Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trial.

Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, -3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; -9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols.

Decision aids linked to the recommendations in clinical practice guidelines: results of the acceptability of a decision aid for patients with generalized anxiety disorder.

BACKGROUND: Generalized anxiety disorder (GAD) is one of the most prevalent mental health problems. Patients with GAD have unmet needs related to the information received about their disorder, its treatments and their participation in the decision-making process. The aim of this study is to develop and assess the acceptability of a patient decision aid (PtDA) for patients with GAD. METHOD: The PtDA was developed following the International Patient Decision Aid Standards. The recommendations of the Spanish clinical practice guideline (CPG) for patients with GAD were used as the basis. The first prototype was developed by an expert committee, further improvements were made with patients (n = 2), clinical experts (n = 13) and the project management group (n = 7). The acceptability of this second draft was assessed by patients non-involved in the previous phases (n = 11). RESULTS: The final PtDA version included a brief description of GAD and its treatments. Most participants agreed that the PtDA was easy to use, visually appealing and useful. At least half of the participants learned new things about treatments and adverse effects. CONCLUSIONS: A PtDA was developed for patients with GAD based on recommendations from the Spanish CPG. It was improved and accepted by patients and clinical experts involved. An evaluation of its effectiveness on the shared decision-making process during the clinical encounter is planned.

Trends in self-rated health status and health services use in COPD patients (2006-2012). A Spanish population-based survey.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients often have a significant impairment in their health status, which is an independent predictor of health services use. OBJECTIVES: To describe the self-rated health status and the prevalence of health services use among COPD Spanish patients; to identify which factors are independently associated with a worse health status and a higher use of health services; and to study the time trends in the health status and prevalence of use of health services (2006-2012). METHODS: Observational study: We analyzed data from the Spanish National Health Surveys conducted in 2006 and 2012. We included responses from adults aged 40 years or over. Subjects described their health status as very good, good, fair, poor, or very poor, which was dichotomized into very good/good or fair/poor/very poor self-perceived health status. RESULTS: We identified 2,321 COPD patients. The percentage of patients with health status fair, poor, or very poor was 76.8 % in 2006 and 74.8 % in 2012 (p > 0.05). Regarding the health resources use, we observed a significant decrease in the number of visits to primary care over time in women (67.8 vs. 57.2 %, p < 0.05) and men (62.2 vs. 54.0 %, p < 0.05). However, we did not find improvement in the prevalence of emergency department visits or hospitalizations. Associated factors with a worse self-rated health status and a higher use of health services in women and men included: having three or more chronic diseases, presence of mental disorders, and absence of leisure time physical activity. CONCLUSIONS: The current study revealed a decrease in the general practitioner visits, without changes in use of other health care services in the COPD Spanish population from 2006 to 2012. The self-rated health status did not changed significantly during this period.

Perception of the economic value of primary care services: a Willingness to Pay study.

OBJECTIVE: Identify the economic value the user attributes to the visit to the family physician, in a setting of a National Health System, by the Willingness to Pay (WTP) expressed. METHODS: Economic evaluation study, by the contingent valuation method. Questions were asked about WTP using a payment card format. Interviews were conducted with 451 subjects, in areas with different socioeconomic characteristics. An ordered probit was used to evaluate model's validity. RESULTS: Median WTP expressed was euro18 (interquartile range euro8-28), not including "zero-answers" of thirty-four subjects (7.5%). This value represents 2% of average adjusted family incomes. Patients with higher incomes or with chronic illnesses presented a probability of 5-14 percentage points of expressing a high WTP. For every point of increase of patient satisfaction, the probability of presenting a WTP in the lowest range decreases 7.0 percentage points. Subjects with a low education level and those older than 65 expressed a lower WTP. Accessibility, risk perception, nationality and having private insurance were not related to the WTP expressed. CONCLUSIONS: Users of primary care have a clear perception of the economic value of care received from the family physician, even in a framework of providing services financed by taxes and without cost at the moment of use. This value increases in subjects with higher incomes, with greater need for care, or more satisfied.

[Measurement of the evaluative capacity of the CVP-35 questionnaire for perceiving the quality of professional life]. / Medición de la capacidad evaluadora del cuestionario CVP-35 para la percepción de la calidad de vida profesional.

OBJECTIVE: To establish the CVP-35 evaluative properties to measure the professional quality of life (PQL). DESIGN: Prospective, observational study. SETTING: A primary care area in the Community of Madrid, Spain. PARTICIPANTS: A total of 149 sanitary workers with some burnout sign measured by Maslach Burnout Inventory (MBI) participated. MEASUREMENTS: They fulfilled MBI, Goldberg Health Questionnaire (GHQ-28), and CVP-35 questionnaires at the beginning and after a year of follow-up, in which 73 subjects took part in activities for coping stress. It was assessed the change of PQL and their domains managerial support (PQL-MS), work load (PQL-WL), intrinsic motivation (PQL-IM) for the subjects with variations at the MBI, or GHQ-28 punctuation greater than 0.5 SD of the initial distribution. RESULTS: Variations in CVP-35 and their domains correlate weakly with changes in MBI and GHQ-28 (r<0.500), but they are congruent with the conceptual model. In the individuals with significant variations in the GHQ-28, they appreciate an average change in PQL and their domains between 0.18 and 0.55 points (absolute value). In those with significant variations in the MBI domains, PQL presented average absolute variations between 0.23 and 0.45 points, PQL-MS between 0.30 and 0.67, PQL-WL between 0.01 and 0.55 and PQL-IM between 0.22 and 0.83 points. CONCLUSIONS: CVP-35 is a sensitive-to-change instrument under population point of view. Changes in PQL perception or in any of their domains of 0.5 points could be pointed as relevant.

[Usefulness of a glaucoma and ocular hypertension screening strategy in primary care]. / Utilidad de una estrategia de cribado de hipertensión ocular y glaucoma en atención primaria.

OBJECTIVES: To evaluate the usefulness of a glaucoma and intraocular hypertension screening strategy for new cases detected. To evaluate the acceptability of taking intra-ocular pressure (IOP) and the appearance of side effects. DESIGN: Cross-sectional, descriptive study. SETTING: An urban health centre and the ophthalmology clinic of its main hospital. PARTICIPANTS: A total of 2044 patients aged over 40, 63.5% women and 36.5% men, with a mean age of 61.23 (SD, 11.42). They were selected by consecutive sampling from patients who visited the health centre over a 9-month period. Subjects diagnosed with glaucoma, ocular hypertension (OH), conjunctivitis, or corneal pathology were excluded. INTERVENTIONS: Taking of IOP with Tonopen XL in primary care. Subjects with IOP > or = 21 mm Hg were referred to ophthalmology. In these patients, IOP was measured with Goldmann, and patients with confirmed OH received ophthalmoscopy and campimetry. MAIN MEASUREMENTS: Percentage of subjects with glaucoma, suspected glaucoma, and OH confirmed in ophthalmology. Positive predictive value (PPV) for OH. RESULTS: One hundred subjects with OH were detected (4.89%; 95% CI, 3.93%-5.85%), of whom 21 were diagnosed with glaucoma (1.04%; 95% CI, 0.57-1.49) and 10 with suspected glaucoma (0.49%; 95% CI, 0.16-0.82). The PPV for OH was 44.27%. The acceptability of the test was 98.09%. No patients presented with side-effects following the taking of their IOP. CONCLUSIONS: The strategy evaluated is useful in terms of the number of subjects with glaucoma and OH detected. The acceptability of taking IOP with Tonopen XL was high.