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Health services
research, with data from both patients and providers on effectiveness,
satisfaction, safety, and cost, have a focus of the Integrative
Medicine Institute. We have helped create data collection networks
in partnership with other researchers linking healthcare practitioners,
patients, and academic medical centers in Europe and the United
States. Dr. Riley continues to collaborate in clinical trials
including randomized controlled clinical trials from the initial
trial design through the final report in collaboration with
partners in the healthcare industry and academia. He has been
involved in protocol development, site selection, clinical investigators
selection, subjects recruitment, trial management, monitoring,
data analysis, and the final report and medical publications.
IMI's efforts to improve patient care through ongoing evaluation
of practices integrating complementary and alternative therapies
will build on the published outcome studies and research experience
of the Integrative Medicine Institute and can be classified
into several categories:
- Ongoing
development and expansion of the health services research
focusing on an ongoing data collection to encompass a core
group of CAM therapies and their integration with conventional
medicine. This data is being used to evaluate clinical outcomes
including clinical events and diagnoses, quality of life,
mortality, and therapy specific measures;
- Development
of evidence based treatment guidelines.
- Provide
the evidence to plan and implement evidence based research
rather than continuing to "shoot in the dark" without
relevant practice based data. Selected Research Projects in
Development or Completed
1. One main
research interest of the Integrative Medicine Institute was
a health services research project expanding on IIPCOS-I (David
Riley et al, March 2001 Vol.7:2, Journal of Complementary and
Alternative Medicine Research). Dr. Riley was involved in the
planning of a multi-center practice based project linking patients
and providers. This are of medicine needs a practice based research
network gathering practice-based data to facilitate the design
of clinical trials and support the ongoing evidence-based integration
of complementary and alternative medical therapies into the
mainstream delivery of healthcare.
There have been two major stumbling blocks to this type of health
services research:
- Complementary
and alternative medicine (CAM) has historically been a consumer
driven movement. The demand by the conventional medical establishment
for randomized controlled clinical trials is understandable
but puts “the cart before the horse”. Data is
first needed on when, how, and why providers and patients
are using these therapies as well as provider and patients
assessments of effectiveness, satisfaction, and costs. These
data can provide a platform for assessing efficacy and effectiveness
in rationally designed randomized controlled trials.
- There
are three key stakeholder groups in the field of Integrative
Medicine: patients, providers, and the scientific community.
The academic medical community - a key partner - does not
have the clinical infrastructure nor the support to deliver
a truly integrative model of healthcare, it is set up to evaluate
therapies that fit solely within the existing accepted scientific
paradigm. Perhaps even more importantly, it does not have
easy access to either the provider community practicing Integrative
Medicine or the patient community seeking it. The academic
community investigating CAM will benefit enormously from this
network.
This type of research will create a foundation of information
from which high quality research can be designed. It will
create the credibility and momentum necessary to advance Integrative
Medicine and impact the delivery of healthcare without becoming
another “this therapy for that disease”.
Here is
how and why:
- Patient
involvement is critical and patient’s perception of
outcome and satisfaction is a key ingredient.
- Patient
participation needs to be independent of the practitioner.
- Practitioner
involvement, particularly those with an active clinical practice
is essential.
- The academic
medical world involved with CAM with some key exceptions is
often a stratified type of healthcare that does not translate
well into real-world medical care or Integrative Medicine.
If the practice-based
data collection network is useful and supports the clinical
practice of medicine practitioners will participate. Use of
the ABC codes from Alternative Link is an obvious first step.
Practitioners should have access to their own personal
data as well as aggregate data from their medical specialty.
This is
health services research. An organized scientific structure
with academic involvement through experts in health services
is important. Other key stakeholders in complementary and alternative
medicine would need to be involved. This project is not a randomized
controlled clinical trial; the buy-in for the academic community
is the data from which other types of clinical research could
be developed.
2. Clinical
trials on the use of complementary and alternative medicine
in the neurosciences. Dr. Riley has the lead consultant
with Conemaugh Health System and the John P. Murtha Neuroscience
Center in Johnstown, PA on the use of complementary therapies
in the neurosciences. The have include Hatha Yoga, mind-body
stress reduction, and the Stanford program “Healthy Living
with a Chronic Condition” for post-polio syndrome and
Charcot Marie Tooth. Other planned studies include acupuncture
for migraine headaches, and Hatha yoga for chronic low back
pain.
3. The International
Integrative Primary Care Outcomes Study (IIPCOS-1) was a prospective
outcomes study comparing patients treated by conventionally
licensed providers integrating homeopathy into their practices
with conventionally licensed providers who use only conventional
medicine. The first phase studied three complaints commonly
encountered in primary care, upper and lower respiratory tract
complaints, and ear complaints. Data was collected on the effectiveness
and safety of homeopathic treatment in every day clinical practice
and included information on cost effectiveness. Six study centers
in five countries participated in this first phase of IIPCOS
with more than 800 patient visits. Phase I was completed in
1997 and the results were published in the Journal of Complementary
and Alternative Medicine Research in March 2001, Vol7(2). Phase
II was completed in 2000 with more than 3,000 patients.
4. Dr. Riley
has conducted more than 60 homeopathic drug provings. They are
similar to phase I clinical trials using conventional and CAM
research methods. These clinical trials began in 1992 and continue
today with over 60 completed to date. He has incorporated the
good clinical practice (GCP) guidelines of the European Community
and the Food and Drug Administration (FDA) to raise the standards
of homeopathic drug provings to a higher level of scientific
rigor.
5. Dr. Riley is involved in a series of basic science research
projects using the quantitative gene expression assays from
Source Precision Medicine to evaluate the action of complementary
and alternative medicine. He was the scientific coordinator
of a multi-year international series of conferences sponsored
by the Fetzer Institute and other health care foundations to
evaluate potential "mechanism of action" theories
for homeopathy.
6. Dr. Riley continues to collaborate in clinical trials including
randomized controlled clinical trials from the initial trial
design through the final report in collaboration with partners
in the healthcare industry and academia.
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Contact: Integrative
Medicine Institute, 6 Amigos Lane, Santa Fe NM 87508
505-983-0546 •
FAX 505 984-9938 • E-mail: dsriley
at integrativemed.org
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