Comparing the efficacy of a web-assisted calprotectin-based treatment algorithm (IBD-live) with usual practices in teenagers with inflammatory bowel disease: Study protocol for a randomized controlled trial

Trials

Volumn 16, Issue 1, 2015, Pages

  Heida, Anke ^a   Dijkstra, Alie ^a   Groen, Henk ^a   Muller Kobold, Anneke ^a   Verkade, Henkjan ^a   van Rheenen, Patrick ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

Calprotectin; Children; Crohn's disease; E health; Inflammatory bowel disease; Self monitoring; Telemedicine; Ulcerative colitis

Indexed keywords

CALGRANULIN; STEROID;

ADULT; ALGORITHM; ARTICLE; AUTOMATION; CHILD; CLINICAL PROTOCOL; COMPARATIVE EFFECTIVENESS; COMPUTER ASSISTED DRUG THERAPY; CONTROLLED STUDY; DISEASE ACTIVITY; DISEASE ACTIVITY SCORE; DRUG EFFICACY; FLAROMETER; FOLLOW UP; GENERAL DEVICE; HIGH RISK PATIENT; HOME MONITORING; HUMAN; INFLAMMATORY BOWEL DISEASE; LOW RISK PATIENT; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT MONITORING; PROTEIN DETERMINATION; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REMISSION; ADOLESCENT; COMPARATIVE STUDY; INFLAMMATORY BOWEL DISEASES; SAMPLE SIZE; STATISTICAL ANALYSIS; TELEMEDICINE;

ADOLESCENT; ADULT; ALGORITHMS; CHILD; CLINICAL PROTOCOLS; DATA INTERPRETATION, STATISTICAL; HUMANS; INFLAMMATORY BOWEL DISEASES; LEUKOCYTE L1 ANTIGEN COMPLEX; OUTCOME ASSESSMENT (HEALTH CARE); SAMPLE SIZE; TELEMEDICINE;

EID: 84939269134     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0787-x     Document Type: Article

References (38)

1. Griffiths AM. Specificities of inflammatory bowel disease in childhood. Best Pract Res Clin Gastroenterol. 2004;18:509-23.
2. Henderson P, Hansen R, Cameron F, Gerasimidis K, Rogers P, Bisset W, et al. Rising incidence of pediatric inflammatory bowel disease in Scotland. Inflamm Bowel Dis. 2012;18:999-1005.
3. Benchimol E, Fortinsky K, Gozdyra P, Van Den Heuvel M, Van Limbergen J, Griffiths A. Epidemiology of pediatric inflammatory bowel disease: a systematic review of international trends. Inflamm Bowel Dis. 2011;17:423-39.
4. Ashton JJ, Wiskin AE, Ennis S, Batra A, Afzal NA, Beattie RM. Rising incidence of paediatric inflammatory bowel disease (PIBD) in Wessex, Southern England. Arch Dis Child. 2014;99:659-64.
5. Romberg-Camps M, Hesselink-van de Kruijs M, Schouten L, Dagnelie P, Limonard C, Kester A, et al. Inflammatory bowel disease in South Limburg (the Netherlands) 1991-2002: incidence, diagnostic delay, and seasonal variations in onset of symptoms. J Crohn's Colitis. 2009;3:115-24.
6. Pineton de Chambrun G, Peyrin-Biroulet L, Lémann M, Colombel JF. Clinical implications of mucosal healing for the management of IBD. Nat Rev Gastroenterol Hepatol. 2010;7:15-29.
7. Hyams J, Ferry G, Mandel F, Gryboski J, Kibort P, Kirschner B. Development and validation of a pediatric Crohn's disease activity index. J Pediatr Gastroenterol Nutr. 1991;12:439-47.
8. Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007;133:423-32.
9. Westwood N, Travis SP. Review article: what do patients with inflammatory bowel disease want for their clinical management? Aliment Pharmacol Ther. 2008;27 Suppl 1:1-8.
10. Vermeire S, Van Assche G, Rutgeerts P. Laboratory markers in IBD: useful, magic, or unnecessary toys? Gut. 2006;55:426-31.
11. Chung-Faye G, Sandhu K, Logan RP, Sherwood RA. Fecal calproctectin is strongly predictive of clinical disease activity and histological severity in inflammatory bowel disease. Gastroenterology. 2011;140:S421.
12. Van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010;341:c3369.
13. Van Rheenen PF. Role of fecal calprotectin testing to predict relapse in teenagers with inflammatory bowel disease who report full disease control. Inflamm Bowel Dis. 2012;18:2018-25.
14. Kappelman MD, Crandall WV, Colletti RB, Goudie A, Leibowitz IH, Duffy L, et al. Short pediatric Crohn's disease activity index for quality improvement and observational research. Inflamm Bowel Dis. 2011;17:112-7.
15. Escher JC, Hagemeijer JW, de Ridden L, Rings EHHM, et al. Guideline on diagnosis and treatment of pediatric IBD. 2008. Available from: http://www.nvk.nl/Portals/0/richtlijnen/inflammatoire%20darmziekten/inflammatoiredarmziekten.pdf. Accessed on 1 April 2015.
16. Van Groningen J, Arnold J, Fishman L. When independence develops in adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2009;49:E57.
17. Elkjaer M, Burisch J, Avnstrøm S, Lynge E, Munkholm P. Development of a Web-based concept for patients with ulcerative colitis and 5-aminosalicylic acid treatment. Eur J Gastroenterol Hepatol. 2010;22:695-704.
18. Chan DS, Callahan CW, Hatch-Pigott VB, Lawless A, Proffitt HL, Manning NE, et al. Internet-based home monitoring and education of children with asthma is comparable to ideal office-based care: results of a 1-year asthma in-home monitoring trial. Pediatrics. 2007;119:569-78.
19. Lehmkuhl HD, Storch EA, Cammarata C, Meyer K, Rahman O, Silverstein J, et al. Telehealth behavior therapy for the management of type 1 diabetes in adolescents. J Diabetes Sci Technol. 2010;4:199-208.
20. Jackson CA, Clatworthy J, Robinson A, Horne R. Factors associated with non-adherence to oral medication for inflammatory bowel disease: a systematic review. Am J Gastroenterol. 2010;105:525-39.
21. Gray WN, Denson LA, Baldassano RN, Hommel KA. Treatment adherence in adolescents with inflammatory bowel disease: the collective impact of barriers to adherence and anxiety/depressive symptoms. J Pediatr Psychol. 2012;37:282-91.
22. Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003;114:39-43.
23. Higgins PD, Rubin DT, Kaulback K, Schoenfield PS, Kane SV. Systematic review: impact of non-adherence to 5-aminosalicylic acid products on the frequency and cost of ulcerative colitis flares. Aliment Pharmacol Ther. 2009;29:247-57.
24. IBD working group of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Inflammatory bowel disease in children and adolescents: recommendations for diagnosis-the Porto criteria. J Pediatr Gastroenterol Nutr. 2005;41:1-7.
25. Loonen HJ, Grootenhuis MA, Last BF, Koopman HM, Derkx HH. Quality of life in paediatric inflammatory bowel disease measured by a generic and a disease-specific questionnaire. Acta Paediatr. 2002;91:348-54.
26. Loonen HJ, Grootenhuis MA, Last BF, de Haan RJ, Bouquet J, Derkx BH. Measuring quality of life in children with inflammatory bowel disease: the impact-II (NL). Qual Life Res. 2002;11:47-56.
27. Otley A, Smith C, Nicholas D, Munk M, Avolio J, Sherman PM, et al. The IMPACT questionnaire: a valid measure of health-related quality of life in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002;35:557-63.
28. Griffiths AM, Nicholas D, Smith C, Munk M, Stephens D, Durno C. Development of a quality-of-life index for pediatric inflammatory bowel disease: dealing with differences related to age and IBD type. J Pediatr Gastroenterol Nutr. 1999;28:S46-52.
29. Van Laerhoven H, van der Zaag-Loonen HJ, Derkx BH. A comparison of Likert scale and visual analogue scales as response options in children's questionnaires. Acta Paediatr. 2004;93:830-5.
30. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67-74.
31. Bar-On R, Parker J. Bar-On Emotional Quotient Inventory: Youth Version (EQ-i:YV): technical manual. Toronto: Multi-Health Systems; 2008.
32. Sýkora J, Siala K, Huml M, Varvaovská J, Schwarz J, Pomahaová R. Evaluation of faecal calprotectin as a valuable non-invasive marker in distinguishing gut pathogens in young children with acute gastroenteritis. Acta Paediatr Int J Paediatr. 2010;99:1389-95.
33. Van de Vijver E, Schreuder AB, Cnossen WR, Muller Kobold AC, van Rheenen PF. Safely ruling out inflammatory bowel disease in children and teenagers without referral for endoscopy. Arch Dis Child. 2012;97:1014-8.
34. Sipponen T, Björkesten CG, Färkkilä M, Nuutinen H, Savilahti E, Kolho K-L. Faecal calprotectin and lactoferrin are reliable surrogate markers of endoscopic response during Crohn's disease treatment. Scand J Gastroenterol. 2010;45:325-31.
35. Cross RK, Finkelstein J. Challenges in the design of a Home Telemanagement trial for patients with ulcerative colitis. Clin Trials. 2009;6:649-57.
36. Cross R, Cheevers N, Rustgi A, Langenberg P, Finkelstein J. Randomized, controlled trial of home telemanagement in patients with ulcerative colitis (UC HAT). Inflamm Bowel Dis. 2012;18:1018-25.
37. Streiner DL. The case of the missing data: methods of dealing with dropouts and other research vagaries. Can J Psychiatry. 2002;47:68-75.
38. Turner D, Griffiths AM, Walters TD, Seah T, Markowitz J, Pfefferkorn M, et al. Mathematical weighting of the pediatric Crohn's disease activity index (PCDAI) and comparison with its other short versions. Inflamm Bowel Dis. 2012;18:55-62.