[Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations]. / Guía metodológica para la evaluación de la eficacia y la seguridad de nuevos fármacos: implementación de las recomendaciones de EUnetHTA.

The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model®, has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting "Evidence synthesis reports: pharmaceuticals" in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model®. In this paper, the methodology that AETSA has developed to create the guideline for "Evidence synthesis reports: pharmaceuticals" is described. The structure of the report itself is also presented.

[Quality of life after brachytherapy or robot-assisted radical prostatectomy for localized prostate cancer]. / Evaluación de la calidad de vida de la braquiterapia vs prostatectomia robotizada en pacientes con carcinoma prostático localizado. Revisión sistemática.

OBJECTIVES: To perform a systematic bibliographic review of the literature assessing the quality of life and complications of robotic prostatectomy (RP) versus low-dose rate brachytherapy (LDR-BT) in patients with localized prostate cancer (PCa). PubMed, EMBASE and Cochrane, Centre for Reviews and Dissemination, Emergency Care Research Institute, Web of Knowledge, Technology Evaluation Center, Clinical Evidence, Uptodate, Hayes and Drug Effectiveness Review Project. Systematic reviews and prospective studies comparing RP to LDR-BT in men with localized PCa were included. The primary outcome was quality of life and the secondary endpoint complications rate. RESULTS: Three systematic reviews and four prospective studies were included. RP showed better results than LDR-BT for SF-12-physical domain (p<0.01) and faster recovery to pre-operative scores. LDR-BT improved scores for UCLAPCI questionnaire-urinary and sexual domains compared to RP during the first three years of follow-up (p<0.001). First postoperative year urinary incontinence rate was favorable for LDR-BT (88.0% vs 84.5%, p<0.001). No differences for intestinal function scores for the first three post-intervention years (p = 0.02) were found. Major complications of LDR-BT were gastrointestinal and genitourinary toxicity, although pooled weighted events rate of the studies was not analyzed. CONCLUSIONS: LDR-BT improves quality of life in terms of urinary and sexual function in patients with localized PCa vs RP during the first three years post-intervention.

Factores determinantes en la indicación de la prótesis invertida de hombro / Facteurs déterminant l'indication de prothèse d'épaule inversée / Determining Factors in Inverted Shoulder Prosthesis Indication

Objetivo: Desarrollar criterios para determinar las indicaciones apropiadas de la prótesis invertida de hombro en artropatías por lesión del manguito rotador y las variables determinantes de este proceso. Método: Se utilizó un panel de expertos mediante metodología RAND/UCLA con 9 expertos en Traumatología, 2 en Rehabilitación y 1 en Reumatología, que evaluaron 192 casos hipotéticos. Cada experto puntuó mediante una escala del 1 (extremadamente inadecuado) al 9 (extremadamente apropiado). Resultados: 22 casos hipotéticos fueron considerados adecuados. El dolor, limitación funcional, necesidad funcional, defecto glenoideo, edad, artrosis y posibilidad de reparación del manguito rotador son variables determinantes para indicar la implantación de una prótesis invertida de hombro. Conclusiones: El método RAND/UCLA es útil para el estudio de las indicaciones de procedimientos como la prótesis invertida de hombro, y proporciona una lista de las indicaciones adecuadas. Las variables requieren ser validadas mediante estudios prospectivos o revisión de historias clínicas(AU)

Objective: Develop criteria to determine the appropriate indications of inverted shoulder prosthesis in arthropathies due to rotator cuff injury and the variables that determine this process. Method: A panel of experts assessed 192 hypothetical cases using RAND/UCLA methodology. Nine Traumatology experts, two Rehabilitation experts and one Rheumatology expert comprised this panel. Each expert scored on a scale from 1 (extremely unsuitable) to 9 (extremely appropriate). Results: 22 hypothetical cases were considered adequate. Pain, functional limitation, functional need, glenoid defect, age, osteoarthritis and possibility of rotator cuff repair are determining as variables to indicate the implantation of an inverted shoulder prosthesis. Conclusions: The RAND/UCLA method is useful for the study of procedure indications such as the inverted shoulder prosthesis, and it provides a list of suitable indications. Prospective studies or medical record reviews should validate these variables(AU)

Objectif: Proposer les critères définissant l'indication appropriée de prothèse d'épaule inversée dans les arthropathies pour lésion de la coiffe des rotateurs, et les variables déterminant ce processus. Méthodes: Un panel d'experts, compris par 9 traumatologues, 2 kinésithérapeutes et 1 rhumatologue, a été utilisé pour évaluer 192 cas hypothétiques par la méthode RAND/UCLA. Chaque expert a fait son évaluation sur une échelle de 1 (extrêmement inapproprié) à 9 (extrêmement approprié). Résultats: Vingt-deux cas hypothétiques ont été considérés comme appropriés. Des variables telles que la douleur, la limitation fonctionnelle, la nécessité fonctionnelle, le défaut glénoïdien, l'âge, l'arthrose et la possibilité de correction de la coiffe des rotateurs, ont déterminé l'indication de prothèse d'épaule inversée. Conclusions: La méthode RAND-UCLA est utile pour l'étude des indications de procédés, tels que la prothèse d'épaule inversée, et procure une liste des indications appropriées. Il faut valider les variables avec des études prospectives ou une révision des dossiers médicaux(AU)