PONE-D-21-14685Facilitators and barriers for clinical implementation of a 30-minute point-of-care test for Neisseria gonorrhoeae and Chlamydia trachomatis into clinical care: a qualitative study within sexual health services in EnglandPLOS ONE

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“I have read the journal's policy and the authors of this manuscript have the following competing interests: ADREU has received funding from Abbott, binx health, Cepheid, SpeedDx, Mologic, Revolugen and Sekisui, for the research and evaluation of their diagnostics. STS has been an invited technical consultant for the WHO for POCTs for STIs. SSF has recieved funding from and been an invited technical consultant for the WHO for implementation of POCTs for STIs.”

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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: Partly

Reviewer #2: Yes

Reviewer #3: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: Yes

Reviewer #3: N/A

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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

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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: Review: Facilitators and barriers for clinical implementation 1 of a 30-minute point-of-care test for Neisseria gonorrhoeae and Chlamydia trachomatis into clinical care: a qualitative study within sexual health services in England.

In this study, sexual health clinics opted into using Point of Care Testing (POCT) for select STI’s in England with the objective of understanding the barriers and facilitators of uptake. Utilizing in depth interviews, health professionals provided their experience and perspective on POCT including considerations for clinic uptake and adoption. The study is novel in that it examines what would make POCT successful given the low uptake of such technologies by clinics globally. The manuscript is strong but requires some revision as outlined below:

1. There are several awkward and unclear, run-on sentences throughout that need to be edited such as:

Despite the potential advantages STI POCTs may bring, their launch into market will not necessarily lead to their adoption into clinical services; many POCTs have struggled to be purchased, implemented and integrated (“adopted”) into healthcare.

With the introduction of a CT/NG POCT, HCPs are likely to provide patients with their results during their consultation; our data show that proximity to the patient in the moment of delivering their diagnoses may increase HCP anxiety about the accuracy of POCT results; we recommend this be given special consideration during implementation plans.

2. In the Methods, Lines 123-125, the domains for the interview guide need to be clarified. Also, the use of ‘probe’ is incorrect as probing is a standard practice in interviews to ask participants to elaborate on what they said. This does not need to be reported. However, it seems that interview domains are: 1) implementation experience and 2) identifying facilitators and barriers to adoption.

3. In the Methods, how did you identify themes? Did you code? If so, please describe this coding process including the development of the codebook. The analytical methods need elaboration.

4. In the Results, Paragraphs starting on lines 235, 249 and 273 seem to be new themes. If not, then more detail is needed to show how these areas are linked to the existing theme. The POCT implementation theme may be too broad as a theme itself. The quote on line 244, needs to be better integrated into the theme for the paragraph above. Also, here, it is unclear if you are talking about clinic clients or healthcare workers. Respondents and participants are used interchangeably. Suggest replacing both with healthcare worker.

5. The conclusion summarizes the Discussion again. Suggest returning to the more global issue of POCT uptake.

Reviewer #2: The manuscript by Pacho et al. addresses several issues related to the process of adoption of point-of-care tests for chlamydia and gonorrhoea into sexual health services in England. It is an interesting and informative paper and discusses some of the real-world barriers to implementation of these technologies. Given the current and future availability of such tests, and the potential benefits that they may bring, this is a very important area of research.

Overall, the manuscript was well written, and I suggest only a handful of edits to provide more information on contextual factors and to improve clarity and consistency.

Abstract

1. Line 41-42: “We conducted 40 total interviews; 31 prior to POCT implementation; 9 post-implementation.”

This sentence could indicate that 40 different individuals were interviewed. Please make it more clear in the abstract that the 9 post-implementation interviews were with participants who had also provided pre-implementation interviews.

Background

2. Line 78-80: “Enquiries into facilitators and barriers to POCT adoption are particularly timely for sexual health: new rapid and POCTs for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are becoming more commonplace”

The authors reference the WHO diagnostic landscape for STIs report to justify this statement that new POCTs for chlamydia and gonorrhoea are “becoming more commonplace”. The term commonplace is a bit ambiguous here, and potentially implies that their adoption in clinical settings has become more frequent.

If the intent of this statement was to inform the reader that there are a number of POCTs for CT and NG currently available and more are likely in in the coming years, I suggest stating this more directly and potentially mentioning the pipeline of diagnostics specifically.

However, if the authors wished to state that the use of POCTs for CT/NG is in fact more commonplace in clinical practice, an alternative reference would be required to justify this.

Methods

3. Line 102-110:

I appreciated the description of the reasons why services that initially expressed interest did not proceed. However, three of the six services that took part in the pre-implementation interviews “ultimately declined participation in the experimental model”, but the reasons for this are not discussed. For completion, please consider providing information on the reasons behind these three services not taking part, if available.

4. Line 127-128: “Interviews were conducted by AP, and analysis conducted by AP and SSF; both have >10 years’ experience with qualitative research.”

Given that this is a purely qualitative study, there is an onus to provide information on factors that may have influenced the analysis itself. Please provide more information on the background of researchers AP and SSF. The SRQR checklist recommends providing information on “researchers’ characteristics that may influence the research, including personal attributes, qualifications/experience, relationship with participants, assumptions, and/or presuppositions; potential or actual interaction between researchers’ characteristics and the research questions, approach, methods, results, and/or transferability”.

5. Please provide a completed qualitative research checklist (SRQR or COREQ) as an appendix, and state and reference this in the methods.

6. I note that the names of the clinics have been withheld. If this is for confidentiality purposes, I suggest stating this explicitly in the methods.

Additionally, if the names are to be withheld, some background could still be provided on the clinics. For example, the cities/towns in which the six clinics are based could be stated without saying which location corresponds to which clinic. Alternatively, if they are all based in cities/large towns and if they are all based at large tertiary centres/smaller community clinics etc could be stated. This may help to provide additional context to the analysis.

7. Line 146-150

The methods state that “A full list of themes is shown in Figure 2 and Figure 3.”

The titles of figures 2 and 3 refer to both “NVivo nodes” and “inductive themes”.

If the terms “NVivo nodes” and “themes” are equivalent, I suggest the use of a single term for consistency.

Results

8. Line 153-154: “Invitation to participate was sent to professionals working in six sexual health services that showed interest in participating in the experimental model.”

The methods description of the interviewees is “professionals identified via the experimental model who self-identified as key in either the decision-making process for adoption of new technologies, and/or implementing new technologies, into their current service.”

These two descriptions in the methods and results sections are slightly incongruent. The methods section description suggests that all participants were key to adoption or implementation. However, the results section suggests that interest in the experimental model was the only pre-requisite.

I suggest re-writing one description or the other to ensure these descriptions are consistent and accurate.

Discussion

9. Line 301: “Our data indicate that a need for solutions to increase patient outcomes and overall wellbeing drove many HCPs’ desire for implementation of the binx POCT.”

I do not feel that this statement was adequately supported by the analysis presented in the results section and it seems to be the first mention of the drivers behind HCPs wanting to implement the binx POCT.

Please mention this in the results section if you wish for it to be a discussion point.

Limitations

10. The majority of respondents were healthcare professionals, and only one commissioner contributed to the pre-implementation data. I suggest commenting on how the breakdown of your respondents may have affected your results.

Additionally, did the authors feel that nine post-implementation interviewees was sufficient? Was data saturation reached?

Reviewer #3: Overall an important study related to implementation of new STI diagnostic technologies. Comments are minor

- I don't see reference 14 anywhere in the text of the manuscript, but I would suggest not using a corporate press release. Similarly, reference 16 is from the manufacturer's package insert and thre are several peer-reviewed articles available describing the io so it would be better to use one of those.

- How many io instruments were supplied to each clinic? If more than 1, is this part of the issue with space?

- Did anyone mention patients having to wait >30 minutes because the instrument was already in use when their sample was taken? Is this an issue of concern for clinicians?

- Did anyone mention results integration concerns (or describe this as an advantage of the system)?

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Facilitators and barriers for clinical implementation of a 30-minute point-of-care test for Neisseria gonorrhoeae and Chlamydia trachomatis into clinical care: a qualitative study within sexual health services in England

PONE-D-21-14685R1

Dear Dr. Sebastian,

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.

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Additional Editor Comments (optional):

Dear Author

Thank you very much for submitting your manuscript to our journal, I am forwarding your article with the comments of the reviewers.

Kind regards.

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 #2: All comments have been addressed

Reviewer #3: All comments have been addressed

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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 #2: Yes

Reviewer #3: (No Response)

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: N/A

Reviewer #3: (No Response)

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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 #2: Yes

Reviewer #3: (No Response)

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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 #2: Yes

Reviewer #3: (No Response)

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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 #2: (No Response)

Reviewer #3: (No Response)

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Reviewer #2: No

Reviewer #3: No