ABSTRACT
Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.
ABSTRACT
Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.
ABSTRACT
<p><b>OBJECTIVE</b>To investigate the clinical efficacy of artery perforator-based flap in the repair of gluteal-sacral pressure sores.</p><p><b>METHODS</b>Gluteal artery perforator-based island flap and perforator-based flap were designed to repair the gluteal-sacral pressure sores of 26 patients according to the location and size of the wounds. The area of the biggest flap was 20 cm x 15 cm, the diameter of perforating vessel was above 1. 1 mm, with the length of free pedicle ranging from 2.0 - 3. 5 cm.</p><p><b>RESULTS</b>All the flaps healed soon after operation, with no flap necrosis and postoperative complications, such as flap necrosis, wound infection and or formation. The color and texture of the flaps were good and the configuration was satisfactory. There was no recurrence of local bedsore in the follow-up period from 6 to 24 months.</p><p><b>CONCLUSION</b>The artery perforator-based flaps have the advantages of delicate texture, easy dissection, reliable blood flow, preservation of the gluteus maximus muscle and no need of skin grafting for the donor defects in most cases. It is an optimal method in surgical treatment of gluteal-sacral pressure sores.</p>