Chronic Obstructive Pulmonary Disease Tool Research Articles

Online Tool for the Assessment of the Burden of COVID-19 in Patients: Development Study.

BackgroundThe impact of COVID-19 has been felt worldwide, yet we are still unsure about its full impact. One of the gaps in our current knowledge relates to the long-term mental and physical impact of the infection on affected individuals. The COVID-19 pandemic hit the Netherlands at the end of February 2020, resulting in over 900,000 people testing positive for the virus, over 24,000 hospitalizations, and over 13,000 deaths by the end of January 2021. Although many patients recover from the acute phase of the disease, experience with other virus outbreaks has raised concerns regarding possible late sequelae of the infection.ObjectiveThis study aims to develop an online tool to assess the long-term burden of COVID-19 in patients.MethodsIn this paper, we describe the process of development, assessment, programming, implementation, and use of this new tool: the assessment of burden of COVID-19 (ABCoV) tool. This new tool is based on the well-validated assessment of burden of chronic obstructive pulmonary disease tool.ResultsAs of January 2021, the new ABCoV tool has been used in an online patient platform by more than 2100 self-registered patients and another 400 patients in a hospital setting, resulting in over 2500 patients. These patients have submitted the ABCoV questionnaire 3926 times. Among the self-registered patients who agreed to have their data analyzed (n=1898), the number of females was high (n=1153, 60.7%), many were medically diagnosed with COVID-19 (n=892, 47.0%), and many were relatively young with only 7.4% (n=141) being older than 60 years. Of all patients that actually used the tool (n=1517), almost one-quarter (n=356, 23.5%) used the tool twice, and only a small group (n=76, 5.0%) used the tool 6 times.ConclusionsThis new ABCoV tool has been broadly and repeatedly used, and may provide insight into the perceived burden of disease, provide direction for personalized aftercare for people post COVID-19, and help us to be prepared for possible future recurrences.

Patient-reported Outcomes for the Detection, Quantification, and Evaluation of Chronic Obstructive Pulmonary Disease Exacerbations

An exacerbation of chronic obstructive pulmonary disease (COPD) is an acute worsening of respiratory symptoms accompanied by a variable degree of physiological deterioration. The traditional assessment of an exacerbation consists of the reporting of symptoms by the patient to a clinician and subsequent clinical assessment. It would be valuable to also gather symptom reports directly from patients, and thus patient-reported outcome (PRO) tools should be ideally suited to the evaluation of COPD exacerbations. However, most pharmaceutical industry- and large academy-sponsored studies have used a healthcare resource use definition alone, which is based on sustained worsening of a patient's condition from the stable state that requires a change in regular medication. This Review explores the use of PROs for the detection, quantification, and evaluation of COPD exacerbations. It examines symptom diary cards as exacerbation detection tools and their evolution into electronic diaries used in pharmaceutical trials. This paper also describes the development of specifically designed PROs that have been used in exacerbation settings, focusing on the Exacerbations and Symptoms in COPD e-Diary, Exacerbations of Chronic Obstructive Pulmonary Disease Tool, COPD Assessment Test, and Chronic Respiratory Disease Questionnaire, highlighting the strengths and weaknesses of these instruments. We describe the effectiveness of these tools to enhance exacerbation reporting; quantify exacerbation characteristics, including the frequency, duration, and severity of events; and evaluate the outcome. We also explore the potential use of PROs in future studies to discriminate the effect of therapies on different exacerbation phenotypes and thus enhance personalized therapeutic approaches.

The reliability and validity of patient-reported chronic obstructive pulmonary disease exacerbations

Despite the increasing awareness of their pathogenesis and clinical consequences, research on and clinical management of acute exacerbations of chronic obstructive lung disease (AECOPDs) have been hindered by the lack of a consistent and reliable definition. Symptom-based definitions of exacerbations are sensitive to events and account for unreported exacerbations. Event (healthcare utilization)-based definitions are somewhat more definitive but miss unreported events. Objective quantification of symptoms in AECOPD is now possible with the development of the Exacerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT-PRO), a patient-reported outcome (PRO) measure. Several studies have revealed that unreported AECOPDs are more frequent than reported events and are associated with long-term adverse consequences. New antibiotic development for AECOPD has been hampered by the lack of validated measures for resolution of exacerbations. As a result of these observations, a unique collaborative effort between academia, industry and regulatory agencies resulted in the development of the EXACT-PRO. It consists of 14 questions that generate a score between 0 and 100, and it has been shown to have excellent reliability and validity. In the absence of a reliable biomarker, the definition and measurement of exacerbations has been subjective and imprecise. PRO measures such as EXACT can provide much needed objectivity in assessing symptom-defined exacerbations, which may translate into a uniform outcome measure in clinical trials. With further development and validation, it may have a role in clinical practice in the earlier detection of exacerbations, stratification of an exacerbation severity and the assessment of clinical response to treatment.

Development of the EXACT-U: A Preference-Based Measure to Report COPD Exacerbation Utilities

Background The exacerbations of chronic obstructive pulmonary disease tool (EXACT) is a condition-specific daily diary recently developed to evaluate the frequency, severity, and duration of chronic obstructive pulmonary disease (COPD) exacerbations. A preference-based algorithm for the EXACT would allow utilities to be reported from patients during an exacerbation when EQ-5D data are not available. Objective To develop the exacerbations of chronic obstructive pulmonary disease tool-utility (EXACT-U), a condition-specific preference-based measure to report utilities from the EXACT for use in cost-effectiveness studies. Methods Five items with three to five levels comprise the EXACT-U. Two groups of health states and respondents were constructed to allow for model development (Development group) and predictive validity testing (Validation group) using independent samples. Members of the UK general public each valued 11 randomized health states using time trade-offs (TTOs) scaled from full health/dead with 10-year durations. Regression models estimated from the Development group using individual data, mean data, and panel designs. Models assessed by number of inconsistent coefficients estimated and R 2 and tested against observed utilities from the Validation group using mean absolute error (MAE) and root mean squared error (RMSE). Results A total of 55 health states, including the best and worst states, were valued in TTO interviews conducted with 400 respondents. Ten models were developed. The final preferred model contained no logical inconsistencies and found MAE = 0.04 and RMSE = 0.05 with a predicted utility range from 0.09 to 0.95. Conclusions The EXACT-U is a condition-specific preference-based measure with strong predictive validity to report daily utilities during an exacerbation.

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

Background This article describes the qualitative methods used to develop the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT), a new patient-reported outcome (PRO) instrument for evaluating frequency, severity, and duration of exacerbations of chronic obstructive pulmonary disease (COPD). Methods Focus groups and interviews were conducted in the United States with COPD patients treated for exacerbations during the past 6 months. Participants were asked to describe exacerbation attributes, care-seeking cues, and indications of progression and recovery. An iterative process was used to identify themes in the data to inform instrument content and structure. Cognitive debriefing interviews were performed to evaluate and revise the draft item pool. Experts in COPD, instrument development, and clinical research participated in the process. Results Eighty-three subjects participated in elicitation focus groups or interviews ( n = 48); elicitation interviews with cognitive debriefing ( n = 23), or cognitive interviews alone ( n = 12). Mean age of the sample was 65 years (SD = 10); 45% were male; mean FEV-1% predicted was 44% (SD = 16). Participants characterized exacerbations as a persistent increase in the severity of respiratory symptoms and other systemic manifestations accompanied by a dramatic reduction in activity. Specific attributes included shortness of breath, chest congestion, cough, sputum, chest discomfort, feeling weak or tired, sleep disturbances, and concern or worry. The diary card of 23 candidate items was debriefed in booklet and electronic format. Conclusions Qualitative data from patients and input from experts formed the basis of the EXACT's structure and item pool, ready for empirically based item reduction and reliability and validity testing.