IMPORTANCE: Ruptured abdominal aortic aneurysms (AAAs) have mortality estimated at 81%. OBJECTIVE: To systematically review the evidence on benefits and harms of AAA screening and small aneurysm ...treatment to inform the US Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMed (publisher supplied only), Database of Abstracts of Reviews of Effects, and Cochrane Central Register of Controlled Trials for relevant English-language studies published through September 2018. Surveillance continued through July 2019. STUDY SELECTION: Trials of AAA screening benefits and harms; trials and cohort studies of small (3.0-5.4 cm) AAA treatment benefits and harms. DATA EXTRACTION AND SYNTHESIS: Two investigators independently reviewed abstracts and full-text articles and extracted data. The Peto method was used to pool odds ratios (ORs) for AAA-related mortality, rupture, and operations; the DerSimonian and Laird random-effects model was used to pool calculated risk ratios for all-cause mortality. MAIN OUTCOMES AND MEASURES: AAA and all-cause mortality; AAA rupture; treatment complications. RESULTS: Fifty studies (N = 323 279) met inclusion criteria. Meta-analysis of population-based randomized clinical trials (RCTs) estimated that a screening invitation to men 65 years or older was associated with a reduction in AAA-related mortality over 12 to 15 years (OR, 0.65 95% CI, 0.57-0.74; 4 RCTs n = 124 926), AAA-related ruptures over 12 to 15 years (OR, 0.62 95% CI, 0.55-0.70; 4 RCTs n = 124 929), and emergency surgical procedures over 4 to 15 years (OR, 0.57 95% CI, 0.48-0.68; 5 RCTS n = 175 085). In contrast, no significant association with all-cause mortality benefit was seen at 12- to 15-year follow-up (relative risk, 0.99 95% CI 0.98-1.00; 4 RCTs n = 124 929). One-time screening was associated with significantly more procedures over 4 to 15 years in the invited group compared with the control group (OR, 1.44 95% CI, 1.34-1.55; 5 RCTs n = 175 085). Four trials (n = 3314) of small aneurysm surgical treatment demonstrated no significant difference in AAA-related mortality or all-cause mortality compared with surveillance over 1.7 to 12 years. These 4 early surgery trials showed a substantial increase in procedures in the early surgery group. For small aneurysm treatment, registry data (3 studies n = 14 424) showed that women had higher surgical complications and postoperative mortality compared with men. CONCLUSIONS AND RELEVANCE: One-time AAA screening in men 65 years or older was associated with decreased AAA-related mortality and rupture rates but was not associated with all-cause mortality benefit. Higher rates of elective surgery but no long-term differences in quality of life resulted from screening.
IMPORTANCE: Falls are the most common cause of injury-related morbidity and mortality among older adults. OBJECTIVE: To systematically review literature on the effectiveness and harms of fall ...prevention interventions in community-dwelling older adults to inform the US Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMed, Cumulative Index for Nursing and Allied Health Literature, and Cochrane Central Register of Controlled Trials for relevant English-language literature published through August 2016, with ongoing surveillance through February 7, 2018. STUDY SELECTION: Randomized clinical trials of interventions to prevent falls in community-dwelling adults 65 years and older. DATA EXTRACTION AND SYNTHESIS: Independent critical appraisal and data abstraction by 2 reviewers. Random-effects meta-analyses using the method of DerSimonian and Laird. MAIN OUTCOMES AND MEASURES: Number of falls (number of unexpected events in which a person comes to rest on the ground, floor, or lower level), people experiencing 1 or more falls, injurious falls, people experiencing injurious falls, fractures, people experiencing fractures, mortality, hospitalizations, institutionalizations, changes in disability, and treatment harms. RESULTS: Sixty-two randomized clinical trials (N = 35 058) examining 7 fall prevention intervention types were identified. This article focused on the 3 most commonly studied intervention types: multifactorial (customized interventions based on initial comprehensive individualized falls risk assessment) (26 trials n = 15 506), exercise (21 trials n = 7297), and vitamin D supplementation (7 trials n = 7531). Multifactorial intervention trials were associated with a reduction in falls (incidence rate ratio IRR, 0.79 95% CI, 0.68-0.91) but were not associated with a reduction in other fall-related morbidity and mortality outcomes. Exercise trials were associated with statistically significant reductions in people experiencing a fall (relative risk, 0.89 95% 13 CI, 0.81-0.97) and injurious falls (IRR, 0.81 95% CI, 0.73-0.90) and with a statistically nonsignificant reduction in falls (IRR, 0.87 95% CI, 0.75-1.00) but showed no association with mortality. Few exercise trials reported fall-related fractures. Seven heterogeneous trials of vitamin D formulations (with or without calcium) showed mixed results. One trial of annual high-dose cholecalciferol (500 000 IU), which has not been replicated, showed an increase in falls, people experiencing a fall, and injuries, while 1 trial of calcitriol showed a reduction in falls and people experiencing a fall; the remaining 5 trials showed no significant difference in falls, people experiencing a fall, or injuries. Harms of multifactorial and exercise trials were rarely reported but generally included minor musculoskeletal injuries. CONCLUSIONS AND RELEVANCE: Multifactorial and exercise interventions were associated with fall-related benefit, but evidence was most consistent across multiple fall-related outcomes for exercise. Vitamin D supplementation interventions had mixed results, with a high dose being associated with higher rates of fall-related outcomes.
Long-term follow-up of population-based randomized, controlled trials (RCTs) has demonstrated that screening for abdominal aortic aneurysms (AAAs) measuring 3 cm or greater decreases AAA-related ...mortality rates in men aged 65 years or older.
To systematically review evidence about the benefits and harms of ultrasonography screening for AAAs in asymptomatic primary care patients.
MEDLINE, the Database of Abstracts of Reviews of Effects, the Cochrane Central Register of Controlled Trials (January 2004 through January 2013), clinical trial registries, reference lists, experts, and a targeted bridge search for population-based screening RCTs through September 2013.
English-language, population-based, fair- to good-quality RCTs and large cohort studies for AAA screening benefits as well as RCTs and cohort and registry studies for harms in adults with AAA.
Dual quality assessment and abstraction of study details and results.
Reviews of 4 RCTs involving 137,214 participants demonstrated that 1-time invitation for AAA screening in men aged 65 years or older reduced AAA rupture and AAA-related mortality rates for up to 10 and 15 years, respectively, but had no statistically significant effect on all-cause mortality rates up to 15 years. Screening was associated with more overall and elective surgeries but fewer emergency operations and lower 30-day operative mortality rates at up to 10- to 15-year follow-up. One RCT involving 9342 women showed that screening had no benefit on AAA-related or all-cause mortality rates.
Trials included mostly white men outside of the United States. Information for subgroups and about rescreening was limited.
One-time invitation for AAA screening in men aged 65 years or older was associated with decreased AAA rupture and AAA-related mortality rates but had little or no effect on all-cause mortality rates.
Agency for Healthcare Research and Quality.
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.
Cardiovascular disease (CVD) is the leading cause of death in the United States.
To update a systematic review about the benefits of aspirin for the primary prevention of cardiovascular events in ...adults aged 40 years or older and to evaluate effect modification in subpopulations.
MEDLINE, PubMed, Cochrane Central Register of Controlled Trials (January 2008 to January 2015), and Cochrane Database of Systematic Reviews.
Two investigators independently reviewed 3396 abstracts and 65 articles according to prespecified criteria. All included trials evaluated aspirin for the primary prevention of cardiovascular events.
Two investigators assessed study quality; data were abstracted by 1 reviewer and checked by a second.
Two good-quality and 9 fair-quality randomized, controlled trials were identified. In analyses of all doses, aspirin reduced the risk for nonfatal myocardial infarction (MI) (relative risk RR, 0.78 95% CI, 0.71 to 0.87) but not nonfatal stroke; aspirin showed little or no benefit for all-cause or cardiovascular mortality. Benefits began within the first 5 years. Older adults achieved greater relative MI reduction, but no other effect modifications were found in analyzed subpopulations. In trials with aspirin doses of 100 mg or less per day, the reduction in nonfatal MI benefit persisted (absolute risk reduction, 0.15 to 1.43 events per 1000 person-years) and a 14% reduction in nonfatal stroke benefit was noted, but no benefit was found for all-cause mortality (RR, 0.95 CI, 0.89 to 1.01) or cardiovascular mortality (RR, 0.97 CI, 0.85 to 1.10).
Evidence for aspirin in primary prevention is heterogeneous and limited by rare events and few credible subgroup analyses.
The beneficial effect of aspirin for the primary prevention of CVD is modest and occurs at doses of 100 mg or less per day. Older adults seem to achieve a greater relative MI benefit.
Agency for Healthcare Research and Quality.
The balance between potential aspirin-related risks and benefits is critical in primary prevention.
To evaluate the risk for serious bleeding with regular aspirin use in cardiovascular disease (CVD) ...primary prevention.
PubMed, MEDLINE, Cochrane Central Register of Controlled Trials (2010 through 6 January 2015), and relevant references from other reviews.
Randomized, controlled trials; cohort studies; and meta-analyses comparing aspirin with placebo or no treatment to prevent CVD or cancer in adults.
One investigator abstracted data, another checked for accuracy, and 2 assessed study quality.
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.
Power to detect effects on hemorrhagic stroke was limited. Harms other than serious bleeding were not examined.
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.
Agency for Healthcare Research and Quality.
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.
IMPORTANCE: Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States. OBJECTIVE: To systematically review literature on the accuracy of screening ...questionnaires and office-based screening pulmonary function testing and the efficacy and harms of treatment of screen-detected COPD. DATA SOURCES: MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials for relevant English-language studies published through January 2015. STUDY SELECTION: Two reviewers independently screened abstracts and studies. The search yielded 13 141 unique citations; 465 full-text articles were reviewed, and 33 studies met the inclusion criteria. DATA EXTRACTION AND SYNTHESIS: Two reviewers rated the quality of each study using USPSTF criteria. MAIN OUTCOMES AND MEASURES: Diagnostic accuracy (sensitivity, specificity, positive predictive value PPV, and negative predictive value NPV; treatment efficacy (COPD exacerbations, all-cause mortality, quality of life, and dyspnea); and treatment harms. RESULTS: All screening questionnaires were based on symptoms as well as risk factors such as age and smoking history. The COPD Diagnostic Questionnaire was the most extensively studied (5 studies, n = 3048), with moderate overall performance for COPD detection: area under the receiver operating characteristic curve (AUC), 0.65 to 0.72; sensitivity, 80% to 93%; and specificity, 24% to 49%, at a threshold of greater than 16.5. Positive predictive value and NPV ranged from 17% to 45% and 76% to 98%, respectively. For pulmonary function–based screening tools, FEV1/FEV6 was the best studied (3 studies, n = 1587), with AUC ranging from 0.84 to 0.85. Sensitivity ranged from 51% to 80%. Specificity (range, 90%-95%) and PPV (range, 63%-75%) appeared better than questionnaires. There was not strong evidence to support that screening and supplying smokers with spirometry results improves smoking cessation rates. Treatment trials were unavailable for screen-detected patients. Trials that reported outcomes in patients with mild to moderate COPD included 2 trials of long-acting β-agonists (LABAs) (n = 3174), 1 RCT of LABAs and inhaled corticosteroids (ICS) (n = 1097), 5 RCTs of the long-acting muscarinic antagonist tiotropium (n = 4592), and 6 RCTs of ICS (n = 3983). They suggested no benefit in all-cause mortality, but a decrease in annual rates of exacerbations with pharmacologic treatments. Few trials reported harms for any individual drug class. Adverse effects were generally mild (eg, dry mouth and cough). CONCLUSIONS AND RELEVANCE: There was no direct evidence available to determine the benefits and harms of screening asymptomatic adults for COPD using questionnaires or office-based screening pulmonary function testing or to determine the benefits of treatment in screen-detected populations. Indirect evidence suggests that the COPD Diagnostic Questionnaire has moderate overall performance for COPD detection. Among patients with mild to moderate COPD, the benefit of pharmacotherapy for reducing exacerbations was modest.
This systematic review to support the 2019 US Preventive Services Task Force Reaffirmation Recommendation Statement on ocular prophylaxis for gonococcal ophthalmia neonatorum summarizes published ...evidence on the benefits and harms of ocular topical medication to prevent gonococcal conjunctival infection in newborns.
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.
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