Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale Development and Validation

被引：168

作者：

Hutcheson, Katherine A. ^{[1
]}

Barrow, Martha P. ^{[1
]}

Barringer, Denise A. ^{[1
]}

Knott, Jodi K. ^{[1
]}

Lin, Heather Y. ^{[2
]}

Weber, Randal S. ^{[1
]}

Fuller, Clifton D. ^{[3
]}

Lai, Stephen Y. ^{[1
]}

Alvarez, Clare P. ^{[1
]}

Raut, Janhavi ^{[4
]}

Lazarus, Cathy L. ^{[5
]}

May, Annette ^{[6
]}

Patterson, Joanne ^{[7
,8
]}

Roe, Justin W. G. ^{[9
,10
,11
]}

Starmer, Heather M. ^{[12
]}

Lewin, Jan S. ^{[1
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Dept Head & Neck Surg, POB 301402,Unit 1445, Houston, TX 77030 USA

[2] Univ Texas MD Anderson Canc Ctr, Dept Biostat, Houston, TX 77030 USA

[3] Univ Texas MD Anderson Canc Ctr, Dept Radiat Oncol, Houston, TX 77030 USA

[4] Univ Texas Hlth Sci Ctr Houston, Sch Publ Hlth, Houston, TX 77030 USA

[5] Icahn Sch Med Mt Sinai, Dept Otolaryngol, New York, NY 10029 USA

[6] Univ Florida, Hlth Canc Ctr, Orlando Hlth, Dept Oncol Speech Pathol, Orlando, FL USA

[7] Sunderland City Hosp Natl Hlth Serv Fdn Trust, Speech & Language Therapy Dept, Sunderland, Tyne & Wear, England

[8] Newcastle Univ, Inst Hlth & Soc, Newcastle Upon Tyne, Tyne & Wear, England

[9] Royal Marsden Natl Hlth Serv Fdn Trust, Therapies Dept, London, England

[10] Imperial Coll Healthcare Natl Hlth Serv Trust, Speech & Language Therapy Dept, London, England

[11] Imperial Coll, Dept Surg & Canc, London, England

[12] Stanford Univ, Dept Otolaryngol, Head & Neck Surg, Palo Alto, CA 94304 USA

来源：

CANCER | 2017年 / 123卷 / 01期

基金：

美国国家卫生研究院;

关键词：

dysphagia; head and neck cancer; radiation; surgery; toxicity; QUALITY-OF-LIFE; NECK-CANCER; OROPHARYNGEAL CANCER; STROKE PATIENTS; DYSPHAGIA; RADIOTHERAPY; HEAD; ASPIRATION; CARCINOMA; OUTCOMES;

D O I：

10.1002/cncr.30283

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

BACKGROUND: The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) is the universal framework for toxicity reporting in oncology trials. The objective of this study was to develop a CTCAE-compatible modified barium swallow (MBS) grade for the purpose of grading pharyngeal dysphagia as a toxicity endpoint in cooperative-group organ-preservation trials for head and neck cancer (HNC). It was hypothesized that a 5-point, CTCAE-compatible MBS grade (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]) based on the interaction of pharyngeal residue and laryngeal penetration/aspiration ratings would be feasible and psychometrically sound. METHODS: A modified Delphi exercise was conducted for content validation, expert consensus, and operationalization of DIGEST criteria. Two blinded raters scored 100 MBSs conducted before or after surgical or nonsurgical organ preservation. Intrarater and interrater reliability was tested with weighted kappa values. Criterion validity against oropharyngeal swallow efficiency (OPSE), the Modified Barium Swallow Impairment Profile (MBSImP (TM)(c)), the MD Anderson Dysphagia Inventory (MDADI), and the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) was assessed with a 1-way analysis of variance and post hoc pairwise comparisons between DIGEST grades. RESULTS: Intrarater reliability was excellent (weighted kappa=0.82-0.84) with substantial to almost perfect agreement between raters (weighted kappa=0.67-0.81). DIGEST significantly discriminated levels of pharyngeal pathophysiology (MBSImP TM VC : r=0.77; P<. 0001), swallow efficiency (OPSE: r=-0.56; P<. 0001), perceived dysphagia (MDADI: r=-0.41; P<. 0001), and oral intake (PSS-HN diet: r=-0.49; P<. 0001). CONCLUSIONS: With the development of DIGEST, the MBS rating has been adapted to the CTCAE nomenclature of ordinal toxicity grading used in oncology trials. DIGEST offers a psychometrically sound measure for HNC clinical trials and investigations of toxicity profiles, dose responses, and predictive modeling. (C) 2016 American Cancer Society.

引用

页码：62 / 70

页数：9