Browsing by Author "Sandbrink, Friedhelm"
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Item A national population-based study of cannabis use and correlates among U.S. veterans prescribed opioids in primary care(BMC, 2023-03-17) Zaman, Tauheed; Bravata, Dawn M.; Byers, Amy L.; Krebs, Erin E.; Leonard, Samuel J.; Sandbrink, Friedhelm; Barker, Wylie; Keyhani, Salomeh; Medicine, School of MedicineBackground: Cannabis is marketed as a treatment for pain. There is limited data on the prevalence of cannabis use and its correlates among Veterans prescribed opioids. Objective: To examine the prevalence and correlates of cannabis use among Veterans prescribed opioids. Design: Cross-sectional study. Participants: Veterans with a urine drug test (UDT) from Primary Care 2014-2018, in 50 states, Washington, D.C., and Puerto Rico. A total of 1,182,779 patients were identified with an opioid prescription within 90 days prior to UDT. Main measures: Annual prevalence of cannabis positive UDT by state. We used multivariable logistic regression to assess associations of demographic factors, mental health conditions, substance use disorders, and pain diagnoses with cannabis positive UDT. Results: Annual prevalence of cannabis positive UDT ranged from 8.5% to 9.7% during the study period, and in 2018 was 18.15% in Washington, D.C. and 10 states with legalized medical and recreational cannabis, 6.1% in Puerto Rico and 25 states with legalized medical cannabis, and 4.5% in non-legal states. Younger age, male sex, being unmarried, and marginal housing were associated with use (p < 0.001). Post-traumatic stress disorder (adjusted odds ratio [AOR] 1.17; 95% confidence interval [CI] 1.13-1.22, p < 0.001), opioid use disorder (AOR 1.14; CI 1.07-1.22, p < 0.001), alcohol use disorder or positive AUDIT-C (AOR 1.34; 95% CI 1.28-1.39, p < 0.001), smoking (AOR 2.58; 95% CI 2.49-2.66, p < 0.001), and other drug use disorders (AOR 1.15; 95% CI 1.03-1.29, p = 0.02) were associated with cannabis use. Positive UDT for amphetamines AOR 1.41; 95% CI 1.26-1.58, p < 0.001), benzodiazepines (AOR 1.41; 95% CI 1.31-1.51, p < 0.001) and cocaine (AOR 2.04; 95% CI 1.75-2.36, p < 0.001) were associated with cannabis positive UDT. Conclusions: Cannabis use among Veterans prescribed opioids varied by state and by legalization status. Veterans with PTSD and substance use disorders were more likely to have cannabis positive UDT. Opioid-prescribed Veterans using cannabis may benefit from screening for these conditions, referral to treatment, and attention to opioid safety.Item A national study of clinical discussions about cannabis use among Veteran patients prescribed opioids(Springer Nature, 2024-03-16) Zaman, Tauheed; Bravata, Dawn M.; Byers, Amy; Krebs, Erin; Leonard, Samuel; Austin, Charles; Sandbrink, Friedhelm; Hasin, Deborah S.; Keyhani, Salomeh; Medicine, School of MedicineBackground: The Veterans Health Administration tracks urine drug tests (UDTs) among patients on long-term opioid therapy (LTOT) and recommends discussing the health effects of cannabis use. Objective: To determine the occurrence of cannabis-related discussions between providers and patients on LTOT during six months following UDT positive for cannabis, and examine factors associated with documenting cannabis use. Design: We identified patients prescribed LTOT with a UDT positive for cannabis in 2019. We developed a text-processing tool to extract discussions around cannabis use from their charts. Subjects: Twelve thousand seventy patients were included. Chart review was conducted on a random sample of 1,946 patients. Main measures: The presence of a cannabis term in the chart suggesting documented cannabis use or cannabis-related discussions. Content of those discussions was extracted in a subset of patients. Logistic regression was used to examine the association between patient factors, including state of residence legal status, with documentation of cannabis use. Key results: Among the 12,070 patients, 65.8% (N = 7,948) had a cannabis term, whereas 34.1% (N = 4,122) of patients lacked a cannabis term, suggesting that no documentation of cannabis use or discussion between provider and patient took place. Among the subset of patients who had a discussion documented, 47% related to cannabis use for medical reasons, 35% related to a discussion of VA policy or legal issues, and 17% related to a discussion specific to medical risks or harm reduction strategies. In adjusted analyses, residents of states with legalized recreational cannabis were less likely to have any cannabis-related discussion compared to patients in non-legal states [OR 0.73, 95% CI 0.64-0.82]. Conclusions: One-third of LTOT patients did not have documentation of cannabis use in the chart in the 6 months following a positive UDT for cannabis. Discussions related to the medical risks of cannabis use or harm reduction strategies were uncommon.Item Association of a Positive Drug Screening for Cannabis With Mortality and Hospital Visits Among Veterans Affairs Enrollees Prescribed Opioids(American Medical Association, 2022-12-01) Keyhani, Salomeh; Leonard, Samuel; Byers, Amy L.; Zaman, Tauheed; Krebs, Erin; Austin, Peter C.; Moss-Vazquez, Tristan; Austin, Charles; Sandbrink, Friedhelm; Bravata, Dawn M.; Medicine, School of MedicineImportance: Cannabis has been proposed as a therapeutic with potential opioid-sparing properties in chronic pain, and its use could theoretically be associated with decreased amounts of opioids used and decreased risk of mortality among individuals prescribed opioids. Objective: To examine the risks associated with cannabis use among adults prescribed opioid analgesic medications. Design, setting, and participants: This cohort study was conducted among individuals aged 18 years and older who had urine drug screening in 2014 to 2019 and received any prescription opioid in the prior 90 days or long-term opioid therapy (LTOT), defined as more than 84 days of the prior 90 days, through the Veterans Affairs health system. Data were analyzed from November 2020 through March 2022. Exposures: Biologically verified cannabis use from a urine drug screen. Main outcomes and measures: The main outcomes were 90-day and 180-day all-cause mortality. A composite outcome of all-cause emergency department (ED) visits, all-cause hospitalization, or all-cause mortality was a secondary outcome. Weights based on the propensity score were used to reduce confounding, and hazard ratios [HRs] were estimated using Cox proportional hazards regression models. Analyses were conducted among the overall sample of patients who received any prescription opioid in the prior 90 days and were repeated among those who received LTOT. Analyses were repeated among adults aged 65 years and older. Results: Among 297 620 adults treated with opioids, 30 514 individuals used cannabis (mean [SE] age, 57.8 [10.5] years; 28 784 [94.3%] men) and 267 106 adults did not (mean [SE] age, 62.3 [12.3] years; P < .001; 247 684 [92.7%] men; P < .001). Among all patients, cannabis use was not associated with increased all-cause mortality at 90 days (HR, 1.07; 95% CI, 0.92-1.22) or 180 days (HR, 1.00; 95% CI, 0.90-1.10) but was associated with an increased hazard of the composite outcome at 90 days (HR, 1.05; 95% CI, 1.01-1.07) and 180 days (HR, 1.04; 95% CI, 1.01-1.06). Among 181 096 adults receiving LTOT, cannabis use was not associated with increased risk of all-cause mortality at 90 or 180 days but was associated with an increased hazard of the composite outcome at 90 days (HR, 1.05; 95% CI, 1.02-1.09) and 180 days (HR, 1.05; 95% CI, 1.02-1.09). Among 77 791 adults aged 65 years and older receiving LTOT, cannabis use was associated with increased 90-day mortality (HR, 1.55; 95% CI, 1.17-2.04). Conclusions and relevance: This study found that cannabis use among adults receiving opioid analgesic medications was not associated with any change in mortality risk but was associated with a small increased risk of adverse outcomes and that short-term risks were higher among older adults receiving LTOT.Item Core Outcome Measures for Chronic Musculoskeletal Pain Research: Recommendations from a Veterans Health Administration Work Group(Oxford, 2019-08) Kroenke, Kurt; Krebs, Erin E.; Turk, Dennis; Von Korff, Michael; Bair, Matthew J.; Allen, Kelli D.; Sandbrink, Friedhelm; Cheville, Andrea L.; DeBar, Lynn; Lorenz, Karl A.; Kerns, Robert D.; Medicine, School of MedicineObjective Chronic musculoskeletal pain (CMSP) disorders are among the most prevalent and disabling conditions worldwide. It would be advantageous to have common outcome measures when comparing results across different CMSP research studies. Methods The Veterans Health Administration appointed a work group to recommend core outcome measures for assessing pain intensity and interference as well as important secondary domains in clinical research. The work group used three streams of data to inform their recommendations: 1) literature synthesis augmented by three recently completed trials; 2) review and comparison of measures recommended by other expert groups; 3) two Delphi surveys of work group members. Results The single-item numerical rating scale and seven-item Brief Pain Inventory interference scale emerged as the recommended measures for assessing pain intensity and interference, respectively. The secondary domains ranked most important included physical functioning and depression, followed by sleep, anxiety, and patient-reported global impression of change (PGIC). For these domains, the work group recommended the Patient-Reported Outcome Information System four-item physical function and sleep scales, the Patient Health Questionnaire two-item depression scale, the Generalized Anxiety Disorder two-item anxiety scale, and the single-item PGIC. Finally, a single-item National Health Interview Survey item was favored for defining chronic pain. Conclusions Two scales comprising eight items are recommended as core outcome measures for pain intensity and interference in all studies of chronic musculoskeletal pain, and brief scales comprising 13 additional items can be added when possible to assess important secondary domains.Item Development and field testing of primary care screening tools for harms of long-term opioid therapy continuation and tapering to discontinuation: a study protocol(BMJ Publishing, 2021-10-07) Timko, Christine; Kroenke, Kurt; Nevedal, Andrea; Lor, Mai Chee; Oliva, Elizabeth; Drexler, Karen; Sandbrink, Friedhelm; Hoggatt, Katherine; Medicine, School of MedicineIntroduction: Despite calls for screening tools to help providers monitor long-term opioid therapy (LTOT) harms, and identify patients likely to experience harms of discontinuation, such screening tools do not yet exist. Current assessment tools are infeasible to use routinely in primary care and focus mainly on behaviours suggestive of opioid use disorder to the exclusion of other potential harms. This paper describes a study protocol to develop two screening tools that comprise one integrated instrument, Screen to Evaluate and Treat (SET). SET1 will indicate if LTOT may be harmful to continue (yes or no), and SET2 will indicate if tapering to discontinue opioids may be harmful to initiate (yes or no). Patients receiving LTOT who screen positive on the SET tools should receive subsequent additional assessment. SET will give providers methods that are feasible to implement routinely to facilitate more intensive and comprehensive monitoring of patients on LTOT and decision-making about discontinuation. Methods and analysis: We will develop the screening tools, SET1 and SET2, concurrently. Tool development will be done in stages: (1) comprehensive literature searches to yield an initial item pool for domains covered by each screening tool; (2) qualitative item analyses using interviews, expert review and cognitive interviewing, with subsequent item revision, to yield draft versions of each tool; and (3) field testing of the draft screening tools to assess internal consistency, test-retest reliability and convergent and discriminant validity. Ethics and dissemination: Ethical approval was obtained from the Institutional Review Boards of Stanford University and the University of California, San Francisco for the VA Palo Alto Health Care System, and the VA San Francisco Healthcare System, respectively. Findings will be disseminated through peer-reviewed manuscripts and presentations at research conferences.Item Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations(International Association for the Study of Pain, 2021) Gewandter, Jennifer S.; Smith, Shannon M.; Dworkin, Robert H.; Turk, Dennis C.; Gan, Tong Joo; Gilron, Ian; Hertz, Sharon; Katz, Nathaniel P.; Markman, John D.; Raja, Srinivasa N.; Rowbotham, Michael C.; Stacey, Brett R.; Strain, Eric C.; Ward, Denham S.; Farrar, John T.; Kroenke, Kurt; Rathmell, James P.; Rauck, Richard; Brown, Colville; Cowan, Penney; Edwards, Robert R.; Eisenach, James C.; Ferguson, McKenzie; Freeman, Roy; Gray, Roy; Giblin, Kathryn; Grol-Prokopczyk, Hanna; Haythornthwaite, Jennifer; Jamison, Robert N.; Martel, Marc; McNicol, Ewan; Oshinsky, Michael; Sandbrink, Friedhelm; Scholz, Joachim; Scranton, Richard; Simon, Lee S.; Steiner, Deborah; Verburg, Kenneth; Wasan, Ajay D.; Wentworth, Kerry; Medicine, School of MedicineRandomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.Item Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement(Wolters Kluwer, 2023) Hohenschurz-Schmidt, David J.; Cherkin, Dan; Rice, Andrew S. C.; Dworkin, Robert H.; Turk, Dennis C.; McDermott, Michael P.; Bair, Matthew J.; DeBar, Lynn L.; Edwards, Robert R.; Farrar, John T.; Kerns, Robert D.; Markman, John D.; Rowbotham, Michael C.; Sherman, Karen J.; Wasan, Ajay D.; Cowan, Penney; Desjardins, Paul; Ferguson, McKenzie; Freeman, Roy; Gewandter, Jennifer S.; Gilron, Ian; Grol-Prokopczyk, Hanna; Hertz, Sharon H.; Iyengar, Smriti; Kamp, Cornelia; Karp, Barbara I.; Kleykamp, Bethea A.; Loeser, John D.; Mackey, Sean; Malamut, Richard; McNicol, Ewan; Patel, Kushang V.; Sandbrink, Friedhelm; Schmader, Kenneth; Simon, Lee; Steiner, Deborah J.; Veasley, Christin; Vollert, Jan; Anesthesia, School of MedicineMany questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions.Item Treatment of a Large Cohort of Veterans Experiencing Musculoskeletal Disorders with Spinal Cord Stimulation in the Veterans Health Administration: Veteran Characteristics and Outcomes(Dove Press, 2020-07-07) Wandner, Laura D.; Fenton, Brenda T.; Goulet, Joseph L.; Carroll, Constance M.; Heapy, Alicia; Higgins, Diana M.; Bair, Matthew J.; Sandbrink, Friedhelm; Kerns, Robert D.; Medicine, School of MedicineObjective Spinal cord stimulator (SCS) implantation is used to treat chronic pain, including painful musculoskeletal disorders (MSDs). This study examined the characteristics and outcomes of veterans receiving SCSs in Veterans Health Administration (VHA) facilities. Methods The sample was drawn from the MSD Cohort and limited to three MSDs with the highest number of implants (N=815,475). There were 1490 veterans with these conditions who received SCS implants from 2000 to 2012, of which 95% (n=1414) had pain intensity numeric rating scale (NRS) data both pre- and post-implant. Results Veterans who were 35–44 years old, White, and married reported higher pain NRS ratings, had comorbid inclusion diagnoses, had no medical comorbidities, had a BMI 25–29.9, or had a depressive disorder diagnosis were more likely to receive an SCS. Veterans 55+ years old or with an alcohol or substance use disorder were less likely to receive an SCS. Over 90% of those receiving an SCS were prescribed opioids in the year prior to implant. Veterans who had a presurgical pain score ≥4 had a clinically meaningful decrease in their pain score in the year following their 90-day recovery period (Day 91–456) greater than expected by chance alone. Similarly, there was a significant decrease in the percent of veterans receiving opioid therapy (92.4% vs 86.6%, p<0.0001) and a significant overall decrease in opioid dose [morphine equivalent dose per day (MEDD) =26.48 vs MEDD=22.59, p<0.0003]. Conclusion Results offer evidence of benefit for some veterans with the examined conditions. Given known risks of opioid therapy, the reduction is an important potential benefit of SCS implants.