Background
Methods
Phase 1. Establishment of a list of items essential in describing the identity of an NP
Selection of items
Participants
Procedure
Delphi Consensus-Round 1
Delphi Consensus-Round 2
Analysis
Phase 2. Establishment of list of important non-NP items
Identification of critical appraisal instruments for RCTs of conventional medications and NPs
Compilation of items from critical appraisal instruments for conventional medications
Analysis
Phase 3. Field test of new assessment instrument
Purpose
Study design
Materials
Procedure
Analysis
Results
Phase 1. Establishment of a list of items essential in describing the identity of an NP
Selection of items
Item
|
Compiled
Responses
|
Participant
Comments
| ||
---|---|---|---|---|
Yes | No | Un certain | ||
1. The genus of the test NP was stated. | 9 | - | 2 | • Items 1 & 2 assume an organism is used, but there are many chemical NPs, so we need to include an unambiguous name if it is a natural chemical e.g. arginine is ambiguous, L-arginine is correct. |
2. The species of the test NP was stated. | 9 | - | 1 | • Need to be more specific by listing cultivars/varieties |
3. The plant part used to prepare the test NP was stated. | 10 | - | 1 | • Also when and where harvested |
4. How the test NP was processed/extracted was described. | 9 | 1 | - | • Chemistry and manufacturing information is required by the NP Regulations • Proprietary data but for government registration should be included but should not be reported in the publication |
5. If test NP was a commercial product, brand name was stated. | 8 | 1 | 1 | • Interesting, but not essential. • Brand is important because of differences in manufacturing. |
6. If test NP was a commercial product, the name of the manufacturer was stated. | 9 | 1 | - | |
7. If test NP was a commercial product, the lot number was stated. | 8 | 2 | - | • Make sure they have enough supply for the complete trial and didn't use different lots throughout study |
8. The name of important chemical(s)of the test NP was stated. | 11 | - | - | • The term "important chemicals" is vague • Full characterization or fingerprinting of the testing material • This could be a problem with some products as active agent(s) may not be known • Should have a percentage of the chemicals present listed • If standardized for the chemical content and the manufacturer wants to be public |
9. The amount of important chemical(s) of the test NP was stated. | 11 | - | - | • The term "important chemicals" is vague • If the makers are not active compounds, there is no need to quantify each compound but it is always good to have some quantitative information |
10. The test NP was analyzed for chemical content. | 11 | - | - | • For registration with to government yes but should be agreed upon by investigator and company before publication. |
11. The dosage form of the test NP was stated. | 10 | - | - | |
12. The dose of the test NP was stated. | 10 | - | - | |
13. The frequency of administration of the test NP was stated. | 10 | - | - | |
14. The route of administration of the test NP was stated. | 10 | - | - | |
15. The placebo or comparison treatment and the test NP were matched in terms of taste, smell, appearance and dosing regimens. | 10 | - | - | |
16. The success of blinding was evaluated. | 10 | - | - |
Participants
Delphi Consensus-Round 1
Delphi Consensus-Round 2
Phase 2. Establishment of important non-NP items
Identification of critical appraisal instruments for RCTs of conventional medications
Compilation of items from critical appraisal instruments for conventional medications
General Item Categories | Part of validated tool | Empirical evidence |
---|---|---|
Participants | yes | |
Interventions | Yes | |
Objectives | Yes | |
Outcomes (Methods) | Yes | |
Sample size | Yes | |
Sequence generation (Randomization) | Yes | Yes |
Allocation concealment (Randomization) | Yes | |
Blinding | Yes | Yes |
Statistical flow | Yes | |
Participant flow | Yes | Yes |
Baseline data | Yes | Yes |
Numbers analyzed | Yes | |
Outcomes and estimation (Results) | Yes | |
Ancillary analysis | Yes | |
Adverse effects | Yes | |
Interpretation | Yes | |
Generalizability | Yes |