RESUMO
INTRODUCTION: Some studies show that participants do not always fully understand the informed consent form (ICF), which is one of the reasons for dropouts. This study aimed to adapt the Quality of Informed Consent (QuIC) questionnaire into a valid instrument to be applied to the Portuguese population and to measure its reliability and validity in the Portuguese population, by applying it to a sample of participants in controlled trials. METHODS: The QuIC questionnaire was developed to assess the quality of informed consent in clinical trials and consists of two parts, addressing both the objective (part A) and the subjective (part B) understanding. After being translated and validated into Portuguese, it was implemented in 100 cardiac participants of phase III clinical trials in a University Hospital Center. RESULTS: The QuIC-PT questionnaire showed excellent stability over time and good validity. All patients evaluated their participation and their health positively and recognized the main purpose of the clinical trial. Almost all participants understood their role in helping future patients and the purpose of the trial and realized that, by signing the ICF, they were participating in a clinical trial. However, none of them knew that their experimental treatment was not proven to be the best alternative for their condition. CONCLUSION: The QuIC-PT questionnaire seems to be a valid and useful instrument to evaluate the participants' understanding of the ICF. In this study, we found that some concepts, like 'study protocol' or 'randomization', were not well understood by participants when signing the ICF, especially by participants with lower education levels. They also believed that the experimental intervention would solve their health condition. Greater awareness about the importance of the informed consent process and ICF is necessary so that participants can fully understand the protocol, especially the risks involved, and their rights as participants.
RESUMO
BACKGROUND: Brachial hemiparesis is one of the most frequent sequelae of stroke, leading to important functional disability given the role of the upper limb in executing activities of daily living (ADL). The Stroke Upper Limb Capacity Scale (SULCS) is a stroke-specific assessment instrument that evaluates functional capacity of the upper limb based on the execution of 10 tasks. The objective of this study is the transcultural adaptation and psychometric validation of the Portuguese version of the SULCS. METHODS: A Portuguese version of the SULCS was developed, using the process of forward-backward translation, after authorisation from the author of the original scale. Then, a multicentre study was conducted in Portuguese stroke patients (n = 122) to validate the psychometric properties of the instrument. The relationship between sociodemographic and clinical characteristics was used to test construct validity. The relationship between SULCS scores and other instruments was used to test criterion validity. RESULTS: Semantic and linguistic adaptation of the SULCS was executed without substantial issues and allowed the development of a Portuguese version. The application of this instrument suggested the existence of celling effect (19.7% of participants with maximum score). Reliability was demonstrated through the intraclass correlation coefficient of 0.98. As for construct validity, SULCS was sensible to muscle tonus and aphasia. SULCS classification impacted the scores of the Motor Evaluation Scale for Upper Extremity in Stroke (MESUPES) and the Stroke Impact Scale (SIS). CONCLUSIONS: The present version of SULCS shows valid and reliable cultural adaptation, with good reliability and stability.
