Literature review to assemble the evidence for response scales used in patient-reported outcome measures

被引:37
作者
Gries K. [1 ]
Berry P. [1 ]
Harrington M. [2 ]
Crescioni M. [3 ]
Patel M. [3 ]
Rudell K. [4 ]
Safikhani S. [5 ]
Pease S. [6 ]
Vernon M. [5 ]
机构
[1] Janssen Global Services LLC, 700 US 202, Raritan Ave, Raritan, 08869, NJ
[2] Shire Pharmaceuticals, 500 Shire Way, Lexington, 02421, MA
[3] Critical Path Institute, Patient-Reported Outcome Consortium, 1730 E River Rd, Tucson, 85718, AZ
[4] Outcomes & Evidence, Global Health & Value, Pfizer Ltd, Tadworth, Surrey
[5] Evidera, 7101 Wisconsin Ave. Suite 1400, Bethesda, 20814, MD
[6] Pfizer Inc, NYC, NY
关键词
Literature review; Patient-reported outcome; Response option; Response scales;
D O I
10.1186/s41687-018-0056-3
中图分类号
学科分类号
摘要
Background: In the development of patient-reported outcome (PRO) instruments, little documentation is provided on the justification of response scale selection. The selection of response scales is often based on the developers’ preferences or therapeutic area conventions. The purpose of this literature review was to assemble evidence on the selection of response scale types, in PRO instruments. The literature search was conducted in EMBASE, MEDLINE, and PsycINFO databases. Secondary search was conducted on supplementary sources including reference lists of key articles, websites for major PRO-related working groups and consortia, and conference abstracts. Evidence on the selection of verbal rating scale (VRS), numeric rating scale (NRS), and visual analogue scale (VAS) was collated based on pre-determined categories pertinent to the development of PRO instruments: reliability, validity, and responsiveness of PRO instruments, select therapeutic areas, and optimal number of response scale options. Results: A total of 6713 abstracts were reviewed; 186 full-text references included. There was a lack of consensus in the literature on the justification for response scale type based on the reliability, validity, and responsiveness of a PRO instrument. The type of response scale varied within the following therapeutic areas: asthma, cognition, depression, fatigue in rheumatoid arthritis, and oncology. The optimal number of response options depends on the construct, but quantitative evidence suggests that a 5-point or 6-point VRS was more informative and discriminative than fewer response options. Conclusions: The VRS, NRS, and VAS are acceptable response scale types in the development of PRO instruments. The empirical evidence on selection of response scales was inconsistent and, therefore, more empirical evidence needs to be generated. In the development of PRO instruments, it is important to consider the measurement properties and therapeutic area and provide justification for the selection of response scale type. © The Author(s).
引用
收藏
相关论文
共 48 条
[1]  
Dworkin R.H., Turk D.C., Farrar J.T., Haythornthwaite J.A., Jensen M.P., Katz N.P., Kerns R.D., Stucki G., Allen R.R., Bellamy N., Carr D.B., Chandler J., Cowan P., Dionne R., Galer B.S., Hertz S., Jadad A.R., Kramer L.D., Manning D.C., Martin S., McCormick C.G., McDermott M.P., McGrath P., Quessy S., Rappaport B.A., Robbins W., Robinson J.P., Rothman M., Royal M.A., Simon L., Stauffer J.W., Stein W., Tollett J., Wernicke J., Witter J., Core outcome measures for chronic pain clinical trials: Imm
[2]  
Liu A.H., Zeiger R., Sorkness C., Mahr T., Ostrom N., Burgess S., Rosenzweig J.C., Manjunath R., Development and cross-sectional validation of the childhood asthma control test, The Journal of Allergy and Clinical Immunology, 119, 4, pp. 817-825, (2007)
[3]  
Matza L.S., Patrick D.L., Riley A.W., Alexander J.J., Rajmil L., Pleil A.M., Bullinger M., Pediatric patient-reported outcome instruments for research to support medical product labeling: Report of the ispor pro good research practices for the assessment of children and adolescents task force, Value in Health, 16, 4, pp. 461-479, (2013)
[4]  
Safikhani S., Gries K.S., Trudeau J.J., Reasner D., Rudell K., Coons S.J., Bush E.N., Hanlon J., Abraham L., Vernon M., (Under review) response scale selection in adult pain measures: Results from a literature review, Journa of Patient-Reported Outcomes.
[5]  
Naegeli A.N., Hanlon J., Gries K.S., Safikhani S., Ryden A., Patel M., Crescioni M., Vernon M., (Under review) literature review to characterize the empirical basis for response scale selection in pediatric populations, Journal of Patient-Reported Outcomes.
[6]  
Streiner D.L., Norman G.R., Health Measurement Scales: A Practical Guide to Their Development and Use, Fourth Edition (Fourth Ed.)., (2008)
[7]  
Likert R.A., A technique for the development of attitude scales, Educational and Psychological Measurement, 12, pp. 313-315, (1952)
[8]  
Laerhoven H., Zaag-Loonen H.J., Derkx B.H., A comparison of likert scale and visual analogue scales as response options in children's questionnaires, Acta Paediatrica, 93, 6, pp. 830-835, (2004)
[9]  
Ferraz M.B., Quaresma M.R., Aquino L.R., Atra E., Tugwell P., Goldsmith C.H., Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis, The Journal of Rheumatology, 17, 8, pp. 1022-1024, (1990)
[10]  
Phan N.Q., Blome C., Fritz F., Gerss J., Reich A., Ebata T., Augustin M., Szepietowski J.C., Stander S., Assessment of pruritus intensity: Prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus, Acta Dermato-Venereologica, 92, 5, pp. 502-507, (2012)