Dr. Brad Spellberg is the chief medical office at the Los Angeles County-University of Southern California Medical Center. Dr. Spellberg is also a professor of clinical medicine and the associate dean for clinical affairs at the USC’s Keck School of Medicine.

I talk with him about why doxy might be a good CAP drug (and when it is not a good choice), guidelines and the process of creating guidelines, and resistance patterns, MICs, and clinical significance.

References:

-Shorter Is Better: https://www.bradspellberg.com/shorter-is-better

-Oral Is the New IV: https://www.bradspellberg.com/oral-antibiotics

-WikiGuidelines: https://www.wikiguidelines.com/

-SH Choi et al.: Clin Infect Dis. 2022 Jul 29;ciac615. https://pubmed.ncbi.nlm.nih.gov/35903011/

-NICE: Pneumonia (community-acquired): antimicrobial prescribing. Published: 16 September 2019. https://www.nice.org.uk/guidance/ng138

-JP Metlay et al. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST. https://pubmed.ncbi.nlm.nih.gov/31573350/

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We talk with the P.I., Dr. Michael Bretthauer, what to make of the study and whether (and in which areas) we should remain doubtful. Dr. Bretthauer is a professor of medicine at the University of Oslo.

References:

• M Bretthauer et al. N Engl J Med. 2022 Oct 27;387(17):1547-1556. https://pubmed.ncbi.nlm.nih.gov/36214590/
• RL Siegel et al. CA Cancer J Clin. 2022;72:7-33. https://pubmed.ncbi.nlm.nih.gov/35020204/
• Ø Holme et al. Ann Intern Med. 2018;168:775-82. https://pubmed.ncbi.nlm.nih.gov/29710125/
• Global Cancer Observatory, https://gco.iarc.fr/
• M Bretthauer et al. Ann Int Med. 2017;166:139-40. https://pubmed.ncbi.nlm.nih.gov/27820949/
• USPSTF: JAMA. 2021;325(19):1965-77 https://jamanetwork.com/journals/jama/fullarticle/2779985
• E Quintero et al. N Engl J Med. 2012;366:697-706 https://pubmed.ncbi.nlm.nih.gov/22356323/
• AB Knudsen et al. JAMA. 2021;325(19):1998-2011 https://pubmed.ncbi.nlm.nih.gov/34003219/
• Ex. calculator: https://ccrisktool.cancer.gov/calculator.html
• LM Helsingen et al. BMJ. 2019367:l5515. https://pubmed.ncbi.nlm.nih.gov/31578196/

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This was a randomized controlled trial of a high-intensity statin, rosuvastatin 20mg daily vs a moderate-intensity statin – 10mg of rosuvastatin daily – plus 10mg of ezetimibe or Zetia. The trial recruited 3,780 patients with atherosclerotic cardiovascular disease and followed them for three years. The primary endpoint was the composite of cardiovascular death, major adverse cardiovascular events, or non-fatal stroke, and was reached in 9.9% in the high-intensity statin group vs 9.1% in the combination group.

Our guest is Christopher P. Cannon, M.D. He is a cardiologist at Brigham and Women’s Hospital in Boston and a professor at Harvard Medical School. He has run major trials of statins and other interventions to prevent major adverse cardiovascular (and cerebrovascular) events, including the IMPROVE-IT study.

References:

• RACING Study: BK Kim et al.: Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial. Lancet. 2022 Jul 30;400(10349):380-90. https://pubmed.ncbi.nlm.nih.gov/35863366/
• IMPROVE-IT: CP Canon et al.: Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med . 2015 Jun 18;372(25):2387-97. https://pubmed.ncbi.nlm.nih.gov/26039521/
• DI Swerdlow et al.: HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: evidence from genetic analysis and randomised trials. Lancet 2015; 385: 351-61. https://pubmed.ncbi.nlm.nih.gov/25262344/
• SU Khan et al.: Association of Lowering Low-Density Lipoprotein Cholesterol With Contemporary Lipid-Lowering Therapies and Risk of Diabetes Mellitus: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019;8:e011581. https://pubmed.ncbi.nlm.nih.gov/30898075/
• MG Silverman et al.: Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions. A Systematic Review and Meta-analysis. JAMA. 2016;316(12):1289-97. https://pubmed.ncbi.nlm.nih.gov/27673306/
• PM Ridker et al.: Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med. 2017;377(12):1119-1131. https://pubmed.ncbi.nlm.nih.gov/28845751/
• Y Ouchi et al.: Ezetimibe Lipid-Lowering Trial on Prevention of Atherosclerotic Cardiovascular Disease in 75 or Older (EWTOPIA 75): A Randomized, Controlled Trial. Circulation. 2019.140(12):992-1003. https://pubmed.ncbi.nlm.nih.gov/31434507/

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Why should we do journal clubs?

Why might be interesting, maybe even necessary?

Why could it even be fun?

Some of this episode - the parts about Newton, Imatinib, "medical reversal", the exponential growth of the medical literature, and how many original articles are publishes each month in just four general medicine journals - is based on a talk that was given by Ben at Mass General Hospital, Boston MA on March 6, 2019 (HMU Pulse Foundational series).

Here are the slides: https://www.slideshare.net/bengggggg/interpreting-the-medical-literature

Check our the end of the pod for our vacancy notice: we're looking for HELP

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While there is currently insufficient evidence to prove that Vitamin D supplementation might prevent cancer or cardiovascular events, several meta-analyses have shown a benefit of Vitamin D plus calcium to prevent hip fractures. This was also seen in a per-protocol analysis of a Women’s Health Initiative study.

The Vitamin D and Ometa-3 Trial or VITAL was a randomized placebo-controlled trial of cholecalciferol (that’s Vitamin D3) and omega-3 fatty acids. Since they tested two interventions, this was studied in two-by-two factorial design. Vitamin D was given as 2000 units daily and the daily omega-3 pills contained 1g of fatty acids. This was an ancillary study of a trial that is hypothesized to test whether these interventions, alone or together, can prevent cancer and cardiovascular disease. The study population is men over 50 and women over 55. There were no other in- or exclusion criteria except that patients could not already have cancer or cardiovascular disease, and also they couldn’t have hypercalcemia.

The study population had a mean age of 67, 51% were female. They recruited entirely in the U.S. and they had 71% Caucasians and 20% African Americans. Notably, it was allowed that patients were already taking Vitamin D supplements, and 43% already did so. 5% were taking osteoporosis medications and 10% had a previous frigitilty fracture. The baseline mean vitamin D level was over 30 ng/ml.

Over the course of the median 5.3 years of follow-up, Vitamin D did not prevent fractures in the total fracture group. The same was true for non-vertebral and hip fractures subgroups.

Our guest, WuQiang Fan, M.D., Ph.D., is an endocrinologist and hospitalist at Mass General Hospital and an Instructior in Medicine at Harvard Medical School. He often functions in the role of the Fracture Liaison Services, seeing patients with a new fracture in consultation, where he might be asked to assess what preventative therapies patients might quality for.

References:

-MS LeBoff et al.. N Engl J Med . 2022 Jul 28;387(4):299-309. https://pubmed.ncbi.nlm.nih.gov/35939577/

-USPSTF: Final Recommendation Statement. Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Community-Dwelling Adults https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/vitamin-d-calcium-or-combined-supplementation-for-the-primary-prevention-of-fractures-in-adults-preventive-medication

-USPSTF: Final Recommendation Statement. Vitamin D Deficiency in Adults: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/vitamin-d-deficiency-screening (retrieved Nov 11, 2022)

-MF Holick, […], Endocrine Society. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. https://pubmed.ncbi.nlm.nih.gov/21646368/

-NEJM Journal Watch Clincal Conversations. Podcast 297, July 29, 2022. https://pca.st/fhr0cdyo

-Three previous meta-analyses in osteoporotic women that included Vitamin D and calcium:

1) MJ Bolland et al.: Calcium intake and risk of fracture: systematic review . BMJ . 2015 Sep 29;351:h4580. https://pubmed.ncbi.nlm.nih.gov/26420387/

2) DIPART Group. BMJ. 2010;340:b5463. https://pubmed.ncbi.nlm.nih.gov/20068257/

3) A Avenell, JC Mak, and D O'Connell. Cochrane Database Syst Rev. 2014. https://pubmed.ncbi.nlm.nih.gov/24729336/

RD Jackson et al. N Engl J Med. 2006 Feb 16;354(7):669-83. https://pubmed.ncbi.nlm.nih.gov/16481635/

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We will consider methods primers whenever we cover a study with a more an usual or slightly more complicated methods.

Last week's network-meta-analysis on DVT prophylaxis with Dr. Tony Breu should certainly qualify!

Meta-analysis (both the classical one and the network type) can provide a quantitative synthesis of controlled studies (e.g., randomized controlled trials).

NETWORK meta-analysis can help with two additional things:

1. Through indirect treatment comparison (or a combination of indirect and direct comparison) it can increase your statistical power and
2. It can also help with comparisons that would otherwise not be possible.

Our methods consultant for this first primer on more an usual or slightly more complicated methods is Professor Dr. Ulrich Mansmann, the chair of the Institute for Epidemiology, Biometry, and Medical Information Processing of LMU Munich (Germany).

After covering some basics, we later dive a bit deeper into network meta-analysis.

References:

• T Bartmus, U Mansmann: A Systematic Review and Network Meta-Analysis Assessing the Effectiveness and Tolerability of Gliptins and Sulfonylureas as Monotherapy in Patients with Type 2 Diabetes Mellitus If Metformin is not Considered Appropriate. Value Health. 2014 Nov;17(7):A333. https://pubmed.ncbi.nlm.nih.gov/27200582/
• RJ Eck, T Elling, AJ Sutton et al. Anticoagulants for thrombosis prophylaxis in acutely ill patients admitted to hospital: systematic review and network meta-analysis. BMJ 2022;378:e070022 https://www.bmj.com/content/378/bmj-2022-070022
• F Song et al.: Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ . 2003 Mar 1;326(7387):472. doi: 10.1136/bmj.326.7387.472. https://pubmed.ncbi.nlm.nih.gov/12609941/
• L Mbuagbaw et al.: Approaches to interpreting and choosing the best treatments in network meta-analyses. Syst Rev . 2017 Apr 12;6(1):79. doi: 10.1186/s13643-017-0473-z. https://pubmed.ncbi.nlm.nih.gov/28403893/

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Our guest speaker couldn’t be more qualified to talk about the new DVT study. Dr. Anthony C. Breu is a Hospitalist at the VA in Boston and an Assistant Professor at Harvard Medical School. He became well known in the med ed community for his tutorials on Twitter ("tweetorials") and for co-editing the Journal for Hospital Medicine’s Things We Do For No Reason series. Together with Drs. Hannah Abrams and Avraham Cooper, he hosts the Curious Clinicians Podcast where he asks "why" a lot.

0:00 Intro

0:34 Plugs

1:10 Why Should Clinicians be Curious?

2:31 Today's Study

22:30 Ben's Take-aways and Outro

References:

-Dr. Breu’s Twitter: https://twitter.com/tony_breu

-Tweetorial on κ/λ ratio in end-stage renal disease: https://twitter.com/tony_breu/status/1572231208599277568

-The Curious Clinicians. A Medical Podcast that asks “Why”? https://curiousclinicians.com/

-RJ Eck, T Elling, AJ Sutton et al. Anticoagulants for thrombosis prophylaxis in acutely ill patients admitted to hospital: systematic review and network meta-analysis. BMJ 2022;378:e070022 https://www.bmj.com/content/378/bmj-2022-070022

-Things We Do For No Reason series: https://twitter.com/twdfnr

Risk stratification tools:

- Check your electronic health record (EHR) system and consider using the built-in system (if there is one)

- S Barbar et al: A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost . 2010 Nov;8(11):2450-7 https://pubmed.ncbi.nlm.nih.gov/20738765/

-M Vardi et al: Venous thromboembolism and the utility of the Padua Prediction Score in patients with sepsis admitted to internal medicine departments. J Thromb Haemost. 2013 Mar;11(3):467-73. https://pubmed.ncbi.nlm.nih.gov/23279085/

-Calculator for the Padua Prediction Score for Risk of VTE: https://www.mdcalc.com/calc/2023/padua-prediction-score-risk-vte

- P Chopard, D Spirk, H Bounameaux: Identifying acutely ill medical patients requiring thromboprophylaxis. J Thromb Haemost. 2006 Apr;4(4):915-6. https://pubmed.ncbi.nlm.nih.gov/16634771/

-M Nendaz et al.: Multicentre validation of the Geneva Risk Score for hospitalised medical patients at risk of venous thromboembolism. Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE). Thromb Haemost. 2014 Mar 3;111(3):531-8. https://pubmed.ncbi.nlm.nih.gov/24226257/

-Calculator for the Geneva Risk Score for Venous Thromboembolism (VTE) Prophylaxis: https://mdcalc.com/calc/10073/geneva-risk-score-venous-thromboembolism-vte-prophylaxis

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Speaker: Rajesh T. Gandhi, MD (Massachusetts General Hospital/Harvard Medical School)

0:00 Intro

1:42 RDV background

4:07 Clinical Data

26:28 Does RDV work? Dr. Gandhi's take

27:36 Q&A

46:17 Outro

Trials mentioned:

-PINETREE https://doi.org/10.1056/nejmoa2116846

-ACCT-1 https://doi.org/10.1056/nejmoa2007764

-Solidarity https://doi.org/10.1016/s0140-6736(22)00519-0

-CATCO https://doi.org/10.1503/cmaj.211698

-GS-US-540-5774 https://doi.org/10.1001/jama.2020.16349

-Meta-anlysis by Lee et al. CMI 2022: https://doi.org/10.1016/j.cmi.2022.04.018

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Mathematical modeling and quantitative analysis of empirical data played a pivotal role to answer the emerging questions as the pandemic unfolds and to better understand and control the pandemic. Three articles are presented that describe and critique the role of modeling during the pandemic.

Speaker: Ulrich Mansmann, Ph.D. (LMU Munich, Germany)

0:00 Intro

2:12 Why model COVID-19?

5:55 Future considerations

14:46 Non-pharmacologic interventions

19:55 New variants, multiple infections/reinfection, vaccinations, vanishing immunity, and endemicity

27:36 Summary

29:41 Q&A

41:29 Outro

References:

-Kolle K et al.: The changing epidemiology of SARS-CoV-2. Science 375(2022);6585:1116-21. https://doi.org/10.1126/science.abm4915

-H-P Dürr

& M Eichner: Corona-Pandemie: Zukunfts-Überlegungen aus der Sicht epidemiologischer Modellierung. MVF 2/2022; 57-63. http://doi.org/10.24945/MVF.02.22.1866-0533.2393

-B Müller: Zur Modellierung der Corona-Pandemie – eine Streitschrift. MVF 6/2021; 68-79. http://doi.org/10.24945/MVF.06.21.1866-0533.2354

#covid19 #epidemiology #modeling #corona

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We discuss the clinical features on the basis of a case series from the U.K. and then have a Q&A with pox virologist and UpToDate author on the topic, Dr. Stuart Isaacs.

Discussant: Stuart N. Isaacs, MD; Perelman School of Medicine at the University of Pennsylvania

Host: Benjamin P. Geisler, MD MPH

Recording date: May 30, 2022

0:00 Intro

1:09 Outline and Study Type

2:13 Background

5:31 Case Series

11:39 Q&A w/ Dr. Isaacs

References:

-Case series: Adler H et al. Lancet ID online early doi: 10.1016/S1473-3099(22)00228-6

-Comparison to Covid-19 case report/series: Rothe C et al N Engl J Med. 382(10); 970-1 doi: 10.1056/NEJMc2001468 https://pubmed.ncbi.nlm.nih.gov/32003551/

-Dr. Isaac’s UpToDate article: https://www.uptodate.com/contents/monkeypox

-Microbe.TV: This Week in Virology (TWiV) Special: Monkeypox clinical update with Dr. Daniel Griffin https://www.youtube.com/watch?v=dMiT73ycw-I

-Program for Monitoring Emerging Diseases (ProMED) Monkeypox update (06), 30 May 2022: https://promedmail.org/

-Centre for Infectious Disease Research and Policy (CIDRAP): WHO says monkeypox containable, but nations should be on alert. https://www.cidrap.umn.edu/news-perspective/2022/05/who-says-monkeypox-containable-nations-should-be-alert

-Phylogenetic trees: Hendrickson RC et al. Viruses 2010(2); 1933-67. doi: 10.3201/eid2409.171283 https://pubmed.ncbi.nlm.nih.gov/30124195/

-Virion schematics: ViralZone, from https://commons.wikimedia.org/wiki/File:Poxprot.jpg

-Discussion of on-going MPXV genome sequencing: https://virological.org/t/discussion-of-on-going-mpxv-genome-sequencing/802

-Genomic epidemiology of monkeypox virus: https://nextstrain.org/monkeypox?l=clock

#monkeypox #virus

🐒🦠

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0:00 Intro

2:01 Pax Romana

2:44 Outpatient Options for Early Treatment to Prevent Hospitalization

6:03 PF-0731332 (nirmatrelvir)

8:33 Paxlovid (Nirmatrelvir-Ritonavir)

10:12 Research on Nirmatrelvir

11:18 The EPIC-HR Study

13:37 Author Affiliations

14:03 Inclusion and exclusion criteria

15:36 Results with subgroup analysis

19:27 Should we believe Paxlovid results?

21:15 Can Paxlovid be used in our patients?

22:35 Absolute contra-indications

23:25 Relative contra-indications

24:52 Should we use Paxlovid over others?

28:01 Can we use Paxlovid for ourselves?

29:11 Summary: Paxlovid Utility

31:00 What's next for Paxlovid?

32:38 Paxlovid Romana?

33:54 Q&A

Speaker: Warren Chuang, MD, MA; Massachusetts General Hospital/Harvard Medical School

Recording date: May 19,2022

Ref: Hammond J et al. N Engl J Med 2022; 386:1397-1408 doi: 10.1056/NEJMoa2118542

#paxlovid #covid19 #treatment

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- What immune responses do various COVID vaccines elicit in them?

- Does the reason why you are immunocompromised make a difference?

- Are there even differences, if small, between the different vaccines?

- What assays should be used if we cannot just rely on small numbers of breakthrough infections as a study endpoint?

- Finally, what are the CDC's current recommendation for this group of patients?

0:00 Intro

1:26 CDC Guidelines for the Immunocompromised

8:14 Background: Immunocompromise and COVID-19

9:21 Study Goals

9:42 Methods

15:25 Baseline Characteristics

17:04 Results

29:23 Summary of the Main Findings

31:16 Limitations

33:00 Discussion

36:28 Outro

Ref: Haidar G et al. Prospective evaluation of COVID-19 vaccine responses across a broad spectrum of immunocompromising conditions: the COVICS study. Clin Infect Dis. 2022 Feb 18;ciac103. doi: 10.1093/cid/ciac103. Online early.

https://pubmed.ncbi.nlm.nih.gov/35179197/

Speakers: Elaine Tennant, MRCP-UK, DTHM, MPHTM, FRACP and Camille N. Kotton, MD, FIDSA, FAST

Host: Ben Geisler

Video editor: Fernando Tábora

Date of recording: March 17, 2022

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COV-BOOST is a multicenter phase-II RCT from the U.K. that was published in December in the Lancet. Ref: Munro et al. Lancet . 2021 Dec 18;398(10318):2258-2276. doi: 10.1016/S0140-6736(21)02717-3 https://bit.ly/COV-Boost

For patients who had received Oxford/AstraZeneca or Pfizer/BioNTech, it compared the the following boosters Oxford/AstraZeneca, Pfizer/BioNTech, Moderna/NIH (100μg dose only), Johnson&Johnson/Janssen, CureVac, Novavax, and Valneva to active control groups.

Endpoints were biological activity/preliminary efficacy (anti-spike IgG at 28d - mean geometric ratios compared to pre-booster, neutralizing Abs against wild-type, pseudoviral neutralization, and T-cell response) as well as reactogenicity (solicited and unsolicited moderate and/or severe adverse events).

We go through what was known before, describe the study, summarize its results, critically appraise the methods, and mention what has been published since, in particular:

-Atmar et al NEJM 2022: D-MID-21-12 https://bit.ly/D-MID-21-12

-Clemens et al Lancet 2022: RHH-001 https://bit.ly/rhh-001

-Mayr et al NEJM 2022: VA research letter https://bit.ly/3I0CP1B

0:00 Intro and outline

1:10 What Was Known Before the Study?

2:31 Nuts and Bolts on COV-BOOST

3:57 What Was the Study Goal?

4:59 Which Combos of Boosters and Primary Series Were Studied?

9:02 Methods

10:32 (Some) baseline characteristics

11:12 Results - Antibody and T-cell concentrations

15:59 Results - Adverse Events

19:43 Results Summary

20:49 Critical Appraisal

22:44 What Has Been Published Since?

27:48 Q&A

35:00 Outro

Speaker: Ben Geisler

Video editor: Fernando Tábora

Date of recording: Feb 25, 2022

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Newsletters with tables of contents are hard to get through after having written all your notes and maybe having done a chart dissection.

Welcome to IM Journal Club!

Our mission: to guide you through some of the most interesting internal medicine studies published in the last few weeks and months that you WOULD have liked to or SHOULD have heard about

Target groups: physicians and other clinicians in general internal or family medicine – hospital medicine and primary care – or in an internal medicine subspecialty; biostatisticians, epidemiologists, or data scientists; journal club enthusiasts!

Hidden agenda: to shed some lights on the studies’ methods AND on the context (what was known before, how do the new results change things – so what does this all mean?). We will give you episodes with primers on particularly difficult methods.

We will come out with a new episode every one to two weeks - we'll upload early on Fridays - so you can listen on your commute or on the weekend.

Please subscribe to this feed in your favorite podcast app.

If you’d like to have some visuals too, please check out our YouTube channel, subscribe, and click the bell icon.

The first six episodes rely more on visuals, so they might be better viewed on YouTube: https://www.youtube.com/channel/UC_EwD8PZTXOPvhSVl8oO1cw

Please let us know what we can do better, or what new study we could cover: You can leave a review in your podcasting app, a comment on YouTube, or drop us a line at hello@imjournalclub.com

We are also on social; our email newsletter will be on Twitter: https://twitter.com/IMJournalClub

---

Show Credits

Host: Benjamin (Ben) Geisler

Video editor: Fernando Tábora

Methods consultant: Professor Ulrich Mansmann

Advisory group (current): Bijay Acharya, Chang-Berm Kang, Jeffrey L. Greenwald, Jonathan W. Heflin, Kathy May Tran, Marcel Müller, Rahul Ganatra, and Warren Chuang

Supported by LMU Munich’s Institute for Epidemiology, Biometry, and Medical Information Processing

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