An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes.

BACKGROUND: For thirty years, the Harmonic scalpel has been used for precise dissection, sealing and transection. There are numerous meta-analyses on individual surgical procedures with Harmonic, but no overarching review covering all the areas. This umbrella review seeks to summarize the clinical results from the use of Harmonic across surgical fields and broadly quantify its effects on patient outcomes. METHODS: MEDLINE, EMBASE, and Cochrane Databases were searched for meta-analyses (MAs) of randomized controlled trials (RCTs) comparing Harmonic devices to conventional techniques or advanced bipolar (ABP) devices. For each procedure type, the most comprehensive MAs were evaluated. RCTs not already analysed in a MA were also included. Operating time, length of stay, intraoperative blood loss, drainage volume, pain, and overall complications were evaluated, and the methodological quality and certainty of evidence were assessed. RESULTS: Twenty-four systematic literature reviews were identified on colectomy, hemorrhoidectomy, gastrectomy, mastectomy, flap harvesting, cholecystectomy, thyroidectomy, tonsillectomy, and neck dissection. There were also 83 RCTs included. In every MA evaluated, Harmonic devices were associated with either statistically significant or numerical improvements in every outcome compared with conventional techniques; most MAs reported a reduction in operating time of ≥ 25 min. Harmonic versus ABP device MAs in colectomy and thyroidectomy showed no significant differences in outcomes. CONCLUSION: Across surgical procedures, Harmonic devices demonstrated improved patient outcomes for operating time, length of stay, intraoperative bleeding, drainage volume, pain, and overall complications compared to conventional techniques. Additional studies are required to assess differences between Harmonic and ABP devices.

A budget impact analysis of a magnetic sphincter augmentation device for the treatment of medication-refractory mechanical gastroesophageal reflux disease: a United States payer perspective.

BACKGROUND: Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective. METHODS: An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs. RESULTS: Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%. CONCLUSIONS: This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.

Value of single-level circumferential fusion: a 10-year prospective outcomes and cost-effectiveness analysis comparing posterior facet versus pedicle screw fixation.

PURPOSE: To compare the clinical and economic outcomes of facet versus pedicle screw instrumentation for single-level circumferential lumbar spinal fusion. METHODS: Outcomes included self-assessment of back and leg pain, pain drawing, ODI, pain medication usage, and procedure success. The CEA was based on the 10-year data collected, and the base-case was from a US payer perspective. Costs included the index surgery, additional surgeries, outpatient/ED visits, and medications. To determine quality-adjusted life years (QALYs), ODI scores were used to predict SF-6D utilities. Sensitivity analyses were performed from a modified payer perspective including device costs and from a societal perspective including productivity loss. Discounted and undiscounted incremental costs and QALYs were calculated. Bootstrapping was performed to estimate the distribution of incremental costs and effects. RESULTS: Clinical improvement was significant from pre-op to 10-year follow-up for both groups (p < 0.01 for all outcomes scales). Outcomes were significantly better for back pain and ODI for the facet versus pedicle group at all follow-up periods > 1 year (p < 0.05). In the CEA base-case, facets had more QALYs (0.68) and lower costs (- $8650) per person compared with pedicle screws. Therefore, facets were dominant (i.e., provided cost savings and greater QALYs) compared with pedicle screws. Facets had a 97% probability of being below a willingness-to-pay threshold of $20,000 per QALY gained and were estimated to be dominant over pedicle screws in 84% of the simulations. CONCLUSION: One-level circumferential spinal fusion using facet screws was clinically superior and provided cost savings compared with pedicle screw instrumentation in the USA.

Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.

BACKGROUND: Hepatic resection (HR) is the gold standard liver cancer treatment, but few patients are eligible due to comorbidities or tumor location. Microwave ablation (MWA) is an important complementary liver cancer treatment to HR. This systematic review compared MWA with HR for liver cancer treatment. METHODS: A systematic search of MEDLINE, EMBASE, and CENTRAL was conducted for randomized and observational studies published from 2006 onwards. The primary outcome was local tumor recurrence (LTR), and a random effects model was used for meta-analyses. RESULTS: Of the 1845 studies identified, 1 randomized and 15 observational studies met the inclusion criteria. LTR was significantly increased with MWA versus HR (risk ratio (RR) = 2.49; P = 0.016). In secondary measures, HR provided significantly higher 3- and 5-year overall survival (RR = 0.94; P = 0.03 and RR = 0.88; P = 0.01, respectively) and 3-year disease-free survival (RR = 0.78; P = 0.009). MWA exhibited significantly shorter length of stay (weighted mean difference (WMD) = - 6.16 days; P < 0.001) and operative time (WMD = - 58.69 min; P < 0.001), less intraoperative blood loss (WMD = - 189.09 mL; P = 0.006), and fewer complications than HR (RR = 0.31; P < 0.001). When MWA was combined with HR and compared with either modality alone, complications and blood loss were significantly lower with the combination treatment; however, there were no differences in other outcomes. Subgroup and sensitivity analyses were generally aligned with the main results. CONCLUSIONS: MWA can be an effective and safe alternative to HR in patients/tumors that are not amenable to resection. More randomized and economic studies should be performed that compare the two treatments, especially to determine the target population that benefits most from MWA.

Prolonged operative duration is associated with complications: a systematic review and meta-analysis.

BACKGROUND: The aim of this study was to systematically synthesize the large volume of literature reporting on the association between operative duration and complications across various surgical specialties and procedure types. METHODS: An electronic search of PubMed, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews from January 2005 to January 2015 was conducted. Sixty-six observational studies met the inclusion criteria. RESULTS: Pooled analyses showed that the likelihood of complications increased significantly with prolonged operative duration, approximately doubling with operative time thresholds exceeding 2 or more hours. Meta-analyses also demonstrated a 14% increase in the likelihood of complications for every 30 min of additional operating time. CONCLUSIONS: Prolonged operative time is associated with an increase in the risk of complications. Given the adverse consequences of complications, decreased operative times should be a universal goal for surgeons, hospitals, and policy-makers. Future study is recommended on the evaluation of interventions targeted to reducing operating time.

An Economic Analysis of Stent Grafts for Treatment of Vascular Access Stenosis: Point-of-Care and Medicare Perspectives in the United States.

PURPOSE: To conduct an economic analysis on the impact of increased stent graft (SG) use for treatment of arteriovenous graft (AVG) anastomotic stenosis or arteriovenous fistula (AVF)/AVG in-stent restenosis (ISR) from United States point-of-care (POC) and Medicare perspectives. MATERIALS AND METHODS: The analyses compared initial device and reintervention costs over 2 years between current and projected treatment mixes, including percutaneous transluminal angioplasty (PTA), bare metal stents (BMSs), and SGs. In projected scenarios, the absolute increase in SG use was approximately 3%. Costs included procedure reimbursement rates (Medicare) and device list prices (POC) for index procedures and reinterventions. Reintervention rates and types were informed by the RENOVA and RESCUE randomized trials. Reinterventions were primarily PTA only; however, stent use occurred a proportion of the time. BMS reintervention rates were assumed to be identical to PTA based on observational data. A population size of 1,000 patients was assumed. RESULTS: To the POC (n = 1,000), increased SG use was predicted to result in cost savings ranging from $4,106 to $34,420 for AVG anastomotic stenosis. For AVF/AVG ISR, increased SG use was predicted to result in either a cost increase of $17,187 or a cost savings of $13,159. To Medicare (n = 1,000), increased SG use was predicted to save costs for both populations, with savings ranging from $57,401 to $169,544. CONCLUSIONS: The use of SG for treatment of AVG anastomotic stenosis and AVF/AVG ISR appears to be economically favorable for POC providers and Medicare. Further data on reintervention rates are required from other SG trials to validate findings.

Performance of Harmonic devices in surgical oncology: an umbrella review of the evidence.

BACKGROUND: We performed an umbrella review of systematic reviews summarizing the evidence on the Harmonic scalpel (HS) compared with conventional techniques in surgical oncology (including lymph node dissection). METHODS: We searched MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews from inception to end of March of 2017 for meta-analyses or systematic reviews of randomized trials comparing HS to conventional techniques in surgical oncology. We assessed the quality of included systematic reviews with AMSTAR (A MeaSurement Tool to Assess systematic Reviews) and assessed the certainty in evidence for each pooled outcome using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). RESULTS: We identified ten systematic reviews on breast cancer (n = 3), gastric cancers (n = 3), oral, head, and neck cancers (n = 1), and colon cancers (n = 3). Most reviews received a higher rating using AMSTAR. For operative time, systematic reviews reported a reduction of 25 to 29 min for HS compared with conventional methods across oncology types, with the exception of breast cancer where little differences were observed (very low to moderate quality of evidence (GRADE)). For blood loss and drainage volume, the majority of reviews reported statistically significant reductions with HS, and reductions ranged from 42 to 141 mL, and from 42 to 292 mL, respectively (very low to moderate quality of evidence). Hospitalization days were reported to decrease with use of HS by 0.2 to 3.2 days; however, reductions were only statistically significant for half of the included reviews (low to moderate quality of evidence). Regarding perioperative complications, two of six reviews reported a significantly reduced risk with HS use (breast cancer surgery) (moderate to high quality evidence)). CONCLUSION: Across surgical oncology types, the majority of included systematic reviews showed a statistically significant or numerical improvement in surgical outcomes with use of the HS compared with conventional methods. Well-designed randomized studies with large sample sizes will help to provide more precise estimates and reduce the risk of heterogeneity.

Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials.

BACKGROUND: Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). OBJECTIVE: To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. METHODS: A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. RESULTS: The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. CONCLUSIONS: Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Endovascular Interventions for Femoropopliteal Peripheral Artery Disease: A Network Meta-Analysis of Current Technologies.

PURPOSE: To use network meta-analysis (NMA) to determine the optimal endovascular strategy for management of femoropopliteal peripheral artery disease (PAD) given the lack of multiple prospective randomized trials to guide treatment decisions. MATERIALS AND METHODS: NMA is a new meta-analytic method that permits comparisons among any 2 therapies by combining results of a collection of clinical trials conducted in the same or similar patient population. NMA was used to analyze data from 15 randomized controlled trials (RCTs) and 10 prospective, multicenter, single-arm trials (combined evidence [CE] NMA) that evaluated target lesion revascularization (TLR) for 5 endovascular strategies: bare metal stent (BMS), polymer-covered metal stent (CMS), drug-eluting stent (DES), drug-coated balloon (DCB) and percutaneous transluminal angioplasty (PTA). RESULTS: The RCT and CE NMAs included 2,912 (6,091) patients with 3,151 (6,786) person-years of follow-up. In the CE NMA, DCB provided a statistically significant 68% reduction in TLR compared with PTA and a statistically significant 53% reduction in TLR compared with BMS. BMS, CMS, and DES provided reductions in TLR of 33%, 48%, and 58% compared with PTA, with statistical significance achieved for CMS and DES. The significant reductions in TLR for DCB compared with PTA and BMS were replicated in the RCT NMA. CONCLUSIONS: This NMA demonstrated that DCB provided better reduction in TLR rates compared with PTA and BMS.

Correction: Validating the Safe and Effective Use of a Neurorehabilitation System (InTandem) to Improve Walking in the Chronic Stroke Population: Usability Study.

[This corrects the article DOI: 10.2196/50438.].

Ergonomic benefit using heads-up display compared to conventional surgical microscope in Japanese ophthalmologists.

PURPOSE: Occupational musculoskeletal disorders are prevalent in ophthalmic surgeons and can impact surgeons' well-being and productivity. Heads-up displays may reduce ergonomic stress compared to conventional microscopes. This cross-sectional, non-interventional study compared ergonomic experience between heads-up display and conventional ocular microscopes. METHODS: The study protocol was approved by the independent ethics committee and nonprofit organization MINS Institutional Review Board. An online questionnaire was distributed to a sample of ophthalmic surgeons in Japan with experience operating with heads-up display. The questionnaire captured surgeon-specific variables, the standardized Nordic Musculoskeletal Questionnaire, and custom questions to compare heads-up display and conventional microscope and understand long-term impacts of musculoskeletal disorders. RESULTS: Analysis was conducted on responses from 67 surgeons with a mean 25 years of practice and 2.7 years using heads-up display. Many surgeons agreed or strongly agreed that heads-up display reduced the severity (40%) and frequency (40%) of pain and discomfort, improved posture (61%), and improved overall comfort (61%). Of respondents who experienced asthenopia (n = 59) or pain/discomfort during operation (n = 61), 54% reported improvement in asthenopia and 72% reported feeling less pain/discomfort since using heads-up display. Overall, 69% reported preference for heads-up display. CONCLUSION: This study provides novel data on musculoskeletal disorders and the long-term impacts of ergonomic strain reported by ophthalmologists building on existing literature demonstrating ergonomic and other advantages of heads-up display. Future studies with objective ergonomic assessment are warranted to validate these findings.

Economic and healthcare resource utilization assessments of PET imaging in Coronary Artery Disease diagnosis: a systematic review and discussion of opportunities for future economic evaluations.

AIMS: This systematic literature review (SLR) consolidated economic and healthcare resource utilization (HCRU) evidence for positron emission tomography (PET) and single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to inform future economic evaluations. MATERIALS AND METHODS: An electronic search was conducted in MEDLINE, Embase, and Cochrane databases from 2012-2022. Economic and HCRU studies in adults who underwent PET- or SPECT-MPI for coronary artery disease (CAD) diagnosis were eligible. A qualitative methodological assessment of existing economic evaluations, HCRU, and downstream cardiac outcomes was completed. Exploratory meta-analyses of clinical outcomes were performed. RESULTS: The search yielded 13,439 results, with 71 records included. Economic evaluations and comparative clinical trials were limited in number and outcome types (HCRU, downstream cardiac outcomes, and diagnostic performance) assessed. No studies included all outcome types and only one economic evaluation linked diagnostic performance to HCRU. The meta-analyses of comparative studies demonstrated significantly higher rates of early- and late-invasive coronary angiography and revascularization for PET- compared to SPECT-MPI; however, the rate of repeat testing was lower with PET-MPI. The rate of acute myocardial infarction was lower, albeit non-significant with PET- vs. SPECT-MPI. LIMITATIONS AND CONCLUSIONS: This SLR identified economic and HCRU evaluations following PET- and SPECT-MPI for CAD diagnosis and determined that existing studies do not capture all pertinent outcome parameters or link diagnostic performance to downstream HCRU and cardiac outcomes, thus, resulting in simplified assessments of CAD burden. A limitation of this work relates to heterogeneity in study designs, patient populations, and follow-up times of existing studies. Resultingly, it was challenging to pool data in meta-analyses. Overall, this work provides a foundation for the development of comprehensive economic models for PET- and SPECT-MPI in CAD diagnosis, which should link diagnostic outcomes to HCRU and downstream cardiac events to capture the full CAD scope.

Corneal Outcomes Following Cataract Surgery Using Ophthalmic Viscosurgical Devices Composed of Chondroitin Sulfate-Hyaluronic Acid: A Systematic Review and Meta-Analysis.

Background: Ophthalmic viscosurgical devices (OVDs) are commonly used during cataract surgery to protect the corneal endothelium. A systematic literature review and meta-analysis were conducted to assess the clinical evidence of OVDs composed of chondroitin sulfate-hyaluronic acid (CS-HA) versus other OVDs in maintaining endothelial cell density (ECD) and corneal thickness (CT). Methods: MEDLINE and EMBASE databases were searched from 2000 to 2020. Randomized controlled trials (RCTs, N ≥ 20 per group) comparing an OVD containing CS-HA (ie, VISCOAT®, DuoVisc® or DisCoVisc®) to any other OVD were included. The identified comparators were limited to the OVDs found in the literature, which included those composed of HA-only or hydroxypropyl methylcellulose (HPMC). Outcomes of focus included changes in ECD (baseline to 3 months) and CT (baseline to 24 hours). Meta-analyses were performed using R software, to assess mean differences (MD) in ECD and CT change between CS-HA OVDs and HA-only or HPMC OVDs. Results: A total of 966 abstracts were screened, and data were extracted from 12 RCTs. Meta-analyses using a random-effects model revealed significantly lower percent (%) decrease in ECD for CS-HA OVDs compared to both HA-only (MD: -4.10%; 95% CI: -5.81 to -2.40; p < 0.0001; 9 studies) and HPMC (MD: -6.47%; 95% CI: -10.41 to -2.52; p = 0.001; 2 studies) products. Similarly, % CT increase was significantly lower with CS-HA than with HA-only OVDs (MD: -3.22%; 95% CI: -6.24% to -0.20%; p = 0.04; 4 studies). However, there were no significant differences when comparing % CT change between CS-HA and HPMC OVDs (MD: 2.65%; 95% CI: -0.43% to 0.95%; p = 0.4; 2 studies). Conclusion: CS-HA OVDs lead to less postoperative loss of endothelial cells and may better protect corneal endothelium during cataract surgery, relative to other OVDs. Future randomized studies may be needed to solidify these findings.

Validating the Safe and Effective Use of a Neurorehabilitation System (InTandem) to Improve Walking in the Chronic Stroke Population: Usability Study.

BACKGROUND: Persistent walking impairment following a stroke is common. Although rehabilitative interventions exist, few exist for use at home in the chronic phase of stroke recovery. InTandem (MedRhythms, Inc) is a neurorehabilitation system intended to improve walking and community ambulation in adults with chronic stroke walking impairment. OBJECTIVE: Using design best practices and human factors engineering principles, the research presented here was conducted to validate the safe and effective use of InTandem. METHODS: In total, 15 participants in the chronic phase of stroke recovery (≥6 months after stroke) participated in this validation study. Participants were scored on 8 simulated use tasks, 4 knowledge assessments, and 7 comprehension assessments in a simulated home environment. The number and types of use errors, close calls, and operational difficulties were evaluated. Analyses of task performances, participant behaviors, and follow-up interviews were conducted to determine the root cause of use errors and difficulties. RESULTS: During this validation study, 93% (14/15) of participants were able to successfully complete the critical tasks associated with the simulated use of the InTandem system. Following simulated use task assessments, participants' knowledge and comprehension of the instructions for use and key safety information were evaluated. Overall, participants were able to find and correctly interpret information in the materials in order to answer the knowledge assessment questions. During the comprehension assessment, participants understood warning statements associated with critical tasks presented in the instructions for use. Across the entire study, 3 "use errors" and 1 "success with difficulty" were recorded. No adverse events, including slips, trips, or falls, occurred in this study. CONCLUSIONS: In this validation study, people in the chronic phase of stroke recovery were able to safely and effectively use InTandem in the intended use environment. This validation study contributes to the overall understanding of residual use-related risks of InTandem in consideration of the established benefits.

A Comparison of Microwave Ablation and Cryoablation for the Treatment of Renal Cell Carcinoma: A Systematic Literature Review and Meta-analysis.

OBJECTIVE: To conduct a systematic review and meta-analysis comparing microwave ablation (MWA) and cryoablation for renal cell carcinoma (RCC). METHODS: The systematic search was performed in MEDLINE, Embase, and Cochrane databases. Studies published in English from January 2006 to February 2022 that assessed adults with primary RCC who received MWA or cryoablation were included. Study arms from RCTs, comparative observational, and single-arm studies were eligible. The outcomes included local tumor recurrence (LTR), overall survival, disease-free survival, overall/major complications, procedure/ablation time, 1- to 3-month primary technique efficacy, and technical success. Single-arm meta-analyses were performed using the random effects model. Sensitivity analyses excluding low-quality studies assessed using the MINORs scale were performed. Univariable and multivariable examined the effects of prognostic factors. RESULTS: Baseline characteristics were similar between groups and mean tumor size for MWA and cryoablation were 2.74 and 2.69 cm. Single-arm meta-analyses were similar for LTR and secondary outcomes between cryoablation and MWA. Ablation time was significantly shorter with MWA than with cryoablation (meta-regression weighted mean difference 24.55 minutes, 95% confidence interval -31.71, -17.38, P < .0001). One-year LTR was significantly lower with MWA than cryoablation (odds ratio 0.33, 95% confidence interval 0.10-0.93, P = .04). There were no significant differences for other outcomes. CONCLUSION: MWA provides significantly improved 1-year LTR and ablation time compared with cryoablation for patients with RCC. Other outcomes appeared similar or favorable for MWA; however, results were not statistically significant. MWA of primary RCC is as safe and effective as cryoablation, which should be confirmed with future comparative studies.

Recurrence-Free Survival in Patients With Surgically Resected Non-Small Cell Lung Cancer: A Systematic Literature Review and Meta-Analysis.

BACKGROUND: Standard treatment for early-stage or locoregionally advanced non-small cell lung cancer (NSCLC) includes surgical resection. Recurrence after surgery is commonly reported, but a summary estimate for postsurgical recurrence-free survival (RFS) in patients with NSCLC is lacking. RESEARCH QUESTION: What is the RFS after surgery in patients with stage I-III NSCLC at different time points, and what factors are associated with RFS? STUDY DESIGN AND METHODS: A systematic search was performed in MEDLINE, EMBASE, and Cochrane databases between January 2011 and June 2021. The primary outcome was RFS at 1, 2, 3, and 5 years postresection. Single-arm, random-effects meta-analyses were done to calculate effect estimates and 95% CIs. Analyses were stratified by stage/substage as per the AJCC Cancer Staging Manual, and RFS was estimated (1) after pooling studies, using seventh or eighth edition staging criteria; and (2) among studies using only the eighth edition. Meta-regressions were performed to assess associations between RFS and patient demographic/clinical characteristics of interest. RESULTS: Data from 471 studies comprising 1,060 surgical study arms were extracted. RFS estimates from 60,695 patients staged with the seventh or eighth edition were analyzed. RFS ranged from 96% at 1 year postresection to 82% at 5 years for stage I, and from 68% at 1 year to 34% at 5 years for stage III. Estimates for patients staged using only eighth edition criteria were slightly higher. Older age, higher percentage of male patients, advancing stage, larger tumor size, and geographic region (North America/Europe vs Asia) were significantly associated with worse RFS. INTERPRETATION: This study presents a comprehensive assessment of reported RFS from published clinical literature, offering estimates at multiple postsurgical time points and by geographic region. Findings can inform treatment decisions, clinical trial design, and future research to improve outcomes among patients with NSCLC.

Challenges and Burdens in the Coronary Artery Disease Care Pathway for Patients Undergoing Percutaneous Coronary Intervention: A Contemporary Narrative Review.

Clinical and economic burdens exist within the coronary artery disease (CAD) care pathway despite advances in diagnosis and treatment and the increasing utilization of percutaneous coronary intervention (PCI). However, research presenting a comprehensive assessment of the challenges across this pathway is scarce. This contemporary review identifies relevant studies related to inefficiencies in the diagnosis, treatment, and management of CAD, including clinician, patient, and economic burdens. Studies demonstrating the benefits of integration and automation within the catheterization laboratory and across the CAD care pathway were also included. Most studies were published in the last 5-10 years and focused on North America and Europe. The review demonstrated multiple potentially avoidable inefficiencies, with a focus on access, appropriate use, conduct, and follow-up related to PCI. Inefficiencies included misdiagnosis, delays in emergency care, suboptimal testing, longer procedure times, risk of recurrent cardiac events, incomplete treatment, and challenges accessing and adhering to post-acute care. Across the CAD pathway, this review revealed that high clinician burnout, complex technologies, radiation, and contrast media exposure, amongst others, negatively impact workflow and patient care. Potential solutions include greater integration and interoperability between technologies and systems, improved standardization, and increased automation to reduce burdens in CAD and improve patient outcomes.

Stereotactic body radiation therapy and thermal ablation for treatment of NSCLC: A systematic literature review and meta-analysis.

RATIONALE: Stereotactic body radiation therapy (SBRT) is the standard of care for inoperable early stage non-small cell lung cancer (NSCLC). Use of image guided thermal ablation (IGTA; including microwave ablation [MWA] and radiofrequency ablation [RFA]) has increased in NSCLC, however there are no studies comparing all three. OBJECTIVE: To compare the efficacy of IGTA (including MWA and RFA) and SBRT for the treatment of NSCLC. METHODS: Published literature databases were systematically searched for studies assessing MWA, RFA, or SBRT. Local tumor progression (LTP), disease-free survival (DFS), and overall survival (OS) were assessed with single-arm pooled analyses and meta-regressions in NSCLC patients and a stage IA subgroup. Study quality was assessed with a modified methodological index for non-randomized studies (MINORS) tool. RESULTS: Forty IGTA study-arms (2,691 patients) and 215 SBRT study-arms (54,789 patients) were identified. LTP was lowest after SBRT at one and two years in single-arm pooled analyses (4% and 9% vs. 11% and 18%) and at one year in meta-regressions when compared to IGTA (OR = 0.2, 95%CI = 0.07-0.63). MWA patients had the highest DFS of all treatments in single-arm pooled analyses. In meta-regressions at two and three-years, DFS was significantly lower for RFA compared to MWA (OR = 0.26, 95%CI = 0.12-0.58; OR = 0.33, 95%CI = 0.16-0.66, respectively). OS was similar across modalities, timepoints, and analyses. Older age, male patients, larger tumors, retrospective studies, and non-Asian study region were also predictors of worse clinical outcomes. In high-quality studies (MINORS score ≥ 7), MWA patients had better clinical outcomes than the overall analysis. Stage IA MWA patients had lower LTP, higher OS, and generally lower DFS, compared to the main analysis of all NSCLC patients. CONCLUSIONS: NSCLC patients had comparable outcomes after SBRT and MWA, which were better than those with RFA.

The Current Burden and Future Solutions for Preoperative Cataract-Refractive Evaluation Diagnostic Devices: A Modified Delphi Study.

Purpose: To obtain consensus on the key areas of burden associated with existing devices and to understand the requirements for a comprehensive next-generation diagnostic device to be able to solve current challenges and provide more accurate prediction of intraocular lens (IOL) power and presbyopia correction IOL success. Patients and Methods: Thirteen expert refractive cataract surgeons including three steering committee (SC) members constituted the voting panel. Three rounds of voting included a Round 1 structured electronic questionnaire, Round 2 virtual face-to-face meeting, and Round 3 electronic questionnaire to obtain consensus on topics related to current limitations and future solutions for preoperative cataract-refractive diagnostic devices. Results: Forty statements reached consensus including current limitations (n = 17) and potential solutions (n = 23) associated with preoperative diagnostic devices. Consistent with existing evidence, the panel reported unmet needs in measurement accuracy and validation, IOL power prediction, workflow, training, and surgical planning. A device that facilitates more accurate corneal measurement, effective IOL power prediction formulas for atypical eyes, simplified staff training, and improved decision-making process for surgeons regarding IOL selection is expected to help alleviate current burdens. Conclusion: Using a modified Delphi process, consensus was achieved on key unmet needs of existing preoperative diagnostic devices and requirements for a comprehensive next-generation device to provide better objective and subjective outcomes for surgeons, technicians, and patients.

How rebates, copayments, and administration costs affect the cost-effectiveness of osteoporosis therapies.

PURPOSE: Because of rising drug expenditures, cost considerations have become essential, necessitating the requirement for cost-effectiveness analyses for managed care organizations (MCOs). The study objective is to examine the impact of various drug-cost components, in addition to wholesale acquisition cost (WAC), on the cost-effectiveness of osteoporosis therapies. DESIGN: A Markov model of osteoporosis was used to exemplify different drug cost scenarios. METHODOLOGY: We examined the effect of varying rebates for oral bisphosphonates--risedronate and ibandronate--as well as considering the impact of varying copayments and administration costs for intravenous zoledronate. The population modeled was 1,000 American women, > or = 50 years with osteoporosis. Patients were followed for 1 year to reflect an annual budget review of formularies by MCOs. The cost of therapy was based on an adjusted WAC, and is referred to as net drug cost. The total annual cost incurred by an MCO for each drug regimen was calculated using the net drug cost and fracture cost. We estimated cost on a quality adjusted life year (QALY) basis. PRINCIPAL FINDINGS: When considering different rebates, results for risedronate versus ibandronate vary from cost-savings (i.e., costs less and more effective) to approximately $70,000 per QALY. With no risedronate rebate, an ibandronate rebate of approximately 65% is required before cost per QALY surpasses $50,000. With rebates greater than 25% for risedronate, irrespective of ibandronate rebates, results become cost-saving. Results also showed the magnitude of cost savings to the MCO varied by as much as 65% when considering no administration cost and the highest coinsurance rate for zoledronate. CONCLUSION: Our study showed that cost-effectiveness varies considerably when factors in addition to the WAC are considered. This paper provides recommendations for pharmaceutical manufacturers and MCOs when developing and interpreting such analyses.