New study findings call into question the necessity of spirometry as a criterion for participation in palliative care research among patients with chronic obstructive pulmonary disease (COPD).
Quality of life and symptom severity were similar between patients with chronic obstructive pulmonary disease (COPD) with and without spirometry measurements indicating airflow limitation, bringing into question the necessity of spirometry as a criterion for participation in palliative care research.
The authors of this study, published in the Journal of Pain and Symptom Management, noted that these requirements can result in the exclusion of eligible patients with COPD from palliative care research, limiting research results and therefore potentially decreasing quality of palliative care.
Clinical trials often require certain diagnostic criteria to be met for participation, and these criteria can include International Classification of Diseases (ICD) codes and spirometry testing that shows airflow limitation, creating inconsistent eligibility criteria across various trials.
The current analysis was conducted among enrollees in the 2-site randomized Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial conducted in the Veterans Health Administration. Included in the sample were 208 primarily White, male veterans with a mean age of 68 years from the Veterans Health Administration (VA). All were required to be in the top 20th percentile of risk for hospitalization or death within the next year and had a diagnosis of COPD using the ICD. The diagnosis was required to be made upon discharge following at least 2 outpatient visits or single hospitalization.
Additional required criteria were spirometry with airflow limitation, postbronchodilator FEV1% predicted less than 50%, and poor quality of life as defined by the Functional Assessment of Cancer Therapy-General (FACT-G). The requirement for spirometry was dropped after 2 years of trial enrollment due to slow accrual, resulting in 2 cohorts of patients with COPD: those identified by ICD codes and spirometry with airflow limitation and those identified by ICD codes alone.
FACT-G scores were patient-reported, and responses were measured along with depression, fatigue, anxiety, and insomnia.
Quality of life as measured by the FACT-G did not differ in patients identified as having COPD by both ICD codes and spirometry with airflow limitation vs those identified with ICD codes alone (59.0 vs 55.0; P = .33). There were no significant differences in other measures of QOL or symptoms between the groups.
Using spirometry testing as a required criterion for research participation discounts the hurdles to accurate testing, such as difficulty understanding the coach while spirometry is being conducted and the fact that some patients with COPD will not have airflow limitation on spirometry, the authors noted.
They suggested that patients with COPD who are at high risk for adverse outcomes and have poor quality of life may not need to be additionally evaluated via spirometry to be able to participate in palliative research or clinical care. Including this additional criterion can limit and discourage patients who would otherwise benefit from this care.
Excluding spirometry as a requirement of palliative study participation could ease potential roadblocks to care such as access to spirometry (in rural areas and those uninsured), primary care providers who do not include spirometry in routine care of patients with COPD, and non-English speaking patients’ difficulty participating in spirometry testing. By eliminating the spirometry criterion, there would be a greater likelihood of participation and the possibility of applying study results to wider populations.
Given that this study was conducted as a secondary analysis of a larger clinical trial, minor inconsistencies might have been overlooked. Most participants are male and White within the Veterans Health Administration system, and the authors could not test their hypotheses among non-Whites or female patient. The reliance on ICD codes only could result in misdiagnosis, and results cannot yet be translated outside of the trial parameters, suggesting that more research may be necessary.
The researchers stated that patients who have not yet received a COPD diagnosis due to inaccessible spirometry diagnostic testing and experience poor quality of life should still receive palliative care and any other necessary treatments.
Lange AV, Anuj B, Bekelman D. How important is spirometry for identifying patients with COPD appropriate for palliative care? J Pain Symptom Manage. Published online November 21, 2022. doi:10.1016/j.jpainsymman.2022.11.016