Non-randomized Observational Study Research Articles

Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 Diabetes.

This study aims to assess patient-reported satisfaction and metabolic outcomes following the initiation of the second generation of the Freestyle Libre 2 (FSL2) system in patients with type 1 diabetes (T1D). This non-randomized single-arm observation study was conducted on 86 patients with T1D living in Saudi Arabia, who were asked to wear the FSL2 for 12 weeks. The demographic data were collected at baseline, while the continuous glucose monitoring (CGM) metrics were gathered, i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and average duration of hypoglycemic events were collected at baseline, 6th week and 12 weeks. Further, the Continuous Glucose Monitoring Satisfaction (CGM-SAT) was collected at the end of the follow-up. Compared to the 6th week, significant differences were observed in the low glucose events (p = 0.037), % TIR (p = 0.045), and % below 70 mg/dL (p = 0.047) at 12 weeks. Improvement was seen in the other glucometric variables, but no significant changes were evident (p > 0.05). On completion of the study period, the ambulatory glucose profile (AGP) metrics showed a 74.3 ± 5.01 (mg/dL) FSL2 hypoglycemia alarm threshold and a 213 ± 38.1 (mg/dL) hyperglycemia alarm threshold. A majority of the patients stated that CGM-SAT had benefits (mean score > 3.58), although they felt FSL2 had 'additional benefits. With regard to the problems with the use of FSL2 majority of the patients stated that FSL2 has minimal discomfort. Using second-generation FSL2 in patients with T1D is positively associated with patient- reported satisfaction and metabolic outcomes.

Improving diagnostics using extended point-of-care testing during in-home assessments of older adults with signs of emerging acute disease: a prospective observational non-randomised pilot and feasibility study

BackgroundDelayed recognition of acute disease among older adults hinders timely management and increases the risk of hospital admission. Point-of-Care testing, including Focused Lung Ultrasound (FLUS) and in-home analysis of biological material, may support clinical decision-making in suspected acute respiratory disease. The aim of this study was to pilot test the study design for a planned randomised trial, investigate whether in-home extended use of point-of-care testing is feasible, and explore its’ potential clinical impact.MethodsA non-randomised pilot and feasibility study was conducted during September–November 2021 in Kolding Municipality, Denmark. A FLUS-trained physician accompanied an acute community nurse on home-visits to citizens aged 65 + y with signs of acute respiratory disease. The acute community nurses did a clinical assessment (vital signs, capillary C-reactive protein and haemoglobin) and gave a presumptive diagnosis. Subsequently, the physician performed FLUS, venipuncture with bedside analysis (electrolytes, creatinine, white blood cell differential count), nasopharyngeal swab (PCR for upper respiratory pathogens), and urine samples (flow-cytometry). Primary outcomes were feasibility of study design and extended point-of-care testing; secondary outcome was the potential clinical impact of extended point-of-care testing.ResultsOne hundred consecutive individuals were included. Average age was 81.6 (SD ± 8.4). Feasibility of study design was acceptable, FLUS 100%, blood-analyses 81%, PCR for upper respiratory pathogens 79%, and urine flow-cytometry 4%. In addition to the acute community nurse’s presumptive diagnosis, extended point-of-care testing identified 34 individuals with a condition in need of further evaluation by a physician.ConclusionOverall, in-home assessments with extended point-of-care testing are feasible and may aid to identify and handle acute diseases in older adults.

Patients with Advanced or Metastasised Non-Small-Cell Lung Cancer with Viscum album L. Therapy in Addition to PD-1/PD-L1 Blockade: A Real-World Data Study.

Immunotherapy with PD-1/PD-L1 inhibitors has significantly improved the survival rates of patients with metastatic non-small-cell lung cancer (NSCLC). Results of a real-world data study investigating add-on VA (Viscum album L.) to chemotherapy have shown an association with the improved overall survival of patients with NSCLC. We sought to investigate whether the addition of VA to PD-1/PD-L1 inhibitors in patients with advanced or metastasised NSCLC would have an additional survival benefit. In the present real-world data study, we enrolled patients from the accredited national registry, Network Oncology, with advanced or metastasised NSCLC. The reporting of data was performed in accordance with the ESMO-GROW criteria for the optimal reporting of oncological real-world evidence (RWE) studies. Overall survival was compared between patients receiving PD-1/PD-L1 inhibitor therapy (control, CTRL group) versus the combination of anti-PD-1/PD-L1 therapy and VA (combination, COMB group). An adjusted multivariate Cox proportional hazard analysis was performed to investigate variables associated with survival. From 31 July 2015 to 9 May 2023, 415 patients with a median age of 68 years and a male/female ratio of 1.2 were treated with anti-PD-1/PD-L1 therapy with or without add-on VA. Survival analyses included 222 (53.5%) patients within the CRTL group and 193 (46.5%) in the COMB group. Patients in the COMB group revealed a median survival of 13.8 months and patients in the CRTL group a median survival of 6.8 months (adjusted hazard ratio, aHR: 0.60, 95% CI: 0.43-0.85, p = 0.004) after adjustment for age, gender, tumour stage, BMI, ECOG status, oncological treatment, and PD-L1 tumour proportion score. A reduction in the adjusted hazard of death by 56% was seen with the addition of VA (aHR 0.44, 95% CI: 0.26-0.74, p = 0.002) in patients with PD-L1-positive tumours (tumour proportion score > 1%) treated with first-line anti-PD-1/PD-L1 therapy. Our findings suggest that add-on VA correlates with improved survival in patients with advanced or metastasised NSCLC who were treated with PD-1/PD-L1 inhibitors irrespective of age, gender, tumour stage, or oncological treatment. The underlying mechanisms may include the synergistic modulation of the immune response. A limitation of this study is the observational non-randomised study design, which only allows limited conclusions to be drawn and prospective randomised trials are warranted.

Comparison between staged laparoscopic technique in children with high intra-abdominal undescended testis: a systematic review and meta-analysis.

This study performed a systematic review and meta-analysis to compare the outcomes of the staged laparoscopic Fowler-Stephens Laparoscopic Orchiopexy (FSLO) and Staged Laparoscopic Traction Orchiopexy (SLTO) in patients with intra-abdominal testes (IAT). This study reviewed literature published from 2016 to 2024. A systematic literature search was conducted on three databases: PubMed, ScienceDirect, and Google Scholar, using keywords (High intra abdominal testis) AND (("Fowler Stephens laparoscopic orchiopexy" OR (FSLO)) OR (Staged Laparoscopic traction orchiopexy OR (SLTO)). Non-randomized trials and observational studies comparing staged laparoscopic FSLO and SLTO, without any time range restriction are included. Studies without FLSO orchidopexy as a control, case reports, case studies, duplicate publication, no full text and non-English studies are excluded. This study used the PRISMA protocol, the Jadad Scale, and the Newcastle Ottawa Scale (NOS) to evaluate the included studies. To analyze statistical data, the Review Manager (RevMan) software was used. The Chi-squared test was used to calculate statistical heterogeneity in the meta-analysis. There were 240 patients from 5 studies (109 in the SLTO group and 131 FSLO in group). The primary outcome of this study is testicular descent and atrophy. There were no significant differences in testicular descent (RR:1.08[0.96 - 1.23],p<0.20,I 2:0%) and atrophy rate (RR:0.45[0.19 - 1.09],p<0.08,I 2:0%). Secondary outcomes are the duration of operation in both the first and second stages. Statistical analysis reveals a significantly lower first-stage operation time in the FSLO group (MD:9.31[7.08,11.55], p<0.05;I 2:94%). At the same time, lower second-stage operation times are significantly reported in the SLTO group (MD:-4.05[-7.99,-0.12],p<0.05; I 2:60%). In terms of testicular descent and testicular atrophy the SLTO technique yields similar results to the FSLO technique. Both techniques have advantages and disadvantages, and we recommend SLTO as the first choice in children with a high IAT of <4 cm. CRD42023412407.

Targeted Test and Treat at Point of Entry to Reduce Importation of Malaria Parasites: A Systematic Review.

As countries approach malaria elimination, imported cases of malaria make up a larger proportion of all cases and may drive malaria transmission. Targeted test and treat (TTaT) at points of entry (POEs) is a strategy that aims to reduce the number of imported infections in countries approaching elimination by testing and treating individuals at border crossings. No evidence has been systematically collected and evaluated to assess the impact and operational feasibility of this strategy. This systematic review gathered empirical evidence on the effectiveness of the intervention, contextual factors, and results of modeling studies that estimate its potential impact. Bibliographic searches were conducted in March 2021 and updated in April 2022, and a total of 1,569 articles were identified. All study designs were included, but none of them were intervention studies set up to measure the impact of TTaT at POEs. Seven nonrandomized observational studies were eligible for assessment of outcome data in terms of describing the extent of positive cases among people crossing borders. Also included in the review were three studies for assessment of acceptability and feasibility of the intervention and three for assessment of mathematical modeling. The positivity rates reported in the seven studies ranged between 0.0% and 70.0%, which may be attributable to the different settings and operational feasibility. Overall, there is limited evidence of the effect of TTaT at POEs on the prevalence of infection, and the certainty of the evidence was very low owing to critical risk of bias, serious inconsistency, and serious indirectness.

Reduced emergency department use among insured individuals receiving extended-release buprenorphine in a health system setting

IntroductionExtended-release buprenorphine (XR-Bup) is associated with reduced opioid use and opioid negative urine drug screens. Little is known about its use in outpatient addiction care provided within health systems. MethodsIndividuals prescribed XR-Bup were identified from electronic health records; chart abstraction was conducted. Primary outcome was all-cause emergency department (ED) use. Secondary outcomes included ED use or inpatient stays for mental health or substance use, ED use for any other cause, discontinuation reasons, and drug substitution. Statistical comparisons used nonparametric tests from related samples (McNemar’s test and Wilcoxon matched pair tests) to test outcomes six months prior and 6 months following XR-Bup initiation. Results152 individuals had an XR-Bup order, 126 received >1 injection. Among those consistently insured 6 months prior to and following XR-Bup initiation (n=99), the mean number of injections following initiation was 3.95; one-third received 6 doses in the 6 months. The proportion of individuals using ED services for all causes declined (41% prior vs. 28% following XR-Bup initiation, p<.05); similar results were found for secondary ED use outcomes. The proportion of individuals requiring inpatient treatment for mental health or substance use also declined (46% vs. 16%, p<.01). Common reasons for discontinuing XR-Bup included losing insurance (21%) or cost (11%). The most common non-prescribed substances used during treatment were opioids (n=31) and THC (n=20). ConclusionsIn this non-randomized retrospective observational study, use of XR-Bup was associated with reduced ED use 6 months following initiation. XR-Bup may help health systems reduce use of costly ED services.

Role of upper airway evaluation in the multidisciplinary management of obstructive sleep apnea in children below two years of age.

Diagnosis and treatment of obstructive sleep apnea (OSA) in infants and young children is challenging because of its clinical heterogeneity and lack of age-specific guidelines. We report the management and treatment outcome of OSA in children below 2 years of age. Treatment decisions were based upon the pattern of upper airway (UA) obstruction, clinical presentation and OSA severity. Retrospective, non-randomized observational cohort study at a tertiary center. Children with OSA who underwent an UA evaluation (drug-induced sleep endoscopy or direct laryngoscopy) were included. We studied 100 patients, 57 boys and 43 girls, age 0.72 years (0.0-2.0) and OSA confirmed by polysomnography. Multilevel UA collapse was present in 26%, (adeno)tonsillar hypertrophy in 31% and 21% had laryngomalacia. Laryngomalacia was more common in children below 6 months of age and adenotonsillar hypertrophy was observed mainly in children >1.5 year of age. Surgical and nonsurgical treatment guided by UA findings, improved OSA severity at group level with a significant reduction (p < 0.001) in obstructive apnea/hypopnea index from 10.8/h (2.1-99.1) to 1.7/h (0.0-73.0), an improvement in mean oxygen saturation from 96.9% (88.9-98.4) to 97.4% (92.3-99.0), in minimal oxygen saturation from 85.4% (37.0-96.0) to 88.8% (51.0-95.5) and oxygen desaturation index from 5.1/h (0.2-52.0) to 1.3/h (0.0-47.8). Multidisciplinary management of young children with OSA guided by the pattern of UA obstruction and OSA severity, reduces OSA severity. The pattern of UA obstruction changes in the first 2 years of life from a dynamic collapse to structural abnormalities.

Severity of Complications after Locking Plate Osteosynthesis in Distal Femur Fractures.

Background: Locked plating for distal femur fractures is widely recommended and used. We systematically reviewed clinical studies assessing the benefits and harms of fracture fixation with locked plates in AO/OTA Type 32 and 33 femur fractures. Methods: A comprehensive literature search of PubMed, Embase, Cinahl, Web of Science, and the Cochrane Database was performed. The studies included randomized and non-randomized clinical trials, observational studies, and case series involving patients with distal femur fractures. Studies of other fracture patterns, studies conducted on children, pathological fractures, cadaveric studies, animal models, and those with non-clinical study designs were excluded. Results: 53 studies with 1788 patients were found to satisfy the inclusion and exclusion criteria. The most common harms were nonunion (14.8%), malunion (13%), fixation failure (5.3%), infection (3.7%), and symptomatic implant (3.1%). Time to full weight-bearing ranged from 5 to 24 weeks, averaging 12.3 weeks. The average duration of follow-up was 18.18 months, ranging from 0.5 to 108 months. Surgical time ranged between 40 and 540 min, with an average of 141 min. The length of stay in days was 12.7, ranging from 1 to 61. The average plate length was ten holes, ranging from 5 to 20 holes. Conclusion: This review aimed to systematically synthesize the available evidence on the risk associated with locked plating osteosynthesis in distal femur fractures. Nonunion is the most common harm and is the primary cause of reoperation. The overall combined risk of a major and critical complication (i.e., requiring reoperation) is approximately 20%.

AN OBSERVATIONAL STUDY OF EFFECT ON LIPID PROFILE BY SHORT TERM USE OF LOW DOSE STEROID THERAPY IN COMMON ORTHOPAEDIC CONDITIONS

Introduction:Corticosteroids, potent anti-inflammatory drugs used for decades, provide symptomatic relief but carry risks like infection and chronic conditions. Despite complications, theyre prescribed for orthopedic issues. Glucocorticoids influence lipid levels, with conflicting effects. Steroids are termed a double-edged sword. This study aims to assess lipid profile effects of short-term, low-dose steroid therapy in Orthopedics and Rheumatology, evaluating glucocorticoid therapy impact and investigating other effects on musculoskeletal patients. Materials and Methods:This prospective, non-randomized observational study was conducted, focusing on patients with orthopedic and rheumatological issues. Over 150 patients were included, selected through convenient sampling. Inclusion criteria involved patients aged 18-65 without dyslipidemia or cardiovascular conditions, while exclusion criteria included those with specific medical conditions or high BMI. Patients provided written informed consent before undergoing blood tests for lipid profile and blood sugar levels, with vital signs measured. They received Medrol 4 mg thrice daily for ten days, after which outcomes including lipid levels, blood sugar, and blood pressure were assessed. Results:At baseline, 88.67% had desirable cholesterol levels and 11.33% had borderline levels. At follow-up, 20.67% had borderline levels and 79.33% had desirable levels, a statistically significant difference. Mean cholesterol levels decreased from 169.16 ± 19.70 mg/dl to 161.11 ± 27.60 mg/dl, also significant. For triglycerides, 92.67% had normal levels at baseline, decreasing to 65.33% at follow-up, with mean levels increasing from 131.33 ± 6.97 mg/dl to 139.12 ± 23.88 mg/dl. HDL levels showed improvement, with 84.67% having desirable levels at baseline compared to 43.33% at follow-up, with mean levels increasing from 41.09 ± 5.13 mg/dl to 50.71 ± 4.21 mg/dl. LDL levels decreased from 132.43 ± 16.86 mg/dl to 122.59 ± 16.93 mg/dl, with significant changes in distribution. Conclusions:Short-term steroid use for orthopedic conditions affects lipid profiles: Total cholesterol, LDL, and TG rise significantly, countered by increased HDL, offering protection. Long-term effects on lipid profiles and cardiovascular risk require further study. Risk of avascular necrosis due to subtle lipid profile changes also warrants investigation.

Immunogenicity of SARS-CoV-2 vaccines BBV152 (COVAXIN®) and ChAdOx1 nCoV-19 (COVISHIELD™) in seronegative and seropositive individuals in India: a multicentre, nonrandomised observational study

There are limited global data on head-to-head comparisons of vaccine platforms assessing both humoral and cellular immune responses, stratified by pre-vaccination serostatus. The COVID-19 vaccination drive for the Indian population in the age group 18-45 years began in April 2021 when seropositivity rates in the general population were rising due to the delta wave of COVID-19 pandemic during April-May2021. Between June 30, 2021, and Jan 28, 2022, we enrolled 691 participants in the age group 18-45 years across four clinical sites in India. In this non-randomised and laboratory blinded study, participants received either two doses of Covaxin® (4 weeks apart) or two doses of Covishield™ (12 weeks apart) as per the national vaccination policy. The primary outcome was the seroconversion rate and the geometric mean titre (GMT) of antibodies against the SARS-CoV-2 spike and nucleocapsid proteins post two doses. The secondary outcome was the frequency of cellular immune responses pre- and post-vaccination. When compared to pre-vaccination baseline, both vaccines elicited statistically significant seroconversion and binding antibody levels in both seronegative and seropositive individuals. In the per-protocol cohort, Covishield™ elicited higher antibody responses than Covaxin® as measured by seroconversion rate (98.3% vs 74.4%, p<0.0001 in seronegative individuals; 91.7% vs 66.9%, p<0.0001 in seropositive individuals) as well as by anti-spike antibody levels against the ancestral strain (GMT 1272.1 vs 75.4 binding antibody units/ml [BAU/ml], p<0.0001 in seronegative individuals; 2089.07 vs 585.7 BAU/ml, p<0.0001 in seropositive individuals). As participants at all clinical sites were not recruited at the same time, site-specific immunogenicity was impacted by the timing of vaccination relative to the delta and omicron waves. Surrogate neutralising antibody responses against variants-of-concern including delta and omicron was higher in Covishield™ recipients than in Covaxin® recipients; and in seropositive than in seronegative individuals after both vaccination and asymptomatic infection (omicron variant). T cell responses are reported from only one of the four site cohorts where the vaccination schedule preceded the omicron wave. In seronegative individuals, Covishield™ elicited both CD4+ and CD8+ spike-specific cytokine-producing T cells whereas Covaxin® elicited mainly CD4+ spike-specific T cells. Neither vaccine showed significant post-vaccination expansion of spike-specific T cells in seropositive individuals. Covishield™ elicited immune responses of higher magnitude and breadth than Covaxin® in both seronegative individuals and seropositive individuals, across cohorts representing the pre-vaccination immune history of most of the vaccinated Indian population. Corporate social responsibility (CSR) funding from Hindustan Unilever Limited (HUL) and Unilever India Pvt. Ltd. (UIPL).

Abstract 141: Physician Transfer versus Patient Transfer for Mechanical Thrombectomy in Patients With Acute Ischemic Stroke: A Systematic Review and Meta-Analysis

Background: Physician transfer has been explored as an alternate option to patient transfer for the expedient performance of mechanical thrombectomy in acute ischemic stroke patients. Methods: We conducted a systematic review to identify studies that evaluate the effect of physician transfer in patients with acute ischemic stroke who undergo mechanical thrombectomy. Data were extracted from relevant studies found through a search of PubMed, Scopus, and Web of Science until March 2023. A statistical pooling with random-effects meta-analysis was performed to examine the odds of reduced time interval between stroke onset and recanalization, functional independence, mortality, and time from stroke onset to recanalization with physician transfer against no patient transfer. Results: A total of 12 studies (11 nonrandomized observational studies, and 1 non-randomized controlled trial) were included. Physician transfer significantly reduced the time interval between stroke onset and recanalization with a pooled standardized mean difference estimate of -0.60 (95% CI [-1.17, -0.04], p = 0.035, 8 studies involving 1419 patients, and with high between-study heterogeneity in the estimates (I 2 =91.7%). The odds for functional independence at 90 days were significantly higher (OR 1.29, 95% CI 1.00-1.66, p = 0.046, 7 studies involving 1222 patients) with physician transfer with low between-study heterogeneity (I 2 =0%). Physician transfer was associated with higher odds of near complete or complete angiographic recanalization (OR 1.18, 95%CI 0.89-1.57, p = 0.25, I 2 =2.8%, 11 studies, 1856 subjects). Conclusions: We found a significant reduction in the mean time interval between symptom onset and recanalization associated with physician transfer with increased odds for functional independence at 90 days among patients undergoing mechanical thrombectomy.

Quality of Life in Children With Achondroplasia Undergoing Paired Limb Lengthening With an External Fixator and Modified Distraction Control: Observational Nonrandomized Study.

Transosseous distraction osteosynthesis is prioritized in orthopedic care for children with achondroplasia. However, difficulties encountered during treatment and rehabilitation directly impact patients' quality of life. Using rod external fixators within a semicircular frame for osteosynthesis is less traumatic compared to spoke circular devices. Their straightforward assembly and mounting on the limb segment can help significantly reduce treatment duration, thereby improving children's quality of life during treatment and rehabilitation. This study aimed to conduct a comparative analysis of the quality of life (measured by postoperative pain syndrome, physical activity, and emotional state) among children with achondroplasia undergoing paired limb lengthening using either an external fixator with modified distraction control or a circular multiaxial system developed by the authors. This was an observational, prospective, nonrandomized, and longitudinal study with historical control. The study group consisted of 14 patients ranging from 5 to 15 (mean 7.6, SD 2.3) years old with a genetically confirmed diagnosis of achondroplasia. All patients underwent paired limb lengthening with a rod external fixator and a modified distraction control developed by the authors. A total of 28 limb segments, among them 4 (14%) humeri, 8 (29%) femurs, and 16 (57%) tibias, were lengthened in 1 round. Unpublished data from the previous study served as the control group, comprising 9 patients (18 limb segments) of the same age group (mean age at surgery 8.6, SD 2.3 years), who underwent limb lengthening surgery using a circular multiaxial system-2 (11%) humeri, 6 (33%) femurs, and 10 (56%) tibias. The Wong-Baker Faces Rating Scale was used to measure pain symptoms, while the Russified Pediatric Quality of Life (PedsQL) v4.0 questionnaire assessed quality of life. During the latent phase (7 to 10 days after surgery), a more pronounced decrease in the indicators of physical activity and emotional state on the PedsQL v4.0 questionnaire was noted in the control group (mean 52.4, SD 4.8 versus mean 52.8, SD 5.5 points according to children's responses and their parents' responses, respectively) compared to the experimental group (mean 59.5, SD 6.8 points and mean 61.33, SD 6.5 points according to the children's responses and their parents' responses, respectively). The differences between the groups were statistically significant (P<.05 for children's responses and P<.01 for parents' responses). Importantly, 6 months after surgery, these quality-of-life indicators, as reported by children in the experimental group, averaged 70.25 (SS 4.8) points. Similarly, their parents reported a mean of 70.54 (SD 4.2) points. In the control group, the corresponding values were 69.64 (SD 5.6) and 69.35 (SD 6.2), respectively. There was no statistically significant difference between the groups. The external fixator with modified distraction control developed by the authors provides a higher standard of living compared with the circular multiaxial system during the latency phase.

An Observational Dosimetric Study in Definitively Treated Primary Head and Neck Cancers: To Assess the Effect of Weight Loss and Change in Lateral Neck Dimensions on the Difference Between Dose Planned and Received by the Parotid(s) and Correlation with Adaptive Radiation Therapy

The head and neck cancer (HNC) literature is rife with reports of differences in planned versus actual radiation doses to the parotid gland (PG) due to changes in anatomy during the course of radiation therapy. We prospectively studied and quantified changes in planned and delivered doses due to weight loss and changes in lateral neck dimensions. Sixty patients were enrolled in this prospective non-randomized observational study. The inclusion criterion was having a newly diagnosed, histologically proven squamous cell carcinoma of HNC. Weight loss (WL) and change in lateral neck dimensions (LND) were assessed weekly, and new hybrid plans were generated using interval replanning CT scans. Dose variations were monitored and extrapolated for replanning CT scans and correlated with WL and change in LND. The Pearson correlation coefficients for WL and difference in Dmean of ipsilateral and contralateral PG was 0.3292 (P = .0124) and 0.4232 (P = .0010), respectively. There was significantly higher change in the Dmean of bilateral PG (Ipsilateral(I) > contralateral(C)) in patients who experienced WL of >5%. Change in LND correlated with difference in Dmean of ipsilateral PG at 0.4829 (P = .0001) and difference in D50 at 0.4146 (P < .0013). Contralateral PG correlated with difference in Dmean at 0.5952 (P < .0001). The difference in Dmean for ipsilateral PG was 1.8535 Gy for those showing reduction in LND of >1 cm compared with 0.8596 Gy (P = .0091) for those who had ≤1 cm reduction in LND. Either WL of >5% or reduction in LND of >1 cm can be used as an external parameter to help select patients who might benefit most from replanning and adaptive radiation therapy.

Conscious prone positioning in nonintubated COVID-19 patients with acute respiratory distress syndrome: systematic review and meta-analysis.

To systematically review the effect of the prone position on endotracheal intubation and mortality in nonintubated COVID-19 patients with acute respiratory distress syndrome. We registered the protocol (CRD42021286711) and searched for four databases and gray literature from inception to December 31, 2022. We included observational studies and clinical trials. There was no limit by date or the language of publication. We excluded case reports, case series, studies not available in full text, and those studies that included children < 18-years-old. We included ten observational studies, eight clinical trials, 3,969 patients, 1,120 endotracheal intubation events, and 843 deaths. All of the studies had a low risk of bias (Newcastle-Ottawa Scale and Risk of Bias 2 tools). We found that the conscious prone position decreased the odds of endotracheal intubation by 44% (OR 0.56; 95%CI 0.40 - 0.78) and mortality by 43% (OR 0.57; 95%CI 0.39 - 0.84) in nonintubated COVID-19 patients with acute respiratory distress syndrome. This protective effect on endotracheal intubation and mortality was more robust in those who spent > 8 hours/day in the conscious prone position (OR 0.43; 95%CI 0.26 - 0.72 and OR 0.38; 95%CI 0.24 - 0.60, respectively). The certainty of the evidence according to the GRADE criteria was moderate. The conscious prone position decreased the odds of endotracheal intubation and mortality, especially when patients spent over 8 hours/day in the conscious prone position and treatment in the intensive care unit. However, our results should be cautiously interpreted due to limitations in evaluating randomized clinical trials, nonrandomized clinical trials and observational studies. However, despite systematic reviews with meta-analyses of randomized clinical trials, we must keep in mind that these studies remain heterogeneous from a clinical and methodological point of view.

Rehabilitation of COVID-19 convalescents and its impact on cardiovascular endpoints: propensity score matching analysis

Due to the large number of complications and decreased quality of life after coronavirus disease (COVID-19), physical and psychological rehabilitation of patients is relevant. However, the effectiveness of rehabilitation on endpoints has not yet been demonstrated.Aim. To determine the effectiveness of different rehabilitation options in hospitalized patients with COVID-19 on the development of long-term adverse cardiovascular events 1 year after discharge.Material and methods. In a single-center, non-randomized observational study, 3 groups of patients were formed after hospitalization with COVID-19: I — with telemedicine rehabilitation (n=118), II — with rehabilitation in a specialized department (n=46) and III — without rehabilitation (n=175). After 1-year followup, groups were compared regarding following endpoints: cardiovascular mortality, myocardial infarction, stroke, pulmonary embolism, atrial fibrillation and cardiovascular hospitalization. Propensity score matching analysis was used to optimize differences between comparison groups.Results. Rehabilitation after hospitalization of patients with COVID-19, both in the hospital and remotely for 1 year, helps to reduce cardiovascular hospitalization rate. In addition, remote rehabilitation reduces cardiovascular mortality.Conclusion. Both rehabilitation options reduce the incidence of cardiovascular hospitalization compared to no rehabilitation.

Evolution of appraisal tool usage preferences in PROSPERO records: a study of non-Cochrane systematic reviews

ObjectivesThis research-on-research substudy uses a data-driven approach to investigate the range of appraisal tools in non-Cochrane systematic reviews and meta-analyses registered in the International Prospective Register of Systematic Reviews (PROSPERO).Study design and settingA comprehensive web scraping of all completed non-Cochrane registrations in PROSPERO from February 2011 to December 2017 was performed. The focus was classifying the appraisal tools based on study type, assessment aspects, and research topics.ResultsAfter analyzing 17,708 complete records, we found a predominant use of methodological quality assessment tools compared to those for reporting quality or risk of bias (RoB). This indicates a greater emphasis on methodological rigor in the studied protocols. Various tools for assessing methodological quality were observed, reflecting the complexity of such evaluations. Instruments designed for evaluating methodological or reporting quality were mainly intended for non-randomized clinical trials or observational studies, unlike RoB tools more commonly used in randomized clinical trials. No distinct trends in tool usage were observed in specific research conditions or domains, suggesting that tool choice is influenced more by study design than research topic.ConclusionThis study provides insights into the preferential use of various assessment tools in conducting non-Cochrane systematic reviews, as evidenced in PROSPERO records. The findings reveal various methodological assessment tools, underscoring their versatility across different study designs and research areas.

Evaluation of an application for the self-assessment of lifestyle behaviour in cardiac patients.

Currently, no uniform, well-validated and comprehensive lifestyle behaviour self-assessment instrument exists for patients with cardiovascular disease. To evaluate the usability of anovel mobile application (LifeStyleScore) based on validated instruments for the assessment of cardiovascular risk behaviours. Secondly, the application's acceptance by healthcare professionals (HCPs) and its association with improved patient activation and lifestyle behaviour was evaluated. In this single-centre, non-randomised observational pilot study, patients with coronary artery disease or atrial fibrillation entering cardiac rehabilitation (CR) completed the LifeStyleScore application, the Patient Activation Measure (PAM-13®), and the System Usability Scale (SUS) during the CR intake and after CR completion. Afocus group interview was performed with the HCPs involved. We analysed 20participants, 3of whom were women, with amean age of 61.9 ± 6.7years. The LifeStyleScore application was rated with aSUS score above average (> 68) before (69.6 ± 13.4) and after CR (68.6 ± 15.1). All HCPs (n = 8) found the application usable. Patient activation did not increase significantly after CR compared with baseline (62.0 ± 8.6 versus 59.2 ± 9.5, respectively, p = 0.28) and only physical activity levels improved significantly (2.4 ± 0.7 (standardised score) at baseline, 2.8 ± 0.4 after CR, p = 0.04). The LifeStyleScore application was found to be usable for patients receiving CR. Its use did not result in increased patient activation, and of the lifestyle behaviours only physical activity levels improved. Further research is needed to evaluate how such applications can be optimally incorporated in CR programmes.

The effect of penile traction device in men with Peyronie's disease on penile curvature, penile length, and erectile dysfunction: a systematic review and meta-analysis.

Peyronie's disease (PD) results in curvature, pain, and erectile dysfunction (ED). Penile traction devices (PTDs) are a non-invasive treatment option for PD by applying mechanical forces to elicit biochemical responses that reduce curvature and improve penile function. In the present study, we systematically reviewed and analyzed the literature investigating the use of PTD to treat PD. We have conducted electronic and manual search strategies within the databases and included articles to find relevant studies. A total of Five studies met all the predefined inclusion criteria and were selected for inclusion in the review. Outcomes assessed are penile length, penile curvature, and erectile function (EF). The study population consisted of patients with PD, the intervention was penile traction therapy (PTT), the comparison was matched placebo or follow-up, and the study design was randomized controlled trials (RCTs) or cohort studies. The Cochrane risk of bias assessed the studies' quality for randomized studies and the Newcastle-Ottawa scale (NOS) for non-randomized observational studies. All statistical analyses were performed using R software. Results were considered statistically significant for P<0.05. Only five studies met inclusion and exclusion criteria and were published between 2014 and 2021. The sample sizes range [51-110], totaling 419, with a mean of 83.8 patients-the follow-up with a mean of 6.75 months. This meta-analysis evaluated the efficacy of PTD on curvature degree, penile length, and EF in patients. There is a significant positive effect on the curvature degree (P=0.0373), while there is no significant effect on penile length and EF (P=0.5315 and 0.1010), respectively. They are Indicating low heterogeneity with an estimated total heterogeneity of 0. Overall, the available evidence does not support the efficacy of the intervention for penile length or EF. The current evidence suggests that PTDs can be a safe and effective treatment option for men with PD to reduce penile curvature. However, further research, including more RCTs with extended follow-up periods, is needed to fully understand their efficacy and determine the ideal timing and patient subtypes that would benefit from PTD.

Comparison between staged laparoscopic technique in children with high intra-abdominal undescended testis: a systematic review and meta-analysis

Background: This study performed a systematic review and meta-analysis to compare the outcomes of the staged laparoscopic Fowler-Stephens Laparoscopic Orchiopexy (FSLO) and Staged Laparoscopic Traction Orchiopexy (SLTO) in patients with intra-abdominal testes (IAT). Methods: This study reviewed literature published from 2016 to 2023. A systematic literature search was conducted on three databases: PubMed, ScienceDirect, and Google Scholar, using keywords (High intra abdominal testis) AND (("Fowler Stephens laparoscopic orchiopexy" OR (FSLO)) OR (Staged Laparoscopic traction orchiopexy OR (SLTO)). Non-randomized trials and observational studies comparing staged laparoscopic FSLO and SLTO, without any time range restriction are included. Studies without FLSO orchidopexy as a control, case reports, case studies, duplicate publication, no full text and non-English studies are excluded. This study used the PRISMA protocol, the Jadad Scale, and the Newcastle Ottawa Scale (NOS) to evaluate the included studies. To analyze statistical data, the Review Manager (RevMan) software was used. The Chi-squared test was used to calculate statistical heterogeneity in the meta-analysis. Results: This study included four studies of 151 patients (72 SLTO group and 79 FSLO group). There was no significant difference between the two groups in terms of testicular descent (p=0.08), and there was no testicular atrophy in the SLTO group compared to the FSLO group (p=0.04). Statistical analysis revealed a significantly shorter first-stage operation time in the FSLO group (p 0.0001), whereas the SLTO group reported a significantly shorter second-stage operation time (p = 0.04). Conclusions: In terms of testicular descent, the SLTO technique yields similar results to the FSLO technique. The SLTO position is preferable to the FSLO position. Both techniques have advantages and disadvantages, and we recommend SLTO as the first choice in children with a high IAT of 4 cm. PROSPERO registration: CRD42023412407

Compensatory Corneal Epithelial Changes After Femtolaser - Assisted Intracorneal Rings Implantation in Early and Moderate Cases of Keratoconus.

To study the compensatory corneal epithelial changes after femtolaser-assisted intracorneal ring segment (ICRS) implantation in early and moderate cases of keratoconus (KC) using anterior segment optical coherence tomography (AS-OCT). A prospective observational non-randomized study of 40 eyes with mild to moderate KC received femtolaser-assisted ICRS implantation. Ferrara ICRS with different arc lengths and thicknesses were used according to the patients' tomographic pattern. Patients had a clear central cornea, keratometry reading < 60 diopters, and corneal thickness > 400 microns. AS-OCT was performed preoperatively and at 1, 3, and 6 months after surgery. Corneal epithelial thickness (CET) was measured over 17 points (2 mm central and 16 points on 2-5 mm and 5-7 mm annular zones) over the pupil center. All data were collected and analyzed. Comparing the preoperative and postoperative data, there was a statistically significant increase in the CET postoperatively throughout the 6-month follow-up period in all zones (p<0.001). The epithelial thickness (ET) was noticed shortly around and central to the ring ridges by the first month (5-7 mm zone). By the third month, the flattened central cornea (2 mm zone) and the 2-5 mm zone showed a significant increase in ET up to the 6th month. ICRS implantation in KC results in a thicker and more regular epithelium in the central corneal zone as a secondary response to the corneal stromal changes induced by the implants.