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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.

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Recently Completed and Deposited Reports Data

VTE thromboprophylaxis with major orthopedic surgery


Public Report Complete
Statistics: 157 Studies, 1 Key Question, 1 Extraction Form,
Date Created: Feb 21, 2016 06:06PM
Description: Update of review of VTE thromboprophylaxis after total hip replacement, total knee replacement, and hip fracture surgery.

Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD)


Public Report Complete
Statistics: 111 Studies, 3 Key Questions, 3 Extraction Forms,
Date Created: Jun 30, 2017 07:06PM
Description: Objectives. For patients with lower extremity chronic venous disease (LECVD), the optimal diagnostic testing and treatment for symptom relief, preservation of limb function, and improvement in quality of life is not known. This systematic review included a narrative review of diagnostic testing modalities and assessed the comparative effectiveness of exercise training, medical therapy, weight reduction, mechanical compression therapy, and invasive procedures (i.e., surgical and endovascular procedures) in patients with LECVD. Data sources. We searched PubMed®, Embase®, and the Cochrane Database of Systematic Reviews for relevant English-language studies published from January 1, 2000 to June 30, 2016. Review methods. Two investigators screened each abstract and full-text article for inclusion, abstracted the data, and performed quality ratings and evidence grading. Random-effects models were used to compute summary estimates of effects. Results. A total of 111 studies contributed evidence, as follows: Diagnosis of LECVD: A narrative review was conducted due to the scant literature and availability of only 10 observational studies evaluating the comparative effectiveness of diagnostic testing modalities in a heterogeneous population of patients with LECVD. In addition to the history and physical exam, multiple physiologic and imaging modalities (plethysmography, duplex ultrasound, intravascular ultrasonography, magnetic resonance venography, computed tomography venography, and invasive venography) are useful to confirm LECVD and/or localize the disease and guide therapy. There was insufficient evidence to support or refute the recommendations from current clinical guidelines that duplex ultrasound should be used as the firstline diagnostic test for patients being evaluated for LECVD or for those for whom invasive treatment is planned. Treatment of lower extremity chronic venous insufficiency/incompetence/reflux: Ninety-three studies (87 randomized controlled trials, 6 observational) evaluated the comparative effectiveness of exercise training, medical therapy, weight reduction, mechanical compression therapy, surgical intervention, and endovenous intervention in patients with lower extremity chronic venous insufficiency/incompetence/reflux. There was no long-term difference in effectiveness between radiofrequency ablation (RFA) and high ligation plus stripping, but RFA was associated with less periprocedural pain, faster improvement in symptom scores and quality of life, and fewer adverse events. Among patients undergoing endovenous interventions, RFA, endovenous laser ablation (EVLA), and sclerotherapy demonstrated improvement in quality-of-life scores and standardized symptom scores. When compared with patients treated with EVLA, those treated with foam sclerotherapy had significantly less periprocedural pain but lower rates of vein occlusion and higher rates of repeat intervention, and patients treated with RFA had significantly less periprocedural pain but also less short-term improvement in Venous Clinical Severity Score. When compared with patients treated with placebo, those treated with foam sclerotherapy had statistically significant improvement in standardized symptom scores, occlusion rates, and quality of life. When compared with patients treated with placebo or no compression therapy, those treated with compression therapy had significant improvement in standardized symptom scores and quality of life. Treatment of lower extremity chronic venous obstruction/thrombosis: Eight studies (3 randomized controlled trials, 5 observational) evaluated the comparative effectiveness of exercise training, medical therapy, weight reduction, mechanical compression therapy, surgical intervention, and endovenous intervention in patients with lower extremity chronic venous obstruction/thrombosis. In patients with post-thrombotic syndrome, exercise training plus patient education and monthly phone follow-up resulted in improved quality of life but not improved symptom severity when compared with patient education and monthly phone follow-up. In patients with both May-Thurner Syndrome and superficial venous reflux who were treated with EVLA (with or without stent placement), there were fewer recurrent ulcerations, improvement in reflux severity and symptoms, and improvement in quality of life in long-term follow-up. In patients with chronic proximal iliac vein obstruction, treatment with catheter-directed urokinase at the time of endovenous stenting resulted in similar effectiveness but catheter-directed urokinase had higher technical failure rates and bleeding risk when compared with endovenous stenting alone. Very few studies evaluated modifiers of effectiveness in the study population. Conclusions. The available evidence for treatment of patients with LECVD is limited by heterogeneous studies that compared multiple treatment options, measured varied outcomes, and assessed disparate outcome timepoints. Very limited comparative effectiveness data have been generated to study new and existing diagnostic testing modalities for patients with LECVD. When compared with patients’ baseline measures, endovenous interventions (e.g. EVLA, sclerotherapy, and RFA) and surgical ligation demonstrated improvement in quality-of-life scores and Venous Clinical Severity Score at various timepoints after treatment; however, there were no statistically significant differences in outcomes between treatment groups (e.g. endovenous vs. endovenous; endovenous vs. surgical). Several advances in care in endovenous interventional therapy have not yet been rigorously tested, and there are very few studies on conservative measures (e.g., lifestyle modification, compression therapy, exercise training) in the literature published since 2000. Additionally, the potential additive effects of many of these therapies are unknown. The presence of significant clinical heterogeneity of these results makes conclusions for clinical outcomes uncertain and provides an impetus for further research to improve the care of patients with LECVD.

Systematic Review on the Use of Cryotherapy Versus other Treatments for Basal Cell Carcinoma


Public Report Complete
Statistics: 38 Studies, 2 Key Questions, 1 Extraction Form,
Date Created: Apr 08, 2017 09:29PM
Description: Our objective is to determine the efficacy and adverse events profile of cryotherapy for the treatment of basal cell carcinoma compared to other therapeutic options or non intervention.

Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD)


Public Report Complete
Statistics: 111 Studies, 3 Key Questions, 3 Extraction Forms,
Date Created: Jun 30, 2017 07:06PM
Description: Objectives. For patients with lower extremity chronic venous disease (LECVD), the optimal diagnostic testing and treatment for symptom relief, preservation of limb function, and improvement in quality of life is not known. This systematic review included a narrative review of diagnostic testing modalities and assessed the comparative effectiveness of exercise training, medical therapy, weight reduction, mechanical compression therapy, and invasive procedures (i.e., surgical and endovascular procedures) in patients with LECVD. Data sources. We searched PubMed®, Embase®, and the Cochrane Database of Systematic Reviews for relevant English-language studies published from January 1, 2000 to June 30, 2016. Review methods. Two investigators screened each abstract and full-text article for inclusion, abstracted the data, and performed quality ratings and evidence grading. Random-effects models were used to compute summary estimates of effects. Results. A total of 111 studies contributed evidence, as follows: Diagnosis of LECVD: A narrative review was conducted due to the scant literature and availability of only 10 observational studies evaluating the comparative effectiveness of diagnostic testing modalities in a heterogeneous population of patients with LECVD. In addition to the history and physical exam, multiple physiologic and imaging modalities (plethysmography, duplex ultrasound, intravascular ultrasonography, magnetic resonance venography, computed tomography venography, and invasive venography) are useful to confirm LECVD and/or localize the disease and guide therapy. There was insufficient evidence to support or refute the recommendations from current clinical guidelines that duplex ultrasound should be used as the firstline diagnostic test for patients being evaluated for LECVD or for those for whom invasive treatment is planned. Treatment of lower extremity chronic venous insufficiency/incompetence/reflux: Ninety-three studies (87 randomized controlled trials, 6 observational) evaluated the comparative effectiveness of exercise training, medical therapy, weight reduction, mechanical compression therapy, surgical intervention, and endovenous intervention in patients with lower extremity chronic venous insufficiency/incompetence/reflux. There was no long-term difference in effectiveness between radiofrequency ablation (RFA) and high ligation plus stripping, but RFA was associated with less periprocedural pain, faster improvement in symptom scores and quality of life, and fewer adverse events. Among patients undergoing endovenous interventions, RFA, endovenous laser ablation (EVLA), and sclerotherapy demonstrated improvement in quality-of-life scores and standardized symptom scores. When compared with patients treated with EVLA, those treated with foam sclerotherapy had significantly less periprocedural pain but lower rates of vein occlusion and higher rates of repeat intervention, and patients treated with RFA had significantly less periprocedural pain but also less short-term improvement in Venous Clinical Severity Score. When compared with patients treated with placebo, those treated with foam sclerotherapy had statistically significant improvement in standardized symptom scores, occlusion rates, and quality of life. When compared with patients treated with placebo or no compression therapy, those treated with compression therapy had significant improvement in standardized symptom scores and quality of life. Treatment of lower extremity chronic venous obstruction/thrombosis: Eight studies (3 randomized controlled trials, 5 observational) evaluated the comparative effectiveness of exercise training, medical therapy, weight reduction, mechanical compression therapy, surgical intervention, and endovenous intervention in patients with lower extremity chronic venous obstruction/thrombosis. In patients with post-thrombotic syndrome, exercise training plus patient education and monthly phone follow-up resulted in improved quality of life but not improved symptom severity when compared with patient education and monthly phone follow-up. In patients with both May-Thurner Syndrome and superficial venous reflux who were treated with EVLA (with or without stent placement), there were fewer recurrent ulcerations, improvement in reflux severity and symptoms, and improvement in quality of life in long-term follow-up. In patients with chronic proximal iliac vein obstruction, treatment with catheter-directed urokinase at the time of endovenous stenting resulted in similar effectiveness but catheter-directed urokinase had higher technical failure rates and bleeding risk when compared with endovenous stenting alone. Very few studies evaluated modifiers of effectiveness in the study population. Conclusions. The available evidence for treatment of patients with LECVD is limited by heterogeneous studies that compared multiple treatment options, measured varied outcomes, and assessed disparate outcome timepoints. Very limited comparative effectiveness data have been generated to study new and existing diagnostic testing modalities for patients with LECVD. When compared with patients’ baseline measures, endovenous interventions (e.g. EVLA, sclerotherapy, and RFA) and surgical ligation demonstrated improvement in quality-of-life scores and Venous Clinical Severity Score at various timepoints after treatment; however, there were no statistically significant differences in outcomes between treatment groups (e.g. endovenous vs. endovenous; endovenous vs. surgical). Several advances in care in endovenous interventional therapy have not yet been rigorously tested, and there are very few studies on conservative measures (e.g., lifestyle modification, compression therapy, exercise training) in the literature published since 2000. Additionally, the potential additive effects of many of these therapies are unknown. The presence of significant clinical heterogeneity of these results makes conclusions for clinical outcomes uncertain and provides an impetus for further research to improve the care of patients with LECVD.

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.



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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: https://creativecommons.org/licenses/by-nc/3.0/

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