Doctors’ versus patients’ global assessments of treatment effectiveness: empirical survey of diverse treatments in clinical trials

Abstract

Objective To examine whether doctors' global assessments of treatment effects agree with patients' global assessments. Design Survey of trials included in systematic reviews of treatments for diverse conditions. Data sources Cochrane database of systematic reviews. Data extracted Data on patients' global assessments and on doctors' global assessment for the same treatment against the same comparator. Main outcome measures Relative odds ratio (ratio of odds ratios of global improvement with the experimental intervention versus control according to doctors compared with patients), and improvement rates according to doctors and patients. Results Doctors' global assessments were compared with patients' global assessments for 63 different treatment comparisons (240 trials) in 18 conditions. The summary relative odds ratio across the comparisons was not significant (0.98, 95% confidence interval 0.88 to 1.08; I 2 =0%, 95% confidence interval 0% to 30%). In 62 of the 63 comparisons the effects of treatment rated by patients and by doctors did not differ beyond chance, but for single comparisons the confidence intervals were large. Rates of improvement on average did not differ between doctors' assessments and patients' assessments (summary relative odds ratio 0.98, 0.88 to 1.06; I 2 =0%, 0% to 24%). Conclusion Doctors' global assessments of the effects of treatments are on average similar to those of patients. INTRODUCTIONFor several diseases and treatments the global assessment of change in disease status by patients and doctors are key outcomes for determining whether a treatment is effective. For some conditions other types of measurements besides an overall (global) impression are difficult, impractical, costly, or even non-existent. Global assessments have become popular choices as end points in selected disciplines, such as rheumatology, psychiatry, and dermatology, particularly when a single laboratory measurement or clinical measurement or documentation of an event cannot be used to adequately describe what happened to a study participant.An important question is whether patients and doctors agree in their assessment of treatment outcomes. Self assessment by patients may avoid bias by an external assessor, whereas doctors may be more objective than their patients. Doctors may consider additional aspects of conditions that are not assessable by patients and may have insight into whether patients tend to amplify or minimise symptoms.1 In theory, biases may be more likely when a study does not use blinding of doctors or patients, such as when blinding is impossible or compromised. Moreover, in different circumstances and for different diseases biases may operate differently between patients and doctorssome patients with mental or neurological diseases, for example, may be biased or inaccurate in the appraisal of their condition. Similarly, doctors may be inaccurate when they have few or no objective signs and tests on which to base their observations and have to use primarily patient reported information.S...

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