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Screening Bias

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101. Screening for small for gestational age using third-trimester ultrasound markers: protocol for a systematic review and meta-analysis of screening test accuracy. (PubMed)

population using third-trimester ultrasound markers and reporting low birth weight for gestational age (small for gestational age at birth) as a reference will be eligible. Two reviewers will independently screen references for inclusion, assess the risk of bias, and extract data. The Quality Assessment of Diagnostic Accuracy Study 2 (QUADAS-2) tool will be used to assess the methodological quality and validity of individual studies. The hierarchal summary receiver operating characteristic and random (...) Screening for small for gestational age using third-trimester ultrasound markers: protocol for a systematic review and meta-analysis of screening test accuracy. Fetal growth restriction (FGR) is a complication of pregnancy associated with major neonatal morbidity and commonly diagnosed at birth based on birth weight below the 5th or the 10th centile. There is no consensus on the use of routine third-trimester ultrasound for the detection of FGR in a general population. This systematic review

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2018 Systematic reviews

102. Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites

results from the HIV serology. Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range. Positive results of the drug screening. Known hypersensitivity to BIA 5-453. Heavy smokers, i.e., more than 10 cigarettes per day Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation) Subject who had more than 4 flights (with more (...) Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one

2017 Clinical Trials

103. Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics

Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please (...) remove one or more studies before adding more. Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03091868 Recruitment Status : Completed First Posted : March 27, 2017 Last Update Posted : March 27

2017 Clinical Trials

104. Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics

Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save (...) this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details

2017 Clinical Trials

105. Pharmacokinetics of BIA 5-453 and Its Metabolites

, 2008 Actual Primary Completion Date : August 12, 2008 Actual Study Completion Date : August 12, 2008 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: BIA 5-453 (Young) Each subject participated in the study for approximately 7 weeks. Participation included the screening evaluations within 28 days before the first administration, phase A (single dose, a 2-day inpatient period followed by 4 ambulatory (...) subjects only: General An automatic QTc interval reading ≥450 ms at the screening assessment. Prohibited treatments and dietary restrictions Prohibited Treatments: use of any investigational drug within 90 days (young and elderly subjects) or prescription drug within 30 days before BIA 5-453 administration. Elderly subjects only: General An automatic QTc interval reading ≥470 ms at the screening assessment. Contacts and Locations Go to Information from the National Library of Medicine To learn more

2017 Clinical Trials

106. Adult Food Allergy Prevalence: Reducing Questionnaire Bias. (PubMed)

Adult Food Allergy Prevalence: Reducing Questionnaire Bias. Food allergy (FA) prevalence has increased in the last decades, but epidemiologic studies could show overestimated results. The objective of this study is to estimate the prevalence of immediate FA in adults in a region of Central Brazil, using a questionnaire to try to reduce misperceptions about FA reaction.A cross-sectional study was conducted, enrolling an adult population aged 18-65 years comprised of families in a Central (...) Brazilian city. In the first phase, participants answered a self-administered questionnaire for FA screening. In the second phase, the participants who reported an FA in the first questionnaire were visited to complete the second questionnaire applied by trained researchers.Of the 4,916 adults visited, 1,583 returned a completed questionnaire. Reported FA occurred in 171 (10.8%) subjects, and the more frequent citations were cow's milk, pork, fruits, shrimp, and vegetables. One hundred and four

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2017 International Archives of Allergy and Immunology

107. A pilot randomized controlled trial of cognitive bias modification to reduce fear of breast cancer recurrence. (PubMed)

A pilot randomized controlled trial of cognitive bias modification to reduce fear of breast cancer recurrence. The most common, persistent concern among survivors of breast cancer is the fear that their disease will return, yet to the authors' knowledge, few interventions targeting fear of cancer recurrence (FCR) have been developed to date. The current pilot study examined the feasibility, acceptability, and preliminary efficacy of a home-delivered cognitive bias modification intervention (...) months after the intervention.Improvements in health worries (P = .019) and interpretation biases (rates of threat endorsement [P<.001] and reaction times for threat rejection [P = .007]) were found in those survivors who received AIM-FBCR compared with the control arm. Although only 26% of participants who screened into the study agreed to participate, the trial otherwise appeared feasible and acceptable, with 83% of those who initiated the intervention completing at least 5 of 8 sessions, and 90

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2017 Cancer

108. Does lead-time bias have a place in court?

. This is known as “lead-time bias,” where early detection means more time knowing that one has the cancer, not more time one is alive. This means that had the nodule been seen on the patient’s initial chest X-ray she would probably — though not certainly — not have survived much beyond 47. Lead-time bias is a fundamental concept in the statistics of screening. Physicians have it drilled in them. Recognition of this artifact curbs therapeutic and screening optimism. Why does lead-time bias not enter (...) Does lead-time bias have a place in court? Does lead-time bias have a place in court? Does lead-time bias have a place in court? | | January 3, 2017 46 Shares In 2014, a jury in Massachusetts awarded in damages to the daughter of a Bostonian lady who died from lung cancer at 47 for a missed cancer on a chest X-ray. The verdict reminds me of the words of John Bradford, a heretic who was burned at the stake: “There, but for the grace of God, go I.” Many radiologists will sympathize with both

2017 KevinMD blog

109. It's All How You "Spin" It: Interpretive Bias in Research Findings in the Obstetrics and Gynecology Literature. (PubMed)

It's All How You "Spin" It: Interpretive Bias in Research Findings in the Obstetrics and Gynecology Literature. Scientific publications can be subject to varying degrees of interpretive bias, also known as spin. The rate of spin in randomized controlled trials (RCTs) with nonsignificant primary outcomes in the general obstetrics and gynecology literature is unknown. A decade (January 2006 through December 2015) of the tables of contents of Obstetrics & Gynecology and the American Journal (...) of Obstetrics & Gynecology were screened, with 503 RCTs identified. Limiting assessment to only parallel-group RCTs with a nonsignificant primary outcome (P≥.05) resulted in the identification of 194 studies. The abstracts of the articles reported the primary outcome in 93% of studies with 79% containing a precision estimate but only 25% noting an effect size. The extent of any type of spin occurred in 43% of abstracts and 50% of the main text. In articles that contained spin in the abstract, the more

2017 Obstetrics and Gynecology

110. Accounting for misclassification bias of binary outcomes due to underscreening: a sensitivity analysis. (PubMed)

Accounting for misclassification bias of binary outcomes due to underscreening: a sensitivity analysis. Diagnostic tests are performed in a subset of the population who are at higher risk, resulting in undiagnosed cases among those who do not receive the test. This poses a challenge for estimating the prevalence of the disease in the study population, and also for studying the risk factors for the disease.We formulate this problem as a missing data problem because the disease status is unknown (...) department. Our model found that female gender, having fever during ED or at triage, and having severe hypoxia are significantly associated with having radiographic pneumonia. In addition, simulation studies demonstrate that the Bayesian selection model works well even under circumstances when both the disease prevalence and the screening proportion is low.The Bayesian selection model is a viable tool to consider for estimating the disease prevalence and in studying risk factors of the disease, when only

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2017 BMC medical research methodology

111. Temporal evolution of the central fixation bias in scene viewing. (PubMed)

Temporal evolution of the central fixation bias in scene viewing. When watching the image of a natural scene on a computer screen, observers initially move their eyes toward the center of the image-a reliable experimental finding termed central fixation bias. This systematic tendency in eye guidance likely masks attentional selection driven by image properties and top-down cognitive processes. Here, we show that the central fixation bias can be reduced by delaying the initial saccade relative (...) to image onset. In four scene-viewing experiments we manipulated observers' initial gaze position and delayed their first saccade by a specific time interval relative to the onset of an image. We analyzed the distance to image center over time and show that the central fixation bias of initial fixations was significantly reduced after delayed saccade onsets. We additionally show that selection of the initial saccade target strongly depended on the first saccade latency. A previously published model

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2017 Journal of vision

112. Selection bias and subject refusal in a cluster-randomized controlled trial. (PubMed)

Selection bias and subject refusal in a cluster-randomized controlled trial. Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial.The Improved Cardiovascular Risk Reduction to Enhance (...) Rural Primary Care (ICARE) study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site's allocation prior to consent. Patients who consented or declined to participate were compared across

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2017 BMC medical research methodology

113. Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals. (PubMed)

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals. Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals.We searched PubMed (...) for randomized controlled trials from Jan 1, 2010 -Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were

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2017 PloS one

114. Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review. (PubMed)

articles from high-impact general medical journals was performed. Of the 259 records that were screened from ophthalmology-specific journals, 119 trials met all inclusion criteria and were critically appraised. In total, 29.4% of domains had an unclear risk, 13.8% had a high risk and 56.8% had a low risk of bias. In comparison, ophthalmology articles from general medical journals had a lower prevalence of unclear risk (17.1%), higher prevalence of high risk (21.9%) and a higher prevalence of low risk (...) Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review. Evidence-based treatments in ophthalmology are often based on the results of randomised controlled trials. Biased conclusions from randomised controlled trials may lead to inappropriate management recommendations. This systematic review investigates the prevalence of bias risk in randomised controlled trials published in high-impact ophthalmology

2017 The British journal of ophthalmology

115. Editorial: The Effect of Bias on Estimation of Improved Survival After Diagnosis of Barrett's Esophagus. (PubMed)

Editorial: The Effect of Bias on Estimation of Improved Survival After Diagnosis of Barrett's Esophagus. Adjustments for lead and length time bias has been used when examining apparent survival advantages from screening procedures. However, these estimates depend on several assumptions and are modeled from malignancies that are fairly common and large cohorts are available. In smaller retrospective cohorts, adjustments themselves may be based on estimates that may not be biological nor (...) statistically accurate, which can lead to divergent results as has been found in several recent studies of screening in Barrett's esophagus. Only a prospective randomized controlled trial can really determine the benefit though this may not feasible.

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2017 American Journal of Gastroenterology

116. Smokers versus Smoking: Is There Detection Bias for Keratinocyte Carcinomas? (PubMed)

Smokers versus Smoking: Is There Detection Bias for Keratinocyte Carcinomas? Dusingize et al. used a prospective observational cohort study to demonstrate a decreased risk of basal cell carcinoma and an increased risk of squamous cell carcinoma among smokers. This association disappeared after stratifying for skin screening visits, demonstrating the important role of detection bias. In the absence of randomized clinical trials, well-designed and critically analyzed observational studies can

2017 Journal of Investigative Dermatology

117. Evidence of selective reporting bias in hematology journals: A systematic review. (PubMed)

in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included.Of 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were (...) Evidence of selective reporting bias in hematology journals: A systematic review. Selective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has

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2017 PloS one

118. Bias is a dangerous condition in American health care

. The Implicit Association Test (IAT), developed at Harvard University, helps medical students and doctors identify the racial, gender, religious or disability biases they may unknowingly harbor. The test has been an important tool to identify and measure bias — especially in health care, where providers pride themselves on their perceived impartiality. This screening helps individuals identify the many ways that society’s prejudices have been internalized as our own, even for individuals who believe (...) Bias is a dangerous condition in American health care Bias is a dangerous condition in American health care Bias is a dangerous condition in American health care | | April 30, 2017 156 Shares In medicine, there exists a dangerous condition that affects millions of Americans each year but is woefully underdiagnosed. It affects how long we live and how much we pay for health care. It impacts the way doctors treat us and care for us. Yet, many health care providers are reluctant to acknowledge

2017 KevinMD blog

119. Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests. (PubMed)

Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests. There is a growing recognition for the need to expand our evidence base for the clinical effectiveness of diagnostic tests. Many international bodies are calling for diagnostic randomized controlled trials to provide the most rigorous evidence of impact to patient health. Although these so-called test-treatment RCTs are very challenging to undertake due (...) to their methodological complexity, they have not been subjected to a systematic appraisal of their methodological quality. The extent to which these trials may be producing biased results therefore remains unknown. We set out to address this issue by conducting a methodological review of published test-treatment trials to determine how often they implement adequate methods to limit bias and safeguard the validity of results.We ascertained all test-treatment RCTs published 2004-2007, indexed in CENTRAL, including

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2017 BMC medical research methodology

120. Drop-out from cardiovascular magnetic resonance in a randomized controlled trial of ST-elevation myocardial infarction does not cause selection bias on endpoints. (PubMed)

Drop-out from cardiovascular magnetic resonance in a randomized controlled trial of ST-elevation myocardial infarction does not cause selection bias on endpoints. The extent of selection bias due to drop-out in clinical trials of ST-elevation myocardial infarction (STEMI) using cardiovascular magnetic resonance (CMR) as surrogate endpoints is unknown. We sought to interrogate the characteristics and prognosis of patients who dropped out before acute CMR assessment compared to CMR-participants (...) in a previously published double-blinded, placebo-controlled all-comer trial with CMR outcome as the primary endpoint.Baseline characteristics and composite endpoint of all-cause mortality, heart failure and re-infarction after 30 days and 5 years of follow-up were assessed and compared between CMR-drop-outs and CMR-participants using the trial screening log and the Eastern Danish Heart Registry.The drop-out rate from acute CMR was 28% (n = 92). These patients had a significantly worse clinical risk profile

2017 Clinical research in cardiology : official journal of the German Cardiac Society

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