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Objectives. To assess the effects of the Nutri-Score label (relative to the Reference Intakes label or no label) on the nutritional quality of students' food purchases. Methods. A 3-arm randomized controlled trial was conducted in France in 2017; 2907 participants were randomized into 1 of the 3 study arms (Nutri-Score, Reference Intakes, no label) and invited to purchase groceries from an experimental Web-based supermarket. The main outcome was the overall nutritional quality of purchases, measured according to a modified version of the Food Standards Agency Nutrient Profiling System (FSAm-NPS/HCSP) score. Results. The mean (±SD) FSAm-NPS/HCSP score was lower in the Nutri-Score group (2.02 ±3.56) than in the Reference Intakes group (2.69 ±3.44), reflecting higher nutritional quality; however, there was no significant difference between the Nutri-Score and no-label (2.45 ±3.28) groups or between the Reference Intakes and no-label groups. Shopping cart content was lower in calories and saturated fatty acids and higher in fruits and vegetables in the Nutri-Score arm than in the other arms. Conclusions. The Nutri-Score label appeared to improve the nutritional composition of students' food purchases relative to the Reference Intakes label or no label. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of a computer-assisted Screening, Brief Intervention, and Referral to Treatment (SBIRT) on daily consumption of alcohol by patients with hazardous drinking disorder detected after systematic screening during their admission to an emergency department (ED).Design: Two-arm, parallel group, multicentre, randomized controlled trial with a centralised computer-generated randomization procedure.Setting: Four EDs in university hospitals located in the Paris area in France.Participants: Patients admitted in the ED for any reason, with hazardous drinking disorder detected after systematic screening (i.e., Alcohol Use Disorder Identification Test score ≥5 for women and 8 for men OR self-reported alcohol consumption by week ≥7 drinks for women and 14 for men).Interventions: The experimental intervention was computer-assisted SBIRT and the comparator was a placebo-controlled intervention (i.e., a computer-assisted education program on nutrition). Interventions were administered in the ED and followed by phone reinforcements at 1 and 3 months.Main Outcome Measure: The primary outcome was the mean number of alcohol drinks per day in the previous week, at 12 months. Results From May 2005 to February 2011, 286 patients were randomized to the computer-assisted SBIRT and 286 to the comparator intervention. The two groups did not differ in the primary outcome, with an adjusted mean difference of 0.12 (95% confidence interval, -0.88 to 1.11).Conclusions: There was no additional benefit of the computer-assisted alcohol SBIRT as compared with the computer-assisted education program on nutrition among patients with hazardous drinking disorder detected by systematic screening during their admission to an ED. [ABSTRACT FROM AUTHOR]

Background: We aimed to determine the representation of elderly people in published reports of randomized controlled trials (RCTs). We focused on trials of 4 medications-pioglitazone, rosuvastatin, risedronate, and valsartan-frequently used by elderly patients with chronic medical conditions. Methods and Findings: We selected all reports of RCTs indexed in PubMed from 1966 to April 2008 evaluating one of the 4 medications of interest. Estimates of the community-based ''on-treatment'' population were from a national health insurance database (SNIIR-AM) covering approximately 86% of the population in France. From this database, we evaluated data claims from January 2006 to December 2007 for 1,958,716 patients who received one of the medications of interest for more than 6 months. Of the 155 RCT reports selected, only 3 studies were exclusively of elderly patients (2 assessing valsartan; 1 risedronate). In only 4 of 37 reports (10.8%) for pioglitazone, 4 of 22 (18.2%) for risedronate, 3 of 29 (10.3%) for rosuvastatine and 9 of 67 (13.4%) for valsartan, the proportion of patients aged 65 or older was within or above that treated in clinical practice. In 62.2% of the reports for pioglitazone, 40.9% for risedronate, 37.9% for rosuvastatine, and 70.2% for valsartan, the proportion of patients aged 65 or older was lower than half that in the treated population. The representation of elderly people did not differ by publication date or sample size. Conclusions: Elderly patients are poorly represented in RCTs of drugs they are likely to receive. [ABSTRACT FROM AUTHOR]

Objectives: To assess the impact on readers' interpretation of the results reported in an abstract for a hypothetical clinical trial with (1) a statistically significant result (SSR), (2) spin, (3) both an SSR and spin compared with (4) no spin and no SSR., Participants: Health students and professionals from universities and health institutions in France and the UK., Interventions: Participants completed an online questionnaire using Likert scales and free text, after reading one of the four versions of an abstract about a hypothetical randomised trial evaluating 'Naranex' and 'Bulofil' (two hypothetical drugs) for chronic low back pain. The abstracts differed in (1) reported result of 'mean difference of 1.31 points (95% CI 0.08 to 2.54, p= 0.04)' or 'mean difference of 1.31 points (95% CI -0.08 to 2.70, p= 0.06)' and (2) presence or absence of spin. The effect size for the trial's primary outcome (pain disability score) was the same in each abstract, slightly in favour of Naranex., Primary Outcome: The reader's interpretation of the trial's results, based on their answer (1, disagree; 4, neutral; 7, agree) to the following statement: 'About the main findings of the study, what is your opinion about the following statement: 'Naranex is better than Bulofil'?', Results: Two hundred and ninety-seven of the 404 people randomised to receive one of the four abstracts completed the study. Respondents were more likely to favour Narenex when the abstract reported an SSR without spin, a statistically significant result with spin, a non-statistically significant result with spin, compared with when it reported a non-SSR without spin., Conclusion: Statistical significance appears to have influenced readers' perception whatever the level of spin, while spin influenced readers' perception when the results were not statistically significant but did not appear to have an impact when results were statistically significant., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The Nutri-Score, a front-of-pack nutrition label, has been adopted in 2017 in France but its impact on low-income populations is unknown, and they are more at risk of having unhealthy diets. The present study assessed the effects of the Nutri-Score on the nutritional quality of purchasing intentions among low-income individuals, compared with the current French labelling situation: references intakes (RIs) and no label, using a three-arm parallel-group randomised controlled trial., Methods: Low-income active adults from the NutriNet-Santé cohort (household income below €1200/month) were asked to perform a shopping task in an experimental online supermarket after being randomised in one of the three conditions (Nutri-Score, RIs or no labelling). The main outcome was the overall nutritional quality of the virtual shopping cart, assessed with the French-modified Food Standards Agency Nutrient Profiling System (FSAm-NPS), and secondary outcomes were the nutrient content of the shopping carts. 524 subjects were randomised, and 336 included in the analyses., Results: The Nutri-Score resulted in the highest overall nutritional quality of the shopping cart, as reflected by a FSAm-NPS score (1.86 (SD 3.59) points) significantly lower (reflecting higher nutritional quality) than the RIs (3.21 (SD 4.14) points, p≤0.05) but not significantly lower than no label (2.60 (SD 3.09) points, p=0.3). The Nutri-Score also resulted into significantly lower contents in calories and saturated fatty acids in the shopping cart, compared with the RIs only (p≤0.05)., Conclusion: The implementation of the front of pack nutrition label Nutri-Score, adopted in France and in different European countries, appears to have the potential to encourage purchasing intentions of foods from higher nutritional quality among low-income individuals, compared with the RIs label promoted by food manufacturers. Trial registration number: NCT02769455., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To describe the evolution of the use and reporting of propensity score (PS) analysis in observational studies assessing a surgical procedure., Background: Assessing surgery in randomized controlled trials raises several challenges. Observational studies with PS analysis are a robust alternative for comparative effectiveness research., Methods: In this methodological systematic review, we identified all PubMed reports of observational studies with PS analysis that evaluated a surgical procedure and described the evolution of their use over time. Then, we selected a sample of articles published from August 2013 to July 2014 and systematically appraised the quality of reporting and potential bias of the PS analysis used., Results: We selected 652 reports of observational studies with PS analysis. The publications increased over time, from 1 report in 1987 to 198 in 2013. Among the 129 reports assessed, 20% (n = 24) did not detail the covariates included in the PS and 77% (n = 100) did not report a justification for including these covariates in the PS. The rate of missing data for potential covariates was reported in 9% of articles. When a crossover by conversion was possible, only 14% of reports (n = 12) mentioned this issue. For matched analysis, 10% of articles reported all 4 key elements that allow for reproducibility of a PS-matched analysis (matching ratio, method to choose the nearest neighbors, replacement and method for statistical analysis)., Conclusions: Observational studies with PS analysis in surgery are increasing in frequency, but specific methodological issues and weaknesses in reporting exist.

We compared the performance of four rapid diagnostic tests (RDTs) for imported malaria, and particularly Plasmodium falciparum infection, using thick and thin blood smears as the gold standard. All the tests are designed to detect at least one protein specific to P. falciparum (Plasmodium histidine-rich protein 2 (PfHRP2) or Plasmodium LDH (PfLDH)) and one pan-Plasmodium protein (aldolase or Plasmodium LDH (pLDH)). 1,311 consecutive patients presenting to 9 French hospitals with suspected malaria were included in this prospective study between April 2006 and September 2008. Blood smears revealed malaria parasites in 374 cases (29%). For the diagnosis of P. falciparum infection, the three tests detecting PfHRP2 showed high and similar sensitivity (96%), positive predictive value (PPV) (90%) and negative predictive value (NPV) (98%). The PfLDH test showed lower sensitivity (83%) and NPV (80%), despite good PPV (98%). For the diagnosis of non-falciparum species, the PPV and NPV of tests targeting pLDH or aldolase were 94-99% and 52-64%, respectively. PfHRP2-based RDTs are thus an acceptable alternative to routine microscopy for diagnosing P. falciparum malaria. However, as malaria may be misdiagnosed with RDTs, all negative results must be confirmed by the reference diagnostic method when clinical, biological or other factors are highly suggestive of malaria.

Purpose: Inflammation-induced anemia is frequent among critically ill patients and can be aggravated by true iron deficiency (ID) resulting from blood losses. The serum hepcidin level controls the availability of iron for erythropoiesis, and its determination offers new perspectives for the diagnosis of ID in the presence of inflammation. We conducted a prospective observational study to determine the cutoff value and diagnostic accuracy of hepcidin levels for detecting ID in critically ill anemic patients., Methods: Patients suffering from anemia (hemoglobin <100 g/l) and expected to stay for more than 7 days in intensive care had weekly determinations of hematological and iron parameters, including hepcidin levels (ELISA test). The iron status for each set of measures was determined by the consensus of three experts, blinded to hepcidin values., Results: Of 51 patients (36 male/15 female), 5 had ID at inclusion, while 8 developed ID during their stay. A total of 128 iron profiles were analyzed. Median hepcidin levels were 80.5 (0.05-548.3) and 526.6 (246.7-891.4) microg/l for ID and non-ID profiles, respectively. The onset of ID during the ICU stay led to a progressive decline in hepcidin levels, whereas a persistent inflammatory profile remained associated with high hepcidin concentrations. The optimal threshold for serum hepcidin for ID diagnosis was assessed by building 100 ROC curves using a resampling method and found at 129.5 microg/l [95% CI = (115.5-143.4)]., Conclusions: Hepcidin levels may be suppressed by ID even in case of inflammation. Serum hepcidin of 129.5 microg/l was the most accurate threshold for ID diagnosis in critically ill patients with anemia.

Background: Knee arthroplasty is increasing exponentially due to the aging of the population and to the broadening of indications. We aimed to compare physical disability and its evolution over two years in people with knee arthroplasty to that in the general population. A secondary objective was to compare the level of disabilities of people with knee to people with hip arthroplasty., Methodology/principal Findings: 16,945 people representative of the French population were selected in 1999 from the French census and interviewed about their level of disability. This sample included 815 people with lower limb arthroplasty. In 2001, 608 of them were re-interviewed, among whom 134 had knee arthroplasty. Among the other participants re-interviewed, we identified 68 who had undergone knee arthroplasty and 145 hip arthroplasty within the last two years (recent arthroplasty). People with knee arthroplasty reported significantly greater difficulties than the general population with bending forward (odds ratio [OR] = 4.7; 95% confidence interval [CI]: 1.7, 12.6), walking more than 500 meters (OR = 6.0; 95% CI: 1.5, 24.7) and carrying 5 kg kilograms for 10 meters (OR = 4.6; 95% CI: 1.3, 16.4). However, the two years evolution in disability was similar to that in the general population for most activities. The level of mobility was similar between people with recent knee arthroplasty and those with recent hip arthroplasty. Nevertheless, people with recent knee arthroplasty reported a lower level of disability than the other group for washing and bending forward (OR = 0.3; 95% CI: 0.1, 0.6 and OR = 0.4; 95% CI: 0.1, 0.9, respectively)., Conclusions/significance: People with knee arthroplasty reported a higher risk of disability than the general population for common activities of daily living but a similar evolution. There was no relevant difference between recent knee and hip arthroplasties for mobility.

Objective: To describe disability in individuals with hip arthroplasty and its evolution over 2 years compared with that in the general population, and to compare the degree of disability between subjects with recent and older hip arthroplasty., Methods: We selected a national representative sample of 16,945 subjects from the 1999 French population census. This sample, interviewed in 1999 and 2001 about their level of disability, included 527 subjects with hip arthroplasty (i.e., representing 424,000 individuals in the French noninstitutionalized population): 145 who underwent the procedure between 1999 and 2001 (recent hip arthroplasty) and 382 with an older hip arthroplasty., Results: Subjects with hip arthroplasty reported more difficulty in bending forward (odds ratio [OR] 4.5, 95% confidence interval [95% CI] 3.1-6.6), climbing stairs (OR 2.2, 95% CI 1.5-3.1), walking >300 meters (OR 1.6, 95% CI 1.03-2.6), dressing (OR 2.9, 95% CI 2.1-4.2), and getting in and out of a chair (OR 2.5, 95% CI 1.7-3.6) than the general population. However, the evolution in disability was similar to that of the general population. Compared with subjects with older hip arthroplasty, those with recent hip arthroplasty reported more difficulty walking >300 meters (OR 2.7, 95% CI 1.3-5.6), washing (OR 2.9, 95% CI 1.6-5.4), dressing (OR 2.2, 95% CI 1.2-4.2), and getting in and out of a chair (OR 2.1, 95% CI 1.1-3.9)., Conclusion: This study describes the potential future disability in the more elderly population, with implications for health-related planning.