An Approach to Evaluate the Effects of Concomitant Prescribing of Opioids and Benzodiazepines on Veteran Deaths and Suicides (2019) / Chapter Skim
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The concomitant use of opioids and benzodiazepines is also associated with increased rates of unintentional overdose and death and with higher rates of suicide. Responding to the concern about opioid and benzodiazepine use in the veteran population, the VA requested that the National Academies of Sciences, Engineering, and Medicine "develop a protocol/study design to evaluate the relationship between concomitant opioid and benzodiazepine medication practices at the VA, for treating mental health and combatrelated trauma, which potentially led to veteran's deaths and suicides." 1
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Thus, the Committee on Developing a Protocol to Evaluate the Concomitant Prescribing of Opioids and Benzodiazepine Medications and Veteran Deaths and Suicides was charged by the VA to "develop a protocol/ study design to evaluate the relationship between concomitant opioid and benzodiazepine medication practices at the VA, for treating mental health and combat-related trauma, which potentially led to veteran's deaths and suicides." In responding to its task, the committee proposes observational studies using VA and Centers for Disease Control and Prevention (CDC) 1 Benzodiazepine users tend to report a longer history of opioid use and prior detoxifica tions; use higher doses of opioids; higher frequency of injection drug use, needle sharing, and co-occurring use of alcohol and cocaine; and greater criminal activity.
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After reviewing the literature, the committee concluded that patients receiving both medications are at particularly high risk for adverse outcomes relative to patients on opioids alone, and there was very limited evidence regarding opioid prescribing strategies specifically for patients receiving benzodiazepines. Thus, although the effects of opioid initiation and tapering on patient outcomes are important areas of inquiry, the focus on patients prescribed benzodiazepines is more responsive to the Statement of Task and also addresses a particularly important sub-group of patients.
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For that reason, studies using observational data are often appropriate for evaluating the connections between treatments and outcomes. To develop the study strategy using observational data, the committee suggests the use of a "target trial" methodology, which involves describing a hypothetical randomized trial that is emulated (i.e., closely approximated)
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The committee describes seven components in the protocol of the target trials: eligibility criteria, treatment strategies, treatment assignment, start and end of follow-up, outcomes, causal contrasts, and the statistical analysis plan.
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6 FIGURE S-1 Opioid treatment initiation and tapering target trial schematic. NOTE: NSAID = nonsteroidal anti-inflammatory drug.
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TABLE S-1 Proposed Specifications for Initiation and Tapering Target Trials Protocol Component Initiation Target Trial Tapering Target Trial Eligibility Chronic pain diagnosisa Long-term opioid therapy defined as 3+ criteria opioid fills ≥21 days apart in a ≥84-day No prescriptions for opioids or period for ≥84-day supply non-aspirin NSAIDS in the last 90 days Average opioid MMEd/day is ≥30 over the prior 84 dayse Long-term benzodiazepine therapy (defined based on pilot Long-term benzodiazepine therapy data) (defined based on pilot data)
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prescribed for acute pain. However, researchers should consider that there might be a large proportion of veterans prescribed opioids for whom there is not a chronic pain diagnosis.
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Figure S-2 illustrates the proposed observational studies that would emulate those target trials using existing VA and CDC data.
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10 FIGURE S-2 Opioid treatment initiation and tapering study schematic. NOTE: NSAID = nonsteroidal anti-inflammatory drug.
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Additional considerations for emulating the target trials using observational data and potential limitations are detailed in Chapter 3. TABLE S-2 Opioid Initiation Target Trial Emulation Study Component Target Trial Emulation Using Observational Data Eligibility Chronic pain diagnosis Data to determine the use of analgesics criteria during the last 90 days and the use No prescriptions for opioids or of benzodiazepines will come from non-aspirin NSAIDS in the last pharmacy fills and will require 90 days information specifically on fill dates, dose, and supply duration.
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Per-protocol effect to-treat effect: this effect may be close to null and therefore relatively uninformative because adherence to the assigned treatment strategies is expected to be low in the observational data. Observational analog of the per-protocol effect.
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a Serious illness is defined as a health condition that carries a high risk of mortality and negatively affects a person's daily functioning. The committee recommends operationalizing this as any of the following conditions: cancer, chronic obstructive pulmonary disease, congestive heart failure, dementia, or severe neurologic disorder (e.g., amyotrophic lateral sclerosis, multiple sclerosis)
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opioid treatment programs. Exclude: Individuals with serious illnessc Individuals prescribed opioids for the treatment of opioid use disorder Individuals with surgery or acute painful injury within the 90 days prior to baseline Treatment (a)
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Per-protocol effect to-treat effect: this effect may be close to null and therefore relatively uninformative because adherence to the assigned treatment strategies is expected to be low in the observational data. Observational analog of the per-protocol effect.
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c Serious illness is defined as a health condition that carries a high risk of mortality and negatively affects a person's daily functioning. The committee recommends operationalizing this as any of the following conditions: cancer, chronic obstructive pulmonary disease, congestive heart failure, dementia, or severe neurologic disorder (e.g., amyotrophic lateral sclerosis, multiple sclerosis)
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b The VA medical record contains a wealth of clinical information that could be analyzed to determine the potential benefits, as well as risks, to patients with a wide variety of characteristics who were prescribed opioids and benzodiazepines. The committee views the proposed studies and any related investigations as an excellent opportunity to use the rich VA clinical databases to clarify the connections between important clinical conditions, changes in opioid and benzodiazepine prescribing practices over the years 2010–2017, and outcomes.
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18 CONCOMITANT PRESCRIBING OF OPIOIDS AND BENZODIAZEPINES opioid use disorder, yet that leaves many patients struggling to cope with chronic pain problems for which they had previously relied on opioid medication. The proposed observational studies might reveal important insights into health care providers' pain treatment practices, which could inform the use of opioid treatment as part of chronic pain management in the future.
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