Cohort protocol paper : The pain and opioids in treatment (POINT) study

Background: Internationally, there is concern about the increased prescribing of pharmaceutical opioids for chronic
non-cancer pain (CNCP). In part, this is related to limited knowledge about the long-term benefits and outcomes of
opioid use for CNCP. There has also been increased injection of some pharmaceutical opioids by people who inject
drugs, and for some patients, the development of problematic and/or dependent use. To date, much of the
research on the use of pharmaceutical opioids among people with CNCP, have been clinical trials that have
excluded patients with complex needs, and have been of limited duration (i.e. fewer than 12 weeks). The Pain and
Opioids In Treatment (POINT) study is unique study that aims to: 1) examine patterns of opioid use in a cohort of
patients prescribed opioids for CNCP; 2) examine demographic and clinical predictors of adverse events, including
opioid abuse or dependence, medication diversion, other drug use, and overdose; and 3) identify factors predicting
poor pain relief and other outcomes.
Methods/Design: The POINT cohort comprises around 1,500 people across Australia prescribed pharmaceutical
opioids for CNCP. Participants will be followed-up at four time points over a two year period. POINT will collect
information on demographics, physical and medication use history, pain, mental health, drug and alcohol use,
non-adherence, medication diversion, sleep, and quality of life. Data linkage will provide information on medications
and services from Medicare (Australia’s national health care scheme). Data on those who receive opioid substitution
therapy, and on mortality, will be linked.
Discussion: This study will rigorously examine prescription opioid use among CNCP patients, and examine its
relationship to important health outcomes. The extent to which opioids for chronic pain is associated with pain
reduction, quality of life, mental and physical health, aberrant medication behavior and substance use disorders will
be extensively examined. Improved understanding of the longer-term outcomes of chronic opioid therapy will
direct community-based interventions and health policy in Australia and internationally. The results of this study will
assist clinicians to better identify those patients who are at risk of adverse outcomes and who therefore require
alternative treatment strategies.