An update on randomized controlled trials of evidence-based supported employment

BACKGROUND: The Individual Placement and Support (IPS) model of supported employment for clients with severe mental illness has been described as a standardization of evidence-based supported employment. Although several reviews on the literature on its effectiveness have been conducted, the completion of several new studies suggests an updated review is warranted. METHODS: We conducted a comprehensive literature search for randomized controlled trials of IPS, limiting our review to programs with high-fidelity IPS programs, locating 11 studies. We examined the following competitive employment outcomes: employment rates, days to first job, annualized weeks worked, and job tenure in longest job held during the follow-up period. FINDINGS: Across the 11 studies, the competitive employment rate was 61% for IPS compared to 23% for controls. About two-thirds of those who obtained competitive employment worked 20 hours or more per week. Among those who obtained a competitive job, IPS participants obtained their first job nearly 10 weeks earlier than did controls. Among IPS participants who obtained competitive work, duration of employment after the start of the first job averaged 24.2 weeks per year, or 47% of the 52-week year. CONCLUSIONS: The current review is consistent with earlier reviews, although the evidence for high-fidelity IPS appears to be somewhat stronger here than in reviews evaluating studies with more heterogeneity in the supported employment models examined. The number, consistency, and effect sizes of studies of evidence-based supported employment establish it as one of the most robust interventions available for persons with severe mental illness.     

Flow diverters for treatment of intracranial aneurysms: Current status and ongoing clinical trials

The ultimate treatment goal for intracranial aneurysms is to reconstruct the vessel wall and correct the hemodynamic disturbance. A flow diverter is a stent placed in the parent artery to reduce blood flow in the aneurysm sac to the point of stagnation, gradual thrombosis, and neointimal remodeling to maintain outflow in the side branches and perforators. Here, we review the two commercially available flow diverters, the Pipeline Embolization Device (PED) and the SILK flow diverter (SFD). The rates of severe hemorrhagic complications have been reported to be 2% for the PED and 0.8% for the SFD. The results of studies completed thus far show that endovascular reconstruction with flow diverters is an effective treatment of wide-necked, fusiform, large, and giant unruptured intracranial aneurysms, with 5% to 10% of patients experiencing permanent major morbidity and mortality. The results of ongoing studies may resolve whether flow diverters can replace coil embolization for the treatment of all, or selected, intracranial aneurysms.     

Iatrogenic intracranial aneurysms in childhood: case-based update

Purpose

Iatrogenic aneurysms are very rare in children. Characteristic clinical manifestations are variable and asymptomatic course is possible especially for fusiform dilatation of internal carotid artery. Even though radiological diagnosis is easy, the management of iatrogenic intracranial aneurysm is still a subject for discussion.

Methods

Fusiform dilatations of internal carotid artery were diagnosed on three pediatric patients during follow-up imaging after primary surgery for suprasellar–parasellar tumor. All patients were asymptomatic. Conservative treatment was proposed because the lesion did not show any progression in subsequent examinations. Patients are stable under conservative treatment.

Conclusions

Iatrogenic aneurysm may have an unusual presentation and their therapy still remains unclear. Fusiform dilatation of internal carotid artery rarely causes symptoms and there is no published paper of subarachnoid bleeding. Treatment would be difficult, since the main arterial branches arise from the dilated carotid segment. Conservative treatment is a choice only if aneurysm has no progression or in case of spontaneous healing. Intervention should be performed only in case of progression or if the aneurysm becomes symptomatic.     

Current diagnostic modalities for intracranial aneurysms

Aneurysm diagnosis has evolved considerably over the last years. Technological advances have brought CT angiography and MR angiography to the forefront of ruptured and nonruptured intracranial aneurysm diagnosis. This article highlights current diagnostic modalities for intracranial aneurysms.     

Dexmedetomidine as an anesthetic adjuvant for intracranial procedures: Meta-analysis of randomized controlled trials

This meta-analysis aimed to systematically collect the current evidence regarding the efficacy and safety of dexmedetomidine (DEX) as an anesthetic adjuvant for patients undergoing intracranial surgery. A systematic literature search of randomized controlled trials (RCT) was conducted to compare DEX with placebo or opioids in patients undergoing intracranial procedures. Hemodynamic data, opioid consumption, and recovery parameters were pooled. Eight RCT were included. Results showed that patients treated with DEX required less intraoperative treatment for hypertension and hypotension (risk ratio [RR] = 0.48, 95% confidence interval [CI] 0.31–0.75, p = 0.001; and RR = 0.66, 95% CI 0.43–1.01, p = 0.05, respectively) and less postoperative treatment for hypertension and tachycardia (RR = 0.37, 95% CI 0.17–0.79, p = 0.01; and RR = 0.14, 95% CI 0.03–0.59, p = 0.007, respectively) compared with placebo. Patients also had lower mean arterial pressure and heart rate when extubated (mean difference [MD] = −9.74 mmHg, 95% CI −12.35 to −7.12, p < 0.00001; and MD = −16.35 beats/minute, 95% CI −20.00 to −12.70, p < 0.00001, respectively), a lower intraoperative additional fentanyl consumption (MD = −0.78 μg/kg, 95% CI −1.51 to −0.05, p = 0.04), and lower postoperative antiemetic requests (RR = 0.51, 95% CI 0.33–0.80, p = 0.003). DEX may not increase extubation time, postoperative P_aCO₂, or the risk of perioperative bradycardia. Only a small number of RCT are available, but meta-analysis shows evidence that DEX as an anesthetic adjuvant during intracranial procedures leads to better perioperative hemodynamic control, less intraoperative opioid consumption, and fewer postoperative antiemetic requests.     

我国神经疾病防治性研究随机对照试验现状的初步分析

目的探讨我国神经疾病防治性研究随机对照试验（ＲＣＴ）的现状及能否向临床实践提供可靠的研究依据。方法对我国可能刊登上述ＲＣＴ的６种中文杂志进行人工查阅并根据国际标准对其ＲＣＴ报告进行分析。结果查阅杂志３１４期,共含文章１１５２７篇,检索出并分析ＲＣＴ报告７８篇。结论我国神经疾病防治性研究ＲＣＴ的数量与质量还不能满足临床实践的需要。更多地开展高质量ＲＣＴ研究对于提高神经系统疾病的防治水平具有重要意义。     

Selective outcome reporting across psychopharmacotherapy randomized controlled trials

ObjectiveSelective reporting impairs the valid interpretation of trials and leads to bias with regards to the clinical evidence. We aimed to examine factors associated with selective reporting in psychopharmacotherapy trials and thus enable solutions to prevent such selective reporting in the future.MethodsWe retrieved all registry records of trials investigating medication for depressive, bipolar and psychotic disorders. Multivariate logistic regression was performed with selective reporting as outcome, and funding source, psychiatric disorder, year of study start date, participating centers, and anticipated sample size as explanatory variables, after testing for multicollinearity. Adjusted odds ratios (AOR) were calculated. Two‐sided Fisher exact test was used to compare the proportions of newly added positive primary outcomes with the proportions of positive results in the overall group of primary outcomes.ResultsOf 151 included trials (N = 94,303 participants), 21 (14%) showed irregularities between registered and published primary outcomes. Higher odds of such irregularities were associated with non‐industry‐funded RCTs (AOR 5.3; p = 0.014) and trials investigating major depressive disorder (AOR 12.7; p = 0.024) or schizophrenia (AOR 14.5; p = 0.016; Table 1).ConclusionWe demonstrate discrepancies between trial registrations and publications across RCTs investigating debilitating psychiatric disorders, especially in non‐industry funded RCTs.     

Long-term outcomes of ruptured saccular intracranial aneurysm clipping versus coiling: systematic review and meta-analysis of randomized controlled trials

Neurological Sciences - Previous meta-analyses comparing microsurgery and coiling that include BRAT may be inaccurate to compare the outcomes of ruptured saccular aneurysms. This study aims to...     

Reported quality of randomized controlled trials in neglect rehabilitation

The aim of this study is to assess the reported quality of randomized controlled trials (RCTs) on the effectiveness of neglect rehabilitation using a standardized scale. A search of seven electronic databases was carried out. Selected articles were scored using the PEDro scale and classified as high or low quality study both with the original cut off of 6 and a modified cut off of 5. A linear regression analysis between year of publication and quality rate was used to test whether the quality of the studies improved with time. A total of 18 RCTs were selected. Six articles (33.3%) and 10 articles (55.56%) were classified as having high quality when the original cut off or the modified cut off of the PEDro scale were used, respectively. Analysis shows no time-related changes in PEDro scores. The results show that reported quality is moderate for RCTs in neglect rehabilitation.     

Maintenance therapies in bipolar disorder: focus on randomized controlled trials

OBJECTIVE: Lithium remains the cornerstone of maintenance therapy for bipolar disorder despite growing use of other agents, including divalproex, lamotrigine, carbamazepine and the atypical antipsychotics. Lithium has the largest body of data to support its continued use as a prophylactic agent; however, most of this data comes from early studies that did not use contemporary analytic methods. Alternatives to lithium are needed because of the relatively high rate of non-response to lithium monotherapy and the drug's frequent side-effects. This article reviews available data with an emphasis on double-blind, placebo-controlled studies that examine the efficacy of lithium and other putative mood stabilizers: carbamazepine, divalproex, lamotrigine and olanzapine. METHOD: The authors reviewed key literature using Medline searches using key words: bipolar disorder, controlled trials, mood stabilizer, lithium, lomotrigine, divalproex, olanzapine, carbamazepine. RESULTS: Lithium remains the gold standard for overall preventative efficacy in bipolar disorder, especially to decrease manic or hypomanic relapse. Of the mood stabilizers that have marked prophylactic antimanic properties, lithium appears to possess the greatest antidepressant effect. Divalproex may also prevent recurrent bipolar mood episodes but the relative lack of controlled maintenance studies makes this less certain. There now exists an extensive and well-designed research database supporting the use of lamotrigine in the acute and prophylactic management of bipolar I disorder. Lamotrigine offers a spectrum of clinical effectiveness that complements lithium, in that it appears to stabilize mood 'from below baseline' by preventing episodes of depression and has been shown to be effective in rapid-cycling bipolar II disorder. Carbamazepine may be a useful alternative to lithium, divalproex and lamotrigine, particularly for patients with a history of mood-incongruent delusions and other comorbidities, but controlled data is more equivocal and it may lose some of its prophylactic effect over time. Emerging data continue to support the growing use of atypical antipsychotics, particularly olanzapine. CONCLUSIONS: Any monotherapy for use as a maintenance therapy of bipolar disorder appears to be inadequate for long-term use in the management of the majority of patients with bipolar disorder. Combination therapy has become the standard of care in the treatment of bipolar disorder and particularly in patients with treatment-refractory variants such as those with rapid-cycling. The emerging consensus is that patients on monotherapy, if followed for sufficiently long periods, will eventually require concomitant treatment to maintain a full remission. There exists a need for controlled trials that use random assignment to parallel arms including combination therapy followed by data analyses that include both relapse rate and survival techniques.     

Effect of cannabidiol on schizophrenia based on randomized controlled trials: A meta-analysis

Studies and treatments of schizophrenia with cannabidiol (CBD) alone have been reported. However, there have been a variety of different results of the effects of CBD in schizophrenic patients based on the positive and negative syndrome scale (PANSS). Thus, the present meta-analysis aimed to determine the effects of CBD on schizophrenia. We searched internet databases and identified 774 potentially relevant studies, among which nine studies were ultimately included in our present meta-analysis. Our results showed that CBD treatments significantly decreased PANSS positive scores (95% CI, ?2.51, ?0.89, P = 0.27, I² = 18%) but had no effect on other PANSS scores. Interestingly, while the safety of CBD has continued to be further demonstrated over time despite the dosage of CBD being gradually increased, the dosage of delta-9-tetrahydrocannabinol (THC) has remained essentially unchanged. Following our present meta-analysis, we suggest possible mechanisms of CBD-based amelioration of schizophrenic symptoms, such as CBD-induced increases in fronto-striato-thalamic coupling.     

颅内动脉瘤的影像学比较研究

目的比较磁共振血管造影术(MRA)、计算机体层血管造影术(CTA)和数字减影血管造影术(DSA)诊断颅内动脉瘤的临床应用价值,探讨评价颅内动脉瘤更为合理且准确的方法。方法135例颅内动脉瘤患者均经脑血管造影检查明确诊断,其中86例行CTA检查,22例行MRA检查,9例行CTA和MRA联合检查。结果MRA检查的56个动脉瘤中直径≥5mm者27个,与脑血管造影诊断符合率达96.30%(26/27);直径<5mm者29个,诊断符合率为37.93%(11/29),组间差异有统计学意义(χ2=18.914,P=0.000)。CTA检查的110个动脉瘤中直径≥2mm者104个,与脑血管造影诊断符合率达96.15%(100/104);直径<2mm者6个,诊断符合率为16.67%(1/6),组间差异有统计学意义(χ2=36.959,P=0.000)。结论MRA及CTA在一定条件下对颅内动脉瘤的诊断能力与脑血管造影相当,尤其是CTA检查可作为自发性蛛网膜下腔出血患者的首选检查方法,能够降低费用,减少并发症。