Questionnaires in clinical trials: guidelines for optimal design and administration

Springer Science and Business Media LLC - Tập 11 - Trang 1-8 - 2010
Phil Edwards1
1Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK

Tóm tắt

A good questionnaire design for a clinical trial will minimise bias and maximise precision in the estimates of treatment effect within budget. Attempts to collect more data than will be analysed may risk reducing recruitment (reducing power) and increasing losses to follow-up (possibly introducing bias). The mode of administration can also impact on the cost, quality and completeness of data collected. There is good evidence for design features that improve data completeness but further research is required to evaluate strategies in clinical trials. Theory-based guidelines for style, appearance, and layout of self-administered questionnaires have been proposed but require evaluation.

Tài liệu tham khảo

Armstrong BG: Optimizing power in allocating resources to exposure assessment in an epidemiologic study. Am J Epidemiol. 1996, 144: 192-197. Hill AB: Observation and experiment. N Engl J Med. 1953, 248: 995-1001. 10.1056/NEJM195306112482401. Edwards PJ, Roberts I, Clarke MJ, DiGuiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S: Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009, 3: MR000008- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH harmonised tripartite guideline, statistical principles for clinical trials E9. http://www.ich.org/LOB/media/MEDIA485.pdf CIOMS: Management of safety information from clinical trials: report of CIOMS working group VI. 2005, Geneva, Switzerland: Council for International Organisations of Medical Sciences (CIOMS) Streiner DL, Norman GR: Health measurement scales: a practical guide to their development and use. 2004, Oxford University Press, 3 Farr JN, Jenkins JJ, Paterson DG: Simplification of Flesch reading ease formula. J Appl Psychol. 1951, 35: 333-337. 10.1037/h0062427. Armstrong BK, White E, Saracci R: Principles of exposure measurement in epidemiology. Monographs in Epidemiology and Biostatistics. 1995, New York, NY: Oxford University Press, 21: Nieuwenhuijsen M: Design of exposure questionnaires for epidemiological studies. Occup Environ Med. 2005, 62: 272-280. 10.1136/oem.2004.015206. Tourangeau R, Couper MP, Conrad F: Spacing, position, and order: interpretive heuristics for visual features of survey questions. Pub Opin Quart. 2004, 68: 368-393. 10.1093/poq/nfh035. Jenkins CR, Dillman DA: Towards a theory of self-administered questionnaire design.http://www.census.gov/srd/papers/pdf/sm95-06.pdf Tufte E: The visual display of quantitative information. 1999, Cheshire, CT: Graphics Press Garber MC, Nau DP, Erickson SR, Aikens JE, Lawrence JB: The concordance of self-report with other measures of medication adherence: a summary of the literature. Med Care. 2004, 42: 649-652. 10.1097/01.mlr.0000129496.05898.02. Heerwegh D: Mode differences between face-to-face and web surveys: an experimental investigation of data quality and social desirability effects. Int J Pub Opin Res. 2009, 21: 111-121. 10.1093/ijpor/edn054. Willis GB: Cognitive interviewing: a how-to guide.http://www.appliedresearch.cancer.gov/areas/cognitive/interview.pdf Greenland S: Response and follow-up bias in cohort studies. Am J Epidemiol. 1977, 106: 184-187. Kenward MG, Carpenter J: Multiple imputation: current perspectives. Stat Methods Med Res. 2007, 16: 199-218. 10.1177/0962280206075304. Edwards P, Roberts I, Sandercock P, Frost C: Follow-up by mail in clinical trials: does questionnaire length matter?. Contr Clin Trials. 2004, 25: 31-52. 10.1016/j.cct.2003.08.013. Rothman K, Mikkelsen EM, Riis A, Sørensen HT, Wise LA, Hatch EE: Randomized trial of questionnaire length. Epidemiology. 2009, 20: 154-10.1097/EDE.0b013e31818f2e96. Sterne JAC, Davey Smith G: Sifting the evidence - what's wrong with significance tests?. BMJ. 2001, 322: 226-231. 10.1136/bmj.322.7280.226. Edwards P, Cooper R, Roberts I, Frost C: Meta-analysis of randomised trials of monetary incentives and response to mailed questionnaires. J Epidemiol Comm Health. 2005, 59: 987-999. 10.1136/jech.2005.034397. Scott P, Edwards P: Personally addressed hand-signed letters increase questionnaire response: a meta-analysis of randomised controlled trials. BMC Health Serv Res. 2006, 6: 111-10.1186/1472-6963-6-111. Nakash RA, Hutton JL, Jørstad-Stein EC, Gates S, Lamb SE: Maximising response to postal questionnaires - a systematic review of randomised trials in health research. BMC Med Res Methodol. 2006, 6: 5-10.1186/1471-2288-6-5. Kenyon S, Pike K, Jones D, Taylor D, Salt A, Marlow N, Brocklehurst P: The effect of a monetary incentive on return of a postal health and development questionnaire: a randomised trial. BMC Health Serv Res. 2005, 5: 55-10.1186/1472-6963-5-55. Gates S, Williams MA, Withers E, Williamson E, Mt-Isa S, Lamb SE: Does a monetary incentive improve the response to a postal questionnaire in a randomised controlled trial? The MINT incentive study. Trials. 2009, 10: 44-10.1186/1745-6215-10-44. McColl E: Commentary: methods to increase response rates to postal questionnaires. Int J Epidemiol. 2007, 36: 968- McColl E, Jacoby A, Thomas L, Soutter J, Bamford C, Steen N, Thomas R, Harvey E, Garratt A, Bond J: Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technol Assess. 2001, 5: 1-256. Edwards P, Fernandes J, Roberts I, Kuppermann N: Young men were at risk of becoming lost to follow-up in a cohort of head-injured adults. J Clin Epidemiol. 2007, 60: 417-424. 10.1016/j.jclinepi.2006.06.021. Nakash R, Hutton JL, Lamb SE, Gates S, Fisher J: Response and non-response to postal questionnaire follow-up in a clinical trial - a qualitative study of the patient's perspective. J Eval Clin Prac. 2008, 14: 226-235. 10.1111/j.1365-2753.2007.00838.x.