Defining Comprehensive Disease Control for Use as a Treatment Target for Ulcerative Colitis in Clinical Practice: International Delphi Consensus Recommendations

被引:0
作者
Schreiber, Stefan [1 ]
Danese, Silvio [2 ,3 ]
Dignass, Axel [4 ]
Domenech, Eugeni [5 ,6 ,7 ]
Fantini, Massimo C. [8 ]
Ferrante, Marc [9 ]
Halfvarson, Jonas [10 ]
Hart, Ailsa [11 ]
Magro, Fernando [12 ]
Lees, Charlie W. [13 ]
Leone, Salvo [14 ]
Pierik, Marieke J. [15 ]
Peters, Michele [16 ]
Field, Polly [17 ]
Fishpool, Helen [17 ]
Peyrin-Biroulet, Laurent [18 ,19 ,20 ,21 ,22 ,23 ]
机构
[1] Univ Hosp Schleswig Holstein, Dept Internal Med 1, Arnold Heller Str 3, D-24105 Kiel, Germany
[2] IRCCS Osped San Raffaele, Gastroenterol & Endoscopy, Milan, Italy
[3] Univ Vita Salute San Raffaele, Milan, Italy
[4] Goethe Univ, Agaples Markus Hosp, Dept Med 1, Frankfurt, Germany
[5] Hosp Badalona Germans Trias & Pujol, Dept Gastroenterol, Badalona, Spain
[6] CIBEREHD, Badalona, Spain
[7] Univ Autonoma Barcelona, Dept Med, Barcelona, Spain
[8] Univ Cagliari, Dept Med Sci & Publ Hlth, Cagliari, Italy
[9] Katholieke Univ Leuven, Univ Hosp Leuven, Dept Gastroenterol & Hepatol, Leuven, Belgium
[10] Orebro Univ, Fac Med & Hlth, Dept Gastroenterol, Orebro, Sweden
[11] St Marks Hosp, IBD Unit, London, England
[12] Univ Porto, Fac Med, CINTESIS RISE, Porto, Portugal
[13] Western Gen Hosp, Edinburgh Inflammatory Bowel Dis Unit, Edinburgh, Midlothian, Scotland
[14] European Federat Crohns & Ulcerat Colitis Assoc E, Brussels, Belgium
[15] Maastricht Univ, Med Ctr, Div Gastroenterol & Hepatol, Maastricht, Netherlands
[16] Univ Oxford, Nuffield Dept Populat Hlth, Oxford, England
[17] Oxford PharmaGenesis, Oxford, England
[18] Nancy Univ Hosp, Dept Gastroenterol, Vandoeuvre Les Nancy, France
[19] Univ Lorraine, NGERE, INSERM, Nancy, France
[20] Nancy Univ Hosp, INFINY Inst, Vandoeuvre Les Nancy, France
[21] Nancy Univ Hosp, FHU CURE, Vandoeuvre Les Nancy, France
[22] Grp Hosp Prive Ambroise Pare Hartmann, Paris IBD Ctr, Neuilly Sur Seine, France
[23] McGill Univ, Div Gastroenterol & Hepatol, Ctr Hlth, Montreal, PQ, Canada
关键词
Ulcerative colitis; remission; Delphi consensus; patient-reported symptoms; INFLAMMATORY-BOWEL-DISEASE; VALIDATION; IBD; FATIGUE; RELAPSE; GUIDELINES; REMISSION; IMPACT; RISK; LIFE;
D O I
暂无
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background and Aims: Treatment of ulcerative colitis [UC] requires a patient-centric definition of comprehensive disease control that considers improvements in aspects not typically captured by classical landmark trial endpoints. In an international initiative, we reviewed aspects of UC that affect patients and/or indicate mucosal inflammation, to achieve consensus on which aspects to combine in a definition of comprehensive disease control, using a modified Delphi process. Methods: The Delphi panel comprised 12 gastroenterologists and one patient advocate. Two gastroenterologists were elected as chairs and did not vote. To inform statements, we asked 18 patients and the panel members about their experiences of remission and reviewed published literature. Panel members voted on statements anonymously in three rounds, with a live discussion before Round 3. Consensus was met if >= 67% of the panel agreed. Statements without consensus in Rounds 1 and 2 were revised or discarded after Round 3. Results: The panel agreed to measure individual patient benefit using a definition of comprehensive disease control that combines aspects currently measured in trials [rectal bleeding, stool frequency, disease-related quality of life, endoscopy, histological inflammatory activity, inflammatory biomarkers, and corticosteroid use] with additional patient-reported symptoms [bowel urgency, abdominal pain, extraintestinal manifestations, fatigue, and sleep disturbance]. The panel agreed on scoring systems and thresholds for many aspects. Conclusions: Using a robust methodology, we defined comprehensive disease control in UC. Next, we will combine the measurement and scoring of these aspects into a multicomponent tool and will adopt comprehensive disease control as a treatment target in clinical practice and trials.
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页码:91 / 105
页数:15
相关论文
共 54 条
  • [1] Evaluation of the Risk of Relapse in Ulcerative Colitis According to the Degree of Mucosal Healing (Mayo 0 vs 1): A Longitudinal Cohort Study
    Barreiro-de Acosta, Manuel
    Vallejo, Nicolau
    de la Iglesia, Daniel
    Uribarri, Laura
    Baston, Iria
    Ferreiro-Iglesias, Rocio
    Lorenzo, Aurelio
    Enrique Dominguez-Munoz, J.
    [J]. JOURNAL OF CROHNS & COLITIS, 2016, 10 (01) : 13 - 19
  • [2] Insights into the role of gastrointestinal ultrasound in ulcerative colitis
    Bezzio, Cristina
    Vernero, Marta
    Ribaldone, Davide Giuseppe
    Manes, Gianpiero
    Saibeni, Simone
    [J]. THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, 2021, 14
  • [3] Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-Control questionnaire
    Bodger, Keith
    Ormerod, Clare
    Shackcloth, Daniela
    Harrison, Melanie
    [J]. GUT, 2014, 63 (07) : 1092 - 1102
  • [4] Intestinal Ultrasound to Assess Disease Activity in Ulcerative Colitis: Development of a novel UC-Ultrasound Index
    Bots, Steven
    Nylund, Kim
    Lowenberg, Mark
    Gecse, Krisztina
    D'Haens, Geert
    [J]. JOURNAL OF CROHNS & COLITIS, 2021, 15 (08) : 1264 - 1271
  • [5] Development and Validation of Patient-Reported Outcome Measures for Sleep Disturbance and Sleep-Related Impairments
    Buysse, Daniel J.
    Yu, Lan
    Moul, Douglas E.
    Germain, Anne
    Stover, Angela
    Dodds, Nathan E.
    Johnston, Kelly L.
    Shablesky-Cade, Melissa A.
    Pilkonis, Paul A.
    [J]. SLEEP, 2010, 33 (06) : 781 - 792
  • [6] Mucosal Healing in Ulcerative Colitis - When Zero is Better
    Carvalho, Pedro Boal
    de Castro, Francisca Dias
    Rosa, Bruno
    Moreira, Maria Joao
    Cotter, Jose
    [J]. JOURNAL OF CROHNS & COLITIS, 2016, 10 (01) : 20 - 25
  • [7] COMET Initiative, Core outcome measures in effectiveness trials
  • [8] Crohn's & Colitis UK, Fatigue in IBD
  • [9] Complete histologic normalisation is associated with reduced risk of relapse among patients with ulcerative colitis in complete endoscopic remission
    Cushing, Kelly C.
    Tan, William
    Alpers, David H.
    Deshpande, Vikram
    Ananthakrishnan, Ashwin N.
    [J]. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 51 (03) : 347 - 355
  • [10] Development and psychometric testing of inflammatory bowel disease fatigue (IBD-F) patient self-assessment scale
    Czuber-Dochan, Wladyslawa
    Norton, Christine
    Bassett, Paul
    Berliner, Stuart
    Bredin, Francesca
    Darvell, Marcia
    Forbes, Alastair
    Gay, Martin
    Nathan, Indira
    Ream, Emma
    Terry, Helen
    [J]. JOURNAL OF CROHNS & COLITIS, 2014, 8 (11) : 1398 - 1406