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Development of a new patient-reported outcome measure for children with lower limb deformities : concept elicitation, item development and content validation

University of British Columbia

Objectives: To develop a conceptual framework, generate items and scales, and establish content validity for a new patient-reported outcome measure (PROM) for children with lower limb deformities. Methods: A systematic review was conducted to synthesize the evidence on the use of PROMs to measure Health Related Quality of Life (HRQL) of children with lower limb deformities. A qualitative phase involved semi-structured face-to-face interviews with children with lower limb deformities and their parents from Canada, Ethiopia, India and the USA. Using the knowledge gained from these interviews, a list of items was generated and used to create individual scales for the new PROM. The scales were shown to children with lower limb deformities from Australia, Canada and the USA. Feedback was also obtained from clinical experts. The feedback was used to determine if the content of the scales was comprehensible, relevant and comprehensive (i.e., to determine content validity). Results: The systematic review confirmed that there was no condition-specific PROM for children with lower limb deformities. Qualitative interviews allowed us to elicit concepts that matter most to children with such deformities and develop conceptual framework covering the most important concerns. A set of independently functioning scales measuring physical function, leg symptoms, hip symptoms, knee symptoms, ankle symptoms, foot symptoms, leg-related distress, appearance, school function, social function, and psychological function were developed. Items that were difficult to understand were revised. New items were added as suggested by patients and experts. Conclusions: Lower limb deformities can substantially impact HRQL of children. To date, no condition-specific PROMs exist for this patient population. We have developed items for a set of scales, guided by qualitative interviews with the target patient population that formed the basis of a new PROM. The next phase in the development and validation of this PROM includes a pilot test to ensure the scales work as hypothesized, followed by an international field test study to examine its psychometric properties. Once fully validated, this PROM can be used to measure HRQL of children with lower limb deformities and to evaluate the effectiveness of interventions aimed at improving HRQL in these children.

Text

2021-04-27

Attribution-NonCommercial-NoDerivatives 4.0 International

http://hdl.handle.net/2429/77996

Experimental Medicine

University of British Columbia

UBCV

http://creativecommons.org/licenses/by-nc-nd/4.0/