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Completed Systematic Reviews




Adverse Events in Women with Silicone Gel Breast Implants: A Systematic Review


Public Project Complete

Statistics: 57 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Oct 20, 2016 07:52PM
Description: Breast implants are medical devices used to reconstruct the breast following mastectomy, to augment breast size, or to correct a congenital abnormality.1 Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). In the US about half of implants are silicone gel-filled implants. Recently, the Food and Drug Administration (FDA) has recommended the creation of a surveillance registry to monitor for potential adverse events associated with silicone gel breast implants. However, a clinical registry that can provide meaningful data on the long-term safety requires a large number of patients and rigorous patient follow-up, both of which have been difficult for breast implant companies to achieve. The American Society of Plastic Surgeons (ASPS®) and the Plastic Surgery Foundation (PSF) has solicited this systematic review (SR) to summarize the state of the literature on safety outcomes in women with silicone gel breast implants for the purpose of informing the development of the registry.
Contributor(s): Ethan Balk, Gowri Raman, Esther Avendano, Amy Earley
Funding Source: The Plastic Surgery Foundation
Methodology Description: Comprehensive literature searches were conducted in MEDLINE, EMBASE, and Ovid Healthstar (inception through 30 June 2015), as well as the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews (through the first quarter of 2015). Additional citations were solicited from the Advisory Panel. The searches combined terms for silicone gel implants and outcomes of interest. Four researchers screened citations in duplicate, and discrepancies were resolved in a group conference. Reference lists of existing systematic reviews, selected narrative reviews, and included studies were screened. Retrieved full-text articles were rescreened in duplicate. We included studies of any longitudinal design comparing women with and those without breast implants. Studies included women with any history of silicone gel-filled breast implants, excluding injected silicone, silicone tissue expanders, and recalled implants produced by Poly Implant Prothèse (La Seyne-sur-Mer, France). At least one half the participants had to have silicone gel (vs. saline) implants, but to avoid inadvertently excluding eligible studies, we included studies that did not report the proportion of participants with silicone gel implants. Comparison groups included either women with no implants (including the general population), women with saline breast implants, or women undergoing other cosmetic surgery procedures. We excluded studies of only women with specific signs or symptoms (e.g., only women with joint pain) or only women seen in a specialty clinic (e.g., women evaluated by a rheumatologist), who do not represent the general population. Study Extraction and Assessment Data from each study were extracted by 1 of 4 methodologists and confirmed by at least 1 other experienced methodologist. Extracted data included study, participant, and implant characteristics, including use for reconstruction or augmentation; study country; implantation dates and duration; outcomes; analytical methods; and results. We preferentially extracted the most adjusted models comparing implants with no implants, and we captured all factors that were adjusted for. We extracted both direct comparisons of implants versus no implants and indirect comparisons, such as standardized incidence ratios (SIRs). To assess study quality, we applied an adaptation of the McMaster Quality Assessment Scale of Harms (McHarm) Tool. We also applied selected quality questions from the Newcastle-Ottawa Scale for quality assessment of observational and case–control studies.

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Sugars and Health - Evidence Map


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Statistics: 213 Studies, 2 Key Questions, 2 Extraction Forms,
Date Published: Oct 20, 2016 07:42PM
Description: This evidence map on sugars and health outcomes was developed using an iterative process. Evidence Map data are being used to support a stakeholders ‘ decision-making on refining research questions and topic prioritization. The goal of this Future Research Needs project is to characterize the available evidence regarding the intake of sugars and health outcomes and identify priority areas where additional research needs remain.
Contributor(s): Mei Chung, PhD, MPH (Principal Investigator). Team Members: Samantha Berger, Carrie Brown, Jiantao Ma, Joachim Sackey, Deena Wang.
Funding Source: The International Life Sciences Institute (ILSI) North American Branch.
Methodology Description: Abstract submitted to Experimental Biology 2014: Sugars and health: Applying evidence mapping techniques to assess the evidence. Objective: Evidence mapping (EM) is a novel, systematic method for describing the volume and characteristics of research in a broad field. We applied EM to evaluate the empirical evidence of the state of science on the relationships between sugars and cardiometabolic health-related outcomes. Methods: A pre-defined, systematic study selection process was applied to a broad Medline search (through April 2013) of the existing literature on sugars. Studies reporting cardiometabolic risk factors and/or related clinical outcomes were selected for this study. Data from the studies were extracted and deposited to a data repository. Descriptive analyses were performed. Results: Our EM included 207 studies (196 intervention and 11 cohort studies). Of the intervention studies, the most common sugar interventions were sucrose (40%) and fructose (31%), and the top two controls were glucose (14%) and starch (13%). The most studied outcomes were glycemic profiles (27%), plasma lipids (11%), and anthropometrics (7%). Studies were generally short in duration (median 26 days, ranging from <1 to 730 days). 89% were in adults and 6% were in children. The 11 cohort studies investigated 3 different sugar exposures and 9 different hard clinical outcomes. Conclusions: An extensive but heterogeneous body of evidence exists in this broad field of research. EM is a useful method for identifying "hot" research areas and research gaps. Evidence-based methods are effective to direct future research.

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Telehealth: Mapping the Evidence for Patient Outcomes from Systematic Reviews [Entered Retrospectively]


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Statistics: 58 Studies, 2 Key Questions, 1 Extraction Form,
Date Published: Jul 22, 2016 05:09PM
Description: Structured Abstract Background. Telehealth includes a wide range of technologies used to fulfill many functions in in health care for patients with a variety of clinical conditions. For this evidence map, telehealth is defined as the use of information and telecommunications technology in health care delivery for a specific patient involving a provider across distance or time. Various types of telehealth interventions have been evaluated in thousands of research studies and hundreds of systematic reviews. The vast size of the literature and the variations in how the literature has been collected, evaluated, and synthesized make it challenging to determine what is known about the effectiveness of telehealth for specific purposes and what questions remain unanswered. Purpose. The purpose of this brief is to provide an overview of the large and disparate body of evidence about telehealth for use by decisionmakers. The approach used was to create an evidence map of systematic reviews published to date that assess the impact of telehealth on clinical outcomes. This evidence map describes a limited number of key characteristics of the systematic reviews currently available in order to evaluate the bodies of evidence available to inform practice, policy, and research decisions about telehealth. Methods. An evidence map is a specific type of rapid or abbreviated review. While the creation of the evidence map is based on systematic review methodology, its goal is to describe rather than synthesize available research and to use graphics when possible to represent selected characteristics of the evidence. We included systematic reviews that synthesized the impact of telehealth interventions on clinical outcomes, utilization, or cost. We created bubble plots to separately examine the distribution of the evidence from systematic reviews in terms of volume (number of reviews, number of patients in the included studies), conclusions about benefit by clinical focus area, and telehealth function. We also determined how much evidence is available about combinations of clinical areas and telehealth functions reported in existing systematic reviews. We supplemented this by summarizing the topics covered in excluded reviews and the results of exploratory searches for primary studies on selected topics in order to assess the need for future systematic reviews or primary studies in key telehealth domains. Findings. We identified 1,494 citations about telehealth, from which 58 systematic reviews met our inclusion criteria. A large volume of research reported that telehealth interventions produce positive outcomes when used for remote patient monitoring, broadly defined, for several chronic conditions and for psychotherapy as part of behavioral health. The most consistent benefit has been reported when telehealth is used for communication and counseling or remote monitoring in chronic conditions such as cardiovascular and respiratory disease, with improvements in outcomes such as mortality, quality of life, and reductions in hospital admissions. Given sufficient evidence of effectiveness for these topics, the focus of future research should shift to implementation and practice-based research. Topics with an evidence base that could be the focus of future systematic reviews include telehealth for consultation, uses in intensive care units, and applications in maternal and child health. We also identified topics with a limited evidence base such as telehealth for triage in urgent/primary care, management of serious pediatric conditions, patient outcomes for teledermatology, and the integration of behavioral and physical health that may be best addressed by additional primary research. Finally, telehealth research should be integrated into evaluation of new models of care and payment so that the potential of telehealth can be assessed across the continuum of care in organizations that are implementing these reforms.
Contributor(s): Annette M.Totten Ph.D. Dana M. Womack M.S., R.N. Karen B. Eden Ph.D. Marian McDonagh Pharm.D. Jessica Griffin M.S. Sara Grusing B.A. William Hersh M.D.
Funding Source: Prepared by The Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract: 290-2015-00009-I.
Methodology Description: Methods. An evidence map is a specific type of rapid or abbreviated review. While the creation of the evidence map is based on systematic review methodology, its goal is to describe rather than synthesize available research and to use graphics when possible to represent selected characteristics of the evidence. We included systematic reviews that synthesized the impact of telehealth interventions on clinical outcomes, utilization, or cost. We created bubble plots to separately examine the distribution of the evidence from systematic reviews in terms of volume (number of reviews, number of patients in the included studies), conclusions about benefit by clinical focus area, and telehealth function. We also determined how much evidence is available about combinations of clinical areas and telehealth functions reported in existing systematic reviews. We supplemented this by summarizing the topics covered in excluded reviews and the results of exploratory searches for primary studies on selected topics in order to assess the need for future systematic reviews or primary studies in key telehealth domains.

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Nonpharmacologic Interventions for Agitation and Aggression in Dementia [entered retrospectively]


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Statistics: 130 Studies, 4 Key Questions, 1 Extraction Form,
Date Published: Feb 17, 2016 06:42PM
Description: None Provided
Contributor(s): Michelle Brasure, Ph.D., M.S.P.H., M.L.I.S. Eric Jutkowitz, M.P.H. Erika Fuchs, M.P.H., Ph.D. Victoria A. Nelson, M.Sc. Rosalie A. Kane, Ph.D. Tetyana Shippee, Ph.D. Howard Fink, M.D., M.P.H. Mary Butler, Ph.D. Robert L. Kane, M.D.
Funding Source: AHRQ
Methodology Description: Objective. To assess the efficacy, comparative effectiveness, and adverse effects of nonpharmacologic interventions for agitation and aggression in individuals with dementia. Data sources. Ovid MEDLINE®, Ovid Embase®, and the Cochrane Central Register of Controlled Trials bibliographic databases; hand searches of references of relevant studies. Review methods. Two investigators screened abstracts and full-text articles of identified references for eligibility. Eligible studies included randomized controlled trials evaluating nonpharmacologic interventions to manage agitation/aggression in individuals with dementia in nursing homes, assisted living, or community settings. We analyzed outcomes of agitation/aggression, general behavior, patient quality of life, admission to long-term care, and staff and caregiver outcomes related to patient behavior and care burden. We assessed risk of bias, extracted data, and evaluated strength of evidence for each comparison and outcome. We analyzed pooled estimates to assess efficacy and comparative effectiveness. We conducted a qualitative analysis when data could not be pooled. Results. We identified 126 unique randomized controlled trials as of July 2015. Patient-level interventions involving music, aromatherapy with lavender, and bright light were similar to usual treatment or attention control at managing agitation/aggression in persons with dementia (low strength evidence); interventions tailored to recipients’ skills, interests, or both were similar to usual care in managing agitation/aggression in persons with dementia (low strength evidence). Care delivery-level interventions (dementia care mapping and person-centered care) were similar to usual care in managing agitation/aggression in persons with dementia (low strength evidence). Evidence was insufficient to draw conclusions on the effectiveness of most caregiver-level interventions in managing agitation/aggression in persons with dementia; Caregiver interventions targeting caregiver skills and behavior were similar to attention control in managing agitation/aggression (low strength evidence). However, these interventions show benefits in caregiver confidence in caregiving and caregiver distress. Adverse effects were rarely reported. Conclusions. Although many trials have been conducted to determine effective nonpharmacologic intervention for agitation/aggression in dementia, the variety of comparisons, measurement issues, and other methodological limitations provided a weaker evidence base than is needed for such a critical topic. When evidence was sufficient to draw conclusions about effectiveness for a group of interventions, agitation/aggression outcomes were typically similar to controls. Future research is needed to guide providers and informal caregivers towards effective interventions for agitation/aggression in dementia.

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Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia [entered retrospectively]


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Statistics: 57 Studies, 3 Key Questions, 1 Extraction Form,
Date Published: Feb 17, 2016 06:41PM
Description: Objective. To assess the efficacy, comparative effectiveness, and adverse effects of drugs newly used (last 10 years) within several drug classes (i.e., alpha blockers – silodosin; antimuscarinics - tolterodine, solifenacin, fesoterodine; beta-3 adrenoceptor agonists – mirabegron; phosphodiesterase type 5 (PDE-5) inhibitors - tadalafil, sildenafil) to treat lower urinary tract symptoms attributed to BPH. Data sources. Ovid MEDLINE®, the Cochrane Central Register of Controlled Trials, and Ovid Embase bibliographic databases; hand searches of references of relevant studies. Review methods. We searched bibliographic databases from earliest electronic indexing through March 2015. Two investigators screened titles and abstracts of search results and full-text of relevant references for eligibility. Eligible studies included randomized controlled trials (RCTs) and long-term (>1 year duration) observational studies for long-term adverse effects. We assessed risk of bias for RCTs, extracted data, pooled data for analysis when appropriate and feasible and evaluated strength of evidence for comparisons and outcomes. Results. We searched bibliographic databases through July 2015 for studies testing specific drugs or combinations that included newly used drugs. We synthesized evidence from 57 unique trials and 7 observational studies. All trials lasted less than 3 months. Silodosin was more effective than placebo in improving LUTS, but was similar to tamsulosin, and there were more adverse effects with silodosin, including abnormal ejaculation. Solifenacin/alpha blocker (AB) combination therapy was better than placebo, but tolterodine/AB, solifenacin/AB, and fesoterodine/AB combination therapy were similar to AB monotherapy, and there was often evidence of higher adverse effects with combination therapy. Tadalafil improved LUTS more than placebo but had more adverse effects. Traditional ABs achieved better or similar outcomes than tadalafil; most evidence on comparative adverse effects was insufficient. We identified trials testing other drugs (mirabegron, oxybutynin, darifenacin, sildenafil, and vardenafil), but found the evidence insufficient to draw conclusions about efficacy, comparative effectiveness, or adverse effects. Evidence was insufficient on long-term effectiveness, other relevant outcomes (prevention of symptom progression, acute urinary retention or need for surgical intervention) or adverse effects. Conclusions. Several drugs newly used, along or in combination with traditional drugs, to treat LUTS attributed to BPH show some evidence of short-term symptom efficacy when compared to placebo. However, outcomes are similar to traditional alpha-blocker therapy and adverse effects are often higher with the newly used drugs or combination therapies. Data were not available to assess long-term maintenance, prevention of disease progression (including acute urinary retention or need for surgical intervention), and adverse effects.
Contributor(s): Michelle Brasure, Ph.D., M.S.P.H., M.L.I.S. Roderick MacDonald, M.S. Philipp Dahm, M.D., M.H.Sc., F.A.C.S. Carin M. Olson, M.D., M.S. Victoria A. Nelson, M.Sc. Howard A. Fink, M.D., M.P.H. Michael Risk, M.D. Bruce Rwabasonga, M.B.Ch.B., M.P.H., M.H.A. Timothy J. Wilt, M.D., M.P.H.
Funding Source: AHRQ
Methodology Description: None Provided

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