Clinical Investigations

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Contents
1. INTRODUCTION TO CLINICAL INVESTIGATIONS

- Purpose and Importance of Clinical Investigations
- Ethical Considerations in Clinical Investigations
- Types of Clinical Investigations
2. RESEARCH METHODS AND STUDY DESIGNS

- Observational Studies
- Experimental Studies
- Cross-Sectional Studies
- Case-Control Studies
- Cohort Studies
- Randomized Controlled Trials (RCTs)
- Systematic Reviews and Meta-analyses
3. BIOSTATISTICS FOR CLINICAL INVESTIGATIONS

- Descriptive Statistics
- Measures of Central Tendency and Dispersion
- Hypothesis Testing and Confidence Intervals
- P-values and Significance Testing
- Sample Size and Power Calculation
- Regression Analysis
- Survival Analysis
4. DIAGNOSTIC TESTS AND INTERPRETATION

- Sensitivity, Specificity, and Predictive Values
- Receiver Operating Characteristic (ROC) Curve
- Likelihood Ratios and Diagnostic Odds Ratio
- Bayes' Theorem in Diagnostic Testing
- Interpreting Test Results: Positive and Negative Predictive Values
5. SCREENING AND PREVENTION

- Principles of Screening
- Types of Screening Tests
- Evaluating Screening Programs
- Benefits and Harms of Screening
- Primary, Secondary, and Tertiary Prevention
6. CLINICAL TRIALS AND ETHICAL CONSIDERATIONS

- Phases of Clinical Trials
- Informed Consent and Patient Recruitment
- Randomization and Blinding
- Data Collection and Monitoring
- Adverse Events and Safety Reporting
- Publication Bias and Reporting Guidelines
7. CLINICAL DECISION-MAKING AND EVIDENCE-BASED MEDICINE
- Levels of Evidence
- Critical Appraisal of Medical Literature
- Guidelines and Practice Recommendations
- Shared Decision-Making and Patient Preferences
8. INTERPRETATION OF LABORATORY INVESTIGATIONS

- Hematology and Coagulation Studies
- Biochemical Markers and Serum Tests
- Microbiology and Serology Tests
- Imaging and Radiology Investigations
- Genetic and Molecular Testing
9. INTERPRETATION OF IMAGING STUDIES

- Radiography and X-ray Interpretation
- Computed Tomography (CT) Scans
- Magnetic Resonance Imaging (MRI)
- Ultrasonography and Doppler Studies
- Nuclear Medicine and Positron Emission Tomography (PET)
10. COMMUNICATION OF CLINICAL INVESTIGATION RESULTS

- Medical Report Writing
- Effective Presentation of Findings
- Ethical and Legal Considerations in Results Communication
INTRODUCTION TO CLINICAL INVESTIGATIONS
PURPOSE AND IMPORTANCE OF CLINICAL INVESTIGATIONS
1. Purpose of Clinical Investigations

- Clinical investigations aim to generate scientific evidence and knowledge in the field of
medicine.
- They help answer research questions, evaluate interventions, and advance medical
understanding.
- Clinical investigations provide data for evidence-based decision making in patient care.
© Genentech
2. Importance of Clinical Investigations

- Improve patient outcomes: Clinical investigations contribute to improving patient care by
identifying effective treatments, diagnostic methods, and preventive strategies.
- Enhance medical knowledge: They expand our understanding of diseases,
pathophysiology, and mechanisms of action.
- Drive evidence-based medicine: Clinical investigations provide the foundation for
evidence-based practice, ensuring that medical decisions are supported by scientific
evidence.
- Validate existing practices: Investigations help assess the efficacy and safety of existing
treatments, interventions, and diagnostic tests.
- Identify new therapeutic options: They contribute to the discovery and development of
new drugs, therapies, and medical technologies.
- Influence healthcare policies: Clinical investigations provide crucial data for policymakers
to make informed decisions regarding healthcare resource allocation and guidelines.
- Promote patient safety: Investigations uncover adverse events, identify potential risks,
and contribute to the development of safety guidelines.
3. Types of Clinical Investigations
- Observational studies: These studies observe and analyze existing data without
intervention. They include cross-sectional studies, case-control studies, and cohort studies.
- Experimental studies: They involve deliberate intervention, such as randomized controlled
trials (RCTs) to assess treatment effectiveness. These studies provide the highest level of
evidence.
- Systematic reviews and meta-analyses: These studies synthesize existing research to
provide a comprehensive overview and identify trends.
4. Ethical Considerations in Clinical Investigations:

- Protection of human subjects: Ethical guidelines ensure the rights, welfare, and privacy of
study participants.
- Informed consent: Participants must be fully informed about the study's purpose,
procedures, potential risks, and benefits before providing consent.
- Institutional review boards (IRBs): These committees oversee and approve research
studies to ensure ethical compliance.
! Useful Mnemonics!
- PURPLE: Purpose of Clinical Investigations (PURPOSE)
- VENUE: Importance of Clinical Investigations (VALIDATE, ENHANCE, NEW, EVIDENCE-
BASED, UTILIZE, ENHANCE)
- OBSERVE: Types of Observational Studies (Observational)
- EXPERIENCE: Types of Experimental Studies (Experimental)
- SYNTHESIS: Systematic Reviews and Meta-Analyses (Systematic reviews and Meta-
analyses)
- PIE: Ethical Considerations (Protection, Informed consent, Ethical committees)
Explanation of Mnemonics:
- PURPLE: Helps remember the purpose of clinical investigations, as the color purple can
symbolize scientific exploration and knowledge generation.
- VENUE: Represents the importance of clinical investigations, reminding you of the various
ways they contribute to medical practice.
- OBSERVE: A mnemonic to recall the types of observational studies, as they involve
observing and analyzing existing data without intervention.
- EXPERIENCE: Helps recall the types of experimental studies, as they involve deliberate
intervention to assess treatment effectiveness.
- SYNTHESIS: A mnemonic to remember systematic reviews and meta-analyses, as they
involve synthesizing existing research to provide comprehensive overviews.
- PIE: An easy-to-remember mnemonic for ethical considerations, reminding you of the key
aspects: Protection, Informed consent, and Ethical committees.
ETHICAL CONSIDERATIONS IN CLINICAL INVESTIGATIONS
1. Protection of Human Subjects

- Ethical guidelines ensure the rights, welfare, and privacy of study participants.
- Researchers must prioritize the well-being and safety of individuals involved in clinical
investigations.
- Informed consent is a crucial aspect of protecting human subjects.
© Genentech
2. Informed Consent
- Informed consent is the process through which study participants are fully informed about
the purpose, procedures, potential risks, and benefits of the study.
- Participants should have the capacity to understand the information provided and make
voluntary decisions about their participation.
- Informed consent allows individuals to exercise autonomy and ensures respect for their
rights and dignity.
3. Institutional Review Boards (IRBs)

- IRBs are independent committees responsible for reviewing and approving research
- IRBs assess the study design, participant consent process, potential risks, benefits, and
safeguards for participant protection.
- Their role is to ensure that the benefits of the research outweigh the potential risks and
that ethical guidelines are followed.
4. Privacy and Confidentiality

- Researchers must maintain strict confidentiality regarding participant information
obtained during clinical investigations.
- Measures should be in place to protect participant privacy, including data encryption,
anonymization, and secure storage.
- Identifiable information should be kept confidential, and participants' identities should not
be disclosed without explicit consent.
5. Minimization of Harm and Risk
- Researchers should minimize potential harm and risks to study participants.
- Study protocols should be designed to prioritize participant safety, and potential risks
should be thoroughly assessed and disclosed.
- Adequate safeguards should be implemented to minimize any potential adverse effects.
6. Beneficence and Non-maleficence

- Clinical investigations should aim to maximize benefits for individuals and society while
minimizing harm.
- Researchers have an obligation to act in the best interests of participants and avoid
causing unnecessary harm.
- The potential benefits and risks of the study should be carefully balanced and justified.
7. Reporting and Transparency

- Findings from clinical investigations should be reported accurately and transparently.
- Researchers should strive to share their results openly, contributing to scientific
knowledge and allowing others to validate and build upon the findings.
- Transparent reporting helps avoid publication bias and promotes the reliability and
integrity of research.
! Useful Mnemonics!
- HEROIC: Ethical Considerations (Human subjects, Ethical guidelines, Review boards, Privacy
and Confidentiality, Minimization of harm, Beneficence and Non-maleficence, Reporting and
Transparency)
- ICRP: Key aspects of Informed Consent (Information, Capacity, Voluntary decision, Respect
for autonomy, Participant rights)
- HEROIC: This mnemonic encompasses the major ethical considerations in clinical
investigations, making it easy to remember and recall the key points.
- ICRP: Helps remember the essential elements of informed consent, as each letter
corresponds to a crucial aspect: Information, Capacity, Voluntary decision, Respect for
autonomy, and Participant rights.
PURPOSE AND IMPORTANCE OF CLINICAL INVESTIGATIONS
1. Purpose of Clinical Investigations

- Clinical investigations aim to generate scientific evidence and knowledge in the field of
medicine.
- They help answer research questions, evaluate interventions, and advance medical
understanding.
- Clinical investigations provide data for evidence-based decision making in patient care.
2. Importance of Clinical Investigations

- Improve patient outcomes: Clinical investigations contribute to improving patient care by
identifying effective treatments, diagnostic methods, and preventive strategies.
- Enhance medical knowledge: They expand our understanding of diseases,
pathophysiology, and mechanisms of action.
- Drive evidence-based medicine: Clinical investigations provide the foundation for
evidence-based practice, ensuring that medical decisions are supported by scientific
evidence.
- Validate existing practices: Investigations help assess the efficacy and safety of existing
treatments, interventions, and diagnostic tests.
- Identify new therapeutic options: They contribute to the discovery and development of
new drugs, therapies, and medical technologies.
- Influence healthcare policies: Clinical investigations provide crucial data for policymakers
to make informed decisions regarding healthcare resource allocation and guidelines.
- Promote patient safety: Investigations uncover adverse events, identify potential risks,
and contribute to the development of safety guidelines.
3. Types of Clinical Investigations

- Observational studies: These studies observe and analyze existing data without
intervention. They include cross-sectional studies, case-control studies, and cohort studies.
- Experimental studies: They involve deliberate intervention, such as randomized controlled
trials (RCTs) to assess treatment effectiveness. These studies provide the highest level of
evidence.
- Systematic reviews and meta-analyses: These studies synthesize existing research to
provide a comprehensive overview and identify trends.
4. Ethical Considerations in Clinical Investigations

- Protection of human subjects: Ethical guidelines ensure the rights, welfare, and privacy of
study participants.
- Informed consent: Participants must be fully informed about the study's purpose,
procedures, potential risks, and benefits before providing consent.
- Institutional review boards (IRBs): These committees oversee and approve research
! Useful Mnemonics!
- PIE: Purpose and Importance (Patient outcomes, Improve medical knowledge, Evidence-
based medicine)
- VIVID: Types of Clinical Investigations (Observational, Experimental, Systematic reviews and
meta-analyses)
- EIP: Ethical Considerations (Ethical guidelines, Informed consent, Institutional review
boards)
- PIE: An easy-to-remember mnemonic that emphasizes the purpose and importance of
clinical investigations, as it represents the key aspects of improving patient outcomes,
enhancing medical knowledge, and driving evidence-based medicine.
- VIVID: Helps remember the types of clinical investigations, as each letter corresponds to a
specific type: Observational, Experimental, and Systematic reviews and meta-analyses.
- EIP: A mnemonic to recall the ethical considerations in clinical investigations, as it
represents the key aspects of Ethical guidelines, Informed consent, and Institutional review
boards.
TYPES OF CLINICAL INVESTIGATIONS
1. Observational Studies
- These studies observe and analyze existing data without intervention.
- Cross-sectional studies: Collect data from a population at a single point in time to assess
prevalence and associations.
- Case-control studies: Compare individuals with a particular condition (cases) to those
without the condition (controls) to identify potential risk factors.
- Cohort studies: Follow a group of individuals over time to examine the development of
outcomes and identify potential causes or risk factors.
2. Experimental Studies
- These studies involve deliberate intervention to assess treatment effectiveness.
- Randomized Controlled Trials (RCTs): Participants are randomly assigned to treatment
groups (intervention or control) to evaluate the efficacy and safety of interventions.
- Randomization helps minimize bias and ensures comparability between groups.
- RCTs provide the highest level of evidence for evaluating treatment outcomes.
3. Systematic Reviews and Meta-analyses

- Systematic Reviews: These studies systematically collect, appraise, and synthesize
existing research to provide a comprehensive overview of a specific topic.
- Meta-analyses: They involve statistical analysis of data from multiple studies to generate a
pooled estimate of treatment effects, increasing the statistical power and precision of the
results.
- These studies summarize the evidence from multiple sources, aiding in evidence-based
decision making.
4. Other Types of Clinical Investigations

- Case Reports and Case Series: These involve the detailed description and analysis of
individual cases or a small group of cases. They are often used to generate hypotheses or
describe rare conditions.
- Surveys and Questionnaires: These studies collect data through standardized
questionnaires or surveys to gather information on attitudes, behaviors, and opinions of
participants.
- Qualitative Studies: These investigations explore subjective experiences, perspectives,
and meanings through interviews, focus groups, or observations.
! Useful Mnemonics!
- CARS: Types of Clinical Investigations (Cross-sectional, Case-control, Cohort, Randomized
Controlled Trials, Systematic Reviews)
- ESCQ: Other Types of Clinical Investigations (Case Reports and Case Series, Surveys and
Questionnaires, Qualitative Studies)
- CARS: This mnemonic represents the key types of clinical investigations, including Cross-
sectional, Case-control, Cohort, Randomized Controlled Trials, and Systematic Reviews. It
helps in recalling the different types quickly and efficiently.
- ESCQ: This mnemonic helps remember the other types of clinical investigations, including
Case Reports and Case Series, Surveys and Questionnaires, and Qualitative Studies. Each
letter corresponds to a specific type, aiding in retention.
These comprehensive notes, along with the mnemonics, aim to provide a thorough
understanding of the types of clinical investigations while aiding in memorization and recall.
Remember to critically evaluate the study design and level of evidence provided by each type
when interpreting research findings.
RESEARCH METHODS AND STUDY DESIGNS
OBSERVATIONAL STUDIES
1. Definition
- Observational studies are research designs that observe and analyze existing data without
any intervention or manipulation by the researcher.
- They aim to assess associations, examine relationships between variables, and identify
potential risk factors or patterns of disease occurrence.
2. Types of Observational Studies

a. Cross-sectional Studies:
- Data is collected at a single point in time from a representative sample of the population.
- Used to estimate the prevalence of a disease or condition and explore associations
between variables.
- Cannot establish cause-and-effect relationships.
© The Biology Notes
b. Case-control Studies:
- Compare individuals with a particular condition (cases) to those without the condition
(controls).
- Evaluate potential risk factors, exposures, or protective factors associated with the
disease.
- Retrospective in nature and assess associations, not causality.
© Deakin University
c. Cohort Studies:
- Follow a group of individuals (cohort) over time to determine the incidence of outcomes
or diseases.
- Assess exposure to risk factors and track the development of diseases or outcomes.
- Can be prospective (follow-up from the present into the future) or retrospective (using
historical data).
© Simply Psychology
3. Strengths and Limitations
- Strengths:
- Reflect real-world situations and allow the study of multiple factors simultaneously.
- Can explore rare exposures or outcomes.
- Cost-effective and less time-consuming compared to experimental studies.
- Limitations:
- Cannot establish causality or determine the temporal relationship between exposure and
outcome.
- Subject to bias, confounding, and recall errors.
- Limited control over variables compared to experimental studies.
4. Bias in Observational Studies

- Selection bias: Occurs when the study population is not representative of the target
population, leading to inaccurate results.
- Recall bias: Participants may not accurately remember past exposures or events,
introducing errors in the data.
- Confounding bias: Presence of unmeasured or uncontrolled variables that distort the true
association between the exposure and outcome.
! Useful Mnemonics!
- COCO: Types of Observational Studies (Cross-sectional, Case-control, Cohort)
- SCL: Bias in Observational Studies (Selection bias, Recall bias, Confounding bias)
- COCO: This mnemonic represents the key types of observational studies, including Cross-
sectional, Case-control, and Cohort. It helps in quickly recalling the different types.
- SCL: Helps remember the common biases that can affect observational studies, including
Selection bias, Recall bias, and Confounding bias.
understanding of observational studies while aiding in memorization and recall. Remember to
critically evaluate the study design, potential biases, and limitations when interpreting the
findings from observational studies.
EXPERIMENTAL STUDIES
1. Definition
- Experimental studies are research designs that involve deliberate intervention or
manipulation by the researcher to assess the effectiveness of treatments, interventions, or
preventive measures.
- They aim to establish cause-and-effect relationships by comparing an intervention group
to a control group.
2. Randomized Controlled Trials (RCTs)

- RCTs are the gold standard for experimental studies.
- Participants are randomly assigned to either the intervention group (receives the
treatment) or the control group (receives a placebo or standard treatment).
- Randomization helps minimize bias and ensures comparability between the groups.
- They allow for the assessment of treatment efficacy, safety, and side effects.
© PrevMedFellow
3. Key Features of RCTs
- Blinding: Participants and/or researchers are unaware of the assigned intervention to
minimize bias.
- Single-blind: Participants are unaware of their group assignment.
- Double-blind: Both participants and researchers are unaware of the group assignment.
- Triple-blind: In addition to participants and researchers, the data analysts are also
unaware of the group assignment.
- Placebo control: A control group receives a placebo, a treatment with no active ingredient,
to compare against the intervention group.
- Sample size calculation: Determines the number of participants needed to detect a
statistically significant effect.
- Follow-up: Participants are monitored over a specific period to assess long-term
outcomes.

- Strengths:
- Can establish cause-and-effect relationships.
- High level of control over the intervention and study conditions.
- Results provide strong evidence for treatment effectiveness.
- Limitations:
- May not reflect real-world conditions.
- Ethical concerns if withholding potentially beneficial treatment from the control group.
- Expensive and time-consuming.
! Useful Mnemonics!
- RCT-BPS: Key Features of RCTs (Randomization, Control group, Blinding, Placebo control,
Sample size calculation)
- EXCEL: Experimental Studies (Establish cause-and-effect, eXamine interventions, Control
group, Evidence-based practice, Long-term outcomes)
- RCT-BPS: This mnemonic helps remember the key features of randomized controlled trials,
including Randomization, Control group, Blinding, Placebo control, and Sample size
calculation. It aids in quickly recalling the important elements of an RCT.
- EXCEL: This mnemonic represents the key aspects of experimental studies. It stands for
Establish cause-and-effect, eXamine interventions, Control group, Evidence-based practice,
and Long-term outcomes. It helps emphasize the essential components and goals of
experimental studies.
CROSS-SECTIONAL STUDIES
1. Definition
- Cross-sectional studies are observational research designs that collect data from a
population at a single point in time.
- They aim to estimate the prevalence of a disease or condition and explore associations
between variables.
© The Biology Notes
2. Key Features
- Data collection: Information is gathered from a representative sample of the population
through surveys, interviews, or examinations.
- Snapshot of the population: Provides a snapshot of the population's characteristics,
exposures, and outcomes at a specific time.
- Prevalence estimation: Determines the proportion of individuals with a disease or
condition in the population at a given time.
- Associations: Examines associations between exposure and outcome variables, helping
identify potential risk factors or patterns of disease occurrence.

- Strengths:
- Quick and cost-effective.
- Suitable for studying rare diseases or outcomes.
- Can assess multiple variables simultaneously.
- Limitations:
- Cannot establish cause-and-effect relationships.
- Prone to recall bias or information bias.
- Cannot capture temporal relationships or changes over time.
4. Uses of Cross-sectional Studies
- Determine disease prevalence: Provides estimates of the burden of diseases or conditions
in a population.
- Identify risk factors: Investigates associations between exposures and outcomes, helping
identify potential risk factors.
- Generate hypotheses: Findings from cross-sectional studies can generate hypotheses for
further research.
! Useful Mnemonics!
- SNAP: Key Features of Cross-sectional Studies (Snapshot, Prevalence estimation,
Associations)
- PIRATE: Uses of Cross-sectional Studies (Prevalence estimation, Identify risk factors,
Generate hypotheses)
- SNAP: This mnemonic represents the key features of cross-sectional studies, including
Snapshot, Prevalence estimation, and Associations. It aids in quickly recalling the important
aspects of cross-sectional study design.
- PIRATE: This mnemonic represents the common uses of cross-sectional studies, including
Prevalence estimation, Identify risk factors, and Generate hypotheses. It helps emphasize the
practical applications of cross-sectional studies.
understanding of cross-sectional studies while aiding in memorization and recall. Remember
to consider the limitations and potential biases associated with cross-sectional studies when
interpreting the findings.
CASE-CONTROL STUDIES
1. Definition
- Case-control studies are observational research designs that compare individuals with a
particular outcome (cases) to those without the outcome (controls) to investigate
associations between exposures and diseases.
© HowMed
2. Study Design
- Cases: Individuals with the disease or outcome of interest are identified.
- Controls: Individuals without the disease or outcome are selected from the same
population as the cases.
- Exposure assessment: Past exposures or risk factors are assessed retrospectively
through medical records, interviews, or questionnaires.
3. Key Features
- Retrospective: Case-control studies look back in time to assess exposures before the
outcome occurred.
- Efficient for rare outcomes: Suitable for studying rare diseases because cases can be
specifically selected.
- Odds ratio (OR): Calculated to estimate the association between exposure and disease.
- OR > 1: Positive association (exposure increases the odds of disease).
- OR = 1: No association.
- OR < 1: Negative association (exposure reduces the odds of disease).
- Strengths:
- Efficient for studying rare diseases or outcomes.
- Requires a smaller sample size compared to cohort studies.
- Useful for investigating multiple exposures.
- Limitations:
- Prone to recall bias or selection bias.
- Cannot establish causality.
- Difficult to establish temporal relationships between exposure and outcome.
5. Uses of Case-Control Studies

- Identify risk factors: Investigates associations between exposures and outcomes, helping
- Generate hypotheses: Provides a basis for further research and study design.
- Assess rare outcomes: Useful for studying diseases or outcomes that have low prevalence
in the population.
! Useful Mnemonics!
- CASE: Key Features of Case-Control Studies (Cases, Assess exposures, Sample from
population, Estimate association)
- RIG: Interpretation of Odds Ratio (Risk, Increase, Greater than 1)
- CASE: This mnemonic represents the key features of case-control studies, including Cases,
Assess exposures, Sample from population, and Estimate association. It helps in quickly
recalling the essential components of a case-control study design.
- RIG: This mnemonic aids in the interpretation of the odds ratio (OR). It stands for Risk,
Increase, Greater than 1. When the odds ratio is greater than 1, it suggests a positive
association, indicating that the exposure increases the risk or odds of the disease.
understanding of case-control studies while aiding in memorization and recall. Remember to
consider the limitations and potential biases associated with case-control studies when
interpreting the findings.
COHORT STUDIES
1. Definition
- Cohort studies are observational research designs that follow a group of individuals over
time to investigate the association between exposures and outcomes.
© HowMed
2. Study Design
- Selection: Two groups are identified based on exposure status: exposed and unexposed.
- Follow-up: Both groups are followed prospectively to assess the development of outcomes
of interest.
- Exposure assessment: Exposures are measured at the beginning of the study and may be
repeated during follow-up.
3. Key Features
- Prospective: Cohort studies begin with the identification of the study population and
follow them forward in time.
- Exposure precedes outcome: Allows for the assessment of temporal relationships
between exposure and outcome.
- Relative risk (RR): Calculated to estimate the association between exposure and disease.
- RR > 1: Positive association (exposure increases the risk of disease).
- RR = 1: No association.
- RR < 1: Negative association (exposure reduces the risk of disease).
- Strengths:
- Can establish temporal relationships and evaluate cause-and-effect.
- Can study multiple outcomes and examine different exposures.
- Limitations:
- Costly and time-consuming.
- Prone to loss to follow-up and attrition bias.
- Not suitable for rare outcomes or long-latency diseases.
5. Uses of Cohort Studies

- Investigate risk factors: Assess the relationship between exposures and outcomes to
- Evaluate preventive measures: Determine the effectiveness of interventions or
treatments over time.
- Study natural history: Examine the progression and prognosis of diseases.
! Useful Mnemonics!
- FOLLOW: Key Features of Cohort Studies (Follow-up, Observational, Longitudinal, Low risk
of bias)
- PEAR: Interpretation of Relative Risk (Positive association, Exposed group, Above 1, Risk
increased)
- FOLLOW: This mnemonic represents the key features of cohort studies, including Follow-
up, Observational design, Longitudinal nature, and Low risk of bias. It helps in quickly
recalling the essential components of a cohort study design.
- PEAR: This mnemonic aids in the interpretation of the relative risk (RR). It stands for
Positive association, Exposed group, Above 1, Risk increased. When the relative risk is above
1, it suggests a positive association, indicating that the exposure increases the risk of the
disease.
© Jmarchn via Wikimedia Commons
RANDOMIZED CONTROLLED TRIALS (RCTS)
1. Definition
- Randomized controlled trials (RCTs) are experimental research designs that randomly
assign participants to different treatment groups to investigate the efficacy and safety of
interventions or treatments.
2. Study Design
- Randomization: Participants are randomly assigned to either the intervention group or the
control group.
- Intervention: The intervention group receives the experimental treatment, while the
control group receives either a placebo or standard treatment.
- Outcome assessment: The outcomes of interest are measured and compared between the
groups.
3. Key Features
- Random assignment: Participants are assigned to groups randomly, reducing selection
bias and ensuring comparability.
- Control group: The control group provides a reference for comparing the outcomes with
the intervention group.
- Blinding: Blinding can be single-blind (participants or assessors unaware of treatment
allocation) or double-blind (both participants and assessors are unaware).
- Randomized controlled trials can be prospective or retrospective, depending on the study
design.

- Strengths:
- Can establish cause-and-effect relationships.
- Provides a high level of evidence for evaluating treatment efficacy.
- Limitations:
- Expensive and time-consuming.
- Ethical considerations in assigning treatments.
- May not represent real-world clinical scenarios.
5. Uses of RCTs
- Evaluate treatment efficacy: Assess the effectiveness of interventions or treatments
compared to a control group.
- Determine safety profiles: Investigate adverse effects and potential risks associated with
treatments.
- Inform clinical guidelines and practice: RCTs provide strong evidence to guide clinical
decision-making.
! Useful Mnemonics!
- RCT: Randomized Controlled Trials (Random assignment, Comparison groups, Treatment
efficacy)
- GOLD: Benefits of RCTs (Gold standard, Obtain causal relationships, Level of evidence,
Decision-making)
- RCT: This mnemonic represents the key features of randomized controlled trials, including
Random assignment, Comparison groups, and Treatment efficacy. It helps in quickly recalling
the essential components of an RCT study design.
- GOLD: This mnemonic highlights the benefits of RCTs, including being the Gold standard for
evaluating treatment efficacy, the ability to Obtain causal relationships, providing a high Level
of evidence, and guiding clinical Decision-making.
understanding of randomized controlled trials while aiding in memorization and recall.
Remember to consider the strengths and limitations of RCTs when interpreting the findings.
© PrevMedFellow via Wikimedia Commons

SYSTEMATIC REVIEWS AND META-ANALYSES
1. Definition
- Systematic reviews and meta-analyses are research methods that systematically gather
and analyze existing evidence to provide a comprehensive summary of studies on a specific
topic.
© American Educational Research Association
2. Study Design
- Systematic reviews: A rigorous process that identifies, selects, and critically appraises
relevant studies to answer a specific research question.
- Meta-analysis: A statistical technique that combines data from multiple studies to
generate a quantitative summary of the findings.
3. Key Features
- Comprehensive search: Systematic reviews aim to include all relevant studies on a given
topic by performing a thorough search of databases, journals, and other sources.
- Critical appraisal: Selected studies are assessed for their quality, methodology, and risk of
bias to determine their validity and reliability.
- Quantitative synthesis: Meta-analysis statistically combines data from individual studies to
calculate summary effect estimates and assess overall treatment effects.
- Strengths:
- Provide a comprehensive overview of available evidence.
- Can detect patterns, trends, and treatment effects that may not be apparent in individual
studies.
- Limitations:
- Reliability and quality of included studies can impact the validity of the findings.
- Heterogeneity among studies can influence the results.
- Publication bias may occur if only certain studies are included.
5. Uses of Systematic Reviews and Meta-Analyses

- Inform evidence-based practice: Provide a robust summary of available evidence to guide
clinical decision-making.
- Identify research gaps: Highlight areas where further studies are needed to improve
knowledge and practice.
- Influence healthcare policies and guidelines: The findings of systematic reviews and meta-
analyses can shape healthcare policies and recommendations.
! Useful Mnemonics!
- SAMURAI: Key Steps in Systematic Reviews and Meta-Analyses (Search, Appraise, Meta-
analyze, Understand, Report, Apply, Influence)
- SUMMARIZE: Benefits and Purpose of Systematic Reviews and Meta-Analyses (Summary of
evidence, Unbiased synthesis, Measures of effect, Meta-analysis, Appraisal of studies,
Recommendations, Identify gaps, Zest for practice, Educate)
- SAMURAI: This mnemonic represents the key steps involved in conducting systematic
reviews and meta-analyses. It stands for Search, Appraise, Meta-analyze, Understand,
Report, Apply, and Influence. It helps in remembering the essential components of the
process.
- SUMMARIZE: This mnemonic highlights the benefits and purpose of systematic reviews and
meta-analyses. It represents Summary of evidence, Unbiased synthesis, Measures of effect,
Meta-analysis, Appraisal of studies, Recommendations, Identify gaps, Zest for practice, and
Educate. It serves as a reminder of the value and objectives of these research methods.
BIOSTATISTICS FOR CLINICAL INVESTIGATIONS
DESCRIPTIVE STATISTICS
1. Definition
- Descriptive statistics are methods used to summarize and describe the main features of a
dataset or population.
© Scribbr
2. Measures of Central Tendency

- Mean: The average value of a dataset, calculated by summing all values and dividing by the
number of observations.
- Median: The middle value in a dataset when arranged in ascending or descending order.
- Mode: The most frequently occurring value(s) in a dataset.
3. Measures of Dispersion
- Range: The difference between the maximum and minimum values in a dataset.
- Variance: A measure of how spread out the values are from the mean.
- Standard Deviation: The square root of the variance, representing the average distance of
values from the mean.
4. Graphical Representations
- Histogram: A visual representation of the distribution of a dataset, showing the frequency
of values within predefined intervals.
- Box Plot: A graphical display of the minimum, first quartile, median, third quartile, and
maximum values, providing a summary of the dataset's distribution.
- Scatter Plot: A plot showing the relationship between two variables, with each data point
represented by a dot.
5. Interpretation
- Descriptive statistics provide a summary of the dataset's central tendency, dispersion, and
graphical representation.
- They help in understanding the shape of the distribution, identifying outliers, and
describing the variability of the data.
! Useful Mnemonics!
- MMMVRSD: Measures of Central Tendency and Dispersion (Mean, Median, Mode, Variance,
Range, Standard Deviation)
- HBS: Graphical Representations (Histogram, Box Plot, Scatter Plot)
- MMMVRSD: This mnemonic represents the measures of central tendency and dispersion. It
stands for Mean, Median, Mode, Variance, Range, and Standard Deviation. It helps in recalling
these important statistical measures used to describe data.
- HBS: This mnemonic represents the graphical representations commonly used in
descriptive statistics. It stands for Histogram, Box Plot, and Scatter Plot. It aids in
remembering these visual tools for representing data distributions and relationships.
MEASURES OF CENTRAL TENDENCY AND DISPERSION
1. Measures of Central Tendency

- Mean: The average value of a dataset, calculated by summing all values and dividing by the
number of observations.
- Median: The middle value in a dataset when arranged in ascending or descending order.
- Mode: The most frequently occurring value(s) in a dataset.
2. Measures of Dispersion
- Range: The difference between the maximum and minimum values in a dataset.
- Variance: A measure of how spread out the values are from the mean.
- Standard Deviation: The square root of the variance, representing the average distance of
values from the mean.
3. Interpretation
- Measures of central tendency help identify the typical or average value in a dataset.
- The mean is sensitive to extreme values, while the median is more resistant to outliers.
- Measures of dispersion provide information about the spread or variability of the data.
- Range gives an overall sense of the dataset's spread, while variance and standard deviation
provide a more precise measure.
Additional High-Yield Information

- Quartiles: These divide a dataset into four equal parts. The first quartile (Q1) represents the
25th percentile, the second quartile (Q2) is the median, and the third quartile (Q3) is the 75th
percentile.
- Interquartile Range (IQR): The difference between the third quartile (Q3) and the first quartile
(Q1), providing a measure of the spread of the middle 50% of the data.
! Useful Mnemonics!
- MMMVRSD: Measures of Central Tendency and Dispersion (Mean, Median, Mode, Variance,
Range, Standard Deviation)
- Q-Q-Q: Quartiles and Interquartile Range (Quartiles, Interquartile Range)
- MMMVRSD: This mnemonic represents the measures of central tendency and dispersion. It
stands for Mean, Median, Mode, Variance, Range, and Standard Deviation. It helps in recalling
these important statistical measures used to describe data.
- Q-Q-Q: This mnemonic represents quartiles and the interquartile range. It aids in
remembering these concepts and their significance in assessing data variability.
HYPOTHESIS TESTING AND CONFIDENCE INTERVALS
1. Hypothesis Testing
- Hypothesis testing is a statistical method used to make inferences and draw conclusions
about a population based on sample data.
- Null Hypothesis (H0): The statement of no difference or no effect in the population.
- Alternative Hypothesis (H1 or Ha): The statement that contradicts the null hypothesis,
suggesting a difference or effect in the population.
© Repapetilto via Wikimedia Commons
2. Steps in Hypothesis Testing

a. Formulate the Null and Alternative Hypotheses.
b. Choose a significance level (alpha) to determine the threshold for accepting or rejecting
the null hypothesis.
c. Collect and analyze the data using appropriate statistical tests.
d. Calculate the test statistic and compare it to the critical value(s) from the statistical table
or calculate the p-value.
e. Make a decision to either reject or fail to reject the null hypothesis based on the test
statistic or p-value.
3. Confidence Intervals
- Confidence intervals provide a range of values within which a population parameter is
likely to lie.
- Commonly used confidence intervals include the 95% and 99% confidence intervals.
- A 95% confidence interval means that if we were to repeat the study multiple times,
approximately 95% of the intervals would contain the true population parameter.
© Mildred Murray-Ward via Wikimedia Commons
4. Interpretation
- If the p-value is less than the chosen significance level (alpha), we reject the null
hypothesis in favor of the alternative hypothesis.
- If the p-value is greater than or equal to the significance level, we fail to reject the null
hypothesis.
- Confidence intervals help estimate the range of values within which the true population
parameter is likely to fall.

- Type I Error: Rejecting the null hypothesis when it is true (False Positive).
- Type II Error: Failing to reject the null hypothesis when it is false (False Negative).
- Power: The probability of correctly rejecting the null hypothesis when it is false.
! Useful Mnemonics!
- NH, AH, and EH: Null Hypothesis, Alternative Hypothesis, and Error Hypotheses
- P-Value: Probability of Rejecting the Null Hypothesis
- NH, AH, and EH: This mnemonic represents the concepts of Null Hypothesis, Alternative
Hypothesis, and Error Hypotheses. Remembering these abbreviations helps in differentiating
and understanding the key components of hypothesis testing.
- P-Value: The p-value represents the probability of rejecting the null hypothesis. By
associating the letter "P" with p-value, you can easily recall its meaning and significance in
hypothesis testing.
P-VALUES AND SIGNIFICANCE TESTING
1. P-values
- P-values quantify the probability of obtaining a result as extreme as, or more extreme than,
the observed data under the assumption that the null hypothesis is true.
- They range between 0 and 1, where a smaller P-value indicates stronger evidence against
the null hypothesis.
© Repapetilto via Wikimedia Commons

2. Significance Testing
- Significance testing helps determine whether the observed data provides enough
evidence to reject the null hypothesis in favor of the alternative hypothesis.
- The null hypothesis assumes no difference or no effect, while the alternative hypothesis
suggests a difference or effect in the population.
© Analytics Toolkit
3. Interpreting P-values
- If the P-value is less than the chosen significance level (α), typically 0.05 or 0.01, it is
considered statistically significant.
- A small P-value suggests that the observed data is unlikely to occur by chance alone,
supporting the alternative hypothesis.
- If the P-value is greater than the significance level, it is not statistically significant, and we
fail to reject the null hypothesis.
4. Key Points
- P-values do not measure the magnitude or clinical significance of an effect, only the
strength of evidence against the null hypothesis.
- Significance testing helps researchers make decisions based on statistical evidence but
should be interpreted in the context of the study and other relevant factors.

- Confidence Intervals: Confidence intervals provide a range of values within which the true
population parameter is likely to fall.
! Useful Mnemonics!
- P for Proof or P for Probability
- Alpha for Action or Alpha for Acceptance
- P for Proof or P for Probability: Associating the letter "P" with "Proof" or "Probability" helps in
remembering the concept of P-values. It represents the likelihood of obtaining the observed
data assuming the null hypothesis is true or the strength of evidence against the null
hypothesis.
- Alpha for Action or Alpha for Acceptance: The significance level, often denoted as alpha (α),
can be associated with "Action" or "Acceptance." It serves as the threshold for deciding
whether to take action (reject the null hypothesis) or accept the null hypothesis.
SAMPLE SIZE AND POWER CALCULATION
1. Sample Size
- Sample size refers to the number of participants or observations included in a study.
- Determining an appropriate sample size is crucial to ensure the study's validity, reliability,
and generalizability.
© The Roslin Institute
2. Factors Influencing Sample Size

- Effect size: The magnitude of the difference or relationship being investigated.
- Significance level (α): The desired level of confidence for determining statistical
significance.
- Power (1-β): The probability of correctly rejecting the null hypothesis when it is false.
- Variability: The amount of variation or dispersion in the data.
3. Power Calculation
- Power calculation helps determine the probability of detecting a true effect or relationship
in a study.
- It involves balancing the desired power, significance level, effect size, and variability to
estimate the required sample size.
4. Key Points
- A larger sample size increases the study's power, making it more likely to detect a true
effect or relationship.
- Insufficient sample size can lead to underpowered studies, increasing the risk of type II
errors (false negatives).
- Power calculation should be performed during the study design phase to ensure an
adequate sample size.
5. Calculating Sample Size

- Sample size calculation depends on the study design and the statistical test being used.
- Various statistical formulas and software tools are available for estimating the required
sample size based on the study objectives and parameters.
- Confidence Interval: A range of values within which the true population parameter is likely to
fall.
! Useful Mnemonics!
- Bigger is Better: Remember that a larger sample size is generally better as it increases the
study's power and the likelihood of detecting true effects or relationships.
- Power to Detect: Power is the ability of a study to detect a true effect or relationship.
Associating "Power" with "Detect" helps in remembering that power calculation estimates the
study's ability to detect a true effect.
- N-size for Precision: N-size can be associated with "Number" or "N" representing the sample
size. Precision is achieved by having an adequate sample size that reduces the variability and
increases the accuracy of the study results.
- Bigger is Better: This mnemonic emphasizes the importance of a larger sample size in
increasing the power of the study and the likelihood of detecting true effects or relationships.
Remember that a larger sample size provides more robust and reliable results.
- Power to Detect: By associating "Power" with "Detect," this mnemonic highlights that power
calculation determines the study's ability to detect a true effect or relationship. It reminds you
that a higher power increases the chances of correctly identifying significant findings.
- N-size for Precision: This mnemonic helps in remembering that the sample size,
represented by "N," contributes to the precision of the study results. A larger sample size
reduces variability and provides more accurate estimates of population parameters.
REGRESSION ANALYSIS
1. Definition
- Regression analysis is a statistical method used to examine the relationship between a
dependent variable and one or more independent variables.
- It helps determine how changes in the independent variables are associated with changes
in the dependent variable.
2. Types of Regression Models

a. Simple Linear Regression:
- Involves a single independent variable and a linear relationship with the dependent
variable.
- Equation: Y = β0 + β1X + ε, where Y is the dependent variable, X is the independent
variable, β0 and β1 are coefficients, and ε is the error term.
b. Multiple Linear Regression:

- Involves multiple independent variables to predict the dependent variable.
- Equation: Y = β0 + β1X1 + β2X2 + ... + βnXn + ε.
c. Logistic Regression:
- Used when the dependent variable is categorical (binary or multinomial) rather than
continuous.
- Estimates the probability of an event occurring based on independent variables.
3. Key Concepts
a. Coefficients:
- β0 (intercept) represents the value of the dependent variable when all independent
variables are zero.
- β1, β2, ... (slope coefficients) represent the change in the dependent variable associated
with a unit change in the corresponding independent variable.
b. Goodness of Fit:
- R-squared (R^2) measures the proportion of variance in the dependent variable explained
by the regression model.
- Adjusted R-squared adjusts R^2 for the number of predictors in the model.
c. Assumptions:
- Linearity: The relationship between the dependent and independent variables is linear.
- Independence: The observations are independent of each other.
- Homoscedasticity: The variance of the residuals is constant across all levels of the
independent variables.
- Normality: The residuals follow a normal distribution.
4. Interpretation
- Coefficients can be interpreted as the change in the dependent variable associated with a
one-unit change in the corresponding independent variable.
- p-values indicate the statistical significance of the coefficients.
5. Additional Information
a. Residuals:
- Residuals are the difference between the observed and predicted values of the
dependent variable.
- Examining residuals helps assess the model's accuracy and identify any patterns or
outliers.
b. Multicollinearity:
- Multicollinearity occurs when there is a high correlation among independent variables.
- It can affect the reliability of regression estimates, leading to unstable coefficient
estimates.
! Useful Mnemonics!
- Fit for the Good
- Connect the Coefficients
- Fit for the Good: This mnemonic emphasizes the importance of assessing the goodness of
fit in regression analysis. Remember that a higher R-squared value indicates a better fit of the
regression model to the data.
- Connect the Coefficients: By associating "Coefficients" with "Connect," this mnemonic
reminds you that the coefficients in regression analysis connect the independent and
dependent variables. It emphasizes the significance of interpreting these coefficients to
understand the relationship between the variables.
SURVIVAL ANALYSIS
1. Definition
- Survival analysis is a statistical method used to analyze time-to-event data, focusing on
the time until a specific event occurs.
- It is commonly employed in medical research to study outcomes such as patient survival,
disease recurrence, or treatment efficacy.
© Towards Data Science
2. Key Concepts
a. Survival Time:
- Survival time represents the duration until the event of interest occurs (e.g., death,
disease recurrence).
- It is measured in days, months, years, or any relevant time unit.
b. Censoring:
- Censoring occurs when the event of interest has not occurred for some individuals by the
end of the study or they are lost to follow-up.
- Types of censoring:
i. Right-censoring: The event has not occurred by the end of the study.
ii. Left-censoring: The event occurred before the study started, but the exact time is
unknown.
iii. Interval-censoring: The event occurred within a specific time interval, but the exact
time is unknown.
c. Survival Function:
- The survival function, denoted as S(t), represents the probability of survival beyond time
t.
- S(t) = P(T > t), where T is the survival time.
- The survival curve is a graphical representation of the survival function.
d. Hazard Function:
- The hazard function, denoted as h(t), represents the instantaneous risk of experiencing
the event of interest at time t.
- h(t) = lim(dT(t) / dt) / S(t), where dT(t) is the probability of the event occurring in a small
time interval around t.
- The hazard curve provides insights into the changing risk over time.
3. Survival Analysis Techniques

a. Kaplan-Meier Estimator:
- Used to estimate the survival function when there is right-censored data.
- Calculates the survival probabilities at different time points based on the observed data.
- The Kaplan-Meier curve displays the survival probabilities over time.
b. Cox Proportional Hazards Model:

- Allows for the examination of the relationship between covariates and the hazard rate.
- Assumes that the hazard ratio between any two individuals is constant over time.
- Provides estimates of the covariate effects on survival through hazard ratios.
4. Applications of Survival Analysis

- Assessing the effectiveness of treatments in clinical trials.
- Investigating disease progression, recurrence, or survival outcomes.
- Analyzing time-to-event data in epidemiological studies.
! Useful Mnemonics!
- STC: Survival Time and Censoring
- SAS: Survival Analysis Techniques
- KM: Kaplan-Meier Estimator
- CoxPH: Cox Proportional Hazards Model
- STC: This mnemonic helps remember the fundamental components of survival analysis,
emphasizing the importance of considering survival time and the different types of censoring
present in the data.
- SAS: By associating "Survival Analysis Techniques" with "SAS," this mnemonic highlights the
various statistical methods used in survival analysis, including the Kaplan-Meier estimator
and the Cox proportional hazards model.
- KM: The mnemonic "KM" represents the Kaplan-Meier estimator, which is a powerful tool for
estimating the survival function and generating the Kaplan-Meier curve.
- CoxPH: This mnemonic stands for "Cox Proportional Hazards Model," a widely used
statistical model in survival analysis that allows for the examination of covariate effects on
survival outcomes.
DIAGNOSTIC TESTS AND INTERPRETATION
SENSITIVITY, SPECIFICITY, AND PREDICTIVE VALUES
1. Sensitivity
- Sensitivity is the ability of a test to correctly identify individuals with the disease or
condition (true positives).
- It measures the proportion of true positives among all individuals who have the disease.
- Sensitivity = True Positives / (True Positives + False Negatives)
- A highly sensitive test minimizes false negatives, making it useful for ruling out diseases.
2. Specificity
- Specificity is the ability of a test to correctly identify individuals without the disease or
condition (true negatives).
- It measures the proportion of true negatives among all individuals who do not have the
disease.
- Specificity = True Negatives / (True Negatives + False Positives)
- A highly specific test minimizes false positives, making it useful for confirming the
absence of diseases.
3. Positive Predictive Value (PPV)

- PPV represents the probability that a positive test result accurately indicates the presence
of the disease.
- It measures the proportion of true positives among all individuals with a positive test
result.
- PPV = True Positives / (True Positives + False Positives)
- PPV is influenced by the prevalence of the disease in the population. A higher prevalence
increases the PPV.
4. Negative Predictive Value (NPV)

- NPV represents the probability that a negative test result accurately indicates the absence
of the disease.
- It measures the proportion of true negatives among all individuals with a negative test
result.
- NPV = True Negatives / (True Negatives + False Negatives)
- NPV is also influenced by the prevalence of the disease. A lower prevalence decreases the
NPV.
5. Key Points
- Sensitivity and specificity are inherent properties of a test and depend on the test's
performance characteristics.
- Sensitivity and specificity are inversely related to each other. Increasing one often
decreases the other.
- Sensitivity and specificity help evaluate a test's accuracy and its ability to correctly classify
individuals.
- Positive predictive value (PPV) and negative predictive value (NPV) depend not only on the
test's accuracy but also on the prevalence of the disease in the population being tested.
© Luigi Albert Maria
! Useful Mnemonics!
- SnNOut: Sensitive tests, when Negative, can rule Out the disease.
- SpPIn: Specific tests, when Positive, can rule In the disease.
- SnNOut: This mnemonic reminds you that a highly sensitive test (Sn) with a negative result
(N) can effectively rule out the disease. If a sensitive test is negative, it is unlikely that the
person has the disease. Therefore, a negative result helps rule out the disease.
- SpPIn: This mnemonic emphasizes that a highly specific test (Sp) with a positive result (P)
can effectively rule in the disease. If a specific test is positive, it is highly likely that the
person has the disease. Therefore, a positive result helps rule in the disease.
RECEIVER OPERATING CHARACTERISTIC (ROC) CURVE
1. Definition
- The ROC curve is a graphical representation of the diagnostic accuracy of a binary
classifier (e.g., a diagnostic test) as its discrimination threshold is varied.
- It displays the trade-off between sensitivity and specificity across different threshold
values.
- The curve is created by plotting the true positive rate (sensitivity) against the false positive
rate (1-specificity) at various threshold settings.
© MartinThoma
2. Interpretation
- The ROC curve helps assess the overall performance of a diagnostic test.
- The closer the curve is to the top-left corner, the higher the overall accuracy of the test.
- The area under the ROC curve (AUC) is a quantitative measure of the test's discriminative
ability. AUC ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination).
- AUC provides an estimate of the probability that a randomly chosen positive sample will
have a higher test result than a randomly chosen negative sample.
3. Key Points
- The ROC curve allows clinicians to select the optimal threshold that balances sensitivity
and specificity based on the clinical context.
- A test with an AUC of 0.5 has no discriminatory ability, similar to flipping a coin. AUC values
above 0.7 are generally considered acceptable, while values above 0.8 indicate good
discrimination.
- The ROC curve is useful for comparing different diagnostic tests or different models within
the same test.
- The ROC curve is not affected by the prevalence of the disease in the population.
- ROC curves can be used to calculate sensitivity, specificity, positive predictive value (PPV),
and negative predictive value (NPV) at specific threshold values.
! Mnemonic: ROCK Your Diagnostics: Use this mnemonic to remember the significance and
interpretation of ROC curves.
Explanation of Mnemonic:
- ROCK Your Diagnostics: This mnemonic reminds you of the importance of ROC curves in
evaluating diagnostic tests. It links the term "ROC" with the idea of excelling or performing
well (like a rockstar) in diagnostic assessments. It adds a catchy and memorable element to
reinforce the concept.
LIKELIHOOD RATIOS AND DIAGNOSTIC ODDS RATIO
1. Likelihood Ratios (LR)

- Likelihood ratios are statistical measures used to assess the diagnostic accuracy of a test
and help determine the probability of disease given a positive or negative test result.
- LR(+) indicates how much the odds of having the disease increase when the test result is
positive.
- LR(-) indicates how much the odds of having the disease decrease when the test result is
negative.
© University of Gothenburg
2. Interpretation
- LR(+) greater than 1 suggests an increased likelihood of disease when the test is positive.
- LR(+) of 1 indicates that the test does not alter the pre-test probability of the disease.
- LR(-) less than 1 suggests a decreased likelihood of disease when the test is negative.
- LR(-) of 1 indicates that the test does not alter the pre-test probability of the absence of
disease.
3. Diagnostic Odds Ratio (DOR)

- The DOR combines the information from both the positive and negative likelihood ratios
into a single measure.
- It provides an estimate of the odds of a positive test result in diseased individuals
compared to the odds of a positive test result in non-diseased individuals.
- DOR = (LR+)/ (LR-)
4. Key Points
- Higher LR(+) values indicate a stronger association between a positive test result and the
presence of the disease.
- Lower LR(-) values indicate a stronger association between a negative test result and the
absence of the disease.
- DOR values above 1 suggest a higher diagnostic accuracy of the test, with values farther
from 1 indicating stronger diagnostic performance.
© Smsaladi
! Useful Mnemonics!
1. "LR+ to the Sky, LR- Dive":
- This mnemonic emphasizes the interpretation of likelihood ratios: LR(+) increases the
probability of disease (to the sky), while LR(-) decreases the probability (dives).
- Explanation: Visualize the likelihood of disease going up to the sky with a positive test
result (LR+) and diving down with a negative test result (LR-).
2. "DOR: Dividing Odds for Diagnosis":

- This mnemonic helps remember that the Diagnostic Odds Ratio combines information
from both positive and negative likelihood ratios to assess diagnostic accuracy.
- Explanation: The term "DOR" is associated with dividing odds, indicating that the DOR is
calculated by dividing the odds of a positive test result in diseased individuals by the odds in
non-diseased individuals.
3. "DOR Dance: Divide, Odds Advance, Reliable stance":

- This mnemonic provides additional reinforcement for understanding DOR.
- Explanation: "Divide" refers to dividing the odds, "Odds Advance" emphasizes the
improvement in diagnostic accuracy, and "Reliable stance" highlights the reliability of DOR as
a measure of diagnostic performance.
BAYES' THEOREM IN DIAGNOSTIC TESTING
1. Bayes' Theorem
- Bayes' Theorem is a fundamental concept in diagnostic testing that allows us to update the
probability of a disease given a positive or negative test result.
- It combines the prior probability (pre-test probability) of the disease with the likelihood
ratio of the test to calculate the posterior probability (post-test probability) of the disease.
© Swiss TPH
2. Formula
- Bayes' Theorem can be expressed as:
Posterior Probability = (Likelihood Ratio × Prior Probability) / [(Likelihood Ratio × Prior
Probability) + (1 − Prior Probability) × (1 − Likelihood Ratio)]
3. Key Components
a. Prior Probability: The initial probability of the disease before the test result is known. It is
based on factors such as prevalence, risk factors, and clinical judgment.
b. Likelihood Ratio (LR): The ratio of the probability of obtaining a particular test result in
individuals with the disease to the probability of obtaining the same result in individuals
without the disease.
c. Posterior Probability: The updated probability of the disease after considering the test
result.
4. Interpretation
- A positive test result increases the probability of the disease, while a negative test result
decreases the probability.
- The magnitude of the change in probability depends on the likelihood ratio and the pre-test
probability.
- Bayes' Theorem helps clinicians incorporate test results into the overall clinical picture,
considering both the test performance and the prior probability of the disease.
5. Clinical Application
- Bayes' Theorem is useful in clinical decision-making, particularly when interpreting
diagnostic test results and assessing the probability of a disease.
- It helps determine the post-test probability of a disease given a positive or negative test
result, aiding in diagnosis and treatment decisions.
Additional Information
- Factors influencing pre-test probability:

a. Prevalence of the disease in the population
b. Clinical features and risk factors
c. Patient history and symptoms
d. Results of other diagnostic tests or screening tools
- Likelihood ratios (LR):

a. LR+ (Positive Likelihood Ratio): The ratio of the probability of a positive test result in
individuals with the disease to the probability of a positive test result in individuals without
the disease.
b. LR- (Negative Likelihood Ratio): The ratio of the probability of a negative test result in
individuals with the disease to the probability of a negative test result in individuals without
the disease.
! Mnemonic: "BAYES"
- B: Begin with the prior probability
- A: Apply the likelihood ratio
- Y: Yield the posterior probability
- E: Evaluate the clinical significance
- S: Summarize the results
Explanation: The mnemonic "BAYES" provides a concise and memorable way to remember the
steps involved in applying Bayes' Theorem. It represents the key actions to take when using
Bayes' Theorem in diagnostic testing: Begin with the prior probability, Apply the likelihood
ratio, Yield the posterior probability, Evaluate the clinical significance, and Summarize the
results.
INTERPRETING TEST RESULTS: POSITIVE AND NEGATIVE PREDICTIVE VALUES
© Luigi Albert Maria
1. Positive Predictive Value (PPV)

- Positive Predictive Value is the probability that a positive test result accurately indicates
the presence of the disease.
- PPV depends on the sensitivity and specificity of the test, as well as the prevalence of the
disease in the population.
- Formula: PPV = True Positives / (True Positives + False Positives)
2. Factors influencing PPV

a. Prevalence: As disease prevalence increases, PPV also increases for the same test
performance.
b. Test characteristics: A highly sensitive and specific test yields a higher PPV.
c. False-positive rate: Higher false-positive rate leads to lower PPV.
d. Positive likelihood ratio (LR+): Higher LR+ increases the PPV.
3. Negative Predictive Value (NPV)
- Negative Predictive Value is the probability that a negative test result accurately indicates
the absence of the disease.
- NPV depends on the sensitivity and specificity of the test, as well as the prevalence of the
disease in the population.
- Formula: NPV = True Negatives / (True Negatives + False Negatives)
4. Factors influencing NPV

a. Prevalence: As disease prevalence decreases, NPV increases for the same test
performance.
b. Test characteristics: A highly sensitive and specific test yields a higher NPV.
c. False-negative rate: Higher false-negative rate leads to lower NPV.
d. Negative likelihood ratio (LR-): Lower LR- increases the NPV.
5. Clinical Interpretation
- High PPV: A positive test result indicates a high probability of the disease.
- Low NPV: A negative test result does not rule out the possibility of the disease.
- High NPV: A negative test result suggests a low probability of the disease.
- Low PPV: A positive test result does not guarantee the presence of the disease.
6. Likelihood Ratios (LR)

- Likelihood ratios provide additional information about the diagnostic accuracy of a test.
- Positive likelihood ratio (LR+): Ratio of the true positive rate to the false positive rate.
- Negative likelihood ratio (LR-): Ratio of the false negative rate to the true negative rate.
- Higher LR+ increases the PPV, while lower LR- increases the NPV.
! Mnemonic: "PPV-NPV-LR+LR-"
- P: Positive Predictive Value (PPV)
- N: Negative Predictive Value (NPV)
- LR+: Positive Likelihood Ratio
- LR-: Negative Likelihood Ratio
Explanation: The mnemonic "PPV-NPV-LR+LR-" includes the abbreviations for Positive

Predictive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (LR+), and
Negative Likelihood Ratio (LR-). This mnemonic helps you remember the key concepts
related to test result interpretation. It emphasizes the importance of considering both PPV
and NPV, as well as the role of likelihood ratios in understanding the diagnostic accuracy of a
test.
SCREENING AND PREVENTION
PRINCIPLES OF SCREENING
1. Definition
- Screening is a strategy used in public health to identify individuals at risk of a particular
condition or disease in order to intervene early and reduce morbidity and mortality.
© Mcstrother
2. Principles of Screening
a. Suitability: The condition should have a significant impact on health, and effective
treatments or interventions should be available.
b. Target Population: The target population should be clearly defined and easily identifiable.
c. Test Validity: The screening test should be accurate, reliable, and validated for the target
population.
d. Sensitivity and Specificity: The screening test should have high sensitivity to detect true
positives and high specificity to minimize false positives.
e. Harm vs. Benefit: The benefits of screening should outweigh the potential harms, such as
false-positive results, overdiagnosis, and unnecessary interventions.
f. Cost-effectiveness: The screening program should be cost-effective, considering the
resources required for implementation and potential benefits.
g. Ethical Considerations: Screening programs should adhere to ethical principles, including
informed consent, privacy, and confidentiality.
3. Types of Screening
a. Mass Screening: Screening is offered to the entire target population, regardless of
individual risk factors.
b. Selective Screening: Screening is offered to individuals with specific risk factors for the
condition.
c. Opportunistic Screening: Screening is conducted opportunistically when individuals seek
healthcare services.
4. Screening Process
a. Pre-screening: Assess the feasibility, benefits, and potential harms of the screening
program.
b. Screening Test: Choose a validated test with high sensitivity and specificity for the target
condition.
c. Diagnosis: Confirmatory tests are performed on individuals with positive screening
results.
d. Treatment and Follow-up: Provide appropriate interventions and follow-up for individuals
diagnosed with the condition.
5. Evaluating Screening Programs

a. Sensitivity: Proportion of individuals with the condition correctly identified by the
screening test.
b. Specificity: Proportion of individuals without the condition correctly identified as
negative by the screening test.
c. Positive Predictive Value (PPV): Probability of having the condition given a positive
screening test result.
d. Negative Predictive Value (NPV): Probability of not having the condition given a negative
e. False Positive Rate: Proportion of individuals without the condition who receive a positive
f. False Negative Rate: Proportion of individuals with the condition who receive a negative
! Mnemonic: "SCT SHAPES"

- Suitability
- Target Population
- Test Validity
- Sensitivity and Specificity
- Harm vs. Benefit
- Cost-effectiveness
- Ethical Considerations
- Screening Process
Explanation: The mnemonic "SCT SHAPES" encompasses all the important elements of the
principles of screening. Each letter represents a key concept, facilitating memorization and
recall. Additionally, the notes cover the types of screening, the screening process, and the
evaluation measures. Use this mnemonic and the comprehensive notes to reinforce your
understanding of the principles of screening effectively.
TYPES OF SCREENING TESTS
1. Definition
- Screening tests are used to identify individuals at risk of a particular condition or disease
in a population before the onset of symptoms, allowing for early intervention and treatment.
2. Types of Screening Tests

a. Laboratory Tests:
- Blood tests: Measure levels of specific biomarkers or markers of disease.
- Urine tests: Analyze urine for the presence of substances indicative of certain
conditions.
- Genetic tests: Detect specific genetic mutations associated with inherited diseases.
b. Imaging Tests:
- X-rays: Use low-dose radiation to visualize bones and organs.
© BruceBlaus
- Mammography: X-ray imaging of the breasts for early detection of breast cancer.
© BruceBlaus
- CT scan: Provides detailed cross-sectional images of the body.
© FDA
- MRI: Uses magnetic fields and radio waves to produce detailed images of structures.
c. Screening Questionnaires:
- Surveys or questionnaires administered to assess individuals' risk factors or symptoms
related to a specific condition.
d. Physical Examination:
- Hands-on assessment by a healthcare professional to detect abnormalities or signs of
disease.
e. Functional Tests:
- Assess the function of specific organs or systems in the body.
- Examples include lung function tests, stress tests, and eye examinations.
f. Diagnostic Procedures:
- Invasive procedures performed to detect and diagnose diseases.
- Examples include colonoscopy, biopsy, and Pap smear.
3. Selection of Screening Tests

a. Sensitivity: The ability of a test to correctly identify individuals with the condition.
b. Specificity: The ability of a test to correctly identify individuals without the condition.
c. Positive Predictive Value (PPV): The probability that individuals with a positive test result
truly have the condition.
d. Negative Predictive Value (NPV): The probability that individuals with a negative test
result truly do not have the condition.
e. Safety and Risk: Consider the potential risks associated with the test, such as radiation
exposure or invasive procedures.
f. Cost and Availability: Evaluate the cost-effectiveness and accessibility of the screening
test.
! Mnemonic: "SCAN-DiPS"
Explanation:
- SCAN represents the different types of screening tests:
- S: Laboratory Tests (Blood, Urine, Genetic)
- C: Imaging Tests (X-rays, Mammography, CT scan, MRI)
- A: Screening Questionnaires
- N: Physical Examination
- DiPS represents additional screening test categories:
- Di: Diagnostic Procedures
- P: Functional Tests
- S: Safety and Risk considerations
The mnemonic "SCAN-DiPS" helps remember the main categories of screening tests.
EVALUATING SCREENING PROGRAMS
1. Introduction
- Screening programs aim to detect diseases or conditions in a population at an early stage,
allowing for timely intervention and treatment. However, the effectiveness of a screening
program needs to be evaluated to ensure its benefits outweigh the harms.
© European Journal of Epidemiology
2. Key Considerations in Evaluating Screening Programs

a. Sensitivity: The ability of a screening test to correctly identify individuals with the
condition.
b. Specificity: The ability of a screening test to correctly identify individuals without the
condition.
c. Positive Predictive Value (PPV): The probability that individuals with a positive test result
truly have the condition.
d. Negative Predictive Value (NPV): The probability that individuals with a negative test
result truly do not have the condition.
e. False Positive Rate: The proportion of individuals without the condition who receive a
positive test result.
f. False Negative Rate: The proportion of individuals with the condition who receive a
negative test result.
3. Evaluation Metrics for Screening Programs

a. Sensitivity = True Positives / (True Positives + False Negatives)
b. Specificity = True Negatives / (True Negatives + False Positives)
c. Positive Predictive Value (PPV) = True Positives / (True Positives + False Positives)
d. Negative Predictive Value (NPV) = True Negatives / (True Negatives + False Negatives)
e. False Positive Rate = 1 - Specificity
f. False Negative Rate = 1 - Sensitivity
4. Additional Evaluation Factors

a. Cost-Effectiveness: Assess the balance between the cost of the screening program and
the health benefits gained.
b. Harm-to-Benefit Ratio: Evaluate potential harms, such as false-positive results,
overdiagnosis, and overtreatment, against the benefits of early detection and intervention.
c. Population Considerations: Assess the applicability of the screening program to the
target population, taking into account factors such as age, gender, and risk factors.
5. Key Steps in Evaluating Screening Programs

a. Study Design: Conduct well-designed studies, including randomized controlled trials,
cohort studies, or case-control studies, to assess the effectiveness and impact of the
screening program.
b. Data Collection: Collect accurate and reliable data on screening test results, diagnostic
outcomes, and follow-up measures.
c. Analysis: Perform statistical analyses to determine the performance metrics of the
screening program.
d. Interpretation: Evaluate the results in the context of the screening program's goals,
target population, and resources available.
e. Continuous Monitoring and Update: Regularly assess and update the screening program
based on new evidence and emerging technologies.
! Mnemonic: "SENSIPRO-NaF"
Explanation:
- "SENSIPRO" represents the key evaluation metrics and factors:
- S: Sensitivity
- S: Specificity
- PPV: Positive Predictive Value
- NPV: Negative Predictive Value
- PRO: Cost-Effectiveness and Harm-to-Benefit Ratio
- "NaF" refers to the key steps in evaluating screening programs:
- N: Study Design
- a: Data Collection
- F: Analysis
- Continuous Monitoring and Update
The mnemonic "SENSIPRO-NaF" helps students remember the important evaluation metrics
and steps in assessing screening programs.
BENEFITS AND HARMS OF SCREENING
1. Introduction
- Screening is a strategy used to detect diseases or conditions in asymptomatic individuals,
with the aim of reducing morbidity and mortality through early detection and treatment.
However, screening programs come with both benefits and potential harms.
© BY-NC-SA
2. Benefits of Screening
a. Early Detection: Screening can identify diseases at an early stage when treatment is
more effective, leading to better health outcomes.
b. Reduced Mortality: Detecting and treating conditions early can decrease the risk of death
from diseases such as cancer or cardiovascular diseases.
c. Improved Quality of Life: Early detection and intervention can prevent or delay the onset
of symptoms, improving the overall quality of life for individuals.
d. Public Health Impact: Population-based screening programs can reduce the burden of
disease in the community and improve public health.
3. Harms of Screening
a. False-Positive Results: Screening tests can produce false-positive results, leading to
unnecessary anxiety, further invasive tests, and potential harm from treatment or
procedures.
b. False-Negative Results: False-negative results may give individuals a false sense of
security, delaying the diagnosis and treatment of a condition.
c. Overdiagnosis and Overtreatment: Screening may detect conditions that would never
cause harm or symptoms during a person's lifetime, leading to unnecessary treatments and
interventions.
d. Physical and Psychological Harm: Diagnostic procedures, such as biopsies or surgeries,
can have associated risks and complications. Screening can also cause anxiety, stress, and
psychological distress.
e. Financial Costs: Screening programs can be expensive, both for individuals and
healthcare systems, particularly when considering follow-up tests and treatments for false-
positive results.
4. Balancing Benefits and Harms

a. Evidence-Based Guidelines: Screening recommendations should be based on rigorous
evidence and consider the balance between benefits and harms.
b. Informed Decision-Making: Individuals should be provided with clear and accurate
information about the potential benefits and harms of screening, allowing them to make
informed decisions based on their preferences and values.
c. Targeted Screening: Screening should be focused on populations at higher risk for the
disease to maximize benefits and minimize harms.
d. Regular Evaluation: Ongoing monitoring and evaluation of screening programs are
necessary to assess their effectiveness, update guidelines, and minimize harms.
! Mnemonic: "BEHARS" and "PICTURE"

Explanation:
- "BEHARS" represents the key points about the benefits and harms of screening:
- B: Benefits of Screening
- E: False-Positive Results
- H: False-Negative Results
- A: Overdiagnosis and Overtreatment
- R: Physical and Psychological Harm
- S: Financial Costs
- This mnemonic helps students remember the key benefits and potential harms associated
with screening programs.
- "PICTURE" represents the principles for balancing benefits and harms:

- P: Evidence-Based Guidelines
- I: Informed Decision-Making
- C: Targeted Screening
- T: Regular Evaluation
- U: Maximizing Benefits, Minimizing Harms
- R: Review and Update Guidelines
- E: Effective and Efficient Screening Programs
PRIMARY, SECONDARY, AND TERTIARY PREVENTION
© BMJ Journals
1. Primary Prevention
- Primary prevention aims to prevent the development of a disease or condition before it
occurs.
- Strategies:
a. Health Promotion: Promoting healthy behaviors and lifestyles to reduce the risk of
disease. Examples include encouraging physical activity, healthy eating, and smoking
cessation.
b. Immunizations: Administering vaccines to prevent infectious diseases and their
complications.
c. Environmental Interventions: Implementing measures to reduce exposure to harmful
substances or conditions, such as clean water supply, air pollution control, and workplace
safety regulations.
d. Genetic Counseling and Screening: Identifying individuals at risk for genetic disorders
and providing counseling and screening options.
2. Secondary Prevention
- Secondary prevention aims to detect and treat a disease or condition in its early stages to
prevent its progression and reduce complications.
- Strategies:
a. Screening Programs: Conducting routine screenings to detect diseases or risk factors in
asymptomatic individuals. Examples include mammography for breast cancer, Pap smears
for cervical cancer, and blood pressure measurements for hypertension.
b. Diagnostic Testing: Performing tests to confirm the presence of a disease in individuals
with symptoms or risk factors.
c. Early Intervention: Initiating treatment early to prevent or delay the progression of a
disease and its associated complications.
3. Tertiary Prevention
- Tertiary prevention focuses on managing and improving the outcomes of individuals who
already have a disease or condition.
- Strategies:
a. Disease Management Programs: Implementing comprehensive care plans and
interventions to optimize the management of chronic diseases, such as diabetes, heart
disease, or asthma.
b. Rehabilitation Services: Providing therapies and interventions to restore function,
improve quality of life, and minimize disability in individuals with disabilities or after acute
events like stroke or injury.
c. Supportive Care: Offering palliative care, pain management, and psychosocial support to
individuals with advanced or terminal illnesses.
! Mnemonic: "3 P's: Prevent, Detect, Manage"

Explanation:
- The mnemonic "3 P's: Prevent, Detect, Manage" represents the three levels of prevention:
- Prevent: Primary Prevention
- Detect: Secondary Prevention
- Manage: Tertiary Prevention
- This mnemonic helps students remember the purpose of each level of prevention in a
concise and memorable way.
CLINICAL TRIALS AND ETHICAL CONSIDERATIONS
PHASES OF CLINICAL TRIALS
© Cancer Institute NSW
1. Phase 1
- Objective: Assess the safety, dosage, and pharmacokinetics of a new intervention in a
small group of healthy volunteers or patients.
- Number of Participants: Usually involves fewer than 100 participants.
- Key Focus: Determining the maximum tolerated dose, evaluating adverse effects, and
establishing preliminary evidence of efficacy.
- Duration: Generally lasts several months.
2. Phase 2
- Objective: Assess the efficacy and further evaluate the safety of the intervention in a
larger group of patients with the target condition.
- Number of Participants: Typically involves several hundred participants.
- Key Focus: Evaluating the optimal dosage and dosing regimen, monitoring side effects,
and gathering more data on efficacy.
- Duration: Typically lasts several months to two years.
3. Phase 3
- Objective: Assess the intervention's effectiveness and safety in a larger, more diverse
patient population.
- Number of Participants: Involves hundreds to thousands of participants.
- Key Focus: Comparing the new intervention to existing standard treatments or placebos,
assessing the overall benefit-risk profile, and detecting less common adverse effects.
- Duration: Can last several years.
4. Phase 4 (Post-marketing Surveillance)
- Objective: Monitor the intervention's long-term safety, efficacy, and optimal use in a larger
patient population after it has been approved for clinical use.
- Number of Participants: Involves thousands of participants.
- Key Focus: Detecting rare or long-term adverse effects, assessing the intervention's
effectiveness in specific patient subgroups, and evaluating its real-world outcomes.
- Duration: Can continue indefinitely.
! Mnemonic: "Dive Deep, Reach the Shore"

Explanation:
- The mnemonic "Dive Deep, Reach the Shore" helps students remember the key focus of
each phase of clinical trials.
- "Dive Deep" represents Phases 1 and 2, where the focus is on diving deep into the
intervention's safety, dosage, efficacy, and side effects.
- "Reach the Shore" represents Phases 3 and 4, where the focus is on reaching the shore of
larger patient populations, comparing interventions, and monitoring long-term safety and
effectiveness.
INFORMED CONSENT AND PATIENT RECRUITMENT
1. Informed Consent
- Definition: Informed consent is a process where individuals are provided with
comprehensive information about a medical procedure, treatment, or research study,
enabling them to make voluntary and informed decisions about their participation.
- Key Elements:
- Disclosure: Providing relevant information about the purpose, procedures, risks, benefits,
and alternatives involved.
- Understanding: Ensuring that individuals comprehend the information provided.
- Voluntariness: Ensuring that participation is voluntary without coercion or undue
influence.
- Competence: Ensuring that individuals have the capacity to understand and make
decisions.
- Ethical Importance: Informed consent promotes patient autonomy, respects their rights,
and upholds the principle of beneficence.
- Documentation: Informed consent should be documented through written consent forms
signed by the participant or legally authorized representative.
2. Patient Recruitment
- Definition: Patient recruitment is the process of identifying and enrolling eligible
participants for clinical trials or research studies.
- Strategies:
- Advertising: Using various channels to inform potential participants about the study and
its eligibility criteria.
- Referrals: Seeking referrals from healthcare professionals or community organizations.
- Electronic Health Records: Identifying eligible patients through electronic health record
systems.
- Patient Registries: Utilizing databases of individuals interested in participating in
research studies.
- Considerations:
- Inclusion and Exclusion Criteria: Defining specific characteristics and conditions required
for participation.
- Ethics and Privacy: Ensuring confidentiality, privacy, and protection of participants'
rights.
- Informed Consent: Ensuring potential participants are fully informed before their
enrollment.
- Importance: Adequate patient recruitment is crucial for generating valid and generalizable
study results.
! Mnemonic: "PARTNER" and "RECRUIT"
Explanation:
- Mnemonic "PARTNER" captures the essential elements of informed consent:
- P: "Purpose and Procedures" - Reminds to disclose relevant information during the
informed consent process.
- A: "Autonomy and Alternatives" - Emphasizes the importance of voluntary participation and
presenting alternative options.
- R: "Rights and Risks" - Highlights the respect for patient rights and disclosure of potential
risks.
- T: "Transparency and Time" - Stresses the need for transparent communication and
sufficient time for decision-making.
- N: "Non-coercion and Non-influence" - Reminds to avoid any form of coercion or undue
influence during the consent process.
- E: "Ethics and Eligibility" - Considers ethical principles and eligibility criteria.
- R: "Record and Review" - Promotes documentation of informed consent and the need for
periodic review.
! Mnemonic: "RECRUIT" aids in remembering patient recruitment strategies:

- R: "Referrals" - Seeking referrals from healthcare professionals or community
organizations.
- E: "Electronic Health Records" - Utilizing electronic health record systems to identify
eligible patients.
- C: "Community Engagement" - Engaging with the community to raise awareness and
interest in research studies.
- R: "Registries" - Utilizing patient registries to identify individuals interested in research
participation.
- U: "Advertisements" - Using various channels to advertise the study and its eligibility
criteria.
- I: "Inclusion and Exclusion Criteria" - Defining specific characteristics for participation.
- T: "Timing" - Considering the appropriate timing for recruitment to maximize enrollment.
RANDOMIZATION AND BLINDING
1. Randomization
- Definition: Randomization is a process used in clinical trials to assign participants to
different treatment groups or study arms randomly. It helps ensure that the groups are
comparable and minimizes bias in the assignment of treatments.
- Importance:
- Minimizes Bias: Randomization reduces the likelihood of systematic differences between
treatment groups, enhancing the validity of study results.
- Balances Confounding Factors: Random allocation distributes both known and unknown
confounding factors evenly among the groups.
- Methods of Randomization:
- Simple Randomization: Participants are assigned randomly to treatment groups using
methods like coin flipping or computer-generated random numbers.
- Stratified Randomization: Participants are divided into subgroups based on specific
characteristics, and randomization is performed within each subgroup.
- Block Randomization: Participants are allocated to treatment groups in blocks, ensuring a
balanced distribution throughout the study.
- Allocation Concealment: The process of keeping the treatment assignment hidden from
researchers involved in participant enrollment, ensuring unbiased randomization.
© PrevMedFellow
2. Blinding (Masking)
- Definition: Blinding refers to the concealment of treatment allocation from participants,
researchers, or outcome assessors in a clinical trial.
- Types of Blinding:
- Single-Blind: Either the participants or the researchers are unaware of the treatment
assignment.
- Double-Blind: Both the participants and the researchers are unaware of the treatment
assignment.
- Triple-Blind: Participants, researchers, and outcome assessors are all unaware of the
treatment assignment.
- Purpose of Blinding:
- Minimizes Bias: Blinding prevents conscious or subconscious biases that may influence
treatment outcomes.
- Maintains Objectivity: Blinding ensures that the assessment of outcomes remains
impartial and unbiased.
- Challenges in Blinding: Blinding may be challenging in certain interventions or when the
treatment has obvious physical differences or side effects.
! Mnemonic: "RABBIT" (Random Allocation Balances Bias, Independent Treatment)

- Explanation:
- R: Random Allocation - Represents the process of assigning participants randomly to
different treatment groups.
- A: Balances Bias - Emphasizes how randomization helps minimize bias and ensures
comparability between treatment groups.
- B: Independent Treatment - Highlights the independence of treatment assignment from
external factors or influences.
- BIT: A play on words, "BIT" reminds us of the importance of blinding in clinical trials.
DATA COLLECTION AND MONITORING
1. Data Collection
- Definition: Data collection involves gathering information from study participants or
relevant sources to obtain the necessary data for research or clinical purposes.
- Methods of Data Collection:
- Surveys and Questionnaires: Participants respond to a series of predefined questions
about their demographics, medical history, symptoms, or treatment outcomes.
- Interviews: Researchers conduct face-to-face or phone interviews with participants to
collect detailed information or qualitative data.
- Medical Records Review: Researchers extract relevant data from participants' medical
records, including diagnoses, treatments, laboratory results, and follow-up visits.
- Physical Examinations: Clinicians perform systematic evaluations, including vital signs,
physical assessments, and specialized examinations, to collect specific clinical data.
- Biomarker or Laboratory Testing: Blood, urine, or tissue samples are collected and
analyzed to measure biomarkers, genetic markers, or other specific laboratory parameters.
- Data Quality Assurance: Steps taken to ensure accurate and reliable data collection,
including training data collectors, using standardized data collection tools, and implementing
quality control measures.
© Genentech
2. Data Monitoring
- Definition: Data monitoring involves the ongoing review, assessment, and oversight of data
collected during a study or clinical trial.
- Purpose of Data Monitoring:
- Quality Control: Monitor data for completeness, accuracy, and adherence to study
protocols and ethical guidelines.
- Participant Safety: Identify adverse events, evaluate participant compliance, and ensure
the ethical treatment of study participants.
- Study Progress: Assess data collection rates, address data quality issues, and monitor the
overall progress of the study.
- Data Monitoring Committee (DMC): An independent committee responsible for reviewing
and assessing the study's progress, participant safety, and data quality.
- Source Data Verification (SDV): A process of comparing source documents (e.g., medical
records) with the data recorded in the study database to ensure accuracy and reliability.
! Mnemonic: "DIME" (Data, Integrity, Monitoring, Evaluation)

- Explanation:
- D: Data - Represents the process of collecting information from study participants or
relevant sources.
- I: Integrity - Emphasizes the importance of ensuring data accuracy, completeness, and
adherence to protocols.
- M: Monitoring - Highlights the ongoing review and oversight of data collection during the
study or clinical trial.
- E: Evaluation - Signifies the assessment of data quality, participant safety, and study
progress.

- Data Collection Tools: Validated instruments and standardized forms are commonly used
to ensure consistent and reliable data collection.
- Data Entry and Management: Collected data is entered into secure databases and
managed with proper confidentiality and data protection measures.
- Data Monitoring Plans: Study protocols include predefined plans for monitoring data
quality, participant safety, and study progress.
- Adverse Event Reporting: Any unexpected or harmful events experienced by participants
are reported promptly to ensure their safety.
- Data Lock and Analysis: Once data collection is complete, the database is "locked,"
preventing further changes, and statistical analysis is conducted.
ADVERSE EVENTS AND SAFETY REPORTING
1. Adverse Events (AEs)

- Definition: Adverse events refer to any untoward medical occurrence or side effect
experienced by a participant during a clinical trial or as a result of medical intervention.
- Types of Adverse Events:
- Serious Adverse Events (SAEs): Events that result in death, life-threatening situations,
hospitalization, disability, congenital anomalies, or require intervention to prevent permanent
impairment.
- Non-Serious Adverse Events: Events that are not classified as serious but still cause
discomfort, require medical attention, or affect the participant's daily activities.
- Monitoring and Reporting: Adverse events are systematically monitored, recorded, and
reported throughout the course of a clinical trial or medical intervention.
© datamethods
2. Safety Reporting
- Importance of Safety Reporting: Safety reporting ensures the ongoing assessment and
monitoring of participant safety during clinical trials or medical interventions.
- Reporting Parties:
- Investigator: The primary responsible individual who identifies, documents, and reports
adverse events occurring during the trial or medical intervention.
- Sponsor: The entity funding or organizing the clinical trial, which is responsible for
ensuring safety reporting obligations are met.
- Safety Reporting Processes:
- Adverse Event Reporting: Prompt reporting of adverse events by the investigator to the
sponsor, following predefined reporting timelines and formats.
- Serious Adverse Event Reporting: Immediate reporting of serious adverse events that
pose a threat to participant safety.
- Expedited Reporting: Reporting of specific adverse events as required by regulatory
authorities within predefined timeframes.
- Periodic Safety Reports: Comprehensive safety reports submitted at regular intervals
during a trial, summarizing all reported adverse events and their analysis.
- Safety Monitoring Committees: Independent committees tasked with reviewing safety
data, assessing participant safety, and making recommendations for trial modifications or
termination if necessary.
! Useful Mnemonics!
- "SAFE" (Safety, Adverse Events, Reporting, Monitoring):
- Explanation: The mnemonic "SAFE" represents the key aspects of adverse events and
safety reporting:
- S: Safety - Emphasizes the importance of ensuring participant safety during clinical
trials or medical interventions.
- A: Adverse Events - Represents the occurrence of untoward medical events or side
effects experienced by participants.
- F: Reporting - Highlights the systematic process of documenting and reporting adverse
events to the appropriate authorities.
- E: Monitoring - Signifies the ongoing assessment and evaluation of participant safety
throughout the trial or medical intervention.
- "SMART" (Systematic Monitoring, Adverse Events, Reporting, Timely):
- Explanation: The mnemonic "SMART" focuses on the importance of efficient safety
reporting:
- S: Systematic Monitoring - Highlights the need for consistent and organized monitoring
of adverse events.
- M: Adverse Events - Reminds of the importance of capturing and documenting all
adverse events.
- A: Reporting - Emphasizes the prompt reporting of adverse events to ensure timely
action.
- R: Timely - Stresses the need for adherence to predefined reporting timelines.

- Causality Assessment: Investigating the relationship between the intervention and
adverse events to determine causality and attribution.
- Safety Database: A dedicated database used to collect and manage safety-related
information and adverse event reports.
- Pharmacovigilance: The science and activities related to the detection, assessment,
understanding, and prevention of adverse effects or any other drug-related problems.
PUBLICATION BIAS AND REPORTING GUIDELINES
1. Publication Bias
- Definition: Publication bias refers to the selective publication or non-publication of
research studies based on the nature and direction of their results.
- Causes of Publication Bias:
- Positive Results Bias: Studies with statistically significant or positive results are more
likely to be published, while studies with non-significant or negative results are often not
published.
- Language Bias: Studies published in certain languages or from specific geographic
regions may have a higher likelihood of being included, leading to bias in the available
evidence.
- Citation Bias: Well-cited studies are more likely to be published, while less-cited studies
may remain unpublished or unrecognized.
- Impact of Publication Bias: Publication bias can distort the overall evidence base, leading
to an overestimation of treatment effects and potential harm to patient care.
© BMC Medical Research Methodology

2. Reporting Guidelines
- Purpose of Reporting Guidelines: Reporting guidelines aim to enhance the transparency,
completeness, and quality of published research studies.
- Common Reporting Guidelines:
- CONSORT (Consolidated Standards of Reporting Trials): Focuses on randomized
controlled trials (RCTs) and provides a checklist of items to improve the reporting of study
design, interventions, outcomes, and analysis.
- STROBE (Strengthening the Reporting of Observational Studies in Epidemiology):
Designed for observational studies and promotes accurate and detailed reporting of study
methods, results, and interpretation.
- PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses): Focuses
on transparent reporting of systematic reviews and meta-analyses, facilitating critical
appraisal and reproducibility.
- Benefits of Using Reporting Guidelines: Adhering to reporting guidelines improves the
quality and completeness of research reporting, facilitates critical appraisal, and enhances
the reproducibility of study findings.
© scimeditor
! Useful Mnemonics!
- "PUB BIAS" (Publication Bias):
- Explanation: The mnemonic "PUB BIAS" highlights the key points related to publication
bias:
- P: Publication - Represents the selective publication or non-publication of research
studies.
- U: Unfavorable - Signifies the bias against studies with non-significant or negative
results.
- B: Bias - Reflects the distortion in the available evidence due to selective publication.
- I: Impact - Emphasizes the potential harm caused by publication bias to patient care.
- A: Assessment - Reminds researchers to critically assess the presence and impact of
publication bias.
- S: Strategies - Encourages the adoption of strategies to mitigate publication bias.
- "REPORT" (Reporting Guidelines):
- Explanation: The mnemonic "REPORT" reminds researchers of the importance of
following reporting guidelines:
- R: Reliable - Ensures the reliability and accuracy of research findings.
- E: Enhances - Enhances the transparency and completeness of study reporting.
- P: Promotes - Promotes critical appraisal and reproducibility of research.
- O: Outcomes - Emphasizes the reporting of relevant outcomes and measures.
- R: Research - Supports the overall quality and integrity of research studies.
- T: Transparent - Encourages transparent reporting of methods and results.

- Bias Assessment Tools: Tools such as funnel plots, Egger's regression, and trim-and-fill
methods can help assess and detect publication bias.
- Open Access Publishing: Open access journals and preprint platforms promote the
accessibility and inclusivity of research findings, reducing the risk of publication bias.
- Trial Registration: Prospective registration of clinical trials helps combat publication bias
by ensuring transparency and reducing the likelihood of selective reporting.
- Peer Review Process: The peer review process plays a crucial role in identifying and
addressing potential biases and improving the quality of published research.
- Authorship and Conflict of Interest: Transparent reporting of authorship contributions and
declaration of potential conflicts of interest contribute to the credibility and transparency of
research studies.
CLINICAL DECISION-MAKING AND EVIDENCE-BASED MEDICINE
LEVELS OF EVIDENCE
1. Definition of Evidence-Based Medicine (EBM)

- Evidence-Based Medicine is an approach that integrates the best available evidence from
scientific research with clinical expertise and patient values to guide medical decision-
making.
© Tingjoh
2. Levels of Evidence
- Level 1: Systematic Reviews and Meta-Analyses of Randomized Controlled Trials (RCTs)
- Meta-analyses and systematic reviews that summarize findings from multiple high-quality
RCTs.
- Provides the highest level of evidence due to the rigorous design and synthesis of multiple
studies.
- Level 2: Randomized Controlled Trials (RCTs)

- Studies where participants are randomly assigned to intervention or control groups.
- Control for confounding factors and provide comparative data on treatment effects.
- Level 3: Non-Randomized Controlled Trials and Quasi-Experimental Studies

- Studies where participants are assigned to intervention or control groups, but not
through randomization.
- Can still provide valuable evidence but are prone to more bias compared to RCTs.
- Level 4: Case-Control Studies and Cohort Studies

- Case-control studies compare individuals with a specific condition (cases) to individuals
without the condition (controls).
- Cohort studies follow a group of individuals over time and compare outcomes between
exposed and unexposed groups.
- Useful for studying the relationship between risk factors and outcomes.
- Level 5: Case Series and Case Reports

- Descriptive studies that present information on a group of patients with a similar
condition or treatment.
- Provide preliminary evidence and can generate hypotheses for further research but have
limitations in terms of bias and generalizability.
- Level 6: Expert Opinion and Consensus Statements

- Based on expert judgment and clinical experience.
- Considered the lowest level of evidence, but still valuable in areas lacking robust
research.
! Mnemonic:
- "SANTA" (Levels of Evidence):
- Explanation: The mnemonic "SANTA" helps remember the hierarchy of evidence levels:
- S: Systematic reviews and meta-analyses (Level 1)
- A: Randomized controlled trials (Level 2)
- N: Non-randomized controlled trials and quasi-experimental studies (Level 3)
- T: Case-control studies and cohort studies (Level 4)
- A: Case series and case reports (Level 5)

- GRADE (Grading of Recommendations, Assessment, Development, and Evaluation)
framework: Provides a systematic approach to grading the quality of evidence and strength
of recommendations in healthcare guidelines.
- Cochrane Collaboration: A global network that produces systematic reviews and promotes
evidence-based practice.
- Strength of Recommendation Taxonomy (SORT): A system that assigns levels of evidence
and grades of recommendation to clinical guidelines.
5. "SANTA" Explanation:
- The mnemonic "SANTA" represents the hierarchy of evidence levels, making it easier to
remember:
- S: Systematic reviews and meta-analyses (Level 1): These studies gather and analyze data
from multiple high-quality randomized controlled trials, providing strong evidence.
- A: Randomized controlled trials (Level 2): These studies involve random assignment of
participants to intervention or control groups, minimizing bias.
- N: Non-randomized controlled trials and quasi-experimental studies (Level 3): These
studies lack randomization but still provide valuable evidence.
- T: Case-control studies and cohort studies (Level 4): These observational studies
examine associations between risk factors and outcomes.
- A: Case series and case reports (Level 5): These studies describe individual cases,
serving as initial evidence but having limitations in terms of generalizability.
CRITICAL APPRAISAL OF MEDICAL LITERATURE
1. Definition of Critical Appraisal

- Critical appraisal is the process of systematically and objectively assessing the quality,
relevance, and validity of published medical literature to determine its applicability to clinical
practice.
© University of Groningen
2. Steps in Critical Appraisal

- Step 1: Identify the research question: Clearly define the clinical question or issue
addressed in the study.
- Step 2: Assess study design: Understand the study design to determine its
appropriateness for answering the research question. Common study designs include
randomized controlled trials (RCTs), cohort studies, case-control studies, and systematic
reviews.
- Step 3: Evaluate the study methodology: Assess the study's methodology and evaluate its
quality, including aspects such as sample size, study duration, blinding, randomization, and
control of confounding factors.
- Step 4: Examine the results: Evaluate the study's results, including statistical analysis,
measures of effect size, confidence intervals, and p-values. Determine the clinical
significance and relevance of the findings.
- Step 5: Consider bias and limitations: Identify potential sources of bias in the study, such
as selection bias, information bias, or confounding. Assess the study's limitations that may
impact the validity of the results.
- Step 6: Interpret and apply findings: Consider the overall strength of evidence and the
clinical relevance of the study's findings. Determine if the results are applicable to the patient
population or clinical scenario of interest.
! Mnemonic:
- "CARSIE" (Steps in Critical Appraisal):
- Explanation: The mnemonic "CARSIE" helps remember the steps involved in critical
appraisal:
- C: Clinical question
- A: Appropriate study design
- R: Rigorous methodology
- S: Statistical analysis and results
- I: Identify bias and limitations
- E: Evaluate applicability and relevance
"CARSIE" Explanation:
- The mnemonic "CARSIE" represents the steps involved in critical appraisal, aiding in recall
and application:
- C: Clinical question: Clearly define the research question or issue being addressed.
- A: Appropriate study design: Evaluate the suitability of the study design for answering the
research question.
- R: Rigorous methodology: Assess the study's methodology, including sample size,
blinding, randomization, and other quality indicators.
- S: Statistical analysis and results: Evaluate the statistical methods employed and
examine the study's findings.
- I: Identify bias and limitations: Identify potential sources of bias and assess the study's
limitations.
- E: Evaluate applicability and relevance: Consider the overall strength of evidence and
determine if the findings are applicable to the patient population or clinical scenario of
interest.
Additional High-Yield Information:

- GRADE (Grading of Recommendations Assessment, Development, and Evaluation): A
framework used to assess the quality of evidence and strength of recommendations in
systematic reviews and clinical practice guidelines.
GUIDELINES AND PRACTICE RECOMMENDATIONS
1. Definition
- Guidelines and practice recommendations are evidence-based documents developed by
professional organizations or expert panels to provide healthcare practitioners with
standardized approaches to patient care. They aim to improve clinical outcomes, promote
consistency in practice, and enhance patient safety.
© CFCF
2. Key Elements of Guidelines

a. Scope and Purpose:
- Clearly define the clinical question or topic addressed by the guideline.
- Identify the target audience and the intended use of the guideline.
b. Development Process:
- Describe the methods used to gather and evaluate evidence.
- Specify the criteria for selecting and grading the evidence.
c. Recommendations:
- Provide specific recommendations for clinical practice based on the available evidence.
- Classify recommendations into different levels of strength based on the quality and
consistency of the evidence.
d. Supporting Evidence:
- Present the evidence and rationale supporting each recommendation.
- Summarize the key studies, systematic reviews, and meta-analyses considered.
e. Implementation Tools:
- Include practical tools and resources to facilitate guideline implementation, such as
algorithms, decision aids, or educational materials.
f. Updates and Review:

- Specify the timeframe for guideline updates to ensure the incorporation of new evidence.
! Mnemonic:
- "GUIDE" (Key Elements of Guidelines):
- Explanation: The mnemonic "GUIDE" helps remember the key elements of guidelines:
- G: Grounded in evidence
- U: Usable recommendations
- I: Informed by experts
- D: Documented supporting evidence
- E: Engage in updates and review
"GUIDE" Explanation:
- The mnemonic "GUIDE" represents the key elements of guidelines, aiding in recall and
understanding:
- G: Grounded in evidence: Guidelines are based on sound scientific evidence.
- U: Usable recommendations: Guidelines provide practical recommendations for clinical
practice.
- I: Informed by experts: Guidelines are developed by expert panels or professional
organizations.
- D: Documented supporting evidence: Guidelines present the evidence supporting each
recommendation.
- E: Engage in updates and review: Guidelines should be regularly updated to reflect new
evidence.
Remember: Guidelines and practice recommendations serve as valuable resources for

healthcare practitioners, offering evidence-based guidance. Using the mnemonic "GUIDE"
helps reinforce the key elements of guidelines, emphasizing the importance of evidence,
usability, expert input, supporting evidence, and regular updates.

- GRADE (Grading of Recommendations Assessment, Development, and Evaluation): A
widely used framework to assess the quality of evidence and strength of recommendations in
guidelines.
- Applicability and Adaptability: Consideration of the local context and individual patient
characteristics when applying guidelines to ensure relevance and appropriateness.
SHARED DECISION-MAKING AND PATIENT PREFERENCES
1. Definition
- Shared decision-making is a collaborative approach between healthcare providers and
patients, where both parties contribute to the decision-making process based on the best
available evidence and the patient's values, preferences, and goals. It involves discussing the
risks, benefits, and alternatives of different treatment options to reach a mutually agreed-
upon decision.
© BMC Ophthalmology
2. Key Elements of Shared Decision-Making

a. Information Sharing:
- Healthcare providers present accurate, evidence-based information about the patient's
condition, treatment options, and potential outcomes.
- Patients express their concerns, beliefs, values, and preferences.
b. Discussion of Options:
- Providers explain the available treatment options, including their benefits, risks, and
uncertainties.
- Patients ask questions, clarify doubts, and actively participate in the conversation.
c. Clarification of Values and Preferences:

- Providers help patients explore their values, priorities, and personal circumstances that
may influence their decision-making.
- Patients reflect on their preferences, considering factors such as quality of life, potential
side effects, and long-term outcomes.
d. Decision Support Tools:

- Decision aids, such as written materials, videos, or interactive online tools, can assist in
providing additional information and facilitating the decision-making process.
e. Collaborative Decision-Making:
- Providers and patients engage in open dialogue, respecting each other's opinions and
perspectives.
- The final decision reflects a shared agreement between the provider and patient.
! Mnemonic:
- "PARTNER" (Elements of Shared Decision-Making):
- Explanation: The mnemonic "PARTNER" helps remember the key elements of shared
decision-making:
- P: Prepare and present options
- A: Assess patient values and preferences
- R: Recount evidence and information
- T: Talk and discuss
- N: Negotiate a decision
- E: Evaluate the decision
- R: Review the decision
"PARTNER" Explanation:
- The mnemonic "PARTNER" represents the key elements of shared decision-making, aiding
in recall and understanding:
- P: Prepare and present options: Healthcare providers prepare and present the available
treatment options to the patient.
- A: Assess patient values and preferences: Providers assess the patient's values and
preferences to align the decision with their individual needs.
- R: Recount evidence and information: Providers present evidence-based information
regarding the risks, benefits, and uncertainties associated with each option.
- T: Talk and discuss: Providers and patients engage in a dialogue to discuss the
information, address concerns, and answer questions.
- N: Negotiate a decision: Providers and patients collaborate to negotiate and arrive at a
mutually agreed-upon decision.
- E: Evaluate the decision: The decision-making process is evaluated for effectiveness and
patient satisfaction.
- R: Review the decision: Periodic review of the decision is conducted to ensure it remains
aligned with the patient's evolving needs and preferences.

- Decision aids: Tools designed to support patients in understanding their options and the
associated risks and benefits.
- Role of patient education: Providing resources that empower patients to make informed
decisions based on their preferences and values.
- Shared decision-making in complex cases: In certain situations, such as chronic illnesses
or multiple treatment options, shared decision-making becomes especially important.
Remember: Shared decision-making involves a collaborative approach where healthcare

providers and patients work together to make informed treatment decisions. The mnemonic
"PARTNER" reinforces the key elements of shared decision-making: preparing and presenting
options, assessing patient values and preferences, recounting evidence and information,
talking and discussing, negotiating a decision, evaluating the decision, and reviewing it
periodically.
INTERPRETATION OF LABORATORY INVESTIGATIONS
HEMATOLOGY AND COAGULATION STUDIES
1. Complete Blood Count (CBC)

- Measures the number and characteristics of different blood cells.
- Components of CBC:
- Red Blood Cell (RBC) count: Evaluates oxygen-carrying capacity.
- Hemoglobin (Hb) level: Assesses oxygen-carrying capacity.
- Hematocrit (Hct): Measures the proportion of RBCs in the blood.
- White Blood Cell (WBC) count: Assesses immune response.
- Platelet count: Evaluates clotting ability.
© National Cancer Institute
2. Coagulation Profile
- Assess the clotting ability of the blood.
- Components of coagulation profile:
- Prothrombin Time (PT): Measures the extrinsic pathway and common pathway of clotting.
- International Normalized Ratio (INR): Standardizes PT values.
- Activated Partial Thromboplastin Time (aPTT): Measures the intrinsic pathway and
common pathway of clotting.
- Platelet function tests: Assess platelet activity and aggregation.
- D-dimer: Assesses the presence of fibrin degradation products, indicating ongoing clot
formation or degradation.
3. Blood Smear
- Microscopic examination of a blood sample.
- Provides detailed information about blood cell morphology, size, shape, and presence of
abnormalities.
- Helps diagnose various blood disorders such as anemia, infections, and malignancies.
© Reytan
4. Bone Marrow Aspiration and Biopsy
- Involves obtaining a sample of bone marrow tissue.
- Helps evaluate hematopoiesis, diagnose blood disorders, and stage cancers.
- Aspiration: Collects liquid marrow for evaluation.
- Biopsy: Obtains a core of bone marrow for tissue evaluation.
© Blausen Medical Communications

5. Bleeding Time
- Assesses platelet function and primary hemostasis.
- Measures the time taken for a standardized skin incision to stop bleeding.
- Prolonged bleeding time may indicate platelet disorders or impaired platelet function.
© Labpedia.net
6. Clotting Factor Assays
- Measures the activity levels of specific clotting factors.
- Helps diagnose and monitor bleeding disorders such as hemophilia.
© Coagulation Assays
! Mnemonic 1: "CBC, Coagulation, Blood Smear, Be a Clotting Expert" (CBC - Coagulation -

Blood Smear - Clotting Expert)
- Explanation: This mnemonic helps remember the key components of hematology and
coagulation studies. The mnemonic "CBC, Coagulation, Blood Smear, Be a Clotting Expert"
highlights the importance of CBC, coagulation profile, blood smear examination, and
becoming an expert in interpreting clotting tests.
! Mnemonic 2: "RBC, Hb, Hct, WBC, PT, INR, aPTT, Platelets - Smear for Blood Cells, Marrow
for Diagnosis" (RBC - Hb - Hct - WBC - PT - INR - aPTT - Platelets - Smear - Marrow -
Diagnosis)
- Explanation: This mnemonic covers the important components of CBC, coagulation
profile, blood smear, and bone marrow evaluation. The mnemonic "RBC, Hb, Hct, WBC, PT,
INR, aPTT, Platelets - Smear for Blood Cells, Marrow for Diagnosis" helps remember the
specific parameters and tests involved in hematology and coagulation studies.

- Reticulocyte count: Evaluates bone marrow function and assesses for conditions such as
anemia.
- Erythrocyte Sedimentation Rate (ESR): Measures the rate at which RBCs settle in a tube,
indicating inflammation or infection.
- Peripheral Blood Film: Detailed examination of blood cells for morphological
abnormalities.
- Flow Cytometry: Analyzes characteristics of cells using fluorescence and laser-based
detection.
Note: Interpretation of hematology and coagulation studies should be done in the context of
the patient's clinical presentation, medical history, and other relevant investigations.
BIOCHEMICAL MARKERS AND SERUM TESTS
1. Liver Function Tests (LFTs)

- Evaluates liver health and function.
- Components of LFTs:
- Alanine Aminotransferase (ALT): Detects liver cell damage.
- Aspartate Aminotransferase (AST): Assess liver cell damage and other organ involvement.
- Alkaline Phosphatase (ALP): Measures liver and bone activity.
- Total Bilirubin: Assesses liver's ability to process bilirubin.
- Albumin: Evaluates liver synthetic function.
- Prothrombin Time (PT): Measures liver's ability to produce clotting factors.
© Osmosis
2. Kidney Function Tests

- Assess renal function and determine the presence of kidney disease.
- Components of kidney function tests:
- Blood Urea Nitrogen (BUN): Measures urea levels in the blood.
- Creatinine: Assesses renal filtration function.
- Estimated Glomerular Filtration Rate (eGFR): Estimates kidney function based on
creatinine levels.
© MedlinePlus
3. Lipid Profile
- Evaluates lipid metabolism and assesses cardiovascular risk.
- Components of lipid profile:
- Total Cholesterol: Measures total cholesterol levels.
- Low-Density Lipoprotein (LDL) Cholesterol: Assess "bad" cholesterol levels.
- High-Density Lipoprotein (HDL) Cholesterol: Evaluates "good" cholesterol levels.
- Triglycerides: Measures circulating triglyceride levels.
© Pathkinds Labs
4. Glycemic Markers
- Assesses blood glucose levels and diabetes management.
- Components of glycemic markers:
- Fasting Blood Glucose (FBG): Measures glucose levels after fasting.
- Hemoglobin A1c (HbA1c): Reflects average blood glucose levels over several months.
© Jakob Suckale
5. Cardiac Enzymes and Markers
- Evaluates cardiac muscle damage and presence of myocardial infarction.
- Components of cardiac enzymes and markers:
- Troponin: Detects myocardial injury.
- Creatine Kinase-MB (CK-MB): Assess cardiac muscle damage.
- Myoglobin: Measures early marker of myocardial injury.
© J. Heuser
6. Thyroid Function Tests
- Assess thyroid hormone levels and diagnose thyroid disorders.
- Components of thyroid function tests:
- Thyroid-Stimulating Hormone (TSH): Evaluates thyroid function.
- Free T3 and Free T4: Measures levels of active thyroid hormones.
© Jwdietrich2
! Mnemonic: "LTKL-GT: Livers, Thyroids, Kidneys, Lipids - Good Times Ahead!"

- Explanation: This mnemonic helps remember the main categories of biochemical markers
and serum tests. The mnemonic "LTKL-GT: Livers, Thyroids, Kidneys, Lipids - Good Times
Ahead!" emphasizes the importance of monitoring liver, thyroid, kidney, and lipid function for
overall health.
- C-reactive Protein (CRP): Measures inflammation in the body.
- Serum Electrolytes: Assesses levels of sodium, potassium, and other electrolytes.
- Serum Calcium: Evaluates calcium levels and bone health.
- Serum Uric Acid: Assesses uric acid levels and helps diagnose gout.
Note: It is important to interpret biochemical markers and serum tests in the context of the
patient's clinical presentation, medical history, and other relevant investigations.
MICROBIOLOGY AND SEROLOGY TESTS
1. Microbiology Tests
- Used to identify and diagnose infectious diseases caused by microorganisms.
- Types of microbiology tests:
- Gram Stain: Differentiates bacteria into Gram-positive or Gram-negative.
© Biology Lectures
- Culture and Sensitivity: Identifies specific pathogens and determines their susceptibility
to antibiotics.
- Polymerase Chain Reaction (PCR): Amplifies and detects DNA or RNA to identify
pathogens.
© Enzoklop
- Acid-Fast Stain: Detects acid-fast bacteria like Mycobacterium tuberculosis.
© Elizabeth Gray
- Fungal Culture: Identifies fungal pathogens.

- Viral Culture: Identifies viral pathogens.
© eCampusOntario
2. Serology Tests
- Detect antibodies or antigens in the blood to diagnose infectious diseases and assess
immune response.
- Types of serology tests:
- Enzyme-Linked Immunosorbent Assay (ELISA): Detects antibodies or antigens using
enzyme-labeled reagents.
© Aviva Systems Biology
- Rapid Diagnostic Tests (RDTs): Provide quick results for certain infectious diseases (e.g.,
rapid strep test).
- Western Blot: Confirms presence of specific antibodies against multiple antigens.
© Biochemlife
- Fluorescent Antibody Test (FA): Uses fluorescent-labeled antibodies to identify
pathogens.
© Microbe Online
- Neutralization Assay: Measures ability of antibodies to neutralize viral activity.
© Frontiers
3. Blood Culture
- Detects presence of bacteria or fungi in the bloodstream.
- Helps diagnose bloodstream infections (sepsis) and guides appropriate antibiotic therapy.
© Royal College of Pathologists

4. Urine Culture
- Identifies bacterial pathogens in urine samples.
- Diagnoses urinary tract infections (UTIs) and determines appropriate antibiotics.
© Mount Sinai
! Mnemonic: "MICRO-SER: Microbiology, Serology"

- Explanation: This mnemonic highlights the two main categories of tests, Microbiology and
Serology. "MICRO-SER" can be easily remembered as it represents the first syllables of both
terms, aiding in recalling the broader topic of laboratory tests related to microbes and
immune responses.

- Antimicrobial Susceptibility Testing: Determines the most effective antibiotics against
identified pathogens.
- Serological Markers:
- Rheumatoid Factor (RF): Associated with rheumatoid arthritis.
- Anti-nuclear Antibodies (ANA): Screen for autoimmune disorders like systemic lupus
erythematosus.
- Hepatitis B Surface Antigen (HBsAg): Indicates active hepatitis B infection.
- Human Immunodeficiency Virus (HIV) Antibody Test: Screens for HIV infection.
Note: Microbiology and serology tests play a vital role in diagnosing infectious diseases. They
provide valuable information for appropriate treatment decisions. Clinical correlation and
consideration of patient history are essential for accurate interpretation of test results.
IMAGING AND RADIOLOGY INVESTIGATIONS
1. Imaging Modalities
- Radiography (X-ray): Uses ionizing radiation to produce 2D images of bones and certain
organs.
© Mikael Häggström
- Computed Tomography (CT): Combines X-ray and computer technology to create cross-
sectional images of body structures.
© FDA
- Magnetic Resonance Imaging (MRI): Uses strong magnetic fields and radio waves to
produce detailed images of soft tissues and organs.
© Unknown
- Ultrasound: Utilizes high-frequency sound waves to create real-time images of organs,
blood vessels, and fetal development.
© Nevit Dilmen
- Nuclear Medicine: Involves the administration of radioactive substances to visualize organ
function and disease processes.
© Mco44
2. Common Imaging Investigations

- Chest X-ray: Evaluates lung conditions, heart size, and fractures.
© Stillwaterising
- Abdominal Ultrasound: Assesses abdominal organs such as the liver, gallbladder, and
kidneys.
© National Cancer Institute
- Head CT/MRI: Detects brain abnormalities, strokes, and tumors.
© Wei-yuan Huang
- Bone Scan: Identifies bone metastases and evaluates bone disorders.
© James Heilman
- Positron Emission Tomography (PET): Visualizes metabolic activity in tissues, useful in
cancer staging.
© Jens Maus
- Mammography:
Screens for breast
cancer and detects
breast abnormalities.
© BruceBlaus
- Doppler Ultrasound: Evaluates blood flow in arteries and veins, used for deep vein
thrombosis (DVT) diagnosis.
© Drickey
! Mnemonic: "IMAGE-RAD: Imaging, Radiology"

- Explanation: This mnemonic helps remember the broader topic of imaging and radiology
investigations. "IMAGE-RAD" can be easily recalled as it represents the first syllables of both
terms, aiding in memorizing the category of diagnostic tests related to visualizing internal
structures and organs.
! Mnemonic: "SEE US: Sound, Energy, Emissions, Ultrasound"

- Explanation: This mnemonic highlights the key elements of ultrasound imaging. "SEE US"
can be easily remembered as it represents the first letters of Sound (sound waves used in
imaging), Energy (high-frequency waves), Emissions (real-time image creation), and
Ultrasound (the imaging modality itself).

- Contrast Agents: Substances administered to enhance imaging, such as iodine-based
contrast for CT scans or gadolinium for MRIs.
- Radiographic Views:
- Anteroposterior (AP): X-ray beam passes from the front to the back of the body.
- Lateral: X-ray beam passes from the side of the body.
- Oblique: X-ray beam passes at an angle between the AP and lateral views.
- Radiology Reports: Interpretations of imaging studies by radiologists, including findings,
impressions, and recommendations.
Note: Imaging and radiology investigations play a crucial role in diagnosing and monitoring
various medical conditions. Each modality has its specific uses and advantages. The
selection of the appropriate imaging test depends on the suspected pathology and the
information required for diagnosis or treatment planning.
GENETIC AND MOLECULAR TESTING
1. Genetic Testing
- Definition: Analyzes an individual's DNA to identify genetic variations associated with
inherited disorders or disease risk.
- Types of Genetic Testing:
- Diagnostic Testing: Confirms or rules out a suspected genetic condition in individuals
with symptoms.
- Carrier Testing: Determines if an individual carries a gene mutation that could be passed
on to their offspring.
- Predictive Testing: Identifies gene mutations associated with an increased risk of
developing specific conditions.
- Prenatal Testing: Assesses the fetus for genetic abnormalities during pregnancy.
- Newborn Screening: Screens newborns for genetic disorders that may require early
intervention.
- Pharmacogenetic Testing: Predicts an individual's response to certain medications based
on their genetic makeup.
© Darekk2 via Wikimedia Commons
2. Molecular Testing
- Definition: Detects specific molecules (e.g., DNA, RNA, proteins) to diagnose, monitor, or
manage diseases.
- Types of Molecular Testing:
- Polymerase Chain Reaction (PCR): Amplifies DNA segments for detection of genetic
variations or pathogens.
- Fluorescent In Situ Hybridization (FISH): Identifies specific DNA sequences or
chromosomal abnormalities in cells.
- Next-Generation Sequencing (NGS): Analyzes DNA or RNA to identify genetic variants,
mutations, or gene expression patterns.
- Western Blot: Detects specific proteins in a sample using antibody-based techniques.
- Enzyme-Linked Immunosorbent Assay (ELISA): Measures the presence or concentration
of specific substances (antigens or antibodies) in body fluids.
© National Cancer Institute via Wikimedia Commons
High-Yield Information
- Genomic DNA: Extracted from an individual's cells, it contains the complete genetic
information.
- Gene Panels: Focus on specific genes associated with a particular condition or group of
conditions.
- Whole Exome Sequencing (WES): Analyzes the protein-coding regions of an individual's
genome.
- Whole Genome Sequencing (WGS): Determines the complete DNA sequence of an
individual's genome.
- Genetic Counseling: Helps individuals understand and interpret genetic test results,
assess their implications, and make informed decisions.
! Mnemonic: "GENETIC-MOL: Guiding Examinations Navigating Every Test Involving Cells -

Molecular, Omics, and Labs"
- Explanation: This mnemonic provides a comprehensive overview of genetic and molecular
testing. Each letter represents a key aspect:
- G: Guiding Examinations (Genetic Testing)
- E: Every Test
- N: Navigating
- E: Involving
- T: Cells
- I: Molecular
- C: Omics (e.g., genomics, proteomics)
- M: and Labs
- Pharmacogenomic Testing: Evaluates an individual's genetic variations to determine the
most effective medication and dosage.
- Circulating Tumor DNA (ctDNA): Detects tumor-specific genetic alterations from blood
samples, aiding in cancer diagnosis and monitoring.
- Precision Medicine: Customizes medical treatments based on an individual's genetic
makeup and molecular characteristics.
Note: Genetic and molecular testing are valuable tools in diagnosing genetic disorders,
predicting disease risk, and personalizing treatment approaches. These tests provide
insights into an individual's genetic profile and aid in making informed medical decisions.
Genetic counseling is often recommended to help individuals understand the implications of
their test results. The mnemonic "GENETIC-MOL" helps in recalling the key aspects of genetic
and molecular testing.
INTERPRETATION OF LABORATORY INVESTIGATIONS
RADIOGRAPHY AND X-RAY INTERPRETATION
1. Radiography
- Definition: Imaging technique that uses X-rays to create images of the internal structures
of the body.
- Common Applications: Diagnosis, monitoring treatment progress, and guiding medical
procedures.
© Nevit Dilmen via Wikimedia Commons
2. X-ray Interpretation
- Introduction: X-ray images consist of varying shades of gray, representing different tissue
densities.
- Key Principles:
- Dark (Black) Areas: Represents air or gas-filled structures.
- Light (White) Areas: Indicates dense structures like bones and metal objects.
- Shades of Gray: Correspond to varying tissue densities, such as muscles and organs.
3. Anatomical Structures and Findings

- Bones: Assess for fractures, deformities, bone density changes, or calcifications.
- Soft Tissues: Look for abnormal masses, fluid accumulations, or swelling.
- Lungs: Evaluate for pneumonia, pneumothorax, or other pulmonary conditions.
- Heart: Assess cardiac size, shape, and presence of calcifications.
- Abdomen: Identify abnormalities in the gastrointestinal tract, kidneys, or other organs.
- Joints: Examine for joint space narrowing, effusion, or arthritis.
4. Common X-ray Views

- Chest X-ray (CXR): Anteroposterior (AP) and/or Posteroanterior (PA) views to assess the
lungs and heart.
- Abdominal X-ray: Supine or upright views to evaluate the abdomen and gastrointestinal
tract.
- Limb X-ray: Anteroposterior (AP) and lateral views to assess bones, joints, and soft tissues.
- Spine X-ray: Anteroposterior (AP), lateral, and oblique views to evaluate the vertebrae and
spinal alignment.
! Useful Mnemonics!
a. "SEE-X: Simplified Evaluation of Examinations for X-ray Interpretation"
- Explanation: This mnemonic helps recall the key aspects of radiography and X-ray
interpretation.
- S: Structures (bones, soft tissues, lungs, heart, abdomen, joints)
- E: Examination (different X-ray views)
- E: Evaluation (interpreting the X-ray findings)
- X: X-ray
b. "BONES: Better Observation Necessitates Expertise in Shadows"

- Explanation: This mnemonic reminds you to focus on the bones and shadows when
interpreting X-rays.
- B: Bones (fractures, deformities, calcifications)
- O: Observation (careful examination of structures)
- N: Necessitates (requires)
- E: Expertise (knowledge and experience)
- S: Shadows (interpretation of density variations)
- X-ray Safety: Minimize radiation exposure by using proper shielding and following safety
protocols.
- Image Quality: Factors like patient positioning, exposure techniques, and image resolution
impact the quality of X-ray images.
- Radiology Reports: Radiologists provide detailed interpretations of X-ray findings in
radiology reports.
- Image Comparison: Compare current X-rays with previous images, if available, to assess
changes over time.
Note: Radiography is a commonly used imaging modality that utilizes X-rays to visualize
internal structures. Understanding X-ray interpretation involves recognizing anatomical
structures and assessing abnormalities based on variations in tissue density. Different X-ray
views and mnemonics, such as "SEE-X" and "BONES," aid in the systematic evaluation and
interpretation of X-ray findings. It is important to consider patient safety and follow radiation
protection guidelines when performing and interpreting X-rays.
COMPUTED TOMOGRAPHY (CT) SCANS
1. Introduction
- Computed Tomography (CT) scans provide detailed cross-sectional images of the body.
- Interpretation of CT scans involves analyzing anatomical structures and identifying
abnormalities.
© Tomáš Vendiš via Wikimedia Commons
2. Key Steps in CT Scan Interpretation

a. Image Acquisition:
- CT scans are obtained using X-ray technology and computer processing.
- Multiple cross-sectional images are generated.
b. Image Review:
- Sequentially review each image slice from top to bottom or bottom to top.
- Analyze anatomical structures, noting their shape, size, and density.
c. Systematic Approach:
- Use a systematic approach to ensure thorough evaluation of all relevant structures.
- Start with an overview of the scan and proceed to specific regions of interest.
3. Anatomical Evaluation
- Assess the following structures based on the clinical question or suspected pathology:
- Bones and Joints: Look for fractures, dislocations, or degenerative changes.
- Soft Tissues and Organs: Evaluate for masses, fluid collections, or organ enlargement.
- Blood Vessels: Examine the vascular structures for aneurysms, stenosis, or thrombosis.
4. Abnormalities and Pathologies

- Identify and describe any abnormalities observed during CT scan interpretation.
- Use standardized terminology and reference normal anatomical landmarks.
- Document the location, size, shape, density, and characteristics of the abnormalities.
5. Communication and Reporting

- Accurate and concise reporting is essential for effective communication with healthcare
providers.
- Include a detailed description of the findings, differential diagnoses, and
recommendations.
- Provide a structured report, utilizing appropriate headings for each section.
! Useful Mnemonics!
a. "CT SCAN-IT": CT Scan Interpretation Steps
- Explanation: This mnemonic helps remember the key steps in CT scan interpretation.
- C: Cross-sectional images (obtained through CT scans)
- T: Top to bottom review (analyze images sequentially)
- S: Systematic approach (follow a systematic evaluation method)
- C: Clinical question (consider the clinical context)
- A: Anatomical evaluation (assess bones, soft tissues, and blood vessels)
- N: Note abnormalities (identify and describe any pathologies)
- I: Interpret findings (provide an accurate interpretation)
- T: Timely reporting (communicate findings promptly)
b. "FIND-IT": Key Elements in Reporting CT Findings

- Explanation: This mnemonic highlights important elements in reporting CT scan findings.
- F: Findings (describe abnormalities observed)
- I: Interpretation (provide an accurate interpretation)
- N: Normal structures (reference normal anatomical landmarks)
- D: Description (include details about location, size, shape, density)
- I: Impression (summarize the key findings)
- T: Timely reporting (communicate findings promptly)
7. Common CT Scan Findings
a. Ground Glass Opacity (GGO)
- GGO appears hazy on CT scans and may indicate inflammation, infection, or early-stage
lung tumors.
© Opzwartbeek via Wikimedia Commons

b. Consolidation
- Consolidation appears as solid white areas on CT scans and may indicate pneumonia or
lung tissue filling with fluid.
© Mikael Häggström via Wikimedia Commons

c. Mass Effect
- Mass effect refers to the displacement of surrounding structures by a mass or tumor,
seen as a distortion on CT scans.
© Neurosurgery Wiki via Wikimedia Commons

d. Contrast Enhancement
- Contrast enhancement indicates increased vascularity or active inflammation in the
imaged area.
© Kristie Guite via Wikimedia Commons
e. Calcifications
- Calcifications appear as bright white spots on
© Subhaschandra Singh via Wikimedia Commons
CT scans and can indicate conditions such as kidney stones or arterial plaques.
8. Artifacts
- Artifacts are imaging abnormalities unrelated to the patient's anatomy and can impact
interpretation.
- Examples of artifacts include motion artifacts, beam hardening artifacts, and metal
artifacts from implants.
© hg6996 via Wikimedia Commons
Additional Tips
- Consult relevant guidelines and reference materials for specific anatomical and
pathological considerations.
- Collaborate with radiologists and specialists to enhance interpretation skills.
- Continuously update knowledge and skills through case discussions and ongoing learning.
Note: It is important to remember that CT scan interpretation requires hands-on training and
expertise. These notes are meant to provide a general overview and mnemonic aids for easier
understanding.
MAGNETIC RESONANCE IMAGING (MRI)
1. Introduction
- Magnetic Resonance Imaging (MRI) uses strong magnetic fields and radio waves to
generate detailed images of the body.
- MRI provides excellent soft tissue contrast and is useful for diagnosing various conditions.
© Unknown via Wikimedia Commons
2. Key Steps in MRI Interpretation

- MRI scans use different pulse sequences to visualize different tissues and pathology.
- T1-weighted, T2-weighted, and contrast-enhanced sequences are commonly used.
b. Image Review:
- Sequentially review each image series and assess the anatomy and signal
characteristics.
- Compare the images with previous studies if available for comparison.
c. Systematic Approach:
- Use a systematic approach to evaluate different anatomical regions and identify
abnormalities.
- Start with an overview of the scan, followed by detailed assessment of specific areas of
interest.
3. Anatomical Evaluation
- Analyze the following structures based on the clinical question or suspected pathology:
- Brain and Spinal Cord: Assess for masses, infarcts, hemorrhages, or demyelination.
- Musculoskeletal System: Evaluate bones, joints, ligaments, and soft tissues for injuries,
degeneration, or tumors.
- Abdomen and Pelvis: Examine organs for masses, cysts, inflammation, or vascular
abnormalities.
- Vascular System: Evaluate blood vessels for stenosis, aneurysms, or dissections.
4. Signal Characteristics
- Understand the basic signal characteristics of tissues on different MRI sequences:
- T1-weighted: Provides good anatomical detail, with fat appearing bright and fluid
appearing dark.
- T2-weighted: Highlights fluid and pathology, with fluid appearing bright and fat appearing
dark.
- Contrast-enhanced: Enhances vascular structures and lesions with increased vascularity.
5. Abnormalities and Pathologies

- Identify and describe any abnormalities observed during MRI interpretation.
- Document the location, size, shape, signal characteristics, and effects on surrounding
structures.
6. Communication and Reporting

- Accurate and concise reporting is crucial for effective communication with healthcare
providers.
- Describe the findings in a structured manner, including a detailed impression and
recommendations.
! Useful Mnemonics!
a. "MRI SCAN": MRI Interpretation Steps
- Explanation: This mnemonic helps remember the key steps in MRI interpretation.
- M: Magnetic field and radio waves (principles of MRI)
- R: Review images sequentially (series-by-series)
- I: Identify abnormalities (analyze structures for pathology)
- S: Systematic approach (evaluate different anatomical regions)
- C: Clinical question (consider the clinical context)
- A: Anatomical evaluation (assess brain, musculoskeletal system, abdomen, pelvis, and
vessels)
- N: Note signal characteristics (understand tissue signals on different sequences)
b. "SPOT": Signal Characteristics on MRI Sequences

- Explanation: This mnemonic helps recall the basic signal characteristics on different MRI
sequences.
- S: T1-weighted sequence (good anatomical detail, bright fat, dark fluid)
- P: T2-weighted sequence (highlights fluid, bright fluid, dark fat)
- O: Contrast-enhanced sequence (enhances vascularity, lesions)
7. Common MRI Findings

- White Matter Hyperintensities (WMH)
- WMH are areas of increased signal intensity on T2-weighted sequences and may indicate
small vessel disease or demyelination.
© Jmarchn via Wikimedia Commons

- Ligamentous or Meniscal Tears
- Tears in ligaments or menisci can bevisualized as disruptions or abnormal signal intensity
within the affected structures.
© MBq via Wikimedia Commons

- Tumor or Mass
- Masses appear as focal lesions with abnormal signal characteristics, such as increased
signal on T2-weighted images.
© Bobjgalindo via Wikimedia Commons
Note: Proper MRI interpretation requires extensive training and expertise. These notes aim to
provide a general overview and mnemonic aids for easier understanding. Always consult with
radiologists and reference appropriate resources for accurate interpretation and clinical
decision-making.
ULTRASONOGRAPHY AND DOPPLER STUDIES
1. Introduction
- Ultrasonography uses high-frequency sound waves to visualize internal structures and
organs in real-time.
- Doppler studies utilize ultrasound to assess blood flow and vascular abnormalities.
2. Key Concepts in Ultrasonography

- An ultrasound probe emits and receives sound waves, creating images based on their
reflections.
- Different probe frequencies are used depending on the depth and target structure.
b. Image Interpretation:
- Evaluate the size, shape, echogenicity, and vascularity of structures.
- Compare findings with the patient's clinical presentation and previous imaging if
available.
3. Abdominal Ultrasonography
- Assess the liver, gallbladder, kidneys, pancreas, spleen, and abdominal aorta:
- Look for masses, stones, cysts, abscesses, or signs of inflammation.
- Evaluate blood flow using Doppler to detect vascular abnormalities.
© National Cancer Institute via Wikimedia Commons

4. Obstetric Ultrasonography
- Monitor fetal development and assess maternal reproductive organs:
- Confirm gestational age, detect multiple pregnancies, and evaluate fetal anatomy.
- Assess placental position, amniotic fluid volume, and blood flow to the uterus and fetus.
© Nevit Dilmen via Wikimedia Commons

5. Vascular Doppler Studies
- Assess blood flow and vascular disorders:
- Doppler ultrasound can detect stenosis, thrombosis, aneurysms, and venous
insufficiency.
- Color Doppler provides a visual representation of blood flow direction and velocity.
© Mikael Häggström via Wikimedia Commons
6. Musculoskeletal Ultrasonography
- Evaluate tendons, muscles, joints, and soft tissues:
- Assess for tears, inflammation, cysts, and other abnormalities.
- Ultrasound-guided interventions, such as joint injections or biopsies, can be performed.
7. Breast Ultrasonography
- Complement mammography and evaluate breast masses or abnormalities:
- Assess the size, shape, and characteristics of lesions, including solid or cystic nature.
- Guide needle biopsy procedures if needed.
! Useful Mnemonics!
a. "SOAP": Key Concepts in Ultrasonography
- Explanation: This mnemonic helps remember the essential aspects of ultrasonography.
- S: Sound waves (emission and reception)
- O: Organ assessment (evaluate size, shape, echogenicity, and vascularity)
- A: Abdominal and obstetric ultrasound (evaluate abdominal and reproductive organs)
- P: Probe selection (choose appropriate frequency for depth and target structure)
b. "FLOW": Vascular Doppler Studies
- Explanation: This mnemonic aids in recalling the purpose of vascular Doppler studies.
- F: Flow assessment (evaluate blood flow and direction)
- L: Lesion detection (detect stenosis, thrombosis, aneurysms)
- O: Obtain velocity measurements (determine flow velocity)
- W: Vascular wall abnormalities (identify arterial/venous pathologies)
9. Additional Considerations
- Doppler studies can assess deep vein thrombosis, carotid artery stenosis, and peripheral
arterial disease.
- Ultrasonography is a non-invasive, safe, and cost-effective imaging modality.
- It does not involve ionizing radiation and is suitable for evaluating pediatric and pregnant
patients.
Note: Ultrasonography and Doppler studies require training and expertise for accurate
interpretation. These notes serve as a general overview and mnemonic aids for studying
purposes. Always consult with radiologists and reference appropriate resources for precise
interpretation and clinical decision-making.
NUCLEAR MEDICINE AND POSITRON EMISSION TOMOGRAPHY (PET)
1. Introduction
- Nuclear medicine utilizes radioactive tracers to diagnose and treat diseases.
- Positron Emission Tomography (PET) is a nuclear medicine imaging technique that
provides functional information.
2. Key Concepts in Nuclear Medicine and PET Interpretation

a. Radioactive Tracers:
- Tracers emit gamma rays, which are detected by specialized cameras (gamma cameras).
- Different tracers are used to target specific organs or functions.
b. Image Acquisition and Interpretation:

- Tracers are administered to the patient, and their distribution is visualized using gamma
cameras.
- Images show the concentration and activity of the tracer in different body regions.
© National Institutes of Health (NIH) via Wikimedia Commons
3. PET Imaging
- PET scans use positron-emitting radioactive tracers.
- Tracers commonly used in PET imaging include:
- Fluorodeoxyglucose (FDG): Measures glucose metabolism and is widely used in oncology.
- Carbon-11 (C-11) or nitrogen-13 (N-13) labeled compounds: Assess brain function and
perfusion.
4. Interpretation of Nuclear Medicine and PET Scans

- Assess tracer uptake, distribution, and abnormalities:
- Increased uptake may indicate areas of higher metabolic activity (e.g., tumors).
- Decreased or absent uptake may suggest functional impairment or pathology.
5. Applications of Nuclear Medicine and PET

a. Oncology:
- PET scans help in cancer staging, monitoring treatment response, and detecting
metastases.
- FDG-PET is commonly used to identify hypermetabolic lesions.
b. Cardiology:
- Nuclear myocardial perfusion scans assess blood flow to the heart muscle.
- PET can evaluate myocardial viability and detect areas of ischemia.
c. Neurology:
- PET scans aid in the evaluation of neurodegenerative disorders (e.g., Alzheimer's
disease).
- C-11 or N-13 labeled compounds assess brain metabolism and perfusion.
! Useful Mnemonics!
a. "RAD PET": Key Concepts in Nuclear Medicine and PET Interpretation
- Explanation: This mnemonic helps remember the key aspects of nuclear medicine and
PET imaging.
- R: Radioactive tracers (use of gamma-emitting tracers)
- A: Administration of tracers (patient receives the radioactive tracer)
- D: Distribution of the tracer (visualizing tracer concentration in different body regions)
- PET: Positron Emission Tomography (functional imaging technique)
b. "FDG: Find Disease Glucose": Application of FDG-PET in Oncology

- Explanation: This mnemonic helps recall the common use of FDG-PET in oncology.
- Find Disease: PET scans help locate and stage tumors.
- Glucose: FDG measures glucose metabolism in cancer cells.
6. Additional Considerations
- Nuclear medicine and PET scans provide functional and molecular information,
complementing structural imaging.
- Collaboration with nuclear medicine specialists is crucial for accurate interpretation and
clinical correlation.
- Radiation safety precautions are essential due to the use of radioactive tracers.
Note: Interpretation of nuclear medicine and PET scans requires expertise and clinical
correlation. These notes serve as a general overview and mnemonic aid for studying
purposes. Always consult with nuclear medicine specialists and reference appropriate
resources for precise interpretation and clinical decision-making.
COMMUNICATION OF CLINICAL INVESTIGATION RESULTS
MEDICAL REPORT WRITING
1. Introduction
- Medical report writing is a crucial skill for healthcare professionals to effectively
communicate patient information and clinical findings.
- Reports serve as a record of patient encounters, aid in continuity of care, and facilitate
communication among healthcare teams.
2. Key Components of a Medical Report

a. Patient Information:
- Include the patient's demographics, medical history, and relevant personal details.
- Maintain patient confidentiality and adhere to privacy regulations.
b. Chief Complaint:
- Describe the primary reason for the patient's visit or the main concern reported by the
patient.
c. History of Present Illness (HPI):

- Detail the onset, duration, severity, and progression of the patient's symptoms.
- Include associated factors, exacerbating or relieving factors, and any previous
treatments.
d. Past Medical History (PMH):

- Document the patient's pre-existing medical conditions, surgeries, and significant past
illnesses.
e. Medications and Allergies:

- List the patient's current medications, including drug name, dose, and frequency.
- Document any known allergies or adverse reactions to medications.
f. Physical Examination:
- Summarize the findings from the physical examination, including vital signs and relevant
clinical observations.
g. Diagnostic Tests and Results:

- Include the results of laboratory tests, imaging studies, and other diagnostic procedures.
- Provide interpretations and correlations with clinical findings.
h. Assessment and Diagnosis:

- State the healthcare professional's assessment and differential diagnosis based on the
patient's history, examination, and test results.
- Prioritize the most likely diagnoses and consider ruling out other potential conditions.
i. Treatment Plan:
- Outline the recommended treatment strategies, including medications, procedures,
lifestyle modifications, and follow-up plans.
- Include patient education and instructions for self-care, if applicable.
j. Prognosis and Follow-up:

- Discuss the expected course of the patient's condition and potential outcomes.
- Specify the recommended follow-up schedule and any further investigations.
3. Tips for Effective Medical Report Writing

a. Clear and Concise Language:
- Use simple, jargon-free language to ensure the report is easily understood by other
healthcare professionals and patients.
- Avoid ambiguous or subjective statements.
b. Objective and Factual:

- Present information objectively, based on observations and findings.
- Clearly distinguish between subjective information (patient-reported) and objective
findings.
c. Organized Structure:
- Follow a logical and standardized format for consistency and ease of understanding.
- Use headings and subheadings to clearly separate different sections.
d. Accurate and Complete Information:

- Ensure accuracy and completeness of all information provided.
- Double-check details, such as medication names, dosages, and patient identifiers.
e. Professional Tone:
- Maintain a professional and respectful tone throughout the report.
- Avoid personal opinions or biased language.
! Useful Mnemonics!
a. "SOAP" Format: Key Components of a Medical Report
- Explanation: The SOAP format is a mnemonic commonly used in medical report writing.
- Subjective: Chief complaint and patient-reported information.
- Objective: Physical examination findings and objective data.
- Assessment: Assessment and diagnosis based on the gathered information.
- Plan: Treatment plan, follow-up recommendations, and further investigations.
b. "CLEAR" Principles: Writing Clear and Concise Reports

- Explanation: The CLEAR mnemonic helps ensure clarity and conciseness in medical
report writing.
- Concision: Be brief and to the point, avoiding unnecessary details.
- Logical flow: Arrange information in a logical and organized manner.
- Exactness: Use precise and accurate language.
- Accuracy: Ensure information is factually correct.
- Reader-friendly: Write for the intended audience, using language easily understood by
professionals and patients.
EFFECTIVE PRESENTATION OF FINDINGS
1. Introduction
- Effective presentation of findings is crucial in medical practice to communicate
information accurately, efficiently, and in a manner that promotes understanding and
engagement.
- Whether presenting to colleagues, patients, or other stakeholders, a well-structured and
engaging presentation enhances the impact of the information being shared.
2. Key Principles of Effective Presentation

a. Know Your Audience:
- Understand the knowledge level, background, and specific needs of your audience.
- Tailor your presentation to match their understanding and interests.
b. Clear and Concise Content:

- Focus on key findings and essential information to prevent overwhelming the audience.
- Use simple language and avoid excessive technical jargon.
c. Structured Organization:
- Organize your presentation into logical sections, such as introduction, methods, results,
and conclusion.
- Use headings, subheadings, and bullet points to aid clarity and facilitate understanding.
d. Engaging Visuals:
- Utilize visual aids, such as slides or images, to enhance understanding and retention.
- Limit text on slides and use clear, high-quality graphics to support your message.
e. Effective Use of Data:

- Present data in a visually appealing and easy-to-understand format, such as graphs,
charts, or tables.
- Highlight key trends, significant findings, and important statistical information.
f. Engage the Audience:

- Encourage active participation through questions, discussions, or interactive elements.
- Maintain eye contact, use appropriate body language, and speak with enthusiasm and
confidence.
g. Use Stories and Examples:

- Incorporate real-life case studies, anecdotes, or patient stories to make the information
relatable and memorable.
- Illustrate the practical implications and impact of your findings.
h. Time Management:
- Respect the allocated time and ensure that your presentation flows smoothly without
rushing or going over the time limit.
- Practice your presentation to ensure it fits within the designated time frame.
3. Tips for Effective Presentation

a. Practice and Rehearse:
- Familiarize yourself with the content and practice delivering the presentation multiple
times.
- Rehearse transitions, timing, and addressing potential questions.
b. Use a Clear and Confident Voice:
- Speak clearly, vary your tone, and use appropriate pacing.
- Project your voice to ensure everyone in the audience can hear you.
c. Maintain Visual Contact:

- Make eye contact with the audience to establish a connection and engage their attention.
- Avoid reading directly from notes or slides.
d. Address Questions Effectively:

- Be prepared to answer questions and respond to feedback or challenges.
- Stay calm, listen actively, and provide clear and concise responses.
e. Seek Feedback and Improve:

- Request feedback from peers, mentors, or audience members to enhance future
presentations.
- Learn from each presentation experience and continually refine your presentation skills.
! Useful Mnemonics!
a. "CLEAR" Principles: Effective Presentation
- Explanation: The CLEAR mnemonic helps ensure clarity and effectiveness in presenting
findings.
- Clarity: Communicate information clearly and concisely.
- Logical organization: Structure your presentation in a logical and coherent manner.
- Engaging visuals: Utilize visuals and graphics to enhance understanding and
engagement.
- Audience-focused: Tailor the presentation to the needs and interests of the audience.
- Respect time: Manage time effectively and deliver the presentation within the allocated
timeframe.
b. "PREPARE" Approach: Preparation for Effective Presentation

- Explanation: The PREPARE mnemonic guides your preparation process for a successful
presentation.
- Plan ahead: Allocate time for preparation and create a detailed outline.
- Research your audience: Understand their background, interests, and expectations.
- Engage visually: Utilize appropriate visual aids to support your message.
- Practice and rehearse: Familiarize yourself with the content and practice delivery.
- Address potential questions: Anticipate and prepare responses to potential queries.
- Reflect and refine: Seek feedback and evaluate your performance for continuous
improvement.
- Energize your delivery: Maintain enthusiasm and engage the audience through your
presentation.
Remember to adapt these principles and mnemonics to your specific presentation context,
incorporate feedback, and practice regularly to enhance your presentation skills.
ETHICAL AND LEGAL CONSIDERATIONS IN RESULTS COMMUNICATION
1. Introduction
- Effective communication of results in healthcare requires attention to ethical and legal
considerations to protect patient autonomy, privacy, and confidentiality.
- Understanding and adhering to ethical and legal principles ensures responsible and
respectful communication with patients and other stakeholders.
2. Ethical Considerations
a. Autonomy and Informed Consent:
- Respect patient autonomy by providing comprehensive and understandable information
about the results.
- Obtain informed consent before disclosing sensitive or unexpected findings.
b. Confidentiality and Privacy:

- Safeguard patient confidentiality and privacy during all stages of results communication.
- Follow institutional policies and legal requirements for handling and sharing patient
information.
c. Truthfulness and Honesty:

- Communicate results accurately and honestly, avoiding exaggeration or withholding
essential information.
- Maintain transparency by providing balanced explanations of the implications and
uncertainties associated with the results.
d. Respect for Cultural and Individual Differences:

- Consider cultural, religious, and individual beliefs when communicating results.
- Adapt communication style and language to ensure understanding and respect for
diverse perspectives.
e. Patient-Centered Communication:
- Engage in empathetic and compassionate communication, acknowledging the emotional
impact of the results.
- Allow patients to express their feelings, concerns, and preferences, and address them
appropriately.
3. Legal Considerations
a. HIPAA Compliance:
- Adhere to the Health Insurance Portability and Accountability Act (HIPAA) regulations to
protect patient privacy and confidentiality.
- Obtain proper authorization before disclosing patient information to third parties.
b. Consent and Documentation:

- Maintain accurate documentation of patient consent for result disclosure, including any
discussions or decisions made.
- Document the communication process, including the content discussed, patient
questions, and any additional resources provided.
c. Legal Reporting Obligations:

- Familiarize yourself with local, state, and federal reporting requirements for certain test
results, such as communicable diseases or suspected abuse.
- Understand the legal obligations and procedures for reporting results to appropriate
authorities when necessary.
d. Professional Liability and Negligence:

- Exercise professional competence and care when communicating results to avoid
potential legal implications.
- Seek guidance from legal and ethical resources in case of uncertainties or complex
situations.
4. Tips for Ethical and Legal Results Communication

a. Obtain Proper Consent:
- Ensure patients fully understand the purpose, risks, and benefits of the tests before
obtaining informed consent.
- Document the consent process and any discussions or clarifications provided.
b. Use Clear and Understandable Language:

- Explain results in plain language, avoiding excessive medical jargon.
- Provide explanations and clarifications as needed to ensure comprehension.
c. Protect Patient Confidentiality:

- Use secure communication channels and platforms when transmitting sensitive patient
information.
- Follow institutional protocols for sharing results with other healthcare providers involved
in the patient's care.
d. Seek Assistance for Difficult Situations:

- Consult with ethics committees, legal advisors, or senior colleagues when facing
challenging ethical or legal dilemmas.
- Take appropriate steps to address conflicts or uncertainties in a responsible and timely
manner.
! Useful Mnemonics!
a. "CARE" Principles: Ethical Results Communication
- Explanation: The CARE mnemonic emphasizes ethical considerations in results
communication.
- Confidentiality: Maintain patient privacy and confidentiality.
- Autonomy: Respect patient autonomy and involve them in decision-making.
- Respect for diversity: Acknowledge and accommodate cultural and individual
differences.
- Empathy: Demonstrate empathy and compassion during result disclosure.
b. "LEGAL" Guidelines: Legal Considerations

- Explanation: The LEGAL mnemonic serves as a reminder of key legal considerations.
- HIPAA Compliance: Follow HIPAA regulations for patient privacy and security.
- Consent and Documentation: Obtain informed consent and document the
communication process.
- Legal reporting obligations: Understand and fulfill legal requirements for reporting
specific results.
- Professional liability: Exercise professional competence and avoid negligence.
Remember to adhere to professional guidelines, institutional policies, and local regulations,
and seek guidance when facing complex ethical or legal situations to ensure ethical and
legally compliant results communication in medical practice.

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1. INTRODUCTION TO CLINICAL INVESTIGATIONS

2. RESEARCH METHODS AND STUDY DESIGNS

3. BIOSTATISTICS FOR CLINICAL INVESTIGATIONS

4. DIAGNOSTIC TESTS AND INTERPRETATION

5. SCREENING AND PREVENTION

6. CLINICAL TRIALS AND ETHICAL CONSIDERATIONS

8. INTERPRETATION OF LABORATORY INVESTIGATIONS

9. INTERPRETATION OF IMAGING STUDIES

10. COMMUNICATION OF CLINICAL INVESTIGATION RESULTS

PURPOSE AND IMPORTANCE OF CLINICAL INVESTIGATIONS

1. Purpose of Clinical Investigations

2. Importance of Clinical Investigations

4. Ethical Considerations in Clinical Investigations:

1. Protection of Human Subjects

3. Institutional Review Boards (IRBs)

4. Privacy and Confidentiality

6. Beneficence and Non-maleficence

7. Reporting and Transparency

1. Purpose of Clinical Investigations

2. Importance of Clinical Investigations

3. Types of Clinical Investigations

4. Ethical Considerations in Clinical Investigations

3. Systematic Reviews and Meta-analyses

4. Other Types of Clinical Investigations

2. Types of Observational Studies

© The Biology Notes

4. Bias in Observational Studies

2. Randomized Controlled Trials (RCTs)

4. Strengths and Limitations

© The Biology Notes

3. Strengths and Limitations

5. Uses of Case-Control Studies

5. Uses of Cohort Studies

4. Strengths and Limitations

© PrevMedFellow via Wikimedia Commons

© American Educational Research Association

5. Uses of Systematic Reviews and Meta-Analyses

2. Measures of Central Tendency

1. Measures of Central Tendency

Additional High-Yield Information

© Repapetilto via Wikimedia Commons

2. Steps in Hypothesis Testing

© Mildred Murray-Ward via Wikimedia Commons

Additional High-Yield Information

© Repapetilto via Wikimedia Commons

Additional High-Yield Information

© The Roslin Institute

2. Factors Influencing Sample Size

5. Calculating Sample Size

2. Types of Regression Models

b. Multiple Linear Regression:

© Towards Data Science

3. Survival Analysis Techniques

b. Cox Proportional Hazards Model:

4. Applications of Survival Analysis

SENSITIVITY, SPECIFICITY, AND PREDICTIVE VALUES

3. Positive Predictive Value (PPV)

4. Negative Predictive Value (NPV)

1. Likelihood Ratios (LR)

3. Diagnostic Odds Ratio (DOR)