The Learning Healthcare System Workshop Summary (2007) / Chapter Skim
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1 Hints of a Different Way—Case Studies in Practice-Based Evidence
1 Hints of a Different Way—Case Studies in Practice-Based Evidence
Pages 37-80
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From page 37... ...
. Generating evidence by driving the process of discovery as a natural outgrowth and product of care is the foundational principle for the learning healthcare system.
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Alan H Morris' work with computerized protocols -- termed adequately explicit methods -- demonstrates the considerable potential for such protocols to enhance a learning healthcare system.
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is a form of National Coverage Decision (NCD) implemented by CMS that provides an opportunity to develop evidence on the effectiveness of items or services that have great promise but where there are potentially important gaps between efficacy and effectiveness, the potential for harm without benefit in subpopulations, or an opportunity to greatly enrich knowledge relevant to everyday clinical decision making.
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Specific Examples of CED The National Emphysema Treatment Trial (NETT) , funded by CMS, was a multicenter clinical trial designed to determine the role, safety, and effectiveness of bilateral lung volume reduction surgery (LVRS)
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The trial was conducted with the expectation that it would provide answers to important clinical questions about the benefits and risks of the surgery compared with good medical therapy, including the duration of any benefits, and clarification of which subgroups experienced benefit. Some initial barriers included resistance by the public, which considered it unethical to pay for some patients but not others to receive treatment.
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From page 42... ...
, they are typical of the kinds of evidence often needed to ensure the delivery of appropriate and effective health care. Overarching Issues Affecting CED Several overarching issues will affect the long-term viability of CED as a robust policy that spurs the development of a learning healthcare system.
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When participation in a clinical trial is required as part of coverage, as in the NETT, the authority being used by CMS is based on section 1862(a)
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In the case of the NETT trial, some patients were randomized to best medical care instead of the surgery. In general, it is not unethical to offer services that are unproven only in the context of a clinical trial, when the scientific community is in equipoise regarding the risks and benefits of the service versus usual care and the data are insufficient to support a determination that the service is reasonable and necessary.
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As the healthcare system moves toward increasing standardization of medical information and toward adoption of EHRs more extensively, better clinical detail should be readily available to satisfy CAD requirements, and longitudinal data should be readily accessible to address study questions. At that point, the current scientific infrastructure, the number of qualified researchers, and the appetite of peer-reviewed journals for such data analyses may constitute obstacles to a learning healthcare system.
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From page 46... ...
The following case study illustrates the value of collecting, linking, and utilizing data for pharmacovigilance purposes, outlines key elements necessary to encourage similar efforts, and hints at changes that might develop the potential to discover such insights as a natural outcome of care within a learning healthcare system. A project using a nested, case-control design to look at the cardiovascular effects of the COX-2 inhibitor, rofecoxib, in a large HMO population within Kaiser Permanente (KP)
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From page 47... ...
Using Kaiser Permanente data, Graham et al. examined the potential adverse cardiovascular effects of "coxibs." The nested, case-control study design was enabled by the availability of a broad set of data on Kaiser Permanente members, as well as the ability to match data from impacted and non-impacted members.
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Similar observational studies 1-1 conducted elsewhere, some including propensity scoring, have confirmed these results. In addition, a meta-analysis of related observational studies was also conducted and offers a promising method for strengthening the credibility of observational studies.
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Additionally, unlike in clinical trials, the timing of data collection for registries and in clinical practice varies. Therefore, as we shift to collection of data as part of patient care, nonstandard time points will be a variation that will increasingly compound the issue of missing data.
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qUASI-ExPERIMENTAL DESIGNS FOR POLICy ASSESSMENT Stephen Soumerai, Sc.D. Harard Medical School and Harard Pilgrim Health Care Although randomized controlled trials produce the most valid estimates of the outcomes of health services, strong quasi-experimental designs (e.g., interrupted time series)
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Health policy interventions can be analyzed using interrupted time series using segmented, linear regression. The interrupted time series (ITS)
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Similar time series data again show the remarkable and unintended consequences of this policy. These types of studies can clearly provide good evidence for the effectiveness of health policies but they also have a significant effect on policy.
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1994) , if the findings were applied to all 18 states with drug benefit caps today, it might be possible to reduce hundreds or thousands of nursing home admissions and psychotic episodes, while reducing net government health expenditures.
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. One example is a study done by Tamblyn et al., in which interrupted time series analysis looked at the effect of changes in cost sharing on the elderly and welfare populations in Quebec in terms of the use of essential and nonessential drugs, rate of emergency department visits, and serious adverse events associated with reductions in drug use before and after policy implementation.
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Interrupted time series designs address many threats to validity. As natural experiments, these studies are cheaper and faster than RCTs, can use existing data, and are useful when RCTs are not feasible (e.g., most policies cannot be randomized)
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More quasi-experimental studies of natural experiments are needed, especially on the effects of numerous changes in coverage, cost sharing, and utilization in the Medicare drug benefit. This will require more extensive training of clinical and social scientists, journal editors, and federal study sections to recognize the potential strengths of quasi-experimental design in health policy evaluation.
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Pragmatic or practical clinical trials are designed to inform choices between feasible alternatives or two different treatment options by estimating real-world outcome probabilities for each (Schwartz and Lellouch 1967; Tunis et al.
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For example, on the patient eligibility domain, a maximally pragmatic approach would enroll "all comers" who might benefit from the intervention regardless of prior information about their risk, responsiveness to the intervention, or past compliance. The maximally explanatory trial would enroll only individuals or clusters thought, on the basis of prior information, to be at high risk, highly responsive to the intervention, and who have demonstrated high compliance in a pre-trial test.
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experts, with the goal of developing a valid and reliable instrument for scoring the studies included in systematic reviews. The Medicare program has attempted to build interest in pragmatic clinical trials by highlighting the value of such trials in making national coverage decisions.
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While Medicare now has coverage in place for the use of FDG-PET in cases of suspected dementia and at least two reasonable trial protocols have been developed, funding of the studies has not yet been secured, and there is still currently no access for Medicare patients to PET scanning for AD. Conversations are now under way to discuss how best to expand the infrastructure to support comparative effectiveness research, including PCTs such as the one envisioned by Medicare.
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From page 61... ...
Latter Day Saints Hospital and Uniersity of Utah Adequately explicit methods and computerized protocols could allow researchers to efficiently conduct large-scale complex clinical studies and enable translation of research methods into clinical practice. Additionally, they could formalize experiential learning and provide an innovative means of enhancing education for clinicians and clinical researchers.
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. The disappointingly low quality of critical care clinical trials (Cronin et al.
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This effort should involve a serious engagement with clinical trials. Even with compelling clinical trial results, compliance of physicians with evidencebased treatments or guidelines is low across a broad range of healthcare topics (Evans et al.
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Second and more important, most clinical trials are not conducted with adequately explicit methods. For example, high-frequency ventilation studies in neonates (Courtney et al.
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. Performance In manuscripts currently being prepared, computerized protocol decision support provides exportable and replicable adequately explicit methods for clinical investigation and clinical care.
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This suggests that computerized adequately explicit protocols can function as enabling tools that lead clinician decision-makers to more consistently produce the clinical decisions they desire. Adequately Explicit Methods and Scientific Experimental Requirements Guidelines and protocols can reduce variation and increase compliance with evidence-based interventions, can effectively support clinical decision making (Grimshaw and Russell 1993)
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. The distinction between guidelines and protocols, particularly adequately explicit protocols, is crucial (Morris 1998, 2000a; Holcomb et al.
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From page 68... ...
exist among the multiple variables that may determine subject outcome and can alter or reverse the results of clinical trials (Pocock 1983; Hulley et al. 2001; Hennekens and Buring 1987; Rothman and Greenland 1998; Cochrane-Collaboration 2001)
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From page 69... ...
Adequately explicit computerized protocols have already been implemented for continuous quality improvement, for clinical trials, and for clinical care. Work for the past two decades has been focused on the ICU, because of two enabling ICU attributes: a highly quantified environment and rapid evolution of clinical problems.
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From page 70... ...
Formalizing Experiential Learning as a Means of Enabling a Learning Healthcare System Adequately explicit computerized protocols could supplement traditional peer-reviewed publication with direct electronic communication between research investigators and thereafter between investigators and clinical care users. This could introduce a new way of developing and distributing knowledge.
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From page 71... ...
Adequately explicit computerized protocols could take advantage of an electronic infrastructure and translate research experience into clinical practice by adopting a direct electronic education strategy at the point of care or point of decision making. For example, the adequately explicit instructions of eProtocol-insulin could be linked to a new on-demand explanatory educational representation of the protocol logic.
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2004. Design and Analysis of Clinical Trials.
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From page 73... ...
1998. Fundamentals of Clinical Trials.
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1992. Performance of computerized protocols for the management of arterial oxygenation in an intensive care unit.
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The Pulmonary Artery Catheter Study Group. Critical Care Medicine 22:1674-1678.
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2000. Clinical trials of mediator-directed therapy in sepsis: what have we learned?
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1997. Clinical Trials: A Methodologic Perspectie.
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1983. Clinical Trials: A Practical Approach.
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1997. Determinants of change in Medicaid pharmaceutical cost sharing: does evidence affect policy?
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2003. Practical clinical trials: increasing the value of clini cal research for decision making in clinical and health policy.
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