Design and Validation of a Pictographic Informed Consent Form for Patients with Post-Stroke Motor Aphasia
Keywords:
informed consent, aphasia, transcranial magnetic stimulation, pictograms, personal autonomy, bioethicsAbstract
Introduction: Patients with post-stroke motor aphasia retain comprehension but lose verbal expression; as a result, they are systematically excluded from the informed consent process.
Objective: To design and validate a pictographic informed consent model for patients with motor aphasia undergoing transcranial magnetic stimulation.
Methods: A descriptive, cross-sectional study was conducted in the Rehabilitation Department of Celia Sánchez Manduley Clinical-Surgical Teaching Hospital. The study comprised three phases: Phase I, an initial assessment involving interviews with five specialists in Physical and Rehabilitation Medicine and questionnaires completed by ten family members; Phase II, the design of a pictographic informed consent form, evaluated by a 15-member Delphi panel (comprising experts in bioethics, clinical practice, design, and methodology) over two rounds to assess relevance and visual clarity; and Phase III, an evaluation by specialists and previously rehabilitated patients who served as retrospective key informants. Kendall's W coefficient was calculated to determine the level of consensus.
Results: Physicians often delegated decision-making to family members; 80% of family members reported that the patient had not participated in the process, while 90% believed that the use of pictograms would be helpful. In the Delphi process, the first round reached consensus on four pictograms, and following a redesign, the second round reached consensus on ten. Specialists deemed the pictographic informed consent form feasible and useful for supporting patient autonomy; rehabilitated patients confirmed that it had been helpful and stated that they would recommend its use.
Conclusions: The pictographic informed consent form designed and validated here constitutes an ethical, low-cost, and easily implemented tool, as it restores the autonomy of patients with aphasia during rehabilitation involving magnetic stimulation therapy by providing a communication channel tailored to their residual capabilities.
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Copyright (c) 2026 Yisel Caymari López, Yilena de La Caridad Caymari López, Yaneisi López Pacheco, Enrique Rafael Caymari Díaz
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