Precision Evidence

Kim Kristiansen & JG Staal

1 Creator

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 [email protected]

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Top 10 Precision Evidence Episodes

Goodpods has curated a list of the 10 best Precision Evidence episodes, ranked by the number of listens and likes each episode have garnered from our listeners. If you are listening to Precision Evidence for the first time, there's no better place to start than with one of these standout episodes. If you are a fan of the show, vote for your favorite Precision Evidence episode by adding your comments to the episode page.

Addressing Clinical Relevance in Medical Papers (12)

Precision Evidence

05/19/21 • 13 min

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

Clinically Relevance - Looking at Recent Research (11)

Precision Evidence

04/29/21 • 8 min

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...

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: [email protected],

Twitter @PrecisionEBM,

You can learn more at<...

New Clinical Trial on Face Masks & Covid-19 - 4

Precision Evidence

11/24/20 • 13 min

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.

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?

Twitter @PrecisionEBM,

website: www.precision-evidence.com

Hosts:

Dr. Kim Kristiansen, M.D: @KKristiansenMD

JG Staal: @HealthyEvidence

Music thanks to mixkit.co

Covid-19 Vaccine Trials and the Precision of the Evidence - 3

Precision Evidence

11/05/20 • 13 min

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!

Twitter @PrecisionEBM,

website: www.precision-evidence.com

Hosts:

Dr. Kim Kristiansen, M.D: @KKristiansenMD

JG Staal: @HealthyEvidence

Music thanks to mixkit.co

Face Masks: The Evidence and the Research - 2

Precision Evidence

11/05/20 • 14 min

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

Twitter @PrecisionEBM,

website: www.precision-evidence.com

Hosts:

Dr. Kim Kristiansen, M.D: @KKristiansenMD

JG Staal: @HealthyEvidence

Music thanks to mixkit.co

Welcome to The Precision Evidence Podcast - 1

Precision Evidence

11/05/20 • 8 min

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

Twitter @PrecisionEBM

website: www.precision-evidence.com

Music thanks to mixkit.co

The Precision of Clinical Research #7

Precision Evidence

01/15/21 • 19 min

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

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?

Critical Appraisal of the Moderna COVID19 Vaccine Trial #8

Precision Evidence

02/02/21 • 15 min

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

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

Russia's Sputnik COVID19 Vaccine Trial - Efficacy and Limitations #9

Precision Evidence

02/23/21 • 8 min

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

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: [email protected],

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...

Covid-19 Vaccines Trials: Understanding the First Published Results #6

Precision Evidence

12/15/20 • 14 min

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

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