Objectives: The aim of this study was to explore the risk assessment tools and criteria used to assess the risk of medical devices in hospitals, and to explore the link between the risk of a medical device and how those risks impact or alter the training of staff.

Methods: Within a broader questionnaire on implementation of a national guideline, we collected quantitative data regarding the types of risk assessment tools used in hospitals and the training of healthcare staff.

Results: The response rate for the questionnaire was 81 percent; a total of sixty-five of eighty Dutch hospitals. All hospitals use a risk assessment tool and the biggest cluster (40 percent) use a tool developed internally. The criteria used to assess risk most often are: the function of the device (92 percent), the severity of adverse events (88 percent) and the frequency of use (77 percent). Forty-seven of fifty-six hospitals (84 percent) base their training on the risk associated with a medical device. For medium- and high-risk devices, the main method is practical training. As risk increases, the amount and type of training and examination increases.

Conclusions: Dutch hospitals use a wide range of tools to assess the risk of medical devices. These tools are often based on the same criteria: the function of the device, the potential severity of adverse events, and the frequency of use. Furthermore, these tools are used to determine the amount and type of training required for staff. If the risk of a device is higher, then the training and examination is more extensive.

Following sequence analysis of a Leishmania donovani kinetoplast DNA (kDNA) minicircle, we have developed synthetic oligonucleotides for use in the polymerase chain reaction (PCR). With these primers, we have amplified L. donovani kDNA from splenic aspirates and blood samples taken from kala-azar patients. Treatment of the samples for PCR requires only limited DNA purification by lysis in SDS, digestion with proteinase K, phenol extraction and ethanol precipitation of the resulting nucleic acid. We have obtained amplified product routinely with DNA prepared from the equivalent of 2·5–25 µl of splenic aspirate or of 50–500 µl of blood from infected patients. In dilution experiments a visible product has been obtained on amplification of DNA from the equivalent of 2·5 × 10−7 µl of splenic material. We therefore propose the amplification of L. donovani kDNA by PCR as a rapid and highly sensitive method for the diagnosis of kala-azar.

Objectives: Major depression is common in elderly patients. Interpersonal psychotherapy (IPT) is a potentially effective treatment for depressed elderly patients. The objective of this study was to evaluate the cost-effectiveness of IPT delivered by mental health workers in primary care practices, for depressed patients 55 years of age and older identified by screening, in comparison with care as usual (CAU).

Methods: We conducted a full economic evaluation alongside a randomized controlled trial comparing IPT with CAU. Outcome measures were depressive symptoms, presence of major depression, and quality of life. Resource use was measured from a societal perspective over a 12-month period by cost diaries. Multiple imputation and bootstrapping were used to analyze the data.

Results: At 6 and 12 months, the differences in clinical outcomes between IPT and CAU were small and nonsignificant. Total costs at 12 months were €5,753 in the IPT group and €4,984 in the CAU group (mean difference, €769; 95 percent confidence interval, −2,459 – 3,433). Cost-effectiveness planes indicated that there was much uncertainty around the cost-effectiveness ratios.

Conclusions: Based on these results, provision of IPT in primary care to elderly depressed patients was not cost-effective in comparison to CAU. Future research should focus on improvement of patient selection and treatments that have more robust effects in the acute and maintenance phase of treatment.

The ESA space astrometry mission Gaia will measure the positions, parallaxes and proper motions of the 1 billion brightest stars on the sky. Expected accuracies are in the 7–25 μas range down to 15 mag and sub-mas accuracies at the faint limit (20 mag). The astrometric data are complemented by low-resolution spectrophotometric data in the 330–1000 nm wavelength range and, for the brighter stars, radial velocity measurements. The scientific case covers an extremely wide range of topics in galactic and stellar astrophysics, solar system and exoplanet science, as well as the establishment of a very accurate, dense and faint optical reference frame. With a planned launch around 2012 and an (extended) operational lifetime of 6 years, final results are expected around 2021. We give a brief overview of the science goals of Gaia, the overall project organisation, expected performance, and some key technical features and challenges.

Objectives: The present study evaluated the cost-effectiveness of a behavioral graded exercise therapy (GET) program compared with usual care (UC) in terms of the performance of daily activities by patients with chronic shoulder complaints in primary care.

Methods: A total of 176 patients were randomly assigned either to GET (n=87) or to UC (n=89). Clinical outcomes (main complaints, shoulder disability [SDQ] and generic health-related quality of life [EQ-5D], and costs [intervention costs, direct health care costs, direct non–health-related costs, and indirect costs]) were assessed during the 12-week treatment period and at 52 weeks of follow-up.

Results: Results showed that GET was more effective than UC in restoring daily activities as assessed by the main complaints instrument after the 12-week treatment period (p=.049; mean difference, 7.5; confidence interval [CI], 0.0–15.0). These effects lasted for at least 52 weeks (p=.025; mean difference 9.2; CI, 1.2–17.3). No statistically significant differences were found on the SDQ or EQ5D. GET significantly reduced direct health care costs (p=.000) and direct non–health care costs (p=.029). Nevertheless, total costs during the 1-year follow-up period were significantly higher (p=.001; GET=€530 versus UC=€377) due to the higher costs of the intervention. Incremental cost-effectiveness ratios for the main complaints (0–100), SDQ (0–100), and EQ-5D (−1.0–1.0) were €17, €74, and €5,278 per unit of improvement, respectively.

Conclusions: GET proved to be more effective in the short- and long-term and reduces direct health care costs and direct non–health care costs but is associated with higher costs of the intervention itself.