters (not personal) Relevant collaborators from partner institutions are included as co-authors. 6. 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. While there are a relatively high number of interviewees, due to the variety in roles represented in these interviews we believe that transcripts of these interviews are still allow easy identification of individuals even when redacted, particularly in middle and senior management roles. We therefore feel it is not ethical to have these transcripts available as open access, for reasons including potential ramifications for employment or future funding when individuals speak critically about an individual, a process or a partnership. In addition, interviews were conducted on the premise of anonymity, and this was the basis on which the study received approval from the LSTM REC. Requests for access to this data may be made to ccr@lstmed.ac.uk or to rec@lstmed.ac.uk Reviewer comments 1. I would like to see more on the method for analysing the findings revealed through interviews, probably in section 2.3. Were the researchers looking for low, medium and high control from the start, or was that the criteria that emerged from the study? Any other references that you can add on that methodology of a largely qualitative approach? We have clarified that the low, medium and high control criteria in the thematic framework were emergent findings, and that these were incorporated into the thematic framework to provide structure: “At this point, emergent themes related to the degree of control test facilities had over the factors affective progress were identified, and this was used to structure the thematic framework.” Further detail across this section of the methods has been included, with particular reference to relevant references: This study employed semi-structured interviews with staff at each of the five test facilities to construct a narrative of progress towards GLP compliance. A qualitative approach was used in order to capture the experiences and interpretation of those experiences by individuals in a wide range of roles (18). This ensured that there was scope to describe both expected and unexpected events or factors, and offer explanations for these events or factors in order to identify lessons for future capacity strengthening initiatives. In-person interviews were conducted at three test facilities, whilst remote interviews were conducted at two test facilities due to travel restrictions resulting from the COVID-19 pandemic. And: A framework analysis (20) was used to identify themes emerging from the interview transcripts following the five-step process of familiarization, identification of thematic framework, indexing, charting, and mapping/interpretation . The framework approach to analysis was employed to facilitate identification and understanding of the interactions and processes that influenced the rate of progress towards sustainable GLP certification and to facilitate comparison between test facilities, offering a systematic approach to manage qualitative data (20) that allows for both deductive and inductive approaches to analysis. An initial coding framework was based on findings from the case study exploring progress at the KCMUCo-PAMVERC Test Facility (17), with codes based on challenges and enablers to progress identified at this site. Transcripts of interviews conducted in this study were read in detail. Following this familiarization with the interview data, these codes were revised, and further codes were identified and incorporated into the framework. At this point, emergent themes related to the degree of control test facilities had over the factors affective progress were identified, and this was used to structure the thematic framework. This initially deductive approach, using findings from the KCMUCo-PAMVERC Test Facility to inform the initial framework, followed by an inductive approach to develop this framework, supported focus on the specific area of factors affecting GLP certification progress while allowing for unexpected aspects of the GLP certification process described by participants to be included in the analysis (18, 21), sharing some characteristics with Grounded Theory (22). All interview transcripts were indexed with these revised codes, using NVivo software (QSR International). To identify sections of the data that corresponded to the relevant theme, a narrative was constructed to define the key issues, find associations between those issues and, where possible, provide explanations. In sum, this facilitated the development of a model to describe this qualitative data, which can be tested in future research (23). 2. Also, please add a sentence about why you did not consider it worth running any statistical on the results, in 2.5. Added: “Statistical and quantitative methods were not used in this study as test facilities were at substantially different stages in the process of working towards GLP certification, limiting the usefulness of comparison of potentially relevant process-based quantitative data such as checklists and rendering comparison of outcome indicators such as efficiency or data quality not possible.” 3. Line 580 repeats so possibly say, Expanding on the observation noted above (or correct repetition). This is an illustrative quote for the text above (in italics), and this explains why it appears to be repetitive. 4. Please reword sentence line 546-547. This has been revised for clarity to: “As well as calibration and maintenance of equipment, test facilities required support from government bodies that oversaw waste management and animal welfare. As with calibration and maintenance of equipment, these were services and support systems that test facilities needed but had very little control over” 5. Typo line 574. Amended: “Despite a good understanding of the business case for GLP and the need to attract studies from industry, test facilities generally felt they did not have the marketing skills necessary to sell their services on the open market, and identified this as a major risk to sustaining GLP certification:” 6. Table 1, is IRSS private? explain if it is a private lab within a government entity. Amended, this was an admin error: “Government” 7. ABSTRACT - talks about data for regulatory entities but this is never expanded on and who are 'these' is not clear. Is this a key point? If so, clarify better in the intro. At least describe the type of regulators (e.g. which Ministry). Or cite refs to say it is important. Otherwise, it seems a bit undeveloped. Clarified that this is in reference to bodies that determine which products are appropriate for procurement for vector control globally “Data from these test facilities must be of a high quality to be accepted by regulatory authorities, including the WHO Prequalification Team for vector control products.” Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0259849.r002
28 Oct 2021 Decision Letter - Ramzi Mansour, Editor Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification PONE-D-21-09716R1 Dear Dr. Begg, 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, Ramzi Mansour Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0259849.r003
Formally Accepted
4 Nov 2021 Acceptance Letter - Ramzi Mansour, Editor PONE-D-21-09716R1 Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification Dear Dr. Begg: 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. Ramzi Mansour Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0259849.r004

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