Social media attention and citations of published outputs from re-use of clinical trial data: a matched comparison with articles published in the same journals.

BACKGROUND: Data-sharing policies in randomized clinical trials (RCTs) should have an evaluation component. The main objective of this case-control study was to assess the impact of published re-uses of RCT data in terms of media attention (Altmetric) and citation rates. METHODS: Re-uses of RCT data published up to December 2019 (cases) were searched for by two reviewers on 3 repositories (CSDR, YODA project, and Vivli) and matched to control papers published in the same journal. The Altmetric Attention Score (primary outcome), components of this score (e.g. mention of policy sources, media attention) and the total number of citations were compared between these two groups. RESULTS: 89 re-uses were identified: 48 (53.9%) secondary analyses, 34 (38.2%) meta-analyses, 4 (4.5%) methodological analyses and 3 (3.4%) re-analyses. The median (interquartile range) Altmetric Attention Scores were 5.9 (1.3-22.2) for re-use and 2.8 (0.3-12.3) for controls (p = 0.14). No statistical difference was found on any of the components of in the Altmetric Attention Score. The median (interquartile range) numbers of citations were 3 (1-8) for reuses and 4 (1 - 11.5) for controls (p = 0.30). Only 6/89 re-uses (6.7%) were cited in a policy source. CONCLUSIONS: Using all available re-uses of RCT data to date from major data repositories, we were not able to demonstrate that re-uses attracted more attention than a matched sample of studies published in the same journals. Small average differences are still possible, as the sample size was limited. However matching choices have some limitations so results should be interpreted very cautiously. Also, citations by policy sources for re-uses were rare. TRIAL REGISTRATION: Registration: osf.io/fp62e.

Research transparency promotion by surgical journals publishing randomised controlled trials: a survey.

OBJECTIVE: To describe surgical journals' position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion. METHODS: Only "SURGICAL" journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors (OIA) or if they had published randomised controlled trial (RCT) between 1 January 2016 and 31 December 2018. The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data-sharing policies were grouped into 3 categories, inclusion of data-sharing policy mandatory, optional, or not available. Details on research transparency promotion were also collected, namely the existence of a "prospective registration of clinical trials requirement policy", a conflict of interests (COIs) disclosure requirement, and a specific reference to reporting guidelines, such as CONSORT for RCT. RESULTS: Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR = 2.48-3.77], and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR = 5-20.75]. The OIA of four journals (5%) stated that the inclusion of a data-sharing statement was mandatory, optional in 45% (n = 37), and not included in 50% (n = 41). No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A "prospective registration of clinical trials requirement" was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors. Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines. CONCLUSION: Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.

Defending psychiatry or defending the trivial effects of therapeutic interventions? A citation content analysis of an influential paper.

AIMS: Leucht et al. in 2012 described an overview of meta-analyses of the efficacy of medication in psychiatry and general medicine, concluding that psychiatric drugs were not less efficacious than other drugs. Our goal was to explore the dissemination of this highly cited paper, which combined a thought provoking message with a series of caveats. METHODS: We conducted a prospectively registered citation content analysis. All papers published before June 1st citing the target paper were independently rated by two investigators. The primary outcome coded dichotomously was whether the citation was used to justify a small or modest effect observed for a given treatment. Secondary outcomes regarded mentioning any caveats when citing the target paper, the point the citation was making (treatment effectiveness in psychiatry closely resembles that in general medicine, others), the type of condition (psychiatric, medical or both), specific disease, treatment category and specific type. We also extracted information about the type of citing paper, financial conflict of interest (COI) declared and any industry support. The primary analysis was descriptive by tabulating the extracted variables, with numbers and percentages where appropriate. Co-authorship networks were constructed to identify possible clusters of citing authors. An exploratory univariate logistic regression was used to explore the relationship between each of a subset of pre-specified secondary outcomes and the primary outcome. RESULTS: We identified 135 records and retrieved and analysed 120. Sixty-three (53%) quoted Leucht et al.'s paper to justify a small or modest effect observed for a given therapy, and 113 (94%) did not mention any caveats. Seventy-two (60%) used the citation to claim that treatment effectiveness in psychiatry closely resembles that in general medicine; 110 (91%) paper were about psychiatric conditions. Forty-one (34%) papers quoted it without pointing towards any specific treatment category, 28 (23%) were about antidepressants, 18 (15%) about antipsychotics. Forty (33%) of the citing papers included data. COIs were reported in 55 papers (46%). Univariate and multivariate regressions showed an association between a quote justifying small or modest effects and the point that treatment effectiveness in psychiatry closely resembles that in general medicine. CONCLUSIONS: Our evaluation revealed an overwhelmingly uncritical reception and seemed to indicate that beyond defending psychiatry as a discipline, the paper by Leucht et al. served to lend support and credibility to a therapeutic myth: trivial effects of mental health interventions, most often drugs, are to be expected and therefore accepted.Protocol registration: https://osf.io/9dqat/.

Overlapping network meta-analyses on the same topic: survey of published studies.

Background: To assess how common it is for a published network meta-analysis (NMA) to have other published overlapping NMAs, and to evaluate these overlaps. Methods: A total of 88 NMAs of randomized controlled trials evaluating the comparative effectiveness of health interventions were randomly selected. For each of these, we searched for NMAs on the same topic. A random sample of 40 pairs (an index NMA and one of its overlapping NMAs) was selected to assess the overlap in terms of nodes, treatments and references. The topic with the largest number of overlapping NMAs was described in depth. Results: In all, 68 of the 88 index NMAs had at least one overlapping NMA: 77% [95% confidence interval (CI), 69-86%]. We identified 515 pairs of overlapping NMAs. Among the 40 randomly selected pairs, 73% (95% CI, 58-88%) of nodes, 79% (95% CI, 72-86%) of treatments and 48% (95% CI, 37-59%) of references included in the index NMAs were also found in the respective overlapping NMAs. Efficacy of biologics in rheumatoid arthritis had the largest number of overlapping NMAs, with 28 NMAs published between 2003 and 2014. Differences in selection and definition of nodes of treatments resulted in different network geometries. There were also differences in both the direction and the statistical significance of effects. Conclusions: Published NMAs exhibit extensive overlap and potential redundancy. Erratic retrieval of eligible trials, and lack of consensus on the range of interventions to be considered and how they might be merged or split in different nodes, may cause confusion.

The learning curve effect on embolization of cerebral dural arteriovenous fistula single-center experience in 48 consecutive patients.

BACKGROUND: Cerebral dural arteriovenous fistulas (DAVFs) are rare intracranial vascular lesions but can cause significant morbidity and mortality. OBJECTIVES: To analyze the effect of the center's experience on DAVF embolization efficacy and safety. METHODS: From May 2008 to October 2014, 57 embolization procedures were attempted on 48 patients (37 men and 11 women; median age: 63.9 years) for DAVF in a single center. DAVF presented with cortical venous reflux in 44/48 cases (91.7%) and hemorrhagic manifestation in 21/48 cases (43.75%). Angiographic occlusion quality, whether complete or incomplete (efficacy), and neurological complications (safety) were recorded. The patient population was divided into four consecutive quartiles during the inclusion period to assess the progress profile. Efficacy and safety outcomes were compared with Fisher's test. RESULTS: A logistic regression was performed to explore a learning curve phenomenon, showing a significant association between the chronological rank in the cohort and embolization efficacy (P=0.007). Significant differences were found between first and last quarter (P=0.036). The endovascular technique involved an arterial injection of Onyx® in 36/48 cases (75%), administered via the middle meningeal artery in 25/36 cases (69.5%). The complete occlusion rate improved significantly from 33.3% for the first quartile of the population, to 75.0% for the 2nd and 3rd quartiles and 83.3% for the last quartile. Neurological complications were found in 7/48 patients (14.6%), the rate decreased by 41.7% to 16.7%, without statistically difference. CONCLUSION: The efficacy and safety of DAVF embolization improved with the experience gained at the center, suggesting the existence of a learning curve.

Manic switches induced by antidepressants: an umbrella review comparing randomized controlled trials and observational studies.

OBJECTIVE: We aimed to explore whether the prevalence of manic switch was underestimated in randomized controlled trials (RCTs) compared to observational studies (OSs). METHOD: Meta-analyses and simple and systematic reviews were identified by two reviewers in a blinded, standardized manner. All relevant references were extracted to include RCTs and OSs that provided data about manic switch prevalence after antidepressant treatment for a major depressive episode. The primary outcome was manic switch prevalence in the different arms of each study. A meta-regression was conducted to quantify the impact of certain variables on manic switch prevalence. RESULTS: A total of 57 papers (35 RCTs and 22 OSs) were included in the main analysis. RCTs underestimated the rate of manic switch [0.53 (0.32-0.87)]. Overestimated prevalence was related to imipraminics [1.85 (1.22-2.79)]; to serotonin-norepinephrine reuptake inhibitors [1.74 (1.06-2.86)]; and to other classes of drugs [1.58 (1.08-2.31)], compared to placebo treatment. The prevalence of manic switch was lower among adults than among children [0.2 (0.07-0.59)]; and higher [20.58 (8.41-50.31)] in case of bipolar disorder. CONCLUSION: Our results highlight an underestimation of the rates of manic switch under antidepressants in RCTs compared to the rates observed in observational studies.

[Impulsivity: What are the consequences on compliance to rehabilitation?]. / L'impulsivité : quelles conséquences sur l'adhésion aux soins ? Présentation d'une étude réalisée en addictologie.

INTRODUCTION: Impulsivity is a transnosographical dimension with major consequences on medical care with which psychiatrists are frequently confronted. Furthermore, compliance is a major variable that can affect the efficiency of therapeutics and hospitalizations in psychiatry. A study was carried out in three drug and alcohol rehabilitation hospitalization units to find out if impulsivity can have consequences on compliance. METHOD: The studied population was composed of 85 patients aged from 18 to 70, hospitalized for one or more addiction disorders in a psychometric hospital in Vannes (France). Impulsivity was measured for all patients with the BIS-11 at the beginning of the rehabilitation program. Because no tool to evaluate a total rehab program compliance existed, a scale, used at the end of the hospitalization, was created to measure patient compliance. This score was composed of two simple numeric scales (one used by the nurses and one used by the patient's psychiatrist) and a coefficient of hospitalization duration that was the ratio of completed to planned days of hospitalization. Correlations were made between the different dimensions: impulsivity and compliance, impulsivity and hospitalization conditions, compliance and hospitalization conditions (voluntary or involuntary, planned by a psychiatrist or not, etc.). RESULTS: The main statistically significant result of the study was a negative correlation existing between the motor dimension of impulsivity and compliance (r=-0.37 and P=0.001). The other dimensions of impulsivity showed no significant correlation with compliance score. The study revealed that the different hospitalization conditions showed no link with compliance or impulsivity. CONCLUSION: These original results show that motor impulsive patients need an adaptation of the rehabilitation programs. Shorter programs might be more efficient.

Repetitive transcranial magnetic stimulation over the orbitofrontal cortex for obsessive-compulsive disorder: a double-blind, crossover study.

This pilot study was designed to assess the efficacy of low-frequency repetitive transcranial magnetic stimulation (rTMS) over the right orbitofrontal cortex (OFC) by means of a double-cone coil in patients suffering from obsessive-compulsive disorder. We hypothesized that low-frequency stimulation of the OFC would lead to a reduction in clinical symptoms, as measured on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). A randomized, double-blind, crossover design was implemented with two 1-week treatment periods (active stimulation versus sham stimulation) separated by a 1-month washout period. Concomitantly, a subgroup of patients underwent a positron emission tomography (PET) scan after each stimulation sequence. Statistical analyses compared the Y-BOCS scores at the end of each period. At day 7, we observed a significant decrease from baseline in the Y-BOCS scores, after both active (P<0.01) and sham stimulation (P=0.02). This decrease tended to be larger after active stimulation than after sham stimulation: -6 (-29, 0) points versus -2 (-20, 4) points (P=0.07). Active versus sham PET scan contrasts showed that stimulation was related to a bilateral decrease in the metabolism of the OFC. The OFC should definitely be regarded as a key neuroanatomical target for rTMS, as it is easier to reach than either the striatum or the subthalamic nucleus, structures favored in neurosurgical approaches.

[Is the court-ordered treatment indication by the expert based on a medical diagnosis?]. / L'indication d'injonction de soins repose-t-elle sur un diagnostic médical ?

UNLABELLED: Court-ordered treatment was created in 1998, as part of a law against sexual offense recidivism. The creation of court-ordered treatment is based on the premise that many offenders have psychiatric disorders. If the court-ordered treatment is appraised as an effective way to prevent recidivism by the lawmaker, the preeminent role of psychiatry, in the prevention of recidivism has generated controversy in the psychiatric community. Few studies have been conducted on court-ordered treatment in France, and have concerned epidemiological measures. Court-ordered treatment leads to an extension of the expert's mission. In order to prevent recidivism, the interest of a treatment is a new part of the expert's mission. PURPOSE: The main purpose of this study was to assess the kind of diagnosis reported by the forensic psychiatrist who considered the court-ordered treatment as appropriate. METHOD: We led a descriptive and retrospective study among the experts' reports of 68 subjects followed by three psychiatrists. We categorized each diagnosis found in the experts' reports in reference to DSM-IV-TR axis I and axis II. As the expert has no obligation to refer to the DSM-IV-TR, we also considered the "no DSM-IV-TR categorized disorder" as a category. The primary outcome was the proportion of each diagnosis category in experts' reports, in which the forensic psychiatrist agreed with the indication of a court-ordered treatment. RESULTS: We analysed 123 experts' reports in which the mission was to diagnose a mental disorder and to assess the need for a court-ordered treatment. The expert agreed with the need for a court-ordered treatment in 112 reports. In those reports the diagnosis was "no disorder" in 27% of them, "no DSM-IV-TR categorized disorder" in 26% of them, "axis II disorder" in 24% of them, "axis I disorder" in 19% of them, and "association of an axis I and an axis II disorder" in 4% of them. DISCUSSION: The diagnoses were heterogeneous. Their associations with the need for a court-ordered treatment seem to be contradictory when considering the association between "no mental disorder" and "need for a court-ordered treatment" found in 27% of the reports. These paradoxical results led us to question the meaning of mental disorder and treatment.

[Understanding logistic regression]. / Comprendre la régression logistique.

Logistic regression is one of the most common multivariate analysis models utilized in epidemiology. It allows the measurement of the association between the occurrence of an event (qualitative dependent variable) and factors susceptible to influence it (explicative variables). The choice of explicative variables that should be included in the logistic regression model is based on prior knowledge of the disease physiopathology and the statistical association between the variable and the event, as measured by the odds ratio. The main steps for the procedure, the conditions of application, and the essential tools for its interpretation are discussed concisely. We also discuss the importance of the choice of variables that must be included and retained in the regression model in order to avoid the omission of important confounding factors. Finally, by way of illustration, we provide an example from the literature, which should help the reader test his or her knowledge.

[Treatment initiation in psychotic and manic episodes: French attitudes collected by Focus Group]. / L'initiation thérapeutique dans les épisodes psychotiques et maniaques : recueil des attitudes françaises par Focus Group.

An accurate treatment of first episodes in schizophrenia and bipolar disorders has a significant impact on compliance and prognosis. However, existing therapeutic guidelines may be poorly respected and may concern only typical clinical situations. Medical attitudes in clinical practice have been collected and structured on the basis of small interactive meetings (Focus Group [FG]), and a synthesis of practical attitudes has been compared with updated guidelines. The FG method applied to treatment initiation in schizophrenia and bipolar disorder is seen as complementary to evidence-based guidelines. It reveals that, in a reflexive manner, clinical attitudes are often more diverse and frequently consider first treatments after global evaluation, taking more into account external factors such as clinicians' experience, patient's history and willingness, clinical setting, and environment. A symptomatic approach is sometimes preferred, and a better alliance is always considered as a main objective. The FG method could be a supplementary support to continuous medical education.