Analyzing symptom management trials: the value of both intention-to-treat and per-protocol approaches.
OBJECTIVE
Two analytical approaches are described for a randomized trial testing interventions for symptom management.


METHODS
To compare an intention-to-treat with a perprotocol approach.


METHODS
Patients were accrued from six cancer centers.


METHODS
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.


METHODS
Trial arm; summed severity scores; interference-based severity categories at intake, 10 weeks, and 16 weeks; site; and stage of cancer.


RESULTS
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.


CONCLUSIONS
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.
Given
Barbara
B
College of Nursing, Michigan State University in East Lansing, USA.
Given
Charles W
CW
Sikorskii
Alla
A
You
Mei
M
McCorkle
Ruth
R
Champion
Victoria
V
D001943:Breast Neoplasms / Q000451:nursing* / Q000628:therapy*; D015400:Clinical Nursing Research / Q000379:methods*; D015928:Cognitive Behavioral Therapy / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008175:Lung Neoplasms / Q000451:nursing / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009859:Oncology Nursing / Q000379:methods*; D012720:Severity of Illness Index