Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial

Wegwarth, Odette; Spies, Claudia; Schulte, Erica M.; Meerpohl, Joerg J; Schmucker, Christine; Brockmann, Dirk; Donner-Banzhoff, Norbert; Wind, Stefan; Goebel, Eva; Ludwig, Wolf Dieter; Hertwig, Ralph

doi:10.1136/bmjopen-2020-037642

Cited by 6 publications

(8 citation statements)

References 42 publications

(36 reference statements)

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“…The ERONA project was funded by a grant from the German Federal Ministry for Health under the guideline “Risk perception and risk behavior among stakeholders involved in settings of drug safety concern.” The designs and methods have been described in detail and published in a peer-review journal as a study protocol [ 44 ] that has not since been amended. The trial was registered at the German Clinical Trials Register (DRKS00020358) and trial information was made public on the Open Science Framework (OSF).…”

Section: Methodsmentioning

confidence: 99%

Educating physicians on strong opioids by descriptive versus simulated-experience formats: a randomized controlled trial

et al. 2022

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Background Long-term prescriptions of strong opioids for chronic noncancer pain—which are not supported by scientific evidence—suggest miscalibrated risk perceptions among those who prescribe, dispense, and take opioids. Because risk perceptions and behaviors can differ depending on whether people learn about risks through description or experience, we investigated the effects of descriptive versus simulated-experience educative formats on physicians’ risk perceptions of strong opioids and their prescription behavior for managing chronic noncancer pain. Methods Three hundred general practitioners and 300 pain specialists in Germany—enrolled separately in two independent exploratory randomized controlled online trials—were randomly assigned to either a descriptive format (fact box) or a simulated-experience format (interactive simulation). Primary endpoints Objective risk perception (numerical estimates of opioids’ benefits and harms), actual prescriptions of seven therapy options for managing chronic pain. Secondary endpoint Implementation of intended prescriptions of seven therapy options for managing chronic pain. Results Both formats improved the proportion of correct numerical estimates of strong opioids’ benefits and harms immediately after intervention, with no notable differences between formats. Compared to description, simulated experience led to significantly lower reported actual prescription rates for strong and/or weak opioids, and was more effective at increasing prescription rates for non-drug-based therapies (e.g., means of opioid reduction) from baseline to follow-up for both general practitioners and pain specialists. Simulated experience also resulted in a higher implementation of intended behavior for some drug-based and non-drug-based therapies. Conclusions The two formats, which recruit different cognitive processes, may serve different risk-communication goals: If the goal is to improve exact risk perception, descriptive and simulated-experience formats are likely to be equally suitable. If, however, the goal is to boost less risky prescription habits, simulated experience may be the better choice. Trial registration DRKS00020358 (German Clinical Trials Register, first registration: 07/01/2020).

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Section: Methodsmentioning

confidence: 99%

Educating physicians on strong opioids by descriptive versus simulated-experience formats: a randomized controlled trial

et al. 2022

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“…This systematic review has been conducted to inform a RCT, 99 ie, registered in the German Register for Clinical Studies (trial registration number: DRKS00020358); our systematic review is reported in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. 61…”

Section: Methods or Designmentioning

confidence: 99%

“…66,67 Given the existing uncertainties on efficacy and safety as well as differences in recommendations on the long-term use of opioids, particularly strong opioids, for the treatment of CNCP, the aim of the current systematic review and meta-analyses (MAs) was to assess the comparative efficacy and safety of long-term use of strong opioids (WHO-III) in comparison with placebo or nonopioid therapy in patients with CNCP. Special attention was paid to nonspecific CLBP as this patient population was of particular interest for the German randomized controlled trials (RCTs) 99 that the current systematic review aimed to inform and because German guidelines on long-term opioid therapy for CNCP provide no clear guidance for the prolonged use of strong opioids in nonspecific CLBP.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of strong opioids for chronic noncancer pain and chronic low back pain: a systematic review and meta-analyses

Nury

Schmucker

Nagavci

et al. 2021

Pain

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In recent years, long-term prescribing and use of strong opioids for chronic noncancer pain (CNCP) has increased in high-income countries. Yet existing uncertainties, controversies, and differing recommendations make the rationale for prolonged opioid use in CNCP unclear. This systematic review and meta-analyses compared the efficacy, safety, and tolerability of strong opioids with placebo or nonopioid therapy in CNCP, with a special focus on chronic low back pain (CLBP). Systematic literature searches were performed in 4 electronic databases (MEDLINE, Web of Science, Cochrane Library, and CINAHL) in July 2019 and updated by regular alerts until December 2020. We included 16 placebo-controlled randomized controlled trials for CLBP and 5 studies (2 randomized controlled trials and 3 nonrandomized studies) of opioids vs nonopioids for CNCP in the quantitative and qualitative synthesis. Random effects pairwise meta-analyses were performed for efficacy, safety, and tolerability outcomes and subgroup analyses for treatment duration, study design, and opioid experience status. Very low to low certainty findings suggest that 4 to 15 weeks (short or intermediate term) opioid therapy in CLBP (compared with placebo) may cause clinically relevant reductions in pain but also more gastrointestinal and nervous system adverse events, with likely no effect on disability. By contrast, long-term opioid therapy ($6 months) in CNCP may not be superior to nonopioids in improving pain or disability or pain-related function but seems to be associated with more adverse events, opioid abuse or dependence, and possibly an increase in all-cause mortality. Our findings also underline the importance and need for well-designed trials assessing long-term efficacy and safety of opioids for CNCP and CLBP.

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“…The sample frame comprised accredited offline and online panels of IPSOS Health (Nuremberg, Germany) consisting of general populations of pharmacists. To detect a 15% difference in a two-tailed test with a 5% level of significance and a power of 80%, the trial required 150 participants per intervention arm (for details, see Wegwarth et al 40 ). IPSOS started enrolment for the first wave (T1) in April 2020 and concluded it in August 2020.…”

Section: Methods and Analysismentioning

confidence: 99%

Educating Pharmacists on the Risks of Strong Opioids With Descriptive and Simulated Experience Risk Formats: A Randomized Controlled Trial

Wegwarth

Wind

Goebel

et al. 2021

MDM Policy & Practice

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Objectives. High opioid prescription rates in the United States and Europe suggest miscalibrated risk perceptions among those who prescribe, dispense, and take opioids. Findings from cognitive decision science suggest that risk perceptions and behaviors can differ depending on whether people learn about risks by experience or description. This study investigated effects of a descriptive versus an experience-based risk education format on pharmacists’ risk perceptions and counseling behavior in the long-term administration of strong opioids to patients with chronic noncancer pain. Methods. In an exploratory, randomized controlled online trial, 300 German pharmacists were randomly assigned to either a descriptive format (fact box) or a simulated experience format (interactive simulation). Primary Outcome Measures. 1) Objective risk perception, 2) subjective risk perception, and 3) intended and 4) actual counseling behavior. Results. Both risk formats significantly improved pharmacists’ objective risk perception, but pharmacists exposed to the fact box estimated the benefit-harm ratio more accurately than those exposed to the simulation. Both formats proved equally effective in adjusting pharmacists’ subjective risk perception toward a better recognition of opioids’ harms; however, pharmacists receiving the simulation showed a greater change in their actual counseling behavior and higher consistency between their intended and actual counseling than pharmacists receiving the fact box. Conclusion. The simulated experience format was less effective than the descriptive format in improving pharmacists’ objective risk perception, equally effective in motivating pharmacists to counsel patients on less risky treatment alternatives and more effective in changing the reported actual counseling behavior. Implications. These exploratory findings provide important insights into the relevance of the description-experience gap for drug safety and raise questions for future research regarding the specific mechanisms at work.

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Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial

Cited by 6 publications

References 42 publications

Educating physicians on strong opioids by descriptive versus simulated-experience formats: a randomized controlled trial

Educating physicians on strong opioids by descriptive versus simulated-experience formats: a randomized controlled trial

Efficacy and safety of strong opioids for chronic noncancer pain and chronic low back pain: a systematic review and meta-analyses

Educating Pharmacists on the Risks of Strong Opioids With Descriptive and Simulated Experience Risk Formats: A Randomized Controlled Trial

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