BackgroundA variety of definitions of evidence-based practice (EBP) exist. However, definitions are in themselves insufficient to explain the underlying processes of EBP and to differentiate between an evidence-based process and evidence-based outcome. There is a need for a clear statement of what Evidence-Based Practice (EBP) means, a description of the skills required to practise in an evidence-based manner and a curriculum that outlines the minimum requirements for training health professionals in EBP. This consensus statement is based on current literature and incorporating the experience of delegates attending the 2003 Conference of Evidence-Based Health Care Teachers and Developers ("Signposting the future of EBHC").DiscussionEvidence-Based Practice has evolved in both scope and definition. Evidence-Based Practice (EBP) requires that decisions about health care are based on the best available, current, valid and relevant evidence. These decisions should be made by those receiving care, informed by the tacit and explicit knowledge of those providing care, within the context of available resources.Health care professionals must be able to gain, assess, apply and integrate new knowledge and have the ability to adapt to changing circumstances throughout their professional life. Curricula to deliver these aptitudes need to be grounded in the five-step model of EBP, and informed by ongoing research. Core assessment tools for each of the steps should continue to be developed, validated, and made freely available.SummaryAll health care professionals need to understand the principles of EBP, recognise EBP in action, implement evidence-based policies, and have a critical attitude to their own practice and to evidence. Without these skills, professionals and organisations will find it difficult to provide 'best practice'.
What's known on the subject? and What does the study add?
Targeted agents have greatly changed the therapeutic landscape in RCC. A substantial number of trials have been published in recent years.
The current review summarises and analyses the available data to date.
OBJECTIVE
To estimate the effects of drugs with molecular targets on patients with advanced renal cell cancer (RCC).
PATIENTS AND METHODS
MEDLINE, EMBASE, and the Cochrane Collaboration Library were systematically searched on‐line through to June 2011 to identify eligible randomised trials. We also searched abstract reports from major oncology and urology meetings.
We included randomised trials that tested a targeted agent and reported at least one outcome by allocation on an intent‐to‐treat basis. Completeness of ascertainment and risk of bias were assessed.
Our primary outcome was progression‐free survival (PFS).
RESULTS
In all, 28 studies met our inclusion criteria and 10 were placebo‐controlled. Two studies were too small to assess, and five early studies used nonspecific anti‐angiogenic agents with poor activity. In all, 15 studies, in 5587 patients, tested anti‐vascular epithelial growth factor (VEGF) agents: bevacizumab (BEV), sorafenib, sunitinib, pazopanib, tivozanib, or axitinib. Three studies, in 1147 patients, tested the mammalian target of rapamycin (mTOR) inhibitors, temsirolimus or everolimus. Two studies included epidermal growth factor receptor (EGFR) inhibitors, and one tested the combination of temsirolimus plus BEV.
In treatment‐naive patients with mostly good–moderate prognostic risk, in separate trials oral sunitinib (one trial) and intravenous BEV plus subcutaneousinterferon‐α (two trials) improved PFS compared with the previous standard of care interferon‐α within randomised phase III trials. Sorafenib did not improve PFS over interferon‐α in the first‐line setting and the addition of cytokines did not improve sorafenib efficacy. In poor‐risk patients, the mTOR inhibitor temsirolimus improved PFS and overall survival (OS). The studies of other VEGF inhibitors have used placebo controls no longer appropriate in this setting, although pazopanib is an approved option.
Several trials examined agents in the second‐line setting. After cytokine therapy, sorafenib (one study) and pazopanib (one study) prolonged PFS over placebo. A preliminary report of the investigational VEGF receptorinhibitor axitinib gave superior PFS to sorafenib after either prior cytokine or prior sunitinib treatment. After cancer progression ≤6 months of sunitinib and/or sorafenib therapy, everolimusprolonged PFS.
OS was marginally improved in several studies. A more substantial effect on OS may have been diluted by crossover from control therapy to the investigational arm and/or by other anti‐angiogenic agents after trial closure. Patient‐reported outcomes were considered unreliable in trials without ‘blinding’.
A clear cell RCC (ccRCC) component was required for most trials, and information for non‐ccRCCs is consequently limited
CONCLUSIONS
Agents targ...
Background: Interest in assessing the value of health-care services in Germany has considerably increased since the foundation of the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG (Institute for Quality and Efficiency in Health Care). The practical application of value assessment illustrates how problematic the process can be. In all decisions made for the provision of health care, data concerning the measurable dimensions (quantity and quality of efficacy and effectiveness, validity of the results and costs) flow into a complex and not yet standardized decision-making process concerning public financing. Some of these decisions are based on data of uncertain validity, unknown reproducibility and unclear appropriateness.
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