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Phenotypes and body mass in women with PCOS identified in Referral vs. Unselected populations: systematic review and meta-analysis


Public Project Complete

Statistics: 43 Studies, 2 Key Questions, 1 Extraction Form,
Date Published: Aug 01, 2019 12:55PM
Description: Objective: To compare the prevalence of PCOS phenotypes and obesity of PCOS women seen in the clinical (referred) setting vs. those identified in general population.
Contributor(s): Daria Lizneva, Richard Kirubakaran, Katerina Mykhalchenko, Larisa Suturina, Chernukha Galina, Michael P. Diamond, Ricardo Azziz.
Funding Source: Funds from the Career Development Award (MD Medical Group) were used to support D.L. throughout the manuscript preparation. No other funding recourses were identified.
Methodology Description: Objective: To compare the prevalence of polycystic ovary syndrome (PCOS) phenotypes and obesity among patients detected in referral versus unselected populations. Design: Systematic review and meta-analysis. Setting: Not applicable. Patient(s): Thirteen thousand seven hundred ninety-six reproductive-age patients with PCOS, as defined by the extended 2003 Rotterdam criteria. Intervention(s): Review of PUBMED, EMBASE, and Cochrane Library, 2003–2016. Only observational studies were included. Data were extracted using a web-based, piloted form and combined for meta-analysis. Main Outcome Measure(s): PCOS phenotypes were classified as follows: phenotype A, clinical and/or biochemical hyperandrogenism (HA) + oligo-/anovulation (OA) + polycystic ovarian morphology (PCOM); phenotype B, HA+OA; phenotype C, HA+PCOM; and phenotype D, OA+PCOM. Result(s): Forty-one eligible studies, reporting on 43 populations, were identified. Pooled estimates of detected PCOS phenotype prevalence were consequently documented in referral versus unselected populations, as [1] phenotype A, 50% (95% confidence interval [CI], 46%–54%) versus 19% (95% CI, 13%–27%); [2] phenotype B, 13% (95% CI, 11%–17%) versus 25% (95% CI, 15%–37%); [3] phenotype C, 14% (95% CI, 12%–16%) versus 34% (95% CI, 25–46%); and [4] phenotype D, 17% (95% CI, 13%–22%) versus 19% (95% CI, 14%– 25%). Differences between referral and unselected populations were statistically significant for phenotypes A, B, and C. Referral PCOS subjects had a greater mean body mass index (BMI) than local controls, a difference that was not apparent in unselected PCOS. Conclusion(s): The prevalence of more complete phenotypes in PCOS and mean BMI were higher in subjects identified in referral versus unselected populations, suggesting the presence of significant referral bias.

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SRDR Project Indexing


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Statistics: 143 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Jul 31, 2019 03:26PM
Description: This is a Methods Research project that catalogs the various projects with publicly available data on the SRDR Webpage.
Contributor(s): Ian Saldanha, Bryant Smith
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: None Provided

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Screening for Elevated Blood Lead Levels in Childhood [Entered Retrospectively]


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Statistics: 25 Studies, 6 Key Questions, 1 Extraction Form,
Date Published: Jul 31, 2019 03:13PM
Description: Background: In 2006, the United States Preventive Services Task Force (USPSTF) found insufficient evidence to recommend for or against routine screening for elevated blood lead levels in asymptomatic children aged 1 to 5 who are at increased risk for lead poisoning (I recommendation), and recommended against routine screening for those at average risk (D recommendation). Purpose: To synthesize evidence on the effects of screening, testing, and treatment for elevated blood lead level in children aged five and under in the primary care setting, in order to update a prior USPSTF review on screening for elevated blood lead levels in childhood. Data Sources: Cochrane CENTRAL and Cochrane Database of Systematic Reviews (through June 2018), and Ovid MEDLINE (1946 to June 2018), reference lists, and surveillance through December 5, 2018. Study Selection: English-language trials and observational studies of screening effectiveness, test accuracy, benefits and harms of screening and interventions in asymptomatic children five and under. Data Extraction: One investigator abstracted details about study design, patient population, setting, screening method, follow up, and results. Two investigators independently applied pre specified criteria to rate study quality using methods developed by the USPSTF. Discrepancies were resolved through consensus. Data Synthesis (Results): A total of 22 studies were included in this review (N=10,449). No studies directly evaluated clinical benefits or harms of screening versus not screening children for elevated blood lead levels. More than one positive answer on the 5-item 1991 Centers for Disease Control and Prevention (CDC) screening questionnaire was associated with a pooled sensitivity of 48 percent (95% confidence interval [CI], 31.4 to 65.6%) and specificity of 58 percent (95% CI, 39.9 to 74.0%) for identifying children with a venous blood level >10µg/dL (5 studies, N = 2,265). Adapted versions of the CDC questionnaire did not demonstrate improved accuracy. Capillary blood lead testing demonstrated sensitivity of 87 percent to 91 percent and specificity >90 percent, compared with venous measurement (4 studies, N = 1,431). Counseling and nutritional interventions or residential lead hazard control techniques did not reduce blood lead concentrations in asymptomatic children, but studies were few and had methodological limitations (7 studies, N = 1,419). A trial of dimercaptosuccinic acid (DMSA) chelation therapy found reduced blood lead levels in children at one week to one year but not at 4.5 to 6 years (N = 780), while another trial found no effect at one- and six-months (N = 39). Seven-year followup assessments showed no effect on neuropsychological development; a small deficit in linear growth (height difference at 7 years in treated patients 1.17cm; 95% CI, 0.41 to 1.93); and poorer cognitive outcomes reported as the Attention and Executive Functions sub-score of the Developmental Neuropsychological Assessment (NEPSY) (unadjusted difference -1.8; 95% CI, -4.5 to 1.0, adjusted P = 0.045) in children treated with DMSA chelation. Limitations: Limited to English-language articles; quality and applicability of studies were limited due to study design, poor reporting of statistical outcomes, and loss to follow up. Studies were lacking on the effectiveness of screening or effectiveness of treatments in reducing elevated blood lead levels or improving health outcomes in children. There was no direct evidence on the harms of screening children for elevated blood lead levels. Conclusions: Evidence on the benefits and harms of screening children for elevated lead levels is lacking. Screening questionnaires are not accurate for identifying children with elevated blood lead levels. Capillary blood testing is slightly less accurate than venous blood levels for identification of elevated blood levels. Treatment studies of chelating agents, often combined with environmental or household interventions, were not associated with sustained effects on blood level levels but were associated with harms.
Contributor(s): Amy G. Cantor, MD, MPH Rob Hendrickson, MD Ian Blazina, MPH Jessica Griffin, MS Sara Grusing, BA Marian S. McDonagh, PharmD
DOI: DOI pending.
Funding Source: This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA290201500009I, Task Order No. 7)
Methodology Description: Study Selection: English-language trials and observational studies of screening effectiveness, test accuracy, benefits and harms of screening and interventions in asymptomatic children five and under. Data Extraction: One investigator abstracted details about study design, patient population, setting, screening method, follow up, and results. Two investigators independently applied pre specified criteria to rate study quality using methods developed by the USPSTF. Discrepancies were resolved through consensus.

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Screening for Elevated Blood Lead Levels in Pregnancy [Entered Retrospectively]


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Statistics: 2 Studies, 6 Key Questions, 1 Extraction Form,
Date Published: Jul 31, 2019 03:09PM
Description: Structured Abstract Background: In 2006, the United States Preventive Services Task Force (USPSTF) recommended against routine screening for elevated blood lead levels in asymptomatic pregnant women (D recommendation). Purpose: To synthesize evidence on the effects of screening, testing, and treatment for elevated blood lead level in pregnant women, in order to update a 2006 USPSTF systematic review. Data Sources: Cochrane CENTRAL and Cochrane Database of Systematic Reviews (through June 2018), and Ovid MEDLINE (1946 to June 2018), reference lists, and surveillance through December 5, 2018. Study Selection: English-language trials and observational studies of screening effectiveness, test accuracy, benefits and harms of screening and interventions in asymptomatic pregnant women. Data Extraction: One investigator abstracted details about study design, patient population, setting, screening method, follow up, and results. Two investigators independently applied prespecified criteria to rate study quality using methods developed by the USPSTF. Discrepancies were resolved through consensus. Data Synthesis: No studies directly evaluated clinical benefits and harms of screening pregnant women for elevated lead levels versus no screening, or how effectiveness of screening varies according to the gestational age at which screening is performed. One fair quality study (N = 314) evaluated the diagnostic accuracy of using a version of the CDC screening questionnaire for lead exposure in children, modified for identifying pregnant women with elevated lead levels. The study used four out of five of the questions from the CDC questionnaire and found a sensitivity of 75.7 percent and specificity of 46.2 percent. The most predictive single item was living in a home built before 1960. One fair quality RCT from Mexico found calcium supplementation in healthy pregnant women (N = 670; mean baseline lead levels ~ 4 µg/dL) associated with a reduction in serum lead levels compared with placebo (difference 11%, p=0.004). No studies reported health outcomes or harms associated with interventions to reduce blood levels in asymptomatic pregnant women. Limitations: Limited to English-language articles; quality and applicability of studies were limited due to flawed study design, poor reporting of statistical outcomes, and loss to follow up. Two studies addressed the key questions, with no evidence on effects of screening or interventions for elevated lead levels in pregnant women on health outcomes. Conclusions: Evidence on the benefits and harms of screening pregnant women for elevated blood lead levels is extremely limited, with no evidence on effects of screening or interventions for lowering elevated blood lead levels in pregnant women on health outcomes.
Contributor(s): Amy G. Cantor, MD, MPH Marian S. McDonagh, PharmD Ian Blazina, MPH Jessica Griffin, MS Sara Grusing, BA Rob Hendrickson, MD
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No HHSA290201500009I Task Order No. 7)
Methodology Description: Study Selection: English-language trials and observational studies of screening effectiveness, test accuracy, benefits and harms of screening and interventions in asymptomatic pregnant women. Data Extraction: One investigator abstracted details about study design, patient population, setting, screening method, follow up, and results. Two investigators independently applied prespecified criteria to rate study quality using methods developed by the USPSTF. Discrepancies were resolved through consensus.

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Screening for HIV Infection in Asymptomatic, Nonpregnant Adolescents and Adults [Entered Retrospectively]


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Statistics: 29 Studies, 5 Key Questions, 1 Extraction Form,
Date Published: Jul 31, 2019 02:58PM
Description: Background: A 2012 systematic review on HIV screening for the U.S. Preventive Services Task Force (USPSTF) found strong evidence that antiretroviral therapy (ART) is associated with improved clinical outcomes in persons with CD4+ T helper cell (CD4) counts less than 500 cells/mm3 and substantially decreases risk of HIV transmission, with certain antiretroviral agents potentially associated with long-term cardiovascular harms. The USPSTF previously found HIV screening tests to be highly accurate. Purpose: To systematically update the 2012 USPSTF review on screening for HIV in adolescents and adults, focusing on research gaps identified in the prior review. Data Sources: We searched the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and MEDLINE (2012 to June 2018) and manually reviewed reference lists, with surveillance through January 2019. Study Selection: Randomized, controlled trials (RCTs) and controlled observational studies on benefits and harms of screening versus no screening and on the yield of screening at different intervals; the effects of earlier versus later initiation of ART; and long-term (≥2 years) harms of ART. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): We did not identify any studies on benefits or harms of HIV screening versus no screening, or on the yield of repeat versus one-time screening or of screening at different intervals. Two new RCTs conducted completely or partially in low-resource settings found initiation of ART in persons with CD4 counts greater than 500 cells/mm3 associated with lower risk of composite clinical outcomes (mortality, AIDS-defining events, or serious non-AIDS events) (relative risk [RR], 0.44 [95% confidence interval (CI), 0.31 to 0.63] and RR, 0.57 [95% CI, 0.35 to 0.95]); early initiation of ART was not associated with increased risk of cardiovascular events. A large observational study also found initiation of ART in persons in high-resource settings with CD4 counts greater than 500 cells/mm3 to be associated with reduced risk of mortality or AIDS events, although the magnitude of effect was smaller. New evidence regarding the association between abacavir use and increased risk of cardiovascular events was inconsistent, and certain antiretroviral regimens were associated with increased risk of long-term neuropsychiatric, renal, hepatic, and bone adverse events. Limitations: Only English-language articles were included. Observational studies were included. Studies conducted in resource-poor settings were included, which might limit applicability to general screening in the United States. Conclusions: New evidence extends effectiveness of ART to asymptomatic persons with CD4 counts greater than 500 cells/mm3. Certain ART regimens may be associated with long-term cardiovascular, neuropsychiatric, hepatic, renal, or bone harms, but early initiation of ART is not associated with increased risk of cardiovascular events. Research is needed to inform optimal screening intervals.
Contributor(s): Roger Chou, MD Tracy Dana, MLS Sara Grusing, BA Christina Bougatsos, MPH
DOI: DOI pending.
Funding Source: This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-00009-I, Task Order No. 7)
Methodology Description: Study Selection: Randomized, controlled trials (RCTs) and controlled observational studies on benefits and harms of screening versus no screening and on the yield of screening at different intervals; the effects of earlier versus later initiation of ART; and long-term (≥2 years) harms of ART. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF.

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