A systematic review and meta-analysis of complications in conversion arthroplasty methods for failed intertrochanteric fracture fixation.

BACKGROUND: Conversion arthroplasty for failed primary fixation of intertrochanteric fractures can be achieved using various methods, including cemented total hip arthroplasty, uncemented total hip arthroplasty, hybrid total hip arthroplasty, and hemiarthroplasty. Complication rates vary between each conversion method. The purpose of this paper is to examine the effect of conversion method on total conversion complication rates. METHODS: We performed a meta-analysis of five studies with sufficient data for analysis. We created a null hypothesis stating that the expected distribution of complications across conversion methods would reflect the distribution of conversion method used for failed primary fixation. Using a z test, we compared proportions of the expected distribution of complications to the observed distribution of complications. RESULTS: A total of 138 cases of conversion arthroplasty with 49 complications were available for analysis. The mean age was 73 (range, 32-96) years. 19 males and 48 females were included, with one study not including patient gender. The mean time from primary fixation failure to conversion was 11 months, and the mean duration of conversion surgery was 132 min. Expected and observed complication rate distributions were as follows: cemented total hip arthroplasty, 6.5% versus 4.1% (p = 0.79); uncemented total hip arthroplasty, 77.5% versus 81.6% (p = 0.69); hybrid total hip arthroplasty, 2.9% versus 2.0% (p = 1); and hemiarthroplasty, 13% versus 12.2% (p = 1). CONCLUSIONS: Our findings suggest that the method of conversion arthroplasty following failed primary intertrochanteric femur fracture fixation does not influence complication rate.

Correlation of Appointment Times and Subspecialty With the No-Show Rates in an Orthopedic Ambulatory Clinic.

EXECUTIVE SUMMARY: Unexpectedly missed appointments ("no-shows") cause clinic inefficiency, lost time and revenue, wasted healthcare resources, and provider dissatisfaction. No-shows can be associated with miscommunication, transportation difficulties, employment status, age, race, and socioeconomic status. This study investigates the association between no-show rates and patient, appointment time, and provider characteristics. Data for all scheduled appointments in a single orthopedic multispecialty institution during calendar year 2016 were obtained. Data points included patient age, gender, and race; hour; month; and subspecialty. Chi-square testing was used to compare no-show and kept appointments with respect to patient and appointment characteristics. Logistic regression was used to calculate differences in no-show rates between orthopedic subspecialties. The overall no-show rate was 11.5%. Race, age, and subspecialties were all found to be associated with higher no-show rates. No significant differences were observed for gender, appointment time, or month of appointment. The authors suggest that patients at higher risk of not showing up for scheduled appointments may need extra effort from providers to accommodate the patients' schedules when making appointments, to confirm their appointments a few days before, and/or to incentivize patients to minimize no-shows.

How Would MRI-targeted Prostate Biopsy Alter Radiation Therapy Approaches in Treating Prostate Cancer?

OBJECTIVE: To determine if magnetic resonance imaging (MRI)/ultrasound fusion-targeted prostate biopsy (TB) would lead to increased recommendations of aggressive radiotherapy treatments for higher risk prostate cancer compared to systematic biopsy (SB) results. METHODS: Clinicopathologic data of 533 men who underwent both TB and SB from 2014 to 2017 was analyzed. TB was performed in addition to SB in patients with detection of MRI suspicious lesions. Three patient cohorts were established: (1) biopsy naïve (80/533, 15.0%), (2) active surveillance (185/533, 34.7%), and (3) prior negative biopsy (268/533, 50.3%). Cancer risk categorical criteria were established with recommended radiotherapy treatment for each. Variation of risk classification due to biopsy method for all patients and within each cohort was analyzed using either a chi-squared statistic or Fisher's exact test. McNemar's pairwise analyses were performed for all risk categories between TB and SB to assess the effects of TB on high-risk cancer identification and subsequent radiotherapy recommendations. RESULTS: Number of patients within cancer risk categories (1. "No Cancer or Low-Risk"; 2. "More Favorable Intermediate-Risk"; 3. "Less Favorable Intermediate-Risk"; 4. "High-Risk") varied significantly based on TB and SB pathology among all patients combined (P <.0001), in cohort 2 (P = .0005), and in cohort 3 (P <0.0001). Further, among all patients, TB increased cancer risk classification and correspondingly would result in more aggressive radiotherapy recommendations: "No Cancer or Low-Risk" to "Less Favorable Intermediate-Risk" (30/343, P <0.0001) and "No Cancer or Low-Risk" to "High-Risk" (31/353, P <.0001). CONCLUSION: Among men with prostate cancer, TB commonly led to reclassification to a higher risk group, which is accompanied by more aggressive radiotherapy treatment recommendations when compared with SB findings alone.

An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.

The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The BPDG-Formulation Point Share discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices.

[The effects of protein stabilizers on aggregation induced by multiple-stresses].

A successful development of therapeutic proteins requires a formulation optimal for long-term storage of the proteins. During storage and shipment, proteins are subjected to multiple stresses. Here we show that ciliary neurotrophic factor (CNTF) readily aggregates upon exposure to mechanical stress such as agitation and elevated temperature at 37 degrees C. Sucrose and lysine or arginine protect CNTF from heat stress, while detergents such as Tween20 and organic solvents such as propylene glycol (PG) are effective against agitation. Combination of the amino acids and PG protected the protein from both stresses. The results suggest the importance of combining additives, against multiple stresses, which may have negative as well as positive influence individually against one particular stress.