NAFLD and NASH are obesity-independent risk factors in COVID-19: Matched real-world results from the large PINC AI™ Healthcare Database.

BACKGROUND & AIMS: Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are potential risk factors for severe pneumonia and other infections. Available data on the role of NAFLD/NASH in worsening outcomes for COVID-19 are controversial and might be confounded by comorbidities. METHODS: We used the PINC AI™ Healthcare Data Special Release (PHD-SR) to identify patients with COVID-19 (ICD-10) at approximately 900 hospitals in the United States. We performed exact matching (age, gender, and ethnicity) for patients with or without NAFLD/NASH, adjusting for demographics (admission type, region) and comorbidities (e.g., obesity, diabetes) through inverse probability of treatment weighting and then analysed hospitalisation-related outcomes. RESULTS: Among 513 623 patients with SARS-CoV-2 (COVID-19), we identified 14 667 with NAFLD/NASH who could be matched to 14 667 controls. Mean age was 57.6 (±14.9) years, 50.8% were females and 43.7% were non-Hispanic whites. After matching, baseline characteristics (e.g., age, ethnicity, and gender) and comorbidities (e.g., hypertension, obesity, diabetes, and cardiovascular disease) were well balanced (standard difference (SD) <.10), except for cirrhosis and malignancies. Patients with COVID-19 and NAFLD/NASH had higher FIB-4 scores, a significantly longer hospital length of stay (LOS) and intensive care LOS than controls (9.4 vs. 8.3 days, and 10.4 vs. 9.3, respectively), even after adjusting for cirrhosis and malignancies. Patients with COVID-19 and NAFLD/NASH also had significantly higher risk of needing invasive mandatory ventilation (IMV) (odds ratio 1.0727; 95% CI 1.0095-1.1400). Other outcomes were similar in both groups. CONCLUSIONS: In this large real-world cohort of patients hospitalised for COVID-19 in the United States, NAFLD/NASH were obesity-independent risk factors for complicated disease courses.

Economic Evaluation of an Extended Telehealth Worksite Exercise Intervention to Reduce Lost Work Time from Low Back Pain in Career Firefighters.

Purpose Low back pain (LBP) is a leading cause of lost work time (LWT) in firefighters and is related to poor muscle endurance. Although exercise can improve muscle endurance, it must be continued to sustain benefits, and it is unknown if it can reduce LWT. This study conducted an economic evaluation of an extended worksite exercise intervention in career firefighters. Methods A randomized controlled trial allocated 264 firefighters to telehealth with remote instruction ("telehealth"), direct exercise supervision ("direct"), or brief education ("control"). The telehealth and direct groups performed worksite exercises twice weekly for 12 months. Outcomes included quality adjusted life years, LWT from LBP (24-h shifts), costs of LWT from LBP, and net monetary benefits. Results A total of 216 firefighters were included in the economic analysis (telehealth n = 71, direct n = 75, control n = 70). Sixteen experienced LWT from LBP (telehealth n = 4, direct n = 4, control n = 8). The mean number of 24-h shifts lost from LBP were 0.05 (telehealth), 0.28 (direct), and 0.43 (control). Mean study intervention costs per participant were $1984 (telehealth), $5269 (direct), and $384 (control). Net monetary benefit was $3573 for telehealth vs. direct, - $1113 for telehealth vs. control, and - $4686 for direct vs. control. Conclusions Worksite exercise reduced LWT from LBP in firefighters. Telehealth was less costly and more effective at reducing LWT from LBP than direct exercise supervision. If the costs of telehealth were further reduced, a positive net monetary benefit might also be achieved when compared to no intervention.Clinical trial registration: (clinicaltrials.gov): NCT02362243.

A systematic review comparing the costs of chiropractic care to other interventions for spine pain in the United States.

BACKGROUND: Although chiropractors in the United States (US) have long suggested that their approach to managing spine pain is less costly than other health care providers (HCPs), it is unclear if available evidence supports this premise. METHODS: A systematic review was conducted using a comprehensive search strategy to uncover studies that compared health care costs for patients with any type of spine pain who received chiropractic care or care from other HCPs. Only studies conducted in the US and published in English between 1993 and 2015 were included. Health care costs were summarized for studies examining: 1. private health plans, 2. workers' compensation (WC) plans, and 3. clinical outcomes. The quality of studies in the latter group was evaluated using a Consensus on Health Economic Criteria (CHEC) list. RESULTS: The search uncovered 1276 citations and 25 eligible studies, including 12 from private health plans, 6 from WC plans, and 7 that examined clinical outcomes. Chiropractic care was most commonly compared to care from a medical physician, with few details about the care received. Heterogeneity was noted among studies in patient selection, definition of spine pain, scope of costs compared, study duration, and methods to estimate costs. Overall, cost comparison studies from private health plans and WC plans reported that health care costs were lower with chiropractic care. In studies that also examined clinical outcomes, there were few differences in efficacy between groups, and health care costs were higher for those receiving chiropractic care. The effects of adjusting for differences in sociodemographic, clinical, or other factors between study groups were unclear. CONCLUSIONS: Although cost comparison studies suggest that health care costs were generally lower among patients whose spine pain was managed with chiropractic care, the studies reviewed had many methodological limitations. Better research is needed to determine if these differences in health care costs were attributable to the type of HCP managing their care.

Patterns of utilization of complementary and alternative medicine in 2 pediatric gastroenterology clinics.

OBJECTIVES: The aim of the present study was to assess the prevalence and patterns of complementary and alternative medicine (CAM) use among pediatric patients with gastrointestinal (GI) disorders at academic clinics in Canada. METHODS: The survey was carried out at 2 hospital-based gastroenterology clinics: the Stollery Children's Hospital in Edmonton and the Children's Hospital of Eastern Ontario (CHEO) in Ottawa. RESULTS: CAM use at the Stollery was 83% compared with 36% at CHEO (P < 0.001). The most common reason for not using CAM was lack of knowledge about it. Most respondents felt comfortable discussing CAM in their clinic and wanted more information on CAM. The most common CAM products being taken were multivitamins (91%), calcium (35%), vitamin C (32%), probiotics (14%), and fish oil/omega-3 fatty acids (13%). The most common CAM practices being used were massage (43%), chiropractic (27%), faith healing (25%), and relaxation (18%). Most respondents believed that CAM was helpful, and most of the 23 reported adverse effects were minor. Seven were reported as moderate, and 3 were reported as severe. Many (42%) patients used CAM at the same time as prescription medicines, and of these patients, concurrent use was discussed with their physician (76%) or pharmacist (52%). CONCLUSIONS: CAM use is high among pediatric patients with GI disorders and is much greater among those in Edmonton than in Ottawa. Most respondents reported their CAM use as helpful, with little or no associated harm. Many patients fail to disclose their concurrent use of CAM and conventional medicines to their doctors, increasing the likelihood of interactions.

Complementary and alternative medicine: A survey of its use in children with chronic respiratory illness.

BACKGROUND: The use of complementary and alternative medicine (CAM) has increased in recent years, with especially high prevalence in individuals with chronic illnesses. In the United States, the prevalence of CAM use in pediatric asthma patients is as high as 89%. OBJECTIVE: To investigate the epidemiology of pediatric CAM use in respiratory subspecialty clinics. METHODS: A survey was conducted at two hospital-based respiratory clinics in Edmonton (Alberta) and Ottawa (Ontario). Caregivers (most often parents) of children <18 years of age were asked questions regarding child and caregiver use of CAM, including products and practices used, beliefs about CAM, trust in information sources about CAM and characteristics of the respondents themselves. RESULTS: A total of 202 survey questionnaires were completed (151 from Edmonton and 51 from Ottawa). Pediatric CAM use in Edmonton was 68% compared with 45% in Ottawa, and was associated with caregiver CAM use, poorer health and health insurance coverage for CAM. The majority (67%) of children using CAM had taken prescription drugs concurrently and 58% of caregivers had discussed this with their doctor. DISCUSSION: Lifetime use of CAM at these pediatric clinics was higher than reported for children who do not have chronic diseases. CAM practices that are popular may be worthy of further research to evaluate their effectiveness and safety profile with regard to drug interactions. Health care providers should be encouraged to discuss CAM use at every visit, and explore their patient's health-related beliefs, behaviours and treatment preferences.

HISTORIQUE: L'utilisation de la médecine complémentaire et parallèle (MCP) a augmenté ces dernières années. Sa prévalence est particulièrement élevée chez les personnes atteintes d'une maladie chronique. Aux États-Unis, sa prévalence chez les patients asthmatiques d'âge pédiatrique atteint les 89 %. OBJECTIF: Examiner l'épidémiologie de l'utilisation de la MCP en pédiatrie dans des cliniques spécialisées en santé respiratoire. MÉTHODOLOGIE: Les chercheurs ont effectué un sondage dans deux cliniques de santé respiratoire en milieu hospitalier, à Edmonton (Alberta) et à Ottawa (Ontario). Les personnes qui s'occupaient d'enfants de 18 ans ou moins (en général, les parents) se sont fait poser des questions sur l'utilisation de la MCP par l'enfant et par elles, y compris les produits et pratiques utilisés, les croyances au sujet de la MCP, la confiance envers les sources d'information sur la MCP et leurs caractéristiques personnelles. RÉSULTATS: Au total, 202 sondages ont été remplis (151 à Edmonton et 51 à Ottawa). L'utilisation de la MCP en pédiatrie à Edmonton s'élevait à 68 %, et à 45 % à Ottawa. Elle s'associait à l'utilisation de MCP par la personne qui s'occupait de l'enfant, à une moins bonne santé et à une couverture d'assurance pour la MCP. La majorité des enfants (67 %) qui utilisaient la MCP prenaient simultanément des médicaments sur ordonnance, et 58 % des personnes qui s'occupaient d'eux en avaient parlé avec leur médecin. EXPOSÉ: À ces cliniques de pédiatrie, l'utilisation générale de MCP était plus élevée que celle déclarée chez les enfants qui n'ont pas de maladie chronique. Les pratiques de MCP qui sont populaires devraient peut-être faire l'objet de recherches supplémentaires pour en évaluer l'efficacité et le profil d'innocuité en matière d'interactions médicamenteuses. Il faut encourager les dispensateurs de soins à parler de MCP à chaque rendez-vous et à explorer les croyances de leurs patients liées à la santé, leurs comportements et leurs préférences thérapeutiques.

Proposing a framework to quantify the potential impact of pharmacokinetic drug-drug interactions caused by a new drug candidate by using real world data about the target patient population.

Drug development teams must evaluate the risk/benefit profile of new drug candidates that perpetrate drug-drug interactions (DDIs). Real-world data (RWD) can inform this decision. The purpose of this study was to develop a predicted impact score for DDIs perpetrated by three hypothetical drug candidates via CYP3A, CYP2D6, or CYP2C9 in type 2 diabetes mellitus (T2DM), obesity, or migraine. Optum Market Clarity was analyzed to estimate use of CYP3A, CYP2D6, or CYP2C9 substrates classified in the University of Washington Drug Interaction Database as moderate sensitive, sensitive, narrow therapeutic index, or QT prolongation. Scoring was based on prevalence of exposure to victim substrates and characteristics (age, polypharmacy, duration of exposure, and number of prescribers) of those exposed. The study population of 14,163,271 adults included 1,579,054 with T2DM, 3,117,753 with obesity, and 410,436 with migraine. For T2DM, 71.3% used CYP3A substrates, 44.3% used CYP2D6 substrates, and 44.3% used CYP2C9 substrates. For obesity, 57.1% used CYP3A substrates, 34.6% used CYP2D6 substrates, and 31.0% used CYP2C9 substrates. For migraine, 64.1% used CYP3A substrates, 44.0% used CYP2D6 substrates, and 28.9% used CYP2C9 substrates. In our analyses, the predicted DDI impact scores were highest for DDIs involving CYP3A, followed by CYP2D6, and CYP2C9 substrates, and highest for T2DM, followed by migraine, and obesity. Insights from RWD can be used to estimate a predicted DDI impact score for pharmacokinetic DDIs perpetrated by new drug candidates currently in development. This score can inform the risk/benefit profile of new drug candidates in a target patient population.

Risk of mortality in older adults with loss of appetite: An analysis of Medicare fee-for-service data.

OBJECTIVES: Prior research suggested that loss of appetite (LOA) among adults with Medicare fee-for-service (FFS) insurance in the United States increased the risk of mortality within 1 year; those findings were not adjusted for risk factors and confounders. The objective of this study was to compare the risk of mortality among Medicare FFS beneficiaries with LOA to a control group without LOA while controlling or adjusting for age, comorbidities, body mass index (BMI), and weight loss. DESIGN: Retrospective and observational analysis of Medicare FFS health insurance claims data from October 1, 2015 to December 31, 2021. SETTING: Claims from all settings (e.g., hospital inpatient/outpatient, office, assisted living facility, skilled nursing facility, hospice, rehabilitation facility, home) were included in these analyses. PARTICIPANTS: The LOA group included all individuals aged 65-115 years with continuous Medicare FFS medical coverage (Parts A and/or B) for at least 12 months before a claim with ICD-10 diagnosis code "R63.0 Anorexia". The control group was drawn from individuals aged 65-115 years with continuous Medicare FFS coverage who did not have a diagnosis of R63.0. Individuals with LOA were matched 1:3 to those in the control group based on age, sex, and race/ethnicity. MEASUREMENTS: Mortality in the LOA group was compared to mortality in the control group using Kaplan-Meier and Cox regression analyses and stratified or adjusted in terms of Charlson Comorbidity Index (CCI), claims-based frailty index (CFI), BMI, and weight loss. RESULTS: The study population of 1,707,031 individuals with LOA and 5,121,093 controls without LOA was 61.7% female and 82.2% White. More individuals with LOA compared with the control group had a CCI score 5+ (52.4% vs. 19.4%), CFI score 5+ (31.6% vs. 6.4%), and BMI < 20 kg/m2 (11.2% vs. 2.1%). Median follow-up was 12 months (individuals with LOA) and 49 months (control group). In a matched population, the risk of mortality was significantly higher (unadjusted hazard ratio 4.40, 95% confidence interval 4.39-4.42) for individuals with LOA than the control group. Median survival time was 4 months (individuals with LOA) and 26 months (control group); differences in survival time remained when stratifying by CCI, BMI, and weight loss. CONCLUSION: Individuals with LOA had a substantially increased risk of death even after matching for age, sex, race/ethnicity, and adjusting for comorbidities. These findings highlight the burden of illness in older adults with LOA and the need for therapies.

Advancing the utilization of real-world data and real-world evidence in clinical pharmacology and translational research-Proceedings from the ASCPT 2023 preconference workshop.

Real-world data (RWD) and real-world evidence (RWE) are now being routinely used in epidemiology, clinical practice, and post-approval regulatory decisions. Despite the increasing utility of the methodology and new regulatory guidelines in recent years, there remains a lack of awareness of how this approach can be applied in clinical pharmacology and translational research settings. Therefore, the American Society of Clinical Pharmacology & Therapeutics (ASCPT) held a workshop on March 21st, 2023 entitled "Advancing the Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) in Clinical Pharmacology and Translational Research." The work described herein is a summary of the workshop proceedings.

Clinical Pharmacology Applications of Real-World Data and Real-World Evidence in Drug Development and Approval-An Industry Perspective.

Since the 21st Century Cures Act was signed into law in 2016, real-world data (RWD) and real-world evidence (RWE) have attracted great interest from the healthcare ecosystem globally. The potential and capability of RWD/RWE to inform regulatory decisions and clinical drug development have been extensively reviewed and discussed in the literature. However, a comprehensive review of current applications of RWD/RWE in clinical pharmacology, particularly from an industry perspective, is needed to inspire new insights and identify potential future opportunities for clinical pharmacologists to utilize RWD/RWE to address key drug development questions. In this paper, we review the RWD/RWE applications relevant to clinical pharmacology based on recent publications from member companies in the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) RWD Working Group, and discuss the future direction of RWE utilization from a clinical pharmacology perspective. A comprehensive review of RWD/RWE use cases is provided and discussed in the following categories of application: drug-drug interaction assessments, dose recommendation for patients with organ impairment, pediatric plan development and study design, model-informed drug development (e.g., disease progression modeling), prognostic and predictive biomarkers/factors identification, regulatory decisions support (e.g., label expansion), and synthetic/external control generation for rare diseases. Additionally, we describe and discuss common sources of RWD to help guide appropriate data selection to address questions pertaining to clinical pharmacology in drug development and regulatory decision making.

Shared decision making through informed consent in chiropractic management of low back pain.

OBJECTIVE: The purpose of this study was to propose questions that may be helpful to educate patients considering treatment approaches to manage low back pain (LBP) and to determine if the information currently presented in informed consent (IC) documents at chiropractic colleges is sufficient to help a patient considering chiropractic management of LBP make a fully informed decision. METHODS: Questions to inform decision making for a patient contemplating any intervention for LBP were developed by the authors based on their clinical and research experience. Answers to the questions were suggested based on findings from recent clinical practice guidelines and systematic reviews. Institutions that are members of the Association of Chiropractic Colleges (ACC) were surveyed and asked to provide a copy of the IC documents currently used in their outpatient educational clinics. The IC documents were analyzed to determine if they stated (or implied) information that may be helpful in addressing each of the proposed questions. RESULTS: The list of 20 questions included 4 questions on each of the following 5 topics: condition, proposed treatment, potential benefits, potential harms, and possible alternatives. A total of 21 ACC institutions were contacted, of which 20 responded. The number of questions that could potentially be answered with information provided in the IC documents ranged from 2 to 13, with a mean of 6.5, including a mean of 3.6 stated answers and 2.9 implied answers. CONCLUSIONS: Some information to help patients consider chiropractic management of LBP is currently included in the IC documents used in clinics of ACC institutions. However, many of the questions that could help achieve shared decision making are not included. Modifying IC documents may help patients understand the nature, benefits, harms, costs, and alternatives to LBP care.

Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.

Interest in real-world data (RWD) and real-world evidence (RWE) to expedite and enrich the development of new biopharmaceutical products has proliferated in recent years, spurred by the 21st Century Cures Act in the United States and similar policy efforts in other countries, willingness by regulators to consider RWE in their decisions, demands from third-party payers, and growing concerns about the limitations of traditional clinical trials. Although much of the recent literature on RWE has focused on potential regulatory uses (e.g., product approvals in oncology or rare diseases based on single-arm trials with external control arms), this article reviews how biopharmaceutical companies can leverage RWE to inform internal decisions made throughout the product development process. Specifically, this article will review use of RWD to guide pipeline and portfolio strategy; use of novel sources of RWD to inform product development, use of RWD to inform clinical development, use of advanced analytics to harness "big" RWD, and considerations when using RWD to inform internal decisions. Topics discussed will include the use of molecular, clinicogenomic, medical imaging, radiomic, and patient-derived xenograft data to augment traditional sources of RWE, the use of RWD to inform clinical trial eligibility criteria, enrich trial population based on predicted response, select endpoints, estimate sample size, understand disease progression, and enhance diversity of participants, the growing use of data tokenization and advanced analytical techniques based on artificial intelligence in RWE, as well as the importance of data quality and methodological transparency in RWE.

Prevalence of nocturnal hypoglycemia in pediatric type 1 diabetes: a pilot study using continuous glucose monitoring.

OBJECTIVES: To determine the prevalence of nocturnal hypoglycemia (NH) in pediatric type 1 diabetes, to compare the prevalence of NH detected by continuous glucose monitoring (CGM) and self-monitored blood glucose (SMBG), and to compare the prevalence of NH using different thresholds. STUDY DESIGN: Twenty-five patients wore a continuous glucose monitor for 3 nights and also conducted SMBG. NH was defined with three thresholds: (1) <3.9 mmol/L; (2) <3.3 mmol/L; and (3) <2.9 mmol/L. RESULTS: The prevalence of NH with CGM was 68%, 52%, and 48% with the different thresholds. Of the 35 episodes of NH detected by CGM, 25 were not symptomatic and therefore not detected by SMBG. The mean difference in blood glucose between CGM and SMBG was -0.18 mmol/L (P = .35). CONCLUSIONS: This pilot study suggests that the prevalence of NH in pediatric patients with type 1 diabetes with conventional treatment may be as high as 68%, although this varied according to the method of detection and threshold used. Patients may benefit from CGM to detect asymptomatic NH.

Delay in operative stabilization of spine fractures in multitrauma patients without neurologic injuries: effects on outcomes.

BACKGROUND: Optimal timing for surgical stabilization of the fractured spine is controversial. Early stabilization facilitates mobilization and theoretically reduces associated complications. METHODS: We identified consecutive patients without neurologic injury requiring stabilization surgery for a spinal fracture at an academic tertiary-care hospital over a 12-year period. Incidences of postoperative complications were prospectively evaluated. We analyzed results based on the time elapsed before the final surgical stabilization procedure. Multivariate analyses were performed to explore the effects of potential confounders. RESULTS: A total of 83 patients (60 men, 23 women; mean age 39.4 yr) met the eligibility criteria and were enrolled. The mean Injury Severity Score (ISS) was 27.1 (range 12.0-57.0); 35% of patients had a cervical fracture and 65% had a thoraco-lumbar fracture. No statistically significant associations were uncovered between time to surgical stabilization and age, ISS or comorbidities. Comparing patients stabilized after 24 hours with those stabilized within 24 hours, there was an almost 8-fold greater risk of a complication related to prolonged recumbency (p = 0.007). We observed similar effects for other types of complications. Delays of more than 72 hours had a negative effect on complication rates; these effects remained significant after multivariate adjustments for age, comorbidity and ISS. CONCLUSION: This study demonstrates a strong relation between timing of surgical stabilization of spinal fractures in multitrauma patients without neurologic injuries and complications. Further studies with larger samples may allow for better adjustment of potentially confounding factors and identify subgroups in which this effect is most pronounced.

Biomechanical analysis of lateral pin placements for pediatric supracondylar humerus fractures.

AIM: Several clinical studies have shown that lateral pinning alone is of equal stability to crossed pins in the treatment of supracondylar fractures. The aim of this study was to compare the stability of parallel and varied divergent lateral pin configurations to provide an easily reproducible technique for optimal pin placement. METHODS: Twelve third-generation synthetic composite humeri were osteotomized at the level of the coronoid and olecranon fossae to simulate a humeral supracondylar fracture. Each fracture was reduced and fixed using two 1.6 mm (0.062 inches) Kirschner wires (1 fixed, 1 varied) in 4 different positions (from parallel to divergent with respect to fixed wire), and sequentially tested in extension, varus, and valgus as well as internal and external rotations using an MTS 858 Minibionix materials testing load frame (MTS Corporation, Eden Prairie, MN). A 2-way analysis of variance was carried out to compare construct stiffness in all 5 modes of testing according to both pin position and testing sequence. A level of P<0.05 was considered statistically significant. RESULTS: The best torsional, valgus, and extension resistances were found with position 4, which was the most divergent configuration. For both internal and external rotations, position 4 showed statistically higher stiffness as compared with all other configurations (P<0.05). In resistance to extension, both positions 3 and 4 were stiffer than either position 1 or 2 (P<0.05). For resistance in varus testing, position 3 showed statistically greater stiffness than all other pin positions (P<0.05). Although there was no statistical difference between all the 4 positions in valgus testing, position 4 showed greater resistance when compared with other positions. CONCLUSIONS: The lateral pin placed parallel to the metaphyseal flare of the lateral humeral cortex, in combination with a second diverging pin crossing the fracture site at the medial edge of the coronoid fossa (position 4), provided the optimum fixation for supracondylar fractures of the humerus. CLINICAL RELEVANCE: Using these readily available landmarks, the treating surgeon can reproducibly provide appropriate pinning treatment for most of these fractures.

Management of chronic low back pain in active individuals.

Chronic low back pain (LBP) is a common and potentially disabling condition in all adults, including those who are physically active. It currently is challenging for clinicians and patients to choose among the numerous treatment options. This review summarizes recommendations from recent clinical practice guidelines and systematic reviews about common primary care and secondary care approaches to the management of chronic LBP. The best available evidence currently suggests that in the absence of serious spinal pathology, nonspinal causes, or progressive or severe neurologic deficits, the management of chronic LBP should focus on patient education, self-care, common analgesics, and back exercises. Short-term pain relief may be obtained from spinal manipulative therapy or acupuncture. For patients with psychological comorbidities, adjunctive analgesics, behavioral therapy, or multidisciplinary rehabilitation also may be appropriate. Given the importance of active participation in recovery, patient preference should be sought to help select from among the recommended treatment options.

Comparison of Supervised and Telehealth Delivery of Worksite Exercise for Prevention of Low Back Pain in Firefighters: A Cluster Randomized Trial.

OBJECTIVE: This study assessed worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT) related to low back pain (LBP) in firefighters. METHODS: A cluster randomized controlled trial assigned 264 career firefighters to supervised (n = 86) or telehealth (n = 95) back and core exercises 2×/week for 12 months, or control (n = 83). RESULTS: 58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = 5, telehealth n = 5). Participants in the control group experienced 1.15 times as many hours of LWT as the supervised group, and 5.51 times as many hours of LWT as the telehealth group. CONCLUSIONS: Worksite exercise, delivered by on-site supervision or telehealth, can reduce LWT related to LBP in career firefighters.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain.

BACKGROUND CONTEXT: The North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low back pain. The guideline is intended to reflect contemporary treatment concepts for nonspecific low back pain as reflected in the highest quality clinical literature available on this subject as of February 2016. PURPOSE: The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with nonspecific low back pain. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. STUDY DESIGN: This is a guideline summary review. METHODS: This guideline is the product of the Low Back Pain Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guideline was submitted to an internal and external peer review process and ultimately approved by the NASS Board of Directors. RESULTS: Eighty-two clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. CONCLUSIONS: The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with nonspecific low back pain. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx.

Evaluation of ThinkFirst for kids injury prevention curriculum for grades 7/8.

BACKGROUND: Head injury causes substantial morbidity and mortality in children. The ThinkFirst For Kids (TFFK) program improves knowledge of safe behaviours in kindergarten to Grade 6 students. METHODS: This study evaluated the TFFK curriculum for grade 7/8 students. Knowledge acquisition was assessed quantitatively by an injury prevention test at baseline, at curriculum completion, and six weeks later. Participant experiences and behaviours were explored qualitatively by interviews and focus groups. RESULTS: Students (n=204) and teachers (n=6) from four schools participated in this study. Test scores improved from baseline (26.48+/-0.17, n=204), to completion (27.75+/-0.16, n=176), to six weeks post-completion (28.65+/-0.13, n=111) (p<0.05). Most students reported their decision-making and participation in risky behaviors was altered by the curriculum. INTERPRETATION: The TFFK curriculum may promote education about head injury prevention among Grade 7/8 students, with a suggestion of long-term knowledge retention. The curriculum was well-received and may be suitable to reduce risky behavior and injuries in children.