A five-phase model for clinical-outcome research

Department of Communication Disorders, University of Virginia, 2205 Fontaine Avenue, Suite 202, Charlottesville, VA 22908-0781, USA.
Journal of Communication Disorders (Impact Factor: 1.45). 05/2004; 37(5):401-11. DOI: 10.1016/j.jcomdis.2004.04.003
Source: PubMed


Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and third-party payers). Several clinical professions recognize a comprehensive model for organizing and scaffolding the many forms of clinical-outcome research. An adaptation of this five-phase model of clinical-outcome research is examined as a means for structuring forms of clinical research throughout audiology and speech-language pathology. Within the organizing structure, relationships become apparent between types and grades of scientific evidence and the processes underpinning evidence-based practice which ultimately lead to decisions on the status of intervention protocols. LEARNING OUTCOMES: Readers will be able to distinguish the phases of clinical-outcome research in a comprehensive model. Readers will be able to identify relationships between the structure of the model and broadly recognized concepts associated with the terms 'efficacy' and 'effectiveness.' Readers will be able to identify indicators of quality for controlled clinical trials.

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    • "The present study is a Phase II study (Robey, 2004) in which the treatment was controlled in order to analyse the contribution of intensity to CILT for eight individuals with chronic aphasia. Several outcome measures were used to assess change including generalisation to discourse. "
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    ABSTRACT: Background: Studies of intensive aphasia treatments vary widely in terms of treatment focus, in patient population and, in particular, in definition of what is considered “intensive”. Variability makes it difficult to compare among studies and to definitively determine whether more treatment is actually better. Constraint-induced language therapy (CILT) is one treatment that has been successfully replicated at approximately the same dosage with generally positive results. Aims: The current study used a modified multiple baseline design across participants to investigate the administration of CILT at the standard intensive dosage of 30 hours over 2 weeks (CILT-I) compared to a more distributed dosage of 30 hours over 10 weeks (CILT-D). Methods & Procedures: Eight participants with chronic aphasia participated in either CILT-I or CILT-D. Standardised and discourse measures were taken pre- and posttreatment and also 4 weeks after the completion of treatment. Discourse probes were administered after every 6 hours of treatment to assess change in productivity and efficiency over time. Outcomes & Results: All of the participants who received CILT-I and CILT-D showed either an increased effect size on a discourse measure, a clinically significant change on a standardised battery or both. Gains were maintained in nearly all cases. Conclusions: CILT administered in both intensive and distributed dosages resulted in positive changes in aphasia severity and discourse. This study adds evidence to the still inconclusive role of intensity to CILT.
    Aphasiology 08/2015; DOI:10.1080/02687038.2015.1070949
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    • "The objective of the current investigation was to continue the development of this Phase II phonomotor treatment protocol under the rubric of clinical phases of rehabilitation research (Robey, 2004). More specifically, this study was designed to extend prior iterations of the treatment protocol and test a refined version in a relatively large group of persons with aphasia (PWA) who exhibited impairments of lexical/semantics and phonology resulting in anomia. "
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    ABSTRACT: The ultimate goal of aphasia therapy should be to achieve gains in function that generalize to untrained exemplars and daily conversation. Anomia is one of the most disabling features of aphasia. The predominantly lexical/semantic approaches used to treat anomia have low potential for generalization due to the orthogonality of semantic and phonologic representations; this has been borne out in a meta-analysis of treatment studies. The intensive, neurally distributed, phonologic therapy reported here can, in principle, generalize to untrained phonologic sequences because of extant regularities in phonologic sequence knowledge, and should, in principle, generalize to production of words trained as well as those untrained. Twenty-six persons with chronic aphasia due to stroke were treated, in a staggered (immediate vs. delayed treatment) open trial design, with 60 hours of intensive, multi-modal therapy designed to enhance access to and efficiency of phonemes and phonologic sequences. There was an absolute increase of 5% in confrontation naming of untrained nouns at three months and there were 9-10% increases on measures of generalization of phonologic processes. The results of this trial demonstrate generalization of training effects on laboratory measures, which were sustained at three months, and provide support for the theories that motivated the treatment.
    Journal of Speech Language and Hearing Research 03/2015; 58(3). DOI:10.1044/2015_JSLHR-L-14-0131
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    • "speech intelligibility improvement; Beijer, Rietveld, & Geurts, submitted). The above-mentioned EST studies that have been conducted until now fit into Phase I and Phase II of clinical outcome research (Robey, 2004). In Phase I, a therapeutic effect is selected (i.e. "
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    ABSTRACT: Abstract We explored the suitability of perceptual and acoustic outcome measures to prepare E-learning based Speech Therapy (EST) efficacy tests regarding speech intelligibility in dysarthric speakers. Eight speakers with stroke (n = 3), Parkinson's disease (n = 4) and traumatic brain injury (n = 1) participated in a 4 weeks EST trial. A repeated measures design was employed. Perceptual measures were (a) scale ratings for "ease of intelligibility" and "pleasantness" in continuous speech and (b) orthographic transcription scores of semantically unpredictable sentences. Acoustic measures were (c) "intensity during closure" (ΔIDC) in the occlusion phase of voiceless plosives, (d) changes in the vowel space of /a/, /e/ and /o/ and (e) the F0 variability in semantically unpredictable sentences. The only consistent finding concerned an increased (instead of the expected decreased) ΔIDC after EST, possibly caused by increased speech intensity without articulatory adjustments. The importance of suitable perceptual and acoustic measures for efficacy research is discussed.
    Clinical Linguistics & Phonetics 07/2014; 28(12):1-24. DOI:10.3109/02699206.2014.936627
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