A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children's hospital.

BACKGROUND: Low cancer clinical trial (CCT) enrollment may contribute to survival disparities affecting adolescents and young adults (AYAs) (ages 15-39 years). The objective of this study was to evaluate whether differences in CCT availability related to treatment site could explain the low CCT enrollment. METHODS: This prospective, observational cohort study was conducted at an academic children's hospital and its affiliated but geographically separated adult cancer hospital within a National Cancer Institute-designated Comprehensive Cancer Center. For consecutive, newly diagnosed AYA patients, it was determined whether an appropriate CCT existed nationally, was available at the treatment site, and was used for enrollment. Proportions of AYAs in these categories were compared between sites using the chi-square test. RESULTS: One hundred fifty-two consecutive AYA patients were included from the children's hospital (n = 68; ages 15-20 years) and the adult cancer hospital (n = 84; ages 18-39 years). Although there was no difference in CCT existence for individual AYA patients by site (children's hospital [36 of 68 patients; 52.9%] vs adult cancer hospital [45 of 84 patients; 53.6%]; P = .938), CCT availability was significantly lower at the adult cancer hospital (14 of 84 patients [16.7%] vs 30 of 68 [44.1%] at the children's hospital; P < .001). The proportion of AYAs enrolled was low at both sites (8 of 68 patients [11.8%] vs 6 of 84 patients [7.1%], respectively; P = .327). Fewer existing CCTs were available at the adult cancer hospital (4 of 27 patients [14.8%] vs 8 of 14 patients [57.1%], respectively), and those were directed toward solid tumors and new agents. CONCLUSIONS: Efforts to improve low CCT enrollment among AYAs should be differentiated by treatment site. In the adult setting, these efforts should be aimed at improving CCT availability by overcoming site-level barriers to opening existing CCTs.

Case-linked analysis of clinical trial enrollment among adolescents and young adults at a National Cancer Institute-designated comprehensive cancer center.

BACKGROUND: Poor accrual to cancer clinical trials may contribute to the lower improvement in survival observed for adolescents and young adults (AYAs) (those aged 15-39 years) with cancer. This has been difficult to quantify without reliable mechanisms to link incident cases with study enrollments. Using unique resources available at their National Cancer Institute-designated comprehensive cancer center, the authors compared the percentage of AYAs, children, and older adults enrolled onto cancer clinical trials and determined predictors of enrollment. METHODS: Patients diagnosed with cancer from January 2008 through December 2012 at 1 pediatric and 2 adult University of Southern California hospitals were identified through the California Cancer Registry and individually linked to institutional trial enrollment databases. The availability of clinical trials was assessed. RESULTS: Across the center, the enrollment percentage for AYAs (6%) was equal to that of older adults (6%), but was less than that for children (22%) (P < .01). Within the children's hospital, the AYA enrollment percentage was also less than that for children (15% vs 23%, respectively; P<.01). On multivariate analysis, diagnosis and site of care were found to be predictive of AYA enrollment onto therapeutic and nontherapeutic studies. Hispanic and Asian/Pacific Islander individuals were more likely to enroll onto nontherapeutic studies compared with non-Hispanic whites, but no racial/ethnic difference was observed for therapeutic studies. CONCLUSIONS: In the current study, the percentages of AYAs and older adults enrolled onto therapeutic trials were low but similar. Diagnosis, site of care, and race/ethnicity appear to be predictive of enrollment. Prospective mechanisms must be instituted to capture reasons for nonenrollment of AYAs and develop corrective interventions.

Evaluación de un estudio clínico sobre el efecto de la oración intercesora remota en pacientes críticamente enfermos / Critical appraisal of a clinical study on the effect of remote intercessory prayer in severely ill patients

Introducción. Las medicinas alternativas y complementarias son un recurso de salud de amplia difusión en la población general, sin embargo su eficacia clínica es materia de discusión. Algunas instituciones reconocidas en este campo sugieren que las investigaciones sobre los diversos tratamientos deben seguir los mismos requisitos de calidad y de evaluación de la evidencia que las de cualquier intervención médica alopática y someterse a los mismos criterios de verificación de cualquier innovación científica en salud. Objetivo. Evaluar críticamente un ensayo clínico publicado sobre el efecto de la oración intercesora remota (OIR), en pacientes críticos hospitalizados en la unidad de cuidados intensivos. Metodología. Se revisó el estado del arte de la investigación sobre el efecto de la OIR y se describieron puntos de controversia. Se analizó la argumentación que ofrece el estudio y se evaluaron críticamente los aspectos relacionados con el diseño, la recolección de información y la interpretación de resultados. Se utilizó la guía de evaluación elaborada por el National Collaborating Centre of Methods and Tools de McMaster University, del Canadá, que se fundamenta en los criterios compilados por Gordon Guyatt y Drummond Rennie (2002). Resultados. Se observa ausencia de un marco teórico que fundamente el fenómeno de investigación y fallas metodológicas en la distribución aleatoria, el enmascaramiento, la estandarización de la intervención y la valoración e interpretación de los resultados. Conclusión. El estudio no cumple los criterios de calidad de los ensayos clínicos y la evidencia aportada no puede aplicarse a ninguna población. En la literatura científica revisada se menciona que este tipo de problemas son frecuentes en estudios sobre medicinas alternativas.

Introduction. Complementary and alternative medicines are a health resource widespread in the general population, but its clinical efficacy is a matter of discussion. Some recognized institutions in this field suggest that research on complementary therapies should follow the same quality requirements and evaluation of the evidence than any allopathic medical intervention and undergo the same quality standards. Objective. To critically evaluate one published clinical trial on the effect of remote intercessory prayer in critically ill patients hospitalized in an intensive care unit. Methodology. It was done a review of the research on the effect of remote intercessory prayer and a description of the points of dispute. It was made an analysis of the backgrownd and the argument, the methodological issues and the interpretation of results. A guide designed by the National Collaborating Centre of Methods and Tools of McMaster University was used. Results. It was observed an absence of a theoretical framework of research phenomenon and methodological flaws in randomization, blinding, standardization of intervention, outcomes assessment and interpretation of results. Conclusion. The study does not meet the quality criteria of clinical trials and the evidence provided could not be applied to any population. The revised literature mentions that such problems are common in research on alternative and complementary therapies.

Contemporary treatment of unstable angina and non-ST-segment-elevation myocardial infarction (part 2).

In Part 1 of this review, we discussed how plaque rupture is the most common underlying cause of most cases of unstable angina/non-ST-segment-elevation myocardial infarction (UA/NSTEMI) and how early risk stratification is vital for the timely diagnosis and treatment of acute coronary syndromes (ACS). Now, in Part 2, we focus on the medical therapies and treatment strategies (early conservative vs early invasive) used for UA/NSTEMI. We also discuss results from various large randomized controlled trials that have led to the contemporary standards of practice for, and reduced morbidity and death from, UA/NSTEMI. In summary, ACS involving UA/NSTEMI is associated with high rates of adverse cardiovascular events, despite recent therapeutic advances. Plaque composition and inflammation are more important in the pathogenesis of ACS than is the actual degree of arterial stenosis. As results from new trials challenge our current practices and help us develop the optimal treatment strategy for UA/NSTEMI patients, the cornerstones of contemporary treatment remain early risk stratification and aggressive medical therapy, supplemented by coronary angiography in appropriately selected patients. An early-invasive-treatment strategy is of most benefit to high-risk patients, whereas an early-conservative strategy is recommended for low-risk patients. Adjunctive medical therapy with acetylsalicylic acid, clopidogrel or another adenosine diphosphate antagonist, glycoprotein IIb/IIIa inhibitors, and either low-molecular-weight heparin or unfractionated heparin, in the appropriate setting, further reduces the risk of ischemic events secondary to thrombosis. Short- and long-term inhibition of platelet aggregation should be achieved by appropriately evaluating the risk of bleeding complications in these patients.