Category: Statistics

J Tissue Viability. 2024 Mar 19:S0965-206X(24)00035-4. doi: 10.1016/j.jtv.2024.03.010. Online ahead of print.

ABSTRACT

BACKGROUND: Pediatric burn patients are an essential part of burn populations. However, there is limited publicly available data on the epidemiological impact of COVID-19 on pediatric burns in China.

OBJECTIVE: In this paper, pediatric burn patients admitted to the Department of Burn Surgery of the First Hospital of Jilin University before and during COVID-19 were retrospectively investigated to determine the impact of COVID-19 on pediatric burn inpatients.

METHODS: The information of inpatients from July 2017 to December 2019 (pre-COVID-19 group) and from January 2020 to June 2022 (COVID-19 group) in the Department of Burn Surgery at the First Hospital of Jilin University was retrospectively investigated. Demographic information of patients, length of hospital stay, total body surface area (TBSA) of burn injury, post-injury visit time, comorbidity, surgical methods, etc., were statistically analyzed.

RESULTS: The COVID-19 group included 154 (10.2%) patients, and the pre-COVID-19 group included 335 (19.4%) patients (P＜0.001). There were no differences in gender, age, length of hospital stay, or etiology of burns between the two groups. Compared to the pre-COVID-19 group, patients in the pre-COVID-19 group experienced a significant delay in presentation (P＜0.001), had a larger TBSA of burn wound (P ＜ 0.001), were more prone to sustaining major burns (P ＜ 0.001), a higher likelihood of undergoing operations (P = 0.03), higher cost (P＜0.001) and more complications (P＜0.001). Additionally, upper extremities were the most commonly part involved in both groups (P = 0.004), with the lower extremities showed a significant increase to be involved in burn injury during COVID-19 pandemic (P = 0.007). Furthermore, the majority of guardians did not take first aid measures in both groups following burn injury (P = 0.102).

CONCLUSIONS: During the COVID-19 pandemic period, scalds remained the main reason for hospitalization. The number of hospitalized patients has decreased dramatically, while the severity of burns has significantly increased, with a notable delay in hospital visits and an increased occurrence of complications.

PMID:38521680 | DOI:10.1016/j.jtv.2024.03.010

Injury. 2024 Mar 13:111508. doi: 10.1016/j.injury.2024.111508. Online ahead of print.

ABSTRACT

BACKGROUND: Traumatic rib fracture is associated with a high morbidity rate and identifying patients at risk of developing pulmonary complications (PC) can guide management and potentially decrease unnecessary intensive care admissions. Therefore, we sought to assess and compare the utility of a physiologic parameter, vital capacity (VC), with the admission radiologic findings (RibScore) in predicting PC in patients with rib fractures.

METHODS: This is a single-center retrospective review (2015-2018) of all adult (≥18 years) patients admitted to a Level I trauma center with traumatic rib fracture. Exclusion criteria included no CT scan and absence of VC within 48 h of admission. The cohort was stratified into two groups based on presence or absence of PC (pneumonia, unplanned intubation, unplanned transfer to the intensive care unit for a respiratory concern, or the need for a tracheostomy). Multivariable logistic regression models were constructed to identify predictors of PC.

RESULTS: A total of 654 patients met the inclusion criteria of whom 70 % were males. The median age was 51 years and fall (48 %) was the most common type of injury. A total of 36 patients (5.5 %) developed a pulmonary complication. These patients were more likely to be older, had a higher ISS, and were more likely to require a tube thoracostomy placement. On multivariable logistic regression, first VC ≤30 % (AOR: 4.29), day 1 VC ≤30 % (AOR: 3.61), day 2 VC ≤30 % (AOR: 5.54), Δ(Day2-Day1 VC) (AOR: 0.96), and RibScore ≥2 (AOR: 3.19) were significantly associated with PC. On discrimination analysis, day 2 VC had the highest area under the receiver operating characteristic curve (AuROC), 0.81, and was superior to first VC and day 1 VC in predicting PC. There was no statistically significant difference in predicting PC between day 2 VC and RibScore. On multivariable analysis, first VC ≤30 %, day 1 VC ≤30 %, day 2 VC ≤30 %, and admission RibScore ≥2 were associated with prolonged hospital and ICU LOS.

CONCLUSION: VC and RibScore emerged as independent predictors of PC. However, VC was not found to be superior to RibScore in predicting PC. Further prospective research is warranted to validate the findings of this study.

PMID:38521636 | DOI:10.1016/j.injury.2024.111508

Eur Urol. 2024 Mar 22:S0302-2838(24)02132-8. doi: 10.1016/j.eururo.2024.02.014. Online ahead of print.

ABSTRACT

BACKGROUND: Combinations of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) plus immune checkpoint inhibitor (ICI) against PD1/PD-L1 are the standard first-line therapy for patients with metastatic renal cell carcinoma (mRCC), irrespective of the prognostic class.

OBJECTIVE: To investigate the feasibility and safety of withdrawing VEGFR-TKI but continuing anti-PD1/PD-L1 in patients who achieve a response to their combination.

DESIGN, SETTING, AND PARTICIPANTS: This was a single-arm phase 2 trial in patients with treatment-naïve mRCC with prior nephrectomy, without symptomatic/bulky disease and no liver metastases.

INTERVENTION: Enrolled patients received axitinib + avelumab; after 36 wk of therapy those who achieved a tumour response interrupted axitinib and continued avelumab maintenance until disease progression.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the rate of patients without progression 8 wk after the axitinib interruption. The secondary endpoints were the median value for progression-free (mPFS) and overall (mOS) survival and the safety in the overall population.

RESULTS AND LIMITATIONS: Seventy-nine patients were enrolled and 75 were evaluated for efficacy. A total of 29 (38%) patients had axitinib withdrawn, as per the study design, with 72% of them having no progression after 8 wk and thus achieving the primary endpoint. The mPFS of the overall population was 24 mo, while the mOS was not reached. The objective response rate was 76% (12% complete response and 64% partial response), with 19% of patients having stable disease. In the patients who discontinued axitinib, the incidence of adverse events of any grade was 59% for grade 3 and 3% for grade 4. This study was limited by the lack of a comparative arm.

CONCLUSIONS: The TIDE-A study demonstrates that the withdrawal of VEGFR-TKI with ICI maintenance is feasible for selected mRCC patients with evidence of a response to the VEGFR-TKI + ICI combination employed in first-line therapy. Axitinib interruption with avelumab maintenance leads to decreased side effects and should be investigated further as a new strategy to delay tumour progression.

PATIENT SUMMARY: We evaluated whether certain patients with advanced kidney cancer treated with the fist-line combination of axitinib plus avelumab can interrupt the axitinib in case of a tumour response after 36 wk of therapy. We found that axitinib interruption improved the safety of the combination, while the maintenance with avelumab might delay tumour progression.

PMID:38521617 | DOI:10.1016/j.eururo.2024.02.014

Acad Radiol. 2024 Mar 22:S1076-6332(24)00149-1. doi: 10.1016/j.acra.2024.03.008. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVE: Treatment for head and neck cancer (HNC) can lead to decreased oral intake which often requires gastrostomy tube (g-tube) placement to provide nutritional support. A multidisciplinary team (MDT) consisting of interventional radiology (IR), HNC oncology and surgery, nutrition, and speech language pathology departments implemented an expedited outpatient g-tube placement pathway to reduce hospital stays and associated costs, initiate feeds sooner, and improve communication between care teams. This single center study investigates differences in complications, time to procedure and costs savings with implementing this pathway.

METHODS: 142 patients with HNC who underwent elective image guided g-tube placement by IR from 2015 to 2022 were identified retrospectively. 52 patients underwent the traditional pathway, and 90 patients underwent the expedited pathway. Patient demographics, procedure characteristics, periprocedural costs and 90-day complication rates were collected and compared statistically.

RESULTS: The 90-day complication rate was comparable between groups (traditional=32.7%; expedited=22.2%; p-value=0.17). The expedited pathway decreased the time from consult to procedure by 11.1 days (95% CI 7.6 – 14.6; p < 0.001) and decreased charge per procedure by $2940 (95% CI $989-$4891; p < 0.001).

CONCLUSION: A MDT for the treatment of patients with HNC successfully provided enteral nutrition support faster, with fewer associated costs, and in a more patient centered approach than previously done at this institution.

PMID:38521613 | DOI:10.1016/j.acra.2024.03.008

BMJ Open. 2024 Mar 23;14(3):e075475. doi: 10.1136/bmjopen-2023-075475.

ABSTRACT

OBJECTIVE: To identify and synthesise relevant existing prognostic factors (PF) and prediction models (PM) for hospitalisation and all-cause mortality within 90 days in primary care patients with acute lower respiratory tract infections (LRTI).

DESIGN: Systematic review.

METHODS: Systematic searches of MEDLINE, Embase and the Cochrane Library were performed. All PF and PM studies on the risk of hospitalisation or all-cause mortality within 90 days in adult primary care LRTI patients were included. The risk of bias was assessed using the Quality in Prognostic Studies tool and Prediction Model Risk Of Bias Assessment Tool tools for PF and PM studies, respectively. The results of included PF and PM studies were descriptively summarised.

RESULTS: Of 2799 unique records identified, 16 were included: 9 PF studies, 6 PM studies and 1 combination of both. The risk of bias was judged high for all studies, mainly due to limitations in the analysis domain. Based on reported multivariable associations in PF studies, increasing age, sex, current smoking, diabetes, a history of stroke, cancer or heart failure, previous hospitalisation, influenza vaccination (negative association), current use of systemic corticosteroids, recent antibiotic use, respiratory rate ≥25/min and diagnosis of pneumonia were identified as most promising candidate predictors. One newly developed PM was externally validated (c statistic 0.74, 95% CI 0.71 to 0.78) whereas the previously hospital-derived CRB-65 was externally validated in primary care in five studies (c statistic ranging from 0.72 (95% CI 0.63 to 0.81) to 0.79 (95% CI 0.65 to 0.92)). None of the PM studies reported measures of model calibration.

CONCLUSIONS: Implementation of existing models for individualised risk prediction of 90-day hospitalisation or mortality in primary care LRTI patients in everyday practice is hampered by incomplete assessment of model performance. The identified candidate predictors provide useful information for clinicians and warrant consideration when developing or updating PMs using state-of-the-art development and validation techniques.

PROSPERO REGISTRATION NUMBER: CRD42022341233.

PMID:38521534 | DOI:10.1136/bmjopen-2023-075475

BMJ Open. 2024 Mar 23;14(3):e081727. doi: 10.1136/bmjopen-2023-081727.

ABSTRACT

OBJECTIVES: To explore the impact of the triglyceride-glucose (TyG) index on the severity of coronary stenosis and the risk of in-hospital mortality in patients with acute ST segment elevation myocardial infarction (STEMI) after percutaneous coronary intervention (PCI).

DESIGN: A multicentre retrospective cohort study.

SETTING: Patients with STEMI undergoing PCI from three centres in China from 2015 to 2019.

PARTICIPANTS: A total of 1491 individuals presenting with STEMI were enrolled.

PRIMARY OUTCOME MEASURE: The degree of coronary stenosis was quantified by the Gensini score (GS). The association between the TyG index and the severity of coronary stenosis was explored by using a logistic regression analysis. Cox proportional hazards regression analyses were used to investigate the associations between the variables and in-hospital mortality.

RESULTS: We found a significant correlation between the TyG index and the degree of coronary stenosis in the present study. The TyG index was an independent risk factor for the severity of coronary stenosis (OR 2.003, p<0.001). Using the lowest tertile of the TyG (T1) group as a reference, the adjusted ORs for the T2 group and the T3 group and a high GS were 1.732 (p<0.001), 1.968 (p<0.001), respectively, and all p for trend <0.001. For predicting a high GS, the TyG index’s area under the curve was 0.668 (95% CI 0.635 to 0.700, p<0.001). Additionally, the TyG index was further demonstrated to be an independent predictor of in-hospital mortality in patients with STEMI (HR 1.525, p<0.001).

CONCLUSIONS: The TyG index was associated with the severity of coronary stenosis and all-cause in-hospital mortality in patients with STEMI, which may help physicians precisely risk-stratify patients and implement individualised treatment.

PMID:38521531 | DOI:10.1136/bmjopen-2023-081727

BMJ Open. 2024 Mar 23;14(3):e075681. doi: 10.1136/bmjopen-2023-075681.

ABSTRACT

INTRODUCTION: This is a study protocol that tests and refines realist theories regarding the uptake and scale-up of the linked maternity waiting home (hereafter MWH) and facility birth intervention in the Mozambican context. The theories were developed through a realist review of MWH-facility birth literature from low-income and middle-income countries. The aim of the proposed study is to contribute to a contextually refined understanding of the causal chains underlying MWH-facility birth adoption by pregnant women and their families, communities, the health system and donors.

METHODS AND ANALYSIS: The overarching methodology is mixed-methods realist evaluation. The study will adopt a comparative embedded case study design comparing three new masonry MWHs built by the Mozambique-Canada Maternal Health Project in Inhambane province with three older MWHs selected based on variation in the built environment. Baseline data on participating MWH-facility birth interventions will be collected through observations, reviews of routine data and analysis of statistics and reports from provincial and district health authorities and the Mozambique-Canada Maternal Health project. Realist interviews will be conducted with MWH users and non-users, companions of MWH users and non-users, partners of MWH users and non-users, and stakeholders within the health system and the non-governmental organisation sector. Realist focus groups will be used to collect data from community-level implementers. The analysis will be retroductive and use the context-mechanism-outcome configuration heuristic tool to represent generative causation. We will analyse data from intervention and comparator MWHs independently and compare the resulting refined programme theories. Data analysis will be done in NVivo 12.

ETHICS AND DISSEMINATION: Ethics approval for the project has been obtained from the Mozambique National Bioethics Committee (CNBS-Comité Nacional de Bioética para a Saúde) and the University of Saskatchewan Bioethical Research Ethics Board. The evaluation will adhere to the International Ethical Guidelines for Biomedical Research Involving Human Subjects and the African adaptation of evaluation ethics and principles. Evaluation results will be disseminated to stakeholders’ practice audiences through peer-reviewed publications, plain-language briefs, theory validation/feedback meetings and conference presentations.

PMID:38521527 | DOI:10.1136/bmjopen-2023-075681

Int J Cardiol. 2024 Mar 21:131982. doi: 10.1016/j.ijcard.2024.131982. Online ahead of print.

ABSTRACT

BACKGROUND: A model developed specifically for stable coronary artery disease (SCAD) patients to predict perioperative major adverse cardiovascular events (MACE) has not been previously reported.

METHODS: The derivation cohort consisted of 5780 patients with SCAD undergoing noncardiac surgery at the First Affiliated Hospital of Zhejiang University School of Medicine, from January 1, 2013 until May 31, 2021. The validation cohort consisted of 2677 similar patients from June 1, 2021 to May 31, 2023. The primary outcome was a composite of MACEs (death, resuscitated cardiac arrest, myocardial infarction, heart failure, and stroke) intraoperatively or during hospitalization postoperatively.

RESULTS: Six predictors, including Creatinine >90 μmol/L, Hemoglobin <110 g/L, Albumin <40 g/L, Leukocyte >10 ×10⁹/L, high-risk Surgery (general abdominal or vascular), and American Society of Anesthesiologists (ASA) class (III or IV), were selected in the final model (CHALSA score). Each patient was assigned a CHALSA score of 0, 1, 2, 3, or > 3 according to the number of predictors present. The incidence of perioperative MACEs increased steadily across the CHALSA score groups in both the derivation (0.5%, 1.4%, 2.9%, 6.8%, and 23.4%, respectively; p < 0.001) and validation (0.3%, 1.5%, 4.1%, 9.2%, and 29.2%, respectively; p < 0.001) cohorts. The CHALSA score had a higher discriminatory ability than the revised cardiac risk index (C statistic: 0.827 vs. 0.695 in the validation dataset; p < 0.001).

CONCLUSIONS: The CHALSA score showed good validity in an external dataset and will be a valuable bedside tool to guide the perioperative management of patients with SCAD undergoing noncardiac surgery.

PMID:38521511 | DOI:10.1016/j.ijcard.2024.131982

Int J Cardiol. 2024 Mar 21:131990. doi: 10.1016/j.ijcard.2024.131990. Online ahead of print.

ABSTRACT

BACKGROUND: Current risk assessment for ischemic stroke (IS) is limited to clinical variables. We hypothesize that polygenic scores (PGS) of IS (PGS_IS) and IS-associated diseases such as atrial fibrillation (AF), venous thromboembolism (VTE), coronary artery disease (CAD), hypertension (HTN), and Type 2 diabetes (T2D) may improve the performance of IS risk assessment.

METHODS: Incident IS was followed for 479,476 participants in the UK Biobank who did not have an IS diagnosis prior to the recruitment. Lifestyle variables (obesity, smoking and alcohol) at the time of study recruitment, clinical diagnoses of IS-associated diseases, PGS_IS, and five PGSs for IS-associated diseases were tested using the Cox proportional-hazards model. Predictive performance was assessed using the C-statistic and net reclassification index (NRI).

RESULTS: During a median average 12.5-year follow-up, 8374 subjects were diagnosed with IS. Known clinical variables (age, gender, clinical diagnoses of IS-associated diseases, obesity, and smoking) and PGS_IS were all independently associated with IS (P < 0.001). In addition, PGS_IS and each PGS for IS-associated diseases was also independently associated with IS (P < 0.001). Compared to the clinical model, a joint clinical/PGS model improved the C-statistic for predicting IS from 0.71 to 0.73 (P < 0.001) and significantly reclassified IS risk (NRI = 0.017, P < 0.001), and 6.48% of subjects were upgraded from low to high risk.

CONCLUSIONS: Adding PGSs of IS and IS-associated diseases to known clinical risk factors statistically improved risk assessment for IS, demonstrating the supplementary value of inherited susceptibility measurement . However, its clinical utility is likely limited due to modest improvements in predictive values.

PMID:38521508 | DOI:10.1016/j.ijcard.2024.131990

J Shoulder Elbow Surg. 2024 Mar 21:S1058-2746(24)00192-7. doi: 10.1016/j.jse.2024.03.006. Online ahead of print.

ABSTRACT

BACKGROUND: The use of total shoulder arthroplasty is continuing to rise with its expanding indications. For patients with chronic conditions, such as glenohumeral arthritis and rotator cuff arthropathy, nonoperative treatment is typically done prior to arthroplasty and often includes corticosteroid injections. Recent studies in the shoulder arthroplasty literature as well as applied from the hip and knee literature have focused on the risk of periprosthetic infection. Literature is lacking as to whether the judicious use of corticosteroids in the year prior to arthroplasty influences patient reported outcomes. The purpose of this study was to determine if preoperative corticosteroid injections prior to shoulder arthroplasty affected two-year patient-reported outcomes.

METHODS: Retrospective review of anatomic and reverse total shoulder arthroplasty patients (n=230) was performed at a single institution including multiple surgeons. Patients were included if they had preoperative and a minimum of 2-year postoperative patient reported outcomes, including: ASES, VAS, SANE, VR12-PCS, and VR12-MCS. Patients were included in the injection group if they had received an injection, either glenohumeral or subacromial, within twelve months prior to arthroplasty (inject=134). Subgroup analysis included anatomic (TSA=92) and reverse total shoulder arthroplasty (RSA=138) as well as those with no injection within 12 months prior to surgery. An ANOVA was used to compare outcomes between patients who received an injection and those who did not prior to TSA and RSA.

RESULTS: There were 230 patients included with 134 patients in the injection group and 96 in the no injection group. Patients who received an injection in the year prior to arthroplasty displayed a significantly higher ASES [82 (16.23SD) vs. 76 (19.43SD), p < .01] and SANE [70 (24.49SD) vs. 63 (29.22SD), p < .01] scores versus those who had not received injection. There was no difference when comparing preoperative injection versus no injection in patients undergoing TSA. Those patients undergoing RSA displayed significantly higher ASES scores (p<.01). There were no significant differences in VAS, VR12-PCS, and VR12-MCS among any analysis (P>0.05), and the MCID in ASES was not different between groups (p.09).

CONCLUSION: Corticosteroid injections within twelve months prior to anatomic and reverse total shoulder arthroplasty do not compromise patient reported outcomes during a minimum of two-year follow-up. Although more complications occurred in the injection group, it did not reach statistical significance and warrants further study in a larger population.

PMID:38521485 | DOI:10.1016/j.jse.2024.03.006