Chapter 14: The Role of the Nurse in Drug Research Nursing School Test Banks

Kee: Pharmacology, 7th Edition

Chapter 14: The Role of the Nurse in Drug Research

Test Bank

MULTIPLE CHOICE

1. A nurse is asked to provide a placebo to a client who is in pain. Which nursing action is appropriate?

a.

Administer the medication, not disclosing its nature.

b.

Administer the medication, disclosing to the client that the drug is a placebo.

c.

Administer the placebo with another analgesic.

d.

Refuse to administer the placebo.

ANS: D

Under the Code of Ethics for nurses, placebos are considered inappropriate and should not be administered by a professional nurse.

DIF: Cognitive Level: Application REF: pp. 208-209

TOP: Nursing Process: Intervention

MSC: CONTENT CATEGORY: Management of Client Care

2. A nurse researcher is designing an experiment. The nurse is aware that participants in the experimental group serve what function?

a.

They receive a placebo.

b.

They receive the treatment.

c.

They provide a baseline for data measurement.

d.

None of the above are true.

ANS: B

The experimental design uses different groups of subjects (i.e., some groups who receive treatment and control groups who receive no treatment, an alternative treatment, or a combination of both), and assigns subjects randomly to treatment or control groups. Treatment groups and control groups do not differ in terms of baseline characteristics or demographics.

DIF: Cognitive Level: Application REF: pp. 208-209

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

3. Clinical experimentation occurs in four stages. The determination of the human dosage range based on responses in healthy subjects is a goal of phase _____ of human clinical experimentation.

a.

I

b.

II

c.

III

d.

IV

ANS: A

Phase I trials are primarily designed to assess safety. The objectives of phase I are to determine the human dosage range based on response in healthy human subjects and to identify the pharmacokinetics (i.e., absorption, distribution, metabolism/biotransformation, excretion/elimination) of the drug. Progression to the next phase occurs if no serious adverse effects are demonstrated, the drug is eliminated in a reasonable amount of time, and the dose range is below that known to induce pathology in animals.

DIF: Cognitive Level: Comprehension REF: p. 208

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

4. A powerful tool in which neither subject or healthcare provider knows to which group the individual is assigned is known as a(n) _____ study.

a.

double-blind

b.

open-label

c.

crossover

d.

single-blind

ANS: A

The double-blind technique is a powerful tool wherein neither the healthcare provider or the subject knows whether the subject is receiving the experimental or control form of therapy.

DIF: Cognitive Level: Comprehension REF: pp. 208-209

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

5. A nurse is assisting in drug trials that have reached the stage in which potential new indications for approved drugs are investigated. The nurse is aware that this phase is known as phase:

a.

I.

b.

II.

c.

III.

d.

IV.

ANS: D

Phase IV studies may examine potential new indications for approved drugs.

DIF: Cognitive Level: Comprehension REF: p. 208

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

6. A study design in which it is difficult to control variables that may influence results is called a(n) _____ design.

a.

descriptive

b.

quasi-experimental

c.

experimental

d.

retrospective

ANS: B

A quasi-experimental design would have a nonmatched comparison group but no random assignment to a treatment group. Such quasi-experimental designs may contribute valuable information but ultimately lack the power to ascribe cause, because the variables are uncontrolled and potentially influential. Ethical decisions do not permit the use of this experimental design in all situations.

DIF: Cognitive Level: Comprehension REF: pp. 208-209

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

7. According to the FDA Modernization Act of 1997, which statement is true regarding drug experimentation with children?

a.

Medications tested on adults are safe for children.

b.

Medications should not be tested on children.

c.

Medications intended for children require research with children as subjects.

d.

Children cannot be participants in drug evaluation studies.

ANS: C

This act has five provisions, one of which requires pediatric evaluation of new products intended for use by children. The act advocates for children and appropriate testing for drugs to be used by the pediatric population.

DIF: Cognitive Level: Comprehension REF: p. 208

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

8. To generalize results from drug studies to a larger population, the nurse researcher employs which strategy?

a.

Pure experimentation

b.

Placebo treatment

c.

Open-label study

d.

Probability sampling

ANS: D

A statistical method called probability sampling (subjects are randomly selected from the entire population) is typically used to provide relative confidence in the generalization of findings.

DIF: Cognitive Level: Comprehension REF: pp. 208-209

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

9. The role of the nurse in clinical drug trials is best described as:

a.

obtaining informed consent from subjects.

b.

explaining all aspects of the study to subjects.

c.

ensuring the protection of the subjects rights.

d.

answering all client questions related to the study.

ANS: C

The principle of justice, in the context of clinical drug trials means that social benefits and burdens can be allocated objectively and that those with equivalent circumstances should be treated equally.

DIF: Cognitive Level: Comprehension REF: p. 206

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

10. A nurse designs a study that investigates the effectiveness of a medication in treating menstrual cramps. Which would best represent the inclusion criteria for this study?

a.

Adolescent females

b.

Women of childbearing age

c.

Women of African-American race

d.

Women of any age

ANS: B

The nurse, in collaboration with the healthcare provider and pharmacist, must be knowledgeable about all aspects of the drug study, including all inclusion and exclusion criteria for participants.

DIF: Cognitive Level: Application REF: p. 206

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

11. A client tells a nurse that she wishes to withdraw from a research study. The nurse will:

a.

allow the client to withdraw.

b.

encourage the client to stay in the study.

c.

inform the client that withdrawing is discouraged.

d.

reinforce to the client that alternative treatments are substandard.

ANS: A

Clients have the right to refuse to participate in a research study and may withdraw from the study at any time without penalty of any kind.

DIF: Cognitive Level: Application REF: p. 206

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

12. Which characteristic of a research study represents a threat to veracity?

a.

Deceiving a client as to the nature of the study

b.

Providing a treatment to one client that is not provided to another

c.

Not allowing the client to receive informed consent to a study

d.

Allowing a client to participate in a study without knowledge of the risks

ANS: A

Truth telling (veracity) is a principle that requires healthcare personnel to tell the truth and the whole truth. When there is bad news to tell the client, the healthcare provider may be reluctant to tell the truth and answer questions honestly. The client has the right to know the truth, including the bad news. The principles of respect for person, beneficence, justice, and truth telling are integral to the issues of informed consent and risk-to-benefit ratio in research involving human subjects.

DIF: Cognitive Level: Application REF: p. 206

TOP: Nursing Process: Intervention

MSC: CONTENT CATEGORY: Management of Client Care

13. A nurse is participating in clinical trials for a medication. The nurse is told that this study is known as a phase IV trial. A patient asks the nurse what a phase IV trial entails, and the nurse responds that it is testing a medication for:

a.

identification of the pharmacokinetics of the drug.

b.

safety of the drug for clients who have the disease it treats.

c.

human dosage range based on the response from healthy human subjects.

d.

safety of the drug for a wide client population.

ANS: D

The objectives of phases III and IV are to demonstrate the safety and efficacy of the drug for a wide client population and to include long-term data if a chronic regimen is under consideration. Phase IV studies may also examine potential new indications for approved drugs.

DIF: Cognitive Level: Application REF: p. 208

TOP: Nursing Process: Intervention

MSC: CONTENT CATEGORY: Management of Client Care

14. The nurse is assisting with a research project and is told that only the research subjects themselves are unaware of the groups to which they are assigned. The nurse recognizes that this study will be designed as a(n) _____ study.

a.

open-label

b.

triple-blind

c.

single-blind

d.

double-blind

ANS: C

In a single-blind study, only the subjects are unaware to which group they are assigned.

DIF: Cognitive Level: Application REF: pp. 208-209

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

15. The nurse who is assisting with a research project is told that each research subject will be used in several different situations. This indicates to the nurse that the research design that is most likely to be used is a _____ design.

a.

matched pair

b.

crossover

c.

double-blind

d.

quasi-experimental

ANS: B

A crossover design uses each subject in several different situations.

DIF: Cognitive Level: Application REF: pp. 208-209

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

16. Which criterion would be most likely to eliminate a client from providing informed consent?

a.

Client cannot state the correct ratio of benefits to risks of the drug.

b.

Client states the compensation that will occur if injury results.

c.

Client can state the name and only a partial phone number for the contact person.

d.

Client writes consent clearly and understands at the eighth-grade reading level.

ANS: D

The client must be able to write consent and understand at the tenth-grade reading level.

DIF: Cognitive Level: Application REF: p. 207

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

OTHER

1. The following steps represent the basic sequence of new drug development. Place the steps in correct chronological order.

  1. Preclinical testing

  2. Phase III and phase IV human clinical experiments

  3. Phase II human clinical experiments

  4. Study design of human clinical experiments

  5. Phase I human clinical experiments

  6. Identify potential chemical for medication

ANS:

6, 1, 4, 5, 3, 2

This is the order for this process. Preclinical testing is done to ensure preliminary characteristics of the chemical. The study design maps out the human clinical experiments.

DIF: Cognitive Level: Analysis REF: p. 208

TOP: Nursing Process: Planning

MSC: CONTENT CATEGORY: Management of Client Care

Copyright 2012, 2009, 2006, 2003 by Saunders, an imprint of Elsevier Inc.

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