Was It Worth Introducing Health Economic Evaluation of Innovative Drugs in the French Regulatory Setting? The Case of New Hepatitis C Drugs

Objective

This paper constitutes the first attempt to draw lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework.

Risk stratification in breast cancer screening: Cost-effectiveness and harm-benefit ratios for low-risk and high-risk women

In mammography screening programmes, women are screened according to a one-size-fits-all principle. Tailored screening, based on risk levels, may lead to a better balance of benefits and harms. With microsimulation modelling, we determined optimal mammography screening strategies for women at lower (relative risk [RR] 0.75) and higher (RR 1.8) than average risk of breast cancer, eligible for screening, using the incremental cost-effectiveness ratio (ICER) of current uniform screening in the Netherlands (biennial [B] 50-74) as a threshold ICER. Strategies varied by interval (annual [A], biennial, triennial [T]) and age range. The number of life-years gained (LYG), breast cancer deaths averted, overdiagnosed cases, false-positive mammograms, ICERs and harm-benefit ratios were calculated. Optimal risk-based screening scenarios, below the threshold ICER of €8883/LYG, were T50-71 (€7840/LYG) for low-risk and B40-74 (€6062/LYG) for high-risk women. T50-71 screening in low-risk women resulted in a 33% reduction in false-positive findings, a similar reduction in costs and improved harm-benefit ratios compared to the current screening schedule. B40-74 in high-risk women led to an increase in screening benefit, compared to current B50-74 screening, but a relatively higher increase in false-positive findings. In conclusion, optimal screening consisted of a longer interval and lower stopping age than current uniform screening for low-risk women, and a lower starting age for high-risk women. Extending the interval for women at lower risk from biennial to triennial screening reduced harms and costs while maintaining most of the screening benefit.     

Genotoxicity of synthetic amorphous silica nanoparticles in rats following short‐term exposure. Part 1: Oral route

Synthetic amorphous silica (SAS) in its nanosized form is now used in food applications although the potential risks for human health have not been evaluated. In this study, genotoxicity and oxidative DNA damage of two pyrogenic (NM‐202 and 203) and two precipitated (NM‐200 and ‐201) nanosized SAS were investigated in vivo in rats following oral exposure. Male Sprague Dawley rats were exposed to 5, 10, or 20 mg/kg b.w./day for three days by gavage. DNA strand breaks and oxidative DNA damage were investigated in seven tissues (blood, bone marrow from femur, liver, spleen, kidney, duodenum, and colon) with the alkaline and the (Fpg)‐modified comet assays, respectively. Concomitantly, chromosomal damage was investigated in bone marrow and in colon with the micronucleus assay. Additionally, malondialdehyde (MDA), a lipid peroxidation marker, was measured in plasma. When required, a histopathological examination was also conducted. The results showed neither obvious DNA strand breaks nor oxidative damage with the comet assay, irrespective of the dose and the organ investigated. Similarly, no increases in chromosome damage in bone marrow or lipid peroxidation in plasma were detected. However, although the response was not dose‐dependent, a weak increase in the percentage of micronucleated cells was observed in the colon of rats treated with the two pyrogenic SAS at the lowest dose (5 mg/kg b.w./day). Additional data are required to confirm this result, considering in particular, the role of agglomeration/aggregation of SAS NMs in their uptake by intestinal cells. Environ. Mol. Mutagen. 56:218–227, 2015. © 2014 Wiley Periodicals, Inc.     

Reduction of hospitalizations with diarrhea among children aged 0–5 years in Nouakchott,Mauritania, following the introduction of rotavirus vaccine

Introduction

Rotavirus vaccine was introduced in Mauritania in December 2014. We investigated hospitalizations with diarrhea during pre and post-vaccination periods among children aged 0–5?years in Nouakchott, the capital of Mauritania.

Beyond “One Size Fits All”: Physician Nonverbal Adaptability to Patients’ Need for Paternalism and Its Positive Consultation Outcomes

In this study, we tested whether physicians’ ability to adapt their nonverbal behavior to their patients’ preferences for a paternalistic interaction style is related to positive consultation outcomes. We hypothesized that the more physicians adapt their nonverbal dominance behavior to match their patients’ preferences for physician paternalism, the more positively the patients perceive the medical interaction. We assessed the actual nonverbal dominance behavior of 32 general practitioners when interacting with two of their patients and compared it with each of their patients’ preferences for paternalism to obtain a measure of adaptability. Additionally, we measured patient outcomes with a questionnaire assessing patient satisfaction, trust in the physician, and evaluation of physician competence. Results show that the more nonverbal dominance the physician shows toward the patient who prefers a more paternalistic physician, as compared to toward the patient who prefers a less paternalistic physician (i.e., the more the physician shows nonverbal behavioral adaptability), the more positive the consultation outcomes are. This means that physicians’ ability to adapt aspects of their nonverbal dominance behavior to their individual patients’ preferences is related to better outcomes for patients. As this study shows, it is advantageous for patients when a physician behaves flexibly instead of showing the same behavior towards all patients. Physician training might want to focus more on teaching a diversity of different behavior repertoires instead of a given set of behaviors.