Interpreting nonsignificant results in a randomized controlled trial of telehealth care coordination for children with medical complexity / Wendy S. Looman, Michelle A. Mathiason, Tiffany T. Gallagher.

This case describes our experiences with conducting, interpreting, and disseminating the results of a secondary outcome analysis of data from a clinical trial. TeleFamilies was a three-arm, parallel group randomized controlled trial with one control group and two intervention groups. The primary aim...

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Online Access: Full Text (via SAGE)
Main Authors: Looman, Wendy S. (Author), Mathiason, Michelle A. (Author), Gallagher, Tiffany T. (Author)
Format: Electronic eBook
Language:English
Published: London : SAGE Publications Ltd, 2020.
Series:SAGE Research Methods Cases: Medicine and Health.
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Summary:This case describes our experiences with conducting, interpreting, and disseminating the results of a secondary outcome analysis of data from a clinical trial. TeleFamilies was a three-arm, parallel group randomized controlled trial with one control group and two intervention groups. The primary aim was to test the effect of a telehealth care coordination nursing intervention on health care service use by children with complex health conditions. The secondary aim was to test the effects of the intervention on quality of life for children and families. The TeleFamilies study had a number of features that contributed to its methodological rigor, including an experimental design, treatment integrity, and a long intervention dose. Despite these features, the study was ultimately underpowered for our secondary study aim due to threats to internal validity including missing data, attrition, extreme cases, and maturation. In this methods case study, we describe techniques the team used to enhance the study's internal validity, challenges we encountered related to missing data and our secondary outcome measure, and strategies we employed to meaningfully interpret and publish the study results. Because our results for the secondary outcome analysis were nonsignificant, we used a theory-guided approach to discerning whether these results represented a false-negative finding or a true finding. The case also includes discussion of types of bias that can occur in the interpretation and publication stages of research, and how we worked to avoid these biases.
Physical Description:1 online resource : illustrations.
Bibliography:Includes bibliographical references and index.
ISBN:9781529713527
1529713528