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SRDR Project Indexing


Public Project Complete

Statistics: 136 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Jul 09, 2019 06:17PM
Description: This is a Methods Research project that catalogs the various projects with publicly available data on the SRDR Webpage.
Contributor(s): Ian Saldanha, Bryant Smith
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: None Provided

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Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults


Public Project Complete

Statistics: 21 Studies, 2 Key Questions, 1 Extraction Form,
Date Published: Jul 09, 2019 06:08PM
Description: Objective. To assess select adverse events of antidepressants in the treatment of major depressive disorder (MDD) in adults 65 years old or older. Antidepressants included in this review, as determined by expert opinion, are selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), bupropion, mirtazapine, trazodone, vilazodone and vortioxetine. Data sources. MEDLINE®, Embase®, Cochrane Central, and PsycINFO bibliographic databases from earliest date through May 15, 2018; hand searches of references of relevant studies; www.clinicaltrials.gov and the International Controlled Trials Registry Platform. Review methods. Two investigators screened abstracts and subsequently reviewed full-text files. We abstracted data, performed meta-analyses when appropriate, assessed the risk of bias of each individual study, and graded the strength of evidence (SOE) for each comparison and select outcomes. Number needed to harm (NNH) is reported for graded outcomes with statistically significant findings. Results. Nineteen RCTs and two observational studies reported in 41 articles were included. Studies mostly evaluated treatment of the acute phase (<12 weeks) of MDD which was of moderate severity in patients 65 years and older, required subjects to be free from uncontrolled medical comorbidities or psychological conditions, and relied on spontaneous reporting of adverse events. Evidence was scarce and conclusions (based on statistical significance) for a given comparison and outcome are based often on a single study; particularly for specific adverse events. None of the RCTs were powered or designed to capture adverse events and most RCTs studied low doses of antidepressants. Observational data were limited by residual confounding. SSRIs (escitalopram and fluoxetine, moderate SOE), vortioxetine (high SOE) and bupropion XR (moderate SOE) led to a statistically similar frequency of adverse events compared with placebo; whereas SNRIs (duloxetine and venlafaxine) were found to cause a greater number of adverse events (high SOE, NNH 10) compared with placebo during treatment of the acute phase of MDD. Both SSRIs (citalopram, escitalopram and fluoxetine) and SNRIs caused a greater number of withdrawals due to adverse events compared with placebo (SSRIs low SOE, NNH 11; SNRIs moderate SOE, NNH 17). Duloxetine led to a greater number of falls compared with placebo (moderate SOE, NNH 10) during 24 weeks treatment. A single observational study provided evidence on long term use of antidepressants (low SOE) and suggested increased risk of adverse events (SSRIs), falls (SSRIs, SNRI venlafaxine, mirtazapine, trazadone), fractures (SSRIs, SNRI venlafaxine, mirtazapine), and mortality (SSRIs, SNRI venlafaxine, mirtazapine, trazadone), compared to no antidepressant. Evidence for the comparative harms of different antidepressants was limited to single RCTs mostly studying treatment of the acute phase of MDD (<12 weeks). Comparing SSRIs to each other or SSRIs to SNRIs showed statistically similar rates of adverse events (moderate SOE). SSRIs (paroxetine, citalopram, sertraline) had fewer withdrawals due to adverse events compared with TCAs (amitriptyline or nortriptyline) (low SOE, NNT 13) as did mirtazapine compared with paroxetine (low SOE, NNT 9). Vortioxetine had fewer adverse events compared with duloxetine (high SOE, NNT 6 ). Increasing age was associated with greater incidence of serious adverse events with escitalopram (low SOE). The increased risk of falls on duloxetine may be associated with the presence of cardiopulmonary conditions (low SOE). Conclusions. In patients 65 years of age or older with MDD, treatment of the acute phase of MDD with SNRIs (duloxetine and venlafaxine) led to a greater number of adverse events compared with placebo while adverse events were statistically similar to placebo with SSRIs (escitalopram, fluoxetine), vortioxetine and bupropion. SSRIs (citalopram, escitalopram and fluoxetine) and SNRIs (duloxetine and venlafaxine) led to a greater number of study withdrawals due to adverse events compared with placebo and duloxetine increased the risk of falls. Further characterization of the comparative safety of antidepressants is difficult because few studies were identified, comparisons were based on statistical significance, trials were not powered to identify small difference in adverse events and observational studies may be confounded. Comparative, long-term, well-designed studies that report specific adverse events are needed to better inform decisionmaking in this population.
Contributor(s): UConn EPC
DOI: DOI pending.
Funding Source: AHRQ
Methodology Description: MEDLINE®, Embase®, Cochrane Central, and PsycINFO bibliographic databases from earliest date through May 15, 2018; hand searches of references of relevant studies; www.clinicaltrials.gov and the International Controlled Trials Registry Platform. Two investigators screened abstracts and subsequently reviewed full-text files. We abstracted data, performed meta-analyses when appropriate, assessed the risk of bias of each individual study, and graded the strength of evidence (SOE) for each comparison and select outcomes. Number needed to harm (NNH) is reported for graded outcomes with statistically significant findings.

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Diet-Related Fibers and Human Health Outcomes, Version 5.0


Public Project Complete

Statistics: 1156 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Jul 09, 2019 05:48PM
Description: The objectives of this database are to: 1. Systematically compile and provide access to primary, English-language, peer-reviewed science linking dietary fiber intake in humans to one or more of 10 potential health benefits 2. Provide researchers with a tool to understand how different fibers are characterized in studies 3. Facilitate researchers in identifying gaps in the current research 4. Create a database to serve as a starting foundation of primary human literature for conducting evidence-based reviews and meta-analyses 5. Efficiently assist researchers in identifying fibers of interest. This database should serve as a foundation for future work. Specific inclusion and exclusion criteria, detailed in the user manual, were applied in determining database eligibility; thus, this database is not intended to serve as a sole source for identifying all possible fiber literature for the purposes of conducting a meta-analysis or systematic review. This database contains Population, Intervention, Comparator, and Outcome (PICO) data to help users formulate and narrow the focus of their research question. It is expected that secondary searches will be conducted to augment this database.
Contributor(s): Nicola McKeown (PI), Mei Chung (Co-I), Kara Livingston (Sr. Project & Data Manager), Caleigh Sawicki, Danielle Haslam, Deena Wang, Caitlin Blakeley, Yinan Jia, Nicole Baruch, Micaela Karlsen, Carrie Brown, Chenyueyi Ding, Bridget Gayer, Carolyn Lois, Kelly Cara
DOI: DOI pending.
Funding Source: International Life Sciences Institute – North America branch (ILSI-NA)
Methodology Description: Please see user manual.

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Physiologic Predictors of Severe Injury: Systematic Review [Entered Retrospectively]


Public Project Complete

Statistics: 138 Studies, 3 Key Questions, 1 Extraction Form,
Date Published: May 30, 2019 05:31PM
Description: Objectives. To systematically identify and summarize evaluations of measures of circulatory and respiratory compromise, focusing on measures that can be used in field assessment by emergency medical services to inform decisions about the level of trauma care needed. We identified research on the ability of different measures to predict whether a patient was seriously injured and thus required transport to the highest level of trauma care available. Data sources. We searched Ovid MEDLINE®, CINAHL®, and the Cochrane databases from 1996 through August 2017. Reference lists of included articles were reviewed for additional relevant citations. Review methods. We included studies of individual measures and measures that combined circulatory, respiratory, and level of consciousness assessment. Evaluations included diagnostic accuracy (sensitivity and specificity) and area under the receiver operating characteristic curve (AUROC). We used data provided to calculate values that were not reported and pooled estimates across studies when feasible. Results. We identified and included 138 articles reporting results of 134 studies. Circulatory compromise measures evaluated in these studies included systolic blood pressure, heart rate, shock index, lactate, base deficit, and heart rate variability or complexity. The respiratory measures evaluated included respiration rate, oxygen saturation, partial pressure of carbon dioxide, and need for airway support. Many different combination measures were identified, but most were evaluated in only one or two studies. Pooled AUROCs from out-of-hospital data were 0.67 for systolic blood pressure (moderate strength of evidence); 0.67 for heart rate, 0.72 for shock index, 0.77 for lactate, 0.70 for respiratory rate, and 0.89 for Revised Trauma Score combination measure (all low strength of evidence); and were considered poor to fair. The only AUROC that reached a level considered excellent was for the Glasgow Coma Scale, age, and arterial pressure (GAP) combination measure (AUROC, 0.96; estimate based on emergency department data). All of the measures had low sensitivities and comparatively high specificities (e.g., sensitivities ranging from 13% to 74% and specificities ranging from 62% to 96% for out-of-hospital pooled estimates). Conclusions. Physiologic measures usable in triaging trauma patients have been evaluated in multiple studies; however, their predictive utilities are moderate and far from ideal. Overall, the measures have low sensitivities, high specificities, and AUROCs in the poor-to-fair range. Combination measures that include assessments of consciousness seem to perform better, but whether they are feasible and valuable for out-of-hospital use needs to be determined. Modification of triage measures for children or older adults is needed, given that the measures perform worse in these age groups; however, research has not yet conclusively identified modifications that result in better performance.
Contributor(s): Annette M. Totten, Ph.D. Tamara P. Cheney, M.D. Maya E. O'Neil, Ph.D. Craig D. Newgard, M.D., M.P.H. Mohamud Daya, M.D., M.S. Rongwei Fu, Ph.D. Ngoc Wasson, M.P.H. Erica L. Hart, M.S.T. Roger Chou, M.D.
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality (AHRQ)
Methodology Description: Review methods. We included studies of individual measures and measures that combined circulatory, respiratory, and level of consciousness assessment. Evaluations included diagnostic accuracy (sensitivity and specificity) and area under the receiver operating characteristic curve (AUROC). We used data provided to calculate values that were not reported and pooled estimates across studies when feasible.

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Short- and Long-Term Outcomes after Bariatric Surgery in the Medicare Population


Public Project Complete

Statistics: 83 Studies, 5 Key Questions, 1 Extraction Form,
Date Published: May 29, 2019 04:17PM
Description: We conducted a technology assessment to summarize and appraise the current evidence regarding the effectiveness and safety of bariatric surgery in the Medicare-eligible population.
Contributor(s): Orestis A. Panagiotou, M.D., Ph.D. Georgios Markozannes, M.Sc. Rishi Kowalski, M.P.H. Abhilash Gazula, M.P.H. Mengyang Di, M.D. Dale S. Bond, Ph.D. Beth A. Ryder, M.D. Gaelen P. Adam, M.L.I.S. Thomas A. Trikalinos, M.D.
DOI: DOI pending.
Funding Source: AHRQ
Methodology Description: We searched six bibliographic databases and the reference lists of published clinical practice guidelines, relevant narrative and systematic reviews, and scientific information packages from manufacturers and other stakeholders on the outcomes and prediction models of different bariatric procedures studied in the Medicare-eligible population.

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