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Clinical Trials & Surrogate Outcomes Looking for clinical relevance means looking for a lot of details.  A crucial part of that is looking at WHAT is compared with WHAT But what if a comparison is not clinically relevant  - what do you do then? And how about studies using surrogate outcomes perhaps even approved by the FDA - they must be clinically relevant - but are they? In this episode, we talk about how to navigate this and find the best available research You don’t want to miss this episode    Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z   LINKS: Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines Supplemental content, JAMA Oncology (2017) https://jamanetwork.com/journals/jamaoncology/fullarticle/2594542  FDA Approved Surrogate Endpoints: https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure   Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence https://www.jmir.org/2020/7/e17571/    NOTES:  Finding clinically relevance in what is compared with what in a clinical trial  How can we know what a relevant comparison is? Different kinds of comparisons in clinical research The pro and cons of surrogate endpoints Examples of surrogate endpoints you should avoid Outcomes in oncology research FDA rules When is information from placebo trials relevant - and when isn’t it relevant Research with no comparator, when can that be useful?   GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool to use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com    Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, You can learn more at our website, where you can also leave us a voice message. Website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD   &  https://www.linkedin.com/in/kim-kristiansen  JG Staal: @HealthyEvidence  Music thanks to mixkit.co   

Addressing Clinical Relevance in Medical Papers Clinical trials and research should always aim to provide information that is meaningful and relevant for patients. In the last episode, we looked at how many - or rather - how few researchers mentioned and argued for what they would see as clinically relevant outcomes when setting up a study and listing it on clinicaltrials.gov In this episode, we go deeper to look at examples and why this is so important to improve the usefulness of the research   We want to make it mandatory to state the researchers' clinical relevance levels ahead of the trial, mentioning what they will consider clinically relevant when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings in both the paper and abstract when publishing data from the study.    #clinicalrelevance   LINKS: Once-Weekly Semaglutide in Adults with Overweight or Obesity Paper https://www.nejm.org/doi/full/10.1056/NEJMoa2032183  ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/study/NCT03548935  10-Year Update on Study Results Submitted to ClinicalTrials.gov  https://www.nejm.org/doi/full/10.1056/NEJMsr1907644 FDA and NIH let clinical trial sponsors keep results secret and break the law https://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law  Compliance with the legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(19)33220-9.pdf  Our specific page on our website about requesting clinical relevance statement and evaluation https://www.precision-evidence.com/p/clinical-relevance/  Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials  Precision Evidence episode 11: “Clinical relevance - Looking at Recent Papers”  https://www.precision-evidence.com/11  NOTES:   Why is stating levels for clinical relevance important to make before a clinical trial starts? How should authors of clinical research papers refer and compare to clinical relevance statements? Looking at a specific study  Importance of also looking at how the study is done In/exclusion criteria Compliance with listing on clinicaltrials.gov Compliance with publishing results on clinicaltrials.gov Challenges to make a comprehensive review and analysis of a medical paper to make sure the information is both trustworthy and clinically relevant GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool to use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com   Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, You can learn more at our website, where you can also leave us a voice message. Website: www.precision-evidence.com Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z   Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD   &  https://www.linkedin.com/in/kim-kristiansen  JG Staal: @HealthyEvidence  Music thanks to mixkit.co 

Clinical trials and research should always aim to provide information that is meaningful and relevant for patients. However, researchers are rarely addressing that topic when presenting results from trials. In this episode, we look at published papers from high-ranking journals to get a sense of the extent of that problem.  You may be surprised by our findings...   We want to make it mandatory to state the researchers' clinical relevance levels ahead of the trial, mentioning what they will consider clinically relevant when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings in both the paper and abstract when publishing data from the study.    #clinicalrelevance   LINKS: Our specific page on our website about requesting clinical relevance statement and evaluation https://www.precision-evidence.com/p/clinical-relevance/  Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials  Precision Evidence episode 10: “How to Get to Clinically Relevant Research” https://www.precision-evidence.com/10    NOTES:  Statistical significance vs. clinical significance in clinical research Clinical significance, clinical relevance, clinical meaningfulness, clinical evidence Why researchers in the clinical field should always note ahead of starting a trial what they would consider clinically relevant and then refer back to that in the paper and abstract Looking at 44 papers published in early 2021 in high ranking journals and analyzing the mentioning of clinical relevance It is disappointing.... ALWAYS ASK FOR A CLINICAL RELEVANCE EVALUATION OF THE RESULTS - every time, all of us, whatever relation we have to produce, read and use information from clinical research ASK FOR A CLINICAL RELEVANCE EVALUATION OF THE RESULTS - and let's make it just as normal as the p-value #doesitmatter    GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool to use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com     Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, You can learn more at our website, where you can also leave us a voice message. Website: www.precision-evidence.com Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z   Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence  Music thanks to mixkit.co   

How to Get to Clinically Relevant Research The default method to evaluate clinical research is by statistical significance  Unfortunately is statistical significance not related to the meaningfulness of the findings in the research and thereby to its meaningfulness for patients and healthcare If researchers stated ahead of starting the trial what they would consider clinically relevant,  the reader could relate to that and agree or disagree with the researcher It would come from focusing on using the provided information to help patients and improve healthcare - and not just publishing a paper We want to make it mandatory to state the researchers' clinical relevance levels ahead of the trial, mentioning what they will consider clinically relevant when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings in both the paper and abstract when publishing data from the study.    #clinicalrelevance   LINKS: A specific page on our website about requesting clinical relevance statement and evaluation https://www.precision-evidence.com/p/clinical-relevance/  The history behind the chosen level for statistical significance with Ronald Fisher's book from 1925 "Statistical Methods for Research Workers." Precision Evidence Blog: https://www.precision-evidence.com/blog/the-p-value-and-sir-ronald-fischer/   96% of published studies mention a p-value at 0.05 or lower: "What Have We (Not) Learned from Millions of Scientific Papers with P Values?" https://www.tandfonline.com/doi/full/10.1080/00031305.2018.1447512  Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials  Only 15% of clinical research brings value: “Avoidable waste in the production and reporting of research evidence”  https://pubmed.ncbi.nlm.nih.gov/19525005/   Precision Evidence #8: "Critical Appraisal of the Moderna COVID19 Vaccine Trial"  https://www.precision-evidence.com/8   Precision Evidence #6: "Covid-19 Vaccines Trials: Understanding the First Published Results"  https://www.precision-evidence.com/6   Precision Evidence #5: "Covid-19 Vaccines Trials and Press Releases – Looking Beyond the Efficacy"  https://www.precision-evidence.com/5  TED talk with Sir Ken Robinson where he talks about two kinds of people  https://www.ted.com/talks/sir_ken_robinson_bring_on_the_learning_revolution    NOTES:  Statistical significance vs. clinical significance in clinical research Clinical significance, clinical relevance, clinical meaningfulness Should clinical significance be used instead of statistical significance, or should they be used together? Problems with statistical significance Problems with clinical significance Why researchers must state what they consider clinical relevant outcomes before starting a research project and refer back to that when evaluating their findings "Positive" vs. "negative" trials in terms of statistical significance and why all research matters Overrepresentation in published research of statistically significant findings with p-values at 0.05 or lower Efficacy measures with examples "Number Needed to Treat" (NNT) of "Number Needed to Harm" (NNH) The history behind the chosen level for statistical significance with Ronald Fisher's book from 1925 "Statistical Methods for Research Workers."  See also blog:  Peer-reviewers responsibility We want to make it mandatory to state clinical relevance levels by the researchers ahead of the trial, mentioning what they will consider clinically relevant and essential when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings with that both in the paper and abstract when publishing data from the research ALWAYS ASK FOR A CLINICAL RELEVANCE EVALUATION OF THE RESULTS - every time, all of us, whatever relation we have to produce, read and use information from clinical research ASK FOR A CLINICAL RELEVANCE EVALUATION OF THE RESULTS - and let's make it just as normal as the p-value #clinicalrelevance   GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com    Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, You can learn more at our website, where you can also leave us a voice message Website: www.precision-evidence.com Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z   Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence   Music thanks to mixkit.co 

Russia's Sputnik COVID19 Vaccine Trial - Efficacy and Limitations The Russian Sputnik COVID19 vaccine interim analysis has been published in the prestigious medical journal The Lancet Efficacy is comparable to vaccines like the Pfizer/BioNTech and Moderna vaccines But there are some serious concerns with the study and the published data reducing the usefulness of this vaccine and to whom it can be used You don’t want to miss this episode  GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com   LINKS: The Sputnik COVID19 Vaccine trial in the Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext  Precision Evidence #8: “Critical Appraisal of the Moderna COVID19 Vaccine Trial”  https://www.precision-evidence.com/8  Precision Evidence #6: “Covid-19 Vaccines Trials: Understanding the First Published Results”  https://www.precision-evidence.com/6  Precision Evidence #5: “Covid-19 Vaccines Trials and Press Releases – Looking Beyond the Efficacy”  https://www.precision-evidence.com/5    NOTES: The interim analysis of the Russian Sputnik COVID19 vaccine is published in The Lancet It demonstrates efficacy at 94.6% which is comparable to the Pfizer/BioNTech and Moderna vaccine interim analysis Safety is comparable as well There are, however,  when scrutinizing the study, some serious concerns with impact on the usefulness of the vaccine and reducing the precision of the evidence  Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, You can learn more at our website, where you can also leave us a voice message  Website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence   Music thanks to mixkit.co 

Critical Appraisal of the Moderna COVID19 Vaccine Trial There is a big interest in clinical research now due to the Covid19 pandemic Especially the trails behind the Covid vaccines gain interest and is all over the news In this episode, we take a look at the published paper on the Moderna vaccine trial using our last episode of this podcast (#7) about the precision of the evidence We know from the news that the outcome in the Moderna vaccine trial is good with a reduction in risk at 94.1% by getting the vaccine But is the study as a whole clinically relevant and trustworthy? And how many people need to be given the vaccination to prevent one COVID19 infection? - Probably not what you would guess We will cover this and much more in this episode GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com   LINKS: Moderna vaccine trial interim analysis paper (full access) https://www.nejm.org/doi/full/10.1056/NEJMoa2035389  Moderna vaccine trial interim analysis on clinicaltrials.gov  https://clinicaltrials.gov/ct2/show/NCT04470427  Evaluating clinical relevance in 2 x 2 matrix https://www.precision-evidence.com/matrix Precision Evidence #7 https://www.precision-evidence.com/7  Precision Evidence #6 https://www.precision-evidence.com/6  Precision Evidence #5 https://www.precision-evidence.com/5    NOTES:   Moderna vaccine trial has a somewhat confusing abstract Efficacy is high at 94.1%  - and what that means in real life It is statistically significant, but is it also clinically significant and relevant? Stating what to be regarded clinically significant BEFORE stating the trial is important! A closer look at study population and dropouts A closer look at randomization and study period The study on clinicaltrials.gov compared with paper, what can we learn? How many persons need to be given the vaccination to prevent one COVID19 infection? - Probably not what you would guess Safety and other vaccines What we still need to know Phase 3 vs Phase 4 trials Conclusion Future episodes of the Precision Evidence Podcast      Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, You can learn more at our website, where you can also leave us a voice message  Website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence PRECISION EVIDENCE ON TOP LIST Precision Evidence has been selected by Feedspot to the list of   Top 35 Clinical Trials Podcasts You Must Follow in 2021 https://blog.feedspot.com/clinical_trials_podcasts/    Music thanks to mixkit.co   

You’ve probably often heard that “Clinical trials show..” or “ evidence support that..” Unfortunately, a research paper being published in a peer-reviewed medical journal is NOT a guarantee that it is clinically relevant  - even if it is a high ranking journal As it is often the case the devil is in the details, so it is necessary to both read and evaluate the paper’s details and to put it into the context where you need the information In this episode, we will talk about the details you need to look for     GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com    LINKS: Evaluating clinical relevance in 2 x 2 matrix https://www.precision-evidence.com/matrix 96% of published studies mention a p-value at 0.05 or lower: “What Have We (Not) Learned from Millions of Scientific Papers with P Values?” https://www.tandfonline.com/doi/full/10.1080/00031305.2018.1447512  Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials    PRECISION EVIDENCE ON TOP LIST Precision Evidence has been selected by Feedspot to the list of   Top 35 Clinical Trials Podcasts You Must Follow in 2021 https://blog.feedspot.com/clinical_trials_podcasts/    NOTES: The conclusion in a clinical research paper is based on an analysis of data collected from a specific group of people: the study population We have developed helpful tools to guide and help you with the process of screening afnf evaluate a paper from a clinical trial The Abstract Screening Tool The Precision Evidence Matrix for Clinical Relevance Links to both above The clinical usefulness depends on inclusion and exclusion criteria as well as the study design and method The relevance of inclusion and exclusion   Can results be extrapolated to persons not included in a specific clinical trial? What are the relevant outcomes? Clinicaltrials.gov Why it is good and what is missing Clinical relevance P-values vs. clinical relevance Precision of evidence Using surrogate measurements as a stand-in for what we really want to know How do you interpret the results from clinical trials? Can researchers adjust the design and study population after data collection to improve outcomes?  How to save time reading and evaluating clinical research papers   Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence  Music thanks to mixkit.co   

Covid-19 Vaccines Trials: Understanding the First Published Results #6 With massive awareness in the media, we now have some detailed information about the first of the Covid19 vaccine trials They differ in clinical usefulness The efficacy measures of 95% are widely mentioned, but let's be clear about what it means and how can we use that information In this episode, we go beyond the news coverage to find out and calculate how many persons need to be vaccinated to prevent one Covid19 infection both in general and for subgroups   GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at https://www.precision-evidence.com/tool LINKS: Pfizer/BioNTech data from FDA https://www.fda.gov/media/144245/download Pfizer/BioNTech paper in NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home    AstraZeneca Paper in the Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext Precision Evidence Podcast #5 https://www.precision-evidence.com/5 Table with estimates of how many people need to be vaccinated to prevent one case of covid-19 https://www.precision-evidence.com/blog/covid19-and-the-first-clinical-trials-analyzing-the-details/ NOTES: In this episode, we follow up on the last episode of the Precision Evidence Podcast where we went beyond the press releases about the Covid19 vaccines Now we have data from the first trials The Pfizer/BioNTech trial and the AstraZeneca Trial They are different in many ways How valid and useful is the data? The meaning and clinical relevance of efficacy at 95% How about clinical relevance and precision of the evidence To find out, we calculate how many persons must get a vaccination to prevent one Covid19 infection, both in general and for age and comorbidity subgroups Number Needed to Treat (NNT), or instead, Number Needed to Vaccinate Safety of the vaccines What is an mRNA vaccine What do we still not know / and does it matter? Conclusion and what to expect from other vaccine trials   Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence   Music thanks to mixkit.co             

Results from clinical trials should be published in medical papers and not evaluated from selected information in press releases We still need a lot of information from the trials to be able to have a clear picture of the efficacy and safety of the Covid-19 vaccines, let alone the precision and clinical relevance of the findings The information presented in the press releases are not sufficient to make calculations on risk But here is what you can find if you do it anyway   GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at https://www.precision-evidence.com/tool  LINKS:  Table with estimates of how many people need to be vaccinated to prevent one case of covid-19 https://www.precision-evidence.com/blog/how-many-people-need-to-be-vaccinated-to-prevent-one-case-of-covid-19/  Precision Evidence Matrix https://precision-evidence.com/matrix   NOTES:  We only have limited information about the new Covid-19 vaccines released by press releases Unfortunately, there is a broad misunderstanding of how to interpret the efficacy measures and what they mean What is an efficacy value, and what can we learn from that? We only have the raw measures of efficacy without confidence intervals Efficacy versus efficiency and why it matters Based on data from the press releases, we cannot make a valid calculation of how many people need to be vaccinated to prevent one case of covid-19 But we do it anyway… Estimating how many people need to be vaccinated to prevent one case of covid-19 based on the data we have (the Number Needed to Treat or NNT values) Are these values good? Finding clinical relevance and meaningfulness with using the Precision Evidence Matrix Press releases versus future medical papers What are we missing? Comparison between different vaccine trials We will follow up when the research papers are published   Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence   Music thanks to mixkit.co   

The world's currently largest randomized controlled trial (RCT) on Covid-19 protection by face masks is just published. The study showed a reduction in risk for Covid19 by using a facial mask  There are, however, severe limitations in this study and much more to mask-wearing than provided by this study, In this episode, we go beyond the abstract for the details.   GET THE ABSTRACT SCREENING TOOL It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper. Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at https://www.precision-evidence.com/tool   LINKS: Covid-19 and face mask study https://www.acpjournals.org/doi/10.7326/M20-6817 CDC Guidelines https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html Precision Evidence Podcast Episode #2 http://www.precision-evidence.com/2   NOTES: How to interpret the abstract What does it mean that wearing a mask "did not reduce the SARS-CoV-2 infection rate among wearers by more than 50%." Results from the study showed a small insignificant reduction in risk for Covid-19 by wearing a mask How many persons must wear a mans to avoid one person getting Covid-19 The precision of the evidence with few exclusion criteria Evaluating the study population Study design and management Limitations Relate to CDC guidelines What can we conclude based on this paper?   Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence Music thanks to mixkit.co   

In the Covid-19 vaccine trials, there is an essential difference between the relative reduction of risk for covid19 provided by vaccination and the absolute risk reduction for the individual person. But can we expect to find that information in the papers referring the trials - and will we be able to compare results between the different vaccines? Furthermore, must the study population in the vaccine trials reflect those expected to benefit from vaccination. And that seems to be a problem too. In this episode, we are looking at what kind of relevant information we need from the upcoming Covid-19 vaccine trials - and how you can get that information     Links:  FDA guidance https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders JAMA Internernal Medicine, Older People: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091 Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Interventionhttps://www.ajpmonline.org/article/S0749-3797(20)30284-1/fulltext#:~:text=This%20study%20found%20that%20the,(e.g.%2C%20social%20distancing)   Notes: We will get the most valuable information from well designed clinical trials proving high protection for Covid-19 and high safety for those vaccinated based on analysis from a broad study population FDA requires in their guideline and recommendation at least 50% protection That is a relative risk reduction of 50%, but how does that translate into the absolute risk Computational models have calculated the need for higher protection How about precision in terms of study population and usefulness of data Why the comparison between different studies is not possible, and how you can get around that   We will review published Covid-19 vaccine trials here at the Precision Evidence Podcast, so be sure to subscribe and share with friends!     Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence   Music thanks to mixkit.co    

In this episode of the Precision Evidence Podcast, we look at the hot topic of evidence behind the use of face masks as we are in the middle of the Covid-19 pandemic. Does and can evidence-based medicine and clinical relevance play a role here? What do we know? What do we think we know? And what do we want to know? Links: Duke Study around 14 types of masks https://advances.sciencemag.org/content/6/36/eabd3083 RCT in progress: Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System https://www.ncbi.nlm.nih.gov/research/coronavirus/publication/32829745 How to properly put on and take of a face mask  https://uihc.org/health-topics/how-properly-put-and-take-face-mask DOTS (Duration-Opportunity-Transmision-Susceptibility) https://www.the-scientist.com/reading-frames/connecting-the-dots-67839   Notes: Healthcare was unprepared for the Covod-19 pandemic We want to be guided by evidence-based medicine – high-quality research, preferably randomized controlled studies (RCT) Researchers collect evidence as the pandemic is running Unfortunately, there are many low-quality medial papers published about Covid-19 Evidence around types of masks like N-95 and surgical masks Observational studies can provide information about correlation but not causality The challenge of Randomized Controlled Trials with face masks and Covid-19 Spreading of aerosols and droplets Other ways of spreading COVID-19 like how to handle masks Duke study around 14 types of masks Active randomized controlled studies What are we looking for in face maks studies Precision Evidence in face mask studies Follow-up in upcoming episodes Contact us at email: podcast@precision-evidence.com, Twitter @PrecisionEBM, website: www.precision-evidence.com Hosts: Dr. Kim Kristiansen, M.D: @KKristiansenMD JG Staal: @HealthyEvidence   Music thanks to mixkit.co 

The Precision Evidence Podcast is the podcast for those in healthcare interested in finding, evaluating, and using medical research that is meaningful to patients.  Hosted by Dr. Kim Kristiansen, M.D.  https://www.linkedin.com/in/kim-kristiansen - Twitter: @KKristiansenMD A family physician with 30 years of clinical experience, a peer reviewer for medical journals, and former TEDMED research scholar J.G Staal https://www.linkedin.com/in/jgstaal - Twitter: @HealthyEvidence Work in the field of Data Analytics & Data Science. Interested in clinical research as a caregiver and having a hard time making sense of research and, in particular, understanding what is relevant and clinically significant   We want to focus on evaluating clinical research and finding outcomes that are meaningful to patients and applicable to the individual patient. That is what we call Precision Evidence HealthCare is based – or rathe depends - on research. Still, the quality and meaningfulness of the findings and the trials and how they are designed and run are often not relevant or useful from a clinical perspective. What if any health decision would rely on clinically relevant and meaningful information applicable to the individual patient? That’s easier said than done, so this podcast aims to discuss and explore both the need and the ways to find this information / separating the news from the news from the fake news, if you will. Unfortunately, this information can be tough to find. It is not sufficient to read the abstract of a medical paper, let alone the headline or a recap. And even though you can screen a paper by Its abstract - it is crucial to dig deeper into the paper. Evidence in Evidence-Based Medicine has a different meaning in healthcare than in everyday life Not clinically relevant clinical research is a big problem In the Precision Evidence Podcast, we will focus on finding clinically relevant and meaningful research applicable to the individual patient. We will analyze published research and have conversations with people in the field like healthcare professionals, researchers, patients, and caregivers, investors, payers, politicians, regulatory authorities; the list of stakeholders is long Contact us podcast@precision-evidence.com Twitter @PrecisionEBM website: www.precision-evidence.com Music thanks to mixkit.co