Table 3.
Results from Delphi Round 2
| Domain | Statement no. | Item | Agree % | Not applicable | Disagree % |
|---|---|---|---|---|---|
| 1 | 1 | The research question of the study needs to be clearly described in terms of population | 92.9 (26) | 7.1 (2) | |
| 2 | The research question of the study needs to be clearly described in terms of intervention | 100 (28) | 0 | ||
| 3 | The research question of the study needs to be clearly described in terms of comparator | 92.9(26) | 7.1 (2) | ||
| 4 | The research question of the study needs to be clearly described in terms of outcome | 100 (28) | 0 | ||
| 2 | 5 | The study design is appropriate for the research question | 100 (28) | 0 | |
| 3 | 6 | The active intervention is justified by a description of the diagnosis and treatment as per the stated acupuncture paradigm | 96.3 (26) | 3.7 (1) | |
| 4 | 7 | The acupuncture intervention is designed to address the research question | 96.4 (27) | 3.6 (1) | |
| 5 | 8 | Justification of the diagnostic process is provided, by evidence linking to the treatment paradigm | 92.9 (26) | 7.1 (2) | |
| 9 | Justification of the diagnostic process is provided by evidence linking to clinical reasoning | 96.4 (27) | 3.6 (1) | ||
| 6 | 10 | Acupuncture points needled are consistent with differential diagnosis | 92.3 (24) | 7.7 (2) | |
| 11 | Acupuncture points needled are consistent with treatment paradigm | 96.3 (26) | 3.7 (1) | ||
| 12 | Acupuncture points needled are consistent based on literature review or other evidence | 88.9 (24) | 11.1 (3) | ||
| 7 | 13 | Preference is given to a minimum of six needle sites per treatment. If fewer points (e.g., PC6) are used, justification is presented linking to the treatment paradigm | 71.4 (20) | 28.6 (8) | |
| 8 | 14 | Needle brand and gauge is used consistently across all patients. (Please note that this question is less appropriate for pragmatic and effectiveness studies, select N/A) | 60.7 (17) | 25 (7) | 14.3 (4) |
| 9 | 15 | Point location: Standard acupuncture location texts are used as reference or location described in anatomical terms | 100 (25) | 0 | |
| 16 | Point location: An accurate proportional method for locating acupoints used where appropriate | 87.5 (21) | 12.5 (3) | ||
| 10 | 17 | Symmetrical or asymmetrical needling sites are justified according to the clinical condition | 96.2 (25) | 3.8 (1) | |
| 11 | 18 | Depth of needle insertion expressed in millimeters is referenced to a standard text | 83.3 (20) | 16.7 (4) | |
| 19 | Depth of needle insertion expressed in millimeters is expressed as a range | 87.5 (21) | 12.5 (3) | ||
| 12 | 20 | Needle retention: Minimum time of 20 minutes unless justification presented reflecting a different acupuncture paradigm | 78.6 (22) | 21.4 (6) | |
| 13 | 21 | Number of treatments: If a chronic condition a minimum of six treatments are administered, if fewer treatments are delivered appropriate justification is documented | 88.9 (24) | 11.1 (3) | |
| 22 | Number of treatments: If an acute or subacute condition, no minimum of treatments are specified, but appropriate justification is to be provided | 96.3 (26) | 3.7 (1) | ||
| 14 | 23 | A minimum of two treatments per week are administered unless justified by treatment parameters relating to the treatment paradigm | 59.3 (16) | 40.7 (11) | |
| 15 | 24 | Needle manipulation must be standardized and/or applied at least once during the treatment session. Manipulation should be expressed in terms of the rotational degrees or depth of lift and thrust (mm) of the needle | 54.9 (14) | 22.9 (6) | 25.9 (7) |
| 25 | Needle manipulation must be standardized and/or applied at least once during the treatment session. Manipulation should be expressed in terms of the duration (seconds) of needle manipulation | 51.9 (14) | 18.5 (5) | 29.6 (8) | |
| 26 | 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 | 71.4 (20) | 17.9 (5) | 10.7 (3) | |
| 27 | In the absence of needle manipulation, justification is provided of the decision not to undertake needle manipulation | 88.9 (24) | 7.4 (2) | 3.7 (1) | |
| 16 | 28 | Electro-acupuncture machine should demonstrate approval status and compliance for the country where study is being undertaken.a | 70.4 (19) | 22.2 (6) | 7.4 (2) |
| 17 | 29 | The level of patient stimulation response that was sought (e.g., subsensory threshold, suprasensory threshold, above motor stimulation)a | 73.1 (19) | 19.2 (5) | 7.7 (2) |
| 30 | Level of stimulation response is justified and appropriate | 65.4 (17) | 23.1 (6) | 11.5 (3) | |
| 18 | 31 | The acupuncturist administering intervention is registered with a regulatory authority, or meets at least the minimum WHO standard (WHO 1999) | 100 (28) | 0 | |
| 32 | When differential diagnosis is undertaken, evidence is provided that the acupuncturist has undertaken a full training course as per WHO guideline (WHO 1999) | 96.3 (26) | 3.7 (1) | ||
| 33 | Evidence is provided of prior clinical training by study personnel relevant to the acupuncture intervention and health condition | 92.0 (23) | 8.0 (2) | ||
| 34 | Evidence is provided of monitoring the administration of acupuncture in the clinical trial setting | 79.2 (19) | 20.8 (5) |
a
NA (not applicable) response applied to those unqualified to answer.
WHO, World Health Organization.