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Abstract Background Colorectal cancer (CRC) is the second most prevalent type of cancer in the world. Surgery is the only curative option. However, postoperative complications occur in up to 50% of patients and are associated with higher morbidity and mortality rates, lower health related quality of life (HRQoL) and increased expenditure in health care. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Traditional approaches have targeted the postoperative period for rehabilitation and lifestyle changes. However, recent evidence shows that the preoperative period might be the optimal moment for intervention. This study will determine the impact of multimodal prehabilitation on patients’ functional capacity and postoperative complications. Methods/design This international multicenter, prospective, randomized controlled trial will include 714 patients undergoing colorectal surgery for cancer. Patients will be allocated to the intervention group, which will receive 4 weeks of prehabilitation (group 1, prehab), or the control group, which will receive no prehabilitation (group 2, no prehab). Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. The primary outcomes for measurement will be functional capacity (as assessed using the six-minute walk test (6MWT)) and postoperative status determined with the Comprehensive Complication Index (CCI). Secondary outcomes will include HRQoL, length of hospital stay (LOS) and a cost-effectiveness analysis. Discussion Multimodal prehabilitation is expected to enhance patients’ functional capacity and to reduce postoperative complications. It may therefore result in increased survival and improved HRQoL. This is the first international multicenter study investigating multimodal prehabilitation for patients undergoing colorectal surgery for cancer. Trial registration Trial Registry: NTR5947 – date of registration: 1 August 2016.

Abstract Background There is lack of evidence regarding safety, effectiveness and applicability of prehabilitation on cardiac surgery population, particularly in patients candidates to cardiac valve replacement. The aim of the study is to assess and compare the effect of a multimodal prehabilitation program on functional capacity in patients with severe aortic stenosis (AoS) and severe mitral regurgitation (MR) proposed for valve replacement surgery. Methods Secondary analysis from a randomised controlled trial whose main objective was to analyze the efficacy of a 4–6 weeks multimodal prehabilitation program in cardiac surgery on reducing postoperative complications. For this secondary analysis, only candidates for valve replacement surgery were selected. The primary outcome was the change in endurance time (ET) from baseline to preoperative assessment measured by a cycling constant work-rate cardiopulmonary exercise test. Results 68 patients were included in this secondary analysis, 34 (20 AoS and 14 MR) were allocated to the prehabilitation group and 34 (20 AoS and 14 MR) to control group. At baseline, patients with AoS had better left systolic ventricular function and lower prevalence of atrial fibrillation compared to MR (p = 0.022 and p = 0.035 respectively). After prehabilitation program, patients with MR showed greater improvement in ET than AoS patients (101% vs. 66% increase from baseline). No adverse events related to the prehabilitation program were observed. Conclusions A 4–6 week exercise training program is safe and overall improves functional capacity in patients with severe AoS and MR. However, exercise response is different according to the cardiac valve type disfunction, and further studies are needed to know the factors that predispose some patients to have better training response. Trial registration The study has been registered on the Registry of National Institutes of Health ClinicalTrials.gov (NCT03466606) (05/03/2018).

Introduction: The efficacy-effectiveness gap constitutes a well-known limitation for adoption of digitally enabled integrated care services. The current report describes the co-creation process undertaken (2016–2021) to deploy a prehabilitation service at Hospital Clínic de Barcelona with the final aim of achieving sustainable adoption and facilitate site transferability. Methods: An implementation research approach with a population-based orientation, combining experience-based co-design and quality improvement methodologies, was applied. We undertook several design-thinking sessions (Oct-Nov 2017, June 2021 and December 2021) to generate and follow-up a work plan fostering service scalability. The implementation process was assessed using the Comprehensive Framework for Implementation Research, leading to the identification of key performance indicators. Discussion: Personalization and modularity of the intervention according to patients’ surgical risk were identified as core traits to enhance patients’ adherence and value generation. A digitally enabled service workflow, with an adaptive and collaborative case management approach, should combine face-to-face and remotely supervised sessions with intelligent systems for patients’ and professionals’ decision support. The business model envisages operational costs financed by savings generated by the service. Conclusions: Evidence-based co-creation, combining appropriate methodologies and a structured evaluation framework, was key to address challenges associated with sustainable prehabilitation service adoption, scalability and transferability. Resum Introducció: La bretxa eficàcia-efectivitat limita l’adopció de serveis d’atenció integrada amb suport digital. L’estudi descriu el procés de co-creació efectuat (2016–2021) per desplegar, a l’Hospital Clínic de Barcelona, un servei de prehabilitació de pacients de risc per a procediments quirúrgics, amb l’objectiu d’aconseguir una adopció sostenible del servei i facilitar-ne la transferibilitat. Mètodes: Es van aplicar eines de recerca d’implementació amb una orientació poblacional, combinant metodologies de codisseny basades en l’experiència i de millora de la qualitat. Es van realitzar diverses sessions de design-thinking (Octubre-Novembre de 2017, Juny de 2021 i Desembre de 2021) per generar, i fer el seguiment, d’un pla de treball concebut per assolir escalabilitat del servei. El procés d’implementació es va avaluar utilitzant el Consolidated Framework for Implementation Research (CFIR), que va conduir a la identificació d’indicadors clau de rendiment. Discussió: La personalització i la modularitat de la intervenció segons el risc quirúrgic dels pacients es van identificar com a trets bàsics per millorar l’adherència i la generació de valor. La organització de la prehabilitació, amb un enfocament adaptatiu i col·laboratiu de gestió de casos, hauria de combinar sessions presencials i supervisades remotament amb sistemes intel·ligents de suport a la decisió per a pacients i professionals. El model de negoci preveu que els costos operatius de la prehabilitació siguin finançats per l’estalvi generat. Conclusions: El procés de co-creació, combinant metodologies adequades i un marc d’avaluació estructurat, va esser clau per abordar els reptes associats a l’adopció sostenible del servei, així com la seva escalabilitat i transferibilitat. Paraules clau: Activitat física; Atenció continuada; Co-creació; mHealth; Optimització nutricional; Prehabilitació

Abstract Background Multimodal prehabilitation is a preoperative intervention with the objective to enhance cancer patients’ functional status which has been showed to reduce both postoperative morbidity and hospital length of stay in digestive oncologic surgery. However, in lung cancer surgery patients further studies with higher methodological quality are needed to clarify the benefits of prehabilitation. The main aim of the current protocol is to evaluate the cost-effectiveness of a multimodal prehabilitation program supported by information and communication technologies in moderate-to-high risk lung cancer patients undergoing thoracic surgery. Methods A Quadruple Aim approach will be adopted, assessing the prehabilitation program at the following levels: i) Patients’ and professionals’ experience outcomes (by means of standardized questionnaires, focus groups and structured interviews); ii) Population health-based outcomes (e.g. hospital length of stay, number and severity of postoperative complications, peak oxygen uptake and levels of systemic inflammation); and, iii) Healthcare costs. Discussion This study protocol should contribute not only to increase the scientific basis on prehabilitation but also to detect the main factors modulating service adoption. Trial registration NCT04052100 (August 9, 2019).

Abstract Background Comprehensive assessment of integrated care deployment constitutes a major challenge to ensure quality, sustainability and transferability of both healthcare policies and services in the transition toward a coordinated service delivery scenario. To this end, the manuscript articulates four different protocols aiming at assessing large-scale implementation of integrated care, which are being developed within the umbrella of the regional project Nextcare (2016–2019), undertaken to foster innovation in technologically-supported services for chronic multimorbid patients in Catalonia (ES) (7.5 M inhabitants). Whereas one of the assessment protocols is designed to evaluate population-based deployment of care coordination at regional level during the period 2011–2017, the other three are service-based protocols addressing: i) Home hospitalization; ii) Prehabilitation for major surgery; and, iii) Community-based interventions for frail elderly chronic patients. All three services have demonstrated efficacy and potential for health value generation. They reflect different implementation maturity levels. While full coverage of the entire urban health district of Barcelona-Esquerra (520 k inhabitants) is the main aim of home hospitalization, demonstration of sustainability at Hospital Clinic of Barcelona constitutes the core goal of the prehabilitation service. Likewise, full coverage of integrated care services addressed to frail chronic patients is aimed at the city of Badalona (216 k inhabitants). Methods The population-based analysis, as well as the three service-based protocols, follow observational and experimental study designs using a non-randomized intervention group (integrated care) compared with a control group (usual care) with a propensity score matching method. Evaluation of cost-effectiveness of the interventions using a Quadruple aim approach is a central outcome in all protocols. Moreover, multi-criteria decision analysis is explored as an innovative method for health delivery assessment. The following additional dimensions will also be addressed: i) Determinants of sustainability and scalability of the services; ii) Assessment of the technological support; iii) Enhanced health risk assessment; and, iv) Factors modulating service transferability. Discussion The current study offers a unique opportunity to undertake a comprehensive assessment of integrated care fostering deployment of services at regional level. The study outcomes will contribute refining service workflows, improving health risk assessment and generating recommendations for service selection. Trials registration NCT03130283 (date released 04/06/2018), NCT03768050 (date released 12/05/2018), NCT03767387 (date released 12/05/2018).

Prehabilitation has shown its potential for most intra-cavity surgery patients on enhancing preoperative functional capacity and postoperative outcomes. However, its large-scale implementation is limited by several constrictions, such as: i) unsolved practicalities of the service workflow, ii) challenges associated to change management in collaborative care; iii) insufficient access to prehabilitation; iv) relevant percentage of program drop-outs; v) need for program personalization; and, vi) economical sustainability. Transferability of prehabilitation programs from the hospital setting to the community would potentially provide a new scenario with greater accessibility, as well as offer an opportunity to effectively address the aforementioned issues and, thus, optimize healthcare value generation. A core aspect to take into account for an optimal management of prehabilitation programs is to use proper technological tools enabling: i) customizable and interoperable integrated care pathways facilitating personalization of the service and effective engagement among stakeholders; ii) remote monitoring (i.e. physical activity, physiological signs and patient-reported outcomes and experience measures) to support patient adherence to the program and empowerment for self-management; and, iii) use of health risk assessment supporting decision making for personalized service selection. The current manuscript details a proposal to bring digital innovation to community-based prehabilitation programs. Moreover, this approach has the potential to be adopted by programs supporting long-term management of cancer patients, chronic patients and prevention of multimorbidity in subjects at risk.

Introduction Prehabilitation programmes that combine exercise training, nutritional support and emotional reinforcement (multimodal prehabilitation) have demonstrated efficacy reducing postoperative complications in the context of abdominal surgery. However, such programmes have seldom been studied in cardiac surgery, one of the surgeries associated with higher postoperative morbidity and mortality. This trial will assess the feasibility and efficacy in terms of reduction of postoperative complications and cost-effectiveness of a multimodal prehabilitation programme comparing to the standard of care in cardiac surgical patients.Methods and analysis This is a single-centre, randomised, open-label, controlled trial with a 1:1 ratio. Consecutive 160 elective valve replacement and/or coronary revascularisation surgical patients will be randomised to either standard of care or 4–6 weeks of multimodal prehabilitation that will consist in (1) two times/week supervised endurance and strength exercise training sessions, (2) promotion of physical activity and healthy lifestyle, (3) respiratory physiotherapy, (4) nutrition counselling and supplementation if needed, and (5) weekly mindfulness sessions. Baseline, preoperative and 3-month postoperative data will be collected by an independent blinded evaluator. The primary outcome of this study will be the incidence of postoperative complications.Ethics and dissemination This study has been approved by the Ethics Committee of Clinical investigation of Hospital Clinic de Barcelona (HCB/2017/0708). The results will be disseminated in a peer-reviewed journal.Trial registration number NCT03466606.

Abstract Background Chronic diseases are generating a major health and societal burden worldwide. Healthy lifestyles, including physical activity (PA), have proven efficacy in the prevention and treatment of many chronic conditions. But, so far, national PA surveillance systems, as well as strategies for promotion of PA, have shown low impact. We hypothesize that personalized modular PA services, aligned with healthcare, addressing the needs of a broad spectrum of individual profiles may show cost-effectiveness and sustainability. Methods The current manuscript describes the protocol for regional implementation of collaborative self-management services to promote PA in Catalonia (7.5 M habitants) during the period 2017–2019. The protocols of three implementation studies encompassing a broad spectrum of individual needs are reported. They have a quasi-experimental design. That is, a non-randomized intervention group is compared to a control group (usual care) using propensity score methods wherein age, gender and population-based health risk assessment are main matching variables. The principal innovations of the PA program are: i) Implementation of well-structured modular interventions promoting PA; ii) Information and communication technologies (ICT) to facilitate patient accessibility, support collaborative management of individual care plans and reduce costs; and iii) Assessment strategies based on the Triple Aim approach during and beyond the program deployment. Discussion The manuscript reports a precise roadmap for large scale deployment of community-based ICT-supported integrated care services to promote healthy lifestyles with high potential for comparability and transferability to other sites. Trial registration This study protocol has been registered at ClinicalTrials.org (NCT02976064). Registered November 24th, 2016.

Introduction: The efficacy of prehabilitation (PreHab) to reduce surgical complications, and facilitate postoperative recovery, has been demonstrated (Ann Surg. 2018; 267(1):50-56). Deployment of PreHab as mainstream service at Hospital Clínic de Barcelona (HCB) has been undertaken. However, there is a need for consolidation of modular digital health tools to address two main aspects of service scalability: to empower patients for self-management at community level and to support collaborative work among professionals. Practice change implemented: PreHab has a trimodal approach including: supervised endurance training & promotion of physical activity, nutritional balance and psychological support (mindfulness). Supporting technologies include an adaptive case management platform to enhance collaborative work among health professionals and patients themselves using a mobile application for self-management at community level. Aim and theory of change: A recent design thinking process involving all stakeholders identified that transferability of the PreHab service can improve with modularity of both service workflow and digital health tools. Moreover, service accessibility and sustainability should be enhanced by shared care agreements with community-based services. Targeted population: Effectiveness and sustainability of PreHab is currently being assessed in a real world setting (HCB, 300 patients/yr.). Timeline: The technological support with full integration between community (patient) and health information systems at HCB (professionals) was implemented and is currently being evaluated. Next steps, during 2019, are: i) regional deployment of PreHab; ii) integration of the self-management platform into the regional personal health folder (La Meva Salut© - lamevasalut.gencat.cat), iii) evolution of the service toward a perioperative care program with a population-health approach; iv) refinement of the adaptive case management functionalities using the Camunda© (camunda.org) open source workflow and decision automation platform; and, v) transferability of selected traits of PreHab to rehabilitation of chronic stable patients. Highlights: The supervised endurance training sessions are managed and tracked with the proprietary Technogym® equipment (i.e. Mywellness). Patient self-management is based on MyPathway® (mypathway.healthcare). Integration with hospital information systems is performed using an open source HL7 FHIR API (i.e. HAPI). System usability is planned to be assessed by means of a Net Promoter Score survey in case of patients and the User Experience Questionnaire (UEQ) in case of healthcare professionals. Comments on sustainability: PreHab has shown potential for health value generation, both at provider and at health system levels, indicating that the operational costs can be fully covered by savings generated through adoption of the service. Comments on transferability: Regional transferability of PreHab is planned during 2019 and transferability at International level will be undertaken thereafter. Conclusions: PreHab digital health tools for patient self-management with off-line remote monitoring and access to a case manager are ready to be integrated with provider-specific and regional health information systems for a large scale development. Discussions: Individualized work plans should combine face to face supervised sessions and community-based remotely supervised activities, including access to partnering health/wellness centers. Lessons learned: Personalization and modularization of the service, as well as the supporting digital health tools, were identified as core traits to ensure adoption. Supported by CONNECARE H2020-689802, NEXTCARE COMRDI15-1-0016

Background and study aims Endoscopic resection requires use of submucosal injection. This study was conducted to assess efficacy and impact on early healing of hyaluronic acid combined with chondroitin sulfate and poloxamer 407 (Ziverel) when used as a solution for submucosal injection. Materials and methods Prospective and comparative study of gastric endoscopic mucosal resection (EMR) with three groups of two Yorkshire pigs. Six submucosal cushions were created in each animal by injecting 2 mL of Ziverel (Group 1) or succinylated gelatin (SG) (Group 2), enabling 12 EMR in each group. Submucosal cushions were created with Ziverel in Group 3, without resection. Electrosurgery unit settings were the same in all cases. EMR defects and injection sites were marked with clips. The animals were sacrificed 7 days later. EMR specimen size and duration of procedure were recorded. EMR specimens and EMR scars and injection sites were evaluated by a blinded pathologist. Results We successfully performed 24 EMR (15 en-bloc and 9 piecemeal, without differences between groups 1 and 2). Mean EMR specimen dimensions were significantly larger in Group 1 (median 19 mm, range 6 – 40 vs 16.6 mm, range 5‑25; P = 0.019), without changing the electrocautery unit settings. Blinded histopathologist assessment of EMR specimens showed less fibrosis in the submucosa and a trend to fewer cautery artifacts with Ziverel and did not identify any significant differences in early healing of resection sites. Conclusion The combination of Ziverel enables EMR and does not negatively affect early healing.

Background and rationale for the study. Hyperglycemia after graft reperfusion is a consistent finding in liver transplantation (LT) that remains poorly studied. We aim to describe its appearance in LT recipients of different types of grafts and its relation to the graft function.Material & methods. 436 LT recipients of donors after brain death (DBD), donors after cardiac death (DCD), and familial amyloidotic polyneuropathy (FAP) donors were reviewed. Serum glucose was measured at baseline, during the anhepatic phase, after graft reperfusion, and at the end of surgery. Early graft dysfunction (EAD) was assessed by Olthoff criteria. Caspase-3, IFN-γ, IL1β, and IL6 gene expression were measured in liver biopsy.Results. The highest increase in glucose levels after reperfusion was observed in FAP LT recipients and the lowest in DCD LT recipients. Glucose level during the anhepatic phase was the only modifiable predictive variable of hyperglycemia after reperfusion. No relation was found between hyperglycemia after reperfusion and EAD. However, recipients with the highest glucose levels after reperfusion tended to achieve the best glucose control at the end of surgery and those who were unable to control the glucose value after reperfusion showed EAD more frequently. The highest levels of caspase-3 were found in recipients with the lowest glucose values after reperfusion. In conclusion, glucose levels increased after graft reperfusion to a different extent according to the donor type. Contrary to general belief, transient hyperglycemia after reperfusion does not appear to impact negatively on the liver graft function and could even be suggested as a marker of graft quality.

Given the severe shortage of liver donors, a carefully evaluation and selection of patients who are likely to obtain a significant survival benefit from liver transplantation (LT) is imperative in order to attain successful outcomes. Cardiovascular and respiratory events remain one of the leading causes of non-graft-related death in LT. A variety of pre-existing cardiac and pulmonary disorders are commonly identified in LT recipients, more so than in the general population. Uncertainties regarding the optimal assessment of cardiovascular and respiratory function in potential transplant candidates have produced a wide variation in the clinical care of tjis population. There is still no consensus on which assessment algorithm confers the best outcomes. Once the diagnosis has been established, the prognosis should be estimated for risk stratification and to confirm the candidacy for LT. Additionally, the challenge remains in knowing how cardiac or respiratory derangements in candidates affect the long-term outcome after LT and which is the magnitude of risk that we as physicians are willing to accept. This article discusses the cardiac and pulmonary aspects of liver disease that may impact recipient selection. Relevant literature focused upon the most common entities in this field is presented in this review.

Background: Safety is a concern in natural orifice transluminal endoscopic surgery (NOTES) mediastinoscopy. The objective of this study was to compare the safety of NOTES mediastinoscopy with video-assisted mediastinoscopy (VAM). Methods: Twenty-four pigs were randomly assigned to NOTES or VAM. Thirty-minute mediastinoscopies were performed with the identification of seven predetermined structures. The animals were euthanized after 7 days and necropsy was performed. Results: Mediastinoscopy was not possible in one animal in each group. There were more intraoperative adverse events with NOTES than VAM (7 vs. 2, P = 0.04); hemorrhage was the most frequent adverse event (4 and 1, respectively). At necropsy, pathological findings were observed in 13 animals (9 NOTES and 4 VAM; P = 0.03). Inflammatory parameters were not different between groups and were not related to adverse events. Conclusion: Systematic NOTES mediastinoscopy is possible and comparable to VAM in terms of number of organs identified and inflammatory impact. However, the safety profile of NOTES mediastinoscopy has to be improved before it can be adopted in a clinical setting.