Data capture by digital pen in clinical trials: A qualitative and quantitative study.

International audienceOBJECTIVES: To investigate the use of the digital pen (DP) system to collect data in a clinical trial. To assess the accuracy of the system in this setting. DESIGN: Qualitative study based on semistructured interviews and a focus group. Quantitative study comparing the DP system and a double manual data-entry system in accuracy of acquiring data by variable type (tick boxes, dates, numbers, letters). SETTING: An ongoing randomised multicentric clinical trial in tertiary care in France. PARTICIPANTS: 27 investigators involved in the trial (anaesthetists) who did or did not include patients, 4 study monitors and the study coordinator. RESULTS: Six key findings emerged: 1) the DP system was easy to use; its utilisation was intuitive, even for investigators inexperienced in informatics; 2) despite its portability, the DP was not always used in front of patients; 3) the DP system did not affect patient recruitment; 4) most of the technical problems of the system occurred during setup (compatibility, password access, antivirus software); 5) the main advantage was quickness of data availability for the study coordination staff and the main hindrance was the extra time required for online verification; and 6) all investigators were ready to use the system again. The investigators had to check 16% of data obtained by the DP system during the verification step. There is no relevant difference between the number of errors for the DP and the double manual data-entry systems: 8/5022 versus 6/5022 data entries. 5 out of 8 DP-system failures were due to the intelligent character recognition system. CONCLUSION: The DP system has a good acceptability among all investigators in a clinical setting, whether they are experienced with computers or not, and a good accuracy, as compared with double manual data entry

French academic physicians had a poor knowledge of terms used in clinical epidemiology

Objectives: To assess academic physicians' understanding and usage of basic epidemiological terms commonly used in medical journals. Study Design and Setting: Observational study. A total of 274 physicians, working in a teaching hospital in Paris, France were asked to answer a questionnaire including four vignettes presenting the results of a therapeutic, a diagnostic, a prognostic study and a meta-analysis of clinical trials. Results: A total of 130 (47%) questionnaires were returned. We observed the highest proportion of good answers for questions about absolute risk reduction (87.7%), sensitivity (84.6%), and specificity (80%); and the lowest for the calculation and use of the likelihood ratio (16.9% and 9.2%, respectively). The global mean score was 5.0/10 (95% confidence interval54.6e5.4, range 0e9.4). Physicians got higher scores for questions related to treatment than for questions related to diagnosis: mean scores 7.1 (6.6e7.6) vs. 4.2 (3.8e4.6). Regression analysis did not reveal any significant relationship between global performance and physicians' age (r250.002, not significant [NS]). Conclusion: Physicians demonstrated only moderate knowledge and usage of clinical epidemiology terms used in major medical journals. Their capacity to interpret quantitative data from medical scientific literature may be limited. [Authors]]]> Epidemiology ; Health Knowledge, Attitudes, Practice ; Medical Staff, Hospital ; Physicians oai:serval.unil.ch:BIB_470C9DE8C422 2022-05-07T01:17:02Z openaire documents urnserval <oai_dc:dc xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/ http://www.openarchives.org/OAI/2.0/oai_dc.xsd"> https://serval.unil.ch/notice/serval:BIB_470C9DE8C422 A neuron-specific deletion of the microRNA-processing enzyme DICER induces severe but transient obesity in mice. info:doi:10.1371/journal.pone.0116760 info:eu-repo/semantics/altIdentifier/doi/10.1371/journal.pone.0116760 info:eu-repo/semantics/altIdentifier/pmid/25629159 Mang, G.M. Pradervand, S. Du, N.H. Arpat, A.B. Preitner, F. Wigger, L. Gatfield, D. Franken, P. info:eu-repo/semantics/article article 2015 PLoS One, vol. 10, no. 1, pp. e0116760 info:eu-repo/semantics/altIdentifier/eissn/1932-6203 urn:issn:1932-6203 <![CDATA[MicroRNAs (miRNAs) are small, non-coding RNA molecules that regulate gene expression post-transcriptionally. MiRNAs are implicated in various biological processes associated with obesity, including adipocyte differentiation and lipid metabolism. We used a neuronal-specific inhibition of miRNA maturation in adult mice to study the consequences of miRNA loss on obesity development. Camk2a-CreERT2 (Cre+) and floxed Dicer (Dicerlox/lox) mice were crossed to generate tamoxifen-inducible conditional Dicer knockouts (cKO). Vehicle- and/or tamoxifen-injected Cre+;Dicerlox/lox and Cre+;Dicer+/+ served as controls. Four cohorts were used to a) measure body composition, b) follow food intake and body weight dynamics, c) evaluate basal metabolism and effects of food deprivation, and d) assess the brain transcriptome consequences of miRNA loss. cKO mice developed severe obesity and gained 18 g extra weight over the 5 weeks following tamoxifen injection, mainly due to increased fat mass. This phenotype was highly reproducible and observed in all 38 cKO mice recorded and in none of the controls, excluding possible effects of tamoxifen or the non-induced transgene. Development of obesity was concomitant with hyperphagia, increased food efficiency, and decreased activity. Surprisingly, after reaching maximum body weight, obese cKO mice spontaneously started losing weight as rapidly as it was gained. Weight loss was accompanied by lowered O2-consumption and respiratory-exchange ratio. Brain transcriptome analyses in obese mice identified several obesity-related pathways (e.g. leptin, somatostatin, and nemo-like kinase signaling), as well as genes involved in feeding and appetite (e.g. Pmch, Neurotensin) and in metabolism (e.g. Bmp4, Bmp7, Ptger1, Cox7a1). A gene cluster with anti-correlated expression in the cerebral cortex of post-obese compared to obese mice was enriched for synaptic plasticity pathways. While other studies have identified a role for miRNAs in obesity, we here present a unique model that allows for the study of processes involved in reversing obesity. Moreover, our study identified the cortex as a brain area important for body weight homeostasis

Methods of Blinding in Reports of Randomized Controlled Trials Assessing Pharmacologic Treatments: A Systematic Review

BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or adjudication of clinical events. CONCLUSIONS: This review classifies blinding methods and provides a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmalogic trials

Reporting Methods of Blinding in Randomized Trials Assessing Nonpharmacological Treatments

BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on “creative” (nonstandard) methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs) assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment), or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography), or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials

Utilisation d'un stylo numérique pour le recueil des données dans les essais cliniques

PARIS7-Xavier Bichat (751182101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Choix du traitement comparateur dans les essais contrôlés randomisés

Le choix du traitement comparateur dans un essai clinique (EC) influence son intérêt scientifique et son acceptabilité éthique liée aux risques auxquels sont exposés les patients du groupe contrôle. A partir de l'exemple de l'évaluation des biothérapies dans la polyarthrite rhumatoïde, l'analyse des comparateurs utilisés dans les EC lorsqu'il existe un traitement de référence a mis en évidence une nette prédominance des comparaisons versus placebo et un déficit d'essais face-face, respectivement 81 et 5 parmi les 102 comparaisons. Nous avons estimé que dans ces EC 9 879 patients recevaient en 2ème ligne de traitement un placebo et/ou leur précédent traitement considéré comme insuffisamment efficace, cela les exposant à des risques de dommages irréversibles. A partir d'une enquête internet randomisée réalisée sur des cas-papiers de patients fictifs, nous avons montré que pour 71% des 90 patients fictifs les médecins ne considéraient pas approprié de prescrire dans le cadre des soins le traitement correspondant au groupe contrôle de TEC dont le patient était issu. Au total 49% des patients fictifs auraient été inclus dans ces vrais EC alors qu'il était considéré inacceptable de leur prescrire dans le cadre des soins le traitement du groupe contrôle. Le principe d'équipoise n'est pas respecté et, contrairement aux recommandations éthiques internationale, les patients du groupe contrôle sont exposés à des risques de préjudices significatifs et/ou durables. Ces EC n'apporteront pas de données fiables sur l'efficacité et les bénéfices relatifs des différents traitements disponibles, leur pertinence scientifique est ainsi mise en cause.PARIS7-Bibliothèque centrale (751132105) / SudocSudocFranceF

How to perform a critical analysis of a randomised controlled trial.

International audienceGiven the large amount of medical literature of varying methodological quality, care must be taken when translating the results of randomised controlled trials into clinical practice. To assist in this translation process, we provide a method that involves answering three main questions: 'Can I trust the results?' 'How do I understand the results?' and 'To whom do the results apply?' To answer the first question, we describe important items that help in judging the reliability of the findings. For the second question, we address the clinical and statistical significance of results by looking at the size and precision of the effect. Finally, we raise the issue of external validity and of reporting adverse effects to determine which patients may best benefit from the new intervention

Trajectories of Adherence to Low-Dose Aspirin Treatment Among the French Population

International audienceBACKGROUND: Previous studies have shown that adherence to low-dose aspirin (LDA) is suboptimal. However, these studies were based on an average measure of adherence during follow-up, ignoring its dynamic process over time. We described the trajectories of adherence to LDA treatment among the French population over 3 years of follow-up.METHODS: We identified a cohort of 11 793 new LDA users, aged ≥50 years in 2010, by using the French national health-care database. Patients included had at least 3 years of history in the database before study entry to exclude prevalent aspirin users and to assess baseline comorbidities. They were followed from the first date of LDA supply (the index date) until the first date among death, exit from the database, or 3 years after the index date. Adherence to LDA was assessed every 3 months by using the proportion of days covered (PDC) and dichotomized with a cutoff of PDC of 0.8. We used group-based trajectory modeling to identify trajectories of LDA adherence. Predictors of LDA adherence trajectory membership were identified by multinomial logistics regression.RESULTS: We identified 4 trajectories of adherence among new LDA users: the not-adherents (4737 [40.2%]), the delayed not-adherents (gradual decrease in adherence probability, 1601 [13.6%]), the delayed adherents (gradual increase in adherence probability, 1137 [9.6%]), and the persistent adherents (4318 [36.6%]). The probability of belonging to the not-adherent group was increased with female sex, low socioeconomic status, and polymedication and was reduced with a secondary indication for LDA use, such as diabetes, hypertension, and dementia, at least 4 consultations in the previous year, or 1 hospitalization or a cardiologist consultation in the 3 months before the index date.CONCLUSION: This study provides a dynamic picture of adherence behaviors among new LDA users and underlines the presence of critical trajectories that intervention could target to improve adherence

Association between Migrant Women’s Legal Status and Prenatal Care Utilization in the PreCARE Cohort

International audienceBarriers to access to prenatal care may partially explain the higher risk of adverse pregnancy outcomes among migrants compared with native-born women in Europe. Our aim was to assess the association between women’s legal status and inadequate prenatal care utilization (PCU) in France, where access to healthcare is supposed to be universal. The study population was extracted from the PreCARE prospective cohort (N = 10,419). The associations between women’s legal status and a composite outcome variable of inadequate PCU were assessed with multivariate logistic regressions. The proportion of women born in sub-Saharan Africa (SSA) was higher among the undocumented than that of other migrants. All groups of migrant women had a higher risk of inadequate PCU (31.6% for legal migrants with European nationalities, 40.3% for other legal migrants, and 52.0% for undocumented migrants) than French-born women (26.4%). The adjusted odds ratio (aOR) for inadequate PCU for undocumented migrants compared with that for French-born women was 2.58 (95% confidence interval 2.16–3.07) overall, and this association was similar for migrant women born in SSA (aOR 2.95, 2.28–3.82) and those born elsewhere (aOR 2.37, 1.89–2.97). Regardless of the maternal place of birth, undocumented migrant status is associated with a higher risk of inadequate PCU