Analyzing symptom management trials: The value of both intention-to-treat and per-protocol approaches

Barbara Given, Charles W. Given, Mei You, Ruth McCorkle, Victoria Champion

Research output: Contribution to journalShort survey

11 Scopus citations

Abstract

Purpose/Objectives: Two analytical approaches are described for a randomized trial testing interventions for symptom management. Design: To compare an intention-to-treat with a per-protocol approach. Setting: Patients were accrued from six cancer centers. Sample: 94 men and 140 women with solid tumors were accrued. Methods: An intention-to-treat approach (as randomized) and per-protocol analyses (at least one symptom reaching threshold and one follow-up intervention) were compared. The analysis determines how each approach affects results. A two-arm, six-contact, eight-week trial was implemented. In one arm, nurses followed a cognitive behavioral protocol. In the second arm, a non-nurse coach referred patients to a symptom management guide. Main Research Variables: Trial arm; summed severity scores; interference-based severity categories at intake, 10 weeks, and 16 weeks; site; and stage of cancer. Findings: Each arm produced a reduction in severity at 10 and 16 weeks with no differences between arms. In the per-protocol analyses, symptoms reported at the first contact required more time to resolve. Older patients exposed to the nurse arm resolved in fewer contacts. Conclusions: The intention-to-treat analyses indicated that both arms were successful but offered few insights into how symptoms or patients influenced severity. Per-protocol analyses (intervention and dose), when, and which strategies affected symptoms. Implications for Nursing: Each analytical strategy serves a purpose. Intention-to-treat defines the success of a trial. Per-protocol analyses allow nurses to pose clinical questions about response and dose of the intervention. Nurses should participate in analyses of interventions to understand the conditions where interventions are successful.

Original languageEnglish (US)
Number of pages1
JournalOncology nursing forum
Volume36
Issue number6
DOIs
StatePublished - Dec 1 2009
Externally publishedYes

ASJC Scopus subject areas

  • Oncology(nursing)

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