PONE-D-21-06704

A breakthrough series collaborative to increase patient participation with hemodialysis tasks: a stepped wedge cluster randomised controlled trial

PLOS ONE

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PLOS ONE

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JF has received speaker honoraria from Fresenius medical care, and conducts research funded by the National Institute of Health Research (NIHR), Vifor Pharma and Novartis.

MEW has received speaker honoraria Fresenius and Baxter, has acted on an advisory board for Baxter and has conducted research funded by the NIHR.

SJW has received book royalties from Wiley and has received funds from NIHR, the Department of Health and Medical Research Council.

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Reviewers' comments:

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Comments to the Author

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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5. Review Comments to the Author

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Reviewer #1: This is a model of a stepped wedge trial with appropriate sample size considerations, and careful analysis adjusted for step. Given that it was a negative (primary outcome) study, it is important to point out in the conclusions whether the assumed sample size parameters were realized in the trial.

Reviewer #2: This is a useful piece of work because it looks at an area of dialysis practice that is very topical at present and looks at outcomes that might plausibly be generated by an increase in the proportion of patients involved in their own treatment. It was disappointing that the intervention did not lead to many of the possible positive outcomes, but this is important data to have. It would be interesting to understand if the authors felt that the main reason behind this was the relatively high level of patients already performing some self-care at baseline, or if they anticipated that a longer time period or more intervention might have made a difference, for example.

It would be useful to understand more clearly the nature of the interventions made to increase self-care at the participating centres, which would also indicate what person-time resource was required to deliver the interventions. This would have relevance to the dialysis community, especially given the likely inclusion of shared care HD / Home HD as part of the GIRFT requirements.

Reviewer #3: This was a very important study examining if an educational quality improvement intervention increased the proportion of in-centre hemodialysis patients completing 5 or more out of 14 tasks (independently or supervised) or transferring to home haemodialysis, using stepped wedge cluster randomised trial design. Although the primary endpoint was not achieved, significantly more patients transferred to HHD and there was an increase in the number of patients able to perform complete =/>5 tasks in the subgroup that had performed <5 tasks at baseline.

I have a couple of comments that the authors might want to address.

The authors suggest that increasing frailty among HD patients with time is the likely reason for not achieving primary endpoint. If that is so, how did those who could perform <5 tasks at baseline, presumably frailer or more cognitively impaired at baseline, show significant improvement?

I would like to see more detailed discussion on the putative reasons for not achieving primary outcome and if a different study design would have shown positive results.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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A breakthrough series collaborative to increase patient participation with hemodialysis tasks: a stepped wedge cluster randomised controlled trial

PONE-D-21-06704R1

Dear Dr. Fotheringham,

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,

Shahrad Taheri

Academic Editor

PLOS ONE

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Reviewers' comments: