A patient-level key performance indicator set to measure the effectiveness of fracture liaison services and guide quality improvement: a position paper of the IOF Capture the Fracture Working Group, National Osteoporosis Foundation and Fragility Fracture Network.

The International Osteoporosis Foundation (IOF) Capture the Fracture® Campaign with the Fragility Fracture Network (FFN) and National Osteoporosis Foundation (NOF) has developed eleven patient-level key performance indicators (KPIs) for fracture liaison services (FLSs) to guide quality improvement. INTRODUCTION: Fracture Liaison Services (FLSs) are recommended worldwide to reduce fracture risk after a sentinel fracture. Given not every FLS is automatically effective, the IOF Capture the Fracture working group has developed and implemented the Best Practice Framework to assess the organisational components of an FLS. We have now developed a complimentary KPI set that extends this assessment of performance to the patient level. METHODS: The Capture the Fracture working group in collaboration with the Fragility Fracture Network Secondary Fragility Fracture Special Interest Group and National Osteoporosis Foundation adapted existing metrics from the UK-based Fracture Liaison Service Database Audit to develop a patient-level KPI set for FLSs. RESULTS: Eleven KPIs were selected. The proportion of patients: with non-spinal fractures; with spine fractures (detected clinically and radiologically); assessed for fracture risk within 12 weeks of sentinel fracture; having DXA assessment within 12 weeks of sentinel fracture; having falls risk assessment; recommended anti-osteoporosis medication; commenced of strength and balance exercise intervention within 16 weeks of sentinel fracture; monitored within 16 weeks of sentinel fracture; started anti-osteoporosis medication within 16 weeks of sentinel fracture; prescribed anti-osteoporosis medication 52 weeks after sentinel fracture. The final KPI measures data completeness for each of the other KPIs. For these indicators, levels of achievement were set at the < 50%, 50-80% and > 80% levels except for treatment recommendation where a level of 50% was used. CONCLUSION: This KPI set compliments the existing Best Practice Framework to support FLSs to examine their own performance using patient-level data. By using this KPI set for local quality improvement cycles, FLSs will be able to efficiently realise the full potential of secondary fracture prevention and improved clinical outcomes for their local populations.

Mandibular reconstruction with bone transport in a patient with osteogenesis imperfecta.

Osteogenesis imperfecta (OI) was originally considered a connective tissue disorder, primarily involving type 1 collagen. It is characterized by numerous skeletal and extraskeletal defects, including bone fragility, multiple fractures, blue sclerae, hearing deficits, skin and ligament laxity, and dentinogenesis imperfecta (DI). The authors describe a 24-year-old Japanese man with OI and DI who had an ossifying fibroma of the mandible. Segmental resection was performed, and the mandible was reconstructed by distraction osteogenesis with the transport segment technique. This is the first report to describe a patient with OI undergoing mandibular reconstruction with bone transport, to the authors' knowledge.

Idiopathic retroperitoneal fibrosis with duodenal obstruction successfully treated with corticosteroids.

We report a case of idiopathic retroperitoneal fibrosis presenting with duodenal obstruction. A 55-year-old man suddenly developed severe epigastric pain and was admitted to our hospital. On abdominal computed tomography (CT), a large retroperitoneal mass was found. Hypotonic duodenography showed obstruction of the third portion of the duodenum. He was diagnosed as idiopathic retroperitoneal fibrosis and was treated with prednisolone. The patient improved dramatically. He has been well for twelve months without any further treatment.

International harmonization of bioequivalence studies and issues shared in common.

In the course of a review of the current health insurance system in Japan, promotion of the use of generic products of lower price is expected in direction for minifying the drug costs which occupy about 20% thereof. However, the use of generic products has not increased so much as expected. One of the reasons to explain the fact might be that concerns exist about switchability from an innovator product to a generic product or among generic products because of bias in bioequivalence. Namely, hesitation about the difference in quality between generic products and innovator products, particularly in bioequivalence due to differences in the manufacturing process and pharmaceutical technology, exists among professionals in medical practice. The bioequivalence study to guarantee that a generic product is bioequivalent to an innovator product in terms of effectiveness and safety is most important in assuring the quality of generic products. There are various specifications and study methods to prove bioequivalence which differ slightly from one to another in different countries. We have investigated bioequivalence studies which are conducted in the major countries. Consequently, we clarified that bioequivalence studies are in international harmonization in terms of the major portions thereof. However, different conditions, e.g., selection of subjects, food effect, application of multiple dose study, and in vitro dissolution study, are still employed for the studies. Therefore, we consider that these differences constitute the topics to be reviewed in future.

[Late phase II clinical study of RP56976 (docetaxel) in patients with advanced/recurrent breast cancer].

A late phase II clinical study of RP56976 (Docetaxel), a new semisynthetic anticancer agent, was conducted in patients with advanced/recurrent breast cancer. RP56976 (Docetaxel) was in general administered at an intravenous dose of 60 mg/m2 with dose-free intervals of 3-4 weeks. Of the 74 patients enrolled, 64 patients completed the scheduled course of treatment. Three patients showed complete response (CR), 32 patients partial response (PR), 3 patients minor response (MR), 18 patients no change (NC), and 8 patients had progressive disease (PD). The overall response rate was 54.7%. The response rate in patients who previously had received chemotherapy was 55.7%, and the response rate in patients who had resistance to anthracycline agents or who did not respond to previous treatment was 58.7%. Adverse reactions included nausea/vomiting in 38 patients (57.6%), fatigue in 46 patients (69.7%), anorexia in 46 patients (69.7%), fever in 26 patients (39.4%), and alopecia in 60 patients (90.9%), all of which were tolerable. Abnormal laboratory findings included leukopenia (Grade III or more) in 57 patients (86.4%) and neutropenia (Grade III or more) in 56 patients (86.2%). The results show that RP56976 (Docetaxel) is an excellent agent with high antitumor effect for the treatment of advanced/recurrent breast cancer.