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Medical Devices for Screening and DiagnosisMedical Devices for Screening and Diagnosis TEKİN KAYA,...

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Medical Devices for Screening and Diagnosis TEKİN KAYA, İŞBARA ALP SEZEN, HÜSEYİN ALTUĞ, OSMAN NACAR, İSMET KÖKSAL, ALİ SAİT SEPTİOĞLU Contact: [email protected], [email protected], [email protected], [email protected], [email protected], [email protected] References: 1) Breast Cancer Screening by Mammography: Utilization and Associated Factors JANE G. ZAPKA, SCD, ANNE M. STODDARD, SCD, MARY E. COSTANZA, MD, AND HARRY L. GREENE, MD 2) Breast Cancer Screening With Imaging: Recommendations From the Society of Breast Imaging and the ACR on the Use of Mammography, Breast MRI, Breast Ultrasound, and Other Technologies for the Detection of Clinically Occult Breast Cancer; Carol H. Lee, MDCorresponding author contact information, E-mail the corresponding author, D. David Dershaw, MD, Daniel Kopans, MD, Phil Evans, MD, Barbara Monsees, MD, Debra Monticciolo, MD, R. James Brenner, MD, Lawrence Bassett, MD, Wendie Berg, MD, Stephen Feig, MD, Edward Hendrick, PhD, Ellen Mendelson, MD, Carl D'Orsi, MD, Edward Sickles, MD, Linda Warren Burhenne, MD 3) Prenatal screening for congenital heart disease; L D Allan, D C Crawford, S K Chita, and M J Tynan SCREENING To identify a population for unrecognized condition (disease) without looking for symptoms. There are specific applications such as Universal Screening and Case Finding Principles of Screening According to WHO, Wilsons Criteria; 1. The condition should be an important health problem. 2. There should be a treatment for the condition. 3. Facilities for diagnosis and treatment should be available. 4. There should be a latent stage of the disease. 5. There should be a test or examination for the condition. 6. The test should be acceptable to the population. 7. The natural history of the disease should be adequately understood. 8. There should be an agreed policy on whom to treat. 9. The total cost of finding a case should be economically balanced in relation to medical expenditure as a whole. 10. Case-finding should be a continuous process, not just a "once and for all" project. Types of Screening Mass Screening: whole population, irrespective to risk Selective Screening: high risk only Multiphasic Screening: concurrent, 2 or more School Based Screening ABSTRACT Medical equipment used in screening tests usually differ from equipment used in diagnostic tests as screening tests are used to indicate the likely presence or absence of a disease or condition in people not presenting symptoms; while diagnostic medical equipment is used to make quantitative physiological measurements to confirm and determine the progress of a suspected disease or condition. Medical screening equipment must be capable of fast processing of many cases, but may not need to be as precise as diagnostic equipment. Common screening where medical devices are used include: Breast Cancer Screening: There are several approaches on this including molecular breast imaging, ultrasonography and magnetic resonance imaging. Molecular breast imaging uses a radioactive tracer that “lights up” any areas of cancer inside the breast. Medical ultrasonography is a diagnostic aid to mammography. Magnetic resonance imaging has been shown to detect cancers not visible on mammograms. Fetal screening: Ultrasound scanning is used to detect down syndrome. Also electric fetal monitors are used to monitor fetal wellbeing. Diabetic retinopathy: Fungus camera is used to detect this complication. Dental caries: Dental radiographs are used to detect dental caries. Colorectral cancer: Colonoscopy techniques are employed Screening for Breast Cancer: Mamographic screening: - research showed reduced mortality by 30% globally - about 25% of women aged 40–49 years who have invasive cancer will be incorrectly advised that their mammograms are clear Ductal lavage: MRI: -used less frequently Trial Entry Years Age at Entry (yrs) Screening Method Screening Frequency Number of Women HIP 1963–69 40–64 2-view MM & PE Annually 4 rounds 60,696 Malmo 1976–86 45–69 1 or 2-view MM 18–20 mos, 5 rounds 41,478 Two-Country 1977–85 40–74 1-view MM 24–33 mos, 4 rounds 133,065 Stockholm 1981–85 40–64 1-view MM 28 mos, 2 rounds 59,176 Gothenburg 1982–88 40–59 2-view MM 18 mos, 4 rounds 49,553 Edinburgh 1978–85 45–64 1 or 2-view MM & PE 24 mos, 4 rounds 54,671 Canada NBSS I 1980–87 40–49 2-view MM & PE Annually , 5 rounds 50,430 Canada NBSS II 1980–87 50–59 2-view MM & PE vs. PE Annually, 5 rounds 39,405 For women aged 50 or over at entry A significant reduction in breast cancer mortality of around 25%, evident after 7 to 9 years of followup For women below age 50 at entry A significant reduction in breast cancer mortality of around 18%, evident after more than 12 years of followup Prenatal Screening: Hearth rate: - Fetal echocardiogram Group Number of fetuses investigate (n=3085) Number of cases diagnosed (n=46) Incidence (cases per 1000) Screening examinations (no risk factors) 2181 (70·7%) 15 6·9 Screening examinations (maternal risk factors) 540 (17·5%) 3 5·6 Previous child with congenital heart disease 122 Maternal age older than 35 years 257 1 Diabetes mellitus 78 2 Teratogen exposure 49 Infection 34 Indicated examinations (fetal abnormalities) 364 (11·8%) 28 76·9 Abnormal four- chamber view 25 6 Arrhythmia 26 3 Extracardiac organ abnormality 167 9 Amniotic fluid abnormality 70 1 IUGR 62 6 IUGR and amniotic fluid abnormality 14 3 Screening for Diabetic Retinopathy: Fundus Camera: Screening for Dental Caries: Dental Radiograph: Abstract Number: 170951, Poster Number I.06
Transcript
Page 1: Medical Devices for Screening and DiagnosisMedical Devices for Screening and Diagnosis TEKİN KAYA, İŞBARA ALP SEZEN, HÜSEYİN ALTUĞ, OSMAN NACAR, İSMET KÖKSAL, ALİ SAİT SEPTİOĞLU

Medical Devices for Screening and Diagnosis TEKİN KAYA, İŞBARA ALP SEZEN, HÜSEYİN ALTUĞ, OSMAN NACAR, İSMET KÖKSAL, ALİ SAİT SEPTİOĞLU

Contact: [email protected], [email protected], [email protected], [email protected], [email protected],

[email protected]

References: 1) Breast Cancer Screening by Mammography: Utilization and Associated Factors

JANE G. ZAPKA, SCD, ANNE M. STODDARD, SCD, MARY E. COSTANZA, MD, AND HARRY L. GREENE, MD

2) Breast Cancer Screening With Imaging: Recommendations From the Society of Breast Imaging and the ACR on the Use of Mammography, Breast MRI, Breast

Ultrasound, and Other Technologies for the Detection of Clinically Occult Breast Cancer; Carol H. Lee, MDCorresponding author contact information, E-mail the

corresponding author, D. David Dershaw, MD, Daniel Kopans, MD, Phil Evans, MD, Barbara Monsees, MD, Debra Monticciolo, MD, R. James Brenner, MD, Lawrence

Bassett, MD, Wendie Berg, MD, Stephen Feig, MD, Edward Hendrick, PhD, Ellen Mendelson, MD, Carl D'Orsi, MD, Edward Sickles, MD, Linda Warren Burhenne, MD

3) Prenatal screening for congenital heart disease; L D Allan, D C Crawford, S K Chita, and M J Tynan

SCREENING To identify a population for unrecognized condition (disease) without looking for symptoms. There are specific applications such as Universal Screening and Case Finding

Principles of Screening According to WHO, Wilsons Criteria; 1. The condition should be an important health problem. 2. There should be a treatment for the condition. 3. Facilities for diagnosis and treatment should be available. 4. There should be a latent stage of the disease. 5. There should be a test or examination for the condition. 6. The test should be acceptable to the population. 7. The natural history of the disease should be adequately understood. 8. There should be an agreed policy on whom to treat. 9. The total cost of finding a case should be economically balanced in relation to medical

expenditure as a whole. 10. Case-finding should be a continuous process, not just a "once and for all" project.

Types of Screening

Mass Screening: whole population, irrespective to risk

Selective Screening: high risk only Multiphasic Screening: concurrent, 2 or more

School Based Screening

ABSTRACT Medical equipment used in screening tests usually differ from equipment used in diagnostic tests as screening tests are used to indicate the likely presence or absence of a disease or condition in people not presenting symptoms; while diagnostic medical equipment is used to make quantitative physiological measurements to confirm and determine the progress of a suspected disease or condition. Medical screening equipment must be capable of fast processing of many cases, but may not need to be as precise as diagnostic equipment. Common screening where medical devices are used include: • Breast Cancer Screening: There are several approaches on this including molecular breast imaging, ultrasonography and magnetic resonance imaging. Molecular breast imaging uses a radioactive tracer that “lights

up” any areas of cancer inside the breast. Medical ultrasonography is a diagnostic aid to mammography. Magnetic resonance imaging has been shown to detect cancers not visible on mammograms. • Fetal screening: Ultrasound scanning is used to detect down syndrome. Also electric fetal monitors are used to monitor fetal wellbeing. • Diabetic retinopathy: Fungus camera is used to detect this complication. • Dental caries: Dental radiographs are used to detect dental caries. • Colorectral cancer: Colonoscopy techniques are employed

Screening for Breast Cancer: Mamographic screening: - research showed reduced mortality by 30% globally - about 25% of women aged 40–49 years who have invasive cancer will be incorrectly advised that their

mammograms are clear

Ductal lavage:

MRI: -used less frequently

Trial Entry Years Age at Entry (yrs) Screening Method Screening Frequency

Number of Women

HIP 1963–69 40–64 2-view MM & PE Annually 4 rounds 60,696

Malmo 1976–86 45–69 1 or 2-view MM 18–20 mos, 5 rounds

41,478

Two-Country 1977–85 40–74 1-view MM 24–33 mos, 4 rounds

133,065

Stockholm 1981–85 40–64 1-view MM 28 mos, 2 rounds 59,176

Gothenburg 1982–88 40–59 2-view MM 18 mos, 4 rounds 49,553

Edinburgh 1978–85 45–64 1 or 2-view MM & PE

24 mos, 4 rounds 54,671

Canada NBSS I 1980–87 40–49 2-view MM & PE Annually, 5 rounds 50,430

Canada NBSS II 1980–87 50–59 2-view MM & PE vs. PE

Annually, 5 rounds 39,405

For women aged 50 or over at entry

A significant reduction in breast cancer mortality of around 25%, evident after 7 to 9 years of followup

For women below age 50 at entry

A significant reduction in breast cancer mortality of around 18%, evident after more than 12 years of followup

Prenatal Screening: Hearth rate: - Fetal echocardiogram

Group Number of fetuses investigate (n=3085)

Number of cases diagnosed (n=46)

Incidence (cases per 1000)

Screening examinations (no risk factors)

2181 (70·7%) 15 6·9

Screening examinations (maternal risk factors)

540 (17·5%) 3 5·6

Previous child with congenital heart disease

122 ‥

Maternal age older than 35 years

257 1

Diabetes mellitus 78 2

Teratogen exposure 49 ‥

Infection 34 ‥

Indicated examinations (fetal abnormalities)

364 (11·8%) 28 76·9

Abnormal four-chamber view

25 6

Arrhythmia 26 3

Extracardiac organ abnormality

167 9

Amniotic fluid abnormality

70 1

IUGR 62 6

IUGR and amniotic fluid abnormality

14 3

Screening for Diabetic Retinopathy: Fundus Camera:

Screening for Dental Caries: Dental Radiograph:

Abstract Number: 170951, Poster Number I.06

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