PrEP Essentials Podcast: Knowledge for Health

From Daily Pills to Long-Acting Injectables: What’s New in PrEP?

Podcast Summary

Join PrEP Essentials as we explore the latest HIV prevention strategies and the expanding PrEP toolbox. Dr. Jonathan Shuter, Professor of Medicine in Infectious Diseases at Albert Einstein College of Medicine and clinician at Montefiore Medical Center, and Dr. Raffaele Bernardo, an internist and infectious diseases specialist and Medical Director of an LGBTQ+ practice in Northern New Jersey, and Gianni, a patient representative, discuss the full range of PrEP medications — including daily oral pills, long-acting injectables, and the newest breakthrough: lenacapavir for PrEP.

Learn how PrEP works, prescribing guidelines for healthcare professionals, and practical tips for improving adherence. Plus, hear real-world patient experiences with PrEP, including questions and concerns about oral vs. injectable options. Whether you’re a prescriber or part of a care team, this episode delivers actionable insights on PrEP adherence, risk reduction tools, and the future of HIV prevention.

Runtime: 28 minutes

RCT Results: Do Text Message Reminders Increase Cardiovascular Medication Adherence for Nonadherent Patients?

BACKGROUND AND PURPOSE:

• Text message reminders are used to encourage medication adherence, but it’s not clear whether they actually help
• Ho et al. (JAMA, 2024) compared different types of text messaging strategies with usual care to improve medication refill adherence among patients nonadherent to cardiovascular medications

METHODS:

• Patient-level randomized pragmatic trial
  • 3 health care systems in Colorado
• Participants
  • Adults with ≥1 cardiovascular condition and ≥1 prescribed medication to treat the condition who had a 7-day refill gap
• Interventions
  • Generic reminders: generic text message refill reminders
    • e.g. “You are due to refill your [drug name]”
  • Behavioral nudge: text refill reminders incorporating behavioral nudges, with invitation to reply
    • e.g. “Hi [name]. We noticed you haven’t refilled your [drug name]. Reply 1= I’ll get them refilled in the next 2 days. Reply 2=I’m still working on a plan to get this done.”
  • Behavioral nudge + chatbot: text refill reminders plus a fixed-message chatbot
    • As above, chatbot asked about common barriers to adherence
  • Usual care
• Study design
  • Randomization stratified by health care system and number of baseline medications
  • Text messages delivered in either English or Spanish (patient preference)
  • Patients had option to reply with questions | Response by clinical pharmacists
  • If no cell phone (9% of participants): interactive voice response automated telephone calls
• Primary outcome
  • Refill adherence: proportion of days covered at 12 months
• Secondary outcomes
  • Emergency department visits
  • Hospitalization
  • Mortality

RESULTS:

• 9501 patients
  • Mean age: 60 years | Female: 47% | Black: 16% | Hispanic: 49%
• At 12 months, there were no significant difference between text message groups and usual care in mean proportion of days covered (P=0.06)
  • Generic: 62.3%
  • Behavioral nudge: 62.3%
  • Behavioral nudge + chatbot: 63.0%
  • Usual care: 60.6%
• After adjustment, there was still no significant difference (P<0.05/3 after multiple testing corrections) in mean proportion of days covered with intervention vs usual care
  • Generic reminder
    • 2.2 percentage points higher (95% CI, 0.3 to 4.2) | P=0.02
  • Behavioral nudge
    • 2.0 percentage points higher (95% CI, 0.1 to 3.9) | P=0.04
  • Behavioral nudge + chatbot
    • 2.3 percentage points higher (95% CI, 0.4 to 4.2) | P=0.02
• There were no differences in clinical events between study groups

CONCLUSION:

• Text messages reminding nonadherent patients to refill their cardiovascular medications did not increase adherence compared to usual care
• The authors state

Text message reminders were not effective in improving refill adherence at 12 months, regardless of the type of message, generic reminders, behavioral nudges, or behavioral nudges + chatbot

Learn More – Primary Sources:

Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial

Does Meeting Physical Activity Recommendations Reduce Mortality Risk Equally Across Age Groups?

BACKGROUND AND PURPOSE:

• The guidelines for minimum physical activity levels needed to maintain a healthy lifestyle are the same for adults of all ages
• Martinez-Gomez et al. (JAMA Network Open, 2024) explored whether there is an age-dependent association between physical activity and all-cause mortality

METHODS:

• Cohort study (4 population-based prospective cohorts)
  • National Health Interview Survey (1997 to 2018) | UK Biobank (2006 to 2010) | China Kadoorie Biobank (2004 to 2008) | Mei Jau (1997 to 2016)
• Exposure
  • Self-reported leisure-time physical activity
  • Age group
• Study design
  • Cox proportional hazards regression models with stratification by study were used to calculate mortality hazard ratios
• Primary outcome
  • Death

RESULTS:

• 2,011,186 individuals
  • Mean age: 49.1 (SD, 14.3 | Range, 20 to 97) years
  • Women: 55.0%
  • Median follow-up: 11.5 (IQR, 9.3 to 13.5) years
• The association between physical activity and mortality in the total sample showed a nonlinear dose-response pattern
• Physical activity was consistently associated with a lower risk of mortality across all age groups
  • The reduction in risk was greater in older vs younger age groups, especially at high levels of physical activity
  • Age modified this association (P_interaction<0.001)
  • Greatest reduction in risk in older adults was observed at physical activity levels 4 to 5 times higher than current recommendations
• Overall mortality hazard with recommended physical activity
  • Hazard ratio (HR) 0.78 (95% CI, 0.77 to 0.79)
• Meeting physical activity levels was positively associated with modifiable risk factors
  • High educational level | Not smoking |Healthy body weigh | No hypertension | No diabetes
  • Age modified the associations of these modifiable health factors with mortality (all P_interaction<0.001)
  • The magnitude of associations was greater in younger vs older age groups

CONCLUSION:

• Meeting physical activity recommendations was associated with reduced mortality risk throughout adulthood
• The benefit of physical activity may actually increase slightly with age
• Other modifiable health factors such as not smoking also reduced mortality, but unlike physical activity their benefit decreased with increasing age
• The authors state

In this pooled analysis of cohort studies, the association between PA and mortality risk remained consistent across the adult lifespan. This contrasts with other modifiable health factors, including educational level, smoking, alcohol consumption, body weight, hypertension, and diabetes, where we observed that their associations with mortality risk diminished with age

Given these findings, the promotion of regular PA is essential at all stages of adult life

Learn More – Primary Sources:

Physical Activity and All-Cause Mortality by Age in 4 Multinational Megacohorts

Long-Term Sperm Health Remains Unaffected by COVID-19 Vaccination

BACKGROUND AND PURPOSE:

• Concerns about impact on fertility are frequently cited among those hesitant to receive the COVID-19 vaccine
• Diaz et al. (F&S Reports, 2022) updated their previous study to assess the long-term impact of COVID-19 vaccination on male fertility potential 

METHODS:

• Single center prospective follow-up study
• Participants
  • Healthy male volunteers
  • Between the ages of 18 and 50 years
  • Received 2 doses of an mRNA COVID-19 vaccine and participated in the previous survey at 3 months post-vaccination
• Exposures
  • Time since vaccination (baseline, 3 months, 9+ months)
• Study design
  • Semen was collected 9 months post-vaccination and assessed for volume, sperm concentration, motility, and total motile sperm count (TMSC)
• Primary outcome
  • Median change in TMSC at the different exposure time points following vaccination

RESULTS:

• 12 men
  • Median age: 26 (IQR, 25 to 30) years
  • Median time since second vaccination dose: 10 months
  • Received a booster: 50%
  • Had a history of COVID-19: 33%
• There was no difference in TMSC at baseline, 3 months, and 9+ months (P=0.519)
  • Baseline: median 31 (IQR, 4 to 51.3) million
  • 3 months: median 33 (IQR, 13.5 to 85) million
  • 9+ months: median 37.5 (IQR, 8.5 to 117.8) million
• There were no significant differences in any of the sperm parameters at any time point

CONCLUSION:

• There were no long-term (9+ months) significant differences in sperm parameters following mRNA COVID-19 vaccination
• The authors state

A plausible explanation for this maintenance of semen parameters may be due to the mechanism of the mRNA vaccine, lack of live virus, and its inability to alter an individual’s DNA

In addition, the apparent absence of mRNA localization to the gonads is most likely in part due to the blood testis barrier

Learn More – Primary Sources:

Long-Term Evaluation of Sperm Parameters Following COVID-19 mRNA Vaccination

HPV Vaccine Recommendations Including Guidance for Ages 27 to 45

SUMMARY:

The most recent evidence-based HPV vaccine recommendations address when to administer the vaccine and dosing.  One area that has elicited more recent guidance focuses on whether to offer the HPV vaccine to individuals over the age of 26.

• The FDA (October 2018) extended approval of HPV vaccine to individuals age 27 to 45 years
• ACIP (June 2019) voted to
  • Expand routine and catch-up HPV vaccination in males through 26 years of age who are inadequately vaccinated
  • Offer HPV vaccine to individuals age 27 to 45 years who have not been adequately vaccinated based on shared clinical decision making
• ACIP published their final recommendations (August 2019) in the CDC’s Morbidity and Mortality Weekly Report

Children and adults aged 9 through 26 years: HPV vaccination is routinely recommended at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated.

Adults aged >26 years: Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. HPV vaccines are not licensed for use in adults aged >45 years.

These recommendations for children and adults aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of behavioral or medical risk factors for HPV infection or disease.

For persons who are pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy testing is not needed before vaccination.

Persons who are breastfeeding or lactating can receive HPV vaccine. Recommendations regarding HPV vaccination during pregnancy or lactation have not changed.

• ACIP suggests considering the following points for shared-decision making with adults who are 27 to 45 years of age
  • HPV is very common, usually transient and asymptomatic
  • Although typically acquired in young adulthood, some adults are at risk for acquiring new HPV infection
  • A new sex partner is a risk factor, while those in long-term, mutually monogamous partnerships are not likely to acquire a new HPV infection
  • HPV types: Sexually active adults will likely have been exposed to some HPV types, but not all HPV types are vaccine targets
  • There is no antibody test to determine immunity
  • HPV vaccine has high efficacy in persons not yet exposed to vaccine-type HPV
  • Lower vaccine effectiveness may be expected in those with HPV risk factors
    • Multiple lifetime sex partners | Previous infection with vaccine-type HPV | immunocompromising conditions
  • HPV vaccines are prophylactic only and can’t prevent infection progression, improve time to clearance or treat HPV-related disease
• In summary, the CDC states

For adults aged 27 years and older, clinicians can consider discussing HPV vaccination with people who are most likely to benefit. HPV vaccination does not need to be discussed with most adults over age 26 years

CDC Dosing Schedule 

• <15 years: 2 doses spaced 6 to 12 months apart
• ≥15 years: 3-dose schedule
  • Initial dose
  • Second dose at 1 to 2 months after initial 
  • Third dose at 6 months after initial 

Updated ACOG HPV vaccine recommendations 

• Routine HPV vaccination is recommended for females and males 
• Target age is 11 to 12 years but can be given through age 26
  • Can be given from age of 9 
• Do not test for HPV DNA prior to vaccination
  • Vaccinate even if patient was tested and is HPV DNA positive
•  If not vaccinated between 11 to 12 years
  • Vaccinate between 13 to 26 years (catch up period)
  • Offer regardless of sexual activity, prior exposure to HPV, or sexual orientation 
• Women 27 to 45 years and previously unvaccinated
  • Use shared clinical decision making
• ACOG “does not recommend that an individual who received the quadrivalent HPV vaccine be revaccinated with 9-valent HPV vaccine, including those aged 27 to 45 years who previously completed some, but not all, of the vaccine series when they were younger”
• Pregnancy
  • HPV vaccine is not recommended during pregnancy
  • Pregnancy testing prior to HPV vaccination not recommended
  • If vaccination schedule is interrupted by pregnancy, resume postpartum with the next dose
  • HPV vaccine can and should be given to breastfeeding women ≤26 who have not been vaccinated
  • The CDC encourages pregnant patients and healthcare professionals to report to the manufacturer and VAERS system if vaccine was administered during pregnancy | How and where to report is described in “CDC: HPV Vaccine Safety” in Learn More-Primary Sources below  
• Counsel to expect mild local discomfort and that this is not a cause for concern
  • Watch adolescents for at least 15 minutes following vaccination due to risk of fainting in this population

AAP  

• The AAP has also endorsed the CDC HPV recommendations
  • The HPV vaccine should be normalized as a standard of care
  • Recommendation should be clear and unambiguous 
  • AAP provides multiple strategies (see ‘Learn More – Primary Sources’ below) to engaging with patients including focusing on cancer prevention benefits for all children 

ACS

• The ACS endorses ACIP CDC guidance regarding HPV guidance except for the approach to take with individuals who are 27 to 45 years and not adequately vaccinated

The ACS does not endorse the 2019 Advisory Committee on Immunization Practices recommendation for shared clinical decision making for some adults aged 27 through 45 years who are not adequately vaccinated because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit

Adjuvant HPV Vaccine to Prevent CIN Recurrence 

• ACOG recommends considering adjuvant HPV vaccine for unvaccinated individuals 27 to 45 years who are undergoing treatment for CIN 2+

Learn More – Primary Sources:

Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices (MMWR) 

CDC: Clinical Overview of HPV 

ACOG Committee Opinion 809: Human Papillomavirus Vaccination 

CDC HPV Vaccine Safety 

CDC: HPV Educational Materials For Clinicians 

What Motivates Patients to Use Telehealth?

BACKGROUND AND PURPOSE:

• Raj and Lott (American Journal of Managed Care, 2024) examined patient characteristics and motivations associated with telehealth use

METHODS:

• Cross-sectional secondary data analysis
  • 2022 Health Information National Trends Survey
• Population
  • A nationally representative sample of individuals both with and without cancer
• Study design
  • Included only those observations where complete information for measures of interest were available
  • Logistic regression models were used to estimate the relationship between demographic and health characteristics and outcomes
• Primary outcomes
  • Use of telehealth services in the previous 12 months
  • Motivations for using telehealth

RESULTS:

• 6252 respondents
• The most common reason for using telehealth was
  • Recommendation or requirement by a clinician: 73.6%
• Respondents with depression were more likely to use telehealth
  • Odds ratio (OR) 2.73 | P<0.001
• These patients were more likely to be motivated by convenience
  • OR 1.80 | P<0.01
• Hispanic respondents were more likely to use telehealth to avoid exposure to infection
  • OR 1.58 | P<0.05

CONCLUSION:

• Most patients who used telehealth did so because their clinician recommended or required it
• The authors state

Being female; having health insurance, multiple physical health conditions, depression, and more education; and residing in a metropolitan area were associated with a greater likelihood of using telehealth

Given that nearly two-thirds of respondents in this study did not have a telehealth visit in the previous 12 months, it is possible that further study of telehealth’s value—distinct from its utility through the pandemic—is required

Learn More – Primary Sources:

Characterizing Telehealth Use in the US: Analysis of the 2022 Health Information National Trends Survey

What Motivates Patients to Use Telehealth?

BACKGROUND AND PURPOSE:

• Raj and Lott (American Journal of Managed Care, 2024) examined patient characteristics and motivations associated with telehealth use

METHODS:

• Cross-sectional secondary data analysis
  • 2022 Health Information National Trends Survey
• Population
  • A nationally representative sample of individuals both with and without cancer
• Study design
  • Included only those observations where complete information for measures of interest were available
  • Logistic regression models were used to estimate the relationship between demographic and health characteristics and outcomes
• Primary outcomes
  • Use of telehealth services in the previous 12 months
  • Motivations for using telehealth

RESULTS:

• 6252 respondents
• The most common reason for using telehealth was
  • Recommendation or requirement by a clinician: 73.6%
• Respondents with depression were more likely to use telehealth
  • Odds ratio (OR) 2.73 | P<0.001
• These patients were more likely to be motivated by convenience
  • OR 1.80 | P<0.01
• Hispanic respondents were more likely to use telehealth to avoid exposure to infection
  • OR 1.58 | P<0.05

CONCLUSION:

• Most patients who used telehealth did so because their clinician recommended or required it
• The authors state

Being female; having health insurance, multiple physical health conditions, depression, and more education; and residing in a metropolitan area were associated with a greater likelihood of using telehealth

Given that nearly two-thirds of respondents in this study did not have a telehealth visit in the previous 12 months, it is possible that further study of telehealth’s value—distinct from its utility through the pandemic—is required

Learn More – Primary Sources:

Characterizing Telehealth Use in the US: Analysis of the 2022 Health Information National Trends Survey

Does the Recombinant Shingle Vaccine Reduce the Risk of Dementia in Older People?

BACKGROUND AND PURPOSE:

• Evidence suggests that the live herpes zoster (shingles) vaccine may reduce the risk of dementia in older patients
  • However, the live vaccine has been retired in the US and it is not known whether the recombinant vaccine may have the same effect
• Taquet et al. (Nature Medicine, 2024) compared the risk of dementia between vaccine types

METHODS:

• Propensity score matched retrospective cohort study
  • EHR data from the TriNetX US Collaborative Network
  • 62 healthcare organizations
  • >100 million patients 
• Population
  • Individuals in the US who received the shingles vaccine
• Exposures
  • Earlier cohort: Received first vaccine dose between 2014 and 2017
    • 98% live vaccine
  • Later cohort: received first vaccine dose between 2017 and 2020
    • 95% recombinant vaccine
• Primary outcome
  • Dementia

RESULTS:

• Earlier cohort: 103,837 individuals | Later cohort: 103,837 individuals
• Individuals in the group that predominantly received the recombinant vaccine were at a lower risk of developing dementia over the next 6 years compared to those that received the live vaccine
  • Restricted mean time lost (RMTL) ratio 0.83 (95% CI, 0.80 to 0.87) | P<0.0001
• The association was found consistently across dementia subcategories, except for frontotemporal and Lewy body dementia
• There was no difference in all-cause mortality
• Both shingles vaccines were associated with a lower risk of dementia than were the influenza and tetanus–diphtheria–pertussis vaccines
  • RMTL ratios 0.73 to 0.86 | All P<0.0001
• The effect was robust across multiple secondary analyses, and was present in both men and women but was greater in women

CONCLUSION:

• Receipt of the recombinant shingles vaccine is associated with a lower risk of dementia compared to those who received the live vaccine
• The authors state

Compared with the live vaccine, receiving the recombinant shingles vaccine is associated with a lower risk of developing dementia within the next 6 years

An increase by 17% in time lived without a dementia diagnosis (or 164 additional days among those later affected) is clinically meaningful and a particularly large effect size given that the live shingles vaccine is itself associated with a lower risk of dementia, as replicated here

Learn More – Primary Sources:

The recombinant shingles vaccine is associated with lower risk of dementia

How to Say Goodbye to Your Medical Practice 

Perhaps you have reached the day when you have decided to close your practice. Closing out a practice (or selling one) can be a daunting task. However, planning and inclusion of the appropriate professionals with sufficient lead time can make the process less hectic. Some necessary partners include patients, payers, vendors, employees, licensing boards and federal and state agencies. Getting legal advice is important for either a sale or complete closure. Each state where you maintain a license will have different procedures as to patient notification and medical record retention or transfer. The malpractice carriers also have a say. The list below discusses some of the key steps to take.  

1. Talk to your staff – Your staff should hear the news from you first, not anyone else. You can help with the transition to new employment either through a sale or closing. They will have questions regarding their salaries, benefits, and retirement plans.  

2. Notify your patients – Send your patients a letter notifying them of your intent to close the practice. Let them know where their records will be kept and who to contact for a copy. 

3. Review your insurance contracts – business insurance, workers compensation, and other carriers need notice. If you have an agent, talk to the agent about the termination process.  

4. Speak to your malpractice carrier- the malpractice carrier will discuss options about tail coverage, which can allow an insured physician the option to extend coverage after cancellation or termination of a claims-made policy. The carrier may also have requirements about patient notification. 

5. Contact hospitals where you have admitting privileges. The hospital may have a formal process to be followed. 

6. Reach out to your landlord – review your leasing agreement and discuss steps to terminate the lease.  

7. Notify referring physicians of when you plan to close your practice, so they don’t send new patients after that date. 

8. Contact the Drug Enforcement Agency to deactivate your license if you plan not to write another prescription and after you have safely disposed of prescription drugs following the federal guidelines. Destroy all prescription pads and contact drug representatives to determine what to do with unused samples, if needed. 

9. Inventory drugs – you will need to dispose, sell, transfer, or donate according to federal and state requirements. Contact the Drug Enforcement Administration (DEA) for specifics. 

10. Notify all vendors. Inform medical suppliers, office suppliers, collection agencies, laundry services, housekeeping services, hazardous waste disposal services, and any other vendors. Make sure to request a final statement from them so you can close your accounts. 

11. Process your accounts receivable to collect money owed to you. Consider employing a collection agency or staff member to reconcile accounts after the practice has closed. 

12. Take a deep breath – focus on your next phase in life.  

This checklist is not meant to be all-inclusive. Speak to all relevant professionals such as attorneys, insurers, and accountants to ensure all obligations are met. Several specialty organizations provide checklists that can serve as a guide.  

Resources 

AAFP: Closing Your Practice Checklist 

Why Do Physicians Depart Their Practice? A Qualitative Study of Attrition in a Multispecialty Ambulatory Practice Network 

From Geraniums to Guadalajara on the Virtues of Early Retirement 

Does Drinking Coffee Help Counteract the Harms of a Sedentary Lifestyle?

BACKGROUND AND PURPOSE:

• Zhou et al. (BMC Public Health, 2024) evaluated the independent and joint associations of daily sitting time and coffee intakes with mortality from all-cause and cardiovascular disease (CVD) among US adults

METHODS:

• Prospective cohort study
  • National Health and Nutrition Examination Survey (NHANES) Survey
  • 2007 to 2018
• Participants
  • US adults
• Exposures
  • Daily sitting time
  • Coffee consumption per 24-hour period
• Study design
  • Adjusted hazard ratio (HR) calculated using Cox proportional hazards regression
• Primary outcomes
  • All-cause mortality
  • CVD mortality

RESULTS:

• 10,639 participants
  • Deaths 945 | Deaths from CVD: 284
• Compared to those who sat <4 h/d, sitting more than 8 h/d was associated with higher risks of mortality
  • All-cause mortality: HR 1.46 (95% CI, 1.17 to 1.81)
  • CVD mortality: HR 1.79 (95% CI, 1.21 to 2.66)
• Compared with non-coffee drinkers, people in the highest quartile of coffee consumption had reduced risks of mortality
  • All-cause: HR 0.67 (95% CI, 0.54 to 0.84)
  • CVD mortality: HR 0.46 (95% CI, 0.30 to 0.69)
• Compared to coffee drinkers who sat for <6h/d, sedentary non-coffee drinkers had a higher risk of all-cause mortality while sedentary coffee drinkers did not
  • Sedentary non-coffee drinkers: HR 1.58 (95% CI, 1.25 to 1.99)
  • Sedentary coffee drinkers: HR 1.22 (95% CI, 0.97 to 1.54)

CONCLUSION:

• Risk of all-cause and CVD mortality is higher among individuals leading a sedentary lifestyle, but risk was reduced among coffee drinkers
• The authors state

Notably, the results of a joint analysis of this study identified that that the association of sedentary with increased mortality was only observed among adults with no coffee consumption but not among those who had coffee intake

Given that coffee is a complex compound, further research is needed to explore this miracle compound

Learn More – Primary Sources:

Association of daily sitting time and coffee consumption with the risk of all-cause and cardiovascular disease mortality among US adults

Is Cannabis Use Linked to Worse COVID-19 Outcomes?

BACKGROUND AND PURPOSE:

• Smoking cigarettes is associated with worse COVID-19 outcomes, but it is unclear whether cannabis is also associated with poorer COVID-19 outcomes
• Griffith et al. (JAMA Network Open, 2024) examined adverse COVID-19 outcomes associated with cannabis and tobacco use

METHODS:

• Retrospective cohort study
  • Extracted EHR data
  • Large US midwestern academic medical center    
• Population
  • Patients with COVID-19
• Exposures
  • Current tobacco smoking
  • Current cannabis use
• Study design
  • Multivariable modeling used to calculated odds ratio (OR)
  • Adjustment for
    • Tobacco smoking | Vaccination | Comorbidity | Diagnosis date | Demographic factors
• Primary outcomes
  • Health outcomes of hospitalization
  • ICU admission
  • All-cause mortality following COVID-19 infection

RESULTS:

• 72,501 patients with COVID-19
  • Mean age: 48.9 (SD, 19.3) years | 59.7% female
  • Current smoking: 13.4% | Former smoking: 24.4%
  • Current cannabis use: 9.7%
• For patients with COVID-19, current tobacco smoking was associated with an increased risk of
  • Hospitalization: OR 1.72 (95% CI, 1.62 to 1.82) | P<0.001
  • ICU admission: OR 1.22 (95% CI, 1.10 to 1.34) | P<0.001
  • All-cause mortality: OR 1.37 (95% CI, 1.30 to 1.57) | P<0.001
• Cannabis use was associated with an increased risk of
  • Hospitalization: OR 1.80 (95% CI, 1.68 to 1.93) | P<0.001
  • ICU admission: OR 1.27 (95% CI, 1.14 to 1.41) | P<0.001
• Cannabis use was not associated with all-cause mortality
  • OR 0.97 (95% CI, 0.81 to 1.14) | P=0.69

CONCLUSION:

• Tobacco smoking is linked to an increased risk of poorer COVID-19 outcomes
• Cannabis use also appears to be a risk factor for worse COVID-19 outcomes
• The authors state

Given the recent legalization of recreational marijuana use in more states, including the area served by this academic medical center, further research may aid in guiding interventions, such as substance use prevention and treatment, that would benefit patient outcomes moving forward in the COVID-19 pandemic and the associated heath consequences it will have in our communities

Learn More – Primary Sources:

Cannabis, Tobacco Use, and COVID-19 Outcomes

Do Fish Oil Supplements Impact Cardiovascular Health?

BACKGROUND AND PURPOSE:

• Data on fish oil supplements, and their role in cardiovascular disease, are controversial
• Chen et al. (BMJ Medicine, 2024) examined the effects of fish oil supplements on the clinical course of cardiovascular disease across disease states

METHODS:

• Prospective cohort study
  • UK Biobank study
• Participants
  • Adults aged 40 to 69
• Exposures
  • Fish oil supplements
  • Stage of cardiovascular disease
    • Healthy (primary stage) | Atrial fibrillation (secondary stage) | Major cardiovascular events (tertiary stage) | Death
• Primary outcomes
  • Incident cases of atrial fibrillation | Major adverse cardiovascular events | Death

RESULTS:

• Healthy starting population: 415,737
  • Median follow-up 11.9 years
  • Progressed to
    • Atrial fibrillation: 18,367 | Major cardiovascular events: 22,636 | Death: 22,140
• For healthy participants, fish oil was associated with a greater incidence of atrial fibrillation and stroke
  • Atrial fibrillation: Hazard Ratio HR) 1.13 (95% CI, 1.10 to 1.17)
  • Stroke: HR 1.05 (95% CI, 1.00 to 1.11)
• For patients with a diagnosis of cardiovascular disease, regular use of fish oil was beneficial in reducing transitions from
  • Atrial fibrillation to major cardiovascular events: HR 0.92 (95% CI, 0.87 to 0.98)
  • Atrial fibrillation to myocardial infarction: HR 0.85 (95% CI, 0.76 to 0.96)
  • Heart failure to death: HR 0.91 (95% CI, 0.84 to 0.99)

CONCLUSION:

• In the general healthy population, regular use of fish oil supplements may increase the risk of atrial fibrillation and stroke
• For those with cardiovascular disease, fish oil supplements may be beneficial at reducing the risk of transitioning to worse cardiovascular states
• The authors state

When we divided major adverse cardiovascular events into three individual diseases (ie, heart failure, stroke, and myocardial infarction), we found associations that could suggest a mildly harmful effect between regular use of fish oil supplements and transitions from a healthy cardiovascular state to stroke, whereas potential beneficial associations were found between regular use of fish oil supplements and transitions from atrial fibrillation to myocardial infarction, atrial fibrillation to death, and heart failure to death

Learn More – Primary Sources:

Regular use of fish oil supplements and course of cardiovascular diseases: prospective cohort study

Meta-Analysis: What are the “Red Flag” Signs of Early Onset Colorectal Cancer?

BACKGROUND AND PURPOSE:

• Rate of early-onset colorectal cancer (EOCRC; defined as diagnosis <50 years) is increasing
• Demb et al. (JAMA Network Open, 2024) sought to determine the frequency of presenting red flag signs and symptoms among individuals with EOCRC

METHODS:

• Systematic review and meta-analysis
• Study inclusion criteria
  • Patients <50 years diagnosed with nonhereditary CRC
  • Reported on sign and symptom presentation or time from sign and symptom presentation to diagnosis 
• Study design
  • Quality of the included studies and risk of bias was measured
  • Data on frequency of signs and symptoms were pooled using a random-effects model
• Primary outcomes
  • Pooled proportions of signs and symptoms in patients with EOCRC
  • Estimates for association of signs and symptoms with EOCRC risk
  • Time from sign or symptom presentation to EOCRC diagnosis

RESULTS:

• 81 studies | 24,908,126 patients <50
• Most common presenting signs and symptoms (78 studies)
  • Hematochezia: pooled prevalence 45% (95% CI, 40 to 50)
  • Abdominal pain: pooled prevalence 40% (95% CI, 35 to 45)
  • Altered bowel habits: pooled prevalence 27% (95% CI, 22 to 33)
• The signs and symptoms with the greatest association with EOCRC likelihood were
  • Hematochezia: estimate range 5.2 to 54.0
  • Abdominal pain: estimate range 1.3 to 6.0
  • Anemia: estimate range 2.1 to 10.8
• Time from signs and symptoms presentation to EOCRC diagnosis
  • Mean 6.4 (range 1.8 to 13.7) months | 23 studies
  • Median 4 (range 2.0 to 8.7) months | 16 studies

CONCLUSION:

• For patients with early onset colorectal cancer, the most common signs and symptoms were hematochezia and abdominal pain (nearly half of all patients) and altered bowel habits (over a quarter of all patients)
• Hematochezia was associated with the highest risk of EOCRC
• Delays in diagnosis were common, and were generally on the order of 4 to 6 months
• The authors state

These findings and the increasing risk of CRC in individuals younger than 50 years highlight the urgent need to educate clinicians and patients about these signs and symptoms to ensure that diagnostic workup and resolution are not delayed

Adapting current clinical practice to identify and address these signs and symptoms through careful clinical triage and follow-up could help limit morbidity and mortality associated with EOCRC

Learn More – Primary Sources:

Red Flag Signs and Symptoms for Patients With Early-Onset Colorectal Cancer: A Systematic Review and Meta-Analysis

What is the Most Trusted Source of Health Information in the US?

BACKGROUND AND PURPOSE:

• Suran and Bucher (JAMA, 2024) review important survey data that ascertained where individuals in the US get their news and the which health information sources they trust

METHODS:

• Survey of a nationally representative sample of Black, Hispanic and White US adults

RESULTS:

• Trust in health professionals was high, and crossed party lines
  • 95% of both Republicans and Democrats reported that they trusted their personal physicians to provide accurate recommendations on health issues
• Trust in the government was lower, but still relatively high, but varied more across party lines
  • Trust in CDC
    • Republicans: 49% | Democrats: 87%
  • Trust in state and local public health officials
    • Republicans: 58% | Democrats: 74%
• The vast majority (96%) of respondents reported hearing at least one of the 10 false claims presented by the survey
  • e.g. that the MMR vaccine causes autism
• While knowledge of misinformation was high, the percentage of people that believed false claims was generally lower: 14 to 35%
• Most respondents (74%) were concerned about the spread of false health claims
  • Desire for Congress and President Joe Biden to do more: 68 to 78%
  • Desire for US news media to do more: 70%
• Social media use was high, but most people reported not trusting the health information on platforms
  • Users who visited Facebook weekly: 63% | Users who trust health claims on Facebook: 5%
• Use of local and national news media was also high, and respondents reported a greater trust in health information from these sources
  • Local news watchers: 62%
  • Watchers who have “a lot” of trust in health claims on local news: 37%

CONCLUSION:

• Most adults are aware that there are a lot of false health claims circulating on social media, and through society in general
• Despite many respondents having heard these claims, far fewer actually believe them
• The most trusted source for health information was respondent’s personal physician

Learn More – Primary Sources:

False Health Claims Abound, but Physicians Are Still the Most Trusted Source for Health Information

KFF Health Misinformation Tracking Poll Pilot

RCT Follow-Up: How Long Do the Benefits of Early Glycemic Control Last for Those with Diabetes?

BACKGROUND AND PURPOSE:

• The 20-year UK Prospective Diabetes Study (UKPDS) found that individuals who underwent an intensive glycemic control strategy with sulfonylurea or insulin therapy or metformin therapy had better outcomes than those who controlled glycemic levels through diet alone
  • A 10-year follow-up highlighted the long-term benefits of intensive therapy
• Adler et al. (The Lancet, 2024) determined whether the benefits of intensive glycemic control would wane after another 14 years of follow-up

METHODS:

• Extended follow-up of randomized controlled trial
• Participants
  • Individuals with diabetes
• Original intervention (over 20 year period)
  • Intensive glycemic control (sulfonylurea or insulin, or metformin if BMI >27 kg/m2)
  • Conventional glycemic control (primarily diet)
• Study design
  • This study reports on an additional 14 years of follow-up after the initial 10-year post-trial monitoring period
  • Kaplan–Meier time-to-event and log-rank analyses were used
• Primary outcomes
  • Aggregate clinical outcomes
    • Any diabetes-related endpoint | Diabetes-related death | Death from any cause | Myocardial infarction | Stroke | Peripheral vascular disease | Microvascular disease

RESULTS:

• 1489 participants (of 3277 individuals surviving at the start of the initial 10-year follow-up)
  • Mean age at baseline: 50.2 (SD, 8.0) years | Mean age in 2021: 79.9 (IQR, 12.3 to 26.8)
  • Female: 41.3%
• For up to 24 years after trial end, the glycemic and metformin legacy effects showed no sign of waning
• Those allocated to early intensive glycemic control with sulfonylurea or insulin therapy had overall lower risks of
  • Death from any cause: Relative Risk (RR) 0.90 (95% CI, 0.83 to 0.98) | P=0.015
  • Myocardial infarction: RR 0.83 (95% CI, 0.74 to 0.94) | P=0.002
  • Microvascular disease: RR 0.76 (95% CI, 0.64 to 0.89) | P<0.0001
• Early intensive glycemic control with metformin therapy led to overall risk reductions for
  • Death from any cause: RR 0.80 (95% CI, 0.68 to 0.95) | P=0.010
  • Myocardial infarction: RR 0.69 (95% CI, 0.54 to 0.88) | P=0.003
• There were no significant differences in risk of stroke or peripheral vascular disease during or after the trial
  • There was no risk reduction for microvascular disease with metformin therapy

CONCLUSION:

• For patients with type 2 diabetes, early intensive glycemic control confers near life-long risk reduction in all-cause mortality, microvascular complications and myocardial infarction
• The authors state

The legacy benefits from early intensive glycaemic control with sulfonylurea or insulin led to overall relative risk reductions from baseline of 10% for death, 17% for myocardial infarction, and 26% for microvascular complications

Early intensive glycaemic control with metformin led to numerically larger overall relative risk reductions than with sulfonylurea or insulin, from baseline of 20% for death and 31% for myocardial infarction

Achieving near-normal glycaemia immediately after type 2 diabetes is diagnosed appears to be essential to minimise the lifetime risk of diabetes-related complications to the greatest extent possible

Learn More – Primary Sources:

Post-trial monitoring of a randomised controlled trial of intensive glycaemic control in type 2 diabetes extended from 10 years to 24 years (UKPDS 91)

Cochrane Review: Does Zinc Prevent or Shorten Colds?

BACKGROUND AND PURPOSE:

• Zinc supplements are commonly taken to prevent or shorten colds, but evidence to support this practice is generally lacking
• Nault et al. (Cochrane Database of Systematic Reviews, 2024) assessed the effectiveness and safety of zinc for the prevention and treatment of the common cold

METHODS:

• Systematic review and meta-analysis
• Inclusion criteria
  • RCTs
  • Studies that tested any form of zinc against placebo to prevent or treat the common cold or upper respiratory infection (URTI) in children or adults
• Study design
  • Risk of bias was assessed with the Cochrane risk of bias tool
  • Certainty of evidence was assessed using GRADE Criteria
• Primary outcomes
  • Proportion of participants developing colds
  • Duration of cold | Measured in days from start to resolution of the cold
  • Adverse events potentially due to zinc supplements
    • e.g., unpleasant taste, loss of smell, vomiting, stomach cramps, and diarrhea
  • Adverse events considered to be potential complications of the common cold
    • e.g. respiratory bacterial infections

RESULTS:

• 15 prevention studies | 19 treatment studies | 8526 participants
  • On adults: 22 studies | On children: 12 studies
• Most studies evaluated the effectiveness of zinc administered as lozenges
  • Zinc gluconate doses: range 45 and 276 mg/day
  • Time period: range 4.5 and 21 days
• Other forms of zinc administration: Capsules | Dissolved powders | Tablets | Syrups | Intranasal sprays
• Most studies were at unclear or high risk of bias in at least one domain

Prevention of Colds

• There may be little or no reduction in the risk of developing a cold with zinc compared to placebo
  • Risk ratio (RR) 0.93 (95% CI, 0.85 to 1.01)
  • I2=20% | 9 studies | 1449 participants | Low-certainty evidence
• There may be little or no reduction in the mean number of colds that occur over five to 18 months of follow‐up
  • Mean difference (MD) –0.90 (95% CI –1.93 to 0.12)
  • I2 =96% | 2 studies | 1284 participants | Low‐certainty evidence
• If a cold does occur despite use of zinc
  • There is probably little or no difference in the duration of colds in days
    • MD –0.63 (95% CI –1.29 to 0.04)
    • I2 =77% | 3 studies | 740 participants | Moderate‐certainty evidence
  • There may be little or no difference in global symptom severity
    • Standardized mean difference 0.04 (95% CI, –0.35 to 0.43)
    • I2 =0% | 2 studies | 101 participants | Low‐certainty evidence

Used for Cold Treatment

• There may be a reduction in the mean duration of the cold in days
  • MD –2.37 (95% CI, –4.21 to –0.53)
  • I2 =97% | 8 studies | 972 participants | Low‐certainty evidence
• It is uncertain whether there is a reduction in the risk of
  • Having an ongoing cold at the end of follow‐up
    • RR 0.52 (95% CI, 0.21 to 1.27)
    • I2 =65% | 5 studies | 357 participants | Very low‐certainty evidence
  • Global symptom severity
    • SMD ‐0.03 (95% CI, –0.56 to 0.50)
    • I2 =78% | 2 studies | 261 participants | Very low‐certainty evidence

Adverse events

• 31 studies | 2422 participants
• It is uncertain whether there is a
  • Difference in the risk of adverse events with zinc used for cold prevention
    • RR 1.11 (95% CI, 0.84 to 1.47)
    • I2 =0% | 7 studies | 1517 participants | Very low‐certainty evidence
  • Increase in the risk of serious adverse events
    • RR 1.67 (95% CI, 0.78 to 3.57)
    • I2 =0% | 3 studies | 1563 participants | Low‐certainty evidence
• There is probably an increase in the risk of non‐serious adverse events when zinc is used for cold treatment
  • RR 1.34 (95% CI, 1.15 to 1.55)
  • I2 =44% | 2084 participants | 16 studies | Moderate‐certainty evidence
• No treatment study provided information on serious adverse events
• No study provided clear information about adverse events considered to be potential complications of the common cold

CONCLUSION:

• Zinc supplements may have little to no effect on common cold prevention, but may reduce the duration of ongoing colds
• The authors state

Overall, there was wide variation in interventions (including concomitant therapy) and outcomes across the studies, as well as incomplete reporting of several domains, which should be considered when making conclusions about the efficacy of zinc for the common cold

Learn More – Primary Sources:

Zinc for prevention and treatment of the common cold

RCT Results: What is the Best Strategy for Smoking Cessation Following Not Achieving Abstinence After a First Attempt?

BACKGROUND AND PURPOSE:

• Cinciripini et al. (JAMA Netw Open, 2024) determine the best subsequent strategy for nonabstinence following initial treatment with varenicline or combined nicotine replacement therapy (CNRT)

METHODS:

• Double-blind, placebo-controlled, sequential multiple assignment randomized trial
• Participants
  • 18 to 75 years
  • Smoked 5 or more cigarettes per day with an expired CO of ≥6 ppm
• Interventions
  • Initial randomization
    • Varenicline for 6 weeks, 2 mg/d
    • CNRT for 6 weeks, 21 mg patch + 2 mg lozenge
  • Rerandomization for those who were nonabstainers after 6 weeks
    • Continue for 6 weeks
    • Switch to other treatment option for 6 weeks
    • Increase medication dose for 6 weeks
      • ≥3mg/d varenicline | 42 mg patch + lozenges
• Study design
  • All participants received brief weekly counseling
• Primary outcomes
  • Biochemically verified 7-day point prevalence abstinence at the end of treatment at 12 weeks

RESULTS:

• 490 participants
  • Female: 43% | Non-Hispanic White: 58%
  • Mean age: 48.1 years
• After first phase
  • CNRT group
    • Abstinent: 54 participants | Nonabstinent: 191
    • Rerandomized: 151
  • Varenicline:
    • Abstinent: 88 | Nonabstinent: 157
    • Rerandomized: 122
• The end-of-treatment abstinence rate for phase 1 nonabstainers
  • Initial CNRT
    • Continued: 8% (95% credible interval [CrI], 6 to 10)
    • Increased dosage: 14% (95% CrI, 10 to 18)
    • Switched to varenicline: 14% (95% CrI, 10 to 18)
    • Absolute risk difference 6% (95% CrI, 6 to 11)
    • >99% posterior probability that either strategy conferred benefit over continuing the initial dosage
  • Initial varenicline
    • Continued: 3% (95% CrI, 1% to 4%)
    • Increased dosage: 20% (95% CrI, 16 to 26)
    • Switched to CNRT: 0% (95% CrI, 0 to 0)
    • Absolute risk difference 18% (95% CrI, 13% to 24%)
    • >99% posterior probability of increasing the varenicline dosage conferring benefit
• At 6 months, only increased dosages of the CNRT and varenicline provided benefit over continuation of the initial treatment dosages

CONCLUSION:

• For those who attempted to quit smoking using varenicline but did not achieve abstinence after the first attempt, increasing the dosage was more helpful than continuing at the initial dosage
• For those who used CNRT to quit, both increasing the CNRT dosage, or switching to varenicline, were more helpful than continuing at the same dosage
• The authors state

For individuals who do not achieve abstinence after treatment with varenicline, increasing the dosage enhances abstinence relative to continuing at the initial dosage, whereas for those who don’t achieve abstinence with CNRT, a dosage increase or switching to varenicline are viable rescue strategies, with continuous abstinence results favoring a dosage increase

Learn More – Primary Sources:

Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial