Wouter Leclercq

Personalised perioperative care by e-health after intermediate-grade abdominal surgery: A multicentre, single-blind, randomised, placebo-controlled trial 163 10 For participants with missing resumption dates for more than two activities, we could not ascertain accurately the return to normal activities moment, because five-item short forms have little reliability for patients with more extreme scores. 14 We censored these participants at the latest follow-up moment for which we knew return to normal activities was not yet resumed. To check that participants assigned to the control group did not select so-called easier activities than participants allocated to the intervention group, we calculated for each participant the mean first threshold of the IRT item characteristic curve of the eight selected items. In IRT analyses, every item with five response options has four thresholds, indicating the level of physical function at which the highest probability of giving a certain response changes from one response category to the next (also called item difficulty). Secondary outcome measures were: first return to normal activities after surgery (i.e., the moment on which the first activity was resumed); 75% return to normal activities after surgery (i.e., the moment on which 75% of the activities were resumed); physical function (T-score of PROMIS-PF personalised short form); social participation (T-score of PROMIS Ability to Participate in Social Roles and Activities version 2.0 short form 8a [PROMIS-APS]); 19 self-rated health (measured with EuroQol five dimensions three levels [EQ-5D-3L]); 20 time until the first day of return to work; time until full resumption of work activities; physical activity (calculated as total hours of walking, moderate, and vigorous activities per week and measured with the International Physical Activity Questionnaire [IPAQ]); 21 length of recovery (mean score of the Recovery Index short version form [RI5]); 22 pain intensity (measured on a visual analogue scale); 23 and satisfaction with perioperative care and with the care programme (measured with a satisfaction questionnaire on a scale from 1 [low] to 10 [high]). We assessed major complications during and after surgery by reviewing surgical reports and postoperative notes. For the calculation of costs, we included intervention costs (bottom-up approach), health-care costs (primary health-care costs, secondary health-care costs, medication costs, and home care costs [ascertained with a cost questionnaire]), and costs related to productivity loss. 9 To calculate quality-adjusted life-years (QALYs), we used the EQ-5D-3L. Further, we did a process evaluation in which the implementation process of the intervention was evaluated. Results of this study are published elsewhere. 24 A detailed description of the outcome measures in the study, including how and when they were assessed, is in the study protocol. 9