A scale for distinguishing efficacy from effectiveness was adapted and applied to stroke rehabilitation studies

作者：Zettler Laura L^*; Speechley Mark R; Foley Norine C; Salter Katherine L; Teasell Robert W

来源：Journal of Clinical Epidemiology, 2010, 63(1): 11-18.

DOI：10.1016/j.jclinepi.2009.06.007

• Randomized controlled trials
• Research design
• Stroke
• Rehabilitation
• Systematic review
• Reliability

Objectives: To apply a tool that purports to differentiate between efficacy and effectiveness studies to stroke rehabilitation trials and to evaluate its applicability and reliability.
Study Design and Setting: Three raters developed item operational definitions before independently applying the seven-item scale to 151 randomized controlled trials (RCT), published during or after 1997, that evaluated either a pharmacologic (P, n = 78) or a nonpharmacologic (NP, n = 73) intervention. Inter-rater reliability was assessed for both individual items and total scores, separately for P and NP trials.
Results: Item inter-rater reliability (multiple-rater kappa) ranged from 0.00 (95% CI [confidence interval]: -0.13, 0.13) to 0.85 (95% CI: 0.73, 0.98) and from 0.21 (95% CI: 0.08, 0.34) to 0.79 (95% CI: 0.66, 0.92) for P and NP RCTs, respectively. For the total score (dichotomized), kappa values were 0.43 (95% CI: 0.31, 0.56) and 0.51 (95% CI: 0.37, 0.64) for P and NP trials, respectively.
Conclusions: The tool provides a solid foundation on which to base further discussion of the differential criteria of efficacy-effectiveness trial design. Scale items should be properly operationalized depending on the research question of interest and evaluated for reliability before the scale is used for definitively judging a given Study's design or the external validity of its results.

• 出版日期2010-1