Tag: statistics

Adv Ther. 2023 Apr 8. doi: 10.1007/s12325-023-02462-9. Online ahead of print.

ABSTRACT

INTRODUCTION: This study assessed the real-life effectiveness of a single-pill combination (SPC) of bisoprolol/perindopril for controlling blood pressure (BP) and symptoms of angina in patients with hypertension and a history of myocardial infarction (MI).

METHODS: Eligible patients with arterial hypertension and a history of MI were aged 18-79 years and had initiated bisoprolol/perindopril SPC within 3 months of study enrollment as part of routine Russian clinical practice. The primary endpoint was mean change in systolic and diastolic BP (SBP/DBP) at week 12 compared with baseline (data collected retrospectively). Secondary endpoints were assessed at weeks 4 and 12 and included mean change in resting heart rate (HR), proportion of patients reaching target level of resting HR, antianginal effectiveness of the SPC, and proportion of patients reaching target BP levels.

RESULTS: A total of 504 patients were enrolled, of whom 481 comprised the full analysis set (mean age 61.4 ± 8.9 years, 68% men). Mean baseline SBP/DBP and HR values were 148.9 ± 16.8/87.7 ± 11.0 mmHg and 77.4 ± 10.5 bpm, respectively. Mean durations of hypertension and CAD were 12.8 ± 8.4 and 6.1 ± 6.3 years, respectively, and time since MI was 3.8 ± 5.3 years. At week 12, SBP/DBP had decreased by 24.9/12.2 mmHg (P < 0.001 vs baseline). Target BP (< 140/90 mmHg) was achieved by 69.8% and 95.9% of patients at weeks 4 and 12, respectively, and target HR (55-60 bpm) by 17.3% and 34.5% at weeks 4 and 12 versus 3.1% at baseline (P < 0.001). Reductions in angina attacks, nitrate consumption, and improvements in HR were statistically significant. Treatment was well tolerated.

CONCLUSION: Treatment of symptomatic patients with CAD, hypertension, and a history of MI with a bisoprolol/perindopril SPC was associated with significant decreases in SBP/DBP and a high proportion of patients achieving BP treatment goals. This was accompanied by improvements in angina symptoms and reductions in HR in a broad patient population representative of those seen in everyday clinical practice.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04656847.

PMID:37029871 | DOI:10.1007/s12325-023-02462-9

Ann Surg Oncol. 2023 Apr 8. doi: 10.1245/s10434-023-13367-w. Online ahead of print.

ABSTRACT

INTRODUCTION: Imaging guidelines for post-neoadjuvant chemotherapy (NAC) breast cancer patients lack specificity on appropriateness and utility of individual modalities for surgical planning. Microcalcifications confound mammographic interpretation. We examined the correlation between the mammographic extent of microcalcifications present post-NAC, corresponding magnetic resonance imaging (MRI) lesions, and definitive surgical pathology.

METHODS: In this retrospective cohort study, patients with calcifications on mammography were collected from a database of consecutive breast cancer patients receiving NAC. The primary objective was to determine the correlation between maximum dimension of post-NAC calcifications with surgical pathology (invasive disease, tumor bed, and ductal carcinoma in situ [DCIS]), stratified by tumor receptor subgroup. Secondarily, we examined the correlation of residual disease with MRI mass enhancement (ME) and non-ME (NME). Pearson’s correlation coefficient was used to evaluate statistical significance (strong: R² ≥70%; moderate: R²=25-70%; weak: R² ≤25%).

RESULTS: Overall, 186 patients met the inclusion criteria. Mammographic calcifications correlated poorly with invasive disease (R² = 10.8%), overestimating by 57%. In patients with calcifications on mammography, MRI ME and NME correlated weakly with the maximum dimension of invasive disease and DCIS. In triple-negative breast cancer (TNBC) patients, invasive disease correlated strongly with the maximum dimension of calcifications (R² = 83%) and moderately with ME (R² = 37.7%) and NME (R² = 28.4%).

CONCLUSION: Overall, current imaging techniques correlate poorly and overestimate final surgical pathology. This poor correlation may lead to uncertainty in the extent of required surgical excision and the exclusion of potential candidates for non-surgical management in ongoing trials. TNBCs would be good candidates for these trials given the stronger observed correlations between pathology and imaging.

PMID:37029866 | DOI:10.1245/s10434-023-13367-w

Acta Neurol Belg. 2023 Apr 8. doi: 10.1007/s13760-023-02239-5. Online ahead of print.

ABSTRACT

INTRODUCTION: The routinely used computed tomography (CT)-based workup in the setting of acute ischemic stroke (AIS) includes non-contrast brain CT, CT angiography (CTA), and CT perfusion. Several CT, CTA, CTP-based radiological biomarkers of hemorrhagic transformation (HT) were reported.

AIM OF THE STUDY: To assess the predictive value of the combined multimodal CT parameters for HT after AIS and proposal of predictive scoring scale.

METHODS: The source images of the NCCT, CTA and CTP of 282 AIS patients involving the anterior circulation (HT = 91, non-HT = 191) were retrospectively reviewed and the following biomarkers were recorded and analyzed: Early subtle ischemic signs, hyperdense middle cerebral artery sign (HMCAS) and Alberta Stroke Program Early CT Score (ASPECTS) < 7 in NCCT, large-vessel occlusion (LVO), clot burden score (CBS) < 6, large-vessel occlusion, poor collateral score (CS) and Tmax > 6 s ≥ 56.5 ml. A scoring system to predict HT based on these biomarkers was developed. Each biomarker counts for a single point with the total score ranging from 0 to 7.

RESULTS: All the aforementioned multimodal CT biomarkers and the selected cut offs were significantly associated with higher HT risk. The calculated scores were statistically significant different between the HT and the non-HT groups with AUC 0.761 (95% CI 0.703-0.819, P < 0.0000001). Rates of HT were approximately five times higher in patients with score ≥ 3.

CONCLUSION: Multimodal CT-based scoring system may provide highly reliable predictive model of hemorrhagic transformation in acute ischemic stroke.

PMID:37029844 | DOI:10.1007/s13760-023-02239-5

Eur J Orthop Surg Traumatol. 2023 Apr 8. doi: 10.1007/s00590-023-03532-y. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study is to evaluate 90-day outcomes and complications following radial head arthroplasty (RHA) for Mason Type III and IV radial head fractures (RHFs) and determine factors predisposing patients to early complications and revision surgery.

METHODS: Patients undergoing RHA for Mason Type III and IV RHFs were identified retrospectively from an institutional database. Postoperative complications, reoperations, elbow range of motion, radiographs and concomitant injuries on the ipsilateral upper extremity were reviewed. Additionally, injuries were sub-classified as low-energy trauma (LET) or high-energy trauma (HET). Univariate logistic regression was performed to evaluate the risk for complications using patient factors not limited to the presence of concomitant ligamentous or bony injuries. P values < 0.05 were considered statistically significant.

RESULTS: Seventy four patients were included in our study with an average follow-up time of 12.7 months. Complications within 90-days of operation occurred in 8.1% of patients: heterotopic ossification (4.1%), superficial wound dehiscence (2.7%), and posterior interosseous nerve palsy (1.4%). No patients required readmission or revision surgery in the 90-day postoperative period. Univariate regression analysis did not demonstrate a significant association between diabetes, ASA status, HET versus LET, or the presence of concomitant injury. Concomitant injuries were found in 92% of patients.

CONCLUSION: Radial head arthroplasty for RHFs demonstrates a low complication rate in the short-term. Diabetes, ASA class, high versus low energy trauma, and presence of concomitant injury were not found to be associated with higher complication rates in the 90-day postoperative period.

LEVEL OF EVIDENCE: Level of evidence IV, retrospective case series.

PMID:37029835 | DOI:10.1007/s00590-023-03532-y

J Math Biol. 2023 Apr 8;86(5):71. doi: 10.1007/s00285-023-01905-9.

ABSTRACT

The inclusion of cognitive processes, such as perception, learning and memory, are inevitable in mechanistic animal movement modelling. Cognition is the unique feature that distinguishes animal movement from mere particle movement in chemistry or physics. Hence, it is essential to incorporate such knowledge-based processes into animal movement models. Here, we summarize popular deterministic mathematical models derived from first principles that begin to incorporate such influences on movement behaviour mechanisms. Most generally, these models take the form of nonlocal reaction-diffusion-advection equations, where the nonlocality may appear in the spatial domain, the temporal domain, or both. Mathematical rules of thumb are provided to judge the model rationality, to aid in model development or interpretation, and to streamline an understanding of the range of difficulty in possible model conceptions. To emphasize the importance of biological conclusions drawn from these models, we briefly present available mathematical techniques and introduce some existing “measures of success” to compare and contrast the possible predictions and outcomes. Throughout the review, we propose a large number of open problems relevant to this relatively new area, ranging from precise technical mathematical challenges, to more broad conceptual challenges at the cross-section between mathematics and ecology. This review paper is expected to act as a synthesis of existing efforts while also pushing the boundaries of current modelling perspectives to better understand the influence of cognitive movement mechanisms on movement behaviours and space use outcomes.

PMID:37029822 | DOI:10.1007/s00285-023-01905-9

J Cancer Res Clin Oncol. 2023 Apr 8. doi: 10.1007/s00432-023-04736-9. Online ahead of print.

ABSTRACT

PURPOSE: Immune checkpoint inhibitors (ICIs) are increasingly used in the treatment of certain cancers but cause immune-related adverse events (irAEs). Gastrointestinal irAEs may necessitate extended periods of steroid use and the initiation of selective immunosuppressive therapy (SIT) which could theoretically counteract the effect of ICIs. In this study, we aim to explore the impact of immunosuppression use and duration on cancer progression and progression-free survival (PFS).

METHODS: This is a single-center retrospective review exploring cancer outcomes in patients taking ICIs who developed gastrointestinal irAEs within 1 year of ICI initiation. Cancer outcome and progression free survival (PFS) were measured and compared by using IBM SPSS Statistics 26.

RESULTS: Of the 116 patients included in this study, 69 received immunosuppression to treat irAEs. The occurrence of colitis and use of immunosuppression for colitis were associated with less cancer progression by later assessment (p < 0.05). Shorter durations of steroids with or without SIT for colitis were associated with less cancer progression within the study window than no immunosuppression (p < 0.05). Immunosuppression has no effect on PFS (p < 0.05).

CONCLUSION: Our study reported shorter duration of steroid treatment for colitis may be associated with less cancer progression. Though the use of immunosuppression was not found to impact PFS, this may be confounded by the presence of colitis, which is known to improve cancer outcomes and could mask any negative impact of immunosuppression on survival. It may be preferable to limit long-term immunosuppression in the treatment of immune-mediated colitis to minimize potential complications. Prospective studies are needed to clarify this relationship, and treatments that abrogate the need for immunosuppression in these patients such as fecal microbiota transplantation.

PMID:37029815 | DOI:10.1007/s00432-023-04736-9

Eur Spine J. 2023 Apr 8. doi: 10.1007/s00586-023-07662-z. Online ahead of print.

ABSTRACT

INTRODUCTION: Endoscopic techniques are becoming popular among spine surgeons because of their advantages. Though the advantages of endoscopic spine surgery are evident and patients can be discharged home within hours of surgery, readmissions can be sought for incomplete relief of leg pain, recurrent disc herniation, and recurrent leg pain. We aim to find out the factors related to the readmission of patients treated for lumbar pathologies.

MATERIALS AND METHODS: This is a retrospective analysis of the data between the time duration of 2012 and 2022. Patients in the age group of 18-85 years, with lumbar disc herniation treated by transforaminal endoscopic lumbar procedures, were included. The patients who were readmitted within 90 days were included in the R Group and those who were not were included in the NR group. Univariable and multivariable logistic regression analyses were used to find the risk factors for 90-day readmission.

RESULTS: There were a total of 1542 patients enrolled in this study. Sex, number of episodes before admission, hypertension, smoking, BMI, migration, disc height, disc height index, spondylolisthesis, instability, pelvic tilt (PT), and disc cross-sectional area (CSA) were found significant on univariable analysis. Age, spondylolisthesis, instability and muscle CSA were the only variables that were found to be statistically significant on multivariable analysis.

CONCLUSIONS: This study shows that the elderly age group, presence of spondylolisthesis, segmental instability and decreased muscle cross-sectional area are independent risk factors for 90-day hospital readmissions. Patients having the above risk factors should be carefully counseled regarding the possibility of readmission in the future.

PMID:37029807 | DOI:10.1007/s00586-023-07662-z

World J Surg. 2023 Apr 8. doi: 10.1007/s00268-023-06990-x. Online ahead of print.

ABSTRACT

BACKGROUND: The shortage of trained surgeons, anesthesiologists, and obstetricians is a major contributor to the unmet need for surgical care in low- and middle-income countries, and the shortage is aggravated by migration to higher-income countries.

METHODS: We performed a cross-sectional observational study, combining individual-level data of 43,621 physicians from the Health Professions Council of South Africa with data from the registers of 14 high-income countries, and international statistics on surgical workforce, in order to quantify migration to and from South Africa in both absolute and relative terms.

RESULTS: Of 6670 surgeons, anesthesiologists, and obstetricians in South Africa, a total of 713 (11%) were foreign medical graduates, and 396 (6%) were from a low- or middle-income country. South Africa was an important destination primarily for physicians originating from low-income countries; 2% of all surgeons, anesthesiologists, and obstetricians from low- and middle-income countries were registered in South Africa, and 6% in the other 14 recipient countries. A total of 1295 (16%) South African surgeons, anesthesiologists, and obstetricians worked in any of the 14 studied high-income countries.

CONCLUSION: South Africa is an important regional hub for surgical migration and training. A notable proportion of surgical specialists in South Africa were medical graduates from other low- or middle-income countries, whereas migration out of South Africa to high-income countries was even larger.

PMID:37029798 | DOI:10.1007/s00268-023-06990-x

Eur J Trauma Emerg Surg. 2023 Apr 8. doi: 10.1007/s00068-023-02267-z. Online ahead of print.

ABSTRACT

PURPOSE: As blunt thoracic aortic injury (BTAI) treatment has shifted from open to thoracic endovascular aortic repair (TEVAR), logistical challenges exist in creating and maintaining inventories of appropriately sized stent-grafts, including storage demands, shelf-life management and cost. We hypothesized that most injured aortas can be successfully repaired with a narrow range of stent-graft sizes and present a value-based anatomic approach to optimizing inventory.

METHODS: CT-scans of all patients with BTAI admitted to our Level I trauma center from Apr 2010-Dec 2018 were reviewed. Patients with anatomy incompatible with TEVAR were excluded. For each patient, after aortic sizing a set of two stent-grafts most likely to be utilized was selected from a list of twenty commercially available GORE conformable TAG endografts based on manufacturer instructions. Stent-graft sizes were then ranked based on the number of cases they would be suitable for. MATLAB was utilized to determine the combinations of stent-grafts which would cover the most patients.

RESULTS: Twenty-eight patients with BTAI were identified and three were excluded based on iliac diameter. Most patients were male (68%), mean age 42.3 ± 20.2 years, mean ISS 37.0 ± 9.8. Overall mortality was 25%. Of the 20 available stent-graft options, a combination of four stent-grafts would successfully treat 100% of the patients in this series.

CONCLUSIONS: Based on actual CT-scan aortic measurements, we demonstrated that an inventory of four sent-graft sizes was sufficient to treat 100% of patients with BTAI. These data can be utilized as a value-based anatomic approach to aortic stent-graft institutional inventory creation and maintenance.

PMID:37029792 | DOI:10.1007/s00068-023-02267-z

Diabet Med. 2023 Apr 8:e15108. doi: 10.1111/dme.15108. Online ahead of print.

ABSTRACT

AIMS: The contemporary prescription patterns of antidiabetic drugs following guideline changes recommending metformin as first-line gestational diabetes (GDM) pharmacotherapy is underexplored. We aimed to examined use of metformin and insulin during pregnancy among women with GDM over 20 years in the United Kingdom.

METHODS: We conducted a population-based cohort study using linked data from the Clinical Practice Research Datalink, its pregnancy register, and Hospital Episode Statistics from 1998-2017. We included pregnancies of women without prior diabetes history who received GDM diagnosis or initiated an antidiabetic drug after 20 weeks gestation. Patient-level and practice-level characteristics were compared between metformin initiators and insulin initiators. We described trends of initiating metformin as first-line treatment and described time to initiation of rescue insulin overall, and by body mass index among metformin initiators.

RESULTS: Our cohort included 5,633 pregnancies from 5,393 women with GDM, of whom 39.6% initiated pharmacotherapy (41% insulin, 59% metformin). Metformin prescriptions (as opposed to insulin) increased substantially, from < 5% of pregnancies before 2007 to 42.5%. Since 2008. Over 85% of pregnancies that were prescribed a pharmacotherapy were prescribed metformin as first-line treatment in 2015. Among metformin initiators, 16% initiated rescue insulin, typically occurring within 40 days of metformin initiation. Choice of GDM pharmacotherapy varied by characteristics, including smoking, obesity, race/ethnicity, and general practice regions.

CONCLUSIONS: Metformin was the most prescribed medication for GDM, with large increases over the past 2 decades. The increasing use of oral-antidiabetic drugs during pregnancy, consistent with other regions, highlights the need for future studies examining effectiveness and safety of antidiabetic drug use during pregnancy.

PMID:37029772 | DOI:10.1111/dme.15108