Why prudence is needed when interpreting articles reporting clinical trial results in mental health

Background: Clinical trial results' reliability is impacted by reporting bias. This is primarily manifested as publication bias and outcome reporting bias. Mental health trials' specific features: Mental health trials are prone to two methodological deficiencies: (1) using small numbers of participants that facilitates false positive findings and exaggerated size effects, and (2) the obligatory use of psychometric scales that require subjective assessments. These two deficiencies contribute to the publication of unreliable results. Considerable reporting bias has been found in safety and efficacy findings in psychotherapy and pharmacotherapy trials. Reporting bias can be carried forward to meta-analyses, a key source for clinical practice guidelines. The final result is the frequent overestimation of treatment effects that could impact patients and clinician-informed decisions. Mechanisms to prevent outcome reporting bias: Prospective registration of trials and publication of results are the two major methods to reduce reporting bias. Prospective trial registration will allow checking whether they are published (so it will help to prevent publication bias) and, if published, whether those outcomes and analyses that were deemed as appropriate before trial commencement are actually published (hence helping to find out selective reporting of outcomes). Unfortunately, the rate of registered trials in mental health interventions is low and, frequently, of poor quality. Conclusion: Clinicians should be prudent when interpreting the results of published trials and some meta-analyses - such as those conducted by scientists working for the sponsor company or those that only include published trials. Prescribers, however, should be confident when prescribing drugs following the summary of product characteristics, since regulatory agencies have access to all clinical trial results

Functional transcranial Doppler: Selection of methods for statistical analysis and representation of changes in flow velocity

INTRODUCTION Transcranial Doppler (TCD) is a method used to study cerebral hemodynamics. In the majority of TCD studies, regression analysis and analysis of variance are the most frequently applied statistical methods. However, due to the dynamic and interdependent nature of flow velocity, nonparametric tests may allow for better statistical analysis and representation of results. METHOD The sample comprised 30 healthy participants, aged 33.87 ± 7.48 years; with 33% (n = 10) females. During a visuo-motor task, the mean flow velocity (MFV) in the middle cerebral artery (MCA) was measured using TCD. The MFV was converted to values relative to the resting state. The results obtained were analyzed using the general linear model (GLM) and the general additional model (GAM). The fit indices of both analysis methods were compared with each other. RESULTS Both MCAs showed a steady increase in MFV during the visuo-motor task, smoothly returning to resting state values. During the first 20 seconds of the visuo-motor task, the MFV increased by a factor of 1.06 ± 0.07 in the right-MCA and by a factor of 1.08 ± 0.07 in the left-MCA. GLM and GAM showed a statistically significant change in MFV (GLM:F(2, 3598) = 16.76, P < .001; GAM:F(2, 3598) = 21.63, P < .001); together with effects of hemispheric side and gender (GLM:F(4, 3596) = 7.83, P < .005; GAM:F(4, 3596) = 2.13, P = .001). Comparing the models using the χ$^{2}$ test for goodness of fit yields a significant difference χ$^{2}$ (9.9556) = 0.6836, P < .001. CONCLUSIONS Both the GLM and GAM yielded valid statistical models of MFV in the MCA in healthy subjects. However, the model using the GAM resulted in improved fit indices. The GAM's advantage becomes even clearer when the MFV curves are visualized; yielding a more realistic approach to brain hemodynamics, thus allowing for an improvement in the interpretation of the mathematical and statistical results. Our results demonstrate the utility of the GAM for the analysis and representation of hemodynamic parameters

Funcionamento e satisfação pessoal e social com a vida em pacientes com esquizofrenia com e sem distúrbios do sono

Background: Patients with schizophrenia often present sleep complaints which have been related to poor patient quality of life. Physiologic sleep, compatible with work routines is necessary, and may translate into better social functioning, engagement in rehabilitation strategies, and satisfaction with life. Methods: In this cross-sectional, non-interventional study, 811 adult outpatients with a diagnosis of schizophrenia were divided into two groups according to the presence (or absence) of sleep disturbances, and assessed using measures of symptom severity, quality and patterns of sleep (Pittsburgh Sleep Quality Index - PSQI), personal and social functioning, and satisfaction with life. Results: Patients with sleep disturbances were significantly more symptomatic, and revealed worse quality of sleep on all componentes of the PSQI (pAntecedentes: Os pacientes com esquizofrenia muitas vezes apresentam queixas de sono que têm sido relacionados com a má qualidade de vida do paciente. Sono fisiológico, compatível com rotinas de trabalho é necessário, e pode se traduzir em um melhor funcionamento social, o empenhamento nas estratégias de reabilitação e satisfação com a vida. Métodos: Neste estudo transversal, não-intervencionista, 811 pacientes adultos com diagnóstico de esquizofrenia foram divididos em dois grupos de acordo com a presença (ou ausência) de distúrbios do sono, e avaliados através de medidas de gravidade dos sintomas,qualidade e padrões de sono (Pittsburgh Sleep Quality Index - PSQI), o funcionamento pessoal e social, e satisfação com a vida. Resultados: Os pacientes com distúrbios do sono foram significativamente mais sintomáticos, e revelou pior qualidade do sono em todos os Componentes do IQSP (

EPICOG-SCH: A brief battery to screen cognitive impact of schizophrenia in stable outpatients

Brief batteries in schizophrenia, are needed to screen for the cognitive impact of schizophrenia. We aimed to validate and co-norm the Epidemiological Study of Cognitive Impairment in Schizophrenia (EPICOG-SCH) derived brief cognitive battery. A cross-sectional outpatient evaluation was conducted of six-hundred-seventy-two patients recruited from 234 centers. The brief battery included well-known subtests available worldwide that cover cognitive domains related to functional outcomes: WAIS-III-Letter-Number-Sequencing-LNS, Category Fluency Test-CFT, Logical-Memory Immediate Recall-LM, and Digit-Symbol-Coding-DSC. CGI-SCH Severity and WHO-DAS-S were used to assess clinical severity and functional impairment, respectively. Unit Composite Score (UCS) and functional regression-weighted Composite Scores (FWCS) were obtained; discriminant properties of FWCS to identify patients with different levels of functional disability were analyzed using receiver-operating characteristic (ROC) technique. The battery showed good internal consistency, Cronbach's alpha = 0.78. The differences between cognitive performance across CGI-SCH severity level subscales ranged from 0.5 to 1 SD. Discriminant capacity of the battery in identifying patients with up to moderate disability levels showed fair discriminant accuracy with areas under the curve (AUC) > 0.70, p < 0.0001. An FWCS mean cut-off score ≥ 100 showed likelihood ratios (LR) up to 4.7, with an LR+ of 2.3 and a LR− of 0.5. An FWCS cut-off ≥ 96 provided the best balance between sensitivity (0.74) and specificity (0.62). The EPICOG-SCH proved to be a useful brief tool to screen for the cognitive impact of schizophrenia, and its regression-weighted Composite Score was an efficient complement to clinical interviews for confirming patients' potential functional outcomes and can be useful for monitoring cognition during routine outpatient follow-up visits

Assessing the severity of functional impairment of psychiatric disorders: equipercentile linking the mini-ICF-APP and CGI

BACKGROUND The assessment of functioning and impairment due to psychiatric illness has been acknowledged to be crucial for research and practice. This led to the development of the mini-ICF-APP, which provides a reliable and time-efficient measure of functioning and impairment. Although its use is increasing, it remains unclear how it reflects severity and how change might be interpreted from a clinical perspective. METHODS In a clinical sample of 3067 individuals hospitalized for mental health treatment, we used an equipercentile approach to link the mini-ICF-APP with the Clinical Global Impression scale (CGI) at admission and discharge. We linked the mini-ICF-APP sum score to the CGI-S scale and the mini-ICF-APP proportional change between admission and discharge to the CGI-I scale. RESULTS The mini-ICF-APP and CGI scales showed a Spearman correlation of 0.50 (p  .000); "no-change" in the CGI-I corresponded to an increase or decrease of 2%; "minimally-improved" to a mini-ICF-APP reduction of 3-30%; "much-improved" to a reduction of 31-63%; "very-much-improved" to a reduction of ≥64% "minimally-worse" to an increase of 3-34% "much-worse" to an increase of 35-67%; and finally "very-much-worse" with an increase of ≥68%. CONCLUSIONS Our findings improve understanding of the clinical meaning of the mini-ICF-APP sum score and percentage change in patients hospitalized for treatment