Evidence map›Paper›PMID 22136977›Full record

ArticleClinical therapeutics2011

Characteristics of successful recruitment in prospective pediatric pharmacogenetic studies.

Shannon N Saldaña, David K Hooper, Tanya E Froehlich, Kathleen M Campbell, Cynthia A Prows, Senthilkumar Sadhasivam, Todd G Nick, Michael Seid, Alexander A Vinks, Tracy A Glauser

Abstract read
In one paragraph

Article in Clinical therapeutics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 18% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. 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 at 3 institutions in 1 country.

Shannon N SaldañaDivision of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. snsaldana@gmail.com
David K Hooper
Tanya E Froehlich
Kathleen M Campbell
Cynthia A Prows
Senthilkumar Sadhasivam
Todd G Nick
Michael Seid
Alexander A Vinks
Tracy A Glauser
University of Cincinnati Medical Center · USCincinnati Children's Hospital Medical Center · USUniversity of Arkansas for Medical Sciences · US

Funding

Pursuing Perfection in Pediatric TherapeuticsU18HS016957 · AHRQ · CINCINNATI CHILDRENS HOSP MED CTR · PI LANNON, CAROLE MARIE · 2007 to 2010
$4.0M
CHMCC Pediatric Pharmacology Research UnitU10HD037249 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI VINKS, ALEXANDER A · 2004 to 2009
$1.8M
Medication Response in Children with Predominantly Inattentive Type ADHDK23MH083881 · NIMH · CINCINNATI CHILDRENS HOSP MED CTR · PI FROEHLICH, TANYA E. · 2009 to 2013
$865k
AHRQ HHS 18-HS016957-01AHRQ HHS U18 HS016957NICHD NIH HHS 5U10HD037249NICHD NIH HHS U10 HD037249NIMH NIH HHS K23 MH083881NIMH NIH HHS K23MH083881
6 · The paper itself

Abstract

backgroundThere is a need to explore feasible means of accruing an appropriate study cohort to help fill the knowledge gap between pharmacogenetic contributions to drug response and clinical application in the pediatric population.

objectivesThe aim of this study was to identify factors affecting recruitment of eligible subjects in pharmacogenetic studies at a large Midwestern pediatric academic medical center. The objectives were to evaluate recruitment success of ongoing trials and ascertain contributors to differential recruitment rates. We hypothesized that studies with good recruitment of eligible subjects would share characteristics not present in studies with lower than anticipated recruitment. The goal was to better understand barriers to good recruitment in pharmacogenetic studies to help inform future trial and infrastructure design.

methodsInvestigators designed a survey with proposed elements of success, which was then completed by lead and/or site investigators of all pharmacogenetics studies at the institution. Results were evaluated using an investigator-developed likelihood of success scoring system.

resultsTwo studies recruited >95% of the approached eligible patients; 4 studies were consistent with investigator-anticipated recruitment (>50%), and 1 study did not meet expected recruitment. A study's total score on the investigator-devised scoring tool correlated well with the proportion of approached patients recruited (Pearson's correlation, r = 0.82; P < 0.001). Multiple factors impacted successful recruitment into these pharmacogenetic studies. Features of studies with successful recruitment included standardized clinical care, an ongoing team-patient relationship, severe and/or life-threatening outcome measures, study coordinator with experience in clinical research, a study medication with few or no alternative treatment options, and active involvement of the research team in clinical care.

conclusionsA scoring system for study characteristics may be useful to calculate the risk of failure for successful recruitment, allow discrimination among characteristics contributing to the risk, and permit study design alterations to improve likelihood of successful recruitment in pediatric pharmacogenetic studies.

Indexed as

Patient SelectionResearch DesignSample SizeAcademic Medical CentersAdolescentAge FactorsChildChild, PreschoolClinical Trials as TopicHumansInfantInfant, NewbornLinear ModelsOhioPharmacogeneticsProspective Studies

Identifiers

PMID22136977
PMCPMC3319746
OpenAlexW2025478036

What OpenQuestion holds

Textmetadata
LicenceTDM
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.