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The Systematic Review Data Repository (SRDR) is a powerful and easy-to-use tool for the extraction and management of data for systematic review or meta-analysis. It is also an open and searchable archive of systematic reviews and their data.

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Recently Completed and Deposited Reports Data

First- and Second- Generation Antipsychotics for Children and Young Adults


Public Report Complete
Statistics: 81 Studies, 4 Key Questions, 1 Extraction Form,
Date Created: Dec 02, 2013 03:27PM
Description: Methods: Two reviewers conducted study selection and quality assessment independently and resolved discrepancies by consensus. One reviewer extracted data, and a second reviewer verified the data. We conducted a descriptive analysis for all studies and performed metaanalyses when appropriate. Results: Eighty-one studies (64 trials and 17 cohort studies) examined the following conditions: pervasive developmental disorders (12 studies); attention deficit hyperactivity disorder (ADHD) or disruptive behavior disorders (8 studies); bipolar disorder (11 studies); schizophrenia and related psychosis (31 studies); Tourette syndrome (7 studies); behavioral issues (4 studies); and multiple conditions (9 studies). One study reported data on both bipolar disorder and schizophrenia. The majority of the trials had a high risk of bias. The methodological quality of the cohort studies was moderate. Results are presented by outcome below: Symptoms: The strength of evidence for all head-to-head comparisons of FGAs and SGAs was low or insufficient to draw conclusions. SGAs were favored over placebo for behavior symptoms (ADHD and disruptive behavior disorders), the Clinical Global Impressions scale (ADHD and disruptive behavior disorders, bipolar disorder, and schizophrenia), positive and negative symptoms (schizophrenia), and tics (Tourette syndrome) (moderate strength of evidence). Other short- and long-term outcomes: All head-to-head comparisons had low or insufficient strength of evidence. There was no significant difference between SGAs and placebo for suicide related behaviors (moderate strength of evidence). The evidence was rated as insufficient to draw conclusions for health-related quality of life, involvement with the legal system, and other patient-, parent-, or care provider-reported outcomes for all conditions. Adverse events: All outcomes comparing FGAs with SGAs had low or insufficient strength of evidence. Outcomes comparing FGAs versus FGAs and FGAs versus placebo had insufficient evidence. Risperidone was favored over olanzapine for dyslipidemia; olanzapine was favored over risperidone for prolactin-related events; and both quetiapine and risperidone were favored over olanzapine for weight gain (moderate strength of evidence). For nearly all outcomes and comparisons, placebo resulted in significantly fewer adverse events than SGAs. Subpopulations: Thirty-six studies examined the association between various patient subpopulations and outcomes. Most concluded that the results did not differ by subpopulations, or findings were discordant across studies. Conclusion: Evidence comparing FGAs with SGAs, various FGAs, and FGAs with placebo was very limited. Some SGAs appear to have a better side-effect profile than other SGAs. Compared with placebo, SGAs have better symptom improvement but more adverse events. Future high quality research examining head-to-head antipsychotic comparisons is needed.

Treatment of Common Hip Fractures


Public Report Complete
Statistics: 85 Studies, 8 Key Questions, 2 Extraction Forms,
Date Created: Sep 20, 2013 01:00PM
Description: 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.

Off-Label Use of Atypical Antipsychotics: An Update


Public Report Complete
Statistics: 129 Studies, 4 Key Questions, 1 Extraction Form,
Date Created: Aug 18, 2013 03:02PM
Description: 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.

First- and Second- Generation Antipsychotics for Children and Young Adults


Public Report Complete
Statistics: 81 Studies, 4 Key Questions, 1 Extraction Form,
Date Created: Dec 02, 2013 03:27PM
Description: Methods: Two reviewers conducted study selection and quality assessment independently and resolved discrepancies by consensus. One reviewer extracted data, and a second reviewer verified the data. We conducted a descriptive analysis for all studies and performed metaanalyses when appropriate. Results: Eighty-one studies (64 trials and 17 cohort studies) examined the following conditions: pervasive developmental disorders (12 studies); attention deficit hyperactivity disorder (ADHD) or disruptive behavior disorders (8 studies); bipolar disorder (11 studies); schizophrenia and related psychosis (31 studies); Tourette syndrome (7 studies); behavioral issues (4 studies); and multiple conditions (9 studies). One study reported data on both bipolar disorder and schizophrenia. The majority of the trials had a high risk of bias. The methodological quality of the cohort studies was moderate. Results are presented by outcome below: Symptoms: The strength of evidence for all head-to-head comparisons of FGAs and SGAs was low or insufficient to draw conclusions. SGAs were favored over placebo for behavior symptoms (ADHD and disruptive behavior disorders), the Clinical Global Impressions scale (ADHD and disruptive behavior disorders, bipolar disorder, and schizophrenia), positive and negative symptoms (schizophrenia), and tics (Tourette syndrome) (moderate strength of evidence). Other short- and long-term outcomes: All head-to-head comparisons had low or insufficient strength of evidence. There was no significant difference between SGAs and placebo for suicide related behaviors (moderate strength of evidence). The evidence was rated as insufficient to draw conclusions for health-related quality of life, involvement with the legal system, and other patient-, parent-, or care provider-reported outcomes for all conditions. Adverse events: All outcomes comparing FGAs with SGAs had low or insufficient strength of evidence. Outcomes comparing FGAs versus FGAs and FGAs versus placebo had insufficient evidence. Risperidone was favored over olanzapine for dyslipidemia; olanzapine was favored over risperidone for prolactin-related events; and both quetiapine and risperidone were favored over olanzapine for weight gain (moderate strength of evidence). For nearly all outcomes and comparisons, placebo resulted in significantly fewer adverse events than SGAs. Subpopulations: Thirty-six studies examined the association between various patient subpopulations and outcomes. Most concluded that the results did not differ by subpopulations, or findings were discordant across studies. Conclusion: Evidence comparing FGAs with SGAs, various FGAs, and FGAs with placebo was very limited. Some SGAs appear to have a better side-effect profile than other SGAs. Compared with placebo, SGAs have better symptom improvement but more adverse events. Future high quality research examining head-to-head antipsychotic comparisons is needed.

Treatment of Common Hip Fractures


Public Report Complete
Statistics: 85 Studies, 8 Key Questions, 2 Extraction Forms,
Date Created: Sep 20, 2013 01:00PM
Description: 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.

Off-Label Use of Atypical Antipsychotics: An Update


Public Report Complete
Statistics: 129 Studies, 4 Key Questions, 1 Extraction Form,
Date Created: Aug 18, 2013 03:02PM
Description: 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.



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The data contained in this project are distributed under the terms of the Creative Commons Attribution-NonCommerical license, which permits the use, dissemination, and reproduction in any medium, provided the original work is properly cited, and that the use is non-commercial and otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/

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