Comparative Effectiveness Analysis Research Articles

Global Trends and Collaborative Models in Manipulative Therapy for Low Back Pain: A Bibliometric and Academic Network Analysis.

Background Low back pain (LBP) is a prevalent condition that significantly affects work productivity and quality of life. Despite advancements in treatment, LBP continues to pose a global health challenge, with increasing research on manipulative therapy as a non-invasive treatment option. This study aims to provide a comprehensive bibliometric analysis of global research trends in manipulative therapy for LBP. Summary This study utilized the Web of Science Core Collection database to analyze global research dynamics on manipulative therapy for LBP from 1998 to 2023. A total of 2,879 articles were identified and analyzed using CiteSpace software, revealing key research trends, leading countries, and influential contributors. The analysis demonstrated that research on manipulative therapy for LBP has been steadily increasing, particularly between 2019 and 2021. The United States, the Netherlands, and Denmark were among the leading countries in this field. Core research concepts identified through keyword co-occurrence analysis include "low back pain," "manipulative therapy," and "spinal manipulation." Key Messages Manipulative therapy for LBP is a growing field with increasing global interest, particularly between 2019 and 2021. The United States, Netherlands, and Denmark are leading contributors to the research, with notable academic collaborations. Future research should focus on comparative treatment effectiveness, safety assessments, and mechanistic analyses to further validate the role of manipulative therapy in LBP management.

A gift of life, not immortality: Evaluation of a strategy of heart transplant listing in the older patient with advanced heart failure

Patients 65 years of age or older represent the fastest-growing demographic group added to the U.S. heart transplant (HT) list. While post-HT outcomes appear acceptable, immortal time bias is introduced if adverse outcomes that occur while waiting for HT are not considered. Recent durable left ventricular assist device (dLVAD) technological innovations have engendered the question of whether this patient subgroup would achieve equivalent survival from a strategy of primary dLVAD implant as opposed to HT listing. We identified adults ≥65 years of age listed for HT between 2018-2021, excluding persons with dLVAD support and/or multi-organ listing. Among 1176 patients, 2-year survival from HT listing was 78.4 ± 1.2%, similar to the 71% to 75% reported in The Society of Thoracic Surgeons (STS) Intermacs National Database for older adults. Linkage of the Scientific Registry of Transplant Recipients with STS Intermacs would enable comparative effectiveness analyses of surgical heart failure therapeutic strategies in high-risk patient cohorts.

P3 Multivariate Network Meta-Analysis Using Restored Accurate Within-Study Correlation Information: Application to Comparative Effectiveness Analysis of Biologics for Plaque Psoriasis

P3 Multivariate Network Meta-Analysis Using Restored Accurate Within-Study Correlation Information: Application to Comparative Effectiveness Analysis of Biologics for Plaque Psoriasis

Digital health technology to support patient-centered shared decision making at point of care for juvenile idiopathic arthritis.

Despite availability of multiple FDA approved therapies, many children with juvenile idiopathic arthritis (JIA) suffer pain and disability due to uncontrolled disease. The term JIA includes a heterogeneous set of conditions unified by chronic inflammatory arthritis, collectively affecting 1:1,000 children. When reviewing treatment options with families the rheumatologist currently refers to the experience of the average patient in relatively small controlled clinical trials, to consensus-based treatment plans, or increasingly the choice is dictated by the formulary restrictions of insurance payers. The current paradigm for treatment selection does not incorporate real-world evidence of treatment effectiveness centered to the individual patients with whom decisions are to be made. Treatment decisions based on the evidence of the average patient are not optimized to reflect the unique clinical characteristics of an individual with JIA and their disease course, nor does it account for heterogeneous treatment effects. To guide treatment choices centered around each patient, we describe a novel concept of utilizing digital health technology to bring patient-centered information into shared decision-making discussions based on comparative effectiveness analysis of electronic health record or observational clinical registry data of patients with similar characteristics. The envisioned digital tool will organize and present data relevant to the individual patient and enable evidence-based individualized treatment decision making when used in a collaborative manner with the patient family and rheumatologist. Capabilities in digital health technology, data capturing, and analytical methodologies are ripe for this endeavor. This brings the concept of a learning health system directly to the point of care.

Association between smoking and prostate cancer survivors' long-term quality of life and function: an analysis of the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study.

There is limited evidence of tobacco smoking's effect on cancer survivors' quality of life (QOL) and function. As the natural history of localized prostate cancer (PCa) is protracted, there is a need to identify modifiable risk factors that can influence PCa survivorship, such as tobacco smoking. We used up to 10-year survey data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a prospective, population-based, observational study of patients diagnosed with localized PCa in 2011-2012. Survivors were categorized as never, former, and current smokers during survivorship. Adjusted multivariable linear regression models were used to assess the association between smoking and 5-year and 10-year scores on the 26-Item Expanded Prostate Index Composite (EPIC-26; PCa-specific domains) and 5-year scores on the Medical Outcomes Study 36-Item Short Form Survey (SF-36; general health domains). We included 2426 patients of whom 142 (6%) were current smokers, 1039 (43%) were former smokers, and 1245 (51%) were never smokers. Current smokers were more likely to be Black, low-income, and less formally educated (all p < 0.01). After adjustments, there was no association between smoking history with disease-specific functional outcomes (EPIC-26) at 5years or 10years (all p > 0.05). However, in adjusted analyses assessing general health domains (SF-36), compared to participants who never smoked, current smokers during survivorship had worse physical function (- 10.96, 95% CI - 16.37 to - 5.55, p < 0.01) at 5years. PCa survivors who continue to smoke experience worse physical functioning though there is no significant independent effect on PCa-specific functional domains. Prostate cancer survivors who continue to smoke experience worse physical functioning though there is no significant independent effect on PCa-specific functional domains. Smoking cessation may improve prostate cancer survivorship.

Population health value of being in target: Results from the Canadian Multi-Morbidity Model for Type 2 Diabetes

ObjectiveTo develop a microsimulation model for type 2 diabetes using population-level real-world data. Such a model allows for the synthesis of multiple data sources for comparative effectiveness analysis related to a variety of correlated outcomes. ApproachThe model was built using health state features including sex, age, diabetes duration, laboratory test results, and a history of major acute events. Features update using a cycle length of one month. Events modelled include myocardial infarction, stroke, heart failure, amputation and death. Model outputs include counts of events, lifetime healthcare costs and quality-adjusted life-years (QALYs). We then used the model to calculate the number of events that could be averted if a population with type 2 diabetes achieved treatment targets for HbA1c, blood pressure and LDL-cholesterol for 10 years. ResultsBringing all 60-year-olds with type 2 diabetes into target for 10 years would result in annual event reductions of 87.0 per 100,000 person-years for myocardial infarction, 49.4 for stroke, and 166.8 for heart failure. QALYs would improve by 1,155 per 100,000 patients. For 75-year-olds, annual event reductions would be 178.2, 56.8 and 261.6 per 100,000 person-years, respectively, and QALYs would improve by 2,121 per 100,000 patients. ConclusionsPopulation-level real-world data can be used to develop microsimulation models for type 2 diabetes that estimate long-term event risks, mortality and healthcare costs. This model is capable of comparative effectiveness and cost-effectiveness analysis of novel therapies in diabetes.

Breast Cancer Screening Using Mammography, Digital Breast Tomosynthesis, and Magnetic Resonance Imaging by Breast Density

Information on long-term benefits and harms of screening with digital breast tomosynthesis (DBT) with or without supplemental breast magnetic resonance imaging (MRI) is needed for clinical and policy discussions, particularly for patients with dense breasts. To project long-term population-based outcomes for breast cancer mammography screening strategies (DBT or digital mammography) with or without supplemental MRI by breast density. Collaborative modeling using 3 Cancer Intervention and Surveillance Modeling Network (CISNET) breast cancer simulation models informed by US Breast Cancer Surveillance Consortium data. Simulated women born in 1980 with average breast cancer risk were included. Modeling analyses were conducted from January 2020 to December 2023. Annual or biennial mammography screening with or without supplemental MRI by breast density starting at ages 40, 45, or 50 years through age 74 years. Lifetime breast cancer deaths averted, false-positive recall and false-positive biopsy recommendations per 1000 simulated women followed-up from age 40 years to death summarized as means and ranges across models. Biennial DBT screening for all simulated women started at age 50 vs 40 years averted 7.4 vs 8.5 breast cancer deaths, respectively, and led to 884 vs 1392 false-positive recalls and 151 vs 221 false-positive biopsy recommendations, respectively. Biennial digital mammography had similar deaths averted and slightly more false-positive test results than DBT screening. Adding MRI for women with extremely dense breasts to biennial DBT screening for women aged 50 to 74 years increased deaths averted (7.6 vs 7.4), false-positive recalls (919 vs 884), and false-positive biopsy recommendations (180 vs 151). Extending supplemental MRI to women with heterogeneously or extremely dense breasts further increased deaths averted (8.0 vs 7.4), false-positive recalls (1088 vs 884), and false-positive biopsy recommendations (343 vs 151). The same strategy for women aged 40 to 74 years averted 9.5 deaths but led to 1850 false-positive recalls and 628 false-positive biopsy recommendations. Annual screening modestly increased estimated deaths averted but markedly increased estimated false-positive results. In this model-based comparative effectiveness analysis, supplemental MRI for women with dense breasts added to DBT screening led to greater benefits and increased harms. The balance of this trade-off for supplemental MRI use was more favorable when MRI was targeted to women with extremely dense breasts who comprise approximately 10% of the population.

Comparative effectiveness analysis of survival with first-line palbociclib or ribociclib plus AI in HR + /HER2- advanced breast cancer (CEPRA study): preliminary analysis of real-world data from Thailand

BackgroundThe current standard first-line treatment for hormone receptor-positive/human epidermal growth factor receptor 2 negative (HR + /HER2 −) advanced breast cancer (ABC) is a combination of aromatase inhibitor (AI) plus CDK4/6 inhibitors (CDK4/6i). Direct comparison trials of different CDK4/6i are scarce. This real-world study compared the effectiveness of first-line AI plus ribociclib versus palbociclib.MethodsThis multicenter retrospective cohort study, conducted in six cancer centers in Thailand, enrolled patients with HR + /HER2 − ABC treated with first-line AI, and either ribociclib or palbociclib. Propensity score matching (PSM) was performed. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), time to chemotherapy (TTC), and adverse events.ResultsOf the 250 patients enrolled, 134 patients with ribociclib and 49 patients with palbociclib were captured after PSM. Baseline characteristics were well-balanced between groups. Median PFS in patients receiving ribociclib and palbociclib were 27.9 and 31.8 months, respectively (hazard ratio: 0.87; 0.55–1.37). The median OS in the AI + ribociclib arm was 48.7 months compared to 59.1 months in the AI + palbociclib arm (hazard ratio: 0.55; 0.29–1.05). The median TTC in the AI + palbociclib group was 56 months, but not reached in the AI + ribociclib group (p = 0.42). The ORR of AI + ribociclib and AI + palbociclib were comparable (40.5% vs. 53.6%, p = 0.29). Patients receiving palbociclib demonstrated a higher proportion of neutropenia compared to those receiving ribociclib, despite a similar dose reduction rate (p = 0.28). Hepatitis rate was similar between the ribociclib (21%) and palbociclib groups (22%). Additionally, a low incidence of QT prolongation was observed in both the ribociclib (5%) and palbociclib groups (4%).ConclusionThis preliminary analysis of a real-world study demonstrated the comparable effectiveness of ribociclib and palbociclib with AI as an initial therapy for HR + /HER2 − ABC. No statistically significant difference in PFS, OS, and TTC was found in patients treated with AI combined with palbociclib or ribociclib. Longer follow-up and further prospective randomized head-to-head studies are warranted.

Real-World Research on Retinal Diseases Using Health Claims Database: A Narrative Review.

Real-world data (RWD) has emerged as a crucial component in understanding and improving patient outcomes across various medical conditions, including retinal diseases. Health claims databases, generated from healthcare reimbursement claims, offer a comprehensive source of RWD, providing insights into patient outcomes, healthcare utilization, and treatment effectiveness. However, the use of these databases for research also presents unique challenges. This narrative review explores the role of real-world research on retinal diseases using health claims databases, highlighting their advantages, limitations, and potential contributions to advancing our understanding and management of the diseases. The review examines the applications of health claims databases in retinal disease research, including epidemiological studies, comparative effectiveness and safety analyses, economic burden assessments, and evaluations of patient outcomes and quality of care. Previous findings demonstrate the value of these databases in generating prevalence and incidence estimates, identifying risk factors and predictors, evaluating treatment effectiveness and safety, and understanding healthcare utilization patterns and costs associated with retinal diseases. Despite their strengths, health claims databases face challenges related to data limitations, biases, privacy concerns, and methodological issues. Accordingly, the review also explores future directions and opportunities, including advancements in data collection and analysis, integration with electronic health records, collaborative research networks and consortia, and the evolving regulatory landscape. These developments are expected to enhance the utility of health claims databases for retinal disease research, resulting in more comprehensive and impactful findings across diverse retinal disorders and robust real-world insights from a large population.

Characteristics and outcomes of patients with COVID-19 at high risk of disease progression receiving sotrovimab, oral antivirals or no treatment in England: a retrospective cohort study

Objective To describe characteristics and acute clinical outcomes for patients with COVID-19 treated with sotrovimab, nirmatrelvir/ritonavir or molnupiravir, or untreated patients at highest risk per National Health Service (NHS) criteria. Methods Retrospective study of non-hospitalized patients between 1 December 2021 and 31 May 2022, using data from the Discover-NOW dataset (North-West London). Included patients were aged ≥12 years and treated with sotrovimab, nirmatrelvir/ritonavir or molnupiravir, or untreated but expected to be eligible for early treatment per NHS highest-risk criteria. COVID-19-related and all-cause hospitalizations were reported for 28 days from COVID-19 diagnosis (index). Subgroup analyses were conducted in patients with advanced renal disease, those aged 18–64 and ≥65 years, and by period of Omicron BA.1, BA.2 and BA.5 (post-hoc exploratory) predominance. Results Overall, 1503 treated and 4044 eligible high-risk untreated patients were included. A high proportion of patients on sotrovimab had advanced renal disease (29.3%), ≥3 high-risk comorbidities (47.6%) and were aged ≥65 years (36.9%). Five of 696 (0.7%) patients on sotrovimab, <5/337 (0.3–1.2%) on nirmatrelvir/ritonavir, 10/470 (2.1%) on molnupiravir and 114/4044 (2.8%) untreated patients were hospitalized with COVID-19. Similar results were observed across all subgroups. The proportion of patients dying within 28 days of the index period was similarly low across all cohorts (<2%). Conclusion Patients receiving sotrovimab appeared to show evidence of multiple high-risk comorbidities. Low hospitalization rates were observed for all treated cohorts across subgroups and periods of predominant variants of concern. These results require confirmation with comparative effectiveness analyses adjusting for differences in underlying patient characteristics.

Clarifying terminology and definitions in education services for mental health users: A disambiguation study.

In the wake of the mental health crisis in children and adolescents, the coordination of education and mental health services has become a global priority. However, differing terminologies and classifications across sectors, hinder effective comparison. The classification in education focuses mainly on outputs like qualifications or throughputs like teaching programs. This proof-of-concept study tested the applicability of a standard classification of health services, the Description and Evaluation of Services and DirectoriEs (DESDE), to evaluate education services for mental health users in the context of Spain and The Netherlands. It was conducted alongside the PECUNIA project, that sought to develop methods for the assessment of mental health costs and outcomes in different sectors. The study followed an ontoterminology approach involving: 1) identification of services from a predefined list of 46 resource-use items, 2) disambiguation of identified services with the DESDE, and classifying them as accurate, ambiguous, vague or confuse; and 3) external validation by an expert panel. The analysis was conducted at the level of type of resource, target population and care provision. From the initial list, only ten of the resources could be categorized as services using DESDE, and not activities, interventions or professionals. Only four of them (8,65%) were accurate across all disambiguation categories. Experts were unaware of terminology problems in classification of service provision in the education sector. Classifications and glossaries can clarify service naming, description and costing allowing comparative effectiveness analysis and facilitating cross-sectoral planning. This should be grounded in common methodologies, tools, and units of analysis.

Outcomes after anti-tumour necrosis factor originator to biosimilar switching in children and young people with juvenile idiopathic arthritis in the UK: a national cohort study.

For cost-saving purposes, children and young people with juvenile idiopathic arthritis (JIA) are being switched (for non-medical reasons) from biological originators to biosimilars. Here, we aimed to investigate those who switched from an anti-tumour necrosis factor (TNF) originator to a biosimilar, regarding drug survival and disease activity, compared with a matched cohort who continued the originator. This analysis included all patients in the UK JIA Biologics Register switching directly from an anti-TNF originator to a biosimilar of the same product. All patients were matched (age, sex, disease duration, calendar year of when patients started originator therapy, line of therapy, and International League of Associations for Rheumatology [ILAR] category) to patients continuing the originator. For those matched successfully, a Cox proportional hazard model assessed whether drug persistence differed between those who switched compared with those who continued the originator. Overall change in the 71-joint juvenile arthritis disease activity score and the proportion of patients with a clinically important worsening score (by ≥1·7 units) after 6 months was compared between cohorts. This analysis was designed to address a priority research area set by our patient partners. There were 224 children and young people with non-systemic JIA (139 [62%] were female, and 85 [38%] were male) identified as switching from a biological originator to a biosimilar of the same product from Jan 1, 2017, to July 7, 2023. 143 (64%) patients were originally on adalimumab, 56 (25%) on etanercept, and 25 (11%) on infliximab. Of these, 164 patients were matched successfully to those continuing the originator. There was no evidence that patients switching were more likely to stop treatment compared with those continuing the originator, with a hazard ratio of 1·46 (95% CI 0·93-2·30). Of the 51 patients in the biosimilar group who stopped treatment, 18 (35%) switched back to the originator (14 in the first year), 28 (55%) started a different biological drug, and five (10%) discontinued all treatment by the last follow-up. Of the 87 matched patients with available disease activity, there was no evidence that JADAS-71 worsened more after 6 months, with an odds ratio of 0·71 (95% CI 0·34-1·51; p=0·38). In this matched comparative effectiveness analysis, children and young people with JIA switched from originators to biosimilars. Disease activity was similar between patients switching compared with those continuing the originator. Three quarters of patients were still receiving their biosimilar after 1 year, with switching back to originator uncommon, at only 9% after 1 year, suggesting good tolerability of non-medical switching in this patient population. This information is reassuring to clinicians and patients regarding the effect of non-medical biological switching. British Society for Rheumatology, Versus Arthritis, and National Institutes for Health Research Manchester Biomedical Research Centre.

Treatment intensification following glucagon-like peptide-1 receptor agonists in type 2 diabetes: Comparative effectiveness analyses between different basal insulins. RESTORE-G real-world study.

To compare the effectiveness of different basal insulins (BI) prescribed as an add-on to or switch from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy. Retrospective, real-world data from electronic medical records of 32 Italian diabetes clinics were used, after propensity score adjustment, to compare effectiveness after 6 months of treatment with second- versus first-generation BI (2BI vs. 1BI) or glargine 300 U/ml versus degludec 100 U/ml (Gla-300 vs. Deg-100), when added to (ADD-ON) or in substitution of (SWITCH) GLP-1 RA. Only comparisons, including a minimum of 100 patients per group, were performed to ensure adequate robustness of the analyses. In the ADD-ON cohort (N = 700), greater benefits of 2BI versus 1BI were found in glycated haemoglobin {HbA1c; estimated mean difference: -0.32% [95% confidence interval (CI) -0.62; -0.02]; p = .04} and fasting blood glucose [FBG; -20.73 mg/dl (95% CI -35.62; -5.84); p = .007]. In the SWITCH cohort (N = 2097), greater benefits of 2BI versus 1BI were found in HbA1c [-0.22% (95% CI -0.42; -0.02); p = .03], FBG [-10.15 mg/dl (95% CI -19.04; -1.26); p = .03], and body weight [-0.67 kg (95% CI -1.30; -0.04); p = .04]. In the SWITCH cohort starting 2BI (N = 688), marked differences in favour of Gla-300 versus Deg-100 were documented in HbA1c [-0.89% (95% CI -1.26; -0.52); p < .001] and FBG [-17.89 mg/dl (95% CI -32.45; -3.33); p = .02]. Using propensity score matching as a sensitivity analysis, the benefit on HbA1c was confirmed [-0.55% (95% CI -1.02; -0.08); p = .02]. BI titration was suboptimal in all examined cohorts. 2BI are a valuable option to intensify GLP-1 RA therapy. Switching to Gla-300 versus Deg-100 was associated with greater HbA1c improvement.

Pharmacogenomics, Race, and Treatment Outcome in Pediatric Acute Myeloid Leukemia.

Disparities in outcomes exist between Black and White patients with acute myeloid leukemia (AML), with Black patients experiencing poorer prognosis compared with their White counterparts. To assess whether varying intensity of induction therapy to treat pediatric AML is associated with reduced disparities in treatment outcome by race. A comparative effectiveness analysis was conducted of 86 Black and 359 White patients with newly diagnosed AML who were enrolled in the AML02 trial from 2002 to 2008 or the AML08 trial from 2008 to 2017. Statistical analysis was conducted from July 2023 through January 2024. Patients in AML02 were randomly assigned to receive standard low-dose cytarabine-based induction therapy or augmented high-dose cytarabine-based induction therapy, whereas patients in AML08 received high-dose cytarabine-based therapy. Cytarabine pharmacogenomic 10-single-nucleotide variant (ACS10) scores were evaluated for association with outcome according to race and treatment arm. This analysis included 86 Black patients (mean [SD] age, 8.8 [6.5] years; 54 boys [62.8%]; mean [SD] leukocyte count, 52 600 [74 000] cells/µL) and 359 White patients (mean [SD] age, 9.1 [6.2] years; 189 boys [52.6%]; mean [SD] leukocyte count, 54 500 [91 800] cells/µL); 70 individuals with other or unknown racial and ethnic backgrounds were not included. Among all patients without core binding factor AML who received standard induction therapy, Black patients had significantly worse outcomes compared with White patients (5-year event-free survival rate, 25% [95% CI, 9%-67%] compared with 56% [95% CI, 46%-70%]; P = .03). By contrast, among all patients who received augmented induction therapy, there were no differences in outcome according to race (5-year event-free survival rate, Black patients, 50% [95% CI, 38%-67%]; White patients, 48% [95% CI, 42%-55%]; P = .78). Among patients who received standard induction therapy, those with low ACS10 scores had a significantly worse 5-year event-free survival rate compared with those with high scores (42.4% [95% CI, 25.6%-59.3%] and 70.0% [95% CI, 56.6%-83.1%]; P = .004); however, among patients who received augmented induction therapy, there were no differences in 5-year event-free survival rates according to ACS10 score (low score, 60.6% [95% CI, 50.9%-70.2%] and high score, 54.8% [95% CI, 47.1%-62.5%]; P = .43). In this comparative effectiveness study of pediatric patients with AML treated in 2 consecutive clinical trials, Black patients had worse outcomes compared with White patients after treatment with standard induction therapy, but this disparity was eliminated by treatment with augmented induction therapy. When accounting for ACS10 scores, no outcome disparities were seen between Black and White patients. Our results suggest that using pharmacogenomics parameters to tailor induction regimens for both Black and White patients may narrow the racial disparity gap in patients with AML.

D74. Comparative Effectiveness Analysis of Ventral Hernia Repair with Panniculectomy: Evaluating Efficacy With and Without External Oblique Release

D74. Comparative Effectiveness Analysis of Ventral Hernia Repair with Panniculectomy: Evaluating Efficacy With and Without External Oblique Release

Perioperative complications and oncological outcomes of open versus robotic-assisted radical cystectomy: a propensity score-matched study.

To conduct a comparative effectiveness analysis between robot-assisted radical cystectomy (RARC) and open approach (ORC). A retrospective cohort study was conducted involving all patients undergoing radical cystectomy and urinary diversion for invasive bladder cancer at our institution from 2010 to 2018. Of a total 296 patients, we matched ORC and RARC cases based on age, BMI, Charlson comorbidity index, pathological TN staging of the tumor, prior radiotherapy, and type of diversion. The perioperative complications and oncological outcomes were compared. Eighty-nine patients were matched in the ORC and RARC groups. The median operative time was longer in RARC group (430min) than that of ORC group (372min) (p = 0.03); however, the median estimated blood loss (EBL) was significantly lower in RARC group (500ml) than that of ORC (700ml) (p < 0.0001). The median length of hospital stay (LOS) was significantly reduced in the RARC group (7days) compared to the ORC group (8days) (p = 0.02). There were no significant differences between both groups in 30- and 90-day postoperative complications (p = 0.3 and p = 0.2, respectively). A total of 68 deaths (38.2%) were observed, of which 36 (40.4%) were in ORC group while 32 (36%) were in RARC group (p = 0.5). The results were comparable in both groups regarding 5-year survival rate and cancer-specific survival (p = 0.3 and p = 0.1, respectively). RARC showed better perioperative outcomes in the form of less EBL and shortened LOS compared to ORC group. However, both RARC and ORC provide similar postoperative oncologic control, in terms of similar positive surgical margins, cancer-specific rates, and 5-year survival rates.

Serum urate change among gout patients treated with sodium-glucose cotransporter type 2 inhibitors vs. sulfonylurea: A comparative effectiveness analysis

ObjectiveTo investigate the serum urate (SU) change among gout patients initiating SGLT2i, and to compare with sulfonylurea, the second-most widely used glucose-lowering medication after metformin. MethodsWe conducted a cohort study of patients with gout and baseline SU >6 mg/dL who had SU measured within 90 days before and after SGLT2i or sulfonylurea initiation. Using multivariable linear regression, we compared SU change among SGLT2i initiators between those with and without diabetes and then compared SU change between SGLT2i and sulfonylurea. ResultsWe identified 28 patients with gout initiating SGLT2i (including 16 with diabetes) and 28 patients initiating sulfonylurea (all with diabetes). Among SGLT2i initiators, the mean within-group SU change was -1.8 (95 % CI, -2.4 to -1.1) mg/dL, including -1.2 (-1.8 to -0.6) mg/dL and -2.5 (-3.6 to -1.3) mg/dL among patients with and without diabetes, respectively, with an adjusted difference between those with and without diabetes of -1.4 (-2.4 to -0.5) mg/dL. The SU did not change after initiating sulfonylurea (+0.3 [-0.3 to 1.0] mg/dL). The adjusted SU change difference between SGLT2i vs. sulfonylurea initiation was -1.8 (-2.7 to -0.9) mg/dL in all patients. The SU reduction persisted regardless of urate-lowering therapy or diuretic use and the presence of diabetes, chronic kidney disease, or heart failure. ConclusionAmong patients with gout, SGLT2i was associated with a notable reduction in SU compared with sulfonylurea, with a larger reduction among patients without diabetes. With their proven cardiovascular-kidney-metabolic benefits, adding SGLT2i to current gout management could provide streamlined benefits for gout and its comorbidities.

Comparing survival of older ovarian cancer patients treated with neoadjuvant chemotherapy versus primary cytoreductive surgery: Reducing bias through machine learning

ObjectiveTo develop and evaluate a multidimensional comorbidity index (MCI) that identifies ovarian cancer patients at risk of early mortality more accurately than the Charlson Comorbidity Index (CCI) for use in health services research. MethodsWe utilized SEER-Medicare data to identify patients with stage IIIC and IV ovarian cancer, diagnosed in 2010–2015. We employed partial least squares regression, a supervised machine learning algorithm, to develop the MCI by extracting latent factors that optimally captured the variation in health insurance claims made in the year preceding cancer diagnosis, and 1-year mortality. We assessed the discrimination and calibration of the MCI for 1-year mortality and compared its performance to the commonly-used CCI. Finally, we evaluated the MCI's ability to reduce confounding in the association of neoadjuvant chemotherapy (NACT) and all-cause mortality. ResultsWe included 4723 patients in the development cohort and 933 in the validation cohort. The MCI demonstrated good discrimination for 1-year mortality (c-index: 0.75, 95% CI: 0.72–0.79), while the CCI had poor discrimination (c-index: 0.59, 95% CI: 0.56–0.63). Calibration plots showed better agreement between predicted and observed 1-year mortality risk for the MCI compared with CCI. When comparing all-cause mortality between NACT with primary cytoreductive surgery, NACT was associated with a higher hazard of death (HR: 1.13, 95% CI: 1.04–1.23) after controlling for tumor characteristics, demographic factors, and the CCI. However, when controlling for the MCI instead of the CCI, there was no longer a significant difference (HR: 1.05, 95% CI: 0.96–1.14). ConclusionsThe MCI outperformed the conventional CCI in predicting 1-year mortality, and reducing confounding due to differences in baseline health status in comparative effectiveness analysis of NACT versus primary surgery.

Treatment intensification following glucagon-like peptide-1 receptor agonist in type 2 diabetes: Comparative effectiveness analyses between free vs. fixed combination of GLP-1 RA and basal insulin. RESTORE-G real-world study

Background and aimsAdd-on of basal insulin (BI) to intensify the ongoing therapy with glucagon-like peptide 1 receptor agonist (GLP-1 RA) is recommended, but it is unclear if free or fixed combination of BI and GLP-1 RA produce similar outcomes. A retrospective comparative effectiveness analysis of the add-on of glargine 300 U/mL (Gla-300) to ongoing GLP-1 RA vs. switch to fixed ratio combination of degludec and liraglutide (iDegLira) was performed. Methods and resultsReal-world data collected in electronic medical records by 32 Italian diabetes clinics. Propensity score (PS) adjustment was applied to assess changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), body weight, and BI dose after 6 months from Gla-300 or iDegLira initiation.Compared to iDegLira group (N = 260), Gla-300+GLP-1 RA group (N = 255) had older age and higher levels of HbA1c (9.1 vs. 8.9%). After 6 months, statistically significant greater FBG improvement [estimated mean difference and 95% confidence intervals: −24.05 mg/dl (−37.04; −11.06; p = 0.0003) and BI dose increase [+0.03 U/kg (95%CI 0.00; 0.06); p = 0.009] were found in the free vs. fixed combination group, although low doses of BI (0.2 U/kg) were reached in both groups. Trends of larger HbA1c and body weight reductions with the free combination were also found, without reaching the statistical significance. ConclusionAlthough inertia in insulin initiation and titration was documented in both groups, higher benefit on FBG control was obtained with free vs. fixed combination, likely due to a better titration of BI and GLP-1 RA.

Fuzzy logic in association rule mining: limited effectiveness analysis

ABSTRACT This paper presents a comparative effectiveness analysis of fuzzy and non-fuzzy association rule mining (ARM). The corresponding motivation is the lack of relevant papers devoted to the effectiveness comparison between fuzzy and non-fuzzy ARM. The current research applies the results of fuzzy/non-fuzzy ARM to associative classification and uses the classification accuracy of the corresponding classifiers as the effectiveness measure. The research demonstrates that basic effectiveness comparison between fuzzy and non-fuzzy ARM does not necessarily speak in favour of fuzzy ARM. However, then the research demonstrates that fuzzy ARM has a distinctive ability to handle data inconsistencies, which results in the ability of corresponding fuzzy classifiers to not only provide class predictions but also indicate their certainty in the provided output. The research reveals some distinct correlation between classification accuracy and the degree of certainty in fuzzy associative classification: the greater certainty nearly always results in the better classification accuracy. This ability of fuzzy associative classifiers to indicate their certainty in the performed classification and the corresponding ability of fuzzy ARM to handle data inconsistencies are not applicable in non-fuzzy associative classifiers and ARM. Therefore, these abilities are used in the paper to substantiate the relevance of applying fuzzy logic in ARM.