Double blind: Double talk or are there ways to do better research

Ney, Philip G.; Collins, C; Spensor, C.

doi:10.1016/0306-9877(86)90001-0

Cited by 45 publications

(17 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…A basic observation is that efforts to assess blinding to treatment assignment were found in surprisingly few studies or reviews over the past several decades, and rarely in studies of psychiatric treatment [4,8,9,10,11,12,13,14,15,16,17,18,19]. This evidence of a lack of interest in the topic is remarkable, given the importance of blinding, efforts to arrange for it in RCTs, and in view of past recommendations by the CONSORT to report routinely on blinding assessment [22].…”

Section: Discussionmentioning

confidence: 99%

“…Hróbjartsson et al [10], however, with 6%, reported a threefold higher rate in psychiatric trials than in other areas of medicine. Ney et al [13] found a rate of only 4.9% (3/61 trials) in 5 respected psychiatric journals. Overall, despite its obvious importance to the credibility of findings in RCTs, there is remarkably little research on blinding in psychiatry [4,18], and a comprehensive review of the topic is not available.…”

Section: Introductionmentioning

confidence: 99%

“…The topic of verifying the effectiveness of blinding in psychiatric RCTs has been considered from time to time over the past half-century [4,8,11,12,13,14,15,16,17,18,19]. Among very few quantitative assessments, Fergusson et al [17] found that 8/94 trials (8.5%) reported on the effectiveness of blinding in 4 leading psychiatric journals as opposed to the similar figure of 7/97 in general medicine trials.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Systematic Review of Blinding Assessment in Randomized Controlled Trials in Schizophrenia and Affective Disorders 2000-2010

Baethge¹,

Paul²,

Baldessarini³

2013

Psychother Psychosom

View full text Add to dashboard Cite

Background: Blinding is an integral part of many randomized controlled trials (RCTs). However, both blinding and blinding assessment seem to be rarely documented in trial reports. Method: Systematic review of articles on RCTs in schizophrenia and affective disorders research during 2000-2010. Results: Among 2,467 publications, 61 (2.5%; 95% confidence interval: 1.9-3.1%) reported assessing participant, rater, or clinician blinding: 5/672 reports on schizophrenia (0.7%; 0.3-1.6%) and 33/1,079 (3.1%; 2.1-4.2%) on affective disorders, without significant trends across the decade. Rarely was blinding assessed at the beginning, in most studies assessment was at the end. Proportion of patients' and raters' correct guesses of study arm averaged 54.4 and 62.0% per study, with slightly more correct guesses in treatment arms than in placebo arms. Three fourths of responders correctly guessed that they received the active agent. Blinding assessment was more frequently reported in papers on psychotherapy and brain stimulation than on drug trials (5.1%, 1.7-11.9%, vs. 8.3%, 4.3-14.4%, vs. 2.1%, 1.5-2.8%). Lack of assessment of blinding was associated with: (a) positive findings, (b) full industrial sponsorship, and (c) diagnosis of schizophrenia. There was a moderate association of treatment success and blinding status of both trial participants (r = 0.51, p = 0.002) and raters (r = 0.55, p = 0.067). Many RCT reports did not meet CONSORT standards regarding documentation of persons blinded (60%) or of efforts to match interventions (50%). Conclusions: Recent treatment trials in major psychiatric disorders rarely reported on or evaluated blinding. We recommend routine documentation of blinding strategies in reports.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Systematic Review of Blinding Assessment in Randomized Controlled Trials in Schizophrenia and Affective Disorders 2000-2010

Baethge¹,

Paul²,

Baldessarini³

2013

Psychother Psychosom

View full text Add to dashboard Cite

show abstract

“…Blindness checks are reported in less than 5% of the psychotropic drug literature [43]. Fisher and Greenberg [44]conducted a worldwide literature search for psychotropic drug studies that evaluated whether or not the double-blind design had been penetrated.…”

Section: Belief No 1: Antidepressants Are Conclusively More Effectivmentioning

confidence: 99%

Raising Questions about Antidepressants

Antonuccio

Danton

DeNelsky

et al. 1999

Psychother Psychosom

104

View full text Add to dashboard Cite

Antidepressant medication has apparently become the most popular treatment for depression in the USA. Several beliefs about the efficacy of antidepressant medications prevail among mental health professionals and the public. This paper explores relevant research data and raises questions about these beliefs. Many of the common beliefs about these medications are not adequately supported by scientific data. The following issues are raised: (1) industry-funded research studies which result in negative findings sometimes do not get published; (2) placebo washout procedures may bias results in some studies; (3) there are serious questions about the integrity of the double-blind procedure; (4) the ‘true’ antidepressant drug effect in adults appears to be relatively small; (5) there is minimal evidence of antidepressant efficacy in children; (6) side effects are fairly common even with the newer antidepressants; (7) combining medications raises the risk for more serious complications; (8) all antidepressants can cause withdrawal symptoms; (9) genetic influences on unipolar depression appear to be weaker than environmental influences; (10) biochemical theories of depression are as yet unproven; (11) biological markers specific for depression have been elusive; (12) dosage and plasma levels of antidepressants have been minimally related to treatment outcome; (13) preliminary evidence suggests that patients who improve with cognitive-behavioral psychotherapy show similar biological changes as those who respond to medication, and (14) the evidence suggests that psychological interventions are at least as effective as pharmacotherapy in treating depression, even if severe, especially when patient-rated measures are used and long-term follow-up is considered.

show abstract

“…Desondanks wordt de interne validiteit zelden onderzocht door navraag bij de patie¨nten naar wat zij denken gekregen te hebben, of bij de beoordelaars naar wat de patie¨nten volgens hen kregen. Dat was vroeger zo (Ney, Collins, & Spensor, 1986) en is nog steeds zo (Mulrow et al, 1999). Het begrip pact of ignorance van Orne (1969) lijkt hier van toepassing: men doet of zijn neus bloedt, want niemand heeft er belang bij te weten of de proefopzet misschien eigenlijk mislukt of half gelukt is.…”

Section: Onblinderingunclassified

De rol van ‘informed consent’ in placebo-gecontroleerde, dubbelblinde, gerandomiseerde onderzoeken naar de effectiviteit van psychofarmaca

Burg¹

2001

DITH

View full text Add to dashboard Cite

Double blind: Double talk or are there ways to do better research

Cited by 45 publications

References 13 publications

Systematic Review of Blinding Assessment in Randomized Controlled Trials in Schizophrenia and Affective Disorders 2000-2010

Systematic Review of Blinding Assessment in Randomized Controlled Trials in Schizophrenia and Affective Disorders 2000-2010

Raising Questions about Antidepressants

De rol van ‘informed consent’ in placebo-gecontroleerde, dubbelblinde, gerandomiseerde onderzoeken naar de effectiviteit van psychofarmaca

Contact Info

Product

Resources

About