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Completed Systematic Reviews




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Cervical Ripening in the Outpatient Setting


Public Project Complete

Statistics: 40 Studies, 4 Key Questions, 1 Extraction Form,
Date Published: Jun 02, 2021 03:50PM
Description: Structured Abstract Objectives. To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient setting (vs. inpatient, vs. other outpatient intervention) and of fetal surveillance when a prostaglandin is used for cervical ripening. Data sources. Electronic databases (Ovid® MEDLINE®, Embase®, CINAHL®, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) to July 2020; reference lists; and a Federal Register notice. Review methods. Using predefined criteria and dual review, we selected randomized controlled trials (RCTs) and cohort studies of cervical ripening comparing prostaglandins and mechanical methods in outpatient versus inpatient settings; one outpatient method versus another (including placebo or expectant management); and different methods/protocols for fetal surveillance in cervical ripening using prostaglandins. When data from similar study designs, populations, and outcomes were available, random effects using profile likelihood meta-analyses were conducted. Inconsistency (using I2) and small sample size bias (publication bias, if ≥10 studies) were assessed. Strength of evidence (SOE) was assessed. All review methods followed Agency for Healthcare Research and Quality Evidence-based Practice Center methods guidance. Results. We included 30 RCTs and 10 cohort studies (73% fair quality) involving 9,618 women. The evidence is most applicable to women aged 25 to 30 years with singleton, vertex presentation and low-risk pregnancies. No studies on fetal surveillance were found. The frequency of cesarean delivery (2 RCTs, 4 cohort studies) or suspected neonatal sepsis (2 RCTs) was not significantly different using outpatient versus inpatient dinoprostone for cervical ripening (SOE: low). In comparisons of outpatient versus inpatient single-balloon catheters (3 RCTs, 2 cohort studies), differences between groups on cesarean delivery, birth trauma (e.g., cephalohematoma), and uterine infection were small and not statistically significant (SOE: low), and while shoulder dystocia occurred less frequently in the outpatient group (1 RCT; 3% vs. 11%), the difference was not statistically significant (SOE: low). In comparing outpatient catheters and inpatient dinoprostone (1 double-balloon and 1 single-balloon RCT), the difference between groups for both cesarean delivery and postpartum hemorrhage was small and not statistically significant (SOE: low). Evidence on other outcomes in these comparisons and for misoprostol, double-balloon catheters, and hygroscopic dilators was insufficient to draw conclusions. In head to head comparisons in the outpatient setting, the frequency of cesarean delivery was not significantly different between 2.5 mg and 5 mg dinoprostone gel, or latex and silicone single-balloon catheters (1 RCT each, SOE: low). Differences between prostaglandins and placebo for cervical ripening were small and not significantly different for cesarean delivery (12 RCTs), shoulder dystocia (3 RCTs), or uterine infection (7 RCTs) (SOE: low). These findings did not change according to the specific prostaglandin, route of administration, study quality, or gestational age. Small, nonsignificant differences in the frequency of cesarean delivery (6 RCTs) and uterine infection (3 RCTs) were also found between dinoprostone and either membrane sweeping or expectant management (SOE: low). These findings did not change according to the specific prostaglandin or study quality. Evidence on other comparisons (e.g., single-balloon catheter vs. dinoprostone) or other outcomes was insufficient. For all comparisons, there was insufficient evidence on other important outcomes such as perinatal mortality and time from admission to vaginal birth. Limitations of the evidence include the quantity, quality, and sample sizes of trials for specific interventions, particularly rare harm outcomes. Conclusions. In women with low-risk pregnancies, the risk of cesarean delivery and fetal, neonatal, or maternal harms using either dinoprostone or single-balloon catheters was not significantly different for cervical ripening in the outpatient versus inpatient setting, and similar when compared with placebo, expectant management, or membrane sweeping in the outpatient setting. This evidence is low strength, and future studies are needed to confirm these findings.
Contributor(s): Marian McDonagh, PharmD Andrea C. Skelly, PhD, MPH Amy Hermesch, MD, PhD Ellen Tilden, PhD Erika D. Brodt, BS Tracy Dana, MLS Shaun Ramirez, MPH Rochelle Fu, PhD Shelby N. Kantner, BA Frances Hsu, MS Erica Hart, MST
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality (AHRQ)
Methodology Description: Data sources. Electronic databases (Ovid® MEDLINE®, Embase®, CINAHL®, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) to July 2020; reference lists; and a Federal Register notice. Review methods. Using predefined criteria and dual review, we selected randomized controlled trials (RCTs) and cohort studies of cervical ripening comparing prostaglandins and mechanical methods in outpatient versus inpatient settings; one outpatient method versus another (including placebo or expectant management); and different methods/protocols for fetal surveillance in cervical ripening using prostaglandins. When data from similar study designs, populations, and outcomes were available, random effects using profile likelihood meta-analyses were conducted. Inconsistency (using I2) and small sample size bias (publication bias, if ≥10 studies) were assessed. Strength of evidence (SOE) was assessed. All review methods followed Agency for Healthcare Research and Quality Evidence-based Practice Center methods guidance.

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SRDR Project Indexing


Public Project Complete

Statistics: 187 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Jun 02, 2021 03:47PM
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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Management of Primary Headache During Pregnancy


Public Project Complete

Statistics: 53 Studies, 4 Key Questions, 2 Extraction Forms,
Date Published: May 22, 2021 05:20PM
Description: This systematic review will assess the prevention and treatment of primary headache during pregnancy, postpartum, and breastfeeding.
Contributor(s): Brown University Evidence-based Practice Center
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: A full systematic review

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Noninvasive Treatments for Low Back Pain [Entered Retrospectively]


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Statistics: 156 Studies, 2 Key Questions, 1 Extraction Form,
Date Published: Apr 30, 2021 03:58AM
Description: Objectives. Low back pain is common and many pharmacological and nonpharmacological therapies are available. This review examines the evidence on the comparative benefits and harms of noninvasive treatments for low back pain. Data Sources. A prior systematic review (searches through October 2008), electronic databases (Ovid MEDLINE and the Cochrane Libraries, January 2008 to April 2015), reference lists, and clinical trials registries. Review Methods. Using predefined criteria, we selected systematic reviews of randomized trials of pharmacological treatments (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAID]s, opioids, skeletal muscle relaxants, benzodiazepines, antidepressants, antiseizure medications, and systemic corticosteroids) and nonpharmacological treatments (psychological therapies, multidisciplinary rehabilitation, spinal manipulation, acupuncture, massage, exercise and related therapies, and various physical modalities) for nonradicular or radicular low back pain that addressed effectiveness or harms versus placebo, no treatment, usual care, a sham therapy, an inactive therapy, or another active therapy. We also included randomized trials that were not in systematic reviews. The quality of included studies was assessed, data were extracted, and results were summarized qualitatively based on the totality of the evidence. Results. Of the 2,545 citations identified at the title and abstract level, a total of 156 publications were included. Most trials enrolled patients with pain symptoms of at least moderate intensity (e.g., >5 on a 0- to 10-point NRS for pain). Across interventions, pain intensity was the most commonly reported outcome, followed by back-specific function. When present, observed benefits for pain were generally in the small (5 to 10 points on a 0- to 100-point visual analogue scale [VAS] or 0.5 to 1.0 points on a 0- to 10-point numerical rating scale) to moderate (10 to 20 points) range. Effects on function were generally smaller than effects on pain; in some cases there were positive effects on pain but no effects on function, and fewer studies measured function than pain. Benefits were mostly measured at short-term followup. For acute low back pain, evidence suggested that NSAIDs (strength of evidence [SOE]: low to moderate), skeletal muscle relaxants (SOE: moderate), opioids (SOE: low), exercise (SOE: low), and superficial heat (SOE: moderate) are more effective than placebo, no intervention, or usual care and that acetaminophen (SOE: low) and systemic corticosteroids (SOE: low) are no more effective than placebo. For chronic low back pain, effective therapies versus placebo, sham, no treatment, usual care, or wait list are NSAIDs, opioids, tramadol, duloxetine, multidisciplinary rehabilitation, acupuncture, and exercise (SOE: moderate) and benzodiazepines, psychological therapies, massage, yoga, tai chi, and low-level laser therapy (SOE: low); spinal manipulation was as effective as other active interventions (SOE: moderate). Few trials evaluated the effectiveness of treatments for radicular low back pain, but the available evidence found that benzodiazepines, corticosteroids, traction, and spinal manipulation were not effective or associated with small effects (SOE: low). Relatively few trials directly compared the effectiveness of different medications, different nonpharmacological therapies, or compared pharmacological versus nonpharmacological therapies, and generally found no clear differences in effects. Pharmacological therapies were associated with increased risk of adverse events versus placebo (SOE: low to moderate). Trials were not designed or powered to detect serious harms from pharmacological therapies. Although rates appeared to be low, and there was not an increased risk of serious harms versus placebo, this does not rule out significant risk from some treatments. For nonpharmacological therapies, assessment of harms was suboptimal, but serious harms appeared rare (SOE: low). Conclusions. A number of pharmacological and nonpharmacological, noninvasive treatments for low back pain are associated with small to moderate, primarily short-term effects on pain versus placebo, sham, wait list, or no treatment. Effects on function were generally smaller than effects on pain. More research is needed to understand optimal selection of treatments, effective combinations and sequencing of treatments, effectiveness of treatments for radicular low back pain, and effectiveness on outcomes other than pain and function.
Contributor(s): Roger Chou, M.D., FACP Rick (Richard) Deyo, M.D., M.P.H. Janna Friedly, M.D. Andrea Skelly, Ph.D., M.P.H. Robin Hashimoto, Ph.D. Melissa Weimer, D.O., M.C.R. Rochelle Fu, Ph.D. Tracy Dana, M.L.S. Paul Kraegel, M.S.W. Jessica Griffin, M.S. Sara Grusing, B.A. Erika Brodt, B.S.
Funding Source: This project was funded under Contract No. HHSA 290-2012-00014-I from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.
Methodology Description: Review Methods. Using predefined criteria, we selected systematic reviews of randomized trials of pharmacological treatments (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAID]s, opioids, skeletal muscle relaxants, benzodiazepines, antidepressants, antiseizure medications, and systemic corticosteroids) and nonpharmacological treatments (psychological therapies, multidisciplinary rehabilitation, spinal manipulation, acupuncture, massage, exercise and related therapies, and various physical modalities) for nonradicular or radicular low back pain that addressed effectiveness or harms versus placebo, no treatment, usual care, a sham therapy, an inactive therapy, or another active therapy. We also included randomized trials that were not in systematic reviews. The quality of included studies was assessed, data were extracted, and results were summarized qualitatively based on the totality of the evidence.

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Screening for Bacterial Vaginosis in Pregnant Adolescents and Women to Prevent Preterm Delivery


Public Project Complete

Statistics: 45 Studies, 5 Key Questions, 1 Extraction Form,
Date Published: Apr 21, 2021 06:30PM
Description: A review of the evidence about screening for bacterial vaginosis during pregnancy to prevent preterm delivery.
Contributor(s): The authors gratefully acknowledge the following individuals for their contributions to this project: Tina Fan, MD, MPH, AHRQ Medical Officer; Tracy Wolff, MD, MPH, AHRQ Associate Scientific Director; Quyen Ngo-Metzger, MD, MPH, Professor at Kaiser Permanente School of Medicine; current members of the U.S. Preventive Services Task Force; expert peer reviewers Mark Klebanoff, MD, MPH; John Thorp, MD; Valerie J. King, MD, MPH; and Julie van Schalkwyk, MD; two Federal partner reviewers; and RTI International–University of North Carolina EPC staff: Carol Woodell, BSPH; B. Lynn Whitener, DrPH; Sharon Barrell, MA; and Loraine Monroe.
DOI: DOI pending.
Funding Source: AHRQ
Methodology Description: We conducted a systematic review to evaluate the benefits and harms of screening and treatment for bacterial vaginosis during pregnancy to prevent preterm delivery and the diagnostic accuracy of tests used to screen for bacterial vaginosis. We searched 3 databases from January 1, 2006, through May 29, 2019, building on the literature included in the prior 2008 evidence review for the USPSTF. Because the previous reviews on this topic for the USPSTF did not include a systematic search for KQ 2 (diagnostic test accuracy), we conducted a separate PubMed search from inception through December 31, 2005, to supplement our main search for this update. Two investigators screened each abstract and full-text article for inclusion; abstracted data; and performed quality ratings, applicability ratings, and evidence grading. Where appropriate, we performed a quantitative synthesis by fitting the bivariate model to generate a summary receiver operating characteristics curve (SROC) and a pooled summary point estimate of sensitivity and specificity.

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