Treatment training manual

8.15 Questions and answers

For each question you can tick more than one answer.Please tick/check all that you think apply.

Questions

1. Community advocates should be involved in research because…

A    It can help with grant applications.

B    Advocates need jobs too.

C    Advocates can help design a study today that will still be providing good treatment in a years time.

D   Advocates can independently represent patient interests if a study isn’t running well.

E    If advocates understand the research they can give independent information about the risks and benefits to individual patients who may want to join the study.

2. Why is research important for advocates?

A   Because if designed well, it can provide reliable information about how effective and/or harmful a treatment or drug may be.

B   Because it will help a company sell more drugs.

C   Because it can prove a new treatment may be better than an older treatment.

D   Because without evidence, you can only guess at whether something works.

E   Because without evidence people are vulnerable to false claims about miracle drugs.

3. Which of these statements about different trials in drug development are true?

A   Phase IV studies are run to get a drug approved.

B   Phase II studies are run before Phase I studies.

C   Phase I studies are run in animals.

D   Phase III studies are the main large studies that a company runs to get a new drug approved.

E   Phase II studies look at different doses of a drug to try to find the best one.

4. Which of these statements about a trial hypothesis are true?

A   Every trial needs to start with a question, which is called a ‘hypothesis’.

B    The hypothesis is a question that a study is designed to either prove or disprove.

C    The hypothesis has to be true from the start of the study.

D    A hypothesis has to say that one thing is better than another.

E    Some trials do not need a hypothesis.

5. Which of these statements about a trial design are true?

A    A primary endpoint of a study is always seen in the group that does the best.

B    A primary endpoint is decided before the study starts. B

C    A secondary endpoint is only used for studies in older children.

D   A primary endpoint decides what level of evidence or results will be acceptable to prove or disprove the study question.

E    Secondary endpoints can look at a wide range of important things like side-effects and quality of life.

6. Which of these statements about studies are true?

A   A prospective study looks backwards in time to see what happened in the past.

B   A new drug is tested in an interventional study.

C   A retrospective study look backwards in time.

D   A cross-sectional study looks at something happening at one point in time.

E   A longitudinal study looks at how tall people are.

7. Which of the following statements describe a study that randomises

A   A prospective, observational study.

B    A prospective, interventional study.

C    A retrospective, cross-sectional study.

D    A prospective, longitudinal study.

E    A cross-sectional, longitudinal study.

8. Which of the following describes a cross-sectional, retrospective study?

A    A study that give people a new drug to see if it has less side effects.

B    A study that decides to see how many people have lipodystrophy at their next clinic appointment.

C    A study that looks at hospital records to see how many patients are current smokers.

D    A study that looks at hospital records to see how many patients had a heart attack last year.

E    A study to see whether combination therapy with 4 drugs in young children was better than starting with three drugs.

E    A longitudinal study looks at how tall people are.

9. Which of the following statements about randomisation are true?

A   Randomisation helps make sure that people who are more ill stand a better chance of getting a new active drug.

B    Randomisation will help make sure that each arm has the same proportion of women, with similar ages and CD4 counts.

C    Randomisation will help make sure that equal proportion of Gemini, Aries, and Librans are in each arm.

D    Randomisation is likely to be effective if people are chosen by tossing a coin.

E    Randomisation is likely to be effective if people are chosen by the day that they visit the clinic.

10. Which of the following statements about terms used in trials are true?

A    A placebo is a drug that works well but has no taste.

B    A placebo has no active drug and is used to compare results to an investigational drug.

C    Blinding makes sure that a patient knows which drug they get.

D    Double-blinding means that neither the doctor nor patients know which arm they are in.

E    A control group is the name for study arm that is used to compare the results of a new intervention.

11. Which statements about these different types of trial are true?

A   A cohort study is usually an observational study that follows a group of people over time.

B    A cohort study is the best way to see if a new drug works.

C    Prospective, randomised, placebo- controlled, studies are the ‘gold- standard’ for getting the most reliable evidence about an intervention.

D   A cross-sectional study can give you a quick answer to whether a new side effect is being seen in a clinic.

E    A meta-analysis compares results from different studies.

12. Which of the following five terms relates to each of the longer descriptions below?

  1. results
  2. method
  3. discussion
  4. background
  5. conclusion

A   The final summary results – what was learned and how it can affect care.

B   The strengths and weaknesses of the study: cautions about interpretation, what could have been done better, and the implications for clinical practice, treatment guidelines or for further research.

C   What exactly was studied and how it was performed.

D   What is already known about this area of research and why the study is being run.

E   What was seen or demonstrated.

13. Which of these statements about informed consent are true

A    The ‘main’ reason for informed consent is to protect a researcher from legal claims in the future Question 4: A, B

B    The ‘main’ reason for informed consent is to make sure patients understand the potential risks and benefits of a study before they agree to take part

C    Informed consent should be written in simple language and carefully explain any technical terms

D    Informed consent should be in a language that a patient understands

E    Even after someone has signed an informed consent form, they can with draw from the study at any time

14. Advocates can be involved in the following roles in research…

A    Following study recruitment and seeing early results with investigators

B    Suggesting additional analysis of study results

C    Being an independent advisor for whether a trial is appropriate for an individual patient

D    Helping design the trial

E    Highlighting poor or inappropriate research

Answers

Question 1: C, D, E

Question 2: A, C, D, E

Question 3: D, E

Question 4: A, B

Question 5: B, D, E

Question 6: B, C, D

Question 7: B, D

Question 8: D, E

Question 9: B, C, D

Question 10: B, D, E

Question 11: A, C, D, E

Question 12: 1-E, 2-C, 3-B, 4-D, 5-A

Question 13: B, C, D, E

Question 14: A, B, C, D,

If you have questions about the answers, please email:

questions@i-Base.org.uk

Last updated: 2 October 2009.