A modified Delphi method toward multidisciplinary consensus on functional convalescence recommendations after abdominal surgery.

BACKGROUND: Evidence-based information on the resumption of daily activities following uncomplicated abdominal surgery is scarce and not yet standardized in medical guidelines. As a consequence, convalescence recommendations are generally not provided after surgery, leading to patients' insecurity, needlessly delayed recovery and prolonged sick leave. The aim of this study was to generate consensus-based multidisciplinary convalescence recommendations, including advice on return to work, applicable for both patients and physicians. METHOD: Using a modified Delphi method among a multidisciplinary panel of 13 experts consisting of surgeons, occupational physicians and general practitioners, detailed recommendations were developed for graded resumption of 34 activities after uncomplicated laparoscopic cholecystectomy, laparoscopic and open appendectomy, laparoscopic and open colectomy and laparoscopic and open inguinal hernia repair. A sample of occupational physicians, general practitioners and surgeons assessed the recommendations on feasibility in daily practice. The response of this group of care providers was discussed with the experts in the final Delphi questionnaire round. RESULTS: Out of initially 56 activities, the expert panel selected 34 relevant activities for which convalescence recommendations were developed. After four Delphi rounds, consensus was reached for all of the 34 activities for all the surgical procedures. A sample of occupational physicians, general practitioners and surgeons regarded the recommendations as feasible in daily practice. CONCLUSION: Multidisciplinary convalescence recommendations regarding uncomplicated laparoscopic cholecystectomy, appendectomy (laparoscopic, open), colectomy (laparoscopic, open) and inguinal hernia repair (laparoscopic, open) were developed by a modified Delphi procedure. Further research is required to evaluate whether these recommendations are realistic and effective in daily practice.

The involvement of gynaecological patients in the development of a clinical guideline for resumption of (work) activities in the Netherlands.

CONTEXT: Most initiatives for patient involvement in guideline development have been carried out for chronic diseases. The involvement of patients with incidental and non-threatening diseases is more complicated. Little knowledge is available on how these patient groups can successfully be involved in guideline development. OBJECTIVE: To assess the effectiveness of the involvement of gynaecological patients in the guideline development for resumption of (work) activities after surgery. DESIGN: At three different stages patients were involved in the process: (i) three focus group discussions (FGDs) were organized, (ii) patients were involved for the instruction video, and (iii) patients tested the patient version of the clinical guideline. To assess the effectiveness, an evaluation framework was used. The guideline development process was divided into two parallel trajectories in which patients and professionals were consulted separately. Patients were primarily consulted for the development of the patient version, although their input also influenced the recommendations for resumption of (work) activities after surgery. Professionals were mainly involved in the development of the recommendations of the clinical guideline. DISCUSSION AND CONCLUSIONS: The involvement of gynaecological patients in the guideline development for resumption of (work) activities after surgery was successful in many respects. Consultation of individual patients by means of FGDs and with regular feedback moments has been rather effective for a guideline development process related to an incidental, non-threatening disease for which there is no patient organization. Patients' input contributed to applicability of the clinical guideline in daily practice. Increased patient involvement could be achieved by integration of the two parallel trajectories with additional participatory activities, such as a dialogue meeting.

Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial.

BACKGROUND: Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. METHODS/DESIGN: We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. DISCUSSION: The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2087.

eHealth program to empower patients in returning to normal activities and work after gynecological surgery: intervention mapping as a useful method for development.

BACKGROUND: Full recovery after gynecological surgery takes much longer than expected regardless of surgical technique or the level of invasiveness. After discharge, detailed convalescence recommendations are not provided to patients typically, and postoperative care is fragmented, poorly coordinated, and given only on demand. For patients, this contributes to irrational beliefs and avoidance of resumption of activities and can result in a prolonged sick leave. OBJECTIVE: To develop an eHealth intervention that empowers gynecological patients during the perioperative period to obtain timely return to work (RTW) and prevent work disability. METHODS: The intervention mapping (IM) protocol was used to develop the eHealth intervention. A literature search about behavioral and environmental conditions of prolonged sick leave and delayed RTW in patients was performed. Patients' needs, attitudes, and beliefs regarding postoperative recovery and resumption of work were identified through focus group discussions. Additionally, a literature search was performed to obtain determinants, methods, and strategies for the development of a suitable interactive eHealth intervention to empower patients to return to normal activities after gynecological surgery, including work. Finally, the eHealth intervention was evaluated by focus group participants, medical doctors, and eHealth specialists through questionnaires. RESULTS: Twenty-one patients participated in the focus group discussions. Sufficient, uniform, and tailored information regarding surgical procedures, complications, and resumption of activities and work were considered most essential. Knowing who to contact in case of mental or physical complaints, and counseling and tools for work reintegration were also considered important. Finally, opportunities to exchange experiences with other patients were a major issue. Considering the determinants of the Attitude-Social influence-self-Efficacy (ASE) model, various strategies based on a combination of theory and evidence were used, resulting in an eHealth intervention with different interactive functionalities including tailored convalescence recommendations and a video to communicate the most common pitfalls during the perioperative period to patients and employers. Fifteen patients in the focus groups, 11 physicians, and 3 eHealth specialists suggested points for improvement to optimize the usability of the eHealth intervention and judged it an approachable, appropriate, and attractive eHealth intervention to empower gynecological patients. CONCLUSIONS: The IM protocol was a useful method to develop an eHealth intervention based on both theory and evidence. All patients and stakeholders judged the eHealth intervention to be a promising tool to empower gynecological patients during the perioperative period and to help them to return to normal activities and work.

Can prolonged sick leave after gynecologic surgery be predicted? An observational study in The Netherlands.

BACKGROUND: Sick leave frequently has been used as an outcome to evaluate minimal invasive surgery compared with conventional open surgery. However, sick leave is determined not only by the surgical approach. Recently, a postoperative recovery-specific quality-of-life questionnaire, the Recovery Index (RI-10), has been developed and validated. This study investigated the relation of the Recovery Index 10, the RI-6 (a subset of 6 questions), and the type of surgery to sick leave. METHODS: The study enrolled 46 patients with a paid job scheduled for elective gynecologic surgery, who filled out the RI-10. After 8 weeks, the patients were approached by telephone to give information on their return to work. RESULTS: Of the 46 patients, 23 (50%) returned to work completely after 8 weeks, 14 (30%) resumed work partly, and 9 (20%) did not resume work at all. In the analysis, the patients who completely returned to work were compared with those who did not return or partially returned. Recovery as expressed in the RI-6 improved with time after surgery. It appeared that the measurement 2 weeks after surgery showed the best discriminative capacity to predict sick leave after 8 weeks, with an area under the curve of 0.88 (confidence interval, 0.74-1.03). The subjective postoperative recovery as expressed by the RI-6 is more closely related to the type of surgery (p = 0.001) sick leave is (p = 0.14). CONCLUSIONS: The subjective recovery scored by the patient on a questionnaire of six questions is a better outcome than sick leave for evaluating surgical approaches. If administered 2 weeks after surgery, it may predict prolonged sick leave.

Prevalence, neonatal characteristics, and first-year mortality of Down syndrome: a national study.

OBJECTIVE: To determine the prevalence, neonatal characteristics, and first-year mortality in Down syndrome (DS) among children in The Netherlands. STUDY DESIGN: The number of DS births registered by the Dutch Paediatric Surveillance Unit (DPSU) in 2003 was compared with total live births (reference population) and perinatal registrations. RESULTS: The prevalence of DS was 16 per 10,000 live births. Compared with the reference population, the 182 children with trisomy 21 had a gestational age of 38 weeks versus 39.1 weeks (P < .001), a birth weight of 3119 g versus 3525 g in males (P < .001) and 2901 g versus 3389 g in females (P < .001), and mothers with a parity of > or = 4.17% versus 5% (P < .001) and a mean age of 33.6 years versus 31 years (P < .001) and 33% (n = 54) > or = 36 years). The mean age of DS diagnosis was 10.2 days in nonhospital deliveries and 1.8 days in hospital deliveries (P < .001). Children with DS were less often breast-fed (P < .05), and 86% (n = 156) were hospitalized after birth. Neonatal and infant mortality were higher in DS, 1.65% versus 0.36% (P < .02) and 4% versus 0.48% (P < 0.001), respectively. CONCLUSIONS: The prevalence of DS in The Netherlands exceeds previously reported levels and is influenced by the mother's age. Neonatal and infant DS mortality have declined, but still exceed those in the reference population.

Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation.

OBJECTIVE: To evaluate the implementation and effectiveness of an internet-based perioperative care programme for patients following gynaecological surgery for benign disease. DESIGN: Stepped-wedge cluster randomised controlled trial. SETTING: Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS: 433 employed women aged 18-65 years scheduled for hysterectomy and/or laparoscopic adnexal surgery. INTERVENTIONS: An internet-based care programme was sequentially rolled out using a multifaceted implementation strategy. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or the care programme (n=227). The care programme included an e-health intervention equipping patients with tailored personalised convalescence advice. MAIN OUTCOME MEASURES: The primary outcome was duration until full sustainable return to work (RTW). The degree of implementation of the care programme was evaluated at the level of the patient, healthcare provider and organisation by indicators measuring internet-based actions by patients and providers. RESULTS: Median time until RTW was 49 days (IQR 27-76) in the intervention group and 62 days (42-85) in the control group. A piecewise Cox model was fitted to take into account non-proportionality of hazards. In the first 85 days after surgery, patients receiving the intervention returned to work faster than patients in the control group (HR 2.66, 95% CI 1.88 to 3.77), but this effect was reversed in the small group of patients that did not reach RTW within this period (0.28, 0.17 to 0.46). Indicators showed that the implementation of the care programme was most successful at the level of the patient (82.8%) and professional (81.7%). CONCLUSIONS: Implementation of an internet-based care programme has a large potential to lead to accelerated recovery and improved RTW rates following different types of gynaecological surgeries. TRIAL REGISTRATION NUMBER: NTR2933; Results.

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.

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. TRIAL REGISTRATION: Netherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84).