Understanding Patient Values and the Manifestations in Clinical Research with Traditional Chinese Medicine—With Practical Suggestions for Trial Design and Implementation

Table 1

Manifestations of patient values in each phase of a randomized controlled trial.

Phase	Circumstance A	Circumstance B	B’s implications	Patient values’ role	Manifestations
Enrollment	Gave informed consent including consent to randomization	Refused to give informed consent and did not admit	Delays of recruitment; Reduced sample size	Made judgments	Choices
Randomization and intervention allocation	Agreed to receive allocated treatment	Randomized to an unopted treatment and refused to continue	Ended participation; Decreased statistical power	Made judgments	Choices
		Attended preference controlled trials	Entered the opted group	Directed preferences	Preferences
Treatment duration	Received treatment as required	Received treatment not as required	Violation of protocols	Guided behaviors	Compliance
		Withdrew from treatment or participation	Withdrawals
	Reported outcomes			Made judgments	Patient reported outcomes
Followup	Completed all visits as required	Missed visits	Violation of protocols	Guided behaviors	Compliance
		Withdrew from the trial	Lost to followup
	Reported outcomes			Made judgments	Patient reported outcomes