Osteoarthritis (OA) is the most prevalent joint
disorder; its primary signs and symptoms
of joint pain, swelling, and stiffness reflect the
loss of joint cartilage integrity.1,2 There is currently no
cure for OA. Available treatments include a range of
pharmacologic and nonpharmacologic interventions
designed to reduce pain and inflammation, maintain or
improve mobility, and limit functional disability.2
Osteoarthritis has been shown in a variety of US-based
studies to be a leading contributor to the cost of
medical appointments, over-the-counter drug use, and
restricted activity.3-5 Drug therapy represents a large
proportion of the direct costs, with analgesics accounting
for approximately 20% of the total. The treatment of
gastrointestinal (GI) adverse reactions related to non-selective
nonsteroidal anti-inflammatory drug (NSAID)
use adds significantly to both direct and indirect
costs.6,7 Nonpharmacologic modalities such as physical
and occupational therapy also contribute to these costs.
Indirect costs (eg, absenteeism) are responsible for the
majority of the economic burden of OA.
As a result of our aging population, the increased
demand for healthcare for this disease adds to these
concerns. There is a critical need to develop strategies
to manage the disease more cost effectively through better
diagnosis, safer and more effective treatment, and
enhanced patient education. This paper describes an
innovative approach using patient health management
to address this need.
CURRENT TRENDS IN THE PHARMACOLOGIC
TREATMENT OF OSTEOARTHRITIS
Despite their side effects, conventional NSAIDs have
been widely used and are the agents of choice in the
treatment of OA8 for patients who do not respond to
acetaminophen. In Canada, the most commonly prescribed
NSAIDs include diclofenac sodium, a combination
of diclofenac and misoprostol, ibuprofen, and
naproxen.6 However, current concerns about the
greater risk of GI toxicity associated with prolonged use
of NSAIDs,9-16 including potentially fatal perforation,
ulcer, and bleed (PUB),11 have led to a reexamination of
their role in the treatment of the disease. Risk factors
for GI toxicity include age more than 65 years, a history
of peptic ulcer or upper-GI bleeding, concomitant use
of oral corticosteroids and anticoagulants, comorbidities
such as cardiac conditions, and renal dysfunction.11-14 For patients with GI risk factors,
coprescription of a gastroprotective (GPA) agent has
been advised. More recently, with the introduction of
the cyclooxygenase-2 (COX-2) inhibitors, it has been
recommended that patients who require chronic analgesia
and who are at risk for GI adverse events with
NSAIDs receive first-line alternative therapy with acetaminophen;
if they do not respond, they should receive
a COX-2 inhibitor.17
The COX-2 inhibitors have recently emerged as an
alternative class of anti-inflammatory drugs with efficacy
in reducing pain and inflammation equivalent to that
of NSAIDs 18-26 and a clearly reduced potential for upper-GI injury relative to
NSAIDs.18,22-24,26-28 Traditional
NSAIDs inhibit both the COX-1 and COX-2 forms of the
cyclooxygenase enzyme. Prostaglandins involved in the
protection of the GI mucosa are produced by COX-1,
whereas those that mediate inflammation and pain
are induced by COX-2.23 The COX-2 inhibitors rofecoxib
and celecoxib (coxibs) selectively inhibit COX-2,
with little effect on COX-1.25-29 However, they are not
free of side effects: dyspepsia has been reported with
coxib use, but at a lower frequency than with
NSAIDs.30,31
A retrospective cohort study conducted in Québec
between April and November 2000 reported that coxibs
were more frequently prescribed than acetaminophen
or NSAIDs to elderly (≥65 years) patients with musculoskeletal
diseases. The study also found that elderly
patients with a history of GI events were more frequently
given a coxib or acetaminophen as opposed to
NSAIDs. The study also reported that coxibs were 47%
less likely to be prescribed with a GPA than were
NSAIDs.32
BACKGROUND
The Healthcare System in Québec
The Régie de l'assurance maladie du Québec (RAMQ)
applies and administers the provincial health insurance
plan established by the Health Insurance Act. The public
prescription drug insurance plan, instituted in 1997,
guarantees basic coverage for all Québec residents for
drugs purchased in Québec and listed on the provincial
formulary (liste de médicaments). Adults with access to
a private insurance plan through their workplace (4.2
million individuals; 57% of the population) must pay to
receive coverage for themselves and their dependents.
All others are covered by the provincial plan, including
those receiving employment assistance and persons age
65 years and over.33-36 Celecoxib became eligible for
reimbursement by RAMQ in October 1999, followed in
April 2000 by rofecoxib. In the first half of 2000, no
published guidelines or consensus existed for the utilization
of these new anti-inflammatory drugs. Clinical
experience was still developing.
Profile of NSAID Use in Québec
In the planning stage of this study, we conducted a
literature review to profile and identify the care gaps in
NSAID and coxib utilization in Québec.
A study conducted in 1997 by the Québec College of
Physicians using administrative data obtained from
RAMQ revealed inappropriate utilization of NSAIDs.
The study found that general practitioners (GPs) often
ignored drug interactions, dosages, and adverse events
in prescribing NSAIDs and did not prescribe GPAs as
advised by the guidelines.37,38 In a second study,
Choquette et al surveyed the NSAID prescription patterns
of all GPs in the province of Québec (D.
Choquette, MD unpublished data, 1999). The results of
this self-reported questionnaire, based on 2328 participants
(30% response rate), corroborated the finding of
the Québec College of Physicians and demonstrated a
lack of understanding of the indications, contraindications,
dosage, and duration of NSAID treatment.
A recent study by Rahme et al concluded that the use
of NSAIDs significantly increased the risk of GI adverse
events by 2.48-fold, requiring an additional cost of 0.66
Canadian dollars per patient-day of treatment with
NSAIDs.39
Tamblyn et al40 conducted a blinded, office-based
study using simulated patients, in which 2 clinical cases
(chronic hip pain due to early OA and NSAID-induced
gastropathy) were used to assess the management decisions
of 112 physicians for elderly patients with arthritis.
In 41.7% of office visits, unnecessary prescriptions
for NSAIDs or other drugs were given. Gastropathy
related to NSAID use was properly diagnosed in 93.4% of
cases, but acceptably managed in only 77.4% of cases.
The risk for suboptimal management of NSAID-related
adverse events was increased 16.6-fold with an incorrect
diagnosis versus a correct diagnosis.
These studies revealed significant gaps between optimal
and actual practice. The results raise questions
about the appropriateness of NSAID use in the elderly
population at large and concerns that current prescribing
patterns are contributing to GI morbidity in the elderly,
with the associated avoidable health costs.
Selective utilization of coxibs in the elderly is perhaps a
better medical practice. Their acquisition cost is much
higher than that of NSAIDs. However, the cost of treatment
with an NSAID plus a proton pump inhibitor in
Canada is greater than the cost of a COX-2 inhibitor
alone.41 In a public healthcare system such as that of
Québec, the widespread utilization of coxibs and
NSAIDs plus proton pump inhibitors, combined with
their high acquisition costs, makes them affordable only
at the expense of other healthcare services. Therefore,
programs that promote appropriate utilization of the
coxibs and NSAIDs are needed.
The CURATA Program
CURATA (Concertation pour une Utilisation
Raisonnée des Anti-inflammatoires dans le Traitement
de l'Arthrose [An Integrated Approach to Improving the
Appropriate Utilization of Anti-Inflammatory/Analgesic
Medications in the Treatment of Osteoarthritis in
Québec]) is a patient health management program
developed by the Association of Rheumatologists and
Merck Frosst Canada in 2000. It was developed to
address the gaps in OA care and implement effective
interventions to promote evidence-based medication
prescription for OA patients, with the goal of optimizing
the management of OA. Its objectives are to
improve the quality of life of OA patients
and to encourage the appropriate utilization
of NSAIDs and coxibs in the treatment of the
disease.
The patient health management approach
seeks to optimally manage disease through
improvement of practice patterns and
patient outcomes. It is a patient-centered
approach in which best practices are compared
with current practices, and modifications
are introduced to improve therapeutic
results in the most cost-effective manner. Its
goal is to bring the greatest health benefit to
the largest number of people at the best cost.
To be optimally effective, patient health
management mobilizes a wide range of
healthcare stakeholders: governments, third-party
payers, university researchers, health
charities, community specialists, family
physicians, nurses, pharmacists, special-interest
groups, pharmaceutical companies,
and above all, patients. These partnerships
will ensure the broadest application of the
program and its interventions.
The key to success of this process is continuous
measurement and feedback of outcomes obtained from
the broadest application of evidence-based therapies.42,43
A community-based approach to research provides
the greatest opportunity for highly committed stakeholders
to identify the gaps in care and to work as
partners to define best practices to achieve optimal outcomes
at the lowest possible cost. Another view might
be that partnership-directed, evidence-based disease
management represents healthcare improvement from
the ground up, as opposed to the top down. The functional
processes are illustrated in Figure 1.
The Continuing Medical Education Department of
the University of Montréal, in collaboration with delegates
of the Association of Rheumatologists, developed
the CURATA educational tools. The partners in the program
include representatives from government, academia,
charitable organizations, and the pharmaceutical
industry (Appendix).
METHODS
The program activities were coordinated by using a
modified structure similar to that utilized by the
National Institutes of Health to conduct a large-scale
study.44
The primary objectives of the CURATA program were
to (1) improve the GP's ability to identify OA patients
through appropriate questioning and musculoskeletal
examination and (2) to enhance the GP's ability to select
appropriate pharmacologic and nonpharmacologic therapy
according to a defined decision tree. The underlying
hypothesis was that an integrated program involving
professionals and patients whose goals were to enhance
the appropriate use of NSAIDs and GPAs would facilitate
bridging the gap that exists between the current state of
care and optimal practice.
Phases of the CURATA Program
In the first phase of the program, the current level of
care was evaluated in an effort to identify potential discrepancies
with optimal evidence-based treatment.
Studies identified in this stage of the program are
described in the section titled Profile of NSAID Use in
Québec. In summary, there were major gaps in physicians'
knowledge of (1) risk factors for GI toxicity associated
with NSAIDs; (2) NSAID-induced toxicity
associated with long-term administration and contraindications
for NSAID use in patients with hypertension,
cardiovascular disease, or renal insufficiency; (3)
choice of cytoprotection; and (4) use of nonpharmacologic
treatments for OA.37-40
In the second phase, interventions were introduced.
To provide guidelines for the appropriate utilization of
NSAIDs and coxibs as well as GPAs, the CURATA
development committee created a decision tree with
an algorithm for optimizing OA treatment approaches
(Figure 2).45 To maximize adoption of this decision
tree, the committee developed a workshop including 3
clinical cases on the diagnosis and treatment of OA. It
has been demonstrated that small-group, interactive,
case-based workshops ideally facilitate the dissemination
of such material and provide a forum for peer discussion
and emulation of the desire to excel.46
For each clinical case, a participant worked individually
to answer questions, then shared his or her answers
with all others in a small group. The group produced a
summary of individual responses on transparency for discussion
in a plenary session. In this session, experts
shared their experience with all participants. This format
allowed participants to reflect on their own processes of
data interpretation in making clinical decisions and to
examine those of experts. The workshop was accredited
by the College of Family Physicians of Canada and provided
1.5 hours of MAINPRO-C credit to its participants.
A large group session was held for pharmacists and
other health professionals. A patient follow-up sheet
was created for pharmacists, which included questions
regarding patients' use of homeopathic and other alternative
medicine products. A series of 5 brochures
detailing the various joints affected by OA was developed
for patients. In addition, there was a brief presentation
by a physiotherapist and an occupational
therapist to describe their role in patient management
of OA. A multidisciplinary panel including a physician,
pharmacist, physiotherapist, and occupational therapist
then discussed a case study.
Evaluation of the Educational Intervention
To assess the impact of CURATA, 2 measurements
were undertaken: one to evaluate the impact on medication
prescription and the other to determine the
immediate and remote impact on retention of knowledge
regarding treatment selection for OA. Although
CURATA was implemented throughout the province of
Québec, the evaluation was undertaken in 8 cities.
Impact on Medication Prescription. The intervention
was comprised of the workshop and a decision tree
in the form of a laminated sheet. There were 4 intervention
types: workshop and tree, workshop only, decision
tree only, and control group; each type was
assigned to 2 cities.
Records of all patients age 65 years or older who had
filled a prescription for a coxib, NSAID, or acetaminophen
between May 2000 and June 2001 (the date when
the data were requested) from an eligible GP (GP with
≥2 NSAID prescriptions) were retrieved from the RAMQ
database. Only new prescriptions preceded by a diagnosis
of OA in the previous 3 years were considered. In
general, prescriptions for a chronic condition are written
with the possibility of 3 refills. New prescriptions
were either a new treatment or a continued treatment
filled for the first time (nonrenewal). Because a prescription
could have been written before the workshop
took place and refilled later, refills were not assessed. A
0/1 score was given to every filled prescription according
to the instruction on the decision tree. All acetaminophen
prescriptions were given a score of 1, and
all patients were presumed to have used acetaminophen
before NSAIDs or coxibs prescriptions.
Mean scores were calculated for each GP in the
preintervention and postintervention periods. The
analyses were done both by "intent-to-treat" (including
all GPs who practice in 1 of the 8 cities) and "per protocol"
(including only GPs who attended the workshops
in the intervention groups) and were compared with the
scores of all GPs in the control group.
Details of the methodology adopted in this study and
the results have been published.45
RESULTS
In the intent-to-treat analysis, the study demonstrated
an adjusted significant improvement on mean scores
of 8% (P = .003) between the control group and the
workshop and workshop and tree groups combined. No
significant improvement was reported in the tree group
versus the control group. A per protocol analysis
revealed a 12% (P = .008) improvement in mean scores.
In summary, the intervention had a positive impact on
these physicians' prescription patterns for OA. In view of
the widespread use of coxibs, nonselective NSAIDs, and
acetaminophen, and given that more than 50% of these
prescriptions were for the treatment of OA, the positive
impact should reflect considerable cost savings.
Immediate and Remote Impact on Retention of
Knowledge. The GPs were asked to fill a questionnaire
consisting of 8 multiple-choice questions before (pretest)
and after (posttest) the workshop, as well as 3 and 6
months later. (For a copy of this questionnaire, please
contact the author.) Each question was scored 1 or 0
according to whether or not the checked answer agreed
with the workshop content. Overall pretest and posttest
scores for each GP were calculated and compared by
using a paired t test. Questions were divided into 2 types,
those concerning patients with no GI risk factors and
those concerning patients with GI risk factors. Of 52 GPs
invited to the workshop, 26 completed the questionnaire.
Nonparametric tests were used to compare the median
pretest and posttest scores for the 2 types of questions.
Overall median scores (pretest, posttest, and P value)
were 2.0, 3.5, and <.0001, respectively, for questions
describing patients with no GI risk factors (4 questions)
and 3.0, 3.5, and <.01, respectively, for questions describing
patients with GI risk factors (4 questions). At the 6-month evaluation, the knowledge improvement was
sustained; scores were similar to those seen on the
immediate posttest. Thus, physicians who attended the
workshop were, in fact, better assessors of GI bleeding,
both immediately afterwards and 6 months later; and
they selected a more appropriate therapeutic regimen.
On completion of this workshop, the GPs were able
to adopt a structured approach to the assessment of
joint pain, identify the principal signs of OA on clinical
examination, use a decision tree to manage patients
with OA, and select an anti-inflammatory medication
appropriate to the patient's clinical condition.
In light of these encouraging results, 50 small-group
sessions and 2 large-group sessions were held, with a
total of 1000 physicians attending. The decision tree
was disseminated to 7500 physicians in June 2001. We
anticipate that the positive effect of CURATA will be
even greater once the intervention for pharmacists and
other health professionals is implemented.
CONCLUSION
The results of the initial evaluations have demonstrated
that these evidence-based interventions were
successful not only in improving physicians' knowledge
regarding the diagnosis and management of OA, but
also–more importantly–in changing their behavior to
make more appropriate therapy choices for their
patients. The observed modification of their prescription
patterns reflects an improvement in their medical practice,
which may lead to better patient outcomes and generate
greater cost efficiencies for the health care system.
The immediate impact of this patient health management
approach was demonstrated in late 2001, when
the reimbursement policy for coxibs was being reevaluated
by the Québec Ministry of Health and transition to
exception-medication status was under consideration.
This reevaluation was motivated by concerns about
increased consumption and the associated costs, as well
as questions regarding the appropriateness of coxib use.
Results of the CURATA evaluation provided sufficient
evidence for the government to decide to maintain an
open reimbursement policy for this new class of drugs.
The widespread implementation of the interventions
of the CURATA program will further encourage the
appropriate use of coxibs, and through these efforts evidence-based guidelines will be developed. The capacity
for programs such as CURATA to shape the healthcare
environment is further validated by the current
requirement of the Ministry of Health to establish
patient health management programs as a measure to
ensure appropriate utilization of various classes of
drugs. In addition, a concurrent drug utilization review
must be carried out. The Ministry also has required the
collaborative involvement of multiple pharmaceutical
industry partners in these programs. This collaboration
represents the next challenge.
The establishment of effective patient health management
programs relies heavily on the commitment and
cooperation of a broad range of partners representing
academia, government, industry, and most importantly,
patients.42,43 The general public has become increasingly
aware of health concerns in recent times and is eager to
be involved in such innovative approaches to optimizing
the quality of health and healthcare delivery. Similarly,
there is an evolving role for the pharmaceutical industry.
Beyond an interest in profits, the pharmaceutical industry
shares the commitment of its partners as well as its
expertise in the development of programs that will
enhance patient adherence to optimal therapies, while
controlling costs and improving health outcomes. The
promising results of programs such as CURATA demonstrate
their potential to achieve the ultimate goal of
patient health management: to provide the best health for
the greatest number of people at the best possible cost.
Acknowledgment
We would like to acknowledge the collaboration of Marilyn
Krelenbaum, MSc, in the writing and editing of the manuscript.
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