Table 4.

Composition of Finalized Items

Domain	Statement no.	Item
1	1	The research question of the study is clearly described in terms of population
	2	The research question of the study is clearly described in terms of intervention
	3	The research question of the study is clearly described in terms of comparator
	4	The research question of the study is clearly described in terms of outcome
2	5	The study design is appropriate for the research question
3	6	The active intervention is justified by a description of the diagnosis and treatment as per the stated acupuncture paradigm
4	7	The acupuncture intervention is designed to address the research question
5	8	Justification of the diagnostic process is provided by evidence linking to the treatment paradigm
	9	Justification of the diagnostic process is provided by evidence linking to clinical reasoning
6	10	Acupuncture points needled consistent with differential diagnosis
	11	Acupuncture points needled consistent with treatment paradigm
	12	Acupuncture points needled consistent with literature review or other evidence
7	13	Needle brand and gauge is used consistently across all participants and sessions. (Please note that this question does not apply for pragmatic and effectiveness studies)
8	14	Point location: Published standard acupuncture location texts are used as reference or location described in anatomical terms
	15	Point location: An accurate proportional method for locating acupoints used where appropriate
9	16	Symmetrical or asymmetrical needling sites are justified according to the clinical condition
10	17	Depth of needle insertion expressed in millimeters as a range and is justified or referenced to a standard text
11	18	Number of treatments: If a chronic condition a minimum of six treatments are administered, if fewer treatments are delivered appropriate justification is documented
	19	Number of treatments: If an acute or subacute condition no minimum of treatments are specified, but appropriate justification is to be provided
12	20	Needle manipulation must be standardized and/or applied at least once during the treatment session. Manipulation should be expressed in terms of the number of times the needle was manipulated and applied
	21	In the absence of needle manipulation, justification is provided of the decision not to undertake needle manipulation
13	22	Electro-acupuncture machine should demonstrate approval status and compliance for the country where study is being undertaken
14	23	The acupuncturist administering intervention is registered with a regulatory authority, or meets at least the minimum WHO standard (WHO 1999)
	24	When a traditional diagnosis is undertaken, evidence is provided that the practitioner has undertaken a full training course as per WHO guideline (WHO 1999)
	25	Evidence is provided of prior clinical training by study personnel relevant to the acupuncture intervention and health condition
	26	Evidence is provided of monitoring the administration of acupuncture in the clinical trial setting

WHO, World Health Organization.