Monday, July 29, 2013

3 New From Biomed Central

Coulter ID, Herman PH, Nataraj S. Economic analysis of complementary, alternative, and integrative medicine: considerations raised by an expert panel. BMC Compl Alternative Med 2013, 13:191 doi:10.1186/1472-6882-13-191

Background: An international panel of experts was convened to examine the challenges faced in conducting economic analyses of Complementary, Alternative and Integrative Medicine (CAIM).
Methods: A one and a half-day panel of experts was convened in early 2011 to discuss what was needed to bring about robust economic analysis of CAIM. The goals of the expert panel were to review the current state of the science of economic evaluations in health, and to discuss the issues involved in applying these methods to CAIM, recognizing its unique characteristics. The panel proceedings were audiotaped and a thematic analysis was conducted independently by two researchers. The results were then discussed and differences resolved. This manuscript summarizes the discussions held by the panel members on each theme.
Results: The panel identified seven major themes regarding economic evaluation that are particularly salient to determining the economics of CAIM: standardization (in order to compare CAIM with conventional therapies, the same basic economic evaluation methods and framework must be used); identifying the question being asked, the audience targeted for the results and whose perspective is being used (e.g., the patient perspective is especially relevant to CAIM because of the high level of self-referral and out-of-pocket payment); the analytic methods to be used (e.g., the importance of treatment description and fidelity); the outcomes to be measured (e.g., it is important to consider a broad range of outcomes, particularly for CAIM therapies, which often treat the whole person rather than a specific symptom or disease); costs (e.g., again because of treating the whole person, the impact of CAIM on overall healthcare costs, rather than only disease-specific costs, should be measured); implementation (e.g., highlighting studies where CAIM allows cost savings may help offset its image as an "add on" cost); and generalizability (e.g., proper reporting can enable study results to be useful beyond the study sample).
Conclusions: The business case for CAIM depends on economic analysis and standard methods for conducting such economic evaluations exist. The challenge for CAIM lies in appropriately applying these methods. The deliberations of this panel provide a list of factors to be considered in meeting that challenge.

Agich G. Education and the improvement of clinical ethics services. BMC Med Educ 2013, 13:41 doi:10.1186/1472-6920-13-41
The proliferation of clinical ethics in health care institutions around the world has raised the question about the qualifications of those who serve on ethics committees and ethics consultation services. This paper discusses some of weaknesses associated with the most common educational responses to this concern and proposes a complementary approach. Since the majority of those involved in clinical ethics are practicing health professionals, the question of qualification is especially challenging as the role of ethics committees and, increasingly, ethics consultation services are becoming increasingly important to the functioning of health care institutions. Since the challenging nature of health care finances often leads institutions to rely on voluntary participation of committed health professional with only token administrative or clerical support to provide the needed ethics services, significant challenges are created for attaining competence and functional effectiveness. The article suggests that a complementary approach should be adopted for sustaining and building capacity in clinical ethics. Ethics committees and consultation services should systematically adopt quality improvement techniques to effect designed changes in clinical ethics performance and to build ethical capacity within targeted clinical units and services. Demonstrating improvements in functioning can go a long way to build confidence and capacity for clinical ethics and can help in justifying the need for support. To do so, however, requires that ethics committees and consultation services first shift attention to those areas that demonstrate weak or questionable ethical performance, including the established practices of the ethics committee and consultation service, and second seek collaboration with the involved health care providers to pursue demonstrable change. Such an approach has a much better chance of improving the capacity for clinical ethics in health care institutions than relying on educational approaches alone.
Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick J. Improving understanding in the research informed consent process:a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics 2013, 14:28 doi:10.1186/1472-6939-14-28
Background: Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.
Background: To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods.
Methods: The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus.Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs.39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions.A data extraction form was created in Distiller, an online reference management system, through an iterative process.One author collected data on study design, population, demographics, intervention, and analytical technique.
Results: Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84).By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats.
Conclusions: Enhanced consent forms and extended discussions were most effective in improving participant understanding. Multimedia interventions, for all interventions, it is clear that they are of no threat to participant satisfaction levels or rates of accrual into studies.


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