Medical malpractice litigation after total shoulder arthroplasty: a comprehensive analysis based on the Westlaw legal database.

INTRODUCTION: Orthopedic surgery is one of the most common subspecialties subject to medical malpractice claims. Although total shoulder arthroplasty (TSA) is associated with favorable patient outcomes and relatively low complication rates, surgeons performing this procedure may be subject to malpractice litigation leading to significant economic and psychological burden on the provider. The purpose of this study is to characterize and describe malpractice claims against orthopedic surgeons performing TSA using the Westlaw legal database. METHODS: The Westlaw legal database was queried for all cases related to TSA using the terms "malpractice" AND "shoulder replacement" OR "shoulder arthroplasty." Cases were excluded if the defendant was not an orthopedic surgeon, the procedure involved was not a TSA, or if the patient was a minor. Patient demographics, causes cited for litigation, case outcomes, and indemnity payments were analyzed to determine common factors that lead plaintiffs to pursue legal action. RESULTS: Thirty-five TSA cases were identified that met inclusion criteria. The mean plaintiff age was 55 years with 63.6% female. The most common category of negligence alleged was intraoperative error, which occurred in 25 claims (71%). The most common types of damages incurred were nerve injury (23%), functional limitation (20%), and infection (17%). Overall, 27 cases (77%) resulted in a defense verdict. Four cases (11%) resulted in settlements and 4 cases (11%) resulted in plaintiff verdicts. The average inflation-adjusted monetary award in these cases was $1,619,919 (standard deviation, $1,689,452). DISCUSSION: This study provides a comprehensive summary of malpractice claims and associated outcomes in TSA. Given the rapidly increasing rate of TSA in the United States and the burden of associated malpractice claims, understanding potential legal implications of TSA is of great value to orthopedic surgeons. Intraoperative error was the category of negligence cited most commonly in TSA malpractice claims. Nerve injury, functional limitation, and infection were the most commonly cited specific damages. These findings highlight the need for orthopedic surgeons to educate patients regarding potential postoperative complications while continuing to focus on minimizing their occurrence.

Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions.

INTRODUCTION: The ability to deploy transcranial direct current stimulation (tDCS) at home is a key usability advantage to support scaling for pivotal clinical trials. We have established a home-based tDCS protocol for use in clinical trials termed remotely supervised (RS)-tDCS. OBJECTIVE: To report the tolerability and feasibility of tDCS sessions completed to date using RS-tDCS in clinical trials. METHODS: We analyzed tolerability (i.e., adverse events, AEs) reported in six Class I/II/III trials using RS-tDCS to study symptom outcomes over 10 to 60 daily applications. Across the six clinical trials, 308 participants (18-78 years old) completed an average of 23 sessions for a total of 6779 RS-tDCS administrations. The majority of participants were diagnosed with multiple sclerosis, and open-label trials included those diagnosed with a range of other conditions (e.g., Parkinson's disease, post-stroke aphasia, traumatic brain injury, cerebellar ataxia), with minimum-to-severe neurologic disability. Clinical trial feasibility (i.e., treatment fidelity and blinding integrity) was examined using two Class I randomized controlled trials (RCTs). RESULTS: No serious AEs occurred. Across administrations, three sessions (0.04%) were aborted due to discomfort, but no participant discontinued due to tolerability. The AEs most commonly reported by participants were tingling (68%), itching (41%) and warmth sensation (42%) at the electrode site, and these were equally reported in active and sham tDCS conditions. The two Class I RCTs resulted in rapid enrollment, high fidelity to treatment completion, and blinding integrity. CONCLUSIONS: At-home RS-tDCS is tolerable, including when used over extended periods of time. Home-based RS-tDCS is feasible and can enable Class I tDCS clinical trial designs.

Virtual reality is a feasible intervention platform in multiple sclerosis: A pilot protocol and acute improvements in affect.

BACKGROUND: People living with multiple sclerosis (MS) experience a high symptom burden that interferes with daily functioning. Virtual reality (VR) is an emerging technology with a range of potential therapeutic applications that may include ameliorating the experience of some common MS symptoms. OBJECTIVE: We tested the feasibility and tolerability of a VR intervention and its preliminary effects on affect. METHODS: Participants with MS were recruited to complete a pilot study of eight sessions of VR over four weeks. RESULTS: A total of n = 16 participants with MS completed the study (age range: 28-63). Feasibility goals were met with 100% of the sample completing at least n = 4/8 of their intervention sessions, with a total of 119/128 (93%) completed sessions. Two of the n = 16 participants experienced brief adverse events (balance, vertigo) but these resolved with headset removal and were not otherwise treatment limiting. There was a preliminary indication of overall improved affect from baseline to intervention end, with significantly improved positive affect (t(15) = -3.19, p = 0.006) and decreased negative affect (t(15) = 2.25, p = 0.040). CONCLUSION: VR interventions are feasible, safe, and tolerable for individuals living with MS and may improve affect.

Upper Extremity Motor Fatigability as an Early Indicator in Pediatric Onset Multiple Sclerosis.

AIM: To adopt a computer-based protocol to assess grip fatigability in patients with pediatric-onset multiple sclerosis to provide detection of subtle motor involvement identifying those patients most at risk for future decline. METHOD: Pediatric-onset multiple sclerosis patients were recruited during routine outpatient visits to complete a grip assessment and compared to a group of healthy age- and sex-matched controls. All participants completed a computer-based measurement of standard maximal grip strength and repetitive and sustained grip performance measured by dynamic and static fatigue indices. RESULTS: A total of 38 patients with pediatric-onset multiple sclerosis and 24 healthy controls completed the grip protocol (right-hand dominant). There were no significant group differences in maximal grip strength bilaterally (right: 21.8 vs 19.9 kg, P = .25; left: 20.4 vs 18.7 kg, P = .33), although males with pediatric-onset multiple sclerosis were significantly less strong than healthy controls (right: 26.53 vs 21.23 kg, P = .009; left; 25.13 vs 19.63 kg, P = .003). Both dynamic and static fatigue indices were significantly higher bilaterally in pediatric-onset multiple sclerosis compared with healthy control participants (left-hand dynamic fatigue index: 18.6% vs 26.7%, P = .003; right-hand static fatigue index: 28.3% vs 41.3%, P < .001; left-hand static fatigue index: 31.9% vs 42.6%, P < .001). CONCLUSION: Brief repeatable grip assessment including measures of dynamic and sustained static output can be a sensitive indicator of upper extremity motor involvement in pediatric-onset multiple sclerosis, potentially identifying those in need of intervention to prevent future disability.

Real-time PCR-based serotyping of Streptococcus agalactiae.

Group B Streptococcus (GBS) is an encapsulated, gram-positive pathogen that is an important cause of neonatal invasive infections, including sepsis and meningitis. There are ten known GBS serotypes based on distinct capsule compositions (Ia, Ib, II-IX), and current candidate capsular polysaccharide conjugate vaccines target only a subset of these. Serotyping of GBS isolates is important for understanding local epidemiology and for monitoring for serotype replacement or capsular switching. However, serotyping generally requires either latex agglutination, multiplex PCR with analysis of band sizes, or analysis of whole genome sequences-all techniques that are either expensive or not widely available. Here we report the development of a robust real-time PCR assay for determining GBS serotypes. Using both a diverse reference set of strains encompassing all ten serotypes and a collection of clinical isolates, we demonstrate concordance between real-time PCR serotyping and latex agglutination. We propose that real-time PCR serotyping represents an attractive alternative to current serotyping methods and may allow for improved acquisition of GBS serotype data.