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1) Genetic testing for age-related macular degeneration (AMD) is not currently recommended for routine use because no specific treatments have been shown to benefit individuals based on their genetic profiles in clinical trials. 2) While over 50% of AMD is attributable to genetic factors like CFH and ARMS2 variants, current genetic tests are less accurate than clinical exams in detecting treatable dry AMD or wet AMD. 3) A study comparing two commercial genetic tests to clinical diagnoses found the tests could distinguish AMD from normal controls but not dry AMD from wet AMD, and one test failed to detect a common genetic variant.
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This document defines key terms used in evidence-based medicine including those related to validity, therapy, diagnosis, bias and statistics. It provides definitions for internal and external validity, randomization, concealment, blindness, intention-to-treat analysis, sensitivity, specificity, likelihood ratios, absolute risk reduction, relative risk reduction, number needed to treat, confidence intervals, and biases such as detection and publication bias. An example is also given to calculate and interpret results including relative risk, absolute risk reduction, relative risk reduction and number needed to treat from a randomized controlled trial.
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1. Pharmacoepidemiology studies aim to answer relevant questions about drug effects, side effects, and value that arise following drug registration and widespread use.
2. Observational study designs like cohort studies and case-control studies are often used in pharmacoepidemiology as they allow investigation of exposures and outcomes that would be unethical or impractical to study experimentally.
3. Both study design and analysis must account for potential biases like selection bias and information bias to obtain valid results.
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This study prospectively evaluated 54 patients with ovarian sex cord-stromal tumors (OSCST) to develop diagnostic standards and risk-adapted treatment strategies. Most patients presented with stage IA tumors confined to the ovary and were followed regularly, while some with stage IC or higher received cisplatin-based chemotherapy. After a median follow-up of 59 months, event-free survival was 86% and overall survival was 89%. Prognosis correlated with stage, and chemotherapy seemed effective for advanced-stage tumors. The study provides a standardized approach to classify and treat OSCST.
multi-sDNA versus faecal immunochemical testing
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Evaluating the Medical Literature
1) The document discusses evaluating medical literature to answer a clinical question about whether duct tape is an effective treatment for warts in children.
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Breast Poster
Breast cancer displays wide variation in phenotypes even among a relatively homogenous patients of the same ethnicity. Estrogen receptor and progesterone receptor phenotypes occur together in similar patterns. In this study, ER and PR followed the same trends in several aspects; namely, they were both expressed as positive in the majority of patients and both positive states were strongly correlated with higher Ki67 expression. Other poor prognostic factors were not correlated in this study. The majority of cancers represented by this group of records were intermediate to high grade (poorly differentiated) and thus had relatively unfavorable prognoses. This data characterization provides the foundation and framework for a future study in identifying the hypothesized molecular markers (mRNA, miRNA, and DNA) for oligomet
Science and Policy Making in Public Health
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3) Measures to enhance blood safety should continue but scrutiny should also focus on evidence for specific medical therapies.
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The Electrocardiogram - Physiologic Principles
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
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3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
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- 1. Genetic Testing for Macular Degeneration Edwin M. Stone, M.D., Ph.D. The Howard Hughes Medical Institute The University of Iowa Institute for Vision Research
- 2. Financial Interests to Disclose None
- 3. AMD Prevalence 35% > Age 75
- 4. US Population over 75 years (will increase 44% by 2025) 19 million in 2012 27 million in 2025 From the US Census Bureau
- 5. Prevention is the Key
- 6. AMD is Genetic • More than 50% of all AMD is attributable to genetic factors • Several genes, especially CFH and ARMS2, have been significantly associated with the development of AMD
- 7. The Role of Genetics • Elucidate molecular mechanisms • Create in vitro and animal models • Enable novel mechanism-specific presymptomatic therapies • Identify patient populations for clinical trials of these therapies
- 9. Task Force Recommendation Avoid routine genetic testing for genetically complex disorders like age-related macular degeneration . . . until specific treatment or surveillance strategies have been shown in one or more published clinical trials to be of benefit to individuals with specific disease-associated genotypes. In the meantime, confine the genotyping of such patients to research studies. Ophthalmology. 2012 Nov;119(11):2408-10
- 10. Current AMD genetic tests have not been shown to improve clinical outcome • Less sensitive and specific than clinicians • There is no mechanism-specific therapy available • None of the tests can reliably distinguish between dry AMD and CNV
- 11. ARMS2 Normal vs AMD, p = 1.1 x 10-23 Dry vs CNV, p = 0.29 (NS) High Risk Het Low Risk
- 12. Complement Factor H Normal vs AMD, p = 3.8 x 10-19 Dry vs CNV, p = 0.36 (NS) High Risk Het Low Risk
- 13. PIIR Study (Pepose Institute, Illinois Retina) N. Holekamp, A. Almony, M. MacCumber • 103 subjects were tested for free by two commercial labs: Artic Dx (Macula Risk) and Sequenom (RetnaGene) • 97 subjects had sufficient genotypic and clinical information for comparison • 17/97 were normal controls (avg age 76.9 yrs) • 33/97 had dry AMD (avg age 79.3 yrs) • 47/97 had CNV (avg age 79.3 years)
- 14. Genotyping Errors • Artic Dx failed to detect the CFH H3 haplotype in any patients (this haplotype is present in about 30% of the population). • There were no detectable genotyping errors in the data provided by Sequenom.
- 15. Risk Comparison Method • Patients were assigned a risk rank from 1 (mildest) to 97 (most severe) based on the risk score assigned to them from each company. • These risk ranks were compared to each other and to the clinical phenotype assigned by the investigators.
- 21. Statistics Normal vs AMD Dry vs CNV Company 1 p = 1.4 x 10-5 p = 0.81 (NS) Company 2 p = 2.9 x 10-5 p = 0.74 (NS)
- 22. Conclusions • Avoid routine genetic testing for AMD until specific treatments have been shown in clinical trials to be of benefit to individuals with specific disease-associated genotypes. • For now, the standard clinical examination is more sensitive and specific for detecting treatable disease than any genetic test.