Development of a Patient-Reported Outcome Measure for Children With Streptococcal Pharyngitis

N, Shaikh; Jm, Martin; Casey, Joseph R.; Me, Pichichero; Er, Wald; Dk, Colborn; Ma, Gerber; Dh, Kearney; Tl, Balentine; Ma, Haralam; Hoberman, Alejandro

doi:10.1542/peds.2009-0331

Cited by 6 publications

(3 citation statements)

References 19 publications

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“…• Strep-PRO The Strep-PRO is a seven-item questionnaire developed to assess the symptoms of Group A streptococcus (GAS) pharyngitis in children aged 5-15 years [15]. While not specific to the common cold, it is a validated child-reported measure of several symptoms relevant to the cold (e.g., sore throat), and so was included to evaluate convergent validity.…”

Section: Study Assessmentsmentioning

confidence: 99%

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold

Arbuckle

Halstead

Marshall

et al. 2020

Patient

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Objectives Given the lack of validated patient-reported outcomes (PRO) instruments assessing cold symptoms, a new pediatric PRO instrument was developed to assess multiple cold symptoms: the Child Cold Symptom Questionnaire (CCSQ). The objective of this research was to evaluate the measurement properties of the CCSQ. Methods This observational study involved daily completion of the self-report CCSQ by children aged 6–11 years in their home for 7 days. These data were used to develop a scoring algorithm and item-scale structure and evaluate the psychometric properties of the resulting scores. Analyses included evaluation of item and dimensionality performance (item response distributions and confirmatory factor analysis) and assessment of test–retest reliability in stable patients, construct validity (convergent and known groups validity), and preliminary responsiveness. Qualitative exit interviews in a subgroup of the children with colds and their parents were conducted. Results More than 90% of children had no missing data during the testing period, reflecting an excellent completion rate. For most items, responses were distributed across the options, with approximately normal distributions. Test–retest reliability was adequate, with intra-class correlation coefficients ranging from 0.63 to 0.83. A logical pattern of correlations with the validated Strep-PRO instrument provided evidence supporting convergent validity. Single- and multi-item symptom scores distinguished between children who differed in their cold severity based on global ratings, providing evidence of known groups validity. Preliminary evidence indicates the CCSQ is responsive to changes over time. Conclusions The findings demonstrate that the CCSQ items and multi-item scores provide valid and reliable patient-reported measures of cold symptoms in children aged 6–11 years. They provide strong evidence supporting the validity of these items and multi-item scores for inclusion as endpoints in clinical trials to evaluate the efficacy of cold medicines. Electronic supplementary material The online version of this article (10.1007/s40271-020-00462-3) contains supplementary material, which is available to authorized users.

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Section: Study Assessmentsmentioning

confidence: 99%

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold

Arbuckle

Halstead

Marshall

et al. 2020

Patient

View full text Add to dashboard Cite

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“…Pediatric PRO instruments are available to assess conditions with symptoms that overlap with the common cold. These include the Strep PRO, which assesses sore throat [7] and the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire [8], which assesses runny nose and sneezing. However, none providing a comprehensive assessment of cold symptoms are found in the literature.…”

Section: Sample and Recruitmentmentioning

confidence: 99%

Development and Content Validity Testing of Patient-Reported Outcome Items for Children to Self-Assess Symptoms of the Common Cold

Halstead

Arbuckle

Marshall

et al. 2019

Patient

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Background and objective No pediatric patient-reported outcome instruments specific to the common cold are found in the literature. This study involved development and content validity testing of patient-reported outcome items (questions and response options) assessing cold symptoms in children aged 6-11 years. Methods Draft patient-reported outcome instructions, items, response scales, and recall periods were developed based on the literature and existing measures. Qualitative interviews were conducted with children (n = 39) who were currently (n = 31) or had recently (n = 8) experienced a cold and ten parents of a subset of children aged 6-8 years. The interviews were conducted over two rounds and included open-ended concept elicitation questioning, a free-drawing task, a card sorting task, and a task involving circling parts of the body, followed by cognitive debriefing of draft items. Thematic analysis of verbatim transcripts was performed to analyze the qualitative data. The findings were used to support revisions to the draft patient-reported outcome. Results Ten symptom concepts were reported by the children during concept elicitation. The creative tasks helped the children to describe their symptoms, generally using consistent language to do so, irrespective of age. Nineteen patient-reported outcome items were developed and subject to cognitive debriefing. Debriefing with both children and parents informed several small revisions and provided evidence that the majority of children found most patient-reported outcome items easy to understand, and that the items were mainly interpreted consistently and as intended. Conclusions This in-depth qualitative study has supported identification of relevant symptom concepts and the development and refinement of patient-reported outcome items to assess those concepts. The findings support the content validity of the items and suggest that they can be used with confidence in children aged 9 years and older. For children aged 6-8 years, it is recommended the items are administered with initial adult supervision to explain the more difficult concepts or through parent/interviewer administration.

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“…Responsiveness is defined as the ability of an instrument to detect changes as a result of rehabilitation in a patient's condition and thus helps clinicians recognize the effect of a treatment on the patient [18]. Criterion-related validity includes concurrent validity and predictive validity, which considers the degree of consistency of an instrument with the criterion measures and the ability of an instrument to predict subsequent events [19].…”

Section: Introductionmentioning

confidence: 99%

Psychometric comparisons of the Stroke Impact Scale 3.0 and Stroke-Specific Quality of Life Scale

Lin

et al. 2010

Qual Life Res

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Development of a Patient-Reported Outcome Measure for Children With Streptococcal Pharyngitis

Abstract: The scale seems to measure effectively both pain and overall functional status in children with GAS pharyngitis. These data support the use of Strep-PRO as a measure of outcome in future clinical trials.

Cited by 6 publications

References 19 publications

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold

Development and Content Validity Testing of Patient-Reported Outcome Items for Children to Self-Assess Symptoms of the Common Cold

Psychometric comparisons of the Stroke Impact Scale 3.0 and Stroke-Specific Quality of Life Scale

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