Quality assessment of clinical practice guidelines for chronic kidney disease : A systematic review

Chronic kidney disease (CKD) is a worldwide public health problem. Clinical practice guidelines (CPGs) are being developed and implemented in order to improve clinical practice related to the detection and treatment of CKD. The objective of our study was to evaluate the quality of CPGs regarding the CKD and to examine whether there are factors which influence their quality. A systematic search was conducted to identify all CPGs regarding the early diagnosis and treatment of CKD. The CPGs quality were evaluated by three reviewers using the AGREE II instrument to decide if the guidelines are recommended for their use in clinical practice. In total, 13 CPGs were identified: five from America, six from Europe, one from Asia, and one from Oceania. Five CPGs were recommended for their use in clinical practice; since all their domains achieved the medium or high category. Furthermore, six CPGs were recommended with modifications, as the stakeholders' involvement, applicability, and editorial independence domains were evaluated as low category. These domains, as well as the rigor of the development domain, reached the very low category in those CPGs that were not recommended for its use in clinical practice. In all CPGs, the domains with the lowest average were the stakeholder involvement and the applicability. When comparing the domains of the CPGs according to the origin, type of developer group, the checklist used during the development and the publication period, a significantly higher average in the domain stakeholder involvement was found in the CPGs from Asia and Oceania compared to the ones in Latin America. Additionally, a significantly higher average in the applicability domain was found in the CPGs developed by CPGs developer organizations compared to those developed by medical societies. In total, 85% of the CPGs regarding CKD were recommended or recommended with modifications. The stakeholder involvement and applicability domains are assessed in the low category, which might affect the CPGs implementation. In order to save resources in low- and middle-income countries, an adaptation of the recommended CPGs should be considered

Basal procalcitonin, C-reactive protein, interleukin-6, and presepsin for prediction of mortality in critically ill septic patients: a systematic review and meta-analysis

Biomarkers; Mortality; SepsisBiomarcadores; Mortalidad; SepsisBiomarcadors; Mortalitat; SèpsiaBackground Numerous biomarkers have been proposed for diagnosis, therapeutic, and prognosis in sepsis. Previous evaluations of the value of biomarkers for predicting mortality due to this life-threatening condition fail to address the complexity of this condition and the risk of bias associated with prognostic studies. We evaluate the predictive performance of four of these biomarkers in the prognosis of mortality through a methodologically sound evaluation. Methods We conducted a systematic review a systematic review and meta-analysis to determine, in critically ill adults with sepsis, whether procalcitonin (PCT), C-reactive protein (CRP), interleukin-6 (IL-6), and presepsin (sCD14) are independent prognostic factors for mortality. We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to March 2023. Only Phase-2 confirmatory prognostic factor studies among critically ill septic adults were included. Random effects meta-analyses pooled the prognostic association estimates. Results We included 60 studies (15,681 patients) with 99 biomarker assessments. Quality of the statistical analysis and reporting domains using the QUIPS tool showed high risk of bias in > 60% assessments. The biomarker measurement as a continuous variable in models adjusted by key covariates (age and severity score) for predicting mortality at 28–30 days showed a null or near to null association for basal PCT (pooled OR = 0.99, 95% CI = 0.99–1.003), CRP (OR = 1.01, 95% CI = 0.87 to 1.17), and IL-6 (OR = 1.02, 95% CI = 1.01–1.03) and sCD14 (pooled HR = 1.003, 95% CI = 1.000 to 1.006). Additional meta-analyses accounting for other prognostic covariates had similarly null findings. Conclusion Baseline, isolated measurement of PCT, CRP, IL-6, and sCD14 has not been shown to help predict mortality in critically ill patients with sepsis. The role of these biomarkers should be evaluated in new studies where the patient selection would be standardized and the measurement of biomarker results.Instituto de Salud Carlos III, Spain and European Union (“Fondo Europeo de Desarrollo Regional, Una manera de hacer Europa”), grant number [PI 19/0048]

Desfibrilador automático implantable para prevención primaria de la muerte súbita cardíaca en España: eficacia, seguridad y eficiencia

Desfibrilador automático implantable; Muerte súbita cardíaca; Prevención primariaImplantable cardioverter defibrillator; Sudden cardiac death; Primary preventionDesfibril·lador automàtic implantable; Mort sobtada cardíaca; Prevenció primàriaInforme que té com a objectius analitzar nova evidència disponible i conèixer el valor actual del cost-utilitat del DAI, més el tractament mèdic convencional (TMC) enfront de TMC per a prevenció primària d’arrítmies cardíaques des de la perspectiva del Sistema Nacional de Salut (SNS).Report that report that aims to analyze new available evidence and to know the current value of the cost-utility of the Implantable Cardioverter Defibrillator (ICD) plus Conventional Medical Treatment (CCT) versus CCT for primary prevention of cardiac arrhythmias from the perspective of the Spanish National Health System (SNS).Informe que tiene como objetivo analizar nueva evidencia disponible y conocer el valor actual del coste-utilidad del Desfibrilador Automático Implantable (DAI) más Tratamiento Médico Convencional (TMC) frente a TMC para prevención primaria de arritmias cardiacas desde la perspectiva del Sistema Nacional de Salud (SNS)

Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights

Composite endpoints; Correlation; Sample sizePuntos finales compuestos; Correlación; Tamaño de la muestraPunts finals compostos; Correlació, Grandària de la mostraBackground The real impact of the degree of association (DoA) between endpoint components of a composite endpoint (CE) on sample size requirement (SSR) has not been explored. We estimate the impact of the DoA between death and acute myocardial infarction (AMI) on SSR of trials using use the CE of major adverse cardiac events (MACE). Methods A systematic review and quantitative synthesis of trials that include MACE as the primary outcome through search strategies in MEDLINE and EMBASE electronic databases. We limited to articles published in journals indexed in the first quartile of the Cardiac & Cardiovascular Systems category (Journal Citation Reports, 2015–2020). The authors were contacted to estimate the DoA between death and AMI using joint probability and correlation. We analyzed the SSR variation using the DoA estimated from RCTs. Results Sixty-three of 134 publications that reported event rates and the therapy effect in all component endpoints were included in the quantitative synthesis. The most frequent combination was death, AMI, and revascularization (n = 20; 31.8%). The correlation between death and AMI, estimated from 5 trials¸ oscillated between − 0.02 and 0.31. SSR varied from 14,602 in the scenario with the strongest correlation to 12,259 in the scenario with the weakest correlation; the relative impact was 16%. Conclusions The DoA between death and AMI is highly variable and may lead to a considerable SSR variation in a trial including MACE.Intramural CIBER-ESP PR22 from the Center for Biomedical Research in Epidemiology and Public Health Network (CIBERESP)

Breast Cancer Screening Coverage with clinical examination and Mammography Among insured women in Bogota

Objetivo: Determinar la cobertura de examen clínico y mamografía de tamización para cáncer de mama en un grupo de mujeres bogotanas afiliadas a seguros de salud. Métodos: Se realizó una encuesta telefónica a 4.526 mujeres entre 50 y 69 años, residentes en Bogotá y en municipios vecinos, afiliadas a tres compañías de seguros de salud. Se excluyeron las mujeres con antecedente personal de cáncer de mama. La cobertura de tamización se valoró como la proporción de mujeres con antecedente de mamografía y examen clínico de la mama. Se estimó la frecuencia en la vida, en los últimos dos años y en el último año. Se analizaron factores asociados a la práctica de tamización, mediante el cálculo de OR ajustados. Resultados: La frecuencia de vida de uso del examen clínico y mamografía fue de 59,3% y 79,8% respectivamente; el 49,7% y el 65,6% de las mujeres se realizó los exámenes con fines de tamización; el resto, con fines diagnósticos (sintomáticas). El 34,2% tenía examen clínico en el último año, y el 54%, mamografía en los últimos dos años. La educación y el antecedente familiar de cáncer de mama estuvieron asociados a la práctica de tamización. Conclusiones: La cobertura de examen clínico de la mama como método de tamización es baja. Las coberturas de mamografía son superiores a lo exigido por el sistema colombiano, pero inferiores a las coberturas útiles reportadas en países desarrollados.Objectives: To determine the coverage of clinical breast examination (CBE) and mammography for screening of breast cancer among a group of insured women in Bogotá. Methods: A telephone survey was carried out with 4,526 women between the ages of 50 and 69, residing in Bogotá or its suburbs, who were insured by one of three commercial health plans. Women with a history of breast cancer were excluded. Screening coverage was estimated as the proportion of women who had had a mammography or CBE. Estimates were established for lifetime frequency, two years prior the survey, and one year prior the survey. Factors associated with screening procedures were analyzed with calculations based on adjusted OR. Results: Lifetime frequency of CBE was 59.3% and 79.8% for mammography; and 49.7% and 65.6% of women respectively underwent the tests for screening purposes; the remainder, for diagnostic purposes (breast symptoms). CBE reported a 34.2% one year coverage and mammography reported a 54% two years coverage. Screening was associated to cancer education and family history of breast cancer. Conclusion: Coverage of CBE for screening purposes is low. Mammography coverage is above that required by the Colombian Health Ministry, but below that reported by developed countrie

Bladder cancer index: cross-cultural adaptation into Spanish and psychometric evaluation

BACKGROUND: The Bladder Cancer Index (BCI) is so far the only instrument applicable across all bladder cancer patients, independent of tumor infiltration or treatment applied. We developed a Spanish version of the BCI, and assessed its acceptability and metric properties. METHODS: For the adaptation into Spanish we used the forward and back-translation method, expert panels, and cognitive debriefing patient interviews. For the assessment of metric properties we used data from 197 bladder cancer patients from a multi-center prospective study. The Spanish BCI and the SF-36 Health Survey were self-administered before and 12 months after treatment. Reliability was estimated by Cronbach's alpha. Construct validity was assessed through the multi-trait multi-method matrix. The magnitude of change was quantified by effect sizes to assess responsiveness. RESULTS: Reliability coefficients ranged 0.75-0.97. The validity analysis confirmed moderate associations between the BCI function and bother subscales for urinary (r = 0.61) and bowel (r = 0.53) domains; conceptual independence among all BCI domains (r ≤ 0.3); and low correlation coefficients with the SF-36 scores, ranging 0.14-0.48. Among patients reporting global improvement at follow-up, pre-post treatment changes were statistically significant for the urinary domain and urinary bother subscale, with effect sizes of 0.38 and 0.53. CONCLUSIONS: The Spanish BCI is well accepted, reliable, valid, responsive, and similar in performance compared to the original instrument. These findings support its use, both in Spanish and international studies, as a valuable and comprehensive tool for assessing quality of life across a wide range of bladder cancer patients

Initiatives to improve the appropriateness of clinical practice in the hospital setting

Introducció. La millora de l’adequació de la pràctica clínica fa referència a l’elecció de proves diagnòstiques, tractaments i altres prestacions que, segons l’evidència científica, tenen més beneficis que riscos, un balanç cost-benefici raonable i s’ajusten a les preferències de les persones i de la societat. Aquest procés inclou identificar i eliminar pràctiques de poc valor i promoure aquelles de valor. Objectius 1. Documentar les iniciatives destinades a millorar l’adequació de la pràctica clínica en l’àmbit mundial; 2. Desenvolupar recursos metodològics que permetin avaluar i millorar l’adequació en l’entorn hospitalari i 3. Analitzar la percepció dels professionals sobre les pràctiques de poc valor i sobre les recomanacions per a eliminar aquestes pràctiques. Mètodes. Vam dur a terme cinc estudis. Per a documentar les iniciatives vam fer una revisió de la literatura. Com a nous recursos metodològics vam crear una pàgina web que permet consultar iniciatives per millorar l’adequació de la pràctica clínica i información d’interés. A més, vam desenvolupar una sèrie d’indicadors basats en revisions sistemàtiques per a avaluar l’adequació en dues àrees de l’entorn hospitalari. Finalment, per a aconseguir el tercer objectiu vam realitzar dues enquestes i dos grups focals amb professionals de medicina i infermeria. Resultats. Amb la cerca vam identificar 22 iniciatives de 10 països, incloent-hi Espanya. Fins a juliol de 2015, aquestes iniciatives havien generat 2.940 recomanacions i anàlisis d’adequació procedents principalment de guies de pràctica clínica i majoritàriament de societats científiques. Vam trobar una gran variabilitat en el rigor metodològic per a desenvolupar aquests recursos i garantir que estiguessin basats en la millor evidència científica disponible. A partir d’aquests resultats vam crear el lloc web Dianasalud.com, que inclou una base de dades amb aquestes iniciatives i les seves recomanacions i anàlisis d’adequació. Vam obtenir 18 indicadors aplicables en l’atenció del part a partir de 303 revisions sistemàtiques (6%) i sis indicadors procedents de 149 revisions (4%) en l’atenció de la malaltia arterial perifèrica. En les enquestes vam trobar un alt grau d’acord amb les recomanacions per a reduir pràctiques de poc valor entre professionals de medicina i infermeria (83% i 96%, respectivament). Aquests creuen que hi ha una bona adherència a aquestes recomanacions a l’hospital (90% i 80%) i les consideren útils (70% i 90%). En els grups focals vam identificar com a principals barreres per a reduir pràctiques de poc valor: medicina defensiva, mala gestió de la incertesa i evidència científica contradictòria. Com a facilitadors destaquen el lideratge positiu i el treball en equip. Conclusions. Les iniciatives més conegudes són aquelles que han produït recomanacions per a eliminar pràctiques de poc valor, provinents de societats científiques. Malgrat les seves importants contribucions, la falta d’una metodologia rigorosa i estandarditzada desperta inquietuds i limita la seva implementació. Respecte als dos recursos metodològics desenvolupats, el lloc web contínua actiu i és consultat sovint. Quant als indicadors, la quantitat que se’n podrien formular està limitada per la falta d’evidència sòlida sobre pràctiques de poc valor i que la seva implementació depèn del grau de detall i la qualitat de la informació clínica. A més de l’evidència científica, la millora de l’adequació implica altres aspectes relacionats amb les creences i actituds dels professionals sanitaris, l’entorn hospitalari i la dinàmica del sistema sanitari i de la societat en general. Aquests aspectes s’han de treballar simultàniament i amb la mateixa intensitat amb la qual es busca assegurar que les iniciatives es basen en la millor evidència disponible.Introducción. La mejora de la adecuación de la práctica clínica hace referencia a la elección de pruebas diagnósticas, tratamientos y demás prestaciones que, según la evidencia científica, tienen más beneficios que riesgos, un balance coste-beneficio razonable y se ajustan a las preferencias de las personas y la sociedad. Este proceso incluye identificar y eliminar prácticas de poco valor y promover aquellas de valor. Objetivos. 1. Documentar las iniciativas destinadas a mejorar la adecuación de la práctica clínica a nivel mundial; 2. Desarrollar recursos metodológicos que permitan evaluar y mejorar la adecuación a nivel hospitalario y 3. Analizar la percepción de los profesionales sobre las prácticas de poco valor y sobre recomendaciones para eliminar aquellas prácticas. Métodos. Llevamos a cabo cinco estudios. Para documentar las iniciativas hicimos una revisión de la literatura. Como nuevos recursos metodológicos creamos una página web que permite consultar iniciativas para la mejora de la adecuación de la práctica clínica e información de interés. Además, desarrollamos una serie de indicadores basados en revisiones sistemáticas para evaluar la adecuación en dos áreas del entorno hospitalario. Finalmente, para el tercer objetivo realizamos dos encuestas y dos grupos focales con profesionales de medicina y enfermería. Resultados. Con la búsqueda identificamos 22 iniciativas originarias de 10 países, incluyendo España. Hasta julio de 2015, dichas iniciativas habían generado 2940 recomendaciones y análisis de adecuación procedentes principalmente de guías de práctica clínica y mayoritariamente de sociedades científicas. Encontramos una gran variabilidad en el rigor metodológico para desarrollar estos recursos y garantizar sus bases en la mejor evidencia científica disponible. A partir de éstos resultados creamos la página DianaSalud.com que incluye una base de datos con dichas iniciativas y sus recomendaciones y análisis de adecuación. Obtuvimos 18 indicadores aplicables en la atención del parto a partir de 303 revisiones sistemáticas (6%) y seis indicadores a partir de 149 revisiones (4%) en la atención de la enfermedad arterial periférica. En las encuestas encontramos un alto grado de acuerdo con las recomendaciones para reducir prácticas de poco valor entre profesionales de medicina y enfermería (83% y 96% respectivamente), quienes creen que hay una buena adherencia a dichas recomendaciones en el hospital (90% y 80%) y las consideran útiles (70% y 90%). En los grupos focales identificamos como principales barreras para reducir prácticas de poco valor: medicina defensiva, mala gestión de la incertidumbre y evidencia científica contradictoria. Como facilitadores destacan el liderazgo positivo y el trabajo en equipo. Conclusiones. Las iniciativas más conocidas son aquellas que han producido recomendaciones para eliminar prácticas de poco valor, provenientes de sociedades científicas. Pese a sus importantes contribuciones, la falta de una metodología rigurosa y estandarizada para identificar prácticas de poco valor o generar recomendaciones despierta inquietudes y limita su implementación. Con respecto a los dos recursos metodológicos desarrollados, la página web continua activa y es frecuentemente consultada. En cuanto a los indicadores, observamos que la cantidad que podrían formularse está limitada por la falta de evidencia sólida sobre prácticas de poco valor y que su implementación depende del grado de detalle y la calidad de la información clínica. Además de la evidencia científica, la mejora de la adecuación implica otros aspectos relacionados con las creencias y actitudes de los profesionales sanitarios, el entorno hospitalario y la dinámica del sistema sanitario y de la sociedad en general. Estos aspectos deben trabajarse simultáneamente y con la misma intensidad con la que se busca asegurar que las iniciativas se basan en la mejor evidencia científica disponible.Introduction. Improving the appropriateness of clinical practice refers to the choice of tests, treatments and other interventions that, according to scientific evidence, possess more benefits than risks, a reasonable cost-benefit ratio, and are compatible with the preferences of people and the society. This process includes identifying and eliminating low-value practices and promoting those that are more appropriate. Objectives. 1. to describe the initiatives aimed at improving the appropriateness of clinical practice worldwide; 2. to develop methodological resources that assess and improve appropriateness in the hospital setting; and 3. to analyse the perceptions of health professionals about inappropriate or low-value practices and recommendations to reduce them. Methods. We carried out five studies. To document initiatives of interest, we conducted a literature review. As methodological resources, we developed an open online database for consulting initiatives to improve the appropriateness of clinical practice and other information of interest. We also developed a set of indicators based on systematic reviews to assess appropriateness in two areas of the hospital setting. Finally, to achieve our third objective, we carried out two surveys and two focus groups with doctors and nurses. Results. With the literature review we identified 22 initiatives from 10 countries, including Spain. As of July 2015, these initiatives produced 2,940 outputs in the form of recommendations and appropriateness analyses mainly from clinical practice guidelines and most commonly from scientific societies. We found great variability in the methodological rigor employed to develop these resources and to guarantee that they draw on the best evidence. Based on our search results we created the website DianaHealth.com, which includes a database of the initiatives and their associated recommendations and appropriateness analyses. We obtained 18 indicators applicable on delivery care from 303 systematic reviews (6%) and six indicators on peripheral arterial disease care from 149 reviews (4%). In the surveys, we found a high agreement among doctors and nurses (83% and 96% respectively) with the recommendations for reducing low-value practices. In both groups, professionals believe that there is good adherence to these guidelines in the hospital (90% and 80%) and consider them useful (70% and 90%). In the focus groups we identified defensive medicine, bad management of uncertainty and contradictory scientific evidence as the main barriers to reducing low-value practices. As facilitators, positive leadership and teamwork stand out. Conclusions. The best-known initiatives for improving the appropriateness are those producing recommendations to reduce low-value practices, developed by scientific societies. Despite their important contributions, the lack of a rigorous and standardised methodology for identifying low-value practices or producing recommendations arouses concerns and jeopardises the implementation of their contributions. Regarding the two methodological resources developed in this tehsis work, DianaHealth.com is still active and it is frequently consulted. As for the indicators based on systematic reviews, we found that the number of indicators that could be produced is limited by the lack of solid evidence on low-value practices and their implementation depends on the degree of detail, as well as the quality of clinical information. In addition to employing scientific evidence, improving the appropriateness of clinical practice involves other aspects related to the beliefs and attitudes of healthcare professionals, the hospital environment and the dynamics of the healthcare system and society in general. These aspects should be worked on simultaneously and with the same intensity that should be devoted to ensuring that the initiatives are supported by the best scientific evidence available.Universitat Autònoma de Barcelona. Programa de Doctorat en Metodologia de la Recerca Biomèdica i Salut Públic