Which Of The Following Is Not A "Control" In An Experimental Procedure?

• A randomized controlled trial (or randomized control trial; RCT) is a blazon of scientific (oftentimes medical) experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments.
• Information technology is a trial in which subjects are randomly assigned to one of two groups: one (the experimental group) receiving the intervention that is beingness tested, and the other (the comparison grouping or command) receiving an alternative (conventional) handling.
• The two groups are so followed up to see if there are any differences between them in the result.

Prototype Source: http://www.edinburgh-eyetests.co.uk/ebm.htm

• Features of Randomized Controlled Trials (RCTs)
• Principle of Randomized Controlled Trials (RCTs)
• Steps in Randomized Controlled Trials (RCTs)
  • i. The protocol
  • 2. Selecting reference and experimental populations
  • 3. Randomization
  • 4. Manipulation
  • 5. Follow-upward
  • 6. Assessment
• Potential Bias in RCTs
• The Blinding Technique
• Significance of Randomized Controlled Trials (RCTs)
• References

Features of Randomized Controlled Trials (RCTs)

1. They are randomized:The researchers determine randomly as to which participants in the trial receive the new treatment and which receive a placebo, or fake treatment.
2. They are controlled: The trial uses a control grouping for comparison or reference. In the command grouping, the participants do not receive the new treatment just instead receive a placebo or reference treatment.

Principle of Randomized Controlled Trials (RCTs)

1. It is accomplished past randomly allocating subjects to ii or more than groups, treating them differently, then comparing them with respect to a measured response.
2. One group—the experimental group—has the intervention being assessed, while the other—usually called the control grouping—has an culling condition, such as a placebo or no intervention.
3. The groups are followed under conditions of the trial design to run across how effective the experimental intervention was.
4. Treatment efficacy is assessed in comparing to the command.
5. There may be more than one treatment group or more one command grouping.
6. The results and subsequent assay of the trial are used to assess the effectiveness of the intervention, which is the extent to which treatment, procedure, or service does patients more good than damage.

Steps in Randomized Controlled Trials (RCTs)

The basic steps in conducting an RCT include the following:

1. Drawing up a protocol.
2. Selecting reference and experimental populations.
3. Randomization.
4. Manipulation or intervention.
5. Follow-upwards.
6. Cess of outcome

i. The protocol

• One of the essential features of a randomized controlled trial is that the report is conducted under a strict protocol.
• The protocol specifies the aims and objectives of the study, questions to be answered, criteria for the pick of study and control groups, size of the sample, the procedures for allocation of subjects into study and control groups, treatments to be applied when and where and how to what kind of patients, standardization of working procedures and schedules as well as responsibilities of the parties involved in the trial, up to the stage of evaluation of outcome of the study.
• The protocol aims at preventing bias and to reduce the sources of error in the study.

two. Selecting reference and experimental populations

(a) Reference or target population:

• It is the population to which the findings of the trial, if establish successful, are expected to be applicable (east.g., a drug, vaccine or other process).
• A reference population may be equally broad equally mankind or information technology may be geographically limited or limited to persons in specific historic period, sexual practice, occupational or social groups.

 (b) Experimental or study population:

• The study population is derived from the reference population. It is the actual population that participates in the experimental study.
• Ideally, it should be randomly chosen from the reference population, so that information technology has the same characteristics as the reference population.
• If the written report population differs from the reference population, it may not be possible to generalize the findings of the study to the reference population.

The participants or volunteers must fulfill the following three criteria:

1. They must requite "informed consent", that is they must agree to participate in the trial after having been fully informed about the purpose, procedures and possible dangers of the trial;
2. They should exist representative of the population to which they belong (i.east., reference population); and
3. They should exist qualified or eligible for the trial.

3. Randomization

• Randomization is a statistical procedure by which the participants are allocated into groups usually called "study" and "control" groups, to receive or non to receive an experimental preventive or therapeutic procedure, maneuver or intervention.
• Randomization is an attempt to eliminate "bias" and allow for comparability.
• Randomization is the "middle" of a controlled trial. It will give the greatest confidence that the groups are comparable so that "like can be compared with like".
• Randomization is done only after the participant has entered the study that is after having been qualified for the trial and has given his informed consent to participate in the study.
• Randomization is all-time done by using a table of random numbers.

4. Manipulation

• Having formed the study and control groups, the adjacent step is to arbitrate or manipulate the report (experimental) group by the deliberate application or withdrawal or reduction of the suspected causal cistron (e.g., this may exist a drug, vaccine, dietary component, a habit, etc) as laid down in the protocol.
• This manipulation creates an independent variable (e.g., drug, vaccine, a new procedure) whose upshot is then · determined by measurement of the concluding result, which constitutes the dependent variable (e.g., the incidence of disease, survival time, recovery period).

5. Follow-up

• This implies exam of the experimental and control group subjects at defined intervals of time, in a standard manner, with equal intensity, under the aforementioned given circumstances, in the same time frame till final assessment of outcome.
• The duration of the trial is usually based on the expectation that a significant divergence (east.g., mortality) volition exist demonstrable at a given point in time after the start of the trial.
• Thus the follow-up may be brusk or may crave many years depending upon the written report undertaken.

6. Cess

The final pace is the assessment of the issue of the trial in terms of:

(a) Positive results: that is, benefits of the experimental measures such as reduced incidence or severity of the disease, cost to the health service, or other advisable outcomes in the written report and control groups.

(b) Negative results: that is, severity and frequency of side-effects and complications, if any, including decease. Adverse furnishings may exist missed if they are not sought.

• The incidence of positive/negative results is rigorously compared in both the groups and the differences, if whatsoever, are tested for statistical significance.
• Techniques are available for the assay of data equally they are collected (sequential analysis), merely information technology is more useful to analyze the results at the end of the trial.

Potential Bias in RCTs

Bias may arise from errors of assessment of the outcome due to the human being chemical element. These may be from three sources:

1. First, there may exist bias on the part of the participants, who may subjectively feel better or report improvement if they knew they were receiving a new class of handling. This is known as "bailiwick variation".
2. Secondly, there may be observer bias that is the investigator measuring the issue of a therapeutic trial may be influenced if he knows beforehand the detail procedure or therapy to which the patient has been subjected. This is known as "observer bias."
3. Thirdly, in that location may be bias in evaluation that is, the investigator may subconsciously give a favorable report of the issue of the trial.

The Blinding Technique

In order to reduce these problems, a technique known equally "blinding" is adopted, which will ensure that the outcome is assessed objectively.

Blinding can exist done in three means:

(a) SINGLE Blind TRIAL: The trial is so planned that the participant is not aware whether he belongs to the study group or control group.

(B) DOUBLE-Blind TRIAL: The trial is so planned that neither the medico nor the participant is aware of the group allocation and the treatment received.

(C) TRIPLE Blind TRIAL: This goes one step further. The participant, the investigator, and the person analyzing the data are all "bullheaded".

Ideally, of form, triple blinding should be used; simply double-blinding is the most oft used method when a bullheaded trial is conducted.

Significance of Randomized Controlled Trials (RCTs)

• Randomized controlled trials are the about reliable method available for testing new treatments.
• RCTs are the most stringent style of determining whether a crusade-consequence relation exists between the intervention and the outcome
• They have become the standard that pharmaceutical companies must run across for calculating and proving the level of efficacy and safe of an experimental drug.

References

1. https://emj.bmj.com/content/20/2/164
2. https://www.medicalnewstoday.com/articles/280574.php
3. Park, K. (n.d.). Park's textbook of preventive and social medicine.
4. Beaglehole, Robert, Bonita, Ruth, Kjellström, Tord & Earth Health Organization. (‎1993)‎. Basic epidemiology, Updated reprint. World Wellness Organization.
5. Gordis, 50. (2014). Epidemiology (Fifth edition.). Philadelphia, PA: Elsevier Saunders.
6. Hennekens CH, Buring JE. Epidemiology in Medicine, Lippincott Williams & Wilkins, 1987.
7. White, F., Stallones, L., & Last, J. 1000. (2013). Global public health: Ecological foundations. New York, NY: Oxford University Press.

Which Of The Following Is Not A "Control" In An Experimental Procedure?,

Source: https://thebiologynotes.com/randomized-controlled-trial-rcts/

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