This study proposed the diagnosis of COVID-19 by means of Raman spectroscopy. Samples of blood serum from 10 patients positive and 10 patients negative for COVID-19 by RT-PCR RNA and ELISA tests were analyzed. Raman spectra were obtained with a dispersive Raman spectrometer (830 nm, 350 mW) in triplicate, being submitted to exploratory analysis with principal component analysis (PCA) to identify the spectral differences and discriminant analysis with PCA (PCA-DA) and partial least squares (PLS-DA) for classification of the blood serum spectra into Control and COVID-19. The spectra of both groups positive and negative for COVID-19 showed peaks referred to the basal constitution of the serum (mainly albumin). The difference spectra showed decrease in the peaks referred to proteins and amino acids for the group positive. PCA variables showed more detailed spectral differences related to the biochemical alterations due to the COVID-19 such as increase in lipids, nitrogen compounds (urea and amines/amides) and nucleic acids, and decrease of proteins and amino acids (tryptophan) in the COVID-19 group. The discriminant analysis applied to the principal component loadings (PC2, PC4, PC5, and PC6) could classify spectra with 87% sensitivity and 100% specificity compared to 95% sensitivity and 100% specificity indicated in the RT-PCR kit leaflet, demonstrating the possibilities of a rapid, label-free, and costless technique for diagnosing COVID-19 infection. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10103-021-03488-7.

In the context of the COVID-19 pandemic, several drugs have been repurposed as potential candidates for the treatment of COVID-19 infection. While preliminary choices were essentially based on in vitro potency, clinical translation into effective therapies may be challenging due to unfavorable in vivo pharmacokinetic properties at the doses chosen for this new indication of COVID-19 infection. However, available pharmacokinetic and pharmacokinetic-pharmacodynamic studies suffer from severe limitations leading to unreliable conclusions, especially in term of dosing optimization. In this paper we propose to highlight these limitations and to identify some of the major requirements that need to be addressed in designing PK and PK-PD studies in this era of COVID. A special attention should be paid to pre-analytical and analytical requirements and to the proper collection of covariates affecting dose-exposure relationships (co-medications, use of specific organ support techniques and other clinical and para-clinical data). We also promote the development of population PK and PK-PD models specifically dedicated to COVID-19 patients since those previously developed for other diseases (SEL, malaria, HIV) and clinical situations (steady-state, non-ICU patients) are not representative of severe patients. Therefore, implementation of well-designed PK and PD studies targeted to COVID-19 patients is urgently needed. For that purpose we call for multi-institutional collaborative work and involvement of clinical pharmacologists in multidisciplinary research consortia.

Entre as doen?as que acometem bovinos em sistemas de alta produtividade est?o a acidose ruminal e a laminite. Objetivou-se avaliar o quadro de acidose ruminal e da fase inicial de laminite induzidas pela administra??o de oligofrutose em bezerros. Foram usados seis bezerros mesti?os (Bos taurus X Bos indicus) de um ano de idade e pesando em mdia 175 22,6 kg. Inicialmente usaram-se trs animais em um grupo piloto (GP) recebendo oligofrutose na dose de 13 g/kg e em seguida um grupo experimental (GE) recebendo o a?car na dose de 17 g/kg. Avaliaram-se altera??es clnicas, laboratoriais e histolgicas, de fragmentos do casco. A sobrecarga de oligofrutose provocou acidose ruminal caracterizada por baixo pH em ambos os grupos, menor no GE. Observou-se tambm acidose metablica com redu??o de pH, PCO2, bicarbonato e excesso de base. N?o se observou aumento da sensibilidade dos cascos ou claudica??o. Apesar disso, muitos animais apresentaram apatia e marcha mais lenta, possivelmente devido a acidose metablica. Histologicamente observaram-se altera??es circulatrias e infiltrado inflamatrio na derme, irregularidades de membrana basal e altera??es morfolgicas na epiderme basal. As altera??es clnicas e histolgicas foram semelhantes as descritas em outros trabalhos, entretanto, todos realizados em animais taurinos. O protocolo de indu??o de laminite com administra??o intrarruminal de oligofrutose se mostrou eficaz em bezerros mesti?os de um ano de idade. Na fase inicial a laminite se caracterizou por sinais clnicos da enfermidade primria, no caso acidose ruminal, e por altera??es histolgicas indicativas de inflama??o aguda e comprometimento de membrana basal e epiderme.

INTRODUCTION: The COVID-19 virus is highly contagious and thus there is a potential of infecting operating staff when operating on these patients. This case series describes a method of performing open tracheostomy for COVID-19 patients while minimizing potential aerosolization of the virus using typically available equipment and supplies. METHODS: This is a case series of 18 patients who were COVID-19 positive and underwent open tracheostomy in the operating room under a negative pressure plastic hood created using readily available equipment and supplies. Patients had to be intubated for at least 14 days, be convalescing from their cytokine storm, and deemed to survive for at least 14 more days. Other indications for tracheostomy were altered mental status, severe deconditioning, respiratory failure and failed extubation attempts. RESULTS: There were 14 men and 4 women with severe SARS-CoV2 infection requiring long-term intubation since March 23 or later. The mean age was 61.7, BMI was 32.6, and the pre-tracheostomy ventilator day was 20.4. The indications for tracheostomy were altered mental status, severe deconditioning and continued respiratory with hypoxia. Failed extubation attempt rate was 16.7% and hemodialysis rate was 38.9%. All patients were hemodynamically stable, without any evidence of accelerating cytokine storm. To date there was one minor bleeding due to postoperative therapeutic anticoagulation. CONCLUSION: This report describes a method of performing open tracheostomy with minimal aerosolization using readily available equipment and supplies in most hospitals.

Throughout history, gender inequality has persisted in most parts of the world. Since the founding of the People's Republic of China (PRC) in 1949, substantial progress has been made towards gender equality in China. Today, a large number of Chinese women scientists are making significant contributions to advance science. However, are they facing gender discrimination in hiring and promotion? Do they have access to the same opportunities as their male colleagues? What are the potential approaches to further promote gender equality in China's scientific community given myriad unfavorable social factors? Recently, NSR invited five Chinese female scientists and two gender experts to discuss these issues. Here are their observations and suggestions. [Image: see text] Bing Liu Professor at the Department of the History of Science, Tsinghua University [Image: see text] Jun Lu Senior Engineer at Beijing Institute of Tracking and Telecommunications Technology, and Deputy Chief Designer of BeiDou Grounded Test and Validation System [Image: see text] Chih-chen Wang Professor at the Institute of Biophysics, Chinese Academy of Sciences [Image: see text] Hongyang Wang President of the China Women's Association for Science and Technology (CWAST), Director of the National Center for Science in Liver Cancer [Image: see text] Xiaoyun Wang C. N. Yang Professor at the Institute for Advanced Study, Tsinghua University [Image: see text] Yan Zheng Chair Professor at the School of Environmental Science and Engineering, Southern University of Science and Technology [Image: see text] Wenpei Tang (Chair) Professor at the School of Health Humanities, Peking University

BACKGROUND The COVID-19 pandemic has put health systems under unprecedented pressure, challenging their workforce, especially nurses. OBJECTIVE The current paper presented a review of the early literature concerning emerging nursing challenges during the early stages of the COVID-19 pandemic. METHODS A systematic search of the published literature between January and May 2020 was carried out in Medline, Science Direct, and Google Scholar to identify relevant quantitative and qualitative studies. RESULTS Twenty-two original articles were retrieved, the majority of which were survey studies from China. Synthesis of the evidence resulted in four overarching themes including "being physically and mentally drained in the face of fear and uncertainty," "shortage of personal protective equipment and usability issues," "psychosomatic disturbances among nurses," and "moderators to mitigate nurses' challenges." CONCLUSIONS Providing care for demanding COVID-19 patients, nurses experienced a gruelling situation, during which a significant amount of psychological and physical distress was inflicted to them. However, receiving proper support from their organization and society could improve the condition substantially. Further research is required to explore the impact of the COVID-19 pandemic on nurses, especially from Western countries.

Work-life after COVID-19 might never be the same again. After an economic crisis due to the pandemic, the Indonesian government is applying large-scale social restriction relaxation to allow companies to reopen. However, just after a few weeks of social relaxation, new clusters from offices are occurring. With many employees infected with COVID 19, concerns arise among employers;when is the best time for employees to get back to work after COVID-19 infection? This paper provides a general guideline to discontinue isolation in people with suspected or confirmed COVID-19 infection in non-healthcare establishments. According to the newest available evidence, commencing back to work should refer to a symptom-based strategy rather than a test-based strategy. In all circumstances, universal health protocol should be practiced at all times to minimize widespread transmission.

Since Hohenberger, the principle of complete mesocolic excision (CME) has been accepted and increasingly performed by colorectal surgeons [1]. However, compared with D2 dissection, laparoscopic CME or D3 dissection has a longer learning curve and a higher surgery-related risk due to the complicated surgical anatomy and the laparoscopic approach [2]. The aim of this video is to demonstrate the benefits of our three-trocar technique with the use of a vessel sealing device that may reduce surgery-related risk, the learning curve and operative time. The video underlines the key vascular steps needed safely to perform a complete lymphadenectomy. This article is protected by copyright. All rights reserved.

INTRODUCTION Sleeve gastrectomy has become a popular stand-alone bariatric procedure with comparable weight loss and resolution of comorbidities to that of laparoscopic gastric bypass. The simplicity of the procedure and the decreased long-term risk profile make this surgery more appealing. Nonetheless, the ever present risk of a staple-line leak is still of great concern and needs further investigation. METHODS An electronic literature search of MEDLINE database plus manual reference checks of articles published on laparoscopic sleeve gastrectomy for morbid obesity and its complications was completed. Keywords used in the search were "sleeve gastrectomy" OR "gastric sleeve" AND "leak." We analyzed 29 publications, including 4,888 patients. We analyzed the frequency of leak after sleeve gastrectomy and its associated risks of causation. RESULTS The risk of leak after sleeve gastrectomy in all comers was 2.4%. This risk was 2.9% in the super-obese [body mass index (BMI) > 50 kg/m(2)] and 2.2% for BMI < 50 kg/m(2). Staple height and use of buttressing material did not affect leak rate. The use of a size 40-Fr or greater bougie was associated with a leak rate of 0.6% compared with those who used smaller sizes whose leak rate was 2.8%. Leaks were found at the proximal third of the stomach in 89% of cases. Most leaks were diagnosed after discharge. Endoscopic management is a viable option for leaks and was documented in 11% of cases as successful. CONCLUSIONS Sleeve gastrectomy has become an important surgical option for the treatment of the ever growing morbidly obese population. The risk of leak is low at 2.4%. Attention to detail specifically at the esophagogastric junction cannot be stressed enough. Careful patient selection (BMI < 50 kg/m(2)) and adopting the use of a 40-Fr or larger bougie may decrease the risk of leak. Vigilant follow-up during the first 30 days is critical to avoid catastrophe, because most leaks will happen after patient discharge.

INTRODUCTION: The potential role of accumulation of chondroitin sulfates (CSs) in the pathobiology of COVID-19 has not been examined. Accumulation may occur by increased synthesis or by decline in activity of the enzyme arylsulfatase B (ARSB; N-acetylgalactosamine-4-sulfatase) which requires oxygen for activity. METHODS: Immunostaining of lung tissue from 28 patients who died due to COVID-19 infection was performed for CS, ARSB, and carbohydrate sulfotransferase (CHST)15. Measurements of mRNA expression of CHST15 and CHST11, sulfotransferase activity, and total sulfated glycosaminoglycans (GAGs) were determined in human vascular smooth muscle cells following angiotensin (Ang) II treatment. RESULTS: CS immunostaining showed increase in intensity and distribution, and immunostaining of ARSB was diminished in COVID-19 compared to normal lung tissue. CHST15 immunostaining was prominent in vascular smooth muscle cells associated with diffuse alveolar damage due to COVID-19 or other causes. Expression of CHST15 and CHST11 which are required for synthesis of CSE and chondroitin 4-sulfate, total sulfated GAGs, and sulfotransferase activity was significantly increased following AngII exposure in vascular smooth muscle cells. Expression of Interleukin-6 (IL-6), a mediator of cytokine storm in COVID-19, was inversely associated with ARSB expression. DISCUSSION/CONCLUSION: Decline in ARSB and resulting increases in CS may contribute to the pathobiology of COVID-19, as IL-6 does. Increased expression of CHSTs following activation of Ang-converting enzyme 2 may lead to buildup of CSs.

The controversy surrounding the use of hydroxychloroquine (HCQ), an antimalarial drug, for COVID-19 has raised numerous ethical and policy problems. Since the suggestion that HCQ has potential for COVID-19, there have been varying responses from clinicians and healthcare institutions, ranging from adoption of protocols using HCQ for routine care to the conduct of randomised controlled trials to an effective system-wide prohibition on its use for COVID-19. In this article, we argue that the concept of disease public profile has become a prominent, if not the sole, determinant in decision-making across various healthcare responses to the pandemic. In the case of COVID-19, the diseases public profile is based on clinical and non-clinical factors that include contagiousness, clinical presentation and media coverage. In particular, we briefly examine the dangers of a heightened public profile in magnifying the inequality of diseases and undermining three key ethical concepts, namely (1) evidence-based practice, (2) sustainable allocation and (3) meaningful consent.

BACKGROUND: Many children attend Emergency Departments (ED) and Out of Hours (OoH) frequently for acute asthma. Follow up care is often suboptimal leaving these children at risk of a future attacks. We report on the development, implementation and evaluation of a safe asthma discharge care pathway (SADCP). METHODS: This is a retrospective report on the development, implementation and evaluation of outcomes of a SADCP. The pathway was based on the Teach-to-goal educational methodology that supported the mastery correct inhaler technique and ability to action the personalized asthma action plan (PAAP). Children with frequent asthma attacks were entered as they were discharged from the Emergency Department or ward. The first training session occurred within 1C3 weeks of the index asthma attack with 2 further sessions in the following 8 weeks. Children exiting the pathway were discharged either back to primary care or to a hospital clinic. RESULTS: 81 children entered the pathway (median age 5 years) with 72 discharged from the ED and 9 from the medical wards of the Royal Belfast Hospital for Sick Children. At pathway entry 13% had correct inhaler technique, 10% had a Personalized Asthma Action Plan (PAAP), and 5% had >80% (45% >50%) repeat refill evidence of adherence to inhaled corticosteroid over the previous 12 months. On pathway exit all children demonstrated correct inhaler technique and were able to action their PAAP. One year later 51% and 95% had refill evidence of >80% and >50% adherence. Comparisons of the 12 months before and 12 months after exit from the pathway the median number of emergency ED or OoH asthma attendances and courses of oral corticosteroids reduced to zero with >75% having no attacks requiring this level of attention. Similar findings resulted when the SADCP was implemented in a district general hospital pediatric unit. CONCLUSION: Implementing an asthma care pathway, using Teach-to-Goal skill training methods and frequent early reviews after an index asthma attack can reduce the future risk of asthma attacks in the next 6 to 12 months.

Candida auris is a species of fungus that has gained importance in recent years owing to its ability to cause hospital infections and epidemics, resistant to antifungal agents and disinfection processes and frequently misidentified by commercial systems. Hospital outbreaks caused by C.auris have been reported from some countries. It has been determined that C.auris has lower virulence than Candida albicans; however, it is associated with high mortality rates in immunocompromised individuals. An increase in the incidence of invasive fungal infections which can lead to serious complications and death, has been identified in severe coronavirus-2019 (COVID-19) patients or immunocompromised individuals with underlying disease. Studies demonstrated an increase in the frequency of C.auris isolation in COVID-19 patients with candidemia. In this report, the first case of COVID-19 positive C.auris fungemia detected in Turkey was presented. A 71-year-old male patient with a history of myocardial infarction, diabetes mellitus, donation of a single kidney and lobectomy surgery due to lung cancer was hospitalized in the pandemic thoracic surgery service due to the findings consistent with viral pneumonia on thoracic computed tomography. Favipiravir 2 x 600 mg and intravenous dexamethasone 1 x 6 mg therapy was administered. The patient tested positive for SARS-CoV-2 polymerase chain reaction, and severe involvement of the left lung was detected in the following days. Antibiotics were administered, followed by insertion of a right jugular vein catheter and initation of tocilizumab. The patient was transferred to the intensive care unit due to increased respiratory distress. Yeast growth was detected in the patient's hemoculture. The yeast strain could not be identified using API ID 32C (bioMerieux, France) (Sacchromyces kluyveri, Candida sake, unacceptable profile), but was identified as C.auris using the VITEK MALDI TOF MS (bioMerieux, France) (99.9%) system and confirmed by sequencing. The minimum inhibitor concentration values were detected as 3 g/ml for amphotericin B; > 256 g/ml for fluconazole; 0.19 g/ml for voriconazole; 0.19 g/ml for itraconazole; 0.016 g/ml for posaconazole; 1 g/ml for caspofungin and 0.094 g/ml for anidulafungin by using the antibiotic gradient method. The patient's initial treatment comprised meropenem 3 x 1 g, vancomycin 2 x 1 g, caspofungin 1 x 70 mg, and continued as caspofungine 1 x 50 mg after the loading dose, and vancomycin 1 x 1 g/48 hours from the third day of treatment. The patient died on the ninth day after developing candidemia. The present case is the first case of fungemia caused by C.auris in a COVID-19 positive patient in Turkey, and it emphasizes the need of caution for fungemia due to C.auris in intensive care units in our country which has a high COVID-19 incidence.

BACKGROUND The value of frequent, rapid testing to reduce community transmission of SARS-CoV-2 is poorly understood. OBJECTIVE To define performance standards and predict the clinical, epidemiologic, and economic outcomes of nationwide, home-based antigen testing. DESIGN A simple compartmental epidemic model that estimated viral transmission, portrayed disease progression, and forecast resource use, with and without testing. DATA SOURCES Parameter values and ranges as informed by Centers for Disease Control and Prevention guidance and published literature. TARGET POPULATION U.S. population. TIME HORIZON 60 days. PERSPECTIVE Societal; costs included testing, inpatient care, and lost workdays. INTERVENTION Home-based SARS-CoV-2 antigen testing. OUTCOME MEASURES Cumulative infections and deaths, number of persons isolated and hospitalized, and total costs. RESULTS OF BASE-CASE ANALYSIS Without a testing intervention, the model anticipates 11.6 million infections, 119 000 deaths, and $10.1 billion in costs ($6.5 billion in inpatient care and $3.5 billion in lost productivity) over a 60-day horizon. Weekly availability of testing would avert 2.8 million infections and 15 700 deaths, increasing costs by $22.3 billion. Lower inpatient outlays ($5.9 billion) would partially offset additional testing expenditures ($12.5 billion) and workdays lost ($14.0 billion), yielding incremental cost-effectiveness ratios of $7890 per infection averted and $1 430 000 per death averted. RESULTS OF SENSITIVITY ANALYSIS Outcome estimates vary widely under different behavioral assumptions and testing frequencies. However, key findings persist across all scenarios, with large reductions in infections, mortality, and hospitalizations. Costs per death averted are roughly an order of magnitude lower than commonly accepted willingness-to-pay values per statistical life saved ($5 to $17 million). LIMITATIONS Analysis was restricted to at-home testing. There are uncertainties concerning test performance. CONCLUSION High-frequency home testing for SARS-CoV-2 with an inexpensive, imperfect test could contribute to pandemic control at justifiable cost and warrants consideration as part of a national containment strategy. PRIMARY FUNDING SOURCE National Institutes of Health.

Using three different studies on early grade reading from no-fee schools across in South Africa, this paper establishes short-term learning losses in reading for grade 2 and 4 students from under-resourced school contexts. We find that in 2020 grade 2 students lost between 57% and 70% of a year of learning relative to their pre-pandemic peers. Among a grade 4 sample, learning losses are estimated at between 62% and 81% of a year of learning. Considering that in 2020 students in the samples lost between 56% to 60% of contact teaching days due to school closures and rotational timetabling schedules compared to a pre-pandemic year, this implies learning to schooling loss ratios in the region of 1 to 1.4. There is some evidence from the grade 4 sample that the reading trajectories of children benefiting more from attending school pre-pandemic C namely girls and children with stronger initial reading proficiency - are more negatively impacted. Mitigating the long-run implications of these learning losses will require a significant pivoting of the education system to ensure that instructional practices are appropriately levelled to optimise learning.

Rabies in the Greater Kudu (Tragelaphus strepsiceros) in Namibia is unique and found in such magnitude as has not been reported elsewhere in southern Africa. Reasons as to why Kudus appear to be exceptionally susceptible to rabies still remain speculative at best. Because the current severe rabies endemic in Kudus continues to have an enormous negative impact on the Namibian agricultural sector, we set out to question existing dogmas regarding the epidemiology of the disease in a unique experimental setting. In addition, we explored effective measures to protect these antelopes. Although we were able to confirm high susceptibly of kudus for rabies and sporadic horizontal rabies virus transmission to contact animals, we contend that these observations cannot plausibly explain the rapid spread of the disease in Kudus over large territories. Since parenteral vaccination of free-roaming Kudus is virtually impossible, oral rabies vaccination using modified life virus vaccines with a high safety profile would be the ultimate solution to the problem. In a proof-of-concept study using a 3rd generation oral rabies virus vaccine construct (SPBN GASGAS) we found evidence that Kudus can be vaccinated by the oral route and protected against a subsequent rabies infection. In a second phase, more targeted studies need to be initiated by focusing on optimizing oral vaccine uptake and delivery.

Purpose: This study aimed to investigate nurses burnout working in a hospital for Coronavirus Disease 2019 (COVID-19) patients, and identify factors influencing nurses burnout. Methods: We recruited 162 nurses working in a nationally designated hospital for COVID-19 patients. Data were collected on general characteristics, burnout, social support, healthcare safety climate, and job stress using a questionnaire. Data were analyzed using descriptive statistics, an independent t-test, a one-way ANOVA, the Scheff test, Pearson correlation coefficient, multiple regression, and Cronbachs using IBM SPSS Statistics version 26.0 for Windows. Results: The mean scores for burnout, social support, healthcare safety climate, and job stress were 2.96, 3.74, 4.08, and 2.69, respectively. Working department and job stress were significant factors affecting nurses burnout and these variables explained 26.0% of burnout variance. Conclusion: To reduce burnout of nurses working in the COVID-19 frontline, efforts are needed to reduce nurses job stress. In nursing research, further study on what makes a difference in burnout between intensive care units and medical/surgical wards in current COVID-19 situation are needed. The results will be used as basic data to develop intervention and reduce nurses burnout during future infectious disease outbreaks ? 2022. Korean Society of Adult Nursing

From October 1977 to May 1980, 243 stools collected in sedentary and semi-nomadic populations of the Ahaggar (Algerian Sahara) were examined using immunoelectronmicroscopy and tissue culture inoculation. Immunoelectronmicroscopy revealed the presence of rotaviruses in 8, coronaviruses in 26, adenoviruses in 5 and small round viruses in 4. Enteroviruses were isolated in tissue culture from 24 stools. Rotaviruses were present in the Ahaggar but were associated with little acute enteric disease. The high frequency of coronaviruses both in gastroenteritis patients and in patients without disease was surprising. The prevalence of enteroviruses in this hyperarid zone was similar to or higher than that found in noticeably more human countries. Further systematic bacterial, viral and parasitic examinations are required to clarify the role of the above viruses in the aetiology of gastroenteritis in this region.

The epidemiological and clinical characteristics, treatments, and outcomes of patients with traumatic out-of-hospital cardiac arrests (OHCAs) following traffic collisions have not been adequately investigated in Japan. We analyzed the All-Japan Utstein Registry data of 918 pediatric patients aged <20 years with OHCAs following traffic collisions who were resuscitated by bystanders or emergency medical service personnel and were subsequently transported to hospitals between 2013 and 2019. Multiple logistic regression analysis was used to assess factors potentially associated with 1-month survival after OHCA. The 1-month survival rate was 3.3% (30/918), and the rate of neurologically favorable outcomes was 0.7% (60/918). The proportion of 1-month survival of all OHCAs after traffic collision origin did not significantly increase (from 1.9% (3/162) in 2013 to 4.5% (5/111) in 2019), and the adjusted odds ratio (OR) for a 1-year increment was 1.13 (95% confidence interval (CI) 0.93 to 1.37). In a multivariate analysis, ventricular fibrillation arrests and pulseless electrical activity (PEA) were significant predictors of 1-month outcome after OHCAs due to traffic collision. From a large OHCA registry in Japan, we demonstrated that 1-month survival after OHCAs due to traffic collision origin was approximately 3%, and some children even gained full recovery of neurological function.

PURPOSE To characterize the effect of a prostate-rectum spacer on dose to rectum during external beam radiation therapy for prostate cancer and to assess for factors correlated with rectal dose reduction. METHODS AND MATERIALS Fifty-two patients at 4 institutions were enrolled into a prospective pilot clinical trial. Patients underwent baseline scans and then were injected with perirectal spacing hydrogel and rescanned. Intensity modulated radiation therapy plans were created on both scans for comparison. The objectives were to establish rates of creation of 7.5 mm of prostate-rectal separation, and decrease in rectal V70 of 25%. Multiple regression analysis was performed to evaluate the associations between preinjection and postinjection changes in rectal V70 and changes in plan conformity, rectal volume, bladder volume, bladder V70, planning target volume (PTV), and postinjection midgland separation, gel volume, gel thickness, length of PTV/gel contact, and gel left-to-right symmetry. RESULTS Hydrogel resulted in 7.5-mm prostate-rectal separation in 95.8% of patients; 95.7% had decreased rectal V70 of 25%, with a mean reduction of 8.0 Gy. There were no significant differences in preinjection and postinjection prostate, PTV, rectal, and bladder volumes. Plan conformities were significantly different before versus after injection (P=.02); plans with worse conformity indexes after injection compared with before injection (n=13) still had improvements in rectal V70. In multiple regression analysis, greater postinjection reduction in V70 was associated with decreased relative postinjection plan conformity (P=.01). Reductions in V70 did not significantly vary by institution, despite significant interinstitutional variations in plan conformity. There were no significant relationships between reduction in V70 and the other characteristics analyzed. CONCLUSIONS Injection of hydrogel into the prostate-rectal interface resulted in dose reductions to rectum for >90% of patients treated. Rectal sparing was statistically significant across a range of 10 to 75 Gy and was demonstrated within the presence of significant interinstitutional variability in plan conformity, target definitions, and injection results.