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Content Validation by Patients and Experts: Is the PRO Measure Fit for Purpose?

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Abstract

The use of a PRO measure assumes a link between the content in a measure and the targeted underlying construct (Wynd et al. 2003). In addition to other types of data, this is fundamentally demonstrated by evidence of content validity, i.e. the ‘complete relevance’ of the content to the target population and how adequately it represents the underlying construct. Without such evidence, the definition of the underlying concept being measured becomes ambiguous, and the scores would be rendered meaningless (Haynes et al. 1995). While evidence ensuring content validity is generated through inclusion of input from patients in defining the content of the measure, confirming that ‘complete relevance’ has been attained is crucial. This is addressed in Steps IV and V of the roadmap, where respondent understanding of the measure and comprehensives is explicitly explored in Step IV, with practicality and acceptability explored in Step V. Importantly, both steps allow the PRO measure to be fine-tuned to address any issues uncovered in the steps. These steps are illustrated in the current chapter, based on the patient and clinician panels conducted to assess the content validity of the HidroQoL as well as a pilot test of the measure assessing the practicality and acceptability of the HidroQoL.

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Appendix

Appendix

Content verification of the 47-item prototype HidroQoL by patients and Experts

Table 4.1 Patient panel ratings of language clarity, completeness, relevance and scaling of the HidroQoL
Table 4.2 (a) Level of agreement and content validity index for the panel of patients and (b) level of agreement and content validity index for the panel of dermatologists
Table 4.3 Revision to the items of the HidroQoL following content validation panels

Practicality Questions

Box 4.1 Sample Questions Used in Pretesting of New PRO Questionnaires: Presented for the Overall Questionnaire or the Individual Items

  1. 1.

    Did you experience any difficulties in understanding the instructions? [If yes, which specific words or elements were difficult?]

  2. 2.

    Did you experience any difficulties in understanding or completing the items in this questionnaire? [If yes, which specific items, and what difficulties did you encounter?]

  3. 3.

    What are your views regarding the number of items in this questionnaire?

  4. 4.

    Are there any important aspects (items) currently not covered in the questionnaire, which should be added to the questionnaire?

  5. 5.

    Are there any items currently in the questionnaire, which are not relevant and should be removed?

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Kamudoni, P., Johns, N., Salek, S. (2018). Content Validation by Patients and Experts: Is the PRO Measure Fit for Purpose?. In: Living with Chronic Disease: Measuring Important Patient-Reported Outcomes. Adis, Singapore. https://doi.org/10.1007/978-981-10-8414-0_4

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  • DOI: https://doi.org/10.1007/978-981-10-8414-0_4

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  • Publisher Name: Adis, Singapore

  • Print ISBN: 978-981-10-8413-3

  • Online ISBN: 978-981-10-8414-0

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