[show abstract][hide abstract] ABSTRACT: Since evidence syntheses depend on the published literature accurately representing what’s known about medical therapies, reporting biases threaten the veracity of what we know. This document provides guidance on steps that authors of systematic reviews can take to reduce the error in the assessment of the effect of an intervention that arises from biases in the way that studies are published and reported.
[show abstract][hide abstract] ABSTRACT: To systematically review the evidence on the association between knowledge of HIV-positive status or use of antiretroviral therapy (ART) and high-risk transmission behaviors, we searched Ovid MEDLINE from 2004 to February 2012 and the Cochrane Library Database through the first quarter of 2012. Four observational studies meeting inclusion criteria addressed HIV-positive status and seven addressed the use of ART and effects on behavior. Studies including both average and high-risk populations were conducted in developed countries and were rated at least fair quality. Overall, knowledge of HIV-positive status was associated with less engagement in high-risk transmission behaviors, and the use of ART was not found to increase participation in high-risk transmission behaviors by HIV-positive individuals.
[show abstract][hide abstract] ABSTRACT: BACKGROUND AND OBJECTIVE:Screening and preventive interventions by primary care providers could improve outcomes related to early childhood caries. The objective of this study was to update the 2004 US Preventive Services Task Force systematic review on prevention of caries in children younger than 5 years of age.METHODS:Searching Medline and the Cochrane Library (through March 2013) and reference lists, we included trials and controlled observational studies on the effectiveness and harms of screening and treatments. One author extracted study characteristics and results, which were checked for accuracy by a second author. Two authors independently assessed study quality.RESULTS:No study evaluated effects of screening by primary care providers on clinical outcomes. One good-quality cohort study found pediatrician examination associated with a sensitivity of 0.76 for identifying a child with cavities. No new trials evaluated oral fluoride supplementation. Three new randomized trials were consistent with previous studies in finding fluoride varnish more effective than no varnish (reduction in caries increment 18% to 59%). Three trials of xylitol were inconclusive regarding effects on caries. New observational studies were consistent with previous evidence showing an association between early childhood fluoride use and enamel fluorosis. Evidence on the accuracy of risk prediction instruments in primary care settings is not available.CONCLUSIONS:There is no direct evidence that screening by primary care clinicians reduces early childhood caries. Evidence previously reviewed by the US Preventive Services Task Force found oral fluoride supplementation effective at reducing caries incidence, and new evidence supports the effectiveness of fluoride varnish in higher-risk children.
[show abstract][hide abstract] ABSTRACT: Pressure ulcers are associated with substantial health burdens but may be preventable.
To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk.
MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists.
Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes.
Multiple investigators abstracted and checked study details and quality using predefined criteria.
One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses' clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low-air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions.
Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings.
More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.
Agency for Healthcare Research and Quality.
Annals of internal medicine 07/2013; 159(1):28-38. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: 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.
Annals of internal medicine 06/2013; 158(12):890-902. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: Many blood tests have been proposed as alternatives to liver biopsy for identifying fibrosis or cirrhosis.
To evaluate the diagnostic accuracy of blood tests to identify fibrosis or cirrhosis in patients with hepatitis C virus (HCV) infection.
MEDLINE (1947 to January 2013), the Cochrane Library, and reference lists.
Studies that compared the diagnostic accuracy of blood tests with that of liver biopsy.
Investigators abstracted and checked study details and quality by using predefined criteria.
172 studies evaluated diagnostic accuracy. For identifying clinically significant fibrosis, the platelet count, age-platelet index, aspartate aminotransferase-platelet ratio index (APRI), FibroIndex, FibroTest, and Forns index had median positive likelihood ratios of 5 to 10 at commonly used cutoffs and areas under the receiver-operating characteristic curve (AUROCs) of 0.70 or greater (range, 0.71 to 0.86). For identifying cirrhosis, the platelet count, age-platelet index, APRI, and Hepascore had median positive likelihood ratios of 5 to 10 and AUROCs of 0.80 or greater (range, 0.80 to 0.91). The Göteborg University Cirrhosis Index and the Lok index had slightly lower positive likelihood ratios (4.8 and 4.4, respectively). In direct comparisons, the APRI was associated with a slightly lower AUROC than the FibroTest for identifying fibrosis and a substantially higher AUROC than the aspartate aminotransferase-alanine aminotransferase ratio for identifying fibrosis or cirrhosis.
Only English-language articles were included, and most studies had methodological limitations, including failure to describe blinded interpretation of liver biopsy specimens and inadequate description of enrollment methods.
Many blood tests are moderately useful for identifying clinically significant fibrosis or cirrhosis in HCV-infected patients.
Agency for Healthcare Research and Quality.
Annals of internal medicine 06/2013; 158(11):807-20. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: When and how to initiate opioids is challenging--to say the least--given their potential for abuse and worrisome adverse effects. Here's how to integrate opioids into an overall approach to your patient's chronic low back pain.
The Journal of family practice 03/2013; 62(3):S8-S13. · 0.67 Impact Factor
[show abstract][hide abstract] ABSTRACT: COMMENTARY ON: Willems PC, Staal JB, Walenkamp GHIM, de Bie RA. Spinal fusion for chronic low back pain: systematic review on the accuracy of tests for patient selection. Spine J 2013;13:99-109 (in this issue).
The spine journal: official journal of the North American Spine Society 02/2013; 13(2):110-2. · 2.90 Impact Factor
[show abstract][hide abstract] ABSTRACT: Mother-to-infant transmission is the leading cause of childhood hepatitis C virus (HCV) infection, with up to 4000 new cases each year in the United States.
To evaluate effects of mode of delivery, labor management strategies, and breastfeeding practices on risk for mother-to-infant transmission of HCV.
MEDLINE (1947 to May 2012), the Cochrane Library Database, clinical trial registries, and reference lists.
Randomized trials and observational studies on mode of delivery, labor management strategies, and breastfeeding practices and risk for mother-to-infant transmission of HCV.
Investigators abstracted and reviewed study details and quality using predefined criteria.
Eighteen observational studies evaluated the association between mode of delivery, labor management strategies, or breastfeeding practices and risk for mother-to-infant HCV transmission. Fourteen studies (2 good-quality, 4 fair-quality, and 8 poor-quality studies) found no clear association between mode of delivery (vaginal versus cesarean delivery) and risk for transmission. Two studies (1 good-quality and 1 poor-quality study) reported an association between prolonged duration of ruptured membranes and increased risk for transmission. Fourteen studies (2 good-quality, 2 fair-quality, and 10 poor-quality studies) found no association between breastfeeding and risk for transmission.
Only English-language articles were included. Studies were observational, and most had important methodological shortcomings, including failure to adjust for potential confounders and small sample sizes.
No intervention has been clearly demonstrated to reduce the risk for mother-to-infant HCV transmission. Avoidance of breastfeeding does not seem to be indicated for reducing transmission risk.
Agency for Healthcare Research and Quality.
Annals of internal medicine 01/2013; 158(2):109-13. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: Multiple treatments are available for chronic hepatitis C virus (HCV) infection.
To compare benefits and harms of antiviral regimens for chronic HCV infection in treatment-naive adults.
English-language literature from MEDLINE (1947 to August 2012), the Cochrane Library Database, Embase, Scopus, PsychINFO, and clinical trial registries.
Randomized trials of antiviral treatments and cohort studies examining associations between sustained virologic response (SVR) after therapy and clinical outcomes.
Several investigators abstracted study details and quality by using predefined criteria.
No trial evaluated effectiveness of treatment on long-term clinical outcomes. Dual therapy with pegylated interferon alfa-2b plus ribavirin was associated with a lower likelihood of SVR than was pegylated interferon alfa-2a plus ribavirin (absolute difference, 8 percentage points [95% CI, 3 to 14 percentage points]) on the basis of 7 poor- to fair-quality trials. For genotype 2 or 3 infection, dual therapy for 12 to 16 weeks was associated with a lower likelihood of SVR than was therapy for 24 weeks, and lower doses of pegylated interferon alfa-2b were less effective than standard doses (2 to 4 fair-quality trials). For genotype 1 infection, fair-quality trials found that triple therapy with pegylated interferon, ribavirin, and either boceprevir (2 trials) or telaprevir (4 trials) was associated with a higher likelihood of SVR than was dual therapy (absolute difference, 22 to 31 percentage points). Compared with dual therapy, boceprevir triple therapy increased risk for hematologic adverse events and telaprevir triple therapy increased risk for anemia and rash. A large well-designed cohort study and 18 smaller cohort studies found that an SVR after antiviral therapy was associated with lower risk for all-cause mortality than was no SVR.
Trials involved highly selected populations. Observational studies did not always adequately control for confounders.
SVR rates for genotype 1 infection are higher with triple therapy that includes a protease inhibitor than with standard dual therapy. An SVR after antiviral therapy appears associated with improved clinical outcomes.
Agency for Healthcare Research and Quality.
Annals of internal medicine 01/2013; 158(2):114-23. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: Also available: Consumer Reports Patient Resource on High-Value Care for GERD BACKGROUND: Upper endoscopy is commonly used in the diagnosis and management of gastroesophageal reflux disease (GERD). Evidence demonstrates that it is indicated only in certain situations, and inappropriate use generates unnecessary costs and exposes patients to harms without improving outcomes. METHODS: The Clinical Guidelines Committee of the American College of Physicians reviewed evidence regarding the indications for, and yield of, upper endoscopy in the setting of GERD, and to highlight how clinicians can increase the delivery of high-value health care. BEST PRACTICE ADVICE 1: Upper endoscopy is indicated in men and women with heartburn and alarm symptoms (dysphagia, bleeding, anemia, weight loss, and recurrent vomiting). BEST PRACTICE ADVICE 2: Upper endoscopy is indicated in men and women with: Typical GERD symptoms that persist despite a therapeutic trial of 4 to 8 weeks of twice-daily proton-pump inhibitor therapy. Severe erosive esophagitis after a 2-month course of proton-pump inhibitor therapy to assess healing and rule out Barrett esophagus. Recurrent endoscopy after this follow-up examination is not indicated in the absence of Barrett esophagus. History of esophageal stricture who have recurrent symptoms of dysphagia. BEST PRACTICE ADVICE 3: Upper endoscopy may be indicated: In men older than 50 years with chronic GERD symptoms (symptoms for more than 5 years) and additional risk factors (nocturnal reflux symptoms, hiatal hernia, elevated body mass index, tobacco use, and intra-abdominal distribution of fat) to detect esophageal adenocarcinoma and Barrett esophagus. For surveillance evaluation in men and women with a history of Barrett esophagus. In men and women with Barrett esophagus and no dysplasia, surveillance examinations should occur at intervals no more frequently than 3 to 5 years. More frequent intervals are indicated in patients with Barrett esophagus and dysplasia.
Annals of internal medicine 12/2012; 157(11):808-816. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: Identification of hepatitis C virus (HCV)-infected persons through screening could lead to interventions that improve clinical outcomes. PURPOSE: To review evidence about potential benefits and harms of HCV screening in asymptomatic adults without known liver enzyme abnormalities. DATA SOURCES: English-language publications identified from MEDLINE (1947 to May 2012), the Cochrane Library Database, clinical trial registries, and reference lists. STUDY SELECTION: Randomized trials and cohort, case-control, and cross-sectional studies that assessed yield or clinical outcomes of screening; studies reporting harms from HCV screening; and large series reporting harms of diagnostic liver biopsies. DATA EXTRACTION: Multiple investigators abstracted and checked study details and quality by using predefined criteria. DATA SYNTHESIS: No study evaluated clinical outcomes associated with screening compared with no screening or of different risk- or prevalence-based strategies. Three cross-sectional studies in higher prevalence populations found screening strategies that targeted multiple risk factors were associated with sensitivities greater than 90% and numbers needed to screen to identify 1 case of HCV infection of less than 20. Data on direct harms of screening were sparse. A large study of percutaneous liver biopsies (n = 2740) in HCV-infected patients with compensated cirrhosis reported no deaths and a 1.1% rate of serious adverse events (primarily bleeding and severe pain). LIMITATIONS: Modeling studies were not examined. High or unreported proportions of potentially eligible patients in the observational studies were not included in calculations of screening yield because of unknown HCV status. CONCLUSIONS: Although screening tests can accurately identify adults with chronic HCV infection, targeted screening strategies based on the presence of risk factors misses some patients with HCV infection. Well-designed prospective studies are needed to better understand the effects of different HCV screening strategies on diagnostic yield and clinical outcomes. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
Annals of internal medicine 11/2012; · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: A 2005 U.S. Preventive Services Task Force (USPSTF) review found good evidence that HIV screening is accurate and that antiretroviral therapy (ART) for immunologically advanced disease is associated with substantial clinical benefits, but insufficient evidence to determine the effects on transmission or in less immunologically advanced disease.
To update the 2005 USPSTF review on benefits and harms of HIV screening in adolescents and adults, focusing on research gaps identified in the prior review.
MEDLINE (2004 to June 2012) and the Cochrane Library (through the second quarter of 2012).
Randomized trials and observational studies that compared HIV screening strategies and reported clinical outcomes, evaluated the effects of starting ART at different CD4 cell count thresholds and long-term harms, or reported the effects of interventions on transmission risk.
2 authors abstracted and checked study details and quality using predefined criteria.
No study directly evaluated the effects on clinical outcomes of screening versus no screening for HIV infection. A randomized trial and a subgroup analysis from a randomized trial found that ART initiation at CD4 counts less than 0.250 × 109 cells/L was associated with a higher risk for death or AIDS-defining events than initiation at CD4 counts greater than 0.350 × 109 cells/L (hazard ratios, 1.7 [95% CI, 1.1 to 2.5] and 5.3 [CI, 1.3 to 9.6]). Large, fair-quality cohort studies also consistently found that ART initiation at CD4 counts of 0.350 to 0.500 × 109 cells/L was associated with lower risk for death or AIDS-defining events than delayed initiation. New evidence from good-quality cohorts with longer-term follow-up confirms a previously observed small increased risk for cardiovascular events associated with certain antiretrovirals. Strong evidence from 1 good-quality randomized trial and 7 observational studies found that ART was associated with a 10- to 20-fold reduction in risk for sexual transmission of HIV.
Only English-language articles were included. Observational studies were included. Studies done in resource-poor or high-prevalence settings were included but might have limited applicability to general screening in the United States.
Previous studies have shown that HIV screening is accurate, targeted screening misses a substantial proportion of cases, and treatments are effective in patients with advanced immunodeficiency. New evidence indicates that ART reduces risk for AIDS-defining events and death in persons with less advanced immunodeficiency and reduces sexual transmission of HIV.
Agency for Healthcare Research and Quality.
Annals of internal medicine 11/2012; 157(10):706-18. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: A 2005 U.S. Preventive Services Task Force (USPSTF) review found good evidence that prenatal HIV screening is accurate and can lead to interventions that reduce the risk for mother-to-child transmission.
To update the 2005 USPSTF review, focusing on previously identified research gaps and new evidence on treatments.
MEDLINE (2004 to June 2012) and the Cochrane Library (2005 to the second quarter of 2012).
Randomized trials and cohort studies of pregnant women on risk for mother-to-child transmission or harms associated with prenatal HIV screening or antiretroviral therapy during pregnancy.
2 reviewers abstracted and confirmed study details and quality by using predefined criteria.
No studies directly evaluated effects of prenatal HIV screening on risk for mother-to-child transmission or maternal or infant clinical outcomes. One fair-quality, large cohort study (HIV prevalence, 0.7%) found that rapid testing during labor was associated with a positive predictive value of 90%. New cohort studies of nonbreastfeeding women in the United States and Europe confirm that full-course combination antiretroviral therapy reduces rates of mother-to-child transmission (<1% to 2.4% vs. 9% to 22% with no antiretroviral therapy). New cohort studies found antiretroviral therapy during pregnancy to be associated with increased risk for preterm delivery (<37 weeks' gestation); there were no clear associations with low birthweight, congenital abnormalities, or infant neurodevelopment. Evidence on long-term maternal harms after short-term antiretroviral therapy exposure during pregnancy remains sparse.
Only English-language articles were included. Studies conducted in resource-poor settings may be of limited applicability to screening in the United States.
Antiretroviral therapy in combination with avoidance of breastfeeding and elective cesarean section in women with viremia reduces risk for mother-to-child transmission. Use of certain antiretroviral therapy regimens during pregnancy may increase risk for preterm delivery.
Agency for Healthcare Research and Quality.
Annals of internal medicine 11/2012; 157(10):719-28. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: Background. Long-term opioid use has increased substantially over the past decade for U.S. women. Women are more likely than men to have a chronic pain condition, to be treated with opioids, and may receive higher doses. Prescribing trends persist despite limited evidence to support the long-term benefit of this pain treatment approach. Purpose. To review the medical and psychological risks and consequences of long-term opioid therapy in women. Method. Scientific literature containing relevant keywords and content were reviewed. Results and Conclusions. Long-term opioid use exposes women to unique risks, including endocrinopathy, reduced fertility, neonatal risks, as well as greater risk for polypharmacy, cardiac risks, poisoning and unintentional overdose, among other risks. Risks for women appear to vary by age and psychosocial factors may be bidirectionally related to opioid use. Gaps in understanding and priorities for future research are highlighted.
Pain Medicine 08/2012; 13(9):1181-211. · 2.46 Impact Factor
[show abstract][hide abstract] ABSTRACT: Use of lumbar spine imaging, particularly advanced imaging, continues to grow rapidly in the United States. Many lumbar spine imaging tests are obtained in patients who have no clinical symptoms or risk factors suggesting a serious underlying condition, yet evidence shows that this routine imaging is not associated with benefits, exposes patients to unnecessary harms, and increases costs. This article reviews current trends and practice patterns in lumbar spine imaging, direct and downstream costs, benefits and harms, current recommendations, and potential strategies for reducing imaging overuse.
Radiologic Clinics of North America 07/2012; 50(4):569-85. · 1.95 Impact Factor