IMPORTANCE: A 2014 review for the US Preventive Services Task Force (USPSTF) found that oral fluoride supplementation and topical fluoride use were associated with reduced caries incidence in ...children younger than 5 years. OBJECTIVE: To update the 2014 review on dental caries screening and preventive interventions to inform the USPSTF. DATA SOURCES: Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews (to September 2020); surveillance through July 23, 2021. STUDY SELECTION: Randomized clinical trials (RCTs) on screening, preventive interventions, referral to dental care; cohort studies on screening and referral; studies on diagnostic accuracy of primary care oral examination or risk assessment; and a systematic review on risk of fluorosis included in prior USPSTF reviews. DATA EXTRACTION AND SYNTHESIS: One investigator abstracted data; a second checked accuracy. Two investigators independently rated study quality. RESULTS: Thirty-two studies (19 trials, 9 observational studies, and 4 nonrandomized clinical intervention studies total 106 694 participants and 1 systematic review 19 studies) were included. No study evaluated effects of primary care screening on clinical outcomes. One study (n = 258) found primary care pediatrician examination associated with a sensitivity of 0.76 (95% CI, 0.55 to 0.91) and specificity of 0.95 (95% CI, 0.92 to 0.98) for identifying a child with cavities, and 1 study found a risk assessment tool associated with sensitivity of 0.53 and specificity of 0.77 (n = 697, CIs not reported) for a child with future caries. No new trials of dietary fluoride supplementation were identified. For prevention, topical fluoride compared with placebo or no topical fluoride was associated with decreased caries burden (13 trials, n = 5733; mean caries increment difference in decayed, missing, and filled teeth or surfaces, −0.94 95% CI, −1.74 to −0.34) and likelihood of incident caries (12 trials, n = 8177; RR, 0.80 95% CI, 0.66 to 0.95; absolute risk difference, −7%) in higher-risk populations or settings, with no increased fluorosis risk. Evidence on other preventive interventions was limited (education, xylitol) or unavailable (silver diamine fluoride), and no study directly evaluated primary care dentistry referral vs no referral. CONCLUSIONS AND RELEVANCE: There was no direct evidence on benefits and harms of primary care oral health screening or referral to dentist. Dietary fluoride supplementation and fluoride varnish were associated with improved caries outcomes in higher-risk children and settings.
Recombinant human bone morphogenetic protein-2 (rhBMP-2) is used as a bone graft substitute in spinal fusion, which unites (fuses) bones in the spine. The accuracy and completeness of journal ...publications of industry-sponsored trials on the effectiveness and harms of rhBMP-2 has been called into question.
To independently assess the effectiveness and harms of rhBMP-2 in spinal fusion and reporting bias in industry-sponsored journal publications.
Individual-patient data (IPD) from 17 industry-sponsored studies; related internal documents; and searches of MEDLINE (1996 to August 2012), other databases, and reference lists.
Randomized, controlled trials (RCTs) and cohort studies of rhBMP-2 versus any control and uncontrolled studies of harms.
Effectiveness outcomes in IPD were recalculated using consistent definitions. Study characteristics and results were abstracted by 1 investigator and confirmed by another. Two investigators independently assessed quality using predefined criteria.
Thirteen RCTs and 31 cohort studies were included. For lumbar spine fusion, rhBMP-2 and iliac crest bone graft were similar in overall success, fusion, and other effectiveness measures and in risk for any adverse event, although rates were high across interventions (77% to 93% at 24 months from surgery). For anterior lumbar interbody fusion, rhBMP-2 was associated with nonsignificantly increased risk for retrograde ejaculation and urogenital problems. For anterior cervical spine fusion, rhBMP-2 was associated with increased risk for wound complications and dysphagia. At 24 months, the cancer risk was increased with rhBMP-2 (risk ratio, 3.45 95% CI, 1.98 to 6.00), but event rates were low and cancer was heterogeneous. Early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication, and underreporting.
Outcome assessment was not blinded, and ascertainment of harms in trials was poor. No trials were truly independent of industry sponsorship.
In spinal fusion, rhBMP-2 has no proven clinical advantage over bone graft and may be associated with important harms, making it difficult to identify clear indications for rhBMP-2. Earlier disclosure of all relevant data would have better informed clinicians and the public than the initial published trial reports did.
Yale University and Medtronic.
Objective The purpose of this study was to determine the impact of increasing numbers of cesarean deliveries on maternal morbidity. This study was performed for the 2010 National Institutes of Health ...Consensus Development Conference on Vaginal Birth After Cesarean: New Insights. Study Design We conducted a systematic review and metaanalysis of observational studies. Results Twenty-one studies (2,282,922 deliveries) were included. The rate of hysterectomy, blood transfusions, adhesions, and surgical injury all increased with increasing number of cesarean deliveries. The incidence of placenta previa increased from 10/1000 deliveries with 1 previous cesarean delivery to 28/1000 with ≥3 cesarean deliveries. Compared with women with previa and no previous cesarean delivery, women with previa and ≥3 cesarean deliveries had a statistically significant increased risk of accreta (3.3-4% vs 50-67%), hysterectomy (0.7-4% vs 50-67%), and composite maternal morbidity (15% vs 83%; odds ratio, 33.6; 95% confidence interval, 14.6–77.4). Conclusion Serious maternal morbidity progressively increased as the number of previous cesarean deliveries increased.
C-reactive protein (CRP) may help to refine global risk assessment for coronary heart disease (CHD), particularly among persons who are at intermediate risk on the basis of traditional risk factors ...alone.
To assist the U.S. Preventive Services Task Force (USPSTF) in determining whether CRP should be incorporated into guidelines for CHD risk assessment.
MEDLINE search of English-language articles (1966 to November 2007), supplemented by reference lists of reviews, pertinent studies, editorials, and Web sites and by expert suggestions.
Prospective cohort, case-cohort, and nested case-control studies relevant to the independent predictive ability of CRP when used in intermediate-risk persons.
Included studies were reviewed according to predefined criteria, and the quality of each study was rated.
The validity of the body of evidence and the net benefit or harm of using CRP for CHD risk assessment were evaluated. The combined magnitude of effect was determined by meta-analysis. The body of evidence is of good quality, consistency, and applicability. For good studies that adjusted for all Framingham risk variables, the summary estimate of relative risk for incident CHD was 1.58 (95% CI, 1.37 to 1.83) for CRP levels greater than 3.0 mg/L compared with levels less than 1.0 mg/L. Analyses from 4 large cohorts were consistent in finding evidence that including CRP improves risk stratification among initially intermediate-risk persons. C-reactive protein has desirable test characteristics, and good data exist on the prevalence of elevated CRP levels in intermediate-risk persons. Limited evidence links changes in CRP level to primary prevention of CHD events.
Study methods for measuring Framingham risk variables and other covariates varied. Ethnic and racial minority populations were poorly represented in most studies, limiting generalizability. Few studies directly assessed the effect of CRP on risk reclassification in intermediate-risk persons.
Strong evidence indicates that CRP is associated with CHD events. Moderate, consistent evidence suggests that adding CRP to risk prediction models among initially intermediate-risk persons improves risk stratification. However, sufficient evidence that reducing CRP levels prevents CHD events is lacking.
Background
This study evaluates the effectiveness of patient navigation to increase screening for colorectal, breast, and cervical cancer in populations adversely affected by health care disparities.
...Methods
Eligible studies were identified through English-language searches of Ovid® MEDLINE®, PsycINFO®, SocINDEX, and Veterans Affairs Health Services database (January 1, 1996, to July 5, 2019) and manual review of reference lists. Randomized trials and observational studies of relevant populations that evaluated the effectiveness of patient navigation on screening rates for colorectal, breast, or cervical cancer compared with usual or alternative care comparison groups were included. Two investigators independently abstracted study data and assessed study quality and applicability using criteria adapted from the U.S. Preventive Services Task Force. Discrepancies were resolved by consensus with a third reviewer. Results were combined using profile likelihood random effects models.
Results
Thirty-seven studies met inclusion criteria (28 colorectal, 11 breast, 4 cervical cancers including 3 trials with multiple cancer types). Screening rates were higher with patient navigation for colorectal cancer overall (risk ratio RR 1.64; 95% confidence interval CI 1.42 to 1.92;
I
2
= 93.7%; 22 trials) and by type of test (fecal occult blood or immunohistochemistry testing RR 1.69; 95% CI 1.33 to 2.15;
I
2
= 80.5%; 6 trials; colonoscopy/endoscopy RR 2.08; 95% CI 1.08 to 4.56;
I
2
= 94.6%; 6 trials). Screening was also higher with navigation for breast cancer (RR 1.50; 95% CI 1.22 to 1.91;
I
2
= 98.6%; 10 trials) and cervical cancer (RR 1.11; 95% CI 1.05 to 1.19; based on the largest trial). The high heterogeneity of cervical cancer studies prohibited meta-analysis. Results were similar for colorectal and breast cancer regardless of prior adherence to screening guidelines, follow-up time, and study quality.
Conclusions
In populations adversely affected by disparities, colorectal, breast, and cervical cancer screening rates were higher in patients provided navigation services.
Registration: PROSPERO: CRD42018109263
The benefits and harms of intensive insulin therapy (IIT) titrated to strict glycemic targets in hospitalized patients remain uncertain.
To evaluate the benefits and harms of IIT in hospitalized ...patients.
MEDLINE and Cochrane Database of Systematic Reviews from 1950 to January 2010, reference lists, experts, and unpublished sources.
English-language randomized, controlled trials comparing protocols titrated to strict or less strict glycemic targets.
Two reviewers independently abstracted data from each study on sample, setting, glycemic control interventions, glycemic targets, mean glucose levels achieved, and outcomes. Results were grouped by patient population or setting. A random-effects model was used to combine trial data on short-term mortality (≤28 days), long-term mortality (90 or 180 days), infection, length of stay, and hypoglycemia. The Grading of Recommendations Assessment, Development, and Evaluation system was used to rate the overall body of evidence for each outcome.
In a meta-analysis of 21 trials in intensive care unit, perioperative care, myocardial infarction, and stroke or brain injury settings, IIT did not affect short-term mortality (relative risk, 1.00 95% CI, 0.94 to 1.07). No consistent evidence showed that IIT reduced long-term mortality, infection rates, length of stay, or the need for renal replacement therapy. No evidence of benefit from IIT was reported in any hospital setting, although the best evidence for lack of benefit was in intensive care unit settings. Data combined from 10 trials showed that IIT was associated with a high risk for severe hypoglycemia (relative risk, 6.00 CI, 4.06 to 8.87; P < 0.001). Risk for IIT-associated hypoglycemia was increased in all hospital settings.
Methodological shortcomings and inconsistencies limit the data in perioperative care, myocardial infarction, and stroke or brain injury settings. Differences in insulin protocols and patient and hospital characteristics may affect generalizability across treatment settings.
No consistent evidence demonstrates that IIT targeted to strict glycemic control compared with less strict glycemic control improves health outcomes in hospitalized patients. Furthermore, IIT is associated with an increased risk for severe hypoglycemia.
U.S. Department of Veterans Affairs Health Services Research and Development Service.
Lung cancer is the leading cause of cancer-related death in the United States. Because early-stage lung cancer is associated with lower mortality than late-stage disease, early detection and ...treatment may be beneficial.
To update the 2004 review of screening for lung cancer for the U.S. Preventive Services Task Force, focusing on screening with low-dose computed tomography (LDCT).
MEDLINE (2000 to 31 May 2013), the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the fourth quarter of 2012), Scopus, and reference lists.
English-language randomized, controlled trials or cohort studies that evaluated LDCT screening for lung cancer.
One reviewer extracted study data about participants, design, analysis, follow-up, and results, and a second reviewer checked extractions. Two reviewers rated study quality using established criteria.
Four trials reported results of LDCT screening among patients with smoking exposure. One large good-quality trial reported that screening was associated with significant reductions in lung cancer (20%) and all-cause (6.7%) mortality. Three small European trials showed no benefit of screening. Harms included radiation exposure, overdiagnosis, and a high rate of false-positive findings that typically were resolved with further imaging. Smoking cessation was not affected. Incidental findings were common.
Three trials were underpowered and of insufficient duration to evaluate screening effectiveness. Overdiagnosis, an important harm of screening, is of uncertain magnitude. No studies reported results in women or minority populations.
Strong evidence shows that LDCT screening can reduce lung cancer and all-cause mortality. The harms associated with screening must be balanced with the benefits.
Agency for Healthcare Research and Quality.
Summary Background Some clinicians do lumbar imaging routinely or in the absence of historical or clinical features suggestive of serious low-back problems. We investigated the effects of routine, ...immediate lumbar imaging versus usual clinical care without immediate imaging on clinical outcomes in patients with low-back pain and no indication of serious underlying conditions. Methods We analysed randomised controlled trials that compared immediate lumbar imaging (radiography, MRI, or CT) versus usual clinical care without immediate imaging for low-back pain. These trials reported pain or function (primary outcomes), quality of life, mental health, overall patient-reported improvement (based on various scales), and patient satisfaction in care received. Six trials (n=1804) met inclusion criteria. Study quality was assessed by two independent reviewers with criteria adapted from the Cochrane Back Review Group. Meta-analyses were done with a random effects model. Findings We did not record significant differences between immediate lumbar imaging and usual care without immediate imaging for primary outcomes at either short-term (up to 3 months, standardised mean difference 0·19, 95% CI −0·01 to 0·39 for pain and 0·11, −0·29 to 0·50 for function, negative values favour routine imaging) or long-term (6–12 months, −0·04, −0·15 to 0·07 for pain and 0·01, −0·17 to 0·19 for function) follow-up. Other outcomes did not differ significantly. Trial quality, use of different imaging methods, and duration of low-back pain did not affect the results, but analyses were limited by small numbers of trials. Results are most applicable to acute or subacute low-back pain assessed in primary-care settings. Interpretation Lumbar imaging for low-back pain without indications of serious underlying conditions does not improve clinical outcomes. Therefore, clinicians should refrain from routine, immediate lumbar imaging in patients with acute or subacute low-back pain and without features suggesting a serious underlying condition. Funding American Pain Society.
Abstract Objective This article is to establish recommendations for conducting quantitative synthesis, or meta-analysis, using study-level data in comparative effectiveness reviews (CERs) for the ...Evidence-based Practice Center (EPC) program of the Agency for Healthcare Research and Quality. Study Design and Setting We focused on recurrent issues in the EPC program and the recommendations were developed using group discussion and consensus based on current knowledge in the literature. Results We first discussed considerations for deciding whether to combine studies, followed by discussions on indirect comparison and incorporation of indirect evidence. Then, we described our recommendations on choosing effect measures and statistical models, giving special attention to combining studies with rare events; and on testing and exploring heterogeneity. Finally, we briefly presented recommendations on combining studies of mixed design and on sensitivity analysis. Conclusion Quantitative synthesis should be conducted in a transparent and consistent way. Inclusion of multiple alternative interventions in CERs increases the complexity of quantitative synthesis, whereas the basic issues in quantitative synthesis remain crucial considerations in quantitative synthesis for a CER. We will cover more issues in future versions and update and improve recommendations with the accumulation of new research to advance the goal for transparency and consistency.
Coronary heart disease is the leading cause of death in adults. Screening for abnormalities by using resting or exercise electrocardiography (ECG) might help identify persons who would benefit from ...interventions to reduce cardiovascular risk.
To update the 2004 U.S. Preventive Services Task Force evidence review on screening for resting or exercise ECG abnormalities in asymptomatic adults.
MEDLINE (2002 through January 2011), the Cochrane Library database (through the fourth quarter of 2010), and reference lists.
Randomized, controlled trials and prospective cohort studies.
Investigators abstracted details about the study population, study design, data analysis, follow-up, and results and assessed quality by using predefined criteria.
No study evaluated clinical outcomes or use of risk-reducing therapies after screening versus no screening. No study estimated how accurately resting or exercise electrocardiography classified participants into high-, intermediate-, or low-risk groups, compared with traditional risk factor assessment alone. Sixty-three prospective cohort studies evaluated abnormalities on resting or exercise ECG as predictors of cardiovascular events after adjustment for traditional risk factors. Abnormalities on resting ECG (ST-segment or T-wave abnormalities, left ventricular hypertrophy, bundle branch block, or left-axis deviation) or exercise ECG (ST-segment depression with exercise, chronotropic incompetence, abnormal heart rate recovery, or decreased exercise capacity) were associated with increased risk (pooled hazard ratio estimates, 1.4 to 2.1). Evidence on harms was limited, but direct harms seemed minimal (for resting ECG) or small (for exercise ECG). No study estimated harms from subsequent testing or interventions, although rates of angiography after exercise ECG ranged from 0.6% to 2.9%.
Only English-language studies were included. Statistical heterogeneity was present in several of the pooled analyses.
Abnormalities on resting or exercise ECG are associated with an increased risk for subsequent cardiovascular events after adjustment for traditional risk factors, but the clinical implications of these findings are unclear.
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