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Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation.

ABSTRACT: 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.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 ? values. Criterion validity against oropharyngeal swallow efficiency (OPSE), the Modified Barium Swallow Impairment Profile (MBSImP™©), 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.Intrarater reliability was excellent (weighted ??=?0.82-0.84) with substantial to almost perfect agreement between raters (weighted ??=?0.67-0.81). DIGEST significantly discriminated levels of pharyngeal pathophysiology (MBSImP™©: r?=?0.77; P?

SUBMITTER: Hutcheson KA

PROVIDER: S-EPMC5161634 | biostudies-other | 2017 Jan

REPOSITORIES: biostudies-other

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Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation.

Hutcheson Katherine A KA Barrow Martha P MP Barringer Denise A DA Knott Jodi K JK Lin Heather Y HY Weber Randal S RS Fuller Clifton D CD Lai Stephen Y SY Alvarez Clare P CP Raut Janhavi J Lazarus Cathy L CL May Annette A Patterson Joanne J Patterson Joanne J Roe Justin W G JW Starmer Heather M HM Lewin Jan S JS

Cancer 20160826 1

<h4>Background</h4>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 Imag ...[more]

PMID: 27564246

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Project description:BackgroundDynamic Imaging Grade of Swallowing Toxicity (DIGEST) is a validated method to grade the severity of pharyngeal swallowing impairment as a toxicity of cancer based on the degree and patterns of penetration/aspiration and pharyngeal residue over a standardly acquired radiographic modified barium swallow (MBS) study. Since its implementation in 2016, areas for the refinement of grading mild safety impairments have been identified by clinical and research users. The objective of this study was to assess the performance and validity of refined DIGESTsafety grading criteria (per DIGEST version 2 [DIGESTv2 ]).MethodsRefined safety criteria were developed and vetted with clinical and research users. DIGESTv2 included 2 changes to the safety criteria. All MBSs with blinded DIGEST version 1 grading were sampled from a registry database (1331 patients underwent MBS over the period of December 2005 to July 2019). New criteria were applied to derive DIGESTsafety grading version 2. Measures of criterion validity, including the MD Anderson Dysphagia Inventory [MDADI] composite score, the Modified Barium Swallow Impairment Profile (MBSImP) pharyngeal total, the MBSImP hyolaryngeal components (items 8-11), and the Performance Status Scale for Head and Neck Cancer Patients [PSS-HN] diet, were correlated with DIGESTsafety and overall DIGEST grades from versions 1 and 2 and were compared pairwise between reassigned grades.ResultsWith the application of version 2 safety criteria, 112 of 1331 examinations (8.4%) and 79 of 1331 examinations (5.9%) changed in their DIGESTsafety and overall grades, respectively. The safety and overall DIGEST grades (versions 1 and 2) significantly correlated with criterion measures, including the MBSImP pharyngeal total, laryngeal MBSImP parameters of interest, MDADI, and PSS-HN (P < .0001); correlations maintained a similar magnitude between versions 1 and 2. Forty-six upgraded examinations (reassigned from safety grade 1 per version 1 to grade 2 per version 2) performed similarly to other safety grade 2 examinations (version 1), and this was likewise true for 66 downgraded examinations (reassigned from safety grade 1 per version 1 to grade 0 per version 2).ConclusionsRefined criteria defining mild safety impairments with the DIGEST methodology changed grades in small numbers of examinations. DIGESTv2 criteria maintained criterion validity, demonstrated ordinality, and improved the performance of the method in these rare scenarios.Lay summaryDynamic Imaging Grade of Swallowing Toxicity (DIGEST) is a method developed and validated by the investigators in 2016 to grade the severity of pharyngeal swallowing dysfunction (dysphagia) with a decision tree or flowsheet to guide the clinician's review of a standard radiographic modified barium swallow study. This work reports on the validity of updated DIGEST criteria (version 2) that incorporate 2 modifications to the decision tree.

Project description:PurposeThe Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) is a scale to quantify the severity of pharyngeal dysphagia in head and neck cancer (HNC) patients. This study (1) described the training process of the observers for DIGEST in fiberoptic endoscopic evaluation of swallowing (FEES), (2) determined observer agreement on the DIGEST in FEES, (3) explored the effect of bolus consistency on observer agreement, and 4) explored criterion validity of the DIGEST in FEES.MethodsTwenty-seven dysphagic HNC patients were enrolled. Two observers completed a training program for DIGEST in FEES. Observer agreement on the Penetration-Aspiration Scale (PAS), percentage of pharyngeal residue (PPR), and DIGEST grades was determined using linearly weighted Cohen's kappa coefficient (κ).ResultsDue to insufficient observer agreement after the first measurement attempt, additional training was organized using an elaborated manual with descriptions of the visuoperceptual variables, thereby improving observer agreement. Intraobserver agreement was almost perfect on the PAS (κ = 0.86-0.88) and PPR (κ = 0.84-0.86). Interobserver agreement was substantial on the PAS (κ = 0.78), almost perfect on the PPR (κ = 0.82), substantial on the safety grade (κ = 0.64), almost perfect on the efficiency grade (κ = 0.85), and substantial on the summary grade (κ = 0.71). Bolus consistency had an effect on observer agreement. A significant correlation was found between DIGEST efficiency grade and EAT-10.ConclusionThe DIGEST showed to be a reproducible measurement for FEES in terms of observer agreement. However, agreement between novice observers on the DIGEST was only reached after specific observer-tailored training. Observer agreement should be analyzed by taking bolus consistency into account during training, as this might affect the interpretation of the outcome. A manual with well-defined descriptions can optimize the reproducibility of DIGEST measurements.

Project description:BackgroundThe family environment is important for explaining individual health behaviour. While previous research mostly focused on influences among family members and dyadic interactions (parent-child), the purpose of this study was to develop a new measure, the Family Health Climate Scale (FHC-Scale), using a family-based approach. The FHC is an attribute of the whole family and describes an aspect of the family environment that is related to health and health behaviour. Specifically, a questionnaire measuring the FHC (a) for nutrition (FHC-NU) and (b) for activity behaviour (FHC-PA) was developed and validated.MethodsIn Study 1 (N=787) the FHC scales were refined and validated. The sample was randomly divided into two subsamples. With random sample I exploratory factor analyses were conducted and items were selected according to their psychometric quality. In a second step, confirmatory factor analyses were conducted using the random sample II. In Study 2 (N=210 parental couples) the construct validity was tested by correlating the FHC to self-determined motivation of healthy eating and physical activity as well as the families' food environment and joint physical activities.ResultsExploratory factor analyses with random sample I (Study 1) revealed a four (FHC-NU) and a three (FHC-PA) factor model. These models were cross-validated with random sample II and demonstrated an acceptable fit [FHC-PA: χ(2)=222.69, df=74, p<.01; χ(2)/df=3.01; CFI=.96; SRMR=.04; RMSEA=.07, CI .06/.08; FHC-NU: χ(2)=278.30, df=113, p<.01, χ(2)/df=2.46, CFI=.96; SRMR=.04; RMSEA=.06, CI .05/.07]. The perception of FHC correlated (p<.01) with the intrinsic motivation of healthy eating (r=.42) and physical activity (r=.56). Moreover, parental perceptions of FHC-NU correlated with household soft drink availability (r=-.31) and perceptions of FHC-PA with the frequency of joint physical activities with the child (r=.51). These patterns were found on the intraindividual and interindividual level.ConclusionsTwo valid instruments measuring the FHC within families were developed. The use of different informants' ratings demonstrated that the FHC is a family level variable. The results confirm the high relevance of the FHC for individuals' health behaviour. The FHC and the measurement instruments are useful for examining health-related aspects of the family environment.

Dataset Information

Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation.

Publications

Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation.

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