Avoiding Attrition Bias

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Presentation transcript:

Avoiding Attrition Bias Estimating Expected Dropout Rates in Yoga Therapy Research Dr. Holger Cramer Department of Internal and Integrative Medicine, University of Duisburg-Essen, Essen, Germany ARCCIM, University of Technology Sydney, Australia

Designing a Yoga Therapy RCT http://www.uni-due.de/naturheilkunde/ 20.09.2018

Adequate Sample Size for a Yoga RCT? At least 100 patients? At least 100 patients per study arm? At least one more patient than the last study? Enough patients to be able to detect the expected effect size with adequate power! http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation Conventions: α ≤ 0.05 Power ≥ 0.80 Effect size? http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation Conventions: α ≤ 0.05 Power ≥ 0.80 Effect size? http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation Conventions: α ≤ 0.05 Power ≥ 0.80 Effect size? http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation Conventions: α ≤ 0.05 Power ≥ 0.80 Effect size? http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation Conventions: α ≤ 0.05 Power ≥ 0.80 Effect size: depends on the research question http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation Conventions: α ≤ 0.05 Power ≥ 0.80 Effect size: depends on the research question Drop-out rate? http://www.uni-due.de/naturheilkunde/ 20.09.2018

Sample Size Calculation Conventions: α ≤ 0.05 Power ≥ 0.80 Effect size: depends on the research question Drop-out rate? http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates Underestimation: Loss of power (false negative results). Overestimation: Unnecessary large numbers of participants might be exposed to a potentially ineffective or even dangerous intervention; enhanced study expenses. http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Example http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Example 20.4% http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Meta-Analysis http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Meta-Analysis * http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Country of Origin http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Medical Condition http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Medical Condition http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Medical Condition http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Gender http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Age http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Intervention Content http://www.uni-due.de/naturheilkunde/ 20.09.2018

Drop-Out Rates: Intervention Duration http://www.uni-due.de/naturheilkunde/ 20.09.2018

Avoiding Attrition Bias Dropout rates in yoga therapy RCTs usually can be expected to not exceed 15 to 20%. Yet dropout rates beyond 40% are possible depending on the participants’ sociodemographic and health condition. http://www.uni-due.de/naturheilkunde/ 20.09.2018

Avoiding Attrition Bias: Example Yoga vs. usual care for adults of both gender with low back pain. 12-week intervention including asanas, pranayama and meditation. Required sample size n=94. http://www.uni-due.de/naturheilkunde/ 20.09.2018

Avoiding Attrition Bias: Example Yoga (12.73%) vs. usual care (14.72%) for adults (13.06%) of both genders (12.59%) with low back pain (10.55%). 12-week intervention (12.94%) including asanas (13.46%), pranayama (13.33%) and meditation (14.60%).  Estimated 15% drop-out rate should be adequate (total sample size n=111). http://www.uni-due.de/naturheilkunde/ 20.09.2018

Avoiding Attrition Bias Cramer H, Haller H, Dobos G, Lauche R. A systematic review and meta-analysis estimating the expected drop-out rates in randomized controlled trials on yoga interventions. Evid Based Complement Alternat Med. 2016;2016:5859729. http://www.uni-due.de/naturheilkunde/ 20.09.2018

Thanks a lot for your attention! 20.09.2018