Recently Published Projects

Published on March 03, 2021
Recommendations for decision and simulation modeling
69 Studies • 1 Key Questions • 69 Extraction Forms
Project created on March 03, 2021
Last updated on March 03, 2021
Objectives: Purpose: We aimed to update and expand previous syntheses of evidence- and consensus-based guidance on decision and simulation modeling using a systematic review-driven stakeholder-led process.
Published on March 03, 2021
Adverse Events in Women with Silicone Gel Breast Implants: A Systematic Review
57 Studies • 1 Key Questions • 57 Extraction Forms
Project created on March 03, 2021
Last updated on March 03, 2021
Objectives: Breast implants are medical devices used to reconstruct the breast following mastectomy, to augment breast size, or to correct a congenital abnormality.1 Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). In the US about half of implants are silicone gel-filled implants. Recently, the Food and Drug Administration (FDA) has recommended the creation of a surveillance registry to monitor for potential adverse events associated with silicone gel breast implants. However, a clinical registry that can provide meaningful data on the long-term safety requires a large number of patients and rigorous patient follow-up, both of which have been difficult for breast implant companies to achieve. The American Society of Plastic Surgeons (ASPS®) and the Plastic Surgery Foundation (PSF) has solicited this systematic review (SR) to summarize the state of the literature on safety outcomes in women with silicone gel breast implants for the purpose of informing the development of the registry.
Published on March 03, 2021
Treatment of Common Hip Fractures [Entered Retrospectively]
85 Studies • 8 Key Questions • 85 Extraction Forms
Project created on March 03, 2021
Last updated on March 03, 2021
Objectives: Objectives: To conduct a systematic review and synthesize the evidence for the effects of surgical treatments for subcapital and intertrochanteric/subtrochanteric hip fractures on patient-focused outcomes for elderly patients. Data Sources: MEDLINE®, Cochrane databases, Scirus, and ClinicalTrials.gov, and expert consultants. We also manually searched reference lists from relevant systematic reviews. Review Methods: High quality quasi-experimental design studies were used to examine relationships between patient characteristics, type of fracture, and patient outcomes. Randomized controlled trials were used to examine relationships between type of surgical treatment and patient outcomes. Patient mortality was examined with Forest plots. Narrative analysis was used for pain, quality of life (QoL), and functional outcomes due to inconsistently measured and reported outcomes. Results: Mortality does not appear to differ by device class, or by devices within a class. Nor, on the whole, do pain, functioning, and QoL. Some internal fixation devices may confer earlier return to functioning over others for some patients, but such gains are very short lived. Very limited results suggest that subcapital hip fracture patients with total hip replacements have improved patient outcomes over internal fixation, but it is unclear whether these results would continue to hold if the analyses included the full complement of relevant covariates. Age, gender, prefracture functioning, and cognitive impairment appear to be related to mortality and functional outcomes. Fracture type does not appear to be independently related to patient outcomes. Again, however, the observational literature does not include the full complement of potential covariates and it is uncertain if these results would hold. Conclusions: Several factors limit our ability to definitively answer the key questions posed in this study using the existing literature. Limited perspectives lead to incomplete sets of independent variables included in analyses. Specific populations are poorly defined and separated for comparative study. Fractures with widely varying biomechanical problems are often lumped together. Outcome variables are inconsistently measured and reported, making it very difficult to aggregate or even compare results. If future high quality trials continue to support the evidence that differences in devices are short term at best, within the first few weeks to few months of recovery, policy implications involve establishing the value of a shorter recovery relative to the cost of the new device. As the literature generally focuses on community dwelling elderly patients, more attention needs to be directed toward understanding implications of surgical treatment choices for the nursing home population.
Published on March 03, 2021
Off-Label Use of Atypical Antipsychotics: An Update [Entered Retrospectively]
129 Studies • 4 Key Questions • 129 Extraction Forms
Project created on March 03, 2021
Last updated on March 03, 2021
Objectives: Objectives: Antipsychotic medications are approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia, bipolar disorder, and for some drugs, depression. We performed a systematic review on the efficacy and safety of atypical antipsychotic drugs for use in conditions lacking FDA approval. Data Sources: We searched PubMed, Embase, PsycINFO, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Cochrane DARE (Database of Abstracts of Reviews of Effects), and Cochrane CENTRAL (Cochrane Central Register of Controlled Trials) from inception to May 2011. We included only English-language studies. Review Methods: Controlled trials comparing an atypical antipsychotic (risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, asenapine, iloperidone, paliperidone) to either placebo, another atypical antipsychotic drug, or other pharmacotherapy, for the off-label conditions of anxiety disorder, attention deficit hyperactivity disorder, dementia and severe geriatric agitation, major depressive disorder, eating disorders, insomnia, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), personality disorders, substance abuse, and Tourette’s syndrome were included. Observational studies with sample sizes greater than 1,000 were included to assess rare adverse events. Two investigators conducted independent article review, data abstraction, and study quality assessment. Results: One hundred seventy trials contributed data to the efficacy review. Among the placebocontrolled trials of elderly patients with dementia reporting a total/global outcome score that includes symptoms such as psychosis, mood alterations, and aggression, small but statistically significant effect sizes ranging from 0.12 and 0.20 were observed for aripiprazole, olanzapine, and risperidone. For generalized anxiety disorder, pooled analysis of three large trials showed that quetiapine was associated with a 26 percent greater likelihood of "responding," defined as at least 50 percent improvement on the Hamilton Anxiety Scale, compared with placebo. For obsessive-compulsive disorder, risperidone was associated with a 3.9-fold greater likelihood of "responding," defined as a 25 to 35 percent improvement on the Yale Brown Obsessive Compulsive Scale (YBOCS) compared with placebo. We identified 6 trials on eating disorders, 12 on personality disorder, an existing metaanalysis and 10 trials of risperidone or olanzapine for PTSD, 36 trials for depression of which 7 assessed drugs without an FDA-approved indication, and 33 trials of aripiprazole, olanzapine, quetiapine, or risperidone for treating substance abuse disorders. We identified one small trial (N=13) of atypical antipsychotics for insomnia which was inconclusive. For eating disorder patients specifically, evidence shows that atypicals are do not cause significant weight gain. The level of evidence is mixed regarding personality disorders and moderate for an association of risperidone with improving post-traumatic stress disorder. Evidence does not support efficacy of atypical antipsychotics for substance abuse. In elderly patients, adverse events included an increased risk of death (number needed to harm [NNH]=87), stroke (for risperidone, NNH=53), extrapyramidal symptoms (for olanzapine (NNH=10) and risperidone (NNH=20), and urinary symptoms (NNH= from 16 to 36). In nonelderly adults, adverse events included weight gain (particularly with olanzapine), fatigue, sedation, akithisia (for aripiprazole) and extrapyramidal symptoms. Direct comparisons of different atypical antipsychotics for off-label conditions are rare. Conclusions: Benefits and harms vary among atypical antipsychotics for off-label usage. For symptoms associated with dementia in elderly patients, small but statistically significant benefits were observed for aripiprazole, olanzapine, and risperidone. Quetiapine was associated with benefits in the treatment of generalized anxiety disorder, and risperidone was associated with benefits in the treatment of OCD; however, adverse events were common.
Published on March 03, 2021
Therapies for Children with Autism Spectrum Disorders [Entered Retrospectively]
170 Studies • 2 Key Questions • 170 Extraction Forms
Project created on March 03, 2021
Last updated on March 03, 2021
Objectives: The Vanderbilt Evidence-based Practice Center systematically reviewed evidence on therapies for children ages 2 to 12 with autism spectrum disorders (ASDs). We focused on treatment outcomes, modifiers of treatment effectiveness, evidence for generalization of outcomes to other contexts, and evidence to support treatment decisions in children ages 0-2 at risk for an ASD diagnosis.