Prior authorization delays biologic initiation and is associated with a risk of asthma exacerbations.

Background: Biologics are effective treatments for patients with severe allergic disease. Impacts of delays in the prior authorization process on clinical outcomes has not been studied. Objective: The objective was to quantify the times for approval and filling of biologics, and whether patients were at risk of exacerbations during this time frame. Methods: The times for insurance approval and pharmacy filling of biologics (omalizumab, benralizumab, mepolizumab, dupilumab) in 80 subjects with severe asthma (n = 60) or urticaria (n = 20) from our clinic were reviewed. We compared the impact of clinical features, insurance, specialty pharmacy on fill times, and quantified exacerbations and prednisone use while awaiting biologic initiation. Results: The mean ± standard deviation (SD) time (days) from submission of a prescription to the first dose available for injection was 44.0 ± 23.2 days. This was composed of the mean ± SD time for insurance approval (21.5 ± 19.6 days) and the mean ± SD time for a specialty pharmacy to fill the medication (22.8 ± 14.1 days). There was no significant difference between the times for diagnosis (asthma versus urticaria), specific biologic, or insurance. The "buy and bill" system was faster than filling via a specialty pharmacy (mean ± SD, 7.3 ± 8.5 days versus 23.3 ± 21.3 days, respectively, p < 0.001). Clinical features of patients with fast versus slow approval times was not significantly different. The subjects with asthma were at high risk of exacerbations and need for prednisone while awaiting initiation of the biologics; 28 of 59 patients (47%) required prednisone, with an mean cumulative dose of 483.2 ± 273.7 mg per person. Conclusion: The prior authorization process for biologics was slow, and the subjects were at high risk of exacerbations during this time. The system needs to be improved to expedite approval and initiation of these medications.

Use of a new model allowing controlled uniaxial loading to evaluate tendon healing in a bone tunnel.

The optimal mechanical loading regimen for the healing of a tendon graft in a bone tunnel is unknown. We developed a rat model that directly tensions a healing tendon graft, without the use of confounding joint motion. Fifty cycles of either 0, 3, or 6 N of tension were applied to groups daily for 3 or 6 weeks. At 3 weeks the low load (3 N) group had the highest failure load (p = 0.009), but by 6 weeks there were no differences in failure load among groups. At 3 weeks the high load (6 N) group had greater osteoclast activity compared to the immobilized (0 N) group (p < 0.05), and by 6 weeks there were significantly more osteoclasts in the high load group compared to the low load group (p = 0.01). Bone volume fraction was higher in the immobilized group compared to the 3 N load group at 3 weeks (p = 0.014) and 6 weeks (p = 0.007). At 6 weeks, the immobilized group had greater trabecular number compared to both loading groups (p < 0.05). In conclusion, low magnitude loading had a beneficial early effect but continued loading led to poorer new bone formation over time and no beneficial effect at 6 weeks, perhaps due to delayed maturation from cumulative loads. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:852-859, 2016.

Locking and Non-locking Constructs Achieve Similar Radiographic and Clinical Outcomes for Internal Fixation of Intra-articular Distal Humerus Fractures.

BACKGROUND: Locking plates have been used increasingly for the management of distal humerus fractures. Studies that compare patient-centered outcomes between locking and non-locking fixation for distal humerus fractures are lacking. QUESTIONS/PURPOSES: The purposes of this study were to (1) determine whether locking plates offered superior fixation compared with non-locking plates for distal humerus fractures, (2) determine whether the use of locking plates was associated with fewer complications, and (3) determine whether locking plate use resulted in superior radiographic outcome compared with non-locking plates. Lastly, another aim was to determine the average cost difference associated with locking plate use versus non-locking plate use for distal humerus fracture fixation. PATIENTS AND METHOD: Demographic, clinical, and radiographic data including loss of fixation, range of motion, rate of infection, nonunion and reoperation, as well as measures of fixation were collected retrospectively and compared on 96 patients with surgically treated AO type 13C distal humerus fractures (65 locking, 31 non-locking) at 6-week and 6-month follow-up. Average costs of locking and non-locking constructs were calculated and compared. RESULTS: Three in 96 (3.1%) of all cases experienced loss of fixation, with no difference between the two groups. There was no difference between locking and non-locking groups with regard to the rate of nonunion, infection, and reoperation at 6 weeks and 6 months. On average, locking plate constructs were 348% more expensive than non-locking constructs. CONCLUSION: While there are some significant differences in radiographic parameters and cost between locking and non-locking constructs for internal fixation of intra-articular distal humerus fractures, there were no statistically significant differences in clinical outcome.

A comparison of the lenke and king classification systems in the surgical treatment of idiopathic thoracic scoliosis.

STUDY DESIGN: Retrospective case control study. OBJECTIVE: To evaluate the use of the Lenke and King classification systems in the surgical treatment of main thoracic adolescent idiopathic scoliosis (AIS), with a specific focus on radiographic and patient reported outcomes. SUMMARY OF BACKGROUND DATA: There is considerable debate as to whether King or Lenke classification best fulfills the criteria for a useful classification to determine distal fusion level, i.e., is mentally descriptive of the curve being treated, uses reproducible information to provide guidance in determining distal fusion level, is prognostic of patient reported and radiographic outcomes, and has good user reproducibility. METHODS: Patients operated for AIS between 1986 and 2002 with posterior spinal fusion and dual rod posterior instrumentation were retrospectively classified according to the Lenke and King classification systems. Only patients with Lenke type I curves and minimum 2-year follow-up were included. Preoperative and most recent postoperative radiographs were reviewed. The Lenke and King recommended distal fusion levels were calculated for each patient according to criteria obtained from the literature, and were compared to our actual fusion level. Patients were divided into groups based on our actual distal fusion level (i.e., longer, shorter, or in agreement with Lenke and King). The radiographic parameters and SRS 24 outcomes of patients within each group were compared. RESULTS: Seventy-five patients with Lenke type 1 AIS were included in the study. The distribution of King curve types were: 31 King II curves, 34 King III curves, 9 King IV curves, and 1 double major curve. Our actual distal fusion level was in agreement with the calculated Lenke recommendation in 49% and the King recommendation in 51% of the cases. Difficulties in using the Lenke classification system were identified in up to 59% of the study patients. There were no statistically significant objectives or patient reported (SRS) differences between the groups fused in agreement, longer, or shorter than the calculated Lenke or King recommendations. CONCLUSION: At intermediate follow-up, there does not seem to be significant radiographic or patient reported differences whether fusion levels are in agreement, longer, or shorter than those recommended by the Lenke or King classification systems.