Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial):Study protocol for a multicentre randomized controlled trial

Background: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. Methods: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, >= 18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. Discussion: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost) effective treatment

Process evaluation of an integrated care pathway in geriatric rehabilitation for people with complex health problems

Abstract Background An integrated care pathway in geriatric rehabilitation was developed to improve coordination and continuity of care for community-living older adults in the Netherlands, who go through the process of hospital admission, admission to a geriatric rehabilitation facility and discharge back to the home situation. This pathway is a complex intervention and is focused on improving communication, triage and transfers of patients between the hospital, geriatric rehabilitation facility and primary care organisations. A process evaluation was performed to assess the feasibility of this pathway. Methods The study design incorporated mixed methods. Feasibility was assessed thru if the pathway was implemented according to plan (fidelity and dose delivered), (b) if patients, informal caregivers and professionals were satisfied with the pathway (dose received) and (c) which barriers and facilitators influenced implementation (context). These components were derived from the theoretical framework of Saunders and colleagues. Data were collected using three structured face-to-face interviews with patients, self-administered questionnaires among informal caregivers, and group interviews with professionals. Furthermore, data were collected from the information transfer system in the hospital, patient files of the geriatric rehabilitation facility and minutes of evaluation meetings. Results In total, 113 patients, 37 informal caregivers and 19 healthcare professionals participated in this process evaluation. The pathway was considered largely feasible as two components were fully implemented according to plan and two components were largely implemented according to plan. The timing and quality of medical discharge summaries were not sufficiently implemented according to plan and professionals indicated that the triage instrument needed refinement. Healthcare professionals were satisfied with the implementation of the pathway and they indicated that due to improved collaboration, the quality of care provision improved. Although patients and informal caregivers were also satisfied with the care provision in the pathway, they indicated that the care organisations involved should pay more attention towards providing information about their treatment. Conclusions This process evaluation showed that patients, informal caregivers and professionals are fairly satisfied with the care provision in the pathway and professionals reported that collaboration improved. Extra attention should be paid to the components in the ..

Sustainability of healthcare innovations (SUSHI): long term effects of two implemented surgical care programmes (protocol)

BACKGROUND: Two healthcare innovations were successfully implemented using different implementation strategies. First, a Short Stay Programme for breast cancer surgery (MaDO) was implemented in four early adopter hospitals, using a hospital-tailored implementation strategy. Second, the Enhanced Recovery After Surgery (ERAS) programme for colonic surgery was implemented in 33 Dutch hospitals, using a generic breakthrough implementation strategy. Both strategies resulted in a shorter hospital length of stay without a decrease in quality of care. Currently, it is unclear to what extent these innovative programmes and their results have been sustained three to five years following implementation. The aim of the sustainability of healthcare innovations (SUSHI) study is to analyse sustainability and its determinants using two implementation cases. METHODS: This observational study uses a mixed methods approach. The study will be performed in 14 hospitals in the Netherlands, from November 2010. For both implementation cases, the programme aspects and the effects will be evaluated by means of a follow-up measurement in 160 patients who underwent breast cancer surgery and 300 patients who underwent colonic surgery. A policy cost-effectiveness analysis from a societal perspective will be performed prospectively for the Short Stay Programme for breast cancer surgery in 160 patients. To study determinants of sustainability key professionals in the multidisciplinary care processes and implementation change agents will be interviewed using semi-structured interviews. DISCUSSION: The concept of sustainability is not commonly studied in implementation science. The SUSHI study will provide insight in to what extent the short-term implementation benefits have been maintained and in the determinants of long-term continuation of programme activities

Process evaluation of an integrated care pathway in geriatric rehabilitation for people with complex health problems

BACKGROUND: An integrated care pathway in geriatric rehabilitation was developed to improve coordination and continuity of care for community-living older adults in the Netherlands, who go through the process of hospital admission, admission to a geriatric rehabilitation facility and discharge back to the home situation. This pathway is a complex intervention and is focused on improving communication, triage and transfers of patients between the hospital, geriatric rehabilitation facility and primary care organisations. A process evaluation was performed to assess the feasibility of this pathway. METHODS: The study design incorporated mixed methods. Feasibility was assessed thru if the pathway was implemented according to plan (fidelity and dose delivered), (b) if patients, informal caregivers and professionals were satisfied with the pathway (dose received) and (c) which barriers and facilitators influenced implementation (context). These components were derived from the theoretical framework of Saunders and colleagues. Data were collected using three structured face-to-face interviews with patients, self-administered questionnaires among informal caregivers, and group interviews with professionals. Furthermore, data were collected from the information transfer system in the hospital, patient files of the geriatric rehabilitation facility and minutes of evaluation meetings. RESULTS: In total, 113 patients, 37 informal caregivers and 19 healthcare professionals participated in this process evaluation. The pathway was considered largely feasible as two components were fully implemented according to plan and two components were largely implemented according to plan. The timing and quality of medical discharge summaries were not sufficiently implemented according to plan and professionals indicated that the triage instrument needed refinement. Healthcare professionals were satisfied with the implementation of the pathway and they indicated that due to improved collaboration, the quality of care provision improved. Although patients and informal caregivers were also satisfied with the care provision in the pathway, they indicated that the care organisations involved should pay more attention towards providing information about their treatment. CONCLUSIONS: This process evaluation showed that patients, informal caregivers and professionals are fairly satisfied with the care provision in the pathway and professionals reported that collaboration improved. Extra attention should be paid to the components in the pathway that were not implemented according to plan. TRIAL REGISTRATION: ISRCTN90000867 Registered 7 April 2016

Structured Synchronous Implementation of an Enhanced Recovery Program in Elective Colonic Surgery in 33 Hospitals in The Netherlands

It has been clearly shown that after elective colorectal surgery patients benefit from multimodal perioperative care programs. The Dutch Institute for Health Care Improvement started a breakthrough project to implement a multimodal perioperative care program of enhanced recovery after surgery (ERAS). This pre/post noncontrolled study evaluated the success of large-scale implementation of the ERAS program for elective colonic surgery using the breakthrough series. A total of 33 hospitals participated in this breakthrough project during 2005-2009. Each hospital performed a retrospective chart review to gather information on traditionally treated patients (pre-ERAS group, n = 1,451). During the subsequent year patients were treated according to the ERAS program (ERAS group, n = 1 034). Outcomes were length of stay (LOS), functional recovery, adherence to the protocol, and determinants of reduced LOS. Median LOS decreased significantly from 9 to 6 days (p <0.001). In the ERAS group, functional recovery was reached within 3 days. Adherence to the protocol elements was high during the preoperative and perioperative phases but slightly lower during the postoperative phase. Younger age, female sex, American Society of Anesthesiologists grades I/II, and laparoscopic surgery were associated with decreased LOS. Care elements that positively influenced LOS were cessation of intravenous fluids and mobilization on postoperative day 1 and administration of laxatives postoperatively. The ERAS program was successfully implemented in one-third of all Dutch hospitals using the breakthrough series. Participating hospitals reduced the LOS by a median 3 days and were able to improve their standard of care in elective colonic surgery

Interdepartmental Spread of Innovations:: A Multicentre Study of the Enhanced Recovery After Surgery Programme

Spread of evidence-based innovations beyond pioneering settings is essential to improve quality of care. This study aimed to evaluate the influence of a national project to implement 'Enhanced Recovery After Surgery' (ERAS) among colorectal teams on the spread of this innovation to gynaecological procedures.A retrospective observational multicentre study was performed of a consecutive sample of patients who underwent major elective gynaecological surgery in 2012-2013. Ten Dutch hospitals (294 patients) had participated in a colorectal breakthrough project implementing ERAS on a nationwide basis and were assigned to the intervention group. Thirteen hospitals (390 patients) that had not participated in this project acted as controls. Outcome measures were time to functional recovery and total length of postoperative hospital stay. Multilevel models adjusted for clustering and baseline demographics were used for analysis. The uptake of ten selected perioperative care elements was evaluated for each hospital.The estimated mean difference (95% confidence interval) between the intervention and control hospitals was -0.3 (-0.9 to 0.3) days in the time to recovery and 0.2 (-0.8 to 1.3) days in the total length of hospital stay. The mean (+/- standard deviation) absolute rate of implemented perioperative care elements per hospital was 28.9 +/- 14.9% in the control, versus 29.3 +/- 11.1% in the intervention group (p = 0.934).Initial implementation effects seem to be restricted to the participating teams and do not automatically spread to other surgical teams in the same hospital.</p

Characteristics for a tool for timely identification of palliative needs in heart failure:The views of Dutch patients, their families and healthcare professionals

Background Palliative care can improve outcomes for patients with advanced chronic heart failure and their families, but timely recognition of palliative care needs remains challenging. Aim The aim of this study was to identify characteristics of a tool to assess palliative care needs in chronic heart failure that are needed for successful implementation, according to patients, their family and healthcare professionals in The Netherlands. Methods Explorative qualitative study, part of the project 'Identification of patients with HeARt failure with PC needs' (I-HARP), focus groups and individual interviews were held with healthcare professionals, patients with chronic heart failure, and family members. Data were analysed using the Consolidated Framework for Implementation Research. Results A total of 13 patients, 10 family members and 26 healthcare professionals participated. Direct-content analysis revealed desired tool characteristics for successful implementation in four constructs: relative advantage, adaptability, complexity, and design quality and packaging. Healthcare professionals indicated that a tool should increase awareness, understanding and knowledge concerning palliative care needs. A tool needs to: be adaptable to different disease stages, facilitate early identification of palliative care needs and ease open conversations about palliative care. The complexity of chronic heart failure should be considered in a personalized approach. Conclusions The current study revealed the characteristics of a tool for timely identification of palliative care needs in chronic heart failure needed for successful implementation. The next steps will be to define the content of the tool, followed by development of a preliminary version and iterative testing of this version by the different stakeholders

Hemolysis during cardiac surgery is associated with increased intravascular nitric oxide consumption and perioperative kidney and intestinal tissue damage

Introduction: Acute kidney injury (AKI) and intestinal injury negatively impact patient outcome after cardiac surgery. Enhanced nitric oxide (NO) consumption due to intraoperative intravascular hemolysis, may play an important role in this setting. This study investigated the impact of hemolysis on plasma NO consumption, AKI, and intestinal tissue damage, after cardiac surgery. Methods: Hemolysis (by plasma extracellular (free) hemoglobin; fHb), plasma NO-consumption, plasma fHb-binding capacity by haptoglobin (Hp), renal tubular injury (using urinary N-Acetyl-β-D-glucosaminidase; NAG), intestinal mucosal injury (through plasma intestinal fatty acid binding protein; IFABP), and AKI were studied in patients undergoing off-pump cardiac surgery (OPCAB, N = 7), on-pump coronary artery bypass grafting (CABG, N = 30), or combined CABG and valve surgery (CABG+Valve, N = 30). Results: FHb plasma levels and NO-consumption significantly increased, while plasma Hp concentrations significantly decreased in CABG and CABG+Valve patients (p < 0.0001) during surgery. The extent of hemolysis and NO-consumption correlated significantly (r(2) = 0.75, p < 0.0001). Also, NAG and IFABP increased in both groups (p < 0.0001, and p < 0.001, respectively), and both were significantly associated with hemolysis (R(s) = 0.70, p < 0.0001, and R(s) = 0.26, p = 0.04, respectively) and NO-consumption (R(s) = 0.55, p = 0.002, and R(s) = 0.41, p = 0.03, respectively), also after multivariable logistic regression analysis. OPCAB patients did not show increased fHb, NO-consumption, NAG, or IFABP levels. Patients suffering from AKI (N = 9, 13.4%) displayed significantly higher fHb and NAG levels already during surgery compared to non-AKI patients. Conclusions: Hemolysis appears to be an important contributor to postoperative kidney injury and intestinal mucosal damage, potentially by limiting NO-bioavailability. This observation offers a novel diagnostic and therapeutic target to improve patient outcome after cardiothoracic surgery