Performance Status and End-of-Life Outcomes in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Androgen Receptor Targeted Therapy.

OBJECTIVES: Androgen receptor targeted therapies (ARTs) are widely preferred over taxane chemotherapy due to their good tolerability and similar efficacy. However, there is a paucity of data that support the use of ART therapy or describe end-of-life (EOL) outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) with reduced performance status (PS) (European Cooperative Oncology Group [ECOG] ≥2). METHODS: We performed a retrospective, single-institution study of 142 patients with mCRPC who received ART therapy between 2010 and 2021. We assessed each record for baseline demographic and clinical information, ART treatment course, and survival and EOL outcomes. Our primary aim was to compare overall survival (OS) between the two groups (ECOG ≥2 vs 0 to 1), and our secondary aim was to describe EOL outcomes. Fisher exact tests and Wilcoxon signed-rank tests were used to compare baseline characteristics. Cox regression was used to compare OS for patients with ECOG ≥2 at the start of treatment with those who had an ECOG of 0 or 1. Descriptive analyses were performed to assess EOL outcomes between the groups. RESULTS: Patients with mCRPC and decreased PS experienced shorter OS on ART compared with those with higher PS. Moreover, when examining EOL outcomes, a near majority of these patients died in the hospital, with a greater percentage among those with an ECOG ≥2. CONCLUSION: These findings highlight the need for continual assessment of PS, improved shared decision-making in ART treatment, and additional research exploring the association between PS and EOL outcomes.

Preoperative Cervical Epidural Steroid Injections: Utilization and Postoperative Complications in ACDF, PCDF, and Decompression.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Identify factors associated with cervical epidural steroid injection (CESI) receipt before anterior cervical discectomy and fusion (ACDF), posterior cervical decompression and fusion (PCDF), or decompression; evaluate the association between CESI receipt and 90-day postoperative complications; and determine characteristics of CESI associated with complications. SUMMARY OF BACKGROUND DATA: Previous literature has suggested that a preoperative CESI may increase the risk of postoperative complications. However, these studies were limited in the procedures and complications they evaluated. METHODS: The IBM MarketScan database was queried for patients aged 18 years or older who underwent ACDF, PCDF, or cervical decompression for disc herniation, stenosis, radiculopathy, myelopathy, and/or spondylosis without myelopathy between January 1, 2014 and September 30, 2020. CESI receipt within 12 months preoperatively, injection characteristics, and postoperative complications were extracted. Multivariable logistic regression models were used to investigate associations between patient characteristics and receipt of CESI, receipt of a CESI and each 90-day postoperative complication, and CESI characteristics and each 90-day complication. RESULTS: Among the unique patients who underwent each procedure, 20,371 ACDF patients (30.93%), 1259 (22.24%) PCDF patients, and 3349 (36.30%) decompression patients received a preoperative CESI. In all 3 cohorts, increasing age, increasing comorbidity burden, smoker status, and diagnosis of myelopathy were associated with decreased odds of preoperative CESI receipt, while female sex and diagnosis of radiculopathy and spondylosis without myelopathy were associated with increased odds. There were no meaningful between-group comparisons or significant associations between preoperative CESI receipt and any 90-day postoperative complications in multivariable models (all P>0.05). CONCLUSIONS: This study elucidated the main determinants of CESI receipt and found no differences in the odds of developing 90-day postoperative complications, but did identify differential outcomes with regard to some injection characteristics. LEVEL OF EVIDENCE: Level III.

Prolonged Opioid Use and Associated Factors After Open Reduction and Internal Fixation of Tibial Shaft Fractures.

BACKGROUND: The aim of this retrospective cohort study was to determine the rate of prolonged opioid use and identify associated risk factors after perioperative opioid exposure for tibial shaft fracture surgery. MATERIALS AND METHODS: We used the MarketScan Commercial Claims and Encounters database (IBM) to identify patients 18 to 64 years old who filled a peri-operative opioid prescription after open reduction and internal fixation of a tibial shaft fracture from January 2016 to June 2020. Multivariable logistic regression identified factors (eg, demographics, comorbidities, medications) associated with prolonged opioid use (ie, filling an opioid prescription 91 to 180 days postoperatively); adjusted odds ratios (ORs) and 95% CIs were reported. RESULTS: The rate of prolonged opioid use was 10.5% (n=259/2475) in the full cohort and 6.1% (n=119/1958) in an opioid-naive subgroup. In the full cohort, factors significantly associated with increased odds of prolonged use included preoperative opioid use (OR, 4.76; 95% CI, 3.60-6.29; P<.001); perioperative oral morphine equivalents in the 4th (vs 1st) quartile (OR, 2.68; 95% CI, 1.75-4.09; P<.001); age (OR, 1.03; 95% CI, 1.02-1.04; P<.001); and alcohol or substance-related disorder (OR, 1.66; 95% CI, 1.15-2.40; P=.01). Patients in the Northeast and North Central (vs South) regions had decreased odds of prolonged use (OR, 0.61-0.69; P=.02-.04). When removing preoperative use, findings were similar in the opioid-naive subgroup. CONCLUSION: Prolonged opioid use is not uncommon in this orthopedic trauma population, with the strongest risk factor being preoperative opioid use. Nevertheless, shared risk factors exist between the opioid-naive and opioid-tolerant subgroups that can guide clinical decision-making. [Orthopedics. 2024;47(4):e188-e196.].

Risk Factors for Early Treatment Discontinuation Due to Toxicity Among Patients With Metastatic Castration-resistant Prostate Cancer Receiving Androgen Receptor-targeted Therapy.

OBJECTIVES: Androgen receptor-targeted therapies (ARTs) improve survival outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC); however, a significant portion of patients discontinue treatment for various reasons including treatment-related toxicity. We aim to describe reasons for ART treatment discontinuation and identify predictors associated with increased risk of treatment discontinuation due to toxicity. METHODS: We performed a single-institution retrospective review of patients with mCRPC receiving ART between 2010 and 2021. Our primary aim was to identify risk factors for treatment discontinuation due to toxicity. Our secondary aim was to describe ART discontinuation patterns among patients with mCRPC. RESULTS: One hundred thirty-three patients with mCRPC started and discontinued ARTs. Fourteen patients (10.5%) discontinued treatment due to toxicity. Common reasons for treatment discontinuation include Prostate Specific Antigen test progression, radiographic progression, toxicity, and death. Significant predictors of treatment discontinuation due to toxicity on bivariate analysis and multivariate analysis included patient-reported falls (odds ratio [OR]: 7.67, CI: [1.31-40.42]; P =0.016), rash (OR: 13.4, CI: [1.35-134.81]; P =0.026), and weakness (OR: 4.16, CI: [1.15-15.0]; P =0.019). CONCLUSIONS: Our work presents the first description of ART treatment discontinuation and its causes in the real-world setting, as well as patient-reported side effects. Most patients with mCRPC discontinued treatment due to the progression of disease and a minority of patients discontinued secondary to treatment toxicity. Initial multivariable analysis suggests that patient-reported weakness, falls, and rash were associated with a higher likelihood of treatment discontinuation due to toxicity. Early monitoring of this population can prolong the duration of treatment and prevent unnecessary treatment burden.

Randomized Controlled Trials Comparing Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autografts in Anterior Cruciate Ligament Reconstruction Surgery Are Statistically Fragile: A Systematic Review.

PURPOSE: To assess the statistical fragility of recently published randomized controlled trials (RCTs) comparing the use of hamstring tendon autograft with bone-patellar tendon-bone autograft for anterior cruciate ligament (ACL) reconstruction. METHODS: The PubMed, Embase, and MEDLINE databases were queried for RCTs published since 2010 comparing autograft type (bone-patellar tendon-bone vs hamstring tendon) in ACL reconstruction surgery. The fragility index (FI) and reverse FI (rFI) were determined for significant and nonsignificant outcomes, respectively, as the number of outcome reversals required to change statistical significance. The fragility quotient (FQ) and reverse FQ, representing fragility as a proportion of the study population, were calculated by dividing the FI and rFI, respectively, by the sample size. RESULTS: We identified 19 RCTs reporting 55 total dichotomous outcomes. The median FI of the 55 total outcomes was 5 (interquartile range [IQR], 4-7), meaning a median of 5 outcome event reversals would alter the outcomes' significance. Five outcomes were reported as statistically significant with a median FI of 4 (IQR, 2-6), meaning a median of 4 outcome event reversals would change outcomes to be nonsignificant. Fifty outcomes were reported as nonsignificant with a median rFI of 5 (IQR, 4-7), meaning a median of 5 outcome event reversals would change outcomes to be significant. The FQ and reverse FQ for significant and nonsignificant outcomes were 0.025 (IQR, 0.018-0.045) and 0.082 (IQR, 0.041-0.106), respectively. For 61.8% of outcomes, patients lost to follow-up exceeded the corresponding FI or rFI. CONCLUSIONS: There is substantial statistical fragility in recent RCTs on autograft choice in ACL reconstruction surgery given that altering a few outcome events is sufficient to reverse study findings. For over half of outcomes, maintaining patients lost to follow-up may have been sufficient to reverse study conclusions. CLINICAL RELEVANCE: We recommend co-reporting FIs and P values to provide a more comprehensive representation of a study's conclusions when conducting an RCT.

Association Between ABO Blood Groups and Helicobacter pylori Infection: A Meta-Analysis.

There is no consensus among the existing literature on the relationship between ABO blood groups and risk of Helicobacter pylori infection. However, histo-blood group carbohydrates are proposed to influence the risk of acquiring this pathogen via effects on adhesion to the gastric mucosa. The objective of this meta-analysis was to evaluate the association between ABO blood groups and H. pylori infection. All relevant epidemiological studies published in English (up to October 2017) was retrieved through an extensive systematic literature search of MEDLINE/PubMed databases. Pooled estimates of effects were obtained through the use of fixed and random effects meta-analyses. Individuals with O blood group were more likely to be infected with H. pylori (pooled odds ratio (OR) 1.163; 95% confidence interval (CI) 1.074-1.259; P < 0.001). While individuals with B and AB blood group were less likely to be infected with H. pylori (OR 0.831; 95% CI 0.738-0.935; P = 0.002 and OR 0.709; 95% CI 0.605-0.832; P < 0.001, respectively). The results from this meta-analysis of observational studies suggest an estimated 16.3% increased odds of H. pylori infection amongst individuals with the O blood group. If this observed association is causal, a better understanding of the underlying mechanisms could provide indications to potential prevention strategies for H. pylori infection.