A synthesis of qualitative studies on patient and caregiver experiences with cognitive impairment screening and diagnosis.

OBJECTIVES: To understand patient and caregiver perspectives on the experience of being screened or diagnosed with cognitive impairment to inform preventive clinical care. METHODS: Systematic review and synthesis of qualitative studies with searches in Ovid MEDLINE ALL, EBSCOHost CINAHL, and Scopus in February 2021. Included studies were assessed for quality and coded with descriptive, deductive, and inductive codes and findings were rated using GRADE-CER-qual. RESULTS: We included 15 qualitative studies representing 153 patients and 179 caregivers. Most studies involved in-depth interviews. No studies examined screening experiences for older adults presenting without cognitive function concerns; nearly all patients received a diagnosis of cognitive impairment. Seven themes emerged with moderate to high confidence. Findings showed the role of caregivers in pursuing assessment and its benefits in validating concerns and for future planning. Patients were less inclined to be evaluated, fearing judgements or social consequences from the diagnostic label. Caregivers and patients were at times frustrated with the assessment process yet believed it might result in treatments to cure or slow disease progression. CONCLUSION: Clinicians and care systems can support caregivers and patients by providing timely and informative resources to support their shared and separate motivations, needs, and concerns.

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.

Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: It has been estimated that in 2018 nearly 20% of adults in the US were currently using a tobacco product. Objective: To systematically review the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation among adults, including pregnant persons, to inform the US Preventive Services Task Force. Data Sources: PubMed, PsycInfo, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination of Health Technology Assessment; surveillance through September 25, 2020. Study Selection: Systematic reviews of tobacco cessation interventions and randomized clinical trials that evaluated the effects of electronic cigarettes (e-cigarettes) or pharmacotherapy among pregnant persons. Data Extraction and Synthesis: Independent critical appraisal and data abstraction; qualitative synthesis and random-effects meta-analyses. Main Outcomes and Measures: Health outcomes, tobacco cessation at 6 months or more, and adverse events. Results: Sixty-seven reviews addressing pharmacotherapy and behavioral interventions were included as well as 9 trials (N = 3942) addressing e-cigarettes for smoking cessation and 7 trials (N = 2285) of nicotine replacement therapy (NRT) use in pregnancy. Combined pharmacotherapy and behavioral interventions (pooled risk ratio [RR], 1.83 [95% CI, 1.68-1.98]), NRT (RR, 1.55 [95% CI, 1.49-1.61]), bupropion (RR, 1.64 [95% CI, 1.52-1.77]), varenicline (RR, 2.24 [95% CI, 2.06-2.43]), and behavioral interventions such as advice from clinicians (RR, 1.76 [95% CI, 1.58-1.96]) were all associated with increased quit rates compared with minimal support or placebo at 6 months or longer. None of the drugs were associated with serious adverse events. Five trials (n = 3117) reported inconsistent findings on the effectiveness of electronic cigarettes on smoking cessation at 6 to 12 months among smokers when compared with placebo or NRT, and none suggested higher rates of serious adverse events. Among pregnant persons, behavioral interventions were associated with greater smoking cessation during late pregnancy (RR, 1.35 [95% CI, 1.23-1.48]), compared with no intervention. Rates of validated cessation among pregnant women allocated to NRT compared with placebo were not significantly different (pooled RR, 1.11 [95% CI, 0.79-1.56], n = 2033). Conclusions and Relevance: There is strong evidence that a range of pharmacologic and behavioral interventions, both individually and in combination, are effective in increasing smoking cessation in nonpregnant adults. In pregnancy, behavioral interventions are effective for smoking cessation, but data are limited on the use of pharmacotherapy for smoking cessation. Data on the effectiveness and safety of electronic cigarettes for smoking cessation among adults are also limited and results are inconsistent.

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 Unhealthy Drug Use: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Illicit drug use is among the most common causes of preventable morbidity and mortality in the US. Objective: To systematically review the literature on screening and interventions for drug use to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, Embase, and Cochrane Central Register of Controlled Trials through September 18, 2018; literature surveillance through September 21, 2019. Study Selection: Test accuracy studies to detect drug misuse and randomized clinical trials of screening and interventions to reduce drug use. Data Extraction and Synthesis: Critical appraisal and data abstraction by 2 reviewers and random-effects meta-analyses. Main Outcomes and Measures: Sensitivity, specificity, drug use and other health, social, and legal outcomes. Results: Ninety-nine studies (N = 84 206) were included. Twenty-eight studies (n = 65 720) addressed drug screening accuracy. Among adults, sensitivity and specificity of screening tools for detecting unhealthy drug use ranged from 0.71 to 0.94 and 0.87 to 0.97, respectively. Interventions to reduce drug use were evaluated in 52 trials (n = 15 659) of psychosocial interventions, 7 trials (n = 1109) of opioid agonist therapy, and 13 trials (n = 1718) of naltrexone. Psychosocial interventions were associated with increased likelihood of drug use abstinence (15 trials, n = 3636; relative risk [RR], 1.60 [95% CI, 1.24 to 2.13]; absolute risk difference [ARD], 9% [95% CI, 5% to 15%]) and reduced number of drug use days (19 trials, n = 5085; mean difference, -0.49 day in the last 7 days [95% CI, -0.85 to -0.13]) vs no psychosocial intervention at 3- to 4-month follow-up. In treatment-seeking populations, opioid agonist therapy and naltrexone were associated with decreased risk of drug use relapse (4 trials, n = 567; RR, 0.75 [95% CI, 0.59 to 0.82]; ARD, -35% [95% CI, -67% to -3%] and 12 trials, n = 1599; RR, 0.73 [95% CI, 0.62 to 0.85]; ARD, -18% [95% CI, -26% to -10%], respectively) vs placebo or no medication. While evidence on harms was limited, it indicated no increased risk of serious adverse events. Conclusions and Relevance: Several screening instruments with acceptable sensitivity and specificity are available to screen for drug use, although there is no direct evidence on the benefits or harms of screening. Pharmacotherapy and psychosocial interventions are effective at improving drug use outcomes, but evidence of effectiveness remains primarily derived from trials conducted in treatment-seeking populations.

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.

Behavioral Counseling for Skin Cancer Prevention: Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Exposure to UV radiation, especially in childhood, increases skin cancer risk. Objective: To systematically review the evidence on the benefits and harms of behavioral counseling for skin cancer prevention to inform the US Preventive Services Task Force (USPSTF). Data Sources: Cochrane Central Register of Controlled Trials, MEDLINE, and PubMed were searched for studies published from January 2009 to March 31, 2016, for skin cancer prevention and from August 2005 to March 31, 2016, for 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 Measures: Skin 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.

Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Unhealthy alcohol use is common, increasing, and a leading cause of premature mortality. Objective: To review literature on the effectiveness and harms of screening and counseling for unhealthy alcohol use to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through October 12, 2017; literature surveillance through August 1, 2018. Study Selection: Test accuracy studies and randomized clinical trials of screening and counseling to reduce unhealthy alcohol use. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Counseling trials were pooled using random-effects meta-analyses. Main Outcomes and Measures: Sensitivity, specificity, drinks per week, exceeding recommended limits, heavy use episodes, abstinence (for pregnant women), and other health, family, social, and legal outcomes. Results: One hundred thirteen studies (N = 314 466) were included. No studies examined benefits or harms of screening programs to reduce unhealthy alcohol use. For adolescents (10 studies [n = 171 363]), 1 study (n = 225) reported a sensitivity of 0.73 (95% CI, 0.60 to 0.83) and specificity of 0.81 (95% CI, 0.74 to 0.86) using the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) to detect the full spectrum of unhealthy alcohol use. For adults (35 studies [n = 114 182]), brief screening instruments commonly reported sensitivity and specificity between 0.70 and 0.85. Two trials of the effects of interventions to reduce unhealthy alcohol use in adolescents (n = 588) found mixed results: one reported a benefit in high-risk but not moderate-risk drinkers, and the other reported a statistically significant reduction in drinking frequency for boys but not girls; neither reported health or related outcomes. Across all populations (68 studies [n = 36 528]), counseling interventions were associated with a decrease in drinks per week (weighted mean difference, -1.6 [95% CI, -2.2 to -1.0]; 32 studies [37 effects; n = 15 974]), the proportion exceeding recommended drinking limits (odds ratio [OR], 0.60 [95% CI, 0.53 to 0.67]; 15 studies [16 effects; n = 9760]), and the proportion reporting a heavy use episode (OR, 0.67 [95% CI, 0.58 to 0.77]; 12 studies [14 effects; n = 8108]), and an increase in the proportion of pregnant women reporting abstinence (OR, 2.26 [95% CI, 1.43 to 3.56]; 5 studies [n = 796]) after 6 to 12 months. Health outcomes were sparsely reported and generally did not demonstrate group differences in effect. There was no evidence that these interventions could be harmful. Conclusions and Relevance: Among adults, screening instruments feasible for use in primary care are available that can effectively identify people with unhealthy alcohol use, and counseling interventions in those who screen positive are associated with reductions in unhealthy alcohol use. There was no evidence that these interventions have unintended harmful effects.

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.

Behavioral Counseling and Pharmacotherapy Interventions for Tobacco Cessation in Adults, Including Pregnant Women: A Review of Reviews for the U.S. Preventive Services Task Force.

BACKGROUND: Tobacco use is the leading cause of preventable death in the United States. PURPOSE: To review the effectiveness and safety of pharmacotherapy and behavioral interventions for tobacco cessation. DATA SOURCES: 5 databases and 8 organizational Web sites were searched through 1 August 2014 for systematic reviews, and PubMed was searched through 1 March 2015 for trials on electronic nicotine delivery systems. STUDY SELECTION: Two reviewers examined 114 articles to identify English-language reviews that reported health, cessation, or adverse outcomes. DATA EXTRACTION: One reviewer abstracted data from good- and fair-quality reviews, and a second checked for accuracy. DATA SYNTHESIS: 54 reviews were included. Behavioral interventions increased smoking cessation at 6 months or more (physician advice had a pooled risk ratio [RR] of 1.76 [95% CI, 1.58 to 1.96]). Nicotine replacement therapy (RR, 1.60 [CI, 1.53 to 1.68]), bupropion (RR, 1.62 [CI, 1.49 to 1.76]), and varenicline (RR, 2.27 [CI, 2.02 to 2.55]) were also effective for smoking cessation. Combined behavioral and pharmacotherapy interventions increased cessation by 82% compared with minimal intervention or usual care (RR, 1.82 [CI, 1.66 to 2.00]). None of the drugs were associated with major cardiovascular adverse events. Only 2 trials addressed efficacy of electronic cigarettes for smoking cessation and found no benefit. Among pregnant women, behavioral interventions benefited cessation and perinatal health; effects of nicotine replacement therapy were not significant. LIMITATION: Evidence published after each review's last search date was not included. CONCLUSION: Behavioral and pharmacotherapy interventions improve rates of smoking cessation among the general adult population, alone or in combination. Data on the effectiveness and safety of electronic nicotine delivery systems are limited. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Primary Care Interventions to Support Breastfeeding: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Although 80% of infants in the United States start breastfeeding, only 22% are exclusively breastfed up to around 6 months as recommended by a number of professional organizations. Objective: To systematically review the evidence on the benefits and harms of breastfeeding interventions to support the US Preventive Services Task Force in updating its 2008 recommendation. Data Sources: MEDLINE, PubMed, Cumulative Index for Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and PsycINFO for studies published in the English language between January 1, 2008, and September 25, 2015. Studies included in the previous review were re-evaluated for inclusion. Surveillance for new evidence in targeted publications was conducted through January 26, 2016. Study Selection: Review of randomized clinical trials and before-and-after studies with concurrent controls conducted in a developed country that evaluated a primary care-relevant breastfeeding intervention among mothers of full- or near-term infants. Of 211 full-text articles reviewed, 52 studies met inclusion criteria. Thirty-one studies were newly identified, and 21 studies were carried forward from the previous review. Data Extraction and Synthesis: Independent critical appraisal of all provisionally included studies. Data were independently abstracted by one reviewer and confirmed by another. Main Outcomes and Measures: Child and maternal health outcomes, rates and duration of breastfeeding, and harms related to interventions as prespecified before data collection. Results: Fifty-two studies (n = 66 757) in 57 publications were included. Six trials (n = 2219) reported inconsistent effects of the interventions on infant health outcomes; no studies reported maternal health outcomes. Pooled estimates based on random-effects meta-analyses using the DerSimonian and Laird method indicated beneficial associations between individual-level breastfeeding interventions and any breastfeeding for less than 3 months (risk ratio [RR], 1.07 [95% CI, 1.03-1.11]; 26 studies [n = 11 588]), at 3 to less than 6 months (RR, 1.11 [95% CI, 1.04-1.18]; 23 studies [n = 8942]), and for exclusive breastfeeding for less than 3 months (RR, 1.21 [95% CI, 1.11-1.33]; 22 studies [n = 8246]), 3 to less than 6 months (RR, 1.20 [95% CI, 1.05-1.38]; 18 studies [n = 7027]), and at 6 months (RR, 1.16 [95% CI, 1.02-1.32]; 17 studies [n = 7690]). Absolute differences in the rates of any breastfeeding ranged from 14.1% in favor of the control group to 18.4% in favor of the intervention group. There was no significant association between interventions and breastfeeding initiation (RR, 1.00 [95% CI, 0.99-1.02]; 14 studies [n = 9428]). There was limited mixed evidence of an association between system-level interventions and rates of breastfeeding from well-controlled studies as well as for harms related to breastfeeding interventions, including maternal anxiety scores, decreased confidence, and concerns about confidentiality. Conclusions and Relevance: The updated evidence confirms that breastfeeding support interventions are associated with an increase in the rates of any and exclusive breastfeeding. There are limited well-controlled studies examining the effectiveness of system-level policies and practices on rates of breastfeeding or child health and none for maternal health.

Primary care behavioral interventions to prevent or reduce illicit drug use and nonmedical pharmaceutical use in children and adolescents: a systematic evidence review for the U.S. Preventive Services Task Force.

BACKGROUND: Drug use among youths is associated with negative health and social consequences. Even infrequent use increases the risk for serious adverse events by increasing risk-taking behaviors in intoxicated or impaired persons. PURPOSE: To systematically review the benefits and harms of primary care-relevant interventions designed to prevent or reduce illicit drug use or the nonmedical use of prescription drugs among youths. DATA SOURCES: PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through 4 June 2013; MEDLINE through 31 August 2013; and manual searches of reference lists and gray literature. STUDY SELECTION: Two investigators independently reviewed 2253 abstracts and 144 full-text articles. English-language trials of primary care-relevant behavioral interventions that reported drug use, health outcomes, or harms were included. DATA EXTRACTION: One investigator abstracted data from good- and fair-quality trials into prespecified evidence tables, and a second investigator checked these data. DATA SYNTHESIS: Six trials were included, 4 of which examined the effect of the intervention on a health or social outcome. One trial found no effect of the intervention on marijuana-related consequences or driving under the influence of marijuana; 3 trials generally found no reduction in depressed mood at 12 or 24 months. Four of the 5 trials assessing self-reported marijuana use found statistically significant differences favoring the intervention group participants (such as a between-group difference of 0.10 to 0.17 use occasions in the past month). Three trials also reported positive outcomes in nonmedical prescription drug use occasions. LIMITATIONS: The body of evidence was small, and there were heterogeneous measures of outcomes of limited clinical applicability. Trials primarily included adolescents with little or no substance use. CONCLUSION: Evidence is inadequate on the benefits of primary care-relevant behavioral interventions in reducing self-reported illicit and pharmaceutical drug use among adolescents. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Primary care-relevant interventions for tobacco use prevention and cessation in children and adolescents: a systematic evidence review for the U.S. Preventive Services Task Force.

BACKGROUND: Interventions to prevent smoking uptake or encourage cessation among young persons might help prevent tobacco-related illness. PURPOSE: To review the evidence for the efficacy and harms of primary care-relevant interventions that aim to reduce tobacco use among children and adolescents. DATA SOURCES: Three systematic reviews that collectively covered the relevant literature; MEDLINE, PsycINFO, the Cochrane Central Register of Controlled Trials, and the Database of Abstracts of Reviews of Effects through 14 September 2012; and manual searches of reference lists and gray literature. STUDY SELECTION: Two investigators independently reviewed 2453 abstracts and 111 full-text articles. English-language trials of behavior-based or medication interventions that were relevant to primary care and reported tobacco use, health outcomes, or harms were included. DATA EXTRACTION: One investigator abstracted data from good- and fair-quality trials into an evidence table, and a second checked these data. DATA SYNTHESIS: 19 trials (4 good-quality and 15 fair-quality) that were designed to prevent tobacco use initiation or promote cessation (or both) and reported self-reported smoking status or harms were included. Pooled analyses from a random-effects meta-analysis suggested a 19% relative reduction (risk ratio, 0.81 [95% CI, 0.70 to 0.93]; absolute risk difference, -0.02 [CI, -0.03 to 0.00]) in smoking initiation among participants in behavior-based prevention interventions compared with control participants. Neither behavior-based nor bupropion cessation interventions improved cessation rates. Findings about the harms related to bupropion use were mixed. LIMITATIONS: No studies reported health outcomes. Interventions and measures were heterogeneous. Most trials examined only cigarette smoking. The body of evidence was largely published 5 to 15 years ago. CONCLUSION: Primary care-relevant interventions may prevent smoking initiation over 12 months in children and adolescents.

Prioritizing research needs based on a systematic evidence review: a pilot process for engaging stakeholders.

BACKGROUND/CONTEXT: Systematic evidence reviews (SERs) identify knowledge gaps in the literature, a logical starting place for prioritizing future research. Varied methods have been used to elicit diverse stakeholders' input in such prioritization. OBJECTIVE: To pilot a simple, easily replicable process for simultaneously soliciting consumer, clinician and researcher input in the identification of research priorities, based on the results of the 2009 SER on screening adults for depression in primary care. METHODS: We recruited 20 clinicians, clinic staff, researchers and patient advocates to participate in a half-day event in October 2009. We presented SER research methods and the results of the 2009 SER. Participants took part in focus groups, organized by profession; broad themes from these groups were then prioritized in a formal exercise. The focus group content was also subsequently analysed for specific themes. RESULTS: Focus group themes generally reacted to the evidence presented; few were articulated as research questions. Themes included the need for resources to respond to positive depression screens, the impact of depression screening on delivery systems, concerns that screening tools do not address comorbid or situational causes of depression and a perceived 'disconnect' between screening and treatment. The two highest-priority themes were the system effects of screening for depression and whether depression screening effectively leads to improved treatment. CONCLUSION: We successfully piloted a simple, half-day, easily replicable multi-stakeholder engagement process based on the results of a recent SER. We recommend a number of potential improvements in future endeavours to replicate this process.

Pre-Enrollment Steps and Run-Ins in Weight Loss Trials: A Meta-Regression.

INTRODUCTION: The generalizability of study findings may be influenced by pre-enrollment trial procedures, including the use of behavioral run-in periods. The study goals were to determine whether behavioral run-in periods and other pre-enrollment processes affect outcomes in randomized trials of behavioral weight loss interventions that have contributed to clinical guidelines. METHODS: The sample was behavioral weight loss intervention trials included in the 2018 U.S. Preventive Services Task Force systematic review. Information on pre-enrollment processes (total steps, in-person steps, behavioral run-in) was abstracted, and meta-regressions were conducted in 2022 to test whether pre-enrollment processes were associated with weight loss at 6 or 12 months and trial retention at 12 months. RESULTS: Across 80 trials, the median number of total pre-enrollment steps was 2 (range=1-5), and that of in-person pre-enrollment steps was 1 (range=0-4). Almost one-third of the trials (k=24; 30%) used a behavioral run-in. The most common run-in tasks were self-monitoring physical activity (k=9) or both physical activity and diet (k=6). Greater weight loss was observed in trials with behavioral run-ins at 6 months (-2.33 kg; 95% CI= -3.72, -0.93) and, to an attenuated extent, at 12 months (-0.86 kg; 95% CI= -1.72, 0.01) compared to those without run-ins. The total number of pre-enrollment steps was also associated with greater 6-month weight loss (-0.85 kg; 95% CI= -1.59, -0.11). Higher retention was associated with total number of pre-enrollment steps and in-person steps and marginally with the presence of run-ins. DISCUSSION: The use of more pre-enrollment processes is associated with greater weight loss in behavioral weight loss trials and may impact the generalizability of outcomes.

Multilevel predictors of adolescent physical activity: a longitudinal analysis.

BACKGROUND: To examine how factors from a social ecologic model predict physical activity (PA) among adolescents using a longitudinal analysis. METHODS: Participants in this longitudinal study were adolescents (ages 10-16 at baseline) and one parent enrolled in the Transdisciplinary Research on Energetics and Cancer-Identifying Determinants of Eating and Activity (TREC-IDEA) and the Etiology of Childhood Obesity (ECHO). Both studies were designed to assess a socio-ecologic model of adolescent obesity risk. PA was collected using ActiGraph activity monitors at two time points 24 months apart. Other measures included objective height and weight, adolescent and parent questionnaires on multilevel psychological, behavioral and social determinants of PA, and a home PA equipment inventory. Analysis was conducted using SAS, including descriptive characteristics, bivariate and stepped multivariate mixed models, using baseline adjustment. Models were stratified by gender. RESULTS: There were 578 adolescents with complete data. Results suggest few statistically significant longitudinal associations with physical activity measured as minutes of MVPA or total counts from accelerometers. For boys, greater self-efficacy (B = 0.75, p = 0.01) and baseline MVPA (B = 0.55, p < 0.01) remained significantly associated with MVPA at follow-up. A similar pattern was observed for total counts. For girls, baseline MVPA (B = 0.58, p = 0.01) and barriers (B = -0.32, p = 0.05) significantly predicted MVPA at follow-up in the full model. The full multilevel model explained 30% of the variance in PA among boys and 24% among girls. CONCLUSIONS: PA change in adolescents is a complex issue that is not easily understood. Our findings suggest early PA habits are the most important predictor of PA levels in adolescence. Intervention may be necessary prior to middle school to maintain PA through adolescence.

Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force.

BACKGROUND: Overweight and obesity in adults are common and adversely affect health. PURPOSE: To summarize effectiveness and harms of primary care-relevant weight-loss interventions for overweight and obese adults. DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, and PsycINFO from January 2005 to September 2010; systematic reviews for identifying trials before 2005. STUDY SELECTION: Two investigators appraised 6498 abstracts and 648 articles. Clinical trials were included if control groups received minimal interventions. Articles were rated as good, fair, or poor by using design-specific criteria. DATA EXTRACTION: One investigator abstracted study characteristics and findings for good- and fair-quality studies; a second checked them. DATA SYNTHESIS: Behaviorally based treatment resulted in 3-kg (6.6-lb) greater weight loss in intervention than control participants after 12 to 18 months, with more treatment sessions associated with greater loss. Limited data suggest weight-loss maintenance for 1 year or more. Orlistat plus behavioral intervention resulted in 3-kg (6.6-lb) more weight loss than did placebo after 12 months. Metformin resulted in less weight loss. Data on effects of weight-loss treatment on long-term health outcomes (for example, death and cardiovascular disease) were insufficient. Weight-loss treatment reduced diabetes incidence in participants with prediabetes. Effects on intermediate outcomes (for example, lipids and blood pressure) were mixed and small. Data on serious medication harms were insufficient. Medications commonly caused withdrawals due to gastrointestinal symptoms. LIMITATIONS: Few studies reported health outcomes. Behaviorally based treatments were heterogeneous and specific elements were not well-described. Many studies could not be pooled because of insufficient reporting of variance data. Medication trials had high attrition, lacked postdiscontinuation data, and were inadequately powered for rare adverse effects. CONCLUSION: Behaviorally based treatments are safe and effective for weight loss and maintenance. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Rapid Evidence Review of Digital Cognitive-Behavioral Therapy for Adolescents With Depression.

PURPOSE: We conducted a rapid evidence review to explore the benefits and harms of digital cognitive-behavioral therapy (dCBT) and the barriers to and facilitators of implementing dCBT for adolescents. METHODS: We searched MEDLINE, PsycINFO, CENTRAL through December 6, 2021, for controlled trials conducted in settings highly applicable to the United States. Additionally, we searched relevant systematic reviews for eligible studies. Results were summarized qualitatively. RESULTS: We included 12 trials (n = 1,575) that examined the effects of nine dCBT programs. Overall, dCBT was slightly superior to comparators in improving depression symptoms immediately post-intervention, but not at a longer follow-up. The use of dCBT did not appear to result in an increased risk for suicidal attempts or ideation; however, the number of events was very small. Potential barriers to implementing/maintaining dCBT are challenges engaging/retaining patients, developing infrastructure, and training therapists to facilitate dCBT. Data on harms or unintended negative consequences were not reported in the included studies. CONCLUSIONS: A limited body of evidence suggests that dCBT programs might outperform control interventions for reducing depressive symptoms immediately post-intervention, but not at a longer follow-up. The safety of dCBT programs for adolescents with depression is understudied.