PARALLEL PERSPECTIVES ON QUALITY-OF-LIFE DURING ANTIHYPERTENSIVE THERAPY - IMPACT OF RESPONDER, SURVEY ENVIRONMENT, AND QUESTIONNAIRE STRUCTURE

A multicenter clinical trial comparing nifedipine gastrointestinal the rapeutic system (GITS) to atenolol was conducted to evaluate the effec ts of reporter (physician, patient, and spouse) and assessment of envi ronment (clinic vs. take-home), and structure (long vs. short forms). After a 4-week single-blind, placebo washout, 394 male patients with m ild-to-moderate hypertension were randomized to receive 20 weeks of ei ther atenolol or nifedipine GITS, titrated to achieve goal blood press ure of <90 mm Hg for 8 weeks and maintained at the final dose for 12 w eeks. Quality-of-life assessments included ''long-form'' clinical asse ssments by the patient, parallel ''short-form,'' take-home, mail-back assessments by patient and spouse and a side effects and symptom distr ess evaluation by the physician. Patients completing 20 weeks of thera py indicated a more favorable quality-of-life profile (p < 0.05) for n ifedipine GITS compared with atenolol for psychosocial, positive well- being, emotional ties, behavior/emotional control, vitality, and leisu re scales using the long-form clinical assessment. The short-form, tak e-home, mail-back assessments were highly correlated with the clinic a ssessments, but their responsiveness to treatment differences was less owing to item structure and lower return rates. Spouse reports were m ore sensitive to treatment differences in sexual functioning with a mo re favorable response for patients taking nifedipine GITS (p < 0.02). Physicians were less sensitive to the overall impact of side effects, reporting only 14.9% of symptoms reported by the patient. Physician ev aluation of symptoms and side effects does not provide the sensitivity required for detecting quality-of-life treatment differences. The use of short-form, take-home questionnaires should be restricted to large r studies due to reduced sensitivity and return rates. Third-party spo use assessments are useful in sensitive areas such as sexual symptom d istress and psychological disorders. Comprehensive, clinical based qua lity-of-life assessments are most responsive to treatment differences overall.