PONE-D-24-40359How to implement a Clinical Ethics Committee in an Oncological Research Hospital? Qualitative results from a Process Evaluation Study using Normalization Process Theory (EVACEC).PLOS ONE

Dear Dr. Crico,

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PLOS ONE

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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: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Partly

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

Reviewer #1: Yes

Reviewer #2: N/A

Reviewer #3: Yes

Reviewer #4: N/A

Reviewer #5: 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: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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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: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: No

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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: Thank you for allowing me to review this manuscript. In general, I really liked the topic and I believe in the importance of a CEC. I enjoyed how the authors followed the NPT framework and reflected on it to shape it into an adequate model to evaluate and normalize the CEC. It is a valuable, time-consuming and analytical work and I thank them for their effort to put together a nice work. However, I think the manuscript needs improvement in terms of English language, typing errors, some methodology and some structure failures.

Below are my comments:

Title: I suggest you remove the question mark as the structure of the title suggests an informative guide, so the question mark is unnecessary.

I was a bit confused whether the CEC is only for the Oncology consultations or not. You don’t introduce oncology until later in the practical implications but it is not clear if this is your aim. Line 69 and 70 you talk about oncology but then in the methods/results/discussion you don’t explain why and how oncology fits. I suggest you make a certain link clearly early in your manuscript.

Misspelling and punctuation:

Line 13 of an (the) Italian, line 27 relationship- missing an S, line 62 only few regions- missing an a in few: only a few, line 115 double point…

Please keep the same style consistently within your manuscript: the citations embedded within the text in the Results are sometimes italic sometimes not (i.e. line 162/163 and line 218/219)

When CM and LD is used in plural, the s is missing (i.e. line 205 seven CM)

Grammar:

Line 19 informed with, line 27 though- replace with but, however…, Line 40 a kind- replace with a type, a form, a part…, line 82 whose- replace with that, line 91 whose- replace with that, line 350 and 362there is on the one hand in the paragraph

Abstract

Line 23: maybe use another term than the general term stakeholder.

Background

Line 45/46, line 56/57, line 60/61: CESS are used CEC interchangeably. If CEC is part of the CESS why not focus first on the CESS and then move to focus on the CEC.

Line 70/71: it seems like a single statement. It should be better integrated in the paragraph. (might be a good link for the oncology part, see above my comment on oncology)

Methods

Missing: did you have a pilot interview after which you adapted the interview guide

Line 105: introduce a small definition of the steps of the framework NPT (what is coherence, cognitive participation…) in addition to the table.

Line 106: I suggest you include domain 1 and 2 of your COREQ in the methods rather than at the end of the manuscript, specially that you’re using a reflexive analysis, where the reflexivity of the authors and their influence should be clear and thought through from the beginning. I suggest you include a section on the reflexivity of the authors since they might have a relationship to the CEC, members of the CEC? (line 504: this is where you mention that MP works somehow for the CEC, this should be mentioned in the beginning and it should be reflected upon).

Line 114: you mean two separate one for the LDs and one for the CMs? clarify

Line 116/117: you mention PhD project and roles of the researchers later in the limitations section (line 503-403)

Line 119: some key areas are repetitive, can you combine some concepts together?

Line 130/131: clarify how did they get the names, is there a list?

Line 132: was the consent obtained verbally or written

Line 136: were the interviews done in English? Italian and then translated?

Line 142: supplemental material do you mean figure 1?

Line 147: restructure the sentence clarifying if there were conflicts of ideas between researchers and how they were resolved (after discussion, consensus was reached?)

Results

The results descriptive section and the figure 1 do not necessarily correlate. For example, in the coherence part, you enumerate i) multi-disciplinarity ii) focus on holistic care iii) different from the facilitators multidisciplinarity, integration with the BU and focus on ethics.

Line 224: you mention the CEC president, is this person not anonymous on purpose? I suggest you still name them like the other participants.

Line 274: I am confused which HPs and the case discussion? Is it a general statement or a part of your results?

Discussion

Humanisation of care/medicine is a very important finding indeed. You emphasized it beautifully.

I suggest you shorten the discussion by omitting a literature review on the topics that were not mentioned in your results section.

You mix here again the CESS and the CEC. Is it intentional? All your results are on the CEC if I understood correctly so why discuss the CESS?

Line 392/393: how did you come to this conclusion? Can you clarify? otherwise it is more of an assumption?

Line 421: Can you compare to your results? (similar to what you did one line 448 and 460)

Line 430: Interesting! Can you compare to your results? (similar to what you did one line 448 and 460)

Practical implications

Very important part of your research. Make sure you clarify if table 4 proposed outcomes stem all from your results or personal ideas and suggestions?

Reviewer #2: The evaluative work of any new establishment of new project is essential, hoever, some points requiered to be raised:

1- How the health care professional and the practitioner have managed to take care of ethical issues before the inception of this committee.

2- Who and how the need of such committee is decided and how it is regulated according to the Italian rules.

3- What about the other religions and immigrants, does this committee represent all the diverse community who uses health systems in Italy.

4- Do you think this short time of committee assessment is not necessarily a representative of this committee, may be this data used to improve the drawbacks and give the publication of the results more time, normally to change of the people could affect the action of it in the future. So, we can avoid the personal effect and detect more clearly the professional effect of such committee.

5- Does the speciality of oncological hospital require distinct ethics committee, may one regional committee could be enough and for all specialities.

6- There should be part of this work to the patients’ opinion about any improvements has occurred in the services offered.

7- Can the authors elaborate more about the competences of the committee members.

Reviewer #3: Review of the manuscript: How to implement a Clinical Ethics Committee in an Oncological Research Hospital? Qualitative results from a Process Evaluation Study using Normalization Process Theory (EVACEC).

This study highlight the Clinical Ethics Committee (CEC) of an Italian Local Health Authority (LHA) of Reggio Emilia, Italy, is a multi professional service established in 2020 to support healthcare professionals (HPs) in dealing with ethical issues in clinical practice. We evaluated the integration of the CEC into routine practice, 24 months after its implementation.

This manuscript is appropriate for publication by the PLOSONE JOURNAL It has the correct specifications, and approves :

1) Topics.

2) The quality of scientific paper and achieve publication goals, improve consistency and readability. Preserve flow of expression, Professional results, Improve structure and presentation, Plagiarism is check, also the Bibliographic editing, and Formatting finally improve the target of the journal.

3) All content presented in the manuscripts is perfect, and have keep the guidelines of journal, including opinions, Abstract, methods, statistical analysis and materials, results, images-figure especially the factor path diagram , discussions, and conclusions. The article is research work and provide new development of an Oncological Research Hospital, and Qualitative results from a Process Evaluation Study using Normalization Process Theory (EVACEC).

4) Manuscripts using a acceptable file formats use the layout options, on the length of the research articles, keep the main text of the body below appropriate words. Authors provide three separate documents during submission abstract, blinded text, figure 1 , tables with results, and highlights. Grammar and punctuation standards followed the content. References, keywords , figure provide in the text appendix also to the manuscript. International system of units be followed in the representation of all units in the text, recommended structure manuscript follows. References method formatting and style guidelines. Contribution to the literature: the uniqueness and importance of this work in terms of research topics, its methodologies, and outcomes, this article enhances the scholarship in the subject. Ideas are presented clear, concise, and complete manner. Manuscript is free from any repetitions, irrelevant information, or unjustified generalizations. Theoretical framework is explicitly stated. All claims are backed up with evidence and references. Research problems’ position and significance in existing literature is emphasized. Chosen methodology is suitable for the problem. Study’s findings are well presented with sufficient discussions and comparisons to existing literature. Objective and convincing measures exist to support the validity and reliability of the methodology and results. Relevant literature is properly cited, identified key components to support the normalization of CECs and enable their activation within a clinical setting. An active and sustainable CEC be visible, accessible, understood and trusted, clear in purpose, sufficiently integrated into the life of the organisation, adequately resourced, appropriately constituted and competent, accountable and independent. Findings can inform the development of practical strategies for CECs implementation and of appropriate outcomes for further evaluation.

And finally have complete the Aims and scope of the PLOS-ONE Journal.

I suggest: Please Accept the article as it is.

WITH REGARDS

the Reviewer

Reviewer #4: The investigators present a rigorous, scientifically sound method to qualitatively evaluate the impact of the implementation of a Clinical Ethics Committee into the operational setting of an oncological center in Italy. The proposed publication is the first in a series of publications that try to asesss the experiences of CEC members and managers who contributed to the set-up of this organism. his kind of research could be important in order to assess the relevance and impact of CEC implementation in the clinical setting. The study identifies some relevant concepts that participants perceive as important and pivotal to these kind of Committeess. The proposed research is methodologically sound and novel.

Notwithstanding, the following considerations should be taken into account:

1. The discussion should include a part of potential generalisation of study findings. Does the results and reflections extracted from this use case can be taken into account to future centres (oncological or not) that are considering implementing a Clinical Ethics Committee? Is this extrapolable to other countries, or only affects Italy? Please, provide in the discussion some further generalisibility reflections of the results.

2. The word "several" in line 506 has a typo.

Reviewer #5: The manuscript needs to be shorter; there are typos in the paper; too many abbreviations have been used, which is breaking the reader's flow; the target audience is too narrow due to the language used in the paper. The discussion section is longer than the results section which should not be the case as it is a research article. The methods section needs revision as well for more clarity.

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Reviewer #1: No

Reviewer #2: Yes:  Qosay Al-Balas

Reviewer #3: No

Reviewer #4: Yes:  Pau Alcubilla Prats

Reviewer #5: Yes:  Anamika

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How to implement a Clinical Ethics Committee in an Oncological Research Hospital: qualitative results from a Process Evaluation Study using Normalization Process Theory (EVACEC).

PONE-D-24-40359R1

Dear Dr. Crico,

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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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

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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 #1: Yes

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

Reviewer #1: Yes

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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 #1: Yes

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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

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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 #1: The authors have reviewed all my comments and I thank them for taking my suggestions into consideration.

The manuscript has been significantly improved.

I would suggest they give it a last read to correct some very minor punctuation errors (Line 119 missing point, line 130 extra space ...).

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Reviewer #1: No

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