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Objectives: Identify and abstract data from randomized controlled trials (RCTs) examining treatment for posttraumatic stress disorder (PTSD) and comorbid PTSD/substance use disorder to update the previous Agency for Healthcare Research and Quality (AHRQ) report and National Center for PTSD (NCPTSD) PTSD Trials Standardized Data Repository (PTSD-Repository)., Data Sources: We searched PTSDpubs, Ovid ® MEDLINE ® , Cochrane CENTRAL, PsycINFO ® , Embase ® , CINAHL ® , and Scopus ® for eligible RCTs published from June 1, 2018, to January 26, 2022., Review Methods: In consultation with AHRQ and NCPTSD, we updated the evidence tables for the PTSD-Repository by including evidence published after publication of the last update and expanding abstraction of results to include calculated standardized effect sizes. The primary publication for each RCT was abstracted; data and citations from secondary publications (i.e., companion papers) appear in the same record. We assessed risk of bias (RoB) for all newly included studies using the Revised Cochrane Risk of Bias 2 (RoB 2) tool for randomized trials. For studies already in the PTSD-Repository, we will add calculated standardized effect sizes and update RoB using the new RoB 2 tool over the next several annual updates., Results: We added 48 new RCTs examining treatments for PTSD, for a total of 437 included studies published from 1988 to July 30, 2021. Among the 48 newly added RCTs, psychotherapy interventions were the most commonly employed (50%), followed by complementary and integrative health (17%). Approximately half of studies were conducted in the United States (46%), and enrolled community participants (52%) and participants with a mix of trauma types (48%). Studies typically had sample sizes ranging from 25 to 99 participants (69%). RoB was rated as high for 52 percent of studies, 31 percent were rated as low RoB, and the remaining studies were rated as having some concerns (15%)., Conclusions: This report updates the previous AHRQ report to include 48 recently published RCTs, for a total of 437 studies. This update adds comprehensive data, standardized effect sizes for PTSD outcomes, and RoB assessment for the newly included RCTs. As with the previous AHRQ update, this report will inform updates to the PTSD-Repository, a comprehensive database of PTSD trials.

Objective: To assess the comparative benefits and harms across three airway management approaches (bag valve mask [BVM], supraglottic airway [SGA], and endotracheal intubation [ETI]) by emergency medical services in the prehospital setting, and how the benefits and harms differ based on patient characteristics, techniques, and devices., Data Sources: We searched electronic citation databases (Ovid ® MEDLINE ® , CINAHL ® , the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Scopus ® ) from 1990 to September 2020 and reference lists, and posted a Federal Register notice request for data., Review Methods: Review methods followed Agency for Healthcare Research and Quality Evidence-based Practice Center Program methods guidance. Using pre-established criteria, studies were selected and dual reviewed, data were abstracted, and studies were evaluated for risk of bias. Meta-analyses using profile-likelihood random effects models were conducted when data were available from studies reporting on similar outcomes, with analyses stratified by study design, emergency type, and age. We qualitatively synthesized results when meta-analysis was not indicated. Strength of evidence (SOE) was assessed for primary outcomes (survival, neurological function, return of spontaneous circulation [ROSC], and successful advanced airway insertion [for SGA and ETI only])., Results: We included 99 studies (22 randomized controlled trials and 77 observational studies) involving 630,397 patients. Overall, we found few differences in primary outcomes when airway management approaches were compared. For survival, there was moderate SOE for findings of no difference for BVM versus ETI in adult and mixed-age cardiac arrest patients. There was low SOE for no difference in these patients for BVM versus SGA and SGA versus ETI. There was low SOE for all three comparisons in pediatric cardiac arrest patients, and low SOE in adult trauma patients when BVM was compared with ETI. For neurological function, there was moderate SOE for no difference for BVM compared with ETI in adults with cardiac arrest. There was low SOE for no difference in pediatric cardiac arrest for BVM versus ETI and SGA versus ETI. In adults with cardiac arrest, neurological function was better for BVM and ETI compared with SGA (both low SOE). ROSC was applicable only in cardiac arrest. For adults, there was low SOE that ROSC was more frequent with SGA compared with ETI, and no difference for BVM versus SGA or BVM versus ETI. In pediatric patients there was low SOE of no difference for BVM versus ETI and SGA versus ETI. For successful advanced airway insertion, low SOE supported better first-pass success with SGA in adult and pediatric cardiac arrest patients and adult patients in studies that mixed emergency types. Low SOE also supported no difference for first-pass success in adult medical patients. For overall success, there was moderate SOE of no difference for adults with cardiac arrest, medical, and mixed emergency types. While harms were not always measured or reported, moderate SOE supported all available findings. There were no differences in harms for BVM versus SGA or ETI. When SGA was compared with ETI, there were no differences for aspiration, oral/airway trauma, and regurgitation; SGA was better for multiple insertion attempts; and ETI was better for inadequate ventilation., Conclusions: The most common findings, across emergency types and age groups, were of no differences in primary outcomes when prehospital airway management approaches were compared. As most of the included studies were observational, these findings may reflect study design and methodological limitations. Due to the dynamic nature of the prehospital environment, the results are susceptible to indication and survival biases as well as confounding; however, the current evidence does not favor more invasive airway approaches. No conclusion was supported by high SOE for any comparison and patient group. This supports the need for high-quality randomized controlled trials designed to account for the variability and dynamic nature of prehospital airway management to advance and inform clinical practice as well as emergency medical services education and policy, and to improve patient-centered outcomes.

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 I 2 ) 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.

Objectives: To evaluate the effectiveness and comparative effectiveness of nonopioid pharmacologic agents in patients with specific types of chronic pain, considering effects on pain, function, quality of life, and adverse events., Data Sources: Electronic databases (Ovid ® MEDLINE ® , Embase ® , PsycINFO ® , CINAHL ® , Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) through September 10, 2019, reference lists, data requests, and previous reviews., Review Methods: Randomized controlled trials (RCTs) of nonopioid pharmacologic agents in patients with chronic pain were selected using predefined criteria and dual review. This review focused on seven common chronic pain conditions (neuropathic pain, fibromyalgia, osteoarthritis, inflammatory arthritis, low back pain, chronic headache, sickle cell disease), with effects analyzed at short term (1 to <6 months following treatment completion), intermediate term (≥6 to <12 months), and long term (≥12 months). Magnitude of effects were described as small, moderate, or large using previously defined criteria, and strength of evidence was assessed. Meta-analyses were conducted where data allowed, stratified by duration within each intervention type, using random effects models. We evaluated effect modification through subgroup and sensitivity analyses, including specific drug, dose, study quality, and pain type., Results: We included 185 RCTs in 221 publications and 5 systematic reviews. In the short term, anticonvulsants (pregabalin, gabapentin, and oxcarbazepine for neuropathic pain, pregabalin/gabapentin for fibromyalgia), serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressants (duloxetine for neuropathic pain, fibromyalgia, osteoarthritis, and low back pain, milnacipran for fibromyalgia), and nonsteroidal anti-inflammatory drugs (NSAIDs) (for osteoarthritis and inflammatory arthritis) were associated with mostly small improvements (e.g., 5 to 20 points on a 0 to 100 scale) in pain and function. Function was not found to be improved with duloxetine for low back pain or pregabalin/gabapentin for neuropathic pain. Moderate improvement in quality of life was seen with duloxetine in patients with neuropathic pain, and small improvements in patients with osteoarthritis, but evidence was insufficient to draw conclusions for other drugs and conditions. While most comparisons of drugs and doses did not identify differences, diclofenac improved pain and function moderately more than celecoxib. In the intermediate term, limited evidence (1 RCT) showed memantine moderately improved pain, function, and quality of life in patients with fibromyalgia; improvements in pain, but not function, were maintained in the intermediate term with duloxetine and milnacipran for fibromyalgia. Other drugs studied, including acetaminophen (osteoarthritis), capsaicin (neuropathic pain), cannabis (neuropathic pain), amitriptyline (fibromyalgia, neuropathic pain), and cyclobenzaprine (fibromyalgia) had no clear effects. Withdrawal from study due to adverse events was significantly increased with nonopioid drugs, with the greatest increase over placebo seen with cannabis. Large increases in risk of adverse events were seen with pregabalin (blurred vision, cognitive effects, dizziness, peripheral edema, sedation, and weight gain), gabapentin (blurred vision, cognitive effects, sedation, weight gain), and cannabis (nausea, dizziness). Dose reductions reduced the risk of some adverse events with SNRI antidepressants. In the short term small increases in risk of major coronary events and moderate increases in serious gastrointestinal events (both short and long term) were found with NSAIDs., Conclusions: In the short term, small improvements in pain and/or function were seen with SNRI antidepressants for neuropathic pain, fibromyalgia, osteoarthritis, and low back pain; pregabalin/gabapentin for neuropathic pain and fibromyalgia; oxcarbazepine for neuropathic pain; and NSAIDs for osteoarthritis and inflammatory arthritis. Improvement in function was not found with duloxetine for low back pain and pregabalin/gabapentin for neuropathic pain. Intermediate- and long-term outcomes were mostly not assessed. Increased incidence of drug class–specific adverse events led to withdrawal from treatment in some patients, suggesting that careful consideration of patient characteristics is needed in selecting nonopioid drug treatments.