The Role of Compliance in Long-Term Care

Patient compliance with prescribed medical therapy has long been shown to be a critical factor to successful treatment. Patient noncompliance is accountable for an estimated 10% of hospital admissions and 23% of nursing home admissions.^3,4 Poor compliance with oral contraceptive pills accounts for an estimated 700,000 unintended pregnancies.⁵ Noncompliance within the realm of cardiovascular diseases is responsible for approximately 125,000 deaths annually.⁶ Medical noncompliance may burden our healthcare system with $100 billion of annual costs annually.⁷

Several PCOS treatment studies have been limited by high rates of patient dropout. In these studies, the issue of noncompliance was either recognized but not discussed in detail⁸ or addressed, with patients citing excessive time commitment and side effects as the primary factors underlying medication discontinuation.⁹ Several clinical studies have investigated the effectiveness of a combination treatment approach on different clinical outcome measures.^10-12 These studies are limited by the lack of data on patient acceptance of such regimens outside of controlled clinical trials. This small chart review examined patient adherence to prescribed PCOS treatments. This may be useful in predicting how future regimens will be accepted and how successful they may be in treating this unique patient population.

Methods

Subjects We conducted a chart review of women seen for PCOS at a tertiary endocrinology practice at University of California Los Angeles (UCLA). The patients seen at this clinic are principally middle class women from a wide range of ethnic backgrounds, frequently referred by their primary care physician for a confirmatory diagnosis and appropriate treatment plan. Each patient, upon diagnosis or first consult with the endocrinologist, is counseled extensively (for a minimum of ½ hour) regarding the PCOS diagnosis and is provided an informational packet detailing PCOS etiology, its related symptoms, and typical medical management. Exercise and dietary plans are further discussed with overweight individuals. Prescribed medical treatment is initiated within a few weeks, with patients followed roughly every 2 to 4 months. At these return visits, weight and height are noted by the clinic nurse and the degree of patient adherence to their medications is recorded systematically by the same endocrinologist. The charts of these patients, several years post-diagnosis, were reviewed for compliance both to follow-up visits and prescribed
medications as well as for observed change in body
mass index (BMI).

The criteria for PCOS was based upon the 1990 National Child Health and Human Development Consensus Conference guidelines involving clinical or biochemical evidence of hyperandrogenism, oligomenorrhea, and exclusion of other known disorders presenting with hyperandrogenism including 21-hydroxylase deficiency, Cushing's Syndrome, hyper-androgenic insulin resistance acanthosis nigricans or prolactinomas.¹³ Women with documented thyroidabnormalities were included in the study population.Institutional Review Board approval was granted bythe UCLA Human Subjects Review Board for a retrospective chart review. Laboratory tests to confirm thediagnosis were performed by UCLA ClinicalLaboratory, or sent to Quest Diagnostics. Patientcharts were reviewed to detail the number of years ofpatient follow-up, confirm that the patient met theinclusion criteria, and analyze weight and medicationinformation for each patient seen in the clinic for atleast one year's duration.

Outcome Measures
We explored compliance with regard to both "consistency" with appointment follow-up and "persistence" to prescribed medications over time.

Compliance to Follow-Up Visits Assessment of compliance with follow-up care was defined leniently as "patient presence at follow-up appointments for a minimum of 1 year."

Persistence with Prescribed Medications The approach to PCOS management by the clinic endocrinologist involves a combination of treatment strategies. The large majority of patients are prescribed a multi-drug regimen including metformin, oral contraceptives, and spironolactone. An antidepressant is often added as a means of alleviating the depression frequently associated with PCOS.^14,15

Assessment of compliance with regard to medication use can involve either direct measures (detecting a chemical in body fluid/urine) or indirect methods (interviews, patient diaries, tablet counts, or prescription filling dates).¹⁶ The retrospective chart review design of this study limited the measure of persistence with prescriptions to patient report of ongoing, appropriate medication use at each clinic visit. A record was kept of the actual medications taken consistently by the patients over the course of their follow-up, regardless of the number of drugs included in the originally prescribed regimen. Timing between visits and thus medication records varied based upon patient factors (vacations, temporary relocations, scheduling conflicts) and physician discretion as to whether the endocrinologist felt the specific patient would benefit from more or less follow-up care.

Patient responses regarding their medication use were categorized from the physician note as being "compliant to at least a portion of the regimen nearly 100% of the time," or "compliant to no portion of the prescribed regimen." Compliance to the entirety of the initial regimen was not considered an appropriate category as patient goals with treatment may change, particularly with regard to fertility, such that a contraceptive prescription may be discontinued not because of poor compliance but because of desired pregnancy. As all medications were recorded at each visit, it was possible to identify the start and end dates of each specific portion of a patient's prescribed regimen.