Are randomized clinical trials good for us (in the short term)? Evidence for a “trial effect”

Braunholtz, David; Edwards, Sarah; Lilford, Richard

doi:10.1016/s0895-4356(00)00305-x

Cited by 482 publications

(391 citation statements)

References 24 publications

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“…Patient-clinician interaction plays an important role in treatment response, and patients in trials do better as they get more attention and time from clinical staff than patients receiving standard care 26, 27 . Therefore, the interactions between patients and the trial team should be standardised so that the “treatment context” (similar attention from doctors, expectations, and settings) are comparable between the groups.…”

Section: Blinding Of Patients Surgeons Outcome Assessors and Caregimentioning

confidence: 99%

“…It is often difficult to determine what is a specific and what is a non-specific effect in a trial 27, 28 , and to disentangle placebo response from response bias or the effect of patient-doctor interactions 29 . It is beyond the scope of this review to discuss definitions of placebo 1, 29 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…It is beyond the scope of this review to discuss definitions of placebo 1, 29 . Whether something is or is not a placebo depends on the intervention and chosen outcome variables 1 , but in order for blinding to be successful, the control procedure has to be as similar as possible to the investigated procedure 27 . Interventional trials differ from drug trials as they require access to the anatomical structure of interest; therefore, they involve a skin incision or an insertion of a scope.…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…Some of the changes observed in a trial may not be related to the treatment or the placebo intervention, but may be caused by the natural course of the disease, spontaneous remissions or fluctuations in the severity of symptoms or regression to the mean 27, 65 . Some changes may be a result of just being in a trial either because of lifestyle changes that are part of the protocol such as self-monitoring using diaries or avoiding alcohol or due to so called “Hawthorne effect”, which refers to change in the behaviour when people, both patients and doctors, know that they are being observed 27 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…Some changes may be a result of just being in a trial either because of lifestyle changes that are part of the protocol such as self-monitoring using diaries or avoiding alcohol or due to so called “Hawthorne effect”, which refers to change in the behaviour when people, both patients and doctors, know that they are being observed 27 . Finally, it has been demonstrated that adhering to a protocol improves the performance of doctors, and that patients who adhere to treatment regimes have better outcomes 66 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

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Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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Section: Blinding Of Patients Surgeons Outcome Assessors and Caregimentioning

confidence: 99%

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

See 3 more Smart Citations

Blinding in trials of interventional procedures is possible and worthwhile

2017

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Implantable Cardioverter Defibrillators and Quality of Life<subtitle>Results From the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation Study</subtitle>

Subačius²,

et al. 2007

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Background: The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study demonstrated that implantable cardioverter defibrillators (ICDs) significantly reduce the risk of sudden cardiac death in patients with nonischemic cardiomyopathy and an ejection fraction of 35% or less, with no statistically significant decrease in overall mortality. The impact of ICD placement and shock on health-related quality of life (HRQL) in this population is unknown. Methods: The 12-Item Medical Outcomes Short-Form Health Survey and the Minnesota Living with Heart Failure Questionnaire were administered to 458 patients with nonischemic cardiomyopathy, an ejection fraction of 35% or less, and either nonsustained ventricular tachycardia or 10 or more premature ventricular depolarizations per hour atbaseline,1monthafterrandomization,andevery3months thereafter throughout the trial. The subjects were randomized to an ICD or standard medical therapy. Outcomes were compared using hierarchical linear regression. Results: Overall, there were no significant differences in HRQL throughout the trial between patients randomized to an ICD or standard medical therapy. However, in patients with 1 or more ICD shocks, HRQL declined 0.5±0.2 (mean±SD) points per shock on the emotional scale of the Minnesota Living with Heart Failure Questionnaire (P=.04) and 1.0±0.5 points per shock on the mental component score of the 12-Item Medical Outcomes Short-Form Health Survey (P =.04). Conclusions: Overall, HRQL was not affected by ICD implantation in patients in the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study. Implantable cardioverter defibrillator shock was associated with a reduction in some measures of HRQL, but the effects were unlikely to result in a clinically observable alteration until 5 or more shocks were experienced.

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