Diabetic Foot/Hand Disease
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1. Background
Diabetes mellitus (DM) is a serious debilitating and deadly disease causing significant mortality and morbidity globally. Worldwide, the number of diabetic patients was estimated to be 135 million in 1995, 154 million in 2000, and it is expected to reach 300 million in year 2025. The projected increase in the developed countries is 42% but in the developing countries like Malaysia, the increase is estimated to be 170 %.
In Malaysia, the reported prevalence (First National Health and Morbidity Survey; NHMS 1) of DM was 6.3% in 1986, 8.2% in 1996 (NHMS 2; prevalence in Kelantan was 10.5%), and WHO estimated that by 2030, Malaysia would have a total number of 2.48 million diabetes (prevalence of 10.8%), compared to 0.94 million in 2000, which represent 164% increased!
In 1997, a study in major government hospitals in Malaysia showed that the majority of patients had not been given adequate care, similarly, in 2001, a study amongst general practitioners in Peninsular Malaysia showed that the majority of patients were not well controlled with high prevalence of complications; 20% had Hb Alc of < 7.8%, 12.3% had total cholesterol of <4.8 mol/L and 44.1% had systolic blood pressure of < 140mmHg. 30.1% had neuropathy, 23.5% had retinopathy, and 22.9% had albuminemia. In 2003, an almost similar study was carried out in major public hospitals in Malaysia, the result showed that majority of patients were still had poor/unsatisfactory diabetes controlled.
Diabetic foot complications/lesions such as ulceration, infection, and gangrene are the leading causes of hospitalization in patients with diabetes mellitus, and responsible for more hospitalizations than any other complication of diabetes. Approximately 15 to 20 percent of the estimated 16 million persons in the United States with diabetes mellitus will be hospitalized with a foot complication at some time during the course of their disease.
Unfortunately, many of these patients will require amputation within the foot or above the ankle as a consequence of severe infection or peripheral ischemia. The diabetic foot and its sequel account for billions of dollars in direct medical expenditures, as well as lengthy hospital stays and periods of disability.
Diabetic foot ulcers (DFUs) precede 85% of non-traumatic lower-extremity amputations (LEAs). At any times, there are approximately 3-4% of individuals with diabetes currently have foot ulcers or deep infections. Fifteen percent develop foot ulcers during their lifetimes and 12-24% of individuals with a foot ulcer require amputation. Their risk of LEA increases by a factor of 8 once an ulcer develops. Even after successful management resulting in ulcer healing, the recurrence rate in that patient population is 66% and the amputation rate rises to 12%, the 5-year risk of needing a contra-lateral amputation is 50%. At 2 years following trans-tibia amputation, 36% have died.
Lower-extremity amputation is 15 times more likely to occur in people with diabetes versus people without diabetes. Approximately 67,000 amputations were performed each year between 1993 and 1995 among people with diabetes in US. Once amputation occurs, approximately 50 percent of the people with amputations will develop ulceration with associated infection on the contra-lateral limb within 18 months of the amputation; 50 - 60 percent has contra-lateral amputations three to five years subsequent to the first amputation. The three-year mortality rate after the first amputation is between 20 and 50 percent.
In Malaysia, even though fairly huge number of diabetes patients were being admitted into orthopaedic ward in MOH hospitals because of diabetic foot/hand complication; majority of them needed long hospitalization, required repeated hospitalization, required repeated surgery, and a proportion of them underwent creeping amputation around the foot or ankle, and some ended up with below knee or above knee amputation.
In the present economic climate where the distribution of expenditure among various health programmes must be justified and rationalised, it is timely to collect a database relating to incident of diabetic foot and hand in Malaysia, especially since there is an increase in the prevalence and the outcome of treatment. Furthermore, as our population is aging and the rising prevalence of diabetes, it is expected that the number of diabetic foot/hand patient will also increasing substantially.
Lack of Malaysian data is also hampering evidence based efforts to improve patient care, access to treatment, and to inform and plan healthcare policy.
The objectives of the NOHFD are to:
| i. |
Determine the diabetic foot care health educational and
preventive program among patients admitted with diabetic foot/hand
complications in MOH orthopaedic ward in terms of: a. Percentage
of coverage (those received health education) b. Percentage
of patient has good record of diabetic care booklet. c. their daily
practices/life styles |
| ii. |
Determine the diabetic foot/hand
complications workload in MOH orthopaedic ward in terms of: a.
The total number of admission. b.
It's proportion to all orthopaedic admission
in MOH hospitals. c.
The average length of stay d.
Average no of surgeries being performed per
patient e.
The usage of antibiotics, |
| iii. |
Determine the demographic of the diabetic
patients admitted into MOH hospitals because of foot/hand
complications in term of: a.
Gender proportion b.
Age distribution, c.
Racial proportion, d.
Social-economic status/educational level e.
Location of residence |
| iv. |
Determine the diabetic foot/hand
complications treatment outcome in MOH hospitals in terms of: a.
Diabetic control b. Co-morbid
illness c. Total
number of diabetic foot amputation, d.
The level of amputation, e. Mortality |
| v. |
To facilitate service improvements, by
providing robust nationally comparable data for diabetic foot/hand
care. |
| vi. |
Stimulate and facilitate diabetic foot
research, especially in term of economic in treating diabetic foot
complication, activities using this database. |
3. Rationale for diabetic foot/hand database
Expenditure among various health programmes must be justified and rationalized. It is timely to collect a database relating to diabetic foot/hand complications, the outcome of treatment and also the economic impact of the treatment.
The database will also help in term of health care priority planning and financial allocation; assess the effectiveness of diabetic treatment, enable us to compare our treatment outcome with the rest of the world, and also as a tool in diabetes awareness and health education programmed.
Clearly we have a long way to go in reaching our targets with our diabetic foot/hand care in Malaysia. Not at least, we also need convincing data to demonstrate the lack of awareness and proper care in particular and its burden within in this country. 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 diabetic foot/hand 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.
A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, 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 natural course of Diabetic Foot/Hand presenting to clinical centres in Malaysia? |
| 2. | What is the natural course of Diabetic Foot/Hand in different geographic locations? |
| 3. | Does treatment lead to long-term benefits or harm, including delayed complications? |
| 4. | What are the significant predictors of poor outcomes? |
| Clinical and Cost effectiveness | |
| 1. | How successful is existing Diabetic Foot/Hand screening program? |
| 2. | How successful is the existing diabetic health education program? |
| 3. | How is the diabetic treatment compliance? |
| 4. | How is disease progression and patient treatment outcome affected by available therapies? |
| Access to and Quality of care | |
| 1. | How do current treatment practices in diabetic foot/hand vary between regions? |
| 2. | How do clinical practices vary when treating a specific disease? |
| 3. | What characteristics or practices enhance compliance and adherence? |
| 4. | Do quality improvement programs affect patient outcomes, and, if so, how? |
| 5. | What clinical outcomes should be measured to improve quality of patient care? |
| 6. | Are there disparities in the delivery of care among socioeconomic groups, and geographic regions? |
| 7. | 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 Diabetic Foot/Hand Disease 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 Diabetic Foot/Hand Disease in Malaysia. |
| 2. | Each site should have a Principal Investigator who is also a licensed physician and a qualified professional experienced with Diabetic Foot/Hand Disease 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 NODFH. This may include one or more site visits by prior arrangement |
| 1. | All patients with Diabetic Foot/Hand diseases undergoing treatment at a participating clinical site are eligible for entry into the registry. |
| 2. | In addition, a site may opt to enter existing patients on follow-up at the site into the registry. |
7. Inclusion Criteria for DF&H Database
Case definition for "DF&H": 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 18 years old and above
2.
Both IDDM and NIDDM patients
3.
Seen in any of the participating sites.
4.
All the news cases admitted after the launch of the registry.
5.
Diabetic Foot & hand is defined:
- Any newly diagnosed or known diabetic patients present with
- Any form of skin, soft tissue and/ or bone infection, ulceration or gangrenous in their lower limb or upper limb.
- With or without any precipitating factors.
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2.
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3.
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4.
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5.
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6.
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7.
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9.
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10.
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11.
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12.
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http://www.nmrr.gov.my
