A Patient-Centered Approach to Comparative Effectiveness Research Focused on Older Adults: Lessons From the Patient-Centered Outcomes Research Institute.

The mission of the Patient-Centered Outcomes Research Institute (PCORI) is to fund the production of high-quality evidence that will enable patients and clinicians to make informed, personalized healthcare decisions. Since 2012, the PCORI has invested $177 million in patient-centered comparative effectiveness research (CER) that specifically targets the health needs of older adults, with additional relevant studies in its broader portfolio. Developing the PCORI's research portfolio has provided us with significant insights into what factors to consider when conducting CER in older adult populations. When comparing the net benefit of two or more interventions for older adults, investigators should consider the following: absolute risk difference, competing risks, life expectancy, the difference between chronologic and physiologic age, the importance of patient preferences, and other potential drivers of variable treatment effects. Investigators should also engage older adults and their caregivers as partners throughout the research process. Their input helps to identify key outcomes of interest and insights about the conduct of the research. As the PCORI continues to support research that addresses the healthcare decisions of the rapidly growing older adult population, it needs to partner with patients and researchers to identify the most important questions to address. J Am Geriatr Soc 67:21-28, 2019.

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.

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.

Algorithms, clinical practice guidelines, and standardized clinical assessment and management plans: evidence-based patient management standards in evolution.

In this issue, Farias and colleagues describe how to develop a clinical care pathway by using a structured, continuous learning process embedded within the day-to-day delivery of care. Their method is called Standardized Clinical Assessment and Management Plans (SCAMPs). A care pathway, such as a SCAMP, includes multiple decision points and related recommendations. The SCAMP process can test the validity of each decision point if clinicians document patient data and record their reasoning when they deviate from the recommended action at a decision point. The unique feature of SCAMPs is that they encourage dissent, unlike clinical practice guidelines (CPGs), algorithms, and bundled electronic health record protocols, which are designed to be followed. If a clinician deviates from the recommended action at a decision point, an explanation is required. This feedback, which should explain why a patient does not precisely "fit" the logic of the care pathway, may lead the SCAMP developers to modify the decision point. The authors of this Commentary argue that SCAMPs and CPGs, two approaches to developing clinical standards of care, are fundamentally equivalent. The key link between them is the recently described process of deconstructing a CPG into the many steps that are necessary to consistently apply it to clinical practice. The SCAMP process puts these steps to the test of daily practice. The Commentary ends with a list of foundational principles for developing standards of clinical care. These principles should apply to care pathways, algorithms, practice guidelines, or SCAMPs.

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

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.