Podcast
Questions and Answers
What is the primary purpose of vaccine surveillance and testing?
What is the primary purpose of vaccine surveillance and testing?
What is the medical indication for administering immune globulin to individuals recently exposed to hepatitis B?
What is the medical indication for administering immune globulin to individuals recently exposed to hepatitis B?
Why is hepatitis A vaccine or immune globulin administered to individuals traveling to a country where hepatitis A is common?
Why is hepatitis A vaccine or immune globulin administered to individuals traveling to a country where hepatitis A is common?
What is the goal of a randomized field trial in vaccine development?
What is the goal of a randomized field trial in vaccine development?
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What is the purpose of administering a specific antitoxin to individuals who lack active immunity to exotoxin-producing bacteria?
What is the purpose of administering a specific antitoxin to individuals who lack active immunity to exotoxin-producing bacteria?
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Who may benefit from immune globulin administration after exposure to a common but potentially life-threatening infection?
Who may benefit from immune globulin administration after exposure to a common but potentially life-threatening infection?
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What is the difference between active immunization and passive immunization?
What is the difference between active immunization and passive immunization?
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What is the purpose of testing for hypersensitivity to an antitoxin before administering it to an individual?
What is the purpose of testing for hypersensitivity to an antitoxin before administering it to an individual?
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In a randomized controlled trial, what is the purpose of the high-risk season?
In a randomized controlled trial, what is the purpose of the high-risk season?
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What is the formula to calculate the vaccine effectiveness (VE) as a percentage?
What is the formula to calculate the vaccine effectiveness (VE) as a percentage?
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What is the main limitation of retrospective cohort studies?
What is the main limitation of retrospective cohort studies?
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What is the purpose of case-control studies?
What is the purpose of case-control studies?
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What is the result of inadequate antibody production by older people and the delay from vaccine administration until an outbreak appears?
What is the result of inadequate antibody production by older people and the delay from vaccine administration until an outbreak appears?
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What is the formula to calculate the attack rate (AR)?
What is the formula to calculate the attack rate (AR)?
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What is the advantage of randomized field trials?
What is the advantage of randomized field trials?
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What is the result of vaccination on influenza mortality rates in community-dwelling elderly people?
What is the result of vaccination on influenza mortality rates in community-dwelling elderly people?
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Why are retrospective cohort studies done during the influenza season?
Why are retrospective cohort studies done during the influenza season?
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What is the approximate value of the risk ratio (RR) when the disease is uncommon?
What is the approximate value of the risk ratio (RR) when the disease is uncommon?
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What was the outcome of the case-control study of pneumococcal vaccine?
What was the outcome of the case-control study of pneumococcal vaccine?
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What is the purpose of measuring incidence density?
What is the purpose of measuring incidence density?
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Why is it recommended to revaccinate children with measles vaccine before entering school?
Why is it recommended to revaccinate children with measles vaccine before entering school?
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What is the goal of disease control programs through vaccines?
What is the goal of disease control programs through vaccines?
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What is necessary for disease eradication through immunization?
What is necessary for disease eradication through immunization?
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What is the formula for incidence density (ID)?
What is the formula for incidence density (ID)?
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Why was the measles vaccine initially ineffective in infants before 12 months of age?
Why was the measles vaccine initially ineffective in infants before 12 months of age?
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What is the recommended age for revaccination with measles vaccine?
What is the recommended age for revaccination with measles vaccine?
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What is the consequence of delaying measles vaccination?
What is the consequence of delaying measles vaccination?
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What is the duration of immunity produced by measles vaccine?
What is the duration of immunity produced by measles vaccine?
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Why do many companies cease to produce vaccines?
Why do many companies cease to produce vaccines?
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How long does it take to produce significant amounts of vaccine after an influenza H5N1 pandemic strain of virus is isolated?
How long does it take to produce significant amounts of vaccine after an influenza H5N1 pandemic strain of virus is isolated?
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Why are opportunities for immunization often missed during sick-child visits?
Why are opportunities for immunization often missed during sick-child visits?
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What is not considered a contraindication to immunizing children or adults?
What is not considered a contraindication to immunizing children or adults?
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What is the main reason for the reduction of worldwide capacity to produce large amounts of vaccines in a short time?
What is the main reason for the reduction of worldwide capacity to produce large amounts of vaccines in a short time?
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What is often missed during outpatient clinic visits?
What is often missed during outpatient clinic visits?
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What is the primary purpose of screening?
What is the primary purpose of screening?
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What happens after a positive screening test result?
What happens after a positive screening test result?
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What is the main difference between screening and case finding?
What is the main difference between screening and case finding?
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Why is it important to ensure that a screening program is well-planned?
Why is it important to ensure that a screening program is well-planned?
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What is often assumed about screening programs?
What is often assumed about screening programs?
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What is the goal of preventive medicine specialists regarding screening programs?
What is the goal of preventive medicine specialists regarding screening programs?
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What is the process of searching for asymptomatic diseases and risk factors among people in a clinical setting?
What is the process of searching for asymptomatic diseases and risk factors among people in a clinical setting?
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What is the importance of considering the standards of evidence for screening programs?
What is the importance of considering the standards of evidence for screening programs?
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Why is screening for pancreatic cancer currently not valuable?
Why is screening for pancreatic cancer currently not valuable?
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What is a necessary condition for a disease to be suitable for screening?
What is a necessary condition for a disease to be suitable for screening?
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What is the primary objective of community screening programs?
What is the primary objective of community screening programs?
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What is a minimum requirement for establishing a safe, ethical, and cost-effective screening program?
What is a minimum requirement for establishing a safe, ethical, and cost-effective screening program?
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Why is screening for a rare disease often not valuable?
Why is screening for a rare disease often not valuable?
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What is the purpose of understanding the natural history of a disease?
What is the purpose of understanding the natural history of a disease?
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What is the distinction between screening and case finding?
What is the distinction between screening and case finding?
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What is the purpose of establishing baseline findings and laboratory values for a patient?
What is the purpose of establishing baseline findings and laboratory values for a patient?
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What is a requirement for a disease to be suitable for screening?
What is a requirement for a disease to be suitable for screening?
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What is the purpose of a community screening program?
What is the purpose of a community screening program?
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What is the main challenge in screening general populations for a rare disease?
What is the main challenge in screening general populations for a rare disease?
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Why is it often not cost-effective to screen general populations for a rare disease?
Why is it often not cost-effective to screen general populations for a rare disease?
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What is essential for individuals who have positive screening results?
What is essential for individuals who have positive screening results?
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Why is it crucial to have access to treatment after a positive screening result?
Why is it crucial to have access to treatment after a positive screening result?
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What is a key requirement for a screening test?
What is a key requirement for a screening test?
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What is a challenge in using screening tests in the general population?
What is a challenge in using screening tests in the general population?
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Why is it important to define the population to be screened?
Why is it important to define the population to be screened?
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Why is it essential to consider false-positive and false-negative test results?
Why is it essential to consider false-positive and false-negative test results?
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What is a consequence of abandoning individuals who have been informed of a positive test result?
What is a consequence of abandoning individuals who have been informed of a positive test result?
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What is an essential aspect of community screening programs?
What is an essential aspect of community screening programs?
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Why is community screening for ovarian cancer not recommended?
Why is community screening for ovarian cancer not recommended?
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What is a potential benefit of screening programs?
What is a potential benefit of screening programs?
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What is a potential harm of screening programs?
What is a potential harm of screening programs?
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What is an ethical concern in community screening?
What is an ethical concern in community screening?
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What is a consideration in community screening programs?
What is a consideration in community screening programs?
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What is the goal of screening programs?
What is the goal of screening programs?
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What is a potential harm of screening programs?
What is a potential harm of screening programs?
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What is a consideration in performing public screening programs?
What is a consideration in performing public screening programs?
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What is the reason why individuals with slow-growing tumors are more likely to be discovered by screening?
What is the reason why individuals with slow-growing tumors are more likely to be discovered by screening?
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What is the pitfall of not carefully considering the details of repeat screening efforts?
What is the pitfall of not carefully considering the details of repeat screening efforts?
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What is the result of performing multiple screening tests on an individual?
What is the result of performing multiple screening tests on an individual?
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What is the purpose of multiphasic screening programs?
What is the purpose of multiphasic screening programs?
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What is the problem with multiphasic screening in an elderly population?
What is the problem with multiphasic screening in an elderly population?
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What is the consequence of performing 25 screening tests on a disease-free individual?
What is the consequence of performing 25 screening tests on a disease-free individual?
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What is a potential harm of screening programs?
What is a potential harm of screening programs?
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Why is it important to carefully consider the details of repeat screening efforts?
Why is it important to carefully consider the details of repeat screening efforts?
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What is the result of performing multiple screening tests on an individual over a long period of time?
What is the result of performing multiple screening tests on an individual over a long period of time?
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What is the main limitation of multiphasic screening programs?
What is the main limitation of multiphasic screening programs?
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What can false-negative results lead to?
What can false-negative results lead to?
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What is a potential consequence of screening tests?
What is a potential consequence of screening tests?
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What is a potential consequence of screening mammography?
What is a potential consequence of screening mammography?
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What can false-negative results also lead to?
What can false-negative results also lead to?
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What is a potential harm of screening?
What is a potential harm of screening?
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What is the main concern with prostate cancer screening?
What is the main concern with prostate cancer screening?
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What is the main issue with establishing the value of a community screening effort?
What is the main issue with establishing the value of a community screening effort?
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What is the effect of selection bias on a screening program?
What is the effect of selection bias on a screening program?
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What is the main difference between lead-time bias and length bias?
What is the main difference between lead-time bias and length bias?
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What is the purpose of decision aids in screening?
What is the purpose of decision aids in screening?
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What was the outcome of a controlled trial of multiphasic screening?
What was the outcome of a controlled trial of multiphasic screening?
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What is the significance of genetic testing for diseases like coronary artery disease?
What is the significance of genetic testing for diseases like coronary artery disease?
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What has been the impact of prenatal genetic testing on certain populations?
What has been the impact of prenatal genetic testing on certain populations?
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What is an important requirement beyond the accuracy of a genetic test?
What is an important requirement beyond the accuracy of a genetic test?
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What is a limitation of genetic screening tests?
What is a limitation of genetic screening tests?
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What is an important consideration in genetic testing?
What is an important consideration in genetic testing?
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What was a challenge in integrating recommended screening tests into clinical practice?
What was a challenge in integrating recommended screening tests into clinical practice?
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What was found to have a significant impact on population health?
What was found to have a significant impact on population health?
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What is a challenge in genetic testing?
What is a challenge in genetic testing?
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What is a limitation of using uncontrolled trials to assess the effectiveness of screening?
What is a limitation of using uncontrolled trials to assess the effectiveness of screening?
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What was the primary purpose of annual physical examinations, also known as periodic health examinations?
What was the primary purpose of annual physical examinations, also known as periodic health examinations?
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What was the outcome of research on periodic health examinations in adults?
What was the outcome of research on periodic health examinations in adults?
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What led to an increase in the use of periodic health examinations?
What led to an increase in the use of periodic health examinations?
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What term was coined for the approach that involves health protection packages including gender-appropriate and age-appropriate immunizations, screening, and counseling?
What term was coined for the approach that involves health protection packages including gender-appropriate and age-appropriate immunizations, screening, and counseling?
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What was the result of studies on periodic health examinations in children?
What was the result of studies on periodic health examinations in children?
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What is the purpose of health risk assessments (HRAs)?
What is the purpose of health risk assessments (HRAs)?
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What is calculated using an algorithm in health risk assessments?
What is calculated using an algorithm in health risk assessments?
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What was the purpose of early studies on periodic health examinations?
What was the purpose of early studies on periodic health examinations?
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What does a higher 'risk age' indicate in a health risk assessment?
What does a higher 'risk age' indicate in a health risk assessment?
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What type of studies have extensively evaluated health risk assessments?
What type of studies have extensively evaluated health risk assessments?
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What is a limitation of health risk assessments?
What is a limitation of health risk assessments?
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What is the primary goal of organizations that issue screening guidelines and recommendations?
What is the primary goal of organizations that issue screening guidelines and recommendations?
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What type of data is usually collected in health risk assessments?
What type of data is usually collected in health risk assessments?
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What is the purpose of the printed report provided after a health risk assessment?
What is the purpose of the printed report provided after a health risk assessment?
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Which type of organization tends to recommend screening methods related to their field, unless there is evidence of harm?
Which type of organization tends to recommend screening methods related to their field, unless there is evidence of harm?
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What is the primary limitation of conducting a randomized controlled trial (RCT) of a new screening intervention?
What is the primary limitation of conducting a randomized controlled trial (RCT) of a new screening intervention?
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What is the primary goal of health promotion and disease prevention efforts?
What is the primary goal of health promotion and disease prevention efforts?
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What is the primary difference between screening and case finding?
What is the primary difference between screening and case finding?
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Study Notes
Passive Immunization
- Medical indications for passive immunization are limited compared to active immunization.
- Table 15-3 provides information on biologic agents available in the United States and their indications for use in immunocompetent and immunocompromised individuals.
Indications for Passive Immunization
- Hepatitis A vaccine or immune globulin can be administered to immunocompetent individuals at high risk for exposure to hepatitis A, such as travel to a country where it is common.
- Specific immune globulin can be used for post-exposure prophylaxis for individuals recently exposed to hepatitis B or rabies and not known to have a protective antibody titer.
- Antitoxin injection is recommended for individuals who lack active immunity to exotoxin-producing bacteria, such as Clostridium botulinum, after tests are performed to rule out hypersensitivity to the antitoxin.
- Immune globulin can be lifesaving for immunocompromised individuals who have been exposed to a common but potentially life-threatening infection, such as chickenpox, if given intravenously soon after exposure.
Vaccine Surveillance and Testing
- The rates and patterns of reportable diseases are monitored, and any cases thought to be vaccine-associated are investigated.
- Goals of vaccine surveillance and testing include monitoring the effectiveness of vaccines and detecting vaccine failures or adverse effects.
Randomized Field Trials
- Randomized field trials are used to measure the effectiveness of a new vaccine.
- In this type of trial, susceptible persons are randomized into two groups and are given the vaccine or a placebo.
- The vaccinated subjects and unvaccinated controls are followed through the high-risk season to determine the attack rate (AR) in each group.
- Vaccine effectiveness (VE) is calculated using the formula: VE = (AR(unvaccinated) - AR(vaccinated)) x 100 / AR(unvaccinated).
Retrospective Cohort Studies
- These studies are used to evaluate the protective efficacy of vaccines when randomized field trials are not feasible.
- Retrospective cohort studies have limitations, such as potential selection bias, and may not be able to ensure that the participants who were immunized are comparable to those who were not immunized.
Case-Control Studies
- Case-control studies are used to evaluate the effectiveness of vaccines when the disease is uncommon.
- The vaccine effectiveness formula can be rewritten as VE = 1 - [AR(vaccinated) / AR(unvaccinated)] = (1 - RR) ≈ (1 - OR) when the disease is rare.
Incidence Density Measures
- Incidence density measures are used to determine the rate of disease incidence in a population over time.
- The formula for incidence density is: ID = Number of new cases of a disease / Person-time of exposure.
Immunization Goals
- The strategy of developing disease control programs through the use of vaccines depends on the objectives of the vaccine campaign.
- Goals may include eradication of disease, regional elimination of disease, or control of disease to reduce morbidity and mortality.
Vaccine-Related Supplies and Lawsuits
- Recent shortages of some vaccines have caused concern about vaccine supplies.
- Fewer companies are making vaccines for the United States, citing the cost and risk of developing and making vaccines, tighter regulation of production, and the risk of liability for the companies.
- The National Vaccine Injury Compensation Program was established to cover diphtheria, tetanus, pertussis, measles, mumps, rubella, and oral and inactivated polio vaccines.
- The program essentially protects vaccine manufacturers from liability lawsuits, unless it can be shown that their vaccines differed from the federal requirements.
Secondary Prevention
- Based on early detection of disease through screening or case finding, followed by treatment
- Screening involves evaluating a group of people for asymptomatic disease or risk factors in a community setting
- Case finding is the process of searching for asymptomatic diseases and risk factors among people in a clinical setting
Objectives of Screening
- Test large numbers of individuals for one or more diseases or risk factors in a community setting
- Minimum requirements for establishing a safe, ethical, and cost-effective screening program:
- Disease requirements:
- Disease must be serious and have effective therapy
- Natural history of disease must be understood
- Disease must not be too rare or too common
- Screening test requirements:
- Test must be reasonably quick, easy, and inexpensive
- Test must be safe and acceptable to individuals and clinicians
- Operating characteristics of the test must be known and acceptable
- Health care system requirements:
- People with positive test results must have access to follow-up
- Treatment already available for people with the disease
- Individuals with positive results must have access to treatment
- Population to be screened must be clearly defined
- Responsibility for screening, cutoff points, and how findings will be part of participants' medical records
- Disease requirements:
Minimum Requirements for Community Screening Programs
- Disease requirements:
- Hypertension: fulfills requirements
- Hypercholesterolemia: fulfills requirements
- Cervical cancer: fulfills requirements
- Ovarian cancer: fails to fulfill requirements (low yield of detection, and few cancers can be cured by detection)
- Screening test requirements:
- Hypertension: blood pressure measurement
- Hypercholesterolemia: blood screening
- Cervical cancer: Papanicolaou smear
- Ovarian cancer: CT scan (not recommended)
- Health care system requirements:
- Access to follow-up and treatment
- Clear definition of the population to be screened
Ethical Concerns about Community Screening
- Professionals involved have an obligation to show that benefits of screening outweigh costs and potential risks
- Methods used in performing public screening programs should be safe, with minimal side effects
- Potential benefits of screening include reduced mortality, reduced morbidity, and reassurance
- Potential adverse effects of screening include anxiety from false-positive results, false reassurance, and costs
Controversies in Screening Programs
- Breast cancer screening:
- Debate about age to start screening, when to stop, and how often to repeat
- False-positive results and anxiety
- Potential harm of overdiagnosis and overtreatment
- Prostate cancer screening:
- Debate about effectiveness in reducing mortality
- False-positive results and anxiety
- Potential harm of overdiagnosis and overtreatment
- Need for personalized screening decisions based on individual risk preferences and values### Screening Biases
- Selection bias occurs when individuals with a family history of disease or higher risk participate in screening programs, leading to overestimation of screening effectiveness
- Lead-time bias occurs when screening detects disease earlier in its natural history, increasing the period from diagnosis to death, but not changing the natural history of the disease
- Length bias occurs when screening detects slower-growing tumors, leading to longer survival times regardless of treatment given
Repetition of Screening Programs
- Repeating screening programs too soon can lead to disappointing results due to detecting incident cases rather than prevalent cases
- The more screening tests done, the more likely positive findings will occur, including false positives
Multiphasic Screening
- Multiphasic screening involves screening for multiple diseases at once, but has doubtful yield and high frequency of false-positive results
- The probability of false-positive results increases with the number of screening tests done
- One study found no major differences in health outcomes between multiphasic screening and regular care, but higher hospitalization rates in the screened group
Genetic Screening
- Genetic testing can be used for presymptomatic testing or susceptibility testing for diseases like Huntington's disease and coronary artery disease
- Genetic testing has significant implications for population health, particularly for prenatal screening for certain genetic disorders
- Quality requirements for genetic screening tests include clinical validity, clinical utility, and consideration of environmental influences on gene expression
Periodic Health Examination
- Historically, the most common method of prevention in clinical medicine, especially for adults, was the annual physical examination (checkup), now known as the periodic health examination.
- After World War II, the number of available treatments for chronic illnesses increased, and more people began to have an annual checkup.
- Research on the periodic health examination before the 1960s concerned examinations sponsored by businesses or industries or conducted by the few large health plans existing at the time.
- Most investigators agreed that examinations in children were beneficial, but studies began to cast doubts about the cost-effectiveness of periodic health examinations in adults.
- In the 1970s, investigators began moving toward the idea of modifying the periodic examination to focus only on the conditions and diseases that would be most likely to be found in a person of a given age, gender, and family history, termed “lifetime health monitoring.”
- The Canadian Task Force on the Periodic Physical Examination recommended that the traditional form of periodic checkup be replaced by the use of health protection packages that included gender-appropriate and age-appropriate immunizations, screening, and counseling of patients on a periodic basis.
Health Risk Assessments
- Health risk assessments (HRAs) use questionnaires or computer programs to elicit and evaluate information concerning individuals in a clinical or industrial medical practice.
- Each assessed person receives information concerning his or her estimated life expectancy and the types of interventions that are likely to have a positive impact on health and longevity.
- HRAs assess the needs of individual patients as they enter a medical care system or of employees in an industrial setting, develop health education information tailored to the needs of the individuals, and develop cost-containment strategies based on better acquisition of health risk information from individuals.
- Most HRAs use questionnaires or interactive computer programs to gather data concerning each person being assessed, including height, weight, blood pressure, cholesterol level, and previous and present diseases, as well as lifestyle and family history.
- An algorithm calculates the person’s “risk age” on the basis of the data, usually based on findings of the Framingham Heart Study.
Screening Guidelines and Recommendations
- Many organizations issue screening guidelines and recommendations, including specialty organizations, primary care specialties, foundations for the treatment and prevention of particular diseases, and organizations dedicated to evaluating screening recommendations.
- The U.S. Department of Health and Human Services created the U.S. Preventive Services Task Force (USPSTF) to clarify issues concerning screening and case finding and to make evidence-based recommendations.
- The USPSTF reviews data concerning the efficacy of three broad categories of interventions: screening for disease in asymptomatic clinical populations and in certain high-risk groups, counseling to promote good health habits and prevent disease, and immunizations and chemoprophylaxis to prevent specific diseases.
Lung Cancer Screening
- Development of new diagnostic methods offers new screening possibilities, and conducting a randomized controlled trial (RCT) of a new screening intervention is arduous and time-consuming.
- The history of lung cancer screening illustrates the pitfalls of relying on single-arm studies or mathematical modeling of screening interventions through cost-utility analysis.
- The National Lung Screening Trial was launched in 2002, randomizing over 53,000 participants to either three annual helical CT scans or chest x-ray films, and published results in 2011 showing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0%.
- The trial also likely showed evidence of overdiagnosis; even after the gap in detection time between the two screening modalities closed, the screened group had more cancer than the control arm.
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Description
This quiz covers the medical indications and biologic agents for passive immunization in immunocompetent and immunocompromised individuals, including travel-related risks.