Clinical research is undertaken to evaluate the effectiveness of interventions with known efficacy or of community-based interventions requiring active client participation in their implementation. Conducting this type of clinical research while using the experimental design or randomized clinical trial (RCT) presents methodological and conceptual challenges. These challenges stem from differences between the RCT features and the reality of everyday practice. In practice, clients with different characteristics are cared for, are involved in treatment-related decisions, are not denied treatment if beneficial to them, and participate in the implementation of the intervention under the conditions of everyday life. Incorporating these features into the design of clinical research has been considered as threatening the validity of conclusions regarding the intervention effectiveness. Yet, it is needed to enhance the clinical utility of research findings. The purpose of this methodological study is to determine the influence of selected factors on the validity of a clinical study's conclusions.
The specific aims are to determine the influence of clients' characteristics, research design or treatment options, treatment allocation procedures, and intervention components and dosage on clients' decision to enter treatment and outcome achievement. The theory-driven approach to intervention evaluation will guide the study. Different research designs, treatment options, and measurement methods will be used to obtain a comprehensive data set. This data set will permit the conduct of simulation-type analyses to identify the contribution of the methodological and conceptual factors to the validity of conclusions in clinical research.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
1R01NR005075-01A1
Application #
6283575
Study Section
Nursing Research Study Section (NURS)
Program Officer
Aziz, Noreen M
Project Start
2001-07-01
Project End
2006-03-31
Budget Start
2001-07-01
Budget End
2002-03-31
Support Year
1
Fiscal Year
2001
Total Cost
$327,813
Indirect Cost
Name
University of Toronto
Department
Type
DUNS #
259999779
City
Toronto
State
ON
Country
Canada
Zip Code
M5 1-S8
Sidani, Souraya; Epstein, Dana R; Fox, Mary (2017) Psychometric evaluation of a multi-dimensional measure of satisfaction with behavioral interventions. Res Nurs Health 40:459-469
Sidani, Souraya; Epstein, Dana R (2016) Toward a Conceptualization and Operationalization of Satisfaction With Nonpharmacological Interventions. Res Theory Nurs Pract 30:242-257
Sidani, Souraya; Fox, Mary; Epstein, Dana (2015) Conducting a two-stage preference trial: utility and challenges. Int J Nurs Stud 52:1017-24
Johnson, Kirsten; Sidani, Souraya; Epstein, Dana R (2015) Effects of a Multi-Component Behavioral Intervention (MCI) for Insomnia on Depressive and Insomnia Symptoms in Individuals with High and Low Depression. J Evid Inf Soc Work 12:451-61
Deratnay, Penney; Sidani, Souraya (2013) The effect of insomnia on functional status of community-dwelling older adults. J Gerontol Nurs 39:22-30
Sidani, Souraya; Miranda, Joyal; Epstein, Dana R et al. (2009) Relationships between personal beliefs and treatment acceptability, and preferences for behavioral treatments. Behav Res Ther 47:823-9
Sidani, Souraya; Epstein, Dana R; Bootzin, Richard R et al. (2009) Assessment of preferences for treatment: validation of a measure. Res Nurs Health 32:419-31
Bootzin, Richard R; Bailey, Elaine T (2005) Understanding placebo, nocebo, and iatrogenic treatment effects. J Clin Psychol 61:871-80
Miranda, Joyal (2004) An exploration of participants' treatment preferences in a partial RCT. Can J Nurs Res 36:100-14
Sidani, Souraya; Epstein, Dana R; Moritz, Patricia (2003) An alternative paradigm for clinical nursing research: an exemplar. Res Nurs Health 26:244-55

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