Case Series Analysis Research Articles

Association between different GLP-1 receptor agonists and acute pancreatitis: case series and real-world pharmacovigilance analysis

ObjectiveGlucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown notable advancements in managing blood sugar control. Nevertheless, there remains a gap in real-world data regarding the variation in acute pancreatitis (AP) risk among different GLP-1 RAs. Our study aimed to characterize and evaluate AP associated with different GLP-1 RAs (exenatide, lixisenatide, liraglutide, albiglutide, semaglutide, dulaglutide and tirzepatide) in a public adverse events database and to review the relevant case reports.MethodsWe described a case series of patients experiencing AP while on GLP-1 RAs. Additionally, we utilized various algorithms including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) to analyze data from the Food and Drug Administration’s Adverse Event Reporting System (FAERS) regarding suspected adverse events of AP linked to GLP-1 RAs from January 2005 to September 2023.ResultsOur case series comprised thirty-nine patients who experienced AP events while on GLP-1 RAs. Within the FAERS database, we retrieved a total of 6,751 individual case safety reports (ICSRs) involving various GLP-1 RAs. The median age of the patients included in our study was 57 years (range: 14–99), with 98.3% of cases classified as serious. Signals indicating AP were observed across all GLP-1 RAs, with particular emphasis on exenatide and liraglutide.ConclusionThere is a notable reporting signal of AP associated with all GLP-1 RAs. Healthcare providers must remain vigilant and closely monitor this potentially life-threatening adverse event.

BS SO02 - A systematic review to summarise and appraise the reporting of surgical innovation: A case study in robotic Roux-en-Y gastric bypass

Abstract Background Robotic Roux-en-Y gastric bypass (RRYGB) is an innovative alternative to the laparoscopic approach, however its clinical benefits are uncertain. The Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework was developed to improve the evaluation of surgical innovations alongside their adoption into clinical practice. Studies investigating the benefits of RRYGB have been published, however the reporting quality and robustness of literature has not been assessed. The aim of this systematic review was to summarise and appraise the reporting of RRYGB as a case study of a surgical innovation in relation to the IDEAL framework. Method Systematic searches for primary studies evaluating totally RRYGB were undertaken. Their IDEAL stages were determined using a standardised algorithm. Information pertaining to study characteristics, governance/ethical factors, patient selection, demographics, surgeon expertise/training, technique description and outcomes were extracted. A narrative summary was formulated, with descriptive statistics and data arranged chronologically. All methodology was done in accordance with PRISMA guidance. Results Fourty-seven studies published between 2005-2024 were included: case report (n=1), case series (n=11), non-randomised comparative (n=28) and retrospective analysis of registry databases (n=7). IDEAL stages were assigned as follows: stage 1 (n=1), stage 2a (n=6), stage 2b (n=40), stage 3 (n=0), stage 4 (n=0). There was a lack of sequential progression through IDEAL stages as time progressed since the inception of RRYGB. There was incomplete and inconsistent reporting of governance, ethics, patient selection criteria, surgeon expertise/training and technique description. Outcomes were heterogenous and rarely corresponded to progress through the IDEAL model of surgical innovation. Conclusion Reporting of RRYGB literature correlated poorly with IDEAL recommendations. This indicates poor reporting quality of available literature, impeding the ability for surgeons to draw meaningful conclusions from available evidence. This also complicates patients’ ability to take part in shared decision-making and give informed consent. Future studies should report findings in a structured way using IDEAL guidance or a similar reporting standard. This will ensure future research is transparent, robustly designed, prospective, uses COSs and follows an ethos of incremental learning. This may reduce research waste and the premature adoption of surgical innovations, ensuring their safe introduction into clinical practice.

Demographics, Clinical Presentation and Outcome of Metapneumovirus Infection in Adults: A Case Series Analysis at Scarborough General Hospital, United Kingdom

Demographics, Clinical Presentation and Outcome of Metapneumovirus Infection in Adults: A Case Series Analysis at Scarborough General Hospital, United Kingdom

Safety and Efficacy of Dalbavancin in Real Life: Retrospective Analysis of a Large Monocentric Case Series of Patients Treated for Skin/Soft Tissue and Other Difficult-to-Treat Infections

Background: Dalbavancin is a long-acting lipoglycopeptide, approved for treatment of skin and skin structure infections. Its PK/PD profile and safety allow for short hospital stays even in the case of difficult-to-treat infections requiring long courses of therapy, e.g., osteomyelitis, cardiovascular, and prosthetic infections. Objectives: We aimed to evaluate the safety and efficacy of dalbavancin in real life settings for both in-label and off-label indications. Methods: retrospective evaluation of all consecutive patients treated with dalbavancin at our site between May 2017 and September 2021. Results: A total of 100 patients treated with dalbavancin and followed up for 6 months after treatment (58% male; median age 63.5 years, median Charlson Comorbidity Index CCI = 2.7, 28% inpatients) were included with the following indications: acute bacterial skin and skin structure infections (22%), bone and prosthetic infections (57%), and cardiovascular infections (19%). Infections were caused by MSSA (30%), MRSA (5%), MR-CoNS (20%), and Streptococcus spp. (8%). In 32 cases, no isolate was obtained. The average number of infusions was 5 (s.d. = 3). Neither ensuing alteration of renal function nor neutropenia or thrombocytopenia were observed during treatment and follow-up. Two self-limiting skin rashes occurred. The overall clinical success rate was 84%—91% for registered and 82% for unregistered indications. The prescription of higher loading doses was the only predictor independently associated with better outcomes in multivariate models (OR: 5.2, 95%CI: 1.5–17.9, p < 0.01). Conclusions: Dalbavancin proved to be effective for skin and skin structure infections, as well as for difficult-to-treat infections in highly comorbid patients. Regarding tolerability, our results support the use of dalbavancin for long-lasting treatments of deep-seated infections.

Submucosal Thyroarytenoid Myectomy with Arytenoidectomy in Treating Bilateral Vocal Fold Immobility.

Surgery for bilateral vocal fold immobility (BVFI) aims to establish a patent airway while maintaining voice and swallow function, a unique dilemma. Current techniques display unfavorable healing vectors, and exposed endolaryngeal tissue results in substantial airway granulation requiring postoperative care. We present a novel technique to improve glottic airway patency by preserving laryngeal mucosal lining and harnessing lateral retraction of glottic tissue to reduce revisions for granulation tissue and laryngeal scar. Case-series analysis was performed on eight BVFI patients who underwent submucosal thyroarytenoid myectomy with arytenoidectomy for treatment from 2011 to 2021. Patient medical comorbidities and BVFI etiology were reviewed. Decannulation rates, revision procedures, requirement of emergency services, and pre- and postoperative status were assessed by laryngology and speech-language pathology using the following metrics: VHI, DI, Modified Medical Research Council (MMRC), GRBAS, jitter percentage, shimmer percentage, pitch range, maximum phonation time, and dysphonia severity index, and diet type. Pre- and postoperative distal-chip flexible laryngoscopy with stroboscopy was performed. Outcome measures were assessed using paired Student's t-test of pre- and postoperative categorical variables. Successful decannulation was achieved in all (four of eight) patients with previous tracheostomy. All patients reported improved respiratory symptoms without tracheotomy. There was no difference in long-term voice outcomes. All patients tolerated a mechanical soft or regular diet, without new or worsened dysphagia. Submucosal thyroarytenoid myomectomy with arytenoidectomy represents an effective BVFI treatment, through utilizing natural vectors of scarring, preservation of endolaryngeal mucosa, and preservation of the superficial lamina propria and the vocal ligament. 4 Laryngoscope, 2024.

Covid-19 vaccination and menstrual bleeding disturbances among women of fertile age: a Norwegian registry study.

This study evaluated the relationship between Covid-19 vaccination and menstrual bleeding disturbances using a large national registry linkage including 666,467 women between 20 and 40 years of age residing in Norway on January 1st, 2019. Information on vaccination-BNT162b2 and mRNA-1273 - was obtained from the Norwegian vaccination registry. Diagnoses of menstrual disturbances (absent/scanty, excessive, irregular/frequent menstruation, and intermenstrual bleeding) was obtained from the general practitioner database. We examined new-onset menstrual bleeding disturbances using a Cox regression comparing vaccinated to unvaccinated women, where women contributed follow-up time as unvaccinated until the day of vaccination. In addition, we conducted a self-controlled case-series analysis, and a sensitivity analysis excluding all those who remained unvaccinated throughout the pandemic, to evaluate the role of unmeasured confounding. We observed an increased risk of several menstrual bleeding disturbances after vaccination against Covid-19, ranging from an adjusted HR (aHR) of 1.18 (95% CI: 1.04, 1.33) for intermenstrual bleeding to 1.29 (95% CI: 1.23, 1.36) for irregular/frequent menstrual periods. However, estimates were fully attenuated when excluding women who remained unvaccinated at the end of follow-up (aHRs between 0.97 and 1.08). No differences were identified according to vaccine dose or type. Our self-controlled case series analysis confirmed no increased risk after a first dose of vaccination, though there was a slightly increased risk of menstrual bleeding disturbances from 61 days after vaccination with dose 2. In conclusion, the modestly increased risk of menstrual bleeding disturbances after Covid-19 vaccination appeared to reflect a role of unmeasured confounding by women who never received Covid-19 vaccinations, as associations did not remain when risk after vaccination were compared to risk before vaccination among ever vaccinated women.

Risk Factors for Adhesive Small Bowel Obstruction After Liver Cancer Surgery.

Although the frequency of small bowel obstructions after liver surgery is generally considered low, previous studies have followed-up patients for less than a year, thus the incidence of small bowel obstructions several years after surgery is unknown. Furthermore, the rise in laparoscopic surgeries and the use of adhesion prevention materials may influence the occurrence of small bowel obstructions. This study aimed to assess the incidence of small bowel obstructions within a five-year period following liver surgery and identify the associated risk factors. This case series analysis analyzed patients who underwent liver surgery between April 2012 and March 2014 from 32 participating hospitals. Multivariate analysis was conducted to examine risk factors for small bowel obstructions. A total of 953 patients were included in the analysis, and the incidence of small bowel obstructions was 1.6%. The incidence was significantly higher at 3.4% for surgeries related to metastatic liver cancer compared to other types of surgeries. Laparoscopic surgery had no significant effect on the incidence of SBO (p=0.72). There was no significant difference in the incidence of small bowel obstructions between surgeries that employed adhesion prevention materials and those that did not. Multivariable analysis revealed that longer surgical time and re-operation were independent risk factors for small bowel obstructions. The incidence of small bowel obstructions following surgery for metastatic liver cancer is significantly higher compared to other liver surgeries. Neither laparoscopic surgery nor adhesion prevention materials reduce its occurrence. Longer surgical time and re-operation are independent risk factors for small bowel obstructions.

Osteonecrosis of the jaw in patients with clear cell renal cell carcinoma treated with targeted agents: a case series and large-scale pharmacovigilance analysis

ObjectiveTo optimize the use of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) for cancer patients, we characterized and evaluated ONJ related to TKIs and ICIs by analyzing a public database and reviewing the relevant literature. TKIs and ICIs are limited to drugs that treat renal cancer recommended by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Kidney Cancer.MethodsWe described a case series of patients experiencing ONJ while on TKIs or ICIs. We also analyzed spontaneous reports submitted to the FAERS in an observational and retrospective manner between January 2004 and December 2022. Selecting ONJ’ adverse events to TKIs and ICIs. Associations between TKIs, ICIs and ONJ were assessed using reporting odds ratios (ROR), drug interaction signals based on the Ω shrinkage measure.Results29 patients with ONJ events while on TKIs and ICIs were included in our case series. 240 were related to ONJ AEs. Specifically, 32.1% ICSRs were linked to sunitinib, 16.7% to lenvatinib, 12.9% to pazopanib, 12.5% to nivolumab, 10.0% to axitinib, 5.4% to sorafenib, 5.0% to pembrolizumab, 4.2% to cabozantinib, and 1.3% to ipilimumab. More ICSRs were generally seen in male and reported in Europe. The median age was 63 years. Renal cancer and lung cancer was the most common indication for TKIs and ICIs, respectively. Excluding missing data, the prevalence of mortality was highest for sunitinib-related ONJ ICSRs (18.5%), followed by sorafenib-related ONJ ICSRs (15.4%). With the criteria of ROR, sunitinib and lenvatinib were significantly associated with ONJ AEs. With the criteria of Ω, nivolumab + cabozantinib was significantly associated with ONJ AEs.ConclusionTKIs and ICIs have been reported to have significant ONJ side effects. Patients and physicians need to recognize and monitor these potentially fatal adverse events.

A Retrospective Consecutive Controlled Case Series Analysis of the Assessment and Treatment of Elopement in Children with Autism in an Inpatient Setting

A Retrospective Consecutive Controlled Case Series Analysis of the Assessment and Treatment of Elopement in Children with Autism in an Inpatient Setting

Risk of osteoporotic fractures in menopausal women with common mental health diagnoses prescribed SSRIs/SNRIs: cohort and self-controlled case series analyses

SummaryIn a population-based cohort study of menopausal women with common mental health diagnoses, SSRIs/SNRIs were associated with a 32% increased risk of osteoporotic fractures. The risk of osteoporotic fractures was particularly increased for longer periods of treatment with SSRIs/SNRIs (> 5 years) and in younger menopausal women (< 50 years old).PurposeTo investigate the association between selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) and the risk of osteoporotic fractures (OF) in menopausal women with common mental health diagnoses (CMHD).MethodsWe conducted the study with two designs (cohort and self-controlled case series [SCCS]), using the IQVIA Medical Research Database (IMRD) UK. The source population comprised women aged ≥ 50 years and women with a record indicating menopause (< 50 years). All women had a recorded CMHD. For the cohort analysis, the risk of OFs was estimated by comparing women prescribed SSRIs/SNRIs (exposed) to those not exposed. Cox regression was used to estimate hazard ratios (HR) with 95% confidence intervals (CIs). For the SCCS, women acted as their own controls; periods of exposure to SSRIs/SNRIs were compared to periods of non-exposure using conditional Poisson regression to estimate incidence rate ratios (IRR) with 95% CIs.ResultsWe identified 292,848 women, of whom 35,222 experienced OFs within a median follow-up of 6.01 years. We found strong evidence of an association between SSRIs/SNRIs and the risk of OFs (adjusted HR = 1.32, 95% CI:1.29–1.35). Compared to periods of no exposure, SSRIs/SNRIs increased the risk of OFs during the first 30 days (IRR = 1.38, 95% CI:1.26–1.51), during the first 90 days (IRR = 1.58, 95% CI: 1.48–1.69), and the remaining exposure (IRR = 1.42, 95% CI:1.37–1.48).ConclusionsIn a population of menopausal women with CMHDs, the prescribing of SSRIs/SNRIs antidepressants was associated with a higher risk of OFs. Careful assessment of osteoporosis risk needs to be considered when treating menopausal women with SSRIs/SNRIs antidepressants.

Salvage reirradiation for recurrent glioblastoma: a retrospective case series analysis.

To assess the clinical outcome of patients with recurrent glioblastoma treated with salvage reirradiation. Between 2005 and 2022, data from adult patients with glioblastoma treated with surgery and radio-chemotherapy Stupp regimen who developed a local in-field relapse and received stereotactic radiotherapy (SRT) were retrospectively reviewed. The study population included 44 patients with recurrent glioblastoma (median of 9.5 months after the first radiotherapy). Reirradiation alone was given to 47.7% of patients. The median maximum diameter of the recurrence was 13.5 mm. The most common SRT regimen (52.3%) was 35 Gy in 10 fractions. Acute toxicity was mild, with transient worsening of previous neurological symptoms in only 15% of patients. After a median follow-up of 15 months, 40% presented radiological response, but a remarkable number of early distant progressions were recorded (32.5%). The median time to progression was 4.8 months, being the dose, the scheme, the size of the recurrence or the strategy (exclusive RT vs. combined) unrelated factors. The median overall survival (OS) was 14.9 months. Karnofsky index < 70 and the size of the recurrence (maximum diameter < 25 mm) were significant factors associated with OS. Radiological changes after reirradiation were commonly seen (> 50% of patients) hindering the response assessment. Reirradiation is a feasible and safe therapeutic option to treat localized glioblastoma recurrences, able to control the disease for a few months in selected patients, especially those with good functional status and small lesions. Hypofractionated schemes provided a suitable toxicity profile. Radiological changes were common.

A Systematic Imaging Approach to Small Bowel Obstruction: A Case Series Analysis

A Systematic Imaging Approach to Small Bowel Obstruction: A Case Series Analysis

Retrospective Review of the Image Quality of Monoplane Transesophageal Echocardiography in Prehospital Out-of-Hospital Cardiac Arrest: A Single Center Pilot Study

Objectives Out of Hospital Cardiac Arrest (OHCA) is a frequently encountered pathology with resultant poor outcomes in the majority of patients. Echocardiography has been utilized to help guide clinical decision making and monitor effectiveness of resuscitative efforts. Transthoracic echocardiography (TTE) the mainstay of point-of-care ultrasound (POCUS) real time resuscitative imaging has limitations, most notably is the disruption of closed chest compressions. Trans-esophageal echocardiography (TEE) is an emerging technology in emergency care and can potentially overcome these limitations but image quality and accuracy of use in the prehospital environment remains unknown. Our primary objective is to identify the accuracy of Emergency Medical Services (EMS) fellow physicians in performing TEE via the identification of key cardiac structures. Secondarily we assess image quality as well as accuracy on cardiac activity interpretation as compared to TEE-experienced cardiologists. Methods A pilot study using descriptive analysis of a retrospective case-series with specific focus on inter-rater reliability as well as pragmatic management alterations based on real-time image interpretation by EMS physicians. After focused education, 13 patients were eligible for prehospital TEE who suffering OHCA from July 2022 to June 2023. Ultrasound (US) images were interpreted by EMS fellow physicians and over-read by cardiologists with specific focus on inter-rater reliability. After collection of patients presenting data and US images, analysis was performed. Results Of 13 patients initially screened, 10 patients were included in a study with a median age of 50 years old (41–70). Three patients were excluded due to equipment malfunction or insufficient image capture. An interrater reliability identified a kappa of 0.96 with respect to identification of cardiac structures and a kappa of 0.65 for identification of cardiac activity. Conclusions In this small study of prehospital TEE, EMS fellow physicians had high inter-rater reliability in image interpretation pertaining to anatomy and cardiac activity when compared with cardiologists. Further research is needed to determine its efficacy, safety, and widespread application in the prehospital setting.

Suicidal behaviour and CFTR modulators: A case series and WHO database disproportionality analysis

BackgroundA highly effective therapy involving elexacaftor, tezacaftor, and ivacaftor (ETI) for cystic fibrosis (CF) patients has recently raised safety concerns regarding potential psychiatric disorders. The manuscript reports cases of suicide attempts in patients receiving ETI and investigates putative causality using the WHO spontaneous reporting database. MethodsFirst, four cases of suicide attempts/self-injury are described. Second, a disproportionality analysis was conducted using spontaneous reports collected in Vigibase through the standardised MedDRA Query (narrow version) "Suicide/Self-injury" and ETI exposure. Reporting Odds Ratio (ROR) was calculated for the main and subgroup (i/suicide attempt, ii/suicidal ideation) analyses. Sensitivity analyses were performed with variations in exposure, to ivacaftor/lumacaftor to assess the intrinsic psychiatric risk of CF patients, and paracetamol as a positive control for suicide attempt and a negative one for suicidal ideation. Exposure to reduced-dose ETI was studied to evaluate the dose-gradient effect. ResultsFour cases of suicide attempt/self-injury occurred 3 to 13 months after ETI initiation in CF patients and were reported to the Bordeaux Pharmacovigilance centre. Aside, in Vigibase, ETI is associated with an increased likelihood of reporting suicidal behaviour (ROR 2.5, 95 % CI[2.1; 2.8]). A signal of disproportionate reporting was found for the subgroup of suicide attempts (1.4, 95 % CI[1.2; 1.8]), unlike ivacaftor/lumacaftor, which was associated only with the risk of reporting suicidal ideation. Significant ROR values were also found for reduced-dose ETI for all psychiatric effects studied except suicide attempt. ConclusionsETI exposure is related with increased reporting of suicidal behaviour. A potential dose-dependent effect merits further investigation.

12567 Hybrid Closed-loop Insulin Pumps' Role In CFRD Management: A Retrospective Case Series Analysis

12567 Hybrid Closed-loop Insulin Pumps' Role In CFRD Management: A Retrospective Case Series Analysis

Initiating medical abortion in an emergency department in the United States

ObjectivesThe primary objective of this study was to assess the feasibility of initiating medical abortions in a large, academic emergency department (ED) in the United States.MethodsA retrospective case series analysis...

Recent Demographic Trends and Clinical Insights in Pediatric Vascular Rings and Slings: A Retrospective Case Series Analysis

Recent Demographic Trends and Clinical Insights in Pediatric Vascular Rings and Slings: A Retrospective Case Series Analysis

Human papillomavirus nonavalent (HPV9) vaccination and risk of immune mediated diseases, myocarditis, pericarditis, and thromboembolic outcomes in Denmark: self-controlled case series study

ObjectiveTo assess the associations between vaccination with the nonavalent human papillomavirus (HPV9) vaccine and immune mediated diseases, myocarditis, pericarditis, arterial thromboembolism, and venous thromboembolism with or without thrombocytopenia, in adolescent...

Case Series Analysis of Diagnosis and Treatment of Gastrointestinal Metastasis in Lung Cancer Patients.

This study was designed to investigate the clinical, pathological, endoscopic, and imaging characteristics of gastrointestinal metastasis in patients with lung cancer. The clinical data of 20 patients with primary lung cancer with gastrointestinal metastasis. This study included sixteen men and four women, ranging in age from 31 to 75 years. The time interval from the diagnosis of lung cancer to the detection of gastrointestinal metastasis ranged from 13 to 142 months. The most common sites of metastasis were the small intestine (eight cases), colon (four cases), and upper gastrointestinal tract (eight cases). The major symptoms included obstruction, perforation, abdominal pain, abdominal distension, anorexia, and anemia. The predominant pathological type was poorly differentiated adenocarcinoma (seventeen cases). A single ulcer was mostly seen on endoscopy, and some cases showed a slight depression of the intestinal wall. The CT and PET-CT scan revealed bowel wall thickening, intraluminal polypoid masses, and intestinal perforation. Gastrointestinal metastasis of lung cancer is mainly observed in the small intestine, colon, and stomach, and is often detected when severe complications such as gastrointestinal obstruction and perforation occurred. Regular evaluation of gastrointestinal conditions during lung cancer diagnosis and treatment is recommended to improve the diagnostic accuracy and prevent misdiagnosis.

When and how to split the follow-up time in the analysis of epidemiological or clinical studies with follow-ups.

In epidemiological or clinical studies with follow-ups, data tables generated and processed for statistical analysis are often of the "wide-format" type-consisting of one row per individual. However, depending on the situation and purpose of the study, they may need to be transformed into the "long-format" type-which allows for multiple rows per individual. This tutorial clarifies the typical situations wherein researchers are recommended to split follow-up times to generate long-format data tables. In such applications, the major analytical aims consist of (i) estimating the outcome incidence rates or their ratios between ≥ 2 groups, according to specific follow-up time periods; (ii) examining the interaction between the exposure status and follow-up time to assess the proportional hazards assumption in Cox models; (iii) dealing with time-varying exposures for descriptive or predictive purposes; (iv) estimating the causal effects of time-varying exposures while adjusting for time-varying confounders that may be affected by past exposures; and (v) comparing different time periods within the same individual in self-controlled case series analyses. This tutorial also discusses how to split follow-up times according to their purposes in practical settings, providing example codes in Stata, R, and SAS.