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Illustrating idiographic methods for translation research: moderation effects, natural clinical experiments, and complex treatment-by-subgroup interactions

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Translational Behavioral Medicine

Abstract

A critical juncture in translation research involves the preliminary studies of intervention tools, provider training programs, policies, and other mechanisms used to leverage knowledge garnered at one translation stage into another stage. Potentially useful for such studies are rigorous techniques for conducting within-subject clinical trials, which have advanced incrementally over the last decade. However, these methods have largely not been utilized within prevention or translation contexts. The purpose of this manuscript is to demonstrate the flexibility, wide applicability, and rigor of idiographic clinical trials for preliminary testing of intervention mechanisms. Specifically demonstrated are novel uses of state-space modeling for testing intervention mechanisms of short-term outcomes, identifying heterogeneity in and moderation of within-person treatment mechanisms, a horizontal line plot to refine sampling design during the course of a clinic-based experimental study, and the need to test a treatment’s efficacy as treatment is administered along with (e.g., traditional 12-month outcomes).

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Acknowledgments

This was an investigator-initiated study funded by grants from the National Institute on Drug Abuse (P50 05605), National Institute of Child Health and Human Development (R21 061683), an investigator-initiated grant from Hospira, Inc., and Fahs-Beck Fund for Research and Experimentation and the Virginia Tech College of Liberal Arts and Human Sciences Dean’s Faculty Fellowship. The funders played no role in the design, conduct, or analysis of the study nor in the interpretation and reporting of the study findings.

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Authors and Affiliations

  1. RTI, International, Research Triangle Park, NC, USA

    Ty A Ridenour PhD

  2. University of Pittsburgh, Pittsburgh, PA, USA

    Ty A Ridenour PhD, Neal Benedict PhD & Sandra Kane-Gill

  3. Michigan State University, East Lansing, MI, USA

    Andrea K Wittenborn PhD

  4. Rowan University, Glassboro, NJ, USA

    Bethany R Raiff PhD

Authors
  1. Ty A Ridenour PhD
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  2. Andrea K Wittenborn PhD
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  3. Bethany R Raiff PhD
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  4. Neal Benedict PhD
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  5. Sandra Kane-Gill
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Corresponding author

Correspondence to Ty A Ridenour PhD.

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Conflict of interest

Ty Ridenour, Andrea Wittenborn, Bethany Raiff, Neal Benedict, and Sandra Kane-Gill have no conflict of interests to declare regarding the research reported herein.

Adherence to ethical principles

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee, overseen by the institutional review boards of the institutions where the study was conducted, and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Implications

Practice: Idiographic clinical trials need to be employed in pilot studies, research that requires high external validity and clinic-based studies, and to round out knowledge garnered from randomized clinical trials.

Policy: Idiographic clinical trials provide an assortment of rigorous techniques for translational research, especially pertinent to early stages of testing knowledge gained in one type of translation for use in another type.

Research: Idiographic clinical trials need to be used for small populations, rare diseases, when funds are sparse, and for treatment experiments conducted within “real-world” clinical settings.

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Ridenour, T.A., Wittenborn, A.K., Raiff, B.R. et al. Illustrating idiographic methods for translation research: moderation effects, natural clinical experiments, and complex treatment-by-subgroup interactions. Behav. Med. Pract. Policy Res. 6, 125–134 (2016). https://doi.org/10.1007/s13142-015-0357-5

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  • DOI: https://doi.org/10.1007/s13142-015-0357-5

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