Download Duration of study: Fifty consecutive patients with Rheumatoid

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA
PROFOMA FOR REGISTRATION OF SUBJECTS FOR DESSERTATION
1. NAME OF THE CANDIDATE:
ADDRESS:
Dr. Mary Laly K.A (Sr. Divya)
Department of Medicine,
St. John’s Medical College Hospital,
John Nagar, Sarjapur Road,
Koramangala,
Bangalore – 560034
Tel. No. 080-22065352
2. NAME OF THE INSTITUTION:
St.John’s Medical College Hospital,
Bangalore.
3. COURSE OF STUDY AND SUBJECT:
MD – General Medicine
4. DATE OF ADMISSION TO THE COURSE: 21-03-2011
5. TITLE:
Respiratory manifestations in patients with rheumatoid
arthritis
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6. RESUME OF THE INTENED WORK BRIEF
6.1 NEED FOR THE STUDY
Rheumatoid arthritis (RA) affects approximately 1% of the adult population, with a female
preponderance. Pulmonary involvement is common, and may include a variety of manifestations namely
RA-associated interstitial lung disease (ILD) [1, 2], pleural disease [3], rheumatoid nodules and airway
complications (crico-arytenoid arthritis, bronchiectasis, bronchiolitis) [4]. Pulmonary involvement
contributes significantly to morbidity and mortality of patients with rheumatoid arthritis and is the
second most common cause of death, the first being infections [5]. In addition to the disease drugs used
in the treatment can cause pulmonary involvement. Often the pulmonary involvement is asymptomatic.
Therefore, a study of the pulmonary manifestations in patients with rheumatoid arthritis is important.
5.1. REVIEW OF LITERATURE
Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder that may affect many
tissues and organs, but principally attacks synovial joints especially the small joints of the hands and feet
in a symmetric fashion [6]. The process produces an inflammatory response of the synovium (synovitis)
secondary to hyperplasia of synovial cells, excess synovial fluid, and the development of pannus in the
synovium. The pathology of the disease process often leads to the destruction of articular cartilage and
ankylosis of the joints. Rheumatoid arthritis can also produce diffuse inflammation in the lungs,
pericardium, pleura, and sclera, and also nodular lesions, most common in subcutaneous tissue.
Although the cause of rheumatoid arthritis is unknown, autoimmunity plays a pivotal role in both its
chronicity and progression, and RA is considered a systemic autoimmune disease
The American Rheumatism Association proposed diagnostic criteria for RA in 1987. It consisted of seven
criteria.
1. Morning stiffness for at least 1 hour
2. Arthritis of 3 or more joint areas, simultaneously
3. Hand arthritis (wrist, metacarpophalangeal or proximal interphalangeal joint)
4. Symmetric joint involvement
5. Subcutaneous rheumatoid nodules
6. Presence of rheumatoid factor
7. Radiographic erosion or bony decalcification of involved joints
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Diagnosis was based on the presence of at least 4 of the 7 criteria; the first 4 must have been present for
at least 6 weeks.
In 2010 the 2010 ACR / EULAR Rheumatoid Arthritis Classification Criteria were introduced [7]. These
new classification criteria over ruled the "old" ACR criteria of 1987 and are adapted for early RA
diagnosis. The "new" classification criteria, jointly published by the American College of Rheumatology
(ACR) and the European League Against Rheumatism (EULAR) establish a point value between 0 and
10. Every patient with a point total of 6 or higher is unequivocally classified as an RA patient, provided
he has synovitis in at least one joint and given that there is no other diagnosis better explaining the
synovitis. Four areas are covered in the diagnosis [7].
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joint involvement, designating the metacarpophalangeal joints, proximal interphalangeal joints,
the interphalangeal joint of the thumb, second through third metatarsophalangeal joint and
wrist as small joints, and elbows, hip joints and knees as large joints:
o Involvement of 1 large joint gives 0 points
o Involvement of 2-10 large joints gives 1 point
o Involvement of 1-3 small joints (with or without involvement of large joints) gives 2
points
o Involvement of 4-10 small joints (with or without involvement of large joints) gives 3
points
o Involvement of more than 10 joints (with involvement of at least 1 small joint) gives 5
points
serological parameters – including the rheumatoid factor as well as ACPA – "ACPA" stands for
"anti-citrullinated protein antibody":
o Negative RF and negative ACPA gives 0 points
o Low-positive RF or low-positive ACPA gives 2 points
o High-positive RF or high-positive ACPA gives 3 points
acute phase reactants: 1 point for elevated erythrocyte sedimentation rate (ESR) or elevated
c-reactive protein(CRP)
duration of arthritis: 1 point for symptoms lasting six weeks or longer
The new criteria accommodate to the growing understanding of rheumatoid arthritis and the
improvements in diagnosing RA and disease treatment. In the "new" criteria serology and autoimmune
diagnostics carries major weight, as ACPA detection is appropriate to diagnose the disease in an early
state. Destruction of the joints viewed in radiological images was a significant point of the ACR criteria
from 1987 [8] .This criterion no longer is regarded to be relevant, as this is just the type of damage that
treatment is meant to avoid.
The progression of rheumatoid arthritis can be followed using scores such as Disease Activity Score of 28
joints (DAS28). It is widely used as an indicator of RA disease activity and response to treatment, but is
not always a reliable indicator of treatment effect [9]. The joints included in DAS28 are (bilaterally):
proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2),
shoulders (2) and knees (2). When looking at these joints, both the number of joints with tenderness
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upon touching (TEN28) and swelling (SW28) are counted. In addition, the erythrocyte sedimentation
rate (ESR) is measured. Also, the patient makes a subjective assessment (SA) of disease activity during
the preceding 7 days on a scale between 0 and 100, where 0 is "no activity" and 100 is "highest activity
possible". With these parameters, DAS28 is calculated as:[10]
From this, the disease activity of the patient can be classified as follows:[10]
DAS28 difference from initial value
Current
DAS28
≤ 3.2
Inactive
> 3.2 bu ≤ 5.1 Moderate
> 5.1
> 1.2
> 0.6 but ≤ 1.2
≤ 0.6
Good improvement
Moderate improvement No improvement
Moderate improvement Moderate improvement No improvement
Very active Moderate improvement No improvement
No improvement
The following are the respiratory manifestations of RA.
1. PRIMARY AND SECONDARY PLEUROPARENCHYMAL COMPLICATIONS OF RHEUMATOID ARTHRITIS [11]
Pleural disease
Pleural effusions
Pleural fibrosis
Airway disease
Cricoarytenoid arthritis
Bronchiectasis
Follicular bronchiolitis
Bronchiolitis obliterans
Diffuse panbronchiolitis
Interstitial lung disease
Usual interstitial pneumonia
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Nonspecific interstitial pneumonia
Organizing pneumonia
Lymphocytic interstitial pneumonia
Diffuse alveolar damage
Acute eosinophilic pneumonia
Apical fibrobullous disease
Amyloid
Rheumatoid nodules
Pulmonary vascular disease
Pulmonary hypertension
Vasculitis
Diffuse alveolar hemorrhage with capillaritis
Secondary pulmonary complications
Opportunistic infections
Pulmonary tuberculosis
Atypical mycobacterial infections
Nocardiosis
Aspergillosis
Pneumocystis jeroveci pneumonia
Cytomegalovirus pneumonitis
Drug toxicity
Methotrexate
Gold
D-Penicillamine
Sulfasalazine
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5.2. OBJECTIVES OF THE STUDY:
1. To determine the common respiratory manifestation in patients with rheumatoid
arthritis
2. To assess the presence of asymptomatic pulmonary involvement
3. To study possible predictors of pulmonary involvement
6. MATERIALS AND METHODS:
6.1. Source of data
Patients with Rheumatoid arthritis seen in the Medical/Rheumatology OPD of St John’s
Medical College Hospital or admitted in the Medical wards will be included in the study.
Cases will be collected over a period of 1 year.
Study design:
Cross sectional study
Sample size:
50
Duration of study: Fifty consecutive patients with Rheumatoid arthritis seen in the
Medical/Rheumatology OPD of St John’s Medical College Hospital or
admitted in the Medical wards of this hospital will be included in the
study. Cases will be collected over a period of 1 year.
INCLUSION CRITERIA
1. Patients diagnosed with RA newly or those being followed up for the disease
2. Patients with or without respiratory symptoms
3. Consenting to participate in the study.
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EXCLUSION CRITERIA
1. People who smoke
2. Patients who had preexisting respiratory disease like TB, Bronchial asthma, COPD before the
onset of RA
3. Patients in whom the Six Minute Walk test is contraindicated
PROPOSED NUMBER
It is proposed to study 50 patients.
7.2 METHOD OF COLLECTION OF DATA
All patients who are newly diagnosed to have RA or are being followed for the disease & willing to
participate in the study will be evaluated as per the proforma designed for the purpose of the study.
All patients will be classified as rheumatoid arthritis on the basis of 2010 ACR / EULAR Rheumatoid
Arthritis Classification Criteria
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All patients will undergo a detailed clinical examination with particular reference to the
musculoskeletal & the respiratory systems.
Disease activity will be assessed according to the DSA 28 score.
Disability will be assessed according to the HEALTH ASSESSMENT QUESTIONNAIRE
score
All patients will undergo Pulmonary Function Testing (PFT), Chest Radiography and the
Six Minute Walk Test (SMWT).
Further evaluation will be done only if warranted based on the initial evaluation.
The parameters recorded in PFT will be FEV1, FVC, FEV1/FVC ratio, PEF and FEF25-75
The SMWT will be performed as per the guidelines of the American Thoracic Soceity.
A measured walking distance of at least 100 feet is required for performing SMWT.
o Blood pressure, heart rate, respiratory rate, and resting blood saturation by
pulse oxymeter will be obtained prior to testing.
o The patient, after being familiarized with the 10-point Borg Dyspnea Index
Scale, will be asked to rate their perception of the level of shortness of breath
at rest
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o
Reporting formats include distance walked in feet, the average saturation,
dyspnea index at the very conclusion of the walk, and a recovery saturation
reading.
The study is essentially a descriptive one & the data will be analyzed using the EPI Info program.
Prevalence of various pulmonary manifestations & descriptive statistics will be generated using the
program. Correlations will be calculated using Chi-Square test or Pearson’s test.
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PROFORMA- RA and pulmonary disease
No-
Date-
Name________________________________Age/ Sex __________ OPD/IP no_____________________
Address/ Phone no. ____________________________________________________________________
RA Symptoms & Signs
Duration of symptoms
yrs
EMS
Yes/No
EMS duration
min
Total no of joints affected
Symmetry
Yes/No
Rheumatoid nodules
Yes/No
Deformities- List separately
Pallor
Yes/No
Eye symptoms
Yes/No
Skin lesions- if any, describe
Neurologic symptoms/ signs
Clubbing
Lymphadenopathy
Pedal edema
Pulmonary symptoms &signs
ACR Criteria
Cough
Yes/No
Sputum/ Hemoptysis
Yes/No
Dyspnea
Yes/No
MRC grade Dyspnea
Chest pain
Yes/No
Chest expansion
cm
Chest auscultation (Detail)
EULAR criteria
Wheeze
Smoker (pack yrs)
Past h/o pulmonary ds
Tender Joint count- (28 joints)
Yes/No
Yes/No
Swollen Joint Count- (28 joints)
HAQ Score--
VAS Score
Treatment History
Drug
NSAIDS
Prednisolone
Methotrexate
Chloroquin/HCQ
Leflunomide
Sulphasalazine
Biologics
Duration of use
Current use
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Current Dose
Side effects
INVESTIGATIONS
Hb____gm%, TC _____/ cumm, DC- N__L___E___, PC_______Lakhs, ESR- ____mm/ 1st hour,
OthersCreat _______, LFT- N/abN____,
CRP__________ ( normal range _________)
Rheumatoid Factor_________, ANA__________.
CXR______________________________________________________________________________
6 min walk test-
PFT:
FVC
FEV1
FEV1/FVC
MEF 25
MEF 50
MEF 75
PEF
LIST OF REFERENCES
1.
Brown KK. Rheumatoid lung disease. Proc Am Thorac Soc 2007; 4: 443–448.
2.
Antoniou KM, Margaritopoulos G, Economidou F, et al. Pivotal clinical dilemmas in
collagen vascular diseases associated with interstitial lung involvement. Eur Respir J 2009;
33: 882–896.
3.
Bouros D, Pneumatikos I, Tzouvelekis A. Pleural involvement in systemic autoimmune
disorders. Respiration 2008; 75: 361–371.
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4.
Devouassoux G, Cottin V, Liote´ H, et al. Characterisation of severe obliterative
bronchiolitis in rheumatoid arthritis. Eur Respir J 2009; 33: 1053–1061
5.
Anaya J, Diethelm L, Ortiz LA, et al. Pulmonary 1. involvement in rheumatoid arthritis.
Semin Arthritis Rheum 1995; 24: 242-54.
6.
Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987
revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum
1988;31(3):315–24
7.
Aletaha D, Neogi T, Silman AJ, et al. (September 2010). "2010 rheumatoid arthritis
classification criteria: an American College of Rheumatology/European League Against
Rheumatism collaborative initiative
8. DAS28 not always a reliable indicator of treatment effect in RA By Janis Kelly, Medscape
Medical News
9. Arnett F, Edworthy S, Bloch D, McShane D, Fries J, Cooper N, Healey L, Kaplan S, Liang
(March 1988). "The American Rheumatism Association 1987 revised criteria for the
classification of rheumatoid arthritis".
10. Prevoo, ML; Van 't Hof, MA; Kuper, HH; Van Leeuwen, MA; Van De Putte, LB; Van Riel, PL
(1995). "Modified disease activity scores that include twenty-eight-joint counts.
Development and validation in a prospective longitudinal study of patients with
rheumatoid arthritis". Arthritis and rheumatism
38 (1): 44–8.
11. Kevin K Brown: Rheumatoid Arthritis Interstitial Lung Disease .Department of Medicine,
National Jewish Medical and Research Center, University of Colorado Health Sciences
Center, Denver, Colorado
12. Solway S,Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the
measurement properties of functional walk tests used in the cardiorespiratory domain.
Chest 2001;119:256–270.
13. . Barthelemy JC, Geyssant A, Riffat J, Antoniadis A, Berruyer J, LaCour JR. Accuracy of
pulse oximetry during moderate exercise: a comparative study. Scand J Clin Lab Invest
1990;50:533–539.
14. Borg GAV. Psycho-physical bases of perceived exertion. Med Sci Sports Exerc
1982;14:377–381.
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9. SIGNATURE OF THE CANDIDATE
10. REMARKS OF THE GUIDE
11. NAME AND DESIGNATION OF
11.1 GUIDE:
DR.CHANDRAMOULI K S
PROFFESSOR OF MEDICINE
11.2 SIGNATURE:
11.3 CO-GUIDE:
DR.VINEETA SHOBHA
PROFFESOR OF MEDICINE
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT:
DR.S D TAREY
PROFESSOR & HEAD
11.6 SIGNATURE
12.1 REMARKS OF CHAIRMAN AND PRINCIPAL
12.2 SIGNATURE
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ANNEXURE I
HEALTH ASSESSMENT QUESTIONNAIRE
Stanford University School of Medicine -Division of Immunology & Rheumatology
Name
Date
In this section we are interested in learning how your illness affects your ability to function in daily
life. Please feel free to add any comments on the back of this page.
Please check the response which best describes your usual abilities OVER THE PAST WEEK:
Without ANY
difficulty
0
With SOME
difficulty
1
With MUCH
difficulty
2
DRESSING & GROOMING
Are you able to:
-Dress yourself?
-Shampoo your hair?
ARISING
Are you able to:
-Stand up from a straight chair?
-Get in and out of bed?
EATING
Are you able to:
-Cut your meat?
-Lift a full cup or glass
to your mouth?
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UNABLE to do
3
-Open a new milk carton?
WALKING
Are you able to:
-Walk outdoors on flat ground?
-Climb up five steps?
HYGIENE
Are you able to:
-Wash and dry your body?
-Take a tub bath?
-Get on and off the toilet?
REACH
Are you able to:
-Reach and get down a 5-pound
object (such as a bag of sugar)
from just above your head?
-Bend down to pick up clothing
from the floor?
GRIP
Are you able to:
-Open car doors?
-Open jars which have been
previously opened?
-Turn faucets on and off?
ACTIVITIES
Are you able to:
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-Run errands and shop?
-Get in and out of a car?
-Do chores such as vacuuming
or yardwork
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ANNEXURE II
SIX MINUTES WALK TEST
Lap counter: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __
Patient name: ____________________ Patient ID# ___________
Walk # ______ Tech ID: _________ Date: __________
Gender: M F Age: ____ Race: ____ Height: ___ft ____in, ____ meters
Weight: ______ lbs, _____kg Blood pressure: _____ / _____
Medications taken before the test (dose and time): __________________
Supplemental oxygen during the test: No Yes, flow ______ L/min, type _____
Baseline End of Test
Time ___:___ ___:___
Heart Rate _____ _____
Dyspnea ____ ____ (Borg scale)
Fatigue ____ ____ (Borg scale)
SpO2
____ % ____%
Stopped or paused before 6 minutes? No Yes, reason: _______________
Other symptoms at end of exercise: angina dizziness hip, leg, or calf pain
Number of laps: ____ (
60 meters)
final partial lap: _____ meters
Total distance walked in 6 minutes: ______ meters
Predicted distance: _____ meters Percent predicted: _____%
Tech comments:
Interpretation (including comparison with a preintervention 6MWD):
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ANNEXURE III
DAS28 difference from initial value
Current
DAS28
≤ 3.2
Inactive
> 3.2 bu ≤ 5.1 Moderate
> 5.1
> 1.2
> 0.6 but ≤ 1.2
≤ 0.6
Good improvement
Moderate improvement No improvement
Moderate improvement Moderate improvement No improvement
Very active Moderate improvement No improvement
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No improvement