Optimization-Based Stable Balancing Weights Versus Propensity Score Weighting for Samples With High Covariate Imbalance.

PURPOSE: To compare the performance (covariate balance, effective sample size [ESS]) of stable balancing weights (SBW) versus propensity score weighting (PSW). Two applied cases were used to compare performance: (Case 1) extreme imbalance in baseline covariates between groups and (Case 2) substantial discrepancy in sample size between groups. METHODS: Using the Premier Healthcare Database, we selected patients who (Case 1) underwent a surgical procedure with one of two different bipolar forceps between January 2000 and June 2020, or (Case 2) a neurological procedure using one of two different nonabsorbable surgical sutures between January 2000 and March 2020. Average treatment effects on the treated (ATT) weights were generated based on selected covariates. SBW was implemented using two techniques: (1) "grid search" to find weights of minimum variance at the lowest target absolute standardized mean difference (SMD); (2) finding weights of minimum variance at prespecified SMD tolerance. PSW and SBW methods were compared on postweighting SMDs, the number of imbalanced covariates, and ESS of the ATT-weighted control group. RESULTS: In both studies, improved covariate balance was achieved with both SBW techniques. All methods suffered from postweighting ESS that was lower than the unweighted control group's original sample size; however, SBW methods achieved higher ESS for the control groups. Sensitivity analyses using SBW to apply variable-specific SMD thresholds increased ESS, outperforming PSW. CONCLUSIONS: In this applied example, the optimization-based SBW method provided ample flexibility with respect to prespecification of covariate balance goals and resulted in better postweighting covariate balance and larger ESS as compared with PSW.

Increasing Incremental Burden of Surgical Bleeding Associated with Multiple Comorbidities as Measured by the Elixhauser Comorbidity Index: A Retrospective Database Analysis.

Purpose: Disruptive bleeding can complicate surgical procedures, increasing resource use, and impacting patients' well-being. This study aims to elucidate the impact of comorbidity on the risk of disruptive surgical-related bleeding and selected transfusion-associated complications, as well as the incremental cost of such bleeding. Patients and Methods: This retrospective analysis of the Premier Healthcare Database included patients who were age ≥18 years and who had a procedure of interest between 1-Jan-2019-31-Dec-2019: cholecystectomy, coronary artery bypass grafting, cystectomy, hepatectomy, hysterectomy, pancreatectomy, peripheral vascular, thoracic, and valve procedures (first=index). The Elixhauser comorbidity index was assessed on index date and patients were grouped by cumulative comorbidity score (0, 1, 2, 3, 4, 5, ≥6). Outcomes, all measured as in-hospital during index, included bleeding (diagnosis and/or intervention for bleeding), transfusion-associated complications (diagnosis of infection, acute renal failure, or vascular events), and incremental total hospital costs associated with bleeding. Multivariable generalized linear models were used to examine the association of comorbidity/bleeding with outcomes. Results: Of the 304,074 patients included, 7% experienced bleeding. The Elixhauser scores were distributed as follows: 0=29%, 1=23%, 2=18%, 3=12%, 4=8%, 5=5%, ≥6=5%. Odds of bleeding significantly increased with Elixhauser score: 1 comorbidity vs 0 (odds ratio [OR] =1.30, 95% confidence interval [95% CI] =1.19-1.43), and this trend continued to surge (≥6 comorbidities [OR=3.22, 95% CI=2.94-3.53]). Similarly, the odds of transfusion-associated complications significantly increased with comorbidities score: 1 comorbidity vs 0 (OR=2.14, 95% CI=1.88-2.34), ≥6 comorbidities vs 0 (OR=12.37, 95% CI=10.80-14.16). The incremental cost of bleeding also increased with comorbidities score; per-patient costs with and without bleeding were $18,132 vs $13,190, p < 0.001 among patients with 0 comorbidities and $28,952 vs $19,623, p < 0.001 among patients with ≥6 comorbidities. Conclusion: Higher comorbidity burden was associated with significant increases in the risk of surgical bleeding, subsequent transfusion-related complications, and incremental cost burden of bleeding.

Clinical and Economic Burden Associated with Disruptive Surgical Bleeding: A Retrospective Database Analysis.

Background: Hemostatic agents are used to control surgical bleeding; however, some patients experience disruptive bleeding despite the use of hemostats. In patients receiving hemostats, we compared clinical and economic outcomes between patients with vs without disruptive bleeding during a variety of surgical procedures. Methods: This was a retrospective analysis of the Premier Healthcare Database. Study patients were age ≥18 with a hospital encounter for one of 9 procedures with evidence of hemostatic agent use between 1-Jan-2019 and 31-Dec-2019: cholecystectomy, coronary artery bypass grafting (CABG), cystectomy, hepatectomy, hysterectomy, pancreatectomy, peripheral vascular, thoracic, and valve procedures (first procedure = index). Patients were grouped by presence vs absence of disruptive bleeding. Outcomes evaluated during index included intensive care unit (ICU) admission/duration, ventilator use, operating room time, length of stay (LOS), in-hospital mortality, and total hospital costs; 90-day all-cause inpatient readmission was also evaluated. Multivariable analyses were used to examine the association of disruptive bleeding with outcomes, adjusting for patient, procedure, and hospital/provider characteristics. Results: The study included 51,448 patients; 16% had disruptive bleeding (range 1.5% for cholecystectomy to 44.4% for valve). In procedures for which ICU and ventilator use is not routine, disruptive bleeding was associated with significant increases in the risks of admission to ICU and requirement for ventilator (all p≤0.05). Across all procedures, disruptive bleeding was also associated with significant incremental increases in days spent in ICU (all p≤0.05, except CABG), LOS (all p≤0.05, except thoracic), and total hospital costs (all p≤0.05); 90-day all-cause inpatient readmission, in-hospital mortality, and operating room time were higher in the presence of disruptive bleeding and varied in statistical significance across procedures. Conclusion: Disruptive bleeding was associated with substantial clinical and economic burden across a wide variety of surgical procedures. Findings emphasize the need for more effective and timely intervention for surgical bleeding events.

Clinical and Economic Burden Associated with Prolonged Air Leaks Among Patients Undergoing Thoracic Resection: A Retrospective Database Analysis.

Purpose: Prophylactic use of lung sealants among patients undergoing thoracic resection has been reported for the management of intraoperative air leaks and is associated with a lower incidence of prolonged air leak (PAL) and a shorter length of stay (LOS). This study estimated the incremental economic and clinical burden of PAL among patients with lung sealants used during thoracic resection in the United States. Patients and Methods: This retrospective analysis examined hospital data (Premier Healthcare Database) for adults (age ≥18 years) with inpatient thoracic resection between October 2015 - March 2021 (first admission=index) and lung sealant used during their procedure. Follow-up extended through 90 days post-discharge. Patients were grouped by presence/absence of PAL (ie, diagnosis of post-procedural air leak or post-procedural pneumothorax with associated LOS exceeding 5 days). Outcomes included intensive care unit (ICU) days, total index hospital costs, all-cause 30-, 60-, and 90-day readmission, discharge status, and in-hospital mortality. Generalized linear models quantified associations between PAL and outcomes, accounting for hospital-level clustering, and patient, procedure, and hospital/provider characteristics. Results: Among the 9727 patients included for study (51.0% female, 83.9% white, mean age 66 years), 12.5% had PAL, which was associated with significant incremental increases in ICU days (0.93 days, p<0.001) and total hospital cost ($11,119, p<0.001). PAL also decreased the likelihood of discharge to home (from 91.3% to 88.1%, p<0.001) and increased the risk of readmission within 30, 60, and 90 days by up to 34.0% (from 9.3% to 12.6%;11.7% to 15.4%;13.6% to 17.2%, respectively), all p<0.01. Absolute risk of mortality was low, but two times higher in patients with PAL versus those without PAL (2.4% vs 1.1%, p=0.001). Conclusion: This analysis demonstrates that despite the prophylactic use of lung sealants, PAL continues to put a burden on the healthcare system, highlighting an unmet need for improved sealant technology.

Trends and patterns of initial percutaneous nephrolithotomy and subsequent procedures among commercially-insured US adults with urinary system stone disease: a 10-year population-based study.

PURPOSE: To describe trends and patterns of initial percutaneous nephrolithotomy (PCNL) and subsequent procedures from 2010 to 2019 among commercially-insured US adults with urinary system stone disease (USSD). METHODS: Retrospective study of administrative data from the IBM® MarketScan® Database. Eligible patients were aged 18-64 years and underwent PCNL between 1/1/2010 and 12/31/2019. Measures of interest for analysis of trends and patterns included the setting of initial PCNL (inpatient vs. outpatient), percutaneous access (1 vs. 2-step), and the incidence, time course, and type of subsequent procedures (extracorporeal shockwave lithotripsy [SWL], ureteroscopy [URS], and/or PCNL) performed up-to 3 years after initial PCNL. RESULTS: A total of 8,348 patients met the study eligibility criteria. During the study period, there was a substantial shift in the setting of initial PCNL, from 59.9% being inpatient in 2010 to 85.3% being outpatient by 2019 (P < 0.001). The proportion of 1 vs. 2-step initial PCNL fluctuated over time, with a low of 15.1% in 2016 and a high of 22.0% in 2019 but showed no consistent yearly trend (P = 0.137). The Kaplan-Meier estimated probability of subsequent procedures following initial PCNL was 20% at 30 days, 28% at 90 days, and 50% at 3 years, with slight fluctuations by initial PCNL year. From 2010 to 2019, the proportion of subsequent procedures accounted for by URS increased substantially (from 30.8 to 51.8%), whereas SWL decreased substantially (from 39.5 to 14.7%) (P < 0.001). CONCLUSIONS: From 2010 to 2019, PCNL procedures largely shifted to the outpatient setting. Subsequent procedures after initial PCNL were common, with most occurring within 90 days. URS has become the most commonly-used subsequent procedure type.

Bariatric surgery and weight loss in the short- and long-term: Evidence from NHANES 2015-2018.

The present study aimed to examine short- and long-term weight change in a nationally representative sample of US adults who reportedly underwent bariatric surgery. Individuals aged 20-64 at survey from the US National Health and Nutrition Examination Survey 2015-2018 were included in the analyses (n = 6776). The primary comparison groups include 62 participants who underwent bariatric surgery, 1531 eligible but did not receive surgery, and 5183 not eligible for bariatric surgery. After adjusting for demographic characteristics and comorbidity, adults who reported receiving bariatric surgery were 5.0 times (4.0-6.0) more likely to achieve at least 20% weight loss from maximum weight relative to those who were eligible but reported no surgery. The likelihood appeared to be higher when surgery was performed within 10 years (short-term, PR 5.5, 95% CI: 4.0, 7.0) relative to surgeries that were performed for 10 or more years (long-term, PR 3.6, 95% CI: 2.0, 5.3). In this nationally representative sample of US adults, respondents who received bariatric surgery achieved substantial and significant weight loss compared with those who were eligible and did not receive bariatric surgery. Weight loss appeared to be most apparent in the short term and persisted over the long term.

Incremental Healthcare Cost Implications of Retreatment Following Ureteroscopy or Percutaneous Nephrolithotomy for Upper Urinary Tract Stones: A Population-Based Study of Commercially-Insured US Adults.

Purpose: This study describes the incremental healthcare costs associated with retreatment among adults undergoing ureteroscopy (URS) or percutaneous nephrolithotomy (PCNL) for upper urinary tract stones (UUTS). Patients and Methods: The IBM® MarketScan® Commercial Database was used to identify adults aged 18-64 years with UUTS treated with URS or PCNL between January 2010 and December 2019. Patients had 12 months of continuous insurance coverage before (baseline) and after (follow-up) the first (index) procedure. The primary outcome was total all-cause healthcare costs measured over the 365-day follow-up period, not inclusive of index costs. Generalized linear models were used to estimate the incremental costs associated with retreatment within 90 (early) or 91-365 days post-index (later) relative no retreatment. The models adjusted for demographics, comorbidities, stone(s) location, treatment setting, procedural characteristics (eg, 1-step vs 2-step PCNL) and index year. Results: Approximately 23% (27,402/119,800) of URS patients were retreated (82% had early retreatments). The adjusted mean total cost was $10,478 (95% CI: $10,281-$10,675) for patients with no retreatment, $25,476 (95% CI: $24,947-$26,004) for early retreatment ($14,998 incremental increase, p<0.01), and $32,868 [95% CI: $31,887-$33,850] for later retreatment ($22,391 incremental increase, p<0.01). Approximately 36% (1957/5516) of PCNL patients were retreated (78% had early retreatments). The adjusted mean total cost was $13,446 (95% CI: $12,659-$14,273) for patients with no retreatment, $37,036 [95% CI: $34,926-$39,145]) for early retreatment ($23,570 incremental increase, p<0.01), and $35,359 (95% CI: $32,234-$38,484) for later retreatment ($21,893 incremental increase, p<0.01). Conclusion: Retreatment during the first year following URS or PCNL was needed in 23% and 36% of patients, respectively, and was associated with an economic burden of up to $23,500 per patient. The high rate of retreatment and associated costs demonstrate there is an unmet need to improve mid- to long-term results in URS and PCNL.

Real-world economic and clinical outcomes associated with current hemostatic matrix use in spinal surgery.

Aim: Bleeding during spine surgery is controlled using topical hemostatic agents. Studies have reported outcomes between Surgiflo® and Floseal, the most widely used flowable hemostatic matrices, but have not included the latest Surgiflo formulation which is more adherent to the bleeding surface than prior formulations. Materials & methods: A propensity score-matched analysis was conducted using the Premier Healthcare Database to compare economic and clinical outcomes of adults undergoing inpatient spinal surgery between 2013 and 2018 receiving current Surgiflo or Floseal. Results: This retrospective study included 28,910 patients in each group and found comparable outcomes for bleeding events, overall transfusion rate, inpatient mortality and readmissions between Surgiflo and Floseal. Surgiflo was associated with $430 (USD) lower hospitalization costs, shorter length of stay and shorter operating room time than Floseal.

Topical hemostatic agents such as Surgiflo^® and Floseal are used during invasive surgery to manage bleeding. We compared outcomes of spine surgeries that used either of two most frequently used topical hemostatic agents, Surgiflo or Floseal. This is the largest retrospective study presenting economic and clinical outcomes of patients receiving Surgiflo versus Floseal during spine surgery using the latest product formulations. The study suggests that clinical outcomes are comparable between Surgiflo and Floseal groups and that Surgiflo is associated with lower hospitalization costs, slightly shorter hospital stay and shorter operating room time among patients undergoing spine surgery.

Retrospective Comparison of Clinical and Economic Outcomes of Non-Donor Patients Undergoing Radical Nephrectomy Using One of Two Different Linear Stapler Technologies for Transection of the Renal Vessels: Fixed-Height Gripping Surface Reloads vs Variable-Height Reloads.

Purpose: To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels. Patients and Methods: Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission). The primary outcome was in-hospital hemostasis-related complications (hemorrhage, acute posthemorrhagic anemia, and/or procedure to control bleeding) during the index admission. Secondary outcomes included index admission intraoperative injury, blood transfusion, conversion from minimally invasive to open surgery, total hospital costs, length of stay (LOS), discharge status, and mortality as well as 30-day all-cause inpatient readmission. We used stable balancing weights to balance the FHGS and VHTS groups on numerous patient, procedure, and hospital/provider characteristics, allowing a maximum post-weighting standardized mean difference ≤0.01 for all covariates; we also exactly matched the groups on laterality (right vs left kidney) and intended surgical approach (open, laparoscopic, robotic). We used bivariate multilevel mixed-effects generalized linear models accounting for hospital-level clustering to compare the study outcomes between the FHGS and VHTS groups. Results: After weighting, the FHGS and VHTS groups comprised 2952 and 795 patients, respectively. The observed incidence proportion of the primary outcome of hemostasis-related complications during the index admission was similar between the groups (8.6% for FHGS vs 9.0% for VHTS, difference 0.4% [95% CI -3.2% to 2.5%], P=0.808). Differences between the FHGS and VHTS groups were not statistically significant for any of the secondary outcomes. Conclusion: Endoscopic surgical staplers have become common for transection of the renal vessels during radical nephrectomy, with FHGS and VHTS being the predominant reload types. In this retrospective study of 3747 non-donor patients undergoing radical nephrectomy, use of FHGS vs VHTS reloads was associated with similar clinical and economic outcomes.

Clinical and economic outcomes after sternotomy for cardiac surgery with skin closure through 2-octyl cyanoacrylate plus polymer mesh tape versus absorbable sutures plus waterproof wound dressings: a retrospective cohort study.

BACKGROUND: To compare clinical and economic outcomes after sternotomy for cardiac surgery with skin closure through 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT) versus conventional absorbable sutures plus waterproof wound dressings (CSWWD). METHODS: Retrospective study using the Premier Healthcare Database. Patients undergoing a cardiac surgery requiring sternotomy with 2OPMT or CSWWD were included. Primary outcome was 60-day cumulative incidence of diagnosis for wound complications (infection, dehiscence). Secondary outcomes were index admission hospital length of stay (LOS), total hospital-borne costs, discharge status, and 60-day cumulative incidences of inpatient readmission and reoperation. After propensity score matching, outcomes were compared between the 2OPMT and CSWWD groups using bivariate multilevel mixed-effects generalized linear models. RESULTS: Overall, 7,901 2OPMT patients and 10,775 CSWWD patients were eligible for study. After propensity score matching on 68 variables, each group comprised 5,338 patients (total study N = 10,676). The 2OPMT and CSWWD groups did not differ significantly in terms of the 60-day cumulative incidences of wound complication (3.47% vs 3.47%, p = 0.996), inpatient readmission (12.6% vs. 13.6%, p = 0.354), and reoperation (10.3% vs 10.1%, p = 0.808), as well as discharge to home versus non-home setting (77.2% vs. 75.1%), p = 0.254. However, the 2OPMT group had significantly lower LOS (9.2 days vs 10.6 days, p < 0.001) and total hospital-borne costs ($50,174 vs $60,526, p < 0.001). CONCLUSIONS: This large observational study provides evidence that sternotomy skin closure with 2OPMT is associated with nearly identical 60-day cumulative incidence of wound complication as compared with CSWWD, while exhibiting a significant association with lower LOS and total hospital-borne costs. Trial registration Not applicable.

Real-World Clinical and Economic Outcomes Associated with Surgiflo® vs Floseal in Cardiovascular Surgeries in the US.

Background: Topical hemostatic agents are an option for controlling bleeding during cardiovascular surgery. Previous studies comparing topical hemostatic agents in cardiovascular surgery predate the 2012 reformulation of Surgiflo®, which had been re-engineered to increase paste viscosity and thus be more adherent to the bleeding surface. Objective: To compare clinical and economic outcomes in patients receiving the current formulation of Surgiflo vs Floseal during cardiovascular surgeries. Methodology: A retrospective analysis was conducted using the Premier Healthcare Database. Eligible patients had an inpatient cardiovascular surgery between 1/1/2013 and 6/1/2018, were ≥18 years old and received the current formulation of Surgiflo or Floseal during surgery. Propensity score matching was performed, with exact matching on the surgery year and surgery type (aortic, coronary artery bypass grafting, valve, or other). Descriptive analysis and generalized estimating equations models compared outcomes between the Surgiflo and Floseal groups. Results: The matched sample included 5768 patients in each group (mean age: 66.5 years; 66.3% male). In the matched sample, rates of any documented bleeding event were similar in Surgiflo and Floseal groups (6.9% vs 7.2%; P = 0.576). Differences in transfusion rates between patients receiving Surgiflo vs Floseal varied by operational definition and timing of measurement but did not differ by >2 percentage points. Compared to Floseal, patients who received Surgiflo experienced longer surgery duration (306.0 vs 299.4 minutes), lower hospitalization cost ($44,146 vs $46,812), and lower odds of readmission at 30, 60, and 90 days post-discharge (all P < 0.05). Inpatient mortality and LOS were comparable between Surgiflo and Floseal (all P > 0.05). Conclusion: In this large study of real-world clinical and economic outcomes after cardiovascular surgery involving the current formulation of Surgiflo vs Floseal, Surgiflo was associated with mostly similar clinical outcomes as compared with Floseal. Differences in selected economic/resource use outcomes were also observed, for which root-cause analysis in future research would be informative.

Outcomes associated with the use of a new powered circular stapler for left-sided colorectal reconstructions: a propensity score matching-adjusted indirect comparison with manual circular staplers.

BACKGROUND: This was a retrospective, matching-adjusted indirect comparison of clinical outcomes between patients from a single-arm trial of the ECHELON CIRCULAR™ Powered Stapler (ECP) and those from a historical cohort of patients who underwent left-sided colorectal resection using conventional manual circular staplers, extracted from the Premier Healthcare Database. METHODS: Patients in the ECP trial cohort were propensity score matched to those in the historical cohort through nearest neighbor matching. Outcomes included 30-day readmission rates; length of stay (LOS) for the index admission; rates of anastomotic leak, pelvic abscess, ileus/small bowel obstruction, infection, bleeding, and stoma creation. RESULTS: The study included 168 patients in the ECP trial cohort and 4544 patients in the historical cohort; 165 ECP trial patients were matched to 1348 historical cohort patients. After matching, conversions were more prevalent in the historical cohort than the ECP trial cohort (4.2% ECP vs. 10.2% historical, p = 0.001). Relative to the historical cohort, the ECP trial cohort had statistically significant lower rates of 30-day inpatient readmission (6.1% vs. 10.8%, p = 0.019), anastomotic leak (1.8% vs. 6.9%, p < 0.001), ileus/small bowel obstruction (4.8% vs. 14.7%, p < 0.001), infection (1.8% vs. 5.7%, p = 0.001), and bleeding (1.8% vs. 9.2%, p < 0.001) during the index admission or within 30 days thereafter. No statistically significant differences in rates of pelvic abscess, stoma creation, or LOS were found between the two cohorts. Three sensitivity analyses to address the difference in conversion rates yielded largely consistent results, with loss of statistical significance for inpatient admission in some cases. This study is limited by its potential for differences in unmeasurable factors between the ECP trial and historical cohorts. CONCLUSIONS: In this study, the ECP trial cohort had lower incidence proportions of several surgical complications as compared with the historical cohort. Further controlled prospective clinical studies are needed to confirm the validity of this finding.

Applied comparison of large-scale propensity score matching and cardinality matching for causal inference in observational research.

BACKGROUND: Cardinality matching (CM), a novel matching technique, finds the largest matched sample meeting prespecified balance criteria thereby overcoming limitations of propensity score matching (PSM) associated with limited covariate overlap, which are especially pronounced in studies with small sample sizes. The current study proposes a framework for large-scale CM (LS-CM); and compares large-scale PSM (LS-PSM) and LS-CM in terms of post-match sample size, covariate balance and residual confounding at progressively smaller sample sizes. METHODS: Evaluation of LS-PSM and LS-CM within a comparative cohort study of new users of angiotensin-converting enzyme inhibitor (ACEI) and thiazide or thiazide-like diuretic monotherapy identified from a U.S. insurance claims database. Candidate covariates included patient demographics, and all observed prior conditions, drug exposures and procedures. Propensity scores were calculated using LASSO regression, and candidate covariates with non-zero beta coefficients in the propensity model were defined as matching covariates for use in LS-CM. One-to-one matching was performed using progressively tighter parameter settings. Covariate balance was assessed using standardized mean differences. Hazard ratios for negative control outcomes perceived as unassociated with treatment (i.e., true hazard ratio of 1) were estimated using unconditional Cox models. Residual confounding was assessed using the expected systematic error of the empirical null distribution of negative control effect estimates compared to the ground truth. To simulate diverse research conditions, analyses were repeated within 10 %, 1 and 0.5 % subsample groups with increasingly limited covariate overlap. RESULTS: A total of 172,117 patients (ACEI: 129,078; thiazide: 43,039) met the study criteria. As compared to LS-PSM, LS-CM was associated with increased sample retention. Although LS-PSM achieved balance across all matching covariates within the full study population, substantial matching covariate imbalance was observed within the 1 and 0.5 % subsample groups. Meanwhile, LS-CM achieved matching covariate balance across all analyses. LS-PSM was associated with better candidate covariate balance within the full study population. Otherwise, both matching techniques achieved comparable candidate covariate balance and expected systematic error. CONCLUSIONS: LS-CM found the largest matched sample meeting prespecified balance criteria while achieving comparable candidate covariate balance and residual confounding. We recommend LS-CM as an alternative to LS-PSM in studies with small sample sizes or limited covariate overlap.

Association of Complications with Healthcare Utilization and Hospital-Borne Costs Among Patients Undergoing Open Low Anterior Resection Using Curved Cutter Staplers.

PURPOSE: The ability of curved cutter staplers (CCS) to conform to the complex anatomy of the rectum has led to their widespread use in open low anterior resection (LAR). We describe the incidence of complications and their association with healthcare utilization and hospital-borne costs among patients who underwent open LAR with CCS, with the intent to provide contextual epidemiologic and economic burden data for future evaluations of innovations that may lead to a reduced incidence of complications. METHODS: Retrospective cohort study using Premier Healthcare Database. Studied patients were ≥18 years who underwent inpatient open LAR with CCS between October 1, 2016 and March 30, 2020 (index admission). Complications of interest included anastomotic leak, bleeding, infection, transfusion, and device complications/adverse incidents during the index admission. Outcomes included index admission hospital length of stay (LOS), non-home discharge status, total operating room (OR) time, total hospital-borne costs, and all-cause readmissions within 30, 60, and 90 days post discharge from index admission. Multivariable regression models were used to compare outcomes between patients with vs without any complication of interest. RESULTS: The study included 618 patients with a mean age of 61 years, of whom 57% were males. The incidence proportion of any complication during the index admission for open LAR with CCS was 28% (95% CI: [23.9%, 31.0%], n=170). As compared with patients experiencing no complications, those with a complication had higher adjusted mean total hospital costs ($38,159 vs $22,303, p<0.001), non-home discharge status (21.8% vs 9.2%, p=0.004), mean LOS (13 days vs 6 days, p<0.001), and mean OR time (362 mins vs 291 mins, p<0.001). There were no significant differences in all-cause readmissions between patients with vs without complications. CONCLUSION: Among patients undergoing open LAR with CCS, over a quarter of patients experienced a complication, resulting in a substantial burden to the healthcare system.

Real-World Outcomes of Patients Undergoing Open Colorectal Surgery with Wound Closure Incorporating Triclosan-Coated Barbed Sutures: A Multi-Institution, Retrospective Database Study.

PURPOSE: Open colorectal surgery is associated with a high rate of postoperative wound complications. This is a single-arm study of real-world outcomes of triclosan-coated barbed suture (Ethicon's STRATAFIXTM Symmetric PDSTM Plus Knotless Tissue Control Device [SSPP]) used in open colorectal surgery. METHODS: Retrospective cohort study using the Premier Healthcare Database. The study included patients who underwent an inpatient open colorectal surgery with wound closure using SSPP (size 0 or 1 to increase the likelihood the suture was used in fascia) between October 2015-September 2019 (N=593). Wound complications, hospital length of stay, total hospital costs (2019 US$), and all-cause readmissions post-discharge were measured. Post-hoc multivariable analyses compared wound complications between non-elective admissions and elective. RESULTS: The overall incidence of wound complications within 30-days post-procedure was 7.1%, with the majority of those being surgical site infections (SSI) (6.0%). Mean operation time was 190 (standard deviation [SD]=64.4) mins, postoperative length of stay was 8.1 (SD=11.9) days, 30-day readmission rate was 11.8%, and total hospital costs were $31,693 (SD=$40,076). As compared with published literature on the rate of SSI in colorectal surgery, the 30-day rate of SSI in the present study (6.0%) fell within the range of 5.4% to 18.2% for open colorectal surgery and from 4.3% to 21.5% for combined open and minimally invasive procedures. Multivariable-adjusted incidence proportions of wound complications were slightly lower for non-elective admissions and did not differ significantly from those of elective admissions. CONCLUSION: The rate of wound complications observed in the present study falls within the range of rates previously reported in the literature, suggesting a safe and effective role for SSPP in open colorectal surgery. In post hoc analyses, the adjusted rate of wound complications was similar between non-elective and elective admissions. Head-to-head studies are required to determine comparative advantages or disadvantages for SSPP versus other sutures.

Improving visual communication of discriminative accuracy for predictive models: the probability threshold plot.

OBJECTIVES: To propose a visual display-the probability threshold plot (PTP)-that transparently communicates a predictive models' measures of discriminative accuracy along the range of model-based predicted probabilities (Pt). MATERIALS AND METHODS: We illustrate the PTP by replicating a previously-published and validated machine learning-based model to predict antihyperglycemic medication cessation within 1-2 years following metabolic surgery. The visual characteristics of the PTPs for each model were compared to receiver operating characteristic (ROC) curves. RESULTS: A total of 18 887 patients were included for analysis. Whereas during testing each predictive model had nearly identical ROC curves and corresponding area under the curve values (0.672 and 0.673), the visual characteristics of the PTPs revealed substantive between-model differences in sensitivity, specificity, PPV, and NPV across the range of Pt. DISCUSSION AND CONCLUSIONS: The PTP provides improved visual display of a predictive model's discriminative accuracy, which can enhance the practical application of predictive models for medical decision making.

Evolving Treatment Patterns for Hospitalized COVID-19 Patients in the United States in April 2020-July 2020.

We sought to examine the trend (April-July) in the treatment patterns among hospitalized COVID-19 patients using the Premier Healthcare Database (PHD). In the analysis, we identified 53,264 patients from 302 hospitalsthat continuously provided inpatient data from April 1, 2020 to July 31, 2020 to the PHD, a nationwide, population-based multihospital research database in the US. We used generalized estimating equations (GEE) models to assess changes in the proportion of therapies used during the study period. After adjusting for patient and provider factors, a decline in hydroxychloroquine and an increase in azithromycin and dexamethasone were observed among COVID-19 patients during the 4-month study period.