Article

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

ABSTRACT

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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    • "Bovendien had er geen follow-upmeting plaatsgevonden bij de JJIgroep , terwijl dit wel is gebeurd bij de MTFC-groep. Hoewel er dus ook zeker mogelijke beperkingen en risico's ten aanzien van het N=1 design te identificeren zijn, en bovendien de meningen verdeeld zijn over de status van het design als volwaardig alternatief voor het RCT of als aanvulling/opmaat hiervoor (Bartels et al., 2008; Robey, 2004; Task Force APA, 1995; Van Yperen & Bijl, 2006), geeft de studie naar de doeltreffendheid van MTFC wel aan dat het een kansrijk design kan zijn voor het onderzoeken van de effecten voor interventies waarbij het aantal deelnemers laag is. "

    Preview · Article · Dec 2015
    • "This implies that all costs and health benefits are included, regardless of to whom costs are related to or who receives the benefits (Drummond et al., 2005). In the field of speech and language pathology economic evaluations are scarce, but crucial to provide a basis for decisions on implementation and reimbursement of therapies (e.g., Robey, 2004). The aim of the present study was to determine the incremental cost– effectiveness and cost–utility of the LP compared to DCM based treatment. "
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    ABSTRACT: Purpose: The purpose of this study was to evaluate the incremental cost-effectiveness and cost-utility of the Lidcombe Program (LP) compared with treatment based on the Demands and Capacities Model (RESTART-DCM) for preschool children who stutter. Method: A cost-effectiveness and cost-utility analysis were carried out alongside a Randomized Clinical Trial (the RESTART-study). In total, 199 children in 20 speech clinics participated. Outcome measures included the number needed to treat, based on the percentage of children who did not stutter at 18 months, and Health-related Quality of Life (EQ-VAS and HUI3) at 3, 6, 12 and 18 months. Health-related Quality of Life scores were used to calculate quality adjusted life years (V-QALYs for the EQ-VAS and U-QALYs for the HUI3). Direct and indirect costs were measured by cost questionnaires. Missing data were multiply imputed. Percentages of children who did not stutter in both groups were compared by a chi-square test. Between-group differences in mean QALYs and costs, as well as cost effectiveness and cost-utility ratios, were evaluated by applying bootstrapping techniques. Results: After 18 months, health outcomes were slightly better in the LP group, although only the difference in V-QALYs was statistical significant (0.018; 95% CI: 0.008 to 0.027) with a small effect size (Cohen's d=0.17). Mean costs for the LP group were significantly higher compared to the RESTART-DCM group (€3199 versus €3032), again with a small effect size (Cohen's d=0.14). The incremental cost-effectiveness ratio was €3360 for one additional child who did not stutter with the LP, and the estimated cost-utility ratios were €10,413 (extra cost per extra V-QALY) and €18,617 (extra cost per extra U-QALY). The results indicated a high probability that the LP is cost-effective compared to RESTART-DCM treatment given a threshold for willingness-to-pay of €20,000 per QALY. Conclusions: Differences in effects and costs between the LP and RESTART-DCM treatment were small. Cost-effectiveness and cost-utility ratios were in favor of the LP. The LP is considered a good alternative to RESTART-DCM treatment in Dutch primary care.
    No preview · Article · Nov 2015 · Journal of Communication Disorders
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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.
    Full-text · Article · Aug 2015 · Aphasiology
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