Rapid Responses to:

ANALYSIS: Katy J L Bell, Les Irwig, Jonathan C Craig, and Petra Macaskill Use of randomised trials to decide when to monitor response to new treatment BMJ 2008; 336: 361-365 [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

Can we allow ourselves to wait for good scientific evidence for monitoring in daily patient care?

Lisette van den Bemt, Tjard Schermer, Ivo Smeele   (20 February 2008)

Can we allow ourselves to wait for good scientific evidence for monitoring in daily patient care? 20 February 2008
Lisette van den Bemt, health scientist Radboud University Nijmegen Medical Centre, Department of General Practice, the Netherlands, Tjard Schermer, Ivo Smeele Send response to journal: Re: Can we allow ourselves to wait for good scientific evidence for monitoring in daily patient care?	In the recent paper published by Bell and colleagues, the authors suggest a rational approach towards evidence based monitoring of initial response to treatment.(1) Monitoring of patients is one of the main daily tasks of doctors and practice nurses. Therefore, the suggestion put forward by Bell and colleagues to include comprehensive reporting of randomised clinical trials on variability of surrogate markers for long- term outcomes may serve an important goal. However, we would like to emphasize that a more pro-active attitude towards collecting information on the effectiveness of monitoring is required, given the extent of the problem with monitoring in daily medical care. Bell and colleagues argue that monitoring routines are rarely based on scientific evidence while decisions could be based on available trial data. We have recently reviewed the recommended monitoring routines in clinical practice guidelines on the management of patients with chronic obstructive pulmonary disease (COPD).(2) Although many monitoring routines were recommended for COPD, none of the recommendations was based on scientific evidence.(2) In contrast with the suggestion by Bell and colleagues, there was an almost complete lack of empirical studies that could support the introduction of these monitoring routines in daily medical care.(2,3) In fact, the effectiveness of interventions to alter the surrogate markers that were recommended by the guidelines as monitoring routines was usually lacking in randomised clinical trials. To illustrate this point let us contemplate on the widespread use of monitoring lung function in COPD patients. Lung function indices (especially the forced expiratory volume in 1 second, the FEV1) clearly fulfil the criteria proposed by Bell and colleagues for surrogate markers of a clinically important outcome (i.e., mortality). No present therapy other than smoking cessation was found to modify the lung function decline in patients with COPD.(4) Still, monitoring lung function is the single most recommended monitoring routine in clinical practice guidelines on the management of COPD, and lung function measurements in daily medical care have been implemented on a very large scale.(2) It seems that the ‘urge’ to do something for our COPD patients resulted in offering regular monitoring visits that may not necessarily be in the best interest of patients and professionals, which also places a large economic burden on the healthcare system. (It is estimated that if lung function would be monitored once a year in all patients with COPD in the Netherlands, this would cost the society about 15 million Euros annually).(5) We felt that these findings advocate the need for an evaluation of (lung function) monitoring in patients with COPD. Therefore, we have started a randomised clinical trial on this specific issue (clinicaltrial.gov REF: NCT00542061). We realise that we report on a specific chronic condition (i.e., COPD), but the same may apply for implemented monitoring routines for other (chronic) conditions like, for example, ultrasound imaging of the heart in patients with chronic heart failure. So, in addition to the recommendation by Bell and colleagues on the reporting of variability in treatment effect we argue that decisions on whether or not monitoring is indicated should preferably be based on empirical studies on the effectiveness of monitoring in daily patient care. This is especially the case when the information cannot be extracted from available scientific evidence but the monitoring routine is already implemented in daily care on a large scale. Lisette van den Bemt, MSc; Tjard Schermer, PhD; Ivo Smeele, MD PhD References (1) Bell KJL, Irwig L, Craig JC, Macaskill P. Use of randomised trials to decide when to monitor response to new treatment BMJ 2008;336;361-365. (2) Van den Bemt L, Schermer T, Smeele I, Bischoff E, Jacobs J, Grol R, Van Weel C. Monitoring of patients with COPD. A review of current guidelines´ recommendations. Respir Med 2008; doi:10.1016/j.rmed.2007.12.014 (3) Van den Bemt L, Schermer T, van Weel C. Rational monitoring of COPD. Where do current clinical guidelines stand? Eur Respir J 2007;29:1078–1081. (4) Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med 2005;142:233-9. (5) Dekhuijzen PN, Smeele IJM, Smorenburg SM. [Guideline for the non- pharmacological treatment of COPD] Ned Tijdschr Geneeskd. 2006 Jun 3;150(22):1233-7. Dutch. Competing interests: None declared