Development and evaluation of an instrument for the critical appraisal of randomized controlled trials of natural products.
BACKGROUND
The efficacy of natural products (NPs) is being evaluated using randomized controlled trials (RCTs) with increasing frequency, yet a search of the literature did not identify a widely accepted critical appraisal instrument developed specifically for use with NPs. The purpose of this project was to develop and evaluate a critical appraisal instrument that is sufficiently rigorous to be used in evaluating RCTs of conventional medicines, and also has a section specific for use with single entity NPs, including herbs and natural sourced chemicals.


METHODS
Three phases of the project included: 1) using experts and a Delphi process to reach consensus on a list of items essential in describing the identity of an NP; 2) compiling a list of non-NP items important for evaluating the quality of an RCT using systematic review methodology to identify published instruments and then compiling item categories that were part of a validated instrument and/or had empirical evidence to support their inclusion and 3) conducting a field test to compare the new instrument to a published instrument for usefulness in evaluating the quality of 3 RCTs of a NP and in applying results to practice.


RESULTS
Two Delphi rounds resulted in a list of 15 items essential in describing NPs. Seventeen item categories fitting inclusion criteria were identified from published instruments for conventional medicines. The new assessment instrument was assembled based on content of the two lists and the addition of a Reviewer's Conclusion section. The field test of the new instrument showed good criterion validity. Participants found it useful in translating evidence from RCTs to practice.


CONCLUSIONS
A new instrument for the critical appraisal of RCTs of NPs was developed and tested. The instrument is distinct from other available assessment instruments for RCTs of NPs in its systematic development and validation. The instrument is ready to be used by pharmacy students, health care practitioners and academics and will continue to be refined as required.
Jurgens
Tannis
T
College of Pharmacy, Dalhousie University, 5968 College Street, Halifax, Nova Scotia, Canada. tannis.jurgens@dal.ca
Whelan
Anne Marie
AM
MacDonald
Melissa
M
Lord
Lindsay
L
D001688:Biological Products / Q000627:therapeutic use*; D032921:Consensus; D003697:Delphi Technique; D019317:Evidence-Based Medicine; D029001:Herbal Medicine / Q000379:methods*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards*
D001688:Biological Products