PubMed · 10756708
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Q Yang, J Donovan, P Abrams. 2000. The Prostate Trials Office research protocols.. https://doi.org/10.1046/j.1464-410x.2000.00058.x
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Low back pain represents a serious public health problem. Therefore, great efforts have been made in order to improve and assess the efficacy of its treatment. Reports in international literature have presented important studies concerning instruments to assess pain and functional incapacity in patients with low back pain. This study presents a clinical protocol which was developed by a multidisciplinary team. This protocol consists of the evaluation and distribution of pain, The Spitzer Quality of Life, The Oswestry Low Back Pain Disability Questionnaire, and The Center for Epidemiological Studies Depression Scale. Instruments must be urgently developed or adapted in order to be used according to the Brazilian reality.
The increasing rate of hepatitis C virus (HCV) infection in the community means that there is increased risk of occupational exposure for healthcare workers. In metropolitan hospitals in Victoria, we found that 80-150 healthcare workers have occupational exposures from HCV-infected patients annually. As there is a 1.8%-3% risk of transmission of HCV from a needlestick injury, two to five healthcare workers are likely to acquire HCV each year in Victoria. These needlestick injuries pose a personal, legal and professional risk to healthcare workers and their patients. Recent information shows that early antiviral treatment of acute HCV infection has high cure rates. Current local and international protocols for management of healthcare workers exposed to HCV do not address these issues. We propose a management protocol after needlestick injury that is stratified according to the likelihood of HCV acquisition and potential risk of staff-to-patient transmission, and that is consistent with the current legal and clinical context of HCV infection in Australia.
As of May 2004, the new European directive 2001/20/EC will require European member states to follow Good Clinical Practice rules for non-commercial academic clinical investigations. For several member states this poses a serious threat to such investigations. In the Netherlands however, most items of the new directive can be incorporated in the Dutch Medical Research Involving Human Subjects Act. In fact, many of the items are already covered by this Act, notably with respect to data integrity and patient safety. However, an extra effort is needed to implement the quality control standards to which the registration research already complies. The Dutch Medical Research Involving Human Subjects Act is currently being amended to comply with the new European directive. This is also an ideal opportunity for enhancing the national climate of clinical research and ensuring an improved translation of local research ideas into clinical trial protocols.