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Completed Systematic Reviews




Telehealth for Acute and Chronic Care Consultations


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Statistics: 216 Studies, 5 Key Questions, 1 Extraction Form,
Date Published: Sep 20, 2019 09:42AM
Description: Objectives: To conduct a systematic review to identify and summarize the available evidence about the effectiveness of telehealth consultations and to explore using decision modeling techniques to supplement the review. Telehealth consultations are defined as the use of telehealth to facilitate collaboration between two or more providers, often involving a specialist, or among clinical team members, across time and/or distance. Consultations may focus on the prevention, assessment, diagnosis, and/or clinical management of acute or chronic conditions. Data Sources. We searched Ovid MEDLINE®, the Cochrane Central Register of Controlled Trials (CCRCT), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL®) to identify studies published from 1996 to May 2018. We also reviewed reference lists of identified studies and systematic reviews, and we solicited published or unpublished studies through an announcement in the Federal Register. Data for the model came both from studies identified via the systematic review and from other sources. Methods. We included comparative studies that provided data on clinical, cost, or intermediate outcomes associated with the use of any technology to facilitate consultations for inpatient, emergency, or outpatient care. We rated studies for risk of bias and extracted information about the study design, the telehealth interventions, and results. We assessed the strength of evidence and synthesized the findings using quantitative and qualitative methods. An exploratory decision model was developed to assess the potential economic impact of telehealth consultations for traumatic brain injuries in adults. Results. The search yielded 9,366 potentially relevant citations. Upon review, 8,356 were excluded and the full text of 1,010 articles was pulled for review. Of these, 233 articles met our criteria and were included—54 articles evaluated inpatient consultations, 73 emergency care, and 106 outpatient care. The overall results varied by setting and clinical topic, but generally the findings are that telehealth improved outcomes or that there was no difference between telehealth and the comparators. Remote intensive care unit (ICU) consultations likely reduce ICU and total hospital mortality with no significant difference in ICU or hospital length of stay; specialty telehealth consultations likely reduce the time patients spend in the emergency department; telehealth for emergency medical services likely reduces mortality for patients with heart attacks, and remote consultations for outpatient care likely improve access and a range of clinical outcomes (moderate strength of evidence in favor of telehealth). Findings with lower confidence are that inpatient telehealth consultations may reduce length of stay and costs; telehealth consultations in emergency care may improve outcomes and reduce costs due to fewer transfers and also may reduce outpatient visits and costs due to less travel (low strength of evidence in favor of telehealth). Current evidence reports no difference in clinical outcomes with inpatient telehealth specialty consultations, no difference in mortality but also no difference in harms with telestroke consultations, and no difference in satisfaction with outpatient telehealth consultations (low strength of evidence of no difference). Too few studies reported information on potential harms from outpatient telehealth consultations for conclusions to be drawn (insufficient evidence). An exploratory cost model underscores the importance of perspective and assumptions in using modeling to extend evidence and the need for more detailed data on costs and outcomes when telehealth is used for consultations. For example, a model comparing telehealth to transfers and in-person neurosurgical consultations for acute traumatic brain injury identified that the impact of telehealth on costs may depend on multiple factors including how alternatives are organized (e.g., if the telehealth and in-person options are part of the same health care system) and whether the cost of a telehealth versus an in-person consultation differ. Conclusions. In general, the evidence indicates that telehealth consultations are effective in improving outcomes or providing services with no difference in outcomes; however, the evidence is stronger for some applications, and less strong or insufficient for others. Exploring the use of a cost model underscored that the economic impact of telehealth consultations depends on the perspective used in the analysis. The increase in both interest and investment in telehealth suggests the need to develop a research agenda that emphasizes rigor and focuses on standardized outcome comparisons that can inform policy and practice decisions.
Contributor(s): Totten A, Hansen R, Wagner J, Stillman L, Ivlev I, Davis-O’Reilly C, Towle C, Erickson J, Erten-Lyons D, Fu R, Fann J, Babigumira J, Palm-Cruz K, Avery M, McDonagh M.
Funding Source: Agency for Healthcare Research and Quality (AHRQ), Contract No. 290-2015-00009-I
Methodology Description: The conduct of this systematic review followed the Methods Guide for Effectiveness and Comparative Effectiveness Reviews, and it is reported according to the PRISMA checklist. The scope, Key Questions, and inclusion criteria of this review were developed in consultation with a group of technical experts. Detailed methods are available in the full report and the posted protocol. A research librarian created the search strategy and another research librarian reviewed it before searching Ovid MEDLINE®, the Cochrane Central Register of Controlled Trials (CCRCT), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL®) to identify studies published from 1996 through May 2018. We also reviewed reference lists of identified studies and systematic reviews, and solicited suggestions through an announcement in the Federal Register. We limited our study inclusion to the use of telehealth for consultations and outcomes that measure clinical and cost effectiveness. Otherwise our criteria were broad, and we included any technology and any comparative study, including before-after and retrospective as well as prospective designs, with quantitative outcomes data. Studies could compare telehealth consultations to consultations done in a different mode (e.g., in-person or telephone), no access to specialty care, or usual care which could be an unspecified mix of these options. We excluded descriptive studies, studies assessing only diagnostic concordance, studies where there was no nontelehealth comparison, and modeling studies that used hypothetical data. Two team members independently reviewed all abstracts and two reviewers independently assessed each full-text article. Disagreements were resolved by discussion among investigators. For included articles, investigators abstracted key characteristics and data about the studies for quantitative and qualitative synthesis. We were able to conduct meta-analyses for some but not all topics and outcomes due to the heterogeneity of outcome measures, study designs, and telehealth interventions. Two investigators independently rated the risk of bias of each study using predefined criteria consistent with the chapter, “Assessing the Risk of Bias of Individual Studies When Comparing Medical Interventions” in the Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Risk of bias for economic evaluations were assessed using a modified version of the Consensus Health Economic Criteria. Disagreements were resolved by consensus. Strength of evidence was assessed for each outcome and Key Question as described in the Methods Guide for Effectiveness and Comparative Effectiveness Reviews. We assigned a strength of evidence grade of high, moderate, low, or insufficient for the body of evidence for each Key Question, based on evaluation of four domains: study limitations, consistency, directness, and precision. High, moderate, and low ratings reflect our confidence in the accuracy and validity of the findings and whether future studies might alter these findings (magnitude or direction). We gave a rating of insufficient when we were unable to draw conclusions due to serious inconsistencies, serious methodological limitations, or lack of evidence.

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Diet-Related Fibers and Human Health Outcomes, Version 5.0


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Statistics: 1156 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Sep 20, 2019 09:42AM
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
Funding Source: International Life Sciences Institute – North America branch (ILSI-NA)
Methodology Description: Please see user manual.

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Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults


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Statistics: 21 Studies, 2 Key Questions, 1 Extraction Form,
Date Published: Sep 20, 2019 09:42AM
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
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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Intermittent Inhaled Corticosteroids and Long-Acting Muscarinic Antagonists for Asthma


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Statistics: 74 Studies, 6 Key Questions, 1 Extraction Form,
Date Published: Sep 20, 2019 09:42AM
Description: Objective. To assess efficacy of intermittent inhaled corticosteroid (ICS) therapy in different populations (0 to 4 years old with recurrent wheezing, 5 years and older with persistent asthma, with or without long-acting beta agonist [LABA]), and to assess efficacy of added long-acting muscarinic antagonist (LAMA) in patients 12 years and older with uncontrolled, persistent asthma. Data sources. MEDLINE®, Embase®, Cochrane Central, and Cochrane Database of Systematic Reviews bibliographic databases from earliest date through March 23, 2017; hand searches of references of relevant studies; www.clinicaltrials.gov and the International Controlled Trials Registry Platform. Review methods. Two investigators screened abstracts of identified references for eligibility 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 for each comparison and outcome. Outcomes for which data were extracted included exacerbations, mortality, asthma control composite scores, spirometry, asthma-specific quality of life, and rescue medication use. Results. We included 56 unique studies (54 randomized controlled trials, 2 observational studies) in this review. Compared to rescue short-acting beta-agonist (SABA) use, adding intermittent ICS reduces the risk of exacerbation requiring oral steroids and improves caregiver quality of life in children less than 5 years old with recurrent wheezing in the setting of a respiratory tract infection (RTI). In patients 12 years and older with persistent asthma, differences in intermittent ICS versus controller use of ICS were not detected, although few studies provided evidence, leading to primarily low strength of evidence ratings. Using ICS and LABA as both a controller and quick relief therapy reduced the risk of exacerbations and improved symptom control in patients 12 years and older compared to ICS controller (with or without LABA). Data in patients 4 to 11 years old suggest lower risk of exacerbations with ICS and LABA controller and quick relief use, but with a lower strength of evidence than in the older population. In patients 12 years and older with uncontrolled, persistent asthma, LAMA versus placebo as add-on to ICS reduces the risk of exacerbations requiring systemic corticosteroids and improves lung function measure through spirometry. Current evidence does not suggest that a difference exists in the efficacy of LAMA versus LABA as add-on to ICS. Triple therapy of ICS, LAMA, and LABA improves lung function measured through spirometry, although the risk of exacerbation was not different versus ICS and LABA. Conclusions. Intermittent ICS added to SABA during an RTI provides benefit to patients less than 5 years of age with recurrent wheezing. In patients 12 years and older with persistent asthma, differences in intermittent ICS versus controller use of ICS were not detected, although few studies provided evidence for this question. In patients 12 years and older with persistent asthma, using ICS and LABA as both a controller and quick relief therapy may be more effective at preventing exacerbations than ICS controller (with or without LABA). LAMA is effective in the management of uncontrolled, persistent asthma in patients 12 years of age and older, and current evidence does not suggest a difference between LAMA and LABA as add-on to ICS.
Contributor(s): UConn EPC
Funding Source: AHRQ
Methodology Description: Data sources. MEDLINE®, Embase®, Cochrane Central, and Cochrane Database of Systematic Reviews bibliographic databases from earliest date through March 23, 2017; hand searches of references of relevant studies; www.clinicaltrials.gov and the International Controlled Trials Registry Platform. Review methods. Two investigators screened abstracts of identified references for eligibility 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 for each comparison and outcome. Outcomes for which data were extracted included exacerbations, mortality, asthma control composite scores, spirometry, asthma-specific quality of life, and rescue medication use.

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Screening for Elevated Blood Lead Levels in Pregnancy [Entered Retrospectively]


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Statistics: 2 Studies, 6 Key Questions, 1 Extraction Form,
Date Published: Sep 20, 2019 09:42AM
Description: Structured Abstract Background: In 2006, the United States Preventive Services Task Force (USPSTF) recommended against routine screening for elevated blood lead levels in asymptomatic pregnant women (D recommendation). Purpose: To synthesize evidence on the effects of screening, testing, and treatment for elevated blood lead level in pregnant women, in order to update a 2006 USPSTF systematic review. Data Sources: Cochrane CENTRAL and Cochrane Database of Systematic Reviews (through June 2018), and Ovid MEDLINE (1946 to June 2018), reference lists, and surveillance through December 5, 2018. Study Selection: English-language trials and observational studies of screening effectiveness, test accuracy, benefits and harms of screening and interventions in asymptomatic pregnant women. Data Extraction: One investigator abstracted details about study design, patient population, setting, screening method, follow up, and results. Two investigators independently applied prespecified criteria to rate study quality using methods developed by the USPSTF. Discrepancies were resolved through consensus. Data Synthesis: No studies directly evaluated clinical benefits and harms of screening pregnant women for elevated lead levels versus no screening, or how effectiveness of screening varies according to the gestational age at which screening is performed. One fair quality study (N = 314) evaluated the diagnostic accuracy of using a version of the CDC screening questionnaire for lead exposure in children, modified for identifying pregnant women with elevated lead levels. The study used four out of five of the questions from the CDC questionnaire and found a sensitivity of 75.7 percent and specificity of 46.2 percent. The most predictive single item was living in a home built before 1960. One fair quality RCT from Mexico found calcium supplementation in healthy pregnant women (N = 670; mean baseline lead levels ~ 4 µg/dL) associated with a reduction in serum lead levels compared with placebo (difference 11%, p=0.004). No studies reported health outcomes or harms associated with interventions to reduce blood levels in asymptomatic pregnant women. Limitations: Limited to English-language articles; quality and applicability of studies were limited due to flawed study design, poor reporting of statistical outcomes, and loss to follow up. Two studies addressed the key questions, with no evidence on effects of screening or interventions for elevated lead levels in pregnant women on health outcomes. Conclusions: Evidence on the benefits and harms of screening pregnant women for elevated blood lead levels is extremely limited, with no evidence on effects of screening or interventions for lowering elevated blood lead levels in pregnant women on health outcomes.
Contributor(s): Amy G. Cantor, MD, MPH Marian S. McDonagh, PharmD Ian Blazina, MPH Jessica Griffin, MS Sara Grusing, BA Rob Hendrickson, MD
Funding Source: Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No HHSA290201500009I Task Order No. 7)
Methodology Description: Study Selection: English-language trials and observational studies of screening effectiveness, test accuracy, benefits and harms of screening and interventions in asymptomatic pregnant women. Data Extraction: One investigator abstracted details about study design, patient population, setting, screening method, follow up, and results. Two investigators independently applied prespecified criteria to rate study quality using methods developed by the USPSTF. Discrepancies were resolved through consensus.

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