Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration.

BACKGROUND: Calcitonin gene-related peptide (CGRP) is involved in migraine pathophysiology and blood pressure regulation. Although clinical trials have established the cardio-cerebrovascular safety profile of anti-CGRP treatment, limited high-quality real-world evidence exists on its long-term effects on blood pressure (BP). To address this gap, we examined the safety of anti-CGRP treatment on BP in patients with migraine headache in the Veterans Health Administration (VHA). METHODS: We emulated a target trial of patients who initiated anti-CGRP treatment or topiramate for migraine prevention between May 17th, 2018 and February 28th, 2023. We calculated stabilized inverse probability weights to balance between groups and then used weighted linear mixed-effect models to estimate the systolic and diastolic BP changes over the study period. For patients without hypertension at baseline, we estimated the cumulative incidence of hypertension using Kaplan-Meier curve. We also used weight mixed-effect Poisson model to estimate the number of antihypertension medications for patients with hypertension at baseline. RESULTS: This analysis included 69,589 patients and 554,437 blood pressure readings. of these, 18,880 patients received anti-CGRP treatment, and they were more likely to be women, have a chronic migraine diagnosis and higher healthcare utilization than those received topiramate. Among patients without hypertension at baseline, we found no significant differences in systolic BP changes over the four-year follow-up between anti-CGRP (slope [standard error, SE] = 0.48[0.06]) and topiramate treated patients (slope[SE] = 0.39[0.04]). The incidence of hypertension was similar for anti-CGRP and topiramate group (4.4 vs 4.3 per 100 person-years). Among patients with hypertension at baseline who initiated anti-CGRP treatment, we found a small but persistent effect on exacerbating hypertension during the first four years of treatment, as evidenced by a significant annual 3.7% increase in the number of antihypertensive medications prescribed (RR = 1.037, 95%CI 1.025-1.048). CONCLUSIONS: Our findings suggest that anti-CGRP treatment is safe regarding blood pressure in patients without hypertension. However, for those with baseline hypertension, anti-CGRP treatment resulted in a small but persistent increase in the number of antihypertensives, indicating an exacerbation of hypertension. Future studies are needed to evaluate the cardio-cerebrovascular safety of anti-CGRP treatment beyond the first four years.

Changes in opioid prescribing in veterans with headache during the COVID-19 pandemic: A regression discontinuity in time analysis.

OBJECTIVE: To determine changes in opioid prescribing among veterans with headaches during the coronavirus disease of 2019 (COVID-19) pandemic by comparing the stay-at-home phase (March 15 to May 30, 2020) and the reopening phase (May 31 to December 31, 2020). BACKGROUND: Opioid prescribing for chronic pain has declined substantially since 2016; however, changes in opioid prescribing during the COVID-19 pandemic among veterans with headaches remain unknown. METHODS: This retrospective cohort study utilized regression discontinuity in time and difference-in-differences design to analyze veterans aged ≥18 years with a previous diagnosis of headache disorders and an outpatient visit to the Veterans Health Administration (VHA) during the study period. We measured the weekly number of opioid prescriptions, the number of days supplied, the daily dose in morphine milligram equivalents (MMEs), and the number of prescriptions with ≥50 morphine equivalent daily doses (MEDD). RESULTS: A total of 81,376 veterans were analyzed with 589,950 opioid prescriptions. The mean (SD) age was 51.6 (13.5) years, 57,242 (70.3%) were male, and 53,464 (65.7%) were White. During the pre-pandemic period, 323.6 opioid prescriptions (interquartile range 292.1-325.8) were dispensed weekly, with an median (IQR) of 24.1 (24.0-24.4) days supplied and 31.8 (31.2-32.5) MMEs. Transition to stay-at-home was associated with a 7.7% decrease in the number of prescriptions (incidence rate ratio [IRR] 1.077, 95% confidence interval [CI] 0.866-0.984) and a 9.8% increase in days supplied (IRR 1.098, 95% CI 1.078-1.119). Similar trends were observed during the reopening period. Subgroup analysis among veterans on long-term opioid therapy also revealed 1.7% and 1.4% increases in days supplied during the stay-at-home (IRR 1.017, 95% CI 1.009-1.025) and reopening phase (IRR 1.014, 95% CI 1.007-1.021); however, changes in the total number of prescriptions, MME/day, or the number of prescriptions >50 MEDD were insignificant. CONCLUSION: Prescription opioid access was maintained for veterans within VHA during the pandemic. The de-escalation of opioid prescribing observed prior to the pandemic was not seen in our study.

Calcitonin Gene-Related Peptide Monoclonal Antibodies and Risk of SARS-CoV-2 Infection and Severe COVID-19 Outcomes Among Veterans With Migraine Disorder.

Importance: Calcitonin gene-related peptide (CGRP), a neuropeptide involved in migraine pathophysiology, is also a key neuroimmune modulator. CGRP antagonists may help mitigate the hyperinflammatory response observed in patients with COVID-19; however, findings from the literature are contradictory, and to date, no study has investigated the safety and effectiveness of CGRP antagonists against COVID-19. Objective: To evaluate the association between CGRP monoclonal antibody (mAb) treatment and risk of SARS-CoV-2 infection and sequela hospitalization, requiring supplemental oxygen, use of mechanical ventilation, or death. Design, Setting, and Participants: This retrospective cohort study analyzed the electronic health records of US veterans aged 18 to 65 years who were diagnosed with migraine disorder and were at risk of COVID-19 between January 20, 2020, and May 19, 2022. Exposure: Initiation of CGRP mAbs. Main Outcomes and Measures: The main outcome was cumulative incidence of SARS-CoV-2 infection. Odds of 30-day hospitalization, requiring supplemental oxygen, use of mechanical ventilation, or death were secondary outcomes. Results: Among 8 178 652 eligible person-trials (354 294 veterans), 9992 (mean [SD] age, 46.0 [9.5] years; 53.9% male) initiated CGRP mAbs and 8 168 660 (mean [SD] age, 46.6 [10.2] years; 65.7% male) did not initiate CGRP mAbs. Over a 28-month follow-up period, 1247 initiators (12.5%) and 780 575 noninitiators (9.6%) tested positive for SARS-CoV-2. After censoring persons who deviated from treatment, the incidence was 7.4 cases per 1000 person-months among initiators and 6.9 per 1000 person-months among noninitiators. The inverse probability-weighted observational analogs of intention-to-treat and per-protocol hazard ratios were 0.95 (95% CI, 0.89-1.01) and 0.93 (95% CI, 0.86-1.02), respectively. No significant differences in the likelihood of hospitalization (odds ratio [OR], 0.93; 95% CI, 0.62-1.41), requiring supplemental oxygen (OR, 0.77; 95% CI, 0.45-1.30), use of mechanical ventilation (OR, 0.85; 95% CI, 0.26-2.84), or death (OR, 0.67; 95% CI, 0.09-5.23) were observed between CGRP mAb initiators and noninitiators who tested positive for SARS-CoV-2. Conclusions and Relevance: In this cohort study, CGRP mAb treatment was not associated with positive SARS-CoV-2 test results or risk of severe COVID-19 outcomes, suggesting that CGRP mAbs may be used for migraine prevention during the COVID-19 pandemic. Given the few events of requiring supplemental oxygen, use of mechanical ventilation, and death, replication analysis in a larger sample of patients later in the course of disease is warranted.

Understanding headache classification coding within the veterans health administration using ICD-9-CM and ICD-10-CM in fiscal years 2014-2017.

OBJECTIVES: Understand the continuity and changes in headache not-otherwise-specified (NOS), migraine, and post-traumatic headache (PTH) diagnoses after the transition from ICD-9-CM to ICD-10-CM in the Veterans Health Administration (VHA). BACKGROUND: Headache is one of the most commonly diagnosed chronic conditions managed within primary and specialty care clinics. The VHA transitioned from ICD-9-CM to ICD-10-CM on October-1-2015. The effect transitioning on coding of specific headache diagnoses is unknown. Accuracy of headache diagnosis is important since different headache types respond to different treatments. METHODS: We mapped headache diagnoses from ICD-9-CM (FY 2014/2015) onto ICD-10-CM (FY 2016/2017) and computed coding proportions two years before/after the transition in VHA. We used queries to determine the change in transition pathways. We report the odds of ICD-10-CM coding associated with ICD-9-CM controlling for provider type, and patient age, sex, and race/ethnicity. RESULTS: Only 37%, 58% and 34% of patients with ICD-9-CM coding of NOS, migraine, and PTH respectively had an ICD-10-CM headache diagnosis. Of those with an ICD-10-CM diagnosis, 73-79% had a single headache diagnosis. The odds ratios for receiving the same code in both ICD-9-CM and ICD-10-CM after adjustment for ICD-9-CM and ICD-10-CM headache comorbidities and sociodemographic factors were high (range 6-26) and statistically significant. Specifically, 75% of patients with headache NOS had received one headache diagnoses (Adjusted headache NOS-ICD-9-CM OR for headache NOS-ICD-10-CM = 6.1, 95% CI 5.89-6.32. 79% of migraineurs had one headache diagnoses, mostly migraine (Adjusted migraine-ICD-9-CM OR for migraine-ICD-10-CM = 26.43, 95% CI 25.51-27.38). The same held true for PTH (Adjusted PTH-ICD-9-CM OR for PTH-ICD-10-CM = 22.92, 95% CI: 18.97-27.68). These strong associations remained after adjustment for specialist care in ICD-10-CM follow-up period. DISCUSSION: The majority of people with ICD-9-CM headache diagnoses did not have an ICD-10-CM headache diagnosis. However, a given diagnosis in ICD-9-CM by a primary care provider (PCP) was significantly predictive of its assignment in ICD-10-CM as was seeing either a neurologist or physiatrist (compared to a generalist) for an ICD-10-CM headache diagnosis. CONCLUSION: When a veteran had a specific diagnosis in ICD-9-CM, the odds of being coded with the same diagnosis in ICD-10-CM were significantly higher. Specialist visit during the ICD-10-CM period was independently associated with all three ICD-10-CM headaches.

Complex Patient Navigation by Veteran Patients in the Veterans Health Administration (VHA) for Chronic Headache Disease: A Qualitative Study.

Patients living with headache diseases often have difficulty accessing evidence-based care. Authors conducted a qualitative research study with 20 patients receiving headache care at seven Headache Centers of Excellence within the Veterans Health Administration to examine their experiences navigating headache care. This study employed thematic qualitative analysis and conducted cross-case comparisons. Several key findings emerged. 1) Most patients saw multiple healthcare providers over numerous years before reaching a headache specialist to manage chronic headaches. 2) Receipt of high-quality and comprehensive headache specialty care was associated with high satisfaction. 3) Patients with headache diseases reported oftentimes they experienced an arduous journey across multiple healthcare systems and between several healthcare providers before receiving evidence-based headache treatment that they found acceptable. Results demonstrate that most patients were satisfied with their current specialty headache care in the Veterans Health Administration. Authors discuss implications for future studies and highlight ways to improve patient satisfaction and timely access to appropriate headache care.

Long-term opioid therapy trajectories and overdose in patients with and without cancer.

Objective: Pain is experienced by most patients with cancer and opioids are a cornerstone of management. Our objectives were (1) to identify patterns or trajectories of long-term opioid therapy (LTOT) and their correlates among patients with and without cancer and (2) to assess the association between trajectories and risk for opioid overdose, considering the potential moderating role of cancer. Methods and Analysis: We conducted a retrospective cohort study among individuals in the US Veterans Health Administration (VHA) database with incident LTOT with and without cancer (N=44,351; N=285,772, respectively) between 2010-2017. We investigated the relationship between LTOT trajectory and all International Classification of Diseases-9 and 10-defined accidental and intentional opioid-related overdoses. Results: Trajectories of opioid receipt observed in patients without cancer and replicated in patients with cancer were: low-dose/stable trend, low-dose/de-escalating trend, moderate-dose/stable trend, moderate-dose/escalating with quadratic downturn trend, and high-dose/escalating with quadratic downturn trend. Time to first overdose was significantly predicted by higher-dose and escalating trajectories; the two low-dose trajectories conferred similar, lower risk. Conditional hazard ratios (99% CI) for the moderate-dose, moderate-dose/escalating with quadratic downturn and high-dose/escalating with quadratic downturn trends were 1·84 (1·18, 2·85), 2·56 (1·54, 4·25), and 2·41 (1·37, 4·26), respectively. Effects of trajectories on time to overdose did not differ by presence of cancer; inferences were replicated when restricting to patients with stage 3/4 cancer. Conclusion: Patients with cancer face opioid overdose risks like patients without cancer. Future studies should seek to expand and address our knowledge about opioid risk in cancer patients. Trial registration: None.

Frequency, Demographics, Comorbidities, and Health Care Utilization by Veterans With Migraine: A VA Nationwide Cohort Study.

OBJECTIVE: To describe the relative frequency, demographics, comorbidities, and healthcare utilization of veterans who receive migraine care at the Veteran's Health Administration (VHA) and to evaluate differences by gender. METHODS: This study extracted data from VHA administrative sources. Veterans diagnosed with migraine by a healthcare provider between fiscal year 2008-2019 were included. Demographics and military exposures were extracted at cohort entry. Comorbidities were extracted within 18 months of the first migraine diagnosis. Health care utilization and headache comorbidities were extracted across the study period. Differences between men and women were evaluated using chi-square tests and student t-tests. RESULTS: More than half a million (n = 567,121) veterans were diagnosed with migraine during the 12-year study period, accounting for 5.3% of the 10.8 million veterans served in the VHA; in the most recent year of the study period (2019), the annual incidence and one-year period prevalence of medically diagnosed migraine was 2.7% and 13.0% for women, and 0.7% and 2.5% for men. In the total cohort diagnosed with migraine, 27.8% were women and 72.2% men. Among those with diagnosed migraine, a higher proportion of men vs. women also had a TBI diagnosis (3.9% vs. 1.1%; p < 0.001). A higher proportion of women vs. men reported military sexual trauma (35.5% vs. 3.5%; p < 0.001). Participants with diagnosed migraine had an average of 1.44 (SD 1.73) annual encounters for headache. Primary care was the most common headache care setting (88.1%); almost one-fifth of veterans with diagnosed migraine sought care in the ED at least once during the study period. Common comorbidities were overweight/obesity (80.3%), non-headache pain disorders (61.7%), and mental health disorders (48.8%). CONCLUSIONS: Migraine is commonly treated in the VHA setting, but likely under ascertained. Most people treated for migraine in the VHA are men. Pain comorbidities and psychiatric disorders are common. Future research should identify methods to improve diagnosis and treatment and to reduce use of the emergency department.

Telehealth perceptions and utilization for the delivery of headache care before and during the COVID-19 pandemic: A mixed-methods study.

OBJECTIVE: The objective of this study was to evaluate the utilization of telehealth for headache services within the Veterans Health Administration's facilities housing a Headache Centers of Excellence and multiple stakeholder's perspectives to inform future telehealth delivery. BACKGROUND: Telehealth delivery of headache treatment may enhance patient access to headache care, yet little is known about the utilization or patient and provider perceptions of telehealth for veterans with headache. METHODS: This mixed-methods study analyzed multiple data sources: (1) administrative data, which included 58,798 patients with medically diagnosed headache disorders, documented in at least one outpatient visit, from August 2019 through September 2020 from the 12 Veterans Health Administration's facilities with a Headache Center of Excellence and (2) qualitative semistructured interviews with 20 patients and 43 providers 6 months before the coronavirus disease 2019 (COVID-19) pandemic, and 10 patients and 20 providers 6 months during the beginning of the pandemic. RESULTS: During the pandemic, in-person visits declined from 12,794 to 6099 (52.0%), whereas video (incidence rate ratio [IRR] = 2.05, 95% confidence interval [CI] = 1.66, 2.52), and telephone visits (IRR = 15.2, 95% CI = 10.7, 21.6) significantly increased. Utilization differed based on patient age, race/ethnicity, and rurality. Patients and providers perceived value in using telehealth, yet had limited experience with this modality pre-pandemic. Providers preferred in-person appointments for initial encounters and telehealth for follow-up visits. Providers and patients identified benefits and challenges of telehealth delivery, often relying on multiple delivery methods for telehealth to enhance patient engagement. CONCLUSIONS: The uptake of telehealth delivery of headache-related care rapidly expanded in response to the pandemic. Patients and providers were amenable to utilizing telehealth, yet also experienced technological barriers. To encourage equitable access to telehealth and direct resources to those in need, it is crucial to understand patient preferences regarding in-person versus telehealth visits and identify patient groups who face barriers to access.

Essential components of care in a multidisciplinary headache center: Perspectives from headache neurology specialists.

BACKGROUND AND OBJECTIVE: Comprehensive headache care involves numerous specialties and components that have not been well documented or standardized. This study aimed to elicit best practices and characterize important elements of care to be provided in multidisciplinary headache centers. METHODS: Qualitative, semi-structured telephone interviews with a purposive sample of headache neurology specialists from across the US, using open-ended questions. Interviews were recorded, transcribed, and coded. Coded data were further analyzed using immersion/crystallization techniques for final interpretation. RESULTS: Mean years providing headache care was 17.7 (SD = 10.6). Twelve of the 13 participants held United Council for Neurologic Subspecialties headache certification. Six described their practice site as providing multidisciplinary headache care. Participants explained most of their patients had seen multiple doctors over many years, and had tried numerous unsuccessful treatments. They noted patients with chronic headache frequently present with comorbidities and become stigmatized. All participants asserted successful care depends on taking time to talk with and listen to patients, gain understanding, and earn trust. All participants believed multidisciplinary care is essential within a comprehensive headache center, along with staffing enough headache specialists, implementing detailed headache intake and follow-up protocols, and providing the newest medications, neuromodulation devices, botulinum toxin injections, monoclonal antibodies, nerve blocks and infusions, and treatment from a health psychologist. Other essential services for a headache center are other behavioral health practitioners providing cognitive behavioral therapy, mindfulness, biofeedback and pain management; and autonomic neurology, neuropsychology, vestibular audiology, sleep medicine, physical therapy, occupational therapy, exercise physiology, speech therapy, nutrition, complementary integrative health modalities, and highly trained support staff. CONCLUSION: While headache neurology specialists form the backbone of headache care, experts interviewed for this study maintained their specialty is just one of many types of care needed to adequately treat patients with chronic headache, and this is best provided in a comprehensive, multidisciplinary center.

Complementary and integrative medicine perspectives among veteran patients and VHA healthcare providers for the treatment of headache disorders: a qualitative study.

OBJECTIVE: To evaluate veteran patient and provider perceptions and preferences on complementary and integrative medicine (CIM) for headache management. BACKGROUND: The Veterans Health Administration (VHA) has spearheaded a Whole Health system of care focusing on CIM-based care for veteran patients. Less is known about patients' and providers' CIM perceptions and preferences for chronic headache management. METHODS: We conducted semi-structured interviews with 20 veteran patients diagnosed with headache and 43 clinical providers, across 12 VHA Headache Centers of Excellence (HCoE), from January 2019 to March 2020. We conducted thematic and case comparative analyses. RESULTS: Veteran patients and VHA clinical providers viewed CIM favorably for the treatment of chronic headache. Specific barriers to CIM approaches included: (1) A lack of personnel specialized in specific CIM approaches for timely access, and (2) variation in patient perceptions and responses to CIM treatment efficacy for headache management. CONCLUSION: Veteran patients and VHA clinical providers in this study viewed CIM favorably as a safe addition to mainstream headache treatments. Advantages to CIM include favorable adverse effect profiles and patient autonomy over the treatment. By adding more CIM providers and resources throughout the VHA, CIM modalities may be recommended more routinely in the management of veterans with headache.

Comparison of attitudes towards the service connection claims process among veterans filing for PTSD and veterans filing for musculoskeletal disorders.

ABSTRACT: Many veterans have negative views about the service connection claims process for posttraumatic stress disorder (PTSD), which likely impacts willingness to file service connection claims, re-file claims, and use Veterans Healthcare Administration care. Nevertheless, veterans have reported that PTSD claims are important to them for the financial benefits, validation of prior experience and harm, and self-other issues such as pleasing a significant other. It is unknown if reported attitudes are specific to PTSD claimants or if they would be similar to those submitting claims for other disorders, such as musculoskeletal disorders. Therefore, the purpose of this study was to compare attitudes and beliefs about service connection processes between veterans submitting service connection claims for PTSD and musculoskeletal disorders.Participants were Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn veterans filing service connection claims for PTSD (n = 218) or musculoskeletal disorder (n = 257) who completed a modified Disability Application Appraisal Inventory. This secondary data analysis using multiple regression models tested the effect of demographics, clinical characteristics, and claim type on 5 Disability Application Appraisal Inventory subscales: Knowledge about service connection claims, Negative Expectations about the process, and importance of Financial Benefits, importance of Validation of veteran's experience/condition, and importance of Self-Other attitudes.The PTSD group assigned significantly less importance to financial benefits than the musculoskeletal disorder group. In addition, the subset of the PTSD group without depression had significantly more Negative Expectations than musculoskeletal disorder claimants without depression. Negative Expectations did not differ between the PTSD and musculoskeletal disorder groups with depression. Depression was significantly positively associated with Negative Expectations, importance of Financial Benefits, and importance of Validation.Most perceptions around seeking service connection are not specific to PTSD claimants. Depression is associated with having negative expectations about service connection claims and motivations to file claims. Addressing depression and negative expectations during the compensation and pension process might help veterans at this important point of contact with Veterans Healthcare Administration services.

"You will eat shoe polish if you think it would help"-Familiar and lesser-known themes identified from mixed-methods analysis of a cluster headache survey.

OBJECTIVE: To characterize patient-reported ideas and concerns about cluster headache, treatment options, and management strategies. BACKGROUND: Cluster headache patients experience severe pain and often suffer additional consequences from their disease. Patients have identified methods to cope with and combat cluster headache that are not widely known. METHODS: Secondary analysis was performed using deidentified data from the online Clusterbusters Medication Use survey, wherein 10 questions allowed for freely written comments. Using mixed-methods techniques, neurologists with expertise in headache medicine identified themes from these comments. Subgroup analysis sought to identify variables associated with specific themes. RESULTS: Among 2274 free-text responses from 493 adult participants, 23 themes were identified. Themes commonly discussed in the literature included such topics as "nothing worked" (24.7%, 122/493), "side effects" (12.8%, 63/493), and difficulties with "access/cost" (2.4%, 12/493). Less widely recognized themes included the use of "illicit substances" (35.5%, 175/493) and "vitamins/supplements" (12.2%, 60/493) in disease management. Lesser-known themes included "coffee" (5.3%, 26/493) and "exercise/physical activity" (4.7%, 23/493). Using strict significance criteria, no subgroup was associated with any theme. Several poignant quotes highlighted patient thoughts and experiences. CONCLUSIONS: This mixed-methods analysis identified challenges endured by cluster headache patients, as well as a variety of patient-directed disease management approaches. The volunteered information spotlights pharmacological, physiological, and psychological aspects of cluster headache that warrant further exploratory and interventional investigation.

Access to Pain Care From Compensation Clinics: A Relational Coordination Perspective.

BACKGROUND: The Compensation and Pension (C&P) determination process is a potential gateway to accessing pain treatment in the Veterans Health Administration (VHA). However, attitudes about C&P as a gateway and about collaboration with C&P clinics among VHA staff are unknown. METHODS: In preparation for an initiative to link veterans seeking compensation for musculoskeletal disorders to treatment, clinical and administrative staff from the 8 VHA medical centers in New England were invited to complete a relational coordination survey that examined how different workgroups collaborate (communication and relationships) to provide pain care to veterans. A subset of those staff also participated in a semistructured interview about pain treatment referral practices within their medical centers. VHA staff were from primary care, administration, pain management, and C&P teams. RESULTS: Eighty-three VHA staff were invited to complete the relational coordination survey; 66 completed the survey and 39 participated in the semistructured interview. Most C&P staff interviewed thought of the compensation examination as a forensic process and that C&P-based efforts to engage veterans might interfere with the examination or were not their responsibility. However, some examiners described their efforts to determine new veterans' eligibility for VHA care and to connect them to specific treatments. VHA staff reported that there was little communication between the C&P team and other teams. The survey results supported this finding. The C&P group's relational coordination composite scores were lower than any other workgroup. CONCLUSION: Outreach to veterans at New England C&P clinics was inconsistent, and C&P teams rated low on a measure of coordination with workgroups involved in pain treatment. Compensation examinations appear to be underused opportunities to help veterans access treatment. C&P-based treatment engagement is feasible; it is being done by some Compensation teams.

Treatment of a Large Cohort of Veterans Experiencing Musculoskeletal Disorders with Spinal Cord Stimulation in the Veterans Health Administration: Veteran Characteristics and Outcomes.

OBJECTIVE: 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.

Prevalence of and characteristics associated with in-hospital mortality in a Ugandan neurology ward.

BACKGROUND: While the burden of neurologic illness in developing countries is increasing, less is known about mortality among patients admitted to sub-Saharan African hospitals with neurologic disease. We sought to characterize the rate and patient-level predictors of in-hospital mortality in a Ugandan Neurology ward.cc. METHODS: Data was prospectively collected on 335 patients admitted to the Neurology ward of Mulago Hospital, Kampala, Uganda. Kaplan-Meier survival curves and multivariate COX proportional hazard modeling were used to assess survival. RESULTS: Within our sample (n = 307), 35.8% received no diagnosis at time of hospital admission. Stroke (27.3%), head trauma (19.6%), and malaria (16.0%) were the most common diagnoses. Among the 56 (18.5%) patients who died during the index hospitalization, the most common diagnosis at admission and at death was stroke. Adjusted regression analysis showed that patients without a diagnosis at time of death (HR = 7.01 [2.42-20.35], p < .001) and those with diagnoses of infections (HR = 5.21 [2.16-12.58], p = <.001), stroke (HR = 2.69 [1.20-6.04], p = .017), or head trauma (HR = 3.39, [1.27-9.07], p = 0.15) had worse survival. CONCLUSIONS: In-hospital mortality affected nearly 20% of the cohort, with worse survival among those without a diagnosis and with infections, stroke, head trauma. Future work should identify reasons for increased mortality among these high-risk groups and implement targeted interventions.

Managing Functional Neurological Disorders: Protocol of a Cohort Study on Psychogenic Non-Epileptic Seizures Study.

BACKGROUND: Functional neurological disorders (FNDs) are neurological symptoms that cannot be explained by an underlying neurological lesion or other medical illness and that do not have clear neuropathological correlates. Psychogenic non-epileptic seizures (PNES) are a common and highly disabling form of FND, characterized by paroxysmal episodes of involuntary movements and altered consciousness that can appear clinically similar to epileptic seizures. PNES are unique among FNDs in that they are diagnosed by video electroencephalographic (VEEG), a well-established biomarker for the disorder. The course of illness and response to treatment of PNES remain controversial. This study aims to describe the epidemiology of PNES in the Department of Veterans Affairs Healthcare System (VA), evaluate outcomes of veterans offered different treatments, and compare models of care for PNES. METHODS: This electronic health record (EHR) cohort study utilizes an informatics search tool and a natural language processing algorithm to identify cases of PNES nationally. We will use VA inpatient, outpatient, pharmacy, and chart abstraction data across all 170 medical centers to identify cases in fiscal years 2002-2018. Outcome measurements such as seizure frequency, emergency room visits, hospital admissions, suicide-related behavior, and the utilization of psychotherapy prior to and after PNES diagnosis will be used to assess the effectiveness of models of care. DISCUSSION: This study will describe the risk factors and course of treatment of a large cohort of people with PNES. Since PNES are cared for by a variety of different modalities, treatment orientations, and models of care, effectiveness outcomes such as seizure outcomes and utilization of emergency visits for seizures will be assessed. Outcome measurements such as seizure frequency, emergency room visits, hospital admissions, suicide-related behavior, and psychotherapy prior to and after PNES diagnosis will be used to assess the effectiveness of models of care.

Testing implementation facilitation of a primary care-based collaborative care clinical program using a hybrid type III interrupted time series design: a study protocol.

BACKGROUND: Dissemination of evidence-based practices that can reduce morbidity and mortality is important to combat the growing opioid overdose crisis in the USA. Research and expert consensus support reducing high-dose opioid therapy, avoiding risky opioid-benzodiazepine combination therapy, and promoting multi-modal, collaborative models of pain care. Collaborative care interventions that support primary care providers have been effective in medication tapering. We developed a patient-centered Primary Care-Integrated Pain Support (PIPS) collaborative care clinical program based on effective components of previous collaborative care interventions. Implementation facilitation, a multi-faceted and dynamic strategy involving the provision of interactive problem-solving and support during implementation of a new program, is used to support key organizational staff throughout PIPS implementation. The primary aim of this study is to evaluate the effectiveness of the implementation facilitation strategy for implementing and sustaining PIPS in the Veterans Health Administration (VHA). The secondary aim is to examine the effect of the program on key patient-level clinical outcomes-transitioning to safer regimens and enhancing access to complementary and integrative health treatments. The tertiary aim is to determine the categorical costs and ultimate budget impact of PIPS implementation. METHODS: This multi-site study employs an interrupted time series, hybrid type III design to evaluate the effectiveness of implementation facilitation for a collaborative care clinical program-PIPS-in primary care clinics in three geographically diverse VHA health care systems (sites). Participants include pharmacists and allied staff involved in the delivery of clinical pain management services as well as patients. Eligible patients are prescribed either an outpatient opioid prescription greater than or equal to 90 mg morphine equivalent daily dose or a combination opioid-benzodiazepine regimen. They must also have an upcoming appointment in primary care. The Consolidated Framework for Implementation Research will guide the mixed methods work across the formative evaluation phases and informs the selection of activities included in implementation facilitation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of PIPS. DISCUSSION: This implementation study will provide important insight into the effectiveness of implementation facilitation to enhance uptake of a collaborative care program in primary care, which targets unsafe opioid prescribing practices.

Relationships Between Temporomandibular Disorders, MSD Conditions, and Mental Health Comorbidities: Findings from the Veterans Musculoskeletal Disorders Cohort.

Objective: Temporomandibular disorders (TMDs) have been associated with other chronic painful conditions (e.g., fibromyalgia, headache) and suicide and mood disorders. Here we examined musculoskeletal, painful, and mental health comorbidities in men vs women veterans with TMD (compared with non-TMD musculoskeletal disorders [MSDs] cases), as well as comorbidity patterns within TMD cases. Design: Observational cohort. Setting: National Veterans Health Administration. Subjects: A cohort of 4.1 million veterans having 1+ MSDs, entering the cohort between 2001 and 2011. Methods: Chi-square tests, t tests, and logistic regression were utilized for cross-sectional analysis. Results: Among veterans with any MSD, those with TMD were younger and more likely to be women. The association of TMD with race/ethnicity differed by sex. Odds of TMD were higher in men of Hispanic ethnicity (OR = 1.38, 95% CI = 1.27-1.48) and nonwhite race/ethnicity other than black or Hispanic (OR = 1.29, 95% CI = 1.16-1.45) compared with white men. Odds of TMD were significantly lower for black (OR = 0.54, 95% CI = 0.49-0.60) and Hispanic women (OR = 0.84, 95% CI = 0.73-0.995) relative to white women. Non-MSD comorbidities (e.g., irritable bowel syndrome, mental health, headaches) were significantly associated with TMD in male veterans; their pattern was similar in women. Veterans with back pain, nontraumatic joint disorder, or osteoarthritis had more MSD multimorbidity than those with TMD. Conclusions: Complex patterns of comorbidity in TMD cases may indicate different underlying mechanisms of association in subgroups or phenotypes, thereby suggesting multiple targets to improve TMD. Longitudinal comprehensive studies powered to look at sex and racial/ethnic groupings are needed to identify targets to personalize care.

Mixed methods formative evaluation of a collaborative care program to decrease risky opioid prescribing and increase non-pharmacologic approaches to pain management.

INTRODUCTION: Opioid prescribing and subsequent rates of serious harms have dramatically increased in the past two decades, yet there are still significant barriers to reduction of risky opioid regimens. This formative evaluation utilized a mixed-methods approach to identify barriers and factors that may facilitate the successful implementation of Primary Care-Integrated Pain Support (PIPS), a clinical program designed to support the reduction of risky opioid regimens while increasing the uptake of non-pharmacologic treatment modalities. METHODS: Eighteen Department of Veterans Affairs (VA) employees across three sites completed a survey consisting of the Organizational Readiness for Implementing Change (ORIC) scale; a subset of these individuals (n = 9) then completed a semi-structured qualitative phone interview regarding implementing PIPS within the VA. ORIC results were analyzed using descriptive statistics while interview transcripts were coded and sorted according to qualitative themes. RESULTS: Quantitative analysis based on ORIC indicated high levels of organizational readiness to implement PIPS. Interview analysis revealed several salient themes: system-level barriers such as tension among various pain management providers; patient-level barriers such as perception of support and tension between patient and provider; and facilitating factors of PIPS, such as the importance of the clinical pharmacist role. CONCLUSIONS: While organizational readiness for implementing PIPS appears high, modifications to our implementation facilitation strategy (e.g., establishing clinical pharmacists as champions; marketing PIPS to leadership as a way to improve VA opioid safety metrics) may improve capacity of the sites to implement PIPS successfully.

Developing a typology of patient-generated behavioral goals for cognitive behavioral therapy for chronic pain (CBT-CP): classification and predicting outcomes.

Patient-generated treatment goals describe what patients value, yet the content of these goals, and the relationship among goal types, goal accomplishment, and treatment outcomes has received little examination. We used inductive sorting to categorize patient-generated goals made by 147 adults receiving cognitive-behavioral therapy for chronic pain. The resulting goal categories were: Physical Activity (29.0%), Functional Status (24.6%), Wellness (16.3%), Recreational Activities (11.3%), House/Yard Work (9.7%), Socializing (7.1%), and Work/School (2.0%). Next, we examined associations between number of goals by category, goal accomplishment, and clinically meaningful improvements in pain-related interference, pain intensity and depressive symptoms. Improvement in all outcome domains was related to goal accomplishment. Additionally, depressive symptoms were related to number of Physical Activity, House/Yard Work, Recreational Activities, and Wellness goals, whereas improved pain-intensity was significantly related to House/Yard Work. Classifying patient-generated goals facilitates investigation of the relationships among goal type, goal accomplishment and treatment outcomes.