Objective: The purpose of this presentation is to explore design issues and considerations for research on symptom clusters. Research on symptom clusters presents several design challenges. These challenges range from recognizing and dealing with factors likely to influence symptom reporting to establishing temporal precedence within complex causal processes that change over time. Most research on symptoms focuses on a single symptom. Depending upon the level of knowledge development around individual symptoms, studies address topics ranging from describing the incidence of a symptom within a defined population to improving patient outcomes through organizational interventions focused on application of research-based symptom management protocols.
Design: This presentation was developed as a critical analysis of research design issues in an emerging area of clinical research.
Methods: Literature review, discussion, and experience.
Findings: Even though experience gained from work on individual symptoms informs the approach to research on symptom clusters, the level of complexity is increased when multiple symptoms are studied and specific design issues require additional consideration. These issues include the timing of data collection in relation to the clinical context, understanding the natural history of the symptoms comprising the cluster, addressing individual difference variables that influence symptom reporting and acceptance of interventions, considering underlying causal mechanisms that may drive different symptoms at different times, recognizing the potential for differential levels of response shift bias across symptoms, considering the impact of floor and ceiling effects, dealing with missing data and subject mortality issues, constructing appropriate control or comparison conditions when symptom management interventions are being tested, devising sampling plans that access those who are most likely to experience the symptoms of interest, detecting and controlling for the symptom management interventions actually used, and dealing with the possibility that a strategy used to manage one symptom may exacerbate or relieve another symptom in the cluster.
Conclusions/Implications: Even though this partial list of issues is formidable, identifying those relevant to each planned study and developing a rationale for design decisions will provide the methodologic foundation for this critical area of clinical research. This presentation includes a summary of important research design issues in symptom cluster research as applied to specific research examples, proposed strategies for dealing with selected issues, and a beginning set of guidelines to support future research.
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