Evidence map›Paper›PMID 18563051›Full record

ReviewKidney international2008

Negative trials in nephrology: what can we learn?

James E Novak, Jula K Inrig, Uptal D Patel, Robert M Califf, Lynda A Szczech

Abstract readReview
In one paragraph

Review in Kidney international, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Measuring quality of life in trials including patients on haemodialysis: methodological issues surrounding the use of the Kidney Disease Quality of Life Questionnaire.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Pooled it
  2. Pooled it
  3. The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2014
    Pooled it
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Hemodialysis vascular access monitoring: current concepts.Hemodialysis international. International Symposium on Home Hemodialysis · 2009
    Review
  10. 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

5 authors.

James E NovakDivision of Nephrology, Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA. novak005@mc.duke.edu
Jula K Inrig
Uptal D Patel
Robert M Califf
Lynda A Szczech

Funding

Duke CTSIKL2RR024127 · NCRR · DUKE UNIVERSITY · PI CALIFF, ROBERT M · 2006 to 2011
$3.9M
Barriers to Optimal Cardiovascular Medication Use in Diabetes and Renal DiseaseK23DK075929 · NIDDK · DUKE UNIVERSITY · PI PATEL, UPTAL D · 2006 to 2010
$677k
NCRR NIH HHS KL2 RR024127NIDDK NIH HHS K23 DK075929
6 · The paper itself

Abstract

Chronic kidney disease is assuming epidemic proportions, and an increasing number of clinical trials are testing treatments developed to improve morbidity and mortality. Surprisingly, however, a large proportion of these trials have had negative or neutral results. When trials unexpectedly demonstrate either no benefit or a detrimental impact of a treatment, especially when that treatment is already used in practice, critics commonly argue that the results were dictated by flawed trial design rather than the intrinsic properties of the treatment. In kidney disease therapeutics, trials commonly rely on observational data and test the hypothesis that these associations may be extrapolated to cause-and-effect. Other key issues in trial design that may affect outcomes include the impact of enrolling relatively healthier subjects, the complexity of recruiting participants with specific characteristics while maintaining generalizability, and the subtleties of event adjudication and quality of life assessments. In this article, general principles of trial design will be discussed and the potential lessons learned from recent trials in nephrology will be critically reviewed.

Indexed as

Chronic DiseaseClinical ProtocolsClinical Trials as TopicHumansKidney DiseasesPatient SelectionTreatment Outcome

Identifiers

PMID18563051
PMCPMC3660228

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.