Implications of living evidence formats for coverage decisions in the German health care system.

Decision-makers consult systematic reviews and clinical guidelines to make informed coverage decisions based on the current state of evidence. Outdated recommendations in rapidly evolving areas such as lung cancer treatment, are challenging. The COVID-19 pandemic highlighted the need for good decision-making under uncertainty.

Evidence-based health policy in Germany: lack of communication and coordination between academia and health authorities?

Health-care decision making should consider the best available evidence, often in the form of systematic reviews (SRs). The number of existing SRs and their overlap make their identification and use difficult. Decision makers often rely on de novo SRs instead of using existing SRs.

[How robust are studies of currently permanently included digital health applications (DiGA)? Methodological quality of studies demonstrating positive health care effects of DiGA].

Introduction: Since September 2020 digital health applications (DiGA) can be prescribed by physicians and psychotherapists and are reimbursed within the German Statutory Health Insurance (SHI) system for the first time worldwide. For full reimbursement, the manufacturers have to provide evidence based on scientific studies that the DiGA can provide 'positive health care effects'. This study aims to analyze and evaluate the methodological quality of efficacy studies of DiGA in the categories 'Nervensystem' and 'Psyche' of the DiGA register that are permanently accepted.

Disruptive technologies in health care disenchanted: a systematic review of concepts and examples.

Objectives: To clarify the concept of disruptive technologies in health care, provide examples and consider implications of potentially disruptive technologies for health technology assessment (HTA).

Methods: We conducted a systematic review of conceptual and empirical papers on healthcare technologies that are described as "" We searched MEDLINE and Embase from 2013 to April 2019 (updated in December 2021). Data extraction was done in duplicate by pairs of reviewers utilizing a data extraction form.

Around the Tables - Contextual Factors in Healthcare Coverage Decisions Across Western Europe.

Background: Across Western Europe, procedures and formalised criteria for taking decisions on the coverage (inclusion in the benefits basket or equivalent) of healthcare technologies vary substantially. In the decision documents, which display the justification of, the rationale for, these decisions, national healthcare institutes may employ 'contextual factors,' defined here as considerations. Little is known about how the use of such contextual factors compares across countries.

Testing a new taxonomic model for the assessment of medical devices: Is it plausible and applicable? Insights from HTA reports and interviews with HTA institutions in Europe.

Objective: Medical devices (MDs) encompass a broad and heterogeneous range of technologies. While practices vary considerably across countries, MDs often find application in patient care with little or no evaluation of their effectiveness and safety following market approval. A recently proposed taxonomy of MDs considered devices from the viewpoint of Health Technology Assessment (HTA).

[GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health].

Objective: To describe the Grading of Recommendations Assessment, Development and Evaluation (GRADE) interactive Evidence to Decision (EtD) frameworks for tests and test strategies for clinical, public health or coverage decisions.

Study Design And Setting: As part of the GRADE Working Group's DECIDE project we conducted workshops, user testing with systematic review authors, guideline developers and other decision makers, and piloted versions of the EtD framework.

Results: EtD frameworks for tests share the structure, explicitness, and transparency of other EtD frameworks.

Scientific Evidence in Health Technology Assessment Reports: An In-Depth Analysis of European Assessments on High-Risk Medical Devices.

Background: The aim of this study was to examine the scientific evidence on clinical effectiveness and safety used in health technology assessments (HTAs) of high-risk medical devices (MDs) in Europe.

Methods: We applied a systematic approach to identify European institutions involved in HTA and to select reports assessing MDs considered high-risk according to the definition in the new German health care regulation §137h. Reports published between 2010 and 2015 were considered in our subsequent analysis.

Evidence-based decision-making for diagnostic and therapeutic methods: the changing landscape of assessment approaches in Germany.

This article examines the current status and most important changes over time to the legislative framework on the health technology assessment-informed decision-making process on diagnostic and therapeutic 'methods' in Germany. The relevant information was obtained through documentary analysis covering the period 1990 to 2017. The findings show that, even if the outpatient care sector appears to be much more regulated than the inpatient sector (based on a strict separation of the two care settings), developments in Germany have led to a more tightened assessment framework, making the use of evidence a firm component in the decision-making process.

QUALITY OF SAMPLE SIZE ESTIMATION IN TRIALS OF MEDICAL DEVICES: HIGH-RISK DEVICES FOR NEUROLOGICAL CONDITIONS AS EXAMPLE.

Background: The aim of this study was to assess the quality of reporting sample size calculation and underlying design assumptions in pivotal trials of high-risk medical devices (MDs) for neurological conditions.

Methods: Systematic review of research protocols for publicly registered randomized controlled trials (RCTs). In the absence of a published protocol, principal investigators were contacted for additional data.

HTA of medical devices: Challenges and ideas for the future from a European perspective.

Objectives: Health Technology Assessment (HTA) of Medical devices (MDs) and MD-based procedures can be challenging due to the unique features and particularities of this group of technologies, such as device-operator interaction. The aim of this study was to (1) clarify, and supplement earlier findings on European HTA institutions' structural, procedural and methodological characteristics with regard to the assessment of MDs and to (2) capture the institutions' perceptions regarding challenges and future trends.

Methods: Semi-structured telephone interviews with 16 representatives from leading European HTA institutions were performed between April and July 2015.

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT.

Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices.

Methods for Health Economic Evaluation of Vaccines and Immunization Decision Frameworks: A Consensus Framework from a European Vaccine Economics Community.

Background: Incremental cost-effectiveness and cost-utility analyses [health economic evaluations (HEEs)] of vaccines are routinely considered in decision making on immunization in various industrialized countries. While guidelines advocating more standardization of such HEEs (mainly for curative drugs) exist, several immunization-specific aspects (e.g.

[GRADE guidelines: 13. Preparing Summary of Findings tables and evidence profiles - continuous outcomes].

Unlabelled: Presenting continuous outcomes in Summary of Findings tables presents particular challenges to interpretation. When each study uses the same outcome measure, and the units of that measure are intuitively interpretable (e.g.

[The periodic health examination: from law to the directive of the German Federal Joint Committee (G-BA)].

Since 1989 a periodic health examination beginning at the age of 35 for the early detection of "common diseases" (especially cardiovascular and kidney diseases as well as diabetes) by means of history-taking, physical examination, blood and urine tests and counselling has been available in Germany. Altogether, the respective directive of the Federal Joint Committee (G-BA) was revised six times, but a substantive change took place only once (i. e.

The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: up to international standard?

Funding of diagnostic and therapeutic methods in Germany's statutory health insurance (SHI) follows a dichotomy: in outpatient care, only methods with proven benefit are reimbursed while in inpatient care, all methods may be provided unless they are excluded due to proven harm or lack of benefit. In January 2012, a new section 137e was added to the Social Code Book V (SGB V), allowing for the inclusion of innovative and potentially beneficial diagnostic or therapeutic methods in the SHI benefit basket, while additional evidence regarding their effectiveness and safety must be gathered. In 2013, the Federal Joint Committee (G-BA) has specified the details of this new approach, which can be considered a variety of "Coverage with Evidence Development" (CED).

[GRADE guidelines: 12. Developing Summary of Findings tables - dichotomous outcomes].

Summary of Findings (SoF) tables present, for each of the seven (or fewer) most important outcomes, the following: the number of studies and number of participants; the confidence in effect estimates (quality of evidence); and the best estimates of relative and absolute effects. Potentially challenging choices in preparing SoF tables include using direct evidence (which may have very few events) or indirect evidence (from a surrogate) as the best evidence for a treatment effect. If a surrogate is chosen, it must be labeled as substituting for the corresponding patient-important outcome.

[GRADE guidelines: 11. Making an overall rating of confidence in effect estimates for a single outcome and for all outcomes].

GRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidence-high, moderate, low, or very low) for each important or critical outcome. GRADE suggests, for each outcome, the initial separate consideration of five domains of reasons for rating down the confidence in effect estimates, thereby allowing systematic review authors and guideline developers to arrive at an outcome-specific rating of confidence. Although this rating system represents discrete steps on an ordinal scale, it is helpful to view confidence in estimates as a continuum, and the final rating of confidence may differ from that suggested by separate consideration of each domain.

[Learning curve in laser treatment of benign prostatic syndrome: a systematic review].

The aim of the present systematic review was to evaluate the evidence of a potential learning curve for laser treatment of benign prostatic hyperplasia. A systematic literature search was conducted in November 2011 using The Cochrane Library, EMBASE and MEDLINE. Overall, 18 sources (mostly case series) were included for further assessment.