Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): A Patient-Reported Outcome (PRO) Measure

Combination inhalers containing corticosteroids and long-acting b-agonists are used to reduce exacerbation rates in patients with severe chronic obstructive pulmonary disease (COPD).The FORWARD (Foster 48-week Trial to Reduce Exacerbations in COPD) clinical trial in severe COPD patients is a comparison of extrafine beclomethasone dipropionate and formoterol in a combination inhaler with extrafine formoterol; the co-primary end-points are exacerbation rates over 48 weeks and improvement in forced expiratory volume in 1 s over 12 weeks. The traditional physician diagnosis of exacerbations is a co-primary outcome, and the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) means of collecting patient-reported outcome data are also being used to enhance the detection of exacerbation events. EXACT data are being collected using a novel application of a digital platform technology.FORWARD is therefore expected to provide information on the ability of EXACT to detect and measure exacerbations in a large clinical trial setting. The study design of FORWARD is described in this article.

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations

Singh

Kampschulte²,

Wedzicha³

et al. 2012

“…The assessment of exacerbation frequency during clinical trials was an initial aim in the development of the EXACT [14,20]. To facilitate the identification of unreported exacerbations, the instrument pre-specifies a threshold for these symptom-defined events based on a persistent increase in EXACT score over 2-3 days.…”

Section: Discussionmentioning

confidence: 99%

Detection and severity grading of COPD exacerbations using the exacerbations of chronic pulmonary disease tool (EXACT)

Mackay

Donaldson

Patel

et al. 2013

Uncertainty exists over the ability of the exacerbations of chronic pulmonary disease tool (EXACT) patient-reported outcome diary to quantify exacerbation severity and frequency. To clarify this, we investigated the ability of the EXACT to assess severity of exacerbations and examined the relationship between exacerbations diagnosed using London chronic obstructive pulmonary disease (COPD) cohort diary cards, physician review and symptom-defined events using the EXACT.58 patients enrolled in the London Chronic Obstructive Pulmonary Disease (COPD) cohort prospectively completed the EXACT during 128 cohort diary card-defined exacerbations between January 2010 and April 2012.Mean¡SD EXACT scores increased from 42.6¡8.6 at baseline to 48.0¡8.6 at exacerbation onset (p,0.001), and rose further to a maximum score of 54.1¡8.9. Maximum EXACT scores were significantly higher in treated than untreated events. Time taken for EXACT scores to return to baseline was significantly related to symptom recovery time as judged by London COPD cohort diary cards, and to peak expiratory flow rate recovery. ,50% of both diary card-defined and healthcare utilisation exacerbations crossed the EXACT event threshold. However, only 27.9% of diary card-defined and 34.6% of healthcare utilisation exacerbations fully met the criteria for an EXACT event. Patients exhibited smaller rises in the EXACT score at exacerbation as baseline disease severity increased.The EXACT is an effective method of evaluating chronic obstructive pulmonary disease exacerbation severity. However, concerns remain about the ability of the EXACT to accurately detect exacerbations. @ERSpublications The EXACT is an effective method to assess exacerbation severity but uncertainty remains over its ability to detect exacerbations

“…This resulted in use of several different symptom-based algorithms and methods to assess onset rates, recovery, severity and recurrence of exacerbations [13]. Apart from the recent promising EXACT (Exacerbations of Chronic Pulmonary Disease Tool) initiative [14,15], few of the symptom scores have originated perspective and would meet current criteria for ''patient-reported outcomes'' (PROs) [16]. Secondly, it is unknown whether the clinical and societal severity of an exacerbation is appropriately reflected in this symptom-based approach.…”

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confidence: 99%

The impact of using different symptom-based exacerbation algorithms in patients with COPD

Trappenburg¹,

Deventer²,

Troosters³

et al. 2010

Not all exacerbations are captured by reliance on healthcare contacts. Symptombased exacerbation definitions have shown to provide more adequate measures of exacerbation rates, severity and duration. However, no consensus has been reached on what is the most useful method and algorithm to identify these events. This article provides an overview of the existing symptom-based definitions and tests the hypothesis that differences in exacerbation characteristics depend on the algorithms used.We systematically reviewed symptom-based methods and algorithms used in the literature, and quantified the impact of the four most referenced algorithms on exacerbation-related outcome using an existing chronic obstructive pulmonary disease (COPD) cohort (n5137).We identified 51 studies meeting our criteria using 14 widely varying symptom algorithms to define onset, severity and recovery. The most (71%) frequently referenced algorithm (modified Anthonisen) identified an incidence rate of 1.7 episodes?patient-yr -1 (95% CI 1.4-2.1), while for requiring only one major or two major symptoms this was 1.9 episodes?patient-yr -1 (95% CI 1.6-2.3) and 1.5 episodes?patient-yr -1 (95% CI 0.6-1.0), respectively. Studies were generally lacking methods to enhance validity and accuracy of symptom recording. This review revealed large inconsistencies in definitions, methods and accuracy to define symptom-based COPD exacerbations. We demonstrated that minor changes in symptom criteria substantially affect incidence rates, clustering type and classification of exacerbations.