Evidence map›Paper›PMID 35919522›Full record

ArticleKidney3602022

Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy Devices.

Jennifer E Flythe, Derek Forfang, Nieltje Gedney, David M White, Caroline Wilkie, Kerri L Cavanaugh, Raymond C Harris, Mark Unruh, Grace Squillaci, Melissa West and 9 more

Abstract read
In one paragraph

Article in Kidney360, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. From Home to Wearable Hemodialysis: Barriers, Progress, and Opportunities.Clinical journal of the American Society of Nephrology : CJASN · 2024
    Review
  4. Advances in Human-Centered Care to Address Contemporary Unmet Needs in Chronic Dialysis.International journal of nephrology and renovascular disease · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Jennifer E FlytheUniversity of North Carolina (UNC) Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, UNC School of Medicine, Chapel Hill, North Carolina.ORCID 0000-0003-4596-8536
Derek ForfangKidney Health Initiative Patient and Family Partnership Council, San Pablo, California.
Nieltje GedneyHome Dialyzors United, Shepherdstown, West Virginia.ORCID 0000-0002-3576-230
David M WhiteKidney Health Initiative Patient and Family Partnership Council, Hillcrest Heights, Maryland.
Caroline WilkieKidney Health Initiative Patient and Family Partnership Council, Punta Gorda, Florida.
Kerri L CavanaughDivision of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee.ORCID 0000-0002-4031-1714
Raymond C HarrisDivision of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee.
Mark UnruhSchool of Medicine, University of New Mexico, Albuquerque, New Mexico.
Grace SquillaciKidney Health Initiative and American Society of Nephrology, Washington, DC.
Melissa WestKidney Health Initiative and American Society of Nephrology, Washington, DC.
Carol MansfieldRTI Health Solutions, Research Triangle Park, North Carolina.ORCID 0000-0002-3144-8938
Cindy S SoloeRTI Health Solutions, Research Triangle Park, North Carolina.
Katherine TreimanRTI International, Research Triangle Park, North Carolina.ORCID 0000-0001-9589-2491
Dallas WoodRTI Health Solutions, Research Triangle Park, North Carolina.ORCID 0000-0003-4872-8204
Frank P HurstCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Carolyn Y NeulandCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Anindita SahaCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-0306-4264
Murray SheldonCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Michelle E TarverCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.

Funding

Vanderbilt O'Brien Kidney Center - Core D - Clinical and Translational CoreP30DK114809 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI WILSON, MATTHEW H · 2017 to 2021
$5.9M
FDA HHS R18 FD005283NIDDK NIH HHS P30 DK114809
6 · The paper itself

Abstract

Background: Recent innovations have the potential to disrupt the current paradigm for kidney failure treatment. The US Food and Drug Administration is committed to incorporating valid scientific evidence about how patients weigh the benefits and risks of new devices into their decision making, but to date, premarket submission of patient preference information (PPI) has been limited for kidney devices. With input from stakeholders, we developed a survey intended to yield valid PPI, capturing how patients trade off the potential benefits and risks of wearable dialysis devices and in-center hemodialysis. Methods: We conducted concept elicitation interviews with individuals receiving dialysis to inform instrument content. After instrument drafting, we conducted two rounds of pretest interviews to evaluate survey face validity, comprehensibility, and perceived relevance. We pilot tested the survey with in-center hemodialysis patients to assess comprehensibility and usability further. Throughout, we used participant input to guide survey refinements. Results: Thirty-six individuals receiving in-center or home dialysis participated in concept elicitation ( Conclusions: The final survey is a 54-item web-based instrument that will yield estimates of the maximal acceptable risk for the described wearable device and willingness to wait for wearable devices with lower risk.

Indexed as

Kidney Failure, ChronicWearable Electronic DevicesHumansPatient PreferenceRenal DialysisRenal Replacement TherapySurveys and Questionnaireschronic dialysisclinical trialdialysisend stage kidney diseaseend stage renal diseaseESRDhemodialysisinnovationkidney failurepatient preferencerenal replacement therapywearable electronic devices

Identifiers

PMID35919522
PMCPMC9337889

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.