Single Subject Randomization Design For Clinical Research

Ebbels tweet Intervention ResearchDuring the week April 23 – 29, 2017 Susan Ebbels is curated WeSpeechies on the topic Carrying Out Intervention Research in SLP/SLT Practice. Susan kicked off the week with a link to her excellent paper that discusses the strengths and limitations of various procedures for conducting intervention research in the clinical setting. As we would expect, a parallel groups randomized control design was deemed to provide the best level of experimental control. Many ways of studying treatment related change within individual clients, with increasing degrees of control were also discussed. However, all of the ‘within participant’ methods described were vulnerable to confounding by threats to internal validity such history, selection, practice, fatigue, maturation or placebo effects to varying degrees.

One design was missing from the list because it is only just now appearing in the speech-language pathology literature, specifically the Single Subject Randomization Design. The design (actually a group of designs in which treatment sessions are randomly allocated to treatment conditions) provides the superior internal validity of the parallel groups randomized control trial by controlling for extraneous confounds through randomization. As an added benefit the results of a single subject randomization design can be submitted to a statistical analysis, so that clear conclusions can be drawn about the efficacy of the experimental intervention. At the same time, the design can be feasibly implemented in the clinical setting and is perfect for answering the kinds of questions that come up in daily clinical practice. For example, randomized control trials have shown than speech perception training is an effective adjunct to speech articulation therapy on average when applied to groups of children but you may want to know if it is a necessary addition to your therapy program for a speciRomeiser Logan Levels of Evidence SCRfic child.

Furthermore,  randomized single subject experiments are now acceptable as a high level of research evidence by the Oxford Centre for Evidence Based Medicine. An evidence hierarchy has been created for rating single subject trials, putting the randomized single subject experiments at the top of the evidence hierarchy as shown in the following table, taken from Romeiser Logan et al. 2008.

 

Tanya Matthews and I have written a tutorial showing exactly how to implement and interpret two versions of the Single Subject Randomization Design, a phase design and an alternation design. The accepted manuscript is available but behind a paywall at the Journal of Communication Disorders. In another post I will provide a mini-tutorial showing how the alternation design could be used to answer a clinical question about a single client.

Further Reading

Ebbels, Susan H. 2017. ‘Intervention research: Appraising study designs, interpreting findings and creating research in clinical practice’, International Journal of Speech-Language Pathology: 1-14.

Kratochwill, Thomas R., and Joel R. Levin. 2010. ‘Enhancing the scientific credibility of single-case intervention research: Randomization to the rescue’, Psychological Methods, 15: 124-44.

Romeiser Logan, L., R. Hickman, R.R. Harris, S.R. Harris, and C. Heriza. 2008. ‘Single-subject research design: recommendations for levels of evidence and quality rating’, Developmental Medicine and Child Neuroloogy, 50: 99-103.

Rvachew, S. 1988. ‘Application of single subject randomization designs to communicative disorders research’, Human Communication Canada (now Canadian Journal of Speech-Language Pathology and Audiology), 12: 7-13. [open access]

Rvachew, S. 1994. ‘Speech perception training can facilitate sound production learning.’, Journal of Speech and Hearing Research, 37: 347-57.

Rvachew, Susan, and Tanya Matthews. in press. ‘Demonstrating Treatment Efficacy using the Single Subject Randomization Design: A Tutorial and Demonstration’, Journal of Communication Disorders.

 

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