ResearchPad - clinical-article https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Gamma Knife Radiosurgery Using Co-Registration with PET-CT and MRI for Recurrent Nasopharyngeal Carcinoma with Previous Radiotherapy : A Single Center 14-Year Experience]]> https://www.researchpad.co/article/elastic_article_11297 We retrospectively evaluated the efficacy of Gamma Knife radiosurgery (GKS) for recurrent nasopharyngeal carcinoma (NPC) in patients who previously underwent radiotherapy, and analyzed the treatment outcomes over 14 years. MethodsTen patients with recurrent NPC who had previously received radiotherapy underwent stereotactic radiosurgery using a Gamma Knife® (Elekta Inc, Atlanta, GA, USA) between 2005 and 2018. The median target volume was 8.2 cm3 (range, 1.7–17.8), and the median radiation dose to the target was 18 Gy (range, 12–30). The median follow-up period was 18 months (range, 6–76 months). Overall and local failure-free survival rates were determined using the Kaplan-Meier method. ResultsThe NPCs recurred at the primary cancer site in seven patients (70%), as distant brain metastasis in two (20%), and as an extension into brain in one (10%). The recurrent tumors in seven of the 10 patients (70%) were found on the routine follow-up imaging studies. Two patients presented with headache and one with facial pain. Local failure after GKS occurred in five patients (50%) : two of whom died eight and 6 months after GKS, respectively. No adverse radiation effects were noted after GKS. The 1- and 3-year overall survival rates after GKS were 90% and 77%, respectively. The local failure-free survival rates at 6 months, 1 year, and 3 years after GKS were 80%, 48%, and 32%, respectively. The median interval from GKS to local failure was 8 months (range, 6–12). Univariate analysis revealed that using co-registration with positron emission tomography-computed tomography (PET-CT) and magnetic resonance imaging (MRI) was associated with a lower local failure rate of recurrent NPC (p=0.027). ConclusionGKS is an acceptable salvage treatment option for patients with recurrent NPC who previously received radiation therapy. PET-CT and MRI co-registration for dose planning can help achieve local control of recurrent NPC. ]]> <![CDATA[The R-line: A New Imaging Index for Decision Making Regarding C2 Lamina Decompression in Cervical Ossification of the Posterior Longitudinal Ligament]]> https://www.researchpad.co/article/elastic_article_11176 The optimal treatment modality for cervical ossification of the posterior longitudinal ligament (OPLL) including the C2 level remains controversial. Cervical laminoplasty is a widely accepted considering of advantages such as development of few postoperative complications, including kyphosis or neck pain. We encountered seven patients with postoperative disabilities resulting from incomplete decompression after undercutting of the C2 lamina. Based on this experience, we developed a new index to determine the degree of decompression in cervical OPLL—the rostral line (R-line).MethodsTotal of 79 consecutive patients who underwent posterior decompression of cervical OPLL were included in this study. Mean age at the time of operation, the C2-C7 cervical lordotic angle and OPLL thickness at the most stenotic level of the spinal canal, and preoperative/postoperative Japanese Orthopedic Association score was checked in these group. We compared the correspondence between the degree of C2 lamina decompression using the R-line and actual degree of decompression.ResultsIn all patients, the R-line touched the upper half of the C2 lamina on preoperative magnetic resonance imaging (MRI). The C2-C3 local segment lordotic angle and maximal degree of spinal cord compression by OPLL were independently correlated to postoperative C2 cord shifting. This result indicates that the R-line is a valid indicator to determine the degree of C2 lamina decompression in OPLL extending to the C2 level.ConclusionThe results showed that undercutting the C2 lamina can result in incomplete spinal cord decompression and poor clinical outcome if the R-line touches the upper half of the C2 lamina on preoperative MRI. ]]> <![CDATA[Clinical and Radiological Characteristics of Traumatic Pneumocephalus after Traumatic Brain Injury]]> https://www.researchpad.co/article/elastic_article_11173 Traumatic pneumocephalus (TP) is a common complication of traumatic brain injury (TBI), which is characterized by the abnormal entrapment of air in the intracranial cavity after TBI to the meninges. The purpose of this study was to investigate the clinical and radiological characteristics related to TP associated with TBI.MethodsFrom January 2013 to March 2018, the data from 71 patients with TP after TBI were collected. Demographic and clinical characteristics were investigated and the distribution of TP was investigated as radiological characteristics. The author compared the demographic characteristics of TP to the data from the Korean Neurotrauma Data Bank System (KNTDBS).ResultsThere was a higher ratio of males in patients with TP compared with KNTDBS. The mean age was 48.4±20.5 years and the incidence was highest in those 41–60 years of age (42.3%). Surgical treatment was performed in 23.9% patients. The mortality associated with the TP was 4.2%. The most common cause of injury was a traffic accident (52.1%). TP was mainly located in the epidural space (53.5%) and showed a scatter pattern (60.6%). It was mostly located in the frontal and temporal area (81.7%). Skull fractures were observed in 40.8% in the temporal bone and 25.4% in the frontal bone.ConclusionThe author identified epidemiology, clinical, and radiological characteristics of TP associated with TBI. Although this study has many limitations, the author believes it is worthwhile as it examines various characteristics of TP, which previously had relatively little clinical interest. ]]> <![CDATA[The Time-Related Trends in the Presenting of Traumatic Head Injury in a Single Institution]]> https://www.researchpad.co/article/elastic_article_11163 It is important to know the epidemiologic aspects of traumatic brain injury (TBI) for its rapid detection, appropriate treatment, and prevention. The purpose of this study is to classify the time of arrival of patients in the emergency room (ER) by time of day, day of the week, month, and season, and to analyze the relationship between the frequency of presentation at different times and TBI.MethodsThe time of arrival of 327 patients with TBI between January 2016 to December 2017 at the ER was analyzed retrospectively. The trends regarding the frequency of presentation of patients with TBI were analyzed in relation to arrival time at the ER.ResultsPatients with TBI were found to have the greatest number of hospitalizations at 13:00–18:00, on Saturdays, in December, and during the summer. Surgical treatment was not related to the temporal pattern of TBI patient admission. Patients with TBI in the severe group (GCS score <8) arrived at the ER mainly at 07:00–12:00 (p=0.015). Patients with TBI in the mild group (GCS score 13–15) mainly presented in the ER during the summer (p=0.003), while patients TBI in the moderate group (GCS score 9–12) presented mainly in the winter (p=0.244). The combination of the mild and moderate group presented more often in the winter (p=0.014).ConclusionIt is worthwhile understanding the temporal trends of TBI patients. These data may provide useful information in predicting the ER visits of TBI patients in advance and preparing for prompt and appropriate treatment. ]]> <![CDATA[Anatomical Localization of Traumatic Brain Injury Cases in Eastern Macedonia and Thrace, Greece: a 10-year Retrospective Observational Study]]> https://www.researchpad.co/article/elastic_article_11156 Brain trauma is an extremely important economical and social issue with increasing daily incidence. It is important to observe and report brain trauma, in order to provide better conditions for improvement of the trauma prevention and management.MethodsA ten-year retrospective observational analysis was performed on 292 (fatal and non-fatal) incidents of traumatic brain injury among 2,847 totally examined cases in the records of the laboratory of forensic sciences at Democritus University of Thrace between January 1, 2007 and December 31, 2016. The results were further analyzed and classified into pertinent categories associated with the purpose of the study.ResultsThe average age was estimated at 47.24 years with an obvious male domination. The most common cause of TBI, according to the results, is transport accidents (61.85%) followed by trauma inflicted by blunt instrument (22.49%), fall from height (11.65%) and occupational accidents (4.02%). Mortality rates were evaluated for each type, revealing extremely disturbing numbers. Regarding the anatomical localization on the skull, the most common region of cranial fractures is the cranial base (16.48%), followed by the frontal (12.87%), occipital (11.29%) and parietal bones (11.06%). In the majority of the cases, there were associated injuries.ConclusionThe management of traumatic brain injuries is difficult and sometimes impossible. Better prevention measures are required to minimize as much as possible the incidence of brain trauma. ]]> <![CDATA[Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system]]> https://www.researchpad.co/article/elastic_article_7136 Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long‐term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2‐year outcomes.MethodsA total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3‐day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow‐up visits. Adverse events (AEs) are reported in all implanted subjects.ResultsAt 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device‐related AEs.ConclusionsThe Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device‐related AEs. Subjects reported continued satisfaction with their therapy. ]]> <![CDATA[Thrombopoietin enhances hematopoietic stem and progenitor cell homing by impeding matrix metalloproteinase 9 expression]]> https://www.researchpad.co/article/elastic_article_6508 We reported a novel function of recombinant human thrombopoietin (TPO) in increasing hematopoietic stem and progenitor cell (HSPC) homing to the bone marrow (BM), which subsequently resulted in enhanced long‐term engraftment of HSPCs in mice. Notably, single doses of TPO treatment to patients followed by HSCT improved clinical outcomes, especially in patients with severe aplastic anemia.

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<![CDATA[Acute Community-Acquired Sinusitis]]> https://www.researchpad.co/article/N21715625-d417-44dc-8f36-0e23cbeeae67 ]]> <![CDATA[Kidney transplant tolerance associated with remote autologous mesenchymal stromal cell administration]]> https://www.researchpad.co/article/N4e510a15-ffd1-4570-be49-baadd7f7c720

Abstract

Here we report the case of successful immune tolerance induction in a living‐donor kidney transplant recipient remotely treated with autologous bone marrow‐derived mesenchymal stromal cells (MSC). This case report, which to the best of our knowledge is the first in the world in this setting, provides evidence that the modulation of the host immune system with MSC can enable the safe withdrawal of maintenance immunosuppressive drugs while preserving optimal long‐term kidney allograft function.

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<![CDATA[Cough stress tests to diagnose stress urinary incontinence in women with pelvic organ prolapse with indication for surgical treatment]]> https://www.researchpad.co/article/N1a288052-617c-4b47-bdb8-ec5096d7d8f0

Abstract

Aims

To evaluate the diagnostic ability of different cough stress tests (CSTs) in women with pelvic organ prolapse (POP), performed during outpatient urogynaecological exams.

Methods

Prospective, multicentre observational study involving women on waiting lists for POP surgery. With a subjectively full bladder, patients were asked to perform five different CSTs: without prolapse reduction ([a] standing, followed by [b] semilithotomy position); keeping semilithotomy position with prolapse reduced (by [c] posterior speculum, followed by [d] pessary); [e] standing again with the pessary in place. Primary outcome was positive CST in at least one of the five CSTs. Bladder volume was measured and symptoms of stress urinary incontinence (SUI) were detected by two validated questionnaires.

Results

A total of 297 women completed all CSTs and were included in the analyses. Mean (SD) age, parity, and body mass index were 64.8 (9.9) years, 2.7 (1.3) deliveries, and 26.6 (3.4) kg/m2, respectively. In total, 99 women (33.3%) reported SUI symptoms. At least one positive CST was recorded in 152 patients (51.1%), and in 90 (59.2%) of these 152, a positive CST was observed only when POP was reduced (occult SUI). The CST was positive in 92 (92.9%) of the 99 patients with coexisting SUI symptoms and in 60 (30.3%) of the 205 asymptomatic patients. The percentage of patients with a positive CST was significantly lower when bladder volume was <200 mL vs ≥200 mL (P = .046).

Conclusions

The identification of urinary leakage cases with CSTs is best achieved using multiple different patient positions, different prolapse reduction methods, and bladder volumes ≥200 mL.

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<![CDATA[Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation† ]]> https://www.researchpad.co/article/N79ff44fa-cea3-42b3-9901-147a36620e56

Abstract

Objective

To systematically develop evidence‐based bundles for care of postpartum hemorrhage (PPH).

Methods

An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated “GRADE Evidence‐to‐Decision” framework. Twenty‐three global maternal‐health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6‐month period, the expert panel met online and via teleconferences, culminating in a 2‐day in‐person meeting.

Results

The consultation led to the definition of two care bundles for facility implementation. The “first response to PPH bundle” comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The “response to refractory PPH bundle” comprises compressive measures (aortic or bimanual uterine compression), the non‐pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements.

Conclusion

For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

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<![CDATA[The cost-effectiveness of implementing HPV testing for cervical cancer screening in El Salvador]]> https://www.researchpad.co/article/N40a4d234-640d-49ed-ba58-176962636978

Objective

To assess the cost-effectiveness of HPV-based screening and management algorithms for HPV-positive women in phase 2 of the Cervical Cancer Prevention in El Salvador (CAPE) demonstration, relative to the status quo of Pap-based screening.

Methods

Data from phase 2 of the CAPE demonstration (n=8000 women) were used to inform a mathematical model of HPV infection and cervical cancer. The model was used to project the lifetime health and economic outcomes of HPV testing every 5 years (age 30–65 years), with referral to colposcopy for HPV-positive women; HPV testing every 5 years (age 30-65 years), with immediate cryotherapy for eligible HPV-positive women; and Pap testing every 2 years (age 20–65 years), with referral to colposcopy for Pap-positive women.

Results

Despite slight decreases in the proportion of HPV-positive women who received treatment relative to phase 1, the health impact of screening in phase 2 remained stable, reducing cancer risk by 58.5%. As in phase 1, HPV testing followed by cryotherapy for eligible HPV-positive women remained the least costly and most effective strategy (US$490 per year of life saved).

Conclusion

HPV-based screening followed by immediate cryotherapy in all eligible women would be very cost-effective in El Salvador.

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<![CDATA[First‐in‐human high‐cumulative‐dose stem cell therapy in idiopathic pulmonary fibrosis with rapid lung function decline]]> https://www.researchpad.co/article/N66a40bd5-fd77-4f7c-94c2-84781b22a0e9

Abstract

Previous phase I studies demonstrated safety and some beneficial effects of mesenchymal stem cells (MSCs) in patients with mild to moderate idiopathic pulmonary fibrosis (IPF). The aim of our study was to evaluate the safety, tolerability, and efficacy of a high cumulative dose of bone marrow MSCs in patients with rapid progressive course of severe to moderate IPF. Twenty patients with forced ventilation capacity (FVC) ≥40% and diffusing capacity of the lung for carbon monoxide (DLCO) ≥20% with a decline of both >10% over the previous 12 months were randomized into two groups: one group received two intravenous doses of allogeneic MSCs (2 × 108 cells) every 3 months, and the second group received a placebo. A total amount of 1.6 × 109 MSCs had been administered to each patient after the study completion. There were no significant adverse effects after administration of MSCs in any patients. In the group of MSC therapy, we observed significantly better improvement for the 6‐minute walk distance in 13 weeks, for DLCO in 26 weeks, and for FVC in 39 weeks compared with placebo. FVC for 12 months in the MSCs therapy group increased by 7.8% from baseline, whereas it declined by 5.9% in the placebo group. We did not find differences between the groups in mortality (two patients died in each group) or any changes in the high‐resolution computed tomography fibrosis score. In patients with IPF and a rapid pulmonary function decline, therapy with high doses of allogeneic MSCs is a safe and promising method to reduce disease progression.

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<![CDATA[Trends in mesenchymal stem cell clinical trials 2004‐2018: Is efficacy optimal in a narrow dose range?]]> https://www.researchpad.co/article/N2f8205be-ba95-460e-88e8-896bff9ee826

Abstract

The number of clinical trials using mesenchymal stem cells (MSCs) has increased since 2008, but this trend slowed in the past several years and dropped precipitously in 2018. Previous reports have analyzed MSC clinical trials by disease, phase, cell source, country of origin, and trial initiation date, all of which can be downloaded directly from http://clinicaltrials.gov. We have extended analyses to a larger group of 914 MSC trials reported through 2018. To search for potential factors that may influence the design of new trials, we extracted data on routes of administration and dosing from individual http://clinicaltrials.gov records as this information cannot be downloaded directly from the database. Intravenous (IV) injection is the most common, least invasive and most reproducible method, accounting for 43% of all trials. The median dose for IV delivery is 100 million MSCs/patient/dose. Analysis of all trials using IV injection that reported positive outcomes indicated minimal effective doses (MEDs) ranging from 70 to 190 million MSCs/patient/dose in 14/16 trials with the other two trials administering much higher doses of at least 900 million cells. Dose‐response data showing differential efficacy for improved outcomes were reported in only four trials, which indicated a narrower MED range of 100‐150 million MSCs/patient with lower and higher IV doses being less effective. The results suggest that it may be critical to determine MEDs in early trials before proceeding with large clinical trials.

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<![CDATA[Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe]]> https://www.researchpad.co/article/N82be2c4e-40c8-426b-affa-8470c52c1a87

Abstract

Aim

To evaluate the impact of Vesomni/Urizia/Volutsa, a fixed‐dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α‐blocker), on health‐related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice.

Methods

EUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB‐q) symptom bother subscale score. Change from baseline in OAB‐q total and coping, sleep, and social interaction subscale scores, treatment satisfaction‐visual analog scale (TS‐VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire were also evaluated.

Results

Five hundred and eighty‐nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB‐q symptom bother subscale scores were −16.40 (−24.31, −8.49) at weeks 4 to 8 and −19.59 (−28.26, −10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS‐VAS, IPSS, and EQ‐5D‐5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients.

Conclusions

Vesomni was well‐tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH.

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<![CDATA[Long‐Term Results of Cultured Limbal Stem Cell Versus Limbal Tissue Transplantation in Stage III Limbal Deficiency]]> https://www.researchpad.co/article/N36801600-88be-42f8-9ed1-694f2f73c4d3

Abstract

We aimed to evaluate efficiency and safety of transplantation of limbal stem cells (LSC) cultured on human amniotic membrane with no feeders and to compare cultured LSC with limbal tissue transplantation. Thirty eyes with stage III LSC deficiency were treated with autologous (autoLSC) or allogeneic (alloLSC) cultured LSC transplantation (prospective phase II clinical trial; average follow‐up time, 72 months) or autologous (autoLT) or allogeneic (alloLT) limbal tissue transplantation (retrospective control group; average follow‐up time, 132 months) between 1993 and 2014. The 5‐year graft survival defined by absence of recurrence of the clinical signs of limbal deficiency was 71% for autoLSC, 0% for alloLSC, 75% for autoLT, and 33% for alloLT. Visual acuity improved by 9.2 lines for autoLSC and 3.3 lines for autoLT. It decreased by 0.7 lines for alloLSC and 1.9 lines for alloLT. Adverse events were recorded in 1/7 autoLSC, 7/7 alloLSC, 6/8 autoLT, and 8/8 alloLT patients. Corneal epithelial defect was the only adverse event recorded after autoLSC, whereas severe sight‐threatening adverse events were recorded in the remaining three groups. Compared with failed grafts, successful grafts featured greater decrease in fluorescein staining, greater superficial vascularization‐free corneal area, lower variability of the corneal epithelial thickness, and higher corneal epithelial basal cell density. Autologous cultured LSC transplantation was associated with high long‐term survival and dramatic improvement in vision and was very safe. Autologous limbal tissue transplantation resulted in similar efficiency but was less safe. Cadaver allogeneic grafts resulted in low long‐term success rate and high prevalence of serious adverse events. stem cells translational medicine 2019;8:1230&1241

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<![CDATA[Abnormal vaginal microbiome associated with vaginal mesh complications]]> https://www.researchpad.co/article/N8a1b5b38-aaf3-4da4-a6c1-c85bdf54e5f7

Abstract

Aims

To identify differences in the vaginal microbiomes of women after transvaginal mesh (TVM) surgery for pelvic organ prolapse with and without mesh‐associated complications.

Methods

Patients with complications were eligible as cases, patients without as controls. DNA was isolated and the V1‐2 region of the 16S ribosomal RNA gene was amplified and sequenced. Overall richness was quantified using Chao1. Overall diversity was expressed as Shannon diversity and screened for group differences using analysis of variance. Multivariate differences among groups were evaluated with functions from R.

Results

We recruited 14 patients after mesh exposure, 5 after contraction, and 21 as controls. The average number of operational taxonomic unit was 74.79 (SD ± 63.91) for controls, 57.13 (SD ± 58.74) after exposures, and 92.42 (SD ± 50.01) after contractions. Total 89.6% of bacteria in controls, 86.4% in previous exposures, and 81.3% in contractions were classified as either Firmicutes, Proteobacteria, or Actinobacteria (P < .001). Veillonella spp. was more abundant in patients after contraction (P = .045). The individual microbiomes varied, and we did not detect any significant differences in richness but a trend towards higher diversity with complications.

Conclusions

The presence of Veillonella spp. could be associated with mesh contraction. Our study did not identify vaginal microbiotic dysbiosis as a factor associated with exposure. Larger cohort studies would be needed to distinguish the vaginal microbiome of women predisposed to mesh‐related complications for targeted phenotyping of patients who could benefit from TVM surgery.

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<![CDATA[Scientific evidence for pelvic floor devices presented at conferences: An overview]]> https://www.researchpad.co/article/Naacac44d-7447-4367-b9eb-f2a26b84cc91

Abstract

Aims

An increasing number of diagnostic and therapeutic medical devices are available to help patients and physicians manage pelvic floor symptoms in women. Many of these are presented at scientific conferences, and in the absence of a gold standard for evaluation, marketing has become more prominent than scientific evaluation. The goal of this study was to (a) provide an overview of pelvic floor devices for women that have been presented at recent annual meetings of leading scientific societies and (b) to summarize and review the scientific evidence underpinning these devices.

Methods

Manual searches were performed of all abstracts presented in 2016 and 2017 at annual meetings of the International Continence Society, the International Urogynecological Association, the European Association of Urology, and the American Urological Association. The exhibition floor of the 2017 International Continence Society was also searched. Subsequently, literature searches of both the MEDLINE and Embase databases were performed in November 2018 to identify original full‐text publications related to the identified devices.

Results

We identified 11 devices from these sources, which were mainly used for the control of urinary incontinence. Only seven of these pelvic floor devices were covered by publications, with no full‐text records identified for the remaining four devices.

Conclusions

Sample sizes were small and there was a lack of convincing evidence for most devices. Despite this, many devices were available in the market. Our findings indicate that the process for introducing these new devices is in stark contrast with the strict requirements for introducing new drug classes.

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<![CDATA[Gonadal shield: is it the Albatross hanging around the neck of developmental dysplasia of the hip research?]]> https://www.researchpad.co/article/5c37bb67d5eed0c484499c2c

Abstract

Purpose

Prospective randomized controlled trials and long-term studies are essential future directions for building ­evidence-based practices in developmental dysplasia of the hip (DDH), however, sufficient attrition in data (> 20%) can introduce bias deteriorating research quality. Pelvic radiography is synonymous with DDH assessment and so are ­Gonadal Shield (GS) recommendations with pelvic radiography. ­Nonetheless, losses to diagnostic information and inadequate protection have been increasingly implicated to GS usage, with significantly worse implications in female patients. Understandably for DDH, a disease with 80% female prevalence, the impact of GS usage on quality of radiographs and readability of radiological data may be drastic. This study aims to objectively define the implications of GS recommendations in DDH patients.

Methods

Pelvis radiographs of all DDH patients under the hip surveillance programme at a tertiary care hospital with a written protocol for GS usage were evaluated. Images were reviewed for gender, GS presence, adequate gonadal protection and obstruction of essential anatomical landmarks for pelvic indices.

Results

In all, 131 pelvis radiographs with DDH diagnoses (age: 1.25 to 6 years; 107 female, 24 male pelvises) were reviewed. Only 42.67% (56) of pelvis radiographs used GS despite the presence of a clear protocol. Useful anatomical landmarks were obstructed in 58.9% of radiographs with GS present. Lost diagnostic information was more common in female patients than male patients (68.1% versus 11.1%, p < 0.01). GS was ineffective at gonadal protection in 73.2% (41) of the pelvises with worse protection in female patients (78.7% vs 44.4%; p = 0.03).

Conclusions

Ironically, essential anatomy was obstructed in all the adequately protected female pelvises. Routine GS usage results in substantial attrition of radiographic data in DDH patients.

Level of Evidence

III

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<![CDATA[Malignant Glioma with Neuronal Marker Expression : A Clinicopathological Study of 18 Cases]]> https://www.researchpad.co/article/5af8b0b0463d7e0c27c81272

Objective

Malignant gliomas with neuronal marker expression (MGwNM) are rare and poorly characterized. Increasingly diverse types of MGwNM have been described and these reported cases underscore the dilemmas in the classification and diagnosis of those tumors. The aim of this study is to provide additional insights into MGwNM and present the clinicopathological features of 18 patients.

Methods

We reviewed the medical records of 18 patients diagnosed as MGwNM at our institute between January 2006 and December 2012. Macroscopic total resection was performed in 11 patients (61%). We evaluated the methylation status of O6-methylguanine-DNA methyltransferase (MGMT) and expression of isocitrate dehydrogenase 1 (IDH-1) in all cases, and deletions of 1p and 19q in available cases.

Results

The estimated median overall survival was 21.2 months. The median progression-free survival was 6.3 months. Six patients (33%) had MGMT methylation but IDH1 mutation was found in only one patient (6%). Gene analysis for 1p19q performed in nine patients revealed no deletion in six, 19q deletion only in two, and 1p deletion only in one. The extent of resection was significantly correlated with progression free survival on both univariate analysis and multivariate analysis (p=0.002 and p=0.013, respectively).

Conclusion

In this study, the overall survival of MGwNM was not superior to glioblastoma. The extent of resection has a significant prognostic impact on progression-free survival. Further studies of the prognostic factors related to chemo-radio therapy, similar to studies with glioblastoma, are mandatory to improve survival.

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