P041 DEVELOPMENT OF PROMIS PEDIATRIC PATIENT-REPORTED OUTCOME SHORT FORMS FOR FATIGUE AND PAIN INTERFERENCE IN CHILDREN WITH CROHN’S DISEASE

2020 ◽  
Vol 158 (3) ◽  
pp. S101-S102
Author(s):  
Julia Schuchard ◽  
Michael Kappelman ◽  
Andrew Grossman ◽  
Jennifer Clegg ◽  
Christopher Forrest
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Pediatric Patient ◽  
Patient Reported Outcome ◽  
Pain Interference ◽  
Short Forms ◽  
Patient Reported

P041 DEVELOPMENT OF PROMIS PEDIATRIC PATIENT-REPORTED OUTCOME SHORT FORMS FOR FATIGUE AND PAIN INTERFERENCE IN CHILDREN WITH CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S62-S62
Author(s):  
Julia Schuchard ◽  
Michael Kappelman ◽  
Andrew Grossman ◽  
Jennifer Clegg ◽  
Christopher Forrest
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Lived Experiences ◽  
Patient Reported Outcome ◽  
Pain Interference ◽  
Measurement Information ◽  
Cognitive Interviews ◽  
Structured Interviews ◽  
Short Forms ◽  
Patient Reported

Abstract Introduction There is a need for reliable, valid patient-reported outcome (PRO) measures to assess the health and quality of life in pediatric Crohn’s disease (PCD). The development of PROs for this population may be facilitated by using Patient-Reported Outcomes Measurement Information System (PROMIS) item banks, which were developed using rigorous psychometric methods. We aimed to develop disease-specific PROMIS short forms by conducting qualitative research to identify the items that are most relevant to children with PCD. Methods Participants in an initial card sorting study included 42 children with CD (ages 8–17), 70 parents of children with CD, and 26 clinicians with expertise in CD. Using an online program, participants rated the importance of PROMIS items for pediatric CD patients. This exercise indicated that children, parents, and clinicians endorse Fatigue and Pain Interference items as important for PCD. In a separate study, trained research coordinators conducted one-on-one semi-structured interviews with 37 children with CD to further explore their experiences with fatigue and pain. Research coordinators also conducted one-on-one cognitive interviews with 14 children with CD. Each participant completed a questionnaire and then was interviewed about the reasoning for their answers. All interviews were transcribed and coded for meaning units, defined as conceptually distinct statements in the words of the participant. Results In semi-structured interviews, highly reported facets of fatigue and its impact included feelings of tiredness, friendships, and sports/exercise. Highly reported facets of pain and its impact included feelings of hurt, friendships, family, attention, and sports/exercise. Participants’ responses revealed the same breadth and types of lived experiences of fatigue and pain as children from the development samples drawn from the general population. Ratings of children’s reasoning and logic in cognitive interviews showed strong understanding of PROMIS items. Final item selection for the PCD-specific PROMIS short forms involved consideration of the concepts that participants identified as important, item understandability, psychometric evaluation of precision and coverage, and balance across different facets of each domain. Conclusions Results support the content validity and comprehensibility of PROMIS Pediatric Fatigue and Pain Interference measures in PCD. This work contributed to the development of 8-item short forms that are tailored to assess the lived experiences of fatigue and pain interference in PCD.

scholarly journals P359 Platelet-rich stroma injection (PRS) as a novel surgical treatment of refractory perianal fistulas in Crohn’s disease: A pilot study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S341-S341
Author(s):  
J Arkenbosch ◽  
O van Ruler ◽  
R S Dwarkasing ◽  
W R Schouten ◽  
A C de Vries ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Subcutaneous Fat ◽  
Stromal Vascular Fraction ◽  
Major Effect ◽  
Patient Reported Outcome ◽  
Internal Opening ◽  
Radiological Outcome ◽  
Patient Reported ◽  
Moderate Effect

Abstract Background Perianal fistulizing Crohn’s disease (FCD) comes with significant morbidity and severe reduced quality of life. Treatment of FCD is challenging and includes immunosuppressive drugs, antibiotics and surgery. All therapies are associated with high recurrence rates. Platelet-rich stroma (PRS) is a combination of platelet-rich plasma (PRP) and stromal vascular fraction (SVF). Autologous PRS includes stromal cells in their matrix with stimulating factors, plays an essential role in wound repair and defence mechanisms against infection and is easy to obtain and inject. Because of its operating mechanism, PRS could be of additional value in patients with refractory FCD. This study aims to assess the feasibility, safety and efficacy of local injection of PRS in patients with refractory FCD. Methods After informed consent, 10 patients (age ≥16 years) with refractory FCD were included between March 2018 and July 2019. Exclusion criteria were rectovaginal fistulas, persistent proctitis and pelvic abscesses. All patients underwent surgery with harvesting of subcutaneous fat and venous blood sampling to obtain 6 ml of PRS (1 ml of SVF resp. 5 ml of PRP), excision of the external opening(s), fistula curettage, and injection of PRS in the fistula wall and closure of the internal opening. A pre- and postoperative MRI was performed. Endpoints were clinical outcome, both closure and absence of discharge at physical examination, patient-reported outcome (no effect/moderate effect/major effect), as well as radiological outcome (van Assche score). From 3 months postoperative, re-injection of PRS was considered in patients with unfavourable clinical and/or radiological outcome. Results All patients (4:6 female:male; median age 33 (IQR 22.9–38.7) had infralevatoric fistulas with a median van Assche score of 17 [range 14–20] without rectal involvement and abscesses. Median follow-up was 6 months [4–12]. The median duration of FCD was 4 years (IQR 2–5). The median number of drugs given were 4 [1–7] and number of operations 3 [2–3], including stoma formation in 2 patients. Crohn’s disease activity outside the anorectum was present in all patients. 7 patients underwent 1 PRS injection and 3 patients 2 injections. There were no complications of the PRS injection. Fistula closure was present in 5 patients and open in 5 patients, of which 2 patients had no signs of discharge. One patient underwent restoration of bowel continuity. Of 7 postoperative MRIs available to date, median decrease of van Assche score was 4 (17 vs. 13)[0–15]. Patient-reported outcome was major effect in 4, moderate effect in 3, and no effect in 3 patients. Conclusion Autologous PRS appears to be feasible, safe and promising in the treatment of refractory perianal fistulizing Crohn’s disease.

scholarly journals PGI34 A Patient-Reported Outcome Model for Crohn's Disease

2012 ◽  
Vol 15 (7) ◽  
pp. A332
Author(s):  
J. Wilburn ◽  
S. Mckenna ◽  
J. Twiss ◽  
M. Ben-L'amri ◽  
K. Kemp ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Patient Reported Outcome ◽  
Patient Reported

P049 RESPONSIVENESS OF THE PATIENT-REPORTED OUTCOME MEASUREMENT INFORMATION SYSTEM (PROMIS) TO CHANGES IN DISEASE STATUS AND QUALITY OF LIFE AMONG PEDIATRIC PATIENTS WITH CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S66-S66
Author(s):  
Erica Brenner ◽  
Millie Long ◽  
Courtney Mann ◽  
Wenli Chen ◽  
Camila Reyes ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Peer Relationships ◽  
Outcome Measurement ◽  
Disease Status ◽  
Patient Reported Outcome ◽  
Measurement Information ◽  
Patient Reported

Abstract Background Patient Reported Outcome Measurement Information System (PROMIS) provides valid, self-reported measures of physical, emotional, and social health that can inform research and clinical care in children with chronic conditions. Prior research in pediatric Crohn’s disease (CD) has demonstrated robust correlations between PROMIS and disease activity. However, responsiveness, defined as sensitivity to clinical change, has not been yet been thoroughly evaluated. Aims We sought to evaluate the responsiveness of the PROMIS Pediatric measures relative to changes in 1) disease activity and 2) disease-specific health-related quality of life (HRQOL). Methods IBD Partners Kids & Teens is an internet-based cohort of children with IBD. Participants age 9 to 17 report symptoms related to disease activity [Short Crohn’s Disease Activity Index (SCDAI)], the IMPACT III HRQOL measure, and PROMIS domains of Anxiety, Depression, Pain Interference, Fatigue, and Peer Relationships. We conducted longitudinal analyses using mixed linear models to examine the extent to which PROMIS measures were responsive to changes in SCDAI and IMPACT III, adjusting for time and taking into account the clustering of individual participants. A change threshold of 70 points in SCDAI was used as a minimally important difference (MID). We also graphically depicted changes in PROMIS domains corresponding to improved, stable, or worsened disease activity and evaluated changes in PROMIS versus changes in IMPACT III using Pearson’s correlation. Results Our study sample included 544 participants with CD (mean age 13 years, 44% female) from 44 states. All PROMIS domains were responsive to changes in SCDAI, indicating improved physical, emotional, and social health corresponding to improved disease activity (Table 1, p< 0.001). Observed effect estimates ranged from 1.9 for Peer Relationships to 6.9 for Fatigue, in line with estimates of MID in both adult IBD and other pediatric chronic conditions. Of 246 participants with 2 or more completed reports (689 pairs of consecutive reports), disease activity was stable in 527, worse in 72, and improved in 67. Figure 1 demonstrates changes in PROMIS scores as a function of change in disease activity. Changes in PROMIS scores were also strongly associated with changes in IMPACT 35 scores (R=-0.5 for Anxiety, R=-0.5 for Depression, R=-0.6 for Pain Interference, R= -0.7 for Fatigue, and R=0.35 for Peer Relationships). Conclusion This study provides evidence for the longitudinal responsiveness of the PROMIS Pediatric measures to change in disease status and HRQOL in pediatric CD patients. The results support use of the PROMIS Pediatric measures in clinical outcomes research.

scholarly journals P091 Development of a patient-reported outcome measure for Crohn's disease

2013 ◽  
Vol 7 ◽  
pp. S45
Author(s):  
J. Wilburn ◽  
S.P. McKenna ◽  
J. Twiss ◽  
M. Ben-L'amri ◽  
K. Kemp ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Outcome Measure ◽  
Patient Reported Outcome ◽  
Patient Reported Outcome Measure ◽  
Patient Reported

scholarly journals Correlation of Patient-Reported Outcome (PRO-2) with Endoscopic and Histological Features in Ulcerative Colitis and Crohn’s Disease Patients

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Sanja Dragasevic ◽  
Aleksandra Sokic-Milutinovic ◽  
Milica Stojkovic Lalosevic ◽  
Tamara Milovanovic ◽  
Srdjan Djuranovic ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Scoring System ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Inflammatory Bowel

Background and Objectives. Determination of inflammatory bowel disease activity determines further therapeutic approach and follow-up. The aim of our study was to investigate correlation between patients’ reported symptoms and endoscopic and histological disease activity. Methods. A cross-sectional study was conducted in consecutive newly diagnosed patients with inflammatory bowel disease in a tertiary care referral center. The initial evaluation included patient-reported outcome for stool frequency subscore and rectal bleeding. Endoscopic activity was determined using the Mayo scoring system for ulcerative colitis and the Simple Endoscopic Score for Crohn’s disease. Histopathological activity was assessed using a validated numeric scoring system. Results. We included 159 patients (63 Crohn’s disease with colonic involvement and 96 with ulcerative colitis). We found significant correlation between the Mayo endoscopic subscoring system and histology activity in ulcerative colitis, while no correlation was found in patients with Crohn’s disease. Patient-reported outcome showed inverse correlation with endoscopic and histological activity in Crohn’s disease (rs=−0.67; rs=−0.72), while positive correlation was found in ulcerative colitis (rs=0.84; rs=0.75). Interpretation and Conclusions. Patient-reported outcome is a practical and noninvasive tool for assessment of disease activity in ulcerative colitis patients but not in Crohn’s disease.

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