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Table 2 Overview of the ethical consideration

From: Effects of mental practice embedded in daily therapy compared to therapy as usual in adult stroke patients in Dutch nursing homes: design of a randomised controlled trial

Question

Comment

How great was the change in clinical practice?

Minor: use of consistent advice and consistent technique in both groups (embedded in therapy as usual)

What extra burden was imposed upon the patient(s)?

Moderate: some time in collecting data from measures not standard in the protocols of the nursing homes.

What additional risks did the patient(s) (or other participants) face?

Minor: from the mental practice intervention none can be thought of at present, results of QEEG could generate some ethical issues for the researcher if major unexpected abnormalities are discovered

What benefit might accrue to the patient (or other participants)?

Moderate: experimental treatment may be of complementary value to current practice

What benefit might accrue to Society?

Moderate: the study should detect any clinically relevant difference in treatment. Papers in peer reviewed journals will be submitted and researchers will learn and teach in research methodology

Was each participant informed about the study and able to choose whether or not to participate?

The patient is informed orally and in writing. Participation in the study may be considered for at least 2 days. Patient may withdraw from the study at any time without giving reason why. This will not affect treatment negatively

Was the method of recruiting participants fair and appropriate?

As little is known about specific selection of stroke patients likely to benefit most from a mental practice regime in rehabilitation, inclusion criteria were kept as broad as possible