Effectiveness of the Assessment of Burden of COPD (ABC) Tool
Effectiveness of the Assessment of Burden of COPD (ABC) Tool
This paper describes the design of a cluster RCT to evaluate the effectiveness of the newly developed ABC tool. The development of the tool was based on the insight that the severity of COPD has to be determined by both the severity of the airway obstruction and the burden of disease. The 2014 guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), recommend a comprehensive symptom assessment in determining the severity of COPD. The guidelines also introduced a combined COPD assessment resulting in an ABCD classification. This novel classification integrates symptom severity as measured by mMRC, CCQ of CAT, versus prognostic indicators of pathophysiologic severity assessed by airflow obstruction and exacerbation history. The ABC tool offers a different operationalization of this new approach and goes beyond classification. The strength of the tool is that it provides a profile of scores on many different domains of COPD-related health. The tool not only focuses on the quantification of the burden of COPD, but determines the actual integrated health status. In addition, it provides a treatment algorithm which gives the patient and healthcare provider insight into treatment options accordingly. The tool offers a visual display of the integrated health status using balloons to show the scores on the different domains of the ABC scale and additional items such as smoking status and exacerbation history. Furthermore, the algorithm provides treatment advice, including pharmacologic options as well as non-pharmacologic options, to formulate a personalized treatment goal and treatment plan. The tool is designed to provide insight into the patient's individual burden of COPD and therefore enables to make a tailored treatment plan and to make the patient feel co-responsible for their own treatment, using principles of shared decision making.
An important issue during the process of designing the study was the selection of an appropriate primary outcome measure. It is more common to use objective parameters, such as the airway obstruction, as primary outcomes. However, airway obstruction is hypothesized to correlate poorly with health status and/or quality-of-life. We therefore decided to use a health-related quality-of-life questionnaire. Since treatment in the intervention arm is based on the outcomes of this new instrument, which is based on the CCQ, a different quality-of-life instrument will be used to measure the primary outcome. We decided to use the SGRQ, a disease-specific quality-of-life instrument. We hypothesize that the use of the ABC tool in daily care will have a positive effect on the quality-of-life of COPD patients As the CAT is part of the assessment according to the GOLD guidelines, we decided to use it as a secondary outcome measure.
The trial will be conducted throughout the Netherlands, in both primary and secondary care. This will make it possible to evaluate the effectiveness of the ABC tool on the health status of patients with different COPD severities. Conducting the study in many clusters throughout the Netherlands might lead to a higher external validity of the results. Furthermore, it might help facilitating the process of implementation. If the results of this trial are as expected, it will be advised to implement the ABC tool in routine care. To facilitate this, it is recommended to adopt the tool in the registration systems of healthcare providers and in healthcare standards. Using the tool in routine care provides structure in each consultation, and more insight for patients in all factors related to COPD. It might help healthcare providers to discuss difficult issues with their patients related to COPD, such as emotions, smoking cessation and impact of COPD on daily life. Furthermore, it might lead to more commitment of the patient and taking the lead in their own treatment, increasing their self-management.
Discussion
This paper describes the design of a cluster RCT to evaluate the effectiveness of the newly developed ABC tool. The development of the tool was based on the insight that the severity of COPD has to be determined by both the severity of the airway obstruction and the burden of disease. The 2014 guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), recommend a comprehensive symptom assessment in determining the severity of COPD. The guidelines also introduced a combined COPD assessment resulting in an ABCD classification. This novel classification integrates symptom severity as measured by mMRC, CCQ of CAT, versus prognostic indicators of pathophysiologic severity assessed by airflow obstruction and exacerbation history. The ABC tool offers a different operationalization of this new approach and goes beyond classification. The strength of the tool is that it provides a profile of scores on many different domains of COPD-related health. The tool not only focuses on the quantification of the burden of COPD, but determines the actual integrated health status. In addition, it provides a treatment algorithm which gives the patient and healthcare provider insight into treatment options accordingly. The tool offers a visual display of the integrated health status using balloons to show the scores on the different domains of the ABC scale and additional items such as smoking status and exacerbation history. Furthermore, the algorithm provides treatment advice, including pharmacologic options as well as non-pharmacologic options, to formulate a personalized treatment goal and treatment plan. The tool is designed to provide insight into the patient's individual burden of COPD and therefore enables to make a tailored treatment plan and to make the patient feel co-responsible for their own treatment, using principles of shared decision making.
An important issue during the process of designing the study was the selection of an appropriate primary outcome measure. It is more common to use objective parameters, such as the airway obstruction, as primary outcomes. However, airway obstruction is hypothesized to correlate poorly with health status and/or quality-of-life. We therefore decided to use a health-related quality-of-life questionnaire. Since treatment in the intervention arm is based on the outcomes of this new instrument, which is based on the CCQ, a different quality-of-life instrument will be used to measure the primary outcome. We decided to use the SGRQ, a disease-specific quality-of-life instrument. We hypothesize that the use of the ABC tool in daily care will have a positive effect on the quality-of-life of COPD patients As the CAT is part of the assessment according to the GOLD guidelines, we decided to use it as a secondary outcome measure.
The trial will be conducted throughout the Netherlands, in both primary and secondary care. This will make it possible to evaluate the effectiveness of the ABC tool on the health status of patients with different COPD severities. Conducting the study in many clusters throughout the Netherlands might lead to a higher external validity of the results. Furthermore, it might help facilitating the process of implementation. If the results of this trial are as expected, it will be advised to implement the ABC tool in routine care. To facilitate this, it is recommended to adopt the tool in the registration systems of healthcare providers and in healthcare standards. Using the tool in routine care provides structure in each consultation, and more insight for patients in all factors related to COPD. It might help healthcare providers to discuss difficult issues with their patients related to COPD, such as emotions, smoking cessation and impact of COPD on daily life. Furthermore, it might lead to more commitment of the patient and taking the lead in their own treatment, increasing their self-management.