PONE-D-21-38323

Living with a Left Ventricular Assist Device: capturing recipients experiences using group concept mapping software<o:p></o:p>

PLOS ONE

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“This work was supported by funding from the British Heart Foundation (PG/18/58/33944). This paper presents independent research supported by the National Institute of Health Research Birmingham Biomedical Research Centre at the University Hospitals Birmingham National Health Service Foundation Trust and the University of Birmingham. The study funders did not have any role in the study design; the collection, analysis, and interpretation of the data; the writing of the report; or the decision to submit the article for publication.

ALS was supported by funding from: The British Heart Foundation, National Institute for Health Research Invention for Innovation, Medical Research Council, National Institute for Health Research MedTech and INvitro diagnostics Co-operative–Trauma management, National Institute for Health Research Clinical Research Network; National Institute For Health Research  Birmingham Biomedical Research Centre and National Institute For Health Research Surgical Reconstruction and Microbiology Research Centre at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust outside the submitted work.

MC is a National Institute for Health Research Senior Investigator and receives funding from the National Institute for Health Research Birmingham Biomedical Research Centre, the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre and National Institute for Health Research Applied Research Collaboration West Midlands at the at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust, Health Data Research United Kingdom, Innovate United Kingdom (part of United Kingdom Research and Innovation), Macmillan Cancer Support, Health Foundation, UCB Pharma and GSK. MC has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline and the Patient-Centred Outcomes Research Institute (PCORI) outside the submitted work.

DL has received investigator-initiated educational grants (paid to the institution) from Bristol-Myers Squibb (BMS) and personal fees from Boehringer Ingeheim, Bayer, BMS/Pfizer, and Daiichi-Sankyo outside the submitted work.”

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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

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

Reviewer #1: Yes

Reviewer #2: Yes

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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

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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

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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: The authors present the results of a quite sophisticated study of a small group (18) of LVAD recipients who are being followed at one of the Heart Failure Canters in UK. The study targets eliciting and evaluating personal experience of living with an LVAD using Concept Group Mapping (GCM) approach. The participants were first asked to generate statements reflecting such experience in several categories. Such statements were then grouped, and the participants have rated those in three categories of relevance, frequency, and importance. All responses were then put through quite complex statistical analysis which evaluated several clusters and allowed comparisons between the clusters and inside each cluster using scores generated for such comparisons. The authors claim that this approach offers important advantage to other Patient Related Outcome Measures( PROMs) often used in evaluating outcomes of LVAD implantation or other life-modifying procedures. The main such advantage comes from the fact that the data are generated by allowing the actual recipients of the treatment ( such as LVAD) to make statements describing different aspects of their life with the LVAD in their own words rather than answer prepared questions. There is data in the literature that the most accurate information regarding life with the LVAD comes from those who live with the LVAD. In addition, GCM approach has been successfully applied for concept generation and evaluation in the past. It does seem to have allowed the authors to benefit from working with the data generated by a small number of participants. Overall, the findings of the study do contribute some additional information as to is important to the LVAD recipients at which stage of their with the LVAD. However, it is hard to imagine that this information by itself would influence the direction of development of the new generations of LVADs.

Reviewer #2: The implantation of a Left Ventricular Assist Device (LVAD) changes the life of both the patient and their family. Despite clinical improvement in most cases, the user is faced with equipment that imposes restrictions and changes in their image as a result of the surgery and the driveline. Beyond the usual knowledge about LVAD functioning and device-associated complications (such as infections, bleeding, thrombosis, or hemolysis), the attending physician should try to address the patient's feelings about their device. This manuscript does an excellent job of putting the user experience with LVADs at the center of the research, making it possible to identify domains and items that can be used in the development of Patient-Reported Outcome Measures (PROMs) in future research. Using the online Group Concept Mapping (GCM) software to identify these domains and items was also a great success for the authors, as it allowed people using LVADs who lived in different geographic regions to collaborate with the research. In addition to allowing the creation of statements, the GCM allows the research participant to sort and rate them, making it possible to identify what should be prioritized in future PROMS.

Despite the good work done by the investigation team, we were able to list some recommendations to improve the understanding of the information generated by the research.

Figures and Tables:

· Figure 1A: Although the figure looks solid, the language of its legend is not clear, making it difficult to understand. I advise you to put some details on the interpretation of the legend as found in Line 209: "Statements frequently grouped together are located proximally, while less frequently grouped 210 statements are distal to each other."

· Figure 1B: This figure represents the clusters well; however, we suggest that each cluster had a different color to facilitate visualization. It’s interesting to add the description about the size of the clusters found between lines 258 - 260.

· Figure 2: This figure is not clear. We suggest detailing a little more about bridging values in the legend (similar between lines 319 and 325). Also, the lines have similar colors, but different thicknesses, so you could be specified what each line thickness is and there are different color points without explanation.

· Figure 3: This figure is the most important, because it shows the importance, frequency, and relevance of each cluster. My suggestion is to put each cluster and line with different colors.

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Reviewer #1: Yes: Yakov Elgudin, MD, PhD

Reviewer #2: No

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Living with a Left Ventricular Assist Device: capturing recipients experiences using group concept mapping softwareo:p/o:p

PONE-D-21-38323R1

Dear Dr. Slade,

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,

Salil Deo

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you very much for submitting your work to PLOS ONE. We are delighted to inform you that your paper has been accepted for publication.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

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Reviewer #2: 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 #2: Yes

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

Reviewer #2: 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 #2: 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 #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. 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 #2: The authors adequately responded to the reviewers' questions. I suggest that the article be accepted for publication.

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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 #2: No

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