PONE-D-24-54866Device-aided therapies (DATs) in Parkinson´s disease (PD). The DATs-PD GETM Spanish Registry.PLOS ONE

Dear Dr. Santos Garcia,

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Additional Editor Comments:

The authors have provided an interesting summary on device-assisted therapies in Parkinson's disease but, as the reviewers have noted, a clearer abstract followed by a balanced discussion is required. For example, demonstrating benefits and advantages of each device considered in the form of table.

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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

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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?

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Reviewer #1: Yes

Reviewer #2: 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: No

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: No

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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.

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

Reviewer #1: In this paper the authors present the protocol for a register for patients with PD on DAT. This is very important as there is a clear lack of comparative, longitudinal studies between different treatment options of adavnced PD.

The forst objective of the registry would be to:

1) to analyze the sociodemographic and clinical characteristics of PwP

treated with a DAT, comparing the different treatments (DBS vs subcutaneous vs enteral

treatment). It is not clear what subcutaneous (subcutavneous apomorphine pump and foslevodopa/foscarbidopa pump) and eneteral (LCIG, LECIG) DAT options would be taken into account. This needs to be sepcified.

There is an important objective missing - that is to define predictors of a favourable response to different DATs.

Could the authors forsee how long the study will last for?

"The first follow-up visit will be carried out at 6

months +/- 3 months (V3_6M) and then at 1 year +/-3 months and subsequently annually +/- 3

months: 1 year (V3_12M); 2 years (V3_24M); 3 years (V3_36M); 4 years (V3_48M); 5 years

(V3_60M); etc." ETc is not good enough. Please, specifiy - indefenete, or for at least 10 years, or up to 20 years depending on funding...

Also, Table 1 is confusing - at present, it seems there are going to be three visits only!

Figure 1. Please change 31/Dic/2033 to 31/Dec/2033 in

The ABtract needs to be imporved - it does not reflect the exat content of the paper. For example, lines 58-60 in the Abstract - It is not clear of wheterer the follow-up would last for 2, 3 years, or longer as explained later on in the paper.

Please correct typos - for example Abril to April (line 9, page 1) in the Abstract.

Instead of People with Parkinson's disease (PwP) might be Subject(s) with Parkinson's disease (SPD). Xonsider change it.

Reviewer #2: The present protocol has been drafted to inform about clinical reasoning, management, and possible beneficial as well as side effects of newly-introduced device-aided therapies, such as

levodopa-entacapone-carbidopa intestinal gel infusion (LECIG) and subcutaneous

infusion of foslevodopa/foscarbidopa (fLD/fCD).

The protocol looks good and I have some minor suggestions:

- I would avoid using the term "DAT" as it is misleading (too similar to the DaT SPECT Scan). I would rather use "DT" or avoid the abbreviated form.

- In the introduction, I would avoid using the term "parkinson plus syndrome" as it is obsolete. I would rather use "atypical parkinsonism" instead.

- In the Methods, Line 166, I would specify at point 1: "Clinical diagnosis of PD according to the MDS criteria". Please, add a citation here.

- Assessments: Are the authors planning to collect yearly MoCA and/or any cognitive screening tests? I believe this is highly informative. Also, authors use both the terms UPDRS and MDS-UPDRS. I hope they are going to use the MDS-UPDRS scale. Please, clarify. Finally, "MNCD" and "EUROHIS-QOL" should be spelled out. Please, spell out LEDD and explain the methods of calculation (e.g., Tomlinson 2010 or more recent amendments).

- English language should be carefully revised as there are many typos.

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Reviewer #1: No

Reviewer #2: No

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Device-aided therapies (DATs) in Parkinson´s disease (PD). The DATs-PD GETM Spanish Registry.

PONE-D-24-54866R1

Dear Dr. Garcia,

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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Kind regards,

Barry Kweh

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The authors have revised their manuscript by improving the methodological rigour, clarifying terminology such as DAT and provided adequate statistical justification.

Reviewers' comments: