Table 1

Refined domains and criteria used to assess RCTs for model validity of homeopathic treatment (MVHT)a

    Domain I (Rationale)
. Would a significant body of accredited homeopaths support the rationale for the intervention used in the study? b, c


Criteria for a judgment of 'Yes' (i.e. acceptable MVHT for this domain)

    Both
of the following:

• Clinical knowledge and practice inform that, for the condition under investigation, the health of patients may be benefited by homeopathic intervention.

• A substantial number of experienced homeopaths would support the choice of this intervention for this type of patient.


Criteria for a judgment of 'No' (i.e. inadequate MVHT for this domain)

    One or both
of the following:

• Clinical knowledge and practice do not inform that, for the condition under investigation, the health of patients may be benefited by homeopathic intervention.

• A substantial number of experienced homeopaths would not support the choice of this intervention for this type of patient.


Criteria for a judgment of 'Unclear' (i.e. uncertain MVHT for this domain)

    One
of the following:

• There are likely to be important differences amongst experienced homeopathic opinion on the rationale for the intervention used.

• Insufficient information to permit judgment of 'Yes' or 'No'.


    Domain II (Principles)
. Is the specific intervention used consistent with homeopathic principles?


Criteria for a judgment of 'Yes' (i.e. acceptable MVHT for this domain)

    One or both
of the following:

• The intervention used is based on the principle of 'like treats like' or it is based on the principle of isopathy (i.e. use of homeopathic biotherapy, endogenous molecule or aetiological substance).

• Literature sources (materia medica, repertory, etc.) are available that convincingly justify the specific intervention.


Criteria for a judgment of 'No' (i.e. inadequate MVHT for this domain)

    One or both
of the following:

• The intervention used is not based on the principle of 'like treats like' or it is not based on the principle of isopathy (i.e. use of homeopathic biotherapy, endogenous molecule or aetiological substance).

• Literature sources do not convincingly justify the specific intervention.


Criterion for a judgment of 'Unclear' (i.e. uncertain MVHT for this domain)

• Insufficient information to permit judgment of 'Yes' or 'No'.


    Domain III (Practitioner)
. Does the study have suitably qualified and experienced homeopathic practitioner input?


Criteria for a judgment of 'Yes' (i.e. acceptable MVHT for this domain)

    Either
of the following, as appropriate: d

    Individualised homeopathy
: Those who have prescribed the homeopathic medicine(s) in this case are suitably trainede and experienced in homeopathy to manage the condition under investigation.

    Non-individualised homeopathy
: There is evidence that experienced homeopathic input (and/or a suitable literature source - e.g. materia medica, repertory) has been involved in informing the choice of the medicine(s) used commonly for all patients in the study.


Criteria for a judgment of 'No' (i.e. inadequate MVHT for this domain)

    Either
of the following, as appropriate:

    Individualised homeopathy
: Those who have prescribed the homeopathic medicine(s) in this case are not suitably trained and experienced in homeopathy to manage the condition under investigation.

    Non-individualised homeopathy
: There is evidence that experienced homeopathic input (or a suitable literature source - e.g. materia medica, repertory) has not been involved in informing the choice of the medicine(s) used commonly for all patients in the study.


Criterion for a judgment of 'Unclear' (i.e. uncertain MVHT for this domain)

• Insufficient information to permit judgment of 'Yes' or 'No'.


    Domain IV (Outcome measure)
. Does the
    main
outcome measure reflect the
    main
effect expected of the intervention used?


Criterion for a judgment of 'Yes' (i.e. acceptable MVHT for this domain)

• The main clinical effect expected of the intervention is adequately measured by the main outcome used.


Criterion for a judgment of 'No' (i.e. inadequate MVHT for this domain)

• The main clinical effect expected of the intervention is not adequately measured by the main outcome used.


Criterion for a judgment of 'Unclear' (i.e. uncertain MVHT for this domain)

• Insufficient information to permit judgment of 'Yes' or 'No'.


    Domain V (Sensitivity)
. Is the
    main
outcome measure capable of detecting change?


Criteria for a judgment of 'Yes' (i.e. acceptable MVHT for this domain)

    All
of the following:

• The main outcome measure is sensitive to changes of the magnitude expected in the patients under investigation.

• The main outcome measure is capable of determining both improvement and deterioration.

• The main outcome measure shows no evidence of a 'floor effect' and/or 'ceiling effect'.f


Criteria for a judgment of 'No' (i.e. inadequate MVHT for this domain)

    Any one or more
of the following:

• The main outcome measure is not sensitive to changes of the magnitude expected in the patients under investigation.

• The main outcome measure is not capable of determining both improvement and deterioration.

• The main outcome measure shows evidence of a 'floor effect' and/or 'ceiling effect'.


Criterion for a judgment of 'Unclear' (i.e. uncertain MVHT for this domain)

• Insufficient information to permit judgment of 'Yes' or 'No'.


    Domain VI (Follow-up)
. Is the length of follow-up for the
    main
outcome measure appropriate to detect the intended effect of the intervention?


Criterion for a judgment of 'Yes' (i.e. acceptable MVHT for this domain)

• The time-point selected for main follow-up measurement provides sufficient opportunity for a clinical change to be observed.


Criterion for a judgment of 'No' (i.e. inadequate MVHT for this domain)

• The time-point selected for main follow-up measurement does not provide sufficient opportunity for a clinical change to be observed.


Criterion for a judgment of 'Unclear' (i.e. uncertain MVHT for this domain)

• Insufficient information to permit judgment of 'Yes' or 'No'.


aGiven the prior assessment that medicines used were prepared according to homeopathic pharmaceutical practice

bThe assessment should reflect whether the rationale for the intervention could feasibly apply to each and every patient studied

cA novel homeopathic medicine might be eligible to fulfil the criteria for 'Yes' in circumstances where the toxicology or proving symptoms support its use, according to the Principle of Similars, in the study sample

dThe initially refined Domain III did not include the criteria sub-divisions 'Individualised homeopathy' and 'Non-individualised homeopathy'. Some difficulty resulted initially in the ensuing assessments, and so the papers were reappraised, for Domain III only, with the subdivisions added (with the consequent findings as reported in Table 3 and Table 4)

e'Suitably trained': To enable this assessment, the experience, accreditation and qualifications of the practitioners must be stated in the original paper (as per the RedHot guidelines - Homeopathy 2007; 96:42-45)

fThe outcome measure does not reach a minimum (i.e. 'floor effect') and/or a maximum (i.e. 'ceiling effect') value, making it incapable of detecting change across the entire clinically meaningful range of the study sample

Mathie et al. BMC Medical Research Methodology 2012 12:49   doi:10.1186/1471-2288-12-49

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