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Feasibility and Reproducibility of the NIH Consensus Criteria To Evaluate Response in Chronic Graft Versus Host Disease (cGvHD).

Publication ,  Conference
Mitchell, S; Jacobsohn, D; Thormann, K; Cowen, E; Fall-Dickson, J; Turner, M; Schubert, M; Baird, K; Bolanos-Meade, J; Boyd, K; Gerber, L ...
Published in: Blood
November 16, 2006

Background The lack of standardized response criteria is a major obstacle to the development of therapeutic agents for cGvHD. Consensus criteria for evaluating response in cGvHD have been recently published (BBMT, 2006;12:252). We report on 3 pilot trials evaluating the feasibility and reproducibility of these proposed response criteria.Methods Oncology clinicians (n=27) with limited experience with cGvHD, participated in a 2.5 hour training session and received a syllabus and a photo atlas illustrating common manifestations of cGvHD. Feasibility and inter-rater agreement between experts in cGvHD (transplantation, dermatology, oral medicine, and rehabilitation medicine) and novice raters were evaluated using 15 pediatric and adult patients with varying manifestations of cGvHD. Data from each trial were used to strengthen the criteria and the teaching tools, and these materials were then re-tested. Intraclass correlation coefficients (ICCs) and percent agreement (#Agreements/[#Agreements + #Disagreements] × 100) were used in the analysis.ResultsResponse Criterion Trial 1 (8 novices; 4 adult patients) Trial 2 (10 novices; 6 pediatric patients) Trial 3 (9 novices; 5 adult patients) Oral(Median ICC/Range) .50(−.62–.84) .44(.14–.81) .57(−.06–.74) Erythema(Median ICC/Range) .88(.12–.93) .07(−.01–.97) .47(.08–.82) Movable Sclerosis(Median ICC/Range) .33(−.65–.71) .21(−.38–.81) .60(.11–.91) Non-movable Sclerosis(Median ICC/Range) .23(−.06–.62) .16(−.45–.77) .62(.37–.96) Ulcers(%agreement) 97% 95% 67% Gastrointestinal(%agreement) 83%–100% 57%–93% 68%–100% Functional Performance(% novices within 95% confidence interval of expert) 2 Minute Walk:66%;Grip Strength:75% Not evaluated 2 Minute Walk:60%;Grip Strength:66% Performance Status(novices within +/−20% of expert) 100% 80% 100%The concordance between expert and novices for global ratings of cGvHD severity and disease course was also evaluated. The median time to perform and document the evaluation, which includes a Schirmer test, ranged from 32–36 minutes. In the third trial, the agreement among experts for the dimensions of oral manifestations (ICC=0.7) and skin erythema (ICC=0.54) approached satisfactory values. Overall, interobserver agreement was modest; although in the third trial the median ICCs between novices and experts for movable sclerosis, non-movable sclerosis, and oral findings began to approach the 0.7 level.Conclusions These data provided critical information to guide the successive refinement of the response criteria and training materials resulting in improved reproducibility in specific domains, such as oral and movable and non-movable sclerosis. While these data offer preliminary evidence of feasibility, it was challenging for novices to acquire in a single session the skills necessary to grade these patients reliably. Work is ongoing to refine the training materials, and future efforts will examine whether experienced transplant clinicians who receive this educational program can apply the response criteria with greater reproducibility.

Duke Scholars

Published In

Blood

DOI

EISSN

1528-0020

ISSN

0006-4971

Publication Date

November 16, 2006

Volume

108

Issue

11

Start / End Page

5344 / 5344

Publisher

American Society of Hematology

Related Subject Headings

  • Immunology
  • 3213 Paediatrics
  • 3201 Cardiovascular medicine and haematology
  • 3101 Biochemistry and cell biology
  • 1114 Paediatrics and Reproductive Medicine
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

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Mitchell, S., Jacobsohn, D., Thormann, K., Cowen, E., Fall-Dickson, J., Turner, M., … Pavletic, S. (2006). Feasibility and Reproducibility of the NIH Consensus Criteria To Evaluate Response in Chronic Graft Versus Host Disease (cGvHD). In Blood (Vol. 108, pp. 5344–5344). American Society of Hematology. https://doi.org/10.1182/blood.v108.11.5344.5344
Mitchell, S., D. Jacobsohn, K. Thormann, E. Cowen, J. Fall-Dickson, M. Turner, M. Schubert, et al. “Feasibility and Reproducibility of the NIH Consensus Criteria To Evaluate Response in Chronic Graft Versus Host Disease (cGvHD).” In Blood, 108:5344–5344. American Society of Hematology, 2006. https://doi.org/10.1182/blood.v108.11.5344.5344.
Mitchell S, Jacobsohn D, Thormann K, Cowen E, Fall-Dickson J, Turner M, et al. Feasibility and Reproducibility of the NIH Consensus Criteria To Evaluate Response in Chronic Graft Versus Host Disease (cGvHD). In: Blood. American Society of Hematology; 2006. p. 5344–5344.
Mitchell, S., et al. “Feasibility and Reproducibility of the NIH Consensus Criteria To Evaluate Response in Chronic Graft Versus Host Disease (cGvHD).Blood, vol. 108, no. 11, American Society of Hematology, 2006, pp. 5344–5344. Crossref, doi:10.1182/blood.v108.11.5344.5344.
Mitchell S, Jacobsohn D, Thormann K, Cowen E, Fall-Dickson J, Turner M, Schubert M, Baird K, Bolanos-Meade J, Boyd K, Gerber L, Guadagnini JP, Higman M, Imanguli M, Lawley L, Li L, Prachenko O, Reeve B, Smith J, Vogelsang G, Pavletic S. Feasibility and Reproducibility of the NIH Consensus Criteria To Evaluate Response in Chronic Graft Versus Host Disease (cGvHD). Blood. American Society of Hematology; 2006. p. 5344–5344.

Published In

Blood

DOI

EISSN

1528-0020

ISSN

0006-4971

Publication Date

November 16, 2006

Volume

108

Issue

11

Start / End Page

5344 / 5344

Publisher

American Society of Hematology

Related Subject Headings

  • Immunology
  • 3213 Paediatrics
  • 3201 Cardiovascular medicine and haematology
  • 3101 Biochemistry and cell biology
  • 1114 Paediatrics and Reproductive Medicine
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology