Pain Management Collaboratory (PMC) Coronavirus Pandemic Measures
Workgroup of Origination: Phenotypes and Outcomes
The COVID-19 Pandemic has imparted a complex and significant disruption in the lives of millions of Americans. Relevant to the Pain Management Collaboratory (PMC), individuals suffering from painful conditions may experience positive or negative changes in pain severity (including changes in intensity, distress, functional impairment, and lifestyle impact) during this unprecedented time.
Objectively measuring psychosocial, functional, financial, and lifestyle factors and studying their relationship with outcomes has evolved out of necessity in the current clinical research environment, where usual clinical care and clinical research have both been disrupted. We find this especially important in studies investigating health conditions, such as pain, that are known to be exacerbated by heightened periods of stress and anxiety – an emotion shared by many during this time.
The Pain Management Collaboratory Coordinating Center (PMC3) and its Phenotypes and Outcomes Work Group, have developed an outcome assessment tool to ascertain time-dependent mediating factors that may influence our ongoing pain research due to the COVID-19 pandemic across 11 multi-site pragmatic clinical trials. The instrument was designed to assess both the positive and negative impacts of the pandemic on an individual’s psychosocial, functional, and financial status. For our purposes, we identified these factors as potential mediators influencing treatment effects noted during the conduct of the pragmatic clinical trials and pain-related outcomes. However, we avoided direct attribution of these items to pain status to allow for broad interpretation and application.
There are five domains of interest assessed within the measure:
- Access to Healthcare,
- Social Support,
- Ability to Meet Basic Needs, and
- Mental and Emotional Health.
Two additional questions are included to assess the participant’s subjective personal experience with COVID-19, for a total of seven items.
The instrument was developed following review of publicly available questionnaires and surveys related to the COVID-19 pandemic, as well as other published clinical research instruments. Question development was informed by language used in public-facing surveys conducted across the United States in adult populations surveying individual perspectives on COVID-19.
To promote use across the pragmatic clinical trials in the PMC, iterative review by the Phenotypes and Outcomes Work Group chairs, project manager, and members representing the individual clinical trial teams, with oversight and direction from PMC3 leadership, was conducted until consensus was reached over the specific language used in the presented questions. The final version of this instrument has been approved for use by the PMC Steering Committee for harmonized use across its pragmatic clinical trials.
While designed with intended use in the PMC pragmatic clinical trials studying nonpharmacological interventions for pain management in military personnel and veterans, the instrument is written broadly enough to be used as a patient-reported outcome measure in any adult population involved in clinical research. We encourage its use as a method to assess the impact of COVID-19 on the included domains which may broadly influence patient outcomes in clinical research studying many health conditions, including pain conditions.