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Introduction One of the main tasks in information retrieval is the development of Boolean search strategies for systematic searches in bibliographic databases. This includes the identification of free‐text terms and controlled vocabulary. IQWiG has previously implemented its objective approach for search strategy development using a fee‐based text analysis software. However, this implementation is not fully automated, due to a lack of technical options. The aim of our project was to develop a text analysis tool for the development of Boolean search strategies using R. Methods We adopt an incremental approach to software development, with the first goal being to develop a minimum viable product for the previously defined use cases. To create an interactive user interface, we use the shiny framework. Results Our newly developed shiny app searchbuildR is a text analysis tool with a point‐and‐click user interface, that automatically extracts and ranks terms from titles, s, and MeSH terms of a given test set of PubMed records. It returns searchable, interactive tables of free‐text and MeSH terms. Each free‐text term can also be viewed within its original context in the full titles and s or in a user‐defined word window. In addition, 2‐word combinations are extracted and also provided as an interactive table to help the user identify free‐text term combinations, that can be searched with proximity operators in Boolean searches. The results can be exported to a CSV file. The new implementation with searchbuildR was evaluated by validating the text analysis results against the results of the previously used fee‐based software. Conclusions QWiG has developed the shiny app searchbuildR to support the development of search strategies in systematic reviews. It is open source and can be used by researchers and other information specialists without extensive R or programming skills. The package code is openly available on GitHub at www.github.com/IQWiG/searchbuildR.

BackgroundThe surgical community and the medical device industry enjoy a fruitful cooperation for the benefit of patients, but during the last years several high-risk products have led to problems and scandals, thus highlighting the need for reforms in European CE marking requirements. In October 2013, the European Parliament voted on a draft regulation on medical devices that intends to replace the current directives in 2014.PurposeThis article offers guidance to surgeons on how to select and assess medical devices for clinical use. Examples include artificial sphincters, surgical meshes, as well as single-incision and robot-assisted surgery. It is important that surgeons have a basic understanding of the requirements for CE marking of new medical devices. Because device performance rather than effectiveness is required for European market entry, surgeons (and their patients) are often left with the burden of using potentially harmful devices. In addition, potential problems concerning the safety or effectiveness of approved devices are concealed by the lack of data transparency. Because regulatory reforms were blocked at the European level, many member states will now seek other ways of restricting the use of medical devices with unknown effectiveness. One interesting model in this regard is to link the reimbursement of new medical devices to the conduct of clinical trials.ConclusionsSurgeons should develop a structured multidisciplinary approach to innovation management in their hospitals before using a new high-risk device. The key question is how to strike the right balance between innovation and safety.

IntroductionIn 2019, the German government established a new evaluation procedure for digital health applications (DiGAs) to facilitate their reimbursement by statutory health insurance. The procedure involves the assessment of a DiGA’s “positive healthcare effect”, which is defined as a medical benefit and/or “a patient-relevant improvement of structure and processes”. If the available clinical evidence is insufficient to prove the manufacturer’s claim on the positive healthcare effect, but the claim seems plausible, the DiGA is provisionally reimbursed, and further clinical evidence within twelve months must be generated. DiGAs eligible for provisional or permanent reimbursement are publicly listed in the DiGA directory.In contrast to the usual pathways for reimbursement of healthcare technologies which involve IQWiG as the national HTA agency and the G-BA (Federal Joint Committee) as the decision-making body, the DiGA procedure is currently carried out by the national competent authority (BfArM) and thus outside the joint self-government. Furthermore, legal evidence requirements for DiGAs are comparatively low.MethodsThis work analyzed the suitability of clinical studies that intended to prove a DiGA’s medical benefit. For this purpose, the key elements for clinical studies published in the DiGA directory and clinical trial registries were extracted and compared with the usual evidence requirements in the reimbursement context.ResultsAs of October 2020, 20 DiGAs have successfully undergone the application procedure. Fourteen DiGAs (70%) were provisionally accepted. A randomized controlled study (RCT) design was chosen for all clinical studies to be conducted for further evidence generation. However, in four cases (28%), it is questionable whether the clinical study is suitable to demonstrate a medical benefit mainly due to the choice or operationalization of the primary endpoint (n=2), the timing of the endpoint survey (n=2) and/or the choice of the control intervention (n=1).ConclusionsEven though all currently ongoing or planned clinical studies with DiGAs are RCTs, not all of them are adequate to demonstrate a medical benefit according to the usual evidence requirements.

ObjectiveTo systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions.DesignSystematic review and meta-analysis.Data sourcesMEDLINE, Embase, Cochrane Database for Systematic Reviews, INAHTA HTA database, preprint servers (via Europe PMC), ClinicalTrials.gov, WHO ICTRP from 1 January 2020 to 7 May 2021; NICE Evidence Search, NICE Guidance, FIND Website from 1 January 2020 to 24 May 2021.Review methodsDiagnostic cross-sectional or cohort studies were eligible for inclusion if they had paediatric study participants and compared rapid point-of care tests for diagnosing current SARS-CoV-2 infections with reverse transcription polymerase chain reaction (RT-PCR) as the reference standard. The Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool was used to assess the risk of bias and the applicability of the included studies. Bivariate meta-analyses with random effects were performed. Variability was assessed by subgroup analyses.Results17 studies with a total of 6355 paediatric study participants were included. All studies compared antigen tests against RT-PCR. Overall, studies evaluated eight antigen tests from six different brands. Only one study was at low risk of bias. The pooled overall diagnostic sensitivity and specificity in paediatric populations was 64.2% (95% CI 57.4% to 70.5%) and 99.1% (95% CI 98.2% to 99.5%), respectively. In symptomatic children, the pooled diagnostic sensitivity was 71.8% (95% CI 63.6% to 78.8%) and the pooled diagnostic specificity was 98.7% (95% CI 96.6% to 99.5%). The pooled diagnostic sensitivity in asymptomatic children was 56.2% (95% CI 47.6% to 64.4%) and the pooled diagnostic specificity was 98.6% (95% CI 97.3% to 99.3%).ConclusionsThe performance of current antigen tests in paediatric populations under real-life conditions varies broadly. Relevant data were only identified for very few antigen tests on the market, and the risk of bias was mostly unclear due to poor reporting. Additionally, the most common uses of these tests in children (eg, self-testing in schools or parents testing their toddlers before kindergarten) have not been addressed in clinical performance studies yet. The observed low diagnostic sensitivity may impact the planned purpose of the broad implementation of testing programmes.PROSPERO registration numberCRD42021236313.

ObjectiveTo assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe.DesignObservational cross-sectional study.SettingA large German ethics committee.MaterialsFrom the consecutive sample of study applications between March 2010 and December 2013, we selected MD study applications requiring approval by an ethics committee and the competent federal authority. These included pre-market studies on devices that had not yet received a CE (Conformité Européenne) mark or had previously been CE marked for a different indication. Also included were post-CE studies requiring federal authority approval because the study entailed additional invasive or otherwise burdensome components.Primary and secondary outcome measuresBesides the design of the studies, we assessed the planned sample size, study duration and other aspects.Results122 study applications were analysed: 98 (80%) concerned therapeutic rather than diagnostic devices and 84 (69%) were pre-market studies. The proportion of studies on class I, IIa, IIb and III devices was 10%, 15%, 28% and 39%, respectively. 10 studies (8%) investigated IVD MDs. A randomised controlled trial (RCT) was planned in 70 (57%) of the 122 applications; studies with non-randomised control groups (n=23; 19%) or without controls (n=29; 24%) were less common. In the sub-group of pre-market studies on therapeutic devices, the proportion of RCTs was 66% (43/65). The median sample size was 120 participants or samples (IQR 53–229). The median study duration was 24 (14–38) months. 87 studies (71%) considered at least one patient-relevant outcome. 12 (17%) and 37 (53%) of the 70 RCTs applied a fully or partially blinded design, respectively.ConclusionA large proportion of MD studies in Germany apply a randomised controlled design, thus contradicting the industry argument that RCTs on MDs are commonly infeasible.

Objectives: This study aims to describe how a negative reimbursement decision—based on the health technology assessment (HTA) report of a nondrug intervention—affects healthcare providers in Germany. Methods: Knee arthroscopy was chosen as an example, because as of April 2016 this procedure is no longer reimbursed for osteoarthritis, but is still covered for other indications, including meniscal lesions. The exclusion followed an HTA report prepared by the Institute for Quality and Efficiency in Health Care (IQWiG). Here, we examine how the decision to revoke reimbursement for arthroscopy was perceived by the surgical community. Information was collected from official hospital statistics, the internet, and informal interviews with orthopedic surgeons. Results: In 2015, a total of 37,920 arthroscopic procedures were performed for knee osteoarthritis in Germany. Several surgical societies were unhappy with the negative decision, which was issued as a directive in November 2015, and they challenged the decision-making process as well as the underlying scientific evidence. In March 2016, fifteen societies issued joint recommendations on how to differentiate osteoarthritis from other knee diseases and how to document other diseases in a way that inspections by representatives of health insurance funds would not detect any deficiencies. In informal interviews, orthopedic surgeons indicated that miscoding of the principal diagnosis (meniscal tear rather than knee osteoarthritis) is to be expected, especially in the hospital sector. Conclusions: HTA can have a significant impact on the provision of health services, but various loopholes allow physicians to undermine policy decisions. Therefore, it is important to involve all stakeholders in HTA and to convince them of the benefits of evidence-based medicine.

Copyright © Cambridge University Press 20192019Cambridge University PressIntroductionGood quality management (QM) and the sound application of EUnetHTA's (European network for Health Technology Assessment) well-established methodology and tools are fundamental prerequisites for reliable and trustworthy joint work. To provide ultimate support and guidance to the assessment teams of EUnetHTA – and further, to ensure a sustainable mode of work for the post-2020 period – a comprehensive web-based so called “EUnetHTA Companion Guide” is established in Joint Action 3.MethodsThe Companion Guide was created using the open source Wiki software “DokuWiki”. We divided the content into five main parts: 1. EUnetHTA's QM concept, 2. QM for rapid Relative Effectiveness Assessment (REA) Pharma, 3. QM for rapid REA Other Technologies (OT) 4. Scientific Guidance & Tools and 5. QMS-related training material. The assessment processes for rapid REA Pharma and OT have been subdivided into single process steps for which the Companion Guide provides standard operating procedures (SOPs), checklists, templates, guidelines and tools. The content of the Companion Guide is continuously subjected to evaluation by means of a structured survey with regard to the achievement of its purpose of ensuring to ensure high-quality HTA reports.ResultsIn May 2018, the Companion Guide was launched and is now available to all EUnetHTA partners. It provides central access to all components of the newly established QMquality management system for EUnetHTA. The user has access to training modules that provide information on how to use the Companion Guide. Moreover, the training material enables EUnetHTA partners to build up necessary capabilities for QMquality management, and application of methodologies and tools in the context of EUnetHTA.ConclusionsThe purpose of the Companion Guide is to ensure the production of high-quality HTA reports by providing ultimate support and guidance to the EUnetHTA assessment teams during their joint work. The continuous evaluation will reveal necessary revisions and the need for further developments and guidance.