[Digital therapeutics: Which barriers for market access?] / Les thérapies digitales : quels freins pour leur prise en charge ?

Integrated to the e-health field, digital therapeutics can be defined as "software, combined or not to a device, in the purpose of prevention, treatment or monitoring of a disease, participating actively in a mechanism of action and based on strong clinical evidence". The aim of this work was to assess the level of digital therapeutics clinical validation and to reflect on their business model. A qualitative study has been conducted and different health actors have been interviewed. The semi-guided interviews made have been analysed through a three-level coding. Twenty-two interviews have been analysed and six categories have been identified. The interlocutors highlighted the leading role of digital therapeutics in the follow-up and prevention, supporting the empowerment of patients. However, the absence of consensus in their definition has led to heterogeneity of definition and a difficulty to limit their scope. Furthermore, the conduct of clinical trials, not really suited for digital therapeutics, forced the editors/manufacturers to search for funding for which availability and continuity are uncertain. By raising the issue of clinical efficacy, demonstration of digital therapeutics, this study has led to new perspectives in assessment and business model. We could see in digital therapeutics a new nature of innovation associated with new organisations of our healthcare system and not necessarily by new therapeutics.

Influence of complex fibrous media composition on their performances for VOC and particle removal.

Amongst atmospheric pollutants, two major types can be distinguished: airborne particles such as dust, and gaseous compounds such as Volatile Organic Compounds (VOCs). Fibrous filters are commonly used to remove particles while activated carbon beds trap VOCs. In order to obtain a single-stage device as efficient at collecting particles with a size less than 10 microm (PM10) as removing VOCs, prototype fibrous media containing activated carbon fibers (ACF) associated with cellulose fibers (CF), which are non-adsorptive, have been developed. The influence of ACF ratio and the degree of beating of CF on porous structure, mechanical strength and treatment performances of the medium was studied. Experimental results show that an increase in ACF mass ratio increases the inter-fiber porosity and overall adsorption capacity (the intrinsic adsorption capacity of ACF remains constant whatever the composition), but decreases the mechanical strength and particle collection efficiency of the medium. Moreover, an increase in the beating of CF enhances the mechanical strength of the medium and its particle collection efficiency, but decreases its porosity and has no effect on adsorption capacity. Consequently, a medium containing 50% ACF associated with CF with a low degree of beating (16 degrees SR) presents the best performance for combined filtration.

HIV infection and severe malnutrition: a clinical and epidemiological study in Burkina Faso.

OBJECTIVE: To define a clinical profile indicative of HIV infection in a population of severely malnourished children in Burkina Faso. A total of 433 children (average age, 19 months) were recruited at the Sanou Souro National Hospital, Bobo Dioulasso, Burkina Faso. RESULTS: Sixty-three per cent presented with marasmus, 13% with kwashiorkor and 24% with both forms of malnutrition. The prevalence of HIV infection in children aged over 12 months was 13.8%, with a marked predominance of HIV-1 (95.8%). Mother-to-child transmission was proven in 77% of the cases; in 10% of the observed paediatric AIDS cases, transmission may have occurred through multi-injections with contaminated equipment. Marasmus was the form of malnutrition most frequently associated with HIV (P < 0.001); its severity was exacerbated by HIV infection. Adenopathy (P < 0.0001), oral candidiasis (P < 0.0006), skin disorders (P < 0.01) and hepatomegaly (P = 0.01) appeared to be significantly related to HIV infection. Discriminant analysis revealed that the presence of adenopathies was the strongest indicator symptom of HIV infection. Multivariate analysis revealed that a clinical profile of marasmus, adenopathies and oral candidiasis (specificity, 82%) was indicative of HIV infection in this population. The short-term clinical prognosis was poor and usually led to the death of the child when seropositive (P < 0.001). CONCLUSIONS: Among children exhibiting severe malnutrition, HIV-positive children are distinguished by a high horizontal transmission rate, a high specific clinical profile and a very poor prognosis.

PIP: Clinically, malnutrition appears as the last stage in pediatric AIDS. It is, however, difficult to determine the causes of malnutrition without diagnostic facilities and in the absence of differentiating clinical criteria. The authors therefore set out to determine the prevalence of HIV in children, to assess the various modes of infection in children, and to define a clinical profile indicative of HIV infection in malnourished children. They found that among children exhibiting severe malnutrition, HIV-seropositive children are distinguished by a high horizontal transmission rate, a high specific clinical profile, and a very poor prognosis. The study population consisted of 433 severely malnourished children of average age 19 months, in the range 4-48 months, admitted to the Sanou Souro National Hospital in Burkina Faso. 63% presented with marasmus, 13%% with kwashiorkor, and 24% with both forms of malnutrition. 13.8% of children older than 12 months were infected with HIV; HIV-1 in 95.8% of these cases. Mother-to-child transmission was proved in 77% of cases; in 10% of the observed pediatric AIDS cases, transmission may have occurred through multi-injections with contaminated equipment. Marasmus was the form of malnutrition most frequently associated with HIV, with its severity exacerbated by HIV infection. Adenopathy, oral candidiasis, skin disorders, and hepatomegaly appeared to be significantly related to HIV infection. Discriminant analysis, however, revealed that the presence of adenopathies was the strongest indicator symptom of HIV infection. Multivariate analysis defined a clinical profile of marasmus, adenopathies, and oral candidiasis as indicative of HIV infection in the population. The short-term clinical prognosis for the infants was poor and usually led to the death of the child when seropositive.

Mother-to-child transmission of human immunodeficiency virus type 1 and type 2 and dual infection: a cohort study in Banfora, Burkina Faso.

A prospective cohort study on the mother-to-child transmission of human immunodeficiency virus type 1 (HIV1), type 2 (HIV2) and dual positivity (HIV1 + HIV2) was carried out in Banfora, West Burkina Faso. The study samples consist of 117 newborns of HIV-seropositive women matched to 234 newborns of HIV-seronegative women. Among cases, 91 were born of HIV1-seropositive mothers, 15 were born of HIV2-seropositive mothers and 11 were born of HIV1 and HIV2 dual-seropositive mothers and were included in an 18-month follow-up. Calculation of the mother-to-child transmission rate was according to the recommendations of the European Economic Community working group. The HIV1 mother-to-child transmission rate was estimated to be 27.8% (95% confidence interval (CI) 24.5 to 32.4) with one method and 25.5% (95% CI 13.5 to 37.5) with a second method. For HIV2, this rate was estimated to be 29.5% (95% CI 26.0 to 39.8) and was not statistically different from the HIV1 mother-to-child transmission rate. No case of transmission was observed in children born of dual seropositive mothers. Survival rate at month 18 was significantly lower for children born of HIV1 mothers: 83.7% (95% CI 78.2 to 92.2). Survival rates were similar between children born of HIV2-seropositive (86.7), dual HIV1 + 2-positive (100) and seronegative mothers (92.0%). Findings suggest a higher mother-to-child transmission rate of HIV2 in children born in Burkina Faso than in Europe and a low clinical expression of HIV2 in children.

Tuberculosis and human immunodeficiency virus infection in west Burkina Faso: clinical presentation and clinical evolution.

OBJECTIVE: To study the relationship between human immunodeficiency virus (HIV) infection and tuberculosis (TB) in a West African country. DESIGN: A cohort study in TB patients at the TB centre of Bobo Dioulasso, Burkina Faso. RESULTS: HIV seroprevalence rose from 12.5% in 1987 to 24.7% in 1990. Analysis of clinical findings showed that extra-pulmonary TB was not more frequent in HIV-positive patients (18.5%) than in HIV negative patients (17.3%). Four symptoms were independently associated with HIV infection: diarrhoea, lymphadenopathy, weight loss and oral candidiasis. At the end of six months of chemotherapy for TB (2SHRZ/4HR), the mortality rate among HIV-positive TB patients was 27%, versus 10% among HIV-negative TB patients (P < 0.001). There was no difference between treatment failure rates among HIV-positive patients (3.8%) and HIV-negative patients (3.9%). At the final evaluation, 18 months after the start of chemotherapy, the relapse rate was 8% in HIV-positive patients versus 5.6% in HIV-negative patients (NS). Global mortality rate during the whole study period was significantly higher in HIV-1 (40.3%) and HIV-1 + 2 (20%) patients than in HIV-2 (11.1%) and HIV-negative (12.9%) patients. CONCLUSION: We conclude that, according to previous African studies, despite a higher mortality rate due generally to HIV disease itself, short-course chemotherapy of 6 months is as effective in HIV-positive patients as in HIV-negative patients, and must be continued.

Child defecation behaviour, stool disposal practices, and childhood diarrhoea in Burkina Faso: results from a case-control study.

OBJECTIVE: To investigate the association between where young children defecate, where stools are disposed of, and the presence of human stools on the ground in the compound and the rate of hospital admission with diarrhoea. DESIGN: This was a case-control study with two control groups. SETTING: The study took place in Bobo-Dioulasso, the second city of Burkina Faso in West Africa. PARTICIPANTS: Three groups of children aged 36 months and under, and living in Bobo-Dioulasso were studied. Cases were 757 children admitted to hospital with symptoms of diarrhoea or dysentery. The first control group comprised 757 neighbourhood control children approximately matched on age and date of recruitment, and the second, 631 children admitted to the same hospital without symptoms of diarrhoea or dysentery. MAIN RESULTS: There was no evidence of any association between where the child was reported to defecate and hospital admission with diarrhoea or dysentery (odds ratio = 1.10; 95% confidence interval (CI) 0.78, 1.57, cases v neighbourhood controls; odds ratio = 0.84; 95% CI 0.60, 1.18, cases v hospital controls). There was evidence of an association between where the mother reported disposing of the child's stools and hospital admission with diarrhoea or dysentery (odds ratio = 1.50; 95% CI 1.09, 2.06, cases v neighbourhood controls; odds ratio = 1.31; 95% CI 0.96, 1.79, cases v hospital controls). Human stools were more frequently observed in the yards of cases than controls (odds ratio = 1.38; 95% CI 0.98, 1.95, cases compared with neighbourhood controls; odds ratio = 1.33; 95% CI 0.96, 1.84, cases compared with hospital controls). CONCLUSIONS: The findings suggest that it is not where the child defecates that matters but how the mother then deals with the child's stools.

[Diarrheic diseases in children. Rationalization of fecal test]. / Maladies diarrhéiques de l'enfant. Pour une rationalisation des examens de selles.

The level of diarrheic diseases among children in Burkina Faso is very high. The identification of aetiologic agents of diarrhoea in hospitalized children (0-36 months) is one of the objectives of the study. All children less than 37 months old admitted to the Pediatric Unit of the National Hospital Souro Sanou of Bobo-Dioulasso between January 1990 and March 1991, were investigated by a standardized clinical examination, and in addition, we do an analysis of a rectal swab at admission and a stool to identify aetiologic enteric agents. As a conclusion to the study: an agent was isolated in 56% of the children with diarrhoea, and in 40% of the children without diarrhoea; some germs (such Salmonella, Shigella, Entamoeba) are found in children both with and without diarrhoea; also, the total of these examinations comes to 20 US $ per episode, or 100 US $ per children/year in Burkina Faso where the number of bouts reaches 5 times per year per infant who is less than 5 years old. Stool samples are not beneficial for children with diarrhoea, neither for the diagnosis nor for the treatment. There fore these types of routine exams should not be used in Sub-Saharan Africa.