Prospective Nonrandomized Study Research Articles

Assessment of Safety, Efficacy and Predictability of a Trifocal Intraocular Lens. Performance of PanOptix Trifocal Versus Monofocal IOL

Purpose. To evaluate the performance and the visual outcomes of Acrysof PanOptix trifocal IOL in terms of safety, efficacy, predictability and assessment of the quality of vision after implantation as regards; contrast sensitivity and ocular aberrations. Methods. A prospective interventional non randomized study that included forty eyes of twenty one patients with senile cataract. All surgeries were carried out between September 2019 and January 2020. Patients underwent phacoemulsification for cataract removal with IOL implantation. They were divided into two groups; group(A) included twenty eyes of eleven patients who were implanted with AcrySof IQ PanOptix trifocal IOL Model TFNT00. While group (B) included twenty eyes of ten patients who were implanted with monofocal AcrySof IOLs as a control group. Results. There were 21 subjects enrolled in our study. Mean age was 56.6 ± 6.9 years in group (A) and 62.8 ± 7.1 years in group (B),(range 50–70).We found statistical significant difference between both groups with group A showing better post operative uncorrected distance, intermediate, near, and best corrected near visual acuity . Group (B) showed statistically significant better post operative contrast sensitivity compared to group (A). Conclusion: In this study, Acrysof PanOptix trifocal IOL showed excellent safety, efficacy, predictability and spectacle independence at all distances, This prospective interventional non-randomized study showed excellent safety, efficacy and predictability of the PanOptix IOL with higher spectacle independence, slightly impaired contrast sensitivity without affecting daily activities. However, contrast sensitivity was compromised in comparison to the monofocal group and high order aberrations (coma, trefoil) were noted to be higher affecting the quality of vision but not the daily activities of the patient.

Use of Smartphone-Based Video Directly Observed Therapy to Increase Tuberculosis Medication Adherence: An Interventional Study.

Tuberculosis (TB) treatment through Directly Observed Therapy (DOT) has an alternative form of video surveillance therapy (VOT) that utilizes the technological capabilities of smartphones to provide patients with low-cost access to doctors without impacting their work and personal life. We aimed to assess TB patients' drug compliance, perceptions, and feasibility towards smartphone-based video direct observed therapy (VDOT) in Jeddah, KSA. We conducted a prospective non-randomized interventional study. We delivered smartphone-based VDOT among previously unstudied patients to monitor adherence to the treatment regimen. The expected total number of VDOT sessions was1200. We conducted post-intervention interviews to assess acceptability and satisfaction. In this study, we included 20 participants, 16 of whom were males, with a mean age of 34.3 (±12.5) years. No side effects to the treatments were identified in all participants. The adherence rate for the total period was 93% and 99.5%, measured by the first and second methods, respectively. Most participants were satisfied with the VDOT experience, the time spent on sessions, and the approach's privacy. This study provides promising results for the feasibility and effectiveness of smartphone-based VDOT for TB treatment to increase adherence which was indicated by a high compliance rate, acceptability, and high satisfaction level.

Interleukin 33, soluble suppression of tumorigenicity 2, interleukin 27, and galectin 3 as predictors for outcome in patients admitted to intensive care units.

Intensive care units (ICUs) are expert hospital areas that provide treatment and 24 h care for people who are very sick. Sepsis represents a serious, severe condition and it can lead to septic shock and multiple organ dysfunction syndromes and is one of the most common reasons for patients' hospitalization in ICUs. We wanted to explore the prognostic values of interleukin (IL) 33, soluble suppression of tumorigenicity 2 (sST2), IL 27, and galectin 3 in critically-ill patients. We assumed that these parameters in combination or alone could predict mortality in ICU patients. This research represents a clinical non-randomized prospective study, performed at the Medical Military Academy, a tertiary care hospital in Belgrade, Serbia. The patients were divided in four groups: patients with sepsis (peritonitis, pancreatitis, trauma) and patients without sepsis (trauma). Total number of patients enrolled in the study was 151 and average years of patients were 56.48. The values greater than the cut-off were the predictors of mortality. The IL-33, IL-27 as well as galectin-3 can successfully predict the outcome of critically-ill patients in ICUs. The sST2, cannot predict death in critically-ill patients as a single prognostic factor. However, the combination of at least two biomarkers: IL-33, sST2, IL-27, and galectin-3, gives very significant results in predicting the outcome in patients admitted to ICUs.

Subfoveal and Parafoveal Choroidal Thickening in Patients with Keratoconus Using the ETDRS Grid on Swept-Source OCT.

There is growing evidence that confirms morphological changes in the posterior structures in patients with keratoconus (KC); however, isolated alterations could have been missed. This study assesses choroidal thickness (CT) in the fovea and beyond in KC eyes. This prospective case-control and non-randomized study enrolled 107 eyes, 62 eyes of 62 patients with KC, and 45 age-matched eyes of 45 control subjects with axial length in the range of 22-26mm. Swept-source optical coherence tomography (SS-OCT) was performed to manually measure the subfoveal choroidal thickness (SCT) using a single-line scan. CT was obtained automatically from the Early Treatment Diabetic Retinopathy Study (ETDRS) grid using the 12-lines radial scan pattern. A two-way repeated-measures analysis of variance (ANOVA) was conducted to evaluate CT variations among macular eccentricity, parafoveal area, and the interaction between both factors. CT was compared in all parafoveal areas between groups and subgroups of KC. SCT was significantly thicker in KC eyes (357 ± 57µm) than in healthy eyes (325 ± 63µm) (p < 0.001). Significant choroidal thickening was observed in the central ring and outer and inner rings of the temporal, superior, and inferior parafoveal macular areas (p < 0.001), except in the outer ring of the nasal macular zone (p > 0.05) of KC compared to healthy eyes. The CT significantly decreased from the center to the outer ring regardless of the presence of KC (p < 0.001). The choroid in the nasal macular zone was significantly thinner than that in the temporal, superior, and inferior parafoveal areas (p < 0.001). The choroidal structure increased its thickness not only in the subfoveal area, but also in eight parafoveal areas of the ETDRS grid encompassing a wider area of macular examination. These findings demonstrate and corroborate that keratoconus is not a purely corneal disease. Furthermore, it confirms the role that the choroidal structure has in the pathophysiology of keratoconus.

Effectiveness of a coordinated ambulatory care program for patients with mental disorders or multiple sclerosis: results of a prospective non-randomized controlled trial in South Germany.

The Psychiatry, Neurology, Psychosomatics and Psychotherapy (PNP) program of the German statutory health insurance AOK BW promotes coordinated and evidence-based specialist care with the aim of providing individualized, guideline-based outpatient care, strengthening the collaboration between health care providers, as well as reducing care costs. The purpose of this study was to evaluate its effectiveness regarding patient-reported outcomes compared to the less specialized general practitioner program (GP) and usual care (UC). AOK insured patients, who were on sick leave due to a mental disorder (affective disorder, anxiety disorder, adjustment disorder, somatoform disorder, alcohol abuse disorder, schizophrenia) or multiple sclerosis were included in the prospective non-randomized controlled study. All patients either participated in the PNP program (intervention group, IG-PNP), the general practitioner program (control group, CG-GP) or usual care (control group, CG-UC). Entropy balancing was used to adjust for baseline imbalance between groups. Primary outcome was health-related quality of life, assessed by the Short-form health survey (SF-36) 12 months after diagnosis. Secondary outcomes included symptom severity, functional health, and treatment satisfaction. Of the 14,483 insured patients who were contacted, 1,104 patients participated at baseline and 725 at follow-up. The adjusted mean differences of SF-36 sum score did not significantly differ between groups: -1.89 (95%-CI = -4.60; 0.81, p = 0.170) between IG-PNP and CG-GP, and -1.42 (95%-CI = -4.05; 1.22, p = 0.293) between PNP and CG-UC. The adjusted mean differences of secondary outcomes did not differ between groups, except for a slightly higher increase of functional health in CG-UC. We found no evidence that the PNP program is superior to the GP program or to usual care in terms of patient-reported outcomes or treatment satisfaction. The results are limited by the low response rate. Accordingly, future studies should strive for more representative samples. To improve the program, an integration of further collaborative care elements and guideline recommendations might be useful. DRKS (German Clinical Trials Register https://drks.de/search/en); identifier (DRKS00013114).

Significance of interleukins and chemokines in development of vincristine polyneuropathy in children with acute lymphoblastic leukemia

Objective. To analyze the content of interleukins, chemokines in plasma and liquor of children with acute lymphoblastic leukemia depending on the development of vincristine polyneuropathy.&#x0D; Materials and methods. A single-center prospective cohort non-randomized study was conducted involving 131 children aged 3 to 17 years with acute lymphoblastic leukemia who received chemotherapy according to the protocol. The content of interleukins and chemokines in blood plasma and liquor was assessed with the subsequent comparative analysis of the indicators in two groups depending on the development of vincristine polyneuropathy. The level of the studied parameters was determined before the administration of chemotherapy and on the 36th day of treatment using multiparametric immunofluorescence analysis.&#x0D; Results. In the studied cohort of patients vincristine polyneuropathy was registered in 80.9 % (n = 106) of patients. In the majority of cases – 84.9 % (n = 90) neurotoxic complication developed during the induction stage of chemotherapy. In the clinical picture there dominated sensory and motor disorders in 70.7 % (n = 75) of patients. The data of electrophysiologic study testified to motor axonal polyneuropathy with peroneal nerves lesion. When comparing the primary level of interleukins with their concentration after completion of the induction stage of chemotherapy, it was found that in children without vincristine polyneuropathy there was a statistically significant increase in almost all proinflammatory and anti-inflammatory interleukins. Besides, in this group high and medium direct statistically significant correlations between these cytokines were established. Especially close correlations were noted between pro-inflammatory IL-1, IL-17 and anti-inflammatory interleukins (IL-10, IL-13, IL-22 and IL-27). Additionally, in patients with vincristine polyneuropathy, a 3.7-fold increase in CXCL10 (IP-10) and a 1.4-fold increase in CXCL12 (SDF-1α) chemokines (p = 0.005 and p = 0.054, respectively) was detected in the liquor during the completion of the induction phase of chemotherapy.&#x0D; Conclusions. The balanced interleukin response in children with acute lymphoblastic leukemia receiving vincristine probably reflects a link between the immune and nervous systems aimed at preventing peripheral nerve damage. An imbalance of proinflammatory and anti-inflammatory interleukins may contribute to the development of vincristine polyneuropathy. Significant increase in the content of chemokines CXCL10 (IP-10) and CXCL12 (SDF-1α) in the liquor of children with vincristine polyneuropathy gives grounds to consider them as biological markers of vincristine neurotoxicity.

Standardization of Anti-Xa Assay and its Comparison with Activated Partial Thromboplastin Time for Monitoring Unfractionated Heparin Therapy.

Monitoring of anticoagulant activity of unfractionated heparin (UFH) is primarily done with activated partial thromboplastin time (aPTT), which is affected by many factors. Anti-Xa assays are considered to overcome these factors and may provide a better method for monitoring patients on UFH with a narrow therapeutic range. This study aimed to compare the effectiveness of aPTT and anti-Xa assays in UFH monitoring. A prospective non-randomized study was carried out in two stages: first, the anti-Xa assay was standardized using kit instructions; each sample was then analyzed by both tests. The outcomes of the two assays were compared and assessed for agreement of maintaining therapeutic anticoagulant levels. These levels for anti-Xa assay were between 0.3 and 0.7IU/ml, while it was 1.5-2.5 times the control for aPTT assay. Below this range was regarded as subtherapeutic, and above this as supratherapeutic. A total of 90 samples were tested and analyzed using both assays. Most of them (> 70%) were noted to be in subtherapeutic levels with both tests. The overall concordance was 73.3%, and the estimated kappa value was 0.483 (0.396-0.57). The correlation between aPTT and anti-Xa assay was 0.74 (p < 0.001). With anti-Xa levels in the therapeutic range, aPTT levels were in subtherapeutic in 60% and supratherapeutic in 13.3% cases. Although both the testing strategies had a good agreement and correlation, discordance was observed in interpretative values with anti-Xa levels in therapeutic range and aPTT levels in non-therapeutic range. Its clinical implications need to be evaluated further in future studies.

Impact of SARS-CoV-2 Omicron variant infection on the outcomes of patients with spontaneous intracerebral hemorrhage: A prospective cohort study

ObjectiveThis study aims to investigate the impact of the infection with the novel coronavirus Omicron variant on the outcomes of patients with severe spontaneous intracerebral hemorrhage. MethodsWe conducted a multicenter prospective non-randomized cohort study during the peak of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) Omicron strain epidemic. Clinical data were collected from nine centers in China between December 1, 2022, and February 28, 2023. Patients were categorized into good and poor outcomes groups based on modified Rankin Scale scores at discharge. Clinical characteristics were compared, and univariate and multivariate logistic regression analyses were performed. Additionally, coagulation function was compared between SARS-CoV-2 Omicron positive and negative patients. ResultsAmong 86 included patients, 30 (35 %) had a favorable outcome, while 56 (65 %) had an unfavorable outcome. Of these, 32 (37 %) tested positive for SARS-CoV-2 Omicron, while 54 (63 %) tested negative. Multivariate analysis identified Glasgow Coma Scale score and hypertension as independent risk factors affecting outcomes (P < 0.05). Surprisingly, SARS-CoV-2 Omicron infection emerged as a protective factor for patient outcomes (P < 0.05). Additionally, SARS-CoV-2 Omicron-positive patients exhibited significantly elevated fibrinogen levels upon admission (P < 0.05). ConclusionIn comparison to patients without SARS-CoV-2 Omicron infection, patients with severe spontaneous intracerebral hemorrhage who were co-infected with SARS-CoV-2 Omicron exhibited a more favorable short-term outcome.

The impact of New Families home visiting program on first-time mothers’ quality of life and its association with social support: a non-randomized controlled study

BackgroundThe transition to motherhood is characterized by physical, psychological, social, and relational changes. Quality of life (QoL) changes substantially during this transition. Higher QoL is associated with social support, essential for coping with the challenges and changes of becoming a mother. An early universal home visiting program (New Families) is developed to strengthen and support families. The study aims to evaluate the impact of New Families on first-time mothers’ QoL and to investigate the association between their QoL, social support, and selected possible predictive factors.MethodsA prospective non-randomized controlled study with parallel group design. Child Health Services in five city districts of Oslo were matched in intervention and control groups. First-time mothers were allocated based on the residential area and assessed at pregnancy week 28 (N = 228), six weeks postpartum (N = 184), and three months postpartum (N = 167). Measures of the World Health Organization Quality of Life brief, Perinatal Infant Care Social Support Scale, and background variables were collected from October 2018 to June 2020. Multivariate linear regression models were applied to examine intervention impact and assess associations.ResultsOur data did not reveal a significant association between New Families intervention and the QoL levels of first-time mothers at three months postpartum. Thus, we analyzed the whole sample together. Emotional support was significantly associated with higher QoL levels in the physical health (B = 0.19, 95%CI [0.04 to 0.34]) and social relationships (B = 0.40, 95%CI [0.20 to 0.60]) domains. Appraisal support was significantly associated with higher QoL levels in the psychological (B = 0.34, 95%CI [0.18 to 0.50]) and environment (B = 0.33, 95%CI [0.19 to 0.48]) domains. QoL levels in pregnancy were significantly associated with QoL levels postpartum, showing small to medium effect size (ES = 0.30 to 0.55), depending on the domain.ConclusionsFurther research, including qualitative interviews, could provide more insights into the impact of New Families on QoL. A positive association between QoL levels in pregnancy and postpartum suggests that postnatal interventions targeting improved QoL could potentially improve postpartum QoL. Emotional and appraisal support seems beneficial for first-time mothers’ QoL and could be provided and facilitated by public health nurses.Trial registrationclinicaltrial.gov NCT04162626.

Factors affecting and effects of hemodynamic stability of pediatric patients with grades 3–5 renal trauma: a prospective non-randomized comparative study

BackgroundResearches on the effect of hemodynamic stabilization on the implantation of conservative management for pediatric high-grade renal traumas are lacking. We aimed to assess the effect of maintaining the initial hemodynamic stability of pediatric patients with grades 3–5 renal trauma on the implementation of the conservative treatment and identify its defining factors.MethodsA prospective study was performed on pediatric patients with grade 3–5 renal traumas who presented to our hospital during July 2020–June 2022. Hemodynamically stable patients were compared with the unstable patients for clinical characteristics, hemodynamic stabilization, and rates of success of conservative treatment.ResultsForty-three patients were studied, including 26 boys and 17 girls. Of them, 28 (65.1%) patients presented with hemodynamic stability and 15 (34.9%) patients were unstable. Overall, 32 (74.4%) patients achieved and/or maintained hemodynamic stability for conservative management. There was a significant difference in blood pressure level at presentation (p < 0.001). The improvement of the hemodynamic parameters was significant per group and, in comparison (p < 0.001). The size of hematoma was significantly smaller in patients with hemodynamic stability (p = 0.023). Despite the longer (p = 0.033) hospital stay with conservative management, the rates of blood transfusion (p = 0.597) and hospital stay (p = 0.785) were not significantly different between both groups. The rates of nephrectomy and mortality were 14% and 0%, respectively. Blood pressure was independently associated with the achievement of maintained hemodynamic stability for conservative management (p = 0.022).ConclusionsHemodynamic stabilization seems to be effective and safe for implementing successful conservative management for pediatric patients with high-grade renal traumas. Blood pressure was the only independent factor of maintaining hemodynamic stability.

Differences in change of post-operative antioxidant levels between laser-assisted lenticule extraction and femtosecond laser insitu keratomileusis.

To evaluate the change of total antioxidant capacity (TAC) and ascorbic acid (AA) between femtosecond laser insitu keratomileusis (FS-LASIK) and laser-assisted lenticule extraction (LALEX). A prospective non-randomized study was conducted, and 33 and 75 eyes that had undergone FS-LASIK or LALEX surgeries were enrolled, respectively. The tear films near corneal incisions were collected, and the concentrations of TAC and AA were determined. The generalized linear mixed model was adopted to calculate the adjusted odds ratio (aOR) with 95% confidence interval (CI) of TAC and AA between the two groups. The AA reduction was significant 1 month after the LALEX and FS-LASIK procedures (both p < 0.05), and the decrement in AA level was significantly larger in the FS-LASIK group compared to the LALEX group (p = 0.0002). In the subgroup analysis, the LALEX group demonstrated a lower decrement in TAC level in the individuals with dry eye disease (DED) than the FS-LASIK group (p = 0.0424), and the LALEX group demonstrated a significantly lower AA decrement in the participants with high myopia (p = 0.0165) and DED (p = 0.0043). The LALEX surgery causes lesser AA decrement compared to FS-LASIK surgery especially for the patients with DED.

Usefulness of preoperative ice cream consumption and novel postoperative drainage management in patients undergoing left-sided neck dissection for thyroid cancer: a nonrandomized prospective study

PurposeThis study investigated the effects of ice cream consumption on chyle leakage after left lateral neck dissection in patients with thyroid cancer.MethodsA total of 491 patients with thyroid cancer underwent left lateral neck dissection with identification of the thoracic duct following ice cream consumption. Before closing the wound, the anesthesiologist increased the intrathoracic pressure to observe chyle leakage. If chyle leakage occurred postoperatively, the drain was removed using the drain negative pressure release test.ResultsPostoperative chyle leakage was observed in 18 of the 491 patients who underwent left lateral neck dissection. We treated 17 patients conservatively and 1 patient surgically. Drains were removed within five days in all patients. After the drain negative pressure release test had been performed in eight patients, the drainage volume significantly decreased from an average of 175 ml to 31 ml per day. The average number of days until the removal of the drainage tube was 3.2 days. No perioperative complications were associated with ice cream consumption.ConclusionsIn left lateral neck dissection for thyroid cancer, performing surgery following ice cream consumption does not completely prevent chyle leakage; however, early drain removal is possible because there is only mild leakage.

Use of sirolimus as an adjuvant therapy for kidney transplant recipients with high-risk cutaneous squamous cell carcinomas: a prospective non-randomized controlled study

RESUMO Introdução: Pesquisas anteriores demonstraram benefícios da conversão tardia para inibidores de mTOR contra carcinomas espinocelulares cutâneos (CECs) em receptores de transplante renal (RTR), apesar da baixa tolerabilidade. Este estudo investigou se a conversão gradual para monoterapia com sirolimo sem dose de ataque modificou o curso da doença com melhor tolerabilidade. Métodos: Esse estudo prospectivo exploratório incluiu RTR não sensibilizados com mais de 12 meses pós-transplante, uso contínuo de terapia imunossupressora baseado em inibidor de calcineurina (CNI) associado a micofenolato de sódio ou azatioprina, com lesões de CECs de mau prognóstico. Comparou-se densidades de incidência de CECs de alto risco durante 3 anos após conversão para monoterapia com sirolimo à um grupo não randomizado com CECs classificados conforme os mesmos critérios de gravidade do grupo sirolimo, mas inadequado/não disposto à conversão. Resultados: Foram incluídos 44 pacientes (83% homens, idade média 60 ± 9,7 anos, 62% com fototipo de pele II, tempo médio pós-transplante 9 ± 5,7 anos). 25 pacientes foram convertidos para SRL e 19 indivíduos mantidos em CNI. Foi observado tendência de diminuição da densidade de incidência de todos CECs no grupo SRL e de aumento no grupo CNI (1,49 a 1,00 lesões/paciente-ano; 1,74 a 2,08 lesões/paciente-ano; p = 0,141). A densidade de incidência de lesões moderadamente diferenciadas diminuiu significativamente no grupo SRL enquanto aumentou significativamente no grupo CNI (0,31 a 0,11 lesões/paciente-ano; 0,25 a 0,62 lesões/paciente-ano; p = 0,001). No grupo SRL não houve descontinuação do sirolimo, nenhum episódio de rejeição aguda e nenhuma formação de DSA de novo. Função renal permaneceu estável. Conclusões: Esse estudo sugere que a monoterapia com sirolimo pode ser útil como terapia adjuvante de CECs de alto risco em RTR. A estratégia de conversão usada foi bem tolerada e segura em relação aos principais desfechos do transplante a médio prazo.

IBC-Oxford University2023_BJSOral_19Prospective Non-Randomized Study comparing the outcomes of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB)

Abstract Background Single anastomosis Sleeve Jejunal Bypass (SASJ) is a relatively new bariatric/metabolic procedure. It is the single anastomosis modification of the Sleeve Gastrectomy with Bipartition operation developed by Santoro in 2012. Few studies have been published on its efficacy and safety, and fewer studies have been performed comparing its outcome with recognized bariatric procedures. Patients and Methods This is a prospective nonrandomized comparative study. Eighty patients were included in the study, 40 patients underwent SASJ and 40 underwent OAGB, in Ain Shams University Hospitals over 12 months between June 2021 and June 2022. Patients were followed up for at least one year. Both groups are compared for operative time, complications, costs, postoperative weight loss, resolution of co-morbidities, and complications. Results The one year follow up was completed by 34 patients in the SASJ group, and 38 patients in the OAGB group. The difference in operative time was not statistically significant. Intraoperative bleeding occurred in 3 cases in the OAGB group, one was successfully managed by conservative management and 2 required re-laparoscopy for successful control of bleeding. No leakage occurred in both groups. There was no statistically significant difference in EWL%, as it was 68.6 % ± 7.2 one year after SASJ and 71.3 % ± 5.7 % after OAGB. TWL% was 35.9 % ± 4.2 one year after SASJ and 36.2 % ± 3.8 % after OAGB, with no statistical difference. T2 DM resolution took place in 100% of patients after both procedures. However, bile reflux was higher after SASJ (17.6%, 6/34 patients), as compared to OAGB (13.2 %, 5/38 patients), yet statistically, the difference was not significant. Conclusion SASJ is an effective and safe bariatric/metabolic operation. Its outcome is comparable to that of OAGB. It deserves further study.

Взаимосвязь факторов риска и показателей индуцированного окисления крови у больных стабильной ишемической болезнью сердца

Exposure on key modified risk factors, mainly hypercholesterolemia, arterial hypertension and diabetes mellitus, is an essential component of successful management of patients with coronary artery disease (CAD). As far as the concept of cardiovascular continuum goes, the predisposing behavioral factors that contribute to the development of these abnormal conditions include smoking, hypodynamia and obesity. Oxidative stress is closely associated with atherogenesis at every stage of progression. An open non-randomized prospective study is conducted. An observational group includes 89 patients with stable CAD. Key risk factors of cardiovascular diseases and their correlation with the values of induced blood oxidation were analyzed. Statistically significant (p &lt; 0.05) positive correlation between hypercholesteremia and coefficient of oxidative activity (r = 0.22), smoking and initial rate of blood oxidation (r = 0.24), maximum rate of blood oxidation (r = 0.25), coefficient of oxidative activity (r = 0.24), diabetes mellitus and time of the initiation period (r = 0.25); negative correlation between smoking and time of the initiation period (r = –0.4) were detected. The results obtained show there is a correlation between a lifestyle and oxidative status of patients with stable CAD. Thus, influence on behavioral risk factors is the most important task of management of patients with cardiovascular pathology.

ARCHERY: a prospective observational study of artificial intelligence-based radiotherapy treatment planning for cervical, head and neck and prostate cancer – study protocol

IntroductionFifty per cent of patients with cancer require radiotherapy during their disease course, however, only 10%–40% of patients in low-income and middle-income countries (LMICs) have access to it. A shortfall...

Restrictive Versus Liberal Red Blood Cell Transfusion Strategies for Patients with Hematologic Malignancies Receiving Intensive Chemotherapy

Background: It is estimated that one-quarter to one-half of people diagnosed with hematologic malignancies experience anemia and red blood cell (RBC) transfusion plays an essential supportive role in their management. There are different strategies for RBC transfusions to treat anemia. A restrictive transfusion strategy seeks to maintain a lower hemoglobin level (usually between 70 g/L to 90 g/L with a trigger for transfusion when the hemoglobin drops below 70 g/L), whereas a liberal transfusion strategy aims to maintain a higher hemoglobin (usually between 100 g/L to 120 g/L, with a threshold for transfusion when hemoglobin drops below 100 g/L). The most effective and safest strategy is unknown in people with hematological malignancies. Objectives: To determine the efficacy and safety of a restrictive versus liberal RBC transfusion strategies for people diagnosed with hematological malignancies treated with intensive chemotherapy, radiotherapy, or both, with or without a hematopoietic stem cell transplant (HSCT). Methods: Review was completed using Cochrane standard methodological procedures. We included randomized controlled trials RCTs and prospective non-randomized studies NRS that evaluated a liberal compared with a restrictive RBC transfusion strategy in children or adults with malignant hematological disorders receiving intensive chemotherapy/radiotherapy or undergoing HSCT. We searched for RCTs and NRS in MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Trials, and eight other databases and three trial registries to 21 March 2023. For dichotomous outcomes such as mortality, results were presented as a risk ratio (RR) with 95% confidence interval (CI) to compare restrictive versus liberal transfusion strategies. For continuous outcomes using the same scale, we assessed the mean difference (MD) with 95% CI. Where outcome measures were heterogenous, a narrative synthesis was used. Review Manager Web was used to meta-analyze the data. GRADE rating methodology was used for the overall certainty of evidence from included studies. Main Results: Nine studies were included: eight RCTs and one NRS. 644 participants were included in analyses from six completed RCTs (n=560) and one completed NRS (n=84). Two ongoing RCTs consisting of 294 participants (260 adult and 34 pediatric) are pending inclusion. One completed RCT included children receiving HSCT (n=6) and five RCTs only included adults (n=239 with acute leukemia receiving chemotherapy and n=315 with a hematological malignancy receiving HSCT). The restrictive strategies varied from 70 g/L to 80 g/L and liberal strategies from 80 g/L to 120 g/L. A restrictive strategy was found to result in a reduction in the number of RBC units per participant compared to a liberal strategy (Four studies; 457 participants; MD: -2.39, 95%CI -3.38 to -1.39, P = &amp;lt;0.00001). No difference was seen in bleeding between strategies although there was high concern for bias in included trials. Effects were reported in the summary of findings tables for RCTs (Table 1) which included results from adults only to reduce indirectness as a result of limited information from the single published pediatric RCT which was terminated early. Overall, a restrictive RBC transfusion strategy may result in little to no difference in the risk of death at 31 to 100 days compared to a liberal transfusion strategy (three studies; 382 participants; RR 0.74, 95% CI 0.13 to 4.09, P= 0.73; I 2=28%; low-certainty evidence). Two outcomes (mortality at 31 to 100 days and clinically significant bleeding) were reported from the one NRS (Table 2). The evidence is very uncertain whether there is a difference in mortality and clinically significant bleeding between the transfusion strategies based on the very low-certainty evidence. Conclusions: A restrictive transfusion strategy demonstrated a reduction in RBC usage, while there may be no impact on mortality. Definite conclusions are challenging given the relatively few studies with low numbers of included participants, concern for bias, heterogeneity of intervention and outcome reporting and overall certainty of evidence. There is a need for larger and methodologically better designed and executed studies. There is insufficient evidence to answer this review's primary outcome. Further RCTs are required overall, particularly trials inclusive of pediatric participants.

Functional and safety outcomes after benign prostatic enlargement surgeries in men with detrusor underactivity compared with normal detrusor contractility: Systematic review and meta-analysis.

Men with detrusor underactivity (DUA)and concomitant bladder outlet obstruction (BOO)due to benign prostatic enlargement (BPE)may present poorer functional outcomes after surgical desobstruction. This study aimed to evaluate the safety and efficacy of BPE surgery in men with DUA compared with those with normal detrusor contractility (NC). This review was performed according to the 2020 PRISMA framework. A comprehensive literature search was performed until May 7, 2023, using MEDLINE, EMBASE, and Cochrane Database. No date limits were imposed. Only comparative studies were accepted. The primary endpoint was to assess if there was any difference in short- and long-term functional outcomes after BPE surgery in men with DUA and NC. The secondary endpoint was to evaluate the differences in perioperative outcomes and postoperative complications between the two groups. Meta-analysis was performed using Review Manager (RevMan) software. There were 5 prospective nonrandomized studies and 12 retrospective studies, including 1701 DUA and 1993 NC patients. Regarding surgical procedures, there were eightTURP (transurethral resection of the prostate) studies, fourGreenLight PVP (photoselective vaporization of the prostate) studies, twoHoLEP (Holmium laser enucleation of the prostate) studies, oneGreenLight PVP/HoLEPstudy, oneHolmium laser incision of the prostate study, and onestudy did not report the type of surgery. We did not find a statistically significant difference between the two groups in terms of perioperative outcomes, including postoperative catheterization time, hospitalization time, urinary retention, need to recatheterization, transfusion rate, or urinary tract infections. Also, we found no significant differences in long-term complications, such as bladder neck stenosis or urethral stenosis. Posttreatment bladder recatheterization and retreatment rate for BPE regrowth could not be evaluated properly, because only one study reported these findings. When we analyzed functional outcomes at 3 months, those with NC had lower International Prostatic Symptom Score (IPSS),lower quality-of-life (QoL) score, better maximum flow rate (Qmax), and lower post-voiding residual (PVR)of urine. These results were maintained at 6 months postoperatively, with exception of PVR that showed no difference. However, at 12 and more than 12 months the functional outcomes became similar regarding IPSS and QoL. There were few data about Qmax and PVR at longer follow-up. In this meta-analysis, data suggest that BOO surgical treatment in patients with concomitant BPE and DUA appears to be safe. Despite patients with DUA may present worse functional outcomes in the short postoperative term compared with the NC population, IPSS and QoL scores become comparable again after a longer follow-up period after surgery.

A Prospective Comparison of Standard and Modified Acute Malnutrition Treatment Protocols during COVID-19 in South Sudan.

A non-randomized prospective cohort study was conducted in 2022 to compare recovery rate and length of stay (LoS) for acutely malnourished children treated under South Sudan's standard Community Management of Acute Malnutrition (CMAM) protocol and a COVID-modified protocol. Children aged 6-59 months received acute malnutrition (AM) treatment under the standard or modified protocol (mid-upper-arm circumference-only entry/exit criteria and simplified dosing). Primary (recovery rate and LoS) were compared for outpatient therapeutic (OTP) and therapeutic supplementary feeding programs (TSFP) using descriptive statistics and mixed-effects models. Children admitted to OTP under both protocols were similar in age and sex; children admitted to TSFP were significantly older under the modified protocol than the standard protocol. Shorter LoS and higher recovery rates were observed under the modified protocol for both OTP (recovery: 93.3% vs. 87.2%; LoS: 38.3 vs. 42.8 days) and TSFP (recovery: 79.8% vs. 72.7%; LoS: 54.0 vs. 61.9 days). After adjusting for site and child characteristics, neither differences in adjusted odds of recovery [OTP: 2.63; TSFP 1.80] nor LoS [OTP -10.0; TSFP -7.8] remained significant. Modified protocols for AM performed well. Adjusted models indicate similar treatment outcomes to the standard protocol. Adopting simplified protocols could be beneficial post-pandemic; however, recovery and relapse will need to be monitored.

Comparison of transoral endoscopic thyroidectomy vestibular approach and open conventional thyroidectomy regardıng inflammatory responses, pain, and patient satisfaction: a prospective study.

The application of transoral endoscopic thyroidectomy vestibular approach (TOETVA) is becoming widespread throughout the world. We primarily aimed to evaluate the severity of surgical trauma in TOETVA and conventional open thyroidectomy (COT) regarding the inflammatory response including the comparison of surgical stress markers [interleukin-6 (IL-6), C-reactive protein (CRP), white blood cell (WBC)]. This non-randomized prospective study enrolled two groups with 20 patients each: COT group and TOETVA group. Patients aged 18-65 years with benign thyroid disease; with fine needle aspiration biopsy results of Bethesda III, IV or Bethesda V, VI (<1 cm nodule); thyroid volume <50 cm3; nodule diameter <4 cm; female gender without a previous neck, chin, and/or oral surgery; without vocal cord paralysis preoperatively; and patients in euthyroid state were enrolled to the study. Preoperative, postoperative second hour, first day, and second day CRP, WBC, and IL-6 levels were evaluated. Pain intensity was evaluated with the visual analog scale (VAS) score on the 2nd and 12th hour, 1st and 2nd days postoperatively. All the patients were female and mean age was significantly higher in the COT group. The operative time was significantly longer in the TOETVA group. No significant difference was found between the two groups regarding IL-6 levels. In the TOETVA group, postoperative second hour WBC value (p = 0.044) and first (p = 0.002) and second day (p = 0.005) CRP values were significantly higher. In the TOETVA group, the lower lip and lower chin VAS scores were significantly higher at 2nd and 12th hour, on the first and second days. The anterior neck VAS score was significantly higher in the TOETVA group at the second hour (p = 0.025). General and cosmetic satisfactions were similar at the 15th and 30th days in both groups. The longer operative time and higher postoperative CRP level and VAS score in the chin and lower lip in the TOETVA group suggested that the method is not a minimally invasive technique compared to COT. However, the presence of similar total complication rates and early postoperative general and esthetic satisfaction that improves over time in both groups suggests that the clinical effect of increased magnitude of systemic inflammatory response in TOETVA might be temporary and acceptable.