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Supplementation with vitamin D alone does not appear to reduce the risk for fracture, according to a review published online Dec. 20 in JAMA Network Open. Pang Yao, Ph.D., from the University of Oxford in the United Kingdom, and colleagues conducted a systematic review to examine the risks for fracture associated with differences in concentrations of 25-hydroxyvitamin D (25[OH]D) in observational studies and fracture risks associated with vitamin D supplementation alone or in combination with calcium in randomized clinical trials (RCTs). The researchers found that each 10.0-ng/mL increase in 25(OH)D concentration correlated with an adjusted rate ratio (RR) of 0.93 for any fracture and 0.80 for hip fracture based on a meta-analysis of 11 observational studies with 39,141 participants. There was no significantly reduced risk for any fracture or hip fracture in a meta-analysis of 11 RCTs (34,243 participants) of vitamin D supplementation alone (daily or intermittent dose of 400 to 30,000 ...

The researchers, funded by The National Institute for Health Research (NIHR)’s Invention for Innovation programme, created a technology dubbed the “smart needle”, a probe that can identify cancerous tissues or cells “almost instantly.” The probe works by using a technique called “Raman spectroscopy”, which consists of shining a low power laser onto tissue and measuring the light reflected back. So far the probe has been tested on 68 patient samples in the laboratory, showing it can differentiate between healthy and cancerous tissue. Made up of fibre-optics encased within a fine needle, the probe can look for cancer under the skin’s surface in areas such as the neck. Healthy tissue gives a different signature of reflected light from cancerous tissue, and research shows it is possible to detect a “fingerprint” of the disease that can be used to spot cancerous tissue in a few seconds. The smart needle can “measure the molecular changes associated with disease in tissues and cells at the e...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published a draft Recommendation with the aim to provide guidance on evaluating and demonstrating the effectiveness of a Pharmaceutical Quality System (PQS) in relation to risk-based change management. The PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities. This is detailed in Annex 15 of the respective Guide: 11.1. "The control of change is an important part of knowledge management and should be handled within the pharmaceutical quality system." 11.4. "Quality risk management should be used to evaluate planned changes… and to plan for any necessary process validation, verification or requalification efforts." 11.7. "…an evaluation of the effectiveness of change should be carried out…" The Recommendation now seeks to provide practical guidance for GMP inspectors on how to assess thes...

Mortality rates were higher for rural children than their urban peers during 1999 to 2017, according to a report published in the December issue of Health Affairs, a theme issue on rural health. Janice Probst, Ph.D., from the University of South Carolina in Columbia, and colleagues used U.S. Centers for Disease Control and Prevention mortality data to assess whether children living in rural areas experienced declines in mortality from 1999 to 2017 to parallel those experienced by the nation. The researchers found that rural children experienced higher mortality rates than their urban peers throughout the study period and across all age groups. Among rural children, those particularly at risk included non-Hispanic black infants and American Indian/Alaska Native children. "Rural children in the United States die at higher rates than their urban peers do -- a deadly disparity that has been present for years and shows no signs of abating," the authors write. "Many of the hea...