Identifying appropriate outcomes to help evaluate the impact of the Canadian Guideline for Safe and Effective Use of Opioids for Non-Cancer Pain

Our study identified five priority outcomes, and a series of possible associated measures and data sources, to evaluate the impact of the COG. Data to assess four of the five identified priority outcomes (Outcomes 1, 2, 3 and 5) would be best collected directly by using electronic patient health records, and integrated electronic practice tools, such as the Opioid Manager. The Opioid Manager is both a tool and source of data specifically developed to monitor patients with CNCP and on opioids, and captures these outcomes [6, 17, 18]. Medical charts may be another source of data for these outcomes. For Outcome 1, regarding the effects of CNCP and taking opioids for CNCP on quality of life, the Short Form-36 (SF-36) is an example of a validated and reliable measure to assess a patient’s quality of life [19] and can be used in parallel with the Opioid Manager. This example measure, the SF-36, was not identified as a result of this study’s process for selecting outcomes but rather is provided as good example of a measure that can be used for Outcome 1. For Outcome 3, monitoring patients on opioid therapy for aberrant drug-related behaviour, one could also utilize prescription monitoring programs. Outcome 4, mortality rates associated with prescription opioid overdose, could be informed through administrative databases (e.g. coroner’s data and electronic health records). However, further examination of Outcome 4 is warranted as an opioid overdose can involve multiple types of drugs, such as more than one opioid (e.g. fentanyl and an opiate alkaloid), and alcohol. Thus, assessment of mortality rates associated with opioids requires concurrent study of a person’s opioid and other medication use history prior to an opioid overdose [20]. This includes the characterization of prescribed opioids deemed 1) responsible for the overdose, 2) contributing to the overdose (e.g. multiple opioid types or Central Nervous System depressants identified from coroner’s report), or 3) influential in a patient’s history relating to their overdose (e.g. prescribed in their past), and assessment of their concomitant medications. As mentioned above, this characterization can also be found in a coroner’s report and in a patient’s electronic health records.

We believe this research provides insight into a systematic approach that was and can be used again in the future to validate outcomes for guideline evaluation and evaluation processes for other opioid guidelines and perhaps for other guidelines in general. We undertook this systematic approach with the intent to assess the impact of the COG on practice and patient care. The COG provides a knowledge base which can support consistent education and outcome measures. It is helpful to consider our five priority outcomes in relation to Moore’s expanded outcomes model of learning outcomes for assessing education interventions [8]; one of the outcomes (Outcome 4) is at Level 7 (community health outcome), Outcome 1 is at Level 6 (Individual patient health outcomes), and Outcomes 2, 3, and 5, are at Level 5 (Clinicians’ application of knowledge in practice setting or competency).

Currently, there is a lack of studies evaluating the impact of the COG and medical guidelines in general on clinical practice and patient outcomes in Canada [21, 22]. In relation to other efforts and studies to evaluate the impact of guidelines or recommendations on clinical practice, much work has been done by Hypertension Canada to monitor the impact of such efforts to deal with hypertension in Canada in addition to an implementation (knowledge translation) program for such guidelines into primary care [11, 23]. Their initial key outcome was to improve the treatment and control of hypertension in Canada by creating and implementing recommendations. In 2003, they then set up a task force of experts in the field to assess their efforts to improve the treatment and control of hypertension [11]. Their task force, similar to ours, identified a number of areas or outcomes for surveillance in relation to hypertension. They used nationally administered surveys through Statistics Canada as a tool for surveillance. In the future, it may be possible for us to also work with Statistics Canada to include questions addressing outcome 1, on the effects of CNCP and taking opioids for CNCP on quality of life and other outcomes where feasible.

There is little in the way of formal guidance available in evaluating the impact of clinical practice guidelines. Thus, the working group found it necessary to seek guidance from several sources, and convene several groups of advisors, in order to assist in the de novo development of outcomes relevant to the clinical areas addressed by the guideline. We believe that this potential limitation was mitigated by the strength and breadth of expertise of the advisors involved. For instance, the Evaluation Working Group, and the National Pain Centre, which is the sponsoring body for the National Faculty, includes practitioners in the fields of pain and addiction, research scientists, clinicians, pharmacists, physicians and nurses for multi-disciplinary input. The Definitions Outcome Group included scientists with experience in population health research who informed the feasibility of proposed measures, and individuals who had published in support of greater restriction of opioid use as well as greater availability of opioids for analgesia, representing the breadth of clinical problems faced. Additionally, the 5 priority outcomes generated from this process were determined after introduction of 2010 COG but prior to the 2017 update. These priority outcomes are still relevant to assess as most still relate to the updated guideline recommendations and are based on upon a rigorous process that solicited the view of professionals with expertise in pain management, addiction, knowledge translation, epidemiology and patient advocacy, who deemed these outcomes worth evaluating in regards to CNCP management and proper opioid use. However, it is important to note that both the 2010 COG [13] and the most recent 2017 COG [4] were unable to make a strong recommendation or provide strong evidence respectively about the use of treatment agreements, even though it was found in our study that such an outcome would be of importance to evaluate. This suggests it is very likely, in the future, that this outcome would still come up as something important to evaluate as it did in our study despite both the 2010 and 2017 COG stating that such a tool may be helpful to use. This outcome was evidently in the minds of who were surveyed in this study and the modified Delphi process we undertook drew out this outcome.