Evolution of appraisal tool usage preferences in PROSPERO records: a study of non-Cochrane systematic reviews.

OBJECTIVES: This research-on-research substudy uses a data-driven approach to investigate the range of appraisal tools in non-Cochrane systematic reviews and meta-analyses registered in the International Prospective Register of Systematic Reviews (PROSPERO). STUDY DESIGN AND SETTING: A comprehensive web scraping of all completed non-Cochrane registrations in PROSPERO from February 2011 to December 2017 was performed. The focus was classifying the appraisal tools based on study type, assessment aspects, and research topics. RESULTS: After analyzing 17,708 complete records, we found a predominant use of methodological quality assessment tools compared to those for reporting quality or risk of bias (RoB). This indicates a greater emphasis on methodological rigor in the studied protocols. Various tools for assessing methodological quality were observed, reflecting the complexity of such evaluations. Instruments designed for evaluating methodological or reporting quality were mainly intended for non-randomized clinical trials or observational studies, unlike RoB tools more commonly used in randomized clinical trials. No distinct trends in tool usage were observed in specific research conditions or domains, suggesting that tool choice is influenced more by study design than research topic. CONCLUSION: This study provides insights into the preferential use of various assessment tools in conducting non-Cochrane systematic reviews, as evidenced in PROSPERO records. The findings reveal various methodological assessment tools, underscoring their versatility across different study designs and research areas.

Relationships between abstract features and methodological quality explained variations of social media activity derived from systematic reviews about psoriasis interventions.

OBJECTIVES: The aim of this study was to describe the relationship among abstract structure, readability, and completeness, and how these features may influence social media activity and bibliometric results, considering systematic reviews (SRs) about interventions in psoriasis classified by methodological quality. STUDY DESIGN AND SETTING: Systematic literature searches about psoriasis interventions were undertaken on relevant databases. For each review, methodological quality was evaluated using the assessing the methodological quality of systematic reviews tool. Abstract extension, structure, readability, and quality and completeness of reporting were analyzed. Social media activity, which consider Twitter and Facebook mention counts, as well as Mendeley readers and Google scholar citations were obtained for each article. Analyses were conducted to describe any potential influence of abstract characteristics on review's social media diffusion. RESULTS: We classified 139 intervention SRs as displaying high/moderate/low methodological quality. We observed that abstract readability of SRs has been maintained high for last 20 years, although there are some differences based on their methodological quality. Free format abstracts were most sensitive to the increase of text readability as compared with more structured abstracts (Introduction, Methods, Results, and Discussion or eight headings), yielding opposite effects on their quality and completeness depending on the methodological quality: a worsening in low quality reviews and an improvement in those of high quality. Both readability indices and preferred reporting items of systematic reviews and meta-analyses for Abstract total scores showed an inverse relationship with social media activity and bibliometric results in high methodological quality reviews but not in those of lower quality. CONCLUSION: Our results suggest that increasing abstract readability must be specially considered when writing free format summaries of high-quality reviews because this fact correlates with an improvement of their completeness and quality, and this may help to achieve broader social media visibility and article usage.

Systematic reviews and meta-analyses on psoriasis: role of funding sources, conflict of interest and bibliometric indices as predictors of methodological quality.

BACKGROUND: The quality of systematic reviews and meta-analyses on psoriasis, a chronic inflammatory skin disease that severely impairs quality of life and is associated with high costs, remains unknown. OBJECTIVES: To assess the methodological quality of systematic reviews published on psoriasis. METHODS: After a comprehensive search in MEDLINE, Embase and the Cochrane Database (PROSPERO: CDR42016041611), the quality of studies was assessed by two raters using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Article metadata and journal-related bibliometric indices were also obtained. Systematic reviews were classified as low (0-4), moderate (5-8) or high (9-11) quality. A prediction model for methodological quality was fitted using principal component and multivariate ordinal logistic regression analyses. RESULTS: We classified 220 studies as high (17·2%), moderate (55·0%) or low (27·8%) quality. Lower compliance rates were found for AMSTAR question (Q)5 (list of studies provided, 11·4%), Q10 (publication bias assessed, 27·7%), Q4 (status of publication included, 39·5%) and Q1 (a priori design provided, 40·9%). Factors such as meta-analysis inclusion [odds ratio (OR) 6·22; 95% confidence interval (CI) 2·78-14·86], funding by academic institutions (OR 2·90, 95% CI 1·11-7·89), Article Influence score (OR 2·14, 95% CI 1·05-6·67), 5-year impact factor (OR 1·34, 95% CI 1·02-1·40) and article page count (OR 1·08, 95% CI 1·02-1·15) significantly predicted higher quality. A high number of authors with a conflict of interest (OR 0·90, 95% CI 0·82-0·99) was significantly associated with lower quality. CONCLUSIONS: The methodological quality of systematic reviews published about psoriasis remains suboptimal. The type of funding sources and author conflicts may compromise study quality, increasing the risk of bias.

Short-term efficacy and safety of new biological agents targeting the interleukin-23-T helper 17 pathway for moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis.

A new generation of biologics targeting the interleukin-23-T helper 17 pathway has been developed. This study aimed to assess the short-term effectiveness and safety of these new agents using a network meta-analysis. Twenty-seven randomized clinical trials (10 629 patients) were identified by a comprehensive systematic literature review (PROSPERO 2015: CRD42015025472). Quality of evidence was assessed following Cochrane-compliant rules and the Grading of Recommendations, Assessment, Development and Evaluations approach. Efficacy and safety outcomes at weeks 10-16 were compared using a random-effects network meta-analysis within a frequentist framework to estimate pooled odds ratios (ORs) of direct and indirect comparisons among the therapeutic options. There were six direct drug-to-drug comparisons in the network, with a high degree of consistency between the direct and indirect evidence. From the available evidence, infliximab 5 mg kg-1 every 8 weeks [OR 118·89, 95% confidence interval (CI) 60·91-232·04] and secukinumab 300 mg every 4 weeks (OR 87·07, 95% CI 55·01-137·82) are shown to be among the most effective short-term treatments, but are ranked as the biologics most likely to produce any adverse event or an infectious adverse event, respectively. Ustekinumab 90 mg every 12 weeks, the third most efficacious treatment (OR 73·67, 95% CI 46·97-115·56), was the only agent that did not show increased risk of adverse events compared with placebo. Treatment recommendations should also consider long-term outcomes and costs.

Efecto de un sistema automático de dispensación de medicamentos sobre el gasto farmacéutico y el grado de satisfacción del usuario / An automatic dispensing system medications effect in pharmaceutical expenditure and satisfaction user level

Objetivo: Evaluar en términos económicos el efecto de la sustitución de botiquines tradicionales por la implantación de Sistemas Automáticos de Dispensación de Medicamentos en la Unidad de Cuidados Intensivos. Analizar el grado de aceptación de dicho cambio por parte de los usuarios. Método: Para el análisis económico, se consideraron los costes directos e indirectos tangibles, derivados de la implantación: inversión inicial de capital, coste del personal implicado, coste en política de consumo de medicamentos. Todos estos aspectos se evaluaron antes y después de la implantación. El grado de satisfacción de los usuarios se evaluó a través de un cuestionario estandarizado. Resultados: Tras la estimación de los costes, comprobamos que el gasto realizado en la inversión inicial se verá rápidamente compensado fundamentalmente por el coste referido a la política de consumos de medicamentos con una reducción del 24% con respecto al sistema de dispensación anterior. El coste en el capitulo de personal también se ve reducido un 11%, así como el coste/estancia y coste/ingreso que disminuyen un 26% y 30% respectivamente en relación al sistema anterior. La evaluación del cuestionario reveló que los usuarios están satisfechos con la implantación y un 84% del personal de enfermería lo recomendaría a otras unidades. Conclusiones: Los Sistemas Automáticos de Dispensación de Medicamentos constituyen una nueva herramienta tecnológica para el control del gasto farmacéutico, con buena aceptación por parte de los usuarios (AU)

Objective: To evaluate in economic terms, the effect of replacing traditional kits for the implementation of automated dispensing of medications in the Intensive Care Unit. Analyze the degree of acceptance of such changeon the part of users. Method: For the economic analysis is considered tangible direct and indirect costs resulting from the implementation: initial capital investment, cost of staff involved, the political cost of drug consumption. All these aspects were evaluated before and after implantation. The degree of user satisfaction was assessed using a standardized questionnaire. Results: After the estimation of costs, we found that the expenditure incurred on the initial investment will be quickly offset by the cost mainly referred to the politics of consumption of drugs with a reduction of 24% over the previous delivery system. The cost in personal chapter is also reduced by 11%, and the cost per stay and cost / income fell by 26% and 30% respectively over the previous system. The evaluation questionnaire revealed that users are satisfied with the implementation and 84% of nurses would recommend it to other units. Conclusions: Automated Dispensing Systems Drugs are a new technological tool to control drug spending, with good acceptance by users (AU)

[Pharmacogenetic analysis of the absorption kinetics of cyclosporine in a population of Spanish cardiac transplant patients]. / Análisis farmacogenético de la cinética de absorción de ciclosporina en una población española de pacientes trasplantados cardíacos.

OBJECTIVE: To determine how single nucleotide polymorphisms located on genes MDR1, CYP3A4 and CYP3A5 affect the absorption kinetics of cyclosporine in cardiac transplant patients. METHOD: We selected a sample of 30 adult patients having previously undergone a primary cardiac transplant and who had received cyclosporine as an immunosuppressant. During the first month after the transplant, we performed a pharmacokinetic study of each patient to determine values in the cyclosporine concentration area under the 12-hour curve, steady-state cyclosporine concentration, maximum cyclosporine concentration, and time to reach that concentration. Single nucleotide polymorphisms were genotyped in all patients: MDR1 3435C > T, CYP3A4-390A > G and CYP3A5 6986A > G. RESULTS: Being a carrier of the T-allele for polymorphism MDR1 3435C > T is associated with higher values in the cyclosporine concentration area under the 12-hour curve (p = 0.01) and in steady-state cyclosporine concentration (p = 0.05), compared with those from patients who do not carry that allele. DISCUSSION: Our results show that genotype differences in MDR1 3435C > T can explain part of the variability in cyclosporine absorption among individuals in the population of Spanish cardiac transplant recipients.

Análisis farmacogenético de la cinética de absorción de ciclosporina en una población española de pacientes trasplantados cardíacos / Pharmacogenetic analysis of the absorption kinetics of cyclosporine in a population of Spanish cardiac transplant patients

Objetivo: Determinar el papel de polimorfismos de nucleótido único localizados en los genes MDR1, CYP3A4 y CYP3A5 sobre la cinética de absorción de ciclosporina en pacientes trasplantados cardíacos. Método: Se seleccionó una muestra de 30 pacientes adultos sometidos a un primer trasplante de corazón que habían recibido ciclosporina como tratamiento inmunosupresor. En el primer mes después del trasplante se realizó un estudio farmacocinético a cada paciente para determinar los valores del área de concentración de ciclosporina bajo la curva de 12 h, concentración de ciclosporina en estado de equilibrio, concentración de ciclosporina máxima y el tiempo en alcanzar dicha concentración. En todos los pacientes se genotipificaron los polimorfismos de nucleótido único: MDR1 3435C > T, CYP3A4-390A > G y CYP3A5 6986A > G. Resultados: Ser portador del alelo T para el polimorfismo MDR1 3435C > T se asoció a valores mayores de área de concentración de ciclosporina bajo la curva de 12 h (p = 0,01) y de concentración de ciclosporina en estado de equilibrio (p = 0,05), en comparación con los pacientes no portadores de dicho alelo. Discusión: Nuestros resultados muestran que las diferencias genotípicas de MDR1 3435C > T podrían explicar parte de la variabilidad interindividual en la absorción de la ciclosporina en la población española de trasplantados cardíacos (AU)

Objective: To determine how single nucleotide polymorphisms located on genes MDR1, CYP3A4 and CYP3A5 affect the absorption kinetics of cyclosporine in cardiac transplant patients. Method: We selected a sample of 30 adult patients having previously undergone a primary cardiac transplant and who had received cyclosporine as an immunosuppressant. During the first month after the transplant, we performed a pharmacokinetic study of each patient to determine values in the cyclosporine concentration area under the 12-hour curve, steady-state cyclosporine concentration, maximum cyclosporine concentration, and time to reach that concentration. Single nucleotide polymorphisms were genotyped in all patients: MDR1 3435C > T, CYP3A4-390A > G and CYP3A5 6986A > G. Results: Being a carrier of the T-allele for polymorphism MDR1 3435C > T is associated with higher values in the cyclosporine concentration area under the 12-hour curve (p = 0.01) and in steady-state cyclosporine concentration (p = 0.05), compared with those from patients who do not carry that allele. Discussion: Our results show that genotype differences in MDR1 3435C > T can explain part of the variability in cyclosporine absorption among individuals in the population of Spanish cardiac transplant recipients (AU)

14-Base pair polymorphism of human leukocyte antigen-G as genetic determinant in heart transplantation and cyclosporine therapy monitoring.

The 14-base pair (bp) polymorphism within the HLA-G gene has been investigated in heart transplant patients for the first time. The 14-bp polymorphism is associated with HLA-G mRNA stability and the patterns of alternative isoforms splicing, and therefore may influence the functionality of the HLA-G molecule. In heart transplantation, the highest production of soluble HLA-G was related to the -14/-14-bp genotype in the pre- and post-transplantation periods. Our study findings showed that the 14-bp polymorphism of the HLA-G gene influenced the expression of soluble HLA-G in heart transplantation and accordingly resulted in low rejection rates, being a possible marker of genetic variability associated with heart transplantation. In addition, the 14-bp polymorphism of the HLA-G gene is related to the absorber status of cyclosporine of each individual patient, and is useful for determining the oral dose of cyclosporine to manage patients (to adjust immunosuppressive protocols) so as to minimize the risk of a low or high immunosuppression and the side effects in the early stages of heart transplantation.

Validación farmacéutica y detección de errores de prescripción de antineoplásicos en pacientes oncohematológicos / Pharmaceutical validation and error detection in the prescription of antineoplastics in oncohematological patients

Objetivo: Identificar los distintos tipos de error de prescripción de citostáticos en pacientes oncohematológicos adultos y pediátricos de nuestro hospital y proponer estrategias de mejora. Métodos: Estudio observacional longitudinal prospectivo en el que se validaron las prescripciones médicas de antineoplásicos procedentes de Hematología y Oncohematología Pediátrica durante 15 me ses. Se clasificaron los tipos de error atendiendo a la terminología y taxonomía publicadas por Otero et al en el documento "Errores de medicación: estandarización de la terminología y clasificación", recogiéndose 11 variables. Entre otros parámetros se determinaron: porcentaje de error global, por tipo de prescripción y servicios, así como de intervención farmacéutica y grado de aceptación. Resultados: Se detectaron un total de 92 errores correspondientes al 1,4% del total de prescripciones, y los de mayor frecuencia fueron: dosificación incorrecta (28,2%), duración incorrecta (21,7%) y volumen y/o vehículo inadecuados (16,3%). Además se detectó una orden de tratamiento de un paciente pediátrico alérgico al citostático prescrito. El 81,8% de órdenes con error se prescribieron de forma manual. En Hematología se obtuvo un 0,9% de error y en Oncohematología Pediátrica un 3,5%. Tanto el índice de intervención farmacéutica como su grado aceptación fueron del 100% (AU)

Objective: To identify the different types of cytostatic prescription errors in adult and paediatric oncohematological patients in our hospital and to propose strategies for improvement. Methods: Longitudinal, prospective, observational study in which prescriptions for antineoplastics from the haematology and paediatric oncohaematology departments were validated over a 15-monthperiod. The types of error were classified in accordance with the terminology and taxonomy published by Otero and cols in the document “Medication errors: standardisation of terminology and classification”. Eleven variables were recorded. Amongst other parameters, the following were determined: percentage of overall error, percentage of error in type of prescription, percentage of service error, percentage of pharmaceutical intervention and level of acceptance. Results: A total of 92 errors were recorded which corresponded to1.4% of the total prescriptions. The most significant errors were: incorrect dose (28.2%), incorrect duration (21.7%), incorrect volume and/or inadequate vehicle (16.3%), and in one case a prescription was made up where the patient was allergic to the specific cytostatic drug prescribed. 81.8% of prescription errors were made manually. In the haematology department a 0.9% error was recorded, as was a3.5% error in paediatric oncohaematology. Both the rate of pharmaceutical intervention and its level of acceptance were 100% (AU)

[Pharmaceutical validation and error detection in the prescription of antineoplastics in oncohematological patients]. / Validación farmacéutica y detección de errores de prescripción de antineoplásicos en pacientes oncohematológicos.

OBJECTIVE: To identify the different types of cytostatic prescription errors in adult and paediatric oncohematological patients in our hospital and to propose strategies for improvement. METHODS: Longitudinal, prospective, observational study in which prescriptions for antineoplastics from the haematology and paediatric oncohaematology departments were validated over a 15-month period. The types of error were classified in accordance with the terminology and taxonomy published by Otero and cols in the document "Medication errors: standardisation of terminology and classification". Eleven variables were recorded. Amongst other parameters, the following were determined: percentage of overall error, percentage of error in type of prescription, percentage of service error, percentage of pharmaceutical intervention and level of acceptance. RESULTS: A total of 92 errors were recorded which corresponded to 1.4% of the total prescriptions. The most significant errors were: incorrect dose (28.2%), incorrect duration (21.7%), incorrect volume and/or inadequate vehicle (16.3%), and in one case a prescription was made up where the patient was allergic to the specific cytostatic drug prescribed. 81.8% of prescription errors were made manually. In the haematology department a 0.9% error was recorded, as was a 3.5% error in paediatric oncohaematology. Both the rate of pharmaceutical intervention and its level of acceptance were 100%.

[Stability and in vitro activity of voriconazole eyedrops at a concentration of 3 microg/mL]. / La estabilidad y actividad in vitro de voriconazol en colirio a una concentración de 3 microg/mL.

OBJECTIVE: To assess the stability and activity of voriconazole 3 microg/mL eyedrops as prepared for use against amphotericin B- and fluconazole-resistant fungal endophthalmitis. METHOD: Stability (concentration using UV-spectrophotometry; pH, osmolarity, and particle formation) and sterility were analyzed under various preservation conditions--room temperature (22-24 degrees C) or refrigerated (2-8 degrees C). The preparation's in vitro efficacy was analyzed using the standard National Committee for Clinical Laboratory Standards method for 30 days. RESULTS: Voriconazole concentrations were found to be within limits allowed by the United Stated Pharmacopeia (90-115%). pH (room temperature: 6.96-7.60; refrigerated: 6.84-7.21) and osmolarity (room temperature: 265-284 mOsm/l; refrigerated: 270-285 mOsm/l) remained within eye physiological ranges throughout the study under the analyzed conditions. The preparation s antifungal activity remained stable during the first three weeks. CONCLUSIONS: The voriconazole 3 microg/mL eyewash preparation remained stable, sterile and with full antifungal activity for 21 days when stored both at room temperature and under refrigeration conditions.

Estabilidad y actividad in vitro de voriconazol en colirio a una concentración de 3 µg/mL / Stability and in vitro activity of voriconazole eyedrops at a concentrations of 3 mg/mL

Objetivo: Evaluar la estabilidad y actividad de un colirio devoriconazol 3 µg/mL, preparado para su uso en endoftalmitis fúngicasresistentes a anfotericina B y fluconazol.Método: Se analizaron la estabilidad (concentración medianteespectrofotometría-UV; pH, osmolaridad y aparición de partículas)y la esterilidad bajo condiciones de conservación diferentes:temperatura ambiente (22-24 °C) o refrigerado (2-8 °C) y la eficaciain vitro del preparado, mediante el método estándar delNacional Committee for Clinical Laboratory Standards duranteun periodo de 30 días.Resultados: Las concentraciones de voriconazol se encontrarondentro de los márgenes permitidos por la United StatesPharmacopeia (90-115%). El pH (ambiente 6,96-7,60; refrigerado:6,84-7,21) y la osmolaridad (ambiente: 265-284 mOsm/l;refrigerado: 270-285 mOsm/l) se mantuvieron en los intervalosfisiológicos para el ojo, a lo largo de todo el estudio en las doscondiciones analizadas. La actividad antifúngica del colirio permanecióestable durante las tres primeras semanas.Conclusiones: El colirio preparado de voriconazol 3 µg/mLpermanece estable, estéril y con plena actividad antifúngica durante21 días cuando se almacena tanto a temperatura ambientecomo en refrigeración

Objective: To assess the stability and activity of voriconazole3 µg/mL eyedrops as prepared for use against amphotericin Bandfluconazole-resistant fungal endophthalmitis.Method: Stability (concentration using UV-spectrophotometry;pH, osmolarity, and particle formation) and sterility were analyzedunder various preservation conditions – room temperature(22-24 °C) or refrigerated (2-8 °C ). The preparation's in vitroefficacy was analyzed using the standard National Committee forClinical Laboratory Standards method for 30 days.Results: Voriconazole concentrations were found to be withinlimits allowed by the United Stated Pharmacopeia (90-115%). pH(room temperature: 6.96-7.60; refrigerated: 6.84-7.21) andosmolarity (room temperature: 265-284 mOsm/l; refrigerated:270-285 mOsm/l) remained within eye physiological rangesthroughout the study under the analyzed conditions. The preparation'santifungal activity remained stable during the first threeweeks.Conclusions: The voriconazole 3 µg/mL eyewash preparationremained stable, sterile and with full antifungal activity for 21days when stored both at room temperature and under refrigerationconditions