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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

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


Public Report Complete
Statistics: 138 Studies, 3 Key Questions, 1 Extraction Form,
Date Created: Mar 09, 2018 10:11PM
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.

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


Public Report Complete
Statistics: 83 Studies, 5 Key Questions, 1 Extraction Form,
Date Created: Mar 23, 2017 02:38PM
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.

Telehealth for Acute and Chronic Care Consultations


Public Report Complete
Statistics: 216 Studies, 5 Key Questions, 1 Extraction Form,
Date Created: Jan 04, 2019 11:05PM
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.

Medication Use for the Risk Reduction of Primary Breast Cancer in Women: A Systematic Review for the U.S. Preventive Services Task Force [Entered Retrospectively]


Public Report Complete
Statistics: 82 Studies, 4 Key Questions, 1 Extraction Form,
Date Created: Aug 26, 2019 05:25PM
Description: Background: Medications to reduce breast cancer risk are an effective prevention intervention for women at increased risk, although medications also cause adverse effects. Purpose: To update the 2013 U.S. Preventive Services Task Force (USPSTF) systematic review on the use of medications to reduce the risk of primary breast cancer. Data Sources: Searches included the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, EMBASE, and MEDLINE (January 1, 2013 to February 1, 2019); and manual review of reference lists. Studies published before 2013 were identified from prior systematic reviews for the USPSTF. Study Selection: Discriminatory accuracy studies of breast cancer risk assessment methods; double-blind, placebo-controlled or head-to-head randomized controlled trials (RCT) of tamoxifen, raloxifene, and aromatase inhibitors for primary prevention of breast cancer that enrolled women without preexisting breast cancer; and RCTs and observational studies of harms of medications. Data Extraction: One investigator abstracted data on study methods; setting; population characteristics; eligibility criteria; interventions; numbers enrolled and lost to followup; method of outcome ascertainment; and results for each outcome and a second investigator checked abstractions for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): Eighteen risk models evaluated in 25 studies had generally low discriminatory accuracy in predicting the probability of breast cancer in an individual (c-statistics 0.55 to 0.65). Most models performed only slightly better than age alone as a risk predictor. No studies evaluated optimal ages or frequencies of risk assessment. In placebo-controlled trials, tamoxifen (risk ratio [RR] 0.69; 95% confidence interval [CI], 0.59 to 0.84; 7 fewer cases per 1000 women over 5 years of use [95% CI, 4 to 12]; 4 trials), raloxifene (RR 0.44; 95% CI, 0.24 to 0.80; 9 fewer cases [95% CI, 3 to 15]; 2 trials), and the aromatase inhibitors exemestane and anastrozole (RR 0.45; 95% CI, 0.26 to 0.70; 16 fewer cases [95% CI, 8 to 24]; 2 trials) reduced invasive breast cancer. Risk for invasive breast cancer was higher for raloxifene than tamoxifen in the Study of Tamoxifen And Raloxifene (STAR) head-to-head trial (RR, 1.24; 95% CI, 1.05 to 1.47) after long-term followup. Effects did not differ by age of initiation or duration of use (3 to 5 years), although these effects were not directly compared. Risk reduction persisted at least 8 years after discontinuation in tamoxifen trials with long-term followup. All medications reduced estrogen receptor positive, but not estrogen receptor negative invasive breast cancer; tamoxifen reduced noninvasive cancer in two trials; and breast-cancer specific and all-cause mortality were not reduced. In placebo-controlled trials, raloxifene (RR 0.61; 95% CI, 0.53 to 0.73; 2 trials) reduced vertebral fractures; tamoxifen reduced nonvertebral fractures in the National Surgical Adjuvant Breast and Bowel Project (NSABP P-1) trial (RR 0.66; 95% CI, 0.45 to 0.98); while the aromatase inhibitors had no effect on fractures. Tamoxifen and raloxifene had similar effects on reducing fractures at multiple vertebral and nonvertebral sites in the STAR head-to-head trial. In placebo-controlled trials, tamoxifen (RR 1.93; 95% CI, 1.33 to 2.68; 4 trials) and raloxifene (RR 1.56; 95% CI, 1.11 to 2.60; 2 trials) increased thromboembolic events, while aromatase inhibitors did not. Raloxifene caused fewer thromboembolic events (RR 0.75; 95% CI, 0.60 to 0.93) than tamoxifen in the STAR head-to-head trial. Tamoxifen, raloxifene, and aromatase inhibitors did not increase coronary heart disease events or strokes. In placebo-controlled trials, tamoxifen increased endometrial cancer (RR 2.25; 95% CI, 1.17 to 4.41; 3 trials), while raloxifene and aromatase inhibitors did not. In the STAR head-to-head trial, raloxifene caused fewer cases of endometrial cancer (RR 0.55; 95% CI, 0.36 to 0.83) and endometrial hyperplasia (RR 0.19; 95% CI, 0.12 to 0.29), and fewer hysterectomies (RR 0.45; 95% CI, 0.37 to 0.54) than tamoxifen. Tamoxifen increased cataracts (RR 1.22; 95% CI, 1.08 to 1.48; 3 trials) and cataract surgery compared with placebo, while raloxifene and aromatase inhibitors did not. Risks for thromboembolic events and endometrial cancer with tamoxifen were higher for older compared with younger women and returned to normal after discontinuation. All medications caused adverse effects, such as vasomotor or musculoskeletal symptoms, that varied by medication. Risks for invasive cancer were generally reduced in all population subgroups evaluated based on menopausal status (pre and postmenopausal); family history of breast cancer; body mass index categories; modified Gail model risk categories; and age at menarche, parity, or age at first live birth, although results varied. Tamoxifen and anastrozole had larger effects in reducing invasive breast cancer in women with previous breast lesions (lobular carcinoma in situ, atypical ductal hyperplasia, or atypical lobular hyperplasia). Limitations: Trials were limited by clinical heterogeneity related to different medications, exposure durations, eligibility criteria, adherence, and ascertainment of outcomes. No trials compared timing and duration directly. Long-term followup data were lacking from most trials, and followup was particularly short for the aromatase inhibitors. Trials were not designed for subgroup comparisons and analysis of differences may be underpowered. Conclusions: Tamoxifen, raloxifene, and the aromatase inhibitors exemestane and anastrozole reduce invasive breast cancer in women without preexisting breast cancer, but also cause adverse effects that vary by medication. Tamoxifen and raloxifene increase thromboembolic events and tamoxifen increases endometrial cancer and cataracts. Identifying candidates for therapy is complicated by risk stratification methods that demonstrate low accuracy.

Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA1/2-Related Cancer in Women: A Systematic Review for the U.S. Preventive Services Task Force [Entered Retrospectively]


Public Report Complete
Statistics: 110 Studies, 5 Key Questions, 1 Extraction Form,
Date Created: Aug 26, 2019 04:31PM
Description: Background: Pathogenic mutations in breast cancer susceptibility genes BRCA1 and BRCA2 increase risks for breast, ovarian, fallopian tube, and peritoneal cancer in women; interventions reduce risk in mutation carriers. Purpose: To update the 2013 U.S. Preventive Services Task Force review on benefits and harms of risk assessment, genetic counseling, and genetic testing for BRCA1/2-related cancer in women. Data Sources: Cochrane libraries; MEDLINE, PsycINFO, EMBASE (January 1, 2013 to March 6, 2019 for updates; January 1, 1994 to March 6, 2019 for new key questions and populations); reference lists. Study Selection: Discriminatory accuracy studies, randomized controlled trials (RCTs), and observational studies of women without recently diagnosed BRCA1/2-related cancer. Data Extraction: Data on study methods; setting; population characteristics; eligibility criteria; interventions; numbers enrolled and lost to followup; outcome ascertainment; and results were abstracted. Two reviewers independently assessed study quality. Data Synthesis (Results): 103 studies (110 articles) were included. No studies evaluated the effectiveness of risk assessment, genetic counseling, and genetic testing in reducing incidence and mortality of BRCA1/2-related cancer. Fourteen studies of 10 risk assessment tools to guide referrals to genetic counseling demonstrated moderate to high accuracy (area under the receiver operating characteristic curve 0.68 to 0.96). No studies determined optimal ages, frequencies, or harms of risk assessment. Twenty-eight studies indicated genetic counseling is associated with reduced breast cancer worry, anxiety, and depression; increased understanding of risk; and decreased intention for testing. A RCT showed that population-based testing of Ashkenazi Jews detected more BRCA1/2 mutations than family-history based testing, while measures of anxiety, depression, distress, uncertainty, and quality of life were similar between groups; clinical outcomes were not evaluated. Twenty studies indicated breast cancer worry and anxiety were higher after testing for women with positive results and lower for others, and understanding of risk was higher. No RCTs evaluated the effectiveness of intensive screening for breast or ovarian cancer in mutation carriers. In observational studies, false-positive rates, additional imaging, and benign biopsies were higher with magnetic resonance imaging than mammography. In eight RCTs, tamoxifen (risk ratio [RR], 0.69; 95% confidence interval [CI], 0.59 to 0.84; 4 trials), raloxifene (RR, 0.44 95% CI, 0.24 to 0.80; 2 trials), and aromatase inhibitors (RR, 0.45 95% CI, 0.26 to 0.70; 2 trials) were associated with lower risks of invasive breast cancer compared with placebo; results were not specific to mutation carriers. Adverse effects included venous thromboembolic events for tamoxifen and raloxifene; endometrial cancer and cataracts for tamoxifen; and vasomotor, musculoskeletal, and other symptoms for all medications. In observational studies, mastectomy was associated with 90 to 100 percent reduction in breast cancer incidence and 81 to 100 percent reduction in breast cancer mortality; oophorectomy or salpingo-oophorectomy was associated with 69 to 100 percent reduction in ovarian cancer; complications were common with mastectomy. Limitations: Including only English-language articles and studies applicable to the United States; varying number, quality, and applicability of studies; and few studies of untested women previously treated for BRCA1/2-related cancer. Conclusions: Risk assessment, genetic counseling, and genetic testing to reduce BRCA1/2-cancer incidence and mortality as a prevention service has not been directly evaluated by current research. Risk assessment with familial risk tools accurately identifies high-risk women for genetic counseling. Genetic counseling reduces breast cancer worry, anxiety, and depression; increases understanding of risk; and decreases intention for mutation testing, while testing improves accuracy of understanding of risk. The effectiveness of intensive screening is not known, but it increases false-positive results and procedures. Risk-reducing medications and surgery are associated with reduced breast and ovarian cancer, but also have adverse effects. Evidence gaps relevant to prevention remain and additional studies are needed to better inform clinical practice.

Screening for HIV Infection in Asymptomatic, Nonpregnant Adolescents and Adults [Entered Retrospectively]


Public Report Complete
Statistics: 29 Studies, 5 Key Questions, 1 Extraction Form,
Date Created: Jul 11, 2019 07:26PM
Description: Background: A 2012 systematic review on HIV screening for the U.S. Preventive Services Task Force (USPSTF) found strong evidence that antiretroviral therapy (ART) is associated with improved clinical outcomes in persons with CD4+ T helper cell (CD4) counts less than 500 cells/mm3 and substantially decreases risk of HIV transmission, with certain antiretroviral agents potentially associated with long-term cardiovascular harms. The USPSTF previously found HIV screening tests to be highly accurate. Purpose: To systematically update the 2012 USPSTF review on screening for HIV in adolescents and adults, focusing on research gaps identified in the prior review. Data Sources: We searched the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and MEDLINE (2012 to June 2018) and manually reviewed reference lists, with surveillance through January 2019. Study Selection: Randomized, controlled trials (RCTs) and controlled observational studies on benefits and harms of screening versus no screening and on the yield of screening at different intervals; the effects of earlier versus later initiation of ART; and long-term (≥2 years) harms of ART. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): We did not identify any studies on benefits or harms of HIV screening versus no screening, or on the yield of repeat versus one-time screening or of screening at different intervals. Two new RCTs conducted completely or partially in low-resource settings found initiation of ART in persons with CD4 counts greater than 500 cells/mm3 associated with lower risk of composite clinical outcomes (mortality, AIDS-defining events, or serious non-AIDS events) (relative risk [RR], 0.44 [95% confidence interval (CI), 0.31 to 0.63] and RR, 0.57 [95% CI, 0.35 to 0.95]); early initiation of ART was not associated with increased risk of cardiovascular events. A large observational study also found initiation of ART in persons in high-resource settings with CD4 counts greater than 500 cells/mm3 to be associated with reduced risk of mortality or AIDS events, although the magnitude of effect was smaller. New evidence regarding the association between abacavir use and increased risk of cardiovascular events was inconsistent, and certain antiretroviral regimens were associated with increased risk of long-term neuropsychiatric, renal, hepatic, and bone adverse events. Limitations: Only English-language articles were included. Observational studies were included. Studies conducted in resource-poor settings were included, which might limit applicability to general screening in the United States. Conclusions: New evidence extends effectiveness of ART to asymptomatic persons with CD4 counts greater than 500 cells/mm3. Certain ART regimens may be associated with long-term cardiovascular, neuropsychiatric, hepatic, renal, or bone harms, but early initiation of ART is not associated with increased risk of cardiovascular events. Research is needed to inform optimal screening intervals.



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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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