Transparency in the presentation of trial results may not increase patients' trust in medical researchers.
Clin Trials
; 9(1): 90-3, 2012 Feb.
Article
em En
| MEDLINE
| ID: mdl-22049088
ABSTRACT
BACKGROUND:
One of the expected benefits of sharing trial results with participants is that it may enhance trust in medical researchers (TMRs).PURPOSE:
In a prospective study on a sample of clinical trial participants, we investigated the effect on the participants' TMRs of providing final trial results to participants via the Internet.METHODS:
Participants in the FNCLCC-PACS04 trial (ClinicalTrials.gov Identifier NCT00054587) were surveyed on average 6 years after enrollment, when the trial results were available. In the current study, they were randomized to receive (experimental group) or not to receive (control group) a letter informing them that the results of the trial could be consulted on a specific website. TMRs was measured before randomization and 6 months later using mailed self-administered questionnaires.RESULTS:
The response rate was 93% (N = 107). TMRs remained unchanged in the control group (mean effect size = -0.06, 95% confidence interval (CI) -0.28 to 0.17, p = 0.617) but decreased in the experimental group (-0.30, 95% CI -0.53 to -0.06, p = 0.015). However, the difference between the two effect sizes was not statistically significant (p = 0.144).LIMITATIONS:
The results obtained here on the disclosure of final trial results to breast cancer patients via the Internet cannot be generalized to all situations involving the disclosure of phase III randomized controlled trial results.CONCLUSIONS:
Transparency is an ethical research requirement, but it may not enhance participants' TMRs.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pacientes
/
Pesquisadores
/
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Revelação
/
Confiança
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Qualitative_research
Limite:
Female
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Humans
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Middle aged
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article