Evidence map›Paper›PMID 25115882›Full record

ArticleClinical trials (London, England)2014

The transitioning from trials to extended follow-up studies.

Lea T Drye, Anne S Casper, Alice L Sternberg, Janet T Holbrook, Gabrielle Jenkins, Curtis L Meinert

Open access · greenAbstract read
In one paragraph

Article in Clinical trials (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
2.3field-weighted citation impact, top 8% 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

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Trial
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

6 authors at 1 institution in 1 country.

Lea T DryeDepartment of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA ldrye@jhu.edu.
Anne S CasperDepartment of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA.
Alice L SternbergDepartment of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA.
Janet T HolbrookDepartment of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA.
Gabrielle JenkinsDepartment of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA.
Curtis L MeinertDepartment of Epidemiology, Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA.
Johns Hopkins University · US

Funding

ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KOSMISKI, LISA A. · 1985 to 2008
$52.6M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
PREVENTION OF ALZHEIMER DEMENTIA &COGNITIVE DECLINEU01AG015477 · NIA · UNIVERSITY OF WASHINGTON · PI BREITNER, JOHN C S · 2000 to 2010
$44.4M
Multi-Center Uveitis Steriod Treatment (MUST) TrialU10EY014660 · NEI · JOHNS HOPKINS UNIVERSITY · PI HOLBROOK, JANET T. · 2004 to 2016
$33.6M
YOGA FOR THE MANAGEMENT OF HIV-METABOLIC SYNDROMESM01RR000036 · NCRR · WASHINGTON UNIVERSITY · PI NEWCOMER, JOHN W. · 1985 to 2007
$25.4M
ZINC THERAPY FOR SCLERODERMA--PHASE I STUDYM01RR002719 · NCRR · JOHNS HOPKINS UNIVERSITY · PI EARLEY, CHRISTOPHER J · 1986 to 2007
$20.2M
CAMPCS/3U01HL075408 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2003 to 2010
$4.9M
Multicenter Uveitis Steroid Treatment (MUST) TrialU10EY014655 · NEI · JOHNS HOPKINS UNIVERSITY · PI JABS, DOUGLAS A · 2004 to 2016
$4.6M
Reading Center: Multicenter Uveitis Steroid TrialU10EY014656 · NEI · UNIVERSITY OF WISCONSIN-MADISON · PI ALTAWEEL, MICHAEL M · 2004 to 2015
$2.2M
CAMP Continuation Study/Phase 3U01HL075419 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI FUHLBRIGGE, ANNE L · 2003 to 2010
$2.0M
CAMP Continuation Study/Phase 3U01HL075409 · NHLBI · ASTHMA, INC. · PI WILLIAMS, PAUL V · 2003 to 2010
$1.6M
CAMP Continuation Study/Phase 3U01HL075417 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI ADKINSON, N FRANKLIN · 2003 to 2010
$1.4M
NCATS NIH HHS UL1 TR001082NCRR NIH HHS M01 RR000036NCRR NIH HHS M01 RR000051NCRR NIH HHS M01RR00051NCRR NIH HHS M01 RR002719NCRR NIH HHS M01RR0099718-24NCRR NIH HHS M01RR02719-14NCRR NIH HHS RR00036NEI NIH HHS U10 EY014655NEI NIH HHS U10EY014655NEI NIH HHS U10 EY014656NEI NIH HHS U10EY014656NEI NIH HHS U10 EY014660NEI NIH HHS U10EY014660NHLBI NIH HHS N01 HR016044NHLBI NIH HHS N01 HR016045NHLBI NIH HHS N01 HR016046NHLBI NIH HHS N01 HR016047NHLBI NIH HHS N01 HR016048NHLBI NIH HHS N01 HR016049NHLBI NIH HHS N01 HR016050NHLBI NIH HHS N01 HR016051NHLBI NIH HHS N01 HR016052NHLBI NIH HHS N01-HR-16044NHLBI NIH HHS N01-HR-16045NHLBI NIH HHS N01-HR-16046NHLBI NIH HHS N01-HR-16047NHLBI NIH HHS N01-HR-16048NHLBI NIH HHS N01-HR-16049NHLBI NIH HHS N01-HR-16050NHLBI NIH HHS N01-HR-16051NHLBI NIH HHS N01-HR-16052NHLBI NIH HHS U01 HL075232NHLBI NIH HHS U01HL075232NHLBI NIH HHS U01 HL075407NHLBI NIH HHS U01HL075407NHLBI NIH HHS U01 HL075408NHLBI NIH HHS U01HL075408NHLBI NIH HHS U01 HL075409NHLBI NIH HHS U01HL075409NHLBI NIH HHS U01 HL075415NHLBI NIH HHS U01HL075415NHLBI NIH HHS U01 HL075416NHLBI NIH HHS U01HL075416NHLBI NIH HHS U01 HL075417NHLBI NIH HHS U01HL075417NHLBI NIH HHS U01 HL075419NHLBI NIH HHS U01HL075419NHLBI NIH HHS U01 HL075420NHLBI NIH HHS U01HL075420NIA NIH HHS U01 AG015477NIA NIH HHS U01AG015477NIA NIH HHS U01AG15477
6 · The paper itself

Abstract

backgroundInvestigators may elect to extend follow-up of participants enrolled in a randomized clinical trial after the trial comes to its planned end. The additional follow-up may be initiated to learn about longer term effects of treatments, including adverse events, costs related to treatment, or for reasons unrelated to treatment such as to observe the natural course of the disease using the established cohort from the trial. PURPOSE: We examine transitioning from trials to extended follow-up studies when the goal of additional follow-up is to observe longer term treatment effects.

methodsWe conducted a literature search in selected journals from 2000 to 2012 to identify trials that extended follow-up for the purpose of studying longer term treatment effects and extracted information on the operational and logistical issues in the transition. We also draw experience from three trials coordinated by the Johns Hopkins Coordinating Centers that made transitions to extended follow-up: the Alzheimer's Disease Anti-inflammatory Prevention Trial, Multicenter Uveitis Steroid Treatment trial, and Childhood Asthma Management Program.

resultsTransitions are not uncommon in multicenter clinical trials, even in trials that continued to the planned end of the trial. Transitioning usually necessitates new participant consents. If study infrastructure is not maintained during the transition, participants will be lost and re-establishing the staff and facilities will be costly. Merging data from the trial and follow-up study can be complicated by changes in data collection measures and schedules. LIMITATIONS: Our discussion and recommendations are limited to issues that we have experienced in transitions from trials to follow-up studies. DISCUSSION: We discuss issues such as maintaining funding, institutional review board and consent requirements, contacting participants, and combining data from the trial and follow-up phases. We conclude with a list of recommendations to facilitate transitions from a trial to an extended follow-up study.

Indexed as

Follow-Up StudiesRandomized Controlled Trials as TopicHumansMulticenter Studies as TopicOutcome Assessment, Health CareClinical trialextended follow-upmorphingtransitioning

Identifiers

PMID25115882
PMCPMC4229418
OpenAlexW2111451701

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Registered trials

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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.