Nonrandomized Cohort Study Research Articles

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.

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.

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.

Ten years of transitional pain service research and practice: where are we and where do we go from here?

Chronic postsurgical pain (CPSP) is a prevalent yet unintended consequence of surgery with substantial burdens to the individual and their family, the healthcare system, and society at large. The present article briefly reviews the evidence for transitional pain services (TPSs) that have arisen in an effort to prevent and mange CPSP and persistent opioid use, and provides an update on recent novel risk factors for CPSP. Available evidence from one randomized controlled trial (RCT) and three non-randomized cohort studies suggests that TPS treatment is associated with better opioid use outcomes, including fewer opioid tablets prescribed at discharge, better opioid weaning results, a lower incidence of new-onset chronic opioid use, and lower consumption of opioids even at later time points up to 1 year after surgery. Another RCT indicates TPS treatment can be enhanced by provision of perioperative clinical hypnosis. While these preliminary studies are generally positive, large-scale, RCTs are needed to provide a more definitive picture of whether TPSs are effective in reducing opioid consumption and improving pain and mental health outcomes in the short and long term. With the expansion of TPSs across North America and globally, perioperative care focused on reducing the transition to pain chronicity has the potential to help millions of patients. With additional evidence from well-controlled RCTs, TPSs are well poised to continue to evolve and strengthen the role of multidisciplinary care teams in the immediate postdischarge period and beyond.

Automatic multimodal registration of cone-beam computed tomography and intraoral scans: a systematic review and meta-analysis.

To evaluate recent advances in the automatic multimodal registration of cone-beam computed tomography (CBCT) and intraoral scans (IOS) and their clinical significance in dentistry. A comprehensive literature search was conducted in October 2024 across the PubMed, Web of Science, and IEEE Xplore databases, including studies that were published in the past decade. The inclusion criteria were as follows: English-language studies, randomized and nonrandomized controlled trials, cohort studies, case-control studies, cross-sectional studies, and retrospective studies. Of the 493 articles identified, 22 met the inclusion criteria. Among these, 14 studies used geometry-based methods, 7 used artificial intelligence (AI) techniques, and 1 compared the accuracy of both approaches. Geometry-based methods primarily utilize two-stage coarse-to-fine registration algorithms, which require relatively fewer computational resources. In contrast, AI methods leverage advanced deep learning models, achieving significant improvements in automation and robustness. Recent advances in CBCT and IOS registration technologies have considerably increased the efficiency and accuracy of 3D dental modelling, and these technologies show promise for application in orthodontics, implantology, and oral surgery. Geometry-based algorithms deliver reliable performance with low computational demand, whereas AI-driven approaches demonstrate significant potential for achieving fully automated and highly accurate registration. Future research should focus on challenges such as unstable registration landmarks or limited dataset diversity, to ensure their stability in complex clinical scenarios.

P0952 Effect of a Care Pathway for Inflammatory Bowel Disease on Patient Outcomes and Healthcare Utilization: results of the IBD Value Study

Abstract Background Eight hospitals in the southwest of the Netherlands collaborate to improve care for patients with inflammatory bowel disease (IBD). This collaboration aims to deliver high quality and uniform care across the region. To achieve this, a care pathway (CP) was developed and implemented for the management of IBD with biologicals or small new molecules. The CP is a decision-support tool that provides guidelines for medication prescribing, procedures, treatment adjustments, and recommendations for follow-up. The aim of this study is to evaluate the effect of a CP on patient outcomes and healthcare utilization. Methods We designed a longitudinal multicentre non-randomised cohort study with a baseline observation period (December 2020 – December 2021) and a follow-up period (March 2022 – March 2023), in which adult patients with IBD treated with biologics or small new molecules were included (1). Outcomes were collected according to the International Consortium for Health Outcomes Measurement (ICHOM) standard set from electronic medical records or through validated questionnaires. Effect of the CP on these outcomes were analysed with case-mix adjusted (generalized) linear mixed models. Results A total of 1,173 patients participated in the study, with the majority being female (55%) and a median age of 45 years (IQR 33-58). Most patients had Crohn’s disease (64%). The CP was associated with a 14% increase in the probability of patient-reported disease control (p=0.54). Increases in probability were also observed for patient-reported (β=0.25, p=0.29) and biochemical remission (β=0.17, p=0.37), and the presence of active fistulas (β=0.28, p=0.44). Decreases in probability were found for biological (β=-0.04, p=0.84) and clinician-reported remission (β=-0.16, p=0.48). Emergency room visits (β=-0.32, p=0.18), hospital admissions (β=-0.28, p=0.28), and length of stay (β=-0.23, p=0.20) showed reduction, although these associations were also not significant. The CP had no effect on quality of life (β=0.01, p=0.35) or on anaemia probability (β=0.05, p=0.84). Conclusion A CP for the management of IBD with biologicals and small new molecule has clinically significant potential to reduce healthcare utilization, while improving patient-reported disease control, and biochemical remission. These results emphasize the potential of a CP to improve care for a complex disease as IBD. However, the adherence to the CP and whether these results lead to a reduction in healthcare costs, should be further investigated.

Ultrasound-guided Transperineal Prostate Thermal Ablation (TPTA) for Benign Prostatic Hyperplasia: Feasibility of an Outpatient Procedure using Radiofrequency Ablation.

To evaluate the feasibility, safety, and short-term (3-month) results of transperineal prostate thermal ablation (TPTA) as a minimally invasive outpatient treatment for benign prostatic hyperplasia (BPH). A prospective nonrandomized study of 25 patients with lower urinary tract symptoms secondary to BPH seeking care at 2 interventional radiology centers between March and July 2024. TPTA was performed using a 17G radiofrequency needle with a 10-mm active tip under unconscious sedation combined with bilateral perineal and periprostatic nerve blocks. The primary outcome measure was technical success, defined as successful bilateral ablation of the prostate transition zone. Secondary outcome measures included changes of international prostate symptom score (IPSS), quality of life (QoL), prostate volume, intravesical prostatic protrusion (IPP), prostate-specific antigen (PSA), post-void residual volume (PVR), maximum urinary flow rate (Qmax), and need for BPH medical therapy at 3months relative to baseline. All procedures were technically successful (100%). The median patient age was 69.4years (IQR 54-74), and all were discharged within 3h of the end of the procedure. Sixteen patients (64.0%) were discharged without a urinary catheter, and 6 patients (24.0%) reported mild complications. At 3-month follow-up, there were significant reductions in IPSS (79.1%), QoL score (70.3%), prostate volume (36.9%), IPP (70.8%), PSA (54.7%), and PVR (51.1%), whereas Qmax increased significantly (102.3%). Twenty-four patients (96.0%) reported discontinuation of medical therapy after TPTA. Ultrasound-guided TPTA using radiofrequency ablation is feasible and safe in the outpatient setting, with significant clinical improvements after 3months of the procedure. Level 3 [non-randomized prospective cohort study].

Diagnostic accuracy of 99mTc-HDP SPECT/CT and MRI for foot and ankle osteoarthritis (ProSPECT-trial): Study protocol.

Accurate localisation of symptomatic osteoarthritic (OA) lesions in the midfoot, hindfoot and ankle remains challenging due to their complex anatomy. Conventional radiographs have limitations in complex areas or overlapping structures. SPECT/CT has shown promising results in detecting symptomatic OA lesions, yet its superiority over MRI, the current standard for soft tissue pathology, remains uncertain. We designed the ProSPECT-trial to systematically investigate the diagnostic accuracy of SPECT/CT compared to MRI in OA of the foot and ankle. The ProSPECT-trial is a non-randomised single-center prospective cohort study. Eligible patients with suspected OA of the midfoot, hindfoot and ankle are recruited. Diagnostic performance of SPECT/CT and MRI is assessed based on sensitivity, specificity, positive and negative predictive values. Intra- and interobserver reliability of both imaging modalities are evaluated. Imaging protocols include SPECT/CT using technetium-99m hydroxymethylene disphosphonate (99mTc-HDP) and MRI without contrast agents. Anatomical regions are scored for OA presence using standardised radiographic- and clinical criteria. Diagnoses are confirmed via ultrasound-guided injections containing steroid and anaesthetics. With a calculated sample size of 369 patients, the study aims to show significant sensitivity and specificity differences between SPECT/CT and MRI, assuming a 15 % clinically relevant difference. The ProSPECT trial assesses the diagnostic accuracy of SPECT/CT and MRI in midfoot, hindfoot, and ankle OA. The findings aim to standardise clinical decision-making and guide future treatment protocols, ultimately optimising patient care and resource utilisation in managing midfoot, hindfoot, and ankle OA.

Cone beam computed tomography outcomes in patients diagnosed with compromised bone health undergoing dental implant therapy and bone augmentation

Studies examining mid-term treatment outcomes of implant placement with bone augmentation in patients with compromised bone health are lacking. The purpose of this prospective, nonrandomized cohort study was to evaluate the cone bean computed tomography (CBCT) outcomes of implant placement with bone augmentation in postmenopausal women. For this best practice, standard of care study, 78 participants received 1 test implant along with 1 or a combination of 3 bone augmentation procedures: particulate graft, expansion, or block graft. Participants were categorized as healthy (n=49) or bone compromised (n=29). Using CBCT scans made preoperatively, immediately postoperatively, and 2 years postoperatively, the augmented alveolar ridge widths were measured in a buccolingual (BL) dimension 2mm and 6mm apical to the coronal aspect of the implant's rough surface. Additionally, peri-implant bone height was measured on the mesial and distal implant surfaces at the mid-alveolar aspect of the ridge using a coronal panoramic view. Both study groups exhibited an increase in horizontal BL measurements at the 2-mm and 6-mm landmarks from preoperative to immediate postoperative time points and a minimal decrease from intermediate postoperative to 2 years postoperative. The mean proximal height decreased over time in healthy participants but did not show a significant change in participants with compromised bone. The linear mixed effects model results revealed that the mean difference between groups significantly decreased over time at the 2-mm landmark (P<.05); however, no significant group-time interactions were found for the BL width at the 6-mm landmark and proximal height measurements (P=.627). Mid-term CBCT measurements showed significant bone augmentation immediately after surgery and 2 years after surgery and stable proximal bone adjacent to implants in postmenopausal women diagnosed with compromised bone health.

Specific Recommendations for the Evaluation of Orphan Drugs in Spain: The EvalRare project

Introduction and Objective: Rare diseases (RDs) are low-prevalence conditions that significantly impact patients’ lives, often requiring orphan drugs (ODs) for treatment. This study aims to establish a national framework for assessing the quality of clinical evidence for ODs in Spain, to better manage associated uncertainties and support informed decision-making by stakeholders. Materials and Methods: A qualitative study using focus group methodology was carried out. A review was conducted to identify evaluation criteria from Therapeutic Positioning Reports (TPRs) by the Spanish Agency for Medicines and Health Products (AEMPS) and the GENESIS group of the Spanish Society of Hospital Pharmacy (SEFH). A multidisciplinary focus group of experts from national, regional, and hospital levels discussed and refined these criteria, proposing new variables and reaching consensus on final recommendations. Results: Key evaluation criteria were identified, including study design, comparison type, primary clinical endpoints, study population, and study duration. Recommendations were categorized by acceptability, addressing the specific challenges in OD development. While randomized clinical trials remain the gold standard, alternative designs, such as uncontrolled non-randomized cohort studies, may be acceptable under certain conditions, particularly when there is a significant unmet medical need and no alternative therapies. Both clinical endpoints and validated quality of life metrics are crucial in assessing ODs. Smaller sample sizes and shorter study durations may be acceptable if justified by the disease’s characteristics and the clinical relevance of the outcomes. Conclusion: The proposed framework offers a tailored guide for evaluating the clinical evidence of ODs, providing recommendations that may enhance decision-making by stakeholders for determining patient access to OD treatments. Key words: orphan drugs, evaluation, research methodology, health decision-making, recommendations, rare diseases.

Management of obesity with semaglutide or metformin in patients with antipsychotic-induced weight gain (MOSA): a non-randomised open-label pilot study

BackgroundAntipsychotic-induced weight gain (AIWG) represents a significant clinical challenge for both patients and clinicians, requiring appropriate interventions to prevent or reverse weight gain in patients using antipsychotics. Glucagon-like peptide 1 (GLP-1) agonists represent a novel approach to the management of obesity that has recently attracted considerable attention. Semaglutide (a GLP-1 agonist) has been demonstrated to result in notable weight loss. The present study investigates whether semaglutide is equally effective in achieving weight loss in patients with AIWG.MethodsA prospective, non-randomised cohort study was conducted with the objective of evaluating the efficacy and safety of oral semaglutide for the treatment of AIWG in routine outpatient clinical practice. Subsequently, the results were compared with those of a control group of AIWG patients taking metformin.ResultsAfter 16 weeks, the mean body weight loss was 4.5 kg (95% confidence interval (CI), -6.7 to -2.3 kg; p < 0.001) in the semaglutide group (n = 10) versus 2.9 kg (95% CI, -4.5 to -1.4 kg; p < 0.001) in the metformin group (n = 26). This corresponds to an average body weight loss of 4% for semaglutide, and 2.5% for metformin. The respective reductions in body mass index (BMI) and waist circumference were -1.7 kg/m2 (95% CI, -2.4 to -1.0 kg/m2; p < 0.001) and -6.8 cm (95% CI, -9.7 to -3.8 cm; p < 0.001) for semaglutide. The observed reductions for metformin were -0.8 kg/m2 (95% CI, -1.4 to -0.3 kg/m2; p = 0.001) and -3.4 cm (95% CI, -5.4 to -1.3 cm; p = 0.001). The differences between the two groups were not statistically significant. In both groups, adverse effects were typically mild and transient, predominantly nausea. Furthermore, psychiatric symptoms were reduced, and quality of life improved.ConclusionsOral semaglutide represents a viable, effective, and safe treatment option for psychiatric patients. However, further investigation is required to corroborate these findings.

The impact of smartphone-dispatched CPR-trained volunteers on OHCA outcomes is influenced by patient age

The early initiation of cardiopulmonary resuscitation (CPR) measures by non-professionals before the arrival of Emergency Medical Service (EMS) is known to be crucial for improving outcomes after out-of-hospital cardiac arrest (OHCA). We assessed the impact of deploying CPR-trained volunteers via a smartphone-based alerting system on the outcome of OHCA patients. In a retrospective nonrandomized cohort study, all OHCA cases in the city of Aachen over a six-year period were analysed. We compared patient data, CPR metrics, alerting system data as well as outcome data between the intervention and control groups. From June 2017 to May 2023, 101 out of 852 resuscitations were initiated by volunteers alerted via a smartphone-based alerting system in OHCA events. We found no overall rise in the return of spontaneous circulation (ROSC) rate. An age-dependent subgroup analysis indicated an increased incidence of initially shockable rhythms and an increased ROSC rate for patients younger than 60 years in the intervention group, while implying a lower ROSC rate in patients older than 80 years after mobile responder CPR. Although this study was underpowered to yield statistically significant results, our findings suggest the need for an age-sensitive approach when evaluating the effects of first-responder systems on OHCA cases.

Higher compliance with the enhanced recovery after surgery protocol improves postoperative recovery and 6-month mortality in upper gastrointestinal surgery

IntroductionThe enhanced recovery after surgery (ERAS) protocol has been proven to accelerate recovery without increasing morbidity, but few data are available from developing countries. We aimed to demonstrate the correlation between compliance with the ERAS protocol and short-term outcomes in upper gastrointestinal (UGI) surgery. Materials and MethodsPatients that underwent esophageal and gastric surgeries during March 2019 to June 2021 were prospectively enrolled in this nonrandomized cohort study. The ERAS protocol was applied based on patient-doctor agreement. Patients were categorized into conventional care (CC), moderate-compliance (MC), and high-compliance (HC) groups. Short-term outcomes including gastrointestinal (GI) function recovery, length of hospital stay (LOS), postoperative complications and mortality rate were compared. Results158 patients were enrolled: 58 in the CC, 33 in the MC, and 67 in the HC group. The HC group demonstrated reduced time to tolerate oral diet (8 vs 7 vs 3 days; p = 0.034), recovery of GI function (72 vs 96 vs 61 h; p = 0.001) and median LOS (12.5 vs 10 vs 6 days; p < 0.001). Postoperative overall (p = 0.08) and major complications (p = 0.09) were not significantly different. Non-surgical complications were lower in the HC group (31.0 % vs 54.5 % vs 25.4 %; p = 0.013). The 28-day readmission rate was not different (8.6 % vs 3.0 % vs 1.5 %; p = 0.14). The 30-day postoperative mortality was not different (0 % vs 3.1 % vs 0 %; p = 0.15), but the 6-month mortality rate was significantly lower in the HC group (13.8 % vs 15.2 % vs 0 %; p < 0.001). ConclusionThe level of compliance with the ERAS protocol is associated with improved short-term postoperative outcome in UGI surgery. High compliance patients recovered faster, were discharged sooner, and had better 6-month survival.

Daily intake of a dairy-based nutritional supplement improved self-reported gastrointestinal symptoms and modulated microbiota in adult Chinese volunteers

Mild and persisting gastrointestinal symptoms (MPGS) as bloating, constipation or diarrhea are widespread in older adults and often accompanied by gut microbiota dysbiosis. Nutritional interventions help to regulate and restore microbiota and gut function. In this non-randomized continuous prospective cohort study, we evaluated the effects of a 21-day intervention using a dietary dairy-based supplement (AGIJOY™) on self-reported gastrointestinal (GI) symptoms, fecal microbiota composition and short chain fatty acids (SCFA) levels in a cohort of Chinese adults (N = 46, age 27–73) suffering from MPGS. Questionnaire data and fecal samples were collected at baseline (D0), on day 7 and 21 of intervention (D7 and D21). The results showed significant improvement in the self-reported GI symptoms on D21 and a gradual shift in the fecal microbiota composition. In the first week of intervention, the relative abundance (RA) of fecal bifidobacteria significantly increased and the RA of Bacteroides and Helicobacter decreased (p < 0.05). The levels of fecal SCFA remained unchanged during the study. To our knowledge, this is the first study testing the effect of this prebiotic and postbiotic containing milk-based supplement blend on gut microbiota and MPGS among Chinese population under a real living environment.

Treatment of Posttraumatic Zygomatic Coronoid Ankylosis. Systematic Review.

Facial trauma is mostly associated with traffic accidents, fights, and sports accidents. The mandible, midface, and temporomandibular joint are usually the region's most frequently affected. Coronoid process fractures are rare, representing ∼2% of facial fractures in the literature, usually being the result of direct trauma to the zygomatic region. Due to the anatomical relationship of the coronoid process, it may be associated with other facial fractures, such as fractures of the zygomatic bone. Zygomatic-coronoid ankylosis is a rare clinical entity with variable etiology. It is most commonly associated with trauma (13%-100%), local or systemic infection (0%-53%), or systemic diseases, such as ankylosing spondylitis, rheumatoid arthritis, or psoriasis. The aim of this research is to evaluate the different treatments for ankylosis from the coronoid process to the zygoma after trauma, allowing to determine the treatment to obtain the best results. A systematic review was carried out following PRISMA "preferred reports for systematic reviews and meta-analyses" search matrix, based on a PICO question; was used PubMed, Embase, Sciencedirect, Cochrane, Google Scholar, and manual search in high-impact journals between 1946 and 2023 publications in English or Spanish, including randomized and nonrandomized clinical trials, prospective and retrospective cohort studies, case-control studies, series, and case reports. A total of 1993 articles were obtained from the 4 databases. After corroborating duplicate articles, 847 articles were excluded. Another 1112 articles were excluded in the title evaluation, and an additional 1093 after the abstract review; a total of 19 articles eligible for full-text evaluation were established and 1 article was added as a result of the manual search. After the full-text review, it was decided to include 16 articles in the study that met the objectives of the systematic review. After evaluating the different treatments described in the literature, the authors can determine that coronoidectomy through an intraoral approach is the most appropriate treatment for zygomatic coronoid ankylosis, accompanied by postoperative physiotherapy to achieve greater oral opening without recurrences.

Risk of cancer development associated with disease-modifying therapies for multiple sclerosis: study protocol for a systematic review and meta-analysis of randomised and non-randomised studies

BackgroundThe association between cancer and multiple sclerosis has long been investigated. Several studies and reviews have examined the risk of cancer among patients with multiple sclerosis treated with disease-modifying therapies (DMTs) but with conflicting results. This study will aim to investigate the association between DMTs for multiple sclerosis and subsequent cancer risk using research synthesis methods.Methods/designWe designed and registered a study protocol for a systematic review and meta-analysis. We will include randomised and non-randomised trials, prospective or retrospective cohort studies, and case–control studies of treatment with DMTs compared with placebo, no treatment, or another active agent. The primary outcome will be the risk of cancer (all-malignant neoplasms) in association with the exposure of DMTs. Secondary outcomes will include site-specific cancers (e.g. breast cancer). Literature searches will be conducted in multiple electronic databases (from their inception onwards), including the following: PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). Two researchers will screen all citations, full-text articles, and abstract data independently. The risk of bias (quality) of individual studies will be appraised using an appropriate tool. If feasible, we will use a two-stage approach to evidence synthesis: (1) Peto’s method for meta-analysis of data from randomised trials alone; and (2) Random-effects model for meta-analysis adding data from non-randomised studies. We will calculate odds ratios and their associated 95% confidence intervals. Potential sources of heterogeneity will be explored in additional analyses (e.g. subgroups considering different DMTs individually, mechanism of action, type of control, length of follow-up, mode of treatment).DiscussionThis systematic review and meta-analysis of randomised and non-randomised studies will provide an updated synthesis of the risk of cancer associated with DMTs for adult patients with multiple sclerosis. This study will also examine some factors that may explain potential variations across studies. The findings will be published in a peer-reviewed journal.Systematic review registrationOpen Science Framework (https://osf.io/v4sez).

The Effectiveness of Letrozole Alone or in Combination with Methotrexate in the Management of Ectopic Pregnancy, A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to investigate the effect of letrozole alone or in combination with Methotrexate on the management of ectopic pregnancy. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were applied for reporting. The EMBASE, PubMed, Scopus, and Web of Science databases were searched for relevant studies focused on women diagnosed with ectopic pregnancy and managed non-surgically with letrozole alone or in combination with methotrexate (MTX) until April 2024. The success rate, laboratory findings, and complications were analyzed and reported. Meta-analysis was done using RevMan 5.4.1 software. Out of 129 unique studies obtained, 7 of them were found eligible for final review; of which, 3 were nonrandomized prospective cohort studies, 2 were randomized clinical trials, and 2 study were case studies. In 5 studies letrozole was used as monotherapy. While in another study letrozole was used with MTX. The meta-analysis showed a significantly lower level of β-HCG in the letrozole group compared to MTX, 7days after initiation of treatment (Fixed effect model, MD = -92.22, 95%CI: [-159.39, -25.04], P = 0.007, I2 = 0%). There was no significant difference in the level of anti-mullerian hormone (AMH) between groups (Fixed effect model, MD = 0.18, 95%CI: [-0.09, 0.45], P = 0.20, I2 = 0%). Success rate, platelet count, and level of liver enzymes seemed to be better or similar among patients receiving Letrozole compared to patients receiving Methotrexate. Letrozole exhibits potential as a therapeutic option for ectopic pregnancies; however, further randomized clinical trials are necessary to establish strong evidence.

Impact of eating behavior on 24-month weight change after treatment of severe obesity-A clinical prospective cohort study.

This study aimed to evaluate the effects of self-reported baseline eating behaviors on 24-month weight change in adults with severe obesity. A prospective, nonrandomized clinical cohort study on surgical and medical obesity treatment included 971 adults (75% women) with a mean BMI of 42.0 (SD 4.9) kg/m2. To assess baseline eating behaviors and binge eating disorder, the Questionnaire on Eating and Weight Patterns-Revised and the Three-Factor Eating Questionnaire were used. In analyses adjusted for treatment, age, sex, baseline weight, and BMI, those with nocturnal eating lost less weight (3.5 kg [95% CI: 0.02-6.9]; p < 0.05) at 24 months compared to those without nocturnal eating. Binge eating disorder was not significantly associated with weight loss over 24 months. Emotional eating was associated with less weight loss at 12 months: 1.16 kg per z score (95% CI: 0.37-1.95; p < 0.05). Compared with completers, dropout from medical obesity treatment was associated with emotional and uncontrolled eating at baseline (both p < 0.001). The association between pretreatment eating behaviors and weight change was found to be generalizable and not restricted to any specific treatment. Certain eating behaviors may affect weight loss as well as attrition. Identifying eating behaviors that may impair treatment efficacy are suggested in the treatment of severe obesity.

Impact of Cardiac Rehabilitation Program on the Quality of Life of Young Adults versus Elderly Egyptians with Ischemic Heart Disease

Abstract Background Exercise-based cardiac rehabilitation is underutilized in patients after myocardial infarction, especially in the elderly population. The ageing biology of this senior population is definitely unique, and they are more likely to experience different consequences for which cardiac rehabilitation can be especially useful. Objective To investigate the impact of a 12-week completed cardiac rehabilitation program on the quality of life of two different age groups with recent myocardial infarction. Methods This non-randomized prospective cohort study was conducted on 50 patients, divided into two groups; 25 patients for each, group1 included those more than 60 years, group 2 from 18 to 60 years. Both groups underwent cardiac rehabilitation programs during the period of May 2018 to August 2020 at Ain Shams university hospitals. Quality of life assessment was performed via RAND-36 questionnaire, while depression screening was done via PHQ-9 questionnaire. Results Both groups showed improvement in the quality of life after completion of the cardiac rehabilitation program. The younger group achieved better improvement in the domains related to physical functioning, general health, role limitation due to physical health, energy/fatigue, and also showed better improvement in depressive symptoms, dyslipidemia and left ventricular Ejection fraction, whereas the senior group showed better improvement regarding role limitation due to emotional problems. Conclusion Exercise training in the context of comprehensive CR program improves quality of life in young as well as elderly patients. The young population improved mainly in the domains related to physical health while the elderly group improved regarding emotional domain in the quality of life questionnaires.

Evaluating the Potential Use of Wearable Fitness Devices as a Measure of Outcomes in Orthopaedics

Category: Sports; Other Introduction/Purpose: Orthopaedic surgeons routinely utilize Patient Reported Outcome Measures (PROMs) to evaluate surgical and nonsurgical treatment outcomes. PROMs can be cumbersome to both patients and surgeons with issues of noncompliance. With the rise of wearable fitness devices and smartphone applications, alternative methods are being explored for a more efficient and objective measurement of outcomes. There is a lack of studies directly comparing PROMs with patient wearable outcome (PWO) methods. This study aims to compare PWOs to PROMs and determine the feasibility of using PWOs as an outcome measurement tool in orthopaedics. The findings of this study could have implications for surgeons to integrate phone application-based technology into orthopaedic care in conjunction with PROMs and the potential to be used independently of PROMs to measure outcomes. Methods: This study is a non-randomized prospective cohort study with a known foot and ankle orthopaedic condition presenting to an orthopaedic clinic. Subjects with any foot and ankle condition over the age of 16 were asked to participate. Standard PROM surveys were administered at enrollment and then at 1 month, 2 month, and 3 month time periods. Surveys utilized were the Foot and Ankle Ability Measure Computerized Adaptive Testing (FAAM CAT), PROMIS physical function, mobility and pain interference scores, and Visual Analog Scale (VAS). A mobile phone application was then installed in subjects’ smartphones that utilized past and future health data including step counts and distance traveled. Statistical analysis was performed to correlate PWOs with PROMs. Results: Our study analyzed 19 participants aged 17 to 77, who complied with the treatment protocol. There were strong positive correlations in step counts across consecutive months, notably from 1-month to 2-month (r = 0.913,95% CI: 0.783 to 0.966) and 1-month to 3-month (r = 0.852, 95% CI: 0.648 to 0.942), indicating consistent physical activity. However, the relationship between activity levels (measured by step counts) and pain perception (Pain-VAS scores) proved complex, with variable moderate correlations (3-month Pain-VAS Score vs 3-month Steps, r= 0.416, 95% CI: −0.245to 0.813) suggesting that higher activity might be associated with greater pain at different time points. Conclusion: This study highlights the potential value of integrating objective physical activity data from wearable devices with PROMs for a more holistic assessment. The variable moderate correlations discovered underscores the challenge of correlating pain directly with physical activity. Despite objective measurements of activity consistency, patient-reported scores on factors like daily living and sport were nuanced, underscoring the complex interplay between physical functioning and subjective experience of pain. A balanced approach considering both objective and subjective data is needed to enhance treatment strategies and improve patient outcomes.