Demography is collected to describe the database and to serve as potential covariates in the analysis. When similar demographic information is collected as part of a clinical Case Record Form, discrepancies are resolved with the CRF as the standard. The demographic variables include age, gender, marital status, race/ethnic origin, occupation, education, income, and disability status.
Health Care Resource Use
Summary "health care resource use" includes nights of hospitalization, health care visits (clinic, MD office, ER), home visits, general assistance, and health care provider calls. In addition, work status, workdays per week, bed days, missed workdays, and disability days are assessed.
Overall Perceived Health
This summary scale consists of five 10-point linear analogue scales ("The very worst I ever felt" - "The very best I ever felt")1 that assess five domains: overall, physical, emotional, personal life, and job/work.
The physical function items are drawn from the Duke Activity Status Index.2 The scale contains 12 items assessing personal care, ambulation, household tasks, sexual function and recreational activities.
Mental and Emotional Health
Items in this scale are based upon the Mental Health Index as described by Veit and Ware.3 The index comprises two major domains representing Psychological Distress (24 items) with corresponding subscales of anxiety, depression, and loss of emotional control, and Psychological Well-Being (14 items) with subscales of general positive affect, emotional ties, and life satisfaction.
The general health perception involves an overall measure of General Perceived Health (11 items) with subscales of vitality (4 items), general health, including bodily disorders (3 items)4 5and sleep disturbance (4 adapted items).6,7
Work/Daily Role Well-Being
Daily work responsibilities or performance in daily role or routine is first anchored on a scale of 1 through 7 concerning the most recent work day and how well work was undertaken over the past month. Ten items form the Work Well-Being scale. The items include work/daily role satisfaction, enthusiasm, performance, challenge, keeping up, tiredness/alertness, concentration, feeling physically, and general feelings a the beginning and end of the work day. A single item, Leisure scale, assesses perception about the quality of leisure time activities. 8,9
Sexual Function Sexual Dysfunction
Sexual function is measured using a brief rating index which assesses five levels of sexual-symptom distress.10-12 This section is confidential and contains gender-specific scales.
Side Effects and Symptoms
A standard set of 52 potential side effects of medications determines the presence or absence, frequency, and degree of general distress12. The item is phrased so that it is understandable to those with little or no familiarity with medical terminology. For analytical purposes, side effects are classified according to the Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART) systems.13
General Cognitive Functioning was assessed by three subscales, Mental Acuity (11 items), Cognitive Performance (six items) and Detachment/disorientation (four items).9