28 research outputs found

    Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology

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    Background: There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. Methodology/Principal Findings: We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. Conclusions/Significance: Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials

    Chapter Patient-generated evidence in Epidermolysis Bullosa (EB): Development of a questionnaire to assess the Quality of Life

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    Epidermolysis Bullosa (EB) is a group of genetic conditions that cause fragile and blistering skin. Although there are different types of EB, which differ in severity, their signs and symptoms overlap. As a result of this disorder, patients face an unbearable burden in their lives, and their Quality of Life (QoL) is negatively affected at every life cycle stage. Nevertheless, the assessment of the quality of life of these patients is scanty. This project aims to develop a patient-centered questionnaire to assess the QoL of EB patients. This tool will be a valid aid for clinicians to understand patients better and identify the areas that need more attention; moreover, it will allow them to follow the patients over time and evaluate the impact of any treatments. The methodological process to develop the questionnaire consisted of two phases: firstly, a critical review of scientific literature was performed; secondly, a pseudo-Delphi study was carried out. A multidisciplinary panel (including patients, caregivers, and clinicians) actively participated in round tables to discuss the main areas of interest. Starting from this initial set of areas and through the repetition of Delphi (up to three rounds), a gradual refinement of the statements was carried out to define a list of items to be included in an easy-to-use but meaningful questionnaire. The final patient-centered questionnaire is thus able to measure the QoL beyond the physical symptoms and the clinical evolution of the disease, encompassing functional autonomy, psycho-emotional state, social relations and the working field

    A case of insect colonization before the death

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    Forensic entomology is a branch of forensic science in which insects are used as evidence in legal investigations relating to humans, domestic animals and wildlife. One of the theoretical pillars on which the discipline is based concerns the fact that flies colonize a body after death. However in cases of myiasis, maggots are present before death, with consequences in the correct estimation of the minimum postmortem interval (mPMI). We report here the case of a woman, largely colonized by fly larvae, who has lain alive in her garden for four days prior to being rescued. Larvae were found on the conjunctivae, the bronchi, the rectum and vagina. The woman's death, two months later, was caused by tetanus. The consequences of myiasis on mPMI estimation are here discussed. In fact, despite she was still alive larvae, indicated and estimated age of 1.5–2.5 days, based on environmental and body temperature

    Necrobiosis Lipoidica Diabeticorum

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    Necrobiosis lipoidica is a rare disorder that usually appears in the lower extremities and it is often related to diabetes mellitus. There are few reported cases of necrobiosis lipoidica in children. We present an interesting case in that the patient developed lesions on the abdomen, which is an unusual location

    Conhecimento sobre métodos anticoncepcionais por estudantes adolescentes

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    OBJECTIVE:To compare the knowledge of contraceptive methods as well as to identify factors associated with adequate knowledge among public and private school adolescents. METHODS: A cross-sectional study comprising 1,594 adolescents aged between 12 and 19 years old from 13 public and five private schools in the city of São Paulo city, Brazil, was carried out from June to December 2003. Schools were randomly selected and students filled out a questionnaire about sociodemographic, reproductive and contraceptive methods. The prevalence ratios were estimated with a 95% confidence interval for each question on their knowledge of contraceptive methods and by school group. Each question correctly answered received a half score, and the cut-off value was 50% of correct answers. Statistical tests utilized were Chi-square and Wilcoxon-Gehan tests and Poisson multiple regression model. RESULTS: Of all respondents, 61% were of females in both school groups. Most students had low socioeconomic condition in public schools while they had mostly high socioeconomic condition in private schools (pOBJETIVO: Comparar o conhecimento sobre métodos anticoncepcionais e identificar os fatores associados ao conhecimento adequado dos adolescentes de escolas públicas e privadas. MÉTODOS: Realizou-se estudo transversal, do qual participaram 1.594 adolescentes entre 12 e 19 anos, de 13 escolas públicas e cinco privadas do Município de São Paulo entre junho e dezembro de 2003. As escolas foram selecionadas aleatoriamente e os alunos responderam um questionário sobre características sociodemográficas, reprodutivas e métodos anticoncepcionais. As razões de prevalência foram calculadas com intervalo de confiança de 95% para cada questão sobre conhecimento de métodos e o tipo de escola. Atribuiu-se meio ponto para cada questão correta sobre conhecimento de anticoncepcionais, o ponto de corte foi 50% de acerto. Os testes estatísticos utilizados foram o qui-quadrado, o Wilcoxon-Gehan e a regressão múltipla de Poisson. RESULTADOS: Dentre os adolescentes, 61% eram do sexo feminino nos dois grupos de escolas. Predominou nível socioeconômico baixo nas escolas públicas e alto nas privadas (

    [factors Associated With Condom Use And Knowledge About Std/aids Among Teenagers In Public And Private Schools In São Paulo, Brazil].

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    This study aimed to compare knowledge about STD/AIDS and identify the factors associated with adequate knowledge and consistent use of male condoms in teenagers from public and private schools in the city of São Paulo, Brazil. We selected 1,594 adolescents ranging 12 to 19 years of age in 13 public schools and 5 private schools to complete a questionnaire on knowledge of STD/AIDS and use of male condoms. Prevalence ratios were computed with a 95% confidence interval. The score on STD knowledge used a cutoff point corresponding to 50% of correct answers. Statistical tests were chi-square and Poisson multiple regression. Consistent use of male condoms was 60% in private and 57.1% in public schools (p > 0.05) and was associated with male gender and lower socioeconomic status. Female gender, higher schooling, enrollment in private school, Caucasian race, and being single were associated with higher knowledge of STDs. Teenagers from public and private schools have adequate knowledge of STD prevention, however this does not include the adoption of effective prevention. Educational programs and STD/AIDS awareness-raising should be expanded in order to minimize vulnerability.22315-2

    Revised diagnostic criteria for neurofibromatosis type 1 and Legius syndrome: an international consensus recommendation

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    Purpose By incorporating major developments in genetics, ophthalmology, dermatology, and neuroimaging, to revise the diagnostic criteria for neurofibromatosis type 1 (NF1) and to establish diagnostic criteria for Legius syndrome (LGSS). Methods We used a multistep process, beginning with a Delphi method involving global experts and subsequently involving non-NF experts, patients, and foundations/patient advocacy groups. Results We reached consensus on the minimal clinical and genetic criteria for diagnosing and differentiating NF1 and LGSS, which have phenotypic overlap in young patients with pigmentary findings. Criteria for the mosaic forms of these conditions are also recommended. Conclusion The revised criteria for NF1 incorporate new clinical features and genetic testing, whereas the criteria for LGSS were created to differentiate the two conditions. It is likely that continued refinement of these new criteria will be necessary as investigators (1) study the diagnostic properties of the revised criteria, (2) reconsider criteria not included in this process, and (3) identify new clinical and other features of these conditions. For this reason, we propose an initiative to update periodically the diagnostic criteria for NF1 and LGSS

    A first update on mapping the human genetic architecture of COVID-19

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    Chapter Patient-generated evidence in Epidermolysis Bullosa (EB): Development of a questionnaire to assess the Quality of Life

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    Epidermolysis Bullosa (EB) is a group of genetic conditions that cause fragile and blistering skin. Although there are different types of EB, which differ in severity, their signs and symptoms overlap. As a result of this disorder, patients face an unbearable burden in their lives, and their Quality of Life (QoL) is negatively affected at every life cycle stage. Nevertheless, the assessment of the quality of life of these patients is scanty. This project aims to develop a patient-centered questionnaire to assess the QoL of EB patients. This tool will be a valid aid for clinicians to understand patients better and identify the areas that need more attention; moreover, it will allow them to follow the patients over time and evaluate the impact of any treatments. The methodological process to develop the questionnaire consisted of two phases: firstly, a critical review of scientific literature was performed; secondly, a pseudo-Delphi study was carried out. A multidisciplinary panel (including patients, caregivers, and clinicians) actively participated in round tables to discuss the main areas of interest. Starting from this initial set of areas and through the repetition of Delphi (up to three rounds), a gradual refinement of the statements was carried out to define a list of items to be included in an easy-to-use but meaningful questionnaire. The final patient-centered questionnaire is thus able to measure the QoL beyond the physical symptoms and the clinical evolution of the disease, encompassing functional autonomy, psycho-emotional state, social relations and the working field
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