2. Explain the process involved in EBP.

(12 marks)

 Recognize and identify the need for information or improvement.

 Formulating the clinical questions

- Must be specific to a clinical situation, patient group and outcome.

- Question must be refined to include particular patient population and the action that
the imaging will be used to direct.

 Identification of medical literature

- Carry out literature research for research-based evidence and search for other evidence.

- based on updated online-journals, books, magazines and libraries.

- Assessing the evidence

- by critically evaluate the strength of evidence such as the types of clinical studies, the
diagnostic performance of a test and the cost-effectiveness of the study.

 Summarizing the evidence

- to produce a summary of all the data on the particular clinically relevant questions.

- Can be qualitative analysis, or quantitative analysis or both.

 Applying the evidence

- Apply the summary results of the literatures to the EBI questions.

- Must take into account several types of efficacy.

Define (8 marks)

1. Sensitivity
2. Specificity
3. Positive predictive value
4. Negative predictive value

1. Sensitivity: Sensitivity measures the proportion of true positive results correctly identified
by a diagnostic test. It calculates the percentage of individuals with the condition who
test positive. A higher sensitivity indicates that the test has a lower chance of producing
false negatives. The formula for sensitivity is:

Sensitivity = (True Positives) / (True Positives + False Negatives)

2. Specificity: Specificity measures the proportion of true negative results correctly identified
by a diagnostic test. It calculates the percentage of individuals without the condition who
test negative. A higher specificity indicates that the test has a lower chance of producing
false positives. The formula for specificity is:

Specificity = (True Negatives) / (True Negatives + False Positives)

3. Positive Predictive Value (PPV): PPV represents the probability that a positive test result is
truly positive. It measures the proportion of true positives among all positive test results.
A higher PPV indicates a higher probability of having the condition given a positive test
result. The formula for PPV is:

PPV = (True Positives) / (True Positives + False Positives)

4. Negative Predictive Value (NPV): NPV represents the probability that a negative test
result is truly negative. It measures the proportion of true negatives among all negative
test results. A higher NPV indicates a higher probability of not having the condition given
a negative test result. The formula for NPV is:

NPV = (True Negatives) / (True Negatives + False Negatives)

Explain the significance of predictive value in diagnostic accuracy. (4 marks)

The significance of predictive value in diagnostic accuracy is as follows:

Determining the Probability of Disease: Predictive value helps estimate the likelihood of a positive or
negative test result accurately indicating the presence or absence of a particular disease or condition.
It provides valuable information to healthcare professionals and patients about the probability of
disease.

Guiding Clinical Decision-Making: Predictive value plays a crucial role in guiding clinical decision-
making. By understanding the predictive value of a diagnostic test, healthcare professionals can
make informed decisions about further diagnostic evaluations, treatment options, or interventions.

Assessing Test Performance: Predictive value is an important measure of test performance. It allows
healthcare professionals to assess how well a diagnostic test performs in practice. By considering
both the positive predictive value (PPV) and negative predictive value (NPV), clinicians can evaluate
the reliability and accuracy of a test in correctly identifying the presence or absence of a disease.

Optimizing Resource Allocation: Predictive value aids in optimizing the allocation of healthcare
resources. It helps identify which tests are most effective and efficient in diagnosing specific
conditions. By considering the predictive value, healthcare providers can prioritize and utilize
resources appropriately, minimizing unnecessary testing and associated costs.

In summary, predictive value in diagnostic accuracy provides valuable insights into the probability of
disease, guides clinical decision-making, assesses test performance, and optimizes resource
allocation. It is a crucial measure for healthcare professionals in determining the reliability and
usefulness of diagnostic tests in clinical practice.

Explain the clinical significance of a randomized clinical trial in EBP.

Randomized clinical trials (RCTs) are considered the gold standard in evidence-based
practice (EBP) because they provide the highest level of evidence to establish causality
between an intervention and its effects on patient outcomes. RCTs are designed to compare
the effects of two or more interventions, one of which is often a standard of
care or placebo, on a specific clinical outcome.
The clinical significance of RCTs in EBP is that they provide rigorous and unbiased evidence
on the effectiveness and safety of interventions. RCTs use random allocation of
participants to intervention groups to minimize the risk of bias and ensure that the groups
being compared are similar in all aspects except for the intervention being tested. This
design helps to reduce the influence of extraneous variables that could affect the study's
results.

Basic elements in the study questions in randomized trials can be structured in what
is known as the PICO format. What is PICO stands for?
- P: Patient, Population, or Problem
- I: Intervention
- C: Comparison
- O: Outcome
 O What is efficacy?
O The ability of an intervention to produce the desired beneficial effect in
expert hands and under ideal circumstances.

What is RCT and its relationship with PICO in EBP

RCT stands for Randomized Controlled Trial. It is a type of scientific study used to evaluate
the effectiveness of a particular intervention or treatment. In an RCT, participants are
randomly assigned to either a treatment group or a control group. The treatment group
receives the intervention being tested, while the control group receives either a placebo or
standard care.
PICO is a framework commonly used in evidence-based practice (EBP) to formulate clinical
questions for research. By using the PICO framework, researchers can construct well-
defined research questions that guide their literature search and help identify relevant
studies, including RCTs. The PICO elements provide a structured approach to define the
population, intervention, comparison, and outcome of interest, which helps in formulating
research questions that can be answered through evidence-based research, including
RCTs.
Difference between cross-sectional and longitudinal study.
1. Cross-sectional study:
 Design: A cross-sectional study is a snapshot or a single-point-in-time
investigation. It collects data from a population or sample at a specific
moment to assess the relationship between variables.
 Timeframe: The data is collected at a single time point, providing a "cross-
section" of the population.
 Data collection: Researchers collect information on exposure and outcome
variables simultaneously.
 Outcome: Cross-sectional studies focus on prevalence or the distribution of
variables of interest at a particular time.
 Example: A survey assessing the prevalence of smoking among different age
groups at a specific point in time.
2. Longitudinal study:
 Design: A longitudinal study follows a group of individuals or subjects over an
extended period, capturing data at multiple time points.
 Timeframe: The study extends over months, years, or even decades, allowing
researchers to observe changes and trends over time.
 Data collection: Researchers collect data on the same subjects at multiple
time points, tracking changes in variables of interest.
 Outcome: Longitudinal studies aim to examine the patterns, trajectories, and
causal relationships between variables over time.
 Example: A study tracking the physical activity levels of a group of individuals
over five years to determine how it correlates with the development of chronic
diseases.
In summary, cross-sectional studies provide a snapshot of a population at a specific time,
focusing on prevalence, while longitudinal studies track changes in individuals or groups
over time, aiming to understand trends, patterns, and causal relationships.
Difference between case-control study and cohort study
Case-Control Studies:
 Design: Start with individuals who already have the outcome (cases) and compare
them to individuals without the outcome (controls).
 Selection: Cases and controls are selected based on the presence or absence of the
outcome, with controls often matched to cases based on certain characteristics.
 Data Collection: Collect data on past exposures or risk factors retrospectively.
 Outcome: Focus on estimating the odds ratio (OR) to measure the association
between exposure and outcome.
 Efficiency: Efficient for studying rare outcomes because cases can be easily
identified.
Cohort Studies:
 Design: Start with individuals without the outcome and categorize them based on
exposure status. Follow the cohort over time to observe the development of the
outcome.
 Selection: Participants categorized into exposed and unexposed groups based on
their exposure to a particular risk factor or intervention.
 Data Collection: Collect data on exposure at the beginning of the study and follow
participants to observe the occurrence of the outcome.
 Outcome: Calculate the relative risk (RR) or incidence rate ratio (IRR) to measure the
association between exposure and outcome.
 Efficiency: Efficient for studying rare exposures because exposure status is
determined before the outcome develops.
In summary, case-control studies start with individuals with and without the outcome, assess
past exposures, and estimate odds ratios. Cohort studies start with individuals exposed and
unexposed to a factor, follow them over time, and estimate relative risks or incidence rate
ratios. The choice between these study designs depends on the research question,
availability of data, and feasibility.
what is the difference between case report/series vs RCT
Case Reports/Series:
 Design: Descriptive and observational study designs.
 Objective: To describe and document unique or rare cases, new diseases, unusual
presentations, adverse events, or treatment outcomes.
 Data Collection: Retrospective or prospective data collection from medical records,
diagnostic tests, interviews, and observations.
 Sample Size: Case reports involve a single case, while case series include a small
group of cases (typically less than 10).
 Statistical Analysis: Case reports/series often lack statistical analysis and primarily
focus on presenting clinical details and observations.
Randomized Controlled Trials (RCTs):
 Design: Experimental study design with random allocation of participants into
treatment and control groups.
 Objective: To evaluate the efficacy, safety, and effectiveness of interventions or
treatments and compare them with alternatives.
 Data Collection: Prospective data collection according to a predefined protocol,
including standardized measurements, outcomes, and follow-up procedures.
 Sample Size: Involves larger sample sizes to achieve statistical power and allow for
generalizability of findings.
 Statistical Analysis: RCTs employ rigorous statistical analysis to assess differences
in outcomes between treatment and control groups, using measures such as p-
values, confidence intervals, and effect sizes.
In summary, case reports/series are descriptive and observational, providing insights into
unique or rare clinical situations. They describe individual cases or small groups of cases.
On the other hand, RCTs are experimental studies comparing interventions or treatments in
randomized groups, aiming to provide robust evidence for treatment efficacy and guide
clinical decision-making.
.
what is the differences between prospective study vs retrospective study?
Prospective Studies:
 Design: Researchers identify a group of participants and follow them forward in time.
 Timing: Data collection starts at the present time and continues into the future.
 Data Collection: Information on exposure, risk factors, and outcomes is collected in
real-time as the study progresses.
 Information Accuracy: Considered to provide more accurate and reliable data since
information is collected prospectively without recall bias.
Retrospective Studies:
 Design: Researchers start by identifying a group of participants and look back in time
to collect data.
 Timing: Data collection occurs after the study design, involving examination of
existing records or databases.
 Data Collection: Researchers collect data that has already been recorded, such as
medical records or historical documents.
 Information Accuracy: May be prone to recall bias as participants recall past
exposures or events.
Both prospective and retrospective studies have their strengths and limitations, and the
choice between them depends on the research question and available resources.
Prospective studies offer the advantage of collecting data in real-time, while retrospective
studies utilize existing data. Understanding these differences helps researchers select the
appropriate study design for their specific research needs.
what is the difference between meta-analysis vs systemic review
A systematic review is a comprehensive and rigorous review of existing literature on a
specific research question. It involves searching for relevant studies, selecting them based
on predetermined criteria, extracting data from the selected studies, and qualitatively
summarizing the findings. The objective of a systematic review is to provide an overview of
the available evidence and draw conclusions based on the synthesized information.

On the other hand, meta-analysis is a statistical technique that is often performed within a
systematic review. It involves selecting studies that meet the inclusion criteria, extracting
relevant data from these studies, and statistically combining the data to calculate a pooled
effect size or odds ratio. Meta-analysis provides a quantitative summary of the data across
studies, offering a more precise estimate of the treatment effect or association.

In summary, a systematic review is a comprehensive synthesis of existing literature,

presenting findings in a narrative format, while a meta-analysis is a statistical technique used
within a systematic review to quantitatively combine and analyze data from selected studies,
providing a pooled effect estimate.

3. List the assumptions made during diagnostic testing. (6 marks)

• Patient either has the disease or not

- Disease present or disease absent

- Not varying severity of disease

• There is a ‘gold standard test available

- This unambiguously tells us whether the disease is present or absent.

• Our test gives a dichotomous result

- Test positive or test negative - no equivocal results

- But may not always be right.

A diagnostic accuracy table, also known as a 2x2 contingency table or a cross-tabulation table, is a
table used to summarize the results of a diagnostic test or screening test. It provides a simple and
organized way to present the performance characteristics of the test in terms of sensitivity,
specificity, positive predictive value (PPV), negative predictive value (NPV), and other related
measures. Here's an explanation of the components of a diagnostic accuracy table:

1. True Positive (TP): The number of individuals with the target condition who test positive on
the diagnostic test.

2. False Positive (FP): The number of individuals without the target condition who test positive
on the diagnostic test (false alarms or false positives).

3. True Negative (TN): The number of individuals without the target condition who test
negative on the diagnostic test.

4. False Negative (FN): The number of individuals with the target condition who test negative
on the diagnostic test (missed cases or false negatives).

The diagnostic accuracy measures derived from these components include:

 Sensitivity: It represents the proportion of true positives among all individuals with the
target condition. Sensitivity is calculated as TP / (TP + FN). It measures the test's ability to
correctly identify individuals with the condition.

 Specificity: It represents the proportion of true negatives among all individuals without the
target condition. Specificity is calculated as TN / (TN + FP). It measures the test's ability to
correctly identify individuals without the condition.

 Positive Predictive Value (PPV): It represents the probability that individuals who test positive
actually have the target condition. PPV is calculated as TP / (TP + FP).

 Negative Predictive Value (NPV): It represents the probability that individuals who test
negative truly do not have the target condition. NPV is calculated as TN / (TN + FN).

 Accuracy: It represents the overall correctness of the test's results. Accuracy is calculated as
(TP + TN) / (TP + TN + FP + FN).

A diagnostic accuracy table allows for a clear visualization of the performance of a diagnostic test by
presenting the true positive, false positive, true negative, and false negative results. From these
values, sensitivity, specificity, PPV, NPV, and accuracy can be calculated to assess the diagnostic test's
validity and utility in accurately identifying individuals with or without the target condition.
Performance of
Clinical Utilisation
Diagnostic Test

 Desired when the disease to be diagnosed is serious, should not be

missed, and is treatable, and false positive results do not have serious
adverse consequences for the patient.

 Want to identify every single patient with the disease for treatment or
A high sensitivity test
further clinical evaluation, even at the cost of misdiagnosing some
healthy people as diseased.

 Preferred when the disease is serious but not treatable, knowledge that
the disease is absent has psychological or public health value, and false
positive results may have serious adverse consequences for the patient.

 Want to identify every single non-affected or healthy individual, even at

the cost of misidentifying some diseased patients as healthy.

 Example would be a test to diagnose an untreatable degenerative

neurologic disorder such as Alzheimer’s disease, where knowledge that
A high specificity test the patient does not have the disease is reassuring but misdiagnosis of a
patient with another treatable form of dementia may deny him or her
appropriate medical treatment.

Performance of
Clinical Utilisation
Diagnostic Test

 Is preferred when the disease to be diagnosed is serious, should not be

missed, and is treatable, and false positive results may have serious
A high positive adverse consequences for the patient.
predictive value
 Want to be certain that every patient with a positive test has the disease
in question, even at the risk of missing some diseased patients.

 Desired when the disease is serious but not treatable, knowledge that
the disease is absent has psychological or public health value, and false
A high negative negative results will not have serious adverse consequences for the
predictive value patient.

 This is the least common clinical reality.

High test efficiency  Is preferred when the disease to be diagnosed is serious, should not be
 missed, and is treatable, and false positive and false negative results are
equally serious or potentially injurious to the patient.

 Want to be certain that the test result is accurate whether it is positive or

negative. Most often the case in clinical practice.

 Test efficiency is the least well known of the statistical measures of test
performance. Most often the best measure of the clinical utility of a
diagnostic test. Given the choice of several different diagnostic tests for a
specific disease, with no prior knowledge of the relative performance of
the tests, clinicians will usually end up using the test with the highest test
efficiency.