Concepts Journal Club 2

Question 1

Informed consent

Answer 1

Process for getting permission. Permission granted in full knowledge of the possible consequences, typically what is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits.

Question 2

Internal validity

Answer 2

It is the extent to which you are able to say that no other variables except the one you are studying caused the result. E.g. if we are studying the variable of pay and the result of hard work, we want to be able to say that no other reason (not personality) causes the hard work. Confounding effect, you say something is caused by something but you do not know by what.

Question 3

External validity

Answer 3

Is the extent to which results of a study can be generalized to the world as large so applying the conclusions of a study outside the context of that study.

Question 4

Diagnostic study

Answer 4

In depth-evaluation with a relatively narrow scope of analysis, aimed at identification of a specific condition or problem.

Question 5

Prognostic study

Answer 5

The standard prognostic study is a cohort study in which a group of people with a particular condition or set of characteristics is followed over a period of time. At the start of the period, a range of factors that may influence outcomes are measured and outcomes are measured over the period.

Question 6

Observational study

Answer 6

Draw inferences from a sample to a population where the independent variable is not under the control of the researcher because of ethical concerns or logistical constraints. It is a type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome.

Question 7

Experimental study

Answer 7

A study in which all of the risk factors are under the direct control of the investigator. Experimental studies are usually randomized, meaning the subjects are grouped by chance.

Question 8

Cross-sectional study

Answer 8

It can compare different population groups at a single point in time, which allows researchers to compare many different variables at the same time, but they may not provide definite information about cause-and-effect relationships.

Question 9

Longitudinal study

Answer 9

A research design that involves repeated observations of the same variables over long periods of time.

Question 10

Ecological study

Answer 10

An observational study in which at least one variable is measured at the group level. An ecological study is especially appropriate for initial investigation of causal hypothesis.

Question 11

Case-control

Answer 11

A study that compares two groups of people, those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls).

Question 12

Randomized control trial

Answer 12

Prospective studies that measure the effectiveness of a new intervention or treatment. Although no study is likely on its own to prove causality, randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome.

Question 13

Trial design

Answer 13

An important aspect of interventional trials that serves to optimize, ergonomic, and economize the clinical trial conduct. The purpose of the clinical trial is an assessment of efficacy, safety, or risk-benefit ratio. The goals may be superiority, non-inferiority, or equivalence.

Question 14

Flow diagram

Answer 14

A diagram of the sequence of movements or actions of people or things involved in a complex system of activity.

Question 15

Trial protocol

Answer 15

The protocol is a document that describes how a clinical trial will be conducted and ensures the safety of the trial subjects and integrity of the data collected.

Question 16

Setting

Answer 16

The place or type of surroundings where something is positioned or where an event takes place.

Question 17

Pre-test, Post-test

Answer 17

A pre-test is an assessment measure given to participants before they have undergone some type of treatment as a part of a research study. A post-test is an assessment measure given to participants after they have received treatment as part of a research study.

Question 18

Control

Answer 18

An example of a control in science would be cells that get no treatment in an experiment.

Question 19

Randomly assigned

Answer 19

An experimental technique for assigning human participants or animal subjects to different groups in an experiment using randomization. With this methods, every member of the sample has a known or equal chance of being placed in a control group or an experimental group.

Question 20

Random allocation

Answer 20

The assignment of subjects or patients to treatment groups in an unpredictable fashion.

Question 21

Random selection

Answer 21

The choosing of subjects based on chance alone.

Question 22

Pseudo-random sampling

Answer 22

The numerical practice of generating pseudo-random numbers that are distributed according to a give probability distribution.

Question 23

Eligibility

Answer 23

The state of having the right to do or obtain something through satisfaction of the appropriate conditions.

Question 24

Exclusion criteria

Answer 24

Any characteristics in the study protocol that would preclude an potential subject’s participation in the study.

Question 25

Enrolled

Answer 25

Officially register as a member of an institution or a student on a course.

Question 26

Recruitment dates

Answer 26

Date of recruitment means the first day of the employment of the researcher.

Question 27

Intervention(s) of treatment

Answer 27

Involved making a change, or intervening, in order to study the outcome of what has been changed. An intervention is introduced immediately after the baseline period with the aim of affecting an outcome. The intervention itself is the aspect that is being manipulated in your research.

Question 28

Compliance

Answer 28

A state of being in accordance with established guidelines or specifications, or the process of becoming so.

Question 29

Complete-case analysis

Answer 29

A method of dealing with incomplete data. It involves using only completed causes, with no imputed values to missing data, with the risk of bias if the sample with omissions is not representative.

Question 30

Dropped out

Answer 30

To withdraw from participation or membership.

Question 31

Lost to follow-up

Answer 31

Refers to patients who at one point in time were actively participating in a clinical research trial, but have become lost (either by error in a computer tracking system or by being unreachable) at the point of follow-up in the trial.

Question 32

Intention to treat analysis

Answer 32

Based on the initial treatment assignment and not on the treatment eventually received.

Question 33

Harms, Unintended effects

Answer 33

Not planned as a purpose or goal.

Question 34

Limitations

Answer 34

Represent weaknesses within the study that may influence the outcomes and conclusions of the research.