Wouter Leclercq
Personalised perioperative care by e-health after intermediate-grade abdominal surgery: A multicentre, single-blind, randomised, placebo-controlled trial 161 10 Procedures The intervention care programme comprised three parts: a website, an app, and an activity tracker. The aim of the different parts of the intervention was to prepare participants in the best way for surgery and to support them during the postoperative period. 12 With the intervention programme, participants had the option to develop a personalised convalescence plan, could access information about the perioperative period by text and video animations, could use a monitor providing personal feedback on the recovery process, and had use of an e-consult function. By using an activity tracker, participants assigned the intervention programme were provided on a day-to-day basis with their current recovery status, based on a baseline measurement from the week before surgery. Figure 10.1 shows the different aspects of the intervention, and these are described in detail elsewhere. 9 The control programme consisted of usual care and access to a placebo website, consisting of a patient information leaflet with information about the surgical procedure, general recovery advice provided by the hospital, and telephone numbers of their hospital. The reason for giving patients access to this placebo website was to minimise bias in estimation of the intervention effect (Figure 10.1). In addition to the baseline questionnaire completed in the 4-week period before surgery (T0), participants received electronic questionnaires by email 1 week (T1), 3 weeks (T2), 6 weeks (T3), 3 months (T4), and 6 months (T5) after surgery. We used responses to these questionnaires for outcome assessment. Outcomes The primary outcome measure was time elapsing between surgery and return to normal activities after surgery. We used the Dutch–Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PROMIS-PF) item bank version 1.2 to assess return to normal activities after surgery. 13-15 The PROMIS-PF item bank includes 121 items, covering a wide range of activities from self- care (everyday activities) to more complex activities requiring a combination of skills. Every item contains five response categories. The PROMIS-PF item bank was developed using Item Response Theory (IRT) analyses and has been validated extensively in diverse populations and countries, including our own population. 13,14,16,17 The items included in IRT-based item banks are all manifestations of the same underlying construct, and after calibration and validation of an item bank, subsets of items can be administered, giving valid and reliable scores that can be compared on the same scale with scores obtained from answering the whole item bank. 13,14,18 PROMIS scores are expressed as T-scores, where a T-score of 50
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