Abstract
Background : Issues with questionnaire completion introduce bias and limit examinations in trials. Improving communication with participants abouttrial processes, such as outcome and questionnaire development, may improve questionnaire completion and response rates. Providing information about the involvement ofstakeholders in thedevelopment of core outcome sets (COS) measured in trialsmay improve respondingby tapping into subjective norms and behaviour change mechanisms. The aim of this Study Within a Trial (SWAT) is to examine if questionnaire response rates and participants' attitudes towards questionnaire completion are impacted by providinginformation aboutCOS usein a trial of a complex intervention. Methods: This is a randomised, single-blinded, parallel group intervention SWAT, embedded within a feasibility trial of an infant feeding intervention to prevent childhood obesity. The SWAT interventionconsisting of abrief written description andexplanation about the development and use of a COS of infant feeding outcomes to prevent childhood obesity, used in the trial. Participants are parents or caregivers of infants aged two months at questionnaire completion. Participants will be randomly assigned to receive the SWAT intervention prior to questionnaire completion (I1 condition), or to receive the information following completion of all questionnaires (I2 condition).The SWAT will be assessed usingclosed-ended and an open-ended question to evaluate participants' attitudes about questionnaire completion.Response rates will be measured as proportion of full questionnaire completion and individual item response rates. Discussion:We hypothesise that providing information about development and use of a COS will increase questionnaire response rates and attitudes toward questionnaire completion relative to the control condition. Findings will indicate the potential usefulness of this strategy for improving participant attitudes and response rates in trials. Trial Registration: This SWAT is registered on the Northern Ireland Hub for Trials Methodology: Research SWAT Repository ( SWAT57).
Highlights
Evaluation of questionnaire responses is an important dimension of the critical appraisal of health research (Edwards et al, 2009)
Reviews have highlighted heterogeneity among strategies used across trials limiting synthesis and conclusions that can be drawn about effectiveness (Edwards et al, 2009)
The Study Within a Trial (SWAT) embedded within the Cherish feasibility trial is an important step for evaluating additional potential benefits of core outcome sets (COS) in trial methodology beyond the benefits of COSs for evidence synthesis (Williamson et al, 2012)
Summary
Evaluation of questionnaire responses is an important dimension of the critical appraisal of health research (Edwards et al, 2009). Providing information about the involvement of stakeholders in the development of core outcome sets (COS) measured in trials may improve responding by tapping into subjective norms and behaviour change mechanisms. The aim of this Study Within a Trial (SWAT) is to examine if questionnaire response rates and participants’ attitudes towards questionnaire completion are impacted by providing information about COS use in a trial of a complex intervention. The SWAT intervention consisting of a brief written description and explanation about the development and use of a COS of infant feeding outcomes to prevent childhood obesity, used in the trial. Participants will be randomly assigned to receive the SWAT intervention prior to questionnaire completion (I1 condition), or to receive the information following completion of all questionnaires version 2
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