Updated: 10/11/2016

Clinical Trial Design

Topic
Review Topic
0
0
Questions
8
0
0
Evidence
2
0
0
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Introduction
  • Clinical trial design impacts Level of Evidence 
  • Clinical trials may be either observational or experimental
    • observational
      • researchers observe patient groups without allocation of intervention
      • may be either prospective or retrospective
      • may be descriptive or analytic
        • descriptive
          • useful for obtaining background information for more advance studies
          • examples
            • case reports
            • case series
            • cross-sectional studies
        • analytic
          • explores the association between a given outcome and a potentially related variable
          • examples
            • case-control
            • cohort
            • meta-analysis
    • experimental
      • researchers allocate treatment
      • allows the evaluation of efficacies of therapeutic interventions
      • examples
        • double-blinded, prospective, randomized clinical trial is the gold standard for evidence based medicine
Randomized controlled trial 
Cohort study
Case-control study
Meta-analysis
Cross-sectional Study
Case Series
 

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Questions (8)

(OBQ11.243) A clinical trial is underway for patients with wrist extensor tendinitis. One group of 100 patients are treated with short arm casting. Another group of 100 patients are treated with physical therapy. During analysis of the results, it becomes apparent that 30 patients in the physical therapy group did not complete the full course of physical therapy. Despite not completing a full course of physical therapy, these 30 patients were included in the physical therapy group for analysis. This analysis is an example of which of the following? Review Topic

QID: 3666
1

Per-protocol

6%

(312/4894)

2

Crossover analysis

6%

(298/4894)

3

Intent-to-treat

79%

(3868/4894)

4

Bayesian analysis

5%

(227/4894)

5

Effect size

3%

(149/4894)

ML 2

Select Answer to see Preferred Response

PREFERRED RESPONSE 3
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(OBQ13.195) A study was designed to measure the benefit of subacromial corticosteroid injections. Participants were randomized to methylprednisolone acetate 40 mg with lidocaine 1% or lidocaine 1% alone. The participants were not provided with information of their treatment allocation. The subacromial injection was prepared and administered by a single orthopaedic surgeon. Results were collected by the orthopaedic surgeon using clinical and patient satisfaction outcome scores at 6, 12, and 24 weeks. Which of the following would best describe this type of study? Review Topic

QID: 4830
1

Double blinded randomized and controlled study

3%

(132/3817)

2

Single blinded randomized study

89%

(3404/3817)

3

Retrospective study

1%

(25/3817)

4

Case-control study

2%

(70/3817)

5

Prospective cohort study

4%

(154/3817)

ML 1

Select Answer to see Preferred Response

PREFERRED RESPONSE 2

(OBQ05.86) A clinical study for lateral epicondylitis allocates 1 group to receive physical therapy for 4 weeks and another group a new oral medication for 4 weeks. Then the 2 groups immediately switch therapies with one another for the next 4 weeks. The half-life of the medication used in the study is 2 weeks. Which of the following best describes the bias that is present in this study design? Review Topic

QID: 972
1

Recall bias

5%

(42/847)

2

Verification bias

3%

(29/847)

3

Washout period bias

74%

(627/847)

4

Detection bias

8%

(64/847)

5

Incorporation bias

10%

(83/847)

ML 2

Select Answer to see Preferred Response

PREFERRED RESPONSE 3

(OBQ04.149) A research study is initially designed as a high-quality randomized control trial. The study seeks to demonstrate a different clinical outcome with treatment A compared to treatment B for a specific disease. However, at the completion of the study the investigators are only able to obtain 70% follow-up of patients. What level of evidence should be assigned to this study? Review Topic

QID: 1254
1

1

19%

(231/1210)

2

2

71%

(858/1210)

3

3

8%

(96/1210)

4

4

2%

(19/1210)

5

5

0%

(3/1210)

ML 2

Select Answer to see Preferred Response

PREFERRED RESPONSE 2

(OBQ09.34) What is the primary purpose of utilizing a computer random number generator for patient randomization when designing a Level I therapeutic controlled trial? Review Topic

QID: 2847
1

To increase treatment effect

0%

(2/571)

2

To prevent selection bias

97%

(553/571)

3

To generate enough power

1%

(3/571)

4

To achieve statistical significance

2%

(9/571)

5

To perform as-treated analysis

0%

(1/571)

ML 1

Select Answer to see Preferred Response

PREFERRED RESPONSE 2
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Topic COMMENTS (4)
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