PONE-D-23-04586Impact of hospitalization on nutritional status and dysphagia in persons aged 65 years and over (NUTRIFRAG Study): protocol for a prospective observational studyPLOS ONE

Dear Dr. Orts Cortés,

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PLOS ONE

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Reviewers' comments:

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

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Reviewer #1: Yes

Reviewer #2: Partly

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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: Partly

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

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: 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.

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Reviewer #1: Abstact

Malnutrition is a recurrent problem that has acquired its own identity in recent years : make this statement more clear, what do u mean with own identity.

Objective:

‘’assess the risk of malnutrition and nutritional status on admission and its evolution until discharge’’ and the dysphagia? Doesnt go with the title

Why is it registered in brazi? registration number RBR-5jnbyhk in the Brazilian clinical trials database (ReBEC) for observational studies.

‘’These results will serve to improve their health status’’: cold you be less general?

180. Still confused with the title what is the role of the dysphagia there; 181 Research hypothesis

the main aim is not something new, i would have expected they testing and intervention to prevent inhospital malnutrition or to find risk markers for dysphagia and malnutrition

421. 431 ''This project will help to understand the different contexts of action (at specialized care and hospitalization unit level) to propose the creation of an evidence-based protocol that allows for comprehensive and multidisciplinary care of malnutrition and dysphagia. In this way, a new approach to planning quality care for the patient/family will be implemented, thereby reducing the variability of action in clinical practice''

How is this project going to extrapolate to the creation of protocols. Protocol of detection? Are they in the objetives testing an instruments? Ot protocolo for intervention? Are they testing an intervention? The study is very Good, well design and they are collecting valuable information. hOWEVER what they Will do with that information is blurry, jsut to see who develops malnutrition’’ and what with that ?

437. ''In the conclusions: evidence on the usefulness of screening and monitoring malnutrition and dysphagia during hospital admission of people aged 65 and over, ''

That conclusion does not reflected in any of the objectives

446.'' These results will serve as a basis for the development and evaluation of nutritional interventions adapted to the presence of malnutrition and dysphagia and above all to the clinical situation of the patients. ''

How?, using the dietary records that you are measuring? Measuring textures for those with dysphagia ???

Following the objetives again this project cant do any of this, the main objective is to asses malnutrition incidence, but from that to these conclusión there is a huge gap

Reviewer #2: This study protocol entitled “Impact of hospitalization on nutritional status and dysphagia in persons aged 65 years and over (NUTRIFRAG Study): protocol for a prospective observational study” explored the issue of malnutrition, dysphagia, and associated outcomes in the elderly inpatients in Spain. Even this topic is worth to explore, several points needed to be stated more clearly in advance.

First, the title stated that NUTRIFRAG Study is a prospective observational study. For observational mostly means that the physician and medical team will do nothing when disclosing malnutrition or dysphagia, no nutrient suggestion, no speech therapy, neither medication adjustment. This study is indeed a prospective study, and the term of “observational” might not be suitable for description. It was suggested to modify this term for that all inpatient would receive standardized medical care during hospitalization ethically. While food preparation and management looks to be an intervention, therefore not so "observational" in methodology.

Second, for body weight change playing a critical role on calculating the nutitrional score in previous 7 days, there is no adequate explanation on avoiding possible bias among medical inpatient with fluid overload (weight loss due to treatment in hospitalization), or in surgical inpatient receiving organ resection (weight loss) or prosthesis implantation (weight gain).

Third, it was stated that patient meeting any exclusion criteria at any time would be withdrawal from analysis. If patient with severe dysphagia received enteral nutrition by feeding tube, will the patient be removal from analysis? For tube feeding being a clinical management for dysphagia in general, will that patient withdrawal lead to another potentially analytic bias?

Final, we will need a clear statistical model for data analysis. For example, how to definite the reference group for comparison with your target population? What confounders will be adjusted in multivariate analysis and Cox regression model? It was encouraged to be stated clearly prior to participants’ enrollment.

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Reviewer #1: No

Reviewer #2: Yes: Liang-Yu Chen

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Impact of hospitalization on nutritional status in persons aged 65 years and over (NUTRIFAG Study): protocol for a prospective observational study

PONE-D-23-04586R1

Dear Dr. Orts Cortés,

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,

Mario Ulises Pérez-Zepeda, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you for your revised work, I think you have addressed the reviewers' concerns, so I am happy to move forward with the acceptance of your work.

Reviewers' comments: