Nonrandomized Study Research Articles

A systematic review, ANCOVA meta-analysis, and meta-regression of clinical trials : Orlistat and body mass index of overweight and obese patients

Background: Obesity or overfat (i.e., excessive fat accumulation in the host) contributes to cerebrocardiovascular and other diseases. Orlistat is a good obesity medication, unlike other drugs that have higher cardiac toxicity. It reversibly inhibits pancreatic and gastric lipases, and improves oxysterol metabolism. This study summarizes and elaborates the impact of orlistat on BMI in overweight and obese adult patients. Methods: All authors systematically searched and retrieved 288 controlled trial articles on orlistat and BMI from three databases, two registries, and citation searches using specific keywords. The quality and bias risks were determined by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), Risk of Bias in Non-Randomized Study (ROBINS-I), and modified Jadad scale. R version 4.2.2 software calculated the effect size and the analysis of covariance (ANCOVA) effect, and subsequently analyzed using metafor. Results: This novel meta-analysis included 114 studies with 24,600 overweight or obese participants. We showed that orlistat substantially reduced BMI (mean difference −0.78 [−0.94, −0.63], p < 0.0001; I2 = 90.19%, pheterogeneity < 0.0001). Similarly, meta-regression showed a significant impact of orlistat daily dose (ß = −0.0019), yet not for duration (ß = −0.0024) and location (ß = −0.8591, −0.0190). Conclusion: Orlistat has the capacity to reduce BMI in overweight and obese individuals. Medical practitioners shall prescribe orlistat as a BMI lowering agent to complement other intervention in those patients

A clinical study to evaluate the efficacy of yogaraja rasayana in pandu roga (w.s.r. to iron deficiency anemia)

Objectives: To evaluate the efficacy of Yogaraja rasayana in pandu. Materials and Methods: A non-randomized and open single arm study was conducted on 100 patients suffering from pandu. Results: The trial drug showed encouraging results in the overall health status of selected cases of pandu [with special reference (w.s.r.) iron deficiency anemia (IDA)] with >75% improvement in 61 cases and >50% improvement in 36 patients. Conclusion: Yogaraja rasayana is an unique herbo-mineral combination containing iron rich content ‘mandoor’ along with other herbal drugs helps in increasing the hemoglobin percentage in cases of pandu.

Effectiveness of Non-Pharmacological Interventions in the Management of Pediatric Chronic Pain: A Systematic Review

(1) Background: Chronic pain in children remains an under-researched area, especially compared to acute pain. This systematic review aims to evaluate the effectiveness of non-pharmacological interventions in the management of pediatric chronic pain and their impact on the well-being of both children and their families. Given the growing interest in integrative treatments to reduce reliance on pharmacological solutions, this review addresses the need for alternative therapeutic approaches. (2) Methods: A systematic review was conducted following the PRISMA guidelines, covering studies published between 2019 and 2024 from PubMed, Cochrane Library, Web of Science, and Scopus. Eligible studies included children aged 2 to 18 years with chronic pain who received non-pharmacological interventions. Data were extracted on intervention types, participant characteristics, and outcomes. The risk of bias was assessed using RoB2 for randomized trials and ROBINS-I for non-randomized studies. (3) Results: A total of 11 studies involving 1739 children were included, assessing interventions such as cognitive behavioral therapy, personalized psychosocial follow-up programs, hypnotherapy, music therapy, and digital tools. The results demonstrated significant reductions in pain severity, improvements in emotional and physical well-being, and high patient satisfaction. However, the generalizability of findings was limited by the small sample sizes and variability in study designs. (4) Conclusions: Non-pharmacological interventions appear effective in managing pediatric chronic pain, offering improvements in pain reduction and quality of life. Further research is needed to optimize these approaches and confirm their long-term benefits across diverse populations. These interventions represent promising alternatives or complements to pharmacological treatments in pediatric pain management.

The Effectiveness of eHealth Interventions in Promoting the Health Literacy of Informal Caregivers: A Systematic Literature Review Protocol

Background: Digital Information and Communication Technologies (ICTs) offer significant opportunities to enhance public health, particularly through their strategic use in promoting health literacy. Objectives: This systematic review protocol aims to outline the methodological steps necessary to conduct a systematic review of the effectiveness of digital interventions in improving health literacy among informal caregivers. Methods: This review will include studies involving adult informal caregivers (≥18 years) undergoing a digital health intervention promoting health literacy. Intervention, effectiveness or efficacy, RCT, quasi-experimental, and observational studies will be eligible. This review will follow the methodology for Cochrane Systematic Review and Meta-Analysis. The search strategy will identify studies published in the databases SCOPUS and Web of Science, as well as CINAHL (via EBSCO) and PubMed and gray literature sources. Two in-dependent reviewers will screen the studies, extract data, and critically appraise the selected studies. It is planned that the risk of bias will be assessed using the RoB2, Newcastle-Ottawa Scale (NOS), and the ROBINS-I (Risk Of Bias In Non-randomized Studies of Interventions). From the included studies, data will be extracted on the identification of the study, the aim of the study, characteristics of the population, study method and intervention and control conditions, study variables, and significant results. Conclusions: It is anticipated that the results of the study will guide healthcare professionals and managers in incorporating digital technologies into health literacy programs for informal caregivers. Whenever possible, a statistical meta-analysis will be performed to combine study results. The PROSPERO registration number is CRD42024589465.

What is the relationship between hospital management practices and quality of care? A systematic review of the global evidence.

There is a widely held view that good management improves organisational performance. However, hospitals are complex organisations and the relationship between management practices and health service delivery is not straightforward. We conducted a global, systematic literature review of the quantitative evidence on the link between the adoption of management practices and quality of care in hospitals. We searched in PubMed, EMBASE, EconLit, Global Health and Web of Science on 16th October 2024, without language or country restrictions. We included empirical studies from January 1, 2000, onward, examining the quantitative association between hospital management practices and quality of care. Outcomes included structural quality (availability of resources such as drugs and equipment), clinical quality (adherence to guidelines), health outcomes and patient satisfaction or experience with care. In every study, each tested association was categorised as significantly positive (at the 5 percent level), null or significantly negative. The study was registered with PROSPERO (CRD42022301462). Of 11,731 articles, 25 studies met the inclusion criteria and had acceptable risk of bias. Studies were equally distributed between high-income and low- and middle-income countries, with 22 cross-sectional and three intervention studies. Of 111 associations, 55 (49.5%) were significantly positive, 1 (1%) was significantly negative, and 55 (49.5%) were null. Among associations tested, the majority were significantly positive for structural quality (79%), clinical quality (60%) and health outcomes (57%), while most associations between hospital management and patient satisfaction (80%) were null. The findings are mixed, with a similar proportion of positive and null associations between management practices and quality of care across studies. The evidence is limited by risk of bias introduced by non-randomised study designs. Evidence of positive associations in some settings warrants further investigation of the association through intervention studies or natural experiments. This could leverage methodological developments in quantitatively measuring management, highlighted by this review.

Narrative nursing for negative emotions in patients with acute pancreatitis: Based on model construction and application.

Acute pancreatitis (AP), as a common acute abdomen disease, has a high incidence rate worldwide and is often accompanied by severe complications. Negative emotions lead to increased secretion of stress hormones, elevated blood sugar levels, and enhanced insulin resistance, which in turn increases the risk of AP and significantly affects the patient's quality of life. Therefore, exploring the intervention effects of narrative nursing programs on the negative emotions of patients with AP is not only helpful in alleviating psychological stress and improving quality of life but also has significant implications for improving disease outcomes and prognosis. To construct a narrative nursing model for negative emotions in patients with AP and verify its efficacy in application. Through Delphi expert consultation, a narrative nursing model for negative emotions in patients with AP was constructed. A non-randomized quasi-experimental study design was used in this study. A total of 92 patients with AP with negative emotions admitted to a tertiary hospital in Nantong City of Jiangsu Province, China from September 2022 to August 2023 were recruited by convenience sampling, among whom 46 patients admitted from September 2022 to February 2023 were included in the observation group, and 46 patients from March to August 2023 were selected as control group. The observation group received narrative nursing plan, while the control group was given with routine nursing. Self-rating anxiety scale (SAS), self-rating depression scale (SDS), positive and negative affect scale (PANAS), caring behavior scale, patient satisfaction scale and 36-item short form health survey questionnaire (SF-36) were used to evaluate their emotions, satisfaction and caring behaviors in the two groups on the day of discharge, 1-and 3-month following discharge. According to the inclusion and exclusion criteria, a total of 45 cases in the intervention group and 44 cases in the control group eventually recruited and completed in the study. On the day of discharge, the intervention group showed significantly lower scores of SAS, SDS and negative emotion (28.57 ± 4.52 vs 17.4 ± 4.44, P < 0.001), whereas evidently higher outcomes in the positive emotion score, Caring behavior scale score and satisfaction score compared to the control group (P < 0.05). Repeated measurement analysis of variance showed that significant between-group differences were found in time effect, inter-group effect and interaction effect of SAS and PANAS scores as well as in time effect and inter-group effect of SF-36 scores (P < 0.05); the SF-36 scores of two groups at 3 months after discharge were higher than those at 1 month after discharge (P < 0.05). The application of narrative nursing protocols has demonstrated significant effectiveness in alleviating anxiety, ameliorating negative emotions, and enhancing satisfaction among patients with AP.

Central venous catheter-related infections: a systematic review, meta-analysis, trial sequential analysis and meta-regression comparing ultrasound guidance and landmark technique for insertion

BackgroundDuring central venous catheterization (CVC), ultrasound (US) guidance has been shown to reduce mechanical complications and increase success rates compared to the anatomical landmark (AL) technique. However, the impact of US guidance on catheter-related infections remains controversial. This systematic review and meta-analysis aimed to compare the risk of catheter-related infection with US-guided CVC versus AL technique.MethodsA systematic search on MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases was conducted until July 31, 2024. Randomized controlled trials (RCTs) and non-randomized studies of intervention (NRSI) comparing US-guided versus AL-guided CVC placement were included. The primary outcome was a composite outcome including all types of catheter-related infection: catheter-related bloodstream infections (CRBSIs), central line-associated bloodstream infections (CLABSIs), catheter colonization, or any other type of reported infection. The secondary outcomes included individual infection types and mortality at day-28. Subgroup analyses based on study type and operator experience were also performed.ResultsPooling twelve studies (8 RCTs and 4 NRSI), with a total of 5,092 CVC procedures (2072 US-guided and 3020 AL-guided), US-guided CVC was associated with a significant reduction in catheter-related infections compared with the AL technique (risk ratio (RR) = 0.68, 95% confidence interval (CI) 0.53–0.88). In the RCT subgroup, the pooled RR was 0.65 (95% CI 0.49–0.87). This effect was more pronounced in procedures performed by experienced operators (RR = 0.60, 95% CI 0.41–0.89). In inexperienced operators, the infection risk reduction was not statistically significant. The pooled analysis of CRBSIs and CLABSIs also favored US guidance (RR = 0.65, 95% CI 0.48–0.87).ConclusionUS-guided CVC placement significantly reduces the risk of catheter-related infections compared to the AL technique, particularly when performed by experienced operators.Trial registration PROSPERO CRD42022350884. Registered 13 August 2022.

Evaluation of Satisfaction Levels Following Orthognathic Treatment in Adult Patients: A Systematic Review.

Dentofacial deformities can significantly impact an individual's quality of life, affecting facial aesthetics, self-esteem, and overall well-being. The combined orthognathic surgery-orthodontic treatment is the preferred approach for correcting moderate-to-severe deformities. However, patient satisfaction following orthognathic surgery remains a crucial outcome measure, influenced by various factors, including the type of malocclusion, surgical procedure, and demographic characteristics. This systematic review aimed to synthesize the available evidence regarding patient satisfaction following orthognathic surgery, exploring the effects of the type of malocclusion, surgical procedure, age, and gender on satisfaction rates, addressing a gap left by previous outdated reviews. A comprehensive literature search was conducted across multiple databases, including PubMed®, Scopus®, Web of Science™, and Embase®. Eligibility criteria were defined using the PICOS (population, intervention, comparison, outcomes, and study design) framework. Cochrane's ROBINS-I (Risk of Bias In Non-randomized Studies-of Interventions) tool was employed for non-randomized intervention studies within clinical controlled trials to assess the risk of bias. In parallel, a revised version of the Newcastle-Ottawa scale determined the methodological quality of cohort and cross-sectional studies. Sixteen studies were analyzed, revealing satisfaction levels ranging from 83% to 100%. Findings indicate that class III malocclusion patients report higher satisfaction than class II patients and satisfaction varies based on surgical type, with bimaxillary procedures generally yielding better outcomes. While most studies found no significant correlation between satisfaction and demographic factors such as age and gender, some suggested younger patients may express higher satisfaction and that female patients might report lower satisfaction levels. The review highlights the importance of effective patient communication and expectation management in achieving optimal satisfaction outcomes in orthognathic surgery. Limitations such as memory bias and methodological diversity across studies restrict the ability to perform meta-analyses, underscoring the need for further research in this area.

Impact of nonsurgical periodontal treatment on arterial stiffness outcomes related to endothelial dysfunction: A systematic review and meta-analysis.

To assess the available evidence on whether nonsurgical periodontal treatment (NSPT) improves arterial stiffness outcomes in patients with periodontitis (PD). Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and population, intervention, comparison, outcomes, and study design (PICOS) question, electronic databases were screened for clinical interventional studies addressing the impact of NSPT on pulse wave velocity (PWV), carotid intima-media thickness (CIMT), and flow-mediated dilatation (FMD) outcomes in PD patients. Furthermore, the research strategy was implemented using a hand search. Studies were selected, and data were extracted by two independent reviewers. Random effects models were applied to perform a meta-analysis, and methodological index for nonrandomized studies (MINORS) and Cochrane Rob2 tools were used to assess the risk of bias. Fifteen articles were finally included for qualitative synthesis. Among them, eight single-arm cohort studies met the final inclusion criteria for meta-analysis. The Rob2 analysis evidenced that one randomized clinical trial (RCT) had a low risk, three RCTs raised some concerns, and three RCTs had a high risk of bias, while the MINORS scores ranged from 9 to 14. The meta-analysis showed that NSPT significantly impacted FMD (p<0.001) and CIMT (p=0.004), while changes in PWV were not statistically significant. However, there was high heterogeneity among studies (I2=78% for FMD and I2=62% for CIMT). Despite some beneficial effects on FMD and CIMT, due to study limitations, high heterogeneity, and risk of bias, it cannot be concluded that NSPT is effective in improving arterial stiffness. Therefore, further studies are necessary to achieve high-quality evidence on the effect of NSPT on arterial stiffness outcomes in PD patients. PROSPERO ID CRD42024501399. Periodontitis (PD) has been associated with alterations in arterial stiffness outcomes related to early endothelial dysfunction. Based on noninterventional studies, this meta-analysis indicates that nonsurgical periodontal treatment (NSPT) may reduce cardiovascular disease risk in patients with PD. The moderate evidence derived from the studies that were finally included showed that NSPT had beneficial effects on flow-mediated dilatation and carotid intima-media thickness, while this trend was not observed for pulse wave velocity. Moreover, the findings of the present meta-analysis were characterized by high heterogeneity and risk of bias and were derived from uncontrolled clinical trials or randomized clinical trials with limitations. Therefore, more studies with standardized protocols and homogeneous arterial stiffness outcomes are needed to elevate the quality of the present evidence.

Arthroscopic assisted versus open core decompression for osteonecrosis of the femoral head: A systematic review and meta-analysis.

Minimally invasive treatment options for osteonecrosis of the femoral head (ONFH) have been a prominent area of research in recent years. Arthroscopic-assisted treatments have been applied in the clinical management of ONFH; however, high-quality evidence verifying their effectiveness and safety is still lacking. To systematically assess the clinical efficacy and safety of arthroscopic-assisted core decompression (AACD) in treating ONFH. A comprehensive literature search was conducted in PubMed, Web of Science, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, WanFang, and the Chinese BioMedical Literature Database, from inception to June 25, 2024. We identified randomized controlled trials and non-randomized controlled studies on AACD for the treatment of ONFH based on predefined inclusion and exclusion criteria. A meta-analysis was performed using Review Manager 5.4.1 and Stata 17.0 software. The analyzed outcomes included operative time, intraoperative blood loss, length of hospital stay, postoperative femoral head collapse rate, Harris hip score, and postoperative complication rate. The Grades of Recommendations, Assessment, Development, and Evaluations (GRADE) system was used to assess the quality of evidence for the outcome indicators. A total of fourteen studies were included in this meta-analysis, comprising 1,063 patients-541 in the core decompression (CD) group and 522 in the AACD group. The meta-analysis revealed no significant differences between the two groups in terms of intraoperative blood loss, length of hospital stay, 12-month postoperative Harris hip score, or overall postoperative complication rate (P > 0.05). However, the AACD group had a longer operative time (MD = 31.19, 95% Cl: 5.32 to 57.07, P = 0.02) and a lower overall postoperative femoral head collapse rate (RR = 0.49, 95% Cl: 0.27 to 0.89, P = 0.02) compared with the CD group. Additionally, the AACD group showed significant improvements in Harris hip scores at 3 months (MD = 6.39, 95% Cl: 5.44 to 7.33, P < 0.00001), 6 months (MD = 7.56, 95% Cl: 6.63 to 8.49, P < 0.00001), ≥ 24 months (MD = 7.00, 95% Cl: 4.80 to 9.21, P < 0.00001), and at the last follow-up (MD = 6.89, 95% Cl: 5.30 to 8.48, P < 0.00001) compared to the CD group. The GRADE evidence assessment indicated that the overall postoperative complication rate was supported by moderate-quality evidence, while the evidence for operative time, intraoperative blood loss, postoperative femoral head collapse rate, and Harris hip score was of low quality. The evidence for length of hospital stay was deemed very low quality. This meta-analysis suggests that AACD is an effective and safe treatment for patients with ONFH. However, due to the limited quantity and quality of the included studies, these results should be interpreted with caution. Further high-quality studies are recommended to confirm these findings.

Indocyanine green fluorescence imaging for lymph node detection and long-term clinical outcomes in colorectal cancer surgery: A systematic review and meta-analysis.

The indocyanine green fluorescence imaging (ICG-FI) technique is increasingly being used in laparoscopic colorectal surgery for lymph node mapping. However, there is no definitive standard regarding whether the application of this technique can significantly increase the detection rate of metastatic lymph nodes and improve long-term prognosis. PubMed, Embase, Web of Science, and Cochrane Library databases were searched to include studies including ICG-FI in laparoscopic colorectal surgery. Data on the detection rate of lymph nodes, metastatic rate of ICG-positive nodes, and long-term clinical outcomes were extracted following inclusion criteria. Eighteen studies with a total of 1552 patients 922 with ICG-guided laparoscopic and 630 without ICG technique were finally included. Clinical stage II/III colorectal tumors were the most commonly studies types. The patients using the ICG-FI technique had more harvested lymph nodes (weighted mean: 23.5 vs. 18.9; WMD=4.6; p<0.00001) during dissection but a lower metastasis rate of ICG-positive nodes (61/218 [28%] vs. 96/333 [28.9%]; OR=1.45; p=0.08). Compared with conventional laparoscopic colorectal surgery, additional ICG-FI technique did not improve the 3year overall survival rate (272/289 [94.1%] vs. 269/289 [93.1%]; OR=1.19; p=0.61), relapse-free survival (246/289 [85.1%] vs. 249/289 [86.2%]; OR=0.92; p=0.72), and local recurrence rate (22/289 [7.6%] vs. 28/289 [9.7%]; OR=0.77; p=0.38). The overall detection rate of sentinel lymph nodes, lymph flow, and metastatic rate of ICG-positive nodes with the help of ICG-FI were 86.8%, 89.9%, and 22.8%, respectively. No patients experienced major adverse events during ICG injection preoperatively or postoperatively. Indocyanine green fluorescence imaging-guided procedure, compared to conventional laparoscopic dissection, can assist in obtaining a greater number of harvested lymph nodes and metastatic lymph nodes, however, it did not significantly improve the long-term clinical outcomes. Level III systematic review of randomized control and nonrandomized studies.

A systematic review of mental health stigma reduction trainings for law enforcement officers.

The aim of the present systematic review was to evaluate the outcome of law enforcement officer (LEO) trainings on mental health (MH) stigma and other outcomes. A systematic search of Pubmed, APA PsycInfo, and Cochrane Central Register of Controlled Trials was conducted to identify studies examining MH stigma trainings implemented within the LEO profession. Both randomized and nonrandomized studies were considered. Risk of bias was assessed via the Cochrane Risk-of-Bias tool for randomized trials and the Risk of Bias in Non-Randomized Study of Intervention (Version 2). The present review identified 18 studies comprised of 2,399 participants (Mage = 37.37, SD = 4.76). Samples were predominantly composed of police officers (k = 16), followed by correctional officers (k = 2) and both (k = 1). Although the review aimed to investigate trainings targeting institutional, public, and self-stigma, all studies implemented trainings intended to decrease public stigma. Outcomes evaluated across studies included attitudes toward MH, knowledge about MH, self-efficacy/confidence, behavioral responses/de-escalation skills, social distance, and awareness, support, and utilization of MH resources. Although the outcomes evaluated were somewhat consistent across studies, there was variability in how variables were defined and measured. Due to this, data could not be compared across studies, and thus, conclusions could not be drawn regarding which trainings demonstrated the most effectiveness in reducing MH. Despite the increased research investigating the outcomes of trainings on stigma within the LEO population, the variability in methodology and the high rate of bias exhibited across studies suggest that more rigorous and better quality evaluations are warranted. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Modified Balloon Use After Rotational Atherectomy Reduces Major Adverse Cardiovascular Event Rates in Severely Calcified Coronary Lesions: A Systematic Review and Meta-Analysis.

Background/Objectives: Calcified coronary lesions require plaque modification techniques for optimal stent apposition, of which rotational atherectomy (RA) is the most commonly used one. Challenging cases require the use of additional dedicated devices (such as modified balloons, MB); however, data available for evidence-based device selection are limited. The aim of this study is to determine the impact of the balloon-based technology used after successful RA treatment on outcomes. Methods: This study was carried out according to the PRISMA guidelines. MEDLINE, CENTRAL and Embase databases were systematically searched for eligible randomized and non-randomized studies. Results: A total of nine studies and 1024 patients were included in the analysis. Patients were treated with RA followed by either plain balloon angioplasty (RA + BA) or modified balloon (RA + MB) treatment prior to stent implantation. There was no significant difference in MACE (major adverse cardiovascular events; OR: 0.53; 95% CI: 0.21-1.34; p = 0.153), all-cause mortality (OR: 0.68; 95% CI: 0.33-1.42; p = 0.265), and target lesion revascularization (OR: 0.64; 95% CI: 0.27-1.55; p = 0.264) between the two groups. However, a sensitivity analysis demonstrated a significant decrease in MACE for patients with severely calcified lesions (OR: 0.42; 95% CI: 0.25-0.70; p = 0.009) in the RA + MB group. The analyses of the safety outcomes of slow flow/no reflow (OR: 0.59; 95% CI: 0.29-1.22; p = 0.128) and coronary artery perforation (OR: 1.18; 95% CI: 0.70-1.99; p = 0.480) showed no difference between the two groups. Conclusions: Our meta-analysis suggests that the benefit of the more invasive RA + MB treatment is statistically significant for severely calcified lesions, but is not associated with additional procedural complications.

NEW TECHNOLOGIES AVAILABLE FOR MICRONEUROSURGICAL REMOVAL OF ACOUSTIC NEUROMAS

Introduction The aim of this study was to analyze the results of microsurgery removal of acoustic neuromas (AN) using new technologies: flexible hand-held laser fiber, Sonopet Ultrasound Aspirator, Facial Nerve “detector” monopolar stimulation (for localize position and course of facial nerve), BAER’s with level specific (LS) CE-Chirp stimulus for hearing preservation, endoscope for IAC final check, and injectable bone substitute for closure. We report a retrospective nonrandomized clinical study on 300 cases consecutively operated on. Material and Methods From July, 2010 to December, 2023, 350 consecutive patients suffering from AN have been operated on with microneurosurgical technique by key-hole retrosigmoid approach. In majority of cases tumor resection was performed with the aid of a handheld flexible laser fiber. In the same period, Sonopet Ultrasound aspirator was used for tumor debulking and/or opening of the internal auditory meatus and canal. From May 2015, hearing preservation by means LS CE-Chirp BAER was attempted in patients with preoperative socially useful hearing (AAO-HNS class A and B). In addition, we check the removal of tumor inside the internal auditory canal (IAC) by using the flexible and/or rigid endoscope, for completing tumor removal near the fundus. Results Overall time from incision to skin suture changed in relation to size of tumor (from 165 to 575 minutes) and was not affected by the use of hand-held laser. Facial nerve function was clinically assessed with the House-Brackmann (HB) scale preoperatively, in the early postoperative period (after 1 week), and at 6-month follow-up. In 3 cases a preoperative facial nerve palsy was observed (HB III and HB IV, respectively). In the remaining cases, 6 months after surgery facial nerve preservation rate (HB I) was 92%, Hearing preservation rate (AAO-HNS A and B, pre- and postoperatively) was 52% in eligible cases. Total and “nearly total” removal of tumor was possible in about 80% of cases. Dura closure was performed with underlaying autologous pericranium. Injectable bone substitute in the gaps after bone flap repositioning minimized postoperative CSF leakage and improved the aesthetic result. Conclusions The use of new technologies (handheld flexible laser fibers, Sonopet Ultrasound Aspirator, fluoreceine, Nimbus facial nerve continuous monitoring, LS CE-Chirp BAER, endoscope for IAC final check) in AN microsurgery seems to be safe and efficacious and facilitates tumor resection, especially in ‘‘difficult’’ conditions (e.g., large size, highly vascularized, or hard tumors). The good functional outcome following conventional microsurgery seems to be further improved and the extent of tumor removal could be increased with the proper use of the new technologies available in the neurosurgical armamentarium.

Effectiveness of a three-component intervention supporting unemployed individuals with mental health issues in their job search and mental health recovery (3for1): study protocol of a non-randomized controlled study

BackgroundThere is a vicious cycle between unemployment and mental health issues. Unemployed individuals with mental health issues require individualized support at multiple levels in order to promote their mental health, and obtain and retain employment. The 3for1-intervention program aims to provide such support with three components (short-term psychotherapy, job coaching based on the Individual Placement and Support approach, and peer support). This study protocol outlines how the effectiveness of this three-component intervention program in terms of re-employment, mental health, and psychosocial outcomes will be evaluated.MethodsThe 3for1-intervention program will be evaluated with a non-randomized controlled trial design in a multi-center study. 500 eligible participants aged between 18 and 60 years from six job centers in Southern Germany will be allocated to a control group or an intervention group. Allocation is time-based, with the control group being recruited first, followed by recruitment of the intervention group. The control group will receive treatment as usual, whereas the intervention group will receive treatment as usual as well as access to the three intervention components over a period of 12 months. Assessment will be conducted at baseline (t0), and 12 (t1) and 18 (t3) months later. The primary outcome will be the proportion of participants who are in employment subject to social insurance contributions at t1. Differences between control and intervention group will be tested with logistic regression analysis, controlling for relevant covariates. Analyses of secondary outcomes will relate to group differences regarding re-employment, health and well-being, social integration, help-seeking, and self-stigma at t1 and t2, applying logistic regression analysis or analysis of covariance. Additionally, usage of health services will be measured to evaluate the intervention program’s cost effectiveness.DiscussionThe 3for1-intervention aims to improve employability and mental health outcomes of a vulnerable population with high need for assistance. Improvements for this population would benefit the German welfare state as well. This study could provide valuable insights into the feasibility, implementation, and sustainability of this individualized, multi-level support program within German job centers.Trial registrationThis trial is registered with the German Clinical Trials Register: DRKS00029002 (registered on 11 May 2022).

Impact of structured checklist-based preoperative counseling versus standard counseling on postoperative patient-reported outcomes after elective surgery

IntroductionSurgery, even on an elective-basis, often induces significant stress in patients, characterized by preoperative anxiety and heightened stress levels due to anticipation of the unknown. However, the primary objective of preoperative counseling is to mitigate these concerns, particularly when delivered in a structured and comprehensive manner. While previous research has highlighted the beneficial impact of preoperative counseling on patient-reported outcomes, none have specifically explored the implementation of a structured checklist-based approach during counseling sessions. To bridge this gap in the literature, our study aims to investigate the effects of implementing a checklist-based structured counseling approach on patient-reported outcomes following elective surgery.MethodsIn this prospective cohort study conducted over one year from January to December 2023, a total of 600 patients undergoing elective surgery across three specialties—orthopedic surgery, general surgery, and urology—were examined. The patients were divided into two groups: an intervention group consisting of 300 patients and a control group with an equal number of patients. The study evaluated three key outcomes—postoperative pain, anxiety, and satisfaction—at three specific time points following surgery: 24 h, 48 h, and 72 h.ResultsPatients receiving structured checklist counseling showed significantly lower pain scores (24 h: 6.6 vs. 7.03, p = 0.041; 48 h: 5.62 vs. 6.55, p = 0.029; 72 h: 2.54 vs. 2.90, p = 0.035) and anxiety scores (24 h: 8.58 vs. 9.25, p = 0.039; 48 h: 7.50 vs. 8.45, p = 0.030; 72 h: 4.53 vs. 5.98, p = 0.031), as well as higher satisfaction scores (24 h: 5.99 vs. 5.06, p = 0.043; 48 h: 6.99 vs. 6.02, p = 0.033; 72 h: 9.10 vs. 8.20, p = 0.039) compared to controls. These improvements were consistently significant across all three surgical specialties studied (p < 0.05).ConclusionThe structured checklist-based counseling method proves to be effective and essential. This method is associated with reduced postoperative pain and anxiety levels, along with increased patient satisfaction, when compared to the standard approach.Level of evidenceProspective non-randomized study, Level II.

Impact of arteriovenous fistula formation on trajectory of kidney function decline: a target trial emulation

Abstract Background Prior nonrandomised studies have suggested nephroprotective effects of arteriovenous fistula (AVF) formation, but these are plausibly susceptible to immortal time and selection biases. Methods We studied patients attending nephrology clinics in the West of Scotland during 2010-2022 with an eGFR ≤15mL/min/1.73m2 and no prior AVF. Using target trial emulation and a sequential trial design, we simulated a hypothetical trial that would randomise patients to either undergo AVF formation immediately or not to undergo AVF formation. The primary outcome was the difference in eGFR slope for the first six months of follow-up, estimated using a mixed-effects model. The secondary outcomes were 5-year absolute risks of dialysis and death, estimated using the Aalen-Johansen and Kaplan-Meier estimators respectively. Results 1,364 unique patients (mean age 51.1, 55.7% male) contributed 3,125 person-trials, with 561 in the AVF and 2,564 in the no AVF group. Mean eGFR was 12.6mL/min/1.73m2 and the median number of eGFR measurements per person-trial was 7 (IQR 4 – 12). Slope of eGFR decline did not differ significantly between the AVF and no AVF groups (between group difference -0.67mL/min/1.73m2/year, 95%CI -1.43, 0.10). The 5-year absolute risk of dialysis was 87% (95%CI 84, 91) in the AVF group and 75% (95%CI 73, 77) in the no AVF group and the 5-year survival probability was 77% (95%CI 70, 83) in the AVF group and 67% (95%CI 64, 69) in the no AVF group. Conclusions In this study of patients with advanced CKD, there was no evidence of a nephroprotective effect of AVF formation.

Sutureless Bioprostheses for Aortic Valve Replacement: An Updated Systematic Review with Long-Term Results.

Background: In recent years, in case of aortic valve replacement (AVR), a significant increase in the use of bioprostheses has been observed. The Perceval sutureless bioprosthesis has proven to be safe and reliable in the short and mid-term, with limited but promising long-term results. An updated systematic review with the long-term results of patients who underwent a sutureless bioprosthesis implantation with a Perceval biological valve is herewith presented. Methods: Studies published between 2015 and 2024, including the long-term outcomes-with clinical as well as echocardiographic information for up to five years-of patients who underwent a Perceval implantation for AVR were selected from the published literature. The Cochrane GRADE system was used to assess the study quality, and the risk of bias in non-randomized studies (ROBINS-I) tool was used to evaluate studies. Results: Ten studies were selected with an overall number of 5221 patients. The long-term survival ranged from 64.8 to 87.9%, freedom from structural valve degeneration (SVD) from 96.1 to 100%, freedom from significant paravalvular leak from 98.5 to 100%, freedom from prosthetic endocarditis from 90.7 to 99%, and freedom from reintervention from 94 to 100%. The long-term mortality ranged from 6.5 to 27.4%. SVD was observed in 0-4.8% patients. Significant paravalvular leak was observed in 0-3.4% patients, and infective endocarditis was observed in 0-3.4%. A bioprosthesis-related reintervention at long-term follow-up was required for 0-4.3% of patients, and 1.7-7.1% of patients required a late new pacemaker implantation. The transprosthetic mean pressure gradient ranged from 9 to 14.7 mmHg, peak pressure gradient ranged from 17.8 to 26.5 mmHg, and EOA ranged from 1.5 to 1.7 cm2. Conclusions: This systematic review shows that there is still a paucity of data about sutureless bioprostheses. Nevertheless, the clinical results from prospective studies or retrospective series are encouraging. Medium- and long-term results seem to support the increasing use of this type of prosthesis.

Meta-Analysis of the Efficacy of Rapid Rehabilitation Surgical Nursing in Lumbar Disc Herniation.

Background: Lumbar disc herniation (LDH) is a common cause of lower back pain and radiculopathy. In recent years, the enhanced recovery after surgery (ERAS) concept has been increasingly applied in orthopedics and gastrointestinal surgery. Purpose: To investigate the effect of using rapid rehabilitation surgical care for lumbar disc herniation by meta-analysis. Data source: Google Scholar, PubMed Medical, Cochrane and Embase databases were used for the analysis. Research selection: An initial search yielded a total of 322 relevant articles. Duplicate pieces of literature were screened using Endnote. In addition, non-randomized controlled trials and studies with a sample size of less than 30 were excluded. A total of seven papers were included in this study. Main outcomes: The Rapid Rehabilitation Surgical Nursing (RRSN) group showed significantly higher patient satisfaction (RR = 1.24; 95% CI: 1.06, 1.26; p < 0.01) and self-assessed health (Total MD = 5.67; 95% CI: 4.27, 7.06; p < 0.01) compared to the Normal Nursing (NN) group. Pain levels (MD = -0.66; 95% CI: -0.97, -0.36; p < 0.01), disability levels (MD = -18.64; 95% CI: -32.53, -4.76; p < 0.01), anxiety risk (SAS-MD = -4.33; 95% CI: -6.23, -2.44; p < 0.01), and depression risk (SDS-MD = -4.29; 95% CI: -7.50, -1.07; p < 0.01) were significantly lower in the RRSN group compared to the NN group. According to the GRADE classification, the certainty for patient satisfaction is high, while the certainty for post-care pain, functional capacity, risk of psychological disorders, and self-assessed health status is moderate. Conclusions: Rapid recovery surgical nursing can significantly improve postoperative recovery of lumbar disc herniation, increase patient satisfaction, reduce the risk of psychological disorders, improve lumbar function, and alleviate patient pain.

Timing Matters: A Comprehensive Meta-Analysis on the Optimal Period for Cranioplasty After Severe Traumatic Brain Injury

BACKGROUND AND OBJECTIVES: Craniectomy is a commonly performed procedure in severe traumatic brain injury (TBI) to control intracranial hypertension and reduce mortality. The optimal timing for cranioplasty after craniectomy remains a topic of debate. The aim of this study was to investigate the ideal timing for cranioplasty after severe TBI, focusing on complications associated with temporal aspects and materials used in cranioplasty. METHODS: Multiple databases, including PubMed, Embase, Cochrane, and Web of Science, were searched for studies reporting on the subject. Inclusion criteria involved randomized and observational studies comparing early and late cranioplasty procedures. Quality assessment was performed using the Methodological Index for Non-Randomized Studies scale. Results were pooled in a single-arm meta-analysis and presented as mean and 95% confidence interval. RESULTS: Early cranioplasty was associated with a lower likelihood of subdural effusion (odds ratio [OR] 0.3735 [0.1643; 0.8490], P = .0187). However, no differences were detected for the presence of infection between both groups (OR 0.7460 [0.2065; 2.6945], P = .6548). Cranioplasties performed within or equal to 3 months from the TBI incident were associated with a reduced likelihood of minor complications (OR 0.4471 [0.2467; 0.8102], P = .0080). Paradoxically, this time frame exhibited an elevated risk of hydrocephalus (OR 3.2035 [1.4860; 6.9059], P = .0030), as well as total complications (OR 1.4190 [1.0453; 1.9262] P = .0248). CONCLUSION: This comprehensive review highlights the current lack of consensus on the optimal timing for cranioplasty after severe TBI. Early cranioplasty, within 35 days, showed a reduced risk of subdural effusion, but no disparity in the odds of infection was found. A reduced incidence of minor complications was observed in the earlier approach, however with an elevated risk for hydrocephalus and total complications. The association between timing and complications, including hydrocephalus, highlights the need for further research and standardization in this critical aspect of TBI management.