Week 4: Clinical Trials and Design
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Questions and Answers

Which of the following is a continuous quantitative variable?

  • Length of a crown (correct)
  • Color of gingiva
  • Number of amalgam fillings
  • Patient status

The color of gingiva is a quantitative variable.

False (B)

What type of variable is 'pulse rate'?

quantitative continuous

The ______ classification is a qualitative variable related to jaw structure.

<p>orthognathic jaw</p> Signup and view all the answers

Match the following dental variables with their types:

<p>Patient status = Qualitative Number of patients without medical insurance = Quantitative Discrete Mercury concentration in amalgam = Quantitative Continuous Size of periradicular lesion = Quantitative Continuous</p> Signup and view all the answers

Which of the following is a discrete quantitative variable?

<p>Golf score (A)</p> Signup and view all the answers

Shear strength of a bonding material is a qualitative variable.

<p>False (B)</p> Signup and view all the answers

What is the primary purpose of a stem and leaf plot?

<p>To display individual observations while summarizing the data (A)</p> Signup and view all the answers

In a stem and leaf plot, the leaves correspond to the leftmost digits of the observed values.

<p>False (B)</p> Signup and view all the answers

What information does a stem and leaf plot provide that a histogram does not?

<p>Individual values of observations</p> Signup and view all the answers

Match the clinical trial components to their descriptions:

<p>Efficacy = Effectiveness of a treatment Safety = Assessment of adverse effects Risk-benefit ratio = Comparison of risks and advantages Trial optimization = Improving the trial design and process</p> Signup and view all the answers

What is one of the advantages of using a stem and leaf plot over a histogram?

<p>It provides all individual observations (A)</p> Signup and view all the answers

It is essential for the leaves in a stem and leaf plot to be listed in ascending order.

<p>False (B)</p> Signup and view all the answers

What is a key step in constructing a stem and leaf plot?

<p>Separate each value into a stem and a leaf component</p> Signup and view all the answers

What are the possible goals of a clinical trial?

<p>Superiority, non-inferiority, or equivalence (B)</p> Signup and view all the answers

Participants in clinical trials are usually paid for their involvement.

<p>False (B)</p> Signup and view all the answers

What is the purpose of control groups in a clinical trial?

<p>To provide a comparison for the experimental group by monitoring responses without the treatment.</p> Signup and view all the answers

A clinical trial involves an experimental group and a __________ group.

<p>control</p> Signup and view all the answers

What can a treatment in a clinical trial be classified as?

<p>A drug, medical device, medical procedure, or change in behavior (D)</p> Signup and view all the answers

What term is used to refer to people who participate in clinical trials?

<p>Participants or subjects</p> Signup and view all the answers

Match the following terms with their descriptions:

<p>Experimental group = Group receiving the treatment Negative control group = Group not receiving the treatment or is given a placebo Positive control group = Group receiving a standard treatment for comparison Participants = Volunteers in the clinical trial</p> Signup and view all the answers

A clinical trial can include only one type of control group.

<p>False (B)</p> Signup and view all the answers

What is the primary purpose of a positive control group in an experiment?

<p>To show subjects' capability of response (C)</p> Signup and view all the answers

What is the primary factor that influences tooth mobility?

<p>Occlusal force measured in millipascals (A)</p> Signup and view all the answers

A placebo has therapeutic value similar to the active medication.

<p>False (B)</p> Signup and view all the answers

Type of drug used in general anesthesia does not affect the outcome of a surgical procedure.

<p>False (B)</p> Signup and view all the answers

What is the placebo effect?

<p>The phenomenon where some individuals experience benefits after receiving an inactive substance.</p> Signup and view all the answers

What does the degree of curvature of a root refer to?

<p>The angle or bend in the root structure of a tooth.</p> Signup and view all the answers

The group that does not receive the test treatment in an experiment is called the ______.

<p>control group</p> Signup and view all the answers

Match the following terms with their descriptions:

<p>Positive Control = A group that shows capability of response Placebo = An inactive substance with no therapeutic value Placebo Effect = Benefits experienced after receiving a placebo Control Group = Participants receiving no test treatment</p> Signup and view all the answers

Which of the following is NOT a form of placebo?

<p>Active medication (B)</p> Signup and view all the answers

Match the following dental procedures and factors that influence them:

<p>Tooth Mobility = Occlusal force Bone Grafting = Bone graft type Root Canal Treatment = Type of filling material Surgical Complication = Level of complexity</p> Signup and view all the answers

A negative control group is the same as a positive control group.

<p>False (B)</p> Signup and view all the answers

In the example provided, what mouth rinse product was Wellness, Inc. introducing?

<p>Oral-Fresh</p> Signup and view all the answers

What does a single-blind study mean?

<p>Patients do not know whether they are in the experimental or control group. (D)</p> Signup and view all the answers

In a double-blind study, only patients are kept uninformed about their treatment assignment.

<p>False (B)</p> Signup and view all the answers

What is the simplest and most widely used design for clinical trials?

<p>Parallel groups design</p> Signup and view all the answers

In a parallel design, subjects receive only one of the __________.

<p>treatments</p> Signup and view all the answers

Match each term with its description:

<p>Single-blind = Patients do not know their group assignment Double-blind = Both patients and investigators are uninformed about treatment Parallel groups design = Subjects are randomly assigned to one treatment only Treatment group = Group receiving the experimental intervention</p> Signup and view all the answers

What is one limitation of the parallel groups design?

<p>Subjects only receive one treatment, limiting understanding of interactions. (C)</p> Signup and view all the answers

Patients in a double-blind trial are informed whether they are receiving treatment or placebo.

<p>False (B)</p> Signup and view all the answers

Flashcards

Crossover Design (3 Treatments)

A clinical trial design where each subject receives all treatments, in a specific order, with washout periods between treatments. Used to compare the effects of different treatments on the same subject.

Qualitative Variable

A variable that describes a quality or characteristic, not a numerical value. Categories or labels are used.

Quantitative Variable (Discrete)

A variable that can be counted, representing whole numbers or distinct units.

Quantitative Variable (Continuous)

A variable that can take on any value within a given range, represented by a measurable value.

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Patient Status

Describes the health condition of a patient; a way of categorizing patients.

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Level of Measurement Scale

A way to classify variables based on the type of information they convey. (e.g., nominal, ordinal, interval, ratio).

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Washout Period

A period of time between treatments in a crossover study, designed to minimize carryover effects from previous treatments.

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Dental Variables

Characteristics of patients and treatments in dental studies, examples are Patient status, Color of gingiva, etc.

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Stem and Leaf Plot

A display method that shows data values in a way that allows viewing individual data points while summarizing the data.

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Stem Component

The part of a value that represents all digits except the last one.

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Leaf Component

The last digit of a value in the stem and leaf plot.

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Stem and leaf plot construction step 1

Separating each value into its stem and leaf components.

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Stem and leaf plot construction step 2

Writing the numerical stems in ascending order. The smallest one first, the largest one last.

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Stem and leaf plot construction step 3

Writing the leaf values to the right of the corresponding stem in ascending order.

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Clinical trial design

The process of planning an interventional clinical trial to get maximum output.

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Clinical trial purpose

To evaluate a treatment's effectiveness, safety, or risk-benefit ratio.

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Tooth Mobility

The degree to which a tooth can move in its socket.

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Clinical Trial

A research study examining if a treatment improves health for specific diseases.

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Bone Graft Type

Different types of materials used to replace or rebuild bone.

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Experimental Group

Group receiving the treatment being tested in a study.

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Surgical Approach Type

The specific method used to perform a surgical procedure.

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Negative Control Group

Group not receiving any treatment; used as a baseline.

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Investigational Treatment

A potential new treatment, drug, device, or behavioral change being studied.

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Occlusal Force

The force exerted on teeth during chewing.

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Alveolar Ridge Shape

The shape of the bone that surrounds the teeth in the jaw.

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Clinical Trial Goal

To determine if a treatment is superior, non-inferior, or equivalent to existing treatments.

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Subject/Participant

A volunteer who takes part in a clinical trial.

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Experiment

Study with an experimental group, negative control group, and sometimes a positive control group.

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Control Group

Group providing a baseline for comparison; may include placebo.

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Positive Control Group

A group in an experiment that is given a known treatment to demonstrate a positive response and is used to verify the experimental design.

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Negative Control Group

A group in an experiment that does not receive any treatment and its purpose is to show that no response occurs if there are no treatment.

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Placebo

An inactive substance or treatment that looks like the real treatment to reduce psychological factors' influence.

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Placebo Effect

The psychological response to a treatment that appears to be effective, even though it's inactive.

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Experimental Group

The group in an experiment that receives the treatment being tested and is the main focus of comparison.

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Clinical Trial

A research study that evaluates the effectiveness and safety of a new treatment or intervention in humans.

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Gingivitis

Inflammation of the gums, often caused by plaque buildup.

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Mouth Rinse effectiveness

The ability of a mouth rinse to improve gum health.

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Single-Blind Study

A clinical trial where patients don't know if they're in the treatment or control group, but the researchers do.

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Double-Blind Study

A clinical trial where neither the patients nor the researchers know which group (treatment or control) a participant is in.

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Parallel Groups Design

A clinical trial design where subjects are randomly assigned to one of the treatment groups and only receive one treatment.

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Random Assignment

Assigning participants to treatment groups using a random process to avoid bias.

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Treatment Group

The group of participants receiving the specific treatment or intervention being studied in a clinical trial.

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Control Group

The group in a clinical trial that does not receive the treatment being studied or receives a placebo.

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Sample Size

The number of participants in a clinical trial or study.

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Clinical Trial Design

The overall plan for conducting a clinical trial, including the method of assigning subjects to groups and the type of study (single-blind, double-blind, etc.).

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Study Notes

Biostatistics

  • Biostatistics is a subject taught in Semester 1, Week 4.
  • Course is offered by the Bahçeşehir University Faculty of Dentistry.

Stem and Leaf Plots

  • Data is organized in a stem and leaf plot by separating each value into a stem (all but the last digit) and a leaf (last digit).
  • Leafs are arranged sequentially.
  • Plots show the frequency of each leaf.

Systolic Blood Pressure Data (112 Patients)

  • Data presents systolic blood pressure measurements (mmHG) for 112 patients.
  • Values are displayed in a stem and leaf plot format.
  • The plot displays frequencies for each leaf.
  • The first column of frequencies shows how often each leaf value appears.

Clinical Trials and Designs

  • Clinical trials are experimental studies involving humans.
  • Participants are called volunteers or subjects and assist in research for better treatments.
  • Results of every clinical trial provide researchers with information on risks and benefits of treatments.
  • Trials aim for optimizing, ergonomic, and efficient clinical trial implementation by evaluating efficacy, safety.

Phases of a Clinical Trial

  • Clinical trials are divided into phases.
  • Phase 1 focuses on safety, determining how the drug affects the human body.
  • Phase 2 adds safety and dosing, monitoring side effects and optimal dosage.
  • Phase 3 evaluates safety and efficacy further, confirming effectiveness and monitoring long-term safety.
  • Phase 4 monitors post-marketing safety and efficacy.

Types of Control Groups

  • Negative control groups mimic control groups, and are commonly a placebo group or untreated group.
  • Positive controls are treatment groups expected to produce a response.

Placebo Effect

  • Placebos are inactive substances with similar attributes to the actual treatment.
  • The placebo effect occurs when participants show a positive response due to the belief that they are receiving a treatment.

Clinical Trials Example

  • Wellness, Inc. was developing a new mouth rinse called Oral-Fresh for prevention of gingivitis.
  • The Effectiveness of the mouth rinse was assessed by measuring gingival indices at a 3-month time point.

Single-Blind and Double-Blind Studies

  • Single-blind studies: Patients are unaware of the treatment group (experimental or control).
  • Double-blind studies: Both patients and researchers are unaware of the treatment type.

Clinical Designs: Parallel Groups

  • Parallel group designs—treatments are compared across different groups
  • Subjects are randomly assigned to one of the treatments.

Crossover Design

  • Crossover designs: Each subject receives all treatments sequentially.
  • Subjects are randomly assigned to receive one of two or more treatments.
  • A washout period allows for removal of carryover effects between treatments

Exercises (Qualitative/Quantitative Data)

  • Various dental variables are listed.
  • Instructions are to classify if the measurement is qualitative or quantitative and whether the variable is discrete or continuous.

Exercises (Level of Measurement Scale)

  • Classify the following measures according to level of measurement scales.
  • A list of measures is provided for classification.

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Biostatistics Semester 1 Week 4 PDF

Description

This quiz covers Biostatistics concepts discussed in Semester 1, Week 4. It includes topics such as stem and leaf plots, systolic blood pressure data analysis, and the fundamentals of clinical trials. Test your understanding of how data can be organized and interpreted in the context of healthcare studies.

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