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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 1 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 2 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]. 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 3 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 4 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 5 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. 6 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 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 7 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. 8 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 9 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. 10 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. 11 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 12 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? 13 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: 14 -Run errands and shop? -Get in and out of a car? -Do chores such as vacuuming or yardwork 15 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): 16 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 17 No improvement