Patient and public involvement is suboptimal in randomized controlled trials addressing a chronic condition.

OBJECTIVES: To describe patient and public involvement (PPI) in randomized controlled trials (RCTs) addressing a chronic condition and to analyze whether PPI is associated with trial characteristics. STUDY DESIGN AND SETTING: We used PubMed search to identify RCTs addressing a chronic condition and published in journals with a mandatory PPI statement. RESULTS: Across 101 RCTs; 40 (40%) reported PPI at any stage of the research process. PPI contribution occurred mostly at the design stage of RCTs (n = 36), especially for assessing the burden of the intervention (n = 24), and at the conduct stage (n = 21), with the elaboration of communication materials (n = 14). Less than one-third (13/40) of RCTs included PPI in the development or choice of outcome measures. As compared with non-PPI RCTs, PPI RCTs more frequently were published in The BMJ, had a corresponding author from the United Kingdom, reported a public funding source, had a higher inclusion rate, used usual care as a control and evaluated a digital intervention. PPI RCTs were associated with less frequent use of placebo as a control group. CONCLUSION: Our results underline that PPI is not uncommon in RCTs of chronic conditions but infrequently occurred at a key stage. Yet, the engagement of patients as a real partner in RCTs of chronic conditions should be enhanced.

French 2013 guidelines for antiretroviral therapy of HIV-1 infection in adults.

INTRODUCTION: These guidelines are part of the French Experts' recommendations for the management of people living with HIV/AIDS, which were made public and submitted to the French health authorities in September 2013. The objective was to provide updated recommendations for antiretroviral treatment (ART) of HIV-positive adults. Guidelines included the following topics: when to start, what to start, specific situations for the choice of the first session of antiretroviral therapy, optimization of antiretroviral therapy after virologic suppression, and management of virologic failure. METHODS: Ten members of the French HIV 2013 expert group were responsible for guidelines on ART. They systematically reviewed the most recent literature. The chairman of the subgroup was responsible for drafting the guidelines, which were subsequently discussed within, and finalized by the whole expert group to obtain a consensus. Recommendations were graded for strength and level of evidence using predefined criteria. Economic considerations were part of the decision-making process for selecting preferred first-line options. Potential conflicts of interest were actively managed throughout the whole process. RESULTS: ART should be initiated in any HIV-positive person, whatever his/her CD4 T-cell count, even when >500/mm3. The level of evidence of the individual benefit of ART in terms of mortality or progression to AIDS increases with decreasing CD4 cell count. Preferred initial regimens include two nucleoside reverse transcriptase inhibitors (tenofovir/emtricitabine or abacavir/lamivudine) plus a non-nucleoside reverse transcriptase inhibitor (efavirenz or rilpivirine), or a ritonavir-boosted protease inhibitor (atazanavir or darunavir). Raltegravir, lopinavir/r, and nevirapine are recommended as alternative third agents, with specific indications and restrictions. Specific situations such as HIV infection in women, primary HIV infection, severe immune suppression with or without identified opportunistic infection, and person who injects drugs are addressed. Options for optimization of ART once virologic suppression is achieved are discussed. Evaluation and management of virologic failure are described, the aim of any intervention in such situation being to reduce plasma viral load to <50 copies/ml. CONCLUSION: These guidelines recommend that any HIV-positive individual should be treated with ART. This recommendation was issued both for the patient's own sake and for promoting treatment as prevention.

High prevalence and impact on the quality of life of facial lipoatrophy and other abnormalities in fat tissue distribution in HIV-infected patients treated with antiretroviral therapy.

Few data report the prevalence in actual clinical settings of lipodystrophy (LD), and in particular of facial lipoatrophy (LA), in HIV-infected patients treated with long-term antiretroviral therapy (ART). A French, multicenter, cross-sectional, observational study was conducted in HIV-infected patients on continuous ART for more than 12 months. The main objective was to assess the prevalence of facial LA in this population. Additional objectives were to make the same assessments for nonfacial LA and lipohypertrophy. The presence of LD signs, type, and severity was assessed by clinicians and compared with patient self-evaluations through two questionnaires. A total of 2,131 assessable patients had a median age of 46 years and a median time on ART of 10 years. Physicians diagnosed facial LA in 54% of patients and these subjects had received ART for a longer duration than those without LA. Thymidine analog usage was associated with an increased likelihood of facial LA, but 28% of patients recently treatment-initiated (1-5 years) were also affected. At other sites, LA and lipohypertrophy were diagnosed in 59% and 57% of cases, respectively. The concordance between physician and patient assessments was good for facial and buttocks LA. In this study, facial LA affects more than half of the subjects and is frequent even among the most recently treated patients. The prevalence of facial LA significantly increases with the duration of ART, with male gender, hepatitis C virus (HCV) coinfection, and non-African origin being independent risk factors. Lipohypertrophy is frequent and appears early after ART initiation.