|
Back
PRACTICE
OUTCOMES DOCUMENTATION SYSTEMS (PODS)
INTRODUCTION
Many local
medical practices around the world fall outside those
used in mainstream hospitals and
clinics in the West. Few of these practices have
been scientifically examined, although many
claim dramatic benefit for serious disease.
One of the first steps in their evaluation is
objective documentation of these
effects. Since most clinics do not collect
sufficient information to evaluate the effects,
prospective data collection systems are needed to
assess which practices warrant more
extensive investigation. The Practice Outcomes
Documentation Systems (PODS) will serve this
purpose.
PROCEDURE AND COMPONENTS
Participants (with consultants) jointly identify and
prioritize practices for evaluation. Practices claimed
by local people to be effective in the prevention and
treatment of infectious disease (malaria, hepatitis C,
HIV, tuberculosis), cancer, depression and
heart disease are our highest priority. The Samueli
Institute will dedicate a
full-time epidemiologist to run the program. The
epidemiologist will develop PODS
protocols in conjunction with: the local practitioners,
local research nurse/investigator for data
collection and training, population/condition
expert for determining outcomes measurement,
and local hospitals, laboratories,
and Investigational Review Boards (IRB) for
data collection and research approval. The
program will also establish timelines, cost estimates,
and milestone papers and reports, as well as
coordination mechanisms with participants and
sponsors. Each PODS protocol will
include:
-
The location and practice to be evaluated
-
Data and outcomes to be collected
-
Pilot phase before full sample study
-
Contract agreements with practitioners and
researchers at the location, and any required
local government approvals
-
All documents for informed consent, IRB and
human use approval
-
All collection procedures, data collection
forms and transmittal procedures
-
Individuals to collect and verify data
-
Quality assurance procedures
-
Timelines for protocol approvals, local
approvals, data collection forms development
and training procedures, scientific review, start
dates for pilot and full study completion, and
stopping points
-
Full study cost estimates, budget and audit
procedures
Each PODS protocol will be reviewed by
the Samueli Institute Scientific Advisory Committee
(SAC) to ensure high scientific quality and eventual
publication in peer-reviewed journals and program
reports. Participating sponsors will jointly
develop a resource plan and budget for each PODS
project.
OPPORTUNITIES
Initiated under the MIL-CAM appropriation, and in
conjunction with the National Foundation for
Alternative Medicine, PODS will develop an
epidemiological template to evaluate the efficacy of
certain low-cost, locally applied and accepted
practices for particular conditions. We seek regional
partners who are interested in studying or validating
particular clinical settings, treatments or
conditions.
|
|

An
international, interdisciplinary program to
document the effects of indigenous or
complementary medical practices around
the world.
|