BMJ  2008;336:361-365 (16 February), doi:10.1136/bmj.39476.623611.25

Analysis

Use of randomised trials to decide when to monitor response to new treatment

¹ Screening and Test Evaluation Program, School of Public Health, Edward Ford Building (A27), The University of Sydney, NSW 2006, Australia

Is monitoring initial response to treatment always helpful in clinical management of patients? Bell and colleagues have developed a framework for deciding whether surrogate outcomes should be used to monitor initial response to treatment in chronic disease.

The first 150 words of the full text of this article appear below.

Monitoring entails periodic measurement to guide management¹ and is widely practised in clinical medicine to inform decisions throughout the course of a disease and to provide prognostic information to patients. It is helpful to divide monitoring into phases: pretreatment, initial response, maintenance, re-establish control, and post-treatment.¹

Initial response monitoring uses repeat measurement soon after a new treatment is started to check that the response is within a range that maximises the benefits while minimising the harms. Table 1 summarises different types of initial response monitoring. We have limited our discussion to the use of surrogate outcomes for monitoring initial response to treatment. Surrogate outcomes are commonly used to monitor initial response in patients with chronic conditions. This type of initial response monitoring is common in clinical practice and can result in inappropriate decisions. We looked at two scenarios to develop a rational framework for deciding whether this form of initial . . . [Full text of this article]

Rationale and pitfalls of monitoring initial response

Estimating variability in treatment effects between individuals from placebo controlled randomised trials

Blood pressure and lipid lowering

Should blood pressure be monitored after addition of a diuretic to angiotensin II receptor antagonist treatment for patients with essential hypertension?
Is monitoring of cholesterol concentration needed after patients with known ischaemic heart disease start taking 40 mg pravastatin?

A framework for choosing whether to monitor initial response to a new drug

What to do next

Summary points

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