Short-term safety of COVID-19 mRNA vaccines with respect to all-cause mortality in the older population in Norway.

BACKGROUND: There have been concerns about COVID-19 vaccination safety among frail older individuals. We investigated the relationship between COVID-19 mRNA vaccination and mortality among individuals aged ≥ 70 years and whether mortality varies across four groups of health services used. METHODS: In this nationwide cohort study, we included 688,152 individuals aged ≥ 70 years at the start of the Norwegian vaccination campaign (December 27, 2020). We collected individual-level data from theNorwegian Emergency Preparedness Register for COVID-19. Vaccinated and unvaccinated individuals were matched (1:1 ratio) on the date of vaccination based on sociodemographic and clinical characteristics. The main outcome was all-cause mortality during 21 days after first dose of COVID-19 mRNA vaccination. Kaplan-Meier survival functions were estimated for the vaccinated and unvaccinated groups. We used Cox proportional-hazards regression to estimate hazard ratios (HRs) of death between vaccinated and unvaccinated individuals, with associated 95% confidence intervals (CIs), overall and by use of health services (none, home-based, short- and long-term nursing homes) and age group. RESULTS: Between December 27, 2020, and March 31, 2021, 420,771 older individuals (61.1%) were vaccinated against COVID-19. The Kaplan-Meier estimates based on the matched study sample showed a small absolute risk difference in all-cause mortality between vaccinated and unvaccinated individuals, with a lower mortality in the vaccinated group (overall HR 0.28 [95% CI: 0.24-0.31]). Similar results were obtained in analyses stratified by use of health services and age group. CONCLUSION: We found no evidence of increased short-term mortality among vaccinated individuals in the older population after matching on sociodemographic and clinical characteristics affecting vaccination and mortality.

Older patients' perspectives on illness and healthcare during the early phase of the COVID-19 pandemic.

BACKGROUND: Equal access to healthcare is a core principle in Norway's public healthcare system. The COVID-19 pandemic challenged healthcare systems in the early phase - in particular, related to testing and hospital capacity. There is little knowledge on how older people experienced being infected with an unfamiliar and severe disease, and how they experienced the need for healthcare early in the pandemic. AIM: To explore the experiences of older people infected by COVID-19 and their need for testing and hospitalisation. RESEARCH DESIGN: An explorative and descriptive approach, with qualitative interviews conducted in October 2020. PARTICIPANTS AND RESEARCH CONTEXT: Seventeen participants above 60 years of age hospitalised due to COVID-19 during spring 2020 were recruited 6 months after discharge. ETHICAL CONSIDERATIONS: Ethical approval was granted by the Regional Committee for Medical and Health Research Ethics in South-Eastern Norway (155425). FINDINGS: The main finding was that the informants experienced vulnerability and arbitrariness. This finding was supported by three sub-themes: experiences with a severe and unfamiliar disease, the strict criteria and the importance of someone advocating needs. DISCUSSION: Participants described varying access to healthcare. Those who did not meet the national criteria to be tested or hospitalised struggled against the system. Findings reveal arbitrary access to healthcare, in contrast to Norway's ethical principle of fair and just access to health services. Moreover, to access and receive necessary healthcare, informants were dependent on their next-of-kin's advocacy. CONCLUSION: Even when dealing with an unfamiliar disease, health professionals' assessments of symptoms must be performed with an ethical obligation to applicate competent appraisal and the exercise of discernment; this is in line with care ethics and ethical standards for nurses. These perspectives are a significant part of caring and the intension of doing good.

The delirium screening tool 4AT in routine clinical practice: prediction of mortality, sensitivity and specificity.

PURPOSE: Delirium is common and associated with poor outcomes, partly due to underdetection. We investigated if the delirium screening tool 4 A's test (4AT) score predicts 1 year mortality and explored the sensitivity and specificity of the 4AT when applied as part of a clinical routine. METHODS: Secondary analyses of a prospective study of 228 patients acutely admitted to a Medical Geriatric Ward. Physicians without formal training conducted the index test (the 4AT); a predefined cut-off ≥ 4 suggested delirium. Reference standard was delirium diagnosed by two geriatricians using the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5). We calculated hazard ratios (HR) using Cox regression based on the groups 4AT = 0, 1-3, 4-7 and ≥ 8, first unadjusted, then adjusted for the covariates age, comorbidity, and personal activities of daily living. We calculated sensitivity, specificity, and the area under the receiver operating curve (AUC). RESULTS: Mean age of patients was 86.6 years, 139 (61.0%) were female, 78 (34.2%) had DSM-5 delirium; of these, 56 had 4AT-delirium. 1 year mortality was 27.6% (63 patients). Compared to 4AT score 0, the group 4AT ≥ 8 had increased 1 year mortality (HR 2.86, 95% confidence interval 1.28-6.37, p = 0.010). The effect was reduced in multiadjusted analyses (HR 1.69, 95% confidence interval 0.70-4.07, p = 0.24). Sensitivity, specificity, and AUC were 0.72, 0.84, and 0.88, respectively. CONCLUSIONS: 4AT ≥ 8 indicates increased mortality, but the effect was reduced in multiadjusted analyses. 4AT had acceptable sensitivity and specificity when applied as a clinical routine.

Health-related quality of life in older patients with acute coronary syndrome randomised to an invasive or conservative strategy. The After Eighty randomised controlled trial.

Objective: in the After Eighty study (ClinicalTrials.gov.number, NCT01255540), patients aged 80 years or more, with non-ST-elevation myocardial infarction (NSTEMI), and unstable angina pectoris (UAP), were randomised to either an invasive or conservative management approach. We sought to compare the effects of these management strategies on health related quality of life (HRQOL) after 1 year. Methods: the After Eighty study was a prospective randomised controlled multicenter trial. In total, 457 patients aged 80 or over, with NSTEMI or UAP, were randomised to either an invasive strategy (n = 229, mean age: 84.7 years), involving early coronary angiography, with immediate evaluation for percutaneous coronary intervention, coronary artery bypass graft, optimal medical therapy, or to a conservative strategy (n = 228, mean age: 84.9 years). The Short Form 36 health survey (SF-36) was used to assess HRQOL at baseline, and at the 1-year follow-up. Results: baseline SF-36 completion was achieved for 208 and 216 patients in the invasive and conservative groups, respectively. A total of 137 in the invasive group and 136 patients in the conservative group completed the SF-36 form at follow-up. When comparing the changes from follow-up to baseline (delta) no significant changes in quality-of-life scores were observed between the two strategies in any of the domains, expect for a small but statistically significant difference in bodily pain. This difference in only one of the SF-36 subscales may not necessarily be clinically significant. Conclusion: from baseline to the 1 year follow-up, only minor differences in change of HRQOL as measured by SF-36 were seen by comparing an invasive and conservative strategy. ClinicalTrials.gov identifier: NCT01255540.

Perioperative hemodynamics and risk for delirium and new onset dementia in hip fracture patients; A prospective follow-up study.

BACKGROUND: Delirium is common in hip fracture patients and many risk factors have been identified. Controversy exists regarding the possible impact of intraoperative control of blood pressure upon acute (delirium) and long term (dementia) cognitive decline. We explored possible associations between perioperative hemodynamic changes, use of vasopressor drugs, risk of delirium and risk of new-onset dementia. METHODS: Prospective follow-up study of 696 hip fracture patients, assessed for delirium pre- and postoperatively, using the Confusion Assessment Method. Pre-fracture cognitive function was assessed using the Informant Questionnaire of Cognitive Decline in the Elderly and by consensus diagnosis. The presence of new-onset dementia was determined at follow-up evaluation at six or twelve months after surgery. Blood pressure was recorded at admission, perioperatively and postoperatively. RESULTS: Preoperative delirium was present in 149 of 536 (28%) assessable patients, and 124 of 387 (32%) developed delirium postoperatively (incident delirium). The following risk factors for incident delirium in patients without pre-fracture cognitive impairment were identified: low body mass index, low level of functioning, severity of physical illness, and receipt of ≥ 2 blood transfusions. New-onset dementia was diagnosed at follow-up in 26 of 213 (12%) patients, associated with severity of physical illness, delirium, receipt of vasopressor drugs perioperatively and high mean arterial pressure postoperatively. CONCLUSION: Risk factors for incident delirium seem to differ according to pre-fracture cognitive status. The use of vasopressors during surgery and/or postoperative hypertension is associated with new-onset dementia after hip fracture.