Personalised electronic health programme for recovery after major abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.

BACKGROUND: Despite the adoption of minimally invasive techniques, recovery after abdominal surgery takes a long time. Electronic health (eHealth) modalities can provide guidance to patients, facilitating early return to normal activities. We aimed to assess the impact of a personalised eHealth programme on patients' return to normal activities after major abdominal surgery. METHODS: This single-blind, randomised, placebo-controlled trial was done at 11 teaching hospitals in the Netherlands. Eligible participants were aged 18-75 years who underwent a laparoscopic or open colectomy or hysterectomy. An independent researcher randomly allocated participants (in a 1:1 ratio) to either the intervention or control group by use of computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised eHealth programme consisting of both standard face-to-face care and eHealth, that comprised interactive tools offering goal attainment and a personalised outcome measurement, which managed recovery expectations and provided postoperative guidance tailored to each patient. Patients were provided with an activity tracker and had access to a website and mobile app with an electronic consultation (eConsult) functionality. The control group received standard care and access to a placebo website containing recovery advice provided by the hospital. The primary outcome was the number of days between surgery and personalised return to normal activities, assessed with Kaplan-Meier curves. Intention-to-treat and per-protocol analyses were done with a Cox regression model. This trial is registered with the Netherlands National Trial Register (NTR5686). FINDINGS: Between Feb 11, 2016, and Aug 9, 2017, 355 participants were randomly assigned to the intervention (n=178) or control (n=177) groups. 342 participants were included in the intention-to-treat analysis. The median time until return to normal activities was 52 days (IQR 33-111) in the intervention group, and 65 days (39-152) in the control group (adjusted hazard ratio 1·30 [95% CI 1·03-1·64]; p=0·027). The frequency of postoperative complications did not differ between groups. INTERPRETATION: This eHealth programme, delivering personalised care based on goal attainment scaling, enabled patients to return to their normal activities 13 days earlier than those who received standard care. FUNDING: ZonMw.

[Non-metastatic oesophageal cancer: diagnosis and treatment]. / Niet-gemetastaseerde slokdarmkanker.

The incidence of oesophageal cancer is on the rise, particularly due to an increase in the number of adenocarcinomas of the distal oesophagus. Adenomas and squamous cell carcinomas are the most common histological subtypes; each should be considered as a different entity. The diagnosis 'oesophageal cancer' is confirmed on the basis of histopathological investigation of biopsies, whereas tumour staging is conducted through transoesophageal endoscopic ultrasound and FDG-PET/CT diagnostics. There are various options to treat patients with oesophageal cancer, such as endoscopic resection, multimodal therapy or definitive chemoradiotherapy. Since 2012, neoadjuvant chemoradiotherapy followed by surgery is the standard treatment for oesophageal cancer, except with regard to patients with a T1 or M1 tumour. In the Netherlands, most surgical procedures are now minimally invasive procedures. Despite improved treatment options, mortality rates associated with oesophageal cancer remain high.

Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development.

BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

Electronic Health Program to Empower Patients in Returning to Normal Activities After Colorectal Surgical Procedures: Mixed-Methods Process Evaluation Alongside a Randomized Controlled Trial.

BACKGROUND: Long-term recovery takes longer than expected despite improved surgical techniques and Enhanced Recovery After Surgery programs. An electronic health (eHealth) care program ("ikherstel") was developed to partially substitute perioperative care for patients undergoing colorectal surgical procedures. Successfully tested eHealth programs are not always implemented in usual care, and it is, therefore, important to evaluate the process to optimize future implementation. OBJECTIVE: The aim of this study was to evaluate whether the eHealth intervention was executed as planned. METHODS: A mixed-methods process evaluation was carried out alongside a multicenter randomized controlled trial (RCT). This evaluation was performed using the Linnan and Steckler framework for the quantitative part of this study, measuring the components reach, dose delivered, dose received, fidelity, and participants' attitudes. Total implementation scores were calculated using the averaging approach, in which the sum of all data points is divided by the number of data points and the total adherence to the protocol is measured. For the qualitative part, the Unified Theory of Acceptance and Use of Technology framework was used. The quantitative data were based on participants' questionnaires, a logistic database, a weblog, and participants' medical files and were obtained by performing semistructured interviews with participants of the RCT. RESULTS: A total of 151 participants of 340 eligible patients were included in the RCT, of which 73 participants were allocated to the intervention group. On the basis of the quantitative process data, total implementation scores for the website, mobile app, electronic consult, and activity tracker were 64%, 63%, 44%, and 67%, respectively. Participants in the qualitative part experienced the program as supportive and provided guidance on their recovery process after colorectal surgery. Most frequently mentioned barriers were the limited interaction with and feedback from health care professionals and the lack of tailoring of the convalescence plan in case of a different course of recovery. CONCLUSIONS: The intervention needs more interaction with and feedback from health care professionals and needs more tailored guidance in case of different recovery or treatment courses. To ensure a successful implementation of the program in daily practice, some adjustments are required to optimize the program in a blended care form. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC= 5686 (Archieved by WebCite at http://www.webcitation.org/75LrJaHrr).

Definitive Chemoradiotherapy Versus Trimodality Therapy for Resectable Oesophageal Carcinoma: Meta-analyses and Systematic Review of Literature.

BACKGROUND: Standard therapy for loco-regionally advanced, resectable oesophageal carcinoma is trimodality therapy (TMT) consisting of neoadjuvant chemoradiotherapy and oesophagectomy. Evidence of survival advantage of TMT over organ-preserving definitive chemoradiotherapy (dCRT) is inconclusive. The aim of this study is to compare survival between TMT and dCRT. METHODS: A systematic review and meta-analyses were conducted. Randomised controlled trials and observational studies on resectable, curatively treated, oesophageal carcinoma patients above 18 years were included. Three online databases were searched for studies comparing TMT with dCRT. Primary outcomes were 1-, 2-, 3- and 5-year overall survival rates. Risk of bias was assessed using the Cochrane risk of bias tools for RCTs and cohort studies. Quality of evidence was evaluated according to Grading of Recommendation Assessment, Development and Evaluation. RESULTS: Thirty-two studies described in 35 articles were included in this systematic review, and 33 were included in the meta-analyses. Two-, three- and five-year overall survival was significantly lower in dCRT compared to TMT, with relative risks (RRs) of 0.69 (95% CI 0.57-0.83), 0.76 (95% CI 0.63-0.92) and 0.57 (95% CI 0.47-0.71), respectively. When only analysing studies with equal patient groups at baseline, no significant differences for 2-, 3- and 5-year overall survival were found with RRs of 0.83 (95% CI 0.62-1.10), 0.81 (95% CI 0.57-1.14) and 0.63 (95% CI 0.36-1.12). CONCLUSION: These meta-analyses do not show clear survival advantage for TMT over dCRT. Only a non-significant trend towards better survival was seen, assuming comparable patient groups at baseline. Non-operative management of oesophageal carcinoma patients might be part of a personalised and tailored treatment approach in future. However, to date hard evidence proving its non-inferiority compared to operative management is lacking.

Prognostic factors for return to work and work disability among colorectal cancer survivors; A systematic review.

BACKGROUND: Colorectal cancer is diagnosed progressively in employed patients due to screening programs and increasing retirement age. The objective of this study was to identify prognostic factors for return to work and work disability in patients with colorectal cancer. METHODS: The research protocol was published at PROSPERO with registration number CRD42017049757. A systematic review of cohort and case-control studies in colorectal cancer patients above 18 years, who were employed when diagnosed, and who had a surgical resection with curative intent were included. The primary outcome was return to work or work disability. Potentially prognostic factors were included in the analysis if they were measured in at least three studies. Risk of bias was assessed according to the QUality In Prognosis Studies tool. A qualitative synthesis analysis was performed due to heterogeneity between studies. Quality of evidence was evaluated according to Grading of Recommendation Assessment, Development and Evaluation. RESULTS: Eight studies were included with a follow-up period of 26 up to 520 weeks. (Neo)adjuvant therapy, higher age, and more comorbidities had a significant negative influence on return to work. A previous period of unemployment, extensive surgical resection and postoperative complications significantly increased the risk of work disability. The quality of evidence for these prognostic factors was considered very low to moderate. CONCLUSION: Health care professionals need to be aware of these prognostic factors to select patients eligible for timely intensified rehabilitation in order to optimize the return to work process and prevent work disability.

Non responders to neoadjuvant chemoradiation for esophageal cancer: why better prediction is necessary.

BACKGROUND: Patients with pathologic limited or no response (pNR) to neoadjuvant chemoradiation (nCRT) are subjected to curative intended esophagectomy with subsequent perioperative morbidity and mortality, but potentially only harm from nCRT. The primary aim of this study was to compare the overall survival (OS) of patients with pNR and patients who underwent primary esophagectomy to evaluate potentially benefits of nCRT in these patients. The secondary aim was to identify predictive clinicopathologic factors for pNR and pathologic complete response (pCR) to nCRT with the goal to preselect these patients before the start of treatment. METHODS: From the period 2005 to 2016, 206 esophageal cancer (EC) patients treated with Carboplatin/Paclitaxel and radiotherapy with complementary esophagectomy were included in this cohort. OS of patients with pNR was compared with a historical cohort of primary surgically treated patients (n=218) after a propensity score matching resulting in a group of 68 patients with pNR after nCRT versus a group of 68 primary esophagectomy patients. RESULTS: The OS in the pNR group and the primary esophagectomy group was comparable (P=0.986). No predictive factors were found in this cohort for pNR. Female gender (OR 2.5, 95% CI 1.2-5.3) and squamous cell carcinoma (SCC) (OR 2.6, 95% CI 1.3-5.3) were identified as independent predictive factors for pCR. CONCLUSIONS: Patients with a pNR do not benefit from nCRT followed by resection. These patients had a similar OS as those who had a primary esophagectomy alone. Although this indicates that nCRT does not negatively impact the OS of patients with pNR, patients still have an increased morbidity because of nCRT. Hence, it is important to identify factors that predict pNR. The ability to predict pNR (and pCR) will enable tailored and personalized care preventing unnecessary nCRT with increased morbidity.

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial.

BACKGROUND: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. OBJECTIVE: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. METHODS: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. RESULTS: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. CONCLUSIONS: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. CLINICALTRIAL: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy).