The impact of COVID-19 vaccination programme in the Republic of San Marino: Focus on effectiveness of Gam-Covid-Vac.

OBJECTIVE: The adenovirus-based vaccine Gam-COVID-Vac (Sputnik V) showed promising effectiveness in a phase 3 clinical trial; however, data concerning its impact at a population level are scarce. The Republic of San Marino (RSM) conducted a SARS-CoV-2 vaccination programme mainly based (>80%) on Gam-COVID-Vac. Our aims were to investigate the impact of Gam-COVID-Vac vaccination programme and its effectiveness in a retrospective observational study based on the entire RSM population aged ≥12 years. METHODS: We calculated the incidence rate and the vaccine effectiveness (VE) in the entire RSM population not previously infected, against SARS-CoV-2 infection and COVID-19-related hospitalization, from 25 February to 1 October 2021, considering any vaccine and separately according to the vaccine used. Vaccine effectiveness was calculated using a multivariable negative binomial regression model as 1-Incidence Rate Ratio. RESULTS: During the study period, 21 568/28 791 (74.9%) not previously infected subjects received at least one dose of the Gam-COVID-Vac (84%) or BNT162b2, vaccines with 98% completing the vaccination schedule. Overall, 1634 SARS-CoV-2 infections and 166 COVID-19-related hospitalizations were observed with 17 COVID-19-related deaths reported. Incidence rates of SARS-CoV-2 infection and COVID-19-related hospitalization were 7.11 and 0.49/100 000 person-days in the fully vaccinated population, respectively. The adjusted overall VE was 67.6% (95% CI: 61.8-72.5) against SARS-CoV-2 infection and 87.9% (95% CI: 77.4-93.5) against COVID-19-related hospitalizations. Gam-COVID-Vac against SARS-CoV-2 infection VE peaked 91.8% (95% CI: 86.3-95.1) in the first bimester from the second dose, declining to 57.8% (95% CI: 42.2-69.2) at 6 months. Protection against hospitalization with COVID-19 was overall 91.6% (95% CI: 81.5-96.2), with no relevant waning trend over time. DISCUSSION: Our study demonstrated the effectiveness of overall vaccination (Gam-COVID-Vac [84%] and BNT162b2 [16%]) in the prevention SARS-CoV-2 infection (pre-Omicron variant), waning over time but still with sustainable effectiveness against COVID-19-related hospitalization in the Republic of San Marino.

Survey on advance care planning of Italian outpatients on chronic haemodialysis.

OBJECTIVES: The clinical practice guidelines published by the Renal Physicians Association (USA) recommend instituting advance care planning (ACP) for patients with end-stage renal disease. Studies on this issue are lacking in Italy. Our aim was to determine the attitudes of patients on ACP in our dialysis centre. METHODS: We performed a cross-sectional survey. We recruited patients on maintenance haemodialysis (HD) at Hemodialysis Center of Università Cattolica del Sacro Cuore, from 1 March 2014 to 31 March 2015. The only exclusion criterion was inability to give an informed consent. Patients completed a questionnaire concerning their treatment preferences in three hypothetical disease scenarios: persistent vegetative state, advanced dementia, severe terminal illness; for each patients, we also collected clinical, functional and socioeconomic data. RESULTS: Thirty-four HD outpatients completed the study questionnaire. The majority of respondents (85%) considered information about prognosis, health conditions and treatment options, including withdrawing dialysis, as very important and 94% of respondents considered treatment of uraemic/dialytic symptoms the most important issue. In the health scenarios provided, dialysis was the treatment least withheld. Dependence on instrumental activities of daily living (0.048) and higher Charlson Comorbidity Index scores (p=0.035) were associated with continuing dialysis in at least one scenario. CONCLUSIONS: ACP should be tailored to patients' value, culture and preferences. A significant proportion of patients, however, do not want to be involved in end of life decisions. Frail elderly patients, in particular, are not inclined to interrupt dialysis, despite poor quality of life or a poor prognosis.

Effectiveness of comprehensive care programs for patients with multiple chronic conditions or frailty: A systematic literature review.

OBJECTIVE: To describe comprehensive care programs targeting multimorbid and/or frail patients and to estimate their effectiveness regarding improvement of patient and caregiver related outcomes, healthcare utilization and costs. METHODS: Systematic search in six electronic databases for scientific papers published between January 2011 and March 2014, supplemented by reference tracking. Wagner's Chronic Care Model (CCM) was used to operationalize comprehensive care. The quality of the included studies was assessed, and a best-evidence synthesis was applied. RESULTS: Nineteen publications were included describing effects of eighteen comprehensive care programs for multimorbid or frail patients, of which only one was implemented in a European country. Programs varied in target groups, settings, interventions and number of CCM components addressed. Providing comprehensive care might result in more patient satisfaction, less depressive symptoms, a better health-related quality of life or functioning of multimorbid or frail patients, but the evidence is insufficient. There is no evidence that comprehensive care reduces the number of primary care or GP visits or healthcare costs. Regarding the use of inpatient care, the evidence was insufficient. No evidence was found for a beneficial effect of comprehensive care on caregiver-related outcomes. CONCLUSION: Despite the fact that over the years several (good-quality) studies have been performed to estimate the value of comprehensive care for multimorbid and/or frail patients, evidence for their effectiveness remains insufficient. More good-quality studies and/or studies allowing meta-analysis are needed to determine which specific target groups at what moment will benefit from comprehensive care. Moreover, evaluation studies could improve by using more appropriate outcome measures, e.g. measures that relate to patient-defined (personal) goals of care.

Multimorbidity in risk stratification tools to predict negative outcomes in adult population.

INTRODUCTION: Risk stratification tools were developed to assess risk of negative health outcomes. These tools assess a variety of variables and clinical factors and they can be used to identify targets of potential interventions and to develop care plans. The role of multimorbidity in these tools has never been assessed. OBJECTIVES: To summarize validated risk stratification tools for predicting negative outcomes, with a specific focus on multimorbidity. METHODS: MEDLINE, Cochrane Central Register of Controlled Trials and PubMed database were interrogated for studies concerning risk prediction models in medical populations. Review was conducted to identify prediction models tested with patients in both derivation and validation cohorts. A qualitative synthesis was performed focusing particularly on how multimorbidity is assessed by each algorithm and how much this weighs in the ability of discrimination. RESULTS: Of 3674 citations reviewed, 36 articles met criteria. Of these, 29 had as outcome hospital admission/readmission. The most common multimorbidity measure employed in the models was the Charlson Comorbidity Index (12 articles). C-statistics ranged between 0.5 and 0.85 in predicting hospital admission/ readmission. The highest c-statistics was 0.83 in models with disability as outcome. For healthcare cost, models which used ACG-PM case mix explained better the variability of total costs. CONCLUSIONS: This review suggests that predictive risk models which employ multimorbidity as predictor variable are more accurate; CHF, cerebro-vascular disease, COPD and diabetes were strong predictors in some of the reviewed models. However, the variability in the risk factors used in these models does not allow making assumptions.