PONE-D-23-31626Improving quality and patient safety in surgical care through standardisation and harmonisation of perioperative care (SAFEST project): a research protocol for a mixed methods study.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

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

Reviewer #1: This protocol describes a mixed-methods hybrid type III implementation study designed to support the development and adoption of evidence-based practices in order to improve perioperative patient safety. The study will be conducted in 10 hospitals of 5 European countries. Implementation outcomes include 1)adherence to standardised practices, 2)sustainability 3) usability, and 4) validity. The study will also assess adverse outcomes following surgery.

The study protocol is well developed and the methodology adapted to the study purpose. The only point that should be clarified is the link between context analysis through the CIFER protocol and the specific intervention that will be implemented. The study protocol makes the assumptions that it will be a teaching program, but actually, the results of context analysis may suggest alternative strategies than teaching (i.e. computer program, change of the process of care, walk rounds etc…) This should be discussed in the protocol further. There is also an imprecision in the introduction with the citation of the study by “Van Klei WA, Hoff RG, Van Aarnhem EE, et al. Effects of the introduction of the WHO "Surgical Safety Checklist" on in-hospital mortality: a cohort study. Ann Surg 2012;255(1):44-9 , as a reference showing that guidelines decrease surgical mortality. The study by Aarnhem is about a checklist, not about a guideline. I would suggest another reference. The limitation section is a bit vague since obstacles of implementation studies are well known and deserve attention (i.e. ressources, training, duration ). This should be specified in the limitation section.

In conclusion, a nice protocol of a promising study that needs however additional details provided.

Reviewer #2: General comments to authors

Thank you for allowing me to review the protocol for this ambitious but important project funded by the EU – Horizon Europe Framework Programme.

Since this is a substantial project I understand that it is a challenge to describe this in a balanced way in a protocol. But the paper will benefit from being restructured and clarified which will make it easier for the reader to grasp the project, see comments below. I think the main problem with the structure is that you have three processes (phases) sometimes running in parallel, that is the intervention (with planning and developing), the implementation and the evaluation process, but I have written some suggestions for this.

Although guidelines do not solve the whole issue to create safe care, to me this is an important prerequisite with impact on other initiatives that has to be solved. From a context perspective the need is extensive as the surgical specialty is responsible for many patient injuries or adverse events. I am looking forward to see future results from this project.

Specific comments

Title

Improving quality and patient safety in surgical care through standardisation and

harmonisation of perioperative care (SAFEST project): a research protocol for a mixed

methods study.

The title includes both concepts patient safety and quality, but is not explained in the background why the reader get unsure how it is used in the different sections in the paper.

Abstract section

- Needs reformulation according to recommendations below.

Background

Page 3.

- The background is somewhat short but logic except from that some main concepts are missing (see further down) and there is no clear rationale (please add this).

- Is it quality of care or patient safety that is your main focus? Please clarify.

- Furthermore, your main concepts of quality of care or patient safety which also is your outcome measures are barely not mentioned nor defined in this section.

- In the first section important information about adverse events is described. However, there is no clear definition of one of your main concepts i.e. adverse event (AEs). I find it very important that you define and are clear with what AE and patient injuries means for this project.

Page 4.

- Your objective is to improve and harmonise perioperative patient safety, but what does this mean. The focus in the background section is on unsafe care, clarify what you mean by perioperative patient safety? What do you want to achieve, is it less numbers of AEs which is implied? What about outcomes on a patient level? This needs to be developed.

- Is it quality of care or patient safety or both that is your main focus? Please clarify.

- One of the most important measures to achieve patient safety (safe care) in complex systems is to adopt a system perspective. According to me you are adopting a system perspective (system safety) in this project, which is very good. But the paper would benefit from a clearer description of this standpoint.

- In the last section you write multidisciplinary teams – including experts on patient safety and perioperative care. However, this is the only place in your paper where they are mentioned. Since patient safety is your overarching objective, I find it very important that they will be included during the whole process.

- Another concern is that you need to clarify what professions these multidisciplinary teams will consist of?

Objectives

- To clarify this project, it would benefit from identifying overarching research questions. Since you have three main outcomes (clinical effectiveness, patient´s perspectives and the process of implementation) in focus, this would be feasible.

Methods

Page 4. This study is a mixed-methods hybrid type III implementation study, the paper and project would benefit from a short explanation/motivation of why and by adding a reference to this. For example, Landes et al. (2019) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6779135/

- You also write that you will use mixed methods to collect data, add reference to this, for example Creswell & Plano-Clark. I also recommend you describe which design (convergent parallel design or what?), see recommended reference.

- You describe both design and data collection under the design heading. For a clear structure I recommend you to use the sub-headings design, setting (and sample) and data collection.

- Page 4. Quality Improvement Learning Collaborative (QILC) needs to be described and clarified early in the paper. As it is now, this is described at page 5.

- Good that you use Implementation Research Logic Model (IRLM) and CFIR as it clarifies and add to the written text. The paper would benefit from a sub-heading that e.g. says “guiding frameworks”.

- You write; The evidence-based patient safety practices in SAFEST will include structural and process practices to promote patient safety and prevent the occurrence of adverse events and complications to be implemented throughout the continuum of perioperative care.

• Since you have clear project outcomes, and you are adding structure and process, the paper should benefit from adding the reference from your institute Donabedian, A. (2005), Evaluating the Quality of Medical Care. The Milbank Quarterly, 83: 691-729.

• Check this section for sighting error, can be misinterpreted.

• This section explains parts of my concerns described under the background section, please add and explain this in that section.

• Furthermore, above the concept of complications is used but not explained in the background section.

Page 5 (first section) you write that QILC will serve as the main implementation strategy of

the standardized practices. As it is now you mix both hypothesis and strategies, please structure it more clearly. Add a sub-heading for example implementation strategies, and it will become clearer. What other strategies will you use (facilitation, training and/or support) and if, what does it include (content, activities, dose and delivery)?

Setting

Page 5. Under this section you describe that it is the adult perioperative journey with its phases and in or outside the hospital. The paper would benefit from a short description to all readers of what pre, per and post actually means.

Page 5. You write that; the project will be implemented in 10 hospitals from 5 European Countries. But as you focus on the whole patient journey that is inside and outside the hospital there is a need for a further explanation.

Outcomes

Page 5. You write that you will use a composite indicator based on the main priorities established by the participating hospitals. Please explain this briefly.

Described variables to measure implementation outcomes are you really going to use all 7 variables by Proctor? I think intervention fidelity (with its potential moderators) would be enough to evaluate the primary outcome measure adherence to patient safety practices. Rethink and clarify this.

Project procedures

Component 1.

Page 6. The project will consist of 6 main components, please add the six components in the text as it would clarify for the reader. But I can also see that there are different overarching phases which may help the reader to get structure i.e. development/design and planning phase, implementation phase and evaluation and reporting phase. Maybe these headings could help the reader to easily grasp the overarching structure of the work process.

Page 6. Figure 3 is very good to give structure to this project. Although a hybrid type 3 design, has its main focus on quality of care or patient safety implementation outcomes, it is confusing that the part with the development of the clinical intervention is presented after the Implementation Research Logic Model (IRLM) in the paper. It would benefit from describing the connection between figure 1 and 3, that is figure 3 (SAFEST overall approach) is the same as the block clinical intervention in figure 1 and if you could present it in a more logic way.

Page 6 _1.2 You will recruit multidisciplinary expert groups 1) a Scientific Advisory Group

(SAG) and, 2) a Scientific Executive Group (SEG) of experts. Further down in the paper you describe the composition of these groups, but patient safety experts are not mentioned here which I find a bit strange. It does not say on what system level, but patient safety experts from my experience exist even on macro level. Please clarify.

Furthermore component 1 seems clear and well thought out.

Component 2-3.

Page 7.

It seems to me that these components consist of both developing and preparing different tools, handbooks and action plans and an umbrella review together with concrete implementation strategies such as training and support which make this part a bit confusing. I recommend that you structure the section with project procedures in a table, see for example Seismann-Petersen et al. 2022: https://bmcnurs.biomedcentral.com/articles/10.1186/s12912-022-00858-6

If you find the suggestion with a table for the more detailed information you could describe the workflow in the components more briefly.

Component 4

As far as I understand, this component is a prerequisite for component 3 why I suggest that this would benefit from more logically being presented before the actual actions that will take place in component 3.

Component 5.

Page 9, 5.1 You describe that you will develop a core outcomes set for patient safety in perioperative care. Is it patient safety or quality of care or both. These concepts are often intermingled in the literature, I just want to draw your attention to it.

Page 9, 5.2 You are going to review health records of the participating hospitals and/or collect additional data to assess a) adherence to the standardised practices and b) surgical complications measured with the ISO tool. What exactly do you mean by reviewing health records is it systematic retrospective record reviews and on what level of data (patient data), please clarify.

The complications in the ISOS tool, are you going to use them as markers to be reviewed, could be clarified? What is the focus in the ISOS tool on complications, patient injuries or adverse events, needs to be clear?

How will you collect data according to adherence to standardized practices?

Page 9, 5.4 You write, each hospital will also be able to collect process and clinical data into the SAFEST platform, but what kind of data?

Survey of PROMs and PREMs, are you also going to collect a baseline for these variables?

Page 10, 5.5 Again, you could add references and motivate triangulation of data and sequential analysis. Is it a convergent parallel design you aim to do (see comment under method section)?

Component 6

Very good that you also intend to involve patients which is very important for both implementation and safe care.

Consider adding references on co-production/co-creation as I would say you aim to do.

Sustainability

There is a great strength that you intend to consider sustainability which the same as patient involvement is very important to achieve a sustainable project over time.

Analysis

The paper is lacking a clear and logic description of the analytic approach as it is embedded in the six main components with its sub-components or is it activities? If you do not provide a table is it possible to clarify this by a short summary or maybe a table specific for this section?

Discussion

This section seems very short to me as there is no discussion about design, and what the study will provide and what gaps that are addressed and according to what needs and if and what this project could act as a model for, but I will leave this to the editor to decide.

Data sharing statement

How will you handle patient record data included in the record review?

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Reviewer #1: Yes: Prof Guy Haller

Reviewer #2: No

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Improving quality and patient safety in surgical care through standardisation and harmonisation of perioperative care (SAFEST project): a research protocol for a mixed methods study.

PONE-D-23-31626R1

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