The evolving value assessment of cancer therapies: Results from a modified Delphi study.

The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified Delphi process to develop principles for defining and assessing value of cancer therapies that aligns with the current trajectory of oncology research and reflects broader notions of value. 24 experts participated in consensus-building activities across 5 months (16 took part in structured interactions, including a survey, plenary sessions, interviews, and off-line discussions, while 8 participated in interviews). Discussion focused on: 1) which oncology-relevant endpoints should be used for assessing treatments for early-stage cancer and access decisions for early-stage treatments, and 2) the importance of additional value components and how these can be integrated in value assessments. The expert group reached consensus on 4 principles in relation to the first area (consider oncology-relevant endpoints other than overall survival; build evidence for endpoints that provide earlier indication of efficacy; develop evidence for the next generation of predictive measures; use managed entry agreements supported by ongoing evidence collection to address decision-maker evidence needs) and 3 principles in relation to the second (routinely use patient reported outcomes in value assessments; assess broad economic impact of new medicines; consider other value aspects of relevance to patients and society).

Quality scores do not predict discrepant statistical significances among meta-analyses on different targets of glycemic control in type 2 diabetes.

OBJECTIVES: To examine differences in conclusions, statistical significances, and quality of systematic reviews on preventive effects of different targets of blood glucose lowering on macrovascular events in patients with type 2 diabetes. STUDY DESIGN AND SETTING: We searched MEDLINE, the Cochrane Database of Systematic Reviews, and Embase until October 15, 2011. Systematic reviews using meta-analyses to compare macrovascular events in patients with type 2 diabetes randomized to different therapeutic targets of blood glucose were eligible for inclusion in this study. Effect measures were extracted and quality was assessed by Overview Quality Assessment Questionnaire, Assessment of Multiple Systematic Reviews, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. An additional checklist was used to control for completeness and suitability of included trials, correctness of data extraction, and choice of outcome parameters. RESULTS: The 16 included systematic reviews were partially discrepant in statistical significances of reported outcome parameters. Twelve systematic reviews did not include available relevant trials and included eight systematic reviews that should not have been included according to the systematic review's aim and search strategies. Quality differed considerably among systematic reviews. CONCLUSION: Physicians, researchers, and policy makers should bear in mind that common quality assessment instruments are necessary but not sufficient to guarantee reliable results and conclusions obtained from meta-analyses.

The German health care system in international comparison: the primary care physicians' perspective.

BACKGROUND: In 2009, the U.S. Commonwealth Fund conducted a survey of primary care physicians in a number of different countries to determine their views on aspects of their daily work and their perceptions of their countries' health care systems as a whole. A similar survey had been carried out in 2006. METHODS: From February to July 2009, the survey was carried out by interview in representative samples of primary care physicians, general practitioners, internists providing primary care, and pediatricians in 11 countries: Australia, Canada, France, Germany, Italy, the Netherlands, New Zealand, Norway, Sweden, the UK, and the USA. RESULTS: A total of 10 320 interviews were conducted. Only in the Netherlands and Norway did most respondents (60% and 56%, respectively) consider their health care system to be functioning well. Everywhere else, many of the respondents-in particular, 82% of the respondents in Germany-saw a fundamental need for change. 73% of the German physicians stated that recent changes in the health care system had brought about a decline in the quality of care. In all countries but Germany, the percentage of respondents sharing this opinion was 41% at the highest. Nevertheless, most of the German physicians had a positive opinion of the patient care that they themselves delivered. CONCLUSION: The 2009 survey, like its predecessor in 2006, revealed major differences in physicians' perceptions of their health care systems from one country to another. The German respondents' dissatisfaction with, and negative evaluation of, their health care system as a whole contrast with their positive views of their own patient care.

["Expert approved international standards of evidence-based medicine": a proposal]. / Die "in den jeweiligen Fachkreisen anerkannten internationalen Standards der evidenzbasierten Medizin" - ein Vorschlag.

Section 35b of the German Code of Social Law Book V (SGB V) mentions "expert approved international standards of evidence-based medicine" (EbM). An idea which started as a reform movement in and for clinical medicine more than twenty years ago is here, from a socio-legal perspective, being utilised as a normative concept in terms of a standard-creating methodology, which is meant to form the basis for the "methods and criteria" of comparative benefit/risk assessment of medical drugs mentioned in the respective law. The present paper places the standards in a hierarchy between "description and analysis of benefits" at the bottom and, at the top, "fundamental concerns of EbM". Apart from a variety of standards, we propose seven basic principles and four fundamental concerns of EbM (pursuit of empirical truth, patient welfare, pragmatism, procedural justice). Each of the basic principles, standards, methods and criteria can be taken to substantiate the respective superordinate category (basic concerns etc.). The position and role of the standards will be explained using the example "search for and selection of literature".

The German health care system in international comparison: a patient perspective.

BACKGROUND: International health care systems of industrial countries show great differences in organization and financing. During 2008 the Commonwealth Fund interviewed sicker adult patients from eight countries to compare aspects of quality of health care. METHODS: In total, 9633 randomly selected patients from Australia, Canada, France, Germany, The Netherlands, New Zealand, United Kingdom, and the USA were recruited for structured interviews. All participants were adults who reported being in poor health, having a serious illness or disability, having been hospitalized, or having had major surgery in the past two years. RESULTS: In total, only 34% of participants in Germany rated the quality of their health care as "excellent" or "very good". This fraction was larger in the other countries (up to 66%). Sicker adults in Germany consulted more physicians. Problems with coordination were reported by all countries, in particular concerning the communication between specialist/general practitioner, hospital/general practitioner and the flow of information to the patients. CONCLUSION: Although sicker adults report similar experiences and problems with coordination their satisfaction with health care differs internationally. Compared to a similar survey in 2005 the general satisfaction of sicker adults with health care in Germany has improved.

Institute for Quality and Efficiency in Health Care: Germany.

The Institute for Quality and Efficiency in Health Care (IQWiG) was established in 2004 to provide Germany's Federal Joint Committee with evidence-based evaluations of the benefits and cost benefits of health services, and functions in an advisory role. IQWiG reviews available evidence and produces recommendations after an extensive process of consultation with experts and stakeholders. IQWiG's recommendations are then considered by the Joint Committee in issuing coverage and payment directives. Under German law, insurance funds must cover any service that is medically necessary, which means that cost-effectiveness analysis can only be used to exclude a treatment from coverage if at least one equivalent alternative exists.

Comparative effectiveness research and evidence-based health policy: experience from four countries.

CONTEXT: The discussion about improving the efficiency, quality, and long-term sustainability of the U.S. health care system is increasingly focusing on the need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies to evaluate health technologies and broader management strategies to inform health care policy decisions. This article reviews experiences from Britain, France, Australia, and Germany. METHODS: This article draws on the experience of senior technical and administrative staff in setting up and running the CER entities studied. Besides reviewing the agencies' websites, legal framework documents, and informal interviews with key stakeholders, this analysis was informed by a workshop bringing together U.S. and international experts. FINDINGS: This article builds a matrix of features identified from the international models studied that offer insights into near-term decisions about the location, design, and function of a U.S.-based CER entity. While each country has developed a CER capacity unique to its health system, elements such as the inclusiveness of relevant stakeholders, transparency in operation, independence of the central government and other interests, and adaptability to a changing environment are prerequisites for these entities' successful operation. CONCLUSIONS: While the CER entities evolved separately and have different responsibilities, they have adopted a set of core structural, technical, and procedural principles, including mechanisms for engaging with stakeholders, governance and oversight arrangements, and explicit methodologies for analyzing evidence, to ensure a high-quality product that is relevant to their system.