Harlan Krumholz Profile picture
Sep 24, 2020 6 tweets 8 min read Read on X
On the #COVID19 transparency front: JNJ has announced that they will share the Clinical Study Report and clinical trial participant data from their vaccine trial with researchers through @Yale Open Data Access (YODA) Project. @YaleMed @jsross119 @JNJNews jnj.com/coronavirus/le…
@Yale @YaleMed @jsross119 @JNJNews To provide context for the JNJ vaccine data sharing, @Yale YODA Project provides access to data to researchers w/ credible scientific proposal, agreement to report results, & commitment to protect participant privacy. Access decision is independent. yoda.yale.edu
@Yale @YaleMed @jsross119 @JNJNews To date, @Yale Open Data Access (YODA) Project has resulted in 42 submitted publications (31 published) based on JNJ participant-level data sharing. JNJ (Janssen) has committed to sharing data from all their drug and device trials through the YODA project. jnj.com/coronavirus/ou…
@Yale @YaleMed @jsross119 @JNJNews Also, as an aside, JNJ has also shared their protocol for their phase 3 vaccine trial. jnj.com/coronavirus/co…
@Yale @YaleMed @jsross119 @JNJNews So this should be the standard for all companies… share protocol, Clinical Study Report & clinical trial participant-level data. This transparency will increase trust in the process – & enable scientists around the world to study the studies and even extend what we are learning.
If all trial investigators adopt this type of transparency … and tenets of #openscience… we will be much better off in the end. Not just an issue for the pandemic studies… but good for the scientific enterprise overall.

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More from @hmkyale

Aug 30
1/🧵 @SubodhVermaMD @MkosiborodMD and colleagues have published important findings @JACCJournals on inflammation in obesity-related HFpEF from the STEP-HFpEF Program. Let's break it down! #CardioTwitter #HFpEF #ESCCongress jacc.org/doi/10.1016/j.…
2/ The study analyzed data from 1,145 patients with obesity-related HFpEF, looking at the prevalence of inflammation (measured by CRP levels) and its relationship with patient characteristics and outcomes. #ESCCongress @JACCJournals
@JACCJournals 3/ Key finding #1: Inflammation is highly prevalent in obesity-related HFpEF. 71% of patients had CRP levels ≥2 mg/L, with 19% having very high levels (≥10 mg/L). #Inflammation #ObesityHF #ESCCongress @JACCJournals
Read 11 tweets
Jun 20, 2023
What we do now is write a paper...& then preprint @medrxivpreprint ...then we take reviews from the journal & the world & work to make the research better. So, Internal tremors & vibrations in long COVID: a cross-sectional study is open for public comment. https://t.co/xh7dXqPcSGmedrxiv.org/content/10.110…
@medrxivpreprint Our objective: 'We compared demographics, socioeconomic characteristics, pre-pandemic comorbidities, & new-onset conditions between people with internal tremors and vibrations as part of their #LongCovid symptoms & people with long COVID but without these symptoms.' #LISTENstudy
@medrxivpreprint Our finding: Among people with long COVID, those with internal tremors and vibrations have more associated symptoms and worse health status, suggesting it may be associated with a severe phenotype of the condition. @YaleCII @YaleMed @YaleCardiology
Read 5 tweets
Apr 27, 2023
We have been doing a series of studies, led by @jeb1426, on sex differences in symptom complexity & phenotypes in acute myocardial infarction (AMI) and their impact on diagnosis & treatment. Some imp findings. #Cardiology #MedTwitter @YaleMed @YaleCardiology @yuan_lu1 Image
@jeb1426 @YaleMed @YaleCardiology @yuan_lu1 In one study, we found 'Women had more variation in unique symptom phenotypes than men' greater symptom complexity & longer door-to-balloon times. Non-chest pain symptoms are more frequent in women, potentially delaying STEMI recognition. @CircOutcomes ahajournals.org/doi/full/10.11… Image
@jeb1426 @YaleMed @YaleCardiology @yuan_lu1 @CircOutcomes In another study, that focused on older patients... ' Women reported more symptoms and had significantly more symptom phenotypes than men.' @amjmed sciencedirect.com/science/articl… @YaleCardiology @YaleMed Image
Read 7 tweets
Mar 9, 2023
One of most important articles I’ve done… showing the noise in clinic BP measurement is large & makes it impossible to track Rx effects; almost useless in evaluating change from 2 clinic visits. Let me explain… ahajournals.org/doi/abs/10.116… @YaleMed @YaleCardiology @CircOutcomes Image
@YaleMed @YaleCardiology @CircOutcomes But first, kudos to the team @yuan_lu1 @shiwani_mahajan @rohan_khera @SpatzErica @GCLinderman #yuntianliu @jbmortazavi #chenxihuang - great team that persisted on this challenging project. And thanks @CircOutcomes @bnallamo for your support and reviews.
@YaleMed @YaleCardiology @CircOutcomes @yuan_lu1 @shiwani_mahajan @rohan_khera @SpatzErica @GCLinderman @jbmortazavi @bnallamo Now, we often see a patient with hypertension & change the meds and have them return to evaluate Rx effect. If everything goes right, drugs and changing doses may affect BP by ~5 mm Hg. Maybe a little less. We wondered how much natural variability there is between visits.
Read 9 tweets
Feb 3, 2023
Why do people have persistent hypertension? Turns out there are many reasons; we developed a taxonomy to classify them so they can be addressed, based on #EHR data. @yuan_lu1 @CircOutcomes @SpatzErica @YaleMed @YaleCardiology #bloodpressure @AHAScience ahajournals.org/doi/abs/10.116…
@yuan_lu1 @CircOutcomes @SpatzErica @YaleMed @YaleCardiology @AHAScience Several years ago @yuan_lu1 and I introduced the concept of persistent hypertension to describe people with many measures of elevated #bloodpressure; a more encompassing term than resistant hypertension, which was about not responding to drugs. @amjmed sciencedirect.com/science/articl…
@yuan_lu1 @CircOutcomes @SpatzErica @YaleMed @YaleCardiology @AHAScience @amjmed We wrote that persistent hypertension was a condition of repetitive measures of above-goal elevated blood pressure over a period of time (eg, 6 mos), and drug resistance was just one of many causes. And many causes were related to missed opportunities in the care pathways.
Read 6 tweets
Jan 22, 2023
Sleep as medicine... On behalf of hospitalized patients, what is we simply stopped ordering routine lab draws before 7am. What is we wrote an order, do not disturb before 7am except for an urgent need. Or an order for 7 hrs of peace and quiet. @FutureDocs nam12.safelinks.protection.outlook.com/?url=https%3A%…
@FutureDocs I strongly believe that rest and sleep are essential to recovery from acute illness...and yet everything we do in the hospital seems to ignore the role of sleep in treatment. We need to put people in a position to help their bodies heal and recovery... not make it more difficult.
@FutureDocs In our study we found it was normal operating procedures to draw bloods from 4-6am on hospitalized patients...the unintended effect, in my view, is to slow recovery and add stress... and impede healing. Shouldn't the hospital be where people can be treated, healed and recover?
Read 6 tweets

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