Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital.

R, Dahan; Caulin, C; Figea, L; Kanis, J. A.; Caulin, F.; Segrestaa, J. M.

doi:10.1136/bmj.293.6543.363

Cited by 49 publications

(19 citation statements)

References 10 publications

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“…Two studies randomised 82 patients to “n of 1 trials” compared with standard practice—that is, randomised, double blind, multiple crossover comparisons of an active drug with a placebo in a single patient 9 10. One study (60 patients) measured spontaneously self reported side effects in patients who had or had not been informed that they were in an RCT 11. One study (227 patients) reported satisfaction among patients randomised to an RCT compared with patients randomised to a patient preference trial in which they had a choice of treatment 12.…”

Section: Resultsmentioning

confidence: 99%

Systematic review to determine whether participation in a trial influences outcome

Vist

Hagen

Devereaux

et al. 2005

BMJ

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Objective To systematically compare the outcomes of participants in randomised controlled trials (RCTs) with those in comparable non-participants who received the same or similar treatment. Data sources Bibliographic databases, reference lists from eligible articles, medical journals, and study authors. Review methods RCTs and cohort studies that evaluated the clinical outcomes of participants in RCTs and comparable non-participants who received the same or similar treatment. Results Five RCTs (six comparisons) and 50 cohort studies (85 comparisons) provided data on 31 140 patients treated in RCTs and 20 380 comparable patients treated outside RCTs. In the five RCTs, in which patients were given the option of participating or not, the comparisons provided limited information because of small sample sizes (a total of 412 patients) and the nature of the questions considered. 73 dichotomous outcomes were compared, of which 59 reported no statistically significant differences. For patients treated within RCTs, 10 comparisons reported significantly better outcomes and four reported significantly worse outcomes. Significantly heterogeneity was found (I 2 = 89%) among the comparisons of 73 dichotomous outcomes; none of our a priori explanatory factors helped explain this heterogeneity. The 18 comparisons of continuous outcomes showed no significant differences in heterogeneity (I 2 = 0%). The overall pooled estimate for continuous outcomes of the effect of participating in an RCT was not significant (standardised mean difference 0.01, 95% confidence interval − 0.10 to 0.12). Conclusion No strong evidence was found of a harmful or beneficial effect of participating in RCTs compared with receiving the same or similar treatment outside such trials.

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Section: Resultsmentioning

confidence: 99%

Systematic review to determine whether participation in a trial influences outcome

Vist

Hagen

Devereaux

et al. 2005

BMJ

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“…Does the fact of asking for fully informed consent and providing the necessary information on which to base a decision, affect therapeutic outcome? Dahan et al 8 investigated this possibility in a clinical trial of the hypnotic activity of a placebo. Patients were paired and one of each pair was assigned to a control group where there was no informed consent.…”

Section: Informed Consent -Help or Hindrancementioning

confidence: 99%

Informed Consent - Help or Hindrance

Marsh

1990

J R Soc Med

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“…On the other hand, it has been demonstrated that obtaining an informed consent per se affects the outcome of the clinical trial. Patients who were informed of the potential side effects were more likely to report such side effects or to withdraw from the study (Dahan et al, 1986). Such ®ndings were seen by some to support not seeking consent (Baum, 1986).…”

Section: The Null Hypothesismentioning

confidence: 95%

The Inter-role Confidentiality Conflict in Recruitment for Clinical Research

Habiba

Evans²

2002

The Journal of Medicine and Philosophy

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Recruiting patients into clinical research is essential for the advancement of medical knowledge. However, when the physician undertaking the care of the patient is also responsible for recruitment into clinical research, a situation arises of an inter-role breach of confidentiality which is distinguishable from other conflicts of interest. Such discord arises as the physician utilizes confidential information obtained within the therapeutic relationship beyond its primary objective, and safeguards ought to be observed in order to avert this important, and generally overlooked, problem. The moral worth of the pledge of confidentiality is based not on its innate value but on its being a promise on which subsequent interactions and disclosures are founded. Within the patient-doctor interaction, confidentiality is an important facet of the promised fidelity and, as such, a loose interpretation of the notion threatens the essence of the relationship, and any violation thereof requires compelling moral justification. To avoid conflict, patients' confidential information ought not be used for the purpose of recruitment, which needs to be undertaken through general education and non-directed appeals, and a preliminary consent to be approached for research should be obtained from the patient prior to her being identified as a suitable research subject. Securing this prior consent would avoid one source of potential, albeit unintended, coercion.

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Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital.

Cited by 49 publications

References 10 publications

Systematic review to determine whether participation in a trial influences outcome

Systematic review to determine whether participation in a trial influences outcome

Informed Consent - Help or Hindrance

The Inter-role Confidentiality Conflict in Recruitment for Clinical Research

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