Patients Charting the Course Citizen Engagement and the Learning Health System: Workshop Summary (2011) / Chapter Skim
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7 Applying Evidence for Patient-Centered Care: Standards and Expectations
7 Applying Evidence for Patient-Centered Care: Standards and Expectations
Pages 159-186
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The papers in this chapter address how to apply standards for evidence in the context of individual patient-centered care. They point to the importance of generating evidence applicable to individual patient outcomes, preferences, and values.
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THE ROLE OF EVIDENCE IN PATIENT-CENTERED CARE Dale Collins Vidal, M.D., M.S.1 Dartmouth Institute for Health Policy and Clinical Practice In Crossing the Quality Chasm, the Institute of Medicine (IOM) defines patient-centeredness as "providing care that is respectful of and responsive to individual patient preferences, needs, and values, ensuring that patient values guide all clinical decisions" (IOM, 2001)
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. When treatments are not supported by adequate evidence or when they involve trade-offs that could impact a patient's quality of life, the traditional informed consent process is inadequate for helping patients make informed treatment decisions.
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The Dartmouth Atlas Project2 has 2 See http://www.dartmouthatlas.org/downloads/reports/supply_sensitive.pdf (accessed October 14, 2010)
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The project reports on resource and medical care use among beneficiaries living in 3,436 hospital service areas -- aggregated into 306 hospital referral regions -- examining unwarranted variations in the above three categories of clinical care. It has revealed the presence of significant geographic variations in healthcare prices, practices, and providers; patient characteristics; and patient preferences.
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Yet studies reveal that the typical informed consent process usually does not help patients understand the specific risks and benefits of treatment options (Holmboe et al., 2000)
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. Use of Information Technology to Feed Forward the Right Patient Information at the Right Time Dartmouth-Hitchcock Medical Center uses health information technology resources, such as video decision aids and electronic surveys, to collect information from patients about their health history, behaviors, and health preferences in order to provide them with feedback and decision support and facilitate clear communication at the point of care.
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When treatments are not supported by adequate evidence or when they involve trade-offs that can variably impact a patient's quality of life, the decision-making process should be structured in a way that supports informed patient choice, by incorporating a discussion of treatment alternatives, the best evidence available, and the patient's personal values. At Dartmouth-Hitchcock Medical Center, a patient's self-reported health information is collected by computer systems.
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Although evidence hierarchies have evolved over the last two decades, they are oriented largely toward the relative strength of evidence regarding the causal effect of an intervention on particular health outcomes or other endpoints. In these hierarchies, internal validity is associated with study design, and the resulting evidence hierarchy of primary studies -- i.e., those that collect original data -- typically places RCTs at the top as the "gold standard" for primary evidence.
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Further, while RCTs and other experimental study designs are intended to address the internal validity of the causal effect of an intervention on outcomes, they have been misapplied to other types of research questions pertaining to healthcare technologies, such as the accuracy of a screening or diagnostic test, the prognostic accuracy of a test, or rare or delayed adverse effects of a therapy. As is recognized by some evidence hierarchies, relying on study type alone for assessing the quality of evidence can be misleading.
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Limitations of Randomized Controlled Trials RCTs are usually important, and sometimes essential, components of a rigorous evidence base for demonstrating the causal effects of healthcare interventions on outcomes. However, RCTs have important limitations, including some circumstances in which underlying assumptions about them are not valid (Rawlins, 2008; Walach et al., 2006)
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Improving Evidence Hierarchies Approaches to appraising the quality of evidence must extend beyond single hierarchies of study designs. They must consider the strengths and weaknesses of different study designs for answering specific questions, including the use of certain traditionally lower-ranked observational methods such as examination of large claims databases, patient registries, and electronic health records to supply evidence augmenting that derived from other designs.
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, an Evidence Hierarchy That Includes Explicit Consideration of Intervention Type and Quality of Patient-Oriented Outcomes Assessed Study Quality Diagnosis Treatment/ Level 1 -- Validated clinical SR/meta-analysis of SR/meta-analysis good-quality decision rule RCTs with consistent of good-quality patient- SR/meta-analysis findings cohort studies oriented of high-quality High-quality individual Prospective cohort evidence studies RCT study with good High-quality All-or-none study follow-up diagnostic cohort study Level 2 -- Unvalidated clinical SR/meta-analysis of SR/meta-analysis limited-quality decision rule lower-quality clinical of lower-quality patient- SR/meta-analysis trials or of studies cohort studies or oriented of lower-quality with inconsistent with inconsistent evidence studies or studies findings results with inconsistent Lower-quality clinical Retrospective findings trial cohort study or Lower-quality Cohort study prospective cohort diagnostic cohort Case-control study study with poor study or diagnostic follow-up case-control study Case-control study Case series Level 3 -- Consensus guidelines, extrapolations from bench research, usual practice, other evidence opinion, disease-oriented evidence (intermediate or physiologic outcomes only) , or case series for studies of diagnosis, treatment, prevention, or screening SOURCE: Reprinted with permission from "Strength of Recommendation Taxonomy (SORT)
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For appraising evidence for clinical validity -- whether the gene is associated with a given disease or other phenotype of interest -- Level 1 evidence would consist of well-designed longitudinal cohort studies or a validated clinical decision rule. For clinical utility -- which addresses whether a test result affects clinical decision making or patient outcomes -- the evidence hierarchy resembles the more traditional ones, in which Level 1 evidence would be a meta-analysis of RCTs that followed patients from testing through clinical decisions to outcomes.
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. For example, results of RCTs used to obtain Food and Drug Administration approval could be combined with analyses of patient registry data and longer-term follow-up of outcomes and adverse events through a cohort study to help
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fill important gaps between what works under ideal conditions and what is needed to support real-world clinical practice. Such efforts must not simply use multiple study designs, but must also ensure that the methods are complementary.
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Clinical decision support systems are being designed to make relevant evidence (and evidence-based decision
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Regulators and payers are more explicit about evidence expectations, including study designs and designation of health outcomes and other study endpoints. Bayesian and adaptive clinical trial designs, the focus of increased interest, offer flexible variations on primary data collection that optimize the use of accumulated findings to derive evidence more efficiently for responsive and nonresponsive patient groups (Orloff et al., 2009)
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National Breast Cancer Coalition Approaches to translation and communication needs for health care must take into account the broader context within which the public receives health information. The public receives healthcare information from a variety of sources including healthcare providers, traditional media, the Internet, family and friends, and patient and medical advocacy organizations.
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These findings are similar to those reported in a 2008 Center for Studying Health System Change report. According to that report, health information–seeking behavior differed by education level, with 72 percent of people with a graduate degree seeking information from any source, compared with 42 percent of those without a high school diploma (Tu and Cohen, 2008)
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A Case History: The U.S. Preventive Services Task Force The recent uproar over the USPSTF recommendations for breast cancer screening captures many of the difficulties of communicating health information today.
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As a result, the revised screening recommendations were cast as one more example of "big government rationing health care," which added to the hysteria around the recommendations' release. Moreover, there have for years been simplistic messages about breast cancer screening -- for example, that "early detection saves lives" -- from the American Cancer Society, the National Cancer Institute, patient groups, trade associations, and the media.
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Preventive Services Task Force] has presented some new evi dence for consideration, but our policies remain unchanged.
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. Unfortunately, these attacks dominated the media and the public perception of the updated guidelines, despite the fact that public health and primary care experts supported the recommendations: • The American College of Physicians, a professional organization for physicians specializing in internal medicine, had issued clinical practice guidelines in 2007 for mammography screening among women aged 40–49 that encouraged physicians to carefully assess individual women's risks for breast cancer and discuss with them the potential benefits and harms of mammography screening so they can make informed individual decisions about screening (Qaseem et al., 2007)
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Much work on this front is also being done by others, including Gary Schwitzer with his popular HealthNewsReview blog3; the Dartmouth Institute for Health Policy and Clinical Practice's Center for Medicine and the Media4; and the Foundation for Informed Medical Decision Making.5 3 For more information see http://www.healthnewsreview.org/blog/ (accessed October 15, 2010)
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2009. Shared decision making in health care: Achieving evidence based patient choice.
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2007. Toward the "tipping point": Decision aids and informed patient choice.
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2008. Use of Epoetin and Darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hema tology clinical practice guideline update.
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