The French National Health Data System (SNDS) comprises healthcare data that cover 99% of the population (over 67 million individuals) in France. The aim of this study was to present an overview of published pharmacoepidemiological studies using the SNDS in its maturation phase. We conducted a systematic literature review of original research articles in the Pubmed and EMBASE databases from January 2012 until August 2018. A total of 316 full-text articles were included, with an annual increase over the study period. Only 16 records were excluded after screening because they did not involve the SNDS but other French healthcare databases. The study design was clearly reported in only 66% of studies of which 57% were retrospective cohorts and 22% cross-sectional studies. The reported study objectives were drug utilization (65%), safety (22%) and effectiveness (9%). Almost all ATC groups were studied but the most frequent ones concerned the nervous system in 149 studies (49%), cardiovascular system drugs in 104 studies (34%) and anti-infectives for systemic use in 50 studies (16%). The SNDS is of growing interest for studies on drug use and safety, which could be conducted more in specific populations, including children, pregnant women and the elderly, as these populations are often not included in clinical trials.
1 October 2021 in Musculoskeletal Science and Practice
Background: Since 2018, a dengue epidemic has been raging annually in Reunion Island, which poses the major problem of its morbidity and mortality. However, there is no consensus in the literature on factors associated with severity of illness. The objective of this study was to identify the factors associated with the occurrence of severe dengue (SD) according to the criteria adopted in 2009 by the World Health Organization (WHO), during the 2019 epidemic. Methodology/Principal findings: A total of 163 patients with RT-PCR-confirmed dengue were included in a multicenter prospective cohort study in Reunion Island between January and June 2019. Of these, 37 (23%) were classified as SD, which involves presentation dominated by at least one organ failure, and 126 (77%) classified as non-SD (of which 90 (71%) had warning signs). Confusion, dehydration, and relative hypovolemia were significantly associated with SD in bivariate analysis (p < 0.05). The factors associated with SD in multivariate analysis were a time from first symptom to hospital consultation over 2 days (OR: 2.46, CI: 1.42–4.27), a history of cardiovascular disease (OR: 2.75, 95%CI: 1.57–4.80) and being of Western European origin (OR: 17.60, CI: 4.15–74). Conclusions/Significance: This study confirms that SD is a frequent cause of hospitalization during dengue epidemics in Reunion Island. It suggests that cardiovascular disease, Western European origin, and delay in diagnosis and management are risk factors associated with SD fever, and that restoration of blood volume and correction of dehydration must be performed early to be effective. Trial registration: NCT01099852; clinicaltrials.gov
Patients undergoing gynaecological surgery are known to experience anxiety. While the use of music selected by patients based on their personal taste has hardly been evaluated, a recent study suggests that musical preferences significantly alter the anxiolytic and relaxing effects of music. Our study aims to determine whether self-selected music decreases patient anxiety prior to gynaecological surgery, as compared with predetermined music from a software programme such as MUSIC CARE®. The study will consist of a clinical trial comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery. A minimum of 170 patients will be randomised in a 1:1 ratio. Inclusion criteria will be: women aged 18–55 years, awaiting scheduled gynaecological surgery under general/local anaesthesia or under sedation; having created a personal 20-min playlist; and not having received anxiolytic drugs prior to surgery. The primary outcome will be the difference between the preoperative anxiety score taken 15 to 20 min before the music-listening session and the preoperative anxiety score taken shortly after the session, as measured with the STAI for state anxiety. This study should help to identify more effective non-medical treatments for preoperative anxiety, as well as to adapt music therapy to the cultural context of patients. ClinicalTrials.gov, ID: NCT03226834 . Registered on 24 July 2017.
Plasmodium falciparum is responsible for most malaria cases on Mayotte Island, in the Comorian Archipelago. Malaria is endemic and a major public health problem in the archipelago with an intense, stable and permanent transmission. This study reports results of 8 years of malaria surveillance from 2007 to 2014 after the strengthening of malaria control activities in Mayotte and the neighbouring islands. Surveillance was based on physicians’ reports of malaria cases between January 2007 and December 2014. Malaria cases were confirmed by at least a positive rapid diagnostic test and/or demonstration of Plasmodium sp. in a blood smear. The date, and the patients’ age, sex, address, presentation of symptoms, biology, treatment and recent history of travel were collected by verbal questioning during consultation and/or hospitalization. Monthly rainfall data were also compiled during the study period. From 2007 to 2014, 2073 cases were reported on Mayotte Island: 977 imported cases, 807 autochthonous cases and 289 cases of unknown origin. The total malaria annual parasite incidence lowered from 3.0 in 2007 to 0.07 per 1,000 inhabitants in 2014 as the autochthonous malaria incidence decreased from 1.6 to 0.004 per 1,000 inhabitants in the same period and in all age groups. Most of the imported cases came from Comoros (94 %). Severe forms represented approximately 11 % of cases, and only two deaths have been recorded among the imported cases. Approximately 19 % of cases were hospitalized (3 % in an intensive care unit). There is clearly a decrease in malaria transmission in Mayotte since 2007 and the goal of elimination seems more achievable than ever. In 2011, Mayotte entered the elimination phase when P. falciparum API passed under 1 case per 1,000 people at risk. The combination of vector control measures, active surveillance and case management, including effective treatment with artemisinin-based combination therapy, has been essential to achieve a present status of low and decreasing malaria transmission on the island. Mayotte has entered the elimination phase, but some goals remain to be accomplished before a programme re-orientation toward malaria elimination is contemplated. Moreover, a regional management policy is crucial because this would allow control measures to be targeted and based on a regional surveillance-response system rather than isolated.
Sickle cell disease presents a great clinical variability that remains largely misunderstood. New disease protective genetic modifiers acting mainly through an increased Hb F level have recently been described. We studied relations between clinical and hematological phenotypes and known sickle cell disease genetic modifiers in patients from Mayotte Island, a remote French territory located in the Indian Ocean. Eighty-two children with sickle cell disease were enrolled; their median age was 5.9 years (range 1-18). Clinical and hematological features of sickle cell disease were retrospectively collected. Genetic studies included determination of β-globin genotypes [Hb SS, Hb S-β(0)-thalassemia (Hb S-β(0)-thal), Hb S-β(+)-thal], β(S)-globin locus haplotype, α-thalassemia (α-thal), and single nucleotide polymorphisms (SNPs) located in quantitative trait loci for Hb F expression (XmnI polymorphism, BCL11A rs4671393 and rs11886868, intergenic region of HBS1L-MYB rs28384513, rs4895441 and rs9399137). Univariate and multivariate analyses were conducted. Twenty-eight percent of the patients had Hb S-β-thal (eight different mutations in 21 patients), 55.0% had the -α(3.7) (rightward) deletion and 88.0% of the homozygous Hb SS patients were carrying a homozygous Bantu haplotype. In the multivariate model, the prognosis role of the SNP BCL11A rs4671393 was confirmed in the studied population showing a significant association with an elevated Hb F level and with a low hospitalization rate. The -α(3.7) deletion, XmnI polymorphism and intergenic region HBS1L-MYB SNPs were not significantly linked to any clinical criteria of severity. This report, the first to describe the main features of children with sickle cell disease on Mayotte Island, highlights the protective effect of the BCL11A polymorphism in this population.