Search

Introduction: Physical therapy (PT) is recommended as a primary treatment for low back pain (LBP), a common and impactful musculoskeletal condition after limb loss. The purpose of this brief report is to report the duration and cost of PT care, and subsequent escalation of care events, for LBP in service members with and without limb loss., Materials and Methods: This was a retrospective cohort, descriptive study. Service members with and without limb loss (matched) who received PT for LBP at a military treatment facility from 2015 to 2017 were included. Duration of PT care, number of PT visits, and escalation of care events 1 year after PT were extracted from medical records. Escalation of care events was identified as epidural steroid injections, referrals to specialists (e.g., orthopedists, spine surgeons, and pain management), and LBP-related hospitalizations.LBP-related PT encounters were queried; duration of care, number of visits, and cost of care were quantified. Escalation of care events, including opioid prescription, epidural steroid injections, specialty referrals, and hospitalizations, were identified up to 1 year after PT care., Results: The average course of PT care for LBP was 12.9 more visits, 48.7 days longer, and $764.50 more expensive in service members with limb loss (n = 16) vs. those without limb loss (n = 48). Higher rates of opioid prescriptions and specialty referrals were observed in service members with limb loss., Conclusions: This study suggests that service members with limb loss and LBP received higher quantities and longer durations of PT than those without limb loss, yielding a nearly 4 times higher cost of PT., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2024. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Objective: The objective of this study was to examine the associations between active, passive, and manual therapy interventions with the escalation-of-care events following physical therapist care for veterans with low back pain (LBP)., Methods: A retrospective cohort study was conducted in 3618 veterans who received physical therapist care for LBP between January 1, 2015 and January 1, 2018. The Department of Veterans Affairs (VA) Corporate Data Warehouse was utilized to identify LBP-related physical therapist visits and procedures, as well as opioid prescription and non-physical therapy clinic encounters. The association between physical therapist interventions with 1-year escalation-of-care events were assessed using adjusted odds ratios from logistic regression., Results: Nearly all veterans (98%) received active interventions, but only a minority (31%) received manual therapy. In the 1-year follow-up period, the odds of receiving an opioid prescription were 30% lower for those who received manual therapy in addition to active interventions, as compared with patients who received only active interventions. Moreover, the odds of receiving primary care, specialty care, and diagnostic testing were 30% to 130% higher for patients who received electrical stimulation or more than 1 passive intervention in addition to active treatments, as compared with patients who received only active interventions., Conclusion: The use of manual therapy along with active interventions was associated with reduced prescription of opioids, while utilization of specific passive interventions such as electrical stimulation or multiple modalities in conjunction with active interventions resulted in increased escalation-of-care events., Impact: The use of active interventions, which is supported by most clinical practice guidelines, was the cornerstone of physical therapist care for veterans with LBP. However, the use of clinical practice guideline-recommended manual therapy interventions was low but associated with reduced opioid prescriptions. The use of 2 or more different passive interventions along with active interventions was common (34%) and associated with less-than-optimal escalation-of-care outcomes., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: A one-time gait speed measurement predicts mortality risk. A framework for updating a clinician's mortality risk perception with new information from each clinic visit is needed. We used joint modeling of longitudinal and survival data for dynamic prediction of mortality risk., Methods: We fit sex-stratified joint models to 20-meter (bi)annual longitudinal gait speed measured every 6 months and 14-year survival data from the Health, Aging and Body Composition Study allowing for non-linear fluctuations of gait speed and controlling for important covariates such as age, recent hospitalization, blood pressure, obesity, and comorbidities., Results: Participants (N = 3048) were 74 years old with gait speed 1.18 m/s. They were 42% Black, and 52% died over 14 years. Higher gait speed of 0.1 m/s was associated with 23% (95% confidence interval or CI = 20-25%) and 25% (CI = 21-28%) reductions in mortality risk in men and women; and a 0.05 m/s annualized slowing (slope) with 31% (CI = 13-51%) increase in men (all p < 0.05), with findings persisting after covariate adjustment. Distant gait speed history over a year prior contributed little for mortality risk prediction with mean change of only 1-2% in 5-year risk., Conclusion: The two most recent gait speeds appear sufficient to consider for mortality risk in the present initial analysis. More frequent gait speeds need to be considered in mortality risk prediction before definitive conclusions supporting real-world application., (Copyright © 2024 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Purpose: Primary care physicians (PCPs) often face a complex intersection of patient expectations, evidence, and policy that influences their care recommendations for acute low back pain (aLBP). The purpose of this study was to elucidate patterns of PCP orders for patients with aLBP, identify the most common patterns, and describe patient clinical and demographic characteristics associated with patterns of aLBP care., Methods: This prospective cohort study included 9574 aLBP patients presenting to 1 of 77 primary care practices in 4 geographic locations in the United States. We performed a cluster analysis of PCP orders extracted from electronic health records within the first 21 days of an initial visit for aLBP., Results: 1401 (15%) patients did not receive a PCP order related to back pain within the first 21 days of their initial visit. These patients predominantly had aLBP without leg pain, less back-related disability, and were at low-risk for persistent disability. Of the remaining 8146 patients, we found 4 distinct order patterns: combined nonpharmacologic and first-line medication (44%); second-line medication (39%); imaging (10%); and specialty referral (7%). Among all patients, 29% received solely 1 order from their PCP. PCPs more often combined different guideline concordant and discordant orders. Patients with higher self-reported disability and psychological distress were more likely to receive guideline discordant care., Conclusion: Guideline discordant orders such as steroids and NSAIDS are often combined with guideline recommended orders such as physical therapy. Further defining patient, clinician, and health care setting characteristics associated with discordant care would inform targeted efforts for deimplementation initiatives., Competing Interests: Conflict of interest: The authors have no conflicts of interest to declare., (© Copyright by the American Board of Family Medicine.)

Background: Few studies on care transitions following acute stroke have evaluated whether referral to community-based rehabilitation occurred as part of discharge planning. Our objectives were to describe the extent to which patients discharged home were referred to community-based rehabilitation and identify the patient, hospital, and community-level predictors of referral., Methods: We examined data from 40 North Carolina hospitals that participated in the COMPASS (Comprehensive Post-Acute Stroke Services) cluster-randomized trial. Participants included adults discharged home following stroke or transient ischemic attack (N=10  702). In this observational analysis, COMPASS data were supplemented with hospital-level and county-level data from various sources. The primary outcome was referral to community-based rehabilitation (physical, occupational, or speech therapy) at discharge. Predictor variables included patient (demographic, stroke-related, medical history), hospital (structure, process), and community (therapist supply) measures. We used generalized linear mixed models with a hospital random effect and hierarchical backward model selection procedures to identify predictors of therapy referral., Results: Approximately, one-third (36%) of stroke survivors (mean age, 66.8 [SD, 14.0] years; 49% female, 72% White race) were referred to community-based rehabilitation. Rates of referral to physical, occupational, and speech therapists were 31%, 18%, and 10%, respectively. Referral rates by hospital ranged from 3% to 78% with a median of 35%. Patient-level predictors included higher stroke severity, presence of medical comorbidities, and older age. Female sex (odds ratio, 1.24 [95% CI, 1.12-1.38]), non-White race (2.20 [2.01-2.44]), and having Medicare insurance (1.12 [1.02-1.23]) were also predictors of referral. Referral was higher for patients living in counties with greater physical therapist supply. Much of the variation in referral across hospitals remained unexplained., Conclusions: One-third of stroke survivors were referred to community-based rehabilitation. Patient-level factors predominated as predictors. Variation across hospitals was notable and presents an opportunity for further evaluation and possible targets for improved poststroke rehabilitative care., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664., Competing Interests: Disclosures Drs Duncan and Bushnell report ownership interest in Care Directions Inc. Dr Duncan is a research advisor for BQ Technologies. The other authors report no conflicts.

Objectives: This study aimed to test the effect of a 30-minute nap versus a 2-hour nap opportunity taken during a simulated night shift on performance, fatigue, sleepiness, mood, and sleep at the end of shift and during post-night shift recovery., Methods: We conducted a randomized crossover trial of three nap conditions (30-minute, 2-hour, and no-nap) during 12-hour simulated night shifts. We tested for differences in performance, fatigue, sleepiness, mood, and sleep during in-lab and at-home recovery. Performance was measured with the Brief Psychomotor Vigilance Test (PVT-B). Subjective ratings were assessed with single-item surveys., Results: Twenty-eight individuals consented to participate [mean age 24.4 (standard deviation 7.2) years; 53.6% female; 85.7% Emergency Medical Services clinicians]. PVT-B false starts at the end of the 12-hour night shift (at 07:00 hours) and at the start of in-lab recovery (08:00 hours) were lower following the 2-hour nap versus other conditions (P<0.05). PVT-B response time at +0 minutes post-recovery nap was poorer compared to pre-recovery nap for the no-nap condition (P=0.003), yet not detected for other nap conditions (P>0.05). Sleepiness, fatigue, and some mood states were lower at most hourly assessments during the in-lab recovery period following the 2-hour nap condition compared to the other conditions. Sleep during recovery did not differ by duration of night shift nap., Conclusions: A 2-hour nap opportunity versus a 30-minute or no-nap opportunity is beneficial for performance, alertness, and mood post-night shift. No differences were detected in sleep during recovery.

Background: Previously, we identified a population of older adults with chronic low back pain, hip pain, and hip muscle weakness who had worse 12-month low back pain and functional outcomes than age-matched adults with only low back pain, indicating an increased risk for future mobility decline. We sought to determine whether tailored, hip-focused physical therapy reduced pain and functional limitations in this high-risk population compared with non-tailored, spine-focused physical therapy., Methods: We did a multicentre, single-masked, randomised controlled trial at three research-based sites in the USA. We recruited older adults (aged 60-85 years) with hip pain and weakness who reported moderate low back pain intensity at least half the days in the last 6 months. Patients were randomly assigned to hip-focused physical therapy or spine-focused physical therapy using permuted blocks with random block size, stratified by site and sex (ie, male or female). The primary outcomes were self-reported disability using the Quebec Back Pain Disability Scale (QBPDS) and performance-based 10-Meter Walk Test (10MWT) at 8 weeks. All analyses were done in the intention-to-treat population. Adverse events were collected by study staff via a possible adverse event reporting form and then adjudicated by site investigators. This trial was registered with ClinicalTrials.gov, NCT04009837., Findings: Between Nov 1, 2019, and April 30, 2022, 184 participants were randomly assigned to receive hip-focused (n=91) or spine-focused physical therapy (n=93) interventions. The mean age was 70·7 (SD 6·2) years. 121 (66%) of 184 participants were women, 63 (34%) were men, and 149 (81%) were White. At 8 weeks, the mean between-group difference on the QBPDS was 4·0 (95% CI 0·5 to 7·5), favouring hip-focused physical therapy. Both groups had similar, clinically meaningful gait speed improvements (10MWT) at 8 weeks (mean difference 0·004 m/s [95% CI -0·044 to 0·052]). No serious adverse events were related to study participation., Interpretation: Tailored hip-focused physical therapy demonstrated greater improvements in low back pain-related disability at 8 weeks. However, both hip-focused physical therapy and spine-focused physical therapy produced clinically meaningful improvements in disability and function for this high-risk population at 6 months. These findings warrant further investigation before clinical implementation., Funding: US National Institute on Aging of the National Institutes of Health., Competing Interests: Declaration of interest GEH, SZG, JMP, JMS, SP, CBS, JK, and CGP report grants from the US National Institute of Health. CGP also reports grants from the US Department of Defense and the Patient Centered Outcomes Research Institute. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: An attenuated heart rate response to exercise, termed chronotropic incompetence, has been reported in Parkinson's disease (PD). Chronotropic incompetence may be a marker of autonomic dysfunction and a cause of exercise intolerance in early stages of PD., Objective: To investigate the relationship between chronotropic incompetence, orthostatic blood pressure change (supine - standing), and exercise performance (maximal oxygen consumption, VO2peak) in individuals with early PD within 5 years of diagnosis not on dopaminergic medications., Methods: We performed secondary analyses of heart rate and blood pressure data from the Study in Parkinson's Disease of Exercise (SPARX)., Results: 128 individuals were enrolled into SPARX (63.7±9.3 years; 57.0% male, 0.4 years since diagnosis [median]). 103 individuals were not taking chronotropic medications, of which 90 had a normal maximal heart rate response to exercise testing (155.3±14.0 bpm; PDnon-chrono) and 13 showed evidence of chronotropic incompetence (121.3±11.3 bpm; PDchrono, p < 0.05). PDchrono had decreased VO2peak compared to PDnon-chrono (19.7±4.5 mL/kg/min and 24.3±5.8 mL/kg/min, respectively, p = 0.027). There was a positive correlation between peak heart rate during exercise and the change in systolic blood pressure from supine to standing (r = 0.365, p < 0.001)., Conclusions: A subgroup of individuals with early PD not on dopaminergic medication had chronotropic incompetence and decreased VO2peak, which may be related to autonomic dysfunction. Evaluation of both heart rate responses to incremental exercise and orthostatic vital signs may serve as biomarkers of early autonomic impairment and guide treatment. Further studies should investigate whether cardiovascular autonomic dysfunction affects the ability to exercise and whether exercise training improves autonomic dysfunction.

Introduction: Children with unilateral cerebral palsy (UCP) have difficulty in bimanual coordination that restricts the child's independence in daily activities. Although several efficacious interventions to improve bimanual coordination exist, these interventions often require higher training doses and have modest effect sizes. Thus, there is a critical need to find an effective priming agent that, when paired with task-specific training, will facilitate neurobiological processes to enhance the magnitude of training effects and subsequently improve functional capabilities of children with UCP. The aim of this study is to determine the effects of a novel priming agent, remote ischaemic conditioning (RIC), combined with bimanual training on bimanual skill learning and corticospinal excitability in children with UCP., Methods and Analyses: 46 children, aged 8-16 years, will be randomly assigned to receive RIC or sham conditioning combined with 5 days of bimanual skill (cup stacking) training (15 trials per session). RIC or sham conditioning will be performed with a standard conditioning protocol of five cycles of alternative inflation and deflation of a pressure cuff on the affected arm with the pressure of at least 20 mm Hg above systolic blood pressure for RIC and 25 mm Hg for sham conditioning. Primary outcomes will be movement time and corticospinal excitability measures determined with a single-pulse transcranial magnetic stimulation (TMS). Secondary outcomes include Assisting Hand Assessment, spatio-temporal kinematic variables and paired pulse TMS measures. All measures will be conducted before and immediately after the intervention. A mixed model analysis of variance will test the group×time interaction for all outcomes with group (RIC and sham) as between-subject and time (preintervention, postintervention) as within-subject factors., Ethics and Dissemination: The study has been approved by the University Medical Centre Institutional Review Board (UMCIRB #21-001913). We will disseminate the study findings via peer-reviewed publications and presentations at professional conferences., Trial Registration Number: NCT05777070., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The purpose of this study was to quantify characteristics of bimanual movement intensity during 30 h of hand-arm bimanual intensive therapy (HABIT) and bimanual performance (activities and participation) in real-world settings using accelerometers in children with unilateral cerebral palsy (UCP). Twenty-five children with UCP participated in a 30 h HABIT program. Data were collected from bilateral wrist-worn accelerometers during 30 h of HABIT to quantify the movement intensity and three days pre- and post-HABIT to assess real-world performance gains. Movement intensity and performance gains were measured using six standard accelerometer-derived variables. Bimanual capacity (body function and activities) was assessed using standardized hand function tests. We found that accelerometer variables increased significantly during HABIT, indicating increased bimanual symmetry and intensity. Post-HABIT, children demonstrated significant improvements in all accelerometer metrics, reflecting real-world performance gains. Children also achieved significant and clinically relevant changes in hand capacity following HABIT. Therefore, our findings suggest that accelerometers can objectively quantify bimanual movement intensity during HABIT. Moreover, HABIT enhances hand function as well as activities and participation in real-world situations in children with UCP.

As a member of the Back Pain Consortium (BACPAC), the University of Pittsburgh Mechanistic Research Center's research goal is to phenotype chronic low back pain using biological, biomechanical, and behavioral domains using a prospective, observational cohort study. Data will be collected from 1,000 participants with chronic low back pain according to BACPAC-wide harmonized and study-specific protocols. Participation lasts 12 months with one required in person baseline visit, an optional second in person visit for advanced biomechanical assessment, and electronic follow ups at months 1, 2, 3, 4, 5, 6, 9, and 12 to assess low back pain status and response to prescribed treatments. Behavioral data analysis includes a battery of patient-reported outcomes, social determinants of health, quantitative sensory testing, and physical activity. Biological data analysis includes omics generated from blood, saliva, and spine tissue. Biomechanical data analysis includes a physical examination, lumbopelvic kinematics, and intervertebral kinematics. The statistical analysis includes traditional unsupervised machine learning approaches to categorize participants into groups and determine the variables that differentiate patients. Additional analysis includes the creation of a series of decision rules based on baseline measures and treatment pathways as inputs to predict clinical outcomes. The characteristics identified will contribute to future studies to assist clinicians in designing a personalized, optimal treatment approach for each patient., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.)

Objective: One aim of the Back Pain Consortium (BACPAC) Research Program is to develop an integrated model of chronic low back pain that is informed by combined data from translational research and clinical trials. We describe efforts to maximize data harmonization and accessibility to facilitate Consortium-wide analyses., Methods: Consortium-wide working groups established harmonized data elements to be collected in all studies and developed standards for tabular and nontabular data (eg, imaging and omics). The BACPAC Data Portal was developed to facilitate research collaboration across the Consortium., Results: Clinical experts developed the BACPAC Minimum Dataset with required domains and outcome measures to be collected by use of questionnaires across projects. Other nonrequired domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed on the basis of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model to harmonize data structures and facilitate integration of baseline characteristics, participant-reported outcomes, chronic low back pain treatments, clinical exam, functional performance, psychosocial characteristics, quantitative sensory testing, imaging, and biomechanical data. Standards to accommodate the unique features of chronic low back pain data were adopted. Research units submit standardized study data to the BACPAC Data Portal, developed as a secure cloud-based central data repository and computing infrastructure for researchers to access and conduct analyses on data collected by or acquired for BACPAC., Conclusions: BACPAC harmonization efforts and data standards serve as an innovative model for data integration that could be used as a framework for other consortia with multiple, decentralized research programs., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.)

Background: Mild traumatic brain injury (mTBI) affects ~18,000 military personnel each year, and although most will recover in 3-4 weeks, many experience persisting symptoms and impairment lasting months or longer. Current standard of care for U.S. military personnel with complex mTBI involves initial (<48 h) prescribed rest, followed by behavioral (e.g., physical activity, sleep regulation, stress reduction, hydration, nutrition), and symptom-guided management. There is growing agreement that mTBI involves different clinical profiles or subtypes that require a comprehensive multidomain evaluation and adjudication process, as well as a targeted approach to treatment. However, there is a lack of research examining the effectiveness of this approach to assessing and treating mTBI. This multisite randomized controlled trial (RCT) will determine the effectiveness of a targeted multidomain (T-MD) intervention (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI., Methods: This study employs a single-blinded, two-group repeated measures design. The RCT will enroll up to 250 military-aged civilians (18-49 yrs) with a diagnosed complex mTBI within 8 days to 6 months of injury from two concussion specialty clinics. The two study arms are a T-MD intervention and a usual care, behavioral management control group. All participants will complete a comprehensive, multidomain clinical evaluation at their first clinical visit. Information gathered from this evaluation will be used to adjudicate mTBI clinical profiles. Participants will then be randomized to either the 4-week T-MD or control arm. The T-MD group will receive targeted interventions that correspond to the patient's clinical profile (s) and the control group will receive behavioral management strategies. Primary outcomes for this study are changes from enrollment to post-intervention on the Neurobehavioral Symptom Inventory (NSI), Patient Global Impression of Change (PGIC), and functional near-infrared spectroscopy (fNIRS). Time to return to activity (RTA), and healthcare utilization costs will also be assessed., Discussion: Study findings may inform a more effective approach to treat complex mTBI in military personnel and civilians, reduce morbidity, and accelerate safe return-to-duty/activity., Ethics and Dissemination: The study is approved by the University of Pittsburgh Institutional Review board and registered at clinicaltrials.gov. Dissemination plans include peer-reviewed publications and presentations at professional meetings., Clinical Trial Registration: www.clinicaltrials.gov, identifier: NCT04549532., Competing Interests: AK and MC receive funding for research through the University of Pittsburgh from the National Football League and royalties from APA Books. MC was a co-developer and shareholder for ImPACT applications (ended December 2019). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Elbin, Trbovich, Womble, Mucha, Fedor, Stephenson, Holland, Dollar, Sparto, Durfee, Patterson, Smith, Huppert, Okonkwo, Collins and Kontos.)

Objective: We assessed whether race or ethnicity was associated with the incidence of high-impact chronic low back pain (cLBP) among adults consulting a primary care provider for acute low back pain (aLBP)., Methods: In this secondary analysis of a prospective cohort study, patients with aLBP were identified through screening at seventy-seven primary care practices from four geographic regions. Incidence of high-impact cLBP was defined as the subset of patients with cLBP and at least moderate disability on Oswestry Disability Index [ODI >30]) at 6 months. General linear mixed models provided adjusted estimates of association between race/ethnicity and high-impact cLBP., Results: We identified 9,088 patients with aLBP (81.3% White; 14.3% Black; 4.4% Hispanic). Black/Hispanic patients compared to White patients, were younger and more likely to be female, obese, have Medicaid insurance, worse disability on ODI, and were at higher risk of persistent disability on STarT Back Tool (all P < .0001). At 6 months, more Black and Hispanic patients reported high-impact cLBP (30% and 25%, respectively) compared to White patients (15%, P < .0001, n = 5,035). After adjusting for measured differences in socioeconomic and back-related risk factors, compared to White patients, the increased odds of high-impact cLBP remained statistically significant for Black but not Hispanic patients (adjusted odds ration [aOR] = 1.40, 95% confidence interval [CI]: 1.05-1.87 and aOR = 1.25, 95%CI: 0.83-1.90, respectively)., Conclusions: We observed an increased incidence of high-impact cLBP among Black and Hispanic patients compared to White patients. This disparity was partly explained by racial/ethnic differences in socioeconomic and back-related risk factors. Interventions that target these factors to reduce pain-related disparities should be evaluated., Clinicaltrials.gov Identifier: NCT02647658., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Deep brain stimulation (DBS) of the subthalamic nucleus (STN), which consistently improves limb motor functions, shows mixed effects on speech functions in Parkinson's disease (PD). One possible explanation for this discrepancy is that STN neurons may differentially encode speech and limb movement. However, this hypothesis has not yet been tested. We examined how STN is modulated by limb movement and speech by recording 69 single- and multi-unit neuronal clusters in 12 intraoperative PD patients. Our findings indicated: (1) diverse patterns of modulation in neuronal firing rates in STN for speech and limb movement; (2) a higher number of STN neurons were modulated by speech vs. limb movement; (3) an overall increase in neuronal firing rates for speech vs. limb movement; and (4) participants with longer disease duration had higher firing rates. These data provide new insights into the role of STN neurons in speech and limb movement., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Johari, Kelley, Tjaden, Patterson, Rohl, Berger, Corcos and Greenlee.)

Background: Greater than half of emergency medical services (EMS) clinician shift workers report poor sleep, fatigue, and inadequate recovery between shifts. We hypothesized that EMS clinicians randomized to receive tailored sleep health education would have improved sleep quality and less fatigue compared to wait-list controls after 3 months., Methods: We used a cluster-randomized, 2-arm, wait-list control study design (clinicaltrials.gov identifier: NCT04218279). Recruitment of EMS agencies (clusters) was nationwide. Our study was powered at 88% to detect a 0.4 standard deviation difference in sleep quality with 20 agencies per arm and a minimum of 10 individuals per agency. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up. Our intervention was accessible in an online, asynchronous format and comprised of 10 brief education modules that address fatigue mitigation topics prescribed by the American College of Occupational Environmental Medicine., Results: In total, 36 EMS agencies and 678 individuals enrolled. Attrition at 3 months did not differ by study group (Intervention = 17.4% vs. Wait-list control = 18.2%; p = .37). Intention-to-treat analyses detected no differences in PSQI and fatigue scores at 3 months. Per protocol analyses showed the greater the number of education modules viewed, the greater the improvement in sleep quality and the greater the reduction in fatigue (p < .05)., Conclusions: While intention-to-treat analyses revealed no differences in sleep quality or fatigue at 3 months, per protocol findings identified select groups of EMS clinician shift workers who may benefit from sleep health education. Our findings may inform fatigue risk management programs., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Blunting of the sleep-related dip in blood pressure (BP) has been linked to numerous cardiovascular outcomes including myocardial infarction. Blunting of BP dipping occurs during night shift work and previous research suggest that a 60-min or longer on-shift nap is needed to restore normal/healthy BP dipping. We sought to determine the effect of different durations of napping on BP during and following simulated night shifts. We hypothesized that the greatest benefit in terms of restoration of normal BP dipping during night shift work would be observed during a longer duration nap versus a shorter nap opportunity., Methods: We used a randomized crossover laboratory-based study design. Participants consented to complete three separate 72-hr conditions that included a 12-hr simulated night shift. Nap conditions included a 30-min and 2-hr nap compared to a no-nap condition. Ambulatory BP monitoring was assessed hourly and every 10-30 mins during in-lab naps. Blunted BP dipping during in-lab naps was the primary outcome. Goal enrollment of 25 (35 with attrition) provided 80% power to detect a mean difference of 5 mmHg in BP between nap conditions., Results: Of the 58 screened, 28 were consented, and 26 completed all three 72-hr conditions. More than half (53.6%) were female. Mean age was 24.4 years (SD7.2). Most (85.7%) were certified as emergency medical technicians or paramedics. The mean percentage dip in systolic BP (SBP) and diastolic BP (DBP) did not differ between the 30-min and 2-hr nap conditions ( p  > 0.05), yet a greater proportion of participants experienced a 10-20% dip in SBP or DBP during the 2-hr nap versus the 30-min nap ( p  < 0.05). For every additional minute of total sleep during the 30-min nap, the percentage of SBP dip improved by 0.60%, and the percentage of DBP dip improved by 0.68% ( p < 0.05). These improvements approximate to a 6% per minute relative advancement toward normal/healthy BP dipping., Conclusions: Restoration of a normal/healthy dip in BP is achievable during short and long duration nap opportunities during simulated night shift work. Our findings support the hypothesis that BP dipping is more common during longer 2-hr versus shorter 30-min naps., Trial Registration: ClinicalTrials.gov, NCT04469803. Registered on 9 July 2020.

Abstract: Treatment effect modifiers identify patient characteristics associated with treatment responses. The purpose of this secondary analysis was to identify potential treatment effect modifiers for disability from the TARGET trial that compared usual care (control) with usual care + psychologically informed physical therapy (PIPT). The sample consisted of a STarT Back tool identified high-risk patients with acute low back pain that completed Oswestry Disability Index (ODI) data at index visit and 6 months later (n = 1250). Candidate treatment effect modifiers were identified a priori and informed by the literature. Linear mixed models tested for treatment effect modification through tests of statistical interaction. All statistical interactions ( P ≤ 0.20) were stratified by modifier to inspect for specific effects ( P ≤ 0.05). Smoking was identified as a potential effect modifier (treatment * smoking interaction, P = 0.08). In participants who were smokers, the effect of PIPT was (ODI = 5.5; 95% CI: 0.6-10.4; P = 0.03) compared with usual care. In participants who were nonsmokers, the effect of PIPT was (ODI = 1.5; 95% CI: -1.4 to 4.4; P = 0.31) compared with usual care. Pain medication was also identified as a potential effect modifier (treatment × pain medication interaction, P = 0.10). In participants prescribed ≥3 pain medications, the effect of PIPT was (ODI = 7.1; 95% CI: -0.1 to 14.2; P = 0.05) compared with usual care. The PIPT effect for participants prescribed no pain medication was (ODI = 3.5; 95% CI: -0.4 to 7.4; P = 0.08) and for participants prescribed 1 to 2 pain medications was (ODI = 0.6; 95% CI: -2.5 to 3.7; P = 0.70) when compared with usual care. These findings may be used for generating hypotheses and planning future clinical trials investigating the effectiveness of tailored application of PIPT., (Copyright © 2022 International Association for the Study of Pain.)

Objective: We sought to test the effects of different duration naps on post-nap cognitive performance during simulated night shifts., Methods: We used a randomized laboratory-based crossover trial design with simulated 12-hr night shifts and each participant completing three conditions of 72 hrs each (Clinicaltrials.gov; registration # NCT04469803). The three conditions tested included no-nap, a 30-min nap opportunity, and a 2-hr nap opportunity. Naps occurred at 02:00 hrs. Cognitive performance was assessed with the Brief 3-min Psychomotor Vigilance Test (PVT-B). Four PVT-B measures include: reaction time (RT in milliseconds (ms)), lapses (RT > 355 ms), false starts (reactions before stimulus or RT <100 ms), and speed (1,000/RT). The PVT-B was performed at the start of the simulated night shift (19:00), end of shift (07:00), pre-nap (02:00), and at 0 mins, 10 mins, 20 mins, and 30 mins following the 30-min and 2-hr nap conditions. Simultaneously, participants reported subjective ratings of fatigue and other constructs., Results: Twenty-eight (15 female), mostly certified emergency medical technicians or paramedics, consented to participate. For all three conditions, looking within condition, PVT-B lapse performance at the end of the 12-hr simulated night shift (at 07:00) was poorer compared to shift start ( p  < 0.05). Performance on PVT-B speed, RT, and false starts were poorer at shift end than shift start for the no-nap and 30-min nap conditions ( p  < 0.05), but not for the 2-hr nap condition ( p  > 0.05). Compared to pre-nap measures, performance on the PVT-B assessed at 0 mins post-nap showed significant performance declines for lapses and speed for both the 30-min and 2-hr nap conditions ( p  < 0.05), but not at 10, 20, or 30 mins post-nap. After waking from the 2-hr on-shift nap opportunity (at 0 mins), participants rated sleepiness, difficulty with concentration, and alertness poorer than pre-nap ( p  < 0.05). Participants in the 30-min nap condition rated alertness poorer immediately after the nap (at 0 mins) compared to pre-nap ( p  < 0.05)., Conclusions: While sleep inertia was detectable immediately following short 30-min and long 2-hr nap opportunities during simulated night shift work, deficits in cognitive performance and subjective ratings quickly dissipated and were not detectable at 10-30 mins post-nap.

Background: Nearly 2 million youth seek acute medical care following concussion in the U.S. each year. Current standard of care recommends rest for the first 48 h after a concussion. However, research suggests that prolonged rest may lengthen recovery time especially for patients with certain risk profiles. Research indicates that physical activity and behavioral management interventions (sleep, stress management) may enhance recovery. To date, there is limited empirical evidence to inform acute (<72 h) concussion recommendations for physical activity and behavioral management in adolescents., Objective: To determine the effectiveness of physical activity and behavioral management for acute concussion in adolescents and young adults, and to evaluate the role of patient characteristics on treatment response., Methods: This multicenter prospective randomized controlled trial will determine which combination of physical activity and behavioral management is most effective for patients 11-24 years old who present to the emergency department or concussion clinic within 72 h of injury. Participants are randomized into: 1) rest, 2) physical activity, 3) mobile health application (mHealth) behavioral management, or 4) physical activity and mHealth app conditions. Assessments at enrollment, 3-5 days, 14 days, 1 month, and 2 months include: concussion symptoms, balance, vestibular-ocular and cognitive assessments, quality of life, and recovery time. Somatic symptoms and other risk factors are evaluated at enrollment. Compliance with treatment and symptoms are assessed daily using actigraph and daily self-report. The primary study outcome is symptoms at 14 days., Conclusion: Prescribed physical activity and behavioral management may improve outcomes in youth following acute concussion., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Asthma is a prevalent chronic disease that is difficult to manage and associated with marked disparities in outcomes. One promising approach to addressing disparities is shared decision making (SDM), a method by which the patient and provider cooperatively make a decision about asthma care. SDM is associated with improved outcomes for patients; however, time constraints and staff availability are noted implementation barriers. Use of health information technology (IT) solutions may facilitate the utilization of SDM. Coach McLungs SM is a collaborative web-based application that involves pediatric patients, their caregivers, and providers in a personalized experience while gathering patient-reported data. Background logic provides decision support so both audiences can develop a well-informed treatment plan together. The goal of this study is to evaluate the implementation of the Coach McLungs SM intervention into primary care., Methods: Implementation will be evaluated using a stepped wedge randomized control study design at 21 pediatric and family medicine practices within a large, integrated, nonprofit healthcare system. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes. We will use a generalized linear mixed models with logit link to test the hypothesis for the reduction in exacerbation rates specifying the fixed effects of intervention and time and random effects for practice and practice*time. This design achieves 84% power to detect the hypothesized effect size difference of 10% in overall exacerbation between control (40%) and intervention (30%) periods (two-sided, p = 0.05). Implementation will be guided using the Expert Recommendations for Implementing Change (ERIC), a compilation of implementation strategies, and evaluated using the CFIR (Consolidated Framework for Implementation Research) and RE-AIM (Reach Effectiveness, Adoption, Implementation, Maintenance)., Discussion: We anticipate that a tailored implementation of Coach McLungs SM across diverse primary care practices will lead to a decrease in emergency department visits, hospitalizations, and oral steroid use for patients in the intervention group as compared to the control condition., Trial Registration: Clincaltrials.gov, NCT05059210. Registered 28 September 2021, https://www., Clinicaltrials: gov/ct2/show/NCT05059210., (© 2022. The Author(s).)

Introduction: Increased screening efforts and the development of effective antiviral treatments have led to marked improvement in Hepatitis C (HCV) patient outcomes. However, many people in the US are believed to have undiagnosed HCV. Successful screening strategies and access to a coordinated system of care are critical for HCV affected adults. The objective of this study was to evaluate a primary care HCV screening education intervention that took place 2018 to 2019 to improve primary care training and management of patients after the implementation of the electronic medical record (EMR) screening alert., Methods: Using 15 primary care practices located in vicinity of neighborhoods at-risk for higher rates of HCV infections, a stepped wedge randomized control study design was utilized to deliver an educational screening intervention. The education intervention was implemented sequentially with 5 practices being presented to every 3 months. Number of patients within the Baby Boomer cohort (birth years 1945-1965) were collected 3 months before the first practice receiving the intervention to 3 months after the last practice receiving the education intervention. The main outcome collected was the HCV screening. Generalized linear mixed models were used to test the hypothesis of improved screening rates after intervention implementation., Results: There were a total of 85,697 patients within the Baby Boomer cohort seen at the 15 practices. Practices receiving the intervention had patients who were more likely to be screened for HCV ( β = 0.259, P < .001 ; Odds Ratio [OR] [95%CI] 1.296 [1.098-1.529]).In terms of demographics, results showed that females are less likely to be screened than males ( β = -0.141, P < .001 ; OR [95%CI] 0.868[0.813 to 0.927]), Baby Boomer patients aged less than 65 were more likely to be screened than Baby Boomer patients aged 65 and older ( β = 0.293, P < .001 ; OR [95%CI] 1.340[1.251 to 1.436])., Discussion: This study looked at screening rates before and after an educational intervention which happened subsequent to the activation of an EMR alert. Whereas HCV EMR alerts showed an increase in HCV screenings before the education intervention, the addition of the education showed a modest increase in HCV screening rates for Baby Boomer patients., Competing Interests: Conflict of interest: None., (© Copyright by the American Board of Family Medicine.)

Background: To date, no medication has slowed the progression of Parkinson's disease (PD). Preclinical, epidemiological, and experimental data on humans all support many benefits of endurance exercise among persons with PD. The key question is whether there is a definitive additional benefit of exercising at high intensity, in terms of slowing disease progression, beyond the well-documented benefit of endurance training on a treadmill for fitness, gait, and functional mobility. This study will determine the efficacy of high-intensity endurance exercise as first-line therapy for persons diagnosed with PD within 3 years, and untreated with symptomatic therapy at baseline., Methods: This is a multicenter, randomized, evaluator-blinded study of endurance exercise training. The exercise intervention will be delivered by treadmill at 2 doses over 18 months: moderate intensity (4 days/week for 30 min per session at 60-65% maximum heart rate) and high intensity (4 days/week for 30 min per session at 80-85% maximum heart rate). We will randomize 370 participants and follow them at multiple time points for 24 months. The primary outcome is the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor score (Part III) with the primary analysis assessing the change in MDS-UPDRS motor score (Part III) over 12 months, or until initiation of symptomatic antiparkinsonian treatment if before 12 months. Secondary outcomes are striatal dopamine transporter binding, 6-min walk distance, number of daily steps, cognitive function, physical fitness, quality of life, time to initiate dopaminergic medication, circulating levels of C-reactive protein (CRP), and brain-derived neurotrophic factor (BDNF). Tertiary outcomes are walking stride length and turning velocity., Discussion: SPARX3 is a Phase 3 clinical trial designed to determine the efficacy of high-intensity, endurance treadmill exercise to slow the progression of PD as measured by the MDS-UPDRS motor score. Establishing whether high-intensity endurance treadmill exercise can slow the progression of PD would mark a significant breakthrough in treating PD. It would have a meaningful impact on the quality of life of people with PD, their caregivers and public health., Trial Registration: ClinicalTrials.gov NCT04284436 . Registered on February 25, 2020., (© 2022. The Author(s).)

Purpose: Individual-randomized trials are the gold standard for testing the efficacy and effectiveness of drugs, devices, and behavioral interventions. Health care delivery, educational, and programmatic interventions are often complex, involving multiple levels of change and measurement precluding individual randomization for testing. Cluster-randomized trials and cluster-randomized stepped-wedge trials are alternatives where the intervention is allocated at the group level, such as a clinic or a school, and the outcomes are measured at the person level. These designs are introduced along with the statistical implications of similarities among individuals within the same cluster. We also illustrate the parameters that have the most impact on the likelihood of detecting intervention effects, which must be considered when planning these trials., Conclusion: Cluster-randomized and stepped-wedge designs should be considered by researchers as experimental alternatives to individual-randomized trials when testing speech, language, and hearing care interventions in real-world settings.

Context and Purpose: There is an urgent need to develop vitamin D dietary recommendations for dark-skinned populations resident at high latitude. Using data from randomised controlled trials (RCTs) with vitamin D 3 -supplements/fortified foods, we undertook an individual participant data-level meta-regression (IPD) analysis of the response of wintertime serum 25-hydroxyvitamin (25(OH)D) to total vitamin D intake among dark-skinned children and adults residing at ≥ 40° N and derived dietary requirement values for vitamin D., Methods: IPD analysis using data from 677 dark-skinned participants (of Black or South Asian descent; ages 5-86 years) in 10 RCTs with vitamin D supplements/fortified foods identified via a systematic review and predefined eligibility criteria. Outcome measures were vitamin D intake estimates across a range of 25(OH)D thresholds., Results: To maintain serum 25(OH)D concentrations ≥ 25 and 30 nmol/L in 97.5% of individuals, 23.9 and 27.3 µg/day of vitamin D, respectively, were required among South Asian and 24.1 and 33.2 µg/day, respectively, among Black participants. Overall, our age-stratified intake estimates did not exceed age-specific Tolerable Upper Intake Levels for vitamin D. The vitamin D intake required by dark-skinned individuals to maintain 97.5% of winter 25(OH)D concentrations ≥ 50 nmol/L was 66.8 µg/day. This intake predicted that the upper 2.5% of individuals could potentially achieve serum 25(OH)D concentrations ≥ 158 nmol/L, which has been linked to potential adverse effects in older adults in supplementation studies., Conclusions: Our IPD-derived vitamin D intakes required to maintain 97.5% of winter 25(OH)D concentrations ≥ 25, 30 and 50 nmol/L are substantially higher than the equivalent estimates for White individuals. These requirement estimates are also higher than those currently recommended internationally by several agencies, which are based predominantly on data from Whites and derived from standard meta-regression based on aggregate data. Much more work is needed in dark-skinned populations both in the dose-response relationship and risk characterisation for health outcomes., Trail Registration: PROSPERO International Prospective Register of Systematic Reviews (Registration Number: CRD42018097260)., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Objective: Chronic low back pain (CLBP) is a disabling and costly condition for older adults that is difficult to properly classify and treat. In a cohort study, a subgroup of older adults with CLBP who had elevated hip pain and hip muscle weakness was identified; this subgroup differentiated itself by being at higher risk for future mobility decline. The primary purpose of this clinical trial is to evaluate whether a hip-focused low back pain (LBP) treatment provides better disability and physical performance outcomes for this at-risk group compared with a spine-focused LBP treatment., Methods: This study is a multisite, single-blinded, randomized controlled, parallel arm, Phase II trial conducted across 3 clinical research sites. A total of 180 people aged between 60 and 85 years with CLBP and hip pain are being recruited. Participants undergo a comprehensive baseline assessment and are randomized into 1 of 2 intervention arms: hip-focused or spine-focused. They are treated twice weekly by a licensed physical therapist for 8 weeks and undergo follow-up assessments at 8 weeks and 6 months after randomization. Primary outcome measures include the Quebec Low Back Disability Scale and the 10-Meter Walk Test, which are measures of self-report and performance-based physical function, respectively., Impact: This multicenter, randomized clinical trial will determine whether a hip-focused or spine-focused physical therapist intervention results in improved disability and physical performance for a subgroup of older adults with CLBP and hip pain who are at increased risk of mobility decline. This trial will help further the development of effective interventions for this subgroup of older adults with CLBP., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)