Self-reported needs of caregivers of people with Autism Spectrum Disorder.

OBJECTIVES: Autism spectrum disorder (ASD) has a major impact on caregivers. We aimed to describe caregivers' perceptions concerning their level of knowledge about ASD and their needs to better adapt education and training programs. METHODS: This was a descriptive cross-sectional study conducted through a declarative and self-administered survey in France. RESULTS: 1,013 individuals answered the questionnaire in 2020. If most caregivers felt they had sufficient knowledge about ASD, they still expressed a high level of needs regarding acquiring knowledge, identifying available resources, and finding social/emotional support. CONCLUSIONS: This study highlights the high level of needs of caregivers and their expectations of improving their knowledge and skills to help the person with ASD.

A scoping review of education and training interventions in Autism Spectrum Disorder.

OBJECTIVE: Autism Spectrum Disorder (ASD) is a chronic neurodevelopmental disorder. Living with ASD requires that individuals and parents develop skills in order to cope with daily life. Education interventions are recommended to support them. This study aims to get an overview of education and training interventions in ASD. METHODS: A scoping review of international literature was conducted. RESULTS: 43 articles were analyzed. Four main types of intervention stand out: support groups, parental training; psychoeducation; therapeutic patient education. However, the majority of publications is focused on the parents rather than on individuals living with ASD, and the needs assessments identified focused on general needs rather than educational needs. CONCLUSION: While educational interventions for parents and individuals with ASD are now encouraged, considerable heterogeneity is observed. But this variety is not based on a reasoned approach to matching supply and needs. Future studies could focus more on the educational needs of individuals with ASD. PRACTICE IMPLICATIONS: Overview of education and training interventions in ASD help health care providers to better understand the strengths and limitations of their interventions.

Consensus Recommendations for the Use of Simulation in Therapeutic Patient Education.

INTRODUCTION: Simulation is rarely used to help individuals with chronic diseases develop skills. The aim of the study was to provide recommendations for the use of simulation in therapeutic patient education (S-TPE). METHODS: Expert consensus was achieved with the participation of the following 3 groups of experts: (a) expert patients and caregivers; (b) health professionals specialized in therapeutic patient education (TPE); and (c) simulation experts. Each expert received a list of questions by e-mail in 3 iterations. The synthesis of the 2 first questionnaires resulted in 34 first recommendations voted during the consensus conference meeting. Each recommendation was subject to an extensive literature review. The quality of the evidence and the strength of the recommendations were assessed through the evaluation, development, and evaluation criteria categories (GRADE criteria). The third questionnaire selected and illustrated recommendations more specific to the use of S-TPE. RESULTS: At the end of the process, the experts identified 26 recommendations specific to the use of S-TPE. They proposed examples of skills in different diseases and stressed the importance of adapting the conditions of use (location, equipment, time of the care) to the circumstances of the patient learner and skills to be developed. Experts should exercise great caution as this technique presents ethical considerations related to patient care. CONCLUSIONS: These recommendations underline the fact that simulation could bring added value to TPE. They provide a framework and examples for the experimental use of simulation in TPE. Research into feasibility and acceptability is needed.

Formation et conditions facilitant l'intégration de patients dans la coanimation de séances collectives d'éducation thérapeutique.

PURPOSE OF RESEARCH: The purpose of this research was to promote the involvement and intervention of patient-partners (PPs) in collective sessions of therapeutic patient education (TPE), including training and support for the implementation of these sessions, in co-facilitation with a health professional (HP). Therefore, the matter was to co-construct a training model, to experiment with its implementation and to define favorable conditions for this collaboration. METHODS: Collaborative research oriented by the design, led by a steering committee representative of different categories of stakeholders, which has been spread over 2 years, in Paris area and Montpellier, in 4 phases: 1/ exploration (bibliographic review and investigation); 2/ recruitment of PPs affected by different pathologies; 3/ implementation and evaluation of PPs training in inter-pathology; 4/ implementation and evaluation of co-facilitated group sessions. RESULTS: 35 patients solicited, 24 (69%) included. Of these, 22 (92%) completed the training entirely; 17 sessions were conducted in co-facilitation (15 planned) for 151 patients (150 expected). Satisfaction rates for PPs, HPs and patient beneficiaries were very high. CONCLUSIONS: This research validated a training model for patient-partners in therapeutic education and identified some conditions that could facilitate their integration into TPE programs.

[Training and conditions improving the integration of patients in the co-facilitation of collective sessions of therapeutic education]. / Formation et conditions facilitant l'intégration de patients dans la coanimation de séances collectives d'éducation thérapeutique.

Purpose of research: The purpose of this research was to promote the involvement and intervention of patient-partners (PPs) in collective sessions of therapeutic patient education (TPE), including training and support for the implementation of these sessions, in co-facilitation with a health professional (HP). Therefore, the matter was to co-construct a training model, to experiment with its implementation and to define favorable conditions for this collaboration. METHODS: Collaborative research oriented by the design, led by a steering committee representative of different categories of stakeholders, which has been spread over 2 years, in Paris area and Montpellier, in 4 phases: 1/ exploration (bibliographic review and investigation); 2/ recruitment of PPs affected by different pathologies; 3/ implementation and evaluation of PPs training in inter-pathology; 4/ implementation and evaluation of co-facilitated group sessions. RESULTS: 35 patients solicited, 24 (69%) included. Of these, 22 (92%) completed the training entirely; 17 sessions were conducted in co-facilitation (15 planned) for 151 patients (150 expected). Satisfaction rates for PPs, HPs and patient beneficiaries were very high. CONCLUSIONS: This research validated a training model for patient-partners in therapeutic education and identified some conditions that could facilitate their integration into TPE programs.

[Contribution of therapeutic patient education to addiction medicine]. / Ce que l’éducation thérapeutique peut apporter à l’addictologie.

TPE can improve the efficacy of addiction medicine, for the benefit of patients and staff. It can help the patient withdraw from addiction, or at least achieve a better quality of life with this chronic condition..

Pharmacologic boosting of atazanavir in maintenance HIV-1 therapy: the COREYA propensity-score adjusted study.

BACKGROUND: Among HIV-1 infected patients who achieved virologic suppression, the use of atazanavir without pharmacologic boosting is debated. We evaluated the efficacy and tolerance of maintenance therapy with unboosted atazanavir in clinical practice. METHODS AND RESULTS: This multicenter retrospective cohort study evaluated the efficacy of switching HIV-1-infected patients controlled on triple therapy to unboosted (ATV(0), n = 98) versus ritonavir-boosted atazanavir (ATV/r, n = 254) +2 nucleos(t)ide reverse transcriptase inhibitors. The primary endpoint was time to virologic failure (VF, >200 copies/mL). ATV groups were compared controlling for potential confounding bias by inverse probability weighted Cox analysis and propensity-score matching. Overall and adjusted VF rates were similar for both strategies. Both strategies improved dyslipidemia and creatininemia, with less jaundice in the ATV(0) group. CONCLUSION: In previously well-suppressed patients, within an observational cohort setting, ATV(0)-based triple-therapy appeared as effective as ATV/r- based triple-therapy to maintain virologic suppression, even if co-administered with TDF, but was better tolerated.

Human immunodeficiency virus infection and non-small cell lung cancer: survival and toxicity of antineoplastic chemotherapy in a cohort study.

OBJECTIVES: To describe factors associated with survival in human immunodeficiency virus (HIV)-infected subjects with non-small cell lung cancer (NSCLC) and analyze toxicities induced by cytotoxic chemotherapy and antiretroviral compounds. DESIGN: Retrospective analyses of HIV-infected subjects with NSCLC enrolled in the Dat'Aids cohort. A toxicity substudy included subjects treated by at least one cycle of cytotoxic chemotherapy. METHODS: Survival was analyzed using Cox models. In the toxicity substudy, factors associated with grade 4 hematological toxicity of each episode of combination of antiretroviral drugs and cytotoxic chemotherapy were analyzed using marginal logistic regression models. RESULTS: Fifty-two subjects were included in the study: 42 were men, median age was 48 years, 98% were smokers, with a median of 30 pack years, median CD4 was 300 cells/µl, and median survival time was 12 months. CD4 levels ≥200 cells/µl at NSCLC diagnosis (hazard ratio [HR] = 0.29, 95% confidence interval [CI] [0.10-0.89]), performance status less than 2 (HR = 0.32, 95% CI [0.15-0.68]) and highly active antiretroviral therapy (HR = 0.26, 95% CI [0.09-0.74]) were significantly associated with increased survival in the multivariable model. Forty subjects were included in the toxicity substudy, and 14 among 68 different combinations were complicated by a grade 4 hematological toxicity. Protease inhibitor use (odds ratio = 5.22, 95% CI [1.07-25.38]) was significantly associated with grade 4 hematological toxicity in the multivariable analyses. CONCLUSIONS: In HIV-infected patients, CD4 levels at NSCLC diagnosis may be a predictive factor of survival. Use of highly active antiretroviral therapy during NSCLC chemotherapy is warranted, but protease inhibitors should be used with caution, as they may enhance severe hematological toxicities.

A large French prospective cohort of HIV-infected patients: the Nadis Cohort.

OBJECTIVES: The aim of this article is to describe the development of a dynamic French cohort of HIV-infected patients, the methodological issues and decisions made, and the characteristics of the patients currently enrolled. METHODS: Data are collected during medical encounters. Data quality is ensured by automated checks during data capture, by regular controls, by annual assessments, and by ad hoc processes before any scientific analysis is performed. RESULTS: In September 2007, 10,458 patients representing 59,383 patient-years of follow-up were followed in our centres, including 446 with a first HIV diagnosis in the past year. Among these recently diagnosed patients, 25.6% presented with late diagnosis. Our cohort included 3017 women (28.8%). The women were less likely to be receiving highly active antiretroviral therapy (HAART) than men, and when treated were less likely to be receiving nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimens. Our network includes medical centres in overseas territories (1105 patients living overseas). In this particular population, women represented 38.5% of the patients, and the probable route of infection was heterosexual in 75.7% of the patients. Despite epidemiological and social disparities, more patients had nondetectable viral loads when receiving HAART in overseas departments than in metropolitan France. CONCLUSION: The Nadis Cohort represents a collaboration of major French HIV treatment centres. In September 2007, the cohort database contained up-to-date information on more than 10,000 patients, of whom a significant proportion were women. As a consequence of the choices made when building the cohort and the efforts made to ensure the quality of the database, scientific studies are regularly performed using this cohort.

Impact of human immunodeficiency virus type 1 subtype on first-line antiretroviral therapy effectiveness.

OBJECTIVE: The effectiveness of antiretroviral treatment (ART) was compared in 416 naive patients from a French clinical cohort infected with B and non-B HIV-1 subtypes. METHODS: Time to HIV viral load (VL) undetectability was calculated for each subtype group. Three other parameters were estimated 3, 6 and 12 months after enrolment: clinical progression (that is, AIDS-defining events or death), changes in CD4 cell counts from baseline and proportion of patients achieving an undetectable VL (<400 HIV-RNA copies/ml). RESULTS: In this cohort, 317 patients (76%) were infected with a B subtype and 99 (24%) with a non-B subtype. Median time to VL undetectability was similar in the B subtype group [147 days, 95% confidence interval (CI) 119-165] and non-B subtype group (168 days, 95% CI: 105-234; P=0.16). After adjusting for AIDS-defining events at enrolment, baseline CD4 cell counts and VL, and for the treatment on which patients were initiated, no association was found between HIV subtypes and time to VL undetectability (B subtype vs non-B subtype: hazard ratio=0.80, 95% CI: 0.62-1.02, P=0.07). In the 3, 6 and 12 months after enrolment, subtype had no impact on clinical progression, CD4 cell count or VL responses to ART. This suggests that B and non-B subtypes do not affect first-line therapy efficacy, which is encouraging in view of the worldwide spread of non-B HIV-1 subtypes and the increasing availability of ART in developing countries. However, in this study we did not take into account individual non-B subtype species, therefore further studies should be designed to evaluate the efficacy of these regimens in patients with particular non-B subtypes.

Hyperlactataemia during antiretroviral therapy: incidences, clinical data and treatment.

Lactic acidosis is a serious complication of antiretroviral therapy. Symptomatic hyperlactataemia is a milder form of this syndrome, but its incidence is unclear. In this prospective ongoing observational study of a large cohort of HIV-infected adults, hyperlactataemia was diagnosed in 64 patients. Incidences were 18.3/1000 person-years with antiretroviral therapy, and 35.8/1000 person-years for stavudine (d4T) regimens. Ten of the 64 patients developed lactic acidosis during the first 13 months of treatment (incidence 2.9/1000 treated person-years). In four of ten patients, symptoms were absent or mild. More patients on d4T first-line therapy developed lactic acidosis than patients previously treated with other drugs (p = 0.008). Despite the occurrence of one death, the subsequent outcome for the remaining patients was favourable after antiretroviral therapy was stopped and supportive treatment with vitamins and antioxidants initiated. The early diagnosis of cases was the result of great vigilance and, combined with routine measurements of the anion gap, might be the most crucial factor explaining the low mortality rate observed here.

A phase I study of a six-week cycle of immunotherapy with Murabutide in HIV-1 patients naive to antiretrovirals.

BACKGROUND: Limitations in the use of antiretroviral therapy suggest the need for additional approaches to enhance immune restoration and the control of HIV-1 replication. Therefore, we evaluated the clinical tolerance and biological effects of immunotherapy with the synthetic immunomodulator Murabutide in 9 treatment-naive HIV-1 patients presenting with CD4+ lymphocyte counts >500 cells/mm3 and plasma viral loads <30.000 copies/ml. MATERIAL/METHODS: Murabutide was administered at a daily dose of 7 mg on 5 consecutive days per week, for a period of 6 weeks. The study duration extended over 22 weeks, and clinical, virological, and immunological evaluations were carried out on 2 occasions before, during, and after immunotherapy. RESULTS: With acceptable clinical tolerance and only 2 reversible grade III adverse events, clinical and virological parameters remained highly stable throughout the study period. However, maintained or improved lymphoproliferative responses to several recall and HIV-1 antigens, as well as modest but significant increases in the percentages of naive cells were noted during or/and after immunotherapy. These changes could not be demonstrated in an observation group of 9 additional patients who were identically followed for a 22-week period. CONCLUSIONS: Our results suggest that non-specific immunotherapy targeting dysfunctions in innate immunity could bring about restoration of immune responses in HIV disease.

Clinical and immunological effects of a 6 week immunotherapy cycle with murabutide in HIV-1 patients with unsuccessful long-term antiretroviral treatment.

In an effort to evaluate the potential of non-specific immunotherapy in restoring global immunity, we have examined the clinical tolerance and biological effects of a 6 week administration of the immunomodulator, murabutide, in chronically infected HIV-1 patients. Forty-two subjects, presenting weak immune reconstitution and ineffective virus suppression following long-term highly active antiretroviral therapy (HAART), were randomized to receive, or not, murabutide 7 mg/day on five consecutive days/week. Clinical and immunological parameters were monitored before and after the immunotherapy period. Administration of murabutide was generally well tolerated, although some grade III adverse events, reversible on treatment cessation, were observed. Interestingly, in comparison with pre-inclusion levels, at 1 week after the immunotherapy cycle, only murabutide recipients presented a significant increase in CD4 cells, platelet counts, and in the percentage of patients with undetectable viral loads (<50 copies/mL). Statistical significance between the two groups was only evident with the latter parameter. Some of these clinical changes were maintained even up to 12 weeks after murabutide administration, and were accompanied by an increased ability to mount cellular responses to active immunization with a recall antigen, and by a significant increase in the percentage of patients presenting positive lymphoproliferative responses to the viral antigen gp160. These results warrant further evaluation of extended periods or cycles of murabutide immunotherapy as adjunct to HAART.

Clinical tolerance and immunologic effects after single or repeated administrations of the synthetic immunomodulator murabutide in HIV-1-infected patients.

Correction of the virus-induced deficits in innate immunity of HIV-infected subjects could well contribute to enhanced immune recovery and efficacious control of viral replication. The safe synthetic immunomodulator Murabutide (ISTAC Biotechnology, Lille, France) has been found to regulate the function of antigen-presenting cells and to selectively activate CD4 lymphocytes leading to dramatic suppression of HIV replication, in vitro. Therefore, as a first step toward the evaluation of the immunotherapeutic potential of Murabutide in HIV disease, we have conducted two phase 1/2 clinical trials to address the safety and the immunologic effects of Murabutide administration into HIV-infected subjects receiving antiretroviral therapy. The first study revealed that single administration of 5, 7, or 9 mg of Murabutide, to 6 patients per dose, was well tolerated. This was accompanied by a selective induction of cytokines and chemokines detectable in the serum, and the levels appeared to plateau at the 7-mg dose. The second study then evaluated the safety and biological effects of repeated administrations of 7 mg Murabutide, on 5 consecutive days, in 12 HIV-1-infected patients. A good clinical tolerance was noted throughout the study. Moreover, changes in several immune parameters, including downregulation of coreceptor expression on lymphocytes and improved lymphoproliferative responses, were detected during or/and up to 3 weeks after Murabutide administration. These encouraging results warrant further evaluation of longer periods or cycles of immunotherapy with Murabutide in HIV-infected subjects.