Evidence map›Paper›PMID 35669971›Full record

ArticleTransplant international : official journal of the European Society for Organ Transplantation2022

Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions.

Allison Tong, Rainer Oberbauer, Maria Irene Bellini, Klemens Budde, Fergus J Caskey, Fabienne Dobbels, Liset Pengel, Lionel Rostaing, Stefan Schneeberger, Maarten Naesens

Open access · goldAbstract readEditorial
In one paragraph

Article in Transplant international : official journal of the European Society for Organ Transplantation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% of its field
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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Editorial: Living Well After Organ Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Embracing the Wisdom of Ancient Greece in the Era of Personalized Medicine-Uncertainty, Probabilistic Reasoning, and Democratic Consensus.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  17. Article
  18. Review
  19. Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    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

10 authors at 7 institutions in 6 countries.

Allison TongSydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
Rainer OberbauerDepartment of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.
Maria Irene BelliniDepartment of Surgical Sciences, Sapienza University of Rome, Rome, Italy.
Klemens BuddeDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany.
Fergus J CaskeyDepartment of Population Health Sciences, University of Bristol, Bristol, United Kingdom.
Fabienne DobbelsDepartment of Public Health and Primary Care, Academic Center for Nursing and Midwifery, KU Leuven, Leuven, Belgium.
Liset PengelCentre for Evidence in Transplantation, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
Lionel RostaingDepartment of Nephrology, Dialysis and Transplantation, Toulouse University Hospital, Toulouse, France.
Stefan SchneebergerDepartment of General, Transplant and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Maarten NaesensDepartment of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
KU Leuven · BEGerman Society of Medical Intensive Care and Emergency Medicine · DEMedical University of Vienna · ATNuffield Orthopaedic Centre · GBSapienza University of Rome · ITSydney Local Health District · AUUniversity of Bristol · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patient-reported outcomes (PROs) that assess individuals' perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interventional trials that aim to improve outcomes for transplant recipients. Using PRO measures (PROMs) in clinical trials facilitates assessment of the patient's perspective of their health, but few measures have been developed and evaluated in kidney transplant recipients; robust methodologies, which use validated instruments and established frameworks for reporting, are essential. Establishing a core PROM for life participation in kidney transplant recipients is a critically important need, which is being developed and validated by the Standardized Outcomes in Nephrology (SONG)-Tx Initiative. Measures involving electronic medication packaging and smart technologies are gaining traction for monitoring adherence, and could provide more robust information than questionnaires, interviews, and scales. This article summarizes information on PROs and PROMs that was included in a Broad Scientific Advice request on clinical trial design and endpoints in kidney transplantation. This request was submitted to the European Medicines Agency (EMA) by the European Society for Organ Transplantation in 2016. Following modifications, the EMA provided its recommendations in late 2020.

Indexed as

Kidney TransplantationNephrologyHumansPatient Reported Outcome MeasuresQuality of LifeSurveys and QuestionnairesTransplant Recipientsadherencelife participationpatient perspectivepatient-reported outcome measure (PROM)PROMIS®SONG-Tx

Identifiers

PMID35669971
PMCPMC9163311
OpenAlexW4280591734

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.