Anna López

A critical review of guidelines for low back pain treatment

Main problem: Little is known about the methodological quality of guidelines for low back pain treatment. We evaluated the methods used by the developers according to established standards. Methods: PubMed, guideline databases, and the World Wide Web were used to identify guidelines. Seventeen guidelines met the inclusion criteria: interventions for low back pain stated, recommendations based on or explicitly linked to evidence, and English version available. Guidelines were evaluated independently by two appraisers using a practical tool for this purpose, Users’ Guides to the Medical Literature, and the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. Results: Thirteen guidelines (76%) specified the most important therapies applied, but only nine (53%) included a complete description of the target population. Explicit processes to identify, select, and combine evidence were described in only six guidelines (35%). Few guidelines (3; 18%) explicitly considered all main outcomes when formulating therapeutic recommendations, and none contained a process to determine the relative value of different outcomes. Methodological criteria for grading the strength of the recommendations varied, and were often insufficiently specified. None of the guidelines assessed the impact of uncertainty associated with the evidence and values used. According to AGREE the quality score was highest for the scope and purpose, and clarity and presentation domains, and lowest for editorial independence and applicability. With regard to the recommendations, there was consensus for some of the interventions for acute pain (analgesics and NSAIDs, maintaining physical activity, and avoiding excessive bed rest), but explicit recommendations were lacking or ambiguous for 41% of the interventions. Most of the guidelines did not contemplate specific recommendations for chronic pain. Conclusions: A small number of the available guidelines for low back pain treatment achieved acceptable results for specific quality criteria. In general, the methods to develop the guidelines’ therapeutic recommendations need to be more rigorous, more explicit and better explained. In addition, greater importance should be placed on the recommendations for chronic pain.

Ethyl N-(diphenylmethylene)glycinate as anionic glycine equivalent. Monoalkylation, dialkylation and Michael additions under solid-liquid phase-transfer catalysis

Abstract Ethyl N -(diphenylmethylene)glycinate, 1 , undergoes monoalkylations, dialkylations and Michael additions to ethylenic and acetylenic acceptors under appropriate solid-liquid phase transfer catalysis conditions. Further transformations of the α-disubstituted ketimines lead to α-alkylated aspartic and glutamic acid derivatives 10 , 15 , 19 and 26 , to bicyclic amino acids or derivatives featuring pyrazolone and isoxazolone moieties 30 and 33 , and to α-substituted ( E )-3,4-dehydroglutamic acids.

Highly diastereoselective monoalkylation and Michael addition of N-(diphenylmethylene)glycinesultam under solid–liquid phase-transfer catalysis conditions using potassium carbonate as base

Abstract Treatment of a sultam-derived N -(diphenylmethylene)glycinate equivalent 1 with activated (allylic and propargylic) organic bromides and with Michael acceptors under solid–liquid phase-transfer catalysis conditions, using potassium carbonate as base, affords the monoalkylated compounds with high diastereoselectivity (>97% d.e.).

Guía de consenso sobre los contenidos de los protocolos de ensayos clínicos

Independientemente de si un ensayo clinico aleatorizado (ECA) forma parte del desarrollo de un nuevo farmaco propiedad de un laboratorio farmaceutico, o si la idea de realizarlo surge de un investigador o de un centro publico, los preparativos deben seguir una sistematica que asegure la consideracion de todos los aspectos fundamentales para llevar el proyecto a buen fin. Una vez considerados los objetivos y los condicionantes del ensayo se debe elaborar un esbozo de protocolo. Este suele ser el primer documento de trabajo y sirve para encauzar las discusiones que, a continuacion, se llevan a cabo entre todos los involucrados. Durante la fase de preparacion, el protocolo se amplia incorporando las sugerencias recibidas, llegando a constituir el protocolo definitivo. En investigacion clinica las cosas no son estaticas y hay muchas situaciones por las que un protocolo, a pesar de ser definitivo, debe modificarse durante la ejecucion del proyecto, siendo susceptible de sufrir varias enmiendas. El protocolo de un ECA sirve para muchos propositos y se considera un elemento imprescindible. Sus funciones principales son dos. La primera es proporcionar a los investigadores un documento con una descripcion detallada de la razon de ser del proyecto, sus objetivos, su diseno, asi como las distintas etapas de su realizacion y analisis; en definitiva, lo que podriamos considerar la estructura cientifica de la investigacion. La segunda seria guiar la conducta de todos aquellos que participan en el mismo, asi como ser una proteccion para minimizar los subjetivismos, evitando sesgos, y facilitar que la ejecucion del mismo se establezca de forma reglada y, a ser posible, con la maxima coherencia de actuacion y las minimas desviaciones en la ejecucion, valoracion e interpretacion de las variables y, por ende, de los resultados. Dentro de un protocolo ambos aspectos pueden estar mezclados, o aparecer por separado. En cualquier caso, es de gran utilidad presentar, de forma ordenada, los distintos componentes que los constituyen. Existian muchos formatos e indices para la elaboracion de protocolos. Para los comites de etica de la investigacion clinica (CEIC) en nuestro pais, pendientes de ser reconvertidos despues de la Ley de Investigacion Biomedica en comites de etica de la investigacion (CEI), o tambien para instituciones similares en otros entornos

Características y diseño de los estudios que evalúan interacciones farmacológicas

Eva Montané *, Anna López c y Joan Costa a,b a Servicio de Farmacologı́a Clı́nica, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España b Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Barcelona, España c Fundació Institut per a la Investigació en Ciències de la Salut Germans Trias i Pujol, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España