RESUMEN
OBJECTIVES: A new decision-making process was set up by the Austrian Ministry of Health to regulate coverage of new proposed Extra Medical Services (EMS; German: Medizinische Einzel-Leistung [MEL]) in 2008. As part of the annual decision-making process an independent academic institution (LBI-HTA) is evaluating relevant evidence on these new technologies and provides HTAs, including evidence-based recommendations for decision makers. METHODS: About ten EMS assessments are performed annually by the LBI-HTA simultaneously between January and March. Each peer-reviewed report consists of a systematic literature review and critical appraisal of evidence using the GRADE methodology. The generation of numerous reports of good quality standards within the short timeframe is achieved by a standardized workflow with predefined assignment of tasks for all participants. RESULTS: In total, the LBI-HTA performed twenty-five EMS assessments on thirty-three different interventions in the last three years. Coverage was recommended with limitation for eleven (33%) interventions, and not recommended for twenty-two (66%) interventions. The federal health commission decided on acceptance or preliminary acceptance of coverage in seven (22%) cases, rejection in eighteen (55%) cases and changed the status to "subject to approval" in seven (24%) cases. CONCLUSIONS: Pre-coverage assessment of new hospital interventions was implemented successfully in Austria. It has proved to be a useful tool to support decision makers with objective evidence when deciding whether or not to reimburse medical services.
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Toma de Decisiones , Gastos en Salud/estadística & datos numéricos , Política de Salud , Hospitalización/estadística & datos numéricos , Evaluación de Programas y Proyectos de Salud/métodos , Evaluación de la Tecnología Biomédica/métodos , Austria , Grupos Diagnósticos Relacionados/economía , Grupos Diagnósticos Relacionados/estadística & datos numéricos , Humanos , Evaluación de Resultado en la Atención de Salud/métodos , Evaluación de Programas y Proyectos de Salud/economía , Evaluación de Programas y Proyectos de Salud/estadística & datos numéricos , Garantía de la Calidad de Atención de Salud , Factores de TiempoRESUMEN
Cervical total disc replacement (CTDR) has been increasingly used as an alternative to fusion surgery in patients with pain or neurological symptoms in the cervical spine who do not respond to non-surgical treatment. A systematic literature review has been conducted to evaluate whether CTDR is more efficacious and safer than fusion or non-surgical treatment. Published evidence up to date is summarised qualitatively according to the GRADE methodology. After 2 years of follow-up, studies demonstrated statistically significant non-inferiority of CTDR versus fusion with respect to the composite outcome 'overall success'. Single patient relevant endpoints such as pain, disability or quality of life improved in both groups with no superiority of CTDR. Both technologies showed similar complication rates. No evidence is available for the comparison between CTDR and non-surgical treatment. In the long run improvement of health outcomes seems to be similar in CTDR and fusion, however, the study quality is often severely limited. After both interventions, many patients still face problems. A difficulty per se is the correct diagnosis and indication for surgical interventions in the cervical spine. CTDR is no better than fusion in alleviating symptoms related to disc degeneration in the cervical spine. In the context of limited resources, a net cost comparison may be sensible. So far, CTDR is not recommended for routine use. As many trials are ongoing, re-evaluation at a later date will be required. Future research needs to address the relative effectiveness between CTDR and conservative treatment.
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Vértebras Cervicales/cirugía , Discectomía/métodos , Implantación de Prótesis/métodos , Fusión Vertebral/métodos , Humanos , Resultado del TratamientoRESUMEN
CONTEXT: High-intensity focussed ultrasound (HIFU) is an emerging minimally invasive treatment option for prostate cancer. OBJECTIVE: Our aim was to assess the efficacy and safety of HIFU in both primary treatment of men with localised and locally advanced prostate cancer as well as salvage treatment of men with recurrent prostate cancer following treatment failure of radical prostatectomy or external-beam radiation therapy. EVIDENCE ACQUISITION: We conducted a systematic literature search for studies conducted on humans and published in either English or German in several databases from 2000 to 2010. In addition, we screened several Web sites for assessments on HIFU in prostate cancer and contacted the manufacturers of the two currently available HIFU devices for supplemental information on HIFU. We included all prospective studies with >50 study participants and assessed their quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. EVIDENCE SYNTHESIS: We identified 20 uncontrolled prospective case series, each of which treated between 58 and 517 patients. These studies were all conducted within the past decade. In total, 3018 patients were treated with HIFU, 93% for primary therapy and 7% for salvage HIFU. For all HIFU procedures, the biochemical disease-free survival rate at 1, 5, and 7 yr, respectively, was 78-84%, 45-84%, and 69%. The negative biopsy rate was 86% at 3 mo and 80% at 15 mo. Overall survival rates and prostate cancer-specific survival rates were 90% and 100% at 5 yr and 83% and 98% at 8 yr, respectively. Adverse events concerned the urinary tract (1-58%), potency (1-77%), the rectum (0-15%), and pain (1-6%). Quality-of-life assessment yielded controversial results. CONCLUSIONS: Applying the GRADE approach, the available evidence on efficacy and safety of HIFU in prostate cancer is of very low quality, mainly due to study designs that lack control groups. More research is needed to explore the use of HIFU in prostate cancer.
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Ultrasonido Enfocado de Alta Intensidad de Ablación , Neoplasias de la Próstata/cirugía , Anciano , Anciano de 80 o más Años , Supervivencia sin Enfermedad , Medicina Basada en la Evidencia , Ultrasonido Enfocado de Alta Intensidad de Ablación/efectos adversos , Ultrasonido Enfocado de Alta Intensidad de Ablación/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Invasividad Neoplásica , Recurrencia Local de Neoplasia , Prostatectomía , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/radioterapia , Terapia Recuperativa , Tasa de Supervivencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
Despite the large availability of diagnostic tests and procedures and their importance to medicine, evidence for their appropriate use is often limited. Unfortunately, the evaluation of tests is difficult and susceptible to several forms of bias. This paper describes the standard methods for characterizing and comparing the accuracy of diagnostic tests and addresses initiatives such as STARD and QUADAS to improve the quality of diagnostic studies. We inform the reader how to critically appraise the study results and when to rely on the results of diagnostic accuracy studies or randomised clinical trials.
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Técnicas y Procedimientos Diagnósticos/normas , Medicina Basada en la Evidencia , Algoritmos , Austria , Humanos , Oportunidad Relativa , Valor Predictivo de las Pruebas , Garantía de la Calidad de Atención de Salud/normas , Curva ROC , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Valores de ReferenciaRESUMEN
Nowadays the Randomised Controlled Trial (RCT) is seen as the gold standard for estimating the effectiveness of an observed intervention, achieving the highest hierarchy of evidence of primary research settings. Its study design basically includes two groups of patients, an intervention group and a control group; patients are randomly allocated to these two groups. After intervention or control intervention took place, predefined outcomes are quantified and compared in the two groups. The study design aims at eliminating all confounding and distorting factors (Bias and Confounder), so that different outcomes between the groups can be only explained by the intervention. There is a broad variation of quality of published RCTs. The reliability of results and extent to which findings provide a correct basis for generalisation to other circumstances needs to be validated. As part of a methods series of the Wiener Medizinische Wochenschrift this paper will discuss principles of study design, critical appraisal and limitations of RCTs.
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Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Austria , Sesgo , Medicina Basada en la Evidencia , Humanos , Edición , Control de Calidad , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Reproducibilidad de los Resultados , Proyectos de InvestigaciónRESUMEN
Over the past years, systematic reviews and meta-analyses have led to significant changes in clinical medicine and health policy. To date, they can be viewed as the most objective instruments to answer clinical as well health policy questions. In addition, systematic reviews are an important tool to synthesize the enormous amount of new medical knowledge into a manageable format. Nevertheless, the methodological quality of published systematic reviews and meta-analyses varies and biased results can be misleading. Therefore, it is important for readers of systematic reviews to critically evaluate the underlying methods, to be able to assess the validity of their findings. This manuscript is part of a methods series of the Wiener Medizinische Wochenschrift. It summarizes the methodological hallmarks of systematic reviews and meta-analyses to provide readers with the methodological background necessary to critically evaluate systematic reviews and meta-analyses.
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Metaanálisis como Asunto , Literatura de Revisión como Asunto , Austria , HumanosRESUMEN
BACKGROUND: Osteoarthritis of the knee affects up to 10% of the elderly population. The condition is frequently treated by intra-articular injection of hyaluronic acid. We performed a systematic review and meta-analysis of randomized controlled trials to assess the effectiveness of this treatment. METHODS: We searched MEDLINE, EMBASE, CINAHL, BIOSIS and the Cochrane Controlled Trial Register from inception until April 2004 using a combination of search terms for knee osteoarthritis and hyaluronic acid and a filter for randomized controlled trials. We extracted data on pain at rest, pain during or immediately after movement, joint function and adverse events. RESULTS: Twenty-two trials that reported usable quantitative information on any of the predefined end points were identified and included in the systematic review. Even though pain at rest may be improved by hyaluronic acid, the data available from these studies did not allow an appropriate assessment of this end point. Patients who received the intervention experienced a reduction in pain during movement: the mean difference on a 100-mm visual analogue scale was -3.8 mm (95% confidence interval [CI] -9.1 to 1.4 mm) after 2-6 weeks, -4.3 mm (95% CI -7.6 to -0.9 mm) after 10-14 weeks and -7.1 mm (95% CI -11.8 to -2.4 mm) after 22-30 weeks. However, this effect was not compatible with a clinically meaningful difference (expected to be about 15 mm on the visual analogue scale). Furthermore, the effect was exaggerated by trials not reporting an intention-to-treat analysis. No improvement in knee function was observed at any time point. Even so, the effect of hyaluronic acid on knee function was more favourable when allocation was not concealed. Adverse events occurred slightly more often among patients who received the intervention (relative risk 1.08, 95% CI 1.01 to 1.15). Only 4 trials explicitly reported allocation concealment, had blinded outcome assessment and presented intention-to-treat data. INTERPRETATION: According to the currently available evidence, intra-articular hyaluronic acid has not been proven clinically effective and may be associated with a greater risk of adverse events. Large trials with clinically relevant and uniform end points are necessary to clarify the benefit-risk ratio.