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………………..…………………………………………………………………………………………………………………………………….. Jennifer L. Dotson, MD, MPH Assistant Professor of Pediatrics Division of Gastroenterology,

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Presentation on theme: "………………..…………………………………………………………………………………………………………………………………….. Jennifer L. Dotson, MD, MPH Assistant Professor of Pediatrics Division of Gastroenterology,"— Presentation transcript:

1 ………………..…………………………………………………………………………………………………………………………………….. Jennifer L. Dotson, MD, MPH Assistant Professor of Pediatrics Division of Gastroenterology, Hepatology and Nutrition The Ohio State University College of Medicine Principal Investigator, Center for Innovation in Pediatric Practice The Research Institute at Nationwide Children's Hospital December 13, 2013 Feasibility and Validity of the Pediatric Ulcerative Colitis Activity Index (PUCAI) in Routine Clinical Practice Jennifer L. Dotson, MD, MPH, Wallace V. Crandall, MD, Peixin Zhang, PhD, Christopher B Forrest, MD, PhD, L. Charles Bailey, MD, PhD, Richard B. Colletti, MD, and Michael D. Kappelman, MD, MPH

2 ………………..…………………………………………………………………………………………………………………………………….. I have no financial disclosures or conflicts of interest

3 ………………..…………………………………………………………………………………………………………………………………….. Background: PUCAI Standardized assessment tool of UC disease activity Rigorous development process 1 Outstanding clinimetric properties Widely adopted by clinical researchers as a non- invasive measure of disease activity 2-7 Recommended in the clinical management of patients and incorporated into recent clinical guidelines 2,8 1.Turner D, et al. Gastroenterology. Aug 2007 2.Turner D, et al. Am J Gastroenterol. Apr 2011 3.Gray FL, et al. Journal of pediatric surgery. Jul 2013 4.Teitelbaum JE, et al. J Pediatr Gastroenterol Nutr. Jun 2013 5.Turner D, et al. Clin Gastroenterol Hepatol. May 2013 6.Watson S, et al. Inflamm Bowel Dis. Jan 2011 7.Turner D, et al. Inflamm Bowel Dis. Jan 2011 8.Turner D, et al. J Pediatr Gastroenterol Nutr. Sep 2012

4 ………………..…………………………………………………………………………………………………………………………………….. Background: PUCAI Although the use of PUCAI has been evaluated in single-center and small multi-center research studies, 1-6 little is known about its feasibility and performance when used in routine clinical practice 1.Turner D, et al.. Gastroenterology. Aug 2007 2.Turner D, et al. Clin Gastroenterol Hepatol. May 2013. 3.Turner D, et al. Inflamm Bowel Dis. Jan 2012;18(1):55-62. 4.Turner D, et al.. Journal of clinical epidemiology. Apr 2009 5.Turner D, et al. Inflamm Bowel Dis. Apr 2010 6.Lee JJ, et al. J Pediatr Gastroenterol Nutr. Jun 2011

5 ItemPoints 1. Abdominal pain No pain Pain can be ignored Pain cannot be ignored 0 5 10 2. Rectal bleeding None Small amount only, in <50% of stools Small amount with most stools Large amount (>50% of stool content) 0 10 20 30 3. Stool consistency of most stools Formed Partially formed Completely unformed 0 5 10 4. Number of stools per 24 hours 0-2 3-5 6-8 >8 0 5 10 15 5. Nocturnal stools (any episode causing wakening) No Yes 0 10 6. Activity level No limitation of activity Occasional limitation of activity Severe restricted activity 0 5 10 Sum of PUCAI0-85 Turner D, et al. Gastroenterology. Aug 2007

6 ItemPoints 1. Abdominal pain No pain Pain can be ignored Pain cannot be ignored 0 5 10 2. Rectal bleeding None Small amount only, in <50% of stools Small amount with most stools Large amount (>50% of stool content) 0 10 20 30 3. Stool consistency of most stools Formed Partially formed Completely unformed 0 5 10 4. Number of stools per 24 hours 0-2 3-5 6-8 >8 0 5 10 15 5. Nocturnal stools (any episode causing wakening) No Yes 0 10 6. Activity level No limitation of activity Occasional limitation of activity Severe restricted activity 0 5 10 Sum of PUCAI0-85 Disease Severity PUCAI Cut- Points Remission<10 Mild10-34 Moderate35-64 Severe65-85 Turner D, et al. Gastroenterology. Aug 2007

7 ………………..…………………………………………………………………………………………………………………………………….. Objective Evaluate the feasibility, validity, and responsiveness to clinical change of PUCAI in a large, diverse collection of pediatric GI practices

8 ………………..…………………………………………………………………………………………………………………………………….. Methods: Study Design ImproveCareNow (ICN): Network of pediatric GI practices established in 2007 to improve the health of children with IBD Demographic, disease and treatment data collected prospectively and longitudinally during all routine outpatient encounters Patients diagnosed and managed according to the usual practice of the primary GI provider

9 ………………..…………………………………………………………………………………………………………………………………….. Methods: Study Design Extracted data from the 2 most recent encounters for all patients with UC (September 2006-December 2012) Demographics, disease duration, disease extent (Paris classification), Physician Global Assessment (PGA), and PUCAI components

10 ………………..…………………………………………………………………………………………………………………………………….. Methods: Feasibility Analysis Percentage of patients for whom all PUCAI components were recorded at their most recent visit

11 ………………..…………………………………………………………………………………………………………………………………….. Methods: Validity Analysis We examined the correlation between PUCAI and PGA: Distribution of PUCAI scores across PGA categories using boxplots and compared differences using Kruskal-Wallis test Pearson’s correlation coefficient

12 ………………..…………………………………………………………………………………………………………………………………….. Methods: Responsiveness Analysis Responsiveness of an instrument is Its ability to detect minimal clinically important differences Directly related to the magnitude of change Extent to which PUCAI changes in relation to a corresponding change in PGA over time

13 ………………..…………………………………………………………………………………………………………………………………….. Methods: Responsiveness Analysis PGA was unchanged between visits: Assessed the test-retest reliability of the PUCAI with intra-class correlation coefficient using ANOVA PGA changed between visits: Evaluated the distribution of change in PUCAI according to change in PGA using boxplots with the Kruskal-Wallis test

14 ………………..…………………………………………………………………………………………………………………………………….. Methods: Responsiveness Analysis Change in PUCAI defined by: Subtracting the follow-up PUCAI score from the previous visit PUCAI score Change in PGA between the 2 most recent visits defined by: Small change = change in 1 category (e.g. severe to moderate) Moderate change = change in 2 categories (e.g. moderate to remission) Large change = change in 3 categories (e.g. severe to remission)

15 Results: Demographics (most recent visit) Variablen (%) Total number of patients2503 Gender Male1237 (49.4) Age15.2 ± 4.1 years Race/Ethnicity White1920 (81.9) Black199 (8.5) Hispanic or Latino87 (3.7) Asian42 (1.8) Other97 (4.1) Disease duration3.7 ± 3.2 years Paris Classification (n=1773 (70.8%)) E1: ulcerative proctitis154 (8.7) E2: left-sided (distal to splenic flexure)330 (18.6) E3: extensive (hepatic flexure distally)135 (7.6) E4: pancolitis (proximal to hepatic flexure)1154 (65.1) PGA Remission1703 (70.0) Mild518 (21.3) Moderate183 (7.5) Severe30 (1.2)

16 Results: Demographics (most recent visit) Variablen (%) Total number of patients2503 Gender Male1237 (49.4) Age15.2 ± 4.1 years Race/Ethnicity White1920 (81.9) Black199 (8.5) Hispanic or Latino87 (3.7) Asian42 (1.8) Other97 (4.1) Disease duration3.7 ± 3.2 years Paris Classification (n=1773 (70.8%)) E1: ulcerative proctitis154 (8.7) E2: left-sided (distal to splenic flexure)330 (18.6) E3: extensive (hepatic flexure distally)135 (7.6) E4: pancolitis (proximal to hepatic flexure)1154 (65.1) PGA Remission1703 (70.0) Mild518 (21.3) Moderate183 (7.5) Severe30 (1.2)

17 Results: Feasibility (n=2503) PUCAI Components # of visits recorded % of visits recorded Abdominal pain247899.0% Rectal bleeding245197.9% Stool consistency of most stools244697.7% Total number of stools245998.2% Nocturnal stools243897.4% Activity level247698.9% Patients with all components240296%

18 Results: Feasibility (n=2503) PUCAI Components # of visits recorded % of visits recorded Abdominal pain247899.0% Rectal bleeding245197.9% Stool consistency of most stools244697.7% Total number of stools245998.2% Nocturnal stools243897.4% Activity level247698.9% Patients with all components240296%

19 Good correlation with PGA by Pearson’s correlation [r=0.76 (p<0.001)] Results: Validity Kruskal-Wallis p<0.001

20 ………………..…………………………………………………………………………………………………………………………………….. Results: Responsiveness 1236 patients whose PGA was unchanged 1040 (84%) remission 145 (12%) mild 44 (4%) moderate 7 (<1%) severe Test-retest reliability of PUCAI (p<0.001)

21 Results: Responsiveness Kruskal-Wallis p<0.001

22 ………………..…………………………………………………………………………………………………………………………………….. Key Limitations Small sample size at the periphery of the distribution of the change in PGA categories Data derived from an outpatient database, so few UC patients had severe disease activity

23 ………………..…………………………………………………………………………………………………………………………………….. Conclusions First large-scale, multicenter evaluation of PUCAI (approximately 2000 patients from 35 sites) supports the broad generalizability and ease of use in routine outpatient care Demonstrated strong feasibility and validity between PUCAI and PGA Responsiveness of change in PUCAI by change in PGA over time was good

24 ………………..…………………………………………………………………………………………………………………………………….. Summary PUCAI is highly feasible, valid and responsive to change Findings support the use of PUCAI as a clinical and research tool, including serving as a basis for inpatient and outpatient care algorithms

25 ………………..…………………………………………………………………………………………………………………………………….. Mentorship and Funding Wallace V. Crandall, MD Michael D. Kappelman, MD, MPH Kelly Kelleher, MD, MPH This project was supported by a grant from the Agency for Healthcare Research and Quality (R01 HS020024) MDK was supported by a grant from the NIH/NIDDK (K08 DK088957) JLD was supported by the NASPGHAN Foundation/CCFA Young Investigator Development Award

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