Intervention development for integration of conventional tobacco cessation interventions into routine CAM practice.

BACKGROUND: Practitioners of complementary and alternative medicine (CAM) therapies are an important and growing presence in health care systems worldwide. A central question is whether evidence-based behavior change interventions routinely employed in conventional health care could also be integrated into CAM practice to address public health priorities. Essential for successful integration are intervention approaches deemed acceptable and consistent with practice patterns and treatment approaches of different types of CAM practitioners - that is, they have context validity. Intervention development to ensure context validity was integral to Project CAM Reach (CAMR), a project examining the public health potential of tobacco cessation training for chiropractors, acupuncturists and massage therapists (CAM practitioners). This paper describes formative research conducted to achieve this goal. METHODS: Intervention development, undertaken in three CAM disciplines (chiropractic, acupuncture, massage therapy), consisted of six iterative steps: 1) exploratory key informant interviews; 2) local CAM practitioner community survey; 3) existing tobacco cessation curriculum demonstration with CAM practitioners; 4) adapting/tailoring of existing curriculum; 5) external review of adaptations; 6) delivery of tailored curriculum to CAM practitioners with follow-up curriculum evaluation. RESULTS: CAM practitioners identified barriers and facilitators to addressing tobacco use with patients/clients and saw the relevance and acceptability of the intervention content. The intervention development process was attentive to their real world intervention concerns. Extensive intervention tailoring to the context of each CAM discipline was found unnecessary. Participants and advisors from all CAM disciplines embraced training content, deeming it to have broad relevance and application across the three CAM disciplines. All findings informed the final intervention. CONCLUSIONS: The participatory and iterative formative research process yielded an intervention with context validity in real-world CAM practices as it: 1) is patient/client-centered, emphasizing the practitioner's role in a healing relationship; 2) is responsive to the different contexts of CAM practitioners' work and patient/client relationships; 3) integrates relevant best practices from US Public Health Service Clinical Practice Guidelines on treating tobacco dependence; and 4) is suited to the range of healing philosophies, scopes of practice and practice patterns found in participating CAM practitioners. The full CAMR study to evaluate the impact of the CAMR intervention on CAM practitioners' clinical behavior is underway.

Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format.

BACKGROUND: Patients receiving complementary and alternative medicine (CAM) therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately. METHODS: From a database of patient interviews (n = 177) from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation. RESULTS: The resulting questionnaire contained 18 items, in visual analog scale format, in which each line was anchored by the positive and negative extremes relevant to the experiential domain. Because of frequent informant allusions to response set shifts from before to after CAM therapies, we chose a retrospective pretest format. Items cover physical, emotional, cognitive, social, spiritual, and whole person domains. CONCLUSIONS: This paper reports the success of a novel approach to the development of outcome instruments, in which items are extracted from patients' words instead of being distilled from pre-existing theory. The resulting instrument, focused on measuring shifts in patients' perceptions of health and well-being along pre-specified axes, is undergoing continued testing, and is available for use by cooperating investigators.

Medical errors affecting the pediatric intensive care patient: incidence, identification, and practical solutions.

The complexity of patient care and the potential for medical error make the pediatric ICU environment a key target for improvement of outcomes in hospitalized children. This article describes several event-specific errors as well as proven and potential solutions. Analysis of pediatric intensive care staffing, education, and administration systems, although a less "traditional" manner of thinking about medical error, may reveal further opportunities for improved pediatric ICU outcome.

Industry's perception of presenting pharmacoeconomic models to managed care organizations.

BACKGROUND: Previous research has shown that pharmacoeconomic (PE) data are considered important but may not be optimally utilized by decision makers. No research has compared the effectiveness of different types of PE models. OBJECTIVES: The purpose of this study was to examine the perceived value and understanding of PE models among decision makers in managed care organizations. The perspective of this study was from research scientists working in the pharmaceutical industry who present PE models to managed care clients. The study objectives were to (1) examine what types of models are best received by decision makers, (2) investigate the barriers to using PE models, and (3) recommend methods for improving PE models. METHODS: A telephone survey of 39 items was conducted with 20 PE research scientists from various U.S. pharmaceutical and biotechnology companies. Topics addressed included factors contributing to how well PE models are received, barriers to using PE models, and recommendations for improving PE models. RESULTS: Models have an impact on health policy decision making. Nineteen of 20 respondents had at least one experience where a PE model played a role in optimizing the formulary positioning of a product. No single model format (e.g., decision analytic tools, spreadsheet analyses, Markov models, multivariate regression models) was regarded as the most effective model type. Although 7 of 20 respondents said simple spreadsheet models were most effective, well-designed, scientifically sound regression models were also reported to be very effective. CONCLUSIONS: The respondents commonly used models to share PE information, which was said to play a role in making health policy decisions by decision makers in managed care. There was no consensus regarding the type of model that was most effective. Study participants indicated that a variety of model designs are effective, ranging from simple spreadsheet models to multivariate regression models. Recommendations for improving PE models include (1) producing scientifically sound models, (2) customizing models where possible, (3) making models transparent, (4) making models user friendly, and (5) involving a nonbiased third party for model development.

Advances in cardiac intensive care.

PURPOSE OF REVIEW: As surgical survival in children with congenital heart disease, particularly those with univentricular hearts, has improved in recent years, focus has shifted to reducing the morbidity of congenital cardiac malformations and their treatment. This review will focus on emerging therapies aimed at reducing these morbidities in the intensive care unit. RECENT FINDINGS: A protracted stay in the intensive care unit after cardiac surgery is a risk factor for developing various morbidities. Therapies or interventions that may hasten postoperative recovery and minimize the length of stay are thus important to evaluate. Fluid overload, renal dysfunction, low cardiac output and neurological dysfunction remain major contributors to morbidity after cardiac surgery. In addition, the treatment of these adverse states can potentially compound the injury. SUMMARY: The reduction in morbidity after cardiac surgery remains challenging. Recent insights have allowed us to recognize the impact of factors beyond the intraoperative period as significant contributors to morbidity. As our field continues to evolve, future studies should focus on emerging technologies and therapies that facilitate the prevention of physiological states that compound congenital morbidities.