Category: Statistics

J Foot Ankle Surg. 2023 Jul-Aug;62(4):752. doi: 10.1053/j.jfas.2022.12.018.

NO ABSTRACT

PMID:37407146 | DOI:10.1053/j.jfas.2022.12.018

J Am Coll Cardiol. 2023 Jul 11;82(2):89-105. doi: 10.1016/j.jacc.2023.04.051.

ABSTRACT

BACKGROUND: Aspirin is the only antiplatelet agent with a Class I recommendation for long-term prevention of cardiovascular events in patients with coronary artery disease (CAD). There is inconsistent evidence on how it compares with alternative antiplatelet agents.

OBJECTIVES: This study compared P2Y₁₂ inhibitor monotherapy vs aspirin in patients with CAD.

METHODS: We conducted a patient-level meta-analysis of randomized trials comparing P2Y₁₂ inhibitor monotherapy vs aspirin monotherapy for the prevention of cardiovascular events in patients with established CAD. The primary outcome was the composite of cardiovascular death, myocardial infarction, and stroke. Prespecified key secondary outcomes were major bleeding and net adverse clinical events (the composite of the primary outcome and major bleeding). Data were pooled in a 1-step meta-analysis.

RESULTS: Patient-level data were obtained from 7 trials. Overall, 24,325 participants were available for analysis, including 12,178 patients assigned to receive P2Y₁₂ inhibitor monotherapy (clopidogrel in 7,545 [62.0%], ticagrelor in 4,633 [38.0%]) and 12,147 assigned to receive aspirin. Risk of the primary outcome was lower with P2Y₁₂ inhibitor monotherapy compared with aspirin over 2 years (HR: 0.88; 95% CI: 0.79-0.97; P = 0.012), mainly owing to less myocardial infarction (HR: 0.77; 95% CI: 0.66-0.90; P < 0.001). Major bleeding was similar (HR: 0.87; 95% CI: 0.70-1.09; P = 0.23) and net adverse clinical events were lower (HR: 0.89; 95% CI: 0.81-0.98; P = 0.020) with P2Y₁₂ inhibitors. The treatment effect was consistent across prespecified subgroups and types of P2Y₁₂ inhibitors.

CONCLUSIONS: Given its superior efficacy and similar overall safety, P2Y₁₂ inhibitor monotherapy might be preferred over aspirin monotherapy for long-term secondary prevention in patients with established CAD. (P2Y₁₂ Inhibitor or Aspirin Monotherapy as Secondary Prevention in Patients With Coronary Artery Disease: An Individual Patient Data Meta-Analysis of Randomized Trials [PANTHER collaborative initiative]; CRD42021290774).

PMID:37407118 | DOI:10.1016/j.jacc.2023.04.051

BMJ. 2023 Jul 5;382:e073639. doi: 10.1136/bmj-2022-073639.

ABSTRACT

OBJECTIVE: To describe hospital admissions associated with SARS-CoV-2 infection in children and adolescents.

DESIGN: Cohort study of 3.2 million first ascertained SARS-CoV-2 infections using electronic health care record data.

SETTING: England, July 2020 to February 2022.

PARTICIPANTS: About 12 million children and adolescents (age <18 years) who were resident in England.

MAIN OUTCOME MEASURES: Ascertainment of a first SARS-CoV-2 associated hospital admissions: due to SARS-CoV-2, with SARS-CoV-2 as a contributory factor, incidental to SARS-CoV-2 infection, and hospital acquired SARS-CoV-2.

RESULTS: 3 226 535 children and adolescents had a recorded first SARS-CoV-2 infection during the observation period, and 29 230 (0.9%) infections involved a SARS-CoV-2 associated hospital admission. The median length of stay was 2 (interquartile range 1-4) days) and 1710 of 29 230 (5.9%) SARS-CoV-2 associated admissions involved paediatric critical care. 70 deaths occurred in which covid-19 or paediatric inflammatory multisystem syndrome was listed as a cause, of which 55 (78.6%) were in participants with a SARS-CoV-2 associated hospital admission. SARS-CoV-2 was the cause or a contributory factor in 21 000 of 29 230 (71.8%) participants who were admitted to hospital and only 380 (1.3%) participants acquired infection as an inpatient and 7855 (26.9%) participants were admitted with incidental SARS-CoV-2 infection. Boys, younger children (<5 years), and those from ethnic minority groups or areas of high deprivation were more likely to be admitted to hospital (all P<0.001). The covid-19 vaccination programme in England has identified certain conditions as representing a higher risk of admission to hospital with SARS-CoV-2: 11 085 (37.9%) of participants admitted to hospital had evidence of such a condition, and a further 4765 (16.3%) of participants admitted to hospital had a medical or developmental health condition not included in the vaccination programme’s list.

CONCLUSIONS: Most SARS-CoV-2 associated hospital admissions in children and adolescents in England were due to SARS-CoV-2 or SARS-CoV-2 was a contributory factor. These results should inform future public health initiatives and research.

PMID:37407076 | DOI:10.1136/bmj-2022-073639

BMJ Open. 2023 Jul 5;13(7):e064199. doi: 10.1136/bmjopen-2022-064199.

ABSTRACT

OBJECTIVES: In December 2018, China launched national volume-based procurement (NVBP) to negotiate drug prices with manufacturers. Gefitinib was one of the 25 pilot drugs, which is used for treatment of non-small cell lung cancer. Lung cancer is the most common type of cancer in China and targeted drugs like gefitinib have been proven to provide clinical benefits to patients. This study aims to explore the impact of NVBP policy on the usage and expenditure of anticancer drugs.

METHODS: Gefitinib and alternative drugs (icotinib and erlotinib) were used as objects of study. Quarterly data from the China Hospital Pharmaceutical Audit database in 9454 hospitals in China were used for analysis. Descriptive analysis was conducted using purchase volume and expenditure as variables. Interrupted time-series (ITS) analysis was applied to further analyse the effect of NVBP policy on the medicines under study.

RESULTS: During the 12-month period before (2018Q2-2019Q1) and after (2019Q2-2020Q1) the NVBP policy, the total purchase volume of medicines rose from 4.48 million defined daily dose (DDD) to 7.02 million DDD, with an increase of 56.66%. Purchase volume of gefitinib and alternative drugs increased 100.61% and 14.88%, respectively. After the implementation of NVBP policy, procurement volume of alternative drugs decreased by 72 051 DDD (p value=0.044) and trend change decreased by 56 738 DDD (p value<0.01). The overall expenditure reduction was 14.7%, with the expenditure of gefitinib reducing by 38.47% and alternative drugs increasing by 10.70%. ITS analysis indicated statistically significant differences in level and trend changes for expenditure of total drugs and gefitinib.

CONCLUSIONS: The evidence provided in this study indicated that the implementation of NVBP policy was related to the expenditure reduction of the first generation of anti-EGFR lung cancer drugs. The policy effectively controlled the increase in expenditures for corresponding drugs while ensuring the use of drugs.

PMID:37407064 | DOI:10.1136/bmjopen-2022-064199

BMJ Open. 2023 Jul 4;13(7):e068339. doi: 10.1136/bmjopen-2022-068339.

ABSTRACT

INTRODUCTION: Optimal delivery and organisation of care is critical for surgical outcomes and healthcare systems efficiency. Anaesthesia volumes have been recently associated with improved postoperative recovery outcomes; however, the mechanism is unclear. Understanding the individual processes of care (interventions received by the patient) is important to design effective systems that leverage the volume-outcome association to improve patient care. The primary objective of this scoping review is to systematically map the evidence regarding intraoperative processes of care for upper gastrointestinal cancer surgery. We aim to synthesise the quantity, type, and scope of studies on intraoperative processes of care in adults who undergo major upper gastrointestinal cancer surgeries (oesophagectomy, hepatectomy, pancreaticoduodenectomy, and gastrectomy) to better understand the volume-outcome relationship for anaesthesiology care.

METHODS AND ANALYSIS: This scoping review will follow the Arksey and O’Malley framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension framework for scoping reviews. We will systematically search MEDLINE, Embase and Cochrane databases for original research articles published after 2010 examining postoperative outcomes in adult patients undergoing either: oesophagectomy, hepatectomy, pancreaticoduodenectomy, or gastrectomy, which report at least one intraoperative processes of care (intervention or framework) applied by anaesthesia or surgery. The data from included studies will be extracted, charted, and summarised both quantitatively and qualitatively through descriptive statistics and narrative synthesis.

ETHICS AND DISSEMINATION: No ethics approval is required for this scoping review. Results will be disseminated through publication targeted at relevant stakeholders in anaesthesiology and cancer surgery.

TRIAL REGISTRATION NUMBER: 10.17605/OSF.IO/392UG; https://archive.org/details/osf-registrations-392ug-v1.

PMID:37407044 | DOI:10.1136/bmjopen-2022-068339

BMJ Open. 2023 Jul 4;13(7):e073550. doi: 10.1136/bmjopen-2023-073550.

ABSTRACT

INTRODUCTION: Globally, non-communicable diseases (NCDs) are the leading causes of morbidity and mortality with an estimated 41 million deaths (74% of all global deaths) annually. Despite the WHO’s Global Action Plan for the Prevention and Control of NCDs since 2013, progress on implementation of the guidelines has been slow. Although research has shown success of some NCD prevention and treatment interventions, there is a dearth of research on NCD care delivery approaches, cost-effectiveness and larger implementation research, especially in low/middle-income countries (LMICs). The objective of this scoping review is to identify the existing variation in how, why and by whom implementation of NCD guidelines is measured as part of implementation research or non-research programme improvement.

METHODS AND ANALYSIS: Using the methods established by Arksey and O’Malley, the search strategy was developed in consultation with a research librarian together with stakeholder feedback from content experts. We will apply the search to multiple electronic databases and grey literature sources. Two reviewers will independently screen title and abstract for inclusion followed by a full-text screening and all included records will be abstracted using a standardised tool that will be piloted with a sample of articles before application to all records. We will conduct a narrative synthesis of abstracted data and simple quantitative descriptive statistics.

DISSEMINATION: The results will enable stakeholders in LMICs to leverage existing tools and resources for implementation and ongoing evaluation of NCD guidelines, to improve education and capacity building, and ultimately NCD care across the lifespan.

PMID:37407038 | DOI:10.1136/bmjopen-2023-073550

J Epidemiol Community Health. 2023 Jul 4:jech-2022-220030. doi: 10.1136/jech-2022-220030. Online ahead of print.

ABSTRACT

BACKGROUND: Alcohol use is a leading cause of disease. Although low- and middle-income countries (LMICs) have lower per capita alcohol consumption, the alcohol-attributable disease burden is high in these settings with consumption increasing. LMICs are also experiencing unprecedented levels of internal migration, potentially increasing mental stress, changing social restrictions on drinking, and increasing alcohol availability. We assessed the relationship between internal migration, opportunity to drink, and the transition from first use to regular alcohol use and alcohol use disorders (AUD) in Nepal, a low-income, South Asian country.

METHODS: A representative sample of 7435 individuals, aged 15-59 from Nepal were interviewed in 2016-2018 (93% response rate) with clinically validated measures of alcohol use and disorders and life history calendar measures of lifetime migration experiences. Discrete-time hazard models assessed associations between migration and alcohol use outcomes.

RESULTS: Net of individual sociodemographic characteristics, internal migration was associated with increased odds of opportunity to drink (OR 1.32, 95% CI 1.14 to 1.53), onset of regular alcohol use given lifetime use (OR 1.29, 95% CI 1.13 to 1.48) and AUD given lifetime use (OR 1.24, 95% CI 0.99 to 1.57). The statistically significant association between internal migration and opportunity to drink was specific to females, whereas the associations between migration and regular use and disorder were statistically significant for males.

CONCLUSIONS: Despite high rates of internal migration worldwide, most research studying migration and alcohol use focuses on international migrants. Findings suggest that internal migrants are at increased risk to transition into alcohol use and disorders. Support services for internal migrants could prevent problematic alcohol use among this underserved population.

PMID:37407031 | DOI:10.1136/jech-2022-220030

Clin Respir J. 2023 Jul 5. doi: 10.1111/crj.13653. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the outcomes of bronchial artery embolization (BAE) for the treatment of massive hemoptysis in patients with pulmonary tuberculosis and identify risk factors that influence recurrence.

METHODS: A total of 81 patients with massive hemoptysis who underwent BAE between January 2014 and December 2017 were retrospectively reviewed. All of the patients had either a history of pulmonary tuberculosis or a current diagnosis of pulmonary tuberculosis. Follow-up ranged from 18 to 66 months.

RESULTS: Hemoptysis was stopped or markedly decreased, with subsequent clinical improvement in 73 patients, while 11 patients experienced recurrence during the follow-up period. Systemic-pulmonary shunts and clinical failure showed a statistically significant correlation with the recurrence rate. The cumulative non-recurrence rate was 95.3% for 3 months and 81.9% for more than 24 months. Complications were common (12.5%), but self-limiting.

CONCLUSIONS: BAE is a safe and effective treatment option for the control of massive hemoptysis in pulmonary tuberculosis patients. Systemic-pulmonary shunts and clinical failure are the risk factors for recurrence.

PMID:37406999 | DOI:10.1111/crj.13653

J Am Vet Med Assoc. 2023 Jul 5:1-6. doi: 10.2460/javma.23.02.0103. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the performance of an interstitial glucose monitor (IGM) versus a portable blood glucose monitor (PBGM) in sick juvenile dogs in a veterinary ICU.

ANIMALS: 16 client-owned dogs admitted to the university teaching hospital under 1 year of age with systemic illness.

PROCEDURES: Paired interstitial and blood glucose samples were collected. A third glucose measurement with a reference method was obtained when IGM and PBGM values were clinically disparate. Analytical accuracy was measured by Pearson correlation and agreement statistics, including mean absolute relative difference (MARD), bias, and 95% limits of agreement. The Parkes consensus error grid analysis was performed to assess clinical accuracy.

RESULTS: 159 paired glucose measurements were available for analysis. Comparison of IGM readings to PBGM measurements resulted in an MARD of 15.4% and bias of -2.6%, with the 95% limits of agreement ranging from -42.5% to 37.4%. Positive correlation between IGM and PBGM (Pearson r = 0.65) was found. On consensus error grid analysis, 100% of the pairs fell into clinically acceptable zones (74.2% in zone A, and 25.8% in zone B). When disparate IGM and PBGM readings were compared to a laboratory reference standard (n = 13), both methods resulted in high MARD and wide limits of agreement.

CLINICAL RELEVANCE: The IGM provides clinically acceptable glucose measurements compared to PBGM to monitor glucose levels in juvenile dogs in a clinical setting. Further clinical studies with a larger sample size, particularly in the hypoglycemic range, are needed to assess IGM performance in the lower glucose range.

PMID:37406997 | DOI:10.2460/javma.23.02.0103

Biomed Tech (Berl). 2023 Jul 7. doi: 10.1515/bmt-2023-0039. Online ahead of print.

ABSTRACT

Proximal humeral shaft fractures can be treated with helically deformed bone plates to reduce the risk of iatrogenic nerve lesion. Controversially to this common surgical technique that was first established in 1999, no biomechanical investigation on humeral helical plating is recorded by other reviews, which focus on proximal fractures exclusively. Does an additional scope for shaft fractures reveal findings of helical testing? The present systematic literature review was performed based on guidelines by Kitchenham et al. to systematically search and synthesize literature regarding biomechanical testing of osteosynthetic systems for proximal humeral shaft fractures. Therefore, a systematic approach to search and screen literature was defined beforehand and applied on the findings of the database PubMed^®. Synthesized information of the included literature was categorized, summarized and analyzed via descriptive statistics. Out of 192 findings, 22 publications were included for qualitative synthesis. A wide range of different test methods was identified, leading to a suboptimal comparability of specific results between studies. Overall, 54 biomechanical test scenarios were identified and compared. Physiological based boundary conditions (PB-BC) were referenced in 7 publications only. One study of testing straight and helical dynamic compression plates without PB-BCs was identified, showing significant differences under compressional loading. The absence of test standards of specific fields like humeral fractures lead to a high variance in biomechanical testing of osteosynthetic locking plates for proximal humeral shaft fractures. Physiological approaches offer realistic test scenarios but need to be uniformed for enhanced comparability between studies. The impact of helically deformed locking plates under PB-BC was not identified in literature.

PMID:37406349 | DOI:10.1515/bmt-2023-0039