Equivalent Safety Research Articles

Interventional therapy combined with tyrosine kinase inhibitors with or without immune checkpoint inhibitors as initial treatment for hepatocellular carcinoma with portal vein tumor thrombosis: a systematic review and meta-analysis

BackgroundInterventional therapy, in conjunction with tyrosine kinase inhibitors (TKIs), has shown promising outcomes for treating hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT). With the advent of immunotherapy, the combined use of immune checkpoint inhibitors (ICIs) has attracted great attention due to their potential effectiveness in advanced HCC. This study aims to compare the efficacy and safety of a triple therapy regimen (Interventional therapy, TKIs and ICIs, IT-TKI-ICI) with a dual therapy regimen (Interventional therapy and TKIs, IT-TKI) in the treatment of HCC and PVTT (HCC-PVTT).MethodsA comprehensive search was carried out in PubMed, Web of Science, Embase, Scopus, and the Cochrane Library databases. Primary outcome measures were overall survival (OS) and progression-free survival (PFS), while secondary outcomes included tumor response rate, adverse event incidence as well as downstaging surgery rate. Statistical analysis was conducted using Revman 5.4 software.ResultsThe meta-analysis finally included 6 cohort studies. The triple therapy group demonstrated significantly prolonged OS and PFS compared to the dual therapy group. Meanwhile, the former exhibited significantly higher rates of objective response rate (ORR), disease control rate (DCR) and better downstaging effects with a higher salvage surgery rate without significantly increasing adverse events.ConclusionIn comparison to dual therapy, the triple therapy with interventional therapy, TKIs, and ICIs demonstrates superior efficacy and equivalent safety for HCC-PVTT.

FIVE-YEAR OUTCOMES OF A SYNTHETIC CARTILAGE IMPLANT FOR THE FIRST METATARSOPHALANGEAL JOINT IN ADVANCED HALLUX RIGIDUS

Introduction/PurposeA randomized clinical trial of first MTP joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years.MethodsOne hundred nineteen patients were evaluated at 5+ years; 23 could not be reached for follow-up, but implant status was available for 7 of these subjects. Patients completed a pain visual analogue scale (VAS) and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) scores, preoperatively and at 2, 6, 12, 26, 52, 104 and 260 weeks postoperatively. Minimal clinically important differences are: ≥30% difference for pain VAS, 9 points for FAAM Sports, and 8 points for FAAM ADL. Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety parameters were evaluated.ResultsOf 119 patients available at mean 5.8 years follow-up (SD ±0.7; range: 4.4–8.0), 9 underwent implant removal and conversion to fusion in years 2–5, leaving 106 patients. The implant survival rate was 92.4% at 5.8 years. Pain and function outcomes at 5.8 years were similar to those at 2 years. VAS Pain, FAAM Sports, ADL Scores were maintained or improved at 5.8 years. No evidence of avascular necrosis, device migration or fragmentation was observed. There were no unanticipated safety events through 5.8 years. Ninety-three (93%) percent would have the procedure again.ConclusionThe synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with evidence of therapeutic effect and acceptable safety profile at 5.8 years.

Scleral-fixated vs Iris-fixated intraocular lens in pediatric ectopia lentis: A systematic review.

Numerous intraocular lens (IOLs) options are available for treating pediatric ectopia lentis, and this paper reviews recent literature on pediatric ectopia lentis treatment with iris-fixated and scleral-fixated IOLs. A comprehensive search was undertaken on PubMed, Embase, ProQuest, Cochrane, Wiley, SCOPUS, and EBSCO. Studies published in the last ten years that met the inclusion criteria were included in this review. Seventeen studies exhibiting low to moderate risk of bias were included in this review, with eight on iris-fixated IOL (IFIOL), six on scleral-fixated IOL (SFIOL), and three on both IOLs. From the included studies, these data were extracted and compared: best-corrected visual acuity, endothelial cell density, postoperative complications, IOL stability, and intraocular pressure. IFIOL and SFIOL show comparable lens stability, offer good visual rehabilitation, and demonstrate equivalent safety profiles. There is no discerning superiority between IFIOL and SFIOL in treating pediatric ectopia lentis. The choice of which IOL to implant depends on the surgeon's preference.

Abstract 4846: Geographic and physician-level variation in the use of hypofractionated radiotherapy for breast cancer in the U.S.: A cross-classified multilevel analysis

Abstract Hypofractionated whole-breast irradiation (HF-WBI), a radiotherapy with a larger dose per fraction and a shorter schedule for early-stage breast cancer patients post breast-conserving surgery, shows equivalent safety and efficacy compared to conventionally fractionated whole-breast irradiation (CF-WBI) regarding local recurrence and disease-free survival. While several countries have set HF-WBI as the preferred standard of care for these patients, its uptake in the U.S. has lagged behind expectations. We used the Health Care Cost Institute (HCCI) database 2008-2017, covering a third of the U.S. employer-sponsored insurance population, to identify early-stage breast cancer patients. Patients were clustered at different geographic levels (Census region, state, core-based statistical area (CBSA), hospital referral region of Dartmouth Atlas, and zip code) and the radiation oncologist level. These two levels are cross-nested. We used a Bayesian cross-classified multilevel logistic model to simultaneously model the geographic units variability and physician-level variability in HF-WBI use across the U.S. Variation metrics included intracluster correlation coefficient (ICC) and median odds ratios (MOR). ICC with a value of 0 is equivalent to MOR of 1, indicating identical outcomes across all levels. After accounting for these variations in the cross-classified multilevel model framework, we evaluated the association between HF-WBI use and clinical and demographic factors.Our study included 79,747 women (74.0%) who underwent CF-WBI and 27,999 (26.0%) who received HF-WBI. HF-WBI adoption increased over time (2008-2017). Variability across radiation oncologists (ICC = 0.272, MOR = 2.88) was notably larger than geographic areas variability. Variability across CBSA (ICC = 0.097, MOR = 1.76) was the strongest among all the geographic levels. The variation in HF-WBI use was mainly attributed to physician-level variability (ICC=0.222, MOR=2.59) based on the cross-classified multilevel model. No substantial differences were found between young (aged 64 or younger with commercial health plans) and older patients (aged 65 or older with Medicare Advantage plans) in terms of both geographic and physician-level variations. After accounting for variability in radiation oncologists and CBSAs, older age, non-reception of chemotherapy, and several community-level factors, including longer distance from home to facility and higher community education level, were associated with a higher likelihood of HF-WBI use. These results may lend insights into potential facilitators/barriers to HF-WBI uptake. Future studies can further investigate the impact of the 2018 American Society for Radiation Oncology (ASTRO) guideline and the Covid-19 pandemic on HF-WBI use, which would illuminate potential improvements of healthcare practices. Citation Format: Yijia Sun, Loren Saulsberry, Chuanhong Liao, Donald Hedeker, Dezheng Huo. Geographic and physician-level variation in the use of hypofractionated radiotherapy for breast cancer in the U.S.: A cross-classified multilevel analysis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4846.

Comparative Clinical Effectiveness and Cost-Effectiveness of the Cochlear Osia System and Baha Attract System in Patients with Conductive or Mixed Hearing Loss or Single-Sided Deafness.

The aim of this study was to evaluate the comparative clinical effectiveness and cost-utility of the active transcutaneous Osia® System versus the passive transcutaneous Baha® Attract System for patients with conductive or mixed hearing loss or single-sided deafness in an Australian healthcare setting. In the absence of direct comparative evidence, an indirect treatment comparison (ITC) of the clinical effectiveness and utility gains was needed. The ITC was informed by three studies identified through a systematic literature review. A Markov model was developed to evaluate the cost-utility of the Osia System. The literature review identified three studies suitable to inform an ITC: Mylanus et al. 2020 and Briggs et al. 2022 (Osia System) and den Besten et al. 2019 (Baha Attract System). The Osia System was found to be clinically superior to the Baha Attract System, across objective audiological outcomes resulting in a clinically meaningful utility benefit of 0.03 measured by the Health Utility Index with at least equivalent safety. In conclusion, the Osia System is more effective than the Baha Attract System, providing better hearing and health-related quality of life outcomes. In an Australian healthcare setting, the Osia System is cost-effective as demonstrated in a cost-utility analysis versus the Baha Attract System.

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial.

SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp). GEMELLI X was a randomized controlled trial to assess outcomes with a biosimilar in line with the US Food and Drug Administration requirements for designation as an interchangeable biosimilar. This report assessed whether multiple switches between SAR-Asp and NN-Asp lead to equivalent safety and efficacy compared with continuous use of NN-Asp in adults with type 1 diabetes (T1D) treated with multiple daily injections, using once-daily insulin glargine U100 (Lantus) as the basal insulin. This open-label randomized (1:1), parallel-group, phase 3 trial compared four × four weeks of alternating use of individually titrated SAR-Asp and NN-Asp (NN-Asp for first four weeks, SAR-Asp in last four weeks; switching group) vs 16 weeks of continuous use of NN-Asp (nonswitching group). End points included pharmacokinetics, immunogenicity, adverse events, hypoglycemia, insulin dose, and change in efficacy parameters. Of the 210 patients randomized, 200 (95.5%) completed the trial. Patients assigned to switching group (n = 104) and nonswitching group (n = 106) showed similar safety and tolerability, including anti-insulin aspart antibody responses, adverse events, and hypoglycemia. At week 16, there was no relevant difference between switching vs nonswitching groups in the change from baseline in glycated hemoglobin (least square [LS] mean difference = 0.05% [95% confidence interval [CI] = -0.13, 0.22]; 0.50 mmol/mol [-1.40, 2.39]), fasting plasma glucose (LS mean difference = 0.23 mmol/L [95% CI = -1.08, 1.53]; 4.12 mg/dL [-19.38, 27.62]), and changes in insulin dosages. Alternating doses of SAR-Asp and NN-Asp compared with continuous use of NN-Asp showed similar safety, immunogenicity, and clinical efficacy in adults with T1D. This study supports interchangeability between SAR-Asp and NN-Asp in T1D management.

Immunogenicity, Safety, and Efficacy of Influenza Vaccine in T2DM and T2DM with Chronic Kidney Disease.

Patients with Type 2 diabetes mellitus (T2DM) and Chronic Kidney Disease (CKD) face an increased risk of morbidity and mortality after influenza infection. Several studies have shown that the influenza vaccine effectively prevents morbidity and mortality in T2DM patients. However, there has been limited research aimed at assessing the effectiveness of the trivalent influenza vaccine in T2DM-CKD patients. This study aimed to identify Geometric Mean Titers (GMTs), seroprotection, seroconversion, safety, and efficacy. This open-label clinical trial was conducted at AMC Hospital in Bandung, West Java, Indonesia between June 2021 and July 2022. The study subjects consisted of 41 T2DM and 26 T2DM-CKD patients who were administered the trivalent influenza vaccine. There was a significant difference in the average age, with the T2DM-CKD patients being older. Median titers post-vaccination for the B/Washington virus were higher in the T2DM patients compared to the T2DM-CKD patients, and this difference was statistically significant. A majority, comprising 75.6% of the T2DM and 80.8% of the T2DM-CKD patients monitored post-influenza-vaccination, did not experience any adverse reactions. The most common reaction was the sensation of fever, with incidence rates of 12.2% in the T2DM patients and 15.4% in the T2DM-CKD patients. Furthermore, we observed that the incidence of Influenza-like Illness was highest at 7.3% in the T2DM patients and 7.7% in the T2DM-CKD patients. The trivalent influenza vaccine demonstrated equivalent safety and effectiveness in both groups.

The effectiveness of prehospital rapid sequence intubation in critically ill patients

Background Tracheal intubation in critically sick patients presents a significant risk of complications attributable to variables such as respiratory failure, hemodynamic instability, and drug sensitivity. Present recommendations mostly depend on expert opinion and data from elective intubations, lacking substantial evidence from randomized controlled trials (RCTs) in critical care environments (ICU, ED, general wards). This systematic review sought to assess high-quality evidence-based methods for intubation in critically sick patients, concentrating on pharmacological agents, techniques, and equipment. Methods A thorough search of PubMed, BioMed Central, Embase, and the Cochrane Central Register of Clinical Trials found pertinent randomized controlled trials examining treatments aimed at enhancing the success rate and safety of tracheal intubation in critically sick patients. A meta-analysis was conducted when applicable. Results Intubation problems in critically sick patients vary from 4.2% to 39%. Pre-oxygenation by non-invasive ventilation (NIV) has shown enhanced effectiveness over conventional techniques in extending safe apnea duration and minimizing desaturation. Although high-flow nasal cannula (HFNC) enhanced comfort, its advantages for apneic oxygenation were restricted in this demographic. Etomidate and ketamine had equivalent safety and effectiveness as sedatives, whilst succinylcholine and rocuronium showed similar success rates as neuromuscular blocking drugs. The sniffing position outperformed the ramping position for laryngoscopy.

Tracing the barriers to decarbonising ophthalmology: A review.

As climate change demands increasingly urgent mitigation of greenhouse gas emissions, the health sector needs to do its part to decarbonise. Ophthalmologists share concerns about climate change and seek opportunities to reduce their environmental impact. When measuring the footprint of ophthalmology, major contributions are from patient travel to clinics, and from the large amounts of single-use disposable materials that are consumed during surgeries and sterile procedures. Ophthalmic services in India have already demonstrated systems that consume far fewer of these products through efficient throughput of patients and the safe reuse of many items, while maintaining equivalent safety and quality outcomes. Choosing these low-cost low-emission options would seem obvious, but many ophthalmologists experience barriers that prevent them operating as Indian surgeons do. Understanding these barriers to change is a crucial step in the decarbonisation of ophthalmology and the health sector more broadly.

Equivalent efficacy and safety of plastic stents and lumen-apposing metal stents in the treatment of peripancreatic fluid collections: a prospective cohort study.

Endoscopic ultrasound (EUS)-guided transmural drainage using double pigtail plastic stents (DPPS) has been routine for the treatment of peripancreatic fluid collections (PFC). Lumen-apposing metal stents (LAMS) have since their introduction been the preferred choice; however, their superiority has not been proven. The aim of this study was to compare the efficacy and safety of DPPS and LAMS. This was a single-center, prospective study that included consecutive patients undergoing EUS-guided drainage between January 2010 and December 2020. The primary endpoints were technical success, clinical success and adverse event rate, while the secondary endpoints included symptomatic relief, length of hospital stay, and need for adjunct drainage. A subgroup analysis of walled-off necrosis (WON) was performed. A total of 89 patients (median age 56 years) underwent EUS-guided transmural drainage (DPPS: n=53; LAMS: n=36) because of a pseudocyst (n=37) or a WON (n=52). Both DPPS and LAMS had a 100% technical success rate and a comparable adverse event rate (4% vs. 6%, P=0.24). An equivalent efficacy was recorded for the drainage of PFC comparing DPPS and LAMS, and no significant statistical difference was recorded in clinical success (DPPS 60% vs. LAMS 61%, P=0.94) or the need for reintervention (DPPS 11% vs. LAMS 13%, P=0.72). In this large, prospective study of EUS-guided drainage of peripancreatic fluid collections, LAMS and DPPS showed equivalent safety, technical success, clinical success and hospital stay. Both techniques were associated with a comparable need for complementary necrosectomy.

Real-World Clinical Equivalence of Generic and Branded Tofacitinib: A Prospective Longitudinal Cohort Study in Patients With Rheumatoid Arthritis

ObjectivesTo explore the clinical efficacy and safety of generic tofacitinib vs brand name tofacitinib in patients with rheumatoid arthritis (RA) in a single-center comparative study based on a prospective real-world cohort. MethodsPatients with RA receiving tofacitinib, either generic (Kelejia) or branded (Xeljanz), from March 2017, to December 31, 2022, were enrolled. The primary outcome was the simplified disease activity index (SDAI)–defined remission rate at month 6. Secondary outcomes included the rates of remission and low disease activity defined by other composite scores; European Alliance of Associations for Rheumatology response rate, and ultrasonic synovitis scores at months 1, 3, 6, and 12. Cost-effectiveness was investigated. Propensity score–based inverse probability of treatment weighting was adopted to reduce selection bias. ResultsA total of 204 patients were enrolled: 59 in the generic group and 145 in the branded group. An SDAI-defined remission was achieved in 41.1% and 39.2% of patients in the generic and branded groups, respectively, at month 6 (P=.85). Rates of remission and low disease activity achievement, changes in clinical disease activity scores, and power Doppler and gray scale synovitis scores at months 1, 3, 6, and 12 were comparable between the 2 groups. Similar proportions of patients in the groups achieved moderate/good response at months 1, 3, 6, and 12. Rates of drug retention and adverse effects were also similar in the 2 groups. Both Kelejia and Xeljanz were cost-effective, but Kelejia had a lower average cost-effectiveness ratio. ConclusionGeneric tofacitinib (Keljia) had equivalent clinical efficacy and safety and better cost-effectiveness compared with its originator (Xeljanz).

Efficacy and Safety of Ertugliflozin Compared to Placebo in Patients With Type 2 Diabetes: An Updated Systematic Review and Meta-Analysis.

Background: No comprehensive meta-analysis has evaluated the efficacy and safety of ertugliflozin compared to a placebo in patients with Type 2 diabetes (T2D) until now. This meta-analysis fills this gap in knowledge. Methods: A systematic search was carried out in electronic databases to identify randomized controlled trials (RCTs) that included patients with T2D receiving ertugliflozin in the treatment group and placebo in the control group. The change in HbA1c from the baseline values was the primary outcome, whereas changes in plasma glucose and other metabolic parameters and adverse events (AEs), including hypoglycemia, were the secondary outcomes. Results: Seven RCTs involving 7283 subjects met the inclusion criteria. Ertugliflozin outperformed placebo in reducing HbA1c in both 5 mg (MD -0.62%, 95% CI [-0.80, -0.44], p < 0.00001, I 2 = 91%) and 15 mg (MD -0.69%, 95% CI [-0.91, -0.47], p < 0.00001, I 2 = 93%) doses. A higher proportion of patients achieved HbA1c < 7.0% with ertugliflozin than with placebo. Ertugliflozin was also superior to placebo in lowering fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure (BP). Ertugliflozin and placebo had comparable AE profiles, including urinary tract infection (UTI) and hypoglycemia, except for the greater risk of genital mycotic infections (GMIs) with ertugliflozin. Ertugliflozin 5 and 15 mg have equivalent efficacy and safety profiles except for greater weight reduction with ertugliflozin 15 mg. Conclusion: Ertugliflozin has a good glycemic efficacy and a reassuring safety profile in managing T2D. Trial Registration: Registration number: CRD42023456450.

Perception of pharmacological equivalence of generics or biosimilars in healthcare professionals in Vienna

PurposeDue to constantly rising therapy costs, biosimilars and generic drugs have gained tremendous importance through recent decades. Nevertheless, the acceptance among healthcare workers regarding biosimilars and generic drugs in previously published international studies is considerably lower than the scientific data on equivalent safety and efficacy would suggest. The aim of this questionnaire-based survey was to determine the perception and knowledge regarding generic drugs and biosimilars by medical professionals from different healthcare facilities in Vienna, Austria.MethodsThe online questionnaire was sent to public and religious hospitals in Vienna, including the university hospital “Vienna General Hospital.” In addition, doctors’ offices were reached by sending out the questionnaire in the weekly news of the Vienna Medical Association.ResultsA total of 282 physicians and 311 graduated nurses took part in the study. 63% and 62% of the participants were convinced that generic respective biosimilar drugs were clinically equivalent to the original reference drug. On average, 1.6 out of 4 knowledge questions were answered correctly about generics, while only 0.87 out of 4 questions were answered accurately about biosimilars.ConclusionThe results of this study support the outcome from previous surveys demonstrating that a large proportion of healthcare professionals is still skeptical about generics and biosimilars. According to the results of this study, better education of the medical staff might ensure greater acceptance of these types of drugs.

Abstract 236: Effects of intravenous thrombolysis on thrombectomy outcomes: a systematic review and meta‐analysis

Introduction Efficacy and safety of intravenous thrombolysis (IVT) in patients undergoing mechanical thrombectomy (MT) is still debatable. However, IVT's efficacy on stent retriever (SR) and aspiration thrombectomy (ASP) outcomes specifically remain unclear. In our meta‐analysis, we aimed to explore the effects of IVT on SR and ASP thrombectomy outcomes. Methods A systematic literature review was steered using Medline, Embase, Scopus, Web of Science, and Cochrane Center of Clinical Trials databases, according to PRISMA guidelines. Outcomes of interest included successful recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b), functional independence (modified Rankin Scale (mRS) ≤2), modified first pass efficacy (mFPE), symptomatic intracranial hemorrhage (sICH), and embolization to new territories (ENT). Results We included four randomized controlled trials with 1176 patients. SR and ASP had similar mTICI ≥2b, mFPE, and mRS 0‐2 rates whether they received IVT or not. SR without IVT was associated with a lower rate of mFPE compared with the SR+IVT (RR 0.85, 95% CI 0.74 to 0.97). Additionally, ASP without IVT resulted in a lower rate of mRS 0‐2 than the ASP+IVT (RR 0.78, 95% CI 0.60 to 1.01). Finally, bridging therapy did not increase sICH and ENT rates after ASP or SR thrombectomy. Conclusion Our analysis suggests that SR and ASP thrombectomy have equivalent efficacy and safety outcomes regardless of prior IVT administration. Moreover, our results indicate that administration of IVT before MT may improve certain outcomes based on the used first‐line MT technique.

Costs of shoulder and elbow procedures are significantly reduced in ambulatory surgery centers compared to hospital outpatient departments.

Recent literature has shown the advantages of outpatient surgery for many shoulder and elbow procedures, including cost savings with equivalent safety in appropriately selected patients. Two common settings for outpatient surgeries are ambulatory surgery centers (ASCs), which function as independent financial and administrative entities, or hospital outpatient departments (HOPDs), which are owned and operated by hospital systems. The purpose of this study was to compare shoulder and elbow surgery costs between ASCs and HOPDs. Publicly available data from 2022 provided by the Centers for Medicare & Medicaid Services (CMS) was accessed via the Medicare Procedure Price Lookup Tool. Current Procedural Terminology (CPT) codes were used to identify shoulder and elbow procedures approved for the outpatient setting by CMS. Procedures were grouped into arthroscopy, fracture, or miscellaneous. Total costs, facility fees, Medicare payments, patient payment (costs not covered by Medicare), and surgeon's fees were extracted. Descriptive statistics were used to calculate means and standard deviations. Cost differences were analyzed using Mann-Whitney U tests. Fifty-seven CPT codes were identified. Arthroscopy procedures (n=16) at ASCs had significantly lower total costs ($2667±$989 vs. $4899±$1917; P=.009), facility fees ($1974±$819 vs. $4206±$1753; P=.008), Medicare payments ($2133±$791 vs. $3919±$1534; P=.009), and patient payments ($533±$198 vs. $979±$383; P=.009) compared with HOPDs. Fracture procedures (n=10) at ASCs had lower total costs ($7680±$3123 vs. $11,335±$3830; P=.049), facility fees ($6851±$3033 vs. $10,507±$3733; P=.047), and Medicare payments ($6143±$2499 vs. $9724±$3676; P=.049) compared with HOPDs, although patient payments were not significantly different ($1535±$625 vs. $1610±$160; P=.449). Miscellaneous procedures (n=31) at ASCs had lower total costs ($4202±$2234 vs. $6985±$2917; P<.001), facility fees ($3348±$2059 vs. $6132±$2736; P<.001), Medicare payments ($3361±$1787 vs. $5675±$2635; P<.001), and patient payments ($840±$447 vs. $1309±$350; P<.001) compared with HOPDs. The combined cohort (n=57) at ASCs had lower total costs ($4381±$2703 vs. $7163±$3534; P<.001), facility fees ($3577±$2570 vs. $6539.1±$3391; P<.001), Medicare payments ($3504±$2162 vs. $5892±$3206; P<.001), and patient payments ($875±$540 vs. $1269±$393; P<.001) compared with HOPDs. Shoulder and elbow procedures performed at HOPDs for Medicare recipients were found to have average total cost increase of 164% compared with those performed at ASCs (184% savings for arthroscopy, 148% for fracture, and 166% for miscellaneous). ASC use conferred lower facility fees, patient payments, and Medicare payments. Policy efforts to incentivize migration of surgeries to ASCs may translate into substantial health care cost savings.

Anesthesia methods for full-endoscopic lumbar discectomy: a review.

Full-endoscopic lumbar discectomy under local anesthesia is major trends for the treatment of lumbar disc herniation in spine minimally invasive surgery. However, sometimes local anesthesia is not enough for analgesic in surgery especially in interlaminar approach. This study summarizes the current study of anesthesia methods in full-endoscopic lumbar discectomy. Local anesthesia is still the most common anesthesia method in full-endoscopic lumbar discectomy and the comparison group for other anesthesia methods due to high safety. Compared to local anesthesia, Epidural anesthesia is less applied in full-endoscopic lumbar discectomy but reports better intraoperative pain control and equivalent safety due to the motor preservation and pain block characteristic of ropivacaine. General anesthesia can achieve totally pain block during surgery but nerve injury can not be ignored, and intraoperative neuromonitoring can assist. Regional anesthesia application is rare but also reports better anesthesia effects during surgery and equivalent safety. Anesthesia methods for full-endoscopic lumbar discectomy should be based on patient factors, surgical factors, and anesthesiologist factors to achieve satisfactory anesthesia experience and successful surgery.

Cost and Effectiveness of Percutaneous Endoscopic Interlaminar Discectomy versus Microscope-Assisted Tubular Discectomy for L5-S1 Lumbar Disc Herniation

To assess the cost and effectiveness of percutaneous endoscopic interlaminar discectomy (PEID) and microscope-assisted tubular discectomy (MATD) for patients with L5/S1 lumbar disc herniation (LDH). The medical and financial records of patients diagnosed with L5/S1 LDH and who underwent either PEID or MATD from April 2021 to April 2022 were retrospectively collected. Demographic and baseline information, perioperative observational index, clinical outcomes, and inpatient costs were analyzed. Sixty patients were included, with 30 patients in the PEID group and 30 patients in the MATD group. No significant difference was found in demographic and baseline information between the 2 groups (P > 0.05). The PEID group showed significantly shorter incision length, less intraoperative blood loss, shorter hospital stays, and higher intraoperative fluoroscopy frequency compared with the MATD group (P < 0.05). There were no significant differences in visual analog scale back/leg score, Oswestry Disability Index, and 36-Item Short-Form Survey score between PEID and MATD groups before the surgery and at any follow-up time points (P > 0.05). The total cost, surgery cost, and surgical instruments/materials cost were significantly higher in the PEID group compared with the MATD group (P < 0.05). In contrast, the drug and nursing costs were significantly higher in the MATD group than in the PEID group (P < 0.05). PEID and MATD provide equivalent clinical efficacy and safety in treating LDH at L5/S1 segment within a 1-year follow-up. However, PEID is less invasive and MATD is less costly. No one surgical technique is superior in all aspects and patients should make decisions according to their top concern.

Comparison analysis of safety outcomes and the rate of subsequent spinal procedures between interspinous spacer without decompression versus minimally invasive lumbar decompression

IntroductionTreatment for degenerative lumbar spinal stenosis (LSS) typically begins with conservative care and progresses to minimally invasive procedures, including interspinous spacer without decompression or fusion (ISD) or minimally invasive lumbar...

Efficacy and Safety of the Ultrasonic Bone Scalpel in Lumbar Laminectomies.

Despite recent advances in applied instruments and surgical techniques, the incidence of iatrogenic durotomies caused by traditional techniques remains significant. The ultrasonic bone scalpel (UBS) has been shown to improve speed and reduce complications in laminectomies in the cervical and thoracic spine when compared to traditional methods utilizing high-speed burr, punch forceps, or rongeurs. Thus, in this study, we aim to evaluate whether the use of the UBS in the lumbar spine would result in equivalent safety, efficacy, and patient-reported outcomes (PROs) improvement when compared to traditional methods of laminectomy. Data from a prospectively collected, single-institution registry was queried between January 1, 2019 and September 1, 2021 for patients with a primary diagnosis of lumbar stenosis who received a laminectomy (with or without fusion) using traditional methods or UBS method. Outcomes included 3-month and 12-month values for all PROs Measurement Information System (PROMIS) subdomains, Numerical Rating Scale (NRS) pain score, Oswestry Disability Index (ODI) percentage, Patient Health Questionnaire 9 (PHQ-9) score, operative complications, reoperations, and readmissions. Covariates selected for matching included age, operation type, and number of levels. A variety of statistical tests were utilized. As per our findings, 2:1 propensity matching resulted in 64 "traditional group" patients and 32 "UBS group" patients. Post-match analysis found no differences between the traditional and UBS groups for demographic and baseline measures except for race and ethnicity. For the matched sample, no differences were noted in PROs, reoperations, or readmissions. There was a significant difference in rates of durotomies between the traditional and UBS groups (12.5% vs. 0.0%, p=0.049). Results showed the high-frequency oscillation technology implemented by the UBS helps to decrease the rate of injury to the dura, thus reducing the overall incidence of iatrogenic durotomies. We believe these data provide valuable information to surgeons and patients about the safety and efficacy of the UBS in performing lumbar laminectomies.

Efficacy of Low-dose Ketamine for Control of Acute Pain in the Emergency Setting: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Ketamine can be particularly helpful in situations where the clinician is not able to administer opioids and require an alternate analgesic, such as for patients who are already on high-dose opioids, have a history of addiction, or for opioid-naïve children and adults. In this review, our goal was to obtain a comprehensive estimate of the efficacy and safety of low-dose ketamine (dose less than 0.5 milligrams per kilogram or equivalent) compared to opiates for the control of acute pain in the emergency setting. We conducted systematic searches in PubMed Central, EMBASE, MEDLINE, the Cochrane Library, ScienceDirect, and Google Scholar from inception until November 2021. We used the Cochrane risk-of-bias tool to assess the quality of included studies. We carried out a meta-analysis with a random-effects model and reported pooled standardized mean difference (SMD) and risk ratio (RR) with 95% confidence intervals depending on the type of the outcome. We analyzed a total of 15 studies with 1,613 participants. Half of them had high risk of bias and were conducted in the United States of America. The pooled SMD for pain score was -0.12 (95% CI -0.50-0.25; I2=68.8%) within 15 minutes, -0.45 (95% CI -0.84--0.07; I2=83.3%) within 30 minutes, -0.05 (95% CI -0.41-0.31; I2=86.9%) within 45 minutes, -0.07 (95% CI -0.41-0.26; I2=82%) within 60 minutes, and after 60 minutes the pooled SMD was 0.17 (95% CI -0.07-0.42; I2=64.8%). The pooled RR for need of rescue analgesics was 1.35 (95% CI 0.73-2.50; I2=82.2%). The pooled RRs were as follows: 1.18 (95% CI 0.76-1.84; I2=28.3%) for gastrointestinal side effects; 1.41 (95% CI 0.96-2.06; I2=29.7%) for neurological side effects; 2.83 (95% CI 0.98-8.18; I2=47%) for psychological side effects; and 0.58 (95% CI 0.23-1.48; I2=36.1%) for cardiopulmonary side effects. Low-dose ketamine might have higher or equivalent efficacy and safety when compared to opioids for managing acute pain among patients presenting to the emergency setting. However, further studies are required to establish conclusive evidence, owing to the heterogeneity and poor quality of existing studies.