Key Information, (first of 2)
A very important report has been linked on the IV message board (by Fred). I’ll repeat the link in my next post here. First a little background. This report is a meta-analysis (a summary and discussion based on many other reports). It covers the extensive “Level 1” evidence basis for hyperthermia as the “4th Pillar” for cancer treatment. And, remember, BSD Medical is the world-leading developer and provider of hyperthermia systems (also of tumor ablation systems).
Level 1 evidence? That is essentially what fully-controlled Phase 3 trials provide. The numeric designation for “Levels” is in the opposite sense to that used for the “Phases” terminology. Level “1” (or Roman numeral I) denotes the highest Level of evidence, in contrast to the “Phase” nomenclature, where 3 (or III) refers to the highest level. The evidence Levels are defined in a Wikipedia article on Evidence-Based Medicine (wherein, possibly causing confusion, A, B, and C are also used and the USPSTF adds sub-categories for Level II):
http://en.wikipedia.org/wiki/Evidence-based_medicine
<Assessing the quality of evidence
Evidence-based medicine categorizes different types of clinical evidence and rates or grades them [26] according to the strength of their freedom from the various biases that beset medical research. For example, the strongest evidence for therapeutic interventions is provided by systematic review of randomized, triple-blind, placebo-controlled trials with allocation concealment and complete follow-up involving a homogeneous patient population and medical condition. In contrast, patient testimonials, case reports, and even expert opinion (however some critics have argued that expert opinion "does not belong in the rankings of the quality of empirical evidence because it does not represent a form of empirical evidence" and continue that "expert opinion would seem to be a separate, complex type of knowledge that would not fit into hierarchies otherwise limited to empirical evidence alone." [27]) have little value as proof because of the placebo effect, the biases inherent in observation and reporting of cases, difficulties in ascertaining who is an expert and more.>
<US Preventive Services Task Force (USPSTF)
Systems to stratify evidence by quality have been developed, such as this one by the U.S. Preventive Services Task Force for ranking evidence about the effectiveness of treatments or screening:[28]
Level I: Evidence obtained from at least one properly designed randomized controlled trial.
Level II-1: Evidence obtained from well-designed controlled trials without randomization.
Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.>
Pleo: BSD M.’s 2000-series of products have been/are involved in numerous Phase 3 trials, which are for Level I proof. I have seen various statements re the total number of Phase 3 trials reporting results for hyperthermia – 14, 17, 18 – at various times. These trials have supplied much Level 1 evidence *for* hyperthermia therapy. The results have led to at least two professional efforts by leading doctors –to recommend hyperthermia as a major new type of cancer treatment (to add to surgery, radiotherapy, and chemotherapy). One document in particular – issued about mid 2011 – is important reading for anyone interested in new cancer treatments, as it clearly reveals hyperthermia as a well-proven cancer therapy. And, don’t forget, BSD Medical leads in tumor ablation, as well as hyperthermia. |
