Applicability of Outpatient Quality Indicators for Appropriate Antibiotic Use in a Primary Health Care Area: a Point Prevalence Survey.

The ability to measure the quality of antibiotic prescriptions is a critical element in all antimicrobial stewardship programs. The aims of the present study were to evaluate the clinimetric properties of 32 recently developed outpatient quality indicators (OQIs) and to identify potential room for improvement in antibiotic use in a primary health care (PHC) area. The study was performed in a PHC area in Barcelona, Spain with 260,657 inhabitants, nine PHC centers, and a 400-bed acute-care teaching hospital. We selected 9 of the 32 OQIs that were applicable to our PHC area and evaluated them for measurability, adherence, and room for improvement. Nonmeasurable OQIs, OQIs without room for improvement, and OQIs beyond the scope of the PHC antimicrobial stewardship program were excluded. Data from 260,561 registered patients were assessed. Measurability was high for all OQIs except those that required manual recording of the clinical diagnosis (OQIs on group A streptococcal diagnostic testing). Adherence to guidelines was poor for most OQIs, but particularly for the indicator on the avoidance of antibiotics for viral or self-limiting bacterial infections, where we observed more than 60% room for improvement for both acute tonsillitis and sinusitis. The QIs evaluated were applicable to clinical practice and proved useful for identifying areas with room for improvement in our setting and for guiding the design of future interventions with specific objectives.

Assessment of Quality Indicators for Appropriate Antibiotic Use.

One of the critical elements of antimicrobial stewardship programs is the ability to measure the quality of antibiotic prescriptions. The aims of the present study were to evaluate the performance properties of a set of previously developed quality indicators (QIs) and to identify the potential room for improvement in antibiotic use in our setting. A monthly cross-sectional point prevalence survey was conducted in a 400-bed acute care teaching hospital, from June to November 2015. All adult patients treated for ≥24 hours with antibiotic therapy for a suspected hospital- or community-acquired bacterial infection were included. Performance scores (adherence, room for improvement, interobserver reliability, and applicability) were calculated for 8 QIs. A total of 362 patients were evaluated. Adherence to the whole set of QIs was accomplished for 14.1% of evaluable patients. The QIs with greater room for improvement were adequate request for blood cultures (60.6%), therapeutic drug monitoring (TDM) (59.1%), sequential antibiotic therapy within 72 hours (48.2%), and empirical antibiotic therapy according to local guidelines (30.4%). The percentage of patients receiving unnecessary antibiotic treatment in the absence of clinical or microbiological evidence of infection after 5 days was 12.2%. All indicators scored kappa values of ≥0.6, suggesting good interobserver reliability. Low applicability (6.1% of reviewed patients) was found only for the TDM QI. The QIs analyzed were found to be applicable, showed good interobserver reliability, and were useful tools to identify areas with potential room for improvement in antibiotic use.

Impact of a Multifaceted Antimicrobial Stewardship Intervention in a Primary Health Care Area: A Quasi-Experimental Study.

The aim of the study was to evaluate the impact of a multifaceted antimicrobial stewardship intervention on antibiotic consumption in a primary health care (PHC) area in Spain. Quasi-experimental study conducted in a PHC area with nine PHC centers, a 400-bed acute care teaching hospital, and 18 nursing homes serving a population of 260,561. The intervention was based on the 2016 CDC Core Elements of Outpatient Antibiotic Stewardship publication and targeted 130 PHC physicians, 41 PHC pediatricians, 19 emergency physicians, and 18 nursing home physicians. The components were commitment, actions for improving antibiotic prescribing, tracking and feedback, and education and experience. The primary outcome was overall antibiotic consumption. Secondary outcomes were consumption of antibiotics to treat pharyngotonsillitis, acute otitis media, acute sinusitis, acute bronchitis, and urinary tract infection (UTI), percentage of patients treated with specific antibiotics, and dispensing costs. Consumption was measured in defined daily doses per 1,000 inhabitants per day (DID) and compared pre- and postintervention (2016 vs. 2018). Overall antibiotic consumption decreased from 16.01 to 13.31 DID (-16.85%). Consumption of amoxicillin/clavulanic acid and quinolones decreased from 6.04 to 4.72 DID (-21.88%) and 1.64 to 1.23 DID (-25.06%), respectively. The percentage of patients treated with antibiotics decreased from 26.99 to 22.41%. The intervention resulted in cost savings of €72,673. Use of antibiotics to treat pharyngotonsillitis, UTI, and acute otitis media, sinusitis, and bronchitis decreased significantly. Our antimicrobial stewardship program led to a decrease in antibiotic consumption and significantly improved the use of antibiotics for the most prevalent PHC infections.

[Impact of the economic crisis on the activity of a clinical research ethics committee]. / Impacto de la crisis económica en la actividad de un comité ético de investigación clínica.

PURPOSE: Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT) and observational studies (ES) from the activity of an Research Ethics Committee (REC). METHOD: REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1) promoted by pharmaceutical industry, 2) by scientific societies with industry support, 3) by scientific societies with government support and 4) unfunding.Two periods were compared: pre-crisis (2003-2007) and crisis (2008-2012). RESULTS: During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. CONCLUSIONS: Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS.

Objetivos: Analizar el impacto de la crisis económico-social en volumen y financiación de los ensayos clínicos (EC) y estudios observacionales (EO) a partir de la actividad de un Comité Ético de Investigación Clínica (CEIC). Método: Se revisaron las memorias del CEIC desde 2003 hasta 2012. Se analizó la financiación de los EC y los EO clasificándolos en cuatro grupos: 1) promovidos por la industria farmacéutica, 2) por sociedades científicas con soporte de la industria, 3) por sociedades apoyadas por las administraciones públicas y 4) sin financiación. Se compararon dos períodos: precrisis (2003- 2007) y crisis (2008-2012). Resultados: Se evaluaron 744 protocolos: un 71% del grupo 1, un 9% del grupo 2, un 3% del grupo 3 y un 17% carecía de financiación. En cuanto a los EO, un 40%, un 5,4%, un 8,6% y un 46% correspondían a los grupos 1, 2, 3 y 4 respectivamente. Analizando periodo crisis versus precrisis, se observaron diferencias estadísticamente significativas en el número de los EC de fase 2 y fase 3 que disminuyeron y en los EO que aumentaron. En el periodo crisis respecto al precrisis, el Grupo 4 aumentó de manera estadísticamente significativa. Conclusiones: La evolución del número total de estudios evaluados por el CEIC tiende a mantenerse e incluso incrementarse en el tiempo. El CEIC mantiene su actividad e incluso la incrementa, a expensas de EO con y sin financiación.