Patient Selection Bias Research Articles

Findings of Sodium-Glucose Cotransporter-2 Inhibitor Kidney Outcome Trials Applied to a Canadian Chronic Kidney Disease Population: A Retrospective Cohort Study.

The canagliflozin and renal endpoints in diabetes with established nephropathy clinical evaluation (CREDENCE) and dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trials have demonstrated significant kidney benefits with sodium-glucose cotransporter-2 (SGLT2) inhibitors. SGLT2 inhibitors are now standard of care for patients with diabetic kidney disease and have also been shown to be effective in those with albuminuric CKD with or without diabetes. We sought to determine how many patients in nephrology care in British Columbia, Canada, would have been eligible for those trials, to compare rates of outcomes, and to estimate cost avoidance arising from widespread use of SGLT2 inhibitors in this cohort. Retrospective cohort study. British Columbia, Canada. CKD patients followed in the Kidney Care Clinics in British Columbia. We compared the outcomes of kidney failure, sustained estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2, dialysis, transplant, death from any cause, and doubling of serum creatinine. We also compared the composite outcome of kidney failure and doubling of serum creatinine. The cohort was derived using a provincial database by combining the inclusion criteria of CREDENCE and DAPA-CKD trials. We included adult patients aged ≥18 years, urine albumin to creatinine ratio (UACR) ≥20 mg/mmol, and eGFR between 25 and 90 mL/min/1.73 m2, between April 1, 2014 and March 31, 2017. The primary outcome was compared with the outcomes experienced in the placebo arms of CREDENCE and DAPA-CKD. The composite outcome stratified by eGFR categories were compared in the British Columbia cohort and the CREDENCE trial. Cost avoidance was estimated based on the number needed to treat to prevent one instance of kidney failure. A total of 17.5% (3138/17 963) of patients were eligible, resulting in a cohort with a mean age of 69.7 years and 38% women. The eGFR slope of the British Columbia cohort was -4.21 ± 0.47 mL/min. The mean eGFR was 37.0 mL/min/1.73 m2, median UACR was 55.3 mg/mmol, and use of renin-angiotensin-aldosterone system inhibitors was 56.6%. The British Columbia cohort experienced nearly double the outcomes of kidney failure, death from any cause, and doubling of serum creatinine than the placebo arms of CREDENCE and DAPA-CKD. When stratified by eGFR, the British Columbia cohort and the CREDENCE placebo arm had similar event rates for those with an eGFR <45 mL/min but there were still higher rates of outcome in the greater than 45 mL/min eGFR groups in the British Columbia cohort. Treating the British Columbia cohort with canagliflozin could lead to net cost avoidance of $2.31 million over 2.6 years. The database only captures those referred to the Kidney Care Clinics by nephrologists, which may lead to selection bias of higher risk patients in the British Columbia cohort. The cost avoidance analysis was a limited high-level analysis. The British Columbia cohort represents a high-risk group in whom implementation of the use of SGLT2 inhibitors may well improve outcomes and reduce health care system costs.

Celebrating 10 years of the Journal of Comparative Effectiveness Research.

Celebrating 10 years of the Journal of Comparative Effectiveness Research.

Is Long-Term Survival in Metastases from Neuroendocrine Neoplasms Improved by Liver Resection?

Background and Objectives: Although many of the neuroendocrine neoplasms (NEN) have a typically prolonged natural history compared with other gastrointestinal tract cancers, at least 40% of patients develop liver metastases. This study aims to identify whether liver resection improves the overall survival of patients with liver metastases from NEN. Materials and Methods: We conducted a retrospective study at “Fundeni” Clinical Institute over a time period of 15 years; we thereby identified a series of 93 patients treated for NEN with liver metastases, which we further divided into 2 groups as follows: A (45 patients) had been subjected to liver resection complemented by systemic therapies, and B (48 patients) underwent systemic therapy alone. To reduce the patient selection bias we performed at first a propensity score matching. This was followed by a bootstrapping selection with Jackknife error correction, with the purpose of getting a statistically illustrative sample. Results: The overall survival of the matched virtual cohort under study was 41 months (95% CI 37–45). Group A virtual matched patients showed a higher survival rate (52 mo., 95% CI: 45–59) than B (31 mo., 95% CI: 27–35), (p < 0.001, Log-Rank test). Upon multivariate analysis, seven independent factors were identified to have an influence on survival: location (midgut) and primary tumor grading (G3), absence of concomitant LM, number (2–4), location (unilobar), grading (G3) of LM, and 25–50% hepatic involvement at the time of the metastatic disease diagnosis. Conclusions: Hepatic resection is nowadays the main treatment providing potential cure and prolonged survival, for patients with NEN when integrated in a multimodal strategy based on systemic therapy.

SwissPedData: Standardising hospital records for the benefit of paediatric research.

Improvement of paediatric healthcare is hampered by inefficient processes for generating new evidence. Clinical research often requires extra encounters with patients, is costly, takes place in an artificial situation with a biased selection of patients, and entails long delays until new evidence is implemented into health care. Electronic health records (EHR) contain detailed information on real patients and cover the entirety of patients. However, the use of EHR for research is limited because they are not standardised between hospitals. This leads to disproportionate amounts of work for extracting data of interest and frequently data are incomplete and of poor quality. SwissPedData aims to lay the foundation for a paediatric learning health system in Switzerland by facilitating EHR-based research. In this project, we aimed to assess the way routine clinical data are currently recorded in large paediatric clinics in Switzerland and to develop a national EHR-based set of common data elements (CDEs) that covers all processes of routine paediatric care in hospitals. A taskforce of paediatricians from large Swiss children's hospitals reviewed the current status of routine data documentation in paediatric clinical care and the extent of digitalisation. We then used a modified Delphi method to reach a broad consensus on a national EHR-based set of CDEs. All Swiss children's hospitals use EHR to document some or all aspects of care. One hundred and nineteen paediatricians, representing eight hospitals and all paediatric subspecialties, participated in an extended Delphi process to create SwissPedData. The group agreed on a national set of CDEs that comprises a main module with general paediatric data and sub-modules relevant to paediatric subspecialties. The data dictionary includes 336 CDEs: 76 in the main module on general paediatrics and between 11 and 59 CDEs per subspecialty module. Among these, 266 were classified as mandatory, 52 as recommended and 18 as optional. SwissPedData is a set of CDEs for information to be collected in EHR of Swiss children's hospitals. It covers all care processes including clinical and paraclinical assessment, diagnosis, treatment, disposition and care site. All participating hospitals agreed to implement SwissPedData in their clinical routine and clinic information systems. This will pave the way for a national paediatric learning health system in Switzerland that enables fast and efficient answers to urgent clinical questions by facilitating high-quality nationwide retrospective and prospective observational studies and recruitment of patients for nested prospective studies and clinical trials.

Diagnostic Test Accuracy of First-Void Urine Human Papillomaviruses for Presence Cervical HPV in Women: Systematic Review and Meta-Analysis

First-void urine usually contains exfoliated cells of the debris and mucus from the female genital organs and cervix, i.e., high concentration of human papillomavirus deoxyribonucleic acid (HPV DNA). We conducted a meta-analysis of published data and determined an accuracy of HPV detection in first-void urine compared to the women’s cervix. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we carried out a comprehensive literature search. Eligible articles published from 2011 until 2021 were gathered by searching Embase, PubMed and Cochrane Library Central databases. The patient selection, index test, standard test, and patient flow were the factors involved in quality evaluation. A meta-analysis of 15 studies (3412 women) based on 5054 potential records was conducted. Pooled sensitivity for high-risk HPV detection in urine of 78% (70–84%) and specificity of 89% (81–94%) were calculated. Any HPV detection in urine of 87% (74–94%) and 91% (83–96%) were pooled sensitivity and specificity, respectively. HPV 16 and 18 had a pooled sensitivity of 77% (76–77%) and specificity of 98% (98–98%). Meta-analysis indicated variations between the pooled specificities and sensitivities. In meta-regression analysis, a heterogeneity in accuracy by using covariates (bias in patient selection, purpose, sample timing, storage temperature and HPV detection method) were not detected. Our meta-analysis demonstrates the accuracy of detection of HPV in urine for the presence of cervical HPV. Although progress is continuously made in urinary HPV detection, further studies are needed to evaluate and to improve the accuracy of the first-void urine test in order to be comparable with other screening methods.

P163 ROLE OF THE LAPAROSCOPIC APPROACH IN EMERGENT INGUINAL HERNIA REPAIR

Abstract Aim Analyze the evolution of the laparoscopic approach in emergent inguinal hernia repair at our center. Material and Methods Retrospective review of patients with emergent inguinal hernia repair in our center from January 2011 to June 2020. Demographic, clinical and postoperative data were analyzed as well as the evolution of the laparoscopic approach. Results 385 patients with incarcerated/strangulated inguinal hernia were registered. 58.96% were men, with a median age of 71. Of those, 22 patients (5.71%) were treated by laparoscopic approach and 363 (94.29%) by open approach. The open approach had a longer median hospitalization (4.82 vs 1.66 days), higher rate of surgical wound infection (5.51% vs. 0%), higher reoperation rate (3.31% vs 0%) and higher incidence of respiratory complications (1.97% vs 0%). 1 patient (4.54%) with laparoscopic approach required intestinal resection vs 48 patients (13.22%) of the open group, with a dehiscence rate of 0% vs 4.76% respectively. Mortality rate was 0% for the laparoscopic group and 2.75% in the open group. In the last 18 months, 28.98% of urgent hernias repaired have been performed laparoscopically, while previously from 2011 to 2017 only 0.95%, due to the learning curve obtained in elective surgery where the laparoscopic approach has had a major development in the last 3 years. Conclusions Despite the evident patient selection bias because the approach choice by the surgeon in emergent inguinal hernia repair, laparoscopic approach is feasible and has lower morbidity-mortality compared to open approach in our center. In specialized centers this may be a treatment option for selected patient groups.

Selection bias in patients proposed for neurosurgical versus endovascular treatment of aneurysms of the posterior communicating artery.

Microsurgical clipping and endovascular coiling are viable treatment options for posterior communicating artery (PComA) aneurysms, but there are still major limitations to evidence-based decisions regarding standard-of-care treatment. In this study, we aimed at assessing potential selection biases that may influence our ability to extract conclusions about the comparative effectiveness or efficacy of the aneurysm treatment. To study the patient/aneurysm characteristics as possible biases in the option for endovascular or neurosurgical treatment of PComA aneurysms. A single-center, retrospective cohort study was performed, including all patients with treated PComA aneurysms with neurosurgical clipping or endovascular coiling between January 2010 and January 2021. Clinical and morphological data were collected from electronic records, and statistical analysis was performed. A total of 64 patients was eligible for inclusion; 24 (37.5%) patients were proposed for neurosurgical treatment, while 40 (62.5%) for endovascular treatment; 10 patients (25%) crossed over to the clipping group whereas none crossed over to the coiling side. Actual treatment analysis showed significantly higher diameters of mother vessel (t-test, p = 0.034) and aneurysm neck (Mann-Whitney, p = 0.029) in the clipping group and higher aspect and dome-to-neck ratios in the endovascular group (Mann-Whitney, p = 0.008). A significantly higher vasospasm frequency was found in the clipping group but only in the intention-to-treat analysis (Chi-square, p = 0.032). Significant morphological differences between effective endovascular and surgical groups and differences in intention-to-treat analysis may limit the validity of a direct comparison between treatment options and suggest the presence of a possible selection bias.

Polatuzumab Vedotin Use before Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in Aggressive Lymphoma: A US Single Center Experience

Polatuzumab Vedotin Use before Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in Aggressive Lymphoma: A US Single Center Experience

A Novel Early Relapse Prediction Score Based on Age, ISS and Disease Status at the Time of Transplant in Patients with Newly Diagnosed Multiple Myeloma. a Study of the EBMT Chronic Malignancies Working Party

A Novel Early Relapse Prediction Score Based on Age, ISS and Disease Status at the Time of Transplant in Patients with Newly Diagnosed Multiple Myeloma. a Study of the EBMT Chronic Malignancies Working Party

Evaluating maintenance electroconvulsive therapy in Bipolar Disorders: 3-year mirror-image study

BackgorundMaintenance electroconvulsive therapy (mECT) is underused in the treatment of bipolar disorder (BD). We aimed to study the real-life effectiveness of mECT in BD. MethodsNaturalistic 3-year mirror-image study in individuals diagnosed with BD who underwent mECT at a tertiary hospital. Intra-subject comparisons of psychiatric hospitalization were performed using McNemar test. Days and number of psychiatric hospitalizations before and during mECT were compared through wilcoxon signed-rank test. Mean annual days and mean annual number of psychiatric hospitalizations per patient were compared by means of the rate ratio (RR) estimation through a generalized estimating equation (GEE) model. ResultsA total of 43 patients were included and 37 required psychiatric hospitalization during the study. The use of mECT showed an effectiveness of 62.2% for preventing psychiatric hospitalizations (p<0.01). We found significant reduction in days and number of psychiatric hospitalizations during mECT compared to before mECT (p<0.01). Comparison of the 3-year period before/during mECT showed a reduction in mean annual days (RR=0.14; 95%CI: 0.07–0.29) and mean annual number (RR=0.24; 95%CI: 0.13–0.43) of psychiatric hospitalizations, without substantial changes for adjusted models for gender and age of onset of the illness. LimitationsThe main limitations of this study consisted of the mirror-image retrospective naturalistic study design, the relatively small sample size, and possibly patient selection bias. ConclusionsmECT reduced the number of psychiatric hospitalizations and hospitalization days in BD. The use of mECT outlines a mood stabilizing effect in BD. This naturalistic study supports the effectiveness of mECT in BD across several mood states.

Preexisting immune-mediated inflammatory disease is associated with improved survival and increased toxicity in melanoma patients who receive immune checkpoint inhibitors.

BackgroundImmune‐related adverse events (irAEs) are common, clinically significant autoinflammatory toxicities observed with immune checkpoint inhibitors (ICI). Preexisting immune‐mediated inflammatory disease (pre‐IMID) is considered a relative contraindication to ICI due to the risk of inciting flares. Improved understanding of the risks and benefits of treating pre‐IMID patients with ICI is needed.MethodsWe studied melanoma patients treated with ICI and enrolled in a prospective clinicopathological database. We compiled a list of 23 immune‐mediated inflammatory diseases and evaluated their presence prior to ICI. We tested the associations between pre‐IMID and progression‐free survival (PFS), overall survival (OS), and irAEs.ResultsIn total, 483 melanoma patients were included in the study; 74 had pre‐IMID and 409 did not. In patients receiving ICI as a standard of care (SoC), pre‐IMID was significantly associated with irAEs (p = 0.04) as well as improved PFS (p = 0.024) and OS (p = 0.007). There was no significant association between pre‐IMID and irAEs (p = 0.54), PFS (p = 0.197), or OS (p = 0.746) in patients treated through a clinical trial. Pre‐IMID was significantly associated with improved OS in females (p = 0.012), but not in males (p = 0.35).ConclusionsThe dichotomy of the impact of pre‐IMID on survival and irAEs in SoC versus clinical trial patients may reflect the inherit selection bias in patients accrued in clinical trials. Future mechanistic work is required to better understand the differences in outcomes between female and male pre‐IMID patients. Our data challenge the notion that clinicians should avoid ICI in pre‐IMID patients, although close monitoring and prospective clinical trials evaluating ICI in this population are warranted.

Antiviral Therapy Improves Survival in Hepatocellular Carcinoma with Microvascular Invasion: A Propensity Score Analysis.

To investigate the effect of postoperative adjuvant antiviral therapy (AVT) on hepatitis B virus (HBV) related hepatocellular carcinoma (HCC) with microvascular invasion (MVI) after R0 liver resection. A total of 1008 patients with HBV-related HCC with MVI were recruited, which comprises 378 non-AVT groups and 630 AVT groups. Propensity score matching (PSM) was developed to reduce any bias in patient selection. Independent risk factors were identified by Cox regression analysis. After PSM, the 1-, 3-, and 5-year overall survival rates in the AVT group and non-AVT group were 89.2%, 62.4%, 42.1%, and 73.3%, 46.3%, 22.1%, (p < 0.01), respectively. The 1-, 3-, and 5-year recurrence-free survival rates in the AVT group and non-AVT group were 52.5%, 30.4%, 22.1%, and 46.3%, 26.8%, 13.2% (p = 0.02), respectively. Multivariate Cox analysis revealed that postoperative adjuvant AVT was the independent protective factor associated with mortality (HR = 0.55, 95%CI = 0.46-0.67, p < 0.01) and tumor recurrence (HR = 0.81, 95%CI = 0.69-0.96, p = 0.01). Among patients who underwent curative hepatectomy for HBV-related HCC with MVI, postoperative adjuvant AVT was the independent protective factor associated with mortality and tumor recurrence. Given the high rate of postoperative recurrence and poor prognosis of HBV-related HCC with MVI, our findings may have useful clinical significance in the prevention of tumor recurrence in these patients.

Benefit of adjuvant chemotherapy for patients with stage IB non-small cell lung cancer: a systematic review and meta-analysis.

BackgroundAdjuvant chemotherapy (ACT) is routinely the recommended treatment for patients with advanced non-small cell lung cancer (NSCLC) but remains a controversial option in stage IB patients. We therefore pooled the current evidence to determine the prognostic impact of ACT in stage IB NSCLC patients in the context of the eighth tumor, node, metastasis (TNM) staging system.MethodsFive electronic databases were searched for eligible studies up to December 2020 without language restrictions. The primary and secondary outcomes were overall survival (OS) and disease-free survival (DFS). Search results were filtered by a set of eligibility criteria and analyzed in line with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The risk of bias was assessed independently using a modified set. Stata 16.0 was used for general data analysis and meta-analysis, and subgroup analyses were performed to investigate the source of interstudy heterogeneity.ResultsIn all, 12 eligible studies were identified and 15,678 patients included. Our results demonstrated that ACT was associated with improved OS [n=11; hazard ratio (HR) =0.65; 95% confidence interval (CI): 0.60–0.70; P<0.001; I2=33.4%, P=0.131] and DFS (n=9; HR =0.73; 95% CI: 0.63–0.83; P<0.001; I2=66.7%, P=0.002) in stage IB NSCLC patients. Subgroup analysis by histology indicated that administration of ACT conferred more favorable survival to both stage IB squamous cell carcinoma (n=1; HR =0.56; 95% CI: 0.28–0.84; P<0.001) and adenocarcinoma (n=6; HR =0.59; 95% CI: 0.47–0.71; P<0.001; I2=31.0%, P=0.203). Meanwhile, both platinum-based ACT (n=7; HR =0.62; 95% CI: 0.51–0.74; P<0.001; I2=44.8%, P=0.093) and other regimens (n=2; HR =0.66; 95% CI: 0.61–0.72; P<0.001; I2=0.7%, P=0.316) could benefit patients with stage IB disease.DiscussionACT might provide survival benefits to patients with stage IB NSCLC irrespective of histology or regimens. Patient selection and time trend biases were inevitable due to the limitation of retrospective studies. More prospective studies should be initiated to investigate the optimal ACT regimens in different histologic types in stage IB NSCLC patients.

A Propensity-Matched Analysis of Survival of Clinically Diagnosed Early-Stage Lung Cancer and Biopsy-Proven Early-Stage Non-Small Cell Lung Cancer Following Stereotactic Ablative Radiotherapy.

PurposeStereotactic body radiotherapy (SBRT) has been increasingly regarded as a reasonable option for early-stage lung cancer patients without pretreatment pathologic results, but the efficacy and safety in a Chinese population remains unclear. The aim of this study was to compare survival outcomes and toxicities between patients with clinically diagnosed early-stage lung cancer or biopsy-proven early-stage non-small cell lung cancer and to demonstrate the rationality of this treatment.Material and MethodsFrom May 2012 to December 2018, 56 patients with clinically diagnosed early-stage lung cancer and 60 patients with early-stage biopsy-proven were selected into non-pathological group and pathological group, respectively. Propensity score matching (PSM) was performed to reduce patient selection bias. Survival analysis with log-rank test was used to assess the differences of treatment outcomes, which included local control (LC), progression-free survival (PFS), and overall survival (OS).ResultsThe median age was 76 (range 47–93) years, and the median follow-up time was 58.3 (range 4.3–95.1) months in the cohort without pathologic results. The median age was 74 (range 57–88) years, and the median follow-up time was 56.3 (range 2.6–94) months in the cohort with pathologic results. 45 matched-pair were analyzed. The 5-year LC, PFS, and OS rates in matched-pair patients with or without pathologic biopsy were 85.5% and 89.8%, 40.6% and 70.9%, and 63.2% and 76.1%, respectively. On Kaplan-Meier survival analysis after PSM analysis, there was no significant difference between patients with pathologic results versus patients with no pathologic results in terms of LC (P= 0.498) and OS (P=0.141). Of the matched-pair patients treated with SBRT, only 1 patient experienced grade 3 or above radiation pneumonitis.ConclusionFor early-stage lung cancer patients with medically inoperable or not suitable for invasive diagnosis, SBRT may be a good local treatment.

Recurrence of Colorectal Neoplastic Polyps After Incomplete Resection.

Incomplete resection of neoplastic polyps is considered an important reason for the development of colorectal cancer. However, there are no data on the natural history of polyps that were incompletely removed. To examine the risk for metachronous neoplasia during surveillance colonoscopy after documented incomplete polyp resection. Observational cohort study of patients who participated in the CARE (Complete Adenoma REsection) study (2009 to 2012). 2 academic medical centers. Patients who had resection of a 5- to 20-mm neoplastic polyp, had a documented complete or incomplete resection, and had a surveillance examination. Segment metachronous neoplasia, defined as the proportion of colon segments with at least 1 neoplastic polyp at first surveillance examination, was measured. Segment metachronous neoplasia was compared between segments with a prior incomplete polyp resection (incomplete segments) and those with a prior complete resection (complete segments), accounting for clustering of segments within patients. Of 233 participants in the original study, 166 (71%) had at least 1 surveillance examination. Median time to surveillance was shorter after incomplete versus complete resection (median, 17 vs. 45 months). The risk for any metachronous neoplasia was greater in segments with incomplete versus complete resection (52% vs. 23%; risk difference [RD], 28% [95% CI, 9% to 47%]; P = 0.004). Incomplete segments also had a greater number of neoplastic polyps (mean, 0.8 vs. 0.3; RD, 0.50 [CI, 0.1 to 0.9]; P = 0.008) and greater risk for advanced neoplasia (18% vs. 3%; RD, 15% [CI, 1% to 29%]; P = 0.034). Incomplete resection was the strongest independent factor associated with metachronous neoplasia (odds ratio, 3.0 [CI, 1.12 to 8.17]). Potential patient selection bias due to incomplete follow-up. This natural history study found a statistically significantly greater risk for future neoplasia and advanced neoplasia in colon segments after incomplete resection compared with segments with complete resection. None.

Head and Neck Melanoma: What is the Goal for Margins?

Head and Neck Melanoma: What is the Goal for Margins?

Civilian Firearm-Inflicted Brain Injury: Coagulopathy, Vascular Injuries, and Triage.

Civilian firearm-inflicted penetrating brain injury (PBI) carries high morbidity and mortality. Concurrently, the evidence base guiding management decisions remains limited. Faced with large volume of PBI patients, we have made observations in relation to coagulopathy and cerebrovascular injuries. We here review this literature in addition to the question about early prognostication as it may inform neurosurgical decision-making. The triad of coagulopathy, low motor score, and radiographic compression of basal cisterns comprises a phenotype of injury with exceedingly high mortality. PBI leads to high rates of cerebral arterial and venous injuries, and projectile trajectory is emerging as an independent predictor of outcome. The combination of coagulopathy with cerebrovascular injury creates a specific endophenotype. The nature and role of coagulopathy remain to be deciphered, and consideration to the use of tranexamic acid should be given. Prospective controlled trials are needed to create clinical evidence free of patient selection bias.

Diagnostic Accuracy of Machine Learning Models to Identify Congenital Heart Disease: A Meta-Analysis

Background: With the dearth of trained care providers to diagnose congenital heart disease (CHD) and a surge in machine learning (ML) models, this review aims to estimate the diagnostic accuracy of such models for detecting CHD. Methods: A comprehensive literature search in the PubMed, CINAHL, Wiley Cochrane Library, and Web of Science databases was performed. Studies that reported the diagnostic ability of ML for the detection of CHD compared to the reference standard were included. Risk of bias assessment was performed using Quality Assessment for Diagnostic Accuracy Studies-2 tool. The sensitivity and specificity results from the studies were used to generate the hierarchical Summary ROC (HSROC) curve. Results: We included 16 studies (1217 participants) that used ML algorithm to diagnose CHD. Neural networks were used in seven studies with overall sensitivity of 90.9% (95% CI 85.2–94.5%) and specificity was 92.7% (95% CI 86.4–96.2%). Other ML models included ensemble methods, deep learning and clustering techniques but did not have sufficient number of studies for a meta-analysis. Majority (n=11, 69%) of studies had a high risk of patient selection bias, unclear bias on index test (n=9, 56%) and flow and timing (n=12, 75%) while low risk of bias was reported for the reference standard (n=10, 62%). Conclusion: ML models such as neural networks have the potential to diagnose CHD accurately without the need for trained personnel. The heterogeneity of the diagnostic modalities used to train these models and the heterogeneity of the CHD diagnoses included between the studies is a major limitation.

Analysis Of Peripheral T-Cell Lymphoma (PTCL) Subtype By Race and Geography Using The Comprehensive Oncology Measures For Peripheral T-Cell Lymphoma Treatment (COMPLETE) Dataset

Background COMPLETE is a national registry of PTCL patients designed to describe patient characteristics, treatments and outcomes in a ‘real world’ setting. Previous work has suggested that there may be geographic and/or racial differences in the incidence of PTCL subtypes. Using the COMPLETE dataset, we explored the influence of race and geography in the United States on the incidence of PTCL subtypes and examined for interactions between these two variables. Methods We identified patients with locked baseline records and performed univariate analyses comparing disease subtype, stratified by race and geography. A multivariable, multinomial response regression model was used to predict the classification of PTCL subtype based upon race and geographic region. An interaction term for race and region was assessed via a likelihood ratio test and found to be not significant (p = 0.43), thus was removed from the model. Results A total of 247 patients had locked baseline records. Given the small numbers of Asian (7 patients, 3%) and other/race unknown patients (6, 3%), only Black (43, 17%) and White (191, 77%) patients were included in the analyses. Results of the univariate analyses can be found in [Table 1][1]. PTCL-not otherwise specified (NOS) accounted for the largest histologic subtype (35% of patients), consistent with SEER (31%) and other data sources. A trend was noted in distribution of subtype by race and significant differences were seen in histologic distribution by region, with a higher proportion of angioimmunoblastic T-cell lymphoma (AITL) patients diagnosed in the West and a smaller proportion in the South. A higher proportion of patients diagnosed with PTCL-NOS were in the South compared to other regions while a higher proportion of patients in the Northeast were diagnosed with other histologic subtypes. The multinomial regression model suggests there was a relatively high likelihood of being diagnosed with PTCL-NOS for both races in the Midwest, South and West and a relatively high likelihood of being diagnosed with other subtypes of PTCL for patients in the Northeast. White patients in the West have the highest likelihood of being diagnosed with AITL. View this table: Table 1 Results of Univariate Analyses of PTCL Subtype by Race and Region Conclusions These results suggest there is a modest, independent influence of both race and region in the United States on histologic subtype of PTCL. Whether geographic differences are due to patient selection bias or potentially due to environmental factors cannot be determined in this study. As the sample size grows, further analyses are warranted to examine if the effect of race and region is enhanced or diminished while controlling for factors not measured in the current model. Disclosures: Carson: Allos: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau. Foss: merck: Research Funding; spectrum: Research Funding; eisai: Membership on an entity’s Board of Directors or advisory committees; millenium: Honoraria, Membership on an entity’s Board of Directors or advisory committees; celgene: Honoraria, Research Funding; seattle genetics: Research Funding. Pinter-Brown: Allos: Consultancy, Membership on an entity’s Board of Directors or advisory committees. Horwitz: Spectrum (Allos): Consultancy, Research Funding. Rosen: Allos: Consultancy, Honoraria. Gisselbrecht: Allos: Consultancy, Membership on an entity’s Board of Directors or advisory committees. Hsi: Allos: Research Funding; Seattle Genetics: Speakers Bureau; Eli Lilly: Research Funding; Abbott: Research Funding; Cellerant Therapeutics: Research Funding; BD Biosciences: Research Funding; Millennium: Research Funding. [1]: #T1

Dislocation rates following total hip arthroplasty via the direct anterior approach in a consecutive, non-selective cohort.

Use of the direct anterior approach (DAA) for total hip arthroplasty (THA) has increased in recent years due to proposed benefits, including a lower risk of dislocation and improved early functional recovery. This study investigates the dislocation rate in a non-selective, consecutive cohort undergoing THA via the DAA without any exclusion or bias in patient selection based on habitus, deformity, age, sex, or fixation method. We retrospectively reviewed all patients undergoing THA via the DAA between 2011 and 2017 at our institution. Primary outcome was dislocation at minimum two-year follow-up. Patients were stratified by demographic details and risk factors for dislocation, and an in-depth analysis of dislocations was performed. A total of 2,831 hips in 2,205 patients were included. Mean age was 64.9 years (24 to 96), mean BMI was 29.2 kg/m2 (15.1 to 53.8), and 1,595 patients (56.3%) were female. There were 11 dislocations within one year (0.38%) and 13 total dislocations at terminal follow-up (0.46%). Five dislocations required revision. The dislocation rate for surgeons who had completed their learning curve was 0.15% compared to 1.14% in those who had not. The cumulative periprosthetic infection and fracture rates were 0.53% and 0.67%, respectively. In a non-selective, consecutive cohort of patients undergoing THA via the DAA, the risk of dislocation is low, even among patients with risk factors for instability. Our data further suggest that the DAA can be safely used in all hip arthroplasty patients without an increased risk of wound complications, fracture, infection, or revision. The inclusion of seven surgeons increases the generalizability of these results. Cite this article: Bone Joint J2021;103-B(7 Supple B):38-45.