Precision Evidence

Written by: Kim Kristiansen & JG Staal
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  • Summary

  • At the Precision Evidence Podcast, we go beyond the abstract of medical papers to find medical research relevant and meaningful to patients and healthcare professionals and separate the news from the fake news in medicine. Finding, evaluating, and using clinical trials with relevant outcomes for patients and Evidence-Based Medicine is the focus of the podcast’s analysis of medical papers, discussions, and interviews with stakeholders. Hosted by Dr. Kim Kristiansen, M.D., and JG Staal. Twitter: @PrecisionEBM email us at podcast@precision-evidence.com
    Precision Evidence Podcast, 2021
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Physical Illness & Disease Hygiene & Healthy Living Biological Sciences
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Episodes
  • Clinical Trials and Surrogate Outcomes (13)

    Clinical Trials and Surrogate Outcomes (13)
    Jul 27 2021

    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 

     
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    18 mins
  • Addressing Clinical Relevance in Medical Papers (12)

    Addressing Clinical Relevance in Medical Papers (12)
    May 19 2021
    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 doneIn/exclusion criteriaCompliance with listing on clinicaltrials.govCompliance with publishing results on clinicaltrials.govChallenges 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 
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    13 mins
  • Clinically Relevance - Looking at Recent Research (11)

    Clinically Relevance - Looking at Recent Research (11)
    Apr 29 2021

    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 

     
    Show More Show Less
    8 mins

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