Abstract
Background: Research is needed to measure the effects of shared decision-making (SDM) on discontinuation of opioid therapy for chronic pain.
Design: Target trial emulation.
Setting: National pain research registry from September 2016 to January 2024.
Participants: A total of 328 patients currently using opioid therapy for chronic low back pain at baseline, including 164 patients each in greater and lesser SDM groups matched on propensity scores.
Measurements: SDM was measured with the Communication Behavior Questionnaire. Primary outcomes involving discontinuation of opioid therapy and opioid prescribing frequency and secondary outcomes of pain, function, and health-related quality of life were measured over 12 months.
Results: The mean (SD) age of patients was 56.1 (SD, 11.1) years and 239 (72.9%) were female. During 1178 quarterly encounters, greater SDM was associated with less frequent discontinuation of opioid therapy 3 months postbaseline (RR, 0.56; 95% CI, 0.37-0.86; P = .006) and more frequent opioid prescribing 3 to 12 months postbaseline (RR, 1.24; 95% CI, 1.11-1.38: P < .001). Although greater SDM was associated with worse physical function, and opioid therapy was associated with greater back-related disability and worse physical function, these results were not clinically important. SDM x opioid therapy interaction effects were not observed, indicating that more frequent use of opioid therapy with SDM did not yield better outcomes.
Conclusions: SDM was associated with less frequent short-term discontinuation of opioid therapy and more frequent long-term opioid prescribing that was not associated with better outcomes. Thus, SDM is necessary but insufficient to improve opioid prescribing for patients with chronic pain.
- Analgesics
- Chronic Pain
- Communication
- Low Back Pain
- Opioid
- Pain Management
- Patient-Centered Care
- Pharmacology
- Physician's Practice Patterns
- Propensity Score
- Quality of Life
- Shared Decision-Making
- Surveys and Questionnaires
- Target Trial Emulation Study
Introduction
Shared understanding is an important communication strategy during patient-physician encounters.1 Shared decision-making (SDM) is considered especially important when high-quality evidence is unavailable. The Centers for Disease Control and Prevention (CDC) clinical practice guidelines for tapering or discontinuing opioid therapy are based on clinical experience, observational studies with important limitations, or randomized trials with major limitations.2 Thus, SDM is considered critical because different pain treatments may be appropriate for different patients, based on personal circumstances.2 A randomized clinical trial demonstrated the feasibility of training physicians in SDM for opioid prescribing for chronic pain.3 Another trial of SDM training found higher-quality physician interaction with patients having fibromyalgia, but did not measure clinical outcomes.4 More recently, a trial of a communication intervention involving elements of SDM for chronic pain management in primary care found greater physician self-efficacy in communicating about chronic pain in the treatment group, but no between-group difference in prescribed opioid dosage at 2 months.5 Nevertheless, there are methodological challenges in performing pragmatic trials of SDM for opioid prescribing and related outcomes in more natural settings, including ethical concerns with randomizing patients to chronic pain management involving physicians with less-than-optimal SDM skills.
A retrospective cohort study recently found that greater SDM was associated with more frequent opioid prescribing among patients with chronic low back pain (CLBP) over 12 months of follow-up.6 Although the results were controlled for a wide array of potential confounders, the unexpected findings raised questions about causal inference. Target trial emulation (TTE) is a framework for causal inference from observational data when randomized clinical trials are not feasible or ethical.7,8 It is also useful when stopping treatment is of more interest than initiating it.9 This is relevant to studies of opioid therapy for chronic pain because there are many prevalent users owing to the opioid epidemic. In this environment, there may be greater interest and statistical efficiency in studying strategies to help patients taper or discontinue opioid therapy rather than interventions aimed at preventing initiation of opioid therapy. In successful emulations, observational data approximate the outcomes that would have been demonstrated had the target trial been performed. This study aimed to perform a TTE to measure the effects of SDM on discontinuation of opioid therapy for chronic pain and related outcomes.
Methods
Target Trial Protocol and Study Design
This study emulated the target trial with respect to major design elements (Table 1). Patients were selected from the Pain Registry for Epidemiologic, Clinical, and Interventional Studies and Innovation (PRECISION) from September 2016 to January 2024.10 The registry screens participants throughout the contiguous United States using social media advertising. Inclusion criteria were being aged 21 to 79 years; currently using opioid therapy for CLBP; and having a physician who usually provided CLBP management. This physician was considered the designated physician for study purposes, although other physicians or health care providers may have been peripherally involved in CLBP management. Exclusion criteria were being pregnant, residing at an institutional facility, or being unable to complete case report forms in English. Patients provided self-reported data at enrollment (ie, baseline) and up to 4 quarterly encounters over 12 months using a digital research platform for electronic data capture. PRECISION is an observational registry that does not provide direct patient care for participants. Thus, neither physician ratings of their SDM nor independent ratings based on audio or video recordings were available. Additional information about PRECISION is found at ClinicalTrials.gov.10 This research was approved by the North Texas Regional Institutional Review Board and all study participants provided written informed consent.
Target Trial Emulation Comparison
Treatment Strategies
Treatment strategies were emulated by classifying patients as engaging in greater or lesser SDM with their physicians based on patient ratings of their physicians at baseline using the patient participation and patient orientation (PPPO) scale of the Communication Behavior Questionnaire (CBQ).11 This measures physician communication behavior pertaining to essential aspects of the patient-physician relationship.12 The PPPO scale, which represents SDM, was found to be valid, reliable (Cronbach α, 0.93), and not have extreme floor or ceiling effects during development.11 PRECISION data indicate that patient-reported PPPO scale measures at baseline (mean, 68.1) and 24 months (mean, 66.6) are stable among patients who retain the same physician (P = .61). The PPPO scale includes 8 items, each with 6 Likert-scale response options ranging from strongly disagree (0 points) to strongly agree (5 points). These items ask patients whether their physician: “weighs the advantages and disadvantages of different treatment options with you”; “sets treatment and therapy measures in a joint discussion with you”; “discusses the treatment plan with you”; “explains the procedure of your treatment to you thoroughly”; “asks you what helped you in your treatment and what did not”; “discusses the next stage of treatment with you”; “asks you everything about your illness”; and “explains the procedure for your treatment.”12 The greater SDM group consisted of patients who agreed or strongly agreed that their physician demonstrated the optimal communication behaviors on most or all scale items, corresponding to PPPO scale scores ≥ 80 points (of 100 possible points) versus scale scores < 80 in the lesser SDM group.
Double blinding was emulated by registry procedures, which involve collecting data on chronic pain management without specifying research hypotheses. Comprehensive data were self-reported by patients on over 250 items at baseline and 700 items during 12 months of follow-up. Thus, patients were effectively blinded to the research hypotheses and by extension to their assigned SDM group because they were unaware of the items that comprised the PPPO scale and its scoring algorithm. Moreover, to encourage honest feedback from patients about their physicians, the registry does not collect the names of designated physicians or directly involve them in its research. In addition to the patient, the second aspect of blinding involved the registry personnel who collected data either through electronic capture or directly from telephonic encounters, but who were unaware of the study hypotheses or treatment group assignments.
Propensity-Score Matching
To emulate randomization, patients in each SDM group were matched on baseline sociodemographic and clinical characteristics using propensity scores. These were computed with a logistic regression model that included age, sex, race, educational level, lumbar disk herniation, bothersomeness of widespread pain, low back pain intensity, and back-related disability as essential variables in the matching process and yet identified a sufficient number of matched patients to yield adequate statistical power. Bothersomeness of widespread pain was measured with the Minimum Dataset recommended by the National Institutes of Health (NIH).13 Low back pain intensity was measured as the typical pain level over the past 7 days, with a numeric rating scale ranging from 0 to 10. Back-related disability was measured with the Roland-Morris Disability Questionnaire, with scores ranging from 0 to 24.14 The SDM groups were matched within a caliper width of 0.001 on the propensity score.
Outcomes
Current use of opioid therapy was measured with the NIH Minimum Dataset item that queried patients about prescribed opioids for CLBP, with the stem listing generic or brand names of common opioids.13 Primary outcomes included discontinuation of opioid therapy 3 months postbaseline and opioid prescribing frequency from 3 to 12 months postbaseline (ie, the number of quarterly research encounters during which patients reported using opioids for CLBP). Secondary outcomes involved pain, function, and health-related quality of life (HRQOL) measured at quarterly intervals from 3 to 12 months postbaseline. Pain and function were measured with the numeric rating scale for low back pain intensity and the Roland Morris Disability Questionnaire.14 Health-related quality of life was measured with the Patient-Reported Outcomes Measurement Information System with 29 items (PROMIS-29).15 This measured physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, and pain interference. Scores were normed according to the United States general population to yield means (SDs) of 50 (10). The exception was sleep disturbance, which was normed using a calibration sample enriched with patients having chronic illness. Higher scores represent worse secondary outcomes, except for physical function and participation in social roles.
Statistical Analysis
Groups were compared on the essential matched variables and other baseline characteristics on theoretical grounds as potential confounders, including cigarette smoking status, body mass index, low back pain duration, pain extension into the lower extremity, bothersomeness of pain in arms, legs, or joints other than in the back, number of prior lumbar spine surgeries, history of lawsuits or legal claims for low back pain, number of medical comorbidities, pain sensitivity,16 pain catastrophizing,17 pain self-efficacy,18 number of nonpharmacological treatments ever used for low back pain, and current use of nonsteroidal anti-inflammatory drugs for low back pain. Standardized differences were measured with Cohen d.
Discontinuation of opioid therapy 3 months postbaseline was measured with the RR (95% CI) for greater versus lesser SDM. Opioid prescribing frequency from 3 to 12 months postbaseline was measured with a generalized estimating equation (GEE) model, using an autoregressive AR (1) correlation matrix to compute the β-coefficient, estimates of opioid prescribing frequency within each SDM group, and the overall RR (95% CI). Generalized estimating equations models were also used to estimate means (95% CIs) of secondary outcomes over quarterly intervals from 3 to 12 months postbaseline, with SDM, opioid therapy, and SDM x opioid therapy as explanatory variables. Analyses for HRQOL outcomes also included the baseline measure as a covariate because patients were not matched on these. Intention-to-treat analysis, with patients retained in their originally assigned SDM groups, was used to conform to accepted clinical trial methods.19 The clinical importance of between-group differences involving means was measured with Cohen d, using the threshold of |d|≥0.20.20 Cohen d-statistics were coded such that positive values favored the greater SDM and opioid therapy groups. Two GEE analyses were performed to emulate assessment of dose response with increasing levels of SDM. The first measured the association of the PPPO scale score with discontinuation of opioid therapy 3 months postbaseline, whereas the second measured its association with opioid prescribing frequency over 12 months.
Using OpenEpi,21 our sample size exceeded 90% statistical power in detecting a medium effect size (RR, 0.5-0.8; or RR, 1.25-2.0; depending on direction of the effect)22 for discontinuation of opioid therapy, assuming maintenance of opioid therapy in 80% of patients at 3 months. Sample size for comparing opioid prescribing frequency within SDM groups over time was estimated with the General Linear Mixed Model Power and Sample Size program.23 Statistical power exceeded 95% in detecting between-group differences reflecting clinically important effect sizes in a wide variety of scenarios involving the base correlation of prescribing opioid therapy at successive encounters within patients and decay rate of the base correlation with increased time between encounters. All data were analyzed with the IBM SPSS Statistics Software (Version 29) using two-sided testing at the α level of 0.05.
Results
Patient Characteristics and Flow through the Study
There were 1606 registry participants with CLBP during the study period, including 1555 (96.8%) patients having physicians with known PPPO scale scores (Figure 1). A total of 496 (31.9%) of these patients were currently prescribed opioid therapy at baseline. These opioid users included 259 (52.2%) patients engaging in greater SDM (physician PPPO scale score ≥ 80) and 237 (47.8%) engaging in lesser SDM (physician PPPO scale score < 80). There were 164 patients in each SDM group following propensity-score matching. The mean age of these patients was 56.1 (SD, 11.1) years and 239 (72.9%) were female. The mean propensity score was 0.524 in each group (P = .99) and mean (SD) PPPO scale scores were 90.9 (8.3) and 52.5 (21.9), respectively, in the greater and lesser SDM groups (P < .001) (Figure 2). There were no significant differences between SDM groups in any of 21 other baseline variables (Table 2). Overall, 36 (11.0%) patients were lost to follow-up, including 16 (9.8%) and 20 (12.2%) in the greater and lesser SDM groups, respectively (P = .48).
Patient flow through the study.a
Distribution of patient participation and patient orientation scale scores by shared decision-making group.a
Baseline Patient Characteristics By Shared Decision-Making Groupa
Primary Outcomes
A total of 309 patients (155 and 154 in the greater and lesser SDM groups, respectively) completed the 3-month encounter and 311 (156 and 155 in the greater and lesser SDM groups, respectively) were followed in 1178 quarterly encounters over 12 months. There were 26 (16.8%) patients who discontinued opioid therapy 3 months postbaseline in the greater SDM group versus 46 (29.9%) in the lesser SDM group (RR, 0.56; 95% CI, 0.37-0.86, P = .006). The between-group difference in opioid prescribing frequency persisted over 12 months (Figure 3). Overall, opioid therapy was prescribed in 82.9% of encounters in the greater SDM group versus 66.9% of encounters in the lesser SDM group (RR, 1.24; 95% CI, 1.11-1.38; P < .001).
Opioid prescribing frequency over time by shared decision-making group.a
Secondary Outcomes
The only significant difference between SDM groups in secondary outcomes involved physical function (Figure 4). Patients in the greater SDM group had worse physical function than those in the lesser SDM group (mean, 35.2; 95% CI, 34.6 to 35.8 vs mean, 36.1; 95% CI, 35.6 to 36.7; P = .03); however, this between-group difference was not clinically important. Opioid therapy was associated with greater back-related disability (mean, 16.5; 95% CI, 15.9 to 17.1 vs mean, 16.2; 95% CI, 15.4 to 16.9; P = .03) and worse physical function (mean, 35.2; 95% CI, 34.9 to 35.6 vs mean, 36.1; 95% CI, 35.4 to 36.8; P < .001), although neither between-group difference was clinically important. There were no SDM x opioid therapy interaction effects for any secondary outcomes (Figure 5), indicating that more frequent use of opioid therapy with greater SDM did not yield better outcomes.
Pain, function, and health-related quality of life over time by shared decision-making group.a
Continued
Pain, function, and health-related quality of life over time by shared decision-making and prescribed opioid therapy.a
Continued
Dose Response
The mean baseline PPPO scale score for physicians having patients who discontinued opioid therapy 3 months postbaseline was 63.2 (95% CI, 56.9-9.6) versus 74.0 (95% CI, 70.9 to 77.1) for physicians whose patients continued opioid therapy (P = .002; d, −0.43). For each unit increase in the PPPO scale score, the likelihood of discontinuation of opioid therapy 3 months postbaseline decreased (RR, 0.989; 95% CI, 0.983-0.996; P = .001). Correspondingly, for each unit increase in the PPPO scale score, the frequency of prescribing opioid therapy over 12 months increased (RR, 1.005; 95% CI, 1.003-1.008; P < .001). The SDM dose-response for secondary outcomes generally mirrored those of the main analyses, although the association between SDM and physical function was no longer observed. Moreover, there were no longer SDM x opioid therapy interaction effects for any secondary outcomes.
Discussion
Our findings of less frequent discontinuation of opioid therapy at 3 months and more frequent opioid prescribing over 12 months in the greater SDM group, coupled with no apparent benefits from opioid therapy, support the view that SDM is a necessary but insufficient step to improve opioid prescribing for patients with chronic pain.24 To promote better opioid prescribing decisions, the National Institute for Health and Care Excellence (NICE) in the United Kingdom issued guidelines that more specifically advised physicians on dealing with patients already using opioids for chronic pain. In this setting, the guidelines recommended that physicians describe the lack of evidence for continued opioid use in general, explain the individual patient risks of continuing to use opioids if they report little benefit or significant harm, and encourage and support them to reduce opioid dosage or discontinue opioid use if possible.25 Subsequently, NICE issued a more comprehensive guideline for safe prescribing and withdrawal management for patients using opioids for chronic pain. During SDM with a given patient, the guideline recommends consideration of issues such as their changing opioid benefit-to-risk ratio over time, avoidance of abrupt discontinuation of opioids, dose reduction and taper speed, and risks potentially associated with opioid withdrawal and available support options.26 Relatedly, if a physician believes that continued opioid therapy is not in the patient’s best interest but SDM cannot resolve the issue, the General Medical Council in the United Kingdom recommends that the physician not prescribe the opioid, explain the reasons for this decision, document all discussions carefully and provide a copy to the patient, and offer a second opinion.27
There are complex challenges in engaging in SDM during medical encounters for chronic pain management when long-term opioid therapy is being considered.24 These may involve patient issues such as irrational or short-sighted expectations, overdependence on pain intensity in guiding treatment progress, and flawed decision-making owing to long-term opioid use. In response, a model of supplemented SDM has been advocated.24 This may include the participation of spouses, family, and friends, greater focus on physical function and HRQOL in monitoring treatment progress, use of appropriate decision aids, offering evidence-based nonpharmacological treatment options, and clarifying treatment goals through motivational interviewing.
Beyond knowing and wishing to adhere to clinical practice guidelines for prescribing opioid therapy for patients with chronic pain, presenting unbiased opioid risk information to be understood, synthesized, and acted on by patients can be a demanding task for physicians. Prospect theory was originally developed as a model within the field of economics to explain how persons make decisions involving monetary outcomes in the face of risk and uncertainty.28 However, the model may be extended to apply to health care decisions. In this setting, the model posits that patients will choose riskier treatments, such as opioid therapy rather than nonpharmacological or nonopioid alternatives, when faced with the likelihood of ongoing or worsening pain. Alternatively, patients may choose more conservative treatments when physicians use less technical medical terminology, which is perceived to indicate a less severe condition.29 Patients may also be susceptible to availability bias by believing that personal experiences with opioid therapy outweigh evidence, or optimism bias by believing themselves to be less susceptible to opioid harms than others.30
Although the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research introduced the concept of SDM in 1982, ethicists worry that its common application is premature in some ways.31 In particular, patients and physicians both rate performance on weighing the benefits and risks of treatment options lower than all other aspects of SDM.32 When SDM involves maintaining, tapering, or discontinuing opioid therapy it is particularly difficult, as patients may exhibit compromised decisional capacity owing to dependence, abuse, and diversion.24 Engaging in SDM may also be time-consuming and costly in primary care settings.33 While conversation aids may encourage and improve the quality of SDM within medical encounters, they compete for time with other tasks such as documentation for reimbursement.34 Decision aids generally have focused on improving care and reducing costs for medical or surgical procedures, rather than for common ongoing care issues.35 Thus, many are concerned that policy initiatives promoting widespread implementation of SDM, such as recommendations involving chronic disease management in millions of patients, carry the risk of unintended consequences if relational aspects of SDM are not maintained over time.31 Although informing patients about benefits and risks of opioid therapy and seeking input about their values is necessary,2 SDM requires a fundamental shift in the patient-physician relationship in which both parties are considered partners. Less frequent discontinuation of opioid therapy and more frequent opioid prescribing with greater SDM in our study suggest that shared decisions to initiate opioid therapy are more resistant to reversal than unilateral decisions stemming from more paternalistic care. Physicians engaged in greater SDM may be more reluctant to taper or discontinue opioid therapy to avoid the perception of patient abandonment.2
Although SDM may be challenging for young physicians navigating the challenges of acquiring medical experience while also learning to communicate and collaborate with patients, experienced physicians are also often unaware of their deficiencies in SDM by falsely perceiving that they involve patients in decision-making.32 Such physicians may be familiar with guidelines for opioid prescribing among patients with chronic pain but they are not adequately versed in implementing SDM. Consequently, more medical education and better physician training seem warranted to deal with opioid prescribing issues during SDM with patients having chronic pain. Linking SDM curricula with evidence-based medicine is a logical step for educating physicians to implement opioid prescribing guidelines.36 Another strategy involves integrating online SDM courses with existing continuing medical education requirements.37 Two related state-level initiatives are noteworthy. Oregon developed opioid prescribing guidelines to address challenging patient conversations that may arise during SDM, including discussing updated guidelines, compassionate refusal of opioid initiation or dose escalation, and tapering or discontinuing opioid therapy.38 Minnesota has a Shared Decision-Making Collaborative that promotes routine SDM during ongoing CLBP management.39 However, research is needed on the impact of voluntary programs such as those developed in Oregon and Minnesota. Some believe that mandatory physician education may be required to address the crisis of prescription opioid misuse, potentially linking it to medical licensure.40
Study strengths included selecting patients to mirror those with CLBP throughout the United States on characteristics such as age, sex, educational level, cigarette smoking, and medical comorbidities41; a validated measure to assign patients to SDM treatment strategies11; propensity-score matching of SDM groups to control for potential confounders; double blinding of patients and investigators; and follow-up for 12 months using intention-to-treat analysis. Nevertheless, there were study limitations. First, because PRECISION is not a population-based registry, the results may not be generalizable to the United States population. Second, because the patients assigned to treatment strategies had pre-existing relationships with their physicians at baseline, it is unknown if patient ratings of physician SDM may have been influenced by prior opioid prescribing frequency or opioid dosage. It is possible that patients on longstanding opioid therapy at baseline (ie, those less likely to discontinue opioids) may have rated their physicians more highly on SDM than patients who initiated opioid therapy more recently. It is also possible that physicians may have attempted greater SDM with patients having poor adherence to recommended CLBP treatments in the past.42 Third, although there were no statistically significant differences between SDM groups in any of 21 variables measured at baseline, standardized between-group differences in sex, prior lumbar spine surgery, and pain self-efficacy exceeded the 0.1 threshold generally accepted for negligible differences.43,44 Fourth, data were self-reported by patients and not otherwise corroborated, including that opioid therapy may have been prescribed by physicians other than those designated as the usual CLBP providers. Finally, only opioid prescribing frequency was routinely measured, not opioid dosage. Some physicians may prescribe opioids more frequently, but at lower doses, to appease patients.45 Nevertheless, an unplanned post hoc analysis using available PRECISION data on a subset of 142 patients reported in a prior study46 found no difference in baseline morphine milligram equivalent dosages between those in the greater or lesser SDM groups (mean, 40.7 vs 34.0, respectively; P = .12). Thus, it seems unlikely that physicians treating patients in the greater SDM group prescribed opioids at lower doses, or that differences in baseline opioid dosages had a material effect on opioid tapering or discontinuation over time based on recommended taper speed.47
Conclusions
In this TTE involving 328 adult patients currently using opioid therapy for CLBP at baseline, greater SDM was associated with less frequent discontinuation of opioid therapy 3 months postbaseline and with more frequent opioid prescribing over 12 months. The latter was not associated with better outcomes in pain, function, or HRQOL. Thus, SDM is a necessary but insufficient step to improve opioid prescribing among patients with chronic pain. More medical education and better physician training at all levels are needed to reduce opioid prescribing for such patients when the risk of harm outweighs the benefit of therapy.
Notes
This article was externally peer reviewed.
Funding: None.
Conflict of interest: None.
To see this article online, please go to: http://jabfm.org/content/38/2/275.full.
- Received for publication August 2, 2024.
- Revision received October 19, 2024.
- Accepted for publication November 4, 2024.













