IMPORTANCE Adolescent idiopathic scoliosis (AIS), a spinal curvature of 10°or more, is the most common form of scoliosis, with a prevalence of 1% to 3%. Curves progress in approximately two-thirds of patients with AIS before skeletal maturity, and large curves (>50°) may be associated with adverse health outcomes. OBJECTIVE To systematically review evidence on benefits and harms of AIS screening for the US Preventive Services Task Force (USPSTF). DATA SOURCES Cochrane Central Register of Controlled Trials, MEDLINE, ERIC, PubMed, CINAHL, and relevant systematic reviews were searched for studies published from January 1966 to October 20, 2016; studies included in a previous USPSTF report were also reviewed. Surveillance was conducted through July 24, 2017. STUDY SELECTION Fair-and good-quality studies that evaluated the accuracy of screening children and adolescents aged 10 to 18 years for AIS, the benefits of AIS treatment, the harms of AIS screening or treatment, or long-term health outcomes. DATA EXTRACTION AND SYNTHESIS Two investigators independently reviewed abstracts and full-text articles and extracted data into evidence tables. Results were qualitatively summarized. MAIN OUTCOMES AND MEASURES Health outcomes and spinal curvature in adolescence and adulthood, accuracy of screening for AIS, any harm of AIS screening or treatment. RESULTS Fourteen studies (N = 448 276) in 26 articles were included. Accuracy of AIS screening was highest (93.8% sensitivity; 99.2% specificity) in a cohort study of a clinic-based program using forward bend test, scoliometer, and Moiré topography screening (n = 306 082); accuracy was lower in cohort studies of 6 programs using fewer modalities (n = 141 161). Four controlled studies (n = 587) found evidence for benefit of bracing on curve progression compared with controls. A randomized clinical trial and a nonrandomized trial of exercise treatment (N = 184) found favorable reductions in Cobb angle of 0.67°to 4.9°in the intervention group compared with increases of 1.38°to 2.8°in the control group. Two cohort studies (n = 339) on long-term outcomes found that braced participants reported more negative treatment experience and body appearance compared with surgically treated or untreated participants. A study that combined a randomized clinical trial and cohort design (n = 242) reported harms of bracing, which included skin problems on the trunk and nonback body pains. There was no evidence on the effect of AIS screening on adult health outcomes. CONCLUSIONS AND RELEVANCE Screening can detect AIS. Bracing and possibly exercise treatment can interrupt or slow progression of curvature in adolescence. However, there is little or no evidence on long-term outcomes for AIS treated in adolescence, the association between curvature at skeletal maturity and adult health outcomes, the harms of AIS screening or treatment, or the effect of AIS screening on adult health outcomes.
skin self-examination. Surveillance in targeted publications was conducted through February 14, 2018. Studies included in previous USPSTF reports were reevaluated for inclusion.STUDY SELECTION Fair-and good-quality studies of primary care-relevant behavioral interventions focused on improving skin cancer outcomes, intermediate outcomes, or skin cancer prevention and self-examination behaviors.DATA EXTRACTION AND SYNTHESIS Two investigators independently reviewed abstracts and full-text articles and extracted data into evidence tables. Results were qualitatively summarized but not pooled because of heterogeneity of measures. MAIN OUTCOMES AND MEASURESSkin cancer, sunburn, precursor skin lesions, sun protection behaviors, and any harms from interventions.RESULTS Twenty-one trials in 27 publications were included (N = 20 561). No studies assessed skin cancer outcomes in pediatric populations; 1 adult trial (n = 1356) promoting skin self-examination found no significant difference in participants diagnosed with melanoma in the intervention group vs the control group at 12-month follow-up (0 vs 1 diagnosis). There was no consistent improvement in prevention of sunburn for children (3 trials [n = 2508]) or adults (6 trials [n = 3959]). There were small to moderate increases in sun protection behavior in pediatric populations (6 trials [n = 4252]) and adults (12 trials [n = 13 099]) and small increases in skin self-examination in adults (11 trials [n = 7771]; odds ratios, 1.16-2.6). One of 3 trials of indoor tanning found an intervention effect; an appearance-focused intervention (n = 430) resulted in a smaller increase in mean indoor tanning sessions at 6 months in the intervention group vs the control group. Harms were rarely reported: 1 trial of skin self-examination (n = 1356) found an increase in skin procedures in the intervention group vs the control group at 6 months (8.0% vs 3.6%, P < .001) but not between 6 and 12 months (3.9% vs 3.3%, P = .50), and 1 trial (n = 217) found no between-group difference in skin cancer worry (28.9% vs 18.4%, P = .16).CONCLUSIONS AND RELEVANCE Behavioral interventions can increase sun protection behavior, but there is no consistent evidence that interventions are associated with a reduction in the frequency of sunburn in children or adults and minimal evidence on skin cancer outcomes. Intervention can increase skin self-examination in adults but may lead to increased skin procedures without detecting additional atypical nevi or skin cancers.
IMPORTANCE Pancreatic adenocarcinoma is the third most common cause of cancer death among men and women in the United States. OBJECTIVE To systematically review benefits and harms of screening for pancreatic adenocarcinoma to inform the US Preventive Services Task Force.
Background: Many patients with type 2 diabetes mellitus (T2DM) do not have adequate glycemic control, leading to poor patient outcomes and high healthcare costs. Objective: This prospective pragmatic clinical trial evaluated V-Go, a wearable insulin delivery device, compared with standard treatment optimization (STO) among insulin-treated patients with T2DM in a realworld, community-based practice setting. Methods: Study sites, rather than individual patients, were randomized to V-Go or STO via cluster randomization. Patients were treated according to routine clinical practice and followed up to 4 months. T2DM medications and supplies were purchased utilizing usual insurance and co-pay systems. The primary analysis was an unadjusted treatment group comparison of glycosylated hemoglobinA1c (HbA1c) change from baseline to end of study (EOS). A cost of therapy analysis was completed on patients who had received comparable baseline T2DM treatment with multiple daily basal-bolus insulin injections (MDI). Results: Analysis included 415 patients (169 V-Go, 246 STO) enrolled from 52 US sites. Mean baseline HbA1c (9.6%) was higher in V-Go (9.9%, range 8.0% - 14.2%) than STO (9.3%, range 7.9% - 13.9%, p <.001). HbA1c decreased from baseline to EOS in both V-Go (-1.0%, p<.001) and STO (-0.5%, p<.001); V-Go had significantly larger decrease (p=.002). V-Go had a significant reduction (p<.001) in mean insulin total daily dose (TDD; 0.76 U/kg baseline, 0.57 U/kg EOS), not seen in STO (0.72 U/kg baseline and EOS). The MDI group included 95 (56.2%) V-Go and 113 STO (45.9%) patients. Mean baseline HbA1c was significantly higher in V-Go (9.9%) than STO (9.4%). V-Go also experienced larger decrease in HbA1c from baseline (-1.0%) than STO (-0.36%) (p=.006) with a decrease in TDD, while STO TDD remained unchanged. EOS mean per patient per day cost of diabetes treatment was lower for V-Go ($30.59) vs STO ($32.20) (p=.006). V-Go was more cost effective than STO ($24.02 per 1% drop in HbA1c vs $58.86, respectively). Conclusions: This pragmatic clinical trial demonstrated improved HbA1c levels, lower cost, and decreased insulin dose in patients with T2DM initiating V-Go vs STO in a real-world community-based practice setting. Observed baseline HbAlc indicated use of V-Go in more difficult to manage diabetes patients.
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