Abstract
BackgroundA method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice.MethodsUsing an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic.ResultsThe six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one.ConclusionFuture systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.
Highlights
A method for assessing the model validity of randomised controlled trials of homeopathy is needed
These attributes are a suitable reflection of the key characteristics of homeopathy that must be assessed for model validity, but they do not provide a direct means to undertake a practical formal assessment. The importance of such undertaking has been emphasised in two papers by Bornhöft and colleagues [4,22], who expressed concern that the current research literature - and the systematic review of it - may contain high risk of false negative results. We addressed this issue by creating and testing a practical set of judgmental domains and accompanying criteria that may be used, within systematic review, to appraise randomised controlled trial (RCT) for model validity of homeopathic treatment (MVHT)
Following detailed discussion amongst the group, a set of draft assessment domains was proposed as follows: Domain I: Is the condition amenable to homeopathic intervention? Domain II: Is the specific intervention used consistent with homeopathic principles? Domain in the intervention; (III): Would the rationale for the intervention used be supported by a significant body of homeopathic practitioners? Domain IV: Does the main outcome measure reflect the key effects expected of the intervention used? Domain V: Is the main outcome measure capable of detecting change? Domain VI: Is the length of follow-up for the main outcome appropriate to detect the intended effect of the intervention used?
Summary
A method for assessing the model validity of randomised controlled trials of homeopathy is needed. We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect ‘state-of-the-art’ homeopathic practice. Model validity reflects the concordance between the trial study design and “state of the art” practice for the intervention under investigation [4]. The ‘homeopathicity’ [12] of the therapeutic modality and of the clinical outcome measure/s used (i.e. the key characteristics of model validity) have never been formally accounted for in the assessment of trial quality. Recognising that the characteristics of the homeopathic intervention and outcome measures are important seems a prerequisite for developing the most refined and relevant approaches to systematic review in this field of clinical research
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