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A randomized trial to identify accurate and cost-effective fidelity measurement methods for cognitive-behavioral therapy: project FACTS study protocol.

ABSTRACT: This randomized trial will compare three methods of assessing fidelity to cognitive-behavioral therapy (CBT) for youth to identify the most accurate and cost-effective method. The three methods include self-report (i.e., therapist completes a self-report measure on the CBT interventions used in session while circumventing some of the typical barriers to self-report), chart-stimulated recall (i.e., therapist reports on the CBT interventions used in session via an interview with a trained rater, and with the chart to assist him/her) and behavioral rehearsal (i.e., therapist demonstrates the CBT interventions used in session via a role-play with a trained rater). Direct observation will be used as the gold-standard comparison for each of the three methods.This trial will recruit 135 therapists in approximately 12 community agencies in the City of Philadelphia. Therapists will be randomized to one of the three conditions. Each therapist will provide data from three unique sessions, for a total of 405 sessions. All sessions will be audio-recorded and coded using the Therapy Process Observational Coding System for Child Psychotherapy-Revised Strategies scale. This will enable comparison of each measurement approach to direct observation of therapist session behavior to determine which most accurately assesses fidelity. Cost data associated with each method will be gathered. To gather stakeholder perspectives of each measurement method, we will use purposive sampling to recruit 12 therapists from each condition (total of 36 therapists) and 12 supervisors to participate in semi-structured qualitative interviews.Results will provide needed information on how to accurately and cost-effectively measure therapist fidelity to CBT for youth, as well as important information about stakeholder perspectives with regard to each measurement method. Findings will inform fidelity measurement practices in future implementation studies as well as in clinical practice.NCT02820623 , June 3rd, 2016.

SUBMITTER: Beidas RS

PROVIDER: S-EPMC5025620 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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A randomized trial to identify accurate and cost-effective fidelity measurement methods for cognitive-behavioral therapy: project FACTS study protocol.

Beidas Rinad S RS Maclean Johanna Catherine JC Fishman Jessica J Dorsey Shannon S Schoenwald Sonja K SK Mandell David S DS Shea Judy A JA McLeod Bryce D BD French Michael T MT Hogue Aaron A Adams Danielle R DR Lieberman Adina A Becker-Haimes Emily M EM Marcus Steven C SC

BMC psychiatry 20160915 1

<h4>Background</h4>This randomized trial will compare three methods of assessing fidelity to cognitive-behavioral therapy (CBT) for youth to identify the most accurate and cost-effective method. The three methods include self-report (i.e., therapist completes a self-report measure on the CBT interventions used in session while circumventing some of the typical barriers to self-report), chart-stimulated recall (i.e., therapist reports on the CBT interventions used in session via an interview with ...[more]

PMID: 27633780

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Project description:Clinician fidelity to cognitive behavioral therapy (CBT) is an important mechanism by which desired clinical outcomes are achieved and is an indicator of care quality. Despite its importance, there are few fidelity measurement methods that are efficient and have demonstrated reliability and validity. Using a randomized trial design, we compared three methods of assessing CBT adherence-a core component of fidelity-to direct observation, the gold standard. Clinicians recruited from 27 community mental health agencies (n = 126; M age = 37.69 years, SD = 12.84; 75.7% female) were randomized 1:1:1 to one of three fidelity conditions: self-report (n = 41), chart-stimulated recall (semistructured interviews with the chart available; n = 42), or behavioral rehearsal (simulated role-plays; n = 43). All participating clinicians completed fidelity assessments for up to three sessions with three different clients that were recruited from clinicians' caseloads (n = 288; M age = 13.39 years SD = 3.89; 41.7% female); sessions were also audio-recorded and coded for comparison to determine the most accurate method. All fidelity measures had parallel scales that yielded an adherence maximum score (i.e., the highest-rated intervention in a session), a mean of techniques observed, and a count total of observed techniques. Results of three-level mixed effects regression models indicated that behavioral rehearsal produced comparable scores to observation for all adherence scores (all ps > .01), indicating no difference between behavioral rehearsal and observation. Self-report and chart-stimulated recall overestimated adherence compared to observation (ps < .01). Overall, findings suggested that behavioral rehearsal indexed CBT adherence comparably to direct observation, the gold-standard, in pediatric populations. Behavioral rehearsal may at times be able to replace the need for resource-intensive direct observation in implementation research and practice.

Project description:Microsatellite instability (MSI) testing is important for the classification of Lynch syndrome, as a prognostic marker and as a guide for adjuvant chemotherapy in colorectal cancer (CRC). The gold standard for determining MSI status has traditionally been fluorescent multiplex polymerase chain reaction (PCR) and capillary gel electrophoresis (CGE). However, its use in the clinical setting has diminished and has been replaced by immunohistochemical (IHC) detection of loss of mismatch repair protein expression due to practicability and cost. The aim of this study was to develop a simple, cost-effective and accurate MSI assay based on CGE. After amplification of microsatellites by polymerase chain reaction (PCR) using the National Cancer Institute (NCI) panel (BAT 25, BAT26, D5S346, D2S123, D17S250) of MSI markers, parallel CGE was utilized to classify colorectal cancers as MSI-H, MSI-L and MSS using the 5200 Fragment Analyzer System. Cell lines and patient cancer specimens were tested. DNA from 56 formalin-fixed paraffin-embedded cancer specimens and matched normal tissue were extracted and CGE was performed. An automated computational algorithm for MSI status determination was also developed. Using the fragment analyser, MSI status was found to be 100% concordant with the known MSI status of cell lines and was 86% and 87% concordant with immunohistochemistry (IHC) from patient cancer specimens using traditional assessment and our MSI scoring system, respectively, for MSI determination. The misclassification rate was mainly attributed to IHC, with only one (1.8%) sampling error attributed to CGE testing. CGE was also able to distinguish MSI-L from MSI-H and MSS, which is not possible with IHC. An MSI score based on total allelic variability that can accurately determine MSI status was also successfully developed. A significant reduction in cost compared with traditional fluorescent multiplex PCR and CGE was achieved with this technique. A simple, cost-effective and reliable method of determining MSI status and an MSI scoring system based on an automatic computational algorithm to determine MSI status, as well as degree of allelic instability in colorectal cancer, has been developed using the 5200 Fragment Analyzer System.

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Project description:IntroductionAdoption of rigorous standards for reporting treatment fidelity is essential for advancing discovery, validation, and implementation of behavioral treatments. Whereas the NIH Behavior Change Consortium (BCC) developed an assessment tool to assess the quality of reporting and monitoring of treatment fidelity across health behavior change interventions, it has not yet been applied specifically to treatment fidelity in behavioral tobacco treatment trials.Aims and methodsWe conducted a scoping review of peer-reviewed, clinical trials of behavioral adult tobacco treatment interventions published in English between 2006 and 2018. Using the BCC treatment fidelity checklist, articles were coded for the presence or absence of various treatment fidelity strategies within each of 5 domains: Design, Training, Delivery, Receipt, and Enactment. Eligible articles (N = 755) were coded by two independent coders.ResultsThe proportion of reporting strategies varied within the fidelity domains, ranging from 5.2% to 96.3% in Design, 1.9% to 24.9% in Training, 2.6% to 32.3% in Delivery, 5.2% to 44.3% in Receipt, and 6.7% to 43.2% in Enactment. The mean proportion of adherence to treatment fidelity strategies within each domain was: Design (68%), Training (14%), Delivery (15%), Receipt (16%), and Enactment (25%). Only 11 studies achieved ≥80% reporting across >1 fidelity domain. There was no evidence for improvement in fidelity reporting across the 13-year time frame from the initial BCC publication to the present.ConclusionsThese findings illustrate the lack of consistency in fidelity reporting in tobacco treatment trials and underscore the challenges faced in evaluating rigor and reproducibility, as well as interpretation and dissemination of findings. Recommendations are made for improving fidelity reporting in tobacco treatment trials.ImplicationsThe SRNT Treatment Research Network sponsored a scoping review to summarize the current state of reporting treatment fidelity and make recommendations for best practices in reporting fidelity in tobacco treatment trials. The review identified a lack of consistency in fidelity reporting, illustrating the challenges faced in evaluating rigor, and reproducibility, as well as interpretation and dissemination of findings.

Dataset Information

A randomized trial to identify accurate and cost-effective fidelity measurement methods for cognitive-behavioral therapy: project FACTS study protocol.

Publications

A randomized trial to identify accurate and cost-effective fidelity measurement methods for cognitive-behavioral therapy: project FACTS study protocol.

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