Transmyocardial laser revascularization versus medical therapy for refractory angina.

BACKGROUND: This is an update of a review previously published in 2009. Chronic angina and advanced forms of coronary disease are increasingly more frequent. In spite of the improvement in the efficacy of available revascularization treatments, a subgroup of patients continue suffering from refractory angina. Transmyocardial laser revascularization (TMLR) has been proposed to improve the clinical situation of these patients. OBJECTIVES: To assess the effects (both benefits and harms) of TMLR versus optimal medical treatment in people with refractory angina who are not candidates for percutaneous coronary angioplasty or coronary artery bypass graft, in alleviating angina severity, reducing mortality and improving ejection fraction. SEARCH METHODS: We searched the following resources up to June 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the metaRegister of Controlled Trials database, ClinicalTrials.gov, and the WHO International Clinical Trials Registry. We applied no languages restrictions. We also checked reference lists of relevant papers. SELECTION CRITERIA: We selected studies if they fulfilled the following criteria: randomized controlled trials (RCTs) of TMLR, by thoracotomy, in patients with Canadian Cardiovascular Society or New York Heart Association angina grade III-IV who were excluded from other revascularization procedures. DATA COLLECTION AND ANALYSIS: Three authors independently extracted data for each trial about the population and interventions compared and assessed the risk of bias of the studies, evaluating randomisation sequence generation, allocation concealment, blinding (of participants, personnel and outcome assessors), incomplete outcome data, selective outcome reporting, and other potential sources of bias. MAIN RESULTS: From a total of 502 references, we retrieved 47 papers for more detailed evaluation. We selected 20 papers, reporting data from seven studies, which included 1137 participants, of which 559 were randomized to TMLR. Participants and professionals were not blinded, which suggests high risk of performance bias. Overall, 43.8% of participants in the treatment group decreased two angina classes, as compared with 14.8% in the control group: odds ratio (OR) 4.63, 95% confidence interval (CI) 3.43 to 6.25), and heterogeneity was present. Mortality by intention-to-treat analysis was similar in both groups at 30 days (4.0% in the TMLR group and 3.5% in the control group), and one year (12.2% in the TMLR group and 11.9% in the control group). However, the 30-day mortality as-treated was 6.8% in the TMLR group and 0.8% in the control group (pooled OR was 3.76, 95% CI 1.63 to 8.66), mainly due to a higher mortality in participants crossing from standard treatment to TMLR. The assessment of subjective outcomes, such as improvement in angina, was affected by a high risk of bias and this may explain the differences found. Other adverse events such as myocardial infarction, arrhythmias or heart failure, were not considered in this review, as they were not predefined outcomes in trials design and they show a high inconsistency across studies. No new trials on transmyocardial laser revascularization have been published in the last ten years and it is very unlikely that new research will be undertaken in this field. AUTHORS' CONCLUSIONS: This review shows that risks associated with TMLR outweigh the potential clinical benefits. Subjective outcomes are subject to high risk of bias and no differences were found in survival, but a significant increase in postoperative mortality and other safety outcomes suggests that the procedure may pose unacceptable risks.

Evaluación del uso apropiado de procedimientos sanitarios mediante el método RAND: revisión de su aplicación en la literatura biomédica (1999-2004) / Review of the utilization of the RAND appropriateness method in the biomedical literature (1999-2004)

Objetivos: Identificar y describir los estudios de evaluación del uso apropiado de procedimientos sanitarios en los cuales se haya empleado el método RAND/UCLA. Se trata de una técnica de consenso con varias fases para el desarrollo de criterios de uso apropiado. Métodos: La búsqueda bibliográfica se realizó en 2005, consultando las bases de datos OVID-Medline, ISI Web of Knowledge, Índice Médico Español y Highwire. Se seleccionaron los artículos publicados entre 1999 y 2004 que tuviesen las palabras clave «appropriateness», «utilization review» y «physician practice patterns». Se incluyeron los estudios en que se hubiese aplicado el método RAND y se excluyeron aquellos cuya metodología no estuviese suficientemente explicada. De cada artículo se extrajo información sobre el procedimiento estudiado, el lugar y el año de publicación, y las características de la revista. Resultados y discusión: Se identificaron 5.092 referencias y se seleccionaron 205. Algo más de la mitad analizaban procedimientos quirúrgicos o médicos, mientras que el 16,5% se centraba en la evaluación de la calidad asistencial. Más del 50% fueron trabajos publicados en revistas de salud pública, medicina general, y gastroenterología y hepatología. La media del factor de impacto era de 4,07. El 25,4% de los artículos habían sido publicados en 1999. Conclusiones y perspectivas: El método RAND se sigue utilizando ampliamente. Los criterios de uso apropiado pueden emplearse para la revisión de la utilización de procedimientos, como base para elaborar guías o como apoyo para la toma de decisiones. Estas herramientas han de ser sometidas a revisiones para obtener resultados cada vez más válidos y fiables (AU)

Objectives: To identify and describe studies using the RAND/UCLA method to evaluate the appropriateness of health procedures. This method is a consensus technique that involves several phases to develop appropriateness criteria. Methods: We performed a literature search in 2005. OVIDMedline, ISI Web of Knowledge, IME and Highwire were consulted. Articles published between 1999 and 2004 and using the key words «appropriateness», «utilization review» and «physician practice patterns» were selected. Studies using the RAND method were included and those that did not explain the methodology in sufficient detail were excluded. Information on the procedure studied, the place and year of publication, and the characteristics of the journal were extracted from each article. Results and discussion: A total of 5092 articles were identified and 205 were selected. Slightly more than half analyzed surgical or medical procedures, while 16.5% evaluated healthcare quality. More than 50% were published in journals of public health, general medicine, and gastroenterology and hepatology. The mean impact factor was 4.07. A quarter (25.4%) of the articles was published in 1999. Conclusions and perspective: The RAND method is still widely used. Appropriateness criteria can be used to review utilization of procedures, to design guidelines, or to support for decision making. These tools should be reviewed to obtain evermore valid and reliable results (AU)

[Review of the utilization of the RAND appropriateness method in the biomedical literature (1999-2004)]. / Evaluación del uso apropiado de procedimientos sanitarios mediante el método RAND: revisión de su aplicación en la literatura biomédica (1999-2004).

OBJECTIVES: To identify and describe studies using the RAND/UCLA method to evaluate the appropriateness of health procedures. This method is a consensus technique that involves several phases to develop appropriateness criteria. METHODS: We performed a literature search in 2005. OVIDMedline, ISI Web of Knowledge, IME and Highwire were consulted. Articles published between 1999 and 2004 and using the key words "appropriateness", "utilization review" and "physician practice patterns" were selected. Studies using the RAND method were included and those that did not explain the methodology in sufficient detail were excluded. Information on the procedure studied, the place and year of publication, and the characteristics of the journal were extracted from each article. RESULTS AND DISCUSSION: A total of 5092 articles were identified and 205 were selected. Slightly more than half analyzed surgical or medical procedures, while 16.5% evaluated healthcare quality. More than 50% were published in journals of public health, general medicine, and gastroenterology and hepatology. The mean impact factor was 4.07. A quarter (25.4%) of the articles was published in 1999. CONCLUSIONS AND PERSPECTIVE: The RAND method is still widely used. Appropriateness criteria can be used to review utilization of procedures, to design guidelines, or to support for decision making. These tools should be reviewed to obtain evermore valid and reliable results.

Transmyocardial laser revascularization versus medical therapy for refractory angina.

BACKGROUND: Chronic angina and advanced forms of coronary disease are increasingly more frequent. Although the improved efficacy of available revascularization treatments, a subgroup of patients present with refractory angina. Transmyocardial laser revascularization (TMLR) has been proposed to improve the clinical situation of these patients. OBJECTIVES: To assess the efficacy and safety of TMLR versus optimal medical treatment in patients with refractory angina in alleviating the severity of angina and improving survivorship and heart function. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 2 2007), MEDLINE (January 2006 to June 2007), EMBASE ( 2004 to June 2007) and ongoing studies were sought using the metaRegister of Controlled Trials database (mRCT) and ClinicalTrials.gov databases. No languages restrictions were applied. Reference lists of relevant papers were also checked. SELECTION CRITERIA: Studies were selected if they fulfilled the following criteria: randomized controlled trials of TMLR, by thoracotomy, in patients with angina grade III-IV who were excluded from other revascularization procedures. From a total of 181 references, 20 papers were selected, reporting data from seven studies. DATA COLLECTION AND ANALYSIS: Two reviewers abstracted data from selected papers; . The reviewers performed independently both quality assessment and data extraction. Selected studies present methodological weaknesses. None of them fulfilled all the quality criteria. MAIN RESULTS: Seven studies (1137 participants of which 559 randomized to TMLR) were included. Overall, 43.8 % of patients in the treatment group decreased two angina classes as compared with 14.8 % in the control group, odds ratio (OR) of 4.63 (95% confidence interval (CI) 3.43 to 6.25), and heterogeneity was statistically significant. Mortality by intention-to-treat analysis at both 30 days (4.0 % in the TMLR group and 3.5 % in the control group) and 1 year (12.2 % in the TMLR group and 11.9 % in the control group) was similar in both groups. The 30-days mortality as treated was 6.8% in TMLR group and 0.8% in the control group, showing a statistically significant difference. The pooled OR was 3.76 (95% CI 1.63 to 8.66), because of the higher mortality in patients crossing from standard treatment to TMLR. AUTHORS' CONCLUSIONS: There is insufficient evidence to conclude that the clinical benefits of TMLR outweigh the potential risks. The procedure is associated with a significant early mortality.

First-line antiretroviral therapy with efavirenz or lopinavir/ritonavir plus two nucleoside analogues: the SUSKA study, a non-randomized comparison from the VACH cohort.

BACKGROUND: Efavirenz and lopinavir/ritonavir are both recommended antiretroviral agents for combination first-line therapy, although information on direct comparisons between them is scarce. A retrospective longitudinal study from the VACH cohort comparing both regimens was performed. METHODS: Efficacy was examined comparing time to virological failure, CD4 recovery and clinical progression. Tolerability was examined comparing time to treatment discontinuation for any reason and for toxicity. Survival analysis was conducted using the Kaplan-Meier method, and standard and weighted Cox regression models. RESULTS: A total of 1550 antiretroviral-naive patients starting a two-nucleoside reverse transcriptase inhibitor regimen plus either efavirenz (n = 1159) or lopinavir/ritonavir (n = 391) were included in the study. At baseline, patients starting lopinavir/ritonavir had higher HIV-1 RNA and lower CD4+ cell counts. There was no difference in the adjusted hazards of virological failure [efavirenz versus lopinavir/ritonavir hazard ratio (HR) = 0.93, 95% confidence interval (CI): 0.77-1.12, P = 0.43], CD4 recovery (HR = 1.11, 95% CI: 0.95-1.30, P = 0.19) and clinical progression (HR = 0.71, 95% CI: 0.39-1.31, P = 0.27). There was an increased risk of discontinuation for any reason or for toxicity for lopinavir/ritonavir (HR = 2.10, 95% CI: 1.40-3.15, P = 0.0003). CD4 recovery with both drugs was also similar in the lowest CD4 strata. A higher risk of early hypertriglyceridaemia was associated with lopinavir/ritonavir-based regimens. CONCLUSIONS: Our study suggests similar virological efficacy for efavirenz- or lopinavir/ritonavir-based first-line antiretroviral regimens, but an increased risk of discontinuation because of toxicity in case of lopinavir/ritonavir-based therapy. Immunological outcome appeared similar with both regimens.

[Effectiveness of a multifactorial strategy for implementing clinical guidelines on unstable angina: cluster randomized trial]. / Efectividad de la implantación de una guía clínica sobre la angina inestable mediante una estrategia multifactorial. Ensayo clínico aleatorizado en grupos.

UNLABELLED: INTRODUCTION AND OBJECTIVES. Clinical practice in unstable angina is not always based on best evidence. Guidelines have the potential to improve quality of health care. There are no randomised trials assessing implementation strategies in the public healthcare system of Spain yet. OBJECTIVE: to compare the effectiveness of a multifaceted strategy (interactive educational meetings, local consensus process) for guideline implementation in unstable angina, with a passive dissemination strategy. Patients and method. SETTING: 10 wards from 3 university hospitals in Sevilla. PARTICIPANTS: 153 specialists (cardiologists, internists) and their patients admitted for an unstable angina episode. DESIGN: a pragmatic, before and after cluster randomized controlled trial. Intervention was delivered from January to April 1998. Retrospective data collection took place in July 1999, of those pre and post-intervention episodes attended from January to October 1997 and from September 1998 to June 1999, respectively. OUTCOMES: compliance with the guideline recommendations for coronary angiography and stress testing, and ejection fraction assessment. RESULTS: The multifaceted strategy compared with the passive one, was associated with an absolute improvement in the appropriateness of use of coronary angiography and stress testing of 11% (95% CI, 0.85-21.1), P=.03. There was no association for the assessment of the ejection fraction: absolute improvement of 1.1% (95% CI, --15.9 to 18.1), P=.88. CONCLUSIONS: Our results show that a combination of interactive educational meetings and local consensus process delivered to wards of physicians may improve the appropriateness of use of coronary angiography and stress testing.

Efectividad de la implantación de una guía clínica sobre la angina inestable mediante una estrategia multifactorial. Ensayo clínico aleatorizado en grupos / Effectiveness of a multifactorial strategy for implementing clinical guidelines on unstable angina: cluster randomized trial

Introducción y objetivos. La práctica clínica en la angina inestable (AI) no está siempre basada en la mejor evidencia disponible. Las guías clínicas tienen el potencial de mejorar la calidad de la asistencia. Hasta el momento no hay ningún ensayo clínico aleatorizado para evaluar diversas estrategias de implantación de guías en el sistema sanitario público español. El objetivo de este artículo es comparar la efectividad de una estrategia multifactorial de implantación de una guía clínica (sesiones formativas interactivas, procesos de consenso local) en la AI frente a una estrategia de diseminación pasiva. Pacientes y método. El estudio se realizó en 10 unidades de 3 hospitales universitarios de Sevilla. Participaron 153 especialistas (cardiólogos, internistas) y sus pacientes admitidos por AI. La intervención se realizó de enero a abril de 1998. La recogida retrospectiva de datos se hizo en julio de 1999, tanto para los episodios preintervención como postintervención atendidos desde enero a octubre de 1997 y de septiembre 1998 a junio de 1999, respectivamente. En cuanto al diseño, fue un ensayo clínico aleatorizado por grupos, antes-después, pragmático. Los desenlaces fueron: cumplimiento de las recomendaciones de una guía sobre la utilización de la angiografía coronaria, pruebas de estrés y valoración de fracción de eyección. Resultados. La estrategia multifactorial comparada con la pasiva se asoció con una mejoría absoluta en la adecuación de uso de angiografía coronaria y de pruebas de estrés del 11% (intervalo de confianza [IC] del 95%, 0,85-21,1; p = 0,03). Para la valoración de la fracción de eyección no se encontró asociación: mejoría absoluta del 1,1% (IC del 95%, ­-15,9 a 18,1; p = 0,88). Conclusiones. Nuestros resultados muestran que una intervención combinada de sesiones formativas interactivas con procesos de consenso de local administrada a unidades asistenciales de facultativos puede mejorar la adecuación de uso de la angiografía coronaria y de las pruebas de estrés

Introduction and objectives. Clinical practice in unstable angina is not always based on best evidence. Guidelines have the potential to improve quality of health care. There are no randomised trials assessing implementation strategies in the public healthcare system of Spain yet. Objective: to compare the effectiveness of a multifaceted strategy (interactive educational meetings, local consensus process) for guideline implementation in unstable angina, with a passive dissemination strategy. Patients and method. Setting: 10 wards from 3 university hospitals in Sevilla. Participants: 153 specialists (cardiologists, internists) and their patients admitted for an unstable angina episode. Design: a pragmatic, before and after cluster randomized controlled trial. Intervention was delivered from January to April 1998. Retrospective data collection took place in July 1999, of those pre and post-intervention episodes attended from January to October 1997 and from September 1998 to June 1999, respectively. Outcomes: compliance with the guideline recommendations for coronary angiography and stress testing, and ejection fraction assessment. Results. The multifaceted strategy compared with the passive one, was associated with an absolute improvement in the appropriateness of use of coronary angiography and stress testing of 11% (95% CI, 0.85-21.1), P=.03. There was no association for the assessment of the ejection fraction: absolute improvement of 1.1% (95% CI, ­-15.9 to 18.1), P=.88. Conclusions. Our results show that a combination of interactive educational meetings and local consensus process delivered to wards of physicians may improve the appropriateness of use of coronary angiography and stress testing