Evidence map›Paper›PMID 18385390›Full record

ArticleClinical journal of the American Society of Nephrology : CJASN2008

Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study.

Susan T Crowley, Glenn M Chertow, Joseph Vitale, Theresa O'Connor, Jane Zhang, Roland M H Schein, Devasmita Choudhury, Kevin Finkel, Anitha Vijayan, Emil Paganini and 2 more

Abstract read
In one paragraph

Article in Clinical journal of the American Society of Nephrology : CJASN, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 12% 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

12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Timing of kidney replacement therapy initiation for acute kidney injury.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Pooled it
  3. Timing of renal replacement therapy initiation for acute kidney injury.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Intensity of continuous renal replacement therapy for acute kidney injury.The Cochrane database of systematic reviews · 2016
    Pooled it
  5. Intermittent high-volume predilution on-line haemofiltration versus standard intermittent haemodialysis in critically ill patients with acute kidney injury: a prospective randomized study.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2012
    Trial
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Strategies to Maximize Enrollment in a Prospective Study of Comatose Children in the PICU.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016
    Article
  11. Article
  12. 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

12 authors at 8 institutions in 1 country.

Susan T CrowleyRenal Section (111F), VA Connecticut Healthcare System, 950 Campbell Avenue, West Haven, CT 06516, USA. susan.crowley@yale.edu
Glenn M Chertow
Joseph Vitale
Theresa O'Connor
Jane Zhang
Roland M H Schein
Devasmita Choudhury
Kevin Finkel
Anitha Vijayan
Emil Paganini
Paul M Palevsky
VA/NIH Acute Renal Failure Trial Network Study Group
Program Support Center · USCleveland Clinic · USThe University of Texas Health Science Center at Houston · USUniversity of California, San Francisco · USUniversity of Miami · USUniversity of Pittsburgh · USVA Connecticut Healthcare System · USWashington University in St. Louis · US

Funding

NIDDK NIH HHS Y01 DK003508NIDDK NIH HHS Y1-DK-3508-01
6 · The paper itself

Abstract

BACKGROUND AND

objectivesDesign elements of clinical trials can introduce recruitment bias and reduce study efficiency. Trials involving the critically ill may be particularly prone to design-related inefficiencies. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Enrollment into the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study was systematically monitored. Reasons for nonenrollment into this study comparing strategies of renal replacement therapy in critically ill patients with acute kidney injury were categorized as modifiable or nonmodifiable.

results4339 patients were screened; 2744 fulfilled inclusion criteria. Of these, 1034 were ineligible by exclusion criteria. Of the remaining 1710 patients, 1124 (65.7%) enrolled. Impediments to informed consent excluded 21.4% of potentially eligible patients. Delayed identification of potential patients, physician refusal, and involvement in competing trials accounted for 4.4, 2.7, and 2.3% of exclusions. Comfort measures only status, chronic illness, chronic kidney disease, and obesity excluded 11.8, 7.8, 7.6, and 5.9% of potential patients. Modification of an enrollment window reduced the loss of patients from 6.6 to 2.3%.

conclusionsThe Acute Renal Failure Trial Network Study's enrollment efficiency compared favorably with previous intensive care unit intervention trials and supports the representativeness of its enrolled population. Impediments to informed consent highlight the need for nontraditional acquisition methods. Restrictive enrollment windows may hamper recruitment but can be effectively modified. The low rate of physician refusal acknowledges clinical equipoise in the study design. Underlying comorbidities are important design considerations for future trials that involve the critically ill with acute kidney injury.

Indexed as

HemodiafiltrationPatient SelectionRandomized Controlled Trials as TopicRenal DialysisAcute Kidney InjuryBiasClinical Trials as TopicCritical IllnessHumansInformed ConsentIntensive Care UnitsMulticenter Studies as TopicNational Institutes of Health (U.S.)Research DesignTreatment OutcomeUnited States

Identifiers

PMID18385390
PMCPMC2440269
OpenAlexW2107307692

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.