A single-item Expectancy Measure's Validity, Reliability, and Responsiveness to Detect Changes in Clinical Efficacy Studies of Integrative Cancer Therapies: A Methodology Study.

Background: Expectations may modify outcomes. However, studies often fail to measure expectations. This raises the need for a brief valid and reliable expectancy measure.

Objectives: To study treatment expectations in individuals entering acupuncture or rest, validity and test re-test reliability of a single-item expectancy measure graded on a category scale, a Numeric Rating Scale (NRS) and a Visual Analog Scale (VAS), and to identify psychometric differences between the scales.

Method: In this methodology study, treatment expectations were measured in 363 participants before they received acupuncture (genuine traditional penetrating or non-penetrating telescopic sham acupuncture, n = 239, 98%, responded) or a control treatment involving just rest (n = 120, 100%, responded), aimed to improve level of relaxation. A treatment expectancy measure, graded on a five-grade category scale, an eight-grade NRS and a 100 mm VAS, was tested for test re-test reliability. Level of expectation and relaxation was measured at baseline, pre- and post-therapy (n = 729 expectancy measurements).

Results: The participants scheduled for acupuncture or rest believed moderately (Inter Quartile Range, IQR, moderately-much) and much (IQR moderately-much) the treatment to be effective. The Intra-Class Correlation coefficient versus Kappa coefficient between test and re-test was .868/.868 for the category scale, .820/.820 for the NRS, and .856/.854 for the VAS. The middle step "Believe moderately the treatment to be effective" was equivalent with median 4 (IQR, 3-4) on NRS and median 52 mm (IQR 42-52) on VAS. The response rates were 708 (97%) on the category scale, 707 (97%) on the NRS, and 703 (96%) on the VAS. All three scales discriminated that pre-therapy expectations were more positive in the individuals who reported an improvement in relaxation level (P < .001-.003). The VAS presented higher responsiveness to detect expectancy changes over time (71% increased expectation), compared to the NRS (52% increased) and the category scale (12% increased), P < .001.

Conclusions: Individuals entering acupuncture, or a control intervention, presented positive treatment expectations, and the expectancy measure presented satisfactory reliability, validity, high response rates, sensitiveness, and responsiveness. Integrative cancer therapy researchers who want to control for expectancy-related bias in clinical trials should consider measuring expectation using the single-item expectancy measure.