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Abstract: Objective: Before introducing a test in clinical practice, its characteristics and added value should be assessed. Diagnostic accuracy studies only are not sufficient; the test''s impact on patient outcome ought to be assessed as well. To do this, we propose a stepwise evaluation of diagnostic tests. Study Design and Setting: Theoretical–conceptual approach. Results: First, the test''s technical accuracy refers to the ability to produce usable information under standardized conditions. In a second step, the place of the new test in the clinical pathway is determined. Thirdly, the test''s diagnostic accuracy is assessed, depending on its intended goal. The fourth step assesses the test''s impact on the patient outcome. Depending on the place of the test in the clinical pathway, existing evidence can be used, or new evidence will be needed. At the final step, a cost-effectiveness analysis assesses the test''s financial and societal consequences. Conclusion: Diagnostic tests evaluation should consider the technical accuracy, the test''s place in the clinical pathway, its diagnostic accuracy, and its impact on patient outcome. [Copyright &y& Elsevier]

Background The COVID-19 pandemic has given rise to an increasing number of patients with 'long COVID'. Long COVID is the persistence of symptoms for weeks or months after an infection by SARS-CoV-2. It often impacts on the professional life of affected people. Aims The aim of this study is to understand the experiences and needs of people with long COVID in relation to their return to work. Methods A qualitative study, combining individual interviews and online forum discussions, was performed early 2021, as part of a larger mixed method study on the needs of long COVID patients in Belgium. Results One hundred and thirty-four people participated in the study. Participants described various clinical symptoms precluding their return to work. They also face sceptical reactions from employers and colleagues and a lack of support from the social welfare system to facilitate their return to work. These barriers have various impacts, including psychological ones, likely to compromise the professional future of long COVID patients. Conclusions While the analysis of patients' experiences shows variation in long COVID patients' experiences with return to work, it may help occupational physicians and healthcare practitioners to better take up their crucial role in the return to work of long COVID patients, including raising employers' and colleagues' awareness of the specific difficulties related to long COVID. [ABSTRACT FROM AUTHOR]

Background The World Health Organization ( WHO) surgical safety checklist ( SSC) was introduced to improve the safety of surgical procedures. This systematic review evaluated current evidence regarding the effectiveness of this checklist in reducing postoperative complications. Methods The Cochrane Library, MEDLINE, Embase and CINAHL were searched using predefined inclusion criteria. The systematic review included all original articles reporting a quantitative measure of the effect of the WHO SSC on postoperative complications. Data were extracted for postoperative complications reported in at least two studies. A meta-analysis was conducted to quantify the effect of the WHO SSC on any complication, surgical-site infection ( SSI) and mortality. Yule's Q contingency coefficient was used as a measure of the association between effectiveness and adherence with the checklist. Results Seven of 723 studies identified met the inclusion criteria. There was marked methodological heterogeneity among studies. The impact on six clinical outcomes was reported in at least two studies. A meta-analysis was performed for three main outcomes (any complication, mortality and SSI). Risk ratios for any complication, mortality and SSI were 0·59 (95 per cent confidence interval 0·47 to 0·74), 0·77 (0·60 to 0·98) and 0·57 (0·41 to 0·79) respectively. There was a strong correlation between a significant decrease in postoperative complications and adherence to aspects of care embedded in the checklist ( Q = 0·82; P = 0·042). Conclusion The evidence is highly suggestive of a reduction in postoperative complications and mortality following implementation of the WHO SSC, but cannot be regarded as definitive in the absence of higher-quality studies. [ABSTRACT FROM AUTHOR]

What is known and Objective: Variations in market uptake of an orphan drug have important implications with respect to access to care and inequality of treatment. Therefore, the aim of this study was to quantify both the sales and volume uptake of orphan drugs in Europe and to assess whether a country's gross domestic product (GDP) and/or health technology assessment (HTA) influences the orphan drugs' market uptake. Methods: We analysed the numbers of orphan drugs launched and the sales and volume uptake for 17 orphan drugs in 23 European countries from 2001 until the beginning of 2010 using the IMS Health database. Countries were clustered based on GDP and the availability of a formal HTA-organization. Results and Discussion: The uptake of orphan drugs varied across European countries. The highest volumes and contributions of orphan drugs in the first year occurred in countries with a high GDP (and implicitly, a higher budget for healthcare), independently of the existence of an HTA-organization. In contrast, in countries with a low GDP, orphan drugs were less available when there was a formal HTA-organization. There, budgetary restrictions can cause the exclusion of less cost-effective orphan drugs. What is new and Conclusion: We observed substantial variation in the market uptake of orphan drugs. Such variation may have important implications with respect to access to care and inequality of treatment. The uptake of orphan drugs could be promoted through the clinical added value of orphan drugs (CAVOD) project and various conditional pricing and reimbursement mechanisms. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to an article related to perioperative safety of patients in operating rooms, published in previous issue.