SARS-CoV-2 Omicron BA.1 variant breakthrough infections in nursing home residents after an homologous third dose of the Comirnaty® COVID-19 vaccine: Looking for correlates of protection.

We investigated whether peripheral blood levels of SARS-CoV-2 Spike (S) receptor binding domain antibodies (anti-RBD), neutralizing antibodies (NtAb) targeting Omicron S, and S-reactive-interferon (IFN)-γ-producing CD4+ and CD8+ T cells measured after a homologous booster dose (3D) with the Comirnaty® vaccine was associated with the likelihood of subsequent breakthrough infections due to the Omicron variant. An observational study including 146 nursing home residents (median age, 80 years; range, 66-99; 109 female) evaluated for an immunological response after 3D (at a median of 16 days). Anti-RBD total antibodies were measured by chemiluminescent immunoassay. NtAb were quantified by an Omicron S pseudotyped virus neutralization assay. SARS-CoV-2-S specific-IFNγ-producing CD4+ and CD8+ T cells were enumerated by whole-blood flow cytometry for intracellular cytokine staining. In total, 33/146 participants contracted breakthrough Omicron infection (symptomatic in 30/33) within 4 months after 3D. Anti-RBD antibody levels were comparable in infected and uninfected participants (21 123 vs. 24 723 BAU/ml; p = 0.34). Likewise, NtAb titers (reciprocal IC50 titer, 157 vs. 95; p = 0.32) and frequency of virus-reactive CD4+ (p = 0.82) and CD8+ (p = 0.91) T cells were similar across participants in both groups. anti-RBD antibody levels and NtAb titers estimated at around the time of infection were also comparable (3445 vs. 4345 BAU/ml; p = 0.59 and 188.5 vs. 88.9; p = 0.70, respectively). Having detectable NtAb against Omicron or SARS-CoV-2-S-reactive-IFNγ-producing CD4+ or CD8+ T cells after 3D was not correlated with increased protection from breakthrough infection (OR, 1.50; p = 0.54; OR, 0.0; p = 0.99 and OR 3.70; p = 0.23, respectively). None of the immune parameters evaluated herein, including NtAb titers against the Omicron variant, may reliably predict at the individual level the risk of contracting COVID-19 due to the Omicron variant in nursing home residents.

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial.

BACKGROUND: Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients' associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). METHODS/DESIGN: Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients' associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. DISCUSSION: The first data gathered have allowed us to identify the characteristics of the study population and they support the appropriateness of the inclusion criteria.. When the study is complete, the results will enable us to establish whether this kind of intervention can be used as a self-regulation tool for increasing and maintaining walking as unsupervised physical exercise of low to moderate intensity in fibromyalgia patients. TRIAL REGISTRATION NUMBER: ISRCTN68584893.

A study of the prevalence of adverse events in primary healthcare in Spain.

BACKGROUND: Healthcare practices involve risks for patients, but there has been little research to date on the occurrence of adverse events (AE) in primary care (PC). The frequency of AE in PC in Spain, the factors that contribute to their occurrence, their severity and their preventability, were analysed. METHODS: Observational cross-sectional study was carried out in 48 PC centres in 16 regions of Spain. PC professionals were asked to assess whether the AE was caused by the healthcare or if it was an expectable consequence of the patient's underlying condition. A total of 452 healthcare professionals who attended 96 047 consultations were involved. RESULTS: A total of 773 AE were identified, so that the point prevalence of AE was 0.8% [95% confidence interval (CI) 0.76-0.85]. A majority of AE (64.3%) were considered preventable and only 5.9% were severe, usually related to medication [odds ratio (OR) = 4.6; 95% CI 2.1-10.3]. The most frequent causal factor of the AE was associated with medication (adverse drug reactions and medication errors), but problems in communication and management were at the root of many of the AE. Nurses reported more preventable AE (OR = 1.9; 95% CI 1.2-2.8). CONCLUSION: In spite of an AE being less damaging in PC, large numbers of patients and professionals suffer their consequences each year. An awareness of the magnitude and impact of AE is the first step on the road to the cultural change necessary for achieving safer healthcare.

[Adverse events in ambulatory surgical procedures]. / Efectos adversos en cirugía mayor ambulatoria.

OBJECTIVE: To assess the incidence of adverse events and patients with adverse events in ambulatory surgical procedures and to compare it with that of other studies. MATERIAL AND METHOD: Historical cohort study. The scope of the study was the ambulatory surgical procedures unit of a university hospital. All general surgery department patients seen in this unit during the year 2005 were included. RESULTS: The incidence of patients with adverse events directly related to hospital care was of 3% (95% CI, 0.9-5). Of the adverse events identified 5 were considered slight, 3 moderate and none were considered serious. All the moderate ones were considered unavoidable and of slight, only the one was avoidable. Six of the adverse events were associated to a procedure, one due to hospital infections and one with other causes. There was an increase in hospital stay due to 75% of the adverse events, and 25% of them affected admission. CONCLUSIONS: The incidence of adverse events related to medical care in the Spanish hospitals is similar to those found in the studies carried out in American and European countries using the same methodology. The surgical area is considered a high risk unit. However, ambulatory surgical procedures reduce these risks, in such a way that the incidence is far below that of surgery department. Therefore, besides improving the technical efficiency of the clinical services, it is safer for the patients.

[Health assistance as a risk factor: side effects related to clinical practice]. / La asistencia sanitaria como factor de riesgo: los efectos adversos ligados a la práctica clínica.

The increasingly complex health care systems, together with more vulnerable, highly informed and demanding patients, conform a clinical environment in where adverse effects (AE) related to health care practice appear. The incidence of AE in hospitalized patients has been estimated between a 4 and a 17%. Twenty-five per cent of them were serious and half were considered avoidable. Seventy per cent of the AE are due to technical failures, faults in the decision making process, inappropriate performance based on the available information, problems in the anamnesis, and absent or inadequate health care provision. The explanatory model of the causal chain of an adverse effect supports that systems failures are more important than people failures. The IDEA Project seeks to study the incidence of AE related to health care for the first time in Spain. To facilitate the necessary change from a punitive culture to a proactive culture, a multidisciplinary approach of the problem taking into account the point of view of health professionals, patients, community leaders and courts is needed.