Non-comparative Prospective Study Research Articles

Clinical Outcomes of Patients with Colorectal Cancer Who Underwent Comprehensive Genomic Profiling: A Single-institution Non-comparative Prospective Observational Study.

Although some studies have evaluated the effectiveness of comprehensive genomic profiling (CGP) in solid tumors, the effectiveness of CGP in metastatic colorectal cancer (mCRC) has not been evaluated using detailed real-world long-outcome data. This was part of a single institutional non-comparative prospective observational study that observed all patients with solid tumors who underwent CGP at Saitama Medical Center, Saitama Medical University. We enrolled patients with mCRC between June 4, 2020, and March 31, 2023. The primary endpoint was the proportion of patients who received CGP-based therapy. There were 43 patients with mCRC. Of these, six patients (14.0%) received CGP-based therapy. The median overall survival from CGP testing in patients who received CGP-based therapy was 9.7 months. The progression free survival (PFS) ratio of CGP-based therapy and immediate previous therapy ranged from 0.04 to 2.0. The PFS ratio >1.5 was 14.3% (one out of seven treatments). One patient exhibited an exceptional response to pembrolizumab. Before CGP testing, the patient's cancer was classified as non-microsatellite instability-high, although the CGP test revealed a high tumor mutational burden. In Japan, patients with this subtype cannot undergo pembrolizumab without testing for CGP. This prospective observational study's findings provide an overview of CGP testing outcomes in patients with refractory mCRC.

Combination therapy with medical gases (nitric oxide and molecular hydrogen): safety assessment

Inhaled nitric oxide (NO) and molecular hydrogen (iH2) are actively studied nowadays. The therapeutic algorithms for their use in the various conditions are being developed, but the combined use of these medical gases (MG) has not been studied well enough.The aim of the study was to assess the safety of iNO and iH2 combination in healthy volunteers.Methods. 10 healthy volunteers (4 males and 6 females), mean age 24.0 ± 1.3 years, were included in the open non-comparative prospective study. All volunteers received a single combined inhalation of NO and H2 for 90 minutes. The NO concentration was 60 ppm and the H2 concentration did not exceed 4% in the gas mixture. Changes in the vital signs, arterial blood gases, and hemodynamic parameters were evaluated. The hemodynamic parameters were investigated before and after inhalation using echocardiography (Vivid E9 General Electric, USA). We also assessed the microcirculation of the bulbar conjunctiva (“OKO” capillaroscope), the main functional lung parameters, and the diffusion lung capacity (GANSHORN PowerCube Body apparatus). The clinical side effects were recorded. After inhalation, the serum concentration of methemoglobin was evaluated.Results. When comparing the results before and after MG inhalation, there was no negative impact on the vital signs, arterial blood gases (РaO2, РaСO2, SаO2), the functional lung volumes (FEV1, FVC, FEV1 / FVC), the diffusion test parameters, main EchoCG hemodynamic data (ejection fraction, tricuspid annular plane systolic excursion (TAPSE), mean pulmonary artery pressure, left and right ventricular sizes) (p > 0,05). After inhalation, the microcirculatory parameters (the volume velocity in arterioles and venules and the arteriolar diameter) increased significantly (p < 0.05). We did not observe the increase in serum methemoglobin concentration (0.59 ± 0.11%). No clinical side effects were reported during the study.Conclusions. Combined use of inhaled NO / H2 is clinically safe, does not have any negative impact on hemodynamic parameters, functional lung volumes, and arterial blood gases. The improvement of the microcirculation was noted after a single inhalation. This new method can be recommended for further studies of the therapeutic effect in various conditions.

Single Institution Preliminary Evaluation of a National Study for the Development of Daily Online Magnetic Resonance Image Guided Radiotherapy

A 4-stage non-comparative prospective feasibility study to assess and develop imaging protocols for MRIgRT was opened at the first two centers using MR Linac technology in the UK. The primary aims of this study were to determine a) the acceptability of MR images for target and organ at risk delineation and registration; b) inter/intra observer registration and delineation variation. This work reports on the initial results from a single center. In June 2019, following ethical and regulatory approvals the 2nd UK centre began study recruitment as follows: Stage A: non-patient volunteer imaging to determine sequence suitability for normal tissue in 6 anatomical sites (head & neck (H&N), chest wall/breast, lung/esophagus, abdomen, male and female pelvis). Volunteers were recruited in cohorts of 3 participants per region, and image quality was assessed by 3 independent observers using a visual guidance assessment tool (VGA). Stage B: the most suitable sequences defined in stage A used to assess the visibility of targets/normal tissues in patient volunteers using the same methods as in stage A. Stage C: patient volunteers were imaged using sequences selected from stage B to determine inter and intra observer segmentation and registration variation. Stage D recruitment of patient and non-patient volunteers for further image develop and refinement of MRIgRT workflows. All participants completed experience questionnaires to optimize workflows. Participants were asked to undergo 1-12 imaging sessions, lasting no more than 60. To date 151 participants (61 non-patients; 90 patients) have undergone 231 imaging sessions. From stage B, vendor provided, in-workflow sequences have been agreed from 47 completed VGAs by prioritizing high scores in either the tumor (e.g., lung) or organs at risk (e.g., cervix). T2w 3D sequences scored best in cervix, pancreas, prostate, bladder, liver, soft-tissue metastases and rectal cancers; T1w 3D sequences for H&N, and patient a specific approach for lung. No suitable sequences have been selected for partial breast. Research sequences (e.g., diffusion weighted or motion corrected imaging) have been agreed or are in development in stages C & D for H&N, cervix, bladder and prostate cancers. The mean interobserver (n = 8) vector variation in 5 H&N patients was largest (3.6mm) using T1-CT boney registrations and smallest (2.1mm) using T1-T1 soft-tissue registrations (mean observer match confidence 3.7/5). Analyses using MR to CT, MR to MR and CT to CT registrations in lung, pancreas, cervix, bladder, and prostate have also been completed. Interobserver delineation studies are on-going. Using a 4-stage non-comparative prospective feasibility study has facilitated clinical implementation MRIgRT of multiple treatment sites at our institution.

PP68 Dexcom G6® Device For Diabetes During Pregnancy

IntroductionDiabetes mellitus (DM) is one of the most frequent metabolic complications associated with pregnancy, affecting both the prognosis of the pregnant woman and the newborn. Pregestational DM type 1 (T1DM) and type 2 (T2DM) and gestational DM (GDM) are associated with an increased risk of pregnancy complications such as miscarriage, fetal malformations, macrosomia, preeclampsia, and neonatal hypoglycemia, among others. The aim of this review was to evaluate the efficacy and safety of using the Dexcom G6 device (Dexcom, Co., USA) to continuously self-monitor blood glucose levels during pregnancy. This report was requested by the Spanish Ministry of Health.MethodsWe systematically searched for articles published to July 2021 in the MEDLINE, Embase, and Web of Science databases. We included experimental and observational primary studies addressing the safety, efficacy, and cost effectiveness of the Dexcom G6 device for gestational and pregestational diabetes.ResultsTwo non-comparative prospective studies were identified. One study of 25 pregnant women with T1DM, which evaluated glycemic control and complications during pregnancy and postpartum, reported stable hemoglobin A1c levels during gestation in women using the Dexcom G6 device. The percentage of time spent in the therapeutic glucose range (63 to 140 mg/dL) was 59 percent; 38 percent was in the hyperglycemic range and 3 percent was in the hypoglycemic range. Although some patients reported mild erythematous and edematous reactions to the sensor, no moderate or severe reactions or infections occurred at the sensor insertion site. The other study in pregnant women with T1DM (n=20), T2DM (n=3), or GDM (n=9) showed adequate accuracy of the Dexcom G6 device, compared with the reference method, especially when the sensor is placed on the arm.ConclusionsRandomized controlled trials are required to assess the effectiveness and safety of the Dexcom G6 device in maintaining adequate glucose control during pregnancy in women with DM. Studies are also needed to compare the Dexcom G6 device with conventional capillary blood glucose self-monitoring or other monitoring methods. No cost-effectiveness studies have been conducted for the Dexcom G6 device in this patient population.

Normalization of the epidermal barrier as a method of pathogenetic therapy of Atopic Dermatitis in children

Background. A key link in the pathogenesis of atopic dermatitis is a violation of the barrier function of the skin. Artificial skin moisturizing with emollients is the basis of palliative therapy for the disease.
 Aims. The purpose of the study was to assess the effectiveness and tolerability of the cosmetic product Admera.
 Materials and methods. The article presents the results of an open non-comparative prospective observational study of the efficacy and safety of Admera cream in pediatric patients with mild to moderate atopic dermatitis, conducted at the Pierre Wolkenstein Clinic for Skin Diseases in June-August 2020.
 Results. The study included 35 patients aged 4 to 17 years. The study included 35 patients aged 4 to 17 years inclusive. The clinical study demonstrated a statistically significant decrease in the Severity scoring of atopic dermatitis (SCORAD) index total score. The average value of this indicator decreased by 33% from the value 36.2 12.3 at the screening visit to 24.2 11.4 at the visit 3 (p 0.001). Assessment of the dynamics of the Eczema area and severity index (EASI) index showed a significant decrease in the total score of the indicator after 14 and 28 days of therapy relative to the baseline (p 0.001). The cosmetic product studied was well tolerated by patients. During the present study, 3 adverse events were reported in 2 patients. According to expert opinion, the recorded undesirable phenomena were not associated with the application of the studied cosmetic product. Reported adverse events were gastrointestinal disorders and included cases of diarrhea, abdominal pain and at the end of the study completely
 Conclusions. Evaluation of the results of the study showed high efficacy and safety of the study drug as a moisturizing agent: four-week therapy leads to a decrease in the severity of Atopic dermatitis manifestations, a decrease in the intensity of pruritus, an increase in the level of skin hydration in the T-zone and on the patient's body.

1057 Outcome Reporting Following Rectopexy Requires Standardisation for Reproducibility and Transparent Outcome Analysis

Abstract Aim Rectopexy is a surgical procedure commonly used to correct rectal prolapse. Several studies have investigated different approaches (abdominal, perineal) and techniques (open, laparoscopic, robotic) in this field however reporting outcomes vary significantly among studies impeding comparison of techniques. We aimed to comprehensively analyse primary outcome reporting methods following rectopexy in published literature. Method A systematic search was performed in keeping with PRISMA guidelines and search protocol registered with PROSPERO. Published databases were searched using the following terms: “rectopexy”, “abdominal rectopexy” and “rectopexy outcomes”. Randomised controlled trials, comparative and non-comparative prospective and retrospective studies published between 1992 and 2019 were included for analysis. Review articles, letters, editorials, abstracts, and non-English language studies were excluded. A narrative description of outcomes was reported. Results A total of 1089 articles were screened, and 32 articles were identified as suitable for inclusion, reporting on 1780 patients who underwent rectopexy surgery. Over 30 unique methods of reporting outcomes were recorded, with the most common being the rate of recurrence (n = 15), Cleveland Clinic Faecal Incontinence score (CCIS) (n = 11), and customised symptom questionnaires (n = 10). Many studies recognised the impact of symptoms of rectal prolapse on patients’ quality of life (QoL) however, few utilised standardised quality of life scores to evaluate the outcome of the procedures. Conclusions As surgical technique evolves in rectopexy, incorporating minimally invasive surgery and robotic surgery, it is important that outcome reporting is standardised to facilitate transparent comparison. Improving patient QoL is the mainstay of surgical intervention and it is important that QoL outcome measures are incorporated.

Perte de hauteur radiale dans une fracture radiale distale extra-articulaire suite à la fixation par plaque antérieure verrouillée

BackgroundRadial height is an important prognostic factor in treating distal radius fracture. However, does further collapse of radial height in distal radius fractures after with volar locking plate fixation have a great impact on the prognosis? The present study aimed to elucidate radial height loss and determine the associated risk factors after open reduction and internal fixation with volar locking plate in patients with extra-articular distal radius fractures. HypothesisPatients with radial height collapse after fracture reduction and internal fixation with a volar locking plate may have poor outcomes. MethodsData of 87 patients (21 male) undergoing surgery for acute extra-articular distal radius fractures (AO: 23-A2 or 23-A3) between February 2014 and July 2016 were evaluated retrospectively. Patients were divided into two groups by radial height loss. Potential risk factors were tested by Pearson correlation coefficients. Stepwise multiple regression logistic analysis determined significant independent risk factors for extra-articular distal radius fractures. Clinical evaluation was performed by the same surgeon by determining wrist ROM. Grip strength was measured with a Jamar dynamometer and compared with non-affect wrist in percentage. In addition, all the patients were asked to grade modified Mayo wrist score and Visual Analogue Scale (VAS) score. These findings were recorded post-operative 1 year of follow up. ResultsMean radial height loss was 1.3±0.9mm. Age (ß=0.002, p=0.003), postoperative ulnar-positive deformity (ß=0.107, p<0.001), DEXA (ß=−0.015, p=0.008), and shortest diameter of distal fracture fragment in AP and lateral views (ß=−0.050, p=0.037; ß=−0.080, p=0.043) were significantly associated with radial height loss. As for the outcome of clinical prognosis, though radial height collapse group had poorer wrist range of motion, there was no statistical difference. Besides, there were no significant differences in grips strength and VAS score between these two groups. However, in regards of modified Mayo wrist score, the percentage of patients with poor outcomes is significant higher in radial height collapse group (p=0.039). Moreover, all patients with poor outcomes in radial height collapse groups were older than 65-year-old. DiscussionRadial height loss is noted in patients undergoing open reduction and internal fixation with volar locking plate for extra-articular distal radius fractures. Risk factors for radial height collapse include advanced age, poor bone quality, shortest distance between fracture site and articular surface and post-operative ulnar-positive deformity. Level of evidenceIV; non-comparative prospective study.

Telemedicine in Malignant and Nonmalignant Hematology: Systematic Review of Pediatric and Adult Studies.

BackgroundTelemedicine, including video-, web-, and telephone-based interventions, is used in adult and pediatric populations to deliver health care and communicate with patients. In the realm of hematology, telemedicine has recently been used to safely and efficiently monitor treatment side-effects, perform consultations, and broaden the reach of subspecialty care.ObjectiveWe aimed to synthesize and analyze information regarding the feasibility, acceptability, and potential benefits of telemedicine interventions in malignant and nonmalignant hematology, as well as assess the recognized limitations of these interventions.MethodsStudies were identified through a comprehensive Medical Subject Headings (MeSH) search on the PubMed MEDLINE, Controlled Register of Clinical Trials (Cochrane CENTRAL from Wiley), Embase, and CINAHL (EBSCO) databases on February 7, 2018. A second search, utilizing the same search strategy, was performed on October 1, 2020. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in the reporting of included evidence. Included studies were original articles researching the feasibility, acceptability, and clinical outcomes of telemedicine or telehealth interventions in pediatric or adult populations with malignant or nonmalignant hematological conditions. Data items in the extraction form included first author name, publication year, country, malignant or nonmalignant hematological condition or disease focus of the study, participant age, participant age subgroup (pediatric or adult), study design and setting, telemedicine intervention type and description, study purpose, and main study outcomes.ResultsA total of 32 articles met the preset criteria and were included in this study. Most (25/32) studies were conducted in adults, and the remaining (7/32) were conducted in the pediatric population. Of the 32 studies, 12 studied malignant hematological conditions, 18 studied nonmalignant conditions, and two studied both malignant and nonmalignant conditions. Study types included pilot study (11/32), retrospective study (9/32), randomized controlled trial (6/32), cross-sectional study (2/32), case study (1/32), pre-post study (1/32), noncomparative prospective study (1/32), and prospective cohort study (1/32). The three main types of telemedicine interventions utilized across all studies were video-based (9/32), telephone-based (9/32), and web-based interventions (14/32). Study results showed comparable outcomes between telemedicine and traditional patient encounter groups across both pediatric and adult populations for malignant and nonmalignant hematological conditions.ConclusionsEvidence from this review suggests that telemedicine use in nonmalignant and malignant hematology provides similar or improved health care compared to face-to-face encounters in both pediatric and adult populations. Telemedicine interventions utilized in the included studies were well received in both pediatric and adult settings. However, more research is needed to determine the efficacy of implementing more widespread use of telemedicine for hematological conditions.

Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study

Aim. Evaluation of efficacy and safety of alirocumab in patients with atherogenic dyslipidemia in real clinical practice. Materials and methods. Patients with atherogenic dyslipidemia and failure to achieve target lipid levels were included in a prospective, non-comparative study. For the final analysis, the data of 92 patients were studied: 61 men and 31 women; average age 59.8 ± 9.6 years. Alirokumab (Praluent, Sanofi) was administered at a dose of 150 mg subcutaneously once every 2 weeks for 3 months. The primary endpoint was the achievement of the target level of low-density lipoprotein cholesterol (LDL-C). Additionally, the level of lipoprotein(a) (LP(a)) and high-density lipoprotein cholesterol (HDL-C) was assessed. To assess safety, liver tests, creatinine levels and glycemia were examined; side effects have been studied. To test statistical hypotheses, a paired t-test and Wilcoxon’s test were used. Results. After 3 months therapy, there was a statistically significant decrease in LDL-C: 1.45 [0.99; 2.14] vs 3.00 mmol / l [2.17; 3.81] initially ( p &lt; 0.0001); the median of the decline was –47% [–25; –65]; the target level of LDL-C was achieved in 40 (43%) patients. An increase in HDL-C was noted after 3 months treatment, their level was 1.36 ± 0.41 mmol / L vs 1.31 ± 0.38 mmol / L at baseline ( p &lt; 0.01). The concentration of LP(a) was re-measured in 21 patients with a baseline level &gt; 30 mg / dL : a statistically significant decrease was achieved after 3 months: 67 mg / dL [46; 155] vs 85 mg / dL [58; 187] initially ( p &lt; 0.001). Indicators of liver function tests, creatinine and fasting glycemia did not change significantly. Side effects and undesirable effects were not recorded. Conclusion. In real clinical practice, after 3 months treatment with alirokumab there was a significant decrease in the level of LDL-C, target levels were achieved in 43% of patients, there was a significant decrease in the level of LP(a) and an increase in HDL-C.

Kinematic alignment of medial UKA is safe: a systematic review

Owing to the improved understanding of knee kinematics and the successful introduction of the kinematic alignment (KA) technique for implanting total knee arthroplasty (TKA), it was recently understood that the “Cartier angle technique” corresponds to a kinematic implantation of the uni-compartmental knee arthroplasty (UKA) components. When compared to the universally spread mechanical alignment (MA) technique for implanting UKA, the KA method generates a more anatomic prosthetic knee that may be clinically advantageous. The aims of this study are to determine if KA UKAs are associated with acceptable functional performance and patient satisfaction (question 1), rates of residual pain and tibia plateau fracture (question 2), and rates of reoperation and revision (question 3), and to define the component orientation and limb alignment as measured on radiograph (question 4), and the stress shielding related bone loss in the proximal tibia (question 5) with KA UKA, and where possible to compare with MA UKA. KA UKA generates good clinical outcomes, similar or superior to the ones of MA UKA. Systematic review of literature databases were primarily searched using Healthcare Databases Advanced Search (HDAS). Two primary searches were conducted using the electronic databases MEDLINE, EMBASE, and PubMed, and a secondary search was conducted using review articles and bibliography of obtained papers in order to ascertain more material. Nine eligible non-comparative prospective (3) or retrospective (6) cohort studies, which cumulated 593 KA UKAs with follow-up between 3.2 and 12 years, fulfilled the inclusion criteria for this systematic review. The findings demonstrated high Knee Society Score (KSS) (from 87 to 95) and function scores (from 81 to above 91) in addition to patient satisfaction scores of 88%. There was no revision for tibia plateau fracture, 0.8% (5 cases) for unexplained pain tibia, 2.0% (12 cases) for component loosening, and 5.6% (33 cases) for any causes of aseptic failures reported for KA UKA. The prosthetic lower limb and tibia implant alignments were both found to be in slight varus (means between 3 and 5°), and the postoperative joint line and tibia component was shown to be parallel to the floor when standing. The KA UKA components migration, as measured on radiostereometry, was acceptable. The KA technique is an alternative, personalised, more physiological method for implanting UKA, which could be clinically advantageous when compared to the MA technique. The literature supports the good mid- to long-term clinical safety and good efficacy of KA UKA; however, comparison between KA and MA techniques for UKA was not performed due to limited literature. Further investigations are needed to better define the clinical impact of KA UKA, and the acceptable limits for KA of the UKA tibial component. Level 4; systematic review of level 4 studies.

Loss of radial height in extra-articular distal radial fracture following volar locking plate fixation

BackgroundRadial height is an important prognostic factor in treating distal radius fracture. However, does further collapse of radial height in distal radius fractures after with volar locking plate fixation have a great impact on the prognosis? The present study aimed to elucidate radial height loss and determine the associated risk factors after open reduction and internal fixation with volar locking plate in patients with extra-articular distal radius fractures. HypothesisPatients with radial height collapse after fracture reduction and internal fixation with a volar locking plate may have poor outcomes. MethodsData of 87 patients (21 male) undergoing surgery for acute extra-articular distal radius fractures (AO: 23-A2 or 23-A3) between February 2014 and July 2016 were evaluated retrospectively. Patients were divided into two groups by radial height loss. Potential risk factors were tested by Pearson correlation coefficients. Stepwise multiple regression logistic analysis determined significant independent risk factors for extra-articular distal radius fractures. Clinical evaluation was performed by the same surgeon by determining wrist ROM. Grip strength was measured with a Jamar dynamometer and compared with non-affect wrist in percentage. In addition, all the patients were asked to grade modified Mayo wrist score and Visual Analogue Scale (VAS) score. These findings were recorded postoperative 1 year of follow-up. ResultsMean radial height loss was 1.3±0.9mm. Age (ß=0.002, p=0.003), postoperative ulnar-positive deformity (ß=0.107, p<0.001), DEXA (ß=−0.015, p=0.008), and shortest diameter of distal fracture fragment in AP and lateral views (ß=−0.050, p=0.037; ß=−0.080, p=0.043) were significantly associated with radial height loss. As for the outcome of clinical prognosis, though radial height collapse group had poorer wrist range of motion, there was no statistical difference. Besides, there were no significant differences in grips strength and VAS score between these two groups. However, in regards of modified Mayo wrist score, the percentage of patients with poor outcomes is significant higher in radial height collapse group (p=0.039). Moreover, all patients with poor outcomes in radial height collapse groups were older than 65-year-old. DiscussionRadial height loss is noted in patients undergoing open reduction and internal fixation with volar locking plate for extra-articular distal radius fractures. Risk factors for radial height collapse include advanced age, poor bone quality, shortest distance between fracture site and articular surface and postoperative ulnar-positive deformity. Level of evidenceIV; non-comparative prospective study.

Title: efficacy of intravitreal dexamethasone implant on hard exudate in diabetic macular edema

BackgroundTo investigate the effect of intravitreal dexamethasone implant (DEX implant) on hard exudate (HE) accompanying diabetic macular edema (DME).MethodsThis study was a non-comparative non-randomized 1-year prospective interventional study. Patients with DME and HE were treated using DEX implant two or three times. Color fundus photography and optical coherence tomography (OCT) were performed at every visit. HE area was measured semi-automatically from the fundus photographs.ResultsThirty-five patients completed the study. Eleven patients (31.4%) received two injections, while the remaining received three times. HE area (primary outcome) significantly decreased from 1.404±2.094 mm2 (baseline) to 0.212±0.592 mm2 (last visit), which was 24% of the baseline HE area (P<0.001). HE1500 (HE within 1500 μm from the fovea) area also decreased significantly from 0.382±0.467 mm2 to 0.066±0.126 mm2 (P<0.001). Furthermore, anaverage best corrected visual acuity (BCVA) improvement of 4.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters was observed (from 49.9±18.3 to 54.3±20.4 letters) (P= 0.008). Central macular thickness (CMT) decreased from 455.8±23.6 μm to 366.8±31.1 μm (P=0.009). Repetitive measurements for entire study duration was analyzed using generalized estimating equations (GEE), where BCVA was related to age, CMT, and HE1500 area in multivariate analyses.ConclusionDEX implant could reduce and suppress HE in DME for one year with two or three injections. And centrally located HE area (HE1500 area) is related to vision.Trial registrationClinicalTrials.gov, NCT02399657, Registered 26 March 2015.

Developments in surgical fluid therapy rates in veterinary medicine

PICO question&#x0D; Is there sufficient evidence to show surgical fluid therapy delivered at the recommended 3 mL/kg/hour for cats and 5 mL/kg/hour for dogs leads to a better outcome compared with widely accepted rates of 10 mL/kg/hour for both cats and dogs?&#x0D; &#x0D; Clinical bottom line&#x0D; Category of research question&#x0D; Treatment&#x0D; The number and type of study designs reviewed&#x0D; Five studies were appraised. Two of these were opinion pieces, with one non-comparative prospective study, one randomised controlled trial, and one case control study.&#x0D; Strength of evidence&#x0D; Weak&#x0D; Outcomes reported&#x0D; Currently there is limited evidence to show that the surgical fluid therapy recommendations made by the 2013 Journal of the American Animal Hospital Association guidelines (Davis et al., 2013) for cats and dogs lead to a better outcome than accepted fluid therapy rates used. Fluid overload in humans can cause long-term adverse effects, however the same effects have yet to be shown specifically in veterinary patients&#x0D; Conclusion&#x0D; No evidence was found that provides strong, conclusive evidence that the 2013 recommendations by the American Animal Hospital Association and American Association of Feline Practitioners leads to a better outcome for both cats and dogs. The resulting research outlined below identifies a need to conduct clinical studies on the effects of fluid therapy on cats and dogs, and identify clear monitoring protocols to minimise and ideally avoid, fluid overload. When adequate, valid clinical studies have been carried out, this will provide sufficient information for the development of evidence-based recommended rates of fluid therapy for veterinary medicine, in a range of contexts&#x0D; &#x0D; How to apply this evidence in practice&#x0D; The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources.&#x0D; Knowledge Summaries are a resource to help reinforce or inform decision-making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.&#x0D; &#x0D;

Современные подходы к диагностике острого цистита и оценке качества его лечения

Lower urinary tract infections are common infectious diseases. Although there are international valid questionnaires for evaluating a number of urological diseases (prostatitis, BPH, erectile dysfunction), a unified questionnaire for cystitis was absent until recently. Our aim was to evaluate the efficiency and ease of use of the Acute Cystitis Symptom Score (ACSS) in the daily urological practice. A total of 47 women aged 24 to 46 years with typical complaints for acute cystitis were included into multicenter open, non-comparative prospective population-based study. All of them completed the ACSS questionnaire during the first consultation and after 7-10 days at the follow-up visit. The diagnosis of acute cystitis was valid with a total score of 6 or more points. Clinical and laboratory studies were used to diagnose the cystitis. Self-completion of the questionnaire by the patient and its analysis by the physician took about four minutes. The average baseline score for the "typical" domain was 9.8+/-1.3, while a score for the differential diagnostic domain was 1.2+/-0.4. The mean baseline quality of life was 6.4+/-0.8 points. The total score averaged 17.4+/-1.9. All 47 patients had leukocyturia, and 12 (25.5%) had hematuria. A microbiological study was done in 36 (76.7%) patients and revealed an increased concentration of uropathogens in all cases. Thus, acute cystitis diagnosed on the ACSS scale was confirmed, and 41 (87.2%) patients had acute uncomplicated cystitis, and in 6 cases (12.8%) various complications developed. The specificity of the ACSS questionnaire was 100%. The questionnaire can be considered as a necessary tool for studies on LUTS in order to standardize obtained data and ensure their comparability.

Can primary total hip arthroplasty be performed in an outpatient setting? Prospective feasibility and safety study in 321 patients in a day-surgery unit

IntroductionTotal hip arthroplasty (THA) performed as day-surgery is an emerging and growing practice. The main aim of the present study was to assess the feasibility and safety of primary THA in an outpatient setting. The study hypothesis was that, within a specifically dedicated structure, such surgery is feasible and safe. Material and methodsA prospective observational study was performed in two centers, one private hospital and one university hospital, including all patients operated on by two senior surgeons between 2014 and 2017 for primary THA and eligible for day-surgery. The clinical pathway was governed by a pre-established protocol. Preoperatively, all patients took part in an information workshop, with their spouses and the surgeon. Postoperative phone interviews were held on D1 and D3, then out-patient consultations were conducted at 1 and 6 weeks. The main study endpoint was successful outpatient management, failure being defined as crossover or readmission within 1 week of discharge. Secondary endpoints comprised complications rate and satisfaction as assessed by patient and spouse at 6 weeks. ResultsDuring the study period, 1,303 patients received primary THA. 338 (25.9%) were eligible for day-surgery, but 17 (5%) declined; the day-surgery series thus comprised 321 patients (24.6%): 166 men, 155 women; mean age, 61.2±9.7 years. Same-day discharge was not possible for 14 patients (4.5%): 9 due to persistent faintness, 2 to intraoperative femoral fracture, 1 to organizational issues, 1 to an uncomplicated fall, and 1 to hemoglobinemia<11g/100ml in a coronary patient. There were no readmissions during week 1. At 6 weeks’ follow-up, there had been 3 adverse events: 2 dislocations, and 1 periprosthetic fracture. 312 patients (97.2%) were satisfied. ConclusionThe present prospective study found no major adverse events in patients undergoing day-surgery for primary THA. However, patients should be selected, consenting, prepared and managed on a standardized clinical pathway. Level of evidenceIV; non-comparative prospective study.

Possibilities of using the Colibri system for endovenous laser ablation

The purpose of the study was to assess efficacy of endovenous laser ablation of major saphenous veins by means of the Mediola single-ring radial light guides with the use of the 'Optical Handpiece MHP02 (Colibri)'. This non-comparative prospective study included 430 consecutive patients who underwent a total of 511 endovenous laser ablation procedures from January 2018 to March 2019. The great saphenous vein was subjected to obliteration in 343 (67.1%) cases, the anterior accessory saphenous vein - in 94 (18.4%) cases, and the small saphenous vein - in 74 (14.5%) cases. There were 170 (39.5%) men and 260 (60.5%) women, with a mean age of 52±12.8 years. The next day after the intervention the patients revisited the clinic for control examination, with the obtained findings demonstrating that occlusion of the target vein had been achieved in all 511 (100%) cases. At 2 months, we examined 411 (95.6%) people with a total of 484 (94.7%) treated veins. After 6 months, 399 (92.8%) people with 472 (92.4%) veins were examined. Recanalization with pathological reflux during the entire follow-up period was registered in 6 (1.3%) cases. Hence, the long-term rate of obliteration amounted to 98.7%. 1) endovenous laser ablation of major saphenous veins by means of the Mediola laser unit with wavelength of 1470 nm and single-ring radial light guides with the use of the 'Optical Handpiece MHP02 (Colibri)' made it possible to achieve obliteration of the target vein in 98.7% of cases at 6 months of follow up; 2) within the mentioned terms, the need for repeat intervention could appear in 1.1% of cases; 3) the Colibri system provides a possibility of decreasing the final cost of radial light guides for endovenous laser ablation by 30-50%.

Long-term follow-up of biomarkers of vascular calcification after switch from traditional hemodialysis to online hemodiafiltration

Rapid progression of vascular calcification (VC) in hemodialysis (HD) patients is caused by several factors including inflammation and an imbalance between active inducers and inhibitors of VC. Growing evidence shows that online hemodiafiltration (ol-HDF), a combination of diffusive and convective solute transport, has positive effects on the uremic environment that affects patients on dialysis. However, we recently reported that serum 25-hydroxyvitamin D (25(OH)D) decreased after a switch from HD to ol-HDF. As a consequence of this finding, the present study was undertaken to investigate if inducers and inhibitors of VC (i.e. the inactive matrix Gla protein fractions dp-ucMGP and t-ucMGP, fetuin-A, Gla-rich protein (GRP), osteopontin (OPN), bone-specific alkaline phosphatase (BALP), and osteoprotegerin (OPG)) also are affected by ol-HDF. This non-comparative prospective study comprised 35 prevalent patients who were investigated 6, 12, and 24 months after their switch from HD to ol-HDF. Most patients had increased levels of the calcification inhibitors OPN and OPG; and of the inactive calcification inhibitor dp-ucMGP during the study period irrespective of the dialysis modality. BALP and t-ucMGP were mostly within the reference interval, but fetuin-A was mostly below the reference interval during the study period. OPN was significantly associated with BALP and parathyroid hormone, r = 0.62 and r = 0.65 (p < .001), respectively. In conclusion, in contrast to decreased 25(OH)D levels, no differences were found for any of the measured biomarkers of VC following the switch from HD to ol-HDF. Further studies are needed to elucidate how these biomarkers can contribute to calcification risk assessment.

Internal hernia after laparoscopic colorectal surgery: an under-reported potentially severe complication. A systematic review and meta-analysis.

Internal hernia following laparoscopic colorectal surgery is often under-reported. The aim of this review was to evaluate the occurrence rate of internal hernia following laparoscopic colorectal surgery, and to describe clinical presentation and management strategies. A comprehensive literature review was conducted including MEDLINE/Pubmed, EMBASE, SCOPUS, clinicaltrials.gov, and the Cochrane Database of Systematic Reviews through April 2018. The review was conducted according to MOOSE guidelines. Quality was appraised with the Methodological Index for Non-Randomized Studies (MINORS) tool. Meta-analysis was performed using a random effects model. Studies reporting data on internal hernia after laparoscopic colorectal surgery were included. Ten observational studies with a total of 8453 patients were included. All included articles were non-comparative prospective or retrospective cohort studies with an average MINORS score of 8.3 (range 6-11). Summary estimate of proportion of patients developing internal hernia after laparoscopic colorectal resection was 0.5% (95% CI 0.3-0.8%). Heterogeneity was moderate (I2 46%, p = 0.03) and study size (> 1000 vs. <1000 patients) was found to have a significant contribution to heterogeneity (p = 0.002). Thirty patients (90.9%) required surgery, with 5 non-fatal and 3 fatal postoperative complications. Quality of some studies was limited; some patients were followed up for less than 1year; primary surgical procedures included different laparoscopic approaches. Occurrence rate of internal hernia after laparoscopic colorectal resection is around 5 per 1000 patients. Small-sized studies are likely to overestimate the occurrence of internal hernia. Need for reoperation is high with a substantial risk of mortality.

Acute uncomplicated cystitis: is antibiotic unavoidable?

Acute uncomplicated cystitis in women is one of the most frequently diagnosed bacterial infections. In a pilot, open, noncomparative prospective study, 29 nonpregnant, sexually active women with acute uncomplicated cystitis were enrolled. The mean age was 28.9 ± 4.3, range 22-36 years. All patients received unique therapy: the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen, 100 mg once a day for 5 days, and Canephron, 2 dragees three times a day for 1 month. In 2 days, four patients (13.8%) had no tendency to improvement; they were considered as nonresponders and antibiotics were prescribed for them. The remaining 25 patients (86.2%) showed significant improvement and were considered as responders; they continued the therapy with ketoprofen and Canephron. In 7 days, 21 patients (72.4%) had no dysuria and leucocyturia; they were considered as fast responders to phytotherapy. In four patients (13.8%), after 7 days of therapy insignificant dysuria and leucocyturia were found; they were considered as slow responders to phytotherapy. All 25 patients continued the intake of Canephron for 1 month to prevent a relapse. When treatment finished, all patients were well. In 6 months, no relapses were diagnosed. The majority (86.2%) of young, nonpregnant women with acute uncomplicated cystitis were cured by 30 days of phytotherapy combined initially (5 days) with the NSAID ketoprofen; an antibiotic was indicated in only 13.8% of patients. Patients with acute uncomplicated cystitis may be divided into three subgroup: nonresponders to phytotherapy; slow responders to phytotherapy; fast responders to phytotherapy. Antibiotic therapy is indicated in nonresponders, but slow and fast responders may be treated without an antibiotic, by phytotherapy with an initial short course of an NSAID only.

A Non-Comparative Prospective Pilot Study of Ketamine for Sedation in Adult Septic Shock.

Sedation and analgesia in the intensive care unit (ICU) for patients with sepsis can be challenging. Opioids and benzodiazepines can lower blood pressure and decrease respiratory drive. Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist that provides both amnesia and analgesia without depressing respiratory drive or blood pressure. The purpose of this pilot study was to assess the effect of ketamine on the vasopressor requirement in adult patients with septic shock requiring mechanical ventilation. We conducted a two-phase study in a multi-disciplinary adult ICU at a tertiary medical center. The first phase was a retrospective chart review of patients admitted with septic shock between July 2010 and July 2011; 29 patients were identified for a historical control group. The second phase was a prospective, non-randomized, open-label pilot study. Patients were eligible for inclusion if they were 18-89 yr of age with a diagnosis of septic shock, who also required mechanical ventilation for at least 24 h, concomitant sedation, and vasopressor therapy. Pregnant patients, patients in the peri-operative timeframe, and patients with acute coronary syndrome were excluded. Patients enrolled in the phase two pilot study received ketamine as the primary sedative. Ketamine was administered as a 1-2 mg/kg IV bolus, then as a continuous infusion starting at 5 mcg/kg/min, titrated 2 mcg/kg/min every 30 min as needed to obtain a Richmond Agitation Sedation Scale (RASS) goal of -1 to -2. If continuous sedation was still required after 48 h, patients were transitioned off ketamine and sedative strategy reverted to usual ICU sedation protocol. The primary outcome was the dose of vasopressor required at 24, 48, 72 and 96 h after enrollment. Secondary outcomes included cumulative ketamine dose, additional sedative and analgesics used, cumulative sedative and analgesic dosing at all time periods, corticosteroid use, days of mechanical ventilation, ICU LOS, hospital LOS, and mortality. Contiguous data were analyzed with unpaired t-tests and categorical data were analyzed with two-tailed, Fisher's exact test. This study was approved by our Institutional Review Board. From January 2012 to April 2015, a total of 17 patients were enrolled. Patient characteristics were similar in the control and study group. Ketamine was discontinued in one patient due to agitation at 36 h. There was a trend towards decreased norepinephrine and vasopressin use in the study group at all time periods. Regarding secondary outcomes, the study group received less additional analgesia with fentanyl at 24 and 48 h (p < 0.001), and less additional sedation with lorazepam, midazolam or dexmedetomidine at 24 h (p = 0.015). This pilot study demonstrated a trend towards decreased vasopressor dose, and decreased benzodiazepine and opiate use when ketamine is used as the sole sedative. The limitations to our study include a small sample size and those inherent in using a retrospective control group. Our findings should be further explored in a large, randomized prospective study.