Appropriate Treatment Option For Patients Research Articles

Antenatally detected urinary tract dilatation: a pediatric nephrologist's point of view

Antenatally diagnosed urinary tract dilatation (UTD), previously referred to as antenatal hydronephrosis, is the most commonly detected abnormality by prenatal ultrasonography. Several grading systems have been developed for the classification of antenatal UTD using prenatal and postnatal ultrasonography. UTD comprises a wide variety of congenital abnormalities of the kidney and urinary tract ranging from transient UTD to more significant abnormalities such as vesicoureteral reflux, ureteropelvic junction obstruction, ureterocele, ureterovesical junction obstruction, posterior urethral valves, and non-refluxing megaureter. Optimizing the evaluation of antenatally detected UTD is essential to recognize children with important disorders while avoiding excessive investigations. Conservative approach with close follow-up is increasingly accepted as an appropriate treatment option for patients with asymptomatic vesicoureteral reflux and ureteropelvic junction obstruction in recent years. However, predicting permanent kidney damage in an unselected group of children with antenatal UTD is still challenging. The management and follow-up of children with UTD should be individualized based on recommendations from a pediatric nephrologist, a pediatric urologist, or both. Future research directed at predicting long-term outcomes of children diagnosed with UTD from mild findings to severe disease is needed to refine management for those at higher risk of kidney disease progression.

Chemoradiotherapy treatment with gemcitabine improves renal function in locally advanced cervical cancer patients with renal dysfunction

BackgroundCervical cancer (CC) in Mexico is diagnosed mainly in locally advanced (LACC) and advanced (ACC) stages, where ureteral obstruction is more frequent. The standard treatment for this population is concurrent chemoradiotherapy (CCRT) with cisplatin, which is nephrotoxic and could lead to further deterioration of renal function in LACC patients with renal function decline. We aimed to evaluate the effect of CCRT with Gemcitabine on renal function in LACC patients. MethodsThis retrospective study included LACC patients treated with CCRT with Gemcitabine as a radiosensitizer from February 2003 to December 2018. Data were collected from medical archives and electronic records. We assessed renal function before and after CCRT treatment and analyzed the patient's response to treatment and survival. Results351 LACC patients treated were included and stratified into two groups: 198 with Glomerular Filtration Rate (GFR) ≥60ml/min (group A) and 153 with GFR<60ml/min (group B). An improvement in GFR was observed after CCRT in patients in group B, from 33 ml/min to 57.5 ml/min (p<0.001). Complete response was observed in 64.1% of patients in Group A and 43.8% in Group B (p<0.0001). Factors associated with increased risk of death included having a GFR of 15-29 ml/min (HR: 2.17; 1.08-4.35), having GFR<15 ml/min (HR: 3.08; 1.63-5.79), and receiving Boost treatment (HR: 2.09; 1.18-3.69). On the other hand, receiving brachytherapy is a positive predictor for OS (HR:0.51; 0.31-0.84). ConclusionCCRT with gemcitabine is an appropriate treatment option for patients diagnosed with LACC who present impaired renal function due to the disease's obstructive nature or other comorbidities.

Comparing the effectiveness of extracorporeal shockwave therapy and myofascial release therapy in chronic pelvic pain syndrome: study protocol for a randomized controlled trial

BackgroundChronic prostatitis/chronic pelvic pain syndrome is a highly prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve the quality of life in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Theoretically, combined therapy with extracorporeal shockwave therapy and myofascial release therapy will likely have significant advantages in treating CP/CPPS. We, therefore, present a protocol for conducting a well-designed randomized controlled trial to compare the efficacy and safety of each therapy.MethodsThe proposed study will be a three-group randomized control trial (RCT) design that includes 150 participants from Zhongda Hospital Affiliated to Southeast University, with equal allocation of participants to the three intervention groups. The study duration will be 8 weeks, which includes a 4-week treatment period and a 4-week follow-up period. The primary outcome will be the changes in surface electromyography (sEMG) assessment and National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). The secondary outcomes will include the changes in three-dimensional quantification, shear wave elastography (SWE), and sympathetic skin response (SSR) testing. Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and the 4th week after the end of the 8th intervention (T3).DiscussionThis trial will compare the differences in efficacy between single extracorporeal shockwave therapy, single myofascial release therapy, and combined therapy to select the most appropriate treatment option for patients with CP/CPPS. The possible pathogenesis of CP/CPPS would also be analyzed by comparing the intercorrelation between each objective and subjective measurement (NIH-CPSI score, sEMG, SWE, SSR).Trial registrationThe name of the registry: Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome.Registration number: NCT05659199. Date of registration: December 2022.

Successful Confirmation of Dual Genital Herpes Co-Infection with Herpes Simplex Virus 1 and Herpes Simplex Virus 2 Using Unbiased Metagenomic Next-Generation Sequencing.

Dual co-infection with both HSV-1 and HSV-2 is rare, with few cases reported in the literature. In this case report, we describe the successful use of unbiased metagenomic next-generation sequencing (mNGS) as a rapid and alternative method for confirming dual genital herpes co-infection. Our case involves a 74-year-old woman who presented with genital lesions and initially tested positive for both HSV-1 and HSV-2 via the Luminex ARIES HSV 1&2 assay. The entire mNGS process, from nucleic acid extraction to result analysis, was completed in less than 48 h. Using mNGS, we identified mapped reads specific to either HSV-1 or HSV-2 and screened the sequences to rule out mis-genotyping by the Luminex ARIES assay. Notably, the generated sequences can reveal sequence variations within multiple gene regions, demonstrating the potential of mNGS for identifying novel HSV-1 and HSV-2 variants. Our findings suggest that mNGS can serve as a rapid and reliable alternative confirmatory method for dual genital herpes infections, providing valuable information to guide appropriate treatment options for patients. By eliminating the need for prior knowledge of causative agents, mNGS offers an unbiased approach for detecting and characterizing viral co-infections.

Real-World Effectiveness and Risk Factors for Discontinuation of Ustekinumab in Ulcerative Colitis

Introduction: Ustekinumab (UST) has been approved for the treatment of moderate-to-severe ulcerative colitis (UC). Real-world data showing the effectiveness and safety of UST are necessary to confirm the results of clinical trials for applicability in daily clinical practice. Although some studies have reported real-world evidence of UST, only few studies have confirmed its effectiveness in the real world. The aim of this study was to assess the short- and long-term effectiveness, durability, safety, and risk factors for discontinuation of UST in UC in clinical practice. Methods: This was a retrospective, single-center, observational study. From March 2020 to January 2023, all consecutive patients with active UC who were treated with UST at Nagoya University Hospital were included. The primary outcome was the clinical remission rate at weeks 2–8 and weeks 24–48. The secondary outcomes included clinical response, persistence of UST therapy, endoscopic changes during follow-up, risk factors for UST discontinuation, and occurrence of any adverse events. The clinical effectiveness was evaluated using the Lichtiger score. Results: A total of 31 patients were included in this study. The clinical remission rates were 9.7%, 29.0%, 54.8%, and 64.5% at weeks 2, 8, 24, and 48, respectively. Twelve (38.7%) patients discontinued UST during the follow-up period. The probability of continuing UST was 93.5%, 80.6%, 77%, and 70% at weeks 2, 8, 24, and 48, respectively. The major reason for discontinuation of UST was primary failure (75.0%). A high baseline C-reactive protein (CRP) level was a significant risk factor for the discontinuation of UST. No adverse events were observed in this study. Conclusion: UST is effective for patients with UC. High CRP levels were identified as a risk factor for UST discontinuation. The findings of this study would help clinicians to select appropriate treatment options for patients with UC by identifying the risk factors for treatment discontinuation.

Tendon Sheath Incision for Surgical Treatment of Trigger Finger.

Open trigger finger release is an elective surgical procedure that serves as the gold standard treatment for trigger digits. The aim of this procedure is to release the A1 pulley in a setting in which the pulley is completely visible, ultimately allowing the flexor tendons that were previously impinged on to glide more easily through the tendon sheath. Although A1-or the first annular pulley-is the site of triggering in nearly all cases, alternative sites include A2, A3, and the palmar aponeurosis1. Typically, the surgical procedure can be conducted in an outpatient setting and can vary in duration from a few minutes to half an hour. The surgical procedure involves the patient lying in the supine position with the operative hand positioned to the side. A small incision, ranging from 1 to 1.5 cm, is made on the volar side of the hand, just proximal to the A1 pulley in the skin crease in order to minimize scarring. Once the underlying neurovascular structures are exposed, the A1 pulley is released longitudinally at least to the level of the A2 pulley, followed by decompression of the flexor tendons that were previously impinged on. In order to confirm the release, the patient is asked to flex and extend the affected finger. The wound is irrigated and closed once the release is confirmed by both the patient and surgeon. Aside from an open release, trigger finger can be treated nonoperatively with use of splinting and corticosteroid injection. Alternative operative treatments include a percutaneous release, which involves the use of a needle to release the A1 pulley2. Trigger finger can initially be treated nonoperatively. If unsuccessful, surgical intervention is considered the ultimate remedy2. Because of their efficacious nature, corticosteroid injections are indicated preoperatively, particularly in non-diabetic patients3. Splinting is often an appropriate treatment option in patients who wish to avoid a corticosteroid injection1. However, if nonoperative treatment modalities fail to resolve pain and symptoms, surgical intervention is indicated2. In comparison with a percutaneous trigger finger release, an open release provides enhanced exposure and may be safer with respect to avoiding iatrogenic neurovascular injury2. However, in a randomized controlled trial, Gilberts et al. found no difference in the rates of recurrence when comparing open versus percutaneous trigger finger release4. With reported success rates ranging from 90% to 100%, the open release of the A1 pulley is considered a common procedure associated with minimal complications2. Complications of the procedure were assessed in a retrospective analysis of 43 patients who underwent 78 open trigger releases performed by 1 surgeon. In that study, the authors reported a minor complication rate of 28% and a major complication rate of 3%5. Specifically, the 2 major complications noted by the authors were a synovial fistula and a proximal interphalangeal joint arthrofibrosis. In a larger study that included 543 patients who underwent 795 open trigger releases, the authors reported a minor complication rate of 9.6% and major complication rate of 2.4%6. Furthermore, the most common complications involved persistent stiffness, swelling, or pain. In that analysis, the authors suggested that sedation, male gender, and general anesthesia may be associated with greater risk6. At the discretion of the surgeon, a longitudinal, transverse, or oblique incision is made directly on top of the tendon at the level of the metacarpophalangeal joint, which is the preferred incision site because it provides maximal accessibility to the A1 pulley.Local anesthesia is preferred because it allows the patient and surgeon to confirm the release immediately.If conducting an open trigger release on the thumb, the surgeon should identify and protect the radial digital nerve, which courses directly over the A1 pulley. MCP = metacarpophalangeal.

A preliminary study of comprehensive behavioral intervention for tics in Chinese children with chronic tic disorder or Tourette syndrome.

To investigate the adaptability of Comprehensive Behavioral Intervention for Tics (CBIT) for a Chinese population, and evaluate the efficacy of combined CBIT and pharmacotherapy (CBIT + PT) compared to CBIT or pharmacotherapy (PT) alone for reducing tics and for improving the quality of life (QoL) in a sample of Chinese children with chronic tic disorders (CTD) and Tourette syndrome (TS). In this 10-week randomized controlled pilot trial, 37 outpatients aged between 6 and 16 years affected by TS and CTD were randomly assigned to receive CBIT (n = 22) or PT alone (n = 15). Considering the feasibility, the patients allocated to the CBIT treatment group could further choose whether to simultaneously take medicine voluntarily, resulting in a CBIT alone group (n = 12) and a CBIT + PT group (n = 10). At baseline, no significant difference was found between the three groups in the demographic and clinical characteristics (p > 0.05). All three groups showed a significant reduction in tic severity after treatment assessed by the Yale Global Tic Severity Scale (YGTSS) severity score [F (2,33) = 35.05, p < 0.001, η p 2 = 0.51], the score of the Clinical Global Impression scale for Improvement (CGI-I) [F (1,34) = 13.87, p = 0.001, η p 2 = 0.29], and YGTSS impairment score [F (2,33) = 31.71, p < 0.001, η p 2 = 0.48]. Significant interactions were found between the time-point and group in emotional functioning [F (2,29) = 4.39, p = 0.02, η p 2 = 0.23], psychosocial functioning [F (2,29) = 5.93, p = 0.007, η p 2 = 0.29], and total QoL score [F (1,34) = 3.72, p = 0.04, η p 2 = 0.20] of Pediatric Quality of Life Inventory (PedsQL 4.0) for children suggesting a significantly larger improvement in emotional functioning, psychosocial functioning, and total QoL score of the life quality in the CBIT group for children self-report. PedsQL for proxy report only showed a significant main effect of time-point in physical functioning [F (1,33) = 8.35, p = 0.01, η p 2 = 0.2], emotional functioning [F (1,33) = 10.75, p = 0.002, η p 2 = 0.25], psychosocial functioning [F (1,34) = 11.38, p = 0.002, η p 2 = 0.26], and total Qol score [F (1,34) = 13.21, p = 0.001, η p 2 = 0.29]. CBIT is probably effective in reducing tic severity in Chinese children with tic disorders. CBIT + PT may not be superior to CBIT alone in reducing tic severity and improving quality of life. CBIT alone showed advantages in improving quality of life over CBIT + PT and PT alone. CBIT might be an appropriate treatment option for patients with tic disorder in Chinese mainland.

A Southeast Asia Consensus on the Definition and Management of Treatment-Resistant Depression.

Despite the abundance of literature on treatment-resistant depression (TRD), there is no universally accepted definition of TRD and available treatment pathways for the management of TRD vary across the Southeast Asia (SEA) region, highlighting the need for a uniform definition and treatment principles to optimize the management TRD in SEA. Following a thematic literature review and pre-meeting survey, a SEA expert panel comprising 13 psychiatrists with clinical experience in managing patients with TRD convened and utilized the RAND/UCLA Appropriateness Method to develop consensus-based recommendations on the appropriate definition of TRD and principles for its management. The expert panel agreed that "pharmacotherapy-resistant depression" (PRD) is a more suitable term for TRD and defined it as "failure of two drug treatments of adequate doses, for 4-8 weeks duration with adequate adherence, during a major depressive episode". A stepwise treatment approach should be employed for the management of PRD - treatment strategies can include maximizing dose, switching to a different class, and augmenting or combining treatments. Non-pharmacological treatments, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation, are also appropriate options for patients with PRD. These consensus recommendations on the operational definition of PRD and treatment principles for its management can be adapted to local contexts in the SEA countries but should not replace clinical judgement. Individual circumstances and benefit-risk balance should be carefully considered while determining the most appropriate treatment option for patients with PRD.

Cost-Effectiveness of Acthar Gel Versus Standard of Care for the Treatment of Exacerbations in Moderate-to-Severe Systemic Lupus Erythematosus.

Despite current standard of care (SoC), there is an unmet need for the treatment of active systemic lupus erythematosus (SLE). The study assessed the cost-effectiveness of Acthar® Gel (repository corticotropin injection) versus SoC treatment in patients with active, moderate-to-severe SLE from the US payer and societal perspectives over 2 and 3 years. Cost-effectiveness model was developed using a probabilistic cohort-level state-transition approach. Patients received Acthar Gel in an exacerbation state, and the outcomes were assessed at the end of a 3-month cycle for response achievement based on the probability of treatment success with Acthar Gel. Patients may sustain the response or experience an exacerbation. For the base case scenario, moderate-to-severe SLE was defined as British Isles Lupus Assessment Group (BILAG)-2004 ≥ 20 or SLE Disease Activity Index 2000 (SLEDAI-2K) ≥ 10 and clinical response was based on SLE responder index (SRI)-4. Clinical response, productivity loss, and utility were derived from a phase 4 SLE trial; cost and disutility estimates were sourced from the literature. From a payer perspective, Acthar Gel versus SoC resulted in an incremental cost-effectiveness ratio (ICER) of $133,110 per quality-adjusted life-year (QALY) and $94,818 per QALY over 2 and 3 years, respectively. From a societal perspective, Acthar Gel versus SoC results in an ICER of $70,827 per QALY and $32,525 per QALY over 2 and 3 years, respectively. Results from the sensitivity and scenario analyses are consistent with those of the base case model. Acthar Gel is a cost-effective, value-based treatment option for appropriate patients with moderate-to-severe SLE at a willingness-to-pay threshold of $150,000 over 2-3 years from the US payer and societal perspectives. Acthar Gel results in the reduction of direct medical and indirect costs.

No component loosening of a cementless deep dish rotating platform knee at a 5-year follow-up

PurposeCemented fixation remains the gold standard in total knee arthroplasty. With an increasing number of younger patients undergoing total knee arthroplasty and a growing patient population demanding higher physical activity, a rising interest in discussion of cementless fixation is notable. The current scientific literature does not give a clear recommendation for or against uncemented total knee arthroplasty. The purpose of this study was the investigation of the 5-year clinical and radiographic outcomes of a cementless deep-dish rotating platform implant.MethodsA total of 91 primary cementless total knee arthroplasties were included in this single-centre prospective observational study. The primary outcome was revision rate due to aseptic component loosening. Further outcome measures were assessment of the of the radiographic outcome as well as the clinical outcome based on Range of Motion and scores such as American Knee Society Score, Oxford Knee Score, Knee Injury and Osteoarthritis Outcome Score and European Quality of Life 5 Dimension 3 Level at a follow-up of 5 years.ResultsMean age of the study population was 67.3 ± 6.6 years with 49.5% of the participants being female. Aseptic component loosening occurred in none of the patients. Implant survival with revision for any reason as endpoint was 97.8% (95% CI 100–96%) and 95.6% (95% CI 100–94%) with reoperation of any cause as endpoint. Radiolucent lines were detected in a total of eight cases (8.8%) and disappeared within the first year after surgery in five cases. Total Range of Motion improved significantly from 106° ± 15° preoperatively to 118° ± 10° at final FU (p < 0.001). All investigated scores improved significantly after total knee arthroplasty.ConclusionThe results of this study reveal excellent mid-term performance of a cementless deep dish rotating platform total knee implant, with no component loosening, very low overall revision rate, only temporarily present radiolucent lines in a minority of patients and excellent clinical results. Therefore, cementless total knee arthroplasty is an appropriate treatment option for patients with severe osteoarthritis of the knee.Level of evidenceLevel II (prospective cohort study).

A cost-effectiveness modeling study of treatment interventions for stage I to III esophageal squamous cell carcinoma

BackgroundEsophageal cancer causes considerable costs for health systems. Appropriate treatment options for patients with esophageal squamous cell carcinoma (ESCC) can reduce medical costs and provide more improved outcomes for health systems and patients. This study evaluates the cost-effectiveness of treatment interventions for patients with ESCC according to the Iranian health system.Material and methodsA five-state Markov model with a 15-year time horizon was performed to evaluate the cost-effectiveness of treatment interventions based on stage for ESCC patients. Costs ($US 2021) and outcomes were calculated from the Iranian health system, with a discount rate of 3%. One-way sensitivity analyses were performed to assess the potential effects of uncertain variables on the model results.ResultsIn stage I, the Endoscopic Mucosal Resection (EMR) treatment yielded the lowest total costs and highest total QALY for a total of $1473 per QALY, making it the dominant strategy compared with esophagectomy and EMR followed by ablation. In stages II and III, chemoradiotherapy (CRT) followed by surgery dominated esophagectomy. CRT followed by surgery was also cost-effective with an incremental cost-effectiveness ratio (ICER) of $2172.8 per QALY compared to CRT.ConclusionFrom the Iranian health system’s perspective, EMR was the dominant strategy versus esophagectomy and EMR followed by ablation for ESCC patients in stage I. The CRT followed by surgery was a cost-effective intervention compared to CRT and esophagectomy in stages II and III.

Real-World Treatment Strategies to Improve Outcomes in Patients With Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation.

Chronic idiopathic constipation and irritable bowel syndrome with constipation are complex, overlapping conditions. Although multiple guidelines have informed healthcare providers on appropriate treatment options for patients with chronic idiopathic constipation and irritable bowel syndrome with constipation, little direction is offered on treatment selection. First-line treatment options usually include fiber and over-the-counter osmotic laxatives; however, these are insufficient for many individuals. When these options fail, prescription secretagogues (plecanatide, linaclotide, lubiprostone, and tenapanor [pending commercial availability]), or serotonergic agents (prucalopride and tegaserod) are generally preferred. Individuals experiencing concurrent abdominal pain and/or bloating may experience greater overall improvements from prescription therapies because these agents have been proven to reduce concurrent abdominal and bowel symptoms. Should initial prescription treatments fail, retrying past treatment options (if not adequately trialed initially), combining agents from alternative classes, or use of adjunctive therapies may be considered. Given the broad spectrum of available agents, therapy should be tailored by mutual decision-making between the patient and practitioner. Overall, patients need to be actively monitored and managed to maximize clinical outcomes.

Neovaginoplasty with tilapia fish skin: a series of eleven cases.

Mayer-Rokitansky-Küster-Hauser syndrome affects about 1 in 5000 live female births and is associated with gonadal dysgenesis and primary amenorrhea. Neovaginoplasty has been established as an appropriate treatment option for patients who have failed or denied dilation therapy. In search of accessible, economical material with low risk of complications, the team proposed the use of Nile tilapia fish skin (NTFS) as an innovative biomaterial in the neovaginoplasty procedure for vaginal agenesis management. NTFS has noninfectious microbiota, morphologic structure comparable to human skin and high in vivo bioresorption. In this descriptive study, the method offered an anatomical and functional neovagina to 11 patients efficiently, quickly and safely. Correct post-surgical dilation is still extremely important to keep the neovagina's size > 6 cm. Histological and immunohistochemical analysis demonstrated the formation of a stratified squamous epithelium with strong marking for cytokeratins, FGF and EGFR, similar to healthy adult vaginal tissue. Since NTFS is a low cost and easily accessible biomaterial, this technique proves to be an inexpensive therapeutic possibility for the health system with excellent advantages for patients.

Clinical Profile of Non-Traumatic Surgical Abdominal Emergencies in a Tertiary Care Centre in Eastern Part of India

Aim: (a) To study the clinical profile, demographics, symptoms, and indicators of patients with abdominal emergencies requiring non-traumatic surgery. (b) To determine the diagnosis and the appropriate treatment options for patients presenting to the emergency room with abdominal surgical crisis that are not trauma related. (c) To examine the results of various treatment approaches in patients who have non-traumatic surgical abdominal emergencies and present to the emergency room. Methods: The study included all non-trauma patients under 70 years of age who presented to emergency with abdominal pain. Results: In our analysis, acute appendicitis was the most frequent cause of acute abdomen, followed by acute intestinal blockage, cholecystitis, and nephrolithiasis. Conclusion: During the workup of these patients, clinicians must take several diagnoses into account; those individuals who may need surgical exploration should be recognised early to reduce their morbidity and death.

Prognostic Factors and Clinical Characteristics of Duodenal Adenocarcinoma With Survival: A Retrospective Study

BackgroundTo evaluate the clinical risk factors that influence the overall survival in patients with duodenal adenocarcinoma (DA) after tumor resection.MethodsThis study retrospectively analyzed 188 patients who underwent tumor resection for DA between January 2005 and June 2020 at Xiangyang Central Hospital.ResultsThe median survival of the patients who underwent resectional operation was 54 months, longer than of those who underwent palliative surgery (20.8 months) (2,916.17; 95% CI, 916.3−9,280.5; p < 0.001). Survival of non-ampullary duodenal carcinoma patients (50.3 months; 95% CI, 39.7−61.8) was similar to that of ampullary duodenal carcinoma patients (59.3 months; 95% CI, 38.6−66.7) but was significantly better than that of papillary adenocarcinoma patients (38.9 months; 95% CI, 29.8−54.8; p = 0.386). Those with intestinal-type ductal adenocarcinomas had a longer median overall survival than those with the gastric type (61.8 vs. 46.7 months; p < 0.01) or pancreatic type (32.2 months; p < 0.001). Clinical DA samples had significantly diverse expressions of ATG12, IRS2, and IGF2. Higher expressions of the ATG12 and IRS2 proteins were significantly correlated with worse survival. Multivariate Cox regression analysis revealed that lymph node metastasis (hazard ratio (HR), 6.44; 95% CI, 3.68−11.27; p < 0.0001), margin status (HR, 4.94; 95% CI, 2.85−8.54; p < 0.0001), and high expression of ATG12 (HR, 1.89; 95% CI, 1.17−3.06; p = 0.0099) were independent prognostic factors negatively associated with survival in patients undergoing curative resection. There was no survival difference between the groups with ampullary, non-ampullary, and papillary adenocarcinomas treated with adjuvant chemotherapy (p = 0.973).ConclusionGastric/pancreatic type, high expression of ATG12, lymph node metastases, and margin status were negative prognosticators of survival in patients with DAs than in those with tumor anatomical location. Curative resection is the best treatment option for appropriate patients.

Efficacy and Safety of Wenbu Zhibi Granule in Patients with Ankylosing Spondylitis: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

Background. Ankylosing spondylitis (AS) is a chronic disease in which the column is the main lesion. It is caused by a combination of genetic and environmental factors, mainly involving the axial skeleton, resulting in column rigidity and difficulty in movement, and there may be different degrees of eye, lung, cardiovascular, kidney, and other organ damage. Long-term treatment lacks in ankylosing spondylitis. Wenbu Zhibi granule (WZG) is a prescription handed down from the history of Chinese medicine for thousands of years, which is used to treat the pain of patients with AS and to prevent the further development of the disease. However, there is no scientific evidence based on clinical trials to evaluate the efficacy and safety of WZG for ankylosing spondylitis. Methods/Design. We will conduct a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the WZG in the treatment of AS. We will randomly assign 100 patients with active AS to two groups, treated for 16 weeks. The primary efficacy endpoint is the proportion of subjects who reached 40% improvement criteria proposed by Assessment of SpondyloArthritis International Society (ASAS40) at 16 weeks from baseline, the secondary efficacy endpoint includes ASAS20 response rate, ASAS partial remission response rate, 5/6 improvement criteria proposed by ASAS (ASAS5/6) response rate, and change in the Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine score, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score (ASDAS), linear Bath Ankylosing Spondylitis Metrology Index (BASMI), ankylosing spondylitis quality of life (ASQoL). In addition, the time points will be set as baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks. Discussion. The results of this study will elucidate the efficacy and safety of WZG and provide an appropriate treatment option for patients with AS. Trial registration: ClinicalTrials.gov ID: https://clinicaltrials.gov/ct2/show/ChiCTR2000041010. (Chinese Clinical Trail Registry, Registered 16 December 2020, http://www.chictr.org.cn).

Femtosecond Laser and Mechanical Dissection for ICRS and MyoRing Implantation: A Meta-Analysis.

The aims of this meta-analysis were to evaluate the results of intracorneal ring segments (ICRSs) and MyoRing in the management of corneal ectasia and to compare the clinical outcomes and complication rates between mechanical and femtosecond (FS) laser-assisted surgery. An online electronic search was performed for pre-post studies published until April 2020. Uncorrected distance visual acuity, corrected distance visual acuity, sphere, cylinder, spherical equivalent, steep, flat, and mean keratometry values were considered as outcomes. Weighted mean difference with 95% confidence interval was used as a pooled estimation of intervention efficacy. Of 1484 potentially related studies, 115 studies were finally included in the meta-analysis. Findings of this meta-analysis demonstrated considerable improvement in visual, refractive, and keratometric outcomes in all ICRS models and MyoRing. Intrastromal tunnel creation with both methods yielded similar results. Complication rates were without exception higher when mechanical dissection was used. ICRS and MyoRing are appropriate treatment options for patients with corneal ectasia. Both techniques for tunnel creation are efficacious in achieving good visual, keratometric, and refractive results. Mechanical intrastromal tunnel creation is associated with much higher complication rates when compared with FS laser-assisted technique.

PD25-08 PREDICTORS OF INDEX PERCUTANEOUS NEPHROLITHOTOMY CARE SETTING AND IMPACT ON PERIOPERATIVE OUTCOMES AND COST

You have accessJournal of UrologyHealth Services Research: Value of Care: Cost and Outcomes Measures II (PD25)1 Sep 2021PD25-08 PREDICTORS OF INDEX PERCUTANEOUS NEPHROLITHOTOMY CARE SETTING AND IMPACT ON PERIOPERATIVE OUTCOMES AND COST William French, Quoc-Dien Trinh, Roger Sur, and David Friedlander William FrenchWilliam French More articles by this author , Quoc-Dien TrinhQuoc-Dien Trinh More articles by this author , Roger SurRoger Sur More articles by this author , and David FriedlanderDavid Friedlander More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002018.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Percutaneous nephrolithotomy (PCNL) is an appropriate treatment option for patients with a large renal stone burden or complex anatomy. Cost pressures and newer minimally invasive approaches have led to a migration away from the traditional inpatient care setting toward ambulatory surgical centers. However, it is unclear what clinical and non-clinical factors determine where patients receive their surgical care and whether perioperative outcomes and costs differ among these cohorts. We sought to identify predictors of index surgical care setting as well as perioperative outcomes and cost associated with these unique care settings following PCNL surgery. METHODS: All-payer data from the 2014 Healthcare Cost and Utilization Project (HCUP) State Databases from Florida (FL) and New York (NY) were used to identify all patients undergoing an index PCNL. Patient demographics, regional data, 30-day revisit/reoperation rates, and total index/30-day costs were determined. Multivariable logistic regression adjusted for facility clustering was utilized to identify predictors of index surgical care setting and 30-day revisit/reoperation, while gamma generalized linear regression was used to compare index/30-day costs. RESULTS: Of the 747 patients undergoing PCNL, 314 (42.0%) received care in the inpatient setting compared to 433 (58.0%) in the ambulatory care setting at an adjusted mean cost of $11,904.66 vs. $8,876.438 (p<0.001). Predictors of receiving care in the ambulatory care setting included gender (female vs. male: OR 0.49, 95% CI 0.34-0.72; p<0.001), fewer comorbidities (CCI ³2 vs. 0: OR 0.41, 95% CI 0.24-0.68; p=0.01), insurance status (Uninsured vs. private: OR 0.10, 95% CI 0.04-0.27; p<0.001), and rural vs. metropolitan care setting (OR 22.36, 95% CI 6.46-77.38; p<0.001). The 30-day adjusted revisit/reintervention rate for cases performed in the ambulatory vs. inpatient setting was comparable (22.4% vs. 16.2%, p=0.9). Mean cost attributable to a 30-day revisit was $6,918.13. CONCLUSIONS: We demonstrated that both clinical and non-clinical factors predict where patients undergo PCNL, with patients receiving care in the ambulatory setting experiencing dramatically lower costs but comparable 30-day perioperative outcomes. Our findings suggest that ambulatory-based PCNL offers significant cost savings without compromising 30-day outcomes in appropriately selected patients. Source of Funding: Quoc-Dien Trinh is supported by the Brigham Research Institute Fund to Sustain Research Excellence, the Bruce A. Beal and Robert L. Beal Surgical Fellowship, the Genentech Bio-Oncology Career Development Award from the Conquer Cancer Foundation of the American Society of Clinical Oncology, a Health Services Research pilot test grant from the Defense Health Agency, the Clay Hamlin Young Investigator Award from the Prostate Cancer Foundation, and an unrestricted educational grant from the Vattikuti Urology Institute. David F. Friedlander is supported by a National Institutes of Health T32 training grant © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e434-e435 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information William French More articles by this author Quoc-Dien Trinh More articles by this author Roger Sur More articles by this author David Friedlander More articles by this author Expand All Advertisement Loading ...

Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study

BackgroundThe multinational BREAKOUT study (NCT03078036) sought to determine the prevalence of germline BRCA1/2 (gBRCA1/2) and somatic BRCA1/2 (sBRCA1/2) mutations and mutations in other homologous recombination repair (HRR) genes in women with HER2-negative metastatic breast cancer (MBC) starting first-line chemotherapy.MethodsGenetic testing for gBRCA, sBRCA, and HRR gene mutations was performed in patients who started first-line chemotherapy for MBC in the last 90 days (341 patients across 14 countries) who were not selected based on risk factors for gBRCA mutations. We report data from the Asian cohort, which included patients in Japan (7 sites), South Korea (10 sites), and Taiwan (8 sites).ResultsOf 116 patients screened, 104 patients were enrolled in the Asian cohort. The median age was 53.0 (range 25–87) years. gBRCA1/2, gBRCA1, and gBRCA2 mutations were detected in 10.6% (11/104), 5.8% (6/104), and 4.8% (5/104) of patients, respectively; none had mutations in both gBRCA1 and gBRCA2. gBRCA1/2 mutations were detected in 10.0% (6/60) and 11.6% (5/43) of patients with hormone receptor-positive and triple-negative MBC, respectively. HRR gene mutations were tested in 48 patients without gBRCA mutations, and 5 (10.4%) had at least one HRR mutation in sBRCA, ATM, PALB2, and CHEK2.ConclusionWe report for the first time the prevalence of gBRCA and HRR mutations in an Asian cohort of patients with HER2-negative MBC. Our results suggest that BRCA mutation testing is valuable to determine appropriate treatment options for patients with hormone receptor-positive or triple-negative MBC.Study registrationNCT03078036.

A Robust Prognostic Gene Signature Based on eRNAs-Driven Genes in Prostate Cancer.

Prostate cancer (PCa) is the second most common malignancy in men, but its exact pathogenetic mechanisms remain unclear. This study explores the effect of enhancer RNAs (eRNAs) in PCa. Firstly, we screened eRNAs and eRNA -driven genes from The Cancer Genome Atlas (TCGA) database, which are related to the disease-free survival (DFS) of PCa patients;. screening methods included bootstrapping, Kaplan–Meier (KM) survival analysis, and Pearson correlation analysis. Then, a risk score model was established using multivariate Cox analysis, and the results were validated in three independent cohorts. Finally, we explored the function of eRNA-driven genes through enrichment analysis and analyzed drug sensitivity on datasets from the Genomics of Drug Sensitivity in Cancer database. We constructed and validated a robust prognostic gene signature involving three eRNA-driven genes namely MAPK15, ZNF467, and MC1R. Moreover, we evaluated the function of eRNA-driven genes associated with tumor microenvironment (TME) and tumor mutational burden (TMB), and identified remarkable differences in drug sensitivity between high- and low-risk groups. This study identified a prognostic gene signature, which provides new insights into the role of eRNAs and eRNA-driven genes while assisting clinicians to determine the prognosis and appropriate treatment options for patients with PCa.