Dataset Information

Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol.

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).

SUBMITTER: Barberan-Garcia A

PROVIDER: S-EPMC7068871 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol.

Barberan-Garcia Anael A Navarro-Ripoll Ricard R Sánchez-Lorente David D Moisés-Lafuente Jorge J Boada Marc M Messaggi-Sartor Monique M González-Vallespí Laura L Montané-Muntané Mar M Alsina-Restoy Xavier X Campero Betina B Lopez-Baamonde Manuel M Romano-Andrioni Barbara B Guzmán Rudith R López Antonio A Arguis Maria Jose MJ Roca Josep J Martinez-Palli Graciela G

BMC health services research 20200312 1

<h4>Background</h4>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 ...[more]

PMID: 32164687

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Project description:IntroductionRadical cystectomy (RC) is the standard treatment for patients with non-metastatic muscle-invasive bladder cancer, as well as for patients with therapy refractory high-risk non-muscle invasive bladder cancer. However, 50-65% of patients undergoing RC experience perioperative complications. The risk, severity and impact of these complications is associated with a patient's preoperative cardiorespiratory fitness, nutritional and smoking status and presence of anxiety and depression. There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional recovery after major cancer surgery. However, for bladder cancer the evidence is still limited. The aim of this study is to investigate the superiority of a multimodal prehabilitation programme versus standard-of-care in terms of reducing perioperative complications in patients with bladder cancer undergoing RC.Methods and analysisThis multicentre, open label, prospective, randomised controlled trial, will include 154 patients with bladder cancer undergoing RC. Patients are recruited from eight hospitals in The Netherlands and will be randomly (1:1) allocated to the intervention group receiving a structured multimodal prehabilitation programme of approximately 3-6 weeks, or to the control group receiving standard-of-care. The primary outcome is the proportion of patients who develop one or more grade ≥2 complications (according to the Clavien-Dindo classification) within 90 days of surgery. Secondary outcomes include cardiorespiratory fitness, length of hospital stay, health-related quality of life, tumour tissue biomarkers of hypoxia, immune cell infiltration and cost-effectiveness. Data collection will take place at baseline, before surgery and 4 and 12 weeks after surgery.Ethics and disseminationEthical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22-595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals.Trial registration numberNCT05480735.

Project description:ImportanceResearch supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes.ObjectiveTo assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation.Design, setting, and participantsThis single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019.InterventionsMultimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway.Main outcomes and measuresThe primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures.ResultsOf 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups.Conclusions and relevanceIn frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively.Trial registrationClinicalTrials.gov identifier: NCT02502760.

Project description:BackgroundPrehabilitation aims at enhancing patients' functional capacity and overall health status to enable them to withstand a forthcoming stressor like surgery. Our aim was to synthesise the evidence on the cost-effectiveness of prehabilitation for patients awaiting elective surgery compared with usual preoperative care.MethodsWe searched PubMed, Embase, the CRD database, ClinicalTrials.gov, the WHO ICTRP and the dissertation databases OADT and DART. Studies comparing prehabilitation for patients with elective surgery to usual preoperative care were included if they reported cost outcomes. All types of economic evaluations (EEs) were included. The primary outcome of the review was cost-effectiveness based on cost-utility analyses (CUAs). The risk of bias of trial-based EEs was assessed with the Cochrane risk of bias 2 tool and the ROBINS-I tool and the credibility of model-based EEs with the ISPOR checklist. Methodological quality of full EEs was assessed using the CHEC checklist. The EEs' results were synthesised narratively using vote counting based on direction of effect.ResultsWe included 45 unique studies: 25 completed EEs and 20 ongoing studies. Of the completed EEs, 22 were trial-based and three model-based, corresponding to four CUAs, three cost-effectiveness analyses, two cost-benefit analyses, 12 cost-consequence analyses and four cost-minimization analyses. Three of the four trial-based CUAs (75%) found prehabilitation cost-effective, i.e. more effective and/or less costly than usual care. Overall, 16/25 (64.0%) EEs found prehabilitation cost-effective. When excluding studies of insufficient credibility/critical risk of bias, this number reduced to 14/23 (60.9%). In 8/25 (32.0%), cost-effectiveness was unclear, e.g. because prehabilitation was more effective and more costly, and in one EE prehabilitation was not cost-effective.ConclusionsWe found some evidence that prehabilitation for patients awaiting elective surgery is cost-effective compared to usual preoperative care. However, we suspect a relevant risk of publication bias, and most EEs were of high risk of bias and/or low methodological quality. Furthermore, there was relevant heterogeneity depending on the population, intervention and methods. Future EEs should be performed over a longer time horizon and apply a more comprehensive perspective.Trial registrationPROSPERO CRD42020182813.

Project description:IntroductionUndergoing major surgery can induce physical and functional decline. Prehabilitation programmes aim to improve physical fitness and function preoperatively and could enhance postoperative recovery and outcomes. Prehabilitation interventions have been utilised across a range of orthopaedic populations of all ages and can be multimodal in nature. The aim of this study is to evaluate the effectiveness of prehabilitation for patients undergoing orthopaedic surgery including day surgery procedures. It will also investigate the components of prehabilitation to understand optimum duration and frequency of programmes.Methods/designSystematic review and meta-analysis designed in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. A comprehensive electronic search will be performed in MEDLINE, CINAHL, AMED, Embase, PEDro and Cochrane CENTRAL databases in order to identify randomised control trials published between January 2000 to 25 March 2019. ISI Web of Science, System for information on grey literature and the European Union clinical trials registry will identify studies that are underway or unpublished. Two independent reviewers will carry out the searches, study selection (title and abstract and full text stages), data extraction, risk of bias assessment (Cochrane Risk of Bias tool 2.0) and evaluation of overall strength of evidence. Meta-analyses will be used for data which demonstrates homogeneity, otherwise a narrative synthesis will be performed for groups of studies of high heterogeneity (I2 >50%). The overall strength of the body of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis study raises no ethical issues. This study aims to identify the effectiveness of prehabilitation interventions and may assist clinicians in determining which components, duration, frequency and the method of delivery would form the most effective prehabilitation intervention for patients undergoing an orthopaedic surgical procedure. The findings will be disseminated through publication in a peer-reviewed journal and conference presentations.Prospero registration numberCRD42019123268.

Dataset Information

Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol.

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Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol.

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