Interventions for Weight Management in Children and Adolescents: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Body mass index (BMI) of the 95th or greater percentile for age and sex is common among young people, and its prevalence has increased in recent decades. Objective: To examine the benefits and harms of weight management interventions initiated in health care settings among children and adolescents with high BMI. Data Sources: MEDLINE via Ovid, PsycINFO via Ovid, and the Cochrane Central Registry of Controlled Trials through January 12, 2023; ongoing surveillance through January 26, 2024. Study Selection: English-language studies of weight management interventions (behavioral and pharmacologic, including liraglutide, semaglutide, orlistat, and phentermine/topiramate) among children aged 2 to 18 years with high BMI (eg, ≥85th or ≥95th percentile for age and sex) conducted in or recruited from health care settings. Data Extraction and Synthesis: One investigator abstracted data; a second checked for accuracy. Outcomes with sufficient evidence for meta-analysis were pooled using random-effects models. Main Outcomes and Measures: BMI and other weight-related outcomes, cardiometabolic measures, quality of life, physical activity, dietary pattern scores, and harms. Results: Fifty-eight randomized clinical trials (RCTs) were included (N = 10 143). Behavioral interventions were associated with small reductions in BMI and other weight outcomes after 6 to 12 months (28 RCTs [n = 4494]; mean difference in change between groups, -0.7 [95% CI, -1.0 to -0.3]). Larger effects were seen in interventions with higher contact hours and that offered physical activity sessions. Reporting was sparse for outcomes other than BMI, with few significant findings. Semaglutide and phentermine/topiramate had the largest effects on BMI (eg, 1 RCT [n = 201] for semaglutide; mean difference, -6.0 [95% CI, -7.3 to -4.6]). The very few studies that evaluated outcomes after medication discontinuation showed immediate weight regain. Gastrointestinal adverse effects were common with liraglutide, semaglutide, and orlistat. Serious adverse effects were rare, but no studies had follow-up longer than 17 months. Conclusions and Relevance: In the short term, weight management interventions led to lower BMI in children and adolescents, with no evidence of serious harm. Evidence is lacking about how weight management interventions affect BMI beyond 1 year and after medication discontinuation and about longer-term effects on other outcomes.

Screening for Lipid Disorders in Children and Adolescents: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Lipid screening in childhood and adolescence can lead to early dyslipidemia diagnosis. The long-term benefits of lipid screening and subsequent treatment in this population are uncertain. Objective: To review benefits and harms of screening and treatment of pediatric dyslipidemia due to familial hypercholesterolemia (FH) and multifactorial dyslipidemia. Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials through May 16, 2022; literature surveillance through March 24, 2023. Study Selection: English-language randomized clinical trials (RCTs) of lipid screening; recent, large US cohort studies reporting diagnostic yield or screen positivity; and RCTs of lipid-lowering interventions. Data Extraction and Synthesis: Single extraction, verified by a second reviewer. Quantitative synthesis using random-effects meta-analysis. Main Outcomes and Measures: Health outcomes, diagnostic yield, intermediate outcomes, behavioral outcomes, and harms. Results: Forty-three studies were included (n = 491 516). No RCTs directly addressed screening effectiveness and harms. Three US studies (n = 395 465) reported prevalence of phenotypically defined FH of 0.2% to 0.4% (1:250 to 1:500). Five studies (n = 142 257) reported multifactorial dyslipidemia prevalence; the prevalence of elevated total cholesterol level (≥200 mg/dL) was 7.1% to 9.4% and of any lipid abnormality was 19.2%. Ten RCTs in children and adolescents with FH (n = 1230) demonstrated that statins were associated with an 81- to 82-mg/dL greater mean reduction in levels of total cholesterol and LDL-C compared with placebo at up to 2 years. Nonstatin-drug trials showed statistically significant lowering of lipid levels in FH populations, but few studies were available for any single drug. Observational studies suggest that statin treatment for FH starting in childhood or adolescence reduces long-term cardiovascular disease risk. Two multifactorial dyslipidemia behavioral counseling trials (n = 934) demonstrated 3- to 6-mg/dL greater reductions in total cholesterol levels compared with the control group, but findings did not persist at longest follow-up. Harms reported in the short-term drug trials were similar in the intervention and control groups. Conclusions and Relevance: No direct evidence on the benefits or harms of pediatric lipid screening was identified. While multifactorial dyslipidemia is common, no evidence was found that treatment is effective for this condition. In contrast, FH is relatively rare; evidence shows that statins reduce lipid levels in children with FH, and observational studies suggest that such treatment has long-term benefit for this condition.

Behavioral Counseling Interventions to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Cardiovascular Disease Risk Factors: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Unhealthful dietary patterns, low levels of physical activity, and high sedentary time increase the risk of cardiovascular disease. Objective: To synthesize the evidence on benefits and harms of behavioral counseling interventions to promote a healthy diet and physical activity in adults without known cardiovascular disease (CVD) risk factors to inform a US Preventive Services Task Force recommendation. Data Sources: MEDLINE, PsycINFO, and the Cochrane Central Register of Controlled Trials through February 2021, with ongoing surveillance through February 2022. Study Selection: Randomized clinical trials (RCTs) of behavioral counseling interventions targeting improved diet, increased physical activity, or decreased sedentary time among adults without known elevated blood pressure, elevated lipid levels, or impaired fasting glucose. Data Extraction and Synthesis: Independent data abstraction and study quality rating and random effects meta-analysis. Main Outcomes and Measures: CVD events, CVD risk factors, diet and physical activity measures, and harms. Results: One-hundred thirteen RCTs were included (N = 129 993). Three RCTs reported CVD-related outcomes: 1 study (n = 47 179) found no significant differences between groups on any CVD outcome at up to 13.4 years of follow-up; a combined analysis of the other 2 RCTs (n = 1203) found a statistically significant association of the intervention with nonfatal CVD events (hazard ratio, 0.27 [95% CI, 0.08 to 0.88]) and fatal CVD events (hazard ratio, 0.31 [95% CI, 0.11 to 0.93]) at 4 years. Diet and physical activity behavioral counseling interventions were associated with small, statistically significant reductions in continuous measures of blood pressure (systolic mean difference, -0.8 [95% CI, -1.3 to -0.3]; 23 RCTs [n = 57 079]; diastolic mean difference, -0.4 [95% CI, -0.8 to -0.0]; 24 RCTs [n = 57 148]), low-density lipoprotein cholesterol level (mean difference, 2.2 mg/dL [95% CI, -3.8 to -0.6]; 15 RCTs [n = 6350]), adiposity-related outcomes (body mass index mean difference, -0.3 [95% CI, -0.5 to -0.1]; 27 RCTs [n = 59 239]), dietary outcomes, and physical activity at 6 months to 1.5 years of follow-up vs control conditions. There was no evidence of greater harm among intervention vs control groups. Conclusions and Relevance: Healthy diet and physical activity behavioral counseling interventions for persons without a known risk of CVD were associated with small but statistically significant benefits across a variety of important intermediate health outcomes and small to moderate effects on dietary and physical activity behaviors. There was limited evidence regarding the long-term health outcomes or harmful effects of these interventions.

Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Preeclampsia is a hypertensive disorder of pregnancy that poses serious maternal and infant health risks. Previous systematic reviews have established benefits of low-dose aspirin taken during pregnancy to prevent preeclampsia and its sequelae. Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of aspirin use in preventing preeclampsia in individuals at increased risk based on clinical risk factors or measurements associated with higher disease incidence than in the general population. Data Sources: Studies from previous USPSTF review (2014), literature published January 2013 through May 15, 2020, in MEDLINE, PubMed (for publisher-supplied records only), EMBASE, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through January 22, 2021. Study Selection: Good- and fair-quality randomized clinical trials (RCTs) of low-dose aspirin use during pregnancy to prevent preeclampsia among individuals at increased risk; studies conducted in general populations to evaluate potential harms. Data Extraction and Synthesis: Dual article screening and risk-of-bias assessment. Study data abstracted into prespecified forms, checked for accuracy. Random-effects meta-analysis. Main Outcomes and Measures: Diagnosis of preeclampsia; adverse pregnancy health outcomes and complications including eclampsia, perinatal mortality, preterm birth, small for gestational age, and potential bleeding harms or infant/child harms from aspirin exposure. Results: A total of 23 randomized clinical trials (RCTs) (N = 26 952) were included; 18 were conducted among participants at increased preeclampsia risk. Aspirin dosages ranged from 50 mg/d to 150 mg/d. Most trials enrolled majority White populations selected based on a range of risk factors. The incidence of preeclampsia among the trials of participants at increased risk ranged from 4% to 30%. Aspirin use was significantly associated with lower risk of preeclampsia (pooled relative risk [RR], 0.85 [95% CI, 0.75-0.95]; 16 RCTs [n = 14 093]; I2 = 0%), perinatal mortality (pooled RR, 0.79 [95% CI, 0.66-0.96]; 11 RCTs [n = 13 860]; I2 = 0%), preterm birth (pooled RR, 0.80 [95% CI, 0.67-0.95]; 13 RCTs [n = 13 619]; I2 = 49%), and intrauterine growth restriction (pooled RR, 0.82 [95% CI, 0.68-0.99]; 16 RCTs [n = 14 385]; I2 = 41%). There were no significant associations of aspirin use with risk of postpartum hemorrhage (pooled RR, 1.03 [95% CI, 0.94-1.12]; 9 RCTs [n = 23 133]; I2 = 0%) and other bleeding-related harms, or with rare perinatal or longer-term harms. Absolute risk reductions for preeclampsia associated with aspirin use ranged from -1% to -6% across larger trials (n >300) and were greater in smaller trials. For perinatal mortality, absolute risk reductions ranged from 0.5% to 1.1% in the 3 largest trials. Conclusions and Relevance: Daily low-dose aspirin during pregnancy was associated with lower risks of serious perinatal outcomes for individuals at increased risk for preeclampsia, without evident harms.

Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults With Cardiovascular Risk Factors: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Cardiovascular disease is the leading cause of death in the US, and poor diet and lack of physical activity are major factors contributing to cardiovascular morbidity and mortality. Objective: To review the benefits and harms of behavioral counseling interventions to improve diet and physical activity in adults with cardiovascular risk factors. Data Sources: MEDLINE, PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through September 2019; literature surveillance through July 24, 2020. Study Selection: English-language randomized clinical trials (RCTs) of behavioral counseling interventions to help people with elevated blood pressure or lipid levels improve their diet and increase physical activity. Data Extraction and Synthesis: Data were extracted from studies by one reviewer and checked by a second. Random-effects meta-analysis and qualitative synthesis were used. Main Outcomes and Measures: Cardiovascular events, mortality, subjective well-being, cardiovascular risk factors, diet and physical activity measures (eg, minutes of physical activity, meeting physical activity recommendations), and harms. Interventions were categorized according to estimated contact time as low (≤30 minutes), medium (31-360 minutes), and high (>360 minutes). Results: Ninety-four RCTs were included (N = 52 174). Behavioral counseling interventions involved a median of 6 contact hours and 12 sessions over the course of 12 months and varied in format and dietary recommendations; only 5% addressed physical activity alone. Interventions were associated with a lower risk of cardiovascular events (pooled relative risk, 0.80 [95% CI, 0.73-0.87]; 9 RCTs [n = 12 551]; I2 = 0%). Event rates were variable; in the largest trial (Prevención con Dieta Mediterránea [PREDIMED]), 3.6% in the intervention groups experienced a cardiovascular event, compared with 4.4% in the control group. Behavioral counseling interventions were associated with small, statistically significant reductions in continuous measures of blood pressure, low-density lipoprotein cholesterol levels, fasting glucose levels, and adiposity at 12 to 24 months' follow-up. Measurement of diet and physical activity was heterogeneous, and evidence suggested small improvements in diet consistent with the intervention recommendation targets but mixed findings and a more limited evidence base for physical activity. Adverse events were rare, with generally no group differences in serious adverse events, any adverse events, hospitalizations, musculoskeletal injuries, or withdrawals due to adverse events. Conclusions and Relevance: Medium- and high-contact multisession behavioral counseling interventions to improve diet and increase physical activity for people with elevated blood pressure and lipid levels were effective in reducing cardiovascular events, blood pressure, low-density lipoproteins, and adiposity-related outcomes, with little to no risk of serious harm.

Behavioral Counseling Interventions to Prevent Sexually Transmitted Infections: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Increasing rates of preventable sexually transmitted infections (STIs) in the US pose substantial burdens to health and well-being. Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of behavioral counseling interventions for preventing STIs. Data Sources: Studies from the previous USPSTF review (2014); literature published January 2013 through May 31, 2019, in MEDLINE, PubMed (for publisher-supplied records only), PsycINFO, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through May 22, 2020. Study Selection: Good- and fair-quality randomized and nonrandomized controlled intervention studies of behavioral counseling interventions for adolescents and adults conducted in primary care settings were included. Studies with active comparators only or limited to individuals requiring specialist care for STI risk-related comorbidities were excluded. Data Extraction and Synthesis: Dual risk of bias assessment, with inconsistent ratings adjudicated by a third team member. Study data were abstracted into prespecified forms. Pooled odds ratios (ORs) were estimated using the DerSimonian and Laird method or the restricted maximum likelihood method with Knapp-Hartung adjustment. Main Outcomes and Measures: Differences in STI diagnoses, self-reported condom use, and self-reported unprotected sex at 3 months or more after baseline. Results: The review included 37 randomized trials and 2 nonrandomized controlled intervention studies (N = 65 888; 13 good-quality, 26 fair-quality) recruited from primary care settings in the US. Study populations were composed predominantly of heterosexual adolescents and young adults (12 to 25 years), females, and racial and ethnic minorities at increased risk for STIs. Nineteen trials (n = 52 072) reported STI diagnoses as outcomes (3 to 17 months' follow-up); intervention was associated with reduced STI incidence (OR, 0.66 [95% CI, 0.54-0.81; I2 = 74%]). Absolute differences in STI acquisition between groups varied widely depending on baseline population STI risk and intervention effectiveness, ranging from 19% fewer to 4% more people acquiring STI. Thirty-four trials (n = 21 417) reported behavioral change outcomes. Interventions were associated with self-reported behavioral change (eg, increased condom use) that reduce STI risk (OR, 1.31 [95% CI, 1.10-1.56; I2 = 40%, n = 5253). There was limited evidence on persistence of intervention effects beyond 1 year. No harms were identified in 7 studies (n = 3458) reporting adverse outcomes. Conclusions and Relevance: Behavioral counseling interventions for individuals seeking primary health care were associated with reduced incidence of STIs. Group or individual counseling sessions lasting more than 2 hours were associated with larger reductions in STI incidence, and interventions of shorter duration also were associated with STI prevention, although evidence was limited on whether the STI reductions associated with these interventions persisted beyond 1 year.

Screening for Cognitive Impairment in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Early identification of cognitive impairment may improve patient and caregiver health outcomes. Objective: To systematically review the test accuracy of cognitive screening instruments and benefits and harms of interventions to treat cognitive impairment in older adults (≥65 years) to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, and Cochrane Central Register of Controlled Trials through January 2019, with literature surveillance through November 22, 2019. Study Selection: Fair- to good-quality English-language studies of cognitive impairment screening instruments, and pharmacologic and nonpharmacologic treatments aimed at persons with mild cognitive impairment (MCI), mild to moderate dementia, or their caregivers. Data Extraction and Synthesis: Independent critical appraisal and data abstraction; random-effects meta-analyses and qualitative synthesis. Main Outcomes and Measures: Sensitivity, specificity; patient, caregiver, and clinician decision-making; patient function, quality of life, and neuropsychiatric symptoms; caregiver burden and well-being. Results: The review included 287 studies with more than 280 000 older adults. One randomized clinical trial (RCT) (n = 4005) examined the direct effect of screening for cognitive impairment on patient outcomes, including potential harms, finding no significant differences in health-related quality of life at 12 months (effect size, 0.009 [95% CI, -0.063 to 0.080]). Fifty-nine studies (n = 38 531) addressed the accuracy of 49 screening instruments to detect cognitive impairment. The Mini-Mental State Examination was the most-studied instrument, with a pooled sensitivity of 0.89 (95% CI, 0.85 to 0.92) and specificity of 0.89 (95% CI, 0.85 to 0.93) to detect dementia using a cutoff of 23 or less or 24 or less (15 studies, n = 12 796). Two hundred twenty-four RCTs and 3 observational studies including more than 240 000 patients or caregivers addressed the treatment of MCI or mild to moderate dementia. None of the treatment trials were linked with a screening program; in all cases, participants were persons with known cognitive impairment. Medications approved to treat Alzheimer disease (donepezil, galantamine, rivastigmine, and memantine) improved scores on the ADAS-Cog 11 by 1 to 2.5 points over 3 months to 3 years. Psychoeducation interventions for caregivers resulted in a small benefit for caregiver burden (standardized mean difference, -0.24 [95% CI, -0.36 to -0.13) over 3 to 12 months. Intervention benefits were small and of uncertain clinical importance. Conclusions and Relevance: Screening instruments can adequately detect cognitive impairment. There is no empirical evidence, however, that screening for cognitive impairment improves patient or caregiver outcomes or causes harm. It remains unclear whether interventions for patients or caregivers provide clinically important benefits for older adults with earlier detected cognitive impairment or their caregivers.

Screening for Peripheral Artery Disease Using the Ankle-Brachial Index: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Peripheral artery disease (PAD) is associated with a high risk for cardiovascular events and poor ambulatory function, even in the absence of symptoms. Screening for PAD with the ankle-brachial index (ABI) may identify patients in need of treatment to improve health outcomes. Objective: To systematically review evidence for the US Preventive Services Task Force on PAD screening with the ABI, the diagnostic accuracy of the test, and the benefits and harms of treatment of screen-detected PAD. Data Sources: MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials for relevant English-language studies published between January 2012 and May 2, 2017. Surveillance continued through February 7, 2018. Study Selection: Studies of unselected or generally asymptomatic adults with no known cardiovascular disease. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Main Outcomes and Measures: Cardiovascular morbidity; PAD morbidity; mortality; health-related quality of life; diagnostic accuracy; and serious adverse events. Results: Five studies (N = 5864 participants) were included that examined the indirect evidence for the benefits and harms of screening and treatment of screen-detected PAD. No population-based screening trials evaluated the direct benefits or harms of PAD screening with the ABI alone. A single diagnostic accuracy study of the ABI compared with magnetic resonance angiography gold-standard imaging (n = 306) found low sensitivity (7%-34%) and high specificity (96%-100%) in a screening population. Two adequately powered trials (n = 4626) in asymptomatic populations with and without diabetes with a variably defined low ABI (≤0.95 or ≤0.99) showed no statistically significant effect of aspirin (100 mg daily) for composite CVD outcomes (adjusted hazard ratio [HR], 1.00 [95% CI, 0.81-1.23] and HR, 0.98 [95% CI, 0.76-1.26]). One trial (n = 3350) demonstrated no statistically significant increase in major bleeding events with the use of aspirin (adjusted HR, 1.71 [95% CI, 0.99- 2.97]) and no statistically significant increase in major gastrointestinal bleeding (relative risk, 1.13 [95% CI, 0.44-2.91]). Two exercise trials (n = 932) in screen-relevant populations reported no differences in quality of life, Walking Impairment Questionnaire walking distance, or symptoms at 12 and 52 weeks; no harms were reported. Conclusions and Relevance: There was no direct evidence and limited indirect evidence on the benefits of PAD screening with the ABI in unselected or asymptomatic populations. Available studies suggest low sensitivity and lack of beneficial effect on health outcomes, but these studies have important limitations.

Behavioral and Pharmacotherapy Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Overweight and obesity have been associated with adverse health effects. Objective: To systematically review evidence on benefits and harms of behavioral and pharmacotherapy weight loss and weight loss maintenance interventions in adults to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed Publisher-Supplied Records, PsycINFO, and the Cochrane Central Register of Controlled Trials for studies published through June 6, 2017; ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials through August 2017; and ongoing surveillance in targeted publications through March 23, 2018. Studies from previous reviews were reevaluated for inclusion. Study Selection: Randomized clinical trials (RCTs) focusing on weight loss or weight loss maintenance in adults. Data Extraction and Synthesis: Data were abstracted by one reviewer and confirmed by another. Random-effects meta-analyses were conducted for weight loss outcomes in behavior-based interventions. Main Outcomes and Measures: Health outcomes, weight loss or weight loss maintenance, reduction in obesity-related conditions, and adverse events. Results: A total of 122 RCTs (N = 62 533) and 2 observational studies (N = 209 993) were identified. Compared with controls, participants in behavior-based interventions had greater mean weight loss at 12 to 18 months (-2.39 kg [95% CI, -2.86 to -1.93]; 67 studies [n = 22065]) and less weight regain (-1.59 kg [95% CI, -2.38 to -0.79]; 8 studies [n = 1408]). Studies of medication-based weight loss and maintenance interventions also reported greater weight loss or less weight regain in intervention compared with placebo groups at 12 to 18 months (range, -0.6 to -5.8 kg; no meta-analysis). Participants with prediabetes in weight loss interventions had a lower risk of developing diabetes compared with controls (relative risk, 0.67 [95% CI, 0.51 to 0.89]). There was no evidence of other benefits, but most health outcomes such as mortality, cardiovascular disease, and cancer were infrequently reported. Small improvements in quality of life in some medication trials were noted but were of unclear clinical significance. There was no evidence of harm such as cardiovascular disease from behavior-based interventions; higher rates of adverse events were associated with higher dropout rates in medication groups than in placebo groups. Conclusions and Relevance: Behavior-based weight loss interventions with or without weight loss medications were associated with more weight loss and a lower risk of developing diabetes than control conditions. Weight loss medications, but not behavior-based interventions, were associated with higher rates of harms. Long-term weight and health outcomes data, as well as data on important subgroups, were limited.

Nontraditional Risk Factors in Cardiovascular Disease Risk Assessment: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Incorporating nontraditional risk factors may improve the performance of traditional multivariable risk assessment for cardiovascular disease (CVD). Objective: To systematically review evidence for the US Preventive Services Task Force on the benefits and harms of 3 nontraditional risk factors in cardiovascular risk assessment: the ankle-brachial index (ABI), high-sensitivity C-reactive protein (hsCRP) level, and coronary artery calcium (CAC) score. Data Sources: MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials for studies published through May 22, 2017. Surveillance continued through February 7, 2018. Study Selection: Studies of asymptomatic adults with no known cardiovascular disease. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Main Outcomes and Measures: Cardiovascular events, mortality, risk assessment performance measures (calibration, discrimination, or risk reclassification), and serious adverse events. Results: Forty-three studies (N = 267 244) were included. No adequately powered trials have evaluated the clinical effect of risk assessment with nontraditional risk factors on patient health outcomes. The addition of the ABI (10 studies), hsCRP level (25 studies), or CAC score (19 studies) can improve both discrimination and reclassification; the magnitude and consistency of improvement varies by nontraditional risk factor. For the ABI, improvements in performance were the greatest for women, in whom traditional risk assessment has poor discrimination (C statistic change of 0.112 and net reclassification index [NRI] of 0.096). Results were inconsistent for hsCRP level, with the largest analysis (n = 166 596) showing a minimal effect on risk prediction (C statistic change of 0.0039, NRI of 0.0152). The largest improvements in discrimination (C statistic change ranging from 0.018 to 0.144) and reclassification (NRI ranging from 0.084 to 0.35) were seen for CAC score, although CAC score may inappropriately reclassify individuals not having cardiovascular events into higher-risk categories, as determined by negative nonevent NRI. Evidence for the harms of nontraditional risk factor assessment was limited to computed tomography imaging for CAC scoring (8 studies) and showed that radiation exposure is low but may result in additional testing. Conclusions and Relevance: There are insufficient adequately powered clinical trials evaluating the incremental effect of the ABI, hsCRP level, or CAC score in risk assessment and initiation of preventive therapy. Furthermore, the clinical meaning of improvements in measures of calibration, discrimination, and reclassification risk prediction studies is uncertain.

Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Cardiovascular Disease Risk Factors: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

IMPORTANCE: Unhealthful dietary patterns, low levels of physical activity, and high sedentary time increase the risk of cardiovascular disease. OBJECTIVE: To systematically review the evidence on the benefits and harms of behavioral counseling for the primary prevention of cardiovascular disease in adults without known cardiovascular risk factors to inform the US Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, and PsycINFO for studies published in the English language between January 1, 2013, and May 25, 2016, and ongoing surveillance in targeted publications through March 24, 2017. Studies included in the previous review were reevaluated for inclusion. STUDY SELECTION: Randomized clinical trials of behavioral interventions targeting improved diet, increased physical activity, decreased sedentary time, or a combination of these among adults without known hypertension, dyslipidemia, diabetes, or impaired fasting glucose. DATA EXTRACTION AND SYNTHESIS: Independent critical appraisal and data abstraction by 2 reviewers. MAIN OUTCOMES AND MEASURES: Cardiometabolic health and intermediate outcomes, behavioral outcomes, and harms related to interventions. RESULTS: Eighty-eight studies (N = 121 190) in 145 publications were included. There was no consistent benefit of the interventions on all-cause or cardiovascular mortality or morbidity (4 trials [n = 51 356]) or health-related quality of life (10 trials [n = 52 423]). There was evidence of small, statistically significant between-group mean differences for systolic blood pressure (-1.26 mm Hg [95% CI, -1.77 to -0.75]; 22 trials [n = 57 953]), diastolic blood pressure (-0.49 mm Hg [95% CI, -0.82 to -0.16]; 23 trials [n = 58 022]), low-density lipoprotein cholesterol level (-2.58 mg/dL [95% CI, -4.30 to -0.85]; 13 trials [n = 5554]), total cholesterol level (-2.85 mg/dL [95% CI, -4.95 to -0.75]; 19 trials [n = 9325]), and body mass index (-0.41 [95% CI, -0.62 to -0.19]; 20 trials [n = 55 059]) at 6 to 12 months as well as small-to-modest associations with dietary and physical activity behaviors. There was no evidence of greater incidence of serious adverse events, injuries, or falls in intervention vs control participants. CONCLUSIONS AND RELEVANCE: Diet and physical activity behavioral interventions for adults not at high risk for cardiovascular disease result in consistent modest benefits across a variety of important intermediate health outcomes across 6 to 12 months, including blood pressure, low-density lipoprotein and total cholesterol levels, and adiposity, with evidence of a dose-response effect, with higher-intensity interventions conferring greater improvements. There is very limited evidence on longer-term intermediate and health outcomes or on harmful effects of these interventions.

Estimating data from figures with a Web-based program: Considerations for a systematic review.

BACKGROUND: Systematic reviewers often encounter incomplete or missing data, and the information desired may be difficult to obtain from a study author. Thus, systematic reviewers may have to resort to estimating data from figures with little or no raw data in a study's corresponding text or tables. METHODS: We discuss a case study in which participants used a publically available Web-based program, called webplotdigitizer, to estimate data from 2 figures. We evaluated and used the intraclass coefficient and the accuracy of the estimates to the true data to inform considerations when using estimated data from figures in systematic reviews. RESULTS: The estimates for both figures were consistent, although the distribution of estimates in the figure of a continuous outcome was slightly higher. For the continuous outcome, the percent difference ranged from 0.23% to 30.35% while the percent difference of the event rate ranged from 0.22% to 8.92%. For both figures, the intraclass coefficient was excellent (>0.95). CONCLUSIONS: Systematic reviewers should consider and be transparent when estimating data from figures when the information cannot be obtained from study authors and perform sensitivity analyses of pooled results to reduce bias.