• Robert Hatch, Duncan Young, Vicki Barber, David A Harrison, and Peter Watkinson.
• Kadoorie Centre for Critical Care Research and Education, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.
• Bmc Med Res Methodol. 2017 Mar 27; 17 (1): 49.

BackgroundThe effects of postal questionnaire burden on return rates and answers given are unclear following treatment on an intensive care unit (ICU). We aimed to establish the effects of different postal questionnaire burdens on return rates and answers given.MethodsDesign: A parallel group randomised controlled trial. We assigned patients by computer-based randomisation to one of two questionnaire packs (Group A and Group B).SettingPatients from 26 ICUs in the United Kingdom.Inclusion CriteriaPatients who had received at least 24 h of level 3 care and were 16 years of age or older. Patients did not know that there were different questionnaire burdens. The study included 18,490 patients. 12,170 were eligible to be sent a questionnaire pack at 3 months. We sent 12,105 questionnaires (6112 to group A and 5993 to group B).InterventionsThe Group A pack contained demographic and EuroQol group 5 Dimensions 3 level (EQ-5D-3 L) questionnaires, making four questionnaire pages. The Group B pack also contained the Hospital Anxiety and Depression Score (HADS) and the Post-Traumatic Stress Disorder Check List-Civilian (PCL-C) questionnaires, making eight questionnaire pages in total.Main Outcome MeasureQuestionnaire return rate 3 months after ICU discharge by group.ResultsIn group A, 2466/6112 (40.3%) participants responded at 3 months. In group B 2315/ 5993 (38.6%) participants responded (difference 1.7% CI for difference 0-3.5% p = 0.053). Group A reported better functionality than group B in the EQ-5D-3 L mobility (41% versus 37% reporting no problems p = 0.003) and anxiety/depression (59% versus 55% reporting no problems p = 0.017) domains.ConclusionsIn survivors of intensive care, questionnaire burden had no effect on return rates. However, questionnaire burden affected answers to the same questionnaire (EQ-5D-3 L).Trial RegistrationISRCTN69112866 (assigned 02/05/2006).

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