Advanced Search
Welcome to the Systematic
Review Data Repository
Welcome to the Systematic Review Data Repository
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.

To contribute data or comment on deposited projects, simply Register for an account.


Registered users, log in below:
Forgot Password?

Recently Completed and Deposited Reports Data

Glasgow Coma Scale for Field Triage of Trauma: A Systematic Review [Entered Retrospectively]


Public Report Complete
Statistics: 32 Studies, 2 Key Questions, 3 Extraction Forms,
Date Created: Sep 12, 2016 06:43PM
Description: Objectives. To assess the predictive utility, reliability, and ease of use of the total Glasgow Coma Scale (tGCS) versus the motor component of the Glasgow Coma Scale (mGCS) for field triage of trauma, as well as comparative effects on clinical decisionmaking and clinical outcomes. Data Sources. MEDLINE®, CINAHL, PsycINFO, HAPI (Health & Psychosocial Instruments), and the Cochrane Databases (January 1995 through June, 2016). Additional studies were identified from reference lists and technical experts. Study Selection. Studies on the predictive utility of the tGCS versus the mGCS or Simplified Motor Scale (SMS) (a simplified version of the mGCS), randomized trials and cohort studies on effects of the tGCS versus the mGCS on rates of over- or under-triage, and studies on interrater reliability and ease of use of the tGCS, mGCS, and/or SMS. Data Extraction. One investigator abstracted details about study characteristics and results; a second investigator checked data for accuracy. Two investigators independently applied prespecified criteria to rate study quality. Data on discrimination of tGCS versus mGCS and tGCS versus SMS were pooled using a random effects model. The strength of evidence was determined based on the overall risk of bias, consistency, directness, precision, and reporting bias. Results. 33 studies met inclusion criteria; 24 studies addressed predictive utility and 10 addressed interrater reliability or ease of use. No study assessed comparative effects on over- or under-triage or clinical outcomes. For in-hospital mortality, the tGCS is associated with slightly greater discrimination than the mGCS (pooled mean difference in area under the receiver operating characteristic curve [AUROC] 0.015, 95% confidence interval [CI] 0.009 to 0.022, I2=85%, 12 studies; strength of evidence [SOE]: Moderate) or the SMS (pooled mean difference in AUROC 0.030, 95% CI 0.024 to 0.036, I2=0%, 5 studies; SOE: Moderate). This means that for every 100 trauma patients, the tGCS is able to correctly discriminate 1 to 3 more cases of in-hospital mortality from cases without in-hospital mortality than the mGCS or the SMS . The tGCS is also associated with greater discrimination than the mGCS or SMS for receipt of neurosurgical interventions, severe brain injury, and emergency intubation (differences in AUROC ranged from 0.03 to 0.05; SOE: Moderate). Differences in discrimination between the mGCS versus the SMS were small (differences in the AUROC ranged from 0.000 to 0.01; SOE: Moderate). Findings were robust in sensitivity and subgroup analyses based on age, type of trauma, study years, assessment setting (out-of-hospital vs. emergency department), risk of bias assessment, and other factors. Differences between the tGCS, mGCS, and SMS in diagnostic accuracy (sensitivity, specificity) based on standard thresholds (scores of ≤15, ≤5, and ≤1) were small, based on limited evidence (SOE: Low). The interrater reliability of tGCS and mGCS appears to be high, but evidence was insufficient to determine if there were differences between scales (SOE: Insufficient). Three studies found the tGCS associated with a lower proportion of correct scores than the mGCS (differences in proportion of correct scores ranged from 6% to 27%), though the difference was statistically significant in only one study (SOE: Low). Limitations. Evidence on comparative predictive utility was primarily restricted to effects on discrimination. All studies on predictive utility were retrospective and the mGCS and SMS were taken from the tGCS rather than independently assessed. Most studies had methodological limitations. We restricted inclusion to English-language studies and were limited in our ability to assess publication bias. Studies on ease of use focused on scoring of video or written patient scenarios; field studies and studies on other measures of ease of use such as time required and assessor satisfaction were not available. Conclusions. The tGCS is associated with slightly greater discrimination than the mGCS or SMS for in-hospital mortality, receipt of neurosurgical interventions, severe brain injury, and emergency intubation. The clinical significance of small differences in discrimination is likely to be small, and could be offset by factors such as convenience and ease of use. Research is needed to understand how use of the tGCS versus the mGCS or SMS impacts clinical outcomes and risk of over- or under-triage.

Systematic review of the adverse reproductive and developmental effects of caffeine consumption in healthy adults and pregnant women


Public Report Complete
Statistics: 58 Studies, 1 Key Question, 1 Extraction Form,
Date Created: Apr 11, 2017 05:34PM
Description: To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al. (2003). Thus, as an update to this foundational publication, we conducted a systematic review of data on potential adverse effects of caffeine published from 2001 to June 2015. Subject matter experts and research team participants developed five PECO (population, exposure, comparator, and outcome) questions to address five types of outcomes (acute toxicity, cardiovascular toxicity, bone and calcium effects, behavior, and development and reproduction) in four healthy populations (adults, pregnant women, adolescents, and children) relative to caffeine intake doses determined not to be associated with adverse effects by Health Canada (comparators: 400 mg/day for adults [10 g for lethality], 300 mg/day for pregnant women, and 2.5 mg/kg/day for children and adolescents). The a priori search strategy identified >5000 articles that were screened, with 381 meeting inclusion/exclusion criteria for the five outcomes (pharmacokinetics was addressed contextually, adding 46 more studies). Data were extracted by the research team and rated for risk of bias and indirectness (internal and external validity). Selected no- and low-effect intakes were assessed relative to the population-specific comparator. Conclusions were drawn for the body of evidence for each outcome, as well as endpoints within an outcome, using a weight of evidence approach. When the total body of evidence was evaluated and when study quality, consistency, level of adversity, and magnitude of response were considered, the evidence generally supports that consumption of up to 400 mg caffeine/day in healthy adults is not associated with overt, adverse cardiovascular effects, behavioral effects, reproductive and developmental effects, acute effects, or bone status. Evidence also supports consumption of up to 300 mg caffeine/day in healthy pregnant women as an intake that is generally not associated with adverse reproductive and developmental effects. Limited data were identified for child and adolescent populations; the available evidence suggests that 2.5 mg caffeine/kg body weight/day remains an appropriate recommendation. The results of this systematic review support a shift in caffeine research to focus on characterizing effects in sensitive populations and establishing better quantitative characterization of interindividual variability (e.g., epigenetic trends), subpopulations (e.g., unhealthy populations, individuals with preexisting conditions), conditions (e.g., coexposures), and outcomes (e.g., exacerbation of risk-taking behavior) that could render individuals to be at greater risk relative to healthy adults and healthy pregnant women. This review, being one of the first to apply systematic review methodologies to toxicological assessments, also highlights the need for refined guidance and frameworks unique to the conduct of systematic review in this field.

Systematic review of the adverse behavioral effects of caffeine consumption in healthy adults, pregnant women, adolescents, and children


Public Report Complete
Statistics: 80 Studies, 1 Key Question, 1 Extraction Form,
Date Created: Apr 10, 2017 02:09AM
Description: To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al. (2003). Thus, as an update to this foundational publication, we conducted a systematic review of data on potential adverse effects of caffeine published from 2001 to June 2015. Subject matter experts and research team participants developed five PECO (population, exposure, comparator, and outcome) questions to address five types of outcomes (acute toxicity, cardiovascular toxicity, bone and calcium effects, behavior, and development and reproduction) in four healthy populations (adults, pregnant women, adolescents, and children) relative to caffeine intake doses determined not to be associated with adverse effects by Health Canada (comparators: 400 mg/day for adults [10 g for lethality], 300 mg/day for pregnant women, and 2.5 mg/kg/day for children and adolescents). The a priori search strategy identified >5000 articles that were screened, with 381 meeting inclusion/exclusion criteria for the five outcomes (pharmacokinetics was addressed contextually, adding 46 more studies). Data were extracted by the research team and rated for risk of bias and indirectness (internal and external validity). Selected no- and low-effect intakes were assessed relative to the population-specific comparator. Conclusions were drawn for the body of evidence for each outcome, as well as endpoints within an outcome, using a weight of evidence approach. When the total body of evidence was evaluated and when study quality, consistency, level of adversity, and magnitude of response were considered, the evidence generally supports that consumption of up to 400 mg caffeine/day in healthy adults is not associated with overt, adverse cardiovascular effects, behavioral effects, reproductive and developmental effects, acute effects, or bone status. Evidence also supports consumption of up to 300 mg caffeine/day in healthy pregnant women as an intake that is generally not associated with adverse reproductive and developmental effects. Limited data were identified for child and adolescent populations; the available evidence suggests that 2.5 mg caffeine/kg body weight/day remains an appropriate recommendation. The results of this systematic review support a shift in caffeine research to focus on characterizing effects in sensitive populations and establishing better quantitative characterization of interindividual variability (e.g., epigenetic trends), subpopulations (e.g., unhealthy populations, individuals with preexisting conditions), conditions (e.g., coexposures), and outcomes (e.g., exacerbation of risk-taking behavior) that could render individuals to be at greater risk relative to healthy adults and healthy pregnant women. This review, being one of the first to apply systematic review methodologies to toxicological assessments, also highlights the need for refined guidance and frameworks unique to the conduct of systematic review in this field.

Systematic review of the adverse reproductive and developmental effects of caffeine consumption in healthy adults and pregnant women


Public Report Complete
Statistics: 58 Studies, 1 Key Question, 1 Extraction Form,
Date Created: Apr 11, 2017 05:34PM
Description: To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al. (2003). Thus, as an update to this foundational publication, we conducted a systematic review of data on potential adverse effects of caffeine published from 2001 to June 2015. Subject matter experts and research team participants developed five PECO (population, exposure, comparator, and outcome) questions to address five types of outcomes (acute toxicity, cardiovascular toxicity, bone and calcium effects, behavior, and development and reproduction) in four healthy populations (adults, pregnant women, adolescents, and children) relative to caffeine intake doses determined not to be associated with adverse effects by Health Canada (comparators: 400 mg/day for adults [10 g for lethality], 300 mg/day for pregnant women, and 2.5 mg/kg/day for children and adolescents). The a priori search strategy identified >5000 articles that were screened, with 381 meeting inclusion/exclusion criteria for the five outcomes (pharmacokinetics was addressed contextually, adding 46 more studies). Data were extracted by the research team and rated for risk of bias and indirectness (internal and external validity). Selected no- and low-effect intakes were assessed relative to the population-specific comparator. Conclusions were drawn for the body of evidence for each outcome, as well as endpoints within an outcome, using a weight of evidence approach. When the total body of evidence was evaluated and when study quality, consistency, level of adversity, and magnitude of response were considered, the evidence generally supports that consumption of up to 400 mg caffeine/day in healthy adults is not associated with overt, adverse cardiovascular effects, behavioral effects, reproductive and developmental effects, acute effects, or bone status. Evidence also supports consumption of up to 300 mg caffeine/day in healthy pregnant women as an intake that is generally not associated with adverse reproductive and developmental effects. Limited data were identified for child and adolescent populations; the available evidence suggests that 2.5 mg caffeine/kg body weight/day remains an appropriate recommendation. The results of this systematic review support a shift in caffeine research to focus on characterizing effects in sensitive populations and establishing better quantitative characterization of interindividual variability (e.g., epigenetic trends), subpopulations (e.g., unhealthy populations, individuals with preexisting conditions), conditions (e.g., coexposures), and outcomes (e.g., exacerbation of risk-taking behavior) that could render individuals to be at greater risk relative to healthy adults and healthy pregnant women. This review, being one of the first to apply systematic review methodologies to toxicological assessments, also highlights the need for refined guidance and frameworks unique to the conduct of systematic review in this field.

Systematic review of the adverse behavioral effects of caffeine consumption in healthy adults, pregnant women, adolescents, and children


Public Report Complete
Statistics: 80 Studies, 1 Key Question, 1 Extraction Form,
Date Created: Apr 10, 2017 02:09AM
Description: To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al. (2003). Thus, as an update to this foundational publication, we conducted a systematic review of data on potential adverse effects of caffeine published from 2001 to June 2015. Subject matter experts and research team participants developed five PECO (population, exposure, comparator, and outcome) questions to address five types of outcomes (acute toxicity, cardiovascular toxicity, bone and calcium effects, behavior, and development and reproduction) in four healthy populations (adults, pregnant women, adolescents, and children) relative to caffeine intake doses determined not to be associated with adverse effects by Health Canada (comparators: 400 mg/day for adults [10 g for lethality], 300 mg/day for pregnant women, and 2.5 mg/kg/day for children and adolescents). The a priori search strategy identified >5000 articles that were screened, with 381 meeting inclusion/exclusion criteria for the five outcomes (pharmacokinetics was addressed contextually, adding 46 more studies). Data were extracted by the research team and rated for risk of bias and indirectness (internal and external validity). Selected no- and low-effect intakes were assessed relative to the population-specific comparator. Conclusions were drawn for the body of evidence for each outcome, as well as endpoints within an outcome, using a weight of evidence approach. When the total body of evidence was evaluated and when study quality, consistency, level of adversity, and magnitude of response were considered, the evidence generally supports that consumption of up to 400 mg caffeine/day in healthy adults is not associated with overt, adverse cardiovascular effects, behavioral effects, reproductive and developmental effects, acute effects, or bone status. Evidence also supports consumption of up to 300 mg caffeine/day in healthy pregnant women as an intake that is generally not associated with adverse reproductive and developmental effects. Limited data were identified for child and adolescent populations; the available evidence suggests that 2.5 mg caffeine/kg body weight/day remains an appropriate recommendation. The results of this systematic review support a shift in caffeine research to focus on characterizing effects in sensitive populations and establishing better quantitative characterization of interindividual variability (e.g., epigenetic trends), subpopulations (e.g., unhealthy populations, individuals with preexisting conditions), conditions (e.g., coexposures), and outcomes (e.g., exacerbation of risk-taking behavior) that could render individuals to be at greater risk relative to healthy adults and healthy pregnant women. This review, being one of the first to apply systematic review methodologies to toxicological assessments, also highlights the need for refined guidance and frameworks unique to the conduct of systematic review in this field.

Systematic review of acute adverse effects of caffeine consumption in healthy adults, pregnant women, adolescents, and children


Public Report Complete
Statistics: 26 Studies, 1 Key Question, 1 Extraction Form,
Date Created: Apr 10, 2017 02:05AM
Description: To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al. (2003). Thus, as an update to this foundational publication, we conducted a systematic review of data on potential adverse effects of caffeine published from 2001 to June 2015. Subject matter experts and research team participants developed five PECO (population, exposure, comparator, and outcome) questions to address five types of outcomes (acute toxicity, cardiovascular toxicity, bone and calcium effects, behavior, and development and reproduction) in four healthy populations (adults, pregnant women, adolescents, and children) relative to caffeine intake doses determined not to be associated with adverse effects by Health Canada (comparators: 400 mg/day for adults [10 g for lethality], 300 mg/day for pregnant women, and 2.5 mg/kg/day for children and adolescents). The a priori search strategy identified >5000 articles that were screened, with 381 meeting inclusion/exclusion criteria for the five outcomes (pharmacokinetics was addressed contextually, adding 46 more studies). Data were extracted by the research team and rated for risk of bias and indirectness (internal and external validity). Selected no- and low-effect intakes were assessed relative to the population-specific comparator. Conclusions were drawn for the body of evidence for each outcome, as well as endpoints within an outcome, using a weight of evidence approach. When the total body of evidence was evaluated and when study quality, consistency, level of adversity, and magnitude of response were considered, the evidence generally supports that consumption of up to 400 mg caffeine/day in healthy adults is not associated with overt, adverse cardiovascular effects, behavioral effects, reproductive and developmental effects, acute effects, or bone status. Evidence also supports consumption of up to 300 mg caffeine/day in healthy pregnant women as an intake that is generally not associated with adverse reproductive and developmental effects. Limited data were identified for child and adolescent populations; the available evidence suggests that 2.5 mg caffeine/kg body weight/day remains an appropriate recommendation. The results of this systematic review support a shift in caffeine research to focus on characterizing effects in sensitive populations and establishing better quantitative characterization of interindividual variability (e.g., epigenetic trends), subpopulations (e.g., unhealthy populations, individuals with preexisting conditions), conditions (e.g., coexposures), and outcomes (e.g., exacerbation of risk-taking behavior) that could render individuals to be at greater risk relative to healthy adults and healthy pregnant women. This review, being one of the first to apply systematic review methodologies to toxicological assessments, also highlights the need for refined guidance and frameworks unique to the conduct of systematic review in this field.



Creative Commons LicenseThis graphic notice indicates that you are leaving this Federal Government Web site and entering a non-Federal Web site. Creative Commons  
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: https://creativecommons.org/licenses/by-nc/3.0/

Popular Resources



Help


SRDR Announcements


 

Statistics



Maintenance Schedule