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Medicine: Designing and validating a questionnaire

This guide is intended to assist students and researchers to find resources in Medicine

Designing and validating your questionnaire

"All instruments assessing patient reported outcomes have to be evaluated for its reliability and validity in the country prior to its use. The purpose of this is to ensure that the instrument used is measuring what it is supposed to measure. This is applicable to instruments that have been developed in English by other authors, and validated elsewhere; as well as self-developed instruments or those that have been modified (e.g. translated into another language or otherwise)."

(Reference: Lai, P. (2012). Validating instruments of measure: Is it really necessary?. Malaysian Family Physician, 8(1). Retrieved from )

If you are conducting a survey-type study or measuring outcomes using a questionnaire that has not been validated in Malaysia, the resources will guide you on how to validate the instrument before you use it to collect study data.

Books Available in UM Library

Online Resources

1. Lai, P. (2012). Validating instruments of measure : Is it really necessary?. Malaysian Family Physician, 8(1). Retrieved from (FREE)

2. Tsang, S., Royse, C. F., & Terkawi, A. S. (2017). Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi journal of anaesthesia, 11(Suppl 1), S80–S89. (FREE)

3. Rattray, J., & Jones, M. C. (2007). Essential elements of questionnaire design and development. Journal of clinical nursing, 16(2), 234–243
. (FREE)


4. Nguyen, S. V., & Habók, A. (2021). Designing and validating the learner autonomy perception questionnaire. Heliyon7(4), e06831.

5. Boparai JK, Singh S, Kathuria P. How to Design and Validate A Questionnaire: A Guide. Curr Clin Pharmacol. 2018;13(4):210-215. doi: 10.2174/1574884713666180807151328. PMID: 30084336.


6. Edwards P. Questionnaires in clinical trials: guidelines for optimal design and administration. Trials. 2010 Jan 11;11:2. doi: 10.1186/1745-6215-11-2. PMID: 20064225; PMCID: PMC2823735.


7. Soto-Rey I, Dugas M, Fritz F. Clinical Trial Feasibility Study Questionnaire Analysis. Stud Health Technol Inform. 2015;216:1029. PMID: 26262329.


8. Artino AR Jr, La Rochelle JS, Dezee KJ, Gehlbach H. Developing questionnaires for educational research: AMEE Guide No. 87. Med Teach. 2014 Jun;36(6):463-74. doi: 10.3109/0142159X.2014.889814. Epub 2014 Mar 24. PMID: 24661014; PMCID: PMC4059192.


9. Meadows KA. So you want to do research? 5: Questionnaire design. Br J Community Nurs. 2003 Dec;8(12):562-70. doi: 10.12968/bjcn.2003.8.12.11854. PMID: 14688664.