Equivocal Outcomes Research Articles

Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5-8-year follow-up of the ROCSS randomized controlled trial.

The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5-8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall-specific quality of life score. Eligible participants from original UK centres were identified. The primary outcome (abdominal wall-specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients' original allocation, even if the patient was aware of their treatment. Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (-2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04). ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall-specific quality of life 5-8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on. ISRCTN25584182 (http://www.clinicaltrials.gov).

Patient-specific implants in reverse shoulder arthroplasty.

Reverse total shoulder arthroplasty (RTSA) is widely popular among shoulder surgeons and patients, and its prevalence has increased dramatically in recent years. With this increased use, the indicated pathologies associated with RTSA are more likely to be encountered, and challenging patient presentations are more likely to be seen. One prominent challenging presentation is RTSA patients with severe glenoid bone loss. Several techniques with varying degrees of invasiveness, including excessive reaming, alternate centerline, bone grafting, and patient-specific implants (PSIs), have been developed to treat patients with this presentation. PSI treatment uses a three-dimensional reconstruction of a computed tomography scan to design a prosthetic implant or component customized to the patient's glenoid morphology, allowing compensation for any significant bone loss. The novelty of this technology implies a paucity of available literature, and although many studies show that PSIs have good potential for solving challenging shoulder problems, some studies have reported questionable and equivocal outcomes. Additional research is needed to explore the indications, outcomes, techniques, and cost-efficiency of this technology to help establish its role in current treatment guidelines and strategies.

Prognostic Significance of CD30 Expression and Response to Brentuximab Vedotin in Patients with Angioimmunoblastic T Cell Lymphoma

Background Angioimmunoblastic T-cell lymphoma (AITL) is a subtype of peripheral T-cell lymphoma (PTCL) characterized by a follicular helper T-cell phenotype. The standard frontline treatment for AITL typically involves CHOP or CHOP-like regimens, with consideration for autologous stem cell transplant. A promising treatment option for CD30-positive (CD30+) PTCLs, including AITL, is the anti-CD30 antibody drug conjugate, brentuximab vedotin (BV). The ECHELON-2 study demonstrated equivocal outcomes in CD30+ PTCL patients (pts) who received BV-CHP instead of CHOP. However, response of BV in CD30+ AITL pts is still uncertain. This study aims to evaluate the relationship between CD30 expression and the clinical response to BV in pts diagnosed with AITL. Methods This retrospective IRB approved study conducted at MD Anderson Cancer Center, where we analyzed pts with AITL diagnosed between 1997- 2023. Patient demographics, laboratory data at diagnosis, pathology review, treatment, and treatment response were collected and analyzed. Expression of CD30 expression in neoplastic cells was evaluated by immunohistochemistry and scored in 5% increments. Kaplan- Meier method was used to assess overall survival (OS) and log-rank used to compare different groups. Results This study included a cohort of 339 pts with AITL. Among them, 55 (23%, n=237) had no detectable CD30 expression (CD30=0%),182 (77%, n=237) patients had detectable CD30 expression (CD30>1%), and 102 pts had unknown CD30 expression. Table 1 shows patient characteristics by CD30 expression and response to first-, second-, and third- line BV treatment. There were 113 (48%, n=237) females and 124 (52%, n=237) males with a median age of 66 years. Most patients were Whites (88%, n=196) followed by Black (4%, n=196), and Asian (5%, n=196). Fifty-two (n=122) of pts who were CD30+ had stage III, 43% (n=122) had stage IV (p-value= <0.001), and 38% had BM involvement (p- value= 0.3). For pts with disease showing no CD30 expression (CD30neg) 16% (n=43) of pts had stage III, 70% (n=43) had stage IV, and 48% (n=42) had BM involvement. Auto-Stem cell transplant (ASCT) was performed in 48% of those with CD30+ and 43% of CD30neg. The most common first-line treatment was chemotherapy combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) followed by other CHOP like regimens. In total, 35 pts received BV treatment as first-line, 32 patients received BV in combination with chemotherapy and 3 received BV only. For second-line treatment, 11 received BV treatment and for third- line only 6 received BV. First- line treatment with BV showed better clinical response rates, with 82% achieving complete response (CR, n= 34), followed by second line CR with 56% (n= 9) and third- line with 0% (n= 6). The median OS were similar between those with CD30+ who did or did not receive first line BV (20 months vs. 19 months, p>0.05). The median OS for CD30neg pts who did not receive BV was 25 months (p=0.42). Furthermore, there was no statistically significant difference in OS between pts who underwent a ASCT (CD30+ 24.5 months and CD30neg 32.5 months, respectively) and those who did not (CD30+ 18.5 months and CD30neg 24.5 months, respectively, p- value = 0.29). Conclusion While this study did not find CD30 expression to be a predictor of response to BV treatment or ASCT in AITL pts, it provides valuable insights into the prevalence of CD30 expression and BV response as first- line treatment. Notably, 77% of pts had CD30 expression and pts who received BV as first- line had a higher proportion of CRs compared to pts who received BV as second- and third- line treatments. Further investigations with larger patient cohorts are necessary to determine the prognostic and predictive role of CD30 in AITL. Additional studies analyzing CD30 expression levels in malignant cells, immunoblasts, and macrophages are planned for presentation at the upcoming annual meeting.

An international cross-laboratory survey on fish vitellogenin analysis: Methodological challenges and opportunities for best practice

Vitellogenin (VTG) is a biomarker for possible endocrine activity of chemicals acting via the estrogen, androgen, or steroidogenesis pathways. VTG is assessed in standardised fish guideline studies conducted for regulatory safety assessment of chemicals. VTG data can be highly variable leading to concerns for potential equivocal, false positive and/or negative outcomes. Consequently, additional fish testing may be required to address uncertainties in the VTG response, and possibly erroneous/missed identification of endocrine activity. To better understand the technical challenges of VTG assessment and reporting for regulatory purposes, a survey was sent to 27 testing laboratories performing these analyses. The survey results from 16 respondents (6 from the UK, 3 from the USA, and 7 from the EU) were analysed and discussed in a follow-up webinar. High variability in background VTG concentrations was widely acknowledged and thought to be associated with fish batch, husbandry, laboratory practices, and several methodological aspects. These include sample collection and storage, VTG quantification, data handling, and the benchmarks used for data acceptability. Information gathered in the survey provides a basis for improving and harmonizing the measurement of VTG in fish, and an opportunity to reassess the suitability of current acceptability criteria in test guidelines.

Long-term behavior and functional outcomes of ileal-pouch anal anastomosis in inflammatory bowel disease with changing phenotype

BackgroundIleal-pouch-anal anastomosis is the operation of choice after proctocolectomy for ulcerative colitis; some patients will develop Crohn’s disease. We aim to determine long-term behavior and outcomes of inflammatory bowel disease–ileal-pouch-anal anastomosis after colectomy, where a specialist gastrointestinal pathologist re-evaluated the initial colectomy specimen. MethodsPatients with inflammatory bowel disease–ileal-pouch-anal anastomosis were identified from a single-surgeon prospective database containing 1,165 patients accrued from 1991 to 2017 and invited to complete pouch-function and quality-of-life assessments. Medical records were used to obtain clinical outcomes and subjective functional assessments for those unable to be contacted. Data were compared between patients with and without histological assessment disagreement and subsequent inflammatory bowel disease behavior subgroups. ResultsFor 138 patients included in the analysis, the median follow-up was 22.5 (range: 5–39) years. A total of 39.1% of patients had histologic diagnostic change after gastrointestinal pathologist review, and 19% and 39% developed Crohn’s disease-like disease behavior at 10- and 20-year follow-ups. Pouch function and quality-of-life scores were similar across diagnostic change subgroups. Pouch failure was higher in Crohn’s-like disease (31.1 vs 13.0%, P < .05). Intestinal continuity was maintained in 68.9% of Crohn’s disease-like patients, 57.9% required biologics. Gastrointestinal pathologist review did not alter the time to new diagnosis (P = .419) or time to pouch failure (P = .320), mean: 11.0 and 11.41 years, respectively. ConclusionWe describe equivocal patient-reported outcomes in patients with ileal-pouch-anal anastomosis and changing histologic and clinical diagnosis. Although pouch excision and biologic use rates are higher, many Crohn’s disease-like patients maintain their pouch. Diagnostic change and pouch failure often occur >10 years after ileal-pouch-anal anastomosis creation. This supports the consideration of ileal-pouch-anal anastomosis after colectomy in carefully selected patients with inflammatory bowel disease, even those with ambiguous histology and the need for close long-term follow-up.

407 Robotic Assisted Cholecystectomy and Common Bile Duct Exploration for Single Stage Management of Complex Gallstone Disease

Abstract Aim Laparoscopic cholecystectomy and common bile duct exploration (LC-CBDE) is an alternative to endoscopic retrograde cholangiopancreatography (ERCP) for treatment of choledocholithiasis. The ‘Achilles heel’ of LC-CBDE is the choledochotomy incision and closure following duct clearance. Robotic assisted surgery (RAS) aspires to overcome these technical challenges by providing improved views (3D enhancement) and articulated instruments potentially improving surgical precision. We aim to scrutinise the outcomes of an early series of robotic assisted cholecystectomy and common bile duct exploration (RC-CBDE) cases performed at our institution. Method Retrospective analysis from a specialist benign pancreatico-biliary unit in the United Kingdom was undertaken from April 2022 – December 2022 inclusive. All patients who underwent RC-CBDE for complicated gallstone disease were included. Collated data included patient demographics, perioperative investigations, intraoperative approach, and postoperative outcomes. Results 10 patients were identified. Median (IQR) age was 51 (33 – 66) years. Median (IQR) BMI was 26 (21 – 32) kg/m2. Median (IQR) Charlson Co-morbidity Index (CCI) was 1 (0 – 4). 4 patients were operated on during the acute presentation, with median (IQR) bilirubin 51 (34 – 252.5). Median (IQR) operative time was 176 (124 – 222) minutes. Median (IQR) post-operative length of stay was 4 (1 – 5) days. One patient required reintervention for port site hernia repair from drain site. Conclusions RC-CBDE is a safe and effective treatment for choledocholithiasis with equivocal outcomes to LC-CBDE. Benefits of RAS include enhanced views and ergonomics aiding precise closure of choledochotomy, which may both reduce complications and promote wider uptake of common bile duct exploration – a previously underutilised, technically-challenging operative procedure.

Evaluating H295R steroidogenesis assay data for robust interpretation

The in vitro H295R steroidogenesis assay (OECD TG 456) is used to determine a chemical's potential to interfere with steroid hormone synthesis/metabolism. As positive outcomes in this assay can trigger significant higher tiered testing, we compiled a stakeholder database of reference and test item H295R data to characterize assay outcomes. Information concerning whether a Level 5 reproductive toxicity study was triggered due to a positive outcome in the H295R assay was also included.Quality control acceptance criteria were not always achieved, suggesting this assay is challenging to conduct within the guideline specifications. Analysis of test item data demonstrated that pairwise significance testing to controls allowed for overly sensitive statistically significant positive outcomes, which likely contribute to the assay's high positive hit rate. Complementary interpretation criteria (e.g., 1.5-fold change threshold) markedly reduced the rate of equivocal and positive outcomes thus improving identification of robust positive effects in the assay.Finally, a case study (positive H295R outcome and no endocrine adversity in vivo) is presented, which suggests that stricter data interpretation criteria could refine necessary in vivo follow-up testing. Overall, the described additional criteria could improve H295R data interpretation and help inform on how to best leverage this assay for regulatory purposes.

P-007 A Four Arm Prospective Randomized Control Trial to Investigate the Role of Advance Sperm Selection Techniques for Raised Sperm DNA Fragmentation Index

Abstract Study question Role of Testicular Sperm Aspiration (TESA), Magnetic Activated Cell Sorting (MACS), Microfluidics &amp; Daily ejaculation, to reduce raised Sperm DNA Fragmentation Index (SDF) &amp; evaluate impact on outcomes? Summary answer Amongst the advance sperm selection methods, Microfluidic sperm sorting seems to significantly reduce the SDF and offer the best reproductive outcomes What is known already Raised SDF is known to affect the reproductive outcomes of a couple. There are various sperm processing methods/interventions shown to reduce the sperm DNA fragmentation, but their effectiveness to optimize reproductive outcomes is still debatabl. Study design, size, duration RCT approved by the Institutional Ethical Committee. IEC No.:1312/Inst/TG/2019. Couples undergoing IVF with raised SDF were randomized into four arms by computer generated randomized numbers from October 2019 to May 2022 (n = 466). Of those 373 patients recruited to, TESA (n = 129), MACS (n = 92), Microfluidics (n = 116) Daily ejaculation (n = 36) . Males with SDF &amp;gt; 25% &amp; Age 25-40 yrs were included. Women&amp;gt;37 yrs, BMI &amp;gt;30 and men with Smoking, Binge alcohol, varicocele excluded. Couples with one failed IVF were offered SDF. SDF&amp;gt;25%was considered raised and were included in study. Participants/materials, setting, methods After Oocyte Pick Up (OPU), sample processed for ICSI and was sent for post intervention SDF. TESA done as per SOP of clinic. MACS &amp; Microfluidics done as per instruction from manufacturer. Daily ejaculate group, patient ejaculated daily for 1week prior to OPU and at OPU, fresh ejaculate processed through density gradient. Men with high SDF, after randomization were subjected to OPU, ICSI, Blastocyst Culture, Freeze all policy and Frozen Embryo Transfer with 2blastocysts Main results and the role of chance Primary outcome-magnitude of reduction in SDF post intervention Secondary outcomes – Blastocyst Rate (BR), Implantation rates (IR), Live birth (LBR)Mean of SDF on Raw Semen Sample Vs Post Intervention Sample: TESA – 44% Vs 25.75% Microfluidics - 34.4% Vs 9.8% (p &amp;lt; 0.05; Significant) MACS – 32.2% Vs 27.95% Daily Ejaculation 39.37% Vs 19.66% Microfluidics seem to be beneficial intervention in significantly reducing the SDF. MACS seemed to have offered the least reduction of SDF. BR: This was comparable between all groups with no statistical significance Reproductive Outcomes for TESA, Microfluidics, MACS &amp; Daily ejaculation: IR – 39.3% Vs 57.27% Vs 46.4% Vs 61% (p = 0.1) LBR – 60% VS 65% Vs 64% Vs 61% (p = 0.41) Miscarriage Rates and Multiple Pregnancy rates were comparable between the groups and statistically not significant. We observe that microfluidics was the best sperm processing method as it significantly reduced the DFI and had the best reproductive outcomes. It is noninvasive and can be done easily. Even though there was no statistical significance, Daily ejaculation yielded equivocal outcomes than the other 3 groups. Considering the ease, cost effectiveness and optimal reproductive outcomes Daily Ejaculation can also be offered to patients with raised SDF. Though TESA had acceptable outcomes, considering its invasiveness adequate counselling is warranted. Outcomes for MACS were guarded and be suggested with caution. Limitations, reasons for caution The sample size is small in the daily ejaculate arm as there were many dropouts. The unequal size of the arms would affect the results. So, we are continuing the randomization and intend to look into the results with equal size of the arms in the future Wider implications of the findings Published literature has shown raised SDF to be detrimental to reproductive outcomes. There is an urgent need for an efficient intervention which is safe, economical, easy to use and offers the best reproductive outcomes. Daily ejaculation, a traditional concept which is cost effective needs due consideration over other techniques. Trial registration number CTRI. Trial No.: REF/2021/05/043439

The Effect of Resident Involvement in Hip Fracture Surgery: An Analysis of a Single Institution Before and After the Addition of an Orthopaedic Surgical Residency.

Hip fractures are common injuries that are associated with serious morbidity/mortality in the elderly and represent a substantial financial burden to healthcare systems. Previous studies demonstrated that resident involvement in orthopaedic surgeries is associated with increased surgical time and cost, with equivocal or worse outcomes. This study evaluated outcomes of hip fracture surgery at one institution, before and after the introduction of an orthopaedic residency program. A retrospective chart review divided patients who underwent hip fracture surgery between January 2015 and January 2018 into two groups based on resident involvement. Outcomes including surgical time, length of stay (LOS), readmission rate, and direct/indirect costs were compared as were the American Society of Anesthesiologists physical status score and procedure conducted. Six hundred sixty-two hip fracture surgeries were performed in 36 months. Residents were engaged in 303 cases (45.8%) with no notable differences in the two groups regarding American Society of Anesthesiologists score, procedure conducted, or readmission rate. With resident involvement, surgical time was significantly longer (91.2 versus 78.9 minutes, P -value = 0.004), whereas LOS was significantly shorter (5.2 versus 5.6 days, P -value = 0.003). Finally, there were significant reductions in direct costs (8% reduction; P < 0.001) and OR implant costs (12% reduction; P < 0.001), but significant increase in indirect costs (7% increase; P < 0.001). Surgical experience is critical in orthopaedic training. There are concerns regarding potential negative effects of resident involvement on surgical outcomes and healthcare costs. While resident involvement was associated with slightly increased surgical times and indirect costs, it also led to decreased LOS and direct costs. We believe this is the first study to compare patient outcomes at one institution before and after resident involvement. Our findings demonstrated, compared with attendings alone, resident involvement resulted in an overall improvement rather than compromise in patient care.

Effect of Radiation Schedule on Transportation-Related Carbon Emissions: A Case Study in Rectal Cancer

The health care sector is a major contributor of worldwide greenhouse gas (GHG) emissions. Indirect emissions, including those associated with transportation, make up 82% of the US health care sector's environmental footprint. Radiation therapy (RT) treatment regimens present an opportunity for environmental health care-based stewardship owing to the high incidence of cancer diagnosis, significant utilization of RT, and myriad treatment days required for curative regimens. Because the use of short-course RT (SCRT) in the treatment of rectal cancer has demonstrated noninferior clinical outcomes compared with conventional, long-course RT (LCRT), we investigate the environmental and health equity-related outcomes. Patients treated with curative, preoperative RT for newly diagnosed rectal cancer at our institution between 2004 and 2022 and living in-state were included. Travel distance was estimated using patients' reported home address. Associated GHG emissions were calculated and reported in carbon dioxide equivalents (CO2e). Of 334 patients included, the total distance traveled for the treatment course was significantly greater in patients treated with LCRT versus SCRT (median, 1417 vs 319 miles; P < .001). Total CO2e emissions for those undergoing LCRT (n=261) and SCRT (n=73) were 665.3 kg CO2e and 149.9 kg CO2e, respectively, per treatment course (P < .001), with a net difference of 515.4 kg CO2e. Relatively, this suggests that LCRT is associated with 4.5 times greater GHG emissions from patient transportation. Using treatment of rectal cancer as proof-of-principle, we advocate for the inclusion of environmental considerations in the creation of climate-resilient oncologic RT practices, especially in the context of equivocal clinical outcomes between RT fractionation schedules.

Evaluating and developing sealants for the prevention of pulmonary air leakage: A systematic review of animal models.

Sealants may provide a solution for pulmonary air leakage (PAL), but their clinical application is debatable. For sealant comparison, standardized animal models are lacking. This systematic review aims to assess methodology and quality of animal models for PAL and sealant evaluation. All animal models investigating lung sealing devices (e.g., staplers, glues, energy devices) to prevent or treat PAL were retrieved systematically from Embase, Pubmed and Web of science. Methodological study characteristics, risk of bias, reporting quality and publication bias were assessed. A total of 71 studies were included (N = 75 experiments, N = 1659 animals). Six different species and 18 strains were described; 92% of experiments used healthy animals, disease models were used in only six studies. Lesions to produce PAL were heterogenous, and only 11 studies used a previously reported technique, encompassing N = 5 unique lesions. Clinically relevant outcomes were used in the minority of studies (imaging 16%, air leak 10.7%, air leak duration 4%). Reporting quality was poor, but revealed an upward trend per decade. Overall, high risk of bias was present, and only 18.7% used a negative control group. All but one study without control groups claimed positive outcomes (95.8%), in contrast to 84.3% using positive or negative control groups, which also concluded equivocal, adverse or inconclusive outcomes. In conclusion, animal studies evaluating sealants for prevention of PAL are heterogenous and of poor reporting quality. Using negative control groups, disease models and quantifiable outcomes seem important to increase validity and relevance. Further research is needed to reach consensus for model development and standardization.

A COMPARATIVE STUDY OF OPERATIVE MANAGEMENT WITH CONSERVATIVE MANAGEMENT OF CALCANEUM FRACTURES

Background Calcaneal fractures account for approximately 2% of all fractures, with displaced intra-articular fractures comprising 60% to 75% of these injuries1. Studies in fracture patterns, soft-tissue management, and outcomes of calcaneal fractures have led to the debate on the optimal management of calcaneal fractures. Several Prospective randomized studies have shown equivocal outcomes with operative and nonoperative treatment. However, recent trends in the literature suggest that restoration of physiologic parameters of length, height, and alignment of the calcaneus may lead to better long-term results. Initial studies using extensile approaches showed higher rates of wound complications with operative treatment; however, recent studies have shown lower complication rates with sinus tarsi and other minimally invasive techniques. Regardless of the mode of treatment, calcaneal fractures are associated with numerous complications and guarded outcomes with signicant longterm morbidity. Objectives 1. To comparatively study the functional outcome of calcaneum fracture when treated conservatively with that of operative management 2. To study complication when treated conservatively with that of operative management METHODS Study was conducted in Department of Orthopedics, Basaveshwara Teaching and General Hospital, Kalaburagi.30 patients with 30 calcaneum fracture were included in the study. Outcome of conservative and operative management was compared using Creighton Nebrasaka health foundation scoring system. Pre treatment and post treatment (at follow up) Bohler's angle was also compared. Chisquare analysis and paired t test was done to compare the results of conservative and operative management. Restoration of the RESULTS Bohler's angle was better with operative management as compared to conservative management. Functional outcome for type I fractures was better with conservative management. For type II and type III functional outcome was relatively better with operative management for type IV fractures the outcome was signicantly better with operative management. A signicant correlation was seen between the post treatment Bohler's angle and C-N scores. Interpretation &amp; Conclusion Conservative management has better functional outcome for undisplaced fractures. Where as displaced and comminuted fractures anatomical reduction and restoration of Bohler's angle is very important. Bohler's angle has a prognostic importance and correlates well with the functional outcome

The effects of alcohol on short-term memory, working memory, and other executive functioning tasks: A scoping review

Short-term memory, working memory, and other executive functions are related to short-term recall (short-term memory), information manipulation (working memory), and complex cognitive processing. Common tasks include serial recall, manipulation with recall (e.g., n-back), inhibitory control (e.g., Go/No-go), and planning (e.g., Tower of London). Acute alcohol consumption can result in poorer recall, altered spatial recognition, changes in attentional allocation, and reduced planning, task-switching, and cognitive flexibility. However, it is possible that the type of task used may result in equivocal outcomes. The purpose of this scoping review is to describe the different tasks used in the study of the effect of alcohol on short-term memory, working memory, and other executive functioning tasks. Nineteen studies were included with between-group, within-group repeated measures, and mixed factorial designs with various alcohol dosages. Findings of the included studies suggested that the impact of acute alcohol consumption on short-term memory, working memory, and other executive functioning tasks is equivocal. Discrepancies existed between visuospatial and verbal tasks and between array versus sequential recall tasks. Cognitive load may not be significantly affected but could be important in complex sequencing tasks. Deliberation times and response inhibition appear to be negatively affected, possibly due to thinking time rather than reduced performance. This suggests that most studies have not separated short-term memory, working memory, and other executive functions. These modalities may be differently affected by alcohol consumption. In general, further research using consistent, specific methods is required to enhance comparability of studies and clearly demarcate the effects of alcohol on these processes.

The Virtual Rural Generalist Service - a COVID-19 resilient support service for rural and remote communities.

Recruiting and retaining a highly skilled medical workforce in rural and remote communities is challenging1,2. In Western NSW Local Health District (Australia), a Virtual Rural Generalist Service (VRGS) was established to support rural clinicians in providing safe and high quality care. The service leverages the unique skillset of rural generalist doctors to provide hospital-based clinical services in communities without a local doctor or where local doctors request additional support. Presenting observations and outcomes during the first 2 years of operationalising VRGS. This presentation reports on the success factors and challenges in developing VRGS to supplement face-to-face care in rural and remote communities. In its first 2 years, VRGS has provided over 40,000 patient consultations across 30 rural communities. The service has delivered equivocal patient outcomes compared with face-to-face care and has been COVID-19 resilient during a period where existing fly-in-fly-out workforce has been unable to travel due to border restrictions in Australia. Outcomes of the VRGS can be mapped to the quadruple aim3, focusing on improving patient experience, improving the health of populations, increasing the effectiveness of healthcare organisations and ensuring sustainable health care into the future. The findings described regarding VRGS can be translated to support both patients and clinicians in rural and remote settings worldwide.

Pathological Complete Response and Oncological Outcomes in Locally Advanced Breast Cancers Treated with Neoadjuvant Radiotherapy: An Australian Perspective

<h3>Purpose/Objective(s)</h3> To assess the degree of post-operative surgical complication rates, pathological complete response (pCR), and oncological outcomes in women with locally advanced (LABC) or high-risk breast cancers treated with neoadjuvant radiotherapy (NART). The working hypothesis is that treatment sequence reversal with neoadjuvant radiotherapy leads to good tumor response and equivocal oncological outcomes in LABC when compared to standard of care. <h3>Materials/Methods</h3> This retrospective multi-institutional review involved 138 clinically-staged patients with 140 breast cancers treated with NART between January 2014 and February 2021. Treatments involved sequential NACT and NART, followed by mastectomy with or without axillary surgery and immediate breast reconstruction. Descriptive statistics were used to assess patient and disease features, treatment regimens, pathological response and factors affecting post-operative complications. Kaplan-Meier curves were performed to assess locoregional recurrence free, distant metastasis free and overall survival outcomes. <h3>Results</h3> Median age was 47 years (IQR 42–52) with a median BMI of 26 (IQR 24-30). The median follow-up was 35.2 months (IQR 17.1-46.5). pCR was achieved in 36.4% (as defined by Chevallier Classification) or 42.1% (as defined by Miller-Payne scores) of patients. Higher pCR rates were achieved for HER2 (76.2%-85.7%) and triple negative phenotypes (47.6%-57.1%). There were 21 Grade 3 surgical complications including 10 Grade 3B breast events and 8 grade 3B donor-site events, where surgical reintervention was required. At the 3 years mark, the locoregional recurrence free survival was 98.1% (95% CI 94.0-99.4%), distant metastasis free survival was 83.6% (95% CI 75.8-89.1%) and overall survival was 95.3% (95% CI 90.2-97.7%). <h3>Conclusion</h3> NART is feasible to facilitate a single-stage mastectomy and immediate breast reconstruction. This study demonstrated comparable rates of post-operative complication to standard of care, and high rates of pCR which translates to high rates of locoregional control, distant metastasis free survival and overall survival.

Investigating the role of economic complexity in sustainable development and environmental sustainability

ABSTRACT A productive economic structure, represented by economic complexity (ECP), augments the economic development of nations. However, previous empirical investigations on this topic are confined to understanding the direct effects of economic complexity on environmental quality with equivocal outcomes. Therefore, this study not only probed the effects of ECP on the ecological footprint (EF) but also explored the indirect environmental effects of ECP through the channel of economic growth. To do so, the study employed the unit-root tests with structural breaks and without structural breaks. Afterward, the newly developed Augmented Autoregressive Distributed Lag (AARDL) method was used on the time series Indian data from 1970 to 2017 in the Stochastic Impacts by Regression on Population, Affluence and Technology (STIRPAT) framework. The findings disclosed cointegration among the selected variables. Notably, the AARDL test provided a reliable conclusion by using three different tests compared to the conventional ARDL model that relies on just one F-statistics. The long-run empirical results unfolded that ECP not only reduces footprint but also decreases the adverse environmental impacts of economic growth. In addition, energy intensity and economic growth contribute to escalating the EF, and thereby, increase environmental degradation. Nevertheless, population density decreases the footprint, and thus, stimulates ecological sustainability. Besides, ECP Granger causes EF. After this, several diagnostic tests were performed to confirm the stability of the models and the results were verified using the Fully Modified Ordinary Least Squares test. Lastly, the study directed policies to increase the level of sophisticated knowledge-based production for sustainable growth.

Injection of adipose stem cells in the treatment of rotator cuff disease - a narrative review of current evidence.

The purpose of this study is to summarize evidence for the use of adipose stem cell (ASC) injections in the treatment of rotator cuff tears (RCT) and identify future areas of study. A thorough literature search was performed to identify studies investigating the use of ASC injections in the treatment of RCTs. Among animal trials, it is unclear whetherASCs are of benefit for rotator cuff repair. In clinical trials, ASC injection may reduce retear rate with otherwise equivocal clinical outcomes. Although ASC injection may be safe, the literature does not provide a clear consensus as to the efficacy of ASC injections, nor does it delineate which patients would benefit most from this treatment.

MP39-14 COMPARING HEALTHCARE UTILIZATION AND COSTS ACCORDING TO RENAL PRESERVATION VERSUS RADICAL NEPHROURETERECTOMY MANAGEMENT FOR PATIENTS WITH NON-METASTATIC UPPER TRACT UROTHELIAL CARCINOMA

You have accessJournal of UrologyCME1 May 2022MP39-14 COMPARING HEALTHCARE UTILIZATION AND COSTS ACCORDING TO RENAL PRESERVATION VERSUS RADICAL NEPHROURETERECTOMY MANAGEMENT FOR PATIENTS WITH NON-METASTATIC UPPER TRACT UROTHELIAL CARCINOMA Kathryn Fero, Yong Shan, Giri Movva, Jacques Baillargeon, Douglas Tyler, Karim Chamie, and Stephen Williams Kathryn FeroKathryn Fero More articles by this author , Yong ShanYong Shan More articles by this author , Giri MovvaGiri Movva More articles by this author , Jacques BaillargeonJacques Baillargeon More articles by this author , Douglas TylerDouglas Tyler More articles by this author , Karim ChamieKarim Chamie More articles by this author , and Stephen WilliamsStephen Williams More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002599.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Non-metastatic upper tract urothelial carcinoma (UTUC) is a heterogeneous disease with many treatment options that may lead to wide variation in costs. METHODS: We identified 4,114 patients diagnosed with non-metastatic UTUC from 2004-2013 in the Survival Epidemiology and End Results-Medicare linked population-based database. Patients were stratified into low- or high-risk disease groups. Total Medicare costs within one year of diagnosis were compared for patients managed with renal preservation (RP) versus radical nephroureterectomy (NU) using inverse probability of treatment-weighted (IPTW) propensity score models. RESULTS: After risk stratification, 1,027 (25%) and 3,087 (75%) patients were classified into low- vs high-risk UTUC groups and 1,085 (26%) and 3,029 (74%) patients underwent RP and NU, respectively. Median total costs were significantly higher by risk (high vs. low: $141,621 vs. $110,878, p <0.001). Median costs according to categories of services were significantly less for RP vs. NU patients by hospitalization ($22,801 vs. $23,211; Median Difference -$1,369, Hodges-Lehmann (H-L) 95% Confidence Interval (CI), -$2,556 to -$181), office visits ($1,616 vs. $1,874; Median Difference -$238, HL 95% CI, -$340 to -$135), emergency room/critical care ($578 vs. $758; Median Difference -$88, HL 95% CI, -$141 to -$34), consultations ($578 vs. $758; Median Difference -$80, HL 95% CI, -$134 to -$25), and anesthesia ($534 vs. $711; Median Difference -$203; HL 95% CI, -$230 to -$176). The only category which was significantly higher for RP vs. NU was inpatient visits ($1,699 vs. $1,532; Median Difference $152; HL 95% CI, $19 to $286). CONCLUSIONS: Healthcare costs of patients with high-risk UTUC are greater than those of low-risk patients. Median costs were significantly less for RP vs. NU by hospitalization, office visits, emergency room/critical care, consultations, and anesthesia costs. In the absence of data demonstrating superiority of NU over RP, especially for patients with low-risk disease, the increased costs may not be substantiated with equivocal outcomes. Source of Funding: This study was conducted with the support of a Department of Defense Peer Reviewed Cancer Research Program (PRCRP) Career Development Award (W81XWH1710576) (SBW). VS is supported by the Veteran’s Affairs Health Services Research and Development Fellowship. KEF is supported by H&H Lee UCLA Surgical Scholars Program. This project was supported by UroGen Pharma © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e671 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kathryn Fero More articles by this author Yong Shan More articles by this author Giri Movva More articles by this author Jacques Baillargeon More articles by this author Douglas Tyler More articles by this author Karim Chamie More articles by this author Stephen Williams More articles by this author Expand All Advertisement PDF DownloadLoading ...

Inside-Out Approach to Meniscus Repair: Still the Gold Standard?

The purpose of this review is to provide an up-to-date summary on the current literature and trends regarding use of the inside-out approach to meniscus repair. Additionally, the paper describes the authors preferred techniques for inside-out meniscus repair utilizing posteromedial and posterolateral exposures. There has been a substantial increase in recent publications regarding meniscus repair. However, comparisons regarding the optimal repair technique have not been conclusive. Despite the recent increase in use of all-inside devices, multiple investigations with short-to-mid-term follow-up have demonstrated similar rates of meniscus healing between inside-out and all-inside repair techniques. Similarly, current literature describes comparable failure rates of around 20%. There are variations in the profile of complications, with all-inside devices having more implant-related complications and inside-out techniques with higher neurovascular injuries. Inside-out meniscus repair is a versatile, cost-effective technique that remains the gold standard for management of most meniscus tear patterns. Through a thoughtful approach, efficient suture retrieval and repair can be performed while protecting critical neurovascular structures. All-inside meniscus repair devices have increased in popularity and surgeon access, but this technique is not without limitations and comparisons to inside-out meniscus repair demonstrates equivocal outcomes.

Comparing the efficacy of tocilizumab with corticosteroid therapy in treating COVID-19 patients: a systematic review and meta-analysis.

PurposeTocilizumab has shown equivocal outcomes in reducing mortality in COVID-19. The corticosteroids appear to be an affordable alternative to tocilizumab. This study aims to estimate the efficacy of tocilizumab and the corticosteroids particularly dexamethasone and methylprednisolone and to identify possible determinants of their efficacy.MethodsFive electronic databases were searched for studies involving tocilizumab, dexamethasone, and methylprednisolone in treating COVID-19. We included case–control and randomized or partially randomized trials. Meta-regression for patient baseline characteristics, co-medications, and tocilizumab dose regimens was performed to identify contributing factors to drug efficacy.ResultsThirteen randomized controlled trials (RCTs) and twenty-four case–control studies were included in our meta-analysis involving 18,702 patients. Meta-analysis among the RCTs showed that a summary estimate favoring mortality reduction (OR 0.71, 95%CI 0.55 – 0.92) contributed mainly by tocilizumab and dexamethasone. Among case–control studies, meta-analysis showed mortality reduction (OR 0.52, 95%CI 0.36 – 0.75) contributed by tocilizumab and tocilizumab-methylprednisolone combination. Methylprednisolone alone did not reduce mortality except for one study involving high dose pulse therapy. Meta-analysis also found that all three drugs did not significantly reduce mechanical ventilation (OR 0.72, 95%CI 0.32 – 1.60).ConclusionTocilizumab and dexamethasone emerge as viable options in reducing mortality in severe COVID-19 patients. A tocilizumab-corticosteroid combination strategy may improve therapeutic outcome in cases where single therapy fails.Graphical abstract