Measures In Systemic Lupus Erythematosus Health And Social Care Essay
SYSTEMIC LUPUS ERYTHEMATOSUS is a multisystem disease of autoimmune etiology with heterogeneous manifestations. Outcome measures are important in measuring disease activity, to decide the appropriate therapy, documenting the response to therapy and to know the extent of damage or functional limitation caused by the disease. Multiple outcome measures have been developed by various organisations which include more than 40 disease activity instruments reflecting the complexity and the challenges in measuring this multifaceted disease.
THE NEED FOR OUTCOME MEASURES IN LUPUS
SLE is a disease affecting predominantly females of child bearing age. Outcomes in SLE can be described by three domains, namely disease activity, accumulated damage and health status of patients. In the past outcomes in SLE were measured in terms of survival. However with the advent of targeted treatment and better outcomes, survival is more than 80 % in 10 years. A good outcome measure should be able to distinguish between disease activity for example active 'renal lupus' and disease damage due to chronic disease e.g. chronic kidney disease as a sequelae of renal lupus and the resultant functional impairment. Patient may be assessed for various purposes including: routine care- quantifying disease and planning a therapeutic strategy, assess response to the therapy, to verify that the disease is in remission and thus the patient may plan her pregnancy, to include the patient in a clinical trial and to compare the responses of various subpopulations in a Clinical Trial scenario.
CLASSIFICATION OF SLE
SLE can manifest in various ways ranging from subtle laboratory abnormalities eg immune thrombocytopenia , to overt clinical manifestations like classic malar rash or as a life threatening emergencies for example Diffuse Alveolar haemorrhage. Classification criteria of SLE are being constantly revised to incorporate these diverse presentations. A new Classification Criteria for Systemic Lupus Erythematosus has been validated by Systemic Lupus International Collaborating Clinics (SLICC) . These identified seventeen criteria. The SLICC criteria for SLE classification requires: 1) Fulfillment of at least four criteria, with at least one clinical criterion AND one immunologic criterion OR 2) Lupus nephritis as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies.
ASSESSMENT OF DISEASE ACTIVITY
Assessment of Disease Activity in SLE includes a thorough head to toe clinical examination as practically every system in the body can be potentially involved, directed appropriate investigations and relevant serological studies. The questions to be asked are: how long does a particular finding/abnormality has been in existence, whether it can be attributed directly to SLE, is it a new finding, or has the condition improved or worsened or remained the same since initial review. It is important to determine indicators of active lupus, adverse drug effects, complications of disease such as infection or cardiovascular disease, or other comorbidities such as fibromyalgia, depression, cancer or thyroid disease.
USE OF LABORATORY TESTS TO ASSESS DISEASE ACTIVITY
The so called 'routine' blood counts and urine RE/ME are the most important laboratory tests in a patient with lupus and can give a clue to the presence of disease activity. Lymphopenia is the commonest hematological manifestation of Lupus activity. Other features incude thrombocytopenia, anemia and leucopenia or lymphopenia. Most of the cytotoxic immunosupressive regimens will also affect the blood counts. However presence of these abnormalities indicating a active disease will necessitate a more aggressive management for disease control.
Active renal disease is assessed by the presence of heamturia, leucocytouria and proteinuria. Infection, stone or menstrual blood loss needs to be excluded before the abnormality can be attributed to SLE.
Acute Phase reactants can give a clue to the presence of SLE activity. ESR is usually raised in a setting of active disease while C Reactive protein is not. Modest elevations of CRP can be present when associated with serositis or arthritis and coexisting infections can cause a marked increase (usually > 50 mg/L) and these patients should be screened managed for appropriate infections before embarking upon a aggressive immunosupressive regimen.
Other biochemical tests like a falling Albumin level (may indicate a negative acute phase reactant), and raised Lactate DeHydrogenase (LDH) may indirectly give a clue to the presence of active disease.
Serological tests may be useful in certain subsets of patients with Lupus. However these test have to be correlated with the presence of clinical findings. Anti double stranded(ds) DNA titres can a useful marker in individuals who manifest these antibodies (about 60 % of SLE patients). These correlate with the disease activity , however the levels can be falsely low if there is deposition of the antibodies in tissues. Low Complement levels C3 or C4 associated with rising degradation products are seen especially in patients with renal, hematological and vasculitis disease.
DISEASE ACTIVITY MEASURES
There are various standardized measures to assess disease activity in Lupus. The commonly used activity indices are Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group (BILAG), Systemic Lupus Activity Measure (SLAM) and the European Consensus Lupus Activity Measure (ECLAM) Each of these indices have been validated in different population subsets and can be used in adults as well as children. The various clinical and laboratory measures to be assessed vary amongst the indices. The Lupus Activity Index is a concise measure comprised of a 0-3 visual analog scale for 4 symptoms (fatigue, rash, joint involvement, serositis) and 4 signs (neurologic, renal, pulmonary, and hematologic involvement). While its list of SLE features is not comprehensive and its measure of disease activity
is not weighted, it provides a simple, broad, and accurate assessment of activity in much the same fashion as the Physicians’Global Assessment. The SLEDAI and its modifications: SLEDAI 2000 and SELENA-SLEDAI are the simplest of indices to use in a clinical setting. Twenty-four features that are attributed to lupus are listed, with a weighted score given to any one that is present. The more serious manifestations (such as renal, neurologic, and vasculitis) are weighted more than others (such as cutaneous manifestations). The maximum possible score is 105. The BILAG is an organ-system score index compared to other 'global' indices and it records clinical disease activity in 8 different organ systems for a total of 86 items. It is a more comprehensive index and calculation of the scores are aided by a software. It may be cumbersome to use in a routine clinical setting and is more apt for clinical trials and clinical research. Later modification (BILAG -2004 index) includes in addition ophthalmologic and gastrointestinal features which were already covered in some of the other indices.
ASSESMENT OF DAMAGE.
With better management options and resultant increasing longevity in Lupus patients, more number of patients are having long term disease and treatment related complications and resultant organ damage and death. A bimodal pattern of deaths have been reported with patients dying of disease activity early stages and cardiovascular disease later. The Systemic Lupus International Collaborating Clinics- American College of Rheumatology (SLICC-ACR) Damage Index(DI) includes 41 items covering 12 systems. Damage tends to accumulate over time and it is an important outcome measure supplementing disease activity measures. A multi-national study of more than 1000 patients, who were followed-up longitudinally, showed that higher SLICC/ACR DI scores were at higher risk of death. Therefore it is important to identify complications early and prevent their development and treat early.
FUNCTIONAL AND QUALITY OF LIFE ASSESSMENT IN SLE
The disease assessment indices above measure the physicicans assessment of patients disease. However it is also important to know the patients perception of her health and the overall quality of life. No specific measure has been developed for assessment of Quality of Life (QoL) and functional status of patients with SLE. Th Short Form -36 (SF36) is most widely used. It includes one multi-item scale that assesses 8 health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health; 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Health status measures have been shown to be impaired in patients with Lupus. They have been found to correlate more with psychosocial factors and less with disease activity/damage. Hence there may be a set of patients who may require non- pharamacological approaches to therapy including providing education , social support and counseling.
SLE has been compared to the multiple headed Hydra of Greek mythology. In analogy with the Hydra, SLE can present itself in a multitude of guises, usually intermittently active, with sometimes abrupt flares, sometimes prolonged periods of active disease, as well as periods of clinical remission. However, there is always a risk that the disease will reappear. Active disease may cause organ damage, and disease activity over time has been shown to be strongly associated with mortality and organ damage. Good instruments for monitoring disease activity, organ damage, and health status are required for adequate follow up of longterm outcome and judgment of response to treatment.
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