The group designated in Saskatchewan as Clinically Extremely Vulnerable (CEV) is a heterogenous clinical population with factors that impair their immune response to differing degrees.
Very Limited evidence is currently available to assess the immune response following vaccination is selected clinical populations; no evidence is available to assess vaccine efficacy or effectiveness in these populations. The clinical relevance of measured immune response with respect to protection from disease is still uncertain.
In considering the immune response of the CEV population, it is recommended that the absolute difference in immune response between 1 and 2 doses be considered, as it is possible some patient groups will have lowered protection regardless of vaccine strategy.
In terms of clinical subgroups:
oOrgan transplantation recipients on immunosuppressive medication: solid organ transplant recipients receiving anti-metabolite maintenance immunosuppression therapy were less likely to develop an antibody response to an mRNA vaccine, compared to those receiving other types of therapies (37% vs 63%). In a study of 242 kidney transplant recipients on immunosuppressive therapy only 10.8% became seropositive at 28 days after a single dose of mRNA vaccine.
oCancer: A study of 151 elderly patients with solid and hematological malignancies and 54 healthy controls who received one or two doses of BNT162b2 (Pfizer-BioNTech) vaccine shows approximately 39% of solid cancer patients, 13% of hematological cancer patients, and 97% of healthy controls (p<0.0001) developed anti-S IgG 21 days following a single dose vaccine. However, response in solid cancer patients increased to 95% within 2 weeks of the second dose at 21 days.
oOther immunocompromising conditions (e.g., auto-immune disorders and therapy): some level of immunity is generated with vaccination; however, what this means clinically is unknown. It seems that ensuring the dosing is properly timed around biologic therapy is important.
Azizian, A; Lee, S; Shumilak, G; Groot, G; Reeder, B; Miller, L; Howell-Spooner, B. What are the risks or benefits of extended intervals between doses of COVID-19 vaccines compared to recommended dosing in extremely vulnerable populations? 2021 Apr 20, Document no.: EOC210302 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2021. 15 p. (CEST rapid review report).
Azizian, A; Lee, S; Shumilak, G; Groot, G; Reeder, B; Miller, L; Howell-Spooner, B. What are the risks or benefits of extended intervals between doses of COVID-19 vaccines compared to recommended dosing in extremely vulnerable populations? 2021 Apr 20, Document no.: EOC210302 RR Table. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2021. (CEST table).
Miller, L; Howell-Spooner, B. What are the risks or benefits of extended intervals between doses of COVID-19 vaccines compared to recommended dosing in extremely vulnerable populations? 2021 Apr 01; Document no.: EOC210302 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 22 p. (CEST evidence search report).
No scientific evidence was found to support limits of a specific number of visitors. The Newfoundland/Labrador visitor policy referred to evidence supporting restrictions to 6 contact persons including one designated support person and 5 visitors; however, supporting references were not provided (25; 4.1).
The majority of Canadian and international visitation or family presence policies differentiate between general visitors (those attending for social visits) and designated support persons (essential care providers involved in physical, psychosocial, behavioral, cultural, or language support).
Designated support persons are not limited in duration, timing, or frequency of access to resident (3, 7, 9, 11, 12, 14, 16, 24, 26).
The majority of policies limit the number of general visitors to 2 persons. These visits typically have to be scheduled and may be restricted if there is an outbreak, if the resident is COVID+, or if community transmission is high. General visitors are usually not restricted during end of life or other compassionate care reasons.
Although modeling data supports contact restrictions as an effective measure to reduce infection spread, contact restriction can be achieved with infection prevention and control measures of micro-distancing, including hand and respiratory hygiene, physical distancing, and mask use (49). Family presence in LTC can support efforts to reduce resident wandering, micro-distancing, and hand hygiene.
There continues to be no scientific evidence that family presence increases risk of infection spread into and throughout LTC homes (1, 2, 44, 46)
No evidence was found that examined adherence of family caregivers to IPAC practices. A self-report survey of visitors and staff in 87 LTC homes in Hong Kong found that visitors self-reported high compliance with most infection prevention measures despite only one quarter of homes providing education (50). Low knowledge was identified as a primary barrier for infection prevention for visitors.
Education materials have been developed in several jurisdictions for family caregivers regarding COVID-19 IPAC best practices (4, 6, 8, 28).
No evidence was found regarding the impact of staff or family caregiver education on COVID-19 infection or transmission in LTC homes.
Ward, H; Tupper, S; Miller, L; Boden, C; Mueller, M. What is the evidence regarding limiting patient visitors in long-term care facilities to 2 or less, and how are other jurisdictions managing family caregivers? 2020 Dec 4; Document no.: LTC101501 RR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 35 p. (CEST rapid review report)
Miller, L; Boden, C; Mueller, M. What is the evidence regarding limiting patient visitors in long-term care facilities to 2 or less, and how are other jurisdictions managing family caregivers? 2020 Oct 28; Document no.: LTC101501-01 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 25 p. (CEST evidence search report)
· Overall, there is a lack of high quality evidence to support recommended pandemic preparedness strategies (checklist items) to prevent or mitigate respiratory infection outbreaks in LTC.
· In the absence of high-quality or mixed evidence to support strategies for pandemic preparedness, it is advisable to follow clinical practice guideline recommendations that have been based on expert opinion (key sources are identified in red). This is particularly the case for infection control interventions that are likely to have no negative impacts on LTC residents (e.g. hand hygiene, cough etiquette). Strategies that have a potential negative impact on LTC residents (e.g. visitor restrictions) must be handled with more flexibility and individual assessment to determine how infection control can be preserved while minimizing negative consequences for residents and families.
· Internationally recognized pandemic/outbreak preparedness checklists for LTC (e.g. CDC 2020, Buynder et al. 2017) share many similarities to the current SHA Annex R checklists.
· Consideration should be given to converting the checklist into a planner with accountabilities to demonstrate how each item is being addressed (similar to CDC 2020). Links can be embedded in the planner/checklist to more detailed information, such as the PPE burn calculator (CDC 2020), education/training materials (WHO 2020), and communication materials for families (CDC 2020, WHO 2020, Buynder et al. 2017).
· Consider the addition of specific detail to the SHA pandemic preparedness checklists on the date of the next pandemic plan/checklist review, contact names for local resource acquisition or assistance with staffing, tracking forms for dates of education/training with staff and residents, tracking of audits/observation of infection control practices, surge capacity planning items, and expanded items for communication (see attached recommendations from family caregivers of the Saskatchewan LTC Network).
· Discrepancies exist between reported (77-100%) and observed (25-63%) adherence to infection control practices, indicating a need for independent audits. Adherence rates improve with direct observation, frequent education reminders and prompts.
· Even when there is not an outbreak in a home, the pandemic response results in increased workload demands on staff due to infection control practices (e.g. PPE and hand hygiene), loss of family caregiver assistance with resident care, enhanced care needs of residents due to anxiety, increased communication with family caregivers and other members of the care team, monitoring and restricting resident movement in the home, enhanced cleaning, staff absenteeism, and education/training. Consideration is needed for a provincial process for evaluation of needs within individual homes, and allocation of additional human resources, disposable supplies, equipment, or funding to ensure that both infection control and usual care needs of residents are consistently met.
· Maintaining public confidence through communication is a defined infection control strategy. Communication strategies include individual communication between family members and staff, public communication strategies by individual facilities and provincially through dedicated pandemic information pertaining to LTC (e.g. dedicated LTC section on provincial websites).
Screening tools commonly include fever, respiratory symptoms (cough, shortness of breath), and epidemiological risk factors.
· The sensitivity and specificity of screening questionnaires depends considerably on the items used in the questionnaire. The limited published literature demonstrates great variability in the performance of different screening tools: sensitivity ranges from 0 – 48.6 – 84.3 – 100%; specificity ranges from 64.8 – 71.3 – 89.6 – 96%).
· The standard WHO symptom checklist performs poorly, with a sensitivity of 48.6%, and specificity of 89.6%. As such, half of individuals who have SARS-CoV-2 present at the time of testing will be missed by the symptom questionnaire (being either asymptomatic or presymptomatic). Depending on the population being screened the prevalence of the virus may vary widely. Given the sensitivity and specificity of the WHO symptom checklist in a population with prevalence ranging from 0.1% to 1% to 10% the positive predictive value (PPV) will be poor, range from 0.4% to 4.8% to 35%, respectively. Furthermore, the performance characteristics of the screening questionnaire may be poorer than reported if used in a setting or time of year when other respiratory viruses with similar symptoms are circulating.
Fick, F; Neudorf, C; Reeder, B; Dalidowicz, M; Mueller, M. What is the sensitivity and specificity of screening checklists and temperature checks for detecting the presence of COVID-19 in individuals? 2020 Apr 28; Document no.: PH042401 RR. In:
COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 20 p. (CEST rapid review report)
Ellsworth, C. What characteristics of residents in LTC homes affect the ability to provide routine care during a COVID-19 or ILI outbreak? 2020 Apr 28; Document no.: LTC042201-03 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 5 p. (CEST evidence search report)
Dalidowicz, M; Mueller, M. What is the sensitivity and specificity of screening checklists and temperature checks for detecting the presence of COVID-19 in individuals? 2020 Apr 27; Document no.: PH042401-01 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 12 p. (CEST evidence search report)
Dalidowicz, M; Boden, C. What environmental management and built environment factors influence a home’s ability to prevent or manage an ILI outbreak? AND What is the evidence for infection control practices (checklist items) for preventing or managing an ILI outbreak? 2020 Apr 25; Document no.: LTC042201-02 ESR. In: COVID-19 Rapid Evidence Reviews [Internet]. SK: SK COVID Evidence Support Team, c2020. 24 p. (CEST evidence search report)
