Identification and evaluation of risk of generalizability biases in pilot versus efficacy/effectiveness trials: A systematic review and meta-analysis
| Autor: | Marco Geraci, Keith Brazendale, R. Glenn Weaver, David R. Lubans, Lindsay Decker, Xiaming Li, Russell Jago, John P. A. Ioannidis, Michael W. Beets, Gabrielle Turner-McGrievy, James F. Thrasher, Esther M. F. van Sluijs, Andrew Milat, Anthony D. Okely |
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| Přispěvatelé: | Beets, Michael W. [0000-0001-6728-6742], Apollo - University of Cambridge Repository, Beets, Michael W [0000-0001-6728-6742] |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Research design
Pediatric Obesity Youth Medicine (miscellaneous) physical activity Pilot Projects Review 0302 clinical medicine 030212 general & internal medicine Childhood obesity lcsh:RC620-627 intervention scalability youth Nutrition and Dietetics lcsh:Public aspects of medicine Random effects model 3. Good health Weight Reduction Programs lcsh:Nutritional diseases. Deficiency diseases Systematic review Treatment Outcome Research Design Meta-analysis screen time childhood obesity medicine.medical_specialty Framework 030209 endocrinology & metabolism Physical Therapy Sports Therapy and Rehabilitation Intervention youth physical activity sleep diet framework Odds 03 medical and health sciences Screen time Physical medicine and rehabilitation Bias medicine Humans Generalizability theory Exercise business.industry Physical activity Scalability lcsh:RA1-1270 medicine.disease Diet Sedentary Behavior SPS Exercise Nutrition and Health Sciences business Sleep |
| Zdroj: | Beets, M W, Weaver, R G, Ioannidis, J P A, Geraci, M, Brazendale, K, Decker, L, Okely, A D, Lubans, D, van Sluijs, E, Jago, R, Turner-McGrievy, G, Thrasher, J, Li, X & Milat, A J 2020, ' Identification and Evaluation of Risk of Generalizability Biases in Pilot versus Efficacy/Effectiveness Trials : A Systematic Review and Meta-Analysis ', International Journal of Behavioral Nutrition and Physical Activity, vol. 17, 19 (2020) . https://doi.org/10.1186/s12966-020-0918-y The International Journal of Behavioral Nutrition and Physical Activity International Journal of Behavioral Nutrition and Physical Activity, Vol 17, Iss 1, Pp 1-20 (2020) |
| DOI: | 10.1186/s12966-020-0918-y |
| Popis: | Background Preliminary evaluations of behavioral interventions, referred to as pilot studies, predate the conduct of many large-scale efficacy/effectiveness trial. The ability of a pilot study to inform an efficacy/effectiveness trial relies on careful considerations in the design, delivery, and interpretation of the pilot results to avoid exaggerated early discoveries that may lead to subsequent failed efficacy/effectiveness trials. “Risk of generalizability biases (RGB)” in pilot studies may reduce the probability of replicating results in a larger efficacy/effectiveness trial. We aimed to generate an operational list of potential RGBs and to evaluate their impact in pairs of published pilot studies and larger, more well-powered trial on the topic of childhood obesity. Methods We conducted a systematic literature review to identify published pilot studies that had a published larger-scale trial of the same or similar intervention. Searches were updated and completed through December 31st, 2018. Eligible studies were behavioral interventions involving youth (≤18 yrs) on a topic related to childhood obesity (e.g., prevention/treatment, weight reduction, physical activity, diet, sleep, screen time/sedentary behavior). Extracted information included study characteristics and all outcomes. A list of 9 RGBs were defined and coded: intervention intensity bias, implementation support bias, delivery agent bias, target audience bias, duration bias, setting bias, measurement bias, directional conclusion bias, and outcome bias. Three reviewers independently coded for the presence of RGBs. Multi-level random effects meta-analyses were performed to investigate the association of the biases to study outcomes. Results A total of 39 pilot and larger trial pairs were identified. The frequency of the biases varied: delivery agent bias (19/39 pairs), duration bias (15/39), implementation support bias (13/39), outcome bias (6/39), measurement bias (4/39), directional conclusion bias (3/39), target audience bias (3/39), intervention intensity bias (1/39), and setting bias (0/39). In meta-analyses, delivery agent, implementation support, duration, and measurement bias were associated with an attenuation of the effect size of − 0.325 (95CI − 0.556 to − 0.094), − 0.346 (− 0.640 to − 0.052), − 0.342 (− 0.498 to − 0.187), and − 0.360 (− 0.631 to − 0.089), respectively. Conclusions Pre-emptive avoidance of RGBs during the initial testing of an intervention may diminish the voltage drop between pilot and larger efficacy/effectiveness trials and enhance the odds of successful translation. |
| Databáze: | OpenAIRE |
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