Quality Improvement Summit 2016: Shared Decision Making and Prostate Cancer Screening.

INTRODUCTION: The American Urological Association Quality Improvement Summit occurs regularly to provide education and promote dialogue around the issues of quality improvement and patient safety. Nearly all prostate cancer screening guidelines recommend shared decision making strategies when determining whether prostate specific antigen testing is right for a specific patient. This summit, held in partnership with the Society for Medical Decision Making, focused on techniques to identify and understand patient values in relation to prostate cancer screening and treatment, and to promote incorporation of shared decision making into prostate cancer screening discussions. METHODS: Information presented at the Quality Improvement Summit was provided by physicians and leading experts in the field of shared decision making. The open forum of this summit encouraged contributions from participants about their personal experiences with shared decision making and their thoughts on the tools presented during the day. RESULTS: Shared decision making supports collaboration between physician and patient in situations where there are multiple preference sensitive options. CONCLUSIONS: Practitioners should include formal shared decision making procedures surrounding prostate specific antigen testing in their practices to ensure that testing is in accordance with patient values and desired outcomes. Tools and strategies like those reviewed in this Quality Improvement Summit are invaluable for alleviating potential burden on providers, ensuring communication and improving quality of care.

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research.

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

Declaración SPIRIT 2013: definición de los elementos estándares del protocolo de un ensayo clínico / SPIRIT 2013 Statement: defining standard protocol items for clinical trials

El protocolo de un ensayo clínico es la base para planificar, ejecutar, publicar y evaluar el ensayo. Sin embargo, los protocolos y las guías que existen para su elaboración varían enormemente en cuanto a su calidad y contenido. En este artículo se describe la elaboración sistemática y el alcance de la Declaración SPIRIT 2013 (denominada así por la sigla en inglés de Standard Protocol items: Recommendations for Interventional Trials o Elementos estándares de un protocolo: recomendaciones para los ensayos de intervención), una guía en la que se establecen los contenidos mínimos que debe tener el protocolo de un ensayo clínico. La lista de comprobación de la declaración SPIRIT, que consta de 33 elementos, se aplica a los protocolos de todos los ensayos clínicos y se centra más en el contenido que en el formato. En esta lista se recomienda hacer una descripción completa de lo que se ha planificado, aunque no se establece cómo diseñar o ejecutar un ensayo. Al brindar orientación sobre los contenidos fundamentales, las recomendaciones SPIRIT procuran facilitar la redacción de protocolos de alta calidad. El cumplimiento de las recomendaciones SPIRIT debería mejorar la transparencia y la exhaustividad de los protocolos de los ensayos en beneficio de los investigadores, los participantes, los pacientes, los patrocinadores, los financiadores, los comités de ética de la investigación o las juntas de revisión institucionales, los revisores, las revistas biomédicas, los registros de ensayos, los formuladores de políticas, los organismos reguladores y otras partes interesadas clave.

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Assessing progress in reducing the burden of cancer mortality, 1985-2005.

PURPOSE: Measuring the effect of cancer interventions must take into account rising cancer incidence now that people live longer because of declines in mortality from cardiovascular disease (CVD). Cancer mortality rates in the population do not accomplish this objective. We sought a measure that would reveal the effects of changing mortality rates from other diseases. METHODS: We obtained annual breast, colorectal, lung, and prostate cancer mortality rates from the Surveillance, Epidemiology, and End Results registries; we obtained noncancer mortality rates from national death certificates, 1975 to 2005. We used life-table methods to calculate the burden of cancer mortality as the average person-years of life lost (PYLL) as a result of cancer (cancer-specific PYLL) and quantify individual-and perhaps offsetting-contributions of the two factors that affect cancer-specific PYLL: mortality rates as a result of cancer and other-cause mortality. RESULTS: Falling cancer mortality rates reduced the burden of mortality from leading cancers, but increasing cancer incidence as a result of decreasing other-cause mortality rates partially offset this progress. Between 1985 and 1989 and between 2000 and 2004, the burden of lung cancer in males declined by 0.1 year of life lost. This decline reflects the sum of two effects: decreasing lung cancer mortality rates that reduced the average burden of lung cancer mortality by 0.33 years of life lost and declining other-cause mortality rates that raised it by 0.23 years. Other common cancers showed similar patterns. CONCLUSION: By using a measure that accounts for increased cancer incidence as a result of improvements in CVD mortality, we find that prior assessments have underestimated the impact of cancer interventions.

Reconciling primary care and specialist perspectives on prostate cancer screening.

When specialists propose screening guidelines for primary care clinicians to implement, differences in perspectives between the 2 groups can create conflicts. Two recent specialty organization guidelines illustrate this issue. The American Urological Association guideline panel and National Comprehensive Cancer Network recommend that average-risk men first be counseled about the risks and benefits of prostate-specific antigen screening for prostate cancer at age 40 rather than at the previously recommended age of 50 years. There is no direct evidence, however, that this recommendation has any impact on prostate cancer-specific mortality. To avoid distracting primary care clinicians from providing services with proven benefit and value for patients, professional organizations should follow appropriate standards for developing guidelines. Primary care societies and health care systems should also be encouraged to evaluate the evidence and decide whether implementing the recommendations are feasible and appropriate.