Chronic respiratory symptoms following deployment-related occupational and environmental exposures among US veterans.

OBJECTIVES: Characterise inhalational exposures during deployment to Afghanistan and Southwest Asia and associations with postdeployment respiratory symptoms. METHODS: Participants (n=1960) in this cross-sectional study of US Veterans (Veterans Affairs Cooperative Study 'Service and Health Among Deployed Veterans') completed an interviewer-administered questionnaire regarding 32 deployment exposures, grouped a priori into six categories: burn pit smoke; other combustion sources; engine exhaust; mechanical and desert dusts; toxicants; and military job-related vapours gas, dusts or fumes (VGDF). Responses were scored ordinally (0, 1, 2) according to exposure frequency. Factor analysis supported item reduction and category consolidation yielding 28 exposure items in 5 categories. Generalised linear models with a logit link tested associations with symptoms (by respiratory health questionnaire) adjusting for other covariates. OR were scaled per 20-point score increment (normalised maximum=100). RESULTS: The cohort mean age was 40.7 years with a median deployment duration of 11.7 months. Heavy exposures to multiple inhalational exposures were commonly reported, including burn pit smoke (72.7%) and VGDF (72.0%). The prevalence of dyspnoea, chronic bronchitis and wheeze in the past 12 months was 7.3%, 8.2% and 15.6%, respectively. Burn pit smoke exposure was associated with dyspnoea (OR 1.22; 95% CI 1.06 to 1.47) and chronic bronchitis (OR 1.22; 95% CI 1.13 to 1.44). Exposure to VGDF was associated with dyspnoea (OR 1.29; 95% CI 1.14 to 1.58) and wheeze (OR 1.18; 95% CI 1.02 to 1.35). CONCLUSION: Exposures to burn pit smoke and military occupational VGDF during deployment were associated with an increased odds of chronic respiratory symptoms among US Veterans.

Design and analysis of outcomes following SARS-CoV-2 infection in veterans.

BACKGROUND: Understanding how SARS-CoV-2 infection impacts long-term patient outcomes requires identification of comparable persons with and without infection. We report the design and implementation of a matching strategy employed by the Department of Veterans Affairs' (VA) COVID-19 Observational Research Collaboratory (CORC) to develop comparable cohorts of SARS-CoV-2 infected and uninfected persons for the purpose of inferring potential causative long-term adverse effects of SARS-CoV-2 infection in the Veteran population. METHODS: In a retrospective cohort study, we identified VA health care system patients who were and were not infected with SARS-CoV-2 on a rolling monthly basis. We generated matched cohorts within each month utilizing a combination of exact and time-varying propensity score matching based on electronic health record (EHR)-derived covariates that can be confounders or risk factors across a range of outcomes. RESULTS: From an initial pool of 126,689,864 person-months of observation, we generated final matched cohorts of 208,536 Veterans infected between March 2020-April 2021 and 3,014,091 uninfected Veterans. Matched cohorts were well-balanced on all 39 covariates used in matching after excluding patients for: no VA health care utilization; implausible age, weight, or height; living outside of the 50 states or Washington, D.C.; prior SARS-CoV-2 diagnosis per Medicare claims; or lack of a suitable match. Most Veterans in the matched cohort were male (88.3%), non-Hispanic (87.1%), white (67.2%), and living in urban areas (71.5%), with a mean age of 60.6, BMI of 31.3, Gagne comorbidity score of 1.4 and a mean of 2.3 CDC high-risk conditions. The most common diagnoses were hypertension (61.4%), diabetes (34.3%), major depression (32.2%), coronary heart disease (28.5%), PTSD (25.5%), anxiety (22.5%), and chronic kidney disease (22.5%). CONCLUSION: This successful creation of matched SARS-CoV-2 infected and uninfected patient cohorts from the largest integrated health system in the United States will support cohort studies of outcomes derived from EHRs and sample selection for qualitative interviews and patient surveys. These studies will increase our understanding of the long-term outcomes of Veterans who were infected with SARS-CoV-2.

Differences in Prosthetic Prescription Between Men and Women Veterans After Transtibial or Transfemoral Lower-Extremity Amputation: A Longitudinal Cohort Study (2005-2018).

OBJECTIVE: To evaluate whether prosthetic prescription differed by gender and the extent to which differences were mediated by measured factors. DESIGN: Retrospective longitudinal cohort study using data from Veterans Health Administration (VHA) administrative databases. SETTING: VHA patients throughout the United States. PARTICIPANTS: The sample included 20,889 men and 324 women who had an incident transtibial or transfemoral amputation between 2005 and 2018. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Time to prosthetic prescription (up to 1 year). We used parametric survival analysis (an accelerated failure time model) to assess gender differences. We estimated mediation effects of amputation level, pain comorbidity burden, medical comorbidities, depression, and marital status on time to prescription. RESULTS: In the 1 year after amputation, the proportion of women (54.3%) and men (55.7%) prescribed a prosthesis was similar. However, after we controlled for age, race, ethnicity, enrollment priority, VHA region, and service-connected disability, the time to prosthetic prescription was significantly faster among men compared with women (acceleration factor=0.73; 95% confidence interval, 0.61-0.87). The difference in time to prosthetic prescription between men and women was significantly mediated by amputation level (23%), pain comorbidity burden (-14%), and marital status (5%) but not medical comorbidities or depression. CONCLUSIONS: Although the proportion of patients with prosthetic prescription at 1-year postamputation was similar between men and women, women received prosthetic prescriptions more slowly than men, suggesting that more work is needed to understand barriers to timely prosthetic prescriptions among women, and how to intervene to reduce those barriers.

Voices of Women Veterans with Lower Limb Prostheses: a Qualitative Study.

BACKGROUND: Women Veterans with amputation are a group with unique needs whose numbers have grown over the last 5 years, accounting for nearly 3% of all Veterans with amputation in 2019. Although identified as a national priority by the Veterans Health Administration, the needs of this population have remained largely underrepresented in amputation research. OBJECTIVE: To describe the experiences of women Veterans with lower extremity amputation (LEA) related to prosthetic care provision and devices. DESIGN: National qualitative study using semi-structured individual interviews. PARTICIPANTS: Thirty women Veterans with LEA who had been prescribed a prosthesis at least 12 months prior. APPROACH: Inductive content analysis. KEY RESULTS: Four key themes emerged: (1) a sense of "feeling invisible" and lacking a connection with other women Veterans with amputation; (2) the desire for prosthetic devices that meet their biological and social needs; (3) the need for individualized assessment and a prosthetic limb prescription process that is tailored to women Veterans; the current process was often perceived as biased and either dismissive of women's concerns or failing to adequately solicit them; and (4) the desire for prosthetists who listen to and understand women's needs. CONCLUSIONS: Women Veterans with LEA articulated themes reminiscent of those previously reported by male Veterans with LEA, such as the importance of prostheses and the central role of the provider-patient relationship. However, they also articulated unique needs that could translate into specific strategies to improve prosthetic care, such as integrating formal opportunities for social support and peer interaction for women Veterans with LEA, advocating for administrative changes and research efforts to expand available prosthetic component options, and ensuring that clinical interactions are gender-sensitive and free of bias.

The Flares of Low back pain with Activity Research Study (FLAReS): study protocol for a case-crossover study nested within a cohort study.

BACKGROUND: Although it is generally accepted that physical activity and flares of low back pain (LBP) are related, evidence for the directionality of this association is mixed. The Flares of Low back pain with Activity Research Study (FLAReS) takes a novel approach to distinguish the short-term effects of specific physical activities on LBP flares from the cumulative effects of such activities, by conducting a longitudinal case-crossover study nested within a cohort study. The first aim is to estimate the short-term effects (≤ 24 h) of specific physical activities on LBP flares among Veterans in primary care in the Veterans Affairs healthcare system. The second aim is to estimate the cumulative effects of specific activities on LBP-related functional limitations at 1-year follow-up. METHODS: Up to 550 adults of working age (18-65 years) seen for LBP in primary care complete up to 36 "Scheduled" surveys over 1-year follow-up, and also complete unscheduled "Flare Window" surveys after the onset of new flares. Each survey asks about current flares and other factors associated with LBP. Surveys also inquire about activity exposures over the 24 h, and 2 h, prior to the time of survey completion (during non-flare periods) or prior to the time of flare onset (during flares). Other questions evaluate the number, intensity, duration, and/or other characteristics of activity exposures. Other exposures include factors related to mood, lifestyle, exercise, concurrent treatments, and injuries. Some participants wear actigraphy devices for weeks 1-4 of the study. The first aim will examine associations between 10 specific activity categories and participant-reported flares over 1-year follow-up. The second aim will examine associations between the frequency of exposure to 10 activity categories over weeks 1-4 of follow-up and long-term functional limitations at 12 months. All analyses will use a biopsychosocial framework accounting for potential confounders and effect modifiers. DISCUSSION: FLAReS will provide empirically derived estimates of both the short-term and cumulative effects of specific physical activities for Veterans with LBP, helping to better understand the role of physical activities in those with LBP. TRIAL REGISTRATION: ClinicalTrials.gov NCT04828330 , registered April 2, 2021.

Prevalence of Hepatitis B Virus Exposure in the Veterans Health Administration and Association With Military-Related Risk Factors.

BACKGROUND & AIMS: Military veterans have been reported to have higher odds of hepatitis B virus (HBV) exposure after adjustment for demographic factors, family income, and birthplace. It is not clear whether military-related exposures are associated with risk of HBV exposure in veterans. METHODS: A random sample of veterans receiving care from 1998 through 2000 in the national Veterans' Health Administration system completed a risk factor survey and underwent phlebotomy analysis (N = 1146). Stored serum samples were reanalyzed to determine prevalence of HBV exposure (core antibody positive), infection (surface antigen or DNA positive), and immunity (surface antibody positive, surface antigen negative, and core antibody negative). Associations between military-related risk factors and HBV exposure were assessed using logistic regression. RESULTS: The prevalence values for infection, exposure, and immunity were 0.7% (95% CI, 0.3-1.5), 13.6% (95% CI, 11.5-16.1), and 6.2% (95% CI, 4.7-8.2), respectively. Evidence of HBV exposure was highest among respondents with traditional risk factors (such as drug use or high-risk sexual practices). More than half the individuals with HBV exposure (53%) reported no history of traditional risk factors; of these, 59.5% reported a history of combat exposure. After adjustment for demographic and traditional risk factors, service in a combat zone (adjusted odds ratio, 1.56; 95% CI, 1.01-2.41) and being wounded in combat (adjusted odds ratio, 1.79; 95% CI, 1.04-3.08) were associated independently with exposure to HBV. CONCLUSIONS: In an analysis of US military veterans, we found the prevalence of exposure to HBV to be highest among veterans with traditional risk factors but also independently related to military combat or being wounded in combat. Studies are needed to determine whether veterans with combat exposure before the era of universal vaccination should be screened for HBV exposure.

Heritability and individuality of the plasma sodium concentration: a twin study in the United States veteran population.

Little is known about the population genetics of water balance. A recent meta-genome-wide association study on plasma sodium concentration identified novel loci of high biological plausibility, yet heritability of the phenotype has never been convincingly shown in European ancestry. The present study linked the Vietnam Era Twin Registry with the Department of Veterans Affairs VistA patient care clinical database. Participants (n = 2,370, 59.6% monozygotic twins and 40.4% dizygotic twins) had a median of seven (interquartile range: 3-14) plasma sodium determinations between October 1999 and March 2017. Heritability of the mean plasma sodium concentration among all twins was 0.41 (95% confidence interval: 0.35-0.46) and 0.49 (95% confidence interval: 0.43-0.54) after exclusion of 514 twins with only a single plasma sodium determination. Heritability among Caucasian (n = 1,958) and African-American (n = 268) twins was 0.41 (95% confidence interval: 0.34-0.47) and 0.36 (95% confidence interval: 0.17-0.52), respectively. Exclusion of data from twins who had been prescribed medications known to impact systemic water balance had no effect. The ability of the present study to newly detect substantial heritability across multiple racial groups was potentially a function of the cohort size and relatedness, exclusion of sodium determinations confounded by elevated plasma glucose and/or reduced glomerular filtration rate, transformation of plasma sodium for the independent osmotic effect of plasma glucose, and use of multiple laboratory determinations per individual over a period of years. Individual-level plasma sodium concentration exhibited longitudinal stability (i.e., individuality); the degree to which individual-level means differed from the population mean was substantial, irrespective of the number of determinations. In aggregate, these data establish the heritability of plasma sodium concentration in European ancestry and corroborate its individuality.

Psychometric Evaluation of Kingston Caregiver Stress Scale.

OBJECTIVES: Standardized measurement of caregiver stress is a component of Medicare's new health care benefit supporting care planning for people with dementia. In this article we identify existing measures of caregiver stress, strain and burden and propose specific criteria for choosing tools that may be suitable for wide use in primary care settings. We reviewed 22 measures and identified one, the Kingston Caregiver Stress Scale (KCSS), which met all the proposed criteria but had not been studied in a U.S. SAMPLE: We conducted a psychometric evaluation of KCSS to determine its potential usefulness as a care planning tool with a U.S. METHODS: We examined the internal consistency, test-retest reliability, component structure, and relationship to depression and anxiety in 227 dementia caregivers at two U.S. sites. RESULTS: The KCSS has high internal consistency and test-retest reliability, a strong factor structure, and moderate to high correlations with caregiver depression and anxiety. CONCLUSION: KCSS is a good candidate for use as part of comprehensive care planning for people with dementia and their caregivers. CLINICAL IMPLICATIONS: Routine assessment of caregiver stress in clinical care may facilitate timely intervention and potentially improve both patient and caregiver outcomes.

Predicting improvement of postorthodontic white spot lesions.

INTRODUCTION: Patients undergoing orthodontic treatment are at greater risk for developing white spot lesions (WSLs). Although prevention is always the goal, WSLs continue to be a common sequela. For this reason, understanding the patterns of WSL improvement, if any, has great importance. Previous studies have shown that some lesions exhibit significant improvement, whereas others have limited or no improvement. Our aim was to identify specific patient-related and tooth-related factors that are most predictive of improvement with treatment. METHODS: Patients aged 12 to 20 years with at least 1 WSL that developed during orthodontic treatment were recruited from private dental and orthodontic offices. They had their fixed appliances removed 2 months or less before enrollment. Photographs were taken at enrollment and 8 weeks later. Paired photographs of the maxillary incisors, taken at each time point, were blindly assessed for changes in surface area and appearance at the individual tooth level using visual inspection. RESULTS: One hundred one subjects were included in this study. Patient age, brushing frequency, and greater percentage of surface area affected were associated with increased improvement. Central incisors exhibited greater improvements than lateral incisors. Longer time since appliance removal and longer length of orthodontic treatment were associated with decreased levels of improvement. Sex, oral hygiene status, retainer type, location of the lesion (gingival, middle, incisal), staining, and lesion diffuseness were not found to be predictive of improvement. CONCLUSIONS: Of the various patient-related and tooth-related factors examined, age, time since appliance removal, length of orthodontic treatment, tooth type (central or lateral incisor), WSL surface area, and brushing frequency had significant associations with WSL improvement.

Measuring caregiver activation for health care: Validation of PBH-LCI:D.

Improving the quality of health care for individuals living with dementia is a central goal of the National Alzheimer's Plan, and requires the participation of informed family caregivers as active members of the patient's health care team. "Caregiver activation" is an emerging concept for which dementia-specific measures are lacking. We developed and validated a new self-report index of caregiver activation, Partnering for Better Health - Living with Chronic Illness: Dementia ( PBH-LCI: D). PBH-LCI: D has high content validity and good internal consistency and test-retest reliability, with 32 items and a strong six-factor structure reflecting all major health care domains of dementia caregiving. Comparisons with measures of related constructs and potential caregiver and patient predictors of activation indicate that PBH-LCI: D measures a unique construct and therefore should be useful as a marker of caregiver needs for education and behavioral change coaching, and as the foundation for developing interventions to enhance caregiver activation and successful partnership with clinicians.

Gender differences in prosthesis-related outcomes among veterans: Results of a national survey of U.S. veterans.

BACKGROUND: Women with lower extremity amputations (LEAs) tend to have poorer prosthesis-related outcomes than men, although the literature is sparse. To our knowledge, there are no prior studies examining prosthesis-related outcomes of women veterans with LEAs. OBJECTIVE: To examine gender differences (overall and by type of amputation) among veterans who underwent LEAs between 2005 and 2018, received care at the Veterans Health Administration (VHA) prior to undergoing amputation, and were prescribed a prosthesis. It was hypothesized that compared to men, women would report lower satisfaction with prosthetic services, poorer prosthesis fit, lower prosthesis satisfaction, less prosthesis use, and worse self-reported mobility. Furthermore, it was hypothesized that gender differences in outcomes would be more pronounced among individuals with transfemoral than among those with transtibial amputations. DESIGN: Cross-sectional survey. Linear regressions were used to assess overall gender differences in outcomes and gender differences based on type of amputation in a national sample of veterans. SETTING: VHA medical centers. PARTICIPANTS: The sample consisted of 449 veterans who self-identified their gender (women = 165, men = 284) with transtibial (n = 236), transfemoral (n = 135), and bilateral LEAs (n = 68) including all amputation etiologies. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The Orthotics and Prosthetics User's Survey, Trinity Amputation and Prosthesis Experiences Scale, and Prosthetic Limb Users Survey of Mobility-Short Form were used to assess satisfaction with prosthetic services, prosthesis fit, prosthesis satisfaction, prosthesis use, and self-reported mobility. RESULTS: Women had poorer self-reported mobility than men (d = -0.26, 95% confidence interval -0.49 to -0.02, p < .05); this difference was small. There were no statistically significant gender differences in satisfaction with prosthetic services, prosthesis fit, prosthesis satisfaction, daily hours of prosthesis use, or by amputation type. CONCLUSIONS: Contrary to the hypothesis, prosthesis-related outcomes were similar between men and women with LEAs. Minimal differences may in part be due to receiving care from the VHA's integrated Amputation System of Care.

Deployment-related Cigarette Smoking Behaviors and Pulmonary Function Among U.S. Veterans.

INTRODUCTION: The effects of smoking on lung function among post-9/11 Veterans deployed to environments with high levels of ambient particulate matter are incompletely understood. MATERIALS AND METHODS: We analyzed interim data (04/2018-03/2020) from the Veterans Affairs (VA) Cooperative Studies Program #595, "Service and Health Among Deployed Veterans". Veterans with ≥1 land-based deployments enrolled at 1 of 6 regional Veterans Affairs sites completed questionnaires and spirometry. Multivariable linear regression models assessed associations between cigarette smoking (cumulative, deployment-related and non-deployment-related) with pulmonary function. RESULTS: Among 1,836 participants (mean age 40.7 ± 9.6, 88.6% male), 44.8% (n = 822) were ever-smokers (mean age 39.5 ± 9.5; 91.2% male). Among ever-smokers, 86% (n = 710) initiated smoking before deployment, while 11% (n = 90) initiated smoking during deployment(s). Smoking intensity was 50% greater during deployment than other periods (0.75 versus 0.50 packs-per-day; P < .05), and those with multiple deployments (40.4%) were more likely to smoke during deployment relative to those with single deployments (82% versus 74%). Total cumulative pack-years (median [IQR] = 3.8 [1, 10]) was inversely associated with post-bronchodilator FEV1%-predicted (-0.82; [95% CI] = [-1.25, -0.50] %-predicted per 4 pack-years) and FEV1/FVC%-predicted (-0.54; [95% CI] = [-0.78, -0.43] %-predicted per 4 pack-years). Deployment-related pack-years demonstrated similar point estimates of associations with FEV1%-predicted (-0.61; [95% CI] = [-2.28, 1.09]) and FEV1/FVC%-predicted (-1.09; [95% CI] = [-2.52, 0.50]) as non-deployment-related pack-years (-0.83; [95% CI] = [-1.26, -0.50] for FEV1%-predicted; -0.52; [95% CI] = [-0.73, -0.36] for FEV1/FVC%-predicted). CONCLUSIONS: Although cumulative pack-years smoking was modest in this cohort, an inverse association with pulmonary function was detectable. Deployment-related pack-years had a similar association with pulmonary function compared to non-deployment-related pack-years.

Effectiveness of MI Paste Plus and PreviDent fluoride varnish for treatment of white spot lesions: a randomized controlled trial.

INTRODUCTION: White spot lesions are a common sequela of orthodontic therapy. In this parallel-group randomized trial, we assessed the effectiveness of 2 agents commonly used to ameliorate white spot lesions compared with a normal home-care regimen. METHODS: Patients aged 12 to 20 years were recruited from the offices of orthodontists and dentists who belonged to the Practice-based Research Collaborative in Evidence-based Dentistry network. The patients had their orthodontic appliances removed within the past 2 months and had at least 1 white spot lesion affecting their maxillary incisors. The subjects were randomized to 1 of 3 arms: (1) an 8-week regimen of MI Paste Plus (GC America, Alsip, Ill), (2) a single application of PreviDent fluoride varnish (Colgate Oral Pharmaceuticals, New York, NY), and (3) usual home care (control). Photographs were taken at enrollment and 8 weeks later. Two panels consisting of 5 dental professionals and 5 laypersons assessed the before-and-after pairs of photographs in a blinded fashion. Objective assessments and self-assessments were also performed. RESULTS: One hundred fifteen subjects completed the study; 34 were assigned to the MI Paste Plus group, 40 to the fluoride varnish group, and 41 to the control group. The mean improvements assessed by the professional panel were 21%, 29%, and 27% in the MI Paste Plus, fluoride varnish, and control groups, respectively.The results from the lay panel were 29%, 31%, and 25%, respectively. Objective improvements in the surface affected were 16%, 25%, and 17%, respectively; self-assessments of improvement were 37% in all 3 groups. No assessments indicated significant differences between subjects in the active arms compared with the control arm. CONCLUSIONS: MI Paste Plus and PreviDent fluoride varnish do not appear to be more effective than normal home care for improving the appearance of white spot lesions over an 8-week period.

SARS-CoV-2 infection is associated with higher odds of insulin treatment but not with hemoglobin A1c at 120 days in U.S. Veterans with new-onset diabetes.

Aims: To examine associations of SARS-CoV-2 infection/COVID-19 with insulin treatment in new-onset diabetes. Methods: We conducted a retrospective cohort study using Veterans Health Administration data (March 1, 2020-June 1, 2022). Individuals with ≥1 positive nasal swab for SARS-CoV-2 (n = 6,706) comprised the exposed group, and individuals with no positive swab and ≥1 laboratory test of any type (n = 20,518) the unexposed group. For exposed, the index date was the date of first positive swab, and for unexposed a random date during the month of the qualifying laboratory test. Among Veterans with new-onset diabetes after the index date, we modeled associations of SARS-CoV-2 with most recent A1c prior to insulin treatment or end of follow-up and receipt of >1 outpatient insulin prescription starting within 120 days. Results: SARS-CoV-2 was associated with a 40% higher odds of insulin treatment compared to no positive test (95%CI 1.2-1.8) but not with most recent A1c (ß 0.00, 95%CI -0.04-0.04). Among Veterans with SARS-CoV-2, ≥2 vaccine doses prior to the index date was marginally associated with lower odds of insulin treatment (OR 0.6, 95%CI 0.3-1.0). Conclusions: SARS-CoV-2 is associated with higher odds of insulin treatment but not with higher A1c. Vaccination may be protective.

Improving Power and Accuracy in Randomized Controlled Trials of Pain Treatments by Accounting for Concurrent Analgesic Use.

The 0 to 10 numeric rating scale of pain intensity is a standard outcome in randomized controlled trials (RCTs) of pain treatments. For individuals taking analgesics, there may be a disparity between "observed" pain intensity (pain intensity with concurrent analgesic use) and pain intensity without concurrent analgesic use (what the numeric rating scale would be had analgesics not been taken). Using a contemporary causal inference framework, we compare analytic methods that can potentially account for concurrent analgesic use, first in statistical simulations, and second in analyses of real (non-simulated) data from an RCT of lumbar epidural steroid injections. The default analytic method was ignoring analgesic use, which is the most common approach in pain RCTs. Compared to ignoring analgesic use and other analytic methods, simulations showed that a quantitative pain and analgesia composite outcome based on adding 1.5 points to pain intensity for those who were taking an analgesic (the QPAC1.5) optimized power and minimized bias. Analyses of real RCT data supported the results of the simulations, showing greater power with analysis of the QPAC1.5 as compared to ignoring analgesic use and most other methods examined. We propose alternative methods that should be considered in the analysis of pain RCTs. PERSPECTIVE: This article presents the conceptual framework behind a new quantitative pain and analgesia composite outcome, the QPAC1.5, and the results of statistical simulations and analyses of trial data supporting improvements in power and bias using the QPAC1.5. Methods of this type should be considered in the analysis of pain RCTs.

Combining Procedural and Behavioral Treatments for Chronic Low Back Pain: A Pilot Feasibility Randomized Controlled Trial.

Individual treatments for chronic low back pain (CLBP) have small magnitude effects. Combining different types of treatments may produce larger effects. This study used a 2×2 factorial randomized controlled trial (RCT) design to combine procedural and behavioral treatments for CLBP. The study aims were to: (1) assess feasibility of conducting a factorial RCT of these treatments; and (2) estimate individual and combined treatment effects of (a) lumbar radiofrequency ablation (LRFA) of the dorsal ramus medial branch nerves (vs. a simulated LRFA control procedure) and (b) Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program for CLBP (AcTIVE-CBT) (vs. an educational control treatment) on back-related disability at 3 months post-randomization. Participants (n=13) were randomized in a 1:1:1:1 ratio. Feasibility goals included an enrollment proportion ≥30%, a randomization proportion ≥80%, and a ≥80% proportion of randomized participants completing the 3-month Roland-Morris Disability Questionnaire (RMDQ) primary outcome endpoint. An intent-to-treat analysis was used. The enrollment proportion was 62%, the randomization proportion was 81%, and all randomized participants completed the primary outcome. Though not statistically significant, there was a beneficial, moderate-magnitude effect of LRFA vs. control on 3-month RMDQ (-3.25 RMDQ points; 95% CI: -10.18, 3.67). There was a significant, beneficial, large-magnitude effect of AcTIVECBT vs. control (-6.29, 95% CI: -10.97, -1.60). Though not statistically significant, there was a beneficial, large effect of LRFA+AcTIVE-CBT vs. control (-8.37; 95% CI: -21.47, 4.74). We conclude that it is feasible to conduct an RCT combining procedural and behavioral treatments for CLBP.

Evaluation of the Effectiveness of Remote Foot Temperature Monitoring for Prevention of Amputation in a Large Integrated Health Care System.

OBJECTIVE: We evaluated the effectiveness of remote foot temperature monitoring (RTM) in the Veterans Affairs health care system. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study that included 924 eligible patients enrolled in RTM between 2019 and 2021 who were matched up to 3:1 to 2,757 nonenrolled comparison patients. We used conditional Cox regression to estimate adjusted cause-specific hazard ratios (aHRs) and corresponding 95% CIs for lower-extremity amputation (LEA) as the primary outcome and all-cause hospitalization and death as secondary outcomes. RESULTS: RTM was not associated with LEA incidence (aHR 0.92, 95% CI 0.62-1.37) or all-cause hospitalization (aHR 0.97, 95% CI 0.82-1.14) but was inversely associated (reduced risk) with death (aHR 0.63, 95% CI 0.49-0.82). CONCLUSIONS: This study does not provide support that RTM reduces the risk of LEA or all-cause hospitalization in individuals with a history of diabetic foot ulcer. Randomized controlled trials can overcome important limitations.

Early Outcomes of SARS-CoV-2 Infection in a Multisite Prospective Cohort of Inpatient Veterans.

Background: Over 870 000 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections have occurred among Veterans Health Administration users, and 24 000 have resulted in death. We examined early outcomes of SARS-CoV-2 infection in hospitalized veterans. Methods: In an ongoing, prospective cohort study, we enrolled veterans age ≥18 tested for SARS-CoV-2 and hospitalized at 15 Department of Veterans Affairs medical centers between February 2021 and June 2022. We estimated adjusted odds ratios (aORs), adjusted incidence rate ratios (aIRRs), and adjusted hazard ratios (aHRs) for maximum illness severity within 30 days of study entry (defined using the 4-category VA Severity Index for coronavirus disease 2019 [COVID-19]), as well as length of hospitalization and rehospitalization within 60 days, in relationship with demographic characteristics, Charlson comorbidity index (CCI), COVID-19 vaccination, and calendar period of enrollment. Results: The 542 participants included 329 (61%) who completed a primary vaccine series (with or without booster; "vaccinated"), 292 (54%) enrolled as SARS-CoV-2-positive, and 503 (93%) men, with a mean age of 64.4 years. High CCI scores (≥5) occurred in 61 (44%) vaccinated and 29 (19%) unvaccinated SARS-CoV-2-positive participants. Severe illness or death occurred in 29 (21%; 6% died) vaccinated and 31 (20%; 2% died) unvaccinated SARS-CoV-2-positive participants. SARS-CoV-2-positive inpatients per unit increase in CCI had greater multivariable-adjusted odds of severe illness (aOR, 1.21; 95% CI, 1.01-1.45), more hospitalization days (aIRR, 1.06; 95% CI, 1.03-1.10), and rehospitalization (aHR, 1.07; 95% CI, 1.01-1.12). Conclusions: In a cohort of hospitalized US veterans with SARS-CoV-2 infection, those with a higher CCI had more severe COVID-19 illness, more hospital days, and rehospitalization, after adjusting for vaccination status, age, sex, and calendar period.

The Incidence of Diabetes Among 2,777,768 Veterans With and Without Recent SARS-CoV-2 Infection.

OBJECTIVE: To examine associations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 with incident diabetes. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study using Veterans Health Administration data. We defined all patients without preexisting diabetes with one or more nasal swabs positive for SARS-CoV-2 (1 March 2020-10 March 2021; n = 126,710) as exposed and those with no positive swab and one or more laboratory tests (1 March 2020-31 March 2021; n = 2,651,058) as unexposed. The index date for patients exposed was the date of first positive swab and for patients unexposed a random date during the month of the qualifying laboratory test. We fit sex-stratified logistic regression models examining associations of SARS-CoV-2 with incident diabetes within 120 days and all follow-up time through 1 June 2021. A subgroup analysis was performed among hospitalized subjects only to help equalize laboratory surveillance. RESULTS: SARS-CoV-2 was associated with higher risk of incident diabetes, compared with no positive tests, among men (120 days, odds ratio [OR] 2.56 [95% CI 2.32-2.83]; all time, 1.95 [1.80-2.12]) but not women (120 days, 1.21 [0.88-1.68]; all time, 1.04 [0.82-1.31]). Among hospitalized participants, SARS-CoV-2 was associated with higher risk of diabetes at 120 days and at the end of follow-up in men (OR 1.42 [95% CI 1.22-1.65] and 1.32 [1.16-1.50], respectively) but not women (0.72 [0.34-1.52] and 0.80 [0.44-1.45]). Sex ∗ SARS-CoV-2 interaction P values were all <0.1. CONCLUSIONS: SARS-CoV-2 is associated with higher risk of incident diabetes in men but not in women even after greater surveillance related to hospitalization is accounted for.