[Vaccine against COVID-19]. / Vacuna frente al COVID-19.

The COVID-19 pandemic has produced a huge health, economic and psychological collapse in our society. Health workers have had to face one of the greatest challenges in history, trying to show the population how to deal with this disease. We have learned that vaccines are the great instrument for the fight against infectious diseases and a large number of them began to appear, not as a product of chance but as a product of the enormous progress experienced in recent years with vaccines against new infectious diseases, against other diseases such as Alzheimer's and especially against cancer. All this knowledge has been applied to this disease. Practitioners lamented the little information available to them when asked questions from patients. This document wanted to be a response to these concerns, with a scientific desire, with evidence that put aside unverified data and hoaxes. Faced with an avalanche of information, most of it without the appropriate "peer review" as indicated in the introduction, any publication becomes obsolete at the time of publication, and we opted for an "online" publication, with the incorporation of versions. This online publication has been published in the documents of Spanish Society of Chemotherapy, at https://seq.es/vacunacion-covid-19.

Perceived quality in a dementia unit: patients' caregivers as information providers. / Calidad percibida en una unidad de demencias: el portavoz del paciente como proveedor de información.

INTRODUCTION: Dementia units (DU) provide comprehensive and specialised care to patients with dementia. However, assessment in these units normally focuses on patient management. The aim of this study was to determine satisfaction of the caregivers of patients managed in a DU and how they rated DU care. METHODS: We created a self-administered questionnaire which was completed by 236 caregivers visiting the DU in 2015. The questionnaire included 6 dimensions (accessibility, organisation, professionalism, relationship with staff, information, and facilities); data were analysed using problem rates. RESULTS: A total of 53.4% caregivers completed the questionnaire; most were women, patients' spouses, or first-degree relatives. The overall problem rates was 15.0% (95% CI, 13.9-16.1), with sizeable differences between dimensions: from 0.1% (95% CI, 0.0-0.4) for 'relationship with staff' and 'professionalism' to 49.3% (95% CI, 45.4-53.2) for 'information'. Waiting times over 30minutes were perceived as excessive. Information problems were not directly related to patient management. Satisfaction was scored 8.29/10 (median 8; SD 1.45); 77.3% (95% CI, 69.8-74.8) of respondents were highly satisfied. Ninety-nine percent of the caregivers stated that they would recommend the DU. CONCLUSIONS: This questionnaire provides interesting data on care quality as perceived by patients' caregivers. Our results have allowed us to identify problems and implement corrective actions. Our questionnaire has proved to be a useful tool for evaluating and improving care quality in DUs.

[Effectiveness of an intervention to improve safety culture. Less is more?] / Efectividad de una intervención para mejorar la cultura de seguridad. ¿Menos es más?

OBJECTIVE: To assess the impact of a long-term initiative to improve safety culture among professionals working in a Health Area, and to know their perceived usefulness. MATERIAL AND METHODS: An uncontrolled intervention study was designed in a public health care organization including a 3rd level hospital and 5,000 professionals. To measure the impact, the AHRQ Survey was conducted by telephone. A total of 7 dimensions of culture were measured, before starting the project (2012, n=100) and 3 years later (2015, n=207). Variations between 2012 and the respondents aware of the project in 2015 (RAP) were compared, as also between this last group and the rest of respondents (RNAP). The utility was assessed using a 5-item Likert scale, defining higher utility by medians 4 or higher. RESULTS: The response rates were above 80%. In 2015, the 41.5% of respondents were RAP (95%CI: 34.8-48.3), which was perceived as of high utility. Negative variations were detected in "sense of security" (-9.9%, P<.01, vs. 2012, and -4.2% between 2015 groups) and "feedback and communication errors" (-10.0% vs. 2012, and -8.9% between 2015 groups, P<.05). There was a not-significant positive variation in "openness in communication" (1.3% vs. 2012, and 6.9% between 2015 groups). The "management support" showed a not-significant improve in 2015 (37.0%, 95%CI: 30.9-43.1, in RAP; and 38.3%, 95%CI: 33.1-43.4, in RANP) in comparison to 2012 (31.4%, 95%CI: 28.4-39.7). CONCLUSIONS: A paradoxical worsening is detected in several dimensions, this probably due to immaturity of the organization and the instrument used. Thus, tools explicitly considering the degree of maturity may be more appropriate to measure cultural changes, although more studies are needed.

[Consensus document on pneumococcal vaccination in adults at risk by age and underlying clinical conditions. 2017 Update]. / Consenso sobre la vacunación anti-neumocócica en el adulto por riesgo de edad y patología de base. Actualización 2017.

Invasive pneumococcal disease (IPD) and pneumococcal pneumonia (PP) represent an important health problem among aging adults and those with certain underlying pathologies and some diseases, especially immunosuppressed and some immunocompetent subjects, who are more susceptible to infections and present greater severity and worse evolution. Among the strategies to prevent IPD and PP, vaccination has its place, although vaccination coverage in this group is lower than desirable. Nowadays, there are 2 vaccines available for adults. Polysacharide vaccine (PPV23), used in patients aged 2 and older since decades ago, includes a greater number of serotypes (23), but it does not generate immune memory, antibody levels decrease with time, causes an immune tolerance phenomenon, and have no effect on nasopharyngeal colonization. PCV13 can be used from children 6 weeks of age to elderly and generates an immune response more powerful than PPV23 against most of the 13 serotypes included in it. In the year 2013 the 16 most directly related to groups of risk of presenting IPD publised a series of vaccine recommendations based on scientific evidence regarding anti-pneumococcal vaccination in adults with underlying pathologies and special conditions. A commitment was made about updating it if new scientific evidence became available. We present an exhaustive revised document focusing mainly in recommendation by age in which some more Scientific Societies have been involved.

[Can anybody understand the informed consent documents? A proposal to make it easier]. / ¿Pero alguien entiende los consentimientos informados? Una propuesta para facilitar su comprensión.

OBJECTIVE: To assess the readability of informed consent documents as written by doctors, by analysing the results and the differences between the sections of the document and services, with the aim of helping to improve them. MATERIAL AND METHODS: Descriptive study of the texts from 359 documents sent for accreditation in the Arrixaca Hospital (Murcia, Spain). Both length and readability are assessed. Length is measured in words (adequate up to 470, excessive over 940), and readability in INFLESZ points (suitable if over 55). RESULTS: Length ranged from 73 to 1018 words (mean 360, standard error 8.8, adequate length OR 3.66±0.81). The larger sections were "risks" and "nature of the procedure", and the shorter ones, "alternatives" and "contraindications", P<.0001. The INFLESZ value ranged from 18.1 to 86.4 points (mean 45.8, standard error 0.45), and was better in non-surgical services. Only 12.5% of the documents achieved an INFLESZ value over 55 (OR 0.12±0.03), with 70% in non-surgical procedures, P<.0001. The better readability sections were the "nature" and the "risks", and the worst ones, were "contraindications" and "alternatives", P<.0001. CONCLUSIONS: The length of proposed documents is adequate, but they are not sufficiently readable, especially if they come from surgical services. The section length is unbalanced, with "contraindications" and "alternatives" being shorter and more difficult to understand. It is essential to check the readability before using an informed consent document. For this purpose, tools like that proposed could be useful.

[Introduction of an accreditation system for hospital informed consent forms]. / Introducción de un sistema de acreditación para los documentos de consentimiento informado hospitalario.

OBJECTIVE: To describe an accreditation system for informed consent forms (ICF) in a tertiary hospital, as an intervention to improve their quality, and to check the improvements achieved. MATERIAL AND METHODS: Following an external evaluation of the ICF quality in a public hospital in Murcia (Spain), an accreditation committee set the ICF requirements and associated procedures. Effectiveness is assessed by comparing two external evaluations carried out by the EMCA Program (2011 and 2013) and based on 19 criteria and a sample of 60 ICF for every public hospital in Murcia Region. RESULTS: To be accredited, every ICF must meet the 19 external criteria plus 5 based on legibility, readability and scientific and technical validity. A form to fill in the contents of every ICF was agreed, which would be reviewed, approved and validated for five years. Before the implementation, 8.2 defects/ICF were detected. The accreditation system obtained an 89% improvement (0.9 defects/ICF) and achieved significant improvements in 18 criteria, 16 of which are benchmarked. DISCUSSION: The accreditation system achieved a substantial improvement in the ICF (obtaining a better result in external evaluations) and guarantees their contents, legibility and readability. This system needs to be extended to other hospitals, since it is not clear whether common ICFs would be suitable. However, this improvement is structural and does not guarantee that the overall information/consent procedure is done properly, thus complementary strategies for measurement and improvement are required.

[Consensus document on vaccination against influenza in health care workers]. / Consenso sobre la vacunación frente a la gripe en el personal sanitario.

Health care workers (HCW) are included each year among risk groups for vaccination against influenza. However, vaccination coverage among this group in our country is very low, not exceeding 25%. Convinced that one of the best tools to increase this coverage among professionals in our country are the scientific evidence, 19 scientific societies and associations professionals bringing together health professionals more directly related to influenza as an health problem, and the General Nursing Council, met to discuss and develop this consensus document in order to inform HCW about the appropriateness of their vaccination against influenza and the benefits that flow from it for themselves, for their patients and for the rest of the population. This recommendation is based on 3 pillars: argument of necessity, ethics and exemplary.

Klebsiella pneumoniae: development of a mixed population of carbapenem and tigecycline resistance during antimicrobial therapy in a kidney transplant patient.

Nine isolates of Klebsiella pneumoniae were isolated from a renal transplant patient suffering from recurrent urosepsis over a period of 4 months. Imipenem resistance was detected after imipenem-ertapenem therapy. When treatment was switched to tigecycline the K. pneumoniae developed resistance to tigecycline (MIC = 8 mg/L). The nine isolates were tested by determination of agar dilution MICs, phenotypic carbapenemase, extended-spectrum beta-lactamases and metallo-beta-lactamase (MBL) testing and pulsed-field gel electrophoresis. Polymerase chain reaction and sequencing analysis were employed for identification of bla genes and mapping of the integron carrying the MBL gene. The nine isolates were clonally related and all produced the SHV-12 enzyme. Five MBL-producing isolates showed imipenem MICs ranging from 2 to 64 mg/L and all were detected by testing with imipenem and EDTA. The five isolates harboured the bla(VIM-1) gene. Three isolates showed increased tigecycline MICs (4-8 mg/L). Serial blood cultures obtained on the same day resulted in a VIM-positive/tigecycline-susceptible and a VIM-negative/tigecycline-resistant K. pneumoniae isolate. No isolate developed concurrent imipenem and tigecycline resistance. The patient had a persistent urinary tract infection and recurrent bacteraemia caused by a mixed population of Klebesiella pneumoniae isolates adapting to the selective pressure of antimicrobial therapy at the time. The present study is a worrisome example of what could happen when an immunocompromised host is subjected to the pressures of antimicrobial therapy. In addition, we report the first treatment-emergent MIC increase of tigecycline from 0.5 to 8 mg/L in K. pneumoniae.

In vitro activity of retapamulin against linezolid and methicillin-resistant Staphylococcus aureus isolates.

OBJECTIVES: To determine the in vitro activity of retapamulin and other topical antibiotics (mupirocin, bacitracin, and fusidic acid) usually employed for nasal decolonization, against methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant S. aureus (MRSA), and linezolid and methicillin-resistant S. aureus. METHODS: The minimum inhibitory concentrations (MICs) were determined on Mueller-Hinton agar according to the guidelines of the Clinical and Laboratory Standards Institute and of the European Committee for Antimicrobial Susceptibility Testing. Presence of the cfr gene in linezolid and methicillin-resistant S. aureus isolates was detected using polymerase chain reaction. RESULTS: Retapamulin inhibited all the isolates of MSSA and MRSA at 0.125 mg/L, but the 18 linezolid-resistant-MRSA strains proved resistant, with MICs over 32 mg/L. Most MSSA isolates (9/10) were susceptible to mupirocin with MICs under 0.19 mg/L, although this value decreased to half against MRSA, and almost all linezolid-resistant MRSA (17/18) strains were resistant to mupirocin with an MIC range of between 8 mg/L and 28 mg/L. The MIC of fusidic acid increased substantially against linezolid-resistant MRSA, whereas that of bacitracin showed no differences. CONCLUSIONS: Retapamulin demonstrated excellent in vitro activity against MSSA and MRSA strains, but not against MRSA isolates harbouring the cfr gene. The results of this in vitro study support cut-off values for retapamulin of ≤ 0.5, 1, and ≥ 2 mg/L for susceptible, intermediate, and resistant strains, respectively.

In vitro activity of ceftobiprole and seven other antimicrobial agents against invasive Streptococcus pneumoniae isolates in Spain.

The in vitro activity of ceftobiprole was compared with that of seven antimicrobial agents against invasive Streptococcus pneumoniae isolated from adult patients (>15 years old). Characterization of erythromycin-resistant strains and serotype distribution of all pneumococci were also evaluated. Seventy invasive S. pneumoniae strains were isolated from December 2007 to January 2009. Serotyping was carried out by Quellung reaction. Antibiotic susceptibility was tested by broth microdilution (CLSI guidelines). The comparator agents were penicillin, cefotaxime, erythromycin, clindamycin, telithromycin, tetracycline and moxifloxacin. Phenotypic characterization of macrolide resistance was performed by the double disk method. Macrolide resistance genes [erm(B) and mef(A/E)] and the promoter of erm(B) were detected by PCR. Twenty-five different serotypes were detected of which 87% were non-PCV7 types. The percentages of resistance to erythromycin, clindamycin and tetracycline were 20%, 8.6% and 16%, respectively. A penicillin MIC ≥0.12 mg/L was observed in 14 of the 70 invasive pneumococci strains. The cefotaxime and ceftobiprole MIC(50)/MIC(90) of these 14 strains were 1/4 and 0.03/1 mg/L, respectively. Ceftobiprole showed higher in vitro activity than penicillin and cefotaxime with all isolates being inhibited by ≤1 mg/L. Its high in vitro activity should make ceftobiprole a very promising drug for the treatment of pneumococcal infections.

Activity of doripenem against extended-spectrum beta-lactamase-producing Enterobacteriaceae and Pseudomonas aeruginosa isolates.

The in vitro activity of doripenem was evaluated against a recent collection of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae and Pseudomonas aeruginosa isolates (201 ESBL-producing Enterobacteriaceae [153 Escherichia coli and 48 Klebsiella pneumoniae] and 201 P. aeruginosa). Comparator agents included amikacin, tobramycin, ciprofloxacin, cefepime, cefotaxime, ceftazidime piperacillin-tazobactam, imipenem, and meropenem. Both doripenem and meropenem inhibited 100% of the ESBL-producing Enterobacteriaceae at 4 microg/mL. Doripenem is active against ESBL-producing Enterobacteriaceae and P. aeruginosa isolates. Its activity is similar to that of meropenem and slightly better than that of imipenem. The results of this study suggest that doripenem could be an alternative therapeutic agent for infections caused by these organisms.

[Using information technology to improve drug safety in primary care]. / Uso de tecnologías de la información para mejorar la seguridad de la prescripción en Atención Primaria.

PURPOSE: To help family doctors to detect and prevent problems related to drug-drug interactions in order to attain a higher quality prescription and an improvement in patient safety. METHODS: Uncontrolled study of an intervention based on quality evaluation and improvement methods. SETTING: Two health areas in Murcia Region (Spain). PATIENTS: Subjects appointed to 139 family doctors regularly using electronic clinical records (including doctors who were producing over 100 electronic prescriptions per week: 188,953 subjects and 334.088 prescriptions at the start, and 202,988 subjects and 335.198 prescriptions at the end of study). INTERVENTION: (1) A software able to collect patients who had clinically important drug-drug interactions those that should be avoided (BOT I+II) was designed. (2) A report on these interactions was drawn up and delivered periodically to every single doctor, including patient identification and information on the drugs involved, possible consequences, and recommendations about what to do. (3) Clinical and educative sessions given by a trained pharmacist were carried out in doctors' health centre coinciding with their delivery. RESULTS: Drug-drug interactions pre-intervention: prevalence 1.29%; by patient at risk 6.57%; by doctor 20.2. Post-intervention: prevalence 1.06% (improvement 17.6%, P<.000001), by patient at risk 5.17% (improvement 21.4%, P<.000001), by doctor 17.7 (improvement 12.1, P<.001). CONCLUSIONS: Developing this technology leads to progress in patient safety, therefore it should be extended to all our family doctors. Other technologies such as an electronic alert when prescribing should be considered, particularly for either higher frequency or important consequences interactions.

Management of antibiotic-resistant Streptococcus pneumoniae infections and the use of pneumococcal conjugate vaccines.

The epidemiology of Streptococcus pneumoniae, a major cause of meningitis, pneumonia, bacteraemia and acute otitis media in both children and adults, has been altered by the availability of the seven-valent pneumococcal conjugate vaccine (PCV7) and selection pressure from broad-spectrum antibiotics. In Spain, the rates of antimicrobial consumption and resistance are high; of all S. pneumoniae isolates collected between 2001 and 2003, 9.2% were penicillin-resistant and 26.4% were penicillin-intermediate. These rates were even higher in children aged < or =4 years; 52.3% of isolates were penicillin-resistant or penicillin-intermediate. Serogroup 14 comprises nearly 9% of pneumococcal strains and exhibits the highest resistance to penicillin (69%). Since the introduction of PCV7 in Madrid, the isolates collected from hospitalized children aged <15 years from 21 hospitals revealed that only 8% of cases involving S. pneumoniae isolates were due to PCV7 serotypes, and no PCV7 vaccination failures were identified. These isolates demonstrated low rates of penicillin-non-susceptible and erythromycin-non-susceptible strains. Among multiresistant strains, serotype 19A was identified as most important. Although the recent WHO position paper on childhood immunizations speaks to the growing resistance of pneumococci, antibiotic resistance in Spain is noted to be decreasing and must be evaluated in conjunction with global studies.

[Vaccination schedule of the Spanish association of pediatrics: recommendations 2009]. / Calendario vacunal de la Asociación Española de Pediatría: Recomendaciones 2009.

Based on the available evidence, we, the Vaccine Advisory Committee (CAV) of the Spanish Association of Pediatrics (Asociación Española de Pediatría, AEP), provide information about and comments on vaccine-related innovation during 2008. Modifications to the Vaccine Schedule for 2009 are also discussed. The importance of the recommendation of administration of a varicella booster at start of school (3-4 years of age) is highlighted according to the technical specifications of one of the vaccines. The importance of making the heptavalent pneumococcal conjugate vaccine universally available is reiterated in accordance with the unquestionable results of scientific tests, WHO recommendations, the posture adopted by the majority of neighboring European countries, and the decision taken in 2006 by the autonomous community of Madrid (Spain). New scientific reasons are provided, corroborating the recommendation made by this committee in 2008, for the implementation by Spanish pediatricians of the vaccine against rotavirus and human papilloma virus. With regard to the latter, vaccination should be from 11 to 16 years of age, and then extended, in accordance with the technical specifications of the available vaccine preparations, to 26 years of age. As part of the recommendations, we insist that children in risk groups should be given flu vaccine and hepatitis A vaccine. The committee considers that these two vaccines must also be given, when pediatricians consider it appropriate, to children other than those in risk groups. This recommendation can be regarded as the first step towards a future recommendation of universal vaccination. Finally, this year we include an appendix with recommendations and vaccination strategies to be followed in children who have not previously received vaccines or who have not been completely immunized.

[In vitro activities of colistin combinations against Pseudomonas aeruginosa isolated from the intensive care unit]. / Actividad in vitro de terapia combinada con colistina frente a Pseudomonas aeruginosa aisladas en Unidad de Cuidados Intensivos.

Introduction. As the number of multidrug-resistant strains of Pseudomonas aeruginosa has risen in the intensive care unit (ICU) of the San Carlos Clinic Hospital, 12 consecutive isolates from different patients were collected to determine the possibility of an epidemic outbreak caused by the spread of a single strain. We determined the antimicrobial susceptibility to the most common agents used in the treatment of infections caused by this bacteria. The results of susceptibility studies suggest that different strains of P. aeruginosa are responsible for the respiratory tract infections in ICU. Methods. The clonal relationship between the isolates using was determined using BOX and ERIC primers by means of repetitive sequence-based polymerase chain reaction (rep-PCR). The in vitro activity of these strains against colistin, rifampicin, doxicycline and azythromycin was studied to determine in which cases the combination of colistin with any of the other three antibiotics was synergistic. Results. Sensitivity studies point out the presence of several strains of P. aeruginosa as the causal agents of respiratory infections produced by this microorganism in the ICU. Combinations of colistin with doxycicline and colistin with azithromycin were synergistic for some isolates in the synergy studies. Discussion. Clonal studies reveal the presence of five different clones among our isolates. Therefore we can conclude that there was no outbreak of P. aeruginosa in the ICU. Synergistic activity of combinations of colistin plus azithromycin, colistin plus doxicycline and colistin plus rifampicin was less than expected and a high percentage of indifferent results was observed.

[Why are pediatric empyemas on the increase in Spain?]. / Por qué hay más empiemas pediátricos en España?

There is a widespread perception among Spanish pediatricians that the incidence of empyema has significantly increased in the last few years, even though the objective information available is limited, and there is no specific active epidemiological surveillance system for this condition. In the present article, we review the situation of empyema in Spain, and discuss the main hypotheses put forward in the international literature to explain this increase, as well as the limitations of the sources available. Despite the scarcity of information, we draw the following conclusions: 1) the incidence of pediatric empyema is increasing in Spain, both generally and when caused by pneumococcus in particular; 2) the reason for this increase remains unknown, and to date no firm link has been established between this phenomenon and the heptavalent conjugate pneumococcal vaccine; and 3) this situation justifies the establishment of prospective systems for the surveillance and control of empyema and, once again, highlights the importance of developing active surveillance systems for pneumococcal disease.

[Criteria for including vaccines in the immunization schedule of the Spanish Association of Pediatrics]. / Criterios de inclusión de vacunas en el calendario de la Asociación Española de Pediatría.

The Vaccine Advisory Committee of the Spanish Association of Pediatrics analyzes and discusses the criteria followed when preparing their yearly Recommended Immunization Schedule for children and adolescents. The relative importance of each criterion in the final recommendation is assessed. Following a review of the current state of affairs of childhood immunization in Spain and of the crucial role played by pediatricians, some reflections are presented on the problems derived from the vaccines recommended by this Committee but not covered by the national health system. Suggestions are made for individual pediatricians who may need to establish specific priorities in the recommendation of these vaccines.