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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.

Background: In 2013, the United States Preventive Services Task Force (USPSTF) concluded that the evidence was insufficient to assess the balance of benefits and harms of screening for primary open angle glaucoma in adults (I Statement). Although the USPSTF found that treatment of increased intraocular pressure (IOP) and early glaucoma reduces progression of visual field defects, it found inadequate evidence on the effects of treatment on the development of impaired vision or quality of life. There was no direct evidence on benefits and harms of glaucoma screening versus no screening., Purpose: To systematically review the evidence on screening and treatment of glaucoma for populations and settings relevant to primary care in the United States., Data Sources: We searched the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and MEDLINE (through February 9, 2021), reviewed the studies in the prior reports, and manually reviewed reference lists. Surveillance was conducted through January 21, 2022., Study Selection: Randomized controlled trials (RCTs) of screening and referral; studies on diagnostic accuracy of currently utilized screening tests (optical coherence tomography [OCT], optic disc photography, ophthalmoscopy and biomicroscopy, pachymetry, tonometry, and visual fields); and RCTs of medical therapy versus placebo or no treatment, recently approved medical therapies versus older therapies, and selective laser trabeculoplasty versus medical therapy., Data Extraction: One investigator abstracted data and a second checked accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF., Data Synthesis (results): A total of 83 studies (N=75,887) were included in this review (30 trials, and 53 diagnostic accuracy studies). Sixteen studies were carried forward from the prior review and 67 studies were new. One RCT (n=616) found vision screening (including components for glaucoma) by an optometrist was associated with no difference in visual acuity or vision-related quality of life compared with no screening, but greater risk of falls (likelihood of at least 1 fall 65% vs. 50%, relative risk [RR] 1.31, 95% confidence interval [CI] 1.13 to 1.50). No study evaluated effects of referral to an eye health provider versus no referral on vision or other health outcomes. Evidence on accuracy of screening tests for identifying persons with glaucoma was most robust for spectral domain-OCT retinal nerve fiber layer thickness (15 studies, N=4,242, sensitivity 0.79, 95% CI 0.75 to 0.83 and specificity 0.92, 95% CI 0.87 to 0.96), area under the receiver operating characteristic curve (16 studies, N=4,060) 0.90, (95% CI 0.86 to 0.93) and spectral domain-OCT ganglion cell analysis (9 studies, N=1,522, sensitivity 0.74, 95% CI 0.68 to 0.80 and specificity 0.91, 95% CI 0.80 to 0.96), tonometry (13 studies, N=32,892, sensitivity 0.48, 95% CI 0.31 to 0.66 and specificity 0.94, 95% CI 0.90 to 0.96), and the Humphrey Visual Field Analyzer (6 studies, N=11,244, sensitivity 0.87, 95% CI 0.69 to 0.95 and specificity 0.82, 95% CI 0.66 to 0.92). Evidence on other screening tests (swept source-OCT, optic disc photography, ophthalmoscopy and biomicroscopy, and pachymetry) was limited. A pilot study and followup found telemedicine screening in primary care associated with variable sensitivity for identifying persons with glaucoma but high specificity. Evidence on the accuracy of instruments for identifying patients at higher risk of glaucoma was limited to one study that was of limited applicability to screening because prior diagnosis of glaucoma was one of the key risk factors. Medical therapy for ocular hypertension and untreated glaucoma was associated with greater reduction in IOP (16 trials, N=3,706, mean difference −3.14 millimeters mercury [mm Hg], 95% CI −4.19 to −2.08), decreased likelihood of glaucoma progression (7 trials, N=3,771, RR 0.68, 95% CI 0.49 to 0.96; absolute risk difference −4.2%), and increased risk of ocular adverse events (2 trials, RR 1.21, 95% CI 1.10 to 1.33 and RR 3.52, 95% CI 2.46 to 5.02) versus placebo or no treatment. One trial (n=461) found no differences between medical therapy versus placebo or no treatment in visual acuity, quality of life, or function. Recently approved medical therapies for glaucoma (netarsudil and latanoprostene bunod) were associated with similar or slightly greater reduction in IOP versus older therapies (6 trials, N=3,128), but increased risk of adverse events. Selective laser trabeculoplasty and medical therapy were associated with similar effects on IOP, visual acuity, visual fields, quality of life, and adverse events (4 trials, N=957)., Limitations: The screening trial had methodological limitations and few patients were referred for glaucoma evaluation; excluded non-English language studies; statistical heterogeneity in pooled analyses on effects of medical therapy versus placebo or no treatment on IOP, though inconsistency was in the magnitude (not direction) of benefit; evidence on effects of treatment on visual impairment, quality of life, and function remains very limited; excluded case-control studies of diagnostic accuracy; evaluation of publication bias limited by small numbers of studies and statistical heterogeneity; most head-to-head comparisons excluded., Conclusions: Direct evidence on glaucoma screening versus no screening is limited and showed no benefits on vision-related quality of life or function, and increased risk of falls. Screening tests (OCT, visual field assessment) can identify persons with OAG with reasonable accuracy. Treatment for ocular hypertension or untreated OAG is associated with reduction in IOP and reduced risk of glaucoma progression based on visual fields or optic nerve changes, but limited evidence on the association with visual outcome, quality of life, and function indicates no clear effects.

Background: In 2016, the United States Preventive Services Task Force (USPSTF) concluded that the current evidence was insufficient to assess the balance of benefits and harms of screening for impaired visual acuity in older adults (I Statement). Although the USPSTF found that screening can identify persons with impaired visual acuity and that effective treatments are available for common causes of impaired visual acuity, direct evidence found no differences between vision screening and no screening on visual acuity or other clinical outcomes., Purpose: To systematically review the evidence on screening for impaired visual acuity in older adults for populations and settings relevant to primary care in the United States., Data Sources: We searched the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and MEDLINE (through February 9, 2021), reviewed the studies in the prior USPSTF report, and manually reviewed reference lists. Surveillance was conducted through January 21, 2022., Study Selection: Randomized controlled trials (RCTs) and controlled observational studies on benefits and harms of screening compared with no screening; studies on diagnostic accuracy of screening tests and instruments (including questionnaires); and benefits and harms of vascular endothelial growth factor (VEGF) inhibitors for wet age-related macular degeneration (AMD) and antioxidant vitamins and minerals for dry AMD in adults age 65 years and older., Data Extraction: One investigator abstracted data and a second checked accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF., Data Synthesis (results): A total of 25 studies (N=33,586) were included in this review (13 trials, 11 diagnostic accuracy studies, and 1 systematic review [of 19 trials]). Sixteen studies were carried forward from the 2016 review for the USPSTF, eight studies were new, and the systematic review utilized in the 2016 review for the USPSTF was updated to include six new trials. Four trials (N=4,819) of screening compared with no screening, usual care, or delayed screening of older adults found no differences in visual acuity or other clinical outcomes. Visual acuity tests (3 studies; N=6,493) were associated with suboptimal diagnostic accuracy for identifying visual conditions compared with a complete examination by an ophthalmologist (sensitivity 0.27 to 0.75 and specificity 0.51 to 0.87); evidence on other screening tests was limited. Three studies (N=5,203) found that a screening question was not accurate for identifying older persons with impaired visual acuity compared with a visual acuity eye chart (sensitivity 0.17 to 0.81 and specificity 0.19 to 0.84). For wet AMD, four trials (N=2,086) found VEGF inhibitors associated with greater likelihood of ≥15 letters (3 lines) of visual acuity gain (risk ratio [RR] 2.92, 95% confidence interval [CI] 1.20 to 7.12, I 2 =76%; absolute risk difference [ARD] 10%), <15 letters (3 lines) of visual acuity loss (RR 1.46, 95% CI 1.22 to 1.75, I 2 =80%; ARD 27%) and having vision 20/200 or better (RR 1.47, 95% CI 1.30 to 1.66, I 2 =42%; ARD 24%) at 1 year compared with sham injection. VEGF inhibitors were associated with better vision-related function and quality of life measures compared with sham injection at 1 and 2 years; the difference (~8 points on a 0 to 100 scale) was above the minimum clinically important difference threshold. For dry AMD, a systematic review of 19 trials found antioxidant multivitamins associated with decreased risk of progression to late AMD (3 trials, N=2,445 people, odds ratio [OR] 0.72, 95% CI 0.58 to 0.90) and ≥3 lines visual acuity loss (1 trial, N=1,791 people, OR 0.77, 95% CI 0.62 to 0.96) compared with placebo. Results were primarily driven by the large (n=3,640) Age-Related Eye Disease Study (AREDS). Zinc was associated with decreased risk of progression to late AMD compared with placebo (3 trials, N=3,790 people, OR 0.83, 95% CI 0.70 to 0.98) and decreased risk of ≥3 lines visual acuity loss that was of borderline statistical significance (2 trials, 3,791 people, RR 0.87, 95% CI 0.75 to 1.00). Evidence on the effects of other vitamins and mineral treatments was limited or showed no clear effects on AMD progression or visual acuity. The AREDS trial found zinc use associated with increased risk for hospitalization due to genitourinary causes compared with nonuse (7.5% vs. 4.9%, RR, 1.47, 95% CI 1.19 to 1.80); other serious harms were infrequent, with no differences between groups. The AREDS 2 trial found the AREDS formulation with beta carotene was associated with increased risk of lung cancer compared with the AREDS formulation without beta carotene when current smokers were excluded from the analysis (2.0% vs. 0.9%, p=0.04); almost all lung cancers occurred in former smokers., Limitations: Screening trials had methodological limitations that could have attenuated potential benefits; utilized an update to a previously included systematic review on antioxidant multivitamins and minerals for dry AMD; evidence on the effectiveness of treatment for dry AMD relied heavily on results of a single trial (AREDS); non-English-language studies were excluded; too few RCTs to perform formal assessments for publication bias with graphical or statistical methods for small sample effects; and statistical heterogeneity in pooled estimates for VEGF inhibitors compared with sham, though inconsistency was in magnitude (not direction) of effect., Conclusions: Impaired visual acuity is common in older adults and effective treatments are available for common causes of impaired visual acuity. Visual acuity testing is the reference standard for identifying impaired visual acuity, but has low diagnostic accuracy compared with an ophthalmological exam for identifying visual conditions not necessarily associated with impaired visual acuity; screening questions have low diagnostic accuracy compared with visual acuity testing. Direct evidence found no significant difference between vision screening in older adults in primary care settings and no screening in visual acuity-related outcomes or other clinical outcomes.

Background: Counseling and active behavioral interventions to limit excess gestational weight gain (GWG) during pregnancy may improve health outcomes for women and infants., Purpose: To synthesize evidence on the effects of counseling and active behavioral interventions for healthy weight and weight gain during pregnancy for the United States Preventive Services Task Force (USPSTF)., Data Sources: Cochrane Central Register of Controlled Trials (through March 20, 2020) and Cochrane Database of Systematic Reviews (through March 20, 2020), and MEDLINE (1946 to March 20, 2020), and manually reviewed reference lists, with surveillance through February 5, 2021., Study Selection: English-language randomized controlled trials and controlled trials of the effectiveness, benefits, and adverse effects of counseling and active behavioral interventions to limit excess GWG during pregnancy or in women planning pregnancy, including adolescents., Data Extraction: One investigator abstracted details about study design, patient population, setting, intervention, followup, and results, reviewed by a second investigator for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Discrepancies were resolved through consensus., Data Synthesis (results): Sixty-eight studies (64 randomized clinical trials and 4 nonrandomized trials) of interventions to limit excess GWG during pregnancy were included. Sixty-seven studies evaluated interventions during pregnancy and one trial evaluated an intervention prior to pregnancy GWG interventions were associated with small, but statistically significant reductions in risk of gestational diabetes mellitus (GDM) (43 trials; relative risk [RR], 0.87 [95% confidence interval (CI), 0.79 to 0.95]; I 2 =16.4%; absolute risk difference [ARD], −1.6% [95% CI, −2.5 to −0.7]) and emergency cesarean delivery (14 trials; RR, 0.85 [95% CI, 0.74 to 0.96]; I 2 =0%; ARD, −2.4% [95% CI, −4.2 to −0.3]). There was no association between GWG interventions versus controls for gestational hypertension (28 trials; RR, 0.87 [95% CI, 0.70 to 1.04]; I 2 =32.5%; ARD, −0.8% [95% CI, −1.9 to 0.2]), risk of cesarean delivery (34 trials; RR, 0.98 [95% CI, 0.91 to 1.04]; I 2 =10.8%; ARD, −0.7% [95% CI, −2.4 to 0.8]), preeclampsia (27 trials; RR, 0.98 [95% CI, 0.84 to 1.13], I 2 =0%; ARD, 0.1% [95% CI, −0.6 to 0.5]), postpartum hemorrhage (9 trials; RR, 1.00 [95% CI, 0.88 to 1.15]; I 2 =0%; ARD, −0.1% [95% CI, −1.3 to 1.5]), or perineal trauma (8 trials; RR, 0.86 [95% CI, 0.52 to 1.50]; I 2 =57.0%; ARD, −0.7% [95% CI, −3.2 to 1.7]). Stratified analyses demonstrated statistically significant interactions between effects of GWG interventions on gestational hypertension, high intensity interventions (p=0.006 for interaction) and active interventions (p<0.001 for interaction); and effects on perineal trauma and BMI category (p=0.003 for interaction) and intervention intensity (p=0.003 for interaction); but subgroup effects were not observed for other maternal health outcomes. GWG interventions were not associated with maternal death (2 trials), but data were limited by few trials and low event rates. Data on interventions to reduce prepregnancy weight were limited. One trial showed a reduction in prepregnancy weight loss associated with a counseling intervention; however, intervention participants gained more weight versus controls during pregnancy (13.2 kg vs. 10.3 kg, p=0.03), with no effect on rates of excess GWG. For infant health outcomes, GWG interventions were associated with decreased risk of infant macrosomia (25 trials; RR, 0.77 [95% CI, 0.65 to 0.92]; I 2 =38.3%; ARD, −1.9% [95% CI, −3.3 to −0.7]) and large for gestational age (26 trials; RR, 0.89 [95% CI, 0.80 to 0.99]; I 2 =0%; ARD, −1.3, [95% CI, −2.3 to −0.3]), but were not associated with risk of preterm birth, respiratory distress syndrome, shoulder dystocia, or neonatal intensive care unit admission. GWG interventions were not associated with neonatal death or stillbirth (11 trials); data were limited by few trials and low event rates. Stratified analyses demonstrated statistically significant interactions between effects of GWG interventions on macrosomia and high intensity interventions (p=0.03 for interaction), but subgroups effects were not observed for other infant health outcomes. GWG interventions were associated with one kilogram lower weight gain across all prepregnancy weight categories (55 trials; pooled mean difference [MD], −1.02 kg [95% CI, −1.30 to −0.75]; I 2 =60.3%). High-intensity interventions (12 or more sessions) were associated with greater effects (28 trials; MD, −1.47 kg [95% CI, −1.78 to −1.22]; I 2 =13.0%) than moderate- (3-11 sessions) (18 trials; MD, −0.32 kg [95% CI, −0.71 to −0.04]; I 2 =17.6%) or low-intensity interventions (fewer than 2 sessions) (9 trials; MD, −0.64 kg [95% CI, −1.44 to 0.02]; I 2 =48.4%; p<0.001 for interaction). There was no interaction between intervention type (active vs. counseling only) or baseline BMI category and effects on GWG. Interventions were also associated with a lower likelihood of gaining gestational weight in excess of the Institute of Medicine (IOM) recommendations (39 trials; RR, 0.83 [95% CI, 0.77 to 0.89]; I 2 =63.8%; ARD, −7.6% [95% CI, −11.0 to −4.6]), with greater effect for active (p=0.003 for interaction) and high intensity interventions (p<0.001 for interaction); there was no interaction between BMI category and effects on likelihood of excess weight gain. GWG interventions were not associated with increased likelihood of adherence to IOM recommendations for GWG (i.e., neither gaining excessive weight nor failing to gain sufficient weight) or postpartum weight retention at less than 6 or 6 months, but were associated with reduced postpartum weight retention at 12 months (10 trials; MD, −0.63 kg [95% CI, −1.44 to −0.01]; I 2 =65.5%). Data on harms were limited. Twelve studies of the effects of GWG interventions on maternal anxiety and depression showed mixed results. The pooled estimate of the effect of maternal GWG interventions on infants small for gestational age was not statistically significant (20 trials; RR, 0.94 [95% CI, 0.80 to 1.10]; I 2 =0%; ARD, −0.4% [95% CI, −1.7 to 1.0]). Stratified analyses demonstrated a statistically significant interaction between SGA and intervention intensity (p=0.04 for interaction), but not BMI category or intervention type., Limitations: Restricted to English-language articles, statistical heterogeneity in pooled analyses, limited evidence on infant health outcomes and harms of interventions, and most trials had some methodological limitations. Data were lacking on effectiveness of prepregnancy interventions, and on GWG interventions in pregnant adolescents and women with advanced maternal age., Conclusions: Counseling and active behavioral interventions to limit GWG in pregnant women are associated with a modestly decreased risk of GDM, emergency cesarean delivery, macrosomia, and large for gestational age. GWG interventions are also associated with modest reductions in weight gain and decreased likelihood of exceeding IOM recommendations for GWG. Effects of these interventions on mean GWG are slightly more pronounced for high intensity interventions.

Background: A 2014 review for the US Preventive Services Task Force (USPSTF) found antiviral therapy for hepatitis B virus (HBV) infection associated with improved intermediate outcomes, although evidence on clinical outcomes was limited., Purpose: To update the 2014 HBV screening review in nonpregnant adolescents and adults to inform the USPSTF., Data Sources: We utilized the 2014 review, searched the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Ovid MEDLINE (2014 to August 2019); with surveillance through July 24, 2020., Study Selection: Eligible studies included randomized controlled trials (RCTs) and cohort studies on the benefits and harms of screening versus no screening, and the yield of alternative screening strategies; RCTs on the effects of antiviral therapy versus placebo or no therapy and preferred versus nonpreferred therapies on intermediate outcomes, clinical outcomes, and harms; and cohort studies on clinical outcomes and on the association between intermediate outcomes following antiviral therapy and clinical outcomes., 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): Fifty total studies (30 trials and 20 cohort studies) with a total of 94,168 participants were included; of these, 22 were added for this update. No study directly evaluated the effects of screening for HBV infection versus no screening on clinical outcomes, such as mortality, hepatocellular carcinoma, or cirrhosis. Screening strategies that focused on risk factors such as ever having immigrated from high prevalence countries plus demographic and behavioral risk factors would identify nearly all HBV infection cases. In one study (N=21,008), only screening immigrants from high HBV prevalence countries would miss approximately two-thirds of infected persons. Based on 18 trials (N=2,972), antiviral therapy was associated with greater likelihood than placebo or no treatment for achieving intermediate outcomes, such as virologic suppression and hepatitis B e antigen or hepatitis B surface antigen loss or seroconversion; the numbers needed to treat ranged from 2.6 for virological suppression to 17 for hepatitis B e antigen seroconversion. Based on 12 trials (N=4,127), preferred (first-line) antiviral therapies were at least as likely as nonpreferred therapies to achieve intermediate outcomes. Based on 16 trials (N=4,809), antiviral therapy might be associated with improved clinical outcomes, but data were sparse and imprecise. Nine cohort studies (N=3,893) indicated an association between achieving an intermediate outcome following antiviral therapy and improved clinical outcomes, but were heterogeneous (hazards ratios ranged from 0.07 to 0.87). Antiviral therapy was associated with higher risk of withdrawal due to adverse events versus placebo or no antiviral therapy., Limitations: Only English-language articles were included, clinical outcome data for antiviral therapies were limited, observational studies were included on effects of antiviral therapy on long-term clinical outcomes and the association between intermediate and clinical outcomes, and some studies were conducted in countries where the prevalence and natural history of HBV infection are different from the United States., Conclusions: There was no direct evidence for the clinical benefits and harms of HBV screening versus no screening. Antiviral therapy for HBV infection was associated with improved intermediate outcomes and may improve clinical outcomes. Research is needed to clarify effects of screening and subsequent interventions on clinical outcomes and to identify optimal screening strategies.