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01-04-2014

Equivalence and measurement properties of an electronic version of the Psoriasis Symptom Inventory

Gepubliceerd in: Quality of Life Research | Uitgave 3/2014

Abstract

Purpose

To evaluate the equivalence of electronic and paper versions of the Psoriasis Symptom Inventory and to examine measurement properties of the electronic version.

Methods

In a prospective, randomized, crossover, non-interventional study in adult subjects (age ≥18 years) with plaque psoriasis conducted over a period of 15 days, subjects were randomized to two groups, completing either the paper or electronic Psoriasis Symptom Inventory daily for 7 consecutive days followed by the alternate version. Equivalence was assessed by the intraclass correlation coefficient (ICC) between both administration modes. Differences in scores were also tested using paired Student’s t test. Measurement properties included internal consistency reliability, test–retest reliability, and convergent and discriminant validity between the Psoriasis Symptom Inventory and (1) disease-specific (Dermatology Life Quality Index) and (2) general health (SF-36v2) status.

Results

Eighty subjects [74 % (59/80) moderate-to-severe psoriasis; 26 % (21/80) mild psoriasis receiving systemic treatment] were enrolled from 8 sites in the USA. The two modes were highly concordant for both total (ICC = 0.97) and individual item scores (ICC range = 0.93–0.97). Response bias testing showed no differences based on completion order with all ICC values >0.91. All mean score differences, except for one item (“flaking”), were non-significant (P > 0.05). Minimum values for reliability (>0.70) and validity (convergent, r ≥ 0.40) were exceeded for the electronic Psoriasis Symptom Inventory.

Conclusions

Equivalence between paper and electronic versions of the Psoriasis Symptom Inventory and strong measurement properties of the electronic mode indicated a successful migration from paper to electronic format of the Psoriasis Symptom Inventory.

vorige artikel Qualitative development of the ‘Questionnaire on Pain caused by Spasticity (QPS),’ a pediatric patient‐reported outcome for spasticity‐related pain in cerebral palsy

volgende artikel Validity and reliability of the Chinese version of the Short Form of Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)

de Jong, E. M. G. J. (1997). The course of psoriasis. Clinics in Dermatology, 15(5), 687–692.PubMedCrossRef

Martin, M. L., McCarrier, K., Bushnell, D. M., Gordon, K., Chiou, C.-F., Huang, X., Ortmeier, B., & Kricorian, G. (2011). Validation of the Psoriasis Symptom Inventory (PSI), a patient reported outcome measure. In 20th European academy of dermatology and venereology congress. Lisbon, Portugal.

Martin, M. L., McCarrier, K., Bushnell, D. M., Gordon, K., Chiou, C.-F., Huang, X., et al. (2012). Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure. Journal of the American Academy of Dermatology, 66(4, Supplement 1), AB207.

Lui, H., & Mamelak, A. (2009). Plaque psoriasis. Updated: Sep 30, 2009. http://www.emedicine.com/derm/topic365.htm#section~clinical (see causes).

Wilke, R., Burke, L., & Erickson, P. (2004). Measuring treatment impact: A review of patient reported outcomes and other efficacy endpoints in approved product labels. Controlled Clinical Trials, 26, 636–662.

Gwaltney, C. J., Shields, A. L., & Shiffman, S. (2008). Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: A meta-analytic review. Value Health, 11(2), 322–333.PubMedCrossRef

Stone, A. A., Shiffman, S., Schwartz, J. E., Broderick, J. E., & Hufford, M. R. (2002). Patient non-compliance with paper diaries. BMJ, 324(7347), 1193–1194.PubMedCentralPubMedCrossRef

F. a. D. A. (FDA). (2009). Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. Retrieved December, 2009, 2009.

Coons, S. J., Gwaltney, C. J., Hays, R. D., Lundy, J. J., Sloan, J. A., Revicki, D. A., et al. (2009). Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value Health, 12(4), 419–429.PubMedCrossRef

10.

Martin, M., Chen, T., Chau, D., & Viswanathan, H. (2012). Qualitative interviews with psoriasis patients evaluating paper to electronic migration of the Psoriasis Symptom Inventory (PSI). In Paper presented at the ISOQOL 2012. Budapest, Hungary.

11.

Martin, M., McCarrier, K., Chiou, C., Gordon, K., Kimball, A., Van Voorhees, A., Gottlieb, A., Huang, X., Globe, D., Chau, D., Viswanathan, H., & Kricorian, G. (2013). Early development and qualitative evidence of content validity for the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure of psoriasis symptom severity. Journal of Dermatological Treatment, 24(4), 255–260.

12.

Bushnell, D. M., Martin, M. L., McCarrier, K., Gordon, K., Chiou, C. F., Huang, X., Ortmeier, B., & Kricorian, G. (2013). Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity. Journal of Dermatological Treatment, 24(5), 356–360.

13.

Revicki, D. A., Jin, Y., Chau, D., & Viswanathan, H. (2012). Reliability and validity of the Psoriasis Symptom Inventory in Patients with moderate to severe psoriasis. In International society for quality of life research 19th annual conference. Budapest.

14.

Revicki, D. A., Jin, Y., Wilson, H. D., Chau, D., & Viswanathan, H. N. (2013). Reliability and validity of the psoriasis symptom inventory in patients with moderate-to-severe psoriasis. Journal of Dermatological Treatment. doi:10.3109/09546634.2013.769042.

15.

Deyo, R. A., Diehr, P., & Patrick, D. L. (1991). Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation. Controlled Clinical Trials, 12(4 Suppl), 142S–158S.PubMedCrossRef

16.

Cronbach, L. (1951). Coefficient alpha and the internal structure of tests. Psychometrika, 16, 297–334.CrossRef

17.

Lohr, K. (2002). Assessing health status and quality-of-life instruments: Attributes and review criteria. Quality of Life Research, 11(3), 193–205.PubMedCrossRef

18.

Nunnally, J., & Bernstein, I. (1994). Psychometric theory (3rd ed.). New York: McGraw-Hill.

19.

Cohen, J. (1988). Statistical power analysis in the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates, Inc.

20.

Bushnell, D. M., Reilly, M. C., Galani, C., Martin, M. L., Ricci, J. F., Patrick, D. L., et al. (2006). Validation of electronic data capture of the irritable bowel syndrome–quality of life measure, the work productivity and activity impairment questionnaire for irritable bowel syndrome and the EuroQol. Value Health, 9(2), 98–105.PubMedCrossRef

21.

Kvien, T. K., Mowinckel, P., Heiberg, T., Dammann, K. L., Dale, O., Aanerud, G. J., et al. (2005). Performance of health status measures with a pen based personal digital assistant. Annals of the Rheumatic Diseases, 64(10), 1480–1484.PubMedCentralPubMedCrossRef

22.

Saleh, K. J., Radosevich, D. M., Kassim, R. A., Moussa, M., Dykes, D., Bottolfson, H., et al. (2002). Comparison of commonly used orthopaedic outcome measures using palm-top computers and paper surveys. Journal of Orthopaedic Research, 20(6), 1146–1151.PubMedCrossRef

Titel: Equivalence and measurement properties of an electronic version of the Psoriasis Symptom Inventory
Publicatiedatum: 01-04-2014
Gepubliceerd in: Quality of Life Research / Uitgave 3/2014
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-013-0527-1

Bohn Stafleu van Loghum

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Abstract

Purpose

Methods

Results

Conclusions

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