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6 Building a Foundation for Knowing What Works in Health Care
Pages 153-178

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From page 153...
... This chapter considers three alternative approaches to building the Program infrastructure: the status quo, a central agency model, and a hybrid model. In the previous chapters, the committee found convincing evidence that systematic reviews and clinical guidelines are often of poor quality, lacking scientific rigor and objectivity.
From page 154...
... that financial and other types of conflicts of interest may compromise the integrity of research findings and related clinical recommendations, indications that a meaningful proportion of evidence reviews frequently lack scientific rigor, and current efforts fall far short of addressing patients' and health professionals' need for current, trustworthy information on clinical effectiveness. The committee particularly wants to ensure that its recommended Program will be stable over the long term, that its output be judged as objective and meeting broadly accepted standards of scientific rigor, that it will be useful to stakeholders, that it is without conflict of interest or bias, and that its operations be independent of external political pressures.
From page 155...
... Accountability For the Program, accountability refers to accepting the responsibility to meet and demonstrate compliance with a set of program performance standards. Under the status quo, a meaningful proportion of systematic reviews of clinical effectiveness are proprietary and their findings are available only to those who pay for them.
From page 156...
... Scientific rigor Methods minimize bias, provide reproducible results, and are completely reported. Transparency Methods are explicitly defined, consistently applied, and avail able for public review so that observers can readily link judg ments, decisions, or actions to the data on which they are based.
From page 157...
... This lesson has been repeated numerous times during the decades of on-and-off federal involvement in research on clinical effectiveness (Congressional Budget Office, 2007)
From page 158...
... . The investigators analyzed the need for updates of 100 clinically relevant systematic reviews of drugs, devices, and procedures that signaled the need for an update, such as new trial evidence reversing the findings of an earlier effectiveness review.
From page 159...
... . However, as noted earlier, there is considerable evidence indicating that many systematic reviews do not meet scientific standards (Gøtzsche et al., 2007; Moher et al., 2007)
From page 160...
... Scope, Priority Setting, and Evidence Assessments in Selected National Programs Systematic, detailed information on the operations of most national clinical effectiveness programs is limited, and studies assessing and comparing the impacts of these programs are even more limited (Oliver et al., 2004)
From page 161...
... . The programs in Australia, Canada, Germany, and the United Kingdom assess both clinical effectiveness and cost-effectiveness (Table 6-2)
From page 162...
... Medical Services Safety, effectiveness, and Medical profession, industry, External health technology Coverage (advisory Advisory Committee cost-effectiveness of new or others seeking coverage for assessment organizations to Minister of (MSAC) (Australia)
From page 163...
... . Another insight from the international experience with programs that assess clinical effectiveness is that the mere development and publication of information, even by the most authoritative sources, are not in and of themselves sufficient to ensure changes in policy and practice (Battista, 2006; Oliver et al., 2004)
From page 164...
... Both alterna TABLE 6-3  Alternative Approaches to Organizing the Program: Administrative Structure and Primary Functions Organizational Feature or Function Status Quo Structure Administrative infrastructure No change. Degree of program control over There is no change, except when sponsored by the clinical effectiveness assessment AHRQ Effective Health Care Program.
From page 165...
... Status Quo As the previous chapters described, the committee found convincing evidence that systematic reviews and clinical guidelines are often of poor quality, lacking scientific rigor and objectivity. Under the status quo, systematic reviews and clinical guidelines are produced by numerous public Agency Model Hybrid Approach Infrastructure is sufficient to support Infrastructure is sufficient to support significant expansion in evidence assessment significant expansion in and to develop and to develop standards for evidence standards for systematic reviews, clinical assessments, clinical guidelines, and bias guidelines, and bias protections.
From page 166...
... It would have broad authority to fund, carry out, and control the full range of analytic tasks: setting priorities for systematic reviews, producing systematic reviews, and developing clinical guidelines -- all in accordance with mandatory Program standards. Some or all of the Program's procedures could be based in statute (e.g., mandatory priority setting criteria)
From page 167...
... Central agency is Moderate to high. Program is directly Parties are directly guidelines are often proprietary or directly responsible for and reports responsible for priority setting and responsible for available only to members.
From page 168...
... conflict of interest, priority setting, and conflict of interest is production of systematic reviews that minimized minimize statistical bias. Reliance on disclosure of compliance with common standards and end user preference for guidelines produced according to standards.
From page 169...
... Process maximizes Methods minimize may not be used; errors and poor Program standards; program funding likelihood that priority setting and bias, are reliable, documentation are common. ensures that resources are available systematic reviews would meet scientific and completely to support rigorous work.
From page 170...
... In contrast with the agency model, the hybrid model assumes that existing independent entities -- professional medical societies, payers, practice measurement groups, and others -- would continue to develop clinical guidelines. The Program would actively encourage these organizations to voluntarily adopt Program standards for guideline development.
From page 171...
... The Program should • set priorities for, fund, and manage systematic reviews of clinical effectiveness and related topics; • develop a common language and standards for conducting system atic reviews of the evidence and for generating clinical guidelines and recommendations; • provide a forum for addressing conflicting guidelines and recom mendations; and • prepare an annual report to Congress. Recommendation: The secretary of Health and Human Services should appoint a Clinical Effectiveness Advisory Board to oversee the Pro gram.
From page 172...
... The Program should •  priorities for, fund, and manage systematic reviews of clinical effectiveness set and related topics; • develop a common language and standards for conducting systematic reviews of the evidence and for generating clinical guidelines and recommendations; • provide a forum for addressing conflicting guidelines and recommendations; and • prepare an annual report to Congress. The secretary of Health and Human Services should appoint a Clinical Effectiveness Advisory Board to oversee the Program.
From page 173...
... Developing Trusted Guidelines (Chapter 5) Groups developing clinical guidelines or recommendations should use the Program's standards, document their adherence to the standards, and make this documentation publicly available.
From page 174...
... 2006. Health technology assessment http://www.cadth.ca/index.php/en/hta/ (accessed March 28, 2007)
From page 175...
... 1995. Setting priorities for clinical practice guidelines.
From page 176...
... 2004. Health technology assessment and its influ ence on health-care priority setting.
From page 177...
... 2005. Health technology assessment: An introduction to objectives, role of evidence, and structure in Europe.


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