PubMed · 10915177
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R B Freeman. 2000. US viewpoint.. https://doi.org/10.1002/lt.500060410
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Research Ethics Committees are instruments which allow the medical profession to control the research with human subjects. In this context, some medical researchers criticize the increasing bureaucracy and the hindrance of research which interfere with the ability to compete in international research. On the other hand, the public criticizes the missing transparency, independence and democratic legitimization of Research Ethics Committees as well as the possible conflicts of interests of their members. The medical research with human subjects who are incompetent to give informed consent serves as an example to show the necessity of quality control and standardized criteria of assessment. By comparison with the development of Institutional Review Boards in the United States, ideas for the necessary changes of Research Ethics Committees in Germany regarding their work, assembly and transparency are developed.
STUDY DESIGN: A cross-cultural adaptation and cross-sectional study of a sample of lumbar spine patients, with a subsample followed prospectively for retest reliability. OBJECTIVES: To assess the Italian version instrument reliability and validity. SUMMARY OF BACKGROUND DATA: The orthopaedic outcome measurements have been usually focused on objective parameters as radiograph measures or other technical aspects. However, these parameters are weakly related with outcomes that are more relevant to patients as functional status and symptoms. In the last ten years, the patient-oriented measures have become an important aspect of spinal clinical outcome evaluation. The most common instruments to assess patient perspective are self-administered questionnaires that must be validated by a widely accepted process to evaluate reliability and validity, which are fundamental for every instrumental measure. METHODS: The North American Spine Society (NASS) questionnaire was culturally adapted for Italian-speaking people following the Guillemin criteria. The Italian version was tested on 74 consecutive patients who were referred to the authors' department and suffered from low back pain with leg irradiation. The results were compared with other validated patient-oriented measures. Forty-eight-hour retests were performed on a subsample of 45 patients. RESULTS: The questionnaire was favorably accepted by patients. The lumbar spine pain and disability and neurogenic symptoms subscales showed a high correlation with other patient-oriented measures, as hypothesized, and it also showed good values on test-retest. CONCLUSIONS: The questionnaire should be considered for patient health status monitoring and for clinical trials.
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