411 - Post-COVID Conditions (“Long COVID”), Peds COVID Vaccine PS
Take 3 – Practical Practice Pointers©
From the CDC and the Literature
1) “Long Covid” – Caring for Persons with Post-COVID Conditions
As of June 30, 2021, 33.5 million persons in the United States had received a diagnosis of COVID-19. This does not include the numerous others who never received a diagnosis. Although it appears most patients infected with SARS-CoV-2 recover within a few weeks, some experience ongoing post–COVID-19 symptoms.
In June, the CDC issued a set of clinical guidelines addressing treatment of post-COVID conditions, often referred to colloquially as “Long COVID,” which they define as "new, recurring, or ongoing symptoms more than 4 weeks after infection, sometimes after initial symptom recovery" and includes a wide range of physical and mental health concerns. These consequences include both general complications of prolonged illness as well as hospitalization and post-acute sequelae of SARS-CoV-2 infection (PASC), which are more specific to effects of SARS-CoV-2 infection.
At present, robust longitudinal surveillance data on post-COVID conditions are lacking and the prevalence is challenging to estimate, ranging from 5% to 80%. It has been challenging to create a single universal case definition for post-COVID conditions because studies differ in terms of the symptoms or conditions investigated, the temporal criteria used (three weeks up to many months following infection), the study settings included (outpatient vs. inpatient), and how symptoms and conditions are assessed (e.g., self-report vs. electronic health record database).
Post-COVID conditions are associated with a spectrum of physical, social, and psychological consequences, as well as functional limitations that can present substantial challenges to patient wellness and quality of life. Multiple possible onset patterns for post-COVID conditions have been identified that further exemplify their heterogeneity, including, but not limited to: (A) persistent symptoms and conditions that begin at the time of acute COVID-19 illness; (B) new-onset late sequelae following asymptomatic disease or a period of acute symptom relief or remission; (C) an evolution of symptoms and conditions that include some persistent symptoms (e.g., shortness of breath) with the addition of new symptoms or conditions over time (e.g., cognitive difficulties); and/or (D) exacerbations or new manifestations of conditions that predated the COVID-19 illness. Some presentations may share similarities with other post-viral syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), dysautonomia (e.g., postural orthostatic tachycardia syndrome [POTS]), or mast cell activation syndrome (MCAS).
More common longer-term symptoms after COVID infection include: tiredness or fatigue, cognition and/or concentration concerns, headache, loss of taste or smell, palpitations, shortness of breath and/or dyspnea on exertion, chest pain, chronic cough, joint or muscle pains, insomnia, depression and/or anxiety, and low grade fever. It is important to recognize that some symptoms or combination of symptoms may be unusual or not make apparent physiological or anatomical sense, such as post-exertional malaise (PEM), where symptoms worsen following even minor physical or mental exertion for 12-48 hours after activity and often last days or even weeks.
At this time, no laboratory test can definitively distinguish post-COVID conditions from other etiologies, in part due to the heterogeneity of them. Before ordering laboratory testing, the goals of testing should be clear to the healthcare professional and to the patient. Any laboratory testing should be guided by the patient history, physical examination, and clinical findings. More specialized testing may not be needed; however, expanded testing should be considered if symptoms persist for 12 weeks or longer. The guideline notes that more evidence is needed to support the utility of specific imaging tests for evaluation of post-COVID conditions.
The absence of laboratory-confirmed abnormalities or the decision to forgo extensive laboratory testing should not lead to dismissing the possible impact of a patient’s symptoms on their daily function. For most patients, the goal of medical management is to optimize function and quality of life. Where clinically indicated, symptom management and a comprehensive rehabilitation plan based on their patients’ presenting symptoms, underlying medical and psychiatric conditions, personal and social situations, and their treatment goals can be initiated simultaneously with laboratory testing for most patients. Transparency is important for the process of goal setting; healthcare professionals should advise patients that post-COVID conditions are not yet well understood and assure them that regular follow-up and support will continue to be provided as new information emerges.
There are no specific medications presently recommended for the management of patients with post-COVID conditions, and all treatment should be patient-specific based on their symptoms and clinical findings. Though some have used corticosteroids or other anti-inflammatory medications in patient management, their utility is unclear and potential side-effects are well-known. Some data has indicated that receiving a vaccine post-infection has helped alleviate certain symptoms, and this is recommended for all patients who have had COVID-19.
As an ICD-10 code for post-COVID conditions does not yet exist, the CDC recommends documenting these conditions using B94.8 (sequelae of other specified infectious and parasitic diseases).
The CDC concludes:
- The term “Post-COVID Conditions” is an umbrella term for the wide range of physical and mental health consequences experienced by some patients that are present four or more weeks after SARS-CoV-2 infection, including by patients who had initial mild or asymptomatic acute infection.
- Based on current information, many post-COVID conditions can be managed by primary care providers, with the incorporation of patient-centered approaches to optimize the quality of life and function in affected patients.
- Objective laboratory or imaging findings should not be used as the only measure or assessment of a patient’s well-being; lack of laboratory or imaging abnormalities does not invalidate the existence, severity, or importance of a patient’s symptoms or conditions.
- Healthcare professionals and patients are encouraged to set achievable goals through shared decision-making and to approach treatment by focusing on specific symptoms (e.g., headache) or conditions (e.g., dysautonomia); a comprehensive management plan focusing on improving physical, mental, and social wellbeing may be helpful for some patients.
- Understanding of post-COVID conditions remains incomplete and guidance for healthcare professionals will likely change over time as the evidence evolves.
Mark’s Comments:
We know already that the aftereffects of COVID-19 will forever scar some affected individuals, families, and communities, and we’re only beginning to appreciate the impact. The potential number of people who could experience this is staggering, with estimates of well over 3 million, and the health, social, and economic implications are immense. This is certainly a condition that we who practice primary care medicine are uniquely positioned to treat, as it will require a comprehensive biopsychosocialspiritual approach.
Note that the “Assessment and Testing” section in the CDC guideline has some nice Tables for possible laboratory or other diagnostic testing as well as other survey instruments that can be used for assessment.
References:
- CDC - Evaluating and Caring for Patients with Post-COVID Conditions: Interim Guidance. Updated 14 June, 2021. Link to Table of Contents
- Rogers-Brown JS, et al. Outcomes Among Patients Referred to Outpatient Rehabilitation Clinics After COVID-19 Diagnosis – US, January 2020-March 2021. MMWR Morb Mortal Wkly Rep 9 July 2021;70. Link
Question from a Colleague
2) COVID vaccine guidelines and evidence
We received the following (very paraphrased) questions from a colleague about my review of COVID vaccines and the new indications for the Pfizer vaccine for adolescents (Link):
Question: I do not think vaccines should get an “easy pass” from a clinical trial and evidence-based medicine standpoint… While I agree that vaccinating this age group will help us with the overall pandemic and from a social and public health standpoint, I do not think the data on 12- to 15-year-old adolescents is robust from an EBM standpoint or from an individual benefit/risk standpoint. While I do hope (and have some confidence) the COVID vaccines will prove to be safe and effective in these younger age groups, I want to suggest some caution in how we utilize children for the greater good of adults and older folks.
Answer: This colleague detailed their concern about small numbers of patients in the trials, the need to look at children specifically, not just as “little adults,” the concern about lack of “patient-oriented” data on hospitalization, respiratory failure, and deaths in adolescents. I think these points raise an important discussion about the use of the evidence to make guidelines and recommendations.
An evidence-based guideline uses the best available evidence to arrive at a recommendation. In guideline development for any organization (ACIP, USPSTF, etc.), the evidence cannot or does not describe the correct path of action given all the potential contexts in which that guideline would be applied. It is a data-driven, but ultimately very human, process to work in a group to extrapolate evidence in a way that makes sense for the broader problems.
The USPSTF, for example, has extrapolated all sorts of evidence (using both consensus methods and statistical modeling) to arrive at recommendations. The key is being explicit about the process of extrapolation.
The ACIP is very explicit about their process. They use the GRADE framework to assess the evidence in front of them, and then use an Evidence-to-Recommendations (EtR) framework to arrive at a recommendation from that evidence. This framework asks specific questions about context and asks the guideline makers to weigh the potential benefits and potential harms considering that context. The ACIP posts all their EtRs here. The EtR is not yet posted for the Pfizer age change recommendation but should be soon.
In the case of an ongoing pandemic, where vaccine hesitancy is causing a significant problem, schools and states are rejecting masking recommendations, and a variant is causing new chaos, the ACIP took the evidence available and made a decision with very direct appeal to what would result in the “greater good.”
John’s Comments:
First, let me say, hooray! Our colleague’s question is exactly the sort of critical analysis and questioning we need more of in Family Medicine – this is how we best advocate for our patients – focusing on the right types of studies that look at the important outcomes.
In our current pandemic context, yes, vaccines get a little bit of a “pass” because it’s an emergency. I’m personally OK with that, and it also makes me a little uneasy, but we don’t have the luxury of waiting for the evidence we’d want. I’m very comfortable with the multiple ways vaccine safety is monitored by the CDC, which have been increased for COVID vaccines, and that helps me feel a little better.
References:
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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.
Email: mhgreenawald@carilionclinic.org