3. Case scenario

You are a family medicine specialist and co-investigator of a randomised controlled trial that compares the effectiveness of a new weight loss programme to standard clinical care. The weight loss programme involves three months of weekly tailored exercise sessions and cooking lessons on healthy diet.

Mrs X is your patient. She is obese and has been struggling to lose weight. You think she would be a suitable candidate for your study and invited her to come in so that you can tell her about the study.

After going through the participant information sheet with Mrs X, you asked if she would like to participate. Mrs X appears hesitant. She says that she does not have time to come for the weekly sessions because she needs to look after her two young children at home.

Answer the following question.

Question

Which of the following sets of actions are appropriate?

I: Tell her that it is up to her to decide and that she will still be entitled to standard weight loss treatments at your clinic even if she refuses to take part in this study.

II: Tell her that she does not need to decide now if she needs more time to consider, or wants to discuss with her family first. She can call you later if she has more questions or once she has decided.

III: Tell her that you think the new weight loss programme will be beneficial to her and this study is only offered to a limited number of patients.

IV: Remind her that as part of this study, she will receive a RM50 organic food voucher which she can use to buy healthy food for her family.

V: Explore her concerns. You know that the clinical trial centre runs a free child care service for research subjects. You suggest that perhaps the service would be helpful.

Answers

I, II

I, II, V

I, II, III, V

All of the above

None of the above

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Correct.

Re. 1 Yes, you should emphasise that participation is voluntary and refusal will not cause her to lose any benefits that she is otherwise entitled.

Re. 2 Yes, you should allow potential subjects sufficient time to consider. You should also make yourself available if they have any further questions later.

Re. 3 The new weight loss programme is an experimental intervention that is yet to be proven effective. You should not overstate its potential benefits. This is also a randomised trial, so she may not receive the experimental weight loss programme even if she participates.

Re. 4 You should not use financial incentives (food voucher) to influence the decisions of potential subjects.

Re. 5 It is okay to suggest ways that might help potential subjects overcome any inconvenience they face, as long as this provision (child care service) is actually available for your research subjects. You should not make any unfounded promises in order to secure consent.

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Solution

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Correct Option (Feedback)
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Wrong (Feedback)
Wrong (Feedback)