Institute for Quality and Efficiency in Healthcare IQWiG

Köln, Germany

Institute for Quality and Efficiency in Healthcare IQWiG

Köln, Germany
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Hulstaert F.,Belgian Health Care Knowledge Center | Neyt M.,Belgian Health Care Knowledge Center | Vinck I.,Belgian Health Care Knowledge Center | Stordeur S.,Belgian Health Care Knowledge Center | And 9 more authors.
International Journal of Technology Assessment in Health Care | Year: 2012

Objectives: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. Results: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. Conclusions: For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized. © Copyright 2012 Cambridge University Press.


Janssen I.M.,Bielefeld University | Janssen I.M.,Institute for Quality and Efficiency in Healthcare IQWiG | Gerhardus A.,University of Bremen | Schroer-Gunther M.A.,Institute for Quality and Efficiency in Healthcare IQWiG | Scheibler F.,Institute for Quality and Efficiency in Healthcare IQWiG
Health Expectations | Year: 2015

Background: Evidence synthesis has seen major methodological advances in reducing uncertainty and estimating the sizes of the effects. Much less is known about how to assess the relative value of different outcomes. Objective: To identify studies that assessed preferences for outcomes in health conditions. Methods: Search strategy: we searched MEDLINE, EMBASE, PsycINFO and the Cochrane Library in February 2014. Inclusion criteria: eligible studies investigated preferences of patients, family members, the general population or healthcare professionals for health outcomes. The intention of this review was to include studies which focus on theoretical alternatives; studies which assessed preferences for distinct treatments were excluded. Data extraction: study characteristics as study objective, health condition, participants, elicitation method, and outcomes assessed in the study were extracted. Main results: One hundred and twenty-four studies were identified and categorized into four groups: (1) multi criteria decision analysis (MCDA) (n = 71), (2) rating or ranking (n = 25), (3) utility eliciting (n = 5) and (4) studies comparing different methods (n = 23). The number of outcomes assessed by method group varied. The comparison of different methods or subgroups within one study often resulted in different hierarchies of outcomes. Conclusions: A dominant method most suitable for application in evidence syntheses was not identified. As preferences of patients differ from those of other stakeholders (especially medical professionals), the choice of the group to be questioned is consequential. Further research needs to focus on validity and applicability of the identified methods. © 2015 John Wiley & Sons Ltd.


PubMed | Bielefeld University, Institute for Quality and Efficiency in Healthcare IQWiG and University of Bremen
Type: Journal Article | Journal: Health expectations : an international journal of public participation in health care and health policy | Year: 2016

Evidence synthesis has seen major methodological advances in reducing uncertainty and estimating the sizes of the effects. Much less is known about how to assess the relative value of different outcomes.To identify studies that assessed preferences for outcomes in health conditions.we searched MEDLINE, EMBASE, PsycINFO and the Cochrane Library in February 2014.eligible studies investigated preferences of patients, family members, the general population or healthcare professionals for health outcomes. The intention of this review was to include studies which focus on theoretical alternatives; studies which assessed preferences for distinct treatments were excluded.study characteristics as study objective, health condition, participants, elicitation method, and outcomes assessed in the study were extracted.One hundred and twenty-four studies were identified and categorized into four groups: (1) multi criteria decision analysis (MCDA) (n = 71), (2) rating or ranking (n = 25), (3) utility eliciting (n = 5) and (4) studies comparing different methods (n = 23). The number of outcomes assessed by method group varied. The comparison of different methods or subgroups within one study often resulted in different hierarchies of outcomes.A dominant method most suitable for application in evidence syntheses was not identified. As preferences of patients differ from those of other stakeholders (especially medical professionals), the choice of the group to be questioned is consequential. Further research needs to focus on validity and applicability of the identified methods.


Niederstadt C.,Review-Board | Droste S.,Institute for Quality and Efficiency in Healthcare IQWiG
International Journal of Technology Assessment in Health Care | Year: 2010

Background: Information retrieval (IR) in health technology assessment (HTA) calls for transparency and reproducibility, but common practice in the documentation and presentation of this process is inadequate in fulfilling this demand. Objectives: Our objective is to promote good IR practice by presenting the conceptualization of retrieval and transcription readable to non-information specialists, and reporting of effectively processed search strategies. Methods: We performed a comprehensive database search (04/2010) to synthesize the current state-of-the-art. We then developed graphical and tabular presentation methods and tested their feasibility on existing research questions and defined recommendations. Results: No generally accepted standard of reporting of IR in HTA exists. We, therefore, developed templates for presenting the retrieval conceptualization, database selection, and additional hand-searching as well as for presenting search histories of complex and lengthy search strategies. No single template fits all conceptualizations, but some can be applied to most processes. Database interface providers report queries as entered, not as they are actually processed. In PubMed, the huge difference between entered and processed query is shown in Details. Quality control and evaluation of search strategies using a validated tool such as the PRESS checklist is suboptimal when only entry-query based search histories are applied. Conclusions: Moving toward an internationally accepted IR reporting standard calls for advances in common reporting practices. Comprehensive, process-based reporting and presentation would make IR more understandable to others than information specialists and facilitate quality control. Copyright © Cambridge University Press 2010.


Nagele E.,Medical University of Graz | Jeitler K.,Medical University of Graz | Horvath K.,Medical University of Graz | Semlitsch T.,Medical University of Graz | And 9 more authors.
Journal of Hypertension | Year: 2014

Objective: A systematic review and meta-analysis focusing on patient-relevant outcomes and blood pressure was conducted to assess the clinical effectiveness of stressreduction techniques in adults with essential hypertension. Methods: Systematic reviews and randomized controlled trials (RCTs) were identified as part of a systematic search in six electronic databases ending September 2012. RCTs comparing stress-reduction techniques versus no such techniques with a follow-up of at least 24 weeks and published in English or German were included. Outcomes of interest were death, cardiovascular morbidity/mortality, end-stage renal disease, health-related quality of life, adverse events, changes in blood pressure, and changes in antihypertensive medication. When appropriate, metaanalyses were used to combine data. Results: Seventeen RCTs analyzing different stressreduction techniques such as biofeedback, relaxation or combined interventions were identified. Data were not reported for most of the patient-relevant outcomes, and meta-analyses could only be used to evaluate effects on blood pressure. The data indicated a blood pressurelowering effect, but the studies had methodological shortcomings and heterogeneity between them was high. Mean group differences for DBP ranged from -10 to 1mmHg and for SBP from -12 to 10 mmHg. In terms of antihypertensive medication, no favorable effects of stressreduction techniques could be identified. Conclusions: The available RCTs on stress-reduction techniques used for at least 24 weeks appeared to indicate a blood pressure-lowering effect in patients with essential hypertension, but this should be interpreted with caution because of major methodological limitations. A benefit of specific stress-reduction techniques in hypertensive patients remains unproven. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Hofmann B.,Gjøvik University College | Cleemput I.,Hasselt University | Bond K.,Canadian Agency for Drugs and Technologies in Health | Krones T.,University of Zürich | And 3 more authors.
International Journal of Technology Assessment in Health Care | Year: 2014

Background: Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments. Methods: A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation. Results: Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process. Conclusions: HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA. Copyright © Cambridge University Press 2015.


PubMed | Hasselt University, Gjøvik University College, Ecorys Netherlands., Catholic University of the Sacred Heart and 3 more.
Type: Journal Article | Journal: International journal of technology assessment in health care | Year: 2015

Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments.A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation.Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process.HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.

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