Peter Judd

Validation of the oral mucositis assessment scale in pediatric cancer.

Our objective was to examine the construct validity of the Oral Mucositis Assessment Scale (OMAS) in children receiving doxorubicin chemotherapy.

Challenges of mucositis assessment in children: Expert opinion

Mucositis is a challenging treatment-related complication in children receiving therapy for cancer. The conduct of clinical trials that investigate mucositis prevention and treatment requires adequate evaluation of the oral cavity. However, few instruments to measure mucositis in children have been appropriately developed or evaluated. A focus group of nine health care professionals with expertise in mucositis assessment, oral assessment in children and paediatric cancer aimed to determine the challenges and possible solutions to mucositis assessment in children. The results led to the identification of several areas of concern that included: (1) challenges in oral assessment in children related to age and cooperation, (2) the need for proxy responses while recognizing the challenges of reporting pain and function attributed to oral mucositis, (3) the need for an instrument that is simple, quick to complete, and easy to use in almost all children and (4) educational considerations. The results provide a basis from which guidelines for the oral assessment of mucositis in children can begin. This information could be used to aid in the development of a new scale for the assessment of oral mucositis in children.

Validation of the Children's International Mucositis Evaluation Scale (ChIMES) in paediatric cancer and SCT.

Background:Objectives were to describe the reliability and validity of a new paediatric-specific mucositis scale, the Children’s International Mucositis Evaluation Scale (ChIMES).Methods:In a multi-centre prospective study, children aged 0 to ⩽18 years were eligible if they were receiving any of the following: myeloablative stem cell transplantation (SCT), ⩾60 mg m−2 course−1 doxorubicin or ⩾12 g m−2 methotrexate. Multiple measures of mucositis were included along with ChIMES. Respondents were parent proxy report for children aged <12 years, and child self-report for children aged 12–18 years and 8 to <12 years. Mucositis diaries were completed at baseline and on Days 7–17 following chemotherapy/conditioning. On Day 14, the respondent reported presence of mucositis and change since the previous day.Results:The 185 respondents included parents (N=98), children aged 12–18 years (N=66) and children aged 8 to <12 years (N=21). Test–retest reliability was excellent for ChIMES Total Score and ChIMES Percentage Score with r>0.8 for all respondent types. Criteria for construct validation were met across all measures. ChIMES also demonstrated responsiveness with significant differences between baseline and Day 14.Conclusion:ChIMES is a paediatric-specific measure of mucositis with favourable psychometric properties. It exhibits reliability, construct validity and responsiveness. ChIMES should be incorporated into clinical trials of mucositis prevention and treatment in paediatric cancer and SCT.

Establishing literature-based items for an oral mucositis assessment tool in children.

Although there are numerous instruments for oral mucositis (OM) assessment in adults, there is a lack of validated instruments for use in children. The objectives of this systematic review were to describe literature-based items that should be considered for a pediatric mucositis scale and other issues that should be considered when assessing mucositis in children. Literature search of PubMed and bibliography searches identified articles relevant to the assessment of mucositis and mucositis assessment studies in children. The elements established from the literature were grouped under objective, subjective, and functional items. Other issues that require consideration include the conditions for the assessment of the oral cavity and the etiology of OM. The resultant list included 23 items that have been used in mucositis assessment scales. This list of items may be used as an initial step in developing a new pediatric OM scale that particularly focuses on the unique issues in children.

Reliability and construct validity of the oral mucositis daily questionnaire in children with cancer

BACKGROUND The objective of this study was to examine the test-retest reliability and construct validity of parent-reported Oral Mucositis Daily Questionnaire (OMDQ) in children receiving intensive chemotherapy. METHODS Parents of children with cancer receiving intensive chemotherapy for leukaemia/lymphoma or undergoing stem cell transplantation (SCT) were asked to complete OMDQ daily for 21 d after chemotherapy. Other measures of mucositis obtained concurrently with OMDQ included the World Health Organization (WHO) Mucositis Scale, pain Visual Analogue Scale (VAS) and the Functional Assessment of Cancer Therapy Esophageal Cancer Sub-scale (FACT-ECS). RESULTS Parents of 59 children (median age = 5.62) provided complete OMDQ data for inclusion in analysis. The majority of children (73%) received SCT. Test-retest reliability of OMDQ exceeded the expected moderate reliability threshold established a priori and in particular, was good to excellent when mucositis was expected. In general, items of OMDQ that relate to pain, swallowing, drinking, eating and talking demonstrated moderate correlations with WHO, VAS and FACT-ECS indices with correlation coefficients ≥ 0.5. CONCLUSIONS Parent-report of a modified version of OMDQ is reliable and the questions relating to mouth and throat pain, as well as effect on function display construct validity for this population of children receiving intensive chemotherapy.

Determining the Understandability and Acceptability of an Oral Mucositis Daily Questionnaire

Oral mucositis research in children receiving anticancer therapy has been impeded by the lack of an acceptable, appropriate assessment scale. Some scales attempt to measure subjective symptoms associated with mucositis such as pain and difficulty swallowing. These types of patient-reported outcomes are gaining prominence in clinical trials because they capture the perspective of the patients in whom the intervention is designed to benefit. In mucositis research, very few patient-reported outcome measures have been developed. The aim of this study was to determine whether an adaptation of the adult-validated Oral Mucositis Daily Questionnaire is understandable and acceptable for use in the pediatric oncology/hematology population. Twelve subjects were asked to rate their opinion of understandability and acceptability of the adapted Oral Mucositis Daily Questionnaire. As a result of their comments, minor changes were made. Evaluation of the psychometric properties of this instrument can now be performed.

Designing an oral mucositis assessment instrument for use in children: generating items using a nominal group technique

Goals of workThere was a need to develop a mucositis instrument that would be specific for use with children. This paper describes the step of generating items in the process of developing a new instrument for the assessment of oral mucositis in children.Materials and methodsNine health care professionals with expertise in pediatric cancer, mucositis assessment, and oral assessment in children were invited to participate in a nominal group technique to generate items that should be included in an instrument.ResultsThirty items were generated initially. Voting processes established that six of these items were thought to be necessary for inclusion: (1) presence of ulcers, (2) pain assessment, (3) amount of pain medication received, (4) effect on eating, (5) drooling–pooling of saliva, and (6) effect on drinking. Using these six items, an initial draft of an instrument was developed that could be used to assess oral mucositis in children, namely, the Children’s International Mucositis Evaluation Scale.ConclusionThe six items generated by this process provided the basis for a simple, feasible, and reliable instrument. With increased clinical research investigating interventions to reduce and prevent oral mucositis, such an instrument will be critical to the effective conduct of this research in children. Further testing of this instrument is necessary.

Understandability, Content Validity, and Overall Acceptability of the Children's International Mucositis Evaluation Scale (ChIMES) Child and Parent Reporting

Mucositis assessment in children has primarily relied on assessment tools that have been developed for an adult population. A mucositis assessment scale for use in children has previously been developed from expert opinion, namely Childrens International Mucositis Evaluation Scale (ChIMES). After the development of ChIMES, we aimed to evaluate the user perspective of the scale by testing the understandability, content validity, and overall acceptability of ChIMES working with parents, children, and teenagers as content experts. Overall acceptability of the scale was satisfactory; however, comments provided by the participants questioned several aspects of the initial version of ChIMES. After discussion of the results, a refined version of ChIMES was produced that accounts for the views of the target population.

Perspectives toward oral mucositis prevention from parents and health care professionals in pediatric cancer

PurposeThe objectives of this study were: (1) to describe parents and health care professionals (HCPs) perceived importance of oral mucositis prevention in children with cancer; (2) To describe utilities and willingness-to-pay (WTP) to prevent mucositis.MethodsRespondents included parents of children receiving intensive chemotherapy for leukemia/lymphoma or undergoing stem cell transplantation and HCPs caring for children with cancer. Importance of mild and severe oral mucositis was estimated using a visual analogue scale (VAS). Mucositis-associated utilities were elicited using the time trade-off technique (TTO). WTP to avoid mucositis was obtained using contingent valuation. These techniques quantify how much time or money the participant is willing to relinquish in order to prevent mucositis.ResultsEighty-two parents and 60 HCPs were included. Parents and HCPs believed mild mucositis to be of similar importance (median VAS 2.5 versus 3.6; P = 0.357) while parents considered severe mucositis less important than HCPs (median VAS 8.3 versus 9.0; P < 0.0001). No differences in parent versus HCP responses were seen with TTO (mild or severe mucositis) and most parents were not willing to trade any survival time to prevent severe mucositis. Parents were willing to pay significantly more than HCPs to prevent mild mucositis (average median WTP

Serial controlled N-of-1 trials of topical vitamin E as prophylaxis for chemotherapy-induced oral mucositis in paediatric patients

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