# Clinical Core

> **NIH NIH P50** · UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA · 2020 · $251,811

## Abstract

Summary (Clinical Core)
 In speech-language and stroke rehabilitation literature, relatively little attention has been paid to threats
to a study's validity that relate to correct implementation of treatment, and also assessment, procedures. These
threats can increase the chance of Type I or Type II error, or the additional error (“Type III”) of concluding
significance or nonsignificance when in fact the tests or the treatments were not correctly implemented.
Additionally, these threats can prevent causal inference. In the absence of fidelity monitoring, investigators are
unable to confidently determine whether or not results (significant or insignificant) were caused by the targeted
independent variable or were due to other random factors introduced because the clinician “drifted” from the
protocol, or “contaminated” the protocol by adding or omitting elements. Lack of attention to implementation,
then, could be a contributor to the historically mixed results in aphasia treatment research emphasized by
Project 1 and Project 2. Eleven of twelve project aims proposed by Fridriksson, Hillis, Rorden, and Hickok
require recruitment and retention of patients and collection of high quality data. High quality data necessitate
that assessors use prescribed administration procedures and raters adhere to prescribed scoring procedures.
Seven of twelve project aims rely upon treatment and therapists that adhere to prescribed treatment
procedures. The assumption of the investigators is that clinical staff functioning as assessors, raters, and/or
therapists adhere to the study protocol. Efforts to optimize adherence to assessment and treatment
procedures, referred to as assessment and treatment fidelity, are critical to the proposed projects. The Clinical
Core will coordinate activities designed to optimize fidelity, thereby guarding against threats to validity and
improving the power to detect effects for nearly every aim proposed.
 To guard against threats to validity stemming from selection bias, attrition, or missing data points, the
Clinical Core will conduct training and monitoring activities related to recruitment, retention, and data collection
and management. To guard against threats to validity stemming from drift, cross-contamination, clinician-to-
clinician variability, or unblinding, the Clinical Core will conduct extensive training, initially and throughout the
study, and monitoring of activities that will ensure that there is standardized training for all clinical staff, that
assessment and treatment was delivered as intended, and that there is evidence that treatment was received
as planned. As far as we can tell, these will be the first studies in stroke or aphasia rehabilitation to: (1)
incorporate multiple-tier training programs for all study member staff, (2) monitor treatment fidelity through
several complementary methods, and (3) monitor assessment fidelity via adoption of established treatment
fidelity guidelines. Finally, the Clinical C...

## Key facts

- **NIH application ID:** 9889934
- **Project number:** 5P50DC014664-05
- **Recipient organization:** UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
- **Principal Investigator:** Argye E. Hillis
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $251,811
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9889934

## Citation

> US National Institutes of Health, RePORTER application 9889934, Clinical Core (5P50DC014664-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9889934. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*