Hip Fracture Disease
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1. Background
Hip fracture is one of the leading causes of hospitalization especially for elderly people. Since majority of the fractures are osteoporosis related fractures, therefore, the incidence of hip fracture is expected to increase with aging population. In US, there were 300,000 hip fractures out of the 1.5 million osteoporosis-related fractures annually and 25% of women who are above 60 years of age have hip fracture, leading to substantial increased in the mortality (12 to 20%), morbidity (60,000 admitted into nursing home) and the health care cost for the treatment of hip fracture (direct cost of osteoporotic related fractures was US17 billion per year in 2001).
In New Zealand, the reported observed 30-day morbidity and mortality were 58% and 12% respectively and the observed 1-year mortality was 38% for male (mean age 79 years) and 29% for female (mean age 84 years) following hip fracture.
In Central of Norway, The incidence of hip fractures was 18% higher in subjects in urban areas than in subjects in rural areas in 1992 to 1993, and 33% higher in 1997 to 1998 whereas the proportion of trochanteric fractures was 32% in 1972 to 1973 and in 1983 to 1984. It increased to 44% in 1992 to 1993 and to 68% in 1997 to 1998.
In Queensland, Australia a study was undertaken to identify factors influencing outcome in elderly patients operated for hip fracture. The reported overall mortality for surgically treated patients was 13.7% at 100 days and 24.9% at one year. Patient factors including age, gender, health status and place of residence were the predominant influences on mortality. Non-patient and process factors including delay to surgery, type of operation and type of anaesthesia had minimal impact on mortality.
A retrospective study conducted in Singapore showed that the mean age of patients with hip fracture was 80 years. Sixty-eight per cent were female and 58% were intertrochanteric fractures out of which 95% of them were operated upon. The mean total hospitalisation period was 17 days. Seventy-six per cent were staying in their own homes prior to the hip fracture while 22% were admitted from nursing homes. After surgery, 63% of patients returned to their homes while 26% needed nursing home care. The index admission mortality rate was 5.7%. Mortality was 26% at 1 year. Of those alive at 1 year, ambulatory status was: 28% were walking without aids, 39% were walking with aids, 24% were wheelchair bound and 9% were bedridden. Poor ambulatory function at discharge was related to increased mortality at 1 year. The average cost incurred was S$7367.
In Malaysia, hip fractures in elderly is not uncommon, it is usually following a trivial trauma/injury. As our population is aging, with the improvement in social-economic level and health care, the life expectancy has also increased (female 76 years and male 72 years), therefore, we can expect that the number of osteoporosis related fractures, especially hip fractures will also increased substantially. But unfortunately, till today, we lack of a proper and useful database on hip fracture, its treatment and also outcome of treatment.
The objectives of the NOHFD are to:
| i. |
Determine the number and the type of hip
fractures among patients 50 years and above admitted into
orthopaedic ward in KKM hospitals.
|
| ii. | Determine the demographic distribution of hip
fractures in the aspects of: a. Gender proportion b. Age distribution, c. Racial proportion, d. Social-economic status e. Pre-fracture residence f. Mechanism of injury g. Pre-fracture morbidity |
| iii. | Determine the cost/burden of treating hip fracture: a. Average length of stay b. Percentage of such patients underwent surgery, and c. The average waiting time for surgery |
| iv. | Determine the current practice among orthopaedic
surgeon in KKM hospitals in term of: a. Timing of surgery b. Type of surgery (implant used) c. Antibiotic prophylaxis d. Thrombo-embolitic prophylaxis |
| v. | Determine the immediate treatment outcome and
complication and also functional outcome at 4 months and 12 months
post treatment. |
| vi. | To facilitate service improvements, by providing
robust nationally comparable data for staff involved in the fracture
care. |
| vii. | Stimulate and facilitate hip fractures research, especially in term of economic in treating hip fracture activities using this database |
3. Rationale for Hip Fracture database
It is high times that we have our own database on hip fracture for patients above 50 years-old (osteoporotic fracture), in the aspect of demographic distributions, social-economic status of our patients, the health and economic burden of treating hip fractures, the common practice among orthopaedic surgeon in treating hip fractures and the immediate treatment outcome, the functional outcome at one year.
The database will also help in term of budget planning and allocation; enabling us to compare our immediate treatment outcome with the rest of the world, and also as a tool in hip fracture prevention, osteoporosis prevention, policies and health education programmed, also the future budget planning.
Therefore, we need better data and evidence to support our policy and clinical decision-making in improving access to treatment and in improving the provision and delivery of orthopaedics (especially trauma) services in Malaysia. Patient registry can be a valuable tool to provide timely and robust data on the real world view of clinical practice, patient outcomes, safety and treatment comparative clinical and cost effectiveness.
The National Orthopaedic Hip Fracture Registry (NOHFR) is an organized system that uses observational study methods to collect uniform data (clinical and other), to evaluate specified outcomes for patient 50 years and above with hip fracture, demographics, pre fracture status, pre operative, operative and post operative and quality of life of patient and that serves one or more predetermined scientific, clinical, or policy purposes. The resulting clinical database describes a file (or files) derived from the registry.
Patient registry is clearly a powerful tool to observe the course of disease; to understand variations in treatment and outcomes; to examine factors that influence prognosis and quality of life; to describe care patterns, including appropriateness of care, access to treatments and disparities in delivery of care; to assess effectiveness; to monitor safety; and to change behaviour through feedback of data. Its benefits are evident from several perspectives:
| i. |
For clinicians, registries
can collect data about disease presentation and outcomes on large
numbers of patients rapidly, thereby producing a real-world picture
of disease. |
| ii. |
For academic organization or
medical association, a registry might assess the degree to which
clinicians are managing a disease in accordance with evidence-based
guidelines, focus attention on specific aspects of a particular
disease that might otherwise be overlooked, or provide data for
clinicians to compare themselves with their peers. |
| iii. |
From a payer's
perspective, registries can provide detailed information from large
numbers of patients on how procedures, devices, or pharmaceuticals
are actually used and on their effectiveness in different
populations. This information may be useful to drive resource
allocation for under served therapeutic groups and for determining
coverage policies. |
| iv. |
For a drug or device
manufacturer, a registry might demonstrate the performance of a
product in the real world, meet a post-marketing study commitment,
develop hypotheses, or identify patient populations that will be
useful for product development, clinical trials design, and patient
recruitment. The U.S. Food and Drug Administration (FDA) has noted
that 'through the creation of registries,
a sponsor can evaluate safety signals identified from spontaneous
case reports, literature reports, or other sources, and evaluate the
factors that affect the risk of adverse outcomes such as dose,
timing of exposure, or patient characteristics.' |
4. Specific key questions to be addressed by this registry
| Natural history | |
| 1. | What is the status of our patient before the hip fracture? |
| 2. | Any different in term of incident of hip fracture in different geographic locations? |
| 3. | How is the relationship between menopause and hip fracture? |
| 4. | What is the most common mechanism of fracture? |
| 5. | What is the most common fracture type? |
| Clinical and Cost effectiveness | |
| 1. | Does anti-osteoporosis treatment lead to long-term benefits in term of hip fracture reduction? |
| 2. | How successful is existing anti-osteoporosis prevention program? |
| 3. | How successful is existing hip fracture prevention program? |
| 4. | Time taken for surgery once admitted? |
| 5. | What is the average length of hospital stay for hip fracture? |
| 6. | How is disease progression and patient survival outcome affected by different modes of fracture fixation? |
| Product and service safety | |
| 1. | What is the average waiting time for hip fracture fixation? |
| 2. | What is the infection rate for hip fracture fixation? |
| 3. | What is the complication rate for hip fracture fixation? |
| Access to and Quality of care | |
| 1. | Is the patient being treated (operated) by appropriate grade of staffs? |
| 2. | How do current treatment practices in hip fracture vary between regions or hospital? |
| 3. | How clinical practices do varies in deep vein thrombosis prevention? |
| 4. | How clinical practices do varies in antibiotics prophylaxis? |
| 5. | What clinical outcomes should be measured to improve quality of patient care? |
| 6. | How do we compare with other countries? What are our strengths where we are performing above average? In which area can we offer improvements in treatments or services that we provide? |
5. Patient study population and Clinical sites
The registry study population consists of male or female patients with hip fracture to be recruited from participating sites in Malaysia. Participation in this study is voluntary. However, 3 groups of clinical practices are expected to participate in this patient registry. They are:
| 1. |
Practices in the public
sector, especially those in the MOH. |
| 2. | Private practices contracted by the MOH to provide certain services for MOH patients |
| 3. | Private practices who volunteer to participate. |
All clinical centres of sites that
satisfy the following selection criteria will be invited to participate:
| 1. |
This registry is opened to
all clinical sites that provide healthcare services for patients
with hip fracture in |
| 2. |
Each site should have a
Principal Investigator who is also a licensed physician and a
qualified professional experienced with hip fracture management. |
| 3. | Each site must appoint a Site Coordinator (SC). The SC is the person at the participating clinical site who is responsible for all aspects of registry management and data collection at site, and who will liaise with the Registry Manager and CRA at the Registry Coordinating Centre. If a site is unable to provide an SC for the registry, the sponsor is committed but not obliged to provide such an SC to enable the site to participate in the registry. |
| 4. |
Each site should accept
responsibilities for data collection, as well as for ensuring proper
record keeping and registry document filing. |
| 5. |
Each site shall agree to
comply with the registry procedures and are willing to be subjected
to ongoing review of data by CRM or CRA or other representative of
NOHFR. This may include one or more site visits by prior arrangement |
| 1. | All new patients above 50 years of age with hip fracture undergoing treatment at a participating clinical site are eligible for entry into the registry |
| 2. | In addition, a site may option to enter existing patients on follow-up at the site into the registry. |
7. Inclusion Criteria for Hip Fracture Database
Case definition for "NOHFR": All patients who fulfill inclusion criteria:
Since this is not a clinical trial, waiver
from informed consent from individual patient would be sought for from
the Medical & Research Ethics Committee.
1.
Age 50 years old and above
2.
Seen in any of the participating sites.
3.
New admission (freshly new and old/ neglected cases)
4.
A hip fracture is defined as traumatic fractures involving the proximal part of the femur bone from the head to the sub-trochanteric region (5cm from the lesser trochanter).
Lee, J.K., Khir, Amir S.M.
The incidence of hip fracture in Malaysians above 50 years of age:
variation in different ethnic groups. APLAR Journal of Rheumatology.
2007. 10(4): 300-3005.
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3.
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4.
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