RESUMEN

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.

Asunto(s)

Fármacos Antiobesidad , Índice de Masa Corporal , Obesidad Infantil , Humanos , Adolescente , Niño , Obesidad Infantil/terapia , Fármacos Antiobesidad/uso terapéutico , Fármacos Antiobesidad/efectos adversos , Preescolar , Pérdida de Peso , Ejercicio Físico , Femenino , Masculino , Programas de Reducción de Peso , Terapia Conductista

RESUMEN

Importance: Clinical practice guidelines can play an important role in mitigating health inequities. The US Preventive Services Task Force (USPSTF) has prioritized addressing health equity and racism in its recommendations. Objective: To develop a framework that would allow the USPSTF to incorporate a health equity lens that spans the entirety of its recommendation-making process. Evidence Review: Key guidance, policy, and explanatory frameworks related to health equity were identified, and their recommendations and findings were mapped to current USPSTF methods. USPSTF members as well as staff from multiple entities supporting the USPSTF portfolio were consulted. Based on all the gathered information, a draft health equity framework and checklist were developed; they were then circulated to the USPSTF's key partners for input and review. Findings: An equity framework was developed that could be applied to all phases of the recommendation process: (1) topic nomination, selection, and prioritization; (2) development of the work plan; (3) evidence review; (4) evidence deliberation; (5) development of the recommendation statement; and (6) dissemination of recommendations. For each phase, several considerations and checklist items to address are presented. These items include using health equity as a prioritization criterion and engaging a diverse group of stakeholders at the earliest phases in identifying topics for recommendations; developing necessary equity-relevant questions (eg, beyond effectiveness and harms) to address during the protocol phase; using methods in synthesizing the evidence and contextual issues in the evidence review related to specific populations experiencing a disproportionate burden of disease; and examining the magnitude and certainty of net benefit, implementation considerations, risk assessment, and evidence gaps through an equity lens when developing evidence-based recommendations. Conclusions and Relevance: Executing this entire framework and checklist as described will be challenging and will take additional time and resources. Nonetheless, whether adopted in its entirety or in parts, this framework offers guidance to the USPSTF, as well as other evidence-based guideline entities, in its mission to develop a more transparent, consistent, and intentional approach to addressing health equity in its recommendations.

Asunto(s)

Equidad en Salud , Humanos , Comités Consultivos , Lista de Verificación , Inequidades en Salud , Políticas

RESUMEN

Introduction: Despite mounting evidence that the inclusion of race and ethnicity in clinical prediction models may contribute to health disparities, existing critical appraisal tools do not directly address such equity considerations. Objective: This study developed a critical appraisal tool extension to assess algorithmic bias in clinical prediction models. Methods: A modified e-Delphi approach was utilized to develop and obtain expert consensus on a set of racial and ethnic equity-based signaling questions for appraisal of risk of bias in clinical prediction models. Through a series of virtual meetings, initial pilot application, and an online survey, individuals with expertise in clinical prediction model development, systematic review methodology, and health equity developed and refined this tool. Results: Consensus was reached for ten equity-based signaling questions, which led to the development of the Critical Appraisal for Racial and Ethnic Equity in Clinical Prediction Models (CARE-CPM) extension. This extension is intended for use along with existing critical appraisal tools for clinical prediction models. Conclusion: CARE-CPM provides a valuable risk-of-bias assessment tool extension for clinical prediction models to identify potential algorithmic bias and health equity concerns. Further research is needed to test usability, interrater reliability, and application to decision-makers.

RESUMEN

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.

Asunto(s)

Dislipidemias , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Tamizaje Masivo , Adolescente , Niño , Humanos , Colesterol , Dislipidemias/diagnóstico , Dislipidemias/tratamiento farmacológico , Dislipidemias/etiología , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Lípidos , Hipercolesterolemia/complicaciones

RESUMEN

OBJECTIVE: Many children with chronic musculoskeletal pain conditions experience stigma which can have negative downstream consequences. This study compares ratings of clinical pain (current pain intensity and pain interference), experimental pain (temporal summation, cold water tolerance, and cold pain intensity), and pain-related stigma among three groups of youth with rheumatic conditions. The relations among ratings of pain-related stigma and pain variables were explored. METHODS: Eighty-eight youth aged 8-17 years with a diagnosis of juvenile idiopathic arthritis (JIA = 32), juvenile fibromyalgia (JFM = 31), or non-specific chronic pain (NSCP = 25) completed measures of clinical pain ratings (average 7-day pain intensity, day of assessment pain (DoA), and pain interference), experimental pain (cold pain tolerance, cold pain intensity, and temporal summation of mechanical pain), and pain-related stigma. Data analysis compared pain-related stigma and pain ratings across the three groups and examined the relations among pain-related stigma and pain ratings. RESULTS: Youth with JFM reported higher ratings of clinical pain and pain-related stigma than their counterparts with NSCP or JIA. However, there were no differences in experimental pain. Pain-related stigma was associated with greater ratings of pain interference, particularly for those with JIA and NSCP. Pain-related stigma was also associated with greater average daily pain intensity but not DoA. CONCLUSION: Youth with medically unexplained pain report greater stigma and worse pain than their peers; thus, robust assessment of pain in this population is necessary. Future work should longitudinally explore the impact of pain-related stigma on pain outcomes and treatment responses.

RESUMEN

Caregivers of youth with sickle cell disease (SCD) influence the youth disease management and psychosocial outcomes. Effective caregiver coping is important for improving disease management and outcomes since caregivers often report high disease-related parenting stress. This study characterizes caregiver coping and examines its relation to youth clinic nonattendance and health-related quality of life (HRQOL). Participants were 63 youth with SCD and their caregivers. Caregivers completed the Responses to Stress Questionnaire-SCD module to assess primary control engagement (PCE; attempts to change stressors or reactions to stress), secondary control engagement (SCE; strategies to adapt to stress), and disengagement (avoidance) coping. Youth with SCD completed the Pediatric Quality of Life Inventory-SCD module. Medical records were reviewed for the hematology appointment nonattendance rates. Coping factors were significantly different ( F [1.837, 113.924]=86.071, P <0.001); caregivers reported more PCE ( M =2.75, SD =0.66) and SCE ( M =2.78, SD =0.66) than disengagement ( M =1.75, SD =0.54) coping. Responses to short-answer questions corroborated this pattern. Greater caregiver PCE coping was associated with lower youth nonattendance (ß=-0.28, P =0.050), and greater caregiver SCE coping was related to higher youth HRQOL (ß=0.28, P =0.045). Caregiver coping is related to improved clinic attendance and HRQOL in pediatric SCD. Providers should assess caregiver coping styles and consider encouraging engagement coping.

Asunto(s)

Anemia de Células Falciformes , Calidad de Vida , Humanos , Niño , Adolescente , Calidad de Vida/psicología , Cuidadores/psicología , Manejo de la Enfermedad , Anemia de Células Falciformes/complicaciones , Adaptación Psicológica

RESUMEN

OBJECTIVE: Obesity is associated with executive function (EF) deficits across the lifespan. Higher body mass index (BMI), obesity severity, and poorer adherence and weight outcomes in obesity treatment have all been associated with EF deficits. Adult literature has begun to emphasize neuroinflammation in obesity as a possible pathway to later cognitive impairment in EF. However, pediatric obesity literature has yet to establish associations between peripheral inflammation and EF. Thus, the present study examined associations and variability in inflammation, EF, and adiposity in children with or at risk for obesity. Additionally, inflammation was examined as a mediator of the relationship between adiposity and EF. METHODS: Children (N = 39) aged 8-12 years with BMI ≥ 50th percentile were recruited. The NIH Toolbox Cognitive Battery was used to assess performance-based EF. Peripheral inflammation was assessed in fasted sera. Dual-energy X-ray absorptiometry scans were conducted to assess body composition. Linear regression and Hayes' PROCESS Model 4 (Hayes, 2017) were used to evaluate associations between adiposity and inflammation, inflammation and EF, and whether adiposity effects EF through its effect on inflammation. RESULTS: Positive associations were identified between adiposity and inflammation, and negative to null associations were identified between inflammation and EF. Medium indirect effects of adiposity on EF through inflammation were detected. CONCLUSION: Pilot evidence suggests greater adiposity is linked with greater inflammation, which in turn is associated with less EF in some domains. Directionality and causality cannot yet be established, but with replication, findings may inform efforts to target EF in pediatric obesity.

Asunto(s)

Obesidad Infantil , Adulto , Humanos , Niño , Obesidad Infantil/psicología , Adiposidad , Proyectos Piloto , Función Ejecutiva , Índice de Masa Corporal , Inflamación

RESUMEN

Importance: Cardiovascular disease and cancer are the 2 leading causes of death in the US, and vitamin and mineral supplementation has been proposed to help prevent these conditions. Objective: To review the benefits and harms of vitamin and mineral supplementation in healthy adults to prevent cardiovascular disease and cancer to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed (publisher-supplied records only), Cochrane Library, and Embase (January 2013 to February 1, 2022); prior reviews. Study Selection: English-language randomized clinical trials (RCTs) of vitamin or mineral use among adults without cardiovascular disease or cancer and with no known vitamin or mineral deficiencies; observational cohort studies examining serious harms. Data Extraction and Synthesis: Single extraction, verified by a second reviewer. Quantitative pooling methods appropriate for rare events were used for most analyses. Main Outcomes and Measures: Mortality, cardiovascular disease events, cancer incidence, serious harms. Results: Eighty-four studies (N=739 803) were included. In pooled analyses, multivitamin use was significantly associated with a lower incidence of any cancer (odds ratio [OR], 0.93 [95% CI, 0.87-0.99]; 4 RCTs [n=48 859]; absolute risk difference [ARD] range among adequately powered trials, -0.2% to -1.2%) and lung cancer (OR, 0.75 [95% CI, 0.58-0.95]; 2 RCTs [n=36 052]; ARD, 0.2%). However, the evidence for multivitamins had important limitations. Beta carotene (with or without vitamin A) was significantly associated with an increased risk of lung cancer (OR, 1.20 [95% CI, 1.01-1.42]; 4 RCTs [n=94 830]; ARD range, -0.1% to 0.6%) and cardiovascular mortality (OR, 1.10 [95% CI, 1.02-1.19]; 5 RCTs [n=94 506] ARD range, -0.8% to 0.8%). Vitamin D use was not significantly associated with all-cause mortality (OR, 0.96 [95% CI, 0.91-1.02]; 27 RCTs [n=117 082]), cardiovascular disease (eg, composite cardiovascular disease event outcome: OR, 1.00 [95% CI, 0.95-1.05]; 7 RCTs [n=74 925]), or cancer outcomes (eg, any cancer incidence: OR, 0.98 [95% CI, 0.92-1.03]; 19 RCTs [n=86 899]). Vitamin E was not significantly associated with all-cause mortality (OR, 1.02 [95% CI, 0.97-1.07]; 9 RCTs [n=107 772]), cardiovascular disease events (OR, 0.96 [95% CI, 0.90-1.04]; 4 RCTs [n=62 136]), or cancer incidence (OR, 1.02 [95% CI, 0.98-1.08]; 5 RCTs [n=76 777]). Evidence for benefit of other supplements was equivocal, minimal, or absent. Limited evidence suggested some supplements may be associated with higher risk of serious harms (hip fracture [vitamin A], hemorrhagic stroke [vitamin E], and kidney stones [vitamin C, calcium]). Conclusions and Relevance: Vitamin and mineral supplementation was associated with little or no benefit in preventing cancer, cardiovascular disease, and death, with the exception of a small benefit for cancer incidence with multivitamin use. Beta carotene was associated with an increased risk of lung cancer and other harmful outcomes in persons at high risk of lung cancer.

Asunto(s)

Enfermedades Cardiovasculares , Minerales , Neoplasias , Vitaminas , Adulto , Comités Consultivos , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Suplementos Dietéticos/efectos adversos , Humanos , Neoplasias Pulmonares/epidemiología , Neoplasias Pulmonares/prevención & control , Minerales/efectos adversos , Minerales/uso terapéutico , Neoplasias/epidemiología , Neoplasias/prevención & control , Prevención Primaria , Estados Unidos/epidemiología , Vitamina A/efectos adversos , Vitaminas/efectos adversos , Vitaminas/uso terapéutico , beta Caroteno/efectos adversos

RESUMEN

Importance: The US Preventive Services Task Force (USPSTF) is updating its 2016 recommendation on the use of aspirin for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC). Objective: To provide updated model-based estimates of the net balance in benefits and harms from routine use of low-dose aspirin for primary prevention. Design, Setting, and Participants: Microsimulation modeling was used to estimate long-term benefits and harms for hypothetical US cohorts of men and women aged 40 to 79 years with up to 20% 10-year risk for an atherosclerotic CVD event and without prior history of CVD or elevated bleeding risks. Exposures: Low-dose (≤100 mg/d) aspirin for lifetime use, unless contraindicated by a bleeding event, and with stopping ages in 5-year intervals from age 65 to 85 years. Main Outcomes and Measures: Primary outcomes were lifetime net benefits measured in quality-adjusted life-years (QALYs) and life-years. Benefits included reduced nonfatal myocardial infarction and ischemic stroke. Harms included increased nonfatal major gastrointestinal bleeding and intracranial hemorrhage. Reduced CRC incidence was considered in sensitivity analysis. Results: Estimated lifetime net QALYs were positive for both men and women at 5% or greater 10-year CVD risk when starting between ages 40 and 59 years and at 10% or greater 10-year CVD risk when starting between ages 60 and 69 years. These estimates ranged from 2.3 (95% CI, -2.7 to 7.4) to 66.2 (95% CI, 58.2 to 74.1) QALYs per 1000 persons. Lifetime net life-years were positive for men at 5% or greater and women at 10% or greater 10-year CVD risk starting aspirin at ages 40 to 49 years and for men at 7.5% or greater and women at 15% or greater 10-year CVD risk at ages 50 to 59 years. These estimates ranged from 0.4 (95% CI, -6.1 to 6.9) to 52.4 (95% CI, 43.9 to 60.9) life-years per 1000 persons. Lifetime net life-years were negative in most cases for persons starting aspirin between ages 60 and 79 years, as were lifetime net QALYs for persons aged 70 to 79 years. Stopping aspirin between ages 65 and 85 years generally showed little advantage compared with lifetime use. Sensitivity analyses showed lifetime net benefits may be higher if aspirin reduced CRC incidence or CVD mortality and lower if aspirin increased fatal major gastrointestinal bleeding or reduced quality of life with routine use. Conclusions and Relevance: This microsimulation study suggested that several population groups may benefit from taking aspirin for the primary prevention of CVD, primarily in persons starting at younger ages with higher 10-year CVD risk.

Asunto(s)

Aspirina , Enfermedades Cardiovasculares , Neoplasias Colorrectales , Adulto , Anciano , Aspirina/efectos adversos , Aspirina/uso terapéutico , Enfermedades Cardiovasculares/prevención & control , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/epidemiología , Neoplasias Colorrectales/prevención & control , Femenino , Hemorragia Gastrointestinal/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Prevención Primaria , Calidad de Vida

RESUMEN

Importance: Low-dose aspirin is used for primary cardiovascular disease prevention and may have benefits for colorectal cancer prevention. Objective: To review the benefits and harms of aspirin in primary cardiovascular disease prevention and colorectal cancer prevention to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, Embase, and the Cochrane Central Register of Controlled Trials through January 2021; literature surveillance through January 21, 2022. Study Selection: English-language randomized clinical trials (RCTs) of low-dose aspirin (≤100 mg/d) compared with placebo or no intervention in primary prevention populations. Data Extraction and Synthesis: Single extraction, verified by a second reviewer. Quantitative synthesis using Peto fixed-effects meta-analysis. Main Outcomes and Measures: Cardiovascular disease events and mortality, all-cause mortality, colorectal cancer incidence and mortality, major bleeding, and hemorrhagic stroke. Results: Eleven RCTs (N = 134 470) and 1 pilot trial (N = 400) of low-dose aspirin for primary cardiovascular disease prevention were included. Low-dose aspirin was associated with a significant decrease in major cardiovascular disease events (odds ratio [OR], 0.90 [95% CI, 0.85-0.95]; 11 RCTs [n = 134 470]; I2 = 0%; range in absolute effects, -2.5% to 0.1%). Results for individual cardiovascular disease outcomes were significant, with similar magnitude of benefit. Aspirin was not significantly associated with reductions in cardiovascular disease mortality or all-cause mortality. There was limited trial evidence on benefits for colorectal cancer, with the findings highly variable by length of follow-up and statistically significant only when considering long-term observational follow-up beyond randomized trial periods. Low-dose aspirin was associated with significant increases in total major bleeding (OR, 1.44 [95% CI, 1.32-1.57]; 10 RCTs [n = 133 194]; I2 = 4.7%; range in absolute effects, 0.1% to 1.0%) and in site-specific bleeding, with similar magnitude. Conclusions and Relevance: Low-dose aspirin was associated with small absolute risk reductions in major cardiovascular disease events and small absolute increases in major bleeding. Colorectal cancer results were less robust and highly variable.

Asunto(s)

Aspirina , Enfermedades Cardiovasculares , Neoplasias Colorrectales , Aspirina/efectos adversos , Aspirina/uso terapéutico , Enfermedades Cardiovasculares/prevención & control , Neoplasias Colorrectales/prevención & control , Hemorragia/inducido químicamente , Humanos , Prevención Primaria , Ensayos Clínicos Controlados Aleatorios como Asunto

RESUMEN

OBJECTIVE: Youth with poorly-controlled asthma are at increased risk for sleep disturbances caused by nocturnal symptoms like coughing. Asthma-related sleep disturbances can have downstream consequences for youth with asthma and their families. This study aims to describe (1) sleep disturbances in adolescents with poorly-controlled asthma and their caregivers and (2) the relationship between sleep and asthma management. METHODS: Adolescents with poorly-controlled asthma and their caregivers completed the Family Asthma Management System Scale (FAMSS), a semi-structured interview that assesses youth asthma management within the family context. Interviews were audio-recorded and transcribed. Two authors coded each transcript for sleep-related data in NVivo using descriptive content analysis. RESULTS: Thirty-three adolescents ages 12-15 years old (M = 13.2, SD = 1.2) with poorly-controlled asthma and their caregivers participated in this study. Four main themes emerged: sleep difficulties, sleep environment, sleep and self-management, and fatigue and self-management. 42% of youth and caregivers reported worse nocturnal asthma symptoms (e.g. coughing) that caused frequent nighttime awakening. Approximately 27% of caregivers expressed distress over their child's nocturnal asthma and described their management strategies (e.g. co-sleeping, nighttime symptom monitoring). Adolescents described sleepiness as a barrier to asthma self-management tasks (e.g. medication adherence, response to exacerbation). CONCLUSION: Interview responses demonstrated the considerable interrelationship of sleep and asthma management in adolescents with poorly-controlled asthma. Asthma providers should consider discussing sleep difficulties with their adolescent patients and their families. Addressing these difficulties may help adolescents improve their asthma self-management and help caregivers better cope with their child's disease.

Asunto(s)

Asma , Automanejo , Trastornos del Sueño-Vigilia , Adolescente , Asma/tratamiento farmacológico , Cuidadores , Niño , Humanos , Sueño , Trastornos del Sueño-Vigilia/epidemiología , Trastornos del Sueño-Vigilia/etiología

RESUMEN

Importance: Hypertension is a major risk factor for cardiovascular disease and can be modified through lifestyle and pharmacological interventions to reduce cardiovascular events and mortality. Objective: To systematically review the benefits and harms of screening and confirmatory blood pressure measurements in adults, to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, Cochrane Collaboration Central Registry of Controlled Trials, and CINAHL; surveillance through March 26, 2021. Study Selection: Randomized clinical trials (RCTs) and nonrandomized controlled intervention studies for effectiveness of screening; accuracy studies for screening and confirmatory measurements (ambulatory blood pressure monitoring as the reference standard); RCTs and nonrandomized controlled intervention studies and observational studies for harms of screening and confirmation. Data Extraction and Synthesis: Independent critical appraisal and data abstraction; meta-analyses and qualitative syntheses. Main Outcomes and Measures: Mortality; cardiovascular events; quality of life; sensitivity, specificity, positive and negative predictive values; harms of screening. Results: A total of 52 studies (N = 215 534) were identified in this systematic review. One cluster RCT (n = 140 642) of a multicomponent intervention including hypertension screening reported fewer annual cardiovascular-related hospital admissions for cardiovascular disease in the intervention group compared with the control group (difference, 3.02 per 1000 people; rate ratio, 0.91 [95% CI, 0.86-0.97]). Meta-analysis of 15 studies (n = 11 309) of initial office-based blood pressure screening showed a pooled sensitivity of 0.54 (95% CI, 0.37-0.70) and specificity of 0.90 (95% CI, 0.84-0.95), with considerable clinical and statistical heterogeneity. Eighteen studies (n = 57 128) of various confirmatory blood pressure measurement modalities were heterogeneous. Meta-analysis of 8 office-based confirmation studies (n = 53 183) showed a pooled sensitivity of 0.80 (95% CI, 0.68-0.88) and specificity of 0.55 (95% CI, 0.42-0.66). Meta-analysis of 4 home-based confirmation studies (n = 1001) showed a pooled sensitivity of 0.84 (95% CI, 0.76-0.90) and a specificity of 0.60 (95% CI, 0.48-0.71). Thirteen studies (n = 5150) suggested that screening was associated with no decrement in quality of life or psychological distress; evidence on absenteeism was mixed. Ambulatory blood pressure measurement was associated with temporary sleep disturbance and bruising. Conclusions and Relevance: Screening using office-based blood pressure measurement had major accuracy limitations, including misdiagnosis; however, direct harms of measurement were minimal. Research is needed to determine optimal screening and confirmatory algorithms for clinical practice.

Asunto(s)

Determinación de la Presión Sanguínea/métodos , Hipertensión/diagnóstico , Tamizaje Masivo/normas , Adulto , Monitoreo Ambulatorio de la Presión Arterial , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Humanos , Tamizaje Masivo/efectos adversos , Guías de Práctica Clínica como Asunto , Sensibilidad y Especificidad

RESUMEN

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.

Asunto(s)

Enfermedades Cardiovasculares/prevención & control , Consejo , Dieta Saludable , Ejercicio Físico , Adulto , Consejo/métodos , Dislipidemias , Conductas Relacionadas con la Salud , Factores de Riesgo de Enfermedad Cardiaca , Humanos , Hipertensión

Asunto(s)

Antibacterianos/uso terapéutico , Oftalmía Neonatal/prevención & control , Administración Tópica , Antibacterianos/efectos adversos , Eritromicina/uso terapéutico , Humanos , Recién Nacido , Pomadas , Guías de Práctica Clínica como Asunto

RESUMEN

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.

Asunto(s)

Índice Tobillo Braquial , Proteína C-Reactiva/análisis , Enfermedades Cardiovasculares , Enfermedad de la Arteria Coronaria/diagnóstico , Medición de Riesgo/métodos , Calcificación Vascular/diagnóstico , Adulto , Biomarcadores/sangre , Ensayos Clínicos como Asunto , Humanos , Factores de Riesgo

RESUMEN

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.

Asunto(s)

Índice Tobillo Braquial , Tamizaje Masivo/métodos , Enfermedad Arterial Periférica/diagnóstico , Índice Tobillo Braquial/efectos adversos , Aspirina/uso terapéutico , Enfermedades Asintomáticas , Diagnóstico Precoz , Terapia por Ejercicio , Fibrinolíticos/uso terapéutico , Humanos , Tamizaje Masivo/efectos adversos , Enfermedad Arterial Periférica/terapia , Guías de Práctica Clínica como Asunto , Medición de Riesgo

RESUMEN

People should only receive a preventive service if the potential benefits of the service outweigh the potential harms. Both benefits and risks may vary for different populations. Thus, it is clinically important to understand when and how guidelines for preventive services should be stratified according to the underlying risk of the population. For example, preventive services may be risk stratified with specific clinical recommendations based on age, sex, race/ethnicity, family history, genotype, behavior risks, or comorbidities. This paper articulates the conceptual approach and practical tools that were developed for consideration by the U.S. Preventive Services Task Force to determine if and how risk stratification should be incorporated into clinical guidelines. This approach is described in an algorithm with six sequential questions: (1) Are there clinically relevant subpopulations? (2) Are there credible subgroup analyses for these subpopulations? (3) Do subgroup analyses show clinically important differences? (4) Do these differences result in variation of net benefit, or does the evidence only exist in persons with a narrow spectrum of risk? (5) Can the subpopulations be easily identified? and (6) Does a well-validated multivariate risk tool improve identification of clinically relevant subpopulations compared with a simpler approach? This framework allows for a systematic approach to determine if and how to incorporate evidence for specific populations, a consistent application of critical thinking about this evidence, and transparent communication about the derivation of risk-stratified recommendations or evidence gaps.

Asunto(s)

Comités Consultivos/normas , Protocolos Clínicos/normas , Guías como Asunto/normas , Servicios Preventivos de Salud/normas , Algoritmos , Medicina Basada en la Evidencia/métodos , Medicina Basada en la Evidencia/normas , Humanos , Medición de Riesgo , Estados Unidos

RESUMEN

IMPORTANCE: Obesity is common in children and adolescents in the United States, is associated with negative health effects, and increases the likelihood of obesity in adulthood. OBJECTIVE: To systematically review the benefits and harms of screening and treatment for obesity and overweight in children and adolescents to inform the US Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMed, PsycINFO, Cochrane Collaboration Registry of Controlled Trials, and the Education Resources Information Center through January 22, 2016; references of relevant publications; government websites. Surveillance continued through December 5, 2016. STUDY SELECTION: English-language trials of benefits or harms of screening or treatment (behavior-based, orlistat, metformin) for overweight or obesity in children aged 2 through 18 years, conducted in or recruited from health care settings. DATA EXTRACTION AND SYNTHESIS: Two investigators independently reviewed abstracts and full-text articles, then extracted data from fair- and good-quality trials. Random-effects meta-analysis was used to estimate the benefits of lifestyle-based programs and metformin. MAIN OUTCOMES AND MEASURES: Weight or excess weight (eg, body mass index [BMI]; BMI z score, measuring the number of standard deviations from the median BMI for age and sex), cardiometabolic outcomes, quality of life, other health outcomes, harms. RESULTS: There was no direct evidence on the benefits or harms of screening children and adolescents for excess weight. Among 42 trials of lifestyle-based interventions to reduce excess weight (N = 6956), those with an estimated 26 hours or more of contact consistently demonstrated mean reductions in excess weight compared with usual care or other control groups after 6 to 12 months, with no evidence of causing harm. Generally, intervention groups showed absolute reductions in BMI z score of 0.20 or more and maintained their baseline weight within a mean of approximately 5 lb, while control groups showed small increases or no change in BMI z score, typically gaining a mean of 5 to 17 lb. Only 3 of 26 interventions with fewer contact hours showed a benefit in weight reduction. Use of metformin (8 studies, n = 616) and orlistat (3 studies, n = 779) were associated with greater BMI reductions compared with placebo: -0.86 (95% CI, -1.44 to -0.29; 6 studies; I2 = 0%) for metformin and -0.50 to -0.94 for orlistat. Groups receiving lifestyle-based interventions offering 52 or more hours of contact showed greater improvements in blood pressure than control groups: -6.4 mm Hg (95% CI, -8.6 to -4.2; 6 studies; I2 = 51%) for systolic blood pressure and -4.0 mm Hg (95% CI, -5.6 to -2.5; 6 studies; I2 = 17%) for diastolic blood pressure. There were mixed findings for insulin or glucose measures and no benefit for lipids. Medications showed small or no benefit for cardiometabolic outcomes, including fasting glucose level. Nonserious harms were common with medication use, although discontinuation due to adverse effects was usually less than 5%. CONCLUSIONS AND RELEVANCE: Lifestyle-based weight loss interventions with 26 or more hours of intervention contact are likely to help reduce excess weight in children and adolescents. The clinical significance of the small benefit of medication use is unclear.

Asunto(s)

Comités Consultivos , Tamizaje Masivo , Obesidad Infantil/diagnóstico , Obesidad Infantil/terapia , Adolescente , Fármacos Antiobesidad/efectos adversos , Fármacos Antiobesidad/uso terapéutico , Índice de Masa Corporal , Peso Corporal/efectos de los fármacos , Niño , Preescolar , Humanos , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Lactonas/efectos adversos , Lactonas/uso terapéutico , Tamizaje Masivo/efectos adversos , Metformina/efectos adversos , Metformina/uso terapéutico , Ensayos Clínicos Controlados no Aleatorios como Asunto , Orlistat , Sobrepeso/complicaciones , Sobrepeso/diagnóstico , Sobrepeso/terapia , Obesidad Infantil/complicaciones , Ensayos Clínicos Controlados Aleatorios como Asunto , Estados Unidos , Pérdida de Peso

RESUMEN

BACKGROUND: Guideline developers and other users of systematic reviews need information about whether a medical or preventive intervention is likely to benefit or harm some patients more (or less) than the average in order to make clinical practice recommendations tailored to these populations. However, guidance is lacking on how to include patient subpopulation considerations into the systematic reviews upon which guidelines are often based. In this article, we describe methods developed to consistently consider the evidence for relevant subpopulations in systematic reviews conducted to support primary care clinical preventive service recommendations made by the U.S. Preventive Services Task Force (USPSTF). PROPOSED APPROACH: Our approach is grounded in our experience conducting systematic reviews for the USPSTF and informed by a review of existing guidance on subgroup analysis and subpopulation issues. We developed and refined our approach based on feedback from the Subpopulation Workgroup of the USPSTF and pilot testing on reviews being conducted for the USPSTF. This paper provides processes and tools for incorporating evidence-based identification of important sources of potential heterogeneity of intervention effects into all phases of systematic reviews. Key components of our proposed approach include targeted literature searches and key informant interviews to identify the most important subpopulations a priori during topic scoping, a framework for assessing the credibility of subgroup analyses reported in studies, and structured investigation of sources of heterogeneity of intervention effects. CONCLUSIONS: Further testing and evaluation are necessary to refine this proposed approach and demonstrate its utility to the producers and users of systematic reviews beyond the context of the USPSTF. Gaps in the evidence on important subpopulations identified by routinely applying this process in systematic reviews will also inform future research needs.

Asunto(s)

Guías de Práctica Clínica como Asunto , Servicios Preventivos de Salud/normas , Atención Primaria de Salud , Literatura de Revisión como Asunto , Comités Consultivos , Medicina Basada en la Evidencia/normas , Humanos , Entrevistas como Asunto , Estados Unidos , United States Agency for Healthcare Research and Quality

RESUMEN

BACKGROUND: The balance between potential aspirin-related risks and benefits is critical in primary prevention. PURPOSE: To evaluate the risk for serious bleeding with regular aspirin use in cardiovascular disease (CVD) primary prevention. DATA SOURCES: PubMed, MEDLINE, Cochrane Central Register of Controlled Trials (2010 through 6 January 2015), and relevant references from other reviews. STUDY SELECTION: Randomized, controlled trials; cohort studies; and meta-analyses comparing aspirin with placebo or no treatment to prevent CVD or cancer in adults. DATA EXTRACTION: One investigator abstracted data, another checked for accuracy, and 2 assessed study quality. DATA SYNTHESIS: In CVD primary prevention studies, very-low-dose aspirin use (≤100 mg daily or every other day) increased major gastrointestinal (GI) bleeding risk by 58% (odds ratio [OR], 1.58 [95% CI, 1.29 to 1.95]) and hemorrhagic stroke risk by 27% (OR, 1.27 [CI, 0.96 to 1.68]). Projected excess bleeding events with aspirin depend on baseline assumptions. Estimated excess major bleeding events were 1.39 (CI, 0.70 to 2.28) for GI bleeding and 0.32 (CI, -0.05 to 0.82) for hemorrhagic stroke per 1000 person-years of aspirin exposure using baseline bleeding rates from a community-based observational sample. Such events could be greater among older persons, men, and those with CVD risk factors that also increase bleeding risk. LIMITATIONS: Power to detect effects on hemorrhagic stroke was limited. Harms other than serious bleeding were not examined. CONCLUSION: Consideration of the safety of primary prevention with aspirin requires an individualized assessment of aspirin's effects on bleeding risks and expected benefits because absolute bleeding risk may vary considerably by patient. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Asunto(s)

Aspirina/efectos adversos , Enfermedades Cardiovasculares/prevención & control , Fibrinolíticos/efectos adversos , Hemorragia Gastrointestinal/inducido químicamente , Prevención Primaria , Accidente Cerebrovascular/inducido químicamente , Adulto , Aspirina/administración & dosificación , Fibrinolíticos/administración & dosificación , Hemorragia/inducido químicamente , Humanos , Factores de Riesgo