Ethical Issues in Randomized Clinical Trials
Ethics Roundtable: Case Study
| Immediately after a stroke, some centers
provide individual speech-language therapy, while others
primarily rely on group interventions. Many patients are
discharged to home very quickly. Researchers propose a
randomized clinical trial to study the outcomes of three
treatment approaches for aphasia in the acute phase after
stroke.
Patients must be 45 to 85 years of age, must not have
had prior strokes, and must have a speech-language
evaluation within 10 days post-stroke. Patients with
aphasia will be asked to participate in the study. All
patients will continue to receive typical medical and
rehabilitation services for the institution. Those who
consent will be randomized to one of three treatment
arms:
- Individual therapy 5 sessions a week, minimum 14
days, or
- Group therapy (no more than 6 patients per group) 5
sessions a week, minimum of 14 days, or
- Family education and training, 3 sessions. Training
will target individual' s needs, demonstrate
activities, and provide written information about
aphasia, and contact numbers for the speech-language
pathologist.
Services will be given as an inpatient or outpatient,
discharge will not alter the therapy plan. Patients who
participate will be re-evaluated after 14 days, 30 days,
3 months, 6 months, and 1 year. The speech-language
pathologists who evaluate the patients will be blinded to
the treatment approach used.
Questions to consider
- Why is this kind of research important? What are
the likely benefits?
- Are there any issues of concern in this protocol
(e.g., consent, randomization, vulnerable population,
potential harms)? What are the potential risks?
- Are there any potential conflicts for the
speech-language pathologist who evaluates the patients
and enrolls them in the trial in the acute
setting?
- Are there any approaches or research designs that
might lessen these concerns? What resources are
available within institutions and nationally to assist
clinician-researchers?
|
Ethics
Roundtable Home
Responses
Annotated Bibliography
|
To submit cases or to be added to the list of respondents
please contact: Helen Sharp Department of Speech Pathology and
Audiology, 307 WJSHC University of Iowa, Iowa City, IA 52242.
Phone: 319-335-6596, fax 319-335-8851, e-mail:
helen-sharp@uiowa.edu