Eva van der Meij1, Johannes R Anema2, Wouter K G Leclercq3, Marlies Y Bongers4, Esther C J Consten5, Steven E Schraffordt Koops6, Peter M van de Ven7, Caroline B Terwee7, Johanna M van Dongen8, Frederieke G Schaafsma9, Wilhelmus J H J Meijerink10, Hendrik J Bonjer11, Judith A F Huirne1. 1. Department of Obstetrics and Gynaecology, VU University Medical Centre, Amsterdam, Netherlands; Department of Public and Occupational Health, Amsterdam Public Health research institute, VU University Medical Centre, Amsterdam, Netherlands. 2. Department of Public and Occupational Health, Amsterdam Public Health research institute, VU University Medical Centre, Amsterdam, Netherlands. Electronic address: h.anema@vumc.nl. 3. Department of Surgery, Maxima Medical Centre, Veldhoven, Netherlands. 4. Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, Netherlands; Department of Obstetrics and Gynaecology, Maastricht University, Grow Research School, Maastricht, Netherlands. 5. Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands. 6. Department of Obstetrics and Gynaecology, Meander Medical Centre, Amersfoort, Netherlands. 7. Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, VU University Medical Centre, Amsterdam, Netherlands. 8. Department of Health Sciences, Amsterdam Public Health, Faculty of Science, VU University, Amsterdam, Netherlands. 9. Department of Public and Occupational Health, Amsterdam Public Health research institute, VU University Medical Centre, Amsterdam, Netherlands. 10. Department of Operation Rooms, Radboud University Medical Centre, Nijmegen, Netherlands. 11. Department of Surgery, VU University Medical Centre, Amsterdam, Netherlands.
Abstract
BACKGROUND: Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery. METHODS: A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled forlaparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgeryfor a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699. FINDINGS:Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups. INTERPRETATION: A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures. FUNDING: ZonMw.
RCT Entities:
BACKGROUND: Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery. METHODS: A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699. FINDINGS: Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups. INTERPRETATION: A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures. FUNDING: ZonMw.
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