QUESTIONS:

Q. Define RCT. A. A study where people are allocated randomly to receiving a particular intervention or not (this could be two different treatments or one treatment and a placebo). Q How many groups are formed in RCT trails? A. 2 group i.e. treatment group, control group. Q. why consideration of ethical issues is so important for RCT conduction? A. Because it can have adverse effect on outcome of study. Q. Why informed voluntary consent is necessary for each person in any medical trail? A. So that he may know the possible benefits & adverse effects of treatment and medicine and can act accordingly. Q. How much loss of follow up is acceptable in RCT? A. Below 20% is acceptable and above it poses serious threats to validity. Q. Controlled clinical trials are viewed as the .. a) Gold standard b) silver standard Q. According to statistical errors, how many types of RCT are being subject to? What are they? A. RCTs are subject to both type I ("false positive") and type II ("false negative") statistical errors. Q. RCTs reduce .and .in the hierarchy of evidence that influences healthcare policy and practice. A. Spurious causality, bias Q. Why Data Monitoring Committee need to be established? A. Basically, to assess at regularly scheduled intervals the progress of an RCT, safety data, data quality, and the critical efficacy end points. Q. Which of the studies are most validating? a) Case-control b) Cross- sectional c) RCT d) Cohort

Questions 1. What are the two of the primary criteria of evaluation in any measurement or observation? Ans: Whether we are measuring what we intend to measure. Whether the same measurement process yields the same results. These two concepts are validity and reliability. 2. Say you have a piece of wood that is 2 1/2 feet long. You measure it once with the tape measure - you get a measurement of 2 1/2 feet. Measure it again and you get 2 1/2 feet. Measure it repeatedly and you consistently get a measurement of 2 1/2 feet. Are the results valid and reliable? Ans: The tape measure yields reliable results. However, the results will be valid if the measure is actually 2 feet long. Measuring this piece of wood with such a "good" tape measure should produce a correct measurement of the wood's length. 3. State if Valid and Reliable

4.

5.

6.

7. 8.

What are the three most important factors to assess reliability Ans: Observer Variation Physical Variation Errors related to Technical methods What is a good reliability scale? Ans: the higher the reliability value the more reliable the measure. The general convention in research has been prescribed by Nunnally and Bernstein (1994) who state that one should strive for reliability values of .70 or higher. How do I improve the reliability of my survey instrument? Ans: Reliability values increase as test length increases (see Gulliksen, 1950 for a complete discussion of the relationship between test length and reliability). That is, the more items you have in your scale to measure the construct of interest the more reliable your scale will become. However, the problem with simply increasing the number of scale items when performing applied research is that respondents are less likely to participate and answer completely when confronted with the prospect of replying to a lengthy questionnaire. Therefore, the best approach is to develop a scale that completely measures the construct of interest and yet does so as economical a manner as is possible. Define validity?(ans is in slides) What are the two types of validity? Explain (ans is in slides)

9. Specificity is equal to: a. True positive / (true positive + false positive) b. True negative / (true negative + true positive) c. True positive / (true positive + false negative) d. True Negative / (true positive + false positive) 10. An example of False negative is : a. A diseased person incorrectly identified as healthy b. A healthy person incorrectly identified as diseased c. A diseased person correctly diagnosed as diseased d. A healthy person correctly identified as healthy 11. ____________ reflects the diagnostic power of the test (A: Predictive accuracy) 12. If a disease has very low prevalence, you typically get poor values for

a. b. c. d.

Negative predictive value Positive predictive value Sensitivity Specificity

1. Two stage screening will a) Decrease specificity and will reduce sensitivity. b) Increase both sensitivity and specificity. c) Decrease both sensitivity and specificity. d) Increase the specificity and will reduce the sensitivity. ANS: d) 2. The goal of simultaneous testing is to a) Increase both sensitivity and specificity. b) Increase the specificity and reduce the sensitivity c) Decrease both sensitivity and specificity. d) Decrease the specificity and increase the sensitivity. ANS: d) 3. Specificity identifies those patients a) who do not have disease. b) Who are true false as well as true positives. c) Who have disease. ANS: a) 4. Predictive Accuracy reflects a) Diagnostic power of test b) Sensitivity of test c) Specificity of test d) Validity of test ANS: a) 5. The probability that a patient with positive test result has the disease in question is indicated as a) Predictive value of negative results b) Predictive value of positive results c) Sensitivity d) Specificity ANS: b) 6. Those who have disease are told that they do not have disease are known as a) False positives

b) False negatives c) Both of the above d) None of the above ANS: b) 7. Lower the sensitivity of a test, larger the number of false negatives. a) True b) False ANS: a) 8. Which of the following is true? a) False positives burdens the diagnostic facilities. b) False positives discredit to screening programme. c) None of the above. d) Both of the above. ANS: d) 9. What are the components we consider for evaluating the screening test? ANS: 1. Sensitivity 2. Specificity 3. Predictive value of a positive test 4. Predictive value of a negative test 5. Percentage of false negatives 6. Percentage of false positives

10. What are the difference between sensitivity and specificity? ANS: SENSITIVITY: It is defined as the ability of a test to identify correctly all those who have the disease, that is true positive. Sensitivity = a/( a+c) * 100 ii SPECIFICITY: It is the ability of a test to identify correctly those who do not have disease, that is true negative. Specificity = d/ (b+ d) * 100

Question 1. All the following are true in a randomized control trial (RCT) except: 1. Baseline characteristics of intervention and control groups should be similar 2. Investigators bias is minimized by double blinding 3. The sample size required depends on the hypothesis 4. The drop-outs from the trial should be excluded from the analysis. Question 2. What are randomized control trials? Explain its types and discuss advantage and disadvantage of RCT. Question 3. Cause and Effect relationship can be identified through: 1. 2. 3. 4. Surveys Correlation RCTs Case studies

Question 4. Which of the following is considered as gold standard in epidemiological research? 1. Case control 2. Cohort 3. Cross-sectional 4. RCT Question 5. Discuss different types of trials. Question 6. A randomized controlled trial begins with a random (i.e. representative) sample from the population of interest. True or False? Question 7. The purpose of using double-blinding in an RCT is to: 1. Achieve greater comparability of cases and controls. 2. Avoid placebo effects. 3. Avoid objective and subjective bias. 4. Reduce the effects of sampling variation. 5. Reduce the effect of losses to follow-up. Question 8. Randomization in experimental studies ensures that: 1. Assignment to experimental or control groups occurs by chance.

2. 3. 4. 5.

Treatment and control groups are alike in all respects, except the treatment. Bias is eliminated in the observations. Placebo effects are eliminated. The two groups are representative of the population from which they were drawn.

Question 9. How will you design a RCT study? Explain. Question 10. One of the best way to eliminate bias in epidemiological study can be done by using : 1. RCT 2. Cross-sectional study 3. Case-control 4. Cohort Question 11. Write short note on: 1. Randomization 2. Blinding 3. Intention to treat analysis 4. Analysis of RCT Question 12. Bias can be avoided by: 1. Incorporation of blinding 2. By doing randomization 3. Both 1 & 2 4. None of the above

Question 13. Blinding is difficult: 1. Having placebo in the same shape, formula and taste is very costly, and time consuming. 2. Impossible if surgical and medical treatments are compared. 3. Both 1 & 2 4. None of the above Question 14. What ethical considerations should be kept in mind while conducting RCTs ?

Question 15. Temporal relationship problem can be resolved by using which type of study: 1. Case-control 2. RCT 3. Cohort 4. Cross-sectional

Questions
1. What does Single-blind, double-blind & Triple-blind mean? Blinding is a procedure in which one or more persons in the research trial are kept unaware of the treatment assignment(s). Single-blind usually means that the research participant is not told of the treatment assignment. Double-blind usually means that the research participant and Doctor/nurse are kept unaware of the treatment assignment. Triple-blind means when the research participant, doctor and the researcher all are unaware about the treatment assignment. 2. What is a Placebo? A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment. Placebos are used only when no standard treatment exists.

3. What is a protocol & what does it describe? A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions.

A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

4. Who can participate in a clinical trial? The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria." Using inclusion and exclusion criteria is an important principle of medical research that helps to produce reliable results. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. 5. What are the benefits & risks of participating in a clinical trial? Benefits : Well-designed and well-executed clinical trials provide the best approach for eligible participants to:

Play an active role in their health care decisions. Gain access to new research treatments before they are widely available. Obtain expert medical care at leading health care facilities during the trial. Help others by contributing to medical research.

Risks: Clinical trials entail risks, which may include:

There may be unacceptable worsening of the illness or condition if the participant is randomly assigned to a control group and/or receives a placebo. There may be unpleasant, serious or even life-threatening side effects to experimental treatment.

The experimental treatment may not be effective for the participant. The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

6. What are the phases of clinical trial? PHASE 0 TRIALS : Phase 0 trials are first-in-human trials. also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data. PHASE I TRIALS: These studies include the initial introduction of new drugs usually in healthy human volunteers to determine how the human body metabolizes the drug and what the associated side effects are with increasing doses. Generally, less than 100 volunteers participate in this type of study. PHASE II TRIALS: These are controlled clinical studies conducted to evaluate the effectiveness of a drug or device for a particular symptom or symptoms in patients with the disease or condition under study and to determine the common adverse effects and risks. These types of studies generally involve no more than several hundred participants. PHASE III TRIALS: These are larger controlled and uncontrolled studies conducted after preliminary evidence suggests effectiveness of an investigational drug or device. These studies generally involve several hundred to thousands of participants to gather additional information about effectiveness and safety and adequate basis for physician labeling. PHASE IV TRIALS: These studies are commonly referred to as post-marketing studies because they are generally conducted concurrent or after marketing approval to obtain additional information about risks, benefits, and optimal use of a drug or device. These studies could

include, but would not be limited to, studying different doses of a drug that were not done during Phase II trials, or use of a drug/device in other patient populations.

7. What are the different kinds of phase I trial?

There are different kinds of phase I trial: SAD :- (Single ascending dose )studies are those in which small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time. Typically, a small number of participants, usually three, are entered sequentially at a particular dose. If they do not exhibit any adverse side effects, and the pharmacokinetic data is roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose. If unacceptable toxicity is observed in any of the three participants, an additional number of participants, usually three, are treated at the same dose. This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the maximum tolerated dose (MTD)). If an additional unacceptable toxicity is observed, then the dose escalation is terminated and that dose, or perhaps the previous dose, is declared to be the maximally tolerated dose. This particular design assumes that the maximally tolerated dose occurs when approximately one-third of the participants experience unacceptable toxicity. Variations of this design exist, but most are similar. MAD :- (Multiple ascending dose) studies are conducted to better understand the pharmacokinetics and pharmacodynamics of multiple doses of the drug. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. The dose is subsequently escalated for further groups, up to a predetermined level. Food effect :- A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug while fasted, and after being fed. 8. How the patients rights are reserved? Patients rights are reserved by a) Informed consent b) Scientific review c) Institutional review boards (IRBs)

d) Data safety and monitoring boards (DSMBs) Informed Consent: Purpose Procedures Potential risks and benefits Individual rights

Scientific review Institutional review boards (IRBs) are required by federal law for trials that are: --Federally funded --Subject to FDA regulation Data and safety monitoring boards : Ensure that risks are minimized Ensure data integrity Stop a trial if safety concerns arise or objectives have been met.

Multiple Choice Questions

1. All of the following must be determined prior to initiating a clinical trial EXCEPT: a. b. c. d. e. 2. The number of patients needed to evaluate protocol sample size The required laboratory tests and X-rays The study design, i.e. randomized or single-arm trial The degree to which the trial outcomes are met The eligibility criteria

What is the definition of an Adverse Event? a. Any sign or symptom during the course of a clinical trial b. Any event which the PI decides to report during the course of a clinical trial c. Administration of the wrong dose of study agent d. Patient participating in a clinical trial withdraws from study

3.

For what purpose does the IRB review the informed consent? a. Protect the Institution

b. Protect the subject c. Provide the Institution with information about proposed research trials d. Protect the Sponsor

4.

Which one of the following characterizes phase II drug testing? a. It uses a single dose of drug determined from the Phase I experience. b. It always treats divergent pathologies in a single trial. c. It is the first human clinical experience with a new agent. d. It always leads to a new drug approval from FDA

5.

The following must be done prior to the first patient being entered on a clinical trial EXCEPT: a. b. c. d. e. Approval by an Institutional Review Board (IRB) A written protocol A written consent Pharmacy process to obtain drug supplies Data analysis

6.

The trials of which Phase are of Therapeutic Confirmatory type? a. Phase I b. Phase II c. Phase III d. Phase IV Who Is responsible for Clinical trials in India?

7.

Concepts in Epidemiology Q. Define endemic, Pandemic and epidemic with examples? Q. What is incidence and prevalence? Q. What are the components of an epidemiological triad? Q. Define cumulative incidence? Q. Uses of epidemiology?

Q. What are Death rates and its disadvantage? Q. Define Infant, Maternal, Child mortality rates?
Design and Management of Disease Surveillance in Hospital and community situation : SHORT QUESTIONS What is disease surveillance?
Ans: It is the ongoing systematic collection, analysis and interpretation of health data essential to the planning, implementation and evaluation of public health practice as well as timely dissemination of these data to those who need to know. (Centers for Disease Control and Prevention)

Why is disease surveillance necessary?

Ans: It is necessary because of the following: Predicting or detecting disease outbreaks for containment (What ?) Identifying high-risk populations (Who?) Identifying areas requiring special attention and where system performance is poor (Where ?) Determining the frequency of occurrence of a disease in the community and magnitude of the problem (When ?how many?) Identifying underlying causes / risk factors of the disease (Why ?) Guiding response activities, including immunization (How the disease can be prevented, controlled or eliminated ?).

What are the characteristics of an effective surveillance system?

Ans: An effective surveillance system has the following attributes:Simplicity Acceptability Flexibility Sensitivity Data quality High predictive value positive (PVP) Timeliness Stability Representativeness

What are the components of a surveillance system?

Ans: Components of a surveillance system are:Collection of data Compilation of data Analysis and Interpretation Take action Provide feedback

What are the criteria for selecting and prioritizing health problems for surveillance?
Ans: Criteria for disease selection : -Does the disease have a high disease impact? -Does it have a significant epidemic potential? -Is it a specific target of a national, regional, or control program?

international

 -Will the information collect lead to significant public health action?

What do you mean by standard case definition?

Ans: A standard case definition is an agreed set of criteria, usually clinical, used to decide if a person has a particular disease. Use of standard definitions ensures that every case is detected and reported in the same way, regardless of where or when it occurred or who identified it. Case definitions for surveillance must be standardized. Elements of case definition: Criteria for time, place, and person Clinical and laboratory diagnosis Epidemiological features of disease Degree of certainty regarding diagnosis High sensitivity and specificity Standard case definition example: Giardiasis Clinical description An illness caused by the protozoan Giardia lamblia (aka G. intestinalis or G. duodenalis) and characterized by gastrointestinal symptoms such as diarrhea, abdominal cramps, bloating, weight loss, or malabsorption. Laboratory criteria for diagnosis Laboratory-confirmed giardiasis shall be defined as the detection of Giardia organisms in stool, intestinal fluid, tissue samples, biopsy specimens or other biological sample.

 Why capturing hospital data is important for disease surveillance?

Ans: Public sector hospitals cater to large population and thus capture crucial data on many diseases. Hospital is able to notify and report sudden increase in number of cases of a disease . Corrective action can be taken to prevent the spread of the outbreak and control it. Both inpatient and outpatient data needs to be included.

How is data collected?

1. 2. 3. 4. 5. Ans: Types of data collection system:Vital Record systems Existing data sets Surveys Notifications Registries

What rules are used for collecting data?

Ans: Following are some of the rules which are used for collecting data: Zero reporting. Avoid double counting. Count only those cases which have been diagnosed by the health personnel. Count current cases only. Report the occurrence of any unusual clustering of cases or any death immediately by telephone, fax, email, special messenger

etc. This verbal report must be followed by a written case based report.

What are the different types of surveillance?

Ans: The different types of surveillance are Active Surveillance Passive Surveillance Sentinel Surveillance

Classification of hospital based surveillance?

Ans: Following is the classification of hospital based surveillance: Presumptive or probable surveillance: Diagnosis made on the typical history and clinical examination by a medical officer. Laboratory Confirmed : Clinical diagnosis with positive laboratory identification. Syndromic : Diagnosis made on basis of clinical pattern by paramedical personnel and members of the community.

LONG QUESTION What are the steps in planning of disease surveillance in the community?
Ans: Following are the steps in planning of disease surveillance in the community: Establish objectives Develop case definitions Develop data collection system

 Develop data collection instrument Field test methods Develop data analysis approach Determine dissemination mechanism Determine evaluation method

MCQ/TRUE AND FALSE

To be effective, public health surveillance systems must involve public health agencies, healthcare providers, and the public. True False

When an unusual disease case occurs, the public health agency has two weeks to investigate and implement control measures if needed to prevent spread. True False

Describing and monitoring health events and trends through surveillance systems can allow us to: a. Detect sudden changes in disease occurrence and distribution. b. Follow long-term trends and patterns of disease. c. Interpret current disease situations. d. Identify changes in agents and host factors. e. Use appropriate data to direct vaccine production, treatment, and other prevention and control measures. f. All of the above.

There are many sources of data for surveillance purposes. Some of the main ones are: a. Mortality reports b. Environmental data c. Drug and biologics utilization d. Population-based surveys e. All of the above

There are two forms of surveillance, passive and impassive. True False

Every reportable disease has an official case definition that is used to determine whether a case should be counted in the surveillance system. True False

The only purpose of sharing surveillance information is to inform those who need to know. True False

q-1 what do you understand by food borne diseases? Ans; Food borne diseases- Covers illnesses acquired through consumption of contaminated food-food poisoning q-2 write a note on prevention for foodborne diseases? 1. Keep Clean Wash hands before handling food and often during preparation Wash hands after going to toilet Wash n sanities all surfaces n equipment for food preparation-protect kitchen from insects, pets 2. Separate raw and cooked foodSeparate raw meat, poultry n seafood from other foods Use separate utensils for handling raw foods Store food in containers to avoid contact between raw and cooked foods 3. Cook Thoroughly esp. Meat , poultry , eggs and Seafood Bring soups n stews to boiling (ensure>70degree temp) Reheat cooked food thoroughly 4. Keep food at safe temperature Don't leave cooked food at room temp.>2 hours Prompt refrigeration of cooked n perishable food

Keep cooked food piping hot (>60 de.) prior to serving Dont store food too long even in refrigerator Dont thaw frozen food at room temperature 5. Use safe water and raw materialsUse safe water or treat to make it safe Select fresh and wholesome fruits Choose foods processed for safety - pasteurized milk Wash fruits n vegetables if eaten raw Dont use food beyond expiry date 6. Choose restaurants carefully Ques 3-write about waterborne diseases? Diseases caused by ingestion of water contaminated by human or animal excrement, which contain pathogenic microorganisms Include cholera, typhoid, amoebic and bacillary dysentery and other diarrheal diseases In addition, water-borne disease can be caused by the pollution of water with chemicals that have an adverse effect on health Ques-4 write about the Strategies for National Vector Control Program? Ans; The basic approach for vector borne diseases control involves a strategy directed against the parasite and vector and to enlist the involvement of community in practicing various preventive measures Disease management Insecticide resistance Involvement of NGOs /private sector/community Quality assurance on laboratory diagnosis Long lasting insecticide treated nets Improve quality and efficiency of services at primary, secondary and tertiary levels Environmental management Monitoring and evaluation Collaboration with National Malaria Institute of malaria research and medical colleges Inter-sectoral collaboration

Ques-write about vector borne diseases?

vector-borne diseases are infections transmitted by the bite of infected arthropod species, such as mosquitoes, ticks, triatomine bugs, sandflies, and blackflies

Evaluation of efficacy of therapeutic intervention.

Question 1.Define these: A. Potency B. Efficacy. Question 2. What is the difference between efficiency & effectiveness ? explain with example. Question 3: Evaluation & PURPOSE OF EVALUATION? Question 4: Define therapeutic intervention? With example. What are the type of intervention recommended by WHO to prevent malaria & dengue? ANSWERS: 1(.A). POTENCY:

is the relationship between the dose of a drug and the therapeutic effect. It refers to the drug's strength. A drug is considered potent when a small amount of the drug achieves the intended effect. (B).EFFICACY:

is the ability of a drug to produce the desired therapeutic effect. Efficacy means that the drug is effective. When comparing two drugs that work equally, the one with the lower dose has a higher potency. They have equal efficacy. ANSWER 2. Difference between efficiency and effectiveness. Efficiency : is the ratio of the output to the inputs of any system. An efficient system or person is one who achieves higher levels of performance (outcome, output) relative to the inputs (resources, time, money) consumed. Examples: Worker A moved 16 boxes from the truck to the store in one hour and worker B moved 9 boxes in one hour. Worker A is more efficient than worker B. Car T uses 10 gallons to travel 150 miles, car F uses 13 gallons to travel 150 miles. Car T is more fuel efficient than car F. Effectiveness: Extent to which planned outcomes, goals, or objectives are achieved as a result of an activity, strategy, intervention or initiative intended to achieve the desired effect, under ordinary circumstances (not controlled circumstances such as in laboratory). Example: A vaccine is effective when it is capable to produce the desired effect (protection against disease) in the population, under ordinary circumstances.

Being effective means achieving organizational goals. Being efficient means achieving goals with little wasted resources. Effectiveness comes first. ANSWER 3. Evaluation & purpose of evaluation. Evaluation is a systematic determination of a subject's merit, worth and significance, using criteria governed by a set of standards. It can assist an organization, program, project or any other intervention or initiative to assess any aim, realisable concept/proposal, or any alternative, to help in decision-making; or to ascertain the degree of achievement or value in regard to the aim andobjectives and results of any such action that has been completed. PURPOSE: in addition to gaining insight into prior or existing initiatives, is to enable reflection and assist in the identification of future change. ANSWER 4: Therapeutic intervention with example :
Therapeutic intervention refers to a type of intervention that is design to heal the person suffering from the condition. Usually, therapeutic intervention is performed by professionals and it is designed to effect change in a way that restores the health of the person. Therapeutic interve ntions used to treat malaria and dengue: Preventive chemotherapies are key elements of the comprehensive package of malaria prevention and control measures recommended by WHO.

Preventive measures recommended by WHO: Prior to a stay in malaria and dengue affected areas: Evaluate risk in the ports to be visited and remember that the risk of being infected with malaria or dengue varies between different areas within a country. Assess the length of stay in known risk areas, time spent at sea, in port, on rivers, etc., and planned shore leaves by the crew.

Continuously monitor the WHO website and similar sources for official advice as the types of diseases expected within certain areas may change with the seasons. Contact a medical practitioner if in doubt. Inform the crew about the risks and the precautions to be taken as well as actions to be taken if illness occurs at sea. Stress that a slight headache, fever and flu-like symptoms are always reasons for contacting the medical officer.

Evaluate, in close co-operation with a medical doctor and based on the vessels expected exposure time in a risk area, if the crew should take an anti malarial drug.

Questions
1) Define Evidence-Based Healthcare? Evidence-based health care is the conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors.

2) What are the steps of Evidence- Based Healthcare? 1. Constructing a well-built question: translation of uncertainty to an answerable question 2. Finding the Evidence: systematic retrieval of best evidence available 3. Critical Appraisal: testing evidence for validity, clinical relevance, and applicability 4. Making a Decision: application of results in practice 5. Evaluating Performance: auditing evidence-based decisions

3) Explain the PICO model with example? PICO(T): Patient/population/problem Intervention Comparison Outcome Time P Patient/Prob lem C Comparison/Con trol Alternative Intervention? Compared to what other treatment, test, or perhaps compared to doing nothing

I Intervention

O Outcome

Who? How would I describe a group of patients similar to this particular patient?

What?

What happens?

Which treatment, test or other intervention?

What is the patient oriented outcome better prognosis? Higher rate of cure? Etc.?

Example : Q - Does hand washing among healthcare workers reduce hospital acquired infections? P -Hospital acquired infection.

 I - Hand washing C - No hand washing; other solution O - Reduced infection 4) What are the advantages of Evidence Based Healthcare? Minimizes the error in patient care Reduces the cost of treatment Optimizes the quality of patient care Helps in advancement of knowledge and keeping pace with scientific progress Provides material for future research

5) Why is Evidence Based Healthcare required? Caring for patients creates the need for clinically important information - Diagnosis, Treatment, Prognosis, Intervention Inadequate traditional sources: Outdated (Textbooks) Frequently wrong (Expert opinions) Voluminous and variable in validity (Medical Journals) Time constraints in clinical practice New evidence often changes clinical practice

6) What are the misconceptions and challenges related to Evidence Based Healthcare? 1. Design seamless, coordinated care 2. Make effective use of IT, including automating patient records 3. Manage knowledge so that it is delivered into patient care 4. Coordinate care across patient conditions, services, and settings over time 5. Advance the effectiveness of teams 6. Incorporate measurement of care processes and outcomes into daily practice
MCQs 1. Disease is the result of forces within a dynamic system consisting of : A) Agent B) Host C) Environment D) All of the above 2. The presence of an infectious agent on a body surface, on or in clothes, beddings, toys, surgical instruments or dressings, or other articles or substances including water and food. A) Infection B) Contamination C) Infestation D) Disease 3. An insect or any living carrier that transports an infectious agent from an infected individual or its wastes to a susceptible individual or its food or immediate surroundings. A) Vector B) Pathogen C) Reservoir D) None of the above

4.

The unusual occurrence in a community of disease, specific health related behavior, or other health related events clearly in excess of expected occurrence. A) Endemic B) Sporadic C) Epidemic D) Pandemic

5. The cases occur irregularly, haphazardly from time to time, and generally infrequently. A) Endemic B) Sporadic C) Epidemic D) Pandemic 6. The person who comes into and infects a population. A) Primary case B) Secondary case C) Index case D) Both A & C

7. A) B) C) D)

An endemic occurring in animals Epizotic Enzotic Zoonosis None of the above

8. This is infection by organisms that take the opportunity provided by a defect in host defense to infect the host and thus cause disease. A) Hospital Acquired Infection B) Opputunistic Infection C) Both of the above D) None of the above 9. The person, animal, object or substance from which an infectious agent passes or is disseminated to the host. A) Reservoir B) Pathogen C) Host D) Vector. 10. The disease evoking power of a micro-organism in a given host A) Pathogenecity

B) Virulence C) Infectivity D) Survival Differentiate giving example between :1. Epidemic & Endemic 2. Contamination & Infestation 3. Erradication & Elimination 4. Incidence & Prevalence 5. Carrier & case 6. Vector & Reservoir Define with diagram 1. Iceberg Concept of Disease. 2. Epidemiological Triad. 3. Chain of infection.

A 37 year old women with low back pain for the past 4 week wants to know if you recommend surgery. You prefer to base your treatment recommendations on research evidence whenever possible .In the strongest study you can find , investigation reviewed the medical records of 40 consecutive men with low back pain under care at their clinic 22 had been referred for surgery, and the other 18 patients had remained under medical care without surgery. The study compared rates of disabling pain after 2 month s. All of the surgically treated patient and 10 of the medically treated patients were still being seen in the clinic thoroughout this time. Rates of pain relief were slightly higher in the surgically treated patients.

For each of the following statements, circle the one reason that best represent the corresponding threat to validity ( yellow color is answers)
Q1. Because there are relatively few patients in the study it may give a misleading impression of the actual effectiveness of surgery a. Selection Bias b. Measurement bias c. Confounding d. Chance e. Extremely Validity ( genreralizability) Q2. The results of the this study may not apply to your patient , a women because all the patients in the study were men a. Selection Bias b. Measurement bias c. Confounding d. Chance

e. Extremely Validity ( genreralizability) Q3. Fewer patients who did not have surgery remained under care at the clinic two months after surgery a. Selection Bias b. Measurement bias c. Confounding d. Chance e. Extremely Validity ( genreralizability) Q4. The patients who were refered for the surgery were youngest and fitter than those who remained under medical care a. Selection Bias b. Measurement bias c. Confounding d. Chance e. Extremely Validity ( genreralizability) Q5. Compared with the patients who had surgery moght have been less likely to report whatever pain they had and the treating physicians might have been less inclined to record pain the thbe medical record a. Selection Bias b. Measurement bias c. Confounding d. Chance e. Extremely Validity ( genreralizability) Q6 Patient without other medical conditions were both more likely to recover and more likely to be referred for the surgery a. Selection Bias b. Measurement bias c. Confounding d. Chance e. Extremely Validity ( genreralizability) Q7 Histamine is a mediator of inflammation in patients with allergic rhinitis ( hay fever) . Based on this fact which of the following is true a. Drugs that block the effect of histamines will relieve symptoms b. Fall in histamine levels in the nose is a reliable marker of clinical success c. Anti-histamines may be effective and their effects on symptoms ( eg itchy nose, sneezing and congestion ) should be studied in the patients with allergic rhinitis d. Other mediators are not important e. If laboratory studies of disease are convincing , clinical research is unnecessary

Q8. Which of the following statement about the sample of population in incorrect a. Sample of population may have characteristics that differ from the population even though correct population procedures were followed b. Sample of population is the only feasibly way of studying the population c. When population are correctly sampled , extremely validity is ensured d. Sample of population should be selected in a way that every member of population has an equal chance of being chosen Q9. You are making a treatment decision with a 72 year old man with colon cancer. You are aware of several good study that have shown that a certain drug combination prolongs the life of patients with colon cancer however all the patient in these studies were much younger, Which of below statement is correct a. Given these studies the decision about this treatment is a matter of personal judgment b. Relying on these studies for your patient is called internal validity c. The results in these studies are affected by chance but not bias Q10. A study was done to determine whether regular exercise lowers the risk of coronary heart disease . An exercise program was offered to employees of factory and the rates of subsequent coronary events were compared in employees who volunteered for the program and those who did not volunteer . The development of CHD was determined by means of regular voluntary checkup including a careful history and electrocardiogram and a review of routine healt records. Surprisingly the member of exercise group developed a higher rate of CHD even though fewer of them smoked cigarette. This result is least likely to be explained by which of the following a. The volunteers where at a higher risk of developing CHD than those not volunteering before the study began b. The volunteer did not actually increase the exercise and the amount of excerice was same in the two gropes c. Volunteers got more check ups and the silent myocardial infarctions were therefore more likely to have been indentified in the exercise group Q11. Venticular premature depolarization are associated with an increased risk of sudden death from a fatal arrhythmia, especially in people in other evidence of heart disease. You have read there is a new drug for Venticular premature depolarization. What is the most important thing you will like to know about the drug before prescribing it to the patient a. The drugs mechanism of action b. How well the drug prevents Venticular premature depolarization in people using the drug compared to those who do not use the drug c. The rate of sudden death in similar people who do and do not take the drug Question 1.1.2-1.15 are based on the following clinical scenarios Because reports suggested that estrogens increase the risk of clotting, a study compared the frequency of oral contraceptives use among the women admitted to the hospital with thrombophlebitis and a group of women admitted due to other reasons. Medical records were reviewed for indication of oral contraceptives use in two groups . Women with thrombophlebitis were found to have using oral contraceptives more frequently than women admitted for other reasons

For each of the following statement, select the one response that represents the corresponding threat to validity.
Q12 Women with thrombophlebitis may have reported the use of contraceptives more completely that women without thrombophlebitis because they remembered hearing of the association a. Selection Bias b. Measurement Bias c. Confounding d. Chance e. External Validity ( generalizability ) Q13. Doctors mamay have questioned women with thrombophlebitis more carefully about contraceptive use than those without thrombophlebitis ( and recorded the information more carefully in medical records) because they were aware that estrogen causes clotting a. Selection Bias b. Measurement Bias c. Confounding d. Chance e. External Validity ( generalizability ) Q14. Number of women in the study was small a. Selection Bias b. Measurement Bias c. Confounding d. Chance e. External Validity ( generalizability ) Q15. Women with thrombophlebitis were admitted to the hospital by doctors working in different neighborhood than the physicians of those that did not have thrombophlebitis a. Selection Bias b. Measurement Bias c. Confounding d. Chance e. External Validity ( generalizability )

Q .Short not
1. Define clinical epidemiology. 2. Difference in specificity and sensitivity. 3. Enlist steps of clinical epidemiology

1. In which five year plan Medical Certification of Cause of Death (MCCD) was initiated ?

a. b. c. d.

2nd 3rd 4th 5th

Five Year Plan Five Year Plan Five Year Plan Five Year Plan

Ans. 3rd Five Year Plan 2. In the International Death Certificate, Which of the following is True ? a. b. c. d. Part 1 of the certificate deals with immediate and also the underlying cause Part 1 of the certificate deals with immediate cause only Part 2 of the certificate deals with underlying cause Other morbid conditions not related to the cause of death are not included

Ans. Part 1 of the certificate deals with immediate and also the underlying cause

3. The following people can sign a Medical Certificate of Cause of Death ? a. b. c. d. a dentist involved in care of the patient. registered medical practitioner a senior nurse involved in the care of the patient in his/her final illness a Coroner

Ans. registered medical practitioner 4. Death and birth certificates comes under which registration system ? a. Statistics Registration System b. Civil Registration System c. Sample Registration System Ans. Civil Registration System 5. Underlying cause means ? a. Most recent cause b. Next oldest condition c. Initiating condition Ans. Initiating condition

6. IDSP is funded by a) WHO b) World band

c) CDC d) UNICEF Ans. World Bank 7. NFHS 3 was conducted in which year : a) 1992-93 b) 1998-99 c) 2000-01 d) 2005-06 Ans. 2005-06

Short Notes:1. What do you understand by Immediate cause of death ?

Ans1. Immediate cause of death - Most Recent Cause. The final act in a series of provocations leading to a particular result or event, directly producing such result without the intervention of any further provocation. For example, if an individual who was driving while intoxicated crashed his or her car and was killed, the immediate cause of death was the crash. The proximate cause, however, was the individual's state of intoxication.

2. What do you understand by Mechanism of Death? Explain with a suitable example. Ans2. Mechanism Of Death - The specific physiological change in the body that brought about the ending of life Example: If the cause of death was a shooting, the mechanism could be loss of blood (exsanguinations) or cessation of brain function. Example: If the cause of death was massive trauma from a car accident, the mechanism could be pulmonary arrest (lungs stopped working)

3. What do you understand by Underlying cause of Death?

Ans3. Underlying cause of Death - The disease or injury that initiated the train of events leading directly to death, or the circumstances of the accident or violence which produced the fatal injury. 4. What is the value of Death Certificate ? What are the usages of Death certificate?

Ans.4. Value of Death Certificate - One of the most important documents we need to settle the affairs of our loved one is a death certificate. The death certificate is the official legal record of death. It includes information about the person who died and about their cause of death. Insurance companies, the Social Security Administration, and other agencies may request certified copies of the death certificate as proof of death. Certified copies are printed on special paper that cannot be easily duplicated. Usages of death certificate : Claiming life insurance benefits Claiming pensions Settling estates Government programs, pensions, welfare funds, and many other services will require the notice of a death certificate as well.

5. What are the different source of hospital data and use of these data? Ans.5. Source of hospital data: 1) Out Patient Department and clinics 2)Medical Record Department 3)Pathology Laboratories. 4)Autopsy services 5)Hospital patient information system. 6)Other clinical departments of hospital. Uses: 1) Resource management: Drug management, Human resource management. 2) To study disease resulting from hospitalization. 3) To study the natural history of disease. 4) To study attributes related to disease. 5) To determine disease morbidity. 6) To facilitate comparative studies of hospitals. 7) To study administrative planning.

6. What are the problems encountered by ICD?

Ans.6.

Size of the Classification No formal training No user-friendly software to guide No abridged Classification of Diseases based on Indian condition & requirement No Online Help-line system

QUESTIONS:
Q. Define RCT. A. A study where people are allocated randomly to receiving a particular intervention or not (this could be two different treatments or one treatment and a placebo). Q How many groups are formed in RCT trails? A. 2 group i.e. treatment group, control group. Q. why consideration of ethical issues is so important for RCT conduction? A. Because it can have adverse effect on outcome of study. Q. Why informed voluntary consent is necessary for each person in any medical trail? A. So that he may know the possible benefits & adverse effects of treatment and medicine and can act accordingly. Q. How much loss of follow up is acceptable in RCT? A. Below 20% is acceptable and above it poses serious threats to validity. Q. Controlled clinical trials are viewed as the .. a) Gold standard b) silver standard Q. According to statistical errors, how many types of RCT are being subject to? What are they? A. RCTs are subject to both type I ("false positive") and type II ("false negative") statistical errors. Q. RCTs reduce .and .in the hierarchy of evidence that influences healthcare policy and practice. A. Spurious causality, bias Q. Why Data Monitoring Committee need to be established? A. Basically, to assess at regularly scheduled intervals the progress of an RCT, safety data, data quality, and the critical efficacy end points. Q. Which of the studies are most validating? a) Case-control b) Cross- sectional c) RCT d) Cohort

Questions 13. What are the two of the primary criteria of evaluation in any measurement or observation? Ans: Whether we are measuring what we intend to measure. Whether the same measurement process yields the same results. These two concepts are validity and reliability. 14. Say you have a piece of wood that is 2 1/2 feet long. You measure it once with the tape measure - you get a measurement of 2 1/2 feet. Measure it again and you get 2 1/2 feet. Measure it

repeatedly and you consistently get a measurement of 2 1/2 feet. Are the results valid and reliable? Ans: The tape measure yields reliable results. However, the results will be valid if the measure is actually 2 feet long. Measuring this piece of wood with such a "good" tape measure should produce a correct measurement of the wood's length. 15. State if Valid and Reliable

16. What are the three most important factors to assess reliability Ans: Observer Variation Physical Variation Errors related to Technical methods 17. What is a good reliability scale? Ans: the higher the reliability value the more reliable the measure. The general convention in research has been prescribed by Nunnally and Bernstein (1994) who state that one should strive for reliability values of .70 or higher. 18. How do I improve the reliability of my survey instrument? Ans: Reliability values increase as test length increases (see Gulliksen, 1950 for a complete discussion of the relationship between test length and reliability). That is, the more items you have in your scale to measure the construct of interest the more reliable your scale will become. However, the problem with simply increasing the number of scale items when performing applied research is that respondents are less likely to participate and answer completely when confronted with the prospect of replying to a lengthy questionnaire. Therefore, the best approach is to develop a scale that completely measures the construct of interest and yet does so as economical a manner as is possible. 19. Define validity?(ans is in slides) 20. What are the two types of validity? Explain (ans is in slides) 21. Specificity is equal to: e. True positive / (true positive + false positive) f. True negative / (true negative + true positive) g. True positive / (true positive + false negative) h. True Negative / (true positive + false positive)

22. An example of False negative is : e. A diseased person incorrectly identified as healthy f. A healthy person incorrectly identified as diseased g. A diseased person correctly diagnosed as diseased h. A healthy person correctly identified as healthy 23. ____________ reflects the diagnostic power of the test (A: Predictive accuracy) 24. If a disease has very low prevalence, you typically get poor values for e. Negative predictive value f. Positive predictive value g. Sensitivity h. Specificity

Short notes and multiple choice questions on outbreak investigation.

(By Nuzhat Fatema, Roopal Chandrakar, Sonal Agarwal)
Questions: Q1) What is an outbreak? Differentiate between outbreak and epidemic. What are the identification signs of an outbreak? Mention the importance of outbreak investigation. Q2) Mention in brief the steps of outbreak investigation. Q3) Write short notes on: 1) What is the difference between outbreak and epidemic? 2) What are the warning signs of an impending outbreak? 3) What are the step wise actions to be taken during the outbreak? 4) How the outbreak is confirmed? 5) What is case fatality rate? 6) What is attack rate? 7) How the collected data during the outbreak, is analyzed? 8) How the ecological factors responsible for outbreak, are analyzed? 9) What are the sub steps of further investigation of population at risk of outbreak? 10) Explain in detail the procedure of report writing? Multiple choice questions: 1) What is an emerging disease? a) a disease that is always present in a population b) a disease that occurs only occasionally and at unpredictable intervals c) a global outbreak of disease

d) a disease with clinically distinct symptoms whose incidence has increased, particularly over the last two decades

2) What is a sporadic disease? a) a disease that is always present in a population b) a disease that occurs only occasionally and at unpredictable intervals c) a disease with clinically distinct symptoms whose incidence has increased, particularly over the last two decades d) a global outbreak of disease 3) What is an epidemic disease? a) b) c) d) a disease that occurs suddenly and spreads rapidly to many people a disease that occurs only occasionally and at unpredictable intervals a global outbreak of disease a disease with clinically distinct symptoms whose incidence has increased, particularly over the last two decades

4) Most common way(s) that a local health department uncovers outbreaks is/are by a) receiving calls from affected residents b) receiving calls from health care providers c) reviewing all case reports received each week to detect common features d) performing descriptive analysis of surveillance data each week e) both (a) and (b) 5) In an ongoing outbreak of a disease with no known source and mode of transmission, the primary reason for an investigation relates to: a) prevention and control b) training of staff c) learning more about the disease d) being responsive to the concerns of the community e) legal responsibility 6) For an investigation of an outbreak, what is the logical order of the activities listed below? 1. Analyze data by time, place, and person 2. Conduct a case-control study 3. Generate hypotheses 4. Conduct active surveillance for additional cases 5. Verify the diagnosis 6. Confirm that the number of cases exceeds the expected number

7. Coordinate who will talk to the press about the investigation a) 1-2-3-4-5-6-7 b) 5-6-4-1-2-3-7 c) 6-5-1-3-2-4-7 d) 7-6-5-4-1-3-2 e) 5-6-1-3-2-4-7 7) If you were a state employee, the first step in the investigation of an outbreak of meningococcal meningitis 200 miles away might include: a) talking with someone knowledgeable about meningococcal meningitis b) talking with someone knowledgeable about field investigations c) talking with a couple of the initial case-patients d) discussing the feasibility of mass vaccination e) all of the above 8) The appropriate role for an epidemiologist from the CDC in the investigation of a local outbreak of botulism (possibly food borne) a) is to lead the investigation in consultation with CDC experts b) is to provide consultation to the local staff who will conduct the investigation c) is to lend a hand to the local staff d) is whatever is negotiated in advance with the local health department 9) The primary distinction between the terms outbreak and epidemic is: a) outbreak does not imply that the cases are all related b) outbreak implies a grouping of cases but not necessarily more than expected c) outbreak is limited to fewer than 20 cases, epidemic to more than 20 d) outbreak does not generate as much anxiety among the public 10) Why should an investigator who has no clinical background nonetheless talk to a patient or two as an early step in the outbreak investigation? a) To verify the clinical findings as part of verifying the diagnosis b) To verify the laboratory findings as part of verifying the diagnosis c) To learn more about the clinical manifestations of the disease d) To develop hypotheses about the cause of the outbreak e) Both (c) and (d)

11. Common methods of identifying additional cases (expanding surveillance) as part of an outbreak investigation include a) sending a letter to physicians b) telephoning the infection control nurse at the local hospital c) advising the public through newspapers, TV, and radio to contact the local health department

d) asking case-patients who they were with at the time of exposure (if known) e) all of the above

12. The ultimate purpose for characterizing an outbreak by time, place, and person is to: a) identify errors and miscodes in the data b) provide a comprehensive description of an outbreak by portraying its time course, geographic extent, and populations most affected by the disease c) ensure that all true cases are captured by the surveillance system d) generate hypotheses 13) Reasonable ways of generating hypotheses in an outbreak investigation include a) b) c) d) e) asking the local health officer what he/she thinks is the cause asking the case-patients what they think is the cause reviewing a textbook about the disease under investigation postulating explanations for the patterns seen in the descriptive epidemiology focusing on the patients who do not fit the general patterns seen in the descriptive epidemiology

14) For a federal investigator, which of the following communication modes should be used first to announce the findings of an outbreak investigation? a) b) c) d) e) Written report for local authorities Written report for state newsletter Written report for the Morbidity and Mortality Weekly Report Oral report for the local authorities Press conference to explain findings the public

15) Infectious disease outbreak investigation includes both epidemiological and laboratory component. a) True a) False

Questions Q1 what is biostatistics? How is it different from statistics?

Q2 what is hospital data? What are the different types of hospital data analysis? Q3 what are the elements of hospital data analysis. Q4 Mention the uses of hospital data analysis. Q5 why capturing hospital data is important for disease surveillance? Q6 briefly describe hospital based surveillance. Q7 Mention the roles of various personnel involved in establishing surveillance at hospital levels. Q8 what are the limitations of hospital data? True and false 1. Routine Reporting from the hospital to DSU needs to be done once in a month. 2. The L form reporting in the hospital is done by the laboratory technical staff based on the number of samples tested and those found positive.

Answers Ans1 When the data analyzed are derived from the biological science and medicine, the term biostatistics is used to distinguish this particular application of statistical tools and concepts. While Statistics is a field of study concerned with collection, organization, summarization and analysis of data. drawing of inferences about a body of data when only a part of the data is observed

Ans2 Hospital medical records contain immense amounts of information on patients. Hospital accounting records contain a wealth of data on the facilitys business activities. Hospital data analysis is of two types Quantitative analysis Qualitative analysis Ans3 Elements of hospital data analysis Collection Analysis Interpretation Dissemination Ans 4 uses of hospital data analysis Monitoring trends of diseases Can use to measure outcomes of care (death, complications, hospital readmission) Can use to examine disparities in care based on gender, or payer status Can use to examine market share for certain diagnoses, procedures Identifying epidemics Evaluate public policy, cost and interventions Utilization of health care services (resource utilization) Identifying new diseases and infections. Projecting future needs Ans 5

Public sector hospitals cater to large population and thus capture crucial data on many diseases. Hospital is able to notify and report sudden increase in number of cases of a disease . Corrective action can be taken to prevent the spread of the outbreak and control it. Both inpatient and outpatient data needs to be included.

Ans6 Presumptive or probable surveillance: Diagnosis made on the typical history and clinical examination by a medical officer. Laboratory Confirmed : Clinical diagnosis with positive laboratory identification.

Syndromic : Diagnosis made on basis of clinical pattern by paramedical personnel and members of the community.

Ans7 Role of key stakeholders: The key stakeholders are he hospital superintendent, nodal person, doctors, paramedical staff and laboratory staff. o Role of Hospital superintendent: Responsible for establishing, maintenance and reporting arrangements of surveillance in hospitals. He/ she may identify one or more nodal person for facilitating surveillance in respective units.. o Role of Nodal Officer: Organize a briefing to all doctors to emphasize the need for their cooperation in making surveillance possible for larger interest og the community. o Role of doctors: They are the key staff around which the reporting is based. They must write the provisional diagnosis in the OPD register. o Role of Laboratory staff: Fill up the L forms from the lab investigation register being maintained routinely The line listing of all positive cases of diseases to be reported. o Role of paramedical staff (Pharmacist , Nurses): The pharmacist collect information from OPDs and nurses from the inpatient case sheets enter into Tally sheets. o

Ans 8 Limitations of hospital data 1. Hospital admissions are selective in relation to Personal characteristics

 Severity of disease Associated conditions Admission policies 2. Hospital records are not designed for research. They may be Incomplete, illegible, or missing Variable in diagnostic quality 3. Population(s) at risk (denominator) is (are) generally not defined. TRUE AND FALSE 1 FALSE ( IT IS DONE ONCE IN A WEEK) 2 TRUE Q.1:- Describe three uses of Life Table. Q.2:- Describe the different columns of a life table. Q.3:- What are the Strengths and weaknesses of a Life Table. Q.4:- Describe the inferences that are derived from Life Table. Q.5:- Describe the different types of Life Table. Q.6:- Life Table is also known as ---------------- table. Q.7:- Life table consists of --------- no. of columns.

Q.1. Simultaneously two (or more) tests are conducted in 1. Serial testing 2. Sequential testing 3. Both of the option (1,2) 4. Parallel testing Answer : 4 Q.2. the performance of a diagnostic testing strategies can be evaluated by using which measures 1. Validity 2. Both of the two options (1,3) 3. Predictive value 4. Neither of the two options Answer : 2 Q.3. Differentiate between serial testing and parallel testing. In serial testing two or more tests are run consecutively to confirm a diagnosis. Also known as Sequential Testing (Two-Stage Screening) whereas In parallel testing two (or more) tests are conducted in parallel i.e. all at once also known as Simultaneous Testing Serial testing strategy maximizes specificity and positive predictive value but lowers sensitivity and the negative predictive value whereas Parallel testing strategy generally increase the sensitivity and the negative predictive value for a given disease above those of each individual test

Q.4. Define serial testing. Describe the steps of events which are followed in interpreting results. Serial testing is in which two or more tests are run consecutively to confirm a diagnosis.Here diagnosis requires all test to be positive.

results increases specificity and decreases sensitivity

Question 1. All the following are true in a randomized control trial (RCT) except: 1. Baseline characteristics of intervention and control groups should be similar 2. Investigators bias is minimized by double blinding 3. The sample size required depends on the hypothesis 4. The drop-outs from the trial should be excluded from the analysis. Question 2. What are randomized control trials? Explain its types and discuss advantage and disadvantage of RCT. Question 3. Cause and Effect relationship can be identified through: 5. 6. 7. 8. Surveys Correlation RCTs Case studies

Question 4. Which of the following is considered as gold standard in epidemiological research? 5. Case control 6. Cohort 7. Cross-sectional 8. RCT Question 5. Discuss different types of trials. Question 6. A randomized controlled trial begins with a random (i.e. representative) sample from the population of interest. True or False? Question 7. The purpose of using double-blinding in an RCT is to: 1. Achieve greater comparability of cases and controls. 2. Avoid placebo effects. 3. Avoid objective and subjective bias.

4. Reduce the effects of sampling variation. 5. Reduce the effect of losses to follow-up. Question 8. Randomization in experimental studies ensures that: 6. Assignment to experimental or control groups occurs by chance. 7. Treatment and control groups are alike in all respects, except the treatment. 8. Bias is eliminated in the observations. 9. Placebo effects are eliminated. 10. The two groups are representative of the population from which they were drawn. Question 9. How will you design a RCT study? Explain. Question 10. One of the best way to eliminate bias in epidemiological study can be done by using : 5. RCT 6. Cross-sectional study 7. Case-control 8. Cohort Question 11. Write short note on: 5. Randomization 6. Blinding 7. Intention to treat analysis 8. Analysis of RCT Question 12. Bias can be avoided by: 5. Incorporation of blinding 6. By doing randomization 7. Both 1 & 2 8. None of the above

Question 13. Blinding is difficult: 5. Having placebo in the same shape, formula and taste is very costly, and time consuming. 6. Impossible if surgical and medical treatments are compared. 7. Both 1 & 2 8. None of the above

Question 14. What ethical considerations should be kept in mind while conducting RCTs ? Question 15. Temporal relationship problem can be resolved by using which type of study: 5. Case-control 6. RCT 7. Cohort 8. Cross-sectional

QUESTIONS AND ANSWERS Topic: Writing Reports, communication strategy for public information for outbreak of epidemics By: col maan singh gahlot PG/12/42 Dr. Megha sood PG/12/50 Dr. Ridhima Joshi PG/12/74

Q1.What is an outbreak? Ans 1. A disease outbreak is the occurrence of cases of disease

in excess of what would normally be expected in a defined community, geographical area or season. An outbreak may occur in a restricted geographical area, or may extend over several countries. It may last for a few days or weeks, or for several years.

Q2. What is the difference between official, preliminary and daily report?

Ans 2. Official report- may be sent too late for action or response usually meant for documentation & future reference Preliminary report-usually meant as first response & to get more response-to launch control measures-sent asap (usually within the first few hours) Daily report- in major outbreaks- for communication Q3. What are the important points to be avoided during writing a report? Ans 3. the inclusion of careless, inaccurate, or conflicting data the inclusion of outdated or irrelevant data facts and opinions that are not separated unsupported conclusions and recommendations careless presentation and proof-reading Too much emphasis on appearance and not enough on content. Q4. Elaborate the steps involved in report writing. Ans 4. 1) Letter of transmittal: This is a letter to the person who commissioned the report, in which you effectively hand over your work to that person. Include: a salutation (eg. Dear Ms Podolinsky) the purpose of the letter (eg. Here is the final version of the report on Underwater Welding which was commissioned by your organisation.) the main finding of the report any important considerations

 an acknowledgement of any significant help an expression of pleasure or gratitude (eg. Thank you for giving us the opportunity to work on this report.) 2) Title page: This must contain: the report title which clearly states the purpose of the report full details of the person(s) for whom the report was prepared full details of the person(s) who prepared the report the date of the presentation of the report 3) Abbreviations and/or glossary If necessary, you should provide an alphabetical list of the abbreviations you have used in the report, especially if they may not be familiar to all readers of the report. If you have used a lot of technical terms, you should also provide a glossary (an alphabetical list of the terms, with brief explanations of their meanings). 4) Table of Contents usually only if the report is longer than, say, ten pages) This is a list of the headings and appendices of the report. Depending on the complexity and length of the report, you could list tables, figures and appendices separately. Make sure the correct page numbers are shown opposite the contents. Up-to-date word processing packages can generate a table of contents for you.

5) Acknowledgements (if appropriate): This is a short paragraph thanking any person or organization which gave you help in collecting data or preparing the report 6) Abstract (Summary or Executive Summary) An abstract is quite different from an introduction. It is a summary of the report, in which you include one sentence (or so) for every main section of your report. For example, you can include: the context of the research the purpose of the report the major findings (you may need several sentences here) the conclusions the main recommendations Write the abstract after you have written the report. 7) Introduction Give enough background information to provide a context for the report. State the purpose of the report. Clarify key terms and indicate the scope of the report (i.e. what the report will cover). 8)Body The CONTENT of the body depends on the purpose of the report, and whether it is a report of primary or secondary research. A report of primary research (based on your own observations and experiments) would include: LITERATURE REVIEW (what other people have written about this topic). The literature review should lead towards your research question.

 METHOD(summarises what you did and why). Use the past tense. FINDINGS AND RESULTS(describes what you discovered, observed, etc, in your observations and experiements). Use the past tense. DISCUSSION(discusses and explains your findings and relates them to previous research). Use the present tense to make generalisations.

9) Conclusion
Sum up the main points of the report. The conclusion should clearly relate to the objectives of your report. No surprises please! (that is, dont include new information here.) 10) Recommendations These are suggestions for future action. They must be logically derived from the body of your report. Bibliography Q5. Elaborate the various steps for presentation of report. Ans 5. The content and structure of your report is important; so is the presentation and style. First impressions count, so consider these simple tips to ensure your report is reader-friendly: use plenty of white space ensure the separate parts of your report stand out clearly use subheadings allow generous spacing between the elements of your report

 use dot points/ numbers/ letters to articulate these elements Q6. What are the main elements of outbreak communication? Ans 6. Step 1: Assessment Step 2: Coordination Step 3: Transparency Step 4: Listening during outbreaks Step 5: Communication Evaluation. Step 6: Constructing an Emergency Communication Plan Step 7: Training Q7. What communication function or roles should a plan include? Ans 7. Planning Step 6: Constructing an Emergency Communication Plan Capturing the previous steps, develop a written outbreak or emergency communication plan A. What should a plan contain? Setting objectives Pre-event: Set objectives, raising awareness among the public Introduction of disease: first announcement Rapid increase of disease and peak transmission: Effective listening, evaluation and adaptation of communication strategies Decrease in disease and eventual resolution: Outbreak communication must continue, however,

and objectives should include reinforcing vigilance and aiding the recovery process. B. What communication functions or roles should a plan include? A communication plan should describe the various communication roles, or functions, required to achieve the plans objectives Functions and associated responsibilities may include: Communication Leadership: Political liaison: Message Development and material production: Management of Approvals Listening Media Relations Website Management: Partner Communication Coordination Communication evaluation C. Protocols, Procedures, Templates and Contacts Contact lists protocol for the first announcement established system for the distribution of public information Protocols for various high and low technology options for message dissemination Procedures for effective listening in order to determine audience concerns, knowledge, attitudes, and behaviors during the outbreak Potential protocols on the joint announcement of new developments, public health recommendations to limit risk, and other key updates Designation of organization spokespersons

 Specific protocols and arrangements to address common outbreak communication challenges Processes and procedures for communication evaluation during the outbreak Update, simulation and training schedules to promote readiness. Q8. Listening plays a very important role in outbreak communication. Explain. Ans 8. Listening Understanding the publics risk perceptions, views and concerns is critical to effective communication and the broader emergency management function it supports. Without knowing how people understand and perceive a given risk and what their existing beliefs and practices are, decisions and required behavior changes necessary to protect health may not occur and societal or economic disruption may be more severe. Q9. Broaden your views as to how can we train our team during outbreaks? Ans 9. Training programs on risk communication Training exercises such as table top simulations and guided discussions involving both communication staff and outbreak or emergency response management staff. Gaining experience of dealing with the press and media Plans should be reviewed periodically

 Senior management should endorse the emergency communication plan and other outbreak communication planning activities Ensure readiness by establishing a risk communications training program, including simulations and exercises to test the emergency public communication plan and its components Q10. Write down a communication plan for outbreak of dengue in Delhi. Ans 10. Same as Q7. With focus on dengue in Delhi Q11. Which of the following is not essential in writing a report for outbreak? a. Title page b. Introduction c. Body d. Bibliography Ans 11. Bibliography Q12.Fill in the blank
An appendix contains material which is too detailed, technical, or complex to include in the body of the report (for example, specifications, a questionnaire, or a long complex table of figures), but which is referred to in the report Ans 12. Appendix QUESTIONS ON EVIDENCE BASED POLICY
Q1. Evidence based policy is a public policy informed by rigorously established objective evidence What is the meaning of Public Policy in the above statement? Q2. RCT is (a) ______________________ standard for a clinical trial and are used to test the (b) ___________________ and/or (c) ______________________________ of various types of medical intervention within a patient population Answer: (a) Gold, (b) Efficacy and (c) Effectiveness

Q3. How would you define Evidence? Q4. Name the three lenses of evidence based policy and programmes. Answer: Political judgment, professional practices, scientific research Q5. What are the various characteristics of methodologies used for evidence based policy making? Q6. Evidence is also known as ____________________________. Answer: Systematic Research Q7. Systematic research leads to the following: a) __________________________ b) __________________________ c) __________________________ Answer: (a) Policy development (b) Program evaluation (c) Program improvement Q8. What are the limitations of evidence based policy? Q9. The coalition for evidence-based policy is a non-profit organization that advocates that the use of evidence-based policy increases the effectiveness of policy. a) True b) False Answer: a) True

Q10. Define the following a) Evidence based medicine b) Evidence based health service c) Evidence based decision-making

Q11. Describe the types of knowledge bases, which are relevant to evidence based policy. Q12. The crucial enabling factors of evidence-based policy (EBP) are: a) High-quality information bases on relevant topic areas. b) Cohorts of professionals with skills in data analysis and policy evaluation. c) Political incentives for utilizing evidence-based analysis and advice in governmental decisionmaking processes. Mark the correct answer: a) Only A is correct b) A and B are correct c) A, B and C are correct d) None is correct Answer: c) Q13. List down the various flaws in using evidence based policy.

Q14. What is the need for evidence in policy making?

DRAFT QUESTIONS Ques1. Fill in the blanks. a) Two types of Observational studies are _____________ and Analytical studies. b) Descriptive studies basically question time, ____________,and person studies. c) Hypothesis can be accepted or rejected using the techniques of _______________ Epidemiology. Ques 2. State true or false. a) Time distribution has three kinds of distributions short term, periodic and long term. T/F b) During observational studies Intervention of investigation is done by the observer when observing individuals. T/F c) Retrospective studies look forward in time to study events. T/F d) An epidemic is an example of short term distribution of disease in time distribution. T/F e) Descriptive Epidemiology provides data regarding disease magnitude and etiology. T/F

Ques 3- Discuss the following types of research designs in terms of components, strengths, and limitations in determining cause-effect relationships: a. Cross-sectional b. Case-control Ques 4-. Define the following terms briefly: a. Reliability and validity b. Person, time, place variables

Ques 5- What is the difference between clinical and epidemiologic approaches in describing disease?

Ques 6- Distinguish between descriptive and analytic epidemiology.

Ques 7- What are different tests for analysis and discuss significance test?

QUESTIONS SCREENING Q1. Screening is the testing of apparently healthy populations .TRUE/FALSE Q2. Which one of the following is Criteria for Use Of a Screening test 1. Significant burden of disease in the population 2. The disease should be an important public health problem 3. Preclinical stage is detectable and preventable 4. All of above Q3. In natural history of disease the sequence of following events is
A. Clinical stage B. pre-exposure stage C. resolution stage D. pre clinical stage 1. 2. 3. 4. ABCD BDAC ADBC CDAB

Q4. In preclinical stage

1. 2. 3. 4. death

Factors present leading to problem development Exposure to causative agent: no symptoms present Symptoms present Problem resolved. Returned to health or chronic state or

Q5.Mass screening involves screening of: 1. High risk group 2. Whole population 3. None of above 4. Both 1& 2 Q6. Uses of screening is : 1. Case detection2. Control of disease3. Research purpose4. All of above

Q7. Three Characteristics of Screening test : Q8. Screening, in and of itself, does not diagnose disease. TRUE/FALSE Q9.Which one of following is NOT true:
1. 2. 3. 4. Sensitivity detect true positive cases Specificity detect true negative cases Sensitivity detect true negative cases Both 1&2

Q10.Which one of following is true

1. 2. 3. 4. Screening is more expensive than diagnostic test Diagnostic test is more accurate than screening Diagnostic test is not basis for treatment Both 1&3

Solutions

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

TRUE 4 2 2 2 4 ACCEPTIBILITY , REPEATABILITY, VALIDITY TRUE 3 2

CHAPTER 2
UNDERSTANDING AND ANALYZING THE EXTERNAL ENVIRONMENT
Minakshi Gautam Assistant Professor IIHMR, Delhi