RESUMO
Despite the fact that the hepatocellular carcinoma (HCC) represents a major health problem, very few interventions are available for this disease, and only sorafenib is approved for the treatment of advanced disease. Of note, only very few interventions have been thoroughly evaluated over time for HCC patients compared with several hundreds in other, equally highly lethal, tumours. Additionally, clinical trials in HCC have often been questioned for poor design and methodological issues. As a consequence, a gap between what is measured in clinical trials and what clinicians have to face in daily practice often occurs. As a result of this scenario, even the most recent guidelines for treatment of HCC patients use low strength evidence to make recommendations. In this review, we will discuss some of the potential methodological issues hindering a rational development of new treatments for HCC patients.
Assuntos
Carcinoma Hepatocelular/terapia , Ensaios Clínicos como Assunto/métodos , Neoplasias Hepáticas/terapia , Projetos de Pesquisa , Bibliometria , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/mortalidade , Carcinoma Hepatocelular/patologia , Determinação de Ponto Final , Medicina Baseada em Evidências , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/mortalidade , Neoplasias Hepáticas/patologia , Imageamento por Ressonância Magnética , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Fatores de Risco , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
OBJECTIVE: Examine the reproducibility of the RAND method for developing criteria for the appropriateness of medical procedures. DESIGN: Comparison of two sets of explicit criteria for appropriateness of upper gastrointestinal (UGI) endoscopy, developed by separate expert panels from two countries. SETTING: United States, Switzerland. STUDY PARTICIPANTS: National experts from different medical specialties involved in the referral or application of UGI endoscopy. INTERVENTIONS: Each panel was presented with about 500 clinical scenarios (indications) that were rated on a nine-point scale as to the appropriateness of performing UGI endoscopy for a patient with that clinical presentation. MAIN OUTCOME MEASURES: (1) distribution of appropriateness ratings and intrapanel agreement categories between the two panels, (2) between-panel agreement of assigning appropriateness for comparable indications and, (3) percentage of indications with major between-panel differences. RESULTS: Ratings for 2/3 of indications could be compared. The Swiss panel showed higher intrapanel agreement (54.6% versus 46.2%, P = 0.002). Seventy-eight per cent of comparable indications were assigned to identical categories of appropriateness by both panels (kappa = 0.76, P < 0.001). For 93% of the 376 comparable indications, there were no major interpanel differences. CONCLUSION: Separate expert panels in different countries, using a standardized methodology, produce criteria for appropriateness of medical procedures that are similar. Given the resources being invested throughout the world in developing criteria and guidelines, international collaboration in seeking optimal use of limited health care resources should be intensified.
Assuntos
Endoscopia Gastrointestinal/normas , Cooperação Internacional , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Avaliação de Processos em Cuidados de Saúde , Pesquisa sobre Serviços de Saúde , Humanos , Reprodutibilidade dos Testes , Suíça , Avaliação da Tecnologia Biomédica , Estados UnidosRESUMO
BACKGROUND & AIMS: Efforts to reduce costs in health care may raise concerns about underuse of medical procedures. This study prospectively assessed underuse of upper gastrointestinal endoscopy in a cohort of patients in whom we have recently published data on overuse of endoscopy. METHODS: Underuse was identified by formal necessity criteria for endoscopy, obtained by an explicit panel process. Outpatients were consecutively included in two clinical settings. Setting A consisted of 20 primary care physicians and 7215 patient visits that occurred within 1 month. Setting B consisted of 920 visits that occurred during 3 weeks at an outpatient clinic. RESULTS: During these 8135 visits, 611 patients complained of upper digestive symptoms; 63 of them underwent endoscopy. Underuse was identified in 72 patients (11.8%). The two clinical situations mainly responsible for underuse of endoscopy were uninvestigated peptic symptoms resistant to treatment and dysphagia. At first follow-up, 29 of the patients with initial underuse still fulfilled criteria of necessity (underuse rate, 4.7%). One-year follow-up showed underuse of endoscopy in 5 patients. CONCLUSIONS: This prospective evidence shows that underuse of a medical procedure exists. The estimated overuse and underuse of endoscopy in this cohort were approximately equal (5%). Improving quality of care will require reductions of both overuse and underuse of medical procedures.