Outcomes Database Research Articles

Poor Baseline Health of IBD Patients at Presentation to a Surgeon: Results From a Patient-Reported Outcomes Database.

Many patients with inflammatory bowel disease (IBD) are referred to surgeons when medical treatments are ineffective, signifying poor disease control. We aimed to assess the association of IBD diagnosis with physical and mental health upon presentation to a colorectal surgeon. We included all new patients presenting to colorectal surgery clinic over 1.5 years. During registration, patients completed the PROMIS Global-10, a validated outcome measure assessing physical and mental health. We grouped patients by diagnosis: IBD, anorectal, benign colorectal, and malignancy. Details on IBD patients were obtained via chart review. We evaluated the interaction between PROMIS scores and diagnosis through ANOVA analysis and post hoc Tukey-Kramer pairwise comparison. We estimated the strength of association of age, sex, and visit diagnosis with poor physical and mental health (PROMIS: -1 SD) through logistic regression. Eight hundred ninety-seven patients were included. The cohort was as follows: IBD (99) (Crohn = 73; ulcerative colitis = 26), anorectal (378), benign colorectal (224), and malignancy (196). The mean age of patients was 56 (±17) years. Fifty-seven percent were female. The IBD group was youngest (P < 0.001). IBD had significantly lower PROMIS scores on pairwise comparison; anorectal had the highest scores. Controlling for age and sex, the IBD group had 4.1× odds of poor physical health (95% confidence interval 2.46-6.76) and 2.9× odds of poor mental health (95% confidence interval 1.66-5.00). Patients with IBD, specifically Crohn disease, have worse physical and mental health on presentation to a colorectal surgeon compared to patients presenting with other colorectal diagnoses. These patients considering surgery might benefit from added support during the perioperative period.

Correlation Between Aspects of Perceived Patient Loneliness and Spinal Cord Stimulation Outcomes

ObjectivesLoneliness as a whole has been characterized as a health-related risk factor and is associated with worse outcomes after cardiac procedures. Evidence suggests that chronic pain patients are particularly vulnerable to feeling lonely. We examined the relationship between different aspects of loneliness and one-year postoperative outcomes after spinal cord stimulation (SCS) for chronic pain. Materials and MethodsWe contacted 69 patients with thoracic SCS who had participated in our prospective outcomes database with one-year follow-up to complete the validated, abbreviated UCLA Loneliness Scale (UCLA-3). We examined responses on question 9 of the Oswestry Disability Index (ODI), question 12 of the Beck Depression Inventory (BDI), and UCLA-3 due to their relevance to different aspects of loneliness. We conducted regression analyses to determine the relationship between aspects of loneliness and pain outcomes. ResultsWe identified that loss of interest in people, companionship, and feeling excluded were associated with pain outcomes. Loss of interest in people was associated with improvement in pain (NRS worst p = 0.021, r = 0.32, NRS least p = 0.004, r = 0.4; NRS right now p = 0.016, r = 0.33). Companionship and feeling excluded were also associated with pain. We examined the interface between depression and total loneliness and found that while both were related to each other, depression was not associated with pain outcomes. ConclusionsThis study demonstrates an association between loss of interest in people, companionship, and feeling excluded and worse postoperative pain outcomes after receiving SCS. It identifies aspects of loneliness as important factors to consider when predicting the outcomes of SCS therapy for chronic pain control.

"July Effect" Revisited: July Surgeries at Residency Training Programs are Associated with Equivalent Long-term Clinical Outcomes Following Lumbar Spondylolisthesis Surgery.

Retrospective analysis of a prospective registry. We utilized the Quality Outcomes Database (QOD) registry to investigate the "July Effect" at QOD spondylolisthesis module sites with residency trainees. There is a paucity of investigation on the long-term outcomes following surgeries involving new trainees utilizing high-quality, prospectively collected data. This was an analysis of 608 patients who underwent single-segment surgery for grade 1 degenerative lumbar spondylolisthesis at 12 high-enrolling sites. Surgeries were classified as occurring in July or not in July (non-July). Outcomes collected included estimated blood loss, length of stay, operative time, discharge disposition, complications, reoperation and readmission rates, and patient-reported outcomes (Oswestry Disability Index [ODI], Numeric Rating Scale [NRS] Back Pain, NRS Leg Pain, EuroQol-5D [EQ-5D] and the North American Spine Society [NASS] Satisfaction Questionnaire). Propensity score-matched analyses were utilized to compare postoperative outcomes and complication rates between the July and non-July groups. Three hundred seventy-one surgeries occurred at centers with a residency training program with 21 (5.7%) taking place in July. In propensity score-matched analyses, July surgeries were associated with longer operative times ( average treatment effect = 22.4 minutes longer, 95% confidence interval 0.9-449.0, P = 0.041). Otherwise, July surgeries were not associated with significantly different outcomes for the remaining perioperative parameters (estimated blood loss, length of stay, discharge disposition, postoperative complications), overall reoperation rates, 3-month readmission rates, and 24-month ODI, NRS back pain, NRS leg pain, EQ-5D, and NASS satisfaction score (P > 0.05, all comparisons). Although July surgeries were associated with longer operative times, there were no associations with other clinical outcomes compared to non-July surgeries following lumbar spondylolisthesis surgery. These findings may be due to the increased attending supervision and intraoperative education during the beginning of the academic year. There is no evidence that the influx of new trainees in July significantly affects long-term patient-centered outcomes.Level of Evidence: 3.

Recent Trends in Admission Diagnosis and Related Mortality in the Medically Critically Ill.

With decades of declining ICU mortality, we hypothesized that the outcomes and distribution of diseases cared for in the ICU have changed and we aimed to further characterize them. A retrospective cohort analysis of 287,154 nonsurgical-critically ill adults, from 237 U.S. ICUs, using the manually abstracted Cerner APACHE Outcomes database from 2008 to 2016 was performed. Surgical patients, rare admission diagnoses (<100 occurrences), and low volume hospitals (<100 total admissions) were excluded. Diagnoses were distributed into mutually exclusive organ system/disease-based categories based on admission diagnosis. Multi-level mixed-effects negative binomial regression was used to assess temporal trends in admission, in-hospital mortality, and length of stay (LOS). The number of ICU admissions remained unchanged (IRR 0.99, 0.98-1.003) while certain organ system/disease groups increased (toxicology [25%], hematologic/oncologic [55%] while others decreased (gastrointestinal [31%], pulmonary [24%]). Overall risk-adjusted in-hospital mortality was unchanged (IRR 0.98, 0.96-1.0004). Risk-adjusted ICU LOS (Estimate -0.06 days/year, -0.07 to -0.04) decreased. Risk-adjusted mortality varied significantly by disease. Risk-adjusted ICU mortality rate did not change over the study period, but there was evidence of shifting disease burden across the critical care population. Our data provides useful information regarding future ICU personnel and resource needs.

Development of a Machine Learning Algorithm to Predict Nonroutine Discharge Following Unicompartmental Knee Arthroplasty

BackgroundReliable and effective prediction of discharge destination following unicompartmental knee arthroplasty (UKA) can optimize patient outcomes and system expenditure. The purpose of this study is to develop a machine learning algorithm that can predict nonhome discharge in patients undergoing UKA. MethodsA retrospective review of a prospectively collected national surgical outcomes database was performed to identify adult patients who underwent UKA from 2015 to 2019. Nonroutine discharge was defined as discharge to a location other than home. Five machine learning algorithms were developed to predict this outcome. Performance of the algorithms was assessed through discrimination, calibration, and decision curve analysis. ResultsOverall, of the 7275 patients included, 263 (3.6) patients were unable to return home upon discharge following UKA. The factors determined most important for identification of candidates for nonroutine discharge were total hospital length of stay, preoperative hematocrit, body mass index, preoperative sodium, American Society of Anesthesiologists classification, gender, and functional status. The extreme boosted model achieved the best performance based on discrimination (area under the curve = 0.875), calibration, and decision curve analysis. This model was integrated into a web-based open access application able to provide both predictions and explanations. ConclusionThe present model can, following appropriate external validation, be used to augment clinician decision-making in patients undergoing elective UKA. Patients with high preoperative probabilities of nonroutine discharge based on nonmodifiable risk factors should be counseled to start the insurance authorization process with case management to avoid unnecessary inpatient stay, and those with modifiable risk can attempt prehabilitation to optimize these parameters before surgery.

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Degenerative Lumbar Spondylolisthesis.

The factors driving the best outcomes following minimally invasive surgery (MIS) for grade 1 degenerative lumbar spondylolisthesis are not clearly elucidated. To investigate the factors that drive the best 24-mo patient-reported outcomes (PRO) following MIS surgery for grade 1 degenerative lumbar spondylolisthesis. A total of 259 patients from the Quality Outcomes Database lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis with MIS techniques (188 fusions, 72.6%). Twenty-four-month follow-up PROs were collected and included the Oswestry disability index (ODI) change (ie, 24-mo minus baseline value), numeric rating scale (NRS) back pain change, NRS leg pain change, EuroQoL-5D (EQ-5D) questionnaire change, and North American Spine Society (NASS) satisfaction questionnaire. Multivariable models were constructed to identify predictors of PRO change. The mean age was 64.2±11.5 yr and consisted of 148 (57.1%) women and 111 (42.9%) men. In multivariable analyses, employment was associated with superior postoperative ODI change (β-7.8; 95% CI [-12.9 to -2.6]; P=.003), NRS back pain change (β -1.2; 95% CI [-2.1 to -0.4]; P=.004), EQ-5D change (β 0.1; 95% CI [0.01-0.1]; P=.03), and NASS satisfaction (OR=3.7; 95% CI [1.7-8.3]; P<.001). Increasing age was associated with superior NRS leg pain change (β -0.1; 95% CI [-0.1 to -0.01]; P=.03) and NASS satisfaction (OR=1.05; 95% CI [1.01-1.09]; P=.02). Fusion surgeries were associated with superior ODI change (β -6.7; 95% CI [-12.7 to -0.7]; P=.03), NRS back pain change (β -1.1; 95% CI [-2.1 to -0.2]; P=.02), and NASS satisfaction (OR=3.6; 95% CI [1.6-8.3]; P=.002). Preoperative employment and surgeries, including a fusion, were predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain improvement and satisfaction.

Characterization of wound microbes in epidermolysis bullosa: Results from the epidermolysis bullosa clinical characterization and outcomes database.

Patients with epidermolysis bullosa (EB) require care of wounds that are colonized or infected with bacteria. A subset of EB patients are at risk for squamous cell carcinoma, and bacterial-host interactions have been considered in this risk. The EB Clinical Characterization and Outcomes Database serves as a repository of information from EB patients at multiple centers in the United States and Canada. Access to this resource enabled broad-scale analysis of wound cultures. A retrospective analysis of 739 wound cultures from 158 patients from 13 centers between 2001 and 2018. Of 152 patients with a positive culture, Staphylococcus aureus (SA) was recovered from 131 patients (86%), Pseudomonas aeruginosa (PA) from 56 (37%), and Streptococcus pyogenes (GAS) from 34 (22%). Sixty-eight percent of patients had cultures positive for methicillin-sensitive SA, and 47%, methicillin-resistant SA (18 patients had cultures that grew both methicillin-susceptible and methicillin-resistant SA at different points in time). Of 15 patients with SA-positive cultures with recorded mupirocin susceptibility testing, 11 had mupirocin-susceptible SA and 6 patients mupirocin-resistant SA (2 patients grew both mupirocin-susceptible and mupirocin-resistant SA). SCC was reported in 23 patients in the entire database, of whom 10 had documented wound cultures positive for SA, PA, and Proteus species in 90%, 50%, and 20% of cases, respectively. SA and PA were the most commonly isolated bacteria from wounds. Methicillin resistance and mupirocin resistance were reported in 47% and 40% of patients tested, respectively, highlighting the importance of ongoing antimicrobial strategies to limit antibiotic resistance.

National study of the impact of rural immersion programs on intended location of medical practice in New Zealand.

New Zealand (NZ) faces an ongoing shortage of rural medical professionals. In an effort to increase interest in rural practice, both of the medical schools in NZ offer rural immersion programs as well as rural entry pathways. The aim of this study was to compare the effect of long (>33-week) rural immersion with a short (5-week interprofessional) rural immersion or no rural immersion on the career location intentions of NZ medical students. This observational study used linked data from the Commencing Medical Students Questionnaire (CMSQ) and Exit Questionnaire (EQ), collected between 2011 and 2017 as part of the Medical Schools Outcomes Database project, along with information on whether or not a student undertook a rural immersion program. The main outcome measure was EQ career location intention (Rural (population 100 000)). The explanatory variables were rural immersion (long, short, none), age, ethnicity, background, CMSQ career location intention, gender, specialisation preferences and interest in rural medicine. In addition to univariate analysis, data were used to build a multinomial model to determine relative associations of these variables with the outcome. Full data were available for 1367 NZ medical students (47% of all students during the time period). Of these, 17.4% had undertaken a long or short rural immersion program. In univariate analysis, age was the only variable that did not significantly predict EQ rural intention outcome. In the multivariate model, rural immersion was a significant independent predictor of EQ career location intention. Students taking a long rural immersion were 6.4 and 4.4 times more likely to select a Rural or Regional intention, respectively, than those with no rural immersion. This strong effect on rural intentions was seen regardless of background. CMSQ career location intention, background, ethnicity, rural club membership and preference for general practice were also significant predictors. While short rural immersion did not have an independent effect, this finding should be interpreted with caution given the smaller number of students and the response rate. Long rural immersion is highly beneficial for increasing interest in rural work, increasing the likelihood that medical students will intend to work outside an urban setting. Students who signal an early rural intention are strong candidates for such programs later in their course, regardless of their background. A three-category classification for geographic background and career location intention permitted a more detailed understanding of the interplay among demographic variables and rural immersion in influencing career intentions. Following cohorts into their postgraduate years is needed to ascertain if these career location intentions persist.

The Influence of Unemployment and Disability Status on Clinical Outcomes in Patients Receiving Surgery for Low Back-Related Disorders: An Observational Study.

Introduction Employment status plays an essential role as a social determinant of health. Unemployed are more likely to have a longer length of hospital stay and a nearly twofold greater rate of 30 day readmission than those who were well employed at the time of back surgery. This study aimed to investigate whether employment status influenced post-surgery outcomes and if so, the differences were clinically meaningful among groups. Methods This retrospective observational study used data from the Quality Outcomes Database Lumbar Registry. Data refinement was used to isolate individuals 18 to 64 who received primary spine surgeries and had a designation of employed, unemployed, or disabled. Outcomes included 12 and 24 month back and leg pain, disability, patient satisfaction, and quality of life. Differences in descriptive variables, comorbidities, and outcomes measures (at 12 and 24 months) were analyzed using chi-square and linear mixed-effects modeling. When differences were present among groups, we evaluated whether they were clinically significant or not. Results Differences (between employed, unemployed, and disabled) among baseline characteristics and comorbidities were present in nearly every category (p<0.01). In all cases, those who were disabled represented the least healthy, followed by unemployed, and then employed. Clinically meaningful differences for all outcomes were present at 12 and 24 months (p<0.01). In post hoc analyses, differences between each group at nearly all periods were found. Conclusions The findings support that the health-related characteristics are markedly different among employment status groups. Group designation strongly differentiated outcomes. These findings suggest that disability and unemployment should be considered when determining prognosis of the individual.

Abstract 264: Traumatic and Hemorrhagic Complications After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest

Introduction: Extracorporeal cardiopulmonary resuscitation (ECPR) is a rescue therapy for treatment of refractory out-of-hospital cardiac arrests (OHCA). We describe the incidence of traumatic and hemorrhagic complications among patients undergoing ECPR for OHCA and the association between CPR duration and ECPR-related injuries or bleeding. Methods: We examined prospectively collected data from the Extracorporeal Resuscitation Outcomes Database (EROD), which includes ECPR-treated OHCAs from participating hospitals (Oct 2014 - Aug 2019). The primary outcome was traumatic or hemorrhagic complications, defined as injury to the chest, abdomen, or vasculature, or bleeding requiring transfusion or surgery. The primary exposure was the cardiac arrest to ECPR initiation interval (CA-ECPR interval), measured as the time from arrest to initiation of ECPR. Descriptive statistics were used to compare demographic, cardiac arrest, and ECPR characteristics among patients with and without CPR-related traumatic or bleeding complications. Multivariable logistic regression was used to examine the association between CPR duration and traumatic or bleeding complications. Results: A total of 68 patients from 4 hospitals received ECPR for OHCA were entered into EROD and met inclusion criteria. Median age was 51 (IQR 38-58), 81% were male, 40% had BMI &gt; 30, and 70% had pre-existing medical comorbidities. A total of 65% had an initial shockable cardiac rhythm, mechanical CPR was utilized in at least 29% of patients, and 27% were discharged alive. A total of 37% experienced a traumatic or bleeding complication, with major bleeding (32%), vascular injury (18%), and cannula site bleeding (15%) being the most common. Compared to patients with shorter CPR times, patients with a 10 minute longer CA-ECPR interval had 18% (95% CI -2-42%) higher odds of suffering a mechanical or bleeding complication, but this did not reach statistical significance (p=0.08). Conclusions: Traumatic injuries and bleeding complications are common among patients undergoing ECPR. Further study is needed to investigate the relation between arrest duration and complications. Clinicians performing ECPR should anticipate and assess for injuries and bleeding in this high-risk population.

Is There Additional Value to Flexion-Extension Radiographs for Degenerative Spondylolisthesis?

Multicenter retrospective study. Flexion-extension radiographs are frequently used to assess motion in patients with degenerative spondylolisthesis. However, they expose patients to additional radiation and increase cost. The aim of this study is to determine if flexion-extension radiographs provide additional information not seen on upright neutral radiographs and supine magnetic resonance imaging (MRI) that may guide surgical decision making. Supine MRI and upright neutral radiographs are routinely performed in patients with degenerative spondylolisthesis. It is unclear whether additional flexion-extension views play a significant role in surgical planning for this patient population. From the Quality Outcomes Database, patients who had surgery for grade 1 degenerative spondylolisthesis were identified. Magnitude of slip on pre-op supine MRI, upright neutral, flexion, and extension radiographs were measured. Additional motion was defined as 3 mm or more slip difference between radiographs. For the purpose of this analysis, patients with a slip of 7 mm or more on upright neutral radiographs were assumed to require a fusion. A total of 191 patients were identified. Mean age was 61.6 years (114 females, 60%). Only 31 patients (16%) had additional motion on flexion-extension views not seen on upright neutral x-rays versus supine MRI. Of these 31 patients, 19 had slips less than 7 mm on upright x-ray, generating equipoise for fusion. Flexion-extension radiographs may play a limited role in management of degenerative spondylolisthesis. The subset of patients for which flexion-extension views were most likely to provide value were patients with smaller slips (<7 mm) with no evidence of motion on standing radiographs versus MRI. In 90% of spondylolisthesis cases, information used for surgical planning may be ascertained by comparing motion between supine MRI and upright lateral radiographs.Level of Evidence: 3.

Effectiveness and Safety Outcomes in Patients with Hemophilia a Receiving Antihemophilic Factor (Recombinant) for at Least 5 Years in a Real-World Setting: 6-Year Interim Analysis of the Ahead International and German Studies

Effectiveness and Safety Outcomes in Patients with Hemophilia a Receiving Antihemophilic Factor (Recombinant) for at Least 5 Years in a Real-World Setting: 6-Year Interim Analysis of the Ahead International and German Studies

Variation in the Treatment of Multiple Myeloma in the Real World

Variation in the Treatment of Multiple Myeloma in the Real World

Quantifying the collective influence of social determinants of health using conditional and cluster modeling.

ObjectivesOur objective was to analyze the collective effect of social determinants of health (SDoH) on lumbar spine surgery outcomes utilizing two different statistical methods of combining variables.MethodsThis observational study analyzed data from the Quality Outcomes Database, a nationwide United States spine registry. Race/ethnicity, educational attainment, employment status, insurance payer, and gender were predictors of interest. We built two models to assess the collective influence of SDoH on outcomes following lumbar spine surgery—a stepwise model using each number of SDoH conditions present (0 of 5, 1 of 5, 2 of 5, etc) and a clustered subgroup model. Logistic regression analyses adjusted for age, multimorbidity, surgical indication, type of lumbar spine surgery, and surgical approach were performed to identify the odds of failing to demonstrate clinically meaningful improvements in disability, back pain, leg pain, quality of life, and patient satisfaction at 3- and 12-months following lumbar spine surgery.ResultsStepwise modeling outperformed individual SDoH when 4 of 5 SDoH were present. Cluster modeling revealed 4 distinct subgroups. Disparities between the younger, minority, lower socioeconomic status and the younger, white, higher socioeconomic status subgroups were substantially wider compared to individual SDoH.DiscussionCollective and cluster modeling of SDoH better predicted failure to demonstrate clinically meaningful improvements than individual SDoH in this cohort. Viewing social factors in aggregate rather than individually may offer more precise estimates of the impact of SDoH on outcomes.

Outcomes of Active Surveillance Versus Initial Treatment for Nodular Lymphocyte Predominant Hodgkin Lymphoma: A National Cancer Database (NCDB) Analysis of 2,480 Patients

Introduction Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL) is a unique and clinically distinct subtype of Hodgkin lymphoma (HL), comprising approximately 5% of all HL cases with an annual incidence of about 1-2 cases per million. Compared with classical HL (cHL), NLPHL is more likely to present with limited stage and a more indolent clinical course. Despite these favorable traits, systemic chemoimmunotherapies and/or radiation are often used for initial treatment. Deaths directly from NLPHL are uncommon, with mortality in these patients often attributable to treatment-related toxicities or transformation to aggressive non-Hodgkin B-cell lymphomas. There is emerging evidence that NLPHL can be treated more conservatively. Active Surveillance (AS), a strategy by which initial treatment is deferred in favor of close observation, has been evaluated in single-institution retrospective studies spanning decades. Borchmannet alreported comparable overall survival (OS) for patients managed with AS versus upfront treatment (Blood, 2019). While encouraging, additional contemporary data are needed to determine if AS is a safe option for NLPHL patients, given advances in supportive care, addition of anti-CD20 therapies, improved radiation delivery, and better diagnostic methods. This retrospective National Cancer Database (NCDB) study evaluates the effect of initial treatment modality on overall survival in a contemporary population of patients with NLPHL to determine if initial AS has comparable OS when compared with initial treatment. Methods The National Cancer Database (NCDB) is a nationwide oncology outcomes database for more than 1500 accredited cancer programs in the United States. The NCDB was queried for all patients with the diagnosis of NLPHL, defined by histology code 9659. Filters for inclusion included year of diagnosis from 2010 to 2015, B-cell/pre-B/B-precursor histologic subtype, known treatment status, and with survival data available. Demographic, socioeconomic, treatment modality, and clinical factors such as stage and Charlson-Deyo comorbidity indices were summarized. Chi-square tests were used to correlate factors with treatment status. Kaplan-Meier methods were used to estimate overall survival, and log rank test was used to compare OS between patient groups. Cox proportional hazard model was used to associate patient characteristics with OS, and backwards elimination was used to identify the final Cox model, starting from all factors in univariate analysis. Results A total of 2,480 patients with NLPHL diagnosed between 2010 and 2015 were included. Of these, 553 patients were older than 60 years (22.3%), 1,616 were male (65%), and 2,110 had a Charlson-Deyo score of 0 (85%) while 370 had a score of ≥1 (15%). 1,627 had Stage I-II disease (65.6%) while 731 had Stage III-IV disease (29.5%). Overall, 2,330 patients were alive (94%) and 150 were deceased (6%), with a median follow-up of 36.8 months (range 0.1 to 94.3 months). Initial management options included: treatment (radiation, chemo/immunotherapy, and/or surgery), no treatment (e.g. palliative care only), or AS. 2,309 patients (93.1%) were initially treated (IT), 103 (4.15%) received no treatment (NT) and 68 patients (2.74%) underwent AS. OS by treatment strategy is shown in Figure 1. In univariate analysis, there was no OS difference between IT vs AS (HR 0.71; 95% CI 0.31-1.61, P=0.41) or NT vs. AS (HR 2.03; 95% CI 0.75-5.51; P= 0.16), but there was a significant difference between NT and IT (HR 2.87; 95% CI 1.56-5.32, P=0.0008). In the final Cox multivariate analysis, there was no significant difference between three treatment groups (overall P=0.10). Age &amp;gt;60, male gender, those with government insurance, Charlson-Deyo score ≥1, and Stage IV were all associated with decreased OS (Table 1). Conclusion In this large NCDB outcomes analysis of 2,480 NLPHL patients, those selected for AS had no difference in overall survival compared to patients who were initially treated. This lends support to emerging evidence that AS is a viable option for a subset newly diagnosed NLPHL patients, as is routine for indolent non-Hodgkin Lymphoma. Future study is needed to identify clinical features associated with a more indolent NLPHL phenotype that may be amendable to less intense initial management. Disclosures Hill: Karyopharm:Consultancy, Honoraria, Research Funding;Takeda:Research Funding;Celgene:Consultancy, Honoraria, Research Funding;BMS:Consultancy, Honoraria, Research Funding;Novartis:Consultancy, Honoraria;Kite, a Gilead Company:Consultancy, Honoraria, Research Funding;AstraZenica:Consultancy, Honoraria, Research Funding;Beigene:Consultancy, Honoraria, Research Funding;Pharmacyclics:Consultancy, Honoraria, Research Funding;Abbvie:Consultancy, Honoraria, Research Funding;Genentech:Consultancy, Honoraria, Research Funding.

Impact of Dominant Symptom on 12-Month Patient-Reported Outcomes for Patients Undergoing Lumbar Spine Surgery.

The impact of symptom characteristics on outcomes of spine surgery remains elusive. To determine the impact of symptom location, severity, and duration on outcomes following lumbar spine surgery. We queried the Quality Outcomes Database (QOD) for patients undergoing elective lumbar spine surgery for lumbar degenerative spine disease. Multivariable regression was utilized to determine the impact of preoperative symptom characteristics (location, severity, and duration) on improvement in disability, quality of life, return to work, and patient satisfaction at 1 yr. Relative predictor importance was determined using an importance metric defined as Wald χ2 penalized by degrees of freedom. A total of 22 022 subjects were analyzed. On adjusted analysis, we found patients with predominant leg pain were more likely to be satisfied (P<.0001), achieve minimum clinically important difference (MCID) in Oswestry Disability Index (ODI) (P=.002), and return to work (P=.03) at 1 yr following surgery without significant difference in Euro-QoL-5D (EQ-5D) (P=.09) [ref=predominant back pain]. Patients with equal leg and back pain were more likely to be satisfied (P<.0001), but showed no significant difference in achieving MCID (P=.22) or return to work (P=.07). Baseline numeric rating scale-leg pain and symptom duration were most important predictors of achieving MCID and change in EQ-5D. Predominant symptom was not found to be an important determinant of return to work. Worker's compensation was found to be most important determinant of satisfaction and return to work. Predominant symptom location is a significant determinant of functional outcomes following spine surgery. However, pain severity and duration have higher predictive importance. Return to work is more dependent on sociodemographic features as compared to symptom characteristics.

Visual Acuity Outcomes in Patients Receiving Frequent Treatment of Neovascular Age-Related Macular Degeneration in Clinical Practice.

This work evaluates dosing frequency with intravitreal antivascular endothelial growth factor (anti-VEGF) agents over 2 years and visual acuity (VA) outcomes in neovascular age-related macular degeneration (nAMD). This retrospective analysis assesses electronic medical record data (Vestrum Health treatment and outcomes database) of newly diagnosed nAMD in patients who were initiated on intravitreal anti-VEGF treatment at US clinical sites. Eyes were divided into 2 injection frequency subcohorts (≤ 6 or > 6 injections/y); treatment frequency and change in mean VA (Early Treatment Diabetic Retinopathy Study letters) were evaluated. Overall, 8127 of 213 824 eyes met inclusion criteria in year 1 and 4968 in year 2. During year 1, 77% of the eyes received more than 6 injections (n = 6287), the majority of which received injections at the same frequency during year 2. Mean VA gain from baseline at year 1 was lower in the ≤ 6 than > 6 injections/y subcohort (2.2 vs 6.5, P < .001). Decrease in mean VA from the end of year 1 to year 2 was significantly greater for eyes administered 6 or fewer injections in year 2 than those that received more frequent injections, irrespective of the frequency of injections in the first year. In routine clinical practice, most eyes with nAMD that completed at least 1 year of follow-up were treated with more than 6 injections of anti-VEGF agents during the first year of treatment, resulting in better VA gains than eyes treated less frequently during the same period.

Evaluation of transforaminal epidural steroid injections for discogenic axial lumbosacral back pain utilizing PROMIS as an outcome measure

Background contextDiscogenic lumbosacral back pain continues to present a challenging clinical entity with limited, controversial therapeutic options. No study to date has evaluated the efficacy of fluoroscopically guided transforaminal epidural steroid injections (TFESI) in a homogenous patient population with axial lumbosacral back pain from discogenic pathology utilizing strict, explicitly clinical and radiographic criteria. Additionally, there is a paucity of published data utilizing Patient Reported Outcome Measurement Information System (PROMIS) scores as an outcome measure for interventional spine procedures. PurposeEvaluate the therapeutic effect of TFESIs in a specific subset of patients with discogenic axial lumbosacral back pain. Investigate PROMIS as an outcome measure for interventional spine procedures targeting focal degenerative spinal pathology. Study design/settingRetrospective review of patients presenting to a multidisciplinary, tertiary academic spine center. Patient sampleThree thousand eight hundred eighty-one patients were screened for inclusion. A total of 26 patients with discogenic axial low back, based on strict clinical and radiographic criteria, underwent TFESIs. All patients had axial low back pain without radicular pain, ≥3 clinical features of discogenic pain, corroborative radiographic features of active discogenic pathology on lumbar spine magnetic resonance imaging without confounding spinal pathology. Outcome measuresPROMIS Pain Interference (PI) v1.1, PROMIS Physical Function (PF) v1.2/v2.0, and PROMIS Depression (D) v1.0 outcome scores were collected at baseline and postprocedure follow-up. MethodsQuery of an institutional, patient reported outcome database and subsequent retrospective review of electronic medical records was performed. Statistical analysis comparing baseline and postprocedural PROMIS outcome scores and correlation between these instruments was performed. Additionally, an exploratory investigation of minimal clinically important difference achievement rates was performed. ResultsAnalysis determined a statistically significant improvement in PROMIS PI (p=.017, 95% CI=−8.02 to −1.82) and PROMIS PF (p=.003, 95% CI=0.91–8.72) scores after treatment with TFESIs. At post treatment time points, TFESI had medium effect size on pain (d=0.55) and function (d=0.59). Change in PROMIS D scores (p=.488, 95% CI −1.74–3.54; d=.08) did not demonstrate statistical significance. Pearson correlation demonstrated a moderate negative correlation (r=−0.544, p=.004) between PROMIS PF with PROMIS PI. Correlation between PROMIS PF (r=−0.239, p=.24) and PROMIS PI (r=0.198, p=.33) with PROMIS D was not significant. Fourteen (53.8%) and 9 (34.6%) subjects achieved minimum clinically important difference (MCID) for PROMIS PI and PROMIS PF, respectively. Nine subjects (34.6%) achieved MCID for PROMIS D despite not otherwise reaching statistical significance otherwise. ConclusionsUtilizing PROMIS as an outcome measure, discogenic axial lumbosacral back pain patients appear to benefit from TFESI in terms of pain and physical function. This study contributes to the growing body of literature utilizing PROMIS scores in patients with clinical sequelae of degenerative spinal pathology; however, prospective studies are needed.

Utility of Routine Preoperative Laboratory Testing for Low-Risk Patients in Ambulatory Gynecologic Surgery

Study Objective To evaluate the utility of routine preoperative laboratory testing in low-risk patients undergoing ambulatory gynecologic surgery. Design The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database was queried for low-risk patients who underwent elective, ambulatory gynecologic surgery from 2015-2018. Setting The ACS NSQIP database is a validated, risk-adjusted surgical outcomes database that prospectively collects data from participating institutions nationally. Patients or Participants Low-risk patients selected for inclusion in this study were defined as being American Society of Anesthesiologists (ASA) class 1 or 2. This included 19,885 patients. Interventions Patient characteristics, comorbidities, and NSQIP-defined complications were compared between those with and without preoperative laboratory testing. Preoperative laboratory testing was defined as chemistry, hematology, coagulation, or liver function studies obtained within 30 days preoperatively. Measurements and Main Results Of 19,885 patients studied, 14,258 (71.8%) received preoperative laboratory testing, with at least one abnormal test identified in 4,053 (28.4%) patients. There was no statistically significant difference in overall postoperative complication rate when comparing patients who received preoperative laboratory testing with those who did not (2.5% vs. 2.2%, p=0.30). Additionally, there was no statistically significant difference in wound complications (1.0% vs. 1.0% p=0.78), major complications (1.0% vs. 0.8% p=0.11), unplanned return to the operating room (0.1% vs. 0.2%, p=0.40), unplanned readmission (0.7% vs. 0.5% p=0.10), or overall morbidity (2.1% vs. 1.9% p=0.38). Chi-squared analyses were performed to compare categorical variables. Continuous variables were compared using unpaired t-tests. Conclusion Preoperative laboratory testing continues to be performed in the majority of low-risk patients undergoing ambulatory gynecologic surgery despite evidence and guidelines that do not recommend this practice. However, there was no difference in surgical outcomes between patients who did and did not receive preoperative laboratory testing. Postoperative complications are infrequent in this patient population. These results suggest that preoperative laboratory testing should be used more judiciously in low-risk patients undergoing ambulatory gynecologic surgery. To evaluate the utility of routine preoperative laboratory testing in low-risk patients undergoing ambulatory gynecologic surgery. The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database was queried for low-risk patients who underwent elective, ambulatory gynecologic surgery from 2015-2018. The ACS NSQIP database is a validated, risk-adjusted surgical outcomes database that prospectively collects data from participating institutions nationally. Low-risk patients selected for inclusion in this study were defined as being American Society of Anesthesiologists (ASA) class 1 or 2. This included 19,885 patients. Patient characteristics, comorbidities, and NSQIP-defined complications were compared between those with and without preoperative laboratory testing. Preoperative laboratory testing was defined as chemistry, hematology, coagulation, or liver function studies obtained within 30 days preoperatively. Of 19,885 patients studied, 14,258 (71.8%) received preoperative laboratory testing, with at least one abnormal test identified in 4,053 (28.4%) patients. There was no statistically significant difference in overall postoperative complication rate when comparing patients who received preoperative laboratory testing with those who did not (2.5% vs. 2.2%, p=0.30). Additionally, there was no statistically significant difference in wound complications (1.0% vs. 1.0% p=0.78), major complications (1.0% vs. 0.8% p=0.11), unplanned return to the operating room (0.1% vs. 0.2%, p=0.40), unplanned readmission (0.7% vs. 0.5% p=0.10), or overall morbidity (2.1% vs. 1.9% p=0.38). Chi-squared analyses were performed to compare categorical variables. Continuous variables were compared using unpaired t-tests. Preoperative laboratory testing continues to be performed in the majority of low-risk patients undergoing ambulatory gynecologic surgery despite evidence and guidelines that do not recommend this practice. However, there was no difference in surgical outcomes between patients who did and did not receive preoperative laboratory testing. Postoperative complications are infrequent in this patient population. These results suggest that preoperative laboratory testing should be used more judiciously in low-risk patients undergoing ambulatory gynecologic surgery.

Complementary medicines advertising policy Part II: unethical conduct in the Australian market after July 2018.

Objective To assess the effects of Australian complementary medicines advertising policy after major changes in 2018. These included a legally enforceable advertising code, stronger investigative and compliance powers for the Therapeutic Goods Administration (TGA) and enhanced educational resources for industry. Methods Analysis of the TGA complaint outcome database from 1 July 2018 to 30 June 2019 and the new regulatory measures. Results Of 1821 complaint records analysed, 92% were classified as low priority and closed by sending the advertiser a Regulatory Obligation letter. For low priority complaints, no details of the product, advertiser or alleged Code violation were published, and no follow-up was undertaken. Of 121 higher priority complaints, 79% failed to meet their key performance indicator (KPI) time to closure (60-90 days). These included complaints about dangerous sports supplements and ineffective weight loss and hangover products, some of which had been submitted in July 2018. Conclusions Complaint classification and actions taken by the TGA were inconsistent. The TGA's new compliance powers were rarely applied. The new complaint system is less transparent than the one it replaced. There is a high rate of advertising complaints and a low rate of effective regulatory response. Time-based KPIs should be based on outcome measures, not when a case is closed by a process measure. An urgent review of the new system is required. Comment on Australia's 2018 Royal Commission into Misconduct in Banking is equally applicable to the TGA: 'Essentially a failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that.' It also encourages others to break the law, leading to a race to the bottom and consumer detriment. What is known about the topic? The previous co-regulatory system for complementary medicines was the subject of long-standing criticism and high levels of regulatory non-compliance. The new system, operated solely by the TGA, was meant to overcome these problems. What does this paper add? High levels of advertising complaints persist. The TGA was unable to close many higher-priority complaints within the time frame set by its KPIs. These complaints involved serious breaches of the Therapeutic Goods Act 1989 (Cwlth), which can attract both civil and (strict liability) criminal penalties. However, in most cases compliance was achieved by negotiation. The TGA met its KPIs for virtually all complaints it classified as low priority because these were closed by merely sending an obligations letter with no follow-up. What are the implications for practitioners? The persisting high levels of regulatory violation mean that practitioners cannot trust the claims made for complementary medicines or give good advice. In addition, consumers are wasting their money on useless products and are diverted from seeking more evidence-based remedies.