PubMed · 8453886
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G B Edwards, L M Schuring. 1993. Sleep protocol: a research-based practice change.. https://pubmed.ncbi.nlm.nih.gov/8453886/
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Conducting preliminary clinical fieldwork to update clinical knowledge in preparation to plan and perform relevant, meaningful, credible and feasible clinical research is imperative. Clinical nurse investigators cannot generate relevant questions to study a current phenomenon with which they are not experienced. The nurse researcher's early involvement in the clinical world of health care as a prerequisite of proposal development not only contributes to the design of a study that has rigor and significance, but it also augments his or her competence and commitment to the improvement of patient outcomes.
The purposes of this article are to present an overview of randomized clinical trials (RCTs) and describe some of the methodological problems inherent in using RCTs in nursing research. Many nursing intervention studies are fraught with problems that defy the stringent control criteria required for RCTs, leading to biased estimates of intervention efficacy. Five threats to validity in RCTs are presented, including problems related to (a) differential dropout, (b) random assignment, (c) identifying and maintaining an adequate control condition, (d) nonadherence to research protocols, and (e) assessment of clinically meaningful change. Three strategies are recommended for addressing some of the problems posed by RCTs and improving inference.
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