Impact of Tolerability Issues on Chronic Pain

This was a multi-center, non-interventional, observational study of patients receiving opioid treatment for chronic pain. Relevant Canadian data such as pain severity, treatment adherence, medical resource utilization, and interference with activities of daily living were collected to evaluate the impact of opioid-related side effects in chronic pain. The focus was mainly on side effects of the gastro-intestinal (GI) system. The study was divided into 2 components: a prospective, web-based patient survey and a physician-completed, retrospective chart review at study end. The patient survey included one baseline and 12 weekly follow-up surveys. The purpose of the web survey was to collect accurate data from the patient, particularly for outcomes that are not typically recorded in the medical charts, such as weekly pain severity scores, treatment adherence, and patient-reported outcomes (PROs), like medical resource use and impact on activities of daily living. To capture treatment management decisions, a retrospective chart review was performed by the physician or designee at the end of the 12-week period for each patient who completed baseline and at least one follow-up survey. Data collected included prescribed opioid and non-opioid medications for pain control, GI side effect treatments, co-morbid conditions/medications, and medical history. Eligible patients were offered an invitation letter at their usual care visit, where the study website was provided via weblink. Patients were nominally reimbursed for completing the survey. This study was reviewed and approved by an independent Ethics Committee, and informed consent was obtained from all patients. There was no study treatment, since this was a non-interventional, observational study that did not evaluate any J&J product; the duration of the study was 12 weeks of observation.