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Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3

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1 Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3 Theodore Pincus MD Clinical Professor of Medicine New York University

2 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Complexities in quantitative assessment of patients with RA and rheumatic diseases Laboratory tests are limited in diagnosis and treatment decisions Treat radiograph before damage No single ‘Gold Standard’ measure, eg, blood pressure, cholesterol, glucose, for diagnosis and management in all individual patients Therefore, need indices of 3–7 measures

3 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Complexities in quantitative assessment of patients with RA and rheumatic diseases Patient history and physical examination is more important in clinical management decisions than in diseases with gold standard measure, eg, blood pressure, cholesterol, glucose Patient history information may be captured as quantitative "scientific" data using structured patient self-report questionnaires

4 Psychological distress
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM MDHAQ: Page 1 of 2 a - j: Physical function k, l, m: Psychological distress 2. Pain 3. RADAI Self-report joint count 4. Patient global estimate RAPID3

5 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
2.7 9.5 9.0 21.2 Visit 1 – Baseline 5

6 Visit 1 2.7 9.5 9.0 21.2 43 Visit date Q-Function (0–10) Q-Pain (0–10)
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Visit 1 Visit date Visit 1 Q-Function (0–10) 2.7 Q-Pain (0–10) 9.5 Q-Global (0–10) 9.0 RAPID3 (0–30) 21.2 L-ESR 43 Prednisone N-3qd T-Methotrexate N10qw T-Folic acid N1qd T-Tylenol w/Codeine 30tid T-Naproxen 880q6h N=new drug, C=change in dose, T=taper, D/C=discontinue 6

7 Visit 2 – 2 months after baseline  0.5 1.0 
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM 0.5 1.0 Visit 2 – 2 months after baseline 7

8 Visit 2 2.7 9.6 0.3 8.9 21.2 0.6 43 8 Visit Date Q-Function (0-10)
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Visit 2 Visit Date 4Nov03 13Jan04 Q-Function (0-10) 2.7 Q-Pain (0-10) 9.6 0.3 Q-Global (0-10) 8.9 RAPID3 (0-30) 21.2 0.6 L-ESR 43 8 T-Prednisone N3qd T-Methotrexate N10qw T-Folic Acid N1qd T-Tylenol w/Codeine 30tid T-Naproxen 880q6h N = new drug, C = change in dose, T = taper, D/C = discontinue 8

9 Visit 5 – 13 months after baseline   6.0 5.5 11.5         
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Visit 5 – 13 months after baseline 6.0 5.5 11.5

10 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Visit 5 Visit Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Q-Function (0–10) 2.7 0.3 Q-Pain (0–10) 9.6 0.2 0.6 6.0 Q-Global (0–10) 8.9 1.0 5.5 RAPID3 (0–30) 21.2 0.8 1.6 11.5 L-ESR 43 8 13 10 14 T-Prednisone N3qd 3qd T-Methotrexate N10qw C20qw 20qw 15qw T-Folic acid N1qd 1qd T-Tylenol w/Codeine 30tid D/C T-Naproxen 880q6h 440bid N=new drug, C=change in dose, T=taper, D/C=discontinue 10

11 Visit 6 – 15 months after baseline   0.5 0.5            
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Visit 6 – 15 months after baseline 0.5 0.5

12 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Visit 6 Visit Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Q-Function (0–10) 2.7 0.3 Q-Pain (0–10) 9.5 0.5 0.0 6.0 Q-Global (0–10) 9.0 1.0 5.5 RAPID3 (0–30) 21.2 0.8 1.5 11.5 L-ESR 43 8 13 10 14 T-Prednisone N3qd 3qd T-Methotrexate N10qw C20qw 20qw 15qw C25qw C15qw T-Folic acid N1qd 1qd T-Tylenol w/Codeine 30tid D/C T-Naproxen 880q6h 440bid T-Adalimumab N40qow 40qow N=new drug, C=change in dose, T=taper, D/C=discontinue 12

13 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM

14 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM

15 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM

16 Disease Duration (Years) Disease Duration (Years)
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Cross-Sectional Data in Patients With RA: Cohort #2 in 1985 and Cohort #4 in 2000: MDHAQ Scores 1985 2000 2.0 1.5 1.0 0.5 0.0 2.0 1.5 1.0 0.5 0.0 MHAQ MHAQ 5 10 15 20 5 10 15 20 Disease Duration (Years) Disease Duration (Years) Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005

17 Disease Duration (Years) Disease Duration (Years)
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Cross-Sectional Data in Patients With RA: Cohort #2 in 1985 and Cohort #4 in 2000: Swollen Joint Count Scores 1985 2000 20 16 12 8 4 20 16 12 8 4 Swollen Joint Count 28 Swollen Joint Count 28 5 10 15 20 5 10 15 20 Disease Duration (Years) Disease Duration (Years) Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005

18 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Cross-Sectional Data in RA Patients: Cohort # and Cohort #4-2000: Larsen X-Ray score,% of maximum 1985 2000 RF+ RF- RF+ RF- 18

19 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Patients seen for standard rheumatoid arthritis care have significantly better articular, radiographic, laboratory, and functional status in 2000 than in 1985 Measure 1985 n=125 2000 n=150 p Swollen joints(0-28) 12 (6,16) 5 (2,10) <0.001 X-Ray (Larsen ) 20 (2,36) 3 (0,13) ESR 33 (16 , 50) 20 (9,33) 0.016 Hemoglobin (g/L) 129(116,138) 136 (128,143) 0.002 MHAQ Function (0-3) 1.0 (0.6 , 1.4) 0.4 (0.1 , 1.0) Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005 19

20 Jyvaskyla, Finland & Nashville, TN
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Mtx in RA Care: Jyvaskyla, Finland & Nashville, TN Sokka, Pincus,. Rheumatology (Oxford) 47: , 2008.

21 Indices to assess patients with RA
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Indices to assess patients with RA ACR DAS28 CDAI RAPID3 # Tender joints 0.56 sq rt (TJC28) 0-28 -- # Swollen joints 0.28sq rt (SJC28) MD global 0-10 ESR or CRP 0.70  ln (ESR) Patient function Patient pain Patient global 0.014  PTGL TOTAL 0-76 0-30 Repeated studies, and now BeSt have shown that close supervision and monitoring of responses to drive treatment results in better patient outcome measures. However, very few physicians (12%) are obtaining and/or using these measures. Some of the reasons given include: they are too difficult to do outside of a clinical trial, they take too much time (although my poster shows that the method proposed by Ted Pincus takes 20 seconds---shameless plug--), or require labs and formulae that are not available or difficult to calculate. To make these calculations more user friendly, many have proposed alternatives to the ACR criteria or DAS28. Smolen has been using SDAI and now CDAI (which eliminates the CRP), Pincus is using the MD-HAQ and “RAPID” and now Dr. Cush has proposed another, simple measure that can be readily calculated by anyone, at the time of the office visit. Global Arthritis Score: A Rapid Practice Tool for Rheumatoid Arthritis (RA) Assessment PURPOSE: Validated outcome measures have been promoted to assess outcomes in RA clinical trials. However, such tools (ACR20, DAS, DAS28, HAQ-DI, MD-HAQ, SF-36, SDAI, mSDAI, etc) are seldom used in practice or clinical decision making. Reasons for their neglect include time constraints, uncommon measurements (global scores, long surveys), lab delays and complicated calculations. A recent survey of 1130 US rheumatologists revealed that only 12.2% used the HAQ and 6% calculated the disease activity score (DAS) when assessing RA. Half of US Rheums make treatment changes based on MD preferences, yet few use objective measures. This study will demonstrate the value and validity of a novel practice tool, the Global Arthritis Score (GAS), in the assessment and management of RA patients. The GAS is the sum of 3 measures: 1) patient pain (0-10 scale); 2) raw mHAQ (range 0-24; using the 8 question modified Health Assessment Questionnaire[HAQ]); and 3) tender joint count (0-28). GAS totals range from 0-62 and is easily acquired during the routine encounter. METHODS: 44 consecutive RA patients (and 181 clinic visits) form the data set used to compare and validate the GAS against the DAS28, DAS-CRP, simple disease activity index (SDAI), modified SDAI (without CRP), MD global, and swollen joint count (SJC). To be included patients had to have 2 or more visits with available data. All patients meet ACR criteria for RA diagnosis and included 7 men and 37 women with a mean age of 50 yrs and disease duration of 11.7 years. Early RA (< 3yr) comprised 25% of group. Prednisone was used in 39%; with a mean dose of 7 mg/d. Patients had an average of 2.5 prior DMARDs. Half took DMARDs and 27% took MTX at mean of 18.8 mg/wk. TNF inhibitors were used in 59% at some time. Fitness of GAS to measure both activity (variables correlated for all visits) and treatment response (change in variables over time) was assessed. RESULTS: Spearman-rank correlation coefficients from this data set showed highly significant correlations (P< ) between the GAS and other validated outcome measures when assessing disease activity. Responses over time also showed the GAS to be equal or superior to the DAS and other measures. CONCLUSIONS: These analyses demonstrate the construct validity of the Global Arthritis Score (GAS) as applied to patients in clinical practice. The GAS is rapidly acquired, incorporates simple patient measures (pain, mHAQ) and is completed and calculated at the end of the tender joint exam. The GAS can be used to assess current activity, response to therapy and as a target measure of remission or near remission (eg GAS <8). 21 21

22 RAPID3 versus DAS28 in 285 RA patients
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM RAPID3 versus DAS28 in 285 RA patients Pincus, Swearingen, Bergman, Yazici. RAPID3 J Rheumatol. 35: , 2008 Reference 1. Pincus T, Sokka T. Rheum Dis Clin of North Am. 2004;30:725–751. Spearman correlation rho = 0.657 RAPID=Routine Assessment Patient Index Data; DAS=Disease Activity Score.

23 RAPID3 versus CDAI in 285 RA patients
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM RAPID3 versus CDAI in 285 RA patients Pincus, Swearingen, Bergman, Yazici. RAPID3 J Rheumatol. 35: , 2008 Reference 1. Pincus T, Sokka T. Rheum Dis Clin of North Am. 2004;30:725–751. Spearman correlation rho = 0.738 RAPID=Routine Assessment Patient Index Data; CDAI=Clinical Disease Activity Index.

24 Time to Score RA Measures - Seconds
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Time to Score RA Measures - Seconds Pincus et al 2009; Arthritis Care Res. in press 24

25 30 Incomplete Responders 63 Adequate Responders (“Controls”) MTX Start
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Median Levels of all patients at initiation of Mtx and mean of 2.6-years later in: incomplete responders initiating biologic agent “control” adequate responders continuing MTX 30 Incomplete Responders 63 Adequate Responders (“Controls”) MTX Start Biologic Start Follow-up (NO Biologic) ESR 28 18 24 16 MDHAQ-Function 3.2 3.3 2.3 1.0 Pain 5.2 6.8 4.1 1.4 Patient Global 5.5 4.2 0.9 RAPID3 14.9 16.2 10.6 3.6

26 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
% of RA patients with abnormal measures at presentation: Evidence – not eminence – based ESR >28 mm/Hr % CRP > % Rheumatoid factor positive - 69% Anti-CCP positive - 67% Function score >2/ % Pain score >2/ %

27 Pincus T, et al. Rheumatology (Oxford) 47:345-349, 2008
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Changes in scores (0-10) for DAS28 and RAPID3 from baseline () to endpoint ( ) in two abatacept clinical trials AIM DAS28 RAPID3 ATTAIN Pincus T, et al. Rheumatology (Oxford) 47: , 2008 27

28 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
DAS28, CDAI and RAPID3 show similar scores, categories of high, moderate, low severity and remission, and improvement criteria responses in clinical trials of: Leflunomide Methotrexate Adalimumab Abatacept Infliximab Certolizumab

29 DAS28, CDAI and RAPID3 Categories
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM DAS28, CDAI and RAPID3 Categories Activity level DAS28 (0-10) CDAI (0-76) RAPID3 (0-30) High - change therapy or have a good reason not to > 5.1 > 22 > 12 Moderate - strongly consider change 6.1-12 Low - consider change 2.9-10 3.1-6 Remission  2.6  2.8  3 Proposed RAPID3 categories can be used to assess patient status and efficacy of treatment. Using these categories, a RAPID3 score of suggests that therapy is working and that the patient is near remission. A RAPID3 score of suggests that the patient has low disease severity and that therapy could be changed. A RAPID3 score of denotes moderate disease severity and strongly suggests that therapy should be changed. A RAPID3 score greater than 4.1 indicates high disease severity and that therapy should be changed unless contraindicated. Using these categories, the theoretical patient with a RAPID3 score of 6.1 has high disease severity. 29

30 RAPID3 compared to DAS28 categories in 285 RA Patients at 3 Sites
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM RAPID3 compared to DAS28 categories in 285 RA Patients at 3 Sites DAS28 RAPID3 Scores 12.1–30= High Severity 6.1–12.0= Moderate Severity 3.1–6.0= Low Severity 0–3.0=Near Remission Total >5.1 = High Activity 37 (74%) 11 (22%) 1 (2%) 50 (17%) 3.2–5.1 = Moderate Activity 39 (43%) 27 (30%) 16 (18%) 8 (9%) 90 (32%) 2.6–3.19 = Low Activity 4 (10%) 15 (38%) 10 (25%) 11 (27%) 40 (14%) 0–2.6 = Remission 10 (10%) 18 (17%) 24 (23%) 53 (50%) 105 (37%) 90 (31%) 71 (25%) 51 (18%) 73 (26%) 285 Pincus, Swearingen, Yazici, Bergman, J Rheumatol, 35: , 2008 30

31 Patients in Each RAPID3 Category (%)
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Changes in RAPID3 Scores Over 5 Years in RA Patients in Usual Care 53% 30% 13% 3% 37% 33% 17% 13% 29% 25% 27% 18% 36% 25% 18% 21% 30% 12% 28% RAPID3 categories: High severity (>12) Moderate severity ( ) Low severity (3.01-6) Near remission (3) Patients in Each RAPID3 Category (%) Baseline 6 mo 12 mo 24 mo 60 mo (N=60) (N=60) (N=55) (N=56) (N=43) 31 31

32 Multi-Dimensional Health Assessment Questionnaire (MDHAQ) Page 1
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Multi-Dimensional Health Assessment Questionnaire (MDHAQ) Page 1

33 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
HAQ Page Dressing 2. Arising 3. Eating 4. Walking Aids and devices Help from an- other person

34 HAQ & multidimensional HAQ (MDHAQ)
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM HAQ & multidimensional HAQ (MDHAQ) HAQ MDHAQ 1st report Patient completion min min # ADL Psych, sleep No Sleep, anxiety depression Pain VAS 10 cm line 21 circles Pt Global VAS 10 cm line 21 circles Scoring templates No Yes Index No RAPID3 RADAI self-report joint count No Yes MD Global No Optional

35 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
HAQ Page Hygiene 6. Reach 7. Grip 8. Activities Aids and devices Help from an- other person

36 10. Recent medical history
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM MDHAQ: Page 2 5. Review of systems 6. Morning stiffness 7. Change in status 8. Exercise 9. Fatigue 10. Recent medical history Demographic data MD review

37 HAQ & multidimensional HAQ (MDHAQ)
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM HAQ MDHAQ Review of Systems No 60 Symptoms Morning stiffness No Yes Change in status No Yes Exercise No Yes Fatigue No VAS Medical history No Surgery, side effects, falls Demographic data No Yes Social history No Yes MD “eyeball” 15 secs 5 secs Time to score 42 secs 10 secs

38 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Considering all the ways in which illness and health conditions may affect you at this time, please indicate below how you are doing: VERY                      VERY WELL POORLY VERY ______________________________________________ VERY WELL POORLY

39 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Symptom Checklist From MDHAQ Please check (√) if you have experienced any of the following over the last month: __Fever Weight gain (>10 lb) Weight loss (<10 lb) Feeling sickly Headaches Unusual fatigue Swollen glands Loss of appetite Skin rash or hives Unusual bruising or bleeding Other skin problems Loss of hair Dry eyes Other eye problems Problems with hearing Ringing in the ears Stuffy nose Sores in the mouth Dry mouth Problems with smell or taste __Lump in your throat Cough Shortness of breath Wheezing Pain in the chest Heart pounding (palpitations) Trouble swallowing Heartburn or stomach gas Stomach pain or cramps Nausea Vomiting Constipation Diarrhea Dark or bloody stools Problems with urination Gynecologic (female) problems Dizziness Loss of balance Muscle pain, aches, or cramps Muscle weakness __Paralysis of arms or legs Numbness or tingling in arms/legs Fainting spells Swelling of hands Swelling of ankles Swelling in other joints Joint pain Back pain Neck pain Use of drugs not sold in stores Smoked cigarettes More than 2 alcoholic drinks/day Depression - feeling blue Anxiety - feeling nervous Problems with thinking Problems with memory Problems with sleeping Sexual problems Burning in sex organs Problems with social activities

40 Recent Medical History: Self-report
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Recent Medical History: Self-report Over the last 6 months have you had [please check (√)]: No Yes An operation No Yes Inpatient hospitalization No Yes A new illness, accident or trauma No Yes An important new symptom No Yes Side effect(s) of any drug No Yes Cigarettes regularly No Yes Change(s) of arthritis drugs or other drugs No Yes Change of address No Yes Change of marital status No Yes Change of job or work duties, quit work, retired No Yes Change of medical insurance, Medicare, etc. No Yes Change of primary care or other doctor Please explain any “yes" answer below, or indicate any other health matter that affects you: ___________________________________________________________

41 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
The HAQ or MDHAQ, not a joint count, lab test or X-ray, is Best Predictor in RA of… Functional status (Pincus et al Arthritis Rheum 1984; Wolfe et al J Rheumatol 1991) Work disability (Borg et al J Rheumatol 1991; Callahan et al J Clin Epidemiol 1992; Wolfe & Hawley J Rheumatol 1998; Fex et al J Rheumatol 1998; Sokka et al J Rheumatol 1999; Barrett et al Rheumatology 2000) Costs (Lubeck et al Arthritis Rheum 1986) Joint replacement surgery (Wolfe & Zwillich Arthritis Rheum 1998) Death (Pincus et al Arthritis Rheum 1984, Ann Intern Med 1994; Wolfe et al J Rheumatol 1988, Arthritis Rheum 1994; Leigh & Fries J Rheumatol 1991; Callahan et al Arthritis Care Res 1996, 1997; Soderlin et al J Rheumatol 1998; Maiden et al Ann Rheum Dis 1999; Sokka et al Ann Rheum Dis 2004) 41

42 Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM
Mortality in Elderly Normal Finnish population (n=1523) over 5 years by non-biomedical vital signs: a) Functional capacity (HAQ ≥1 vs. <1) b) Pain (>40 vs. ≤40) c) Frequency of physical exercise Cumulative Survival Time (years) HAQ ▬▬ < 1 ▬▬ ≥ 1 Time (years) Pain ▬▬ ≤ 40 ▬▬ > 40 Time (years) Exercise ▬▬ ≥ 1 ▬▬ < 1 ▬▬ none

43 Keep It Simple Stupid Pincus and Sokka, J Rheumatol, 2009
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Keep It Simple Stupid Pincus and Sokka, J Rheumatol, 2009

44 Complexities in assessment of patients with RA and rheumatic diseases
Theodore Pincus, MD; "Measurement in Rheumatic Diseases" 8:35 - 9:15 AM Complexities in assessment of patients with RA and rheumatic diseases A person with hypertension, hyperlipidemia, osteoporosis, diabetes, goes to the doctor to have a test to find out how she/he is doing. A quantitative measure, e.g., blood pressure, lipid level, bone density, HgA1c supports clinical decisions. No lab test is definitive in all patients with rheumatoid arthritis, and the patient tells the doctor about how she/he is doing. Should a doctor make a clinical decision on medications without recording a quantitative score for the patient’s function and pain?


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