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 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.
Original language | English |
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Pages (from-to) | 51-59 |
Number of pages | 9 |
Journal | The Lancet |
Volume | 392 |
Issue number | 10141 |
Early online date | 21 Jun 2018 |
DOIs | |
Publication status | Published - 7 Jul 2018 |
Funding
This study was done with funding from ZonMw, an organisation for health research and development in the Netherlands (project number 837002409). We thank all Departments of Surgery and Obstetrics and Gynecology in the participating hospitals: Diakonessenhuis Utrecht, Flevo Ziekenhuis, Maxima Medisch Centrum, Meander Medisch Centrum, Onze Lieve Vrouwe Gasthuis lokatie Oost, and Spaarne Gasthuis; and M van Baal, P J van Kesteren, S van der Meij, and J E Bosmans for their contribution to the economic evaluation. EvdM, JRA, and JAFH are the developers of the e-health-care programme under study. JRA and JAFH intend to set up a spin-off company for implementation of a mobile application concerning the IKHERSTEL intervention in the Netherlands (ie, the intervention under study). JAFH received grants from Nederlandse Organisatie voor Wetenschappelijk Onderzoek, ZonMw, and Samsung, during the conduct of the study; and received a fee from Olympus, outside the submitted work. JRA holds a chair in insurance medicine paid by the Dutch Social Security Agency; is stockholder of Evalua; and has received grants from ZonMw, Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Instituut Gak, Uitvoeringsinstituut Werknemersverzekeringen, Sociale Zaken en Werkgelegenheid, VWS (volksgezondheid, welzijn en sport), Pfizer, Achmea, CVZ (college voor zorgverzekeringen), and Zorginstituut; all outside the submitted work. HJB received personal fees from Olympus; unrestricted research grants from Medtronic, Applied Medical, and Johnson & Johnson; unrestricted educational support from Stryker; and research grants from ZonMW; all outside the submitted work. FGS, WJHJM, WKGL, MYB, ECJC, SESK, PMvdV, JMvD, and CBT declare no competing interests.
Funders | Funder number |
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Applied Medical | |
Dutch Social Security Agency | |
Sociale Zaken en Werkgelegenheid | |
Uitvoeringsinstituut Werknemersverzekeringen | |
Medtronic | |
Pfizer Pharmaceuticals | |
ZonMw | 837002409 |
Nederlandse Organisatie voor Wetenschappelijk Onderzoek | |
Instituut Gak |