Nonrandomized Study Research Articles

Bilateral internal iliac artery ligation in trauma patients with severe pelvic hemorrhage: A systematic review

Introduction Severe pelvic hemorrhage significantly contributes to mortality in trauma patients, yet the most effective treatment for severe pelvic injuries remains unclear. This systematic review evaluates the mortality and morbidity associated with bilateral internal iliac artery ligation (BIIAL) in patients experiencing severe hemorrhage from traumatic pelvic fractures. Methods Comprehensive searches were conducted in MEDLINE PubMed, EMBASE, and Cochrane databases until February 7, 2024, to identify relevant articles. The risk of bias in observational studies was assessed using the ROBINS-I tool, which evaluates bias risk in nonrandomized intervention studies. The primary outcome was mortality following BIIAL, with the secondary outcome being complications related to the procedure. Results The review included eight studies, all observational. The overall mortality rate after BIIAL ranged from 45.0% to 76.9%. Ischemic complications from BIIAL were infrequent. A high and unclear risk of bias due to confounding and participant selection was noted across the studies. Four studies highlighted distinct indications for BIIAL compared to angioembolization. BIIAL was employed for patients with severe hemodynamic instability or when angiography was not available. Conclusion Due to geographical limitations and significant heterogeneity among the studies reviewed, the true effect size of BIIAL remains indeterminate. Nevertheless, further prospective studies with robust designs are necessary. BIIAL holds potential as a viable option when angioembolization is not accessible or in cases of critical patient instability.

Brexucabtagene autoleucel versus allogeneic hematopoietic cell transplantation in relapsed and refractory mantle cell lymphoma

Abstract Brexucabtagene autoleucel (brexu-cel) and allogeneic hematopoietic cell transplantation (alloHCT) are effective treatments for relapsed or refractory mantle cell lymphoma (r/r MCL), but the optimal choice remains unclear. We conducted an analysis of 64 r/r MCL patients aged ≥50 years treated with brexu-cel in the ZUMA-2 study, matching them 1:1 by propensity score to 64 (out of 272) r/r MCL patients who underwent alloHCT using data from the EBMT registry. Median follow-up time was 36.5 and 34.1 months for the brexu-cel and matched alloHCT cohort, respectively. Brexu-cel patients had a significantly higher overall survival (OS, 81.3% vs 59.2%, HR: 0.39, p=0.004) and lower non-relapse mortality (3.6% vs 21.2%, p=0.015) one year after treatment. Chronic graft-vs-host disease occurred in 26.9% of alloHCT patients within the first year. However, long-term progression-free survival and OS remain comparable. Despite limitations of this non-randomized study, it indicates a superior safety profile for brexu-cel in r/r MCL.

Design and evaluation of a unilateral brace for preventing clubfoot relapse: A prospective study

Introduction The Ponseti technique is highly effective for correcting congenital clubfoot; however, recurrence must be prevented using orthoses. The double abduction brace (D- A) is recommended by Ponseti and is widely used. However, more user-friendly orthoses have been developed because treatment abandonment with the traditional orthosis is frequent. We report the results obtained using a newly designed unilateral orthosis. Methods A unilateral orthosis (UNIC-Brace) was developed and tested in a prospective non-randomized study conducted between 2017 and 2020. The Pirani score was used to monitor the progression of the deformity during plaster correction. The D-A brace (Denis Browne model) served as the control group. The primary outcomes were recurrence rate, treatment adherence, and caregiver satisfaction. Results The study included 58 patients (87 feet) in the test group and 51 patients (75 feet) in the control group, with a minimum follow-up period of 3 years. No significant differences in epidemiological data or follow-up duration were observed between the two groups. The failure feet rates in D-A brace and UNIC-Brace groups were 41.3% and 17.2%, respectively ( p < .001). Non-adherence patients to treatment were 23.5% in the D-A brace and 13.8% in the UNIC-Brace group ( p < .001). Overall, 13.7% of families were not satisfied with the D-A orthosis, whereas 5.2% were not satisfied with the UNIC- Brace ( p < .001). Conclusions The UNIC-Brace yielded better outcomes than the traditional orthosis at a minimum follow-up period of 3 years.

Does conservative or arthroscopic management of canine medial coronoid disease lead to improved outcomes?

Question In dogs diagnosed with medial coronoid disease, does arthroscopic surgical intervention, compared with conservative management, result in improved mobility and reduced pain? Clinical bottom line Category of research: Treatment. Number and type of study designs reviewed: Three studies were identified directly addressing the PICO question. One paper was a retrospective cohort study, another study was a prospective randomised control trial, and the third was a non-randomised non-blinded observational study. Strength of evidence: Weak. Outcomes reported: The first study was a prospective non-randomised study that did not identify a difference in gait evaluation at the 52 week recheck in dogs treated conservatively compared to those treated arthroscopically, with lameness exacerbated in the arthroscopic treatment group until the 26 week recheck. The second study, a retrospective non-randomised cohort study, showed greater, but not statistically different, owner-reported clinical metrology scores in dogs treated arthroscopically compared to those treated conservatively. Liverpool Osteoarthritis in Dogs (LOAD) and Pain Severity Scores (PSS) were higher but not statistically significant, yet Pain Interference Scores (PIS) were statistically significantly higher at 52 weeks in arthroscopically treated dogs compared to conservatively treated dogs. Age at diagnosis and at time of questionnaire completion were statistically significant for LOAD, PSS, and PIS, with older dogs having higher scores. The third study performed a non-blinded observational study assessing canine patients with bilateral medial coronoid disease, with unilateral arthroscopic subtotal coronoidectomy performed on the most clinically affected limb. Radiographs and computed tomography (CT) imaging were performed at diagnosis, with radiographs taken at follow-up. At the time of follow-up, arthroscopically treated limbs had a higher radiographic score than those treated conservatively, although a significant improvement in lameness was seen at the walk in arthroscopically treated limbs. Conservatively managed dogs showed an unchanged (non-significant) gait. Radiographic changes did not appear to correlate to severity of clinical signs. Conclusion: The quality of the published evidence available to answer the PICO question is weak, due to the design of the three reviewed studies. Low patient populations in these three studies also hinder the statistical power of any recommendations made. None of the three studies assesses the complex nature of medial coronoid disease to clearly answer the question posed. The decision to recommend arthroscopy over conservative management therefore depends on the judgement and experience of the veterinary surgeon attending the case. Additionally, assessment of the imaging findings is important when discussing prospective treatment options.

Online Hearing Voices Peer Support Groups: Assessing Feasibility and Acceptability within UK NHS Settings

Abstract Background User-led hearing voices groups (HVGs) have existed for the past 40 years, but little research has been conducted into if and how this approach can be implemented in statutory mental health settings, and whether they can be delivered effectively when held online. The aim of this study was to conduct a feasibility and acceptability trial of an online HVG for the UK National Health Service (NHS) users who hear voices, to inform a future larger-scale trial. Methods A mixed-methods non-randomised feasibility study of an online HVG was conducted with nine participants. Participants attended weekly online meetings for six months, and completed measures of social connectedness, voice hearing, personal recovery, as well as semi-structured interviews, at baseline and 6-months follow-up. Primary outcomes were qualitative and quantitative assessments of feasibility and acceptability. Results 38 participants were referred to the trial, nine of whom were recruited (100% of target sample). The trial had high retention (100%) and engagement (mean = 13.2 groups attended). Participants reported positive features of attending this digital intervention, with 85% reporting it was helpful to meet other voice hearers, that the group helped them make sense of voice hearing experiences, that they received positive messages about recovery, and that the group represented a form of support they could not get elsewhere. Discussion The findings indicate it is feasible and acceptable to run an online HVG within an NHS setting. A larger trial is needed to further investigate the utility, efficacy and cost-effectiveness of running online HVGs in the NHS.

Is platelet-rich plasma better than steroids as epidural drug of choice in lumbar disc disease with radiculopathy? Meta-analysis of randomized controlled trials

The current meta-analysis was performed to analyze the efficacy and safety of platelet-rich plasma (PRP) as an epidural injectate, in comparison with steroids in the management of radiculopathy due to lumbar disc disease (LDD). We conducted independent and duplicate searches of the electronic databases (PubMed, Embase and Cochrane Library) in March 2024 to identify randomized controlled trials (RCTs) analyzing the efficacy of epidural PRP for pain relief in the management of LDD. Animal or in vitro studies, clinical studies without a comparator group, and retrospective or non-randomised clinical studies were excluded. Diverse post-intervention pain scores [visual analog score (VAS)] and functional scores [Oswestry Disability Index (ODI), SF-36], as reported in the reviewed studies, were evaluated. Statistical analysis was performed using STATA 17 software. 5 RCTs including 310 patients (PRP/Steroids = 153/157) were included in the analysis. The included studies compared the efficacy and safety of epidural PRP and steroids at various time-points including 1, 3, 6, 12, 24, and 48 weeks. Epidural PRP injection was found to offer comparable pain relief (VAS; WMD = −0.09, 95% CI [−0.66, 0.47], p = 0.641; I2 = 96.72%, p < 0.001), functional improvement (ODI; WMD = 0.72, 95% CI [-6.81, 8.25], p = 0.524; I2 = 98.73%, p < 0.001), and overall health improvement (SF-36; WMD = 1.01, 95% CI [−1.14, 3.17], p = 0.224; I2 = 0.0%, p = 0.36) as epidural steroid injection (ESI) at all the observed time points in the included studies without any increase in adverse events or complications. Epidural administration of PRP offers comparable benefit as epidural steroid injection (ESI) in the management of radiculopathy due to LDD. The safety profile of the epidural PRP is also similar to ESI.

Impact of thoracoscopic segmental lung resection versus wedge on early post-operative recovery and short-term prognosis in elderly patients with early non-small cell lung cancer: A retrospective non-randomised controlled cohort study.

The post-operative rehabilitation and prognostic indexes of thoracoscopic segmental resection and wedge resection in the treatment of early-stage non-small cell lung cancer (NSCLC) were retrospectively analysed. The objective of this study was to provide a theoretical basis for the treatment of early-stage NSCLC in the elderly. One hundred and twenty elderly patients diagnosed with early-stage NSCLC in our hospital from January 2018 to December 2021 were selected as study subjects. The patients were divided into the thoracoscopic segmental lung resection group and the thoracoscopic wedge resection group. Various clinical data were compared between the two groups of patients. In the thoracoscopic wedge resection group, operation time, anaesthesia time, intraoperative blood loss, post-operative chest tube volume, chest tube indwelling time and hospital stay were significantly higher compared to the thoracoscopic segmental lung resection group. Patients undergoing segmental resection also had higher Visual Analogue Scale scores and serum indices. In addition, the mini-mental state examination scores were lower in the segmental resection group compared to the wedge resection group. Thoracoscopic segmental resection and thoracoscopic wedge resection were both safe and feasible for the treatment of NSCLC. However, thoracoscopic segmental resection had the advantage of effectively reducing the amount of intraoperative bleeding, shortening the operation time and having less impact on lung function and physical function. This was conducive to the patient's faster recovery after surgery.

Clinical efficacy and safety of P-15 peptide enhanced bone graft substitute in surgical bone regenerative procedures in adult maxillofacial, spine, and trauma patients : a systematic literature review.

Autologous bone graft (ABG) is considered the 'gold standard' among graft materials for bone regeneration. However, complications including limited availability, donor site morbidity, and deterioration of regenerative capacity over time have been reported. P-15 is a synthetic peptide that mimics the cell binding domain of Type-I collagen. This peptide stimulates new bone formation by enhancing osteogenic cell attachment, proliferation, and differentiation. The objective of this study was to conduct a systematic literature review to determine the clinical efficacy and safety of P-15 peptide in bone regeneration throughout the skeletal system. PubMed, Embase, Web of Science, and Cochrane Library were searched for relevant articles on 13 May 2023. The systematic review was reported according to the PRISMA guidelines. Two reviewers independently screened and assessed the identified articles. Quality assessment was conducted using the methodological index for non-randomized studies and the risk of bias assessment tool for randomized controlled trials. After screening, 28 articles were included and grouped by surgical indication, e.g. maxillofacial procedures (n = 18), spine (n = 9), and trauma (n = 1). Published results showed that P-15 peptide was effective in spinal fusion (n = 7) and maxillofacial (n = 11), with very few clinically relevant adverse events related to P-15 peptide. This systematic literature review concluded that moderate- (risk of bias, some concern: 50%) to high-quality (risk of bias, low: 46%) clinical evidence exists showing equivalent safety and efficacy in bone regeneration using a P-15 peptide enhanced bone graft substitute compared to ABG. P-15 peptide is safe and effective, resulting in rapid bone formation with a low probability of minor complications.

Immediate results of laparoscopic spleen-preserving distal pancreatectomy: Kimura vs Warshaw procedure

To study the immediate results of spleen-preserving distal pancreatectomy and to compare the outcomes after Kimura and Warshaw procedures. A retrospective non-randomized study included 27 patients with benign tumors of pancreatic tail and body who underwent spleen preserving distal pancreatectomy between 2020 and 2024. All patients were divided into 2 groups: 1 - Kimura procedure (n=16), 2 - Warshaw procedure (n=16). We excluded patients who underwent enucleations, central resections, and other interventions instead of distal pancreatectomy. Mean surgery time was 269.06±70.95 (95% CI 227.74 - 319. 95) and 197.27±42.09 min (95% CI 184.36 - 240.64), respectively (p=0.006). Blood loss, length of hospital day, incidence of laparotomy, splenectomy, splenic infarction, and redo surgeries were similar. Clinically significant postoperative fistula B-C was more common in 1st group (10 (62.4%) vs. 5 (45.5%) cases, p=0.028). There were no significant between-group differences in the incidence of postoperative complications Clavien-Dindo grade >III and mortality. Laparoscopic spleen preserving distal pancreatectomy is the «gold» standard for benign tumors of pancreatic body and tail. The Warshaw and Kimura techniques are safe and effective surgical approaches with similar results. The Warshaw procedure may be more advantageous regarding less surgical resources without deterioration of immediate postoperative results.

The effect of self-compassion versus mindfulness interventions on autonomic responses to stress in generalized anxiety disorders

ObjectiveAlthough research on psychological interventions in generalized anxiety disorder (GAD) has provided evidence of their effectiveness regarding self-reported outcomes, few studies have examined their psychophysiological effects. Heart rate is emerging as a potential biomarker of efficacy in anxiety disorders. This study aimed to investigate the effects of a self-compassion intervention versus a mindfulness intervention on physiological arousal in response to induced stress.MethodsForty-seven patients with GAD had heart rate data collected during a stress task before and after a 2-week pharmacological treatment (known as treatment as usual, TAU), a self-compassion intervention + TAU or a mindfulness intervention + TAU. They also reported state anxiety, positive affect, and negative affect at pre- and post- intervention before the stress task. ANOVAs were conducted to analyze the effects on electrocardiogram data self-reported measurements.ResultsSelf-compassion intervention uniquely decreased heart rate response to a stressor whereas mindfulness intervention did not. Both treatments decreased state anxiety and negative affect to a stressor, while increased positive affect in this context. We also demonstrated a significant correlation between decreased heart rate response and less negative emotions.ConclusionThe Findings provides novel physiological evidence that self-compassion interventions buffer stress reactivity in individuals with GAD. Attention shall be paid to the limitations in small and unequal sample size and a non-randomized study design.

Point-of-care tests in the emergency medical services: a scoping review

BackgroundThis scoping review aimed to summarize existing research on point-of-care tests (POCTs) within emergency medical services (EMS). There is a lack of comprehensive reviews covering the breadth and scope of application of POCTs in EMS despite growing interest and potential benefits in this setting. A review of the research will inform how we target future research efforts to support effective implementation and avoid duplication.MethodsWe searched three databases to April 2023 using comprehensive terms for POCTs. One author screened titles and abstracts, full-text papers and extracted data with a second author checking the data. A scoping review framework was used to categorise studies according to demographics, study design, medical conditions, biomarkers and test devices.ResultsWe found 141 papers that included 158 reports of 9 study designs, 155 reports of 40 combinations of biomarker and condition and 161 reports of 41 test-devices. The majority of research was done in the UK (19%), US (17%), and the Netherlands (16%), mostly in land-based EMS (82%). Most frequently assessed were troponin for acute coronary syndromes (26%), lactate for sepsis (14%) or lactate for trauma/critical illness (13%). The majority of research designs investigated the accuracy of the tests (43%). Few studies were of a design to inform guidelines to change patient pathways and the associated outcomes, including, randomised controlled trials (RCTs) (4%), non-randomised studies able to assess causality (6%), economic analyses (1%) or qualitative work on acceptability (3%). In those few cases where RCTs were done there were long delays between initial test-accuracy research and publication of the first RCT, for example 11 years delay for troponin for acute coronary syndromes.ConclusionsWe identified a thriving base of research on POCT in the EMS, however most studies established the diagnostic accuracy of the tests with few RCTs, economic analyses or qualitative research on acceptability. The time-lag from diagnostic accuracy to developing an RCT is considerable. Investment in funding and infrastructure is needed to support the research pathway for potential POCTs beyond diagnostic accuracy to designs able to assess clinical effectiveness, acceptability and economic effectiveness.

Effectiveness of Gastric Cancer Endoscopic Screening in Intermediate-Risk Countries: Protocol for a Systematic Review and Meta-Analysis.

Gastric cancer (GC) is the fifth most prevalent neoplasm worldwide and the fourth with the highest mortality, and its geographical distribution is not homogeneous with high-risk, intermediate-risk (IR), and low-risk areas. Advanced stages at diagnosis are related to high mortality, but early detection greatly increases the chances of survival. Upper endoscopy with biopsy is the gold standard for GC diagnosis. Several studies have investigated the relevance of endoscopic screening and how to implemente it in IR countries. However, most Western societies recommend screening only in selected populations with high-risk factors for GC. No systematic reviews on GC endoscopic screening in IR countries exist. We aimed to determine the effectiveness of endoscopic GC screening in IR countries. We will include randomized and nonrandomized controlled trials, cohort studies, case-control studies, cross-sectional studies, and economic studies focusing on endoscopic screening of GC in the asymptomatic population of IR countries. The search will be conducted in MEDLINE, SCOPUS, Embase, and Web of Science. Other gray literature sources will be additionally searched. Studies published in English, Portuguese, or Spanish until September 2024 will be included. Two independent reviewers will screen the titles and abstracts of all search results. The selected studies will then be fully analyzed, and the data will be collected and coded in a database. To minimize the risk of bias, the included studies will undergo a quality analysis according to Cochrane risk of bias tools, RoB 2 of randomized trials and ROBINS-I for nonrandomized trials; Newcastle-Ottawa Quality Assessment Scale for case-control and cohort studies; and National Heart, Lung and Blood Institute study quality assessment tools for cross-sectional studies. The data collected will be cataloged in 2 categories: efficacy or effectiveness data and economic data, and separate meta-analyses will be performed for each category if appropriate. This study is expected to provide results on the efficacy, effectiveness, and cost-effectiveness of endoscopic screening in an IR population. To date, 969 studies were screened for title and abstract, 75 were selected for full-text screening, and 44 were retained for data analysis. Additionally, 2 studies were selected from our manual search. Currently, the study is in the early stages of data extraction and risk of bias assessment and is expected to be published in the first quarter of 2025. To our knowledge, this review will be the first to provide evidence on the effectiveness of endoscopic GC screening in IR countries. In doing so, we believe we will help guide future research, inform health care decisions and assist policy makers in this area, and support future decisions to implement GC screening programs in this type of population. PROSPERO CRD42024502174; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=502174. DERR1-10.2196/56791.

Treatment satisfaction and patient reported outcomes among people with opioid use disorder participating in an open-label, non-randomised trial of long-acting injectable buprenorphine treatment in Australian custodial settings.

A trial of long-acting injectable buprenorphine (LAIB) in Australian prisons allowed examination of treatment satisfaction and patient-reported outcomes. UNLOC-T was a 16-week non-randomised open-label study. Men and women aged ≥18 years with moderate/severe DSM-5 opioid use disorder currently serving a custodial sentence ≥6 months were recruited. Participants not in opioid agonist treatment (OAT) commenced LAIB (n = 67); those already stable on oral methadone treatment were recruited to a comparison arm (n = 62). The Treatment Satisfaction Questionnaire for Medication (TSQM), Patient Satisfaction Visual Analogue Scale (PS-VAS) and Treatment Burden Questionnaire assessed treatment satisfaction; the Kessler Psychological Distress Scale (K10), 12-Item Short Form Health Survey (SF-12) and the Australian Treatment Outcomes Profile (ATOP) measured mental health, physical health and quality of life. Among participants receiving LAIB, TSQM global satisfaction scores significantly increased from 68.2 (SD 16.6) to 77.0 (SD 18.4) by week 16 (p = 0.0041), as did satisfaction measured by the PS-VAS (62.5 [SD 29.2] vs. 79.4 [SD 25.5], p = 0.0005). Statistically significant improvements between baseline and week 16 were also observed for K10, SF-12 (total) and SF-12 (mental health) scores. By the end of the study, 'successful' treatment outcomes were observed in the ATOP domains of psychological health (84%), physical health (80%) and quality of life (86%). Participants inducted and stabilised on LAIB reported high treatment satisfaction and improved health and wellbeing. Results suggest LAIB is acceptable to people with opioid use disorder in custody, supporting scaleup of this medication to increase coverage of OAT in these settings. https://www.anzctr.org.au ACTRN12618000942257.

Effect of endoscopic sinus surgery on eustachian tube function in adult patients with chronic rhinosinusitis

BackgroundChronic rhinosinusitis (CRS) is a frequent chronic heterogeneous inflammatory disease of the upper airways and paranasal sinuses persistent for ≥ 12 weeks causing considerable healthcare expenses and reduction of patients’ quality of life due to severe tiredness and disappointment as well as diminished cognitive function. CRS is commonly associated with eustachian tube (ET) dysfunction.Aim of the studyTo evaluate the effect of endoscopic sinus surgery on ET function in the form of (tympanogram, Valsalva maneuver, and total ET dysfunction questionnaire score), in adult patients with CRS.MethodThis non-randomized clinical trial study was conducted at the Otorhinolaryngology department, the Faculty of Medicine, Cairo University, on 40 patients > 18 years old, suffering from CRS with or without sinonasal polyposis who are indicated for endoscopic sinus surgery (ESS) and were recruited from Otorhinolaryngology department’s outpatient clinic in the period from November 2022 to June 2023. All selected patients were subjected to a full history taken, a full general examination, and a local otorhinolaryngology examination. Routine preoperative laboratory investigation including complete blood count (CBC), liver and kidney function tests, and coagulation profile. An electrocardiogram (ECG) examination was done routinely for all patients above 40 years old. Radiological examination included the following: preoperative CT nose and paranasal sinus, axial and coronal soft tissue cuts, and bone windows. Assessment of ET function was done using the ET dysfunction questionnaire (ETDQ-7), Valsalva maneuver, and tympanogram. ET function was reevaluated 6 weeks post-operative in the form of an ETDQ-7, Valsalva maneuver, and tympanogram.ResultsThe ages of selected patients ranged from 21 to 45 years old with mean ± SD = 30.98 ± 10.24 years old. 52.5% of patients were males. Our results showed a statistically significant postoperative improvement in the Valsalva maneuver and the tympanogram type of both ears compared to preoperative with a p-value < 0.001. Similar results were found regarding the assessment of ET function using ETDQ-7 items and the total score (15.35 ± 4.92 vs 26.12 ± 7.79 respectively) with p-value < 0.001.ConclusionA significant improvement in ET function in the form of tympanogram, Valsalva maneuver, and total ET dysfunction questionnaire score, following endoscopic sinus surgery in adult patients with CRS with or without sinonasal polyposis.

Influence of preoperative variables on the 3-month functional outcomes of the Vivity extended depth-of-focus intraocular lens: a prospective case series

BackgroundTo investigate the functional results of the AcrySof IQ Vivity (Alcon, Fort Worth, TX) extended depth-of-focus intraocular lens (EDoF-IOL) and explore correlations between the preoperative biometric parameters and the postoperative functional outcomes.MethodsIn a prospective, single-center, non-randomized study, axial length, keratometry, anterior chamber depth, scotopic and photopic pupil diameters, pupil decentration, corneal asphericity, corneal higher-order aberrations (HOAs), coma and spherical aberration were measured preoperatively. The EDoF-IOL was implanted bilaterally. Three months postoperatively, manifest refraction, monocular and binocular uncorrected and corrected visual acuity at 4 m, 66 cm and 40 cm, binocular defocus curve, binocular contrast sensitivity, halometry and Strehl ratio were measured. Visual disturbances and spectacle independence were assessed with McAlinden and IOLSAT questionnaires, respectively. Assuming a minimum Pearson r correlation coefficient between variables of 0.5 with a power of 80% and a P value less than 0.05, a minimum sample size of 29 (58 eyes) cases was required.ResultsForty-three patients were enrolled. Binocular distance corrected visual acuity was lower than 0.1 logMAR for a defocus between + 1.0 and − 1.5 D. The mean values at 66 cm and 40 cm were − 0.07 ± 0.06 and 0.19 ± 0.13 logMAR, respectively. McAlinden’s questionnaire revealed mean scores close to zero for all questions. The IOLSAT questionnaire showed that spectacles were never used for distance and intermediate vision. Regression analysis did not disclose any significant correlation between the preoperatively measured variables and the postoperative outcomes, with a few exceptions: preoperative higher order corneal aberrations were correlated to halometry area (r2 = 0.2592, P = 0.0006) and the Q value to contrast sensitivity (r2 = 0.1717, P = 0.00574) under photopic conditions with glare at a spatial frequency of 18 cpd and without glare for all spatial frequencies (P < 0.01); it was also correlated to contrast sensitivity under mesopic conditions without glare at a spatial frequency of 12 cpd (r2 = 0.2311, P = 0.0011).ConclusionsIn healthy unoperated eyes, the visual outcomes for this EDoF-IOL are independent of most of the patients’ preoperative parameters. Attention should be paid to preoperative corneal aberrations and asphericity, which did not lead to visual disturbances, but may be potential sources of halo and reduced contrast sensitivity.

Endovascular treatment versus bypass in long SFA atherosclerotic lesions: a non-randomized comparative study

Background: The TransAtlantic Inter-Society Consensus (TASC II) classification categorizes superficial femoral artery (SFA) lesions. This study compares endovascular therapy and bypass surgery for treating challenging TASC II C and D SFA lesions, which are typically complex and involve severe disease. Purpose: the aim is to compare the outcome of endovascular interventions versus surgical bypass in treatment of superficial femoral artery atherosclerotic TASC II C&amp;D lesions in patients with critical limb ischemia in terms of patency and limb salvage within one year follow up. Patients and methods: our study included 41 patients in bypass group (groub A) and 74 patients in endovascular group (groub B) with atherosclerotic TASC II C&amp;D SFA lesion. Patients with non-salvageable limbs, acute ischemia, trauma, aneurysms, connective tissue disorders and arteritis were excluded. All patients had Rutherford 4 to 6. Saphenous vein and synthetic grafts were used in bypass group. POBA, DCB and stents were used in endovascular group. The patients were followed up for 1 year.Results: mean Patients’ age was 63.15 years in endo group and 58.76 years in bypass group, male 78.4% in endo group and 85.4% in bypass group. Patients’ presentation was incapacitating claudications, rest pain, minor tissue loss, and major tissue loss. Technical success achieved in 100% in bypass cases and 95.9%in endo group. 1ry patency rate was 71.4% in the bypass group versus 57.6% in the endo group, still not significant statistically (p-value 0.171). The assisted 1ry patency was 77.1% in bypass group and 83.3% in the endo group,.(p.value 0.449) 2ry patency rates was 82.9% and 89.4% in bypass and endo groups respectively. Our 1-year limb salvage rates were 85% in the bypass group versus 91.7%, the rate was better in the endo group but with statistically insignificant p.value between them (p: 0.343). The rate of reintervention was higher in endo group (31.8%) than bypass group (11.4%) which was statistically significant, (p.value 0.024). Overall mortality during follow up was only 1 patient in the bypass group (2.4%). the bypass group had higher complication rate (41.5%) than the endovascular group (12.2%) with statistically significant (p.value &lt;0.001). Conclusion: Bypass surgery and endovascular management have comparable short terms outcomes in terms of patency and limb salvage in treating long SFA atherosclerotic lesion TASC II C&amp;D. Rate of reintervention is higher with endovascular strategy. However, with lower morbidity and mortality compared with surgery.

Outcomes of Surgical and Non-Surgical Management of Primary Intracerebral Haemorrhage: A Non-Randomized Clinical Trial

Background: Management of primary intracerebral haemorrhage is very important in the context of outcomes. Objective: The purpose of the present study was to compare the outcomes of surgical and non-surgical management of primary intracerebral haemorrhage. Methodology: This non-randomized clinical trial study was conducted in the Department of Neurosurgery at Dhaka Medical College Hospital, Dhaka, Bangladesh from January 2006 to December 2007 for a period of two (02) years. All patients with primary intracerebral haematoma admitted in the Department of Neurosurgery in study period managed conservatively or surgically is the study population. Selected patients were divided into two group of which patients in group A were treated surgically and the group B patients were treated conservatively. Best medical treatment was given for nonsurgical group and operation were done for surgical group and followed up after surgery till discharge by observing GCS, neurological improvement and GOS at discharge. Results: Of the total 60 subjects selected for study, 30 cases were in group A and the rest of 30 cases were in group B. The both groups were almost identical in terms of age. Distribution of patients in relation to age had no significant difference (P­=0.7). In group A 13(43.3%) patients were died and the survival rate was in 17(56.6%) cases. On the other hand, in group B mortality rate were 15(50.0%) patients and survival rate were 15(50%) patients (P=0.605). Considering the Glasgow outcome scale, in group A 13(43.3%) patients died and 7(23.3%) patients had severe and moderate disability and 3(10.0%) patients had good outcome. In group B 15(50%) patients died and 8(26.7%) patients had severe disability as well as 7(23.3%) patients had moderate disability (p=0.360). Conclusion: In conclusion there is no significant difference of outcomes of surgical and non-surgical management of primary intracerebral haemorrhage. Journal of National Institute of Neurosciences Bangladesh, January 2024;10(1):12-16

A phase 2 study of amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) in metastatic pancreatic cancer.

TPS790 Background: Patients with advanced pancreatic adenocarcinoma (PDC) that progresses after first-line therapy face limited treatment options. Despite advances in systemic therapy, the prognosis for PDC is dismal, with a five-year overall survival (OS) of about 5% . Due to the high morbidity of this disease, there is a critical need for innovative treatments to improve patient outcomes. TheraBionic P1, a hand-held device, delivers tumor specific radio frequencies via a spoon-shaped antenna placed on the patient's tongue. The FDA and EMA have confirmed the safety of the device for amplitude-modulated electromagnetic field (AM-EMF) therapy. Improved efficacy outcomes were reported with AM RF EMF in other solid organ tumors including pancreatic cancer in preliminary studies. Preclinical and clinical evidence suggests that AM-EMF can inhibit tumor growth and was recently approved for use in hepatocellular cancer. The safety and clinical activity observed with AM RF EMF, paired with the unmet medical need for additional effective therapies in pancreatic cancer, provided a strong rationale for further clinical investigation. This protocol evaluates the efficacy and tolerability of AM RF EMF in combination with standard of care frontline therapy, gemcitabine and nab-paclitaxel for metastatic PDC. Methods: This is an ongoing, single-center, Phase II, non-randomized study using a Simon two-stage minimax design to assess the efficacy of AM-EMF in combination with gemcitabine/nab-paclitaxel as a first-line treatment in metastatic pancreatic cancer. Gemcitabine and nab-paclitaxel are administered per standard care. AM RF EMF are delivered to patients with a spoon-shaped applicator placed on the tongue three daily 60-minute treatments. Patients will be assessed for response every 8 weeks. Treatment is continued until progression or toxicity. The primary objective of this study is to evaluate the efficacy of the combination of nab-paclitaxel, gemcitabine, and AM RF EMF in improving 6-month overall survival rates in patients with metastatic PDC. Secondary objectives evaluate the safety, tolerability, profession free survival, objective response rate and disease control rate. Exploratory objectives evaluate change in CA19-9 and quality of life using FACT-General (FACT-G) and determine any possible correlation with clinical outcomes. Key eligibility includes treatment-naïve, histologically confirmed metastatic PC, age eighteen years old or greater, ECOG 0-1, and optimal organ function. Clinical trial information: NCT05776524 .

Comparing Cryoprecipitate-Poor Plasma to Fresh Frozen Plasma as Replacement Therapy in Thrombotic Thrombocytopenic Purpura: an Updated Meta-Analysis

Cryoprecipitate-poor plasma (CPP) has been suggested as a promising alternative to the standard fresh frozen plasma (FFP) in plasma exchange therapy (TPE) for thrombotic thrombocytopenic purpura (TTP) given its lower concentrations of von Willebrand Factor (VWF). However, its efficacy and safety remain a topic of debate. We conducted a systematic review and meta-analysis comparing CPP to FFP during TPE in patients with TTP. PubMed, Embase, and Cochrane Central were systematically searched for studies reporting outcomes of all-cause mortality, relapse rate, response to treatment, and the mean number of TPE sessions. Sensitivity analyses restricted to randomized controlled trials (RCTs) were performed. Review Manager v5.4 and RStudio v4.1.2 were used for statistical analysis. The protocol was prospectively registered in PROSPERO (ID CRD42023440665). Eight studies, including three RCTs and five non-randomized studies, met the eligibility criteria. A total of 290 patients with TTP were included, of whom 144 (49.7%) received CPP and 146 (50.3%) received FFP. Use of CPP was associated with lower mortality (RR 0.41; 95% CI 0.23-0.72; p=0.002; I²=0%), while the subgroup analysis restricted to RCTs showed no statistical difference between groups (p=0.36). No significant differences were found in relapse rate, response to treatment, or mean number of TPE sessions between groups. Our findings show that the use of CPP is not inferior to FFP in TPE. Given the limited population, future clinical trials are needed to elucidate its benefits compared to FFP in patients with TTP.

Mechanical circulatory support for complex, high-risk percutaneous coronary intervention.

The evidence base evaluating the use of mechanical circulatory support (MCS) devices in complex, high-risk percutaneous coronary intervention is evolving from a small number of randomised clinical trials to incorporate an amassing body of real-world data. Due to both the growing incidence of the procedures and the limitations of the evidence, there is wide variability in the use of MCS, and the benefits are actively debated. The goal of this review is to perform an integrated analysis of randomised and non-randomised studies which have informed clinical and regulatory decision-making in contemporary clinical practice. In addition, we describe forthcoming studies that have been specifically designed to advance the field and resolve ongoing controversies that remain unanswered for this complex, high-risk patient population.