Double–blind control of the data manager doesn't have any impact on data entry reliability and should be considered as an avoidable cost

<p>Abstract</p> <p>Background</p> <p>Database systems have been developed to store data from large medical trials and survey studies. However, a reliable data storage system does not guarantee data entering reliability.</p> <p>We aimed to evaluate if double-blind control of the data manager might have any effect on data-reliability. Our secondary aim was to assess the influence of the inserting position in the insertion-sheet on data-entry accuracy and the effectiveness of electronic controls in identifying data-entering mistakes.</p> <p>Methods</p> <p>A cross-sectional survey and single data-manager data entry.</p> <p>Data from PACMeR_02 survey, which had been conducted within a framework of the SESy-Europe project (PACMeR_01.4), were used as substrate for this study. We analyzed the electronic storage of 6446 medical charts. We structured data insertion in four sequential phases. After each phase, the data stored in the database were tested in order to detect unreliable entries through both computerized and manual random control. Control was provided in a double blind fashion.</p> <p>Results</p> <p>Double-blind control of the data manager didn't improve data entry reliability. Entries near the end of the insertion sheet were correlated with a larger number of mistakes. Data entry monitoring by electronic-control was statistically more effective than hand-searching of randomly selected medical records.</p> <p>Conclusion</p> <p>Double-blind control of the data manager should be considered an avoidable cost. Electronic-control for monitoring of data-entry reliability is suggested.</p

Probability of Major Depression Classification Based on the SCID, CIDI and MINI Diagnostic Interviews : A Synthesis of Three Individual Participant Data Meta-Analyses

Three previous individual participant data meta-analyses (IPDMAs) reported that, compared to the Structured Clinical Interview for the DSM (SCID), alternative reference standards, primarily the Composite International Diagnostic Interview (CIDI) and the Mini International Neuropsychiatric Interview (MINI), tended to misclassify major depression status, when controlling for depression symptom severity. However, there was an important lack of precision in the results.To compare the odds of the major depression classification based on the SCID, CIDI, and MINI.We included and standardized data from 3 IPDMA databases. For each IPDMA, separately, we fitted binomial generalized linear mixed models to compare the adjusted odds ratios (aORs) of major depression classification, controlling for symptom severity and characteristics of participants, and the interaction between interview and symptom severity. Next, we synthesized results using a DerSimonian-Laird random-effects meta-analysis.In total, 69,405 participants (7,574 [11%] with major depression) from 212 studies were included. Controlling for symptom severity and participant characteristics, the MINI (74 studies; 25,749 participants) classified major depression more often than the SCID (108 studies; 21,953 participants; aOR 1.46; 95% confidence interval [CI] 1.11-1.92]). Classification odds for the CIDI (30 studies; 21,703 participants) and the SCID did not differ overall (aOR 1.19; 95% CI 0.79-1.75); however, as screening scores increased, the aOR increased less for the CIDI than the SCID (interaction aOR 0.64; 95% CI 0.52-0.80).Compared to the SCID, the MINI classified major depression more often. The odds of the depression classification with the CIDI increased less as symptom levels increased. Interpretation of research that uses diagnostic interviews to classify depression should consider the interview characteristics

Randomized controlled augmentation trials in clozapine-resistant schizophrenic patients: a critical review

Approximately 40-70% of treatment-resistant schizophrenic patients fail to benefit from clozapine monotherapy or are partial responders. During the last years several clozapine adjunctive agents have come into clinical practice. This study aims to critically review all published randomized, double-blind, placebo-controlled clinical trials (RCTs) regarding the efficacy and safety of adjunctive agents in dozapine-resistant schizophrenic or schizoaffective patients. A MEDLINE search for RCTs on clozapine adjunctive agents published from January 1980 to February 2004 was conducted. All identified papers were critically reviewed and examined against several methodological features as well as clinical and pharmacological parameters. Eleven trials including 270 patients, partial or non-responders to clozapine, assessed the efficacy of sulpiride, lithium, lamotrigine, fluoxetine, glycine, D-serine, D-cycloserine and ethyl-eicosapentanoate (E-EPA) as clozapine adjuncts. There were eight parallel-group and three crossover trials. The inclusion criteria varied widely. The duration as well as the dosage of clozapine monotherapy were reported adequate in only one trial. Plasma clozapine levels were assessed in only three trials. Main side-effects reported were hypersalivation, sedation, diarrhea, nausea, hyperprolactinaema. The outcome favored clozapine augmentation with sulpiride, lamotrigine and E-EPA. Lithium was shown to benefit only schizoaffective patients. However, the methodological shortcomings of trials analyzed limit the impact of evidence provided. (c) 2005 Elsevier SAS. All rights reserved

The Methodology of Forensic Neuroscience

Insanity is a distinctive element of criminal law because it brings together two very different disciplines, psychiatry and psychology on the one hand and the law on the other. It might strongly benefit from the introduction of structural neuroimaging, that, however, had so far a limited translational impact. Brain imaging purports to demonstrate functional status and thereby it can be useful to provide a scientific explanation for the clinical symptoms strenghtening the medico-legal reasoning. Despite international cases using brain imaging to support diminished responsibility, in Italy there are still a lot of controversies. Is the neuroscientific logic deterministic? How may the classic psychiatric/neurologic examination and neuroscientific evidence work side by side? Are the symptoms not legally relevant really not relevant? Could the study of the brain inform the clinical diagnosis? Could the study of the brain inform the expert opinion on responsibility and insanity? In this chapter, we describe the cognitive and behavioral profile of a defendant charged with murder, as well as his brain imaging correlates. Through the analysis of this real forensic case, we address the above questions and conclude that neuroscience may strengthen the results of psychiatric evaluations, thus reducing uncertainty in the forensic settings. We claim that besides the clinical diagnosis, the study of the brain allows a better understanding of the individual acts

Probability of major depression diagnostic classification based on the SCID, CIDI and MINI diagnostic interviews controlling for Hospital Anxiety and Depression Scale - Depression subscale scores: An individual participant data meta-analysis of 73 primary studies

Objective Two previous individual participant data meta-analyses (IPDMAs) found that different diagnostic interviews classify different proportions of people as having major depression overall or by symptom levels. We compared the odds of major depression classification across diagnostic interviews among studies that administered the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Methods Data accrued for an IPDMA on HADS-D diagnostic accuracy were analysed. We fit binomial generalized linear mixed models to compare odds of major depression classification for the Structured Clinical Interview for DSM (SCID), Composite International Diagnostic Interview (CIDI), and Mini International Neuropsychiatric Interview (MINI), controlling for HADS-D scores and participant characteristics with and without an interaction term between interview and HADS-D scores. Results There were 15,856 participants (1942 [12%] with major depression) from 73 studies, including 15,335 (97%) non-psychiatric medical patients, 164 (1%) partners of medical patients, and 357 (2%) healthy adults. The MINI (27 studies, 7345 participants, 1066 major depression cases) classified participants as having major depression more often than the CIDI (10 studies, 3023 participants, 269 cases) (adjusted odds ratio [aOR] = 1.70 (0.84, 3.43)) and the semi-structured SCID (36 studies, 5488 participants, 607 cases) (aOR = 1.52 (1.01, 2.30)). The odds ratio for major depression classification with the CIDI was less likely to increase as HADS-D scores increased than for the SCID (interaction aOR = 0.92 (0.88, 0.96)). Conclusion Compared to the SCID, the MINI may diagnose more participants as having major depression, and the CIDI may be less responsive to symptom severity.</p