The broad patient base, dedicated
research staff, and computer infrastructure support excellence in
clinical research in the Department of Orthopedics and Physical
Patient Registries: creating longitudinal databases of patient outcomes
The Department of Orthopedics has developed two unique, web-based,
registries that integrate clinical, patient-reported, and long-term
functional outcomes for total joint replacement and spine patients. At
regular intervals, patients complete computer pain and function
assessments (SF-36, Western Ontario Musculoskeletal Assessment,
Oswestry Spine survey) when they visit their surgeon. The data are
scored and printed to support patient-physician treatment decisions.
The information is stored along with patient demographic data, nurse
histories, and physical examination data. Finally, inpatient
information from the hospital information system is merged. In
addition, Hand and Upper Extremity Center patients are now uniformly
documenting function and a registry is being developed.
registry data serve retrospective and prospective research, quality and
outcome assessment for UMass Memorial Healthcare, and support
clinicians in patient care.
Other Orthopedic Clinical Trials
A wide array of
investigator-initiated and multi-center industry-sponsored clinical
trials are ongoing in the Department of Orthopedics and Physical
Rehabilitation. The large volume and diversity of patients from across
central, western, and southern Massachusetts makes the Orthopedic
Clinical Centers ideal places to recruit, enroll, and conduct clinical
research. Experienced research assistants, including nurses, staff each
study and assure regulatory compliance and successful completion of
studies. In addition to faculty, residents and fellows participate in
Areas of recent studies include:ARTHRITIS AND TOTAL JOINT REPLACEMENT CENTER; MEMORIAL CAMPUS
Comparative trials of alternative prosthetic designs and evaluation of surgical and long-term functional outcomes.
Phase I, ll and lll trials for novel treatment of osteoarthritis SPINE CENTER ; MEMORIAL CAMPUS
evaluation of outcomes associated with bone grafting in chronic
degenerative lumbar disease and traumatic cervical injuries. HAND CLINIC; HAHNEMANN CAMPUS
Prospective evaluation of predictors of optimal functional outcome in carpal tunnel surgery. SPORTS CENTER; HAHNEMANN CAMPUS
evaluation of intra-operative administration of hyaluronic acid for
relief of symptoms in knee/shoulder osteoarthritis.
Phase III Clinical trial on operative knee procedures and technique TRAUMA CENTER
Longitudinal evaluation of morbidity and mortality in ankle fractures among the elderly.
Outcomes research seeks to understand the end
results of particular health care practices and interventions. End
results include effects that people experience and care about, such as
change in the ability to function.
In particular, for individuals
with chronic conditions—where cure is not always possible—end results
include quality of life as well as mortality. By linking the care
people get to the outcomes they experience, outcomes research has
become the key to developing better ways to monitor and improve the
quality of care.”
Of interest: Read the AHRQ page on outcome research.
Link to Patricia Franklin research page
UMMS Department of Orthopedics and Physical Rehabilitation has a wide array of ongoing outcomes research.
Background: Osteoarthritis is growing and arthroplasty effectively relieves pain.
is the leading cause of disability among U.S. adults and a significant
public health challenge. By 2020, it is estimated that 60 million
Americans will be affected by arthritis. Twenty seven percent of
Caucasians, 32% of African Americans and 36% of poor U.S. adults report
limited activity due to their arthritis. Currently, half of adults
over 65 years and 60% of women of all ages have arthritis making it the
leading chronic condition among women. Of these, more than 90% have
osteoarthritis (OA), a degenerative condition of joint cartilage with
no known cure. However, OA’s symptoms can be treated. Exercise,
activity, self-care, and medication can effectively relieve knee OA
pain and improve function. Yet less than one percent of arthritic
adults receive self-care instruction. (CDC 2004) Finally, when OA pain
and disability persists despite comprehensive medical care,
arthroplasty is a highly effective option.
The case of TKR: In the
past decade, TKR utilization has increased 73% so that in 2003 more
than 427,000 procedures were performed costing $13.5 billion.
Two-thirds of TKR patients are older than 65 years making TKR
Medicare’s most costly procedure. Furthermore, Healthy People 2010
proposes to increase TKR utilization while eliminating racial and
ethnic disparity in use. However, following technically successful TKR
surgery, 12-25% of patients report minimal 12 month functional
improvement while another 10% report functional gains as high as 3
times the national average. In order to assure uniform functional gains
after successful TKR surgery, we are studying demographic, behavioral,
and clinical predictors of self-care and activity.
• DEVELOPING OBJECTIVE MEASURES OF PERI-TKR EXERCISE AND ACTIVITY
in patients' independent exercise and activity after TKR surgery may
contribute to variable functional outcomes. We are evaluating the use
of daily exercise logs and step activity monitors (accelerometers) to
quantify exercise and home activity after TKR. Pilot data identified
significant variation in quantity of daily exercises after surgery. In
addition, exercise varied with patient attributes. Women with poor
emotional health recorded fewer repetitions and greater variation. More
daily exercise repetitions correlated with larger 6-month functional
improvement. J Arthroplasty. 2006 Sep;21(6 Suppl 2):157-63.
• PERI-OPERATIVE BEHAVIORAL INTERVENTION FOR PATIENTS WITH POOR EMOTIONAL HEALTH TO IMPROVE FUNCTIONAL OUTCOMES
one-third of TKR patients with poor pre-TKR emotional health have
significantly poorer 6 and 12-month post-TKR physical function when
compared with patients with higher emotional health scores. (Heck,
1998; Ayers, 2004) The proposed telephone-support program will address
anxiety and depression, enhance psychological coping, and improve
adherence to prescribed post-TKR exercise and physical activity. Clin
Orthop Relat Res. 2005 Nov;440:157-61.
• OBJECTIVE PREDICTION MODELS TO GUIDE PATIENT AND PHYSICIAN DECISIONS FOR TKR
date, no one patient attribute or surgical factor offers a satisfactory
explanation for this variation. Using a unique national database of
over 8000 TKR patients, we are developing individual patient prediction
models to match pre-TKR patient attributes with likely post-TKR
functional improvement. We will translate these models to an
interactive, web-based program to support patient and referring
COMPUTER-ASSISTED, PATIENT-REPORTED PAIN AND FUNCTION INTO AMBULATORY
CARE TO SUPPORT SHARED DECISION MAKING
Patients in the Arthritis
and Total Joint Center and Spine Center complete web-based,
standardized pain and function assessments at each office visit to (1)
trend symptoms in the ambulatory record, (2) guide patient-physician
discussions of treatment options and (3) document patient outcomes.
These data are stored in a unique registry of clinical and patient
information for future research.
• EVIDENCE-BASED KNOWLEDGE FROM A PATIENT WEB-SITE BEING DEVELOPED THROUGH NATIONAL LIBRARY OF MEDICINE OUTREACH FUNDS
will be introduced to the education web-site while at the Arthritis and
TJR Center. The site will include expert, trusted information that can
be accessed from home, community centers, or primary care physician
offices. NLM resources will include the patient tutorials on
osteoarthritis, TJR, and post-surgery rehabilitation and materials will
be available in English and Spanish.