Integrating organizational impacts into health technology assessment (HTA): an analysis of the content and use of existing evaluation frameworks.

OBJECTIVE: The French health technology assessment (HTA) agency initiated a research between 2018 and 2019 with the aim of determining whether other HTA organizations (agencies, bodies, institutes, and expert networks) and researchers had developed an evaluation framework of organizational impacts (OIs). METHODS: Three types of investigation were carried out: (i) an analysis of documents published by selected HTA organizations, (ii) a rapid review on the OI issues, (iii) a questionnaire survey to experts of the International Network of Agencies for Health Technology Assessment. RESULTS: The analyses highlight six key points: (i) there is no explicit conceptual definition of OIs; (ii) OIs are often not included in a specific dimension of the evaluation or in the same dimensions; (iii) three recurring categories emerge from the assessment of OIs: processes, structure, and culture; (iv) despite its limitations, the European Network for Health Technology Assessment framework (Core Model) is the most mature assessment model to date; (v) the question of the scope of OIs to be considered is unresolved (micro-meso-macro); and (vi) the delineation between OI assessment and economic assessment must be addressed. CONCLUSIONS: Although the issue of considering OI in HTA has been raised for many years, it remains largely unresolved. Defining the concept of OI is a prerequisite for taking the next step toward an evaluation framework. As the question of the impact of innovation goes beyond the health sector, extensive research on how to define and take into account these OIs may be relevant.

[Cost-effectiveness analysis of various strategies of end-stage renal disease patients' care in France]. / Évaluation médico-économique des stratégies de prise en charge de l'insuffisance rénale chronique terminale en France.

End-stage renal disease is a chronic state that may continue for many years before death. Patients may receive various modalities of renal replacement therapy that vary over time, which we describe as a treatment trajectory. The French health insurance system pays dialysis facilities and professionals various fixed fees according to the dialysis modalities they provide; fees are highest for hospital-based haemodialysis care, which treats around 58% of all dialysis patients. As in other European countries, a variety of dialysis modalities are used in France, and their weight and distribution differ from region to region. This study hypothesizes that some patients currently treated in hospital-based haemodialysis could be treated with another RRT modality without any increase in mortality risk. The aim of this study was to propose new care strategies so as to evaluate the medico-economic impact of replacing some hospital-based HD care by various other modalities for French health insurance. Care strategies were modelled using a statistical tool that predicts course and trajectories of a hypothetical cohort of news patients over a 15-year period. The results confirmed that the development of kidney transplantation in six sub-cohorts (according to age and diabetes status) is an efficient strategy, compared to all evaluated strategies. Strategies considering joint development of peritoneal dialysis and hospital-based haemodialysis are efficient for patients over 45 years but their feasibility has to be evaluated. Other alternative strategies also need to be considered because they are as effective and less costly than the current care practices.

Spatial Analysis of Case-Mix and Dialysis Modality Associations.

UNLABELLED: ♦ BACKGROUND: Health-care systems must attempt to provide appropriate, high-quality, and economically sustainable care that meets the needs and choices of patients with end-stage renal disease (ESRD). France offers 9 different modalities of dialysis, each characterized by dialysis technique, the extent of professional assistance, and the treatment site. The aim of this study was 1) to describe the various dialysis modalities in France and the patient characteristics associated with each of them, and 2) to analyze their regional patterns to identify possible unexpected associations between case-mixes and dialysis modalities. ♦ METHODS: The clinical characteristics of the 37,421 adult patients treated by dialysis were described according to their treatment modality. Agglomerative hierarchical cluster analysis was used to aggregate the regions into clusters according to their use of these modalities and the characteristics of their patients. ♦ RESULT: The gradient of patient characteristics was similar from home hemodialyis (HD) to in-center HD and from non-assisted automated peritoneal dialysis (APD) to assisted continuous ambulatory peritoneal dialysis (CAPD). Analyzing their spatial distribution, we found differences in the patient case-mix on dialysis across regions but also differences in the health-care provided for them. The classification of the regions into 6 different clusters allowed us to detect some unexpected associations between case-mixes and treatment modalities. ♦ CONCLUSIONS: The 9 modalities of treatment available make it theoretically possible to adapt treatment to patients' clinical characteristics and abilities. However, although we found an overall appropriate association of dialysis modalities to the case-mix, major inter-region heterogeneity and the low rate of peritoneal dialysis (PD) and home HD suggest that factors besides patients' clinical conditions impact the choice of dialysis modality. The French organization should now be evaluated in terms of patients' quality of life, satisfaction, survival, and global efficiency.

Economic impact of a modification of the treatment trajectories of patients with end-stage renal disease.

BACKGROUND: This study assumed that some patients currently treated at hospital-based haemodialysis centres can be treated with another renal replacement therapy (RRT) modality without any increase in mortality risk and sought to evaluate the monthly cost impact of replacing hospital-based haemodialysis, for which fees are highest, by different proportions of other modalities. METHODS: We used a deterministic model tool to predict the outcomes and trajectories of hypothetical cohorts of incident adult end-stage renal disease (ESRD) patients for 15 years of RRT (10 different modalities). Our estimates were based on data from 67 258 patients in the REIN registry and 65 662 patients in the French national health insurance information system. Patients were categorized into six subcohorts, stratified for age and diabetes at ESRD onset, and analyses run for each subcohort. We simulated new strategies of care by changing any or all of the following: initial distributions in treatment modalities, transition rates and some costs. Strategies were classified according to their monthly per-patient cost compared to current practices (cost-minimization analysis). RESULTS: Simulations of the status quo for the next 15 years predicted a per-patient monthly cost of €2684 for a patient aged 18-45 years without diabetes and €7361 for one older than 70 years with diabetes. All of the strategies we analysed had monthly per-patient costs lower than the status quo, except for daily home HD. None impaired expected survival. Savings varied by strategy. CONCLUSIONS: Alternative strategies may well be less expensive than current practices. The decision to implement new strategies must nonetheless consider the number of patients concerned, feasibility of renal care reorganization, and investment costs. It must also take into account the role of patients' choice and the availability of professionals.

[Cost of a renal transplant: medico-economic analysis of the amount reimbursed by the French national health program to finance renal transplantation]. / Coût d'un greffon rénal: calcul médico-économique des montants remboursés par l'Assurance maladie pour financer les étapes préalables et périphériques à la transplantation rénale.

Successful organ transplantation relies on several ancillary activities such as the identification of a compatible donor, organ allocation and procurement and the coordination of the transplant process. No existing study of the overall costs, in France, of these additional transplantation activities could be identified. This study determines the total additional costs of ancillary transplantation activities by comparing the costs of kidney transplantations with living donors against those using deceased donors. The data used are drawn from the 2013 public healthcare tariff calculations, PMSI recorded activity and transplant activity in 2012 as assessed and reported by the Agence de la biomédecine. The results show that, in 2012, additional transplant costs varied from 13835.44 € to 20050.67 € for a deceased donor and were 13601.66 € for a living donor. In conclusion, this study demonstrates that all the costs covered by National Health Insurance need to be taken into account in the economic impact evaluation of renal transplantation and during the development of this national priority activity.

[Increase kidney transplant: guidelines of Haute Autorité de Santé]. / Développer la transplantation rénale: les recommandations de la Haute Autorité de Santé.

The Haute Autorité de santé, in association with the Agence de la biomédecine, realizes, at the request of the Caisse nationale d'assurance maladie des travailleurs salariés and the Direction générale de l'offre de soins, a medical economic evaluation on treatment's alternative of terminal chronic renal insufficiency. To answer at this request, a multiannual working program was set up. A first part of this work concerned specifically the development of the kidney transplant. Indeed, the kidney transplant occupies a particular place among the various modalities of treatment of the terminal chronic renal insufficiency because it is at the same time the most effective on a medical plan and the least expensive, thus the most efficient. However, its development is constraint by the lack of the transplants and the number of patients registered on the national list of wait increases every year. The objective of this article is to present the method of work as well as the main identified axes of development.

[Evaluation of medical professional practices: historical perspective of the French situation]. / Evaluation des pratiques professionnelles du médecin: historique de la démarche en France.

The evaluation of the professional practices (EPP) is central to the new orientations of French health policies. This evaluation is an essential component of the evaluation process. It aims at increasing the effectiveness and the quality of the health system. Its objective is to help doctors to reflect on their practice, notably in order to engage a continuous improvement process. Contrary to the previous measures taken on this subject, the EPP is common to the whole medical profession (legal obligation). Its method is laid down by decree but the text leaves a free choice as for the method employed. The goal is to accompany doctors in the improvement of their practice by the means of a specific (five years) and continuous evaluation process.

[Epidemiological characteristics of elderly dialysed patients aged 75 and more. Study conducted in the Provence-Alpes-Côte d'Azur region of France]. / Caractéristiques épidémiologiques des personnes dialysées âgées de 75 ans et plus. Etude dans la région Provence-Alpes-Côte d'Azur.

INTRODUCTION: One of the consequences of an ageing French population is the large number of elderly patients with end stage renal failure (ESRF). Nephrologists will be increasingly confronted with the growing number of elderly patients and the sometimes-precarious health of the extremely elderly. OBJECTIVE: To describe the epidemiological characteristics of the populations of patients over 75 years in ESRF, treated by dialysis in the Provence Alpes Côte d'Azur region (Paca) in 1999. METHOD: Cross-sectional survey. RESULT: Of the 2347 patients treated by dialysis and resident in the Paca region, 25,1% are aged 75 or more. The prevalence for this age group is of 1428 patients per million persons (pmp) versus 429 pmp for those aged under 75 years. Elderly patients are more frequently treated by dialysis in centres, with shorter dialysis duration. They have more complications related to treatment (perdialytic hypotension, irregular cardiac rhythm), more dependence and more frequently exhibit comorbidity, with the exception of hepatitis C which is less frequent in this population (p<0.0001). The number of patients aged 75 and over treated with dialysis increased 53% between 1995 and 1999 in the Paca region compared with an overall increase of 17% during the same period. The recourse to hemodialysis in a centre for these patients increased by 39.4% whereas it has decreased by 2.4% in younger populations (p<0.0001). In fact, the use of autodialysis has risen enormously: +309% for those aged 75 years and more and +88.1% for others. CONCLUSION: The increase in the prevalence of elderly people undergoing dialysis will present problems due to a saturation point which is now being reached in dialysis centres. It is clear that those who forecast health care provisions will need to adapt the supply and demand better to the requirements of the population.