GMS health technology assessment最新文献

Background: The majority of clinical practice guidelines do not recommend the use of SYSADOA (Symptomatic Slow Action Drugs for Osteoarthritis) for the treatment of osteoarthritis because of the lack of evidence or uncertainty around their efficacy. Nevertheless, the Spanish Public Health Service continues funding these drugs. Aim: The aim of this study is to describe the prescription status of SYSADOA in the primary care units of the Basque Country during 2011; to determine if variability exists among them; and to examine if the variability could be explained by the health care region each PC unit belongs to. Methods: Prescription data for SYSADOA during 2011 was obtained from the Basque Ministry for Health. In the Basque Country, primary care is divided into seven regions, each region consisting of several primary care units, which were used as the unit of analysis. Defined daily doses (DDD) per 1,000 inhabitant-days (DHD) were calculated. Data were standardized by sex and age using the total population of the Basque Country as the reference population. Small area statistics were calculated (extremal quotient, coefficient of variation and systematic component of variation). The influence of the region to which primary care units belonged was also analysed. R software (version R-2.15.0) was used for the analysis. Results: SYSADOA prescription during 2011 accounted for an expense of 4.5 million euros for the Basque Health Service. The crude rate of consumption of SYSADOA was 7.81 DDD per 1,000 inhabitant-days. The obtained external quotient was 13.67. The prescription of SYSADOA of the primary care units located in the 95th percentile was six times higher than the ones located in the 5th percentile. The region to which units belonged accounted for 57% of the observed variability. Discussion: The uncertainty around these drugs could be reflected in the existing variability of their prescription level. The analysis of the variability in the prescription of drugs with no demonstrated efficacy could help in allocating resources into other services or health technologies supported by evidence, thereby contributing to the improvement of health outcomes.

Introduction: Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically underdeveloped in comparison to other areas of HTA, such as clinical or cost effectiveness. Objective: To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use. Methods: To develop a list of items for the Q-SEA instrument, we systematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations' websites, and solicited views from 32 experts in the field of ethics for HTA at two 2-day workshops. We subsequently refined Q-SEA through its application to an ethics analysis conducted for HTA. Results: Q-SEA instrument consists of two domains - the process domain and the output domain. The process domain consists of 5 elements: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values. Conclusion: Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue.

Background: Dialysis-dependent acute kidney injury (AKI) can be treated using continuous (CRRT) or intermittent renal replacement therapies (IRRT). Although some studies suggest that CRRT may have advantages over IRRT, study findings are inconsistent. This study assessed differences between CRRT and IRRT regarding important clinical outcomes (such as mortality and renal recovery) and cost-effectiveness. Additionally, ethical aspects that are linked to renal replacement therapies in the intensive care setting are considered. Methods: Systematic searches in MEDLINE, EMBASE, and Cochrane Library including RCTs, observational studies, and cost-effectiveness studies were performed. Results were pooled using a random effects-model. Results: Forty-nine studies were included. Findings show a higher rate of renal recovery among survivors who initially received CRRT as compared with IRRT. This advantage applies to the analysis of all studies with different observation periods (Relative Risk (RR) 1.10; 95% Confidence Interval (CI) [1.05, 1.16]) and to a selection of studies with observation periods of 90 days (RR 1.07; 95% CI [1.04, 1.09]). Regarding observation periods beyond there are no differences when only two identified studies were analyzed. Patients initially receiving CRRT have higher mortality as compared to IRRT (RR 1.17; 95% CI [1.06, 1.28]). This difference is attributable to observational studies and may have been caused by allocation bias since seriously ill patients more often initially receive CRRT instead of IRRT. CRRT do not significantly differ from IRRT with respect to change of mean arterial pressure, hypotensive episodes, hemodynamic instability, and length of stay. Data on cost-effectiveness is inconsistent. Recent analyzes indicate that initial CRRT is cost-effective compared to initial IRRT due to a reduction of the rate of long-term dialysis dependence. As regards a short time horizon, this cost benefit has not been shown. Conclusion: Findings of the conducted assessment show that initial CRRT is associated with higher rates of renal recovery. Potential long-term effects on clinical outcomes for more than three months could not be analyzed and should be investigated in further studies. Economical analyzes indicate that initial CRRT is cost-effective when costs of long-term dialysis dependence are considered. However, transferability of the economic analyzes to the German health care system is limited and the conduction of economical analyzes using national cost data should be considered.

In the framework of European law telemedicine is, simultaneously, a health service and an information service, therefore, both regulations apply. In what concerns healthcare and the practice of medicine there are no uniform regulations at the European level. Concerning health services the most relevant achievement to regulate this domain is Directive 2011/24/EU. In what regards information and telecommunications we must have in consideration Directive 95/46/EU, Directive 2000/31/EC and Directive 2002/58/EC. However, many issues still lack uniform regulation, mainly the domain of medical liability and of medical leges artis. Probably such standardization will never take place, since the European Union does not have, until now, a common set of norms regarding tort and criminal liability, much less specific legal norms on medical liability. These gaps may jeopardize a truly European internal market in health services and hamper the development of telemedicine in the European zone.

Complexity entails methodological challenges in assessing health care interventions. In order to address these challenges, a series of characteristics of complexity have been identified in the Health Technology Assessment (HTA) literature. These characteristics are primarily identified and developed to facilitate effectiveness, safety, and cost-effectiveness analysis. However, ethics is also a constitutive part of HTA, and it is not given that the conceptions of complexity that appears relevant for effectiveness, safety, and cost-effectiveness analysis are also relevant and directly applicable for ethical analysis in HTA. The objective of this article is therefore to identify and elaborate a set of key characteristics of complex health care interventions relevant for addressing ethical aspects in HTA. We start by investigating the relevance of the characteristics of complex interventions, as defined in the HTA literature. Most aspects of complexity found to be important when assessing effectiveness, safety, and efficiency turn out also to be relevant when assessing ethical issues of a given health technology. However, the importance and relevance of the complexity characteristics may differ when addressing ethical issues rather than effectiveness. Moreover, the moral challenges of a health care intervention may themselves contribute to the complexity. After identifying and analysing existing conceptions of complexity, we synthesise a set of five key characteristics of complexity for addressing ethical aspects in HTA: 1) multiple and changing perspectives, 2) indeterminate phenomena, 3) uncertain causality, 4) unpredictable outcome, and 5) ethical complexity. This may serve as an analytic tool in addressing ethical issues in HTA of complex interventions.

Aim: To identify new and emerging screening tests for colorectal cancer (CRC) that involves detection of various biomarkers like blood, DNA and RNA in samples of faeces, tissue or blood. Current practice: Screening for CRC can be done by bowel visualisation techniques and tests that measure biomarkers. The Bowel Cancer Screening Programme (BCSP) in England uses a guaiac faecal occult blood test.

Methods: The strategy was to search available literature, identify developers and contact them for relevant information. Advice from experts was sought on potential utility and likely impact of identified technologies on the BCSP.

Results: Ninety-three companies and five research groups were contacted. Sixty-nine relevant tests were identified. Detailed information was available for 48 tests, of these 73% were CE marked and the remainder were considered as emerging. Forty-nine tests use immunochemical methods to detect occult blood in faeces. Eight, four and two tests detect biomarkers in a sample of blood, or exfoliated cells either shed in faeces or collected from rectal mucosa respectively. Six tests were grouped as 'other tests'. Most of the identified tests are performed manually and give qualitative detection of biomarkers.

Conclusion: Variation in test performance and characteristics was observed amongst the 69 identified tests. Automated, quantitative FIT with a variable cut off are the preferred approach in the BSCP. However the units used to report FITs results do not enable comparison across products. Tests detecting biomarkers other than occult blood are more specific to neoplasms but have limited sensitivity due to the heterogeneity of cancer. Research is ongoing to identify an optimal panel of biomarkers, simplifying and automating the test, and reducing the cost.

From the conception of HTA in the 1970s it has been argued that addressing ethical issues is an element of HTA, and many methods for integrating ethics in HTA have become available. However, despite almost 40 years with repeated intentions, only few HTA reports include ethical analysis. Why is this so? How come, ethics is a constituent part of HTA, there are many methods available, but ethics is rarely part of practical HTA work? This is the key question of this article and several reasons why ethics is not a part of HTA are identified. A) Ethicists are professional strangers in HTA. B) A common agreed methodology for integrating ethics is lacking. Ethics methodology appears to be C) deficient, D) insufficient, or E) unsuitable. F) Integrating ethics in HTA is neither efficient nor needed for successful HTA. G) Most moral issues are general, and are not specific to a given technology. H) All relevant ethical issues can be handled within other frameworks, e.g., within economics. I) Ethics can undermine or burst the foundation of HTA. Hence, there are many reasons why ethics is not an integrated part of HTA so many years after identifying ethics as constitutive to HTA. These reasons may all explain why it is so, but on closer scrutiny, they do not work as compelling arguments for not addressing ethical issues in HTA. Hence, the identified reasons may work well as explanations, but not as justifications. In order to move on from a situation of failure we can: Exclude ethics from definitions of HTA, and as a consequence, establish a separate kind of evaluation (Health Technology Evaluation - HTE). Take the existing definition seriously and actually integrate ethics in the performance of HTA practice. Amend, expand or change HTA so that ethics is more genuinely incorporated. Which of these options to choose is open for discussion, but we need to move away from a situation where we have a definition of HTA which does not correspond with HTA practice.

An essential component of health technology assessment (HTA) is the assessment of ethical aspects. In some healthcare contexts, tasks are strictly relegated to different expert groups: the HTA-agencies are limited to assessment of the technology and other actors within the health care sector are responsible for appraisal and recommendations. Ethical aspects of health technologies are considered with reference to values or norms in such a way that may be prescriptive, or offer guidance as to how to act or relate to the issue in question. Given this internal prescriptivity, the distinction between assessment and appraisal seems difficult to uphold, unless the scrutiny stops short of a full ethical analysis of the technology. In the present article we analyse the distinction between assessment and appraisal, using as an example ethical aspects of implementation of GPS-bracelets for people with dementia. It is concluded that for HTA-agencies with a strictly delineated assessment role, the question of how to deal with the internal prescriptivity of ethics may be confusing. A full ethical analysis might result in a definite conclusion as to whether the technology in question is ethically acceptable or not, thereby limiting choices for decision-makers, who are required to uphold certain ethical values and norms. At the same time, depending on the exact nature of such a conclusion, different action strategies can be supported. A positive appraisal within HTA could result in a decision on mandatory implementation, or funding of the technology, thereby making it available to patients, or decisions to allow and even encourage the use of the technology (even if someone else will have to fund it). A neutral appraisal, giving no definite answer as to whether implementation is recommended or not, could result in a laissez-faire attitude towards the technology. A negative appraisal could result in a decision to discourage or even prohibit implementation. This paper presents an overview of the implications of different outcomes of the ethical analysis on appraisal of the technology. It is considered important to uphold the distinction between assessment and appraisal, primarily to avoid the influence of preconceived values and political interests on the assessment. Hence, as long as it is not based on the subjective value judgments of the HTA-agency (or its representative), such an appraising conclusion would not seem to conflict with the rationale for the separation of these tasks. Moreover, it should be noted that if HTA agencies abstain from including full ethical analyses because of the risk of issuing an appraisal, they may fail to provide the best possible basis for decision-makers. Hence, we argue that as long as the ethical analysis and its conclusions are presented transparently, disclosing how well-founded the conclusions are and/or whether there are alternative conclusions, the HTA-agencies should not avoid taking the ethical analysis as close as

Background: Influenza is a worldwide prevalent infectious disease of the respiratory tract annually causing high morbidity and mortality in Germany. Influenza is preventable by vaccination and this vaccination is so far recommended by the The German Standing Committee on Vaccination (STIKO) as a standard vaccination for people from the age of 60 onwards. Up to date a parenterally administered trivalent inactivated vaccine (TIV) has been in use almost exclusively. Since 2011 however a live-attenuated vaccine (LAIV) has been approved additionally. Consecutively, since 2013 the STIKO recommends LAIV (besides TIV) for children from 2 to 17 years of age, within the scope of vaccination by specified indications. LAIV should be preferred administered in children from 2 to 6 of age. The objective of this Health Technology Assessment (HTA) is to address various research issues regarding the vaccination of children with LAIV. The analysis was performed from a medical, epidemiological and health economic perspective, as well as from an ethical, social and legal point of view.

Method: An extensive systematic database research was performed to obtain relevant information. In addition a supplementary research by hand was done. Identified literature was screened in two passes by two independent reviewers using predefined inclusion and exclusion criteria. Included literature was evaluated in full-text using acknowledged standards. Studies were graded with the highest level of evidence (1++), if they met the criteria of European Medicines Agency (EMA)-Guidance: Points to consider on applications with 1. meta-analyses; 2. one pivotal study.

Results: For the medical section, the age of the study participants ranges from 6 months to 17 years. Regarding study efficacy, in children aged 6 months to ≤7 years, LAIV is superior to placebo as well as to a vac-cination with TIV (Relative Risk Reduction - RRR - of laboratory confirmed influenza infection approx. 80% and 50%, respectively). In children aged >7 to 17 years (= 18th year of their lives), LAIV is superior to a vaccination with TIV (RRR 32%). For this age group, no studies that compared LAIV with placebo were identified. It can be concluded that there is high evidence for superior efficacy of LAIV (compared to placebo or TIV) among children aged 6 months to ≤7 years. For children from >7 to 17 years, there is moderate evidence for superiority of LAIV for children with asthma, while direct evidence for children from the general population is lacking for this age group. Due to the efficacy of LAIV in children aged 6 months to ≤7 years (high evidence) and the efficacy of LAIV in children with asthma aged >7 to 17 years (moderate evidence), LAIV is also very likely to be efficacious among children in the general population aged >7 to 17 years (indirect evidence). In the included studies with children aged 2 to 17 years, LAIV was safe and well-tolerated