In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

Afdeling Klinische Chemie en Laboratoriumgeneeskunde (AKCL

COVID-19 and Vaccination in the Setting of Neurologic Disease An Emerging Issue in Neurology

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has left many unanswered questions for patients with neurologic disorders and the providers caring for them. Elderly and immunocompromised patients are at increased risk for severe symptoms due to COVID-19, and the virus may increase symptoms of underlying neurologic illness, particularly for those with substantial bulbar and respiratory weakness or other neurologic disability. Emerging SARS-CoV-2 vaccines offer substantial protection from symptomatic infection, but both patients and providers may have concerns regarding theoretical risks of vaccination, including vaccine safety and efficacy in the context of immunotherapy and the potential for precipitating or exacerbating neurologic symptoms. In this statement on behalf of the Quality Committee of the American Academy of Neurology, we review the current literature, focusing on COVID-19 infection in adults with neurologic disease, in order to elucidate risks and benefits of vaccination in these individuals. Based on existing evidence, neurologists should recommend COVID-19 vaccination to their patients. For those patients being treated with immunotherapies, attention should be paid to timing of vaccination with respect to treatment and the potential for an attenuated immune response

Requirements and standards facilitating quality improvement for reporting systems in gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement

To develop standards for high quality in gastrointestinal (GI) endoscopy, the European Society of Gastrointestinal Endoscopy (ESGE) has established the ESGE Quality Improvement Committee. A prerequisite for quality assurance and improvement for all GI endoscopy procedures is state-of-the-art integrated digital reporting systems for standardized documentation of the procedures. The current paper describes the ESGE's viewpoints on the requirements for high-quality endoscopy reporting systems in GI endoscopy. Recommendations 1 Endoscopy reporting systems must be electronic. 2 Endoscopy reporting systems should be integrated into hospitals' patient record systems. 3 Endoscopy reporting systems should include patient identifiers to facilitate data linkage to other data sources. 4 Endoscopy reporting systems shall restrict the use of free-text entry to a minimum, and be based mainly on structured data entry. 5 Separate entry of data for quality or research purposes is discouraged. Automatic data transfer for quality and research purposes must be facilitated. 6 Double entry of data by the endoscopist or associate personnel is discouraged. Available data from outside sources (administrative or medical) must be made available automatically. 7 Endoscopy reporting systems shall facilitate the inclusion of information on histopathology of detected lesions, patient satisfaction, adverse events, and surveillance recommendations. 8 Endoscopy reporting systems must facilitate easy data retrieval at any time in a universally compatible format. 9 Endoscopy reporting systems must include data fields for key performance indicators as defined by quality improvement committees. 10 Endoscopy reporting systems must facilitate changes in indicators and data entry fields as required by professional organization

What have we learned about interventions to reduce medical errors?

Medical errors and adverse events are now recognized as major threats to both individual and public health worldwide. This review provides a broad perspective on major effective, established, or promising strategies to reduce medical errors and harm. Initiatives to improve safety can be conceptualized as a "safety onion" with layers of protection, depending on their degree of remove from the patient. Interventions discussed include those applied at the levels of the patient (patient engagement and disclosure), the caregiver (education, teamwork, and checklists), the local workplace (culture and workplace changes), and the system (information technology and incident reporting systems). Promising interventions include forcing functions, computerized prescriber order entry with decision support, checklists, standardized handoffs and simulation training. Many of the interventions described still lack strong evidence of benefit, but this should not hold back implementation. Rather, it should spur innovation accompanied by evaluation and publication to share the results

PREVENTIVE CARE FOR CHILDREN IN THE UNITED STATES: Quality and Barriers

Our objective was to examine the academic literature covering quality of childhood preventive care in the United States and to identify barriers that contribute to poor or disparate quality. We systematically reviewed articles related to childhood preventive care published from 1994 through 2003, focusing on 58 large observational studies and interventions addressing well-child visit frequency, developmental and psychosocial surveillance, disease screening, and anticipatory guidance. Although many children attend recommended well-child visits and receive comprehensive preventive care at those visits, many do not attend such visits. Estimates of children who attend all recommended visits range widely (from 37%–81%). In most studies, less than half is the proportion of children who receive developmental or psychosocial surveillance, adolescents who are asked about various health risks, children at risk for lead exposure who are screened, adolescents at risk for Chlamydia who are tested, or children and adolescents who receive anticipatory guidance on various topics. Major barriers include lack of insurance, lack of continuity with a clinician or place of care, lack of privacy for adolescents, lack of clinician awareness or skill, racial/ethnic barriers, language-related barriers, clinician and patient gender-related barriers, and lack of time. In summary, childhood preventive care quality is mixed, with large disparities among populations. Recent research has identified barriers that might be overcome through practice and policy interventions