464 - COVID Boosters, Agenda Setting, Emotional First Aid tRAINing
Take 3 – Practical Practice Pointers©
From the FDA and the ACIP
1) COVID-19 Boosters Update!
Both Moderna and Pfizer have produced bivalent COVID-19 booster vaccines that have received emergency use authorization from the FDA. The mRNA vaccines that we have been giving for the past two years are monovalent – containing the mRNA for the original Wuhan strain spike protein. The new bivalent vaccines contain the spike protein mRNA for both the original strain and the omicron strains.
The booster recommendations are, in a way, simplifying things. Rather than having different numbers of boosters for different risk groups, the underlying recommendation is to ensure a primary series, followed by an “updated booster.” The primary series is still defined as the original series of vaccines (depending on age and immune status). The “updated booster” language reveals the direction that these recommendations are taking – depending on the course of the pandemic, we can expect updates to the boosters along with recommendations to use them once available and we will stop counting numbers of boosters.
The Moderna and Pfizer boosters were studied in the same way that our updated influenza vaccines are studied each year – with immunogenicity studies, but not clinical studies. The studies examined adults (>18y for Moderna, >55y for Pfizer). In the immunogenicity studies, the boosters raised the geometric mean titers of neutralizing antibody as much or better than the original strain vaccines (for both original strain antibody and omicron variant antibody), regardless of prior infection status. There were no serious adverse events related to the vaccines at 29 day follow up, and most adverse events were “reactogenicity” events – fever, fatigue, myalgias, arm soreness, lymphadenopathy (with Pfizer vaccine), etc. Overall, the adverse event rates were similar to the primary series doses and original boosters. Concerns about myocarditis from booster vaccines were reviewed at this Advisory Committee on Immunization Practices (ACIP) meeting, and data from the original (monovalent) boosters indicates that it is less common with booster doses, and generally has a very good prognosis whereas the risk of cardiovascular complications from COVID-19 are more frequent (1.8-5.6 times) in young men than vaccine-related myocarditis. There is no data about the bivalent vaccines and myocarditis incidence.
The ACIP recommends:
· an updated (bivalent) booster dose for all people ages 12 and older who have received a full primary series (including third doses for preschool children and immune compromised patients, where applicable) at least 2 months prior.
· The Pfizer bivalent booster is approved for ages 12 and older, the Moderna bivalent booster is approved for ages 18 and older.
· Under the terms of the EUA, you may NOT give the original vaccine boosters to anyone who is due for an updated (bivalent) booster.
· The monovalent boosters are now only recommended for ages 5-11y.
· It is ok to give a different brand of booster than the primary series as long as the other age requirements are met (e.g., a 15-year-old who received a Moderna primary series can currently only get a Pfizer bivalent booster).
I tried to draft a table to simplify all this, but it was too much. The best site I have found is from the CDC: Up to Date with COVID-19 Vaccines. There are clear instructions and an ‘Up-to-date calculator’ (scroll a bit) that can help you figure out what’s needed for any patient. Get used to the ‘monovalent’/’bivalent’ terminology to keep the vaccine types straight and be careful to look at the age-based recommendations.
Don’t be tempted to give the monovalent boosters to folks who are eligible for the bivalent boosters – that is expressly not allowed under the EUA. Many pharmacies have bivalent boosters now, in case your patient needs one before you have them in stock.
· ACIP COVID-19 Vaccine Recommendations | CDC. Published August 8, 2022. Accessed September 12, 2022. Link
· ACIP September 1, 2022 Meeting Videos | Immunization Practices | CDC. Published September 7, 2022. Accessed September 12, 2022. Link
From the Literature, Clinical Experience, and Colleague’s Question
2) Agenda Setting for More Effective (and Efficient) Clinical Care
Question: “So many of my patients come in with an extensive ‘list’ of problems or don’t reveal an important problem until the ‘by the way’ near the end of a visit. Both drive me batty! Any suggestions?
Answer: This question highlights two great challenges when it comes to providing exceptional clinical care and doing so in an efficient and realistic manner. In both cases, we often feel caught between the possibility of missing a serious problem or getting behind schedule along with the challenge of saying “no” and getting a negative emotional response from the patient. The best approach for managing patients' lists and add-on concerns is through skillful agenda setting. Here's how.
The “What else?” technique and the A-G-R-E-E process can help you determine the patient's real agenda and then negotiate what will be covered in the current visit. In general, after a brief introduction, a clinician uses the “What else?” technique to extract all the concerns the patient may have. After briefly clarifying any individual concern, the clinician repeats “What else” or “Is there anything else?” until the patient says “no.” At this point, the list is complete and negotiation can begin, starting with summarizing what you have heard. Here is how that looks using the A-G-R-E-E prompts:
Acknowledge the patient’s list of concerns:
· “Thank you for bringing a list of questions. Let’s review it together.”
OR (if there is no “list”)
“What is it I can help you with today? …. And what else ….?
Get on the same page: Start by summarizing what you have heard:
· “So, you have a cold with some chest pain that you have been worried about. Your shoulder has been hurting too. And your blood pressure is of concern to both of us. Did I get that right?”
· Instead of saying, “We don't have time to cover all of your issues,” try, “I would like to cover as much as we can from your list, and I also want to take a few minutes to talk about your [diabetes, cholesterol, asthma, etc.] to effectively address your overall health and well-being.”
“There are a couple of issues on your list that we can cover quickly. Would you like to talk about those issues first so we have enough time to discuss your [diabetes, cholesterol, asthma, etc.]?”
“Since this visit is only scheduled for 15 minutes, let's decide on the three most important issues for today.”
NOTE: If more time is required to tackle a patient's list, say, “I wish we had more time to focus on all of your other issues. Let's discuss at your next appointment.
Recap top priorities
· After you and the patient have identified the priorities for today’s visit, make sure you agree. You could say, “Let's make sure we are on the same page. We are going to cover these three issues today…correct?”
“Are you okay with our plan for today's visit? I want to make sure that we are covering the most important issues.”
Ensure all concerns have been acknowledged
· “Have we addressed everything we agreed to at the start of our visit?”
Execute a plan for the next visit
· “Since we were unable to finish talking about all the items on your list today, let's schedule another visit. We’ll be able to follow-up on ____ at the same time.”
The “What else?” technique uncovers pertinent fears and anxieties and any “hidden agendas” up front. Data indicate that without interruption (except for clarification and prompting) patients spontaneously complete their stories in under 2.5 minutes.
The agenda setting model provides the opportunity to embrace, rather than dread, those patient lists, and while you still may experience some “surprises” at the end of a visit, my personal experience is they happen a lot less often, saving frustration for all involved and leaving the patient feeling “heard.”
· Schrager S and Gaard S. What Should You Do When Your Patient Brings a List? Fam Pract Manag. 2009;16(3):23-27. Link
· Freeman A. AAFP Tips: Agenda Setting Course. 15 September 2019. Link
· Olsen K. “Oh, by the Way…”: Agenda Setting in Office Visits. Fam Pract Manag. 2002;9(10):63-64. Link
NOTE: The “AGREE” model modified by Freeman (and then by Greenawald) from Scrhager and Gaard.
From PeerRxMed ( www.PeerRxMed.org )
3) An Emotional First Aid tRAINing Refresher
“We often neglect our psychological wounds until they become severe enough to impair our functioning … Strength does not come from controlling our emotions but from learning to control how we respond to them.” Guy Winch, PhD –
You likely know them well – those emotional “hot buttons” and “pain points” that when pressed can completely derail your day. I sure do! For me this past week all it took was a back injury and flashbacks to a previous injury. And when those buttons get pushed, we’re no longer bringing our best self, or even our “better self”, to the situation. We might even want to claim we don’t know that “self.”
In those moments, a handy emotional first aid tool that can expand our self-awareness and allow more effective emotional management would sure come in handy. Fortunately, there is such a tool, and it comes through the acronym R.A.I.N. The R.A.I.N process was originally developed by Michelle McDonald, a mindfulness teacher, and was popularized and adapted by Tara Brach, PhD, a psychologist, author, and renown meditation teacher. Here is how it looks to "let it R.A.I.N".
Recognize what is happening: This requires stepping outside of oneself and consciously acknowledging and naming the thoughts, feelings and behaviors that may have been triggered rather than seeing them as a justified “reaction” to whatever seems to have set them off. It is often helpful in this step to simply give a name to the emotion or experience, such as “frustration,” “anger,” or “disappointment.”
Allow life to be just as it is: Once one recognizes the strong emotion, there might be a temptation to suppress, avoid, or internally “explain” it away. This step encourages instead to accept the existence of the negative emotion and allow for it to be explored with self-compassion rather than the more common self-criticism.
Investigate with gentle attention: This step provides the opportunity for taking on an attitude of curiosity and openness regarding the emotion, and by doing so, “disarming” some of the negative energy. This is not intellectual detachment, but rather tender exploration. A simple question such as “what is true here?” can help get the process started, often followed by the question “what is needed here?” or personalizing it by asking “What is needed for here for you (even saying or thinking your name)?”
Non-Identification or non-attachment with the emotion. In this final step, the realization of the impersonal and fleeting nature of an emotion allows one to experience it without “becoming” that emotion. Reminders such as “I am not this emotion” or “This too shall pass” are often helpful. This creates the opportunity to experience the sense of spaciousness and freedom that comes when emotions are simply allowed to flow.
The practice of expanding one’s emotional awareness can become an important tool to equip us to “own our emotions” rather than letting them “own us,” remembering that neglecting strong negative or painful emotions will not make them go away. After all, we would likely consider it foolishness to neglect a painful physical wound. Why then would we think differently of an emotional one? Instead, why not let some R.A.I.N. cleanse it. And if it’s significant enough, remember it’s okay to ask for help ….
Mark and John
Carilion Clinic Department of Family and Community Medicine
Feel free to forward Take 3 to your colleagues. Glad to add them to the distribution list.