Rapid Response to COVID-19 by Mobilizing Numeric Data, Treatments such as HCQ+Zinc

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Description: Project for Accelerated Sharing of Treatment Results to Meet Novel Challenges For a rapid and effective response to threats like the SARS-CoV-2 / Covid-19 pandemic, it is necessary to make better use of a vast but neglected reservoir of knowledge: the clinical experiences of treating physicians. Numerous doctors have claimed success in treating Covid-19 with repurposed off-label drugs like hydroxychloroquine with high dose zinc. Lacking hard data, these reports have been largely dismissed as anecdotal. Quantitative treatment results make reports transparent and verifiable, which facilitates understanding, replication and adoption of useful therapies, thereby saving lives and livelihoods. Thus this proposal calls for treating physicians and hospitals to share data, to be compiled and tabulated for publication. We propose a data chart for recording relevant treatment outcomes in practices, currently or retrospectively. The chart (Dataset.xlxs) is in the Files section, and is explained in the Dataset wiki. In this first phase we will focus on the collection, tabulation and publication of treatment data only, rather than experimental research, for reasons discussed in the Ethics wiki. We find that the normal procedure of a physician treating a patient is actually a type of non-research N-of-1 trial. Although less well established than large controlled trials, "N-of-1 trials have been placed, by some, on the pinnacle of the evidence hierarchy for making decisions about treatment benefits and harms... They are ideal... for therapies with a relatively quick onset of action after initiation and quick termination of effect after discontinuation,"[1] which is the situation in Covid-19 treatment. Since this dataset only involves normal treatment practice, physicians and clinics have no added responsibility, liability or regulatory requirements from recording and sharing the data. Practitioners are free to share and publish treatment results.[2] The project fits the profile of a Shared Learning initiative in Quality Improvement[3] along the lines suggested for practices by the Agency for Healthcare Research and Quality, whose mission is "Building Bridges Between Research and Practice: Accelerating learning and innovation in health care delivery."[4] Many useful findings may fall into the huge gap between high-cost mega-studies and casual physician testimonials. A longer-term effort could retrieve some of these. A second phase might include experimental trials in line with the CONSORT extension for reporting N-of-1 trials. Research trials require far greater resources, which are not quickly available in an emergency situation; there are many strictures to safeguard against the dangers of new drugs, in excess of what is needed for repurposed drugs; and they involve complex procedures such as blinding, randomization and placebos, which have little relevance to acute medical treatment. The benefit would be that with an RCT design, N-of-1 trials may be considered Level 1 or "gold standard" of evidence. The principle of the N-of-1 trial in treatment, and of treatment per se, is that if a "problem vanished during the treatment it can be established that the treatment was effective." This has potential to be much more widely applied in modern medicine. The data are available and time is of the essence. The cost of waiting for vaccines or "gold standard" trials is incalculable, when health authorities have no other remedy but to shut down the economy. Millions of words have been written and months have passed debating the best treatments physicians have found. We propose that "Numbers may be worth a thousand words" – and save trillions in economic losses in present and future pandemics. There are no financial conflicts of interest to disclose. Statement regarding project feasibility: Project success is critically dependent on obtaining treatment data from practitioners. It is expected that a sufficient number of practices will be motivated to provide data for humanitarian reasons, and for added goodwill, as sources will be credited as contributors. The project administrator has many years of experience in managing challenging projects, in public accounting, and in publishing. Sufficient funds are available to finance the project. After completion of the initial phase of the project, it is expected to transition into a self-financing learned journal. A team of collaborators and consultants is also available, Feedback from formal and informal peer review will be incorporated on an ongoing basis. [1] CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement https://www.bmj.com/content/350/bmj.h1738 [2] https://effectivehealthcare.ahrq.gov/products/n-1-trials/research-2014-3/ Publication [3] Quality Improvement in Primary Care – Shared Learning https://www.ahrq.gov/research/findings/factsheets/quality/qipc/index.html [4] See https://www.ahrq.gov/cpi/about/impact/index.html

Wiki

Project for Accelerated Sharing of Treatment Results to Meet Novel Challenges -- https://osf.io/qw54t/wiki/home/ KEY POINTS • Potential to Quickly Win the War on COVID-19 • Utilize Evidence From, By and For Physicians and Clinics. • Bridge the gap between "anecdotal" and "gold standard" evidence for promising treatments • Without an IRB, you may treat patients as usual, tabulate results and share ...

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