Lexington Observational Study of Treatment With Compounded Pain Creams
Lexington Observational Study of Treatment With Compounded Pain Creams
A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients
 prescribed compounded pharmaceutical creams for the treatment of pain. The project is
 designed to accumulate tracking information from both patients and physicians over the course
 of therapy as a supplement to the ordinary care that the patients will normally receive. We
 seek to discover aspects of successful and unsuccessful treatment using topical pain creams.
 This information will be analyzed and reports prepared of observations and emergent findings.
 These reports will be sent during the study every 1 or 2 months to patients, physicians and
 pharmacists who are participating in the Study. A final compilation of findings and
 observations will be circulated to participating patients, physicians and pharmacists.
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