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:

  1. Individual therapy 5 sessions a week, minimum 14 days.
  2. Group therapy (no more than 6 patients per group) 5 sessions a week, minimum of 14 days.
  3. 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?

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