Inter-Rater Agreement of Biofield Tuning: Testing a Novel Health Assessment Procedure.

Objectives: Practitioners of Biofield Tuning assess health status of their clients by detecting off-the-body biofield perturbations using tuning fork (TF) vibrations. This study tested inter-rater agreement (IRA) on location of these perturbations. Design: Three Biofield Tuning practitioners, in randomized order, identified locations of the 4-5 "strongest" perturbations along each of 4 sites for the same series of 10 research subjects. Setting/Location: An Integrative Health and Medicine Center in La Jolla, CA. Subjects: Adult volunteers with no serious current illness and no prior experience of a Biofield Tuning session. Interventions: Practitioners used an activated 174 Hz unweighted TF to "comb" the same four sites per subject, located on the left and right sides of the base of the spine and the heart. Outcome Measures: Practitioners identified and vocalized the distance from the body of perturbations along each site. Distances were recorded by a research assistant in the clinic room. No health information related to perturbation sites was discussed with the subjects. Results: Practitioners reported 6.3 ± 0.6 (mean ± standard deviation) perturbations per combed site per subject, with no significant difference among the raters. The overall level of IRA was low based initially on a first-pass, nonstatistical, analysis of results, with "agreement" defined within a tolerance of ±2 inches. In this approach agreement was 33%. More rigorous statistical analysis, including a statistical test using a Monte Carlo approach, strongly supported the conclusion of poor IRA. Conclusions: IRA was low despite attempts to balance the real-world practice of Biofield Tuning with the constraints of research. For example, while IRA necessitates multiple assessments of the same subject, no information exists as to whether an initial assessment may affect subsequent assessments. Our study exemplifies the challenges faced when attempting to fit interventions with incompletely understood procedures and mechanisms into conventional research designs.

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document.

BACKGROUND: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. METHODS: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. RESULTS: Recommendations were developed for "using available data" and "future clinical studies". The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. CONCLUSION: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.

Effectiveness Guidance Document (EGD) for acupuncture research - a consensus document for conducting trials.

BACKGROUND: There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. METHODS: Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. RESULTS: Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. CONCLUSION: The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.

Randomized Controlled Trials of Acupuncture (1997-2007): An Assessment of Reporting Quality with a CONSORT- and STRICTA-Based Instrument.

The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997-2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5). Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P < .001). Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n = 5). The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community.

Research scholars program: a faculty development initiative at the Oregon College of Oriental Medicine.

BACKGROUND: The Research Scholars Program (RSP) was created at the Oregon College of Oriental Medicine (OCOM) to provide faculty development in research literacy, research-informed clinical practice, and research participation skills. The RSP is part of a broad effort, funded by a National Institutes of Health/National Center for Complementary and Alternative Medicine R25 education grant, to infuse an evidence-based perspective into the curriculum at schools of complementary and alternative medicine. The RSP arose from the realization that this curriculum reform would first necessitate faculty training in both research appreciation and pedagogy. OCOM's grant, Acupuncture Practitioner Research Education Enhancement, is a partnership with the Oregon Health & Science University School of Nursing (OHSU SON). DESIGN: The RSP was developed initially as a collaborative effort among the OCOM Dean of Research (R.H.), OCOM Director of Research Education (S.F.), and an OHSU SON education specialist (K.L.). The 9-month, 8 hours per month seminar-style RSP provides the opportunity for a cohort of OCOM faculty and staff to explore research-related concepts and content as well as pedagogical practices that emphasize interactive, learner-centered teaching. The RSP adheres to a competency-based approach as developed by the Education Committee of the grant. As a tangible outcome, each Research Scholar designs a sustainable learning activity that infuses a research perspective into their courses, clinic supervision, or other sphere of influence at the college. In this paper, we describe the creative process and the lessons learned during the planning and initial implementation of the RSP. CONCLUSIONS: We view the early successes of the RSP as encouraging signs that research literacy and an evidence-based perspective are becoming increasingly accepted as needed skill sets for present-day practitioners of acupuncture and Oriental medicine.

Response to a proposal for an integrative medicine curriculum.

BACKGROUND: A paper entitled "Core Competencies in Integrative Medicine for Medical School Curricula: A proposal," published in Academic Medicine, stimulated a broad discussion among complementary and alternative medicine (CAM) educators. This discussion led to a formal process for responding to the issues raised by the paper. METHODS: Representatives from the Academic Consortium for Complementary and Alternative Health Care (ACCAHC) and the Oregon Collaborative for Complementary and Integrative Medicine (OCCIM) formed the ACCAHC/OCCIM Task Force to participate in a Delphi process of consultation and deliberation. This process led to a broad, cross-discipline agreement on important points to include in a response to the integrative medicine (IM) curriculum proposal. RESULTS: Five key areas of concern emerged: (1) the definition of IM as presented in the paper; (2) lack of clarity about the goals of the proposed IM curriculum; (3) lack of recognition of the breadth of whole systems of health care; (4) omission of competencies related to collaboration between MDs and CAM professionals in patient care; and (5) omission of potential areas of partnership in IM education. CONCLUSIONS: A major overall theme emerging from the Delphi process was a desire for closer collaboration between conventional medical schools and CAM academic institutions in developing IM curricula. Several cross-disciplinary venues for addressing the Delphi Task Force themes include the National Center for Complementary and Alternative Medicine's R-25 Initiatives, and the National Education Dialogue. OCCIM is presented as an example of a successful lateral integration approach.