Cross-Cultural Adaptation, Validation, and Piloting of the Patient Reported Experiences and Outcomes of Safety in Primary Care Questionnaire for Its Use in Spain

Objective.The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures.Methods.The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM.Results.Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation.Conclusion.Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

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Cross-cultural Adaptation and Validation of the Polish Version of the Lower Limb Functional Index

10.21203/rs.2.19150/v1 ◽

2019 ◽

Author(s):

Agnieszka Bejer ◽

Agnieszka Podufały ◽

Sylwia Kyc ◽

Magdalena Michałek ◽

Piotr Mataczyński ◽

...

Keyword(s):

Factor Structure ◽

Internal Consistency ◽

Lower Limb ◽

Cultural Adaptation ◽

Error Score ◽

Cross Cultural ◽

Functional Index ◽

Cross Cultural Adaptation ◽

Patient Reported ◽

Polish Version

Abstract Background: Patient reported outcome measures (PROMs) are recommended to enable the standardization of collected data and provide accurate representation of the patients’ subjective opinions of their functional capabilities. The purpose of this study was to perform linguistic and cross-cultural adaptation to establish a Polish version of the Lower Limb Functional Index (LLFI), and to evaluate the psychometric properties of internal consistency, reliability, error score, validity, and factor structure with standardized criteria PROMs in a population with lower limb problems. Methods: Linguistic and cultural adaptation complied with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines to produce the Lower Limb Functional Index-Polish version (LLFI-PL). The study recruited subjects (n=125, age =52.86±19.53 years, range 20-87, 56% female, injury duration =17.69±18.39 weeks, range 5-71). Baseline reliability and criterion validity included the LLFI-PL, Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Euroqol Health Questionnaire 5-Dimensions (EQ-5D-5L), and an 11-point pain Numerical Rating Scale, with retest at 3-7 days. Practicality for readability was considered within the face and content validity. Completion and scoring time were also calculated. Results: Statistical analysis showed excellent internal consistency ( α =0.94) and high test-retest reliability (ICC=0.96). The error score found the SEM=3.49% with MDC 90 =8.11%. Validity analysis showed strong correlations between the LLFI-PL with the WOMAC (r=-0.81) and moderate with the EQ-5D-5L (r=-0.63). Exploratory factor analysis confirmed a single-factor structure. Times for completion (172±33 seconds) and scoring (20±9 seconds) were determined. Conclusions: The LLFI-PL is a psychometrically sound questionnaire for Polish-speaking patients with lower limb musculoskeletal conditions. The results support the findings of previous original-English, Spanish, and Turkish versions for internal consistency, validity, reliability, error score, and factor structure.

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Polish Cross-cultural Adaptation of the Lower Limb Functional Index (LLFI) demonstrates a Valid Outcome Measure for the Lower Limb Region and Joints

10.21203/rs.3.rs-25953/v2 ◽

2020 ◽

Author(s):

Agnieszka Bejer ◽

Agnieszka Podufały ◽

Sylwia Kyc ◽

Magdalena Michałek ◽

Piotr Mataczyński ◽

...

Keyword(s):

Factor Structure ◽

Internal Consistency ◽

Lower Limb ◽

Cultural Adaptation ◽

Error Score ◽

Cross Cultural ◽

Functional Index ◽

Cross Cultural Adaptation ◽

Patient Reported ◽

Polish Version

Abstract Background: Patient reported outcome measures (PROMs) are recommended to enable the standardization of collected data and provide accurate representation of the patients’ subjective opinions of their functional capabilities. The purpose of this study was to perform linguistic and cross-cultural adaptation to establish a Polish version of the Lower Limb Functional Index (LLFI), and to evaluate the psychometric properties of internal consistency, reliability, error score, validity, and factor structure with standardized criteria PROMs in a population with lower limb problems.Methods: Linguistic and cultural adaptation complied with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines to produce the Lower Limb Functional Index - Polish version (LLFI-PL). This was a two-stage, cross-sectional study with repeated measures on two variables during retest examination. The study recruited n=125 subjects (age =52.86±19.53 years, range 20-87, 56% female, injury duration =17.69±18.39 weeks, range 5-71). Baseline reliability and construct validity included the LLFI-PL, Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Euroqol Health Questionnaire 5-Dimensions (EQ-5D-5L), and an 11-point pain Numerical Rating Scale (NRS), with retest at 3-7 days. Practicality for readability was considered within the face and content validity. Completion and scoring time were also calculated. Results: Statistical analysis showed high internal consistency (α=0.94) that is below the 0.95 threshold limit, and excellent test-retest reliability (ICC2.1=0.96). The error score found the SEM=4.85% with MDC90=11.3%. Validity analysis showed strong correlations between the LLFI-PL with the WOMAC (r=-0.81) and moderate with the EQ-5D-5L (r=-0.63). Exploratory factor analysis confirmed a single-factor structure. Times for completion (172±33 seconds) and scoring (20±9 seconds) were determined.Conclusions: The LLFI-PL is a psychometrically sound questionnaire for Polish-speaking patients with lower limb musculoskeletal conditions. The results support the findings of previous original-English, Spanish, and Turkish versions for internal consistency, validity, reliability, error score, and factor structure.

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