Evidence map›Paper›PMID 31697042›Full record

ArticleHemodialysis international. International Symposium on Home Hemodialysis2020

Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.

Troy J Plumb, Luis Alvarez, Dennis L Ross, Joseph J Lee, Jeffrey G Mulhern, Jeffrey L Bell, Graham Abra, Sarah S Prichard, Glenn M Chertow, Michael A Aragon

Abstract readMulticenter Study
In one paragraph

Article in Hemodialysis international. International Symposium on Home Hemodialysis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

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

  1. Home versus in-centre haemodialysis for people with kidney failure.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Self-care training using the Tablo hemodialysis system.Hemodialysis international. International Symposium on Home Hemodialysis · 2021
    Article
  10. Patient-reported outcomes from the investigational device exemption study of the Tablo hemodialysis system.Hemodialysis international. International Symposium on Home Hemodialysis · 2020
    Article
  11. Article
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

10 authors.

Troy J PlumbUniversity of Nebraska, Nebraska Medical Center, Omaha, Nebraska, USA.
Luis AlvarezPalo Alto Medical Foundation, Palo Alto, California, USA.
Dennis L RossKansas Nephrology Research Institute, Wichita, Kansas, USA.
Joseph J LeeNephrology Associates Medical Group, Riverside, California, USA.
Jeffrey G MulhernFresenius Kidney Care Pioneer Valley Dialysis, West Springfield, Massachusetts, USA.
Jeffrey L BellSouthwest Georgia Nephrology Clinic, Albany, Georgia, USA.
Graham AbraSatellite Healthcare, Mountain View, California, USA.
Sarah S PrichardUniversity of Western Ontario, London, Ontario, Canada.
Glenn M ChertowStanford University School of Medicine, Palo Alto, California, USA.
Michael A AragonClinical Development, Outset Medical, San Jose, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHome hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers.

methodsA prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/V

findingsThirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/V

conclusionPrimary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.

Indexed as

AdolescentAdultAgedCohort StudiesCross-Over StudiesFemaleHemodialysis, HomeHumansKidney Failure, ChronicMaleMiddle AgedProspective StudiesRenal DialysisYoung AdultAdequacy of dialysishemodialysishemodialysis delivery systemshomekineticsvolume control

Identifiers

PMID31697042
PMCPMC7027451

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.