Peer Review History

Original SubmissionAugust 9, 2022
Decision Letter - Walid Kamal Abdelbasset, Editor

PONE-D-22-19723Feasibility of a patient-oriented navigation programme for patients with Lung Cancer or Stroke in Germany: protocol of the CoreNAVI studyPLOS ONE

Dear Dr. Gödde,

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.

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We look forward to receiving your revised manuscript.

Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

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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 #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Dear Editor

Plos One

Thank you very much for giving me the opportunity to review the manuscript entitled (Feasibility of a patient-oriented navigation programme for patients with Lung Cancer or Stroke in Germany: protocol of the CoreNAVI study)

The study idea is good. I have some comments to improve the manuscript.

The abstract and introduction sections are so long. The authors should review these sections and remove unnecessary words/sentences.

Reviewer #2: The authors have designed this protocol to show the Feasibility of a patient-oriented navigation program for patients with Lung Cancer or Stroke in Germany. It is a well-designed and well protocol

some points should be explained .

Line 300 301 302

Why did you select these percent (above 70 % and below 40 %)

Line 304 using an ordinal regression model

Explain the selection for that model

Line 307 308

Discuss the selection of ANCOVA for Your Study

Reviewer #3: The research design seems to be conducted in a proper way, The research idea is innovative and focused a new era. Only one explanation need to be clarified about participants age why didn't you make an upper limit for participants age to avoidphysiological cognitive changes?

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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.

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Reviewer #1: Yes: Sherif Mohamed

Reviewer #2: No

Reviewer #3: No

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Revision 1

Answer to the Editor and Reviewers’ comments (this response has also been attached as pdf file to this submission):

Dear Editor,

Thank you very much for the opportunity to submit a revised manuscript for our work entitled ‘Feasibility of a patient-oriented navigation programme for patients with Lung Cancer or Stroke in Germany: protocol of the CoreNAVI study’. We now submitted a marked-up copy as well as an unmarked version of the revised manuscript via the PLOS One submission system.

We are thankful for the helpful comments of the reviewers and are happy to address the raised questions (please see below).

Besides the points described below in the response to the reviewers, the following changes have been made to the manuscript:

Page 4, line 136: correction of wording to ‘We further aim to provide estimates of efficacy regarding selected patient reported outcomes,…’

Page 4, line 142-143: correction and rewording for clarification to ‘Does a patient-oriented navigation programme impact estimates of efficacy (patient reported outcome: satisfaction with care)?’

Page 5, line 170: correction of sentence to ‘This is an open-labelled study since blinding was not possible.’

Page 10, line 288: rewording for clarification to ‘All other outcomes are analysed in a secondary exploratory manner.’

Page 17, line 473-474: addition of an Acknowledgement section

Page 20-25: Table 2 and Table 3: corrections in referencing and title

Page 26, Author’s contributions: Correction of abbreviations

Throughout manuscript: Correction of typos (e.g. page 5, line 180)

Response to reviewer’s comments:

Reviewer #1: Dear Editor Plos One

Thank you very much for giving me the opportunity to review the manuscript entitled (Feasibility of a patient-oriented navigation programme for patients with Lung Cancer or Stroke in Germany: protocol of the CoreNAVI study)

The study idea is good. I have some comments to improve the manuscript.

The abstract and introduction sections are so long. The authors should review these sections and remove unnecessary words/sentences.

Answer: We thank the reviewer for the helpful comment. We now revised the abstract and introduction part in order to shorten it by deleting unnecessary and redundant words and sentences.

See pages 2-4, abstract and introduction

Reviewer #2: The authors have designed this protocol to show the Feasibility of a patient-oriented navigation program for patients with Lung Cancer or Stroke in Germany. It is a well-designed and well protocol. Some points should be explained .

Line 300 301 302

Why did you select these percent (above 70 % and below 40 %)

Answer: These percentages were defined in a discussion process between the participating researchers taking into account their own and published experiences. Criteria were selected with the aim to find indicators that appropriately balance the lost-to-follow up/dropout rate that can be expected in navigation intervention studies in severely affected patients on the one hand and defining a conclusive indicator of feasibility to reflect acceptance/demand/practicality of the intervention on the other hand.

(see for comparable approaches for example: Forster, A., Hartley, S., Barnard, L. et al. An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial. Trials 19, 317 (2018). https://doi.org/10.1186/s13063-018-2669-5 or Walters K, Frost R, Kharicha K, Avgerinou C, Gardner B, Ricciardi F, Hunter R, Liljas A, Manthorpe J, Drennan V, Wood J, Goodman C, Jovicic A, Iliffe S. Home-based health promotion for older people with mild frailty: the HomeHealth intervention development and feasibility RCT. Health Technol Assess. 2017 Dec;21(73):1-128. doi: 10.3310/hta21730.)

We reworded the sentence ‘The programme is categorised as feasible if:’ to ‘We defined the primary feasibility criteria as:’ to indicate that definition of feasibility criteria was done by participating researchers.

See page 8, line 251-252

Line 304 using an ordinal regression model

Explain the selection for that model

Answer: We selected this model as the outcome “satisfaction with care” is measured on a five point Likert-scale and therefore an ordinal scaled measure. That is the reason why we would use an ordinal regression model here. Additionally, we want to adjust for centres, baseline quality of life and type of participant. To do so we use a multiple ordinal regression model.

To clarify this for the reader we now inserted the used scaling in the text.

See page 13, line 361 and 362: …, efficacy of both interventions will be tested separately using an ordinal regression model with ‘satisfaction with care’ (measured on a five point likert scale) 12 months after start of intervention as ordinal dependent variable, …

Line 307 308

Discuss the selection of ANCOVA for Your Study

Answer: We selected ANCOVA models as the state of the art regression models for testing group differences in randomized trials as they allow the adjustment for the specific baseline variables and adjustment for stratification variables, if stratified randomization was done as also described for the present study. See for example Senn, S. (2006), Change from baseline and analysis of covariance revisited. Statist. Med., 25: 4334-4344. https://doi.org/10.1002/sim.2682

We now cited this study to make the selection of the method more clear to the reader. See page 13, line 366

Reviewer #3: The research design seems to be conducted in a proper way, The research idea is innovative and focused a new era. Only one explanation need to be clarified about participants age why didn't you make an upper limit for participants age to avoid physiological cognitive changes?

Answer: We thank the reviewers for this important question. One of the aims of evaluating the feasibility of the patient navigation model was to investigate if the most vulnerable patients are accessed with the used outreach strategy. During the development process of the model, older age was defined as one of the vulnerability characteristics (see Gödde et al. Development of a patient-oriented navigation model for patients with lung cancer and stroke in Germany. BMC Health Serv Res. 2022;2 2(1):785.). Hence, we decided not to set an upper limit for recruitment here to be able to investigate the feasibility of the navigation programme for participants also of older age. However, patients were only enrolled in the study if capable for informed consent. Alternatively, caregivers were able to take part in the study if legal care existed.

Attachments
Attachment
Submitted filename: CoreNAVI_Goedde_et_al_response_to_reviewers.pdf
Decision Letter - Uwe Konerding, Editor

Feasibility of a patient-oriented navigation programme for patients with Lung Cancer or Stroke in Germany: protocol of the CoreNAVI study

PONE-D-22-19723R1

Dear Dr. Gödde,

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.

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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,

Uwe Konerding

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

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

Reviewer #1: Yes

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 and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Dear Authors

Thank you very much for doing your efforts to improve the manuscript. You covered the needed points in this revised manuscript. I think that the revised manuscript is ready for publication in its current form

Reviewer #2: thanks alot for your 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: Yes: Sherif Mohamed

Reviewer #2: No

**********

Formally Accepted
Acceptance Letter - Uwe Konerding, Editor

PONE-D-22-19723R1

Feasibility of a patient-oriented navigation programme for patients with Lung Cancer or Stroke in Germany: protocol of the CoreNAVI study

Dear Dr. Gödde:

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. Uwe Konerding

Academic Editor

PLOS ONE

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