Evidence map›Paper›PMID 22640513›Full record

Trial reportThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2012

Reasons for non-participation in an international multicenter trial of a new drug for tuberculosis treatment.

D Lamunu, K N Chapman, P Nsubuga, G Muzanyi, Y Mulumba, M A Mugerwa, S Goldberg, L Bozeman, M Engle, J Saukkonen and 3 more

Abstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Article
  2. Reasons for acceptance or nonparticipation in iAdhere: a trial of latent TB infection treatment.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2024
    Article
  3. Article
  4. Article
  5. Article
  6. 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

13 authors.

D LamunuUganda-Case Western Reserve University Research Collaboration, Kampala, Uganda. DLamunu@mucwru.or.ug
K N Chapman
P Nsubuga
G Muzanyi
Y Mulumba
M A Mugerwa
S Goldberg
L Bozeman
M Engle
J Saukkonen
S Mastranunzio
H Mayanja-Kizza
J L Johnson

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

settingClinical trials can provide a high standard of patient care and contribute to scientific knowledge; however, only a fraction of the patients screened participate and receive treatment as part of a trial.

objectiveTo explore reasons why patients were not enrolled in an international tuberculosis (TB) treatment trial and to compare experiences among study sites.

designAn analysis of reasons why patients were not enrolled was conducted among patients screened for a TB clinical trial at 26 sites in North and South America, Africa, and Europe.

resultsStaff at study sites screened 1119 potential candidates for the trial: 61% (n = 686) were not enrolled due to 1) failure to meet eligibility criteria (n = 405, 59%), 2) site's decision (n = 168, 24%), or 3) candidate's choice (n = 113, 16%). Study staff recorded a total of 144 reasons for why they believed patients chose not to participate, including concerns over research (28%), conflicts with work or school (21%), and lifestyle and family issues (20%). Socio-demographic and geographic factors also influenced participation.

conclusionIncreased evaluation of screening outcomes and of specific interventions, such as improved education and communication about trial procedures, may increase the efficiency of screening and enrollment in clinical trials.

Indexed as

Patient SelectionAdolescentAdultAgedAged, 80 and overAntitubercular AgentsChildDouble-Blind MethodFemaleHumansMaleMiddle AgedProspective StudiesRefusal to ParticipateTuberculosisYoung AdultAntitubercular Agents

Identifiers

PMID22640513
PMCPMC5349184

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.