PONE-D-21-07533

Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences

PLOS ONE

Dear Dr. Polykarpos,

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.

As an editor, I feel this topic is interesting, releavnt and timely to osteoarthritis care.  Reviwers 1 and 2 raised important similar points which I agreed should all be responded to and where appropriate make chamnges to the manuscript.

Please submit your revised manuscript by 02/09/2021. 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.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled '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: http://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,

Ukachukwu Okoroafor Abaraogu

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 

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. 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.

3. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. 

When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section.

[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: I Don't Know

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

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: Thanks for the opportunity to review the manuscript. This is a feasibility study for a follow-up randomised-controlled trial. The aim was to evaluate the acceptability of a nurse-led non-pharmacological package of care for knee osteoarthritis. The topic is interesting with a good introduction. However, certain aspects of the manuscript need to be clarified. As an improvement, I have made suggestions bellow.

The Abstract and Introduction is satisfactory.

METHODS - The author is likely to benefit from writing in shorter sentences for clarity. The readers may lose the message in the paragraph as it sometimes loses its meaning.

#1. Consider using this format for the method section. First and foremost, describe the method used. Study design... Was ethical approval sort? Consent from participants? Patient and Public Involvement? Please, describe the expertise, background and training of the intervention providers (e.g. number of therapists, professions, expertise). Then use the standard recruitment/participants, settings, intervention, and data collection and analysis.

#2. Lines 92-97. Please consider rewriting.

“Respondents to this survey were individuals aged 40 and over with knee pain for more than 3 months and pain in or around the knee on most days of the previous month. Participants with at least moderate pain in two of the five domains of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale were invited to participate in the study [22]. Study participants were also limited to individuals who can read and write in English.”

#3. Lines 103-106. Please consider rewriting.

“The research nurse had no prior practice experience in rheumatology or allied specialties such as orthopaedics, rehabilitation, or sports medicine. This further necessitated training in delivering treatments for arthritis and musculoskeletal diseases.”

#4. Lines 106-111. Consider rewriting.

The nurse delivered the non-pharmacological package of care over a five-week period and in four one-to-one sessions which comprises (i) holistic assessment; (ii) patient education and advice; (iii) aerobic and strengthening exercise and (iv) weight-loss advice where required. Advice on the use of adjunctive treatments such as the application of heat or cold foot-wear modification and the use of walking aids were discussed in the... session (please name the session).

#5. Lines 116-120 should be discussed as described in #1

#6. Line 116. Sample size. Although it was clear that this is a pilot study, how did the authors come about the sample size used for the study.

There are several literature on suitability of sample size for various research. Please see Charan and Biswas (2013) article on “How to calculate sample size for different study designs in medical research?”

#7. Line 121. Please rename section “Interview study” to “Data collection”

#8. Line 126. “(PhD student and physiotherapist)” is not necessary. Please delete. This should have been discussed as described in #1

#9. Line 126. “The research nurse was approached by PAN to participate in an interview”. This is not clear. Please consider removing.

#10. Line 127. “A theoretical framework for assessing treatment acceptability has been published [24]”. Consider rewriting as “The theoretical framework for assessing treatment acceptability was adapted from those published in previous literature [24].”

Lines 133-135 is not required. See #1

Lines 144-145. “The research nurse interview was conducted by PAN and AF, one week after the final treatment session for the last patient”. Again, see #1.

Lines 148-151. This should be discussed as described in #1. I believe that informed consent has been discussed already in line 101. The authors need to be concise.

Lines 151-153. Again this already appeared in line 98 “setting”. This should have been discussed entirely elucidated in settings. Please see #1.

Lines 153-158. See #1 (Please, describe the expertise, background and training of the intervention providers (e.g. number of therapists, professions, expertise).

RESULTS

Line 304: “Perception of the Arthritis UK booklet”. Please make corrections to table 1 “Perception around the Versus Arthritis UK booklet”.

DISCUSSION

Line 456: “Firstly, the intervention was delivered by a single trained research nurse, and the study was carried out in a research setting”. So what impact does it have on the study?

Line 458: “the participants were recruited from a primary-care based cohort. These factors increase the transferability of the findings to clinical settings” The author already discussed the strength of the study. Is this meant to be a strength or limitation?

Line 460: Please remove “the main interviewer (PAN)”. You can start the sentence with “The fidelity of intervention delivery during the study was assessed using video-recordings of individual treatment sessions.”

ACKNOWLEDGMENTS

This section presently does not really clearly describe any funding or input from any expert that was not included as an author. Suggest you replace with “The authors declare no source of funding” or use text recommended by the journal.

Reviewer #2: Congratulations to all co-authors on this really interesting feasibility study, it was a pleasure to read. This piece of work greatly contributes to an area of research which is poorly understood – particularly as so much prominence is put on pharmacological based interventions.

The framework analysis is not my area of expertise, but I have identified some minor points for clarification:

1. Pg 7, L111 “Advice on the use of adjunctive treatments such as the application of heat or cold, foot-wear modification and the use of walking aids were discussed.”

Could more detail be added to describe the types of footwear modification/ type of walking aids?

2. In the results/discussion, more detail is required on how the intervention changed patients’ perception of managing knee pain – it is unclear how this is nurse-led package of care is acceptable in the clinical settling.

3. The feasibility study could have been enhanced by delivery of more than one-nurse led non-pharmacological intervention, mentioned in limitations but also important that this is taken into consideration when interpreting results. For example, the nurse found discussion of goal setting to be challenging – another practitioner may have found this easier. Please expand on the limitation of evaluating only one nurse-practitioner, as level of experience of delivering behaviour change techniques and familiarity with knee OA and exercise provision will ultimately affect intervention delivery.

4. Pg4, L64 First use of ‘GP’ abbreviation in paper

5. Pg6, L103 Request more details on how the nurse was trained to deliver the intervention? Did they have previous experience of using behaviour change techniques?

6. Pg 23, L445 Have they considered other means of delivering the exercises i.e. using web-based/mobile health which have been used in other areas e.g. inflammatory arthritis?

7. Please clarify: 18 participants were recruited for study, only 17 participated in the interview? This sentence in results section may need restructured to reflect this, and if possible an explanation of exclusion of one participant?

8. There was no detail on the comparison of participants who attended all the sessions Vs those who did not. Could any difference be discussed?

**********

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.

Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences

PONE-D-21-07533R1

Dear Dr.  Nomikos,

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,

Ukachukwu Okoroafor Abaraogu, BMR(PT), MSc, PhD

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 #1: All comments have been addressed

Reviewer #2: 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 #1: Yes

Reviewer #2: Yes

**********

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

Reviewer #1: N/A

Reviewer #2: Yes

**********

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 #1: Yes

Reviewer #2: 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

Reviewer #2: 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 #1: Thank you for the opportunity to review your manuscript. All peer-review suggestions have been addressed. The manuscript could still benefit from the journal's language editing prior to its publication.

Reviewer #2: (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 #1: No

Reviewer #2: Yes: Dr Joanne E Hurst