Notes

The effect of age for the heart rate variability associated with healthy topics.
s required, which should help practitioners when designing targeted training interventions for their reduction.
Jeon, W, Harrison, JM, Stanforth, PR, and Griffin, L. Bone mineral density differences across female Olympic lifters, power lifters, and soccer players. J Strength Cond Res 35(3) 638-643, 2021-Athletic training improves bone mineral density (BMD) through repeated mechanical loading. The location, intensity, and direction of applied mechanical pressure play an important role in determining BMD, making some sports more advantageous at improving BMD at specific regions. Thirty-seven (10 power lifters [PL], 8 Olympic lifters [OL], 8 soccer players [SP], and 11 recreationally active [RA]) women participated in a cross-sectional study. We measured lumbar spine (L1-L4), femoral neck, total-body BMD, and overall body composition (total fat mass, lean mass, percent body fat) with dual-energy x-ray absorptiometry. All athletic groups had greater total BMD than RA (p = 0.01 [PL]; p < 0.001 [OL]; p = 0.01 [SP]). Olympic lifters had the highest total BMD than all other athletic groups. Olympic lifters had the signifiat both the lumbar spine and femoral neck.
Daugherty, HJ, Weiss, LW, Paquette, MR, Powell, DW, and Allison, LE. Potential predictors of vertical jump performance Lower extremity dimensions and alignment, relative body fat, and kinetic variables. J Strength Cond Res 35(3) 616-625, 2021-The association of structural and kinetic variables with restricted vertical jump (RVJ) displacement without and with added mass was examined in 60 men and women. Added mass (weighted vest) simulated a 5% increase in body fat (BF%). Independent variables included BF%, thigh length, and static Q-angle (Q-angles), and while performing RVJ, different expressions of frontal-plane knee angle (FPKA), dynamic Q-angle (Q-angled), vertical ground reaction force (vGRF), concentric vertical impulse (Iz), concentric rate of force development (CRFD), and vertical power (Pz). Variables having significant (p ≤ 0.05) negative correlations with RVJ displacement included BF% (r = -0.76) and Q-angles (r = -0.55). Those having significant (p ≤ 0.05) positive correlations with RVJ displaceement (p = 1.00) for the simulated 5% increase in body fat. To maximize jumping performance, (a) high levels of body fat should be avoided, (b) peak and average Pz, vGRF, and Iz should be maximized through training, and (c) having a lower Q-angles is associated with better jumping ability.
The accuracy of any claim-based study is dependent on the quality of real-world coding of the condition of interest. This retrospective, administrative claims analysis presents a method for using a real-world data source to evaluate the accuracy of coding for nonunion of a fifth metatarsal fracture. Patients 21-80 years old with a diagnosis of a fifth metatarsal fracture between January 1, 2016, and October 31, 2016, and a nonunion of the fifth metatarsal fracture within the next 9 months were identified in the MarketScan Databases. Patient health care claims in the 12 months after the nonunion diagnosis were examined for health care encounters and pharmaceutical treatments considered indicative of treatment for nonunion, such as claims for bone growth stimulation or a second claim with a diagnosis of nonunion. Of the 230 patients who had at least one health care encounter attributable to a nonunion of the fifth metatarsal, 95.2% had at least one subsequent health care encounter confirming nonunion diagnosiion, such as claims for bone growth stimulation or a second claim with a diagnosis of nonunion. Of the 230 patients who had at least one health care encounter attributable to a nonunion of the fifth metatarsal, 95.2% had at least one subsequent health care encounter confirming nonunion diagnosis. The mean number of supporting health care claims was 5.8, and the mean time between nonunion and first confirmatory claim was 33 days. This analysis demonstrated a method for evaluating the quality of coding for a specific condition when a traditional medical chart comparison is not feasible.
The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This article outlines the design and methodology within the fifth metatarsal fracture study; similar approaches are taken in the second and third BONES Program studies, which examine nonunions of the tibia and scaphoid. The BONES Program is an external comparator design and incorporates several unique, fit-for-purpose components to strengthen the approach and allow it to be submitted to the US Food and Drug Administration (FDA) to be considered for a label expansion. BONES consisted of 2 cohorts (1) EXOGEN-treated patients recruited into a patient registry and (2) comparator patients from a large administrative health claims database. The study used International Classification of Diseases, Tenth Revision, nonunion diagnosis cod commercial product complaint system) were used on the registry side, alongside insurance claims data to source the external comparator cohort, to achieve broader understanding of factors predisposing patients to the development of nonunions. In step with the FDA's increasing acceptance of real-world evidence for use in regulatory decision making and coupled with the infeasibility of a randomized clinical trial in this setting, the innovative study design of the BONES Program allowed for both an evaluation of the effect of EXOGEN in mitigating nonunions in a real-world setting and an assessment of the patient experience with EXOGEN treatment.
The signing of the 21st Centuries Cures Act in 2016 was a confirmational step in a long journey toward an understood use and need for real-world evidence (RWE), even though the Food and Drug Administration (FDA) had the legislative authority to accept RWE since 1962 to demonstrate efficacy. The 21st Century Cures Act, as well as the subsequent FDA guidance published in 2017 and other supporting guidance, documents that since are opening the doors for the clinical and research community. BMS777607 They specifically allow for labeling changes and indication expansion based on RWE. The legislative discussion of efficacy requirements started in the late 1950s, when evidence of effectiveness was not required in the United States before the marketing of a drug or medical device, and calls for the real-world comparative effectiveness research were being made by Senator Estes Kefauver. When the thalidomide tragedy stuck, Congress and the Kennedy Administration rushed to pass a new law to require that drugs be "effective in use.
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