Original articleFitting a routine health-care activity into a randomized trial: An experiment possible without informed consent?
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Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges
2019, Journal of the American Medical Directors AssociationCitation Excerpt :If the NH agrees to adopt 1 of the 2 approaches for research, individual residents would not be able to decline participation if the approaches were considered standard of care. Several studies in non-NH settings have argued that research processes embedded in routine health care activities and of minimal risk to the residents do not require informed consent.20,21,38 Depending on the interventions studied, investigators may consider informing residents and families either during or after the study.
Cluster randomised trials: An important method in primary care research
2009, Zeitschrift fur Evidenz, Fortbildung und Qualitat im GesundheitswesenImpact of 2 different levels of performance feedback on compliance with infection control process measures in 2 intensive care units
2008, American Journal of Infection ControlCitation Excerpt :The majority of respondents was also aware that their infection control practices were being observed during the final study phase. The Hawthorne effect, a phenomenon of altered behavior resulting from awareness of being observed, typically occurs during monitoring and feedback.15 To reduce this effect, we randomly observed the process measures by ICPs who routinely conducted a surveillance of HAIs in that unit, and the observers were as unobtrusive as possible.
Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering
2004, Journal of Clinical EpidemiologyCitation Excerpt :Such a design might provide more accurate answers to the problem of the magnitude of the nonspecific effects. Moreover, we did not handle other nonspecific effects, such as the fact that contact between intervention and control physicians can influence outcome, as physicians talk about the quality strategy under study, an effect commonly known as across subject contamination effect or leaking effect [8,25]. We assume that this effect is not particularly great, because GPs normally do not discuss test-ordering performance among themselves and the teams were located in different regions.
Impact of the Hawthorne effect in a longitudinal clinical study: The case of anesthesia
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