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      Cost-effectiveness of a home-based group educational programme on renal replacement therapies: a study protocol

      protocol

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          Abstract

          Introduction

          Living donor kidney transplantation (LDKT) is the optimal treatment for most patients with end-stage renal disease (ESRD). However, there are numerous patients who cannot find a living kidney donor. Randomised controlled trials have shown that home-based education for patients with ESRD and their family/friends leads to four times more LDKTs. This educational intervention is currently being implemented in eight hospitals in the Netherlands. Supervision and quality assessment are being employed to maintain the quality of the intervention. In this study, we aim to: (1) conduct a cost-effectiveness analysis of the educational programme and its quality assurance system; (2) investigate the relationship between the quality of the implementation of the intervention and the outcomes knowledge, communication and LDKT activities; and (3) investigate policy implications.

          Methods and design

          Patients with ESRD who do not have a living kidney donor are eligible to receive the home-based educational intervention. This is carried out by allied health transplantation professionals and psychologists across eight hospitals in the Netherlands. The cost-effectiveness analysis will be conducted with a Markov model. Cost data will be obtained from the literature. We will obtain the quality of life data from the patients who participate in the educational programme. Questionnaires on knowledge and communication will be used to measure the outcomes of the programme. Data on LDKT activities will be obtained from medical records up to 24 months after the education. A protocol adherence measure will be assessed by a third party by means of a telephone interview with the patients and the invitees.

          Ethics and dissemination

          Ethical approval was obtained through all participating hospitals. Results will be disseminated through peer-reviewed publications and scientific presentations. Results of the cost-effectiveness of the educational programme will also be disseminated to the Dutch National Health Care Institute.

          Trial registration number

          NL6529

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          Most cited references22

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          Focusing Events, Mobilization, and Agenda Setting

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            Probabilistic sensitivity analysis using Monte Carlo simulation. A practical approach.

            The data for medical decision analyses are often unreliable. Traditional sensitivity analysis--varying one or more probability or utility estimates from baseline values to see if the optimal strategy changes--is cumbersome if more than two values are allowed to vary concurrently. This paper describes a practical method for probabilistic sensitivity analysis, in which uncertainties in all values are considered simultaneously. The uncertainty in each probability and utility is assumed to possess a probability distribution. For ease of application we have used a parametric model that permits each distribution to be specified by two values: the baseline estimate and a bound (upper or lower) of the 95 percent confidence interval. Following multiple simulations of the decision tree in which each probability and utility is randomly assigned a value within its distribution, the following results are recorded: (a) the mean and standard deviation of the expected utility of each strategy; (b) the frequency with which each strategy is optimal; (c) the frequency with which each strategy "buys" or "costs" a specified amount of utility relative to the remaining strategies. As illustrated by an application to a previously published decision analysis, this technique is easy to use and can be a valuable addition to the armamentarium of the decision analyst.
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              Preference-based quality of life of patients on renal replacement therapy: a systematic review and meta-analysis.

              Various utility measures have been used to assess preference-based quality of life of patients with end-stage renal disease (ESRD). The purposes of this study were to summarize the literature on utilities of hemodialysis (HD), peritoneal dialysis (PD), and renal transplantation (RTx) patients, to compare utilities between these patient groups, and to obtain estimates for quality-of-life adjustment in economic analyses. We searched the English literature for studies that reported visual analog scale (VAS), time trade-off (TTO), standard gamble (SG), EuroQol-5D (EQ-5D), and health utilities index (HUI) values of ESRD patients. We extracted patient characteristics and utilities and calculated mean utilities and 95% confidence intervals (CIs) for categories defined by utility measure and treatment modality using random-effects models. We identified 27 articles that met the inclusion criteria. VAS articles were too heterogeneous to summarize quantitatively and we found only one study reporting HUI values. Thus, we summarized utilities from TTO, SG, and EQ-5D studies. Mean TTO and EQ-5D-index values were lower for dialysis compared to RTx patients, though not statistically significant for TTO values (TTO values: HD 0.61, 95% CI 0.54-0.68; PD 0.73, 95% CI 0.61-0.85; RTx 0.78, 95% CI 0.63-0.93; EQ-5D-index values: HD 0.56, 95% CI 0.49-0.62; PD 0.58, 95% CI 0.50-0.67; RTx 0.81, 95% CI 0.72-0.90). Mean HD versus PD associated TTO, EQ-5D-index and EQ-VAS values were not statistically significantly different. RTx patients tended to have a higher utility than dialysis patients. Among HD and PD patients, there were no statistically significant differences in utility.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                23 March 2019
                : 9
                : 3
                : e025684
                Affiliations
                [1 ] departmentSection Medical Psychology and Psychotherapy, Department of Psychiatry , Erasmus MC , Rotterdam, The Netherlands
                [2 ] EuroQol Research Foundation , Rotterdam, The Netherlands
                [3 ] departmentDepartment of Internal Medicine , Erasmus MC , Rotterdam, The Netherlands
                Author notes
                [Correspondence to ] Mr. Steef Redeker; s.redeker@ 123456erasmusmc.nl
                Article
                bmjopen-2018-025684
                10.1136/bmjopen-2018-025684
                6475347
                30904865
                c5bdb49a-5453-4269-b4e3-830ae3444f5c
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 31 July 2018
                : 06 November 2018
                : 01 February 2019
                Funding
                Funded by: Dutch Health Insurers (Zorgverzekeraars Nederland);
                Funded by: FundRef http://dx.doi.org/10.13039/501100002997, Nierstichting;
                Categories
                Health Economics
                Protocol
                1506
                1701
                Custom metadata
                unlocked

                Medicine
                living donation,kidney transplantation,cost-benefit analysis,kidney diseases,health policy

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