Submitting a Monograph

Method of data analysis shall be matched to the type of data acquired for monograph submission.

Clinical data submitted with comparative data (i.e., historic norms or control results) shall be accompanied by relevant statistical analysis.

Reasons for selection and acquisition of any comparative data shall be reported and justified.

Case reports shall be submitted and evaluated with particular attention to the following aspects:

a) Clinical case reporting guideline requirements, including:

i. The CARE guideline for reporting clinical cases
ii. The HOM-CASE CARE guideline extension for homeopathic case reports

b) Attribution of changes in cases to the IHMP:

iii. Potential for bias with regard to the attribution of observed changes to the IHMP
iv. Ratings based on the HPCUS Case Outcome Assessment Tool (see Section 4.4.7).

c) Number of cases with acceptable reporting and methodology that have sufficient outcome data (see Figure 3 below)
d) Characteristic features of the emergent homeopathic clinical picture of IHMP

Figure 3: Case / Case Series Analysis

Steps. In the review process by the PRC, all submitted cases for monograph evaluation will be reviewed. Those with both acceptable methodology and sufficient outcome to demonstrate at least a probable effect of the treatment will be evaluated for characteristic features. Quantitative and qualitative evaluation with regards to these cases will be used to determine if the IHMP is associated with a sufficient homeopathic clinical picture.

Each submitted case shall include a detailed list of symptoms and signs considered to be relevant to treatment with the IHMP. Symptoms and signs shall be evaluated according to the following criteria:

a) Severity
b) Degree of importance to the subject
c) Assessed degree of importance to the clinician
d) Magnitude of change during the treatment course (along with direction of change, whether improved or worsened)
e) Time period in which change was observed

The first level of analysis is an assessment of overall outcome for the case as well as for changes in individual symptoms.

Outcome assessment for each submitted case will include the following:

a) Subjective global health assessment ratings from the case subject
b) Global health change assessment must be included

i. Measures of time period showing
pre-treatment and post-treatment points of assessment shall be included

c) Individual symptom assessment:

i. Subjective symptom change assessment must be included

ii. Objective symptom / findings change assessment shall include:

• Any observed changes (including examination, physical testing, laboratory results, and other tests such as radiological examinations) shall be included

• Clinician-observed changes in individual symptoms shall be included as objective findings

Cases with both acceptable methodology and sufficient outcome to demonstrate a highly probable effect of the treatment shall be used as a basis for identifying clinical features. Characteristic clinical features, if present, shall be identified and assessed as a subset of particular interest.

This analysis shall include the following:

d) Unexpectedly improved symptoms or objective findings
e) Characteristic and/or highly characteristic symptoms
f) Commonly occurring modalities
g) Frequently occurring symptoms or groups of symptoms related by “red-line” analysis
h) Shared types of pathology or tendencies

Case coherence supports characterization of the homeopathic clinical picture of the IHMP. However, assessment for coherence of cases is not required for monograph submission.

A final level of analysis shall be conducted to assess for an emergent homeopathic clinical picture related to the IHMP.

This analysis shall involve a qualitative synthesis of the most homeopathically relevant and reliable data on the IHMP with particular attention to the following:

a) Characteristic clinical features
b) Recurring clinical features across multiple cases
c) Cases that demonstrate improvement of similar types of clinical features
d) Common threads or red-line symptoms that demonstrate coherence within and across subjects
e) Emergent indications for the IHMP that arise from evaluation of these listed types of data

Outcome assessment shall make use of validated outcome measures whenever possible.

Assessment of the likelihood of causal attribution of the observed changes in subjects due to the IHMP shall take place. Any reported changes must demonstrate a reasonable level of confidence that the change was due to the IHMP.

The criteria used to determine treatment response shall be clearly defined and transparent. “Responders” must experience a clinically significant improvement which is attributable to the IHMP administration.

The analysis strategy will vary depending on the type of trial.

Homeopathic symptoms collected at baseline (without being used in the individualization of treatment) can be investigated post-hoc by analyzing for symptom by IHMP treatment interaction (effect-modification) using the appropriate statistical test.

Primary endpoint analysis shall be conducted and reported.

Additional analysis supporting the development and clarification of a homeopathic clinical picture shall be included.

MRC will conduct a review for monograph purposes based on the HPCUS Technical Submission Guidelines for Monograph Review.

PRC will evaluate all submitted data for monograph purposes using both the HPCUS Proving Guidelines and these Clinical Data Guidelines for reference to the requirements and recommendations for monograph sponsors.

PRC members shall pay particular attention to the following elements during the monograph review (as summarized in Flowchart 2 PRC Clinical Data Quality Review Template that follows at the end of this section:

a) Content and reliability of any existing background data including toxicology reports, proving data, traditional use data, and historical use information of the IHMP
b) Adequacy of design, methodology, and execution in the acquisition of new data on the IHMP
c) Type and quantity of new data
d) Adherence to homeopathic principles in the gathering, evaluation, and reporting of new data
e) Appropriateness of qualitative and/or quantitative methods used to assess outcomes for use of the IHMP
f) Potential for bias when collecting new data
g) Exclusion of any data likely to be biased
h) Presence or absence of a discernible homeopathic clinical picture resulting from all data provided

i) Sufficiency of data to support the emergent homeopathic clinical picture in terms of both quality and quantity of data. Additional data may be requested

Independently, MRC and PRC shall each come to a decision of the suitability of the IHMP for inclusion in the HPUS.

Report of MRC and PRC recommendations shall be forwarded to the Board of Directors through the Editor as either “Favoring inclusion” or “Not favoring inclusion.”