Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial

Eva van der Meij; Johannes R. Anema; Wouter K.G. Leclercq; Marlies Y. Bongers; Esther C.J. Consten; Steven E. Schraffordt Koops; Peter M. van de Ven; Caroline B. Terwee; Johanna M. van Dongen; Frederieke G. Schaafsma; Wilhelmus J.H.J. Meijerink; Hendrik J. Bonjer; Judith A.F. Huirne

doi:10.1016/S0140-6736(18)31113-9

Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial

Eva van der Meij, Johannes R. Anema^*, Wouter K.G. Leclercq, Marlies Y. Bongers, Esther C.J. Consten, Steven E. Schraffordt Koops, Peter M. van de Ven, Caroline B. Terwee, Johanna M. van Dongen, Frederieke G. Schaafsma, Wilhelmus J.H.J. Meijerink, Hendrik J. Bonjer, Judith A.F. Huirne

^*Corresponding author for this work

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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
Pages (from-to)	51-59
Number of pages	9
Journal	The Lancet
Volume	392
Issue number	10141
Early online date	21 Jun 2018
DOIs	https://doi.org/10.1016/S0140-6736(18)31113-9
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
Applied Medical
Dutch Social Security Agency
Sociale Zaken en Werkgelegenheid
Uitvoeringsinstituut Werknemersverzekeringen
Medtronic
Pfizer Pharmaceuticals
ZonMw	837002409
Nederlandse Organisatie voor Wetenschappelijk Onderzoek
Instituut Gak

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Personalised perioperative care by e-health after intermediate-grade abdominal surgeryFinal published version, 437 KBLicence: Article 25fa Dutch Copyright Act

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van der Meij, E., Anema, J. R., Leclercq, W. K. G., Bongers, M. Y., Consten, E. C. J., Schraffordt Koops, S. E., van de Ven, P. M., Terwee, C. B., van Dongen, J. M., Schaafsma, F. G., Meijerink, W. J. H. J., Bonjer, H. J., & Huirne, J. A. F. (2018). Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial. The Lancet, 392(10141), 51-59. https://doi.org/10.1016/S0140-6736(18)31113-9

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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.",

author = "{van der Meij}, Eva and Anema, {Johannes R.} and Leclercq, {Wouter K.G.} and Bongers, {Marlies Y.} and Consten, {Esther C.J.} and {Schraffordt Koops}, {Steven E.} and {van de Ven}, {Peter M.} and Terwee, {Caroline B.} and {van Dongen}, {Johanna M.} and Schaafsma, {Frederieke G.} and Meijerink, {Wilhelmus J.H.J.} and Bonjer, {Hendrik J.} and Huirne, {Judith A.F.}",

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doi = "10.1016/S0140-6736(18)31113-9",

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van der Meij, E, Anema, JR, Leclercq, WKG, Bongers, MY, Consten, ECJ, Schraffordt Koops, SE, van de Ven, PM, Terwee, CB, van Dongen, JM, Schaafsma, FG, Meijerink, WJHJ, Bonjer, HJ & Huirne, JAF 2018, 'Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial', The Lancet, vol. 392, no. 10141, pp. 51-59. https://doi.org/10.1016/S0140-6736(18)31113-9

TY - JOUR

T1 - Personalised perioperative care by e-health after intermediate-grade abdominal surgery

T2 - a multicentre, single-blind, randomised, placebo-controlled trial

AU - van der Meij, Eva

AU - Anema, Johannes R.

AU - Leclercq, Wouter K.G.

AU - Bongers, Marlies Y.

AU - Consten, Esther C.J.

AU - Schraffordt Koops, Steven E.

AU - van de Ven, Peter M.

AU - Terwee, Caroline B.

AU - van Dongen, Johanna M.

AU - Schaafsma, Frederieke G.

AU - Meijerink, Wilhelmus J.H.J.

AU - Bonjer, Hendrik J.

AU - Huirne, Judith A.F.

PY - 2018/7/7

Y1 - 2018/7/7

N2 - 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.

AB - 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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ER -

Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial

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