Lexington Observational Study of Treatment With Compounded Pain Creams

Description Of Data Relevant to Objectives:

The primary objective of this study is to document clinical experience. Specifically, the
study will collect:

1. The expectations from both patient and physician. These underlie patient willingness
to use a topical therapy, and the physician's motivation in prescribing.

2. What is prescribed and used. The composition of compounded creams vary. Is there an
association between the agents / concentrations and the effects on different types of
pain?

3. Patterns of use of the creams. Do patients follow the prescription; do they adapt
frequency and location of application? Why?

4. What happens with use? Do pain scores change? How quickly, and in what ways do pain
scores change with different diagnoses? What is the impact on patient lives? Are
expectations typically fulfilled and/or are there surprises and emergent findings?

5. Observations and structured assessments to tabulate the aspects of successful and
unsuccessful treatment using topical pain creams of various compositions and for
diverse underlying complaints.

6. The level of satisfaction and perceived benefit. If treatment is discontinued, is it
because the problem has been resolved? Or is there burden, cost or lack of benefit?

7. Separate confidential information from patients and physicians so that the study team
can learn how closely the patients' observations match those of the physicians. The
level and nature of the correspondence between patient observations and clinician
observations (or lack of it) will be shared in reports sent to study participants.
Such reports will not disclose the identities of either physicians or patients.

8. Comments on reports. An area of interest for the study is to investigate the interest
in physicians and patients in the reports to be generated concerning the observations
from other patients and other physicians. Will patients be interested in their
trajectory of treatment? Will sharing the information impact the perceived value of
treatment?

Registry Procedures:

1. Data capture is done at visits using structured forms developed in consultation with
treating physicians.

2. Patient data: Patients enter ratings and information using encoded paper forms that are
then sent by mail directly to the Lexington data entry service, or online using a
secure login to send forms to the study database. Such direct from patient transfer is
intended to reduce bias that would otherwise influence self assessments of treatment
benefit because of the desire of the patient to please the treating physician.

3. Diagnostic standards: International Statistical Classification of Diseases and Related
Health Problems, Ninth Revision (ICD9) or International Statistical Classification of
Diseases and Related Health Problems, Tenth Revision ( ICD10) codes for diagnosis of
pain conditions to be treated are required.

4. Checklists for each visit are completed as part of the trial record to ensure standard
processes are followed by treating physicians.

5. If missing or illegible data are not resolvable, then there will be NO imputation.
Reports and analysis will be based only on entries where source values were clear.
Data entry forms include range and completeness checks, prevention of illogical entry.
Free text fields are important for capturing unexpected events and observations. These
will be recorded verbatim into the database.

6. There is no primary hypothesis under test. Observations reported will include counts
for instances and trends. Assessments and ratings will be reported as averages and
distributions.

Inclusion Criteria:

- be informed of the nature of the study and must give written informed consent

- be able to communicate effectively with study personnel

- be diagnosed with a condition for which the physician has prescribed a compounded
pain cream.

Exclusion Criteria:

- History of allergy or adverse reaction to pain cream ingredients

- History of psychiatric disorders