Report to the AHNA Membership regarding Integrative Health Care Policy Consortium
9/27-/9/28/10 Washington, DC
By Rorry Zahourek, AHNA Leadership Council Research Coordinator
This report will focus on the research issues that came up in the conference I attended from 9/27- 9/29 in Washington DC. The conference, “The Affordable Care Act and Beyond: A Stakeholder Conference on Integrated Health Care Reform” was sponsored by the Integrated Healthcare Policy Consortium.
The participants represented their organizations, which included acupuncturists, chiropractors, naturopaths, homeopaths, massage therapists and nurses who were representing their clinical or educational institutions. I represented AHNA. The president of Samueli Institute, Dr. Wayne Jonas, and the director of NCCAM, Dr. Josephine Briggs attended and spoke. Several astute others who were knowledgeable about government and the political and legal process involved with implementing a controversial law also participated.
The following is a brief summary of the law [The Patient Protection and the Affordable Care Act (PPACA)] and how research in the future might be influenced.
Overall there is now an increased emphasis on research that reflects ‘real situations’ and ‘real patient’ responses.
The following is a summary of some of the implications for research:
As stated in the law: Experts in Integrative Health and State Licensed Integrative Health Practitioners will participate in Comparative Effectiveness Research. An institute called the “Patient-Centered Outcomes Research Institute” (PCORI) is being formed which will identify research priorities and establish a research project agenda. These priorities will “take into account factors of disease incidence, prevalence, and burden in the United States (with emphasis on chronic conditions), gaps in evidence in terms of clinical outcomes, practice variations and health disparities in terms of delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities in the National Strategy for quality care”. The institute will determine the research agenda and methods to conduct the research based on the priorities. This will include RCTs, systematic reviews as well as other methodologies deemed appropriate by the committee.
Dr. Ian Coulter from the Rand Corporation and Samueli Institute discussed comparative effectiveness research (CER) one of the emphases in the new PPACA. First he compared effectiveness with efficacy. Effectiveness research is done in real patient settings where decisions are made based on individual needs. It takes into account the whole situation and is grounded in what actually occurs in the encounter. This research is pragmatic rather than explanatory. Effectiveness research helps us deal with the issue of sham treatments and placebo trials in randomized controlled trials (RCTs). It resembles program evaluation and may use qualitative approaches that value people’s response and reactions. In contrast efficacy studies test a therapy under ideal conditions. Application in clinical settings is not always evident.
Dr. Coulter advocates for ‘health services research which links structure, process and outcomes and measures quality of care’. Such research also evaluates access, cost, utilization, and services and measures needs and risks. It determines patient values, satisfaction and HRQOL and uses methods other than RCTs. It is recommended that the emphasis from the IOM (1979) be followed: “Investigation of the relationship between social structure, process and outcomes for personal health services, a transaction between a client and a provider to promote health”. In this model there is value on sociological anthropological observation studies as well as on various other methodologies.
PCORI- The Patient Centered Outcomes Research Institute was authorized through PPACA as an independent nonprofit corporation that aims to assist patients, clinicians, purchasers and policy makers in making informed health decisions by advancing the quality and relevance of evidence. It is responsible for identifying research priorities and establishing and carrying out research project agendas.
The specific duties include:
- Identify research priorities
- Establish research project agenda
- Carry out agenda
- Appoint advisory panels
- Support patient consumer representatives
- Establish a methodology committee
- Provide peer-review process for primary research
- Release all research findings
- Annual reports
It is important that people skilled in various methodologies be appointed to the methods panel. There was a lot of discussion at the conference about this and the timely nature of doing this right away. Several names were submitted of people who were knowledgeable about integrative care and also skilled methodologists. These people however have to be willing to serve and then be acceptable to the board of governors.
If you know anyone you would like to recommend please contact me at firstname.lastname@example.org.
This institute has a board of governors on which there is one integrative practitioner (Chiropractor) and one PhD nurse, Debra Barksdale for University of North Carolina. The rest of the board is MD’s and some JD’s.
Resources to understand the law and its implications are: ANA web site and The Integrator Blog article, “Reference Guide: Language/Sections on CAM and Integrative Practice in HR 3590-Healthcare Overhaul” May 12, 2010.
NIH has allocated 1.1 billion dollars to effectiveness research. NCCAM recognizes the value but there are questions about the potential follow through based on the current NCCAM strategic plan. See below. (Unfortunately, the comment period on this plan has closed. It is still important to be aware of the implications of the draft plan.)
NCCAM’s strategic plan for research 2010. Draft
Draft: 3 Overall goals
1. Advance the science and practice of symptom management
2. Develop effective practical personalized strategies for promoting health and well being
3. Enable better evidence-based decision making regarding CAM use and its integration into health care and health promotion.
- Advance research on CAM pharmacological interventions
- Advance research on mind/body and manipulative/manual CAM interventions and practices
- Increase understanding of ‘real world’ patterns and outcomes of CAM use and it integration into health care and health promotion
- Improve capacity of the field to carry out rigorous research
- Develop and disseminate objective, evidence-based information on CAM interventions
(Note that the top objective continues to be a focus on dietary supplements and natural products (CAM pharmacological research) and RCTs as a result.
The range of research questions that NCCAM will address include:
- Basic science: How does it work?
- Translational research: Can it be studied in people?
- Efficacy: What are the specific effects?
- Effectiveness: How effective is it in the real world settings
Of the 4 only one (#4) is more grounded in the real clinical world
Some of the comments they have received:
- need to evaluate CAM as actually practiced
- need to focus on symptoms, healthy behavior rather than diseases
- collaborate with others – organizations and disciplines
Concerns have been voiced about the continued emphasis on the RCT as the gold standard. That NIH, the parent organization, will demand that be continued
Concerns about what has been left out…. research in biofield interventions.
To see the NCCAM strategic plan, please click here. You will also be able to read summaries of comments made by the public regarding the plan
For discussion of the implications of NCCAM’s strategic plan, please see the Integrator Blog article and review the comments as well.
Hassmiller, S. Nursing’s role in healthcare reform. American Nurse Today 5(9), 68-69.