title: The cost effectiveness of a tailored, web-based care program to enhance postoperative recovery in gynecologic patients in comparison with usual care: protocol of a stepped wedge cluster randomized controlled trial.
abstract: BACKGROUND
  The length of recovery after benign gynecological surgery and return to work frequently exceeds the period that is recommended or expected by specialists. A prolonged recovery is associated with a poorer quality of life. In addition, costs due to prolonged sick leave following gynecological surgery cause a significant financial burden on society.
  
  
  OBJECTIVE
  The objective of our study was to present the protocol of a stepped wedge cluster randomized controlled trial to evaluate the cost effectiveness of a new care program for patients undergoing hysterectomy and/or adnexal surgery for benign disease, compared to the usual care.
  
  
  METHODS
  The care program under study, designed to improve convalescence and to prevent delayed return to work, targets two levels. At the hospital level, guidelines will be distributed among clinical staff in order to stimulate evidence-based patient education. At the patient level, additional perioperative guidance is provided by means of an eHealth intervention, equipping patients with tailored convalescence advice, and an occupational intervention is available for those patients at risk of prolonged sick leave. Due to the stepped wedge design of the trial, the care program will be sequentially rolled out among the 9 participating hospitals, from which the patients are recruited. Eligible for this study are employed women, 18-65 years of age, who are scheduled for hysterectomy and/or laparoscopic adnexal surgery. The primary outcome is full sustainable return to work. The secondary outcomes include general recovery, quality of life, self-efficacy, coping, and pain. The data will be collected by means of self-reported electronic questionnaires before surgery and at 2, 6, 12, 26, and 52 weeks after surgery. Sick leave and cost data are measured by monthly sick leave calendars, and cost diaries during the 12 month follow-up period. The economic evaluation will be performed from the societal perspective. All statistical analyses will be conducted according to the intention-to-treat principle.
  
  
  RESULTS
  The enrollment of the patients started October 2011. The follow-up period will be completed in August 2014. Data cleaning or analysis has not begun as of this article's submission.
  
  
  CONCLUSIONS
  We hypothesize the care program to be effective by means of improving convalescence and reducing costs associated with productivity losses following gynecological surgery. The results of this study will enable health care policy makers to decide about future implementation of this care program on a broad scale.
  
  
  BACKGROUND
  Netherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84).
authors.affiliation: Department of Obstetrics and Gynecology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Esther Va
authors.initials: EV
authors.lastname: Bouwsma
authors.forename: Johannes R
authors.initials: JR
authors.lastname: Anema
authors.forename: Antonie
authors.initials: A
authors.lastname: Vonk Noordegraaf
authors.forename: Dirk L
authors.initials: DL
authors.lastname: Knol
authors.forename: Judith E
authors.initials: JE
authors.lastname: Bosmans
authors.forename: Steven E
authors.initials: SE
authors.lastname: Schraffordt Koops
authors.forename: Paul Jm
authors.initials: PJ
authors.lastname: van Kesteren
authors.forename: W Marchien
authors.initials: WM
authors.lastname: van Baal
authors.forename: Jos P
authors.initials: JP
authors.lastname: Lips
authors.forename: Mark H
authors.initials: MH
authors.lastname: Emanuel
authors.forename: Petrus C
authors.initials: PC
authors.lastname: Scholten
authors.forename: Alexander
authors.initials: A
authors.lastname: Mozes
authors.forename: Albert H
authors.initials: AH
authors.lastname: Adriaanse
authors.forename: Hans Am
authors.initials: HA
authors.lastname: Brölmann
authors.forename: Judith Af
authors.initials: JA
authors.lastname: Huirne
keywords: Internet; convalescence; economic evaluation; gynecology; return to work; telemedicine