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The Hawthorne effect as a pre-placebo expectation in Parkinsons disease patients participating in a randomized placebo-controlled clinical study.

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Title: The Hawthorne effect as a pre-placebo expectation in Parkinsons disease patients participating in a randomized placebo-controlled clinical study.
Authors: Morberg, Bo Mohr, Malling, Anne Sofie, Jensen, Bente Rona, Gredal, Ole, Wermuth, Lene, Bech, Per
Source: Nordic Journal of Psychiatry. Aug2018, Vol. 72 Issue 6, p442-446. 5p.
Subjects: Electromagnetic pulses, Electromagnetic fields, Diseases, Parkinson's disease
Abstract: Background: The Hawthorne effect on clinical studies in Parkinson's disease has not been thoroughly investigated. Evidently the Hawthorne effect may have impact on study outcomes acting as a 'pre-placebo' effect in the recruitment phase, hence before inclusion. Aim: The aim of this study was to discuss the Hawthorne effect in relation to clinical and self-reported outcome measures in a randomized clinical study in the recruitment phase and during the study. Methods: Data from 97 participants with Parkinson's disease treated with Transcranial Pulsed Electromagnetic Fields were applied, randomized to an active (n = 49) or a placebo treated group (n = 48). The participants received one home treatment session, for eight consecutive weeks. Outcome measures were the Unified Parkinson's Disease Rating Scale, The 39-item Parkinson's Disease Questionnaire and the WHO-5. Results: No difference in treatment effect between the two groups was found pertaining the Unified Parkinson's Disease Rating Scale. No difference in treatment effect between the two groups was found pertaining the 39-item Parkinson's Disease Questionnaire, apart from the dimension mobility. No difference in treatment effect between the two groups was found pertaining the WHO-5 scale. Conclusions: The Hawthorne effect may have caused a 'pre-placebo' effect on the outcome measures even before obtaining baseline outcomes measures. This study may have been particularly prone to a Hawthorne effect due to the intense contact with the participants before and during the study. Moreover, the Hawthorne effect should not be viewed upon as a single entity but rather as entities affecting outcome measures throughout the full study period. [ABSTRACT FROM AUTHOR]
Copyright of Nordic Journal of Psychiatry is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: The Hawthorne effect as a pre-placebo expectation in Parkinsons disease patients participating in a randomized placebo-controlled clinical study.
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  Data: <searchLink fieldCode="JN" term="%22Nordic+Journal+of+Psychiatry%22">Nordic Journal of Psychiatry</searchLink>. Aug2018, Vol. 72 Issue 6, p442-446. 5p.
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  Data: <searchLink fieldCode="DE" term="%22Electromagnetic+pulses%22">Electromagnetic pulses</searchLink><br /><searchLink fieldCode="DE" term="%22Electromagnetic+fields%22">Electromagnetic fields</searchLink><br /><searchLink fieldCode="DE" term="%22Diseases%22">Diseases</searchLink><br /><searchLink fieldCode="DE" term="%22Parkinson's+disease%22">Parkinson's disease</searchLink>
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  Data: Background: The Hawthorne effect on clinical studies in Parkinson's disease has not been thoroughly investigated. Evidently the Hawthorne effect may have impact on study outcomes acting as a 'pre-placebo' effect in the recruitment phase, hence before inclusion. Aim: The aim of this study was to discuss the Hawthorne effect in relation to clinical and self-reported outcome measures in a randomized clinical study in the recruitment phase and during the study. Methods: Data from 97 participants with Parkinson's disease treated with Transcranial Pulsed Electromagnetic Fields were applied, randomized to an active (n = 49) or a placebo treated group (n = 48). The participants received one home treatment session, for eight consecutive weeks. Outcome measures were the Unified Parkinson's Disease Rating Scale, The 39-item Parkinson's Disease Questionnaire and the WHO-5. Results: No difference in treatment effect between the two groups was found pertaining the Unified Parkinson's Disease Rating Scale. No difference in treatment effect between the two groups was found pertaining the 39-item Parkinson's Disease Questionnaire, apart from the dimension mobility. No difference in treatment effect between the two groups was found pertaining the WHO-5 scale. Conclusions: The Hawthorne effect may have caused a 'pre-placebo' effect on the outcome measures even before obtaining baseline outcomes measures. This study may have been particularly prone to a Hawthorne effect due to the intense contact with the participants before and during the study. Moreover, the Hawthorne effect should not be viewed upon as a single entity but rather as entities affecting outcome measures throughout the full study period. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Nordic Journal of Psychiatry is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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