[Realist protocol for implementing integrated care pathways in France (waiver 51 LFSS 2018)]. / Évaluer autrement les parcours de soins coordonnés article 51 LFSS 2018 : une innovation, les protocoles réalistes.

The paradox of real world researches supposedly conducted in real life is that they did not succeeded in freeing themselves from the techniques of the randomised trials which they pretended to escape. In the successionist perspective of classical experimental or quasi-experimental methods, the cause always precedes the effect in a linear manner, and any interference that is likely to threaten the stability of this relationship must be neutralised by mobilising the appropriate statistical techniques. In complex systems where everything moves at the same time due to multiple interrelationships that make it impossible to construct a counterfactual, these elements are no longer considered as confounding factors that need to be controlled, but as decisive factors in the smooth running of the experiment. The protocol presented in this article proposes an alternative evaluative technique mobilising the teachings of critical realism, which seems to us to be the most appropriate for understanding what happens "in the black box" recording the events that occur between the implementation of the Article 51 experiments and the observed results. The role of the evaluator is to put the actors back at the heart of the change, since it is achieved (or not) according to their reactions and the contextual elements. This credible explanatory theory allows us to understand: how does it work? For whom does it work? Why do losers lose, winners win? and under what circumstances?

Importance of out-of-pocket costs for adult patients with atopic dermatitis in France.

BACKGROUND: Currently, few studies investigated the economic burden of atopic dermatitis (AD) in adult patients and specifically the estimation of out-of-pocket costs. Patients with skin disorders primarily use comfort care to ease dryness, itch or pain, and the costs of comfort care are not subject to any reimbursement from mandatory or complementary insurance. OBJECTIVE: The purpose of this study was to measure the medical and non-medical expenses paid by the patient. METHODS: Eczema Cohort Longitudinal Adults was a non-interventional study that aimed to assess the burden of AD in terms of quality of life and financial consequences. A self-assessment questionnaire was distributed to adult patients who were cared in four French hospitals. Patients were asked to list the resources consumed for the treatment of AD during the last 12 months and to estimate the corresponding amount of money they had to pay out of their own pockets. The severity of AD was subjected to a stratification based on the PO-SCORAD score. RESULTS: A total of 1024 patients answered the questionnaire: 31.9% with severe AD, 40.4% with moderate AD and 27.6% with mild AD. The mean annual out-of-pocket cost was €462.1 for severe AD and €247.4 for moderate AD. Emollients were the most commonly used product: 74.4% for an average out-of-pocket cost of €151.4. The out-of-pocket costs increased significantly with the severity: 27% of patients with severe AD declared having bought specially textured clothes, while 19% of patients with moderate AD reported the same. The corresponding mean out-of-pocket costs were €162 and €91, respectively. CONCLUSION: The amount of out-of-pocket costs for patients with AD for essential medical and non-medical expenses is relatively high, compared to the average out-of-pocket cost for French households. Integration of these essential resources into the list of reimbursed products and services appears necessary for a better coverage of AD.

[How to measure real-world effectiveness?] / Comment mesurer l'efficacité en vie réelle ?

The new use of medico-administrative databases is a major change in the medical assessment field. Given the limits of the randomized clinical trials when it comes to accurately represent the heterogeneity and complexity of medical care in a real-world context, an increasing demand of observational studies comes from healthcare systems as decision tools. The lack of intervention generates real-world data and assesses both the care and the outcomes of patients in routine practice. Despite this external validity, the bias and confounding factors are a challenge to the internal validity of observational studies. An appropriate study design and statistical methods are necessary to neutralize them and consider a causal relationship between a treatment and a clinical outcome.