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Recently published projects
First published on July 02, 2021
Last edited on July 15, 2021Obstructive Sleep Apnea: CPAP and AHI vs. outcomes
73 Studies • 2 Key Questions • 2 Extraction Forms
Objectives: Purpose of the Review: The Centers for Medicare and Medicaid Services (CMS) nominated the topic to the Agency for Healthcare Research and Quality for a Technology Assessment. The scope of the report’s protocol was developed to inform CMS’s coverage decisions. The report will address contextual questions (CQs) and conduct a systematic review (SR). The CQs cover background material to help to understand the findings of the SR, including information on currently-used treatment modalities for OSA, the postulated rationales for use of CPAP, currently-used measures of AHI and related measures in contemporary research and clinical settings, validated sleep questionnaires. The CQs also cover discussion of the ideal study designs for establishing validity of surrogate or intermediate measures. The CQs will be addressed using a, best-evidence, but nonsystematic approach. The SR will (1) summarize evidence on the validity of measures of sleep and breathing as surrogates (or intermediate outcomes) for clinically significant outcomes in patients with OSA, effectively assessing the linkage between the former and the latter, and (2) synthesize evidence on the (comparative) efficacy, effectiveness and safety of CPAP to prevent clinically important outcomes. The SR will attempt to describe heterogeneity of treatment effects in terms of diversity of patient populations, devices and treatment protocols, outcome definitions and study design characteristics. For included randomized controlled trials (RCT), we will examine the concordance among AHI (and similar measures), validated sleep questionnaires, and clinical outcomes. The intended audience includes CMS and non-CMS stakeholders including guideline developers, clinicians and other providers of care for patients with OSA, healthcare policy makers, and patients.
First published on May 20, 2021
Last edited on June 02, 2021Cervical Ripening in the Outpatient Setting
40 Studies • 4 Key Questions • 1 Extraction Forms
Objectives: 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.
First published on February 12, 2019
Last edited on July 14, 2021SRDR Project Indexing
188 Studies • 1 Key Questions • 1 Extraction Forms
Objectives: This is a Methods Research project that catalogs the various projects with publicly available data on the SRDR Webpage.