Symptom Distress Checklists as a Component of Quality of Life Measurement: Comparing Prompted Reports by Patient and Physician with Concurrent Adverse Event Reports via the Physician

Abstract

The official definition of “safety” in a clinical trials context relies upon the physician to detect signs of illness or injury, and upon the patient to volunteer adverse event data to the physician. For regulatory purposes, this convention works. But patient and physician filter and perhaps distort information.

In two parallel randomized, double-blind, multicenter clinical comparisons of quality of life under treatment with antihypertensive agents, the following were collected concurrently: 1. the usual adverse event information through physician interviews and laboratory reports, 2. the responses of 1,018 patients to a Symptom Distress Checklist (SDC) administered at five office visits, and 3. concurrent physician responses to a parallel form of the SDC. The SDC required the respondent to state for each of 51 symptoms (A) whether the patient had experienced it during the past month; (B) if so, how often; and (C) with how much associated distress.

Of the symptoms to which the typical patient confessed in his SDC responses, about a quarter were also reported by the physician. By one measure, fewer than 7% on average also appeared in the physician's adverse event reports. Some identifiable kinds of symptoms were strikingly more likely than others to be omitted from safety reporting.