CONSENT FORM "HEALTH RELATED QUALITY OF LIFE ASSESSMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS AND ITS CO- RELATION WITH DISEASE SEVERITY" Case Study Number = Participant Initials : Participant Name ; Date of Birth/Age : 1, L understand that I'am being invited to take part in the research study. I confirm that I have read and understood the information sheet dated 26/8/22 version 1.0 for the above study and have had the ‘opportunity to ask questions. 2.1 understand that my participation in the study is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected. 3. 1 understand the-risk and potential benefits of this research study that were explained to me. I freely give my consentto take part in research study described in this form. 4. L understand that the Sponsor of the research study. Others working on the Sponsor's behalf, IEC and ‘the regulatory authorities will not need my permission to look at my health records both in respect of the current study and any further research that may be conducted in relation to it, even if I withdraw from the trial. L agree to this access. However, I understand that my identity will not be revealed in any information released to third parties and published. 5. Lagree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose. 6. Lagree to take part in the above study. Thave read the above information and agreed to participate in this study. I have received a copy of this form. articipant’s Name : [Participant's parents signature and date cides ualification }ccupation inual Income Phone Number |Witness's Name: —- |Witness's signature & date INVESTIGATOR: DR DURGNEDRA SOLANKI SUPERVISOR: DR PREKSHA DWIVEDMMD,DM) ASSOCIATE PROFESSOR DEPARTMENTOF MEDICINE, GMC, BHOPAL,weafa ws "HEALTH RELATED QUALITY OF LIFE ASSESSMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS AND ITS CO-RELATION WITH DISEASE SEVERITY" sera dts - “Ser Rats wafed site adm srrade site Rete wor Rdddwe tkica we dea al-Retera fer dao Sree GT: ufearcht & seca ‘fereraft or ara Peon Sooner at eh sere sone Fre Pear feet of aor oe aa S Re was 3 2A ea the ee @ sift ste gare ert ot eon Soh ge are ae 21H ee wor & afte ete srr A nor aa @ re wada oe & aut went Bat Ei 4. aagar & Pe ater saad wrlioe a ote Sarr wea ae rea ombdelt site Prenae witoret ot adert sera ot siz & ort oe ae sea che S tide A AL eae Ros B tad & Be AG ogak a snare ae got yas Ru, wa GA geek F ze wre 9 oe ce Be Seem & cre, # compet & Re Ase we WY ond She is Boat at ora a AG vera wr waren ae Ree 5. B ga sore 3 ser Oo me Bot of Se an cot & sir wt wf ah mee & A ar a 3 fae wena €) aS wr wel oh vw vit oa gW fee Sa aa or are faem 5 ae @ caren od ste Riera fear rare eer arer prae & eae va aie INVESTIGATOR: DR DURGNEDRA SOLANKI SUPERVISOR: DR PREKSHA DWIVEDI(MD, DM) ASSOCIATE PROFESSOR DEPARTMENTOF MEDICINE, GMC, BHOPAL,PROFORMA Case Code... Date of enrolment... Name [Age/Sex Icr No [Admission No. |Address. |Contact No. fr [Occupation [Date of \discharge/death [Date of admission 3 Complaints pes of onset f symptoms [Total no. of {hospital jadmissions SLICC Criteria Yes No ‘Acute cutaneous lupus Chronic cutaneous lupus Oral ulcers Non scarring alopecia Renal Arthritis SerositisNeurological Hemolytic anemia Thrombocytopenia (<100000) Leucopenia ANA Anti dsDNA’ Anti — Sm ‘Anti phospholipid antibody Low complement (C3/C4) Direct coomb's test ‘Organ involvement Sino. Yes No 7 | Skin @ | Matar rash (i) _ | Photosensitivity (ii) __| Discoid rash (i) _| Oralulcers (| Alopecia @i)_| Vasculitis (vii) _ | Bullous lesions (viii) | Others 2. |MSK @ | Arthralgias (i) | Arthritis Gil) __ | Myopathy/myositis (iv) _ | Osteopenialosteoporosis @ [AW 3. Renal Proteinuria Hematuria Pyuria Oliguria Pedal edemaUrinary casts (vii) azotemia” 4 Neurological @ [Headache ()_ | Seizures (ii) __ | Psychosis (iv) _ | Depression ™ _ | Stroke (vi) _| Cranial nerve disorder (vii) _| Visual disturbances (vill) | Cognitive dysfunction (&)_| Meningitis &) _ | Myelopathy 5. | Cardio-pulmonary @ | Cough (i)__| Expectoration (i)__| Chest pain (iv) _| Breathlessness (v) _ | Hemoptysis (Ww)_| Pleuritis (vii)_| Pericarditis (vill) | Myocarditis/cardiomyopathy (i) _| Diffuse alveolar hemormhage (%)__ | Pulmonary artery hypertension (xi) _| Ischemic heart disease (xi) ILD 6. Hematological (| Hemolytic anemia (i)__ | Thrombocytopenia (ii) | Leucopenia (iv) | Lymphopenia (v) | Anemia due to other causes (vi)__ | Hematological malignancy 7. Gastrointestinal() [Nausea (ii) Vomiting (i) | Constipation @)_ [Diaries (| Pain abdomen (vi)__| Mesenteric ischemia (vil) | Lupus enteritis (vil) | Pancreatitis (&) [Ascites () | Melena (i) | Jaundice Gi) | Peritonitis 8. _ | Constitutional @ | Fever (i) | Weight loss (i) _| Malaise 9. Vascular @ _| Arterial thrombosis (ii) Venous thrombosis Gi) _| Vasculitis 10. | Obstetric complications ()__| Fetal loss before 10 weeks (no) (ii) Fetal loss after 10 weeks. (iii) Pre-eclampsia/ eclampsia (iv) _ | Preterm deliveries SLEDAI:HIV HBsAg Anti-HCV ECG Chest X-ray HRCT chest Blood culture/sensitivity Urine culture/sensitivity Sputum culture/sensitivity ‘Sputum AFB Sputum for fungal stain & culture Body fluids (TLC/DLC/Sugar/Protein) Body fluids microbiology 2D Echocardiography Renal biopsy Other investigationsLaboratory parameters Hb TLE DLC Platelets MCV/RDW MCH/MCHC ESR Na/kK Urea’ Creatinine SGOT SGPT ALP Bilirubin Sr. Protein Sr. Albumin Ca/Phos Uric acid CPK LDH FBS/PPBS Urine routine Microscopy ANA (IF) Anti ds DNA Anti Sm C3. C4 24 hr urinary protein CRP.Drug history Before admission ‘After admission Side effects of therapy Side effects of therapy Outcome at 2 years Cause of death - SlE related YIN Infections YIN Miscellaneous YIN Renal YIN Pulmonary YIN Cardiac YIN UT YIN Pulmonary YIN - CNS YIN CNS YIN ‘Abdominal YIN Gitract YIN Others Hematological YIN Disease activity assessment -SLEDAI2K- SLE damage index — Final diagnosis‘Table 2. SLEDAI- 2K data collection form. Sudy No. Patient Name: Visit Date: | Esterweightin SLEDAI Score column if descriptors present atthe time ofthe vst or inthe preceding 10 days) Weight SLEDAI — Descriptor SCORE Seite ——— Psychosis 8 __ Orgenic brain Definit Recent onset, exclude metabolic, inféetious oc drug causes. Altered ability to function in normal activity due ts severe disturbance in the perception of reality. Include hallucinations, incoherence, marked loose associations, impoverished thought content, marked illogical thinking, bizarre, disorganized, ar S.white blood cellshigh power field. Exclude infection, 2 Rash Inflammatory type rash. 2 Alopecia Abnormal, patchy or diffise loss of hair. 2 Mucosal ulcers. Oral or nasal ulcerations, 2 Pleurisy ‘Pleuritic chest pain with pleura rub or effusion, or pleural thickening, 2 __ Pericarditis Pericardial pain with at eas | of the following: rub, effusion, or electrocardiogram or echocardiogram confimation, 2 ____ Low complement Decrease in CH50, C3, or C4 below the lower limit of normal for testing laboratory 2 Increased DNA binding Increased DNA binding by Farr assay above normal range for testing laboratory. 1 Fever >38°C. Exclude infeetious cause, ' Thrombocytopenia <100,000 platelets / x10", exclude drug causes. {__ Leukopenia <3,000 white blood ces /x10%AL, exclude drug causes. TOTAL SLEDAI SCORELupus PRO Questionnaire ee A. In the past 4 weeks, how often did you experience the following due to your lupus? None of Alittle Some of Most of All of Not j the time of the the time | the time the | Applicable 1 time time | 1. | Loss of hair oO o Clos. | alte oO 2. Rercl ee of previous lupus-related a o e “4 a a 3. | Lupus flare o ts ‘4. | Poor memory ae o a 5. | Lack of concentration a o 6. Pints fos aoaton(s) related bothersome a oO o o 7 [Gedclue wang comedoeugue, [OPS ao [elo * | Goraeys meer” gl CY afola 9: | Worry about ability to prevent unplar og oO oO B. How often were you limited: ily activities because of your physical health due to your lupus over the past 4 weeks? of [Allie of | Some of | Mostof ] Allof | Not the'time the time the time the time the Applicable time 70. | Taking personal (crogsheing let, = a o a a Bi 1. | Ge 1 tig and oy ec ag a o oO o 42. | Fulfilling faflly respotpiiies ao a oO oO ao o 73. | Taking care of io direally depend on me tego a a a Qo Qa a a 44. | A burden to family or friends due to your physical abilities. a 5 Qo 7 Fa oC. How often did you feel the following due to your lupus during the past 4 weeks? perceived me None of [Alito of | Some of | Mostof | Alot | Not thetime | the time | thetime | thetime | the | Applicable time a0 i 75. | Twoke up feeling wom out a = a a a | Tet pai 76. | Telt pain and aching in my body a a a = a V7. [Twas unable to do my usual adivties due to bodiy pain’ a o 5 |e a) 1. [Twas unable to perform uaualecivves |) “af al for long periods of time (e.g. around | home or at work) because of pain or fatigue 78. | Iwas limited n the Kinds of tacks or activities | could perform because of cy iS) es pain or fatigue D. During the past 4 weeks, how often did you feel becaus None,of tof | Alot | Not e thetime | the | Applicable time 20. Word about Tapas impact on my al o a 2F, | Worried about Tsing neame | a al a a 2. | Anwious 5 ai ai 23. | Depressed = a a o 24, | Concared that lupus (ors : may lead to m th probler a Q a a Qa 25. | Concemed that fupus Telated healt problems will ast a long a 9 7 7 2 During at wee, how difen did you feel the folowing due to lupus? , ~ A FB y ed None of | Allie of | Some | Mostofthe | Allo | Not % , thetime | thetime | oftre | time | the | Applicable tm time time | aa 2. | | siked my appearance a a a A a 27. | Tihought less of myself a a ai D o | Tack 77 28. | Vlacked control over my appearance a ai a = a 23. | Twas self conscious aboul my appearance oi o c a a 30. | Twas embarrassed about how others a a 7 a Oo F. During the past 4 weeks, how often did lupus interfere with your:a None of |Alite of | Some | Mostofthe | Alof | Not the time | thetime | ofthe | time | the | Applicable time time 31. | Ability to plan activities and schedule Soe a a ao a a ‘2. | Overall life satisfaction o oO a a a 33. | Enjoyment of ife a o ol-o o 34. | Fullilment of career goals o o oO o o o G. During the past 4 weeks, how often would you say in regards to your lupus? , %, None of | Alittie of | So ‘Alot | __ Not thetime | the time | of tim the | Applicable ti time 35. | Treceived support from my fiends. fs ai oO 36. | Trecéived support from my family. a a o o 37. | focused on making my situation better. | o O o 36, | Tleamed to Ive with my lupus. a oO 39. | Treceived comforistrength from my a D o religious or spiritual beliefs. H, During the past 3 months, how offen ee ing about the medical care for lupus you received? N GF] Some | Mostofthe | Allof ] Not the ima] the ofthe | time | the | Applicable S time time 40. | My doctor was accessible ‘question regarding my lupus. a a a a a My doctor un lupus on my fi G o | My vided me with ink inderstang, my oy a a lpu be 3. | My doctéis discussed) mohitored the side ofeakg un mes is. a a a a By el V Thank you for completing this questionnaire. Please check to make sure all questions have been answered.©™ 2007, Rush University Medical Center and Board of Trustees of the University of lino's at Chicago. Al rights reserved. 091640 Scoring for LupusPRO v1.7 Construct | Domain Deseription Reverse Coding HRQOL, ‘Lupus Symptoms Lupus Symptoms ‘Yes HRQOL ‘Cognition ‘Cognition Yes, HRQOL, ‘Lupus Medications Yes: HRQOL, Procreation : Yes HRQOL, Physical Health Yes HIRQOL. Pain Vitality Yes HRQOL, ‘Emotional Health Yes, HRQOL, ‘Body Image Yes: N-HRQOL | Desires-Goals Yes N-HRQOL | Social support No, N-HRQOL ‘No. N-HRQOL ‘No of the time/not applicable, 1= A little of the ff the time, 5= Not applicable (recode as O for scoring). @ are 12 observed domains. Item scores are totaled for ¥y dividing the total score by the number of items in that res ranging from 0 (worst QOL) to 100 (best QOL) by .onses} minus 1) and then multiplying by 100, as below: Reverse scoring for some each domain item and the mean domain.’ The mean raw domain s dividing by 4 (the 1 (Mean raw domain Transformed domait i yhen at least 50% of the items are answered. Total HRQOL and N- HRQOL scores are ot ransformed domain scores within each construct. ®