Category: Statistics

BMJ Open. 2023 May 3;13(5):e070345. doi: 10.1136/bmjopen-2022-070345.

ABSTRACT

INTRODUCTION: Renin-angiotensin system (RAS) plays a key role in various types of cardiovascular disease and many kinds of RAS inhibitors have been developed. The effect of discontinuation of RAS inhibitors on clinical outcomes is still controversial. This study aims to evaluate the effects of discontinuing RAS inhibitor medication on the clinical outcomes of patients continuously taking these agents.

METHODS AND ANALYSIS: This article presents a systematic review protocol described in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include randomised controlled trials in which the effects of RAS inhibitor withdrawal were evaluated. Initially, four authors will search for eligible studies in MEDLINE, EMBASE, the Cochrane Database Trial Register, European trial registry and ClinicalTrials.gov. Abstracts and full-text screenings will be performed by the four authors with data extraction performed by each author independently. We will include patients taking RAS inhibitors-including ACE inhibitor, angiotensin receptor blocker and angiotensin receptor neprilysin inhibitor and exclude the patients undergoing renal replacement therapy (RRT), adolescents (under 18 years of age) and patients with acute infectious diseases. Our search will be performed on 1 May 2023. Studies in which the patients discontinued RAS inhibitors due to any reason will be included. Patients who continuously took RAS inhibitors under conditions in which the intervention group discontinued these agents will be considered eligible as the comparison group. Death (any cause), Death (cardiovascular disease (CVD)) and CVD events will be set as primary outcomes. Secondary outcomes will be set as RRT, acute kidney injury, renal function (analysis of the change in estimated glomerular filtration rate), hyperkalaemia, proteinuria and blood pressure.

ETHICS AND DISSEMINATION: Research ethics approval was not required in this study due to it being a systematic review, and any data belonging to individuals cannot be identified. The results of this study will be disseminated through peer-reviewed journals and conferences.

TRIAL REGISTRATION NUMBER: PROSPERO CRD42022300777.

PMID:37137558 | DOI:10.1136/bmjopen-2022-070345

BMJ Open. 2023 May 3;13(5):e068499. doi: 10.1136/bmjopen-2022-068499.

ABSTRACT

INTRODUCTION: Negative pressure wound therapy (NPWT) in acute burn care may decrease the time to re-epithelialisation by more than 20%. Despite this, the perceived burden of use; including therapeutic, physical and financial, have limited the use of NPWT in acute burn care. This might be minimised by using the small, ultraportable, single-use NPWT device PICO as opposed to larger devices, which to date has never been studied in acute burn care. This research will; therefore, primarily assess the feasibility, acceptability and safety of PICO in paediatric burns. Secondary outcomes include time to re-epithelialisation, pain, itch, cost and scar formation.

METHODS AND ANALYSIS: This protocol details a clinical trial methodology and is pre-results. This single site, prospective, pilot randomised controlled trial will be conducted in an Australian quaternary paediatric burns centre. Participants must be aged ≤16 years, otherwise well and managed within 24 hours of sustaining a burn that fits beneath a PICO dressing. Thirty participants will be randomised to one of three groups: group A: Mepitel and ACTICOAT, group B: Mepitel, ACTICOAT and PICO and group C: Mepitel, ACTICOAT Flex and PICO. Patient outcomes will be recorded at each dressing change to assess efficacy and safety outcomes until 3 months postburn wound re-epithelialisation. Surveys, randomisation and data storage will be undertaken via online platforms and physical data storage collated at the Centre for Children’s Health Research, Brisbane, Australia. Analysis will be done by using StataSE 17.0 statistical software.

ETHICS AND DISSEMINATION: Ethics has been obtained from Queensland Health and Griffith Human Research Ethics committees including a site-specific approval. These data will be disseminated via clinical meetings, conference presentations and peer-reviewed journals.

TRIAL REGISTRATION NUMBER: ACTRN12622000009718.

PMID:37137557 | DOI:10.1136/bmjopen-2022-068499

Int J Rheum Dis. 2023 May 3. doi: 10.1111/1756-185X.14710. Online ahead of print.

ABSTRACT

INTRODUCTION: Restless leg syndrome (RLS) is a neurological disorder characterized by an uncontrollable desire to move legs along with abnormal sensations, particularly at night, which can lead to sleep disturbance. RLS may mimic rheumatic diseases or can be associated with them, hence their identification and treatment are important to improve sleep quality and overall quality of life in rheumatic diseases.

METHODS: We conducted a search of the PubMed, SCOPUS, and EMBASE databases to identify studies reporting a prevalence of RLS in patients with rheumatic disease. Two authors independently screened, selected, and extracted the data. Heterogeneity was assessed using I² statistics and random effect method of the meta-analysis was used to synthesize the results.

RESULTS: Out of 273 unique records, 17 eligible studies including 2406 rheumatic patients were identified. RLS prevalence (95% CI) among patients of rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, fibromyalgia and ankylosing spondylitis are found to be 26.6% (18.6 34.6); 32.5% (23.1-41.9), 4.4% (2.0-6.8), 38.1% (31.3-45.0) and 30.8% (23.48-39.16) respectively. RLS prevalence was similar for males and females.

CONCLUSION: Our study indicates a high prevalence of RLS in patients with rheumatic diseases. Early detection and treatment of RLS in patients with rheumatic conditions could be beneficial in improving their overall health and quality of life.

PMID:37137528 | DOI:10.1111/1756-185X.14710

Stroke Vasc Neurol. 2023 May 3:svn-2022-002276. doi: 10.1136/svn-2022-002276. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: The ring finger protein 213 gene (RNF213) p.R4810K variant increased the risk of acute ischaemic stroke (AIS) attributable to intracranial arterial stenosis (ICAS) in the Japanese and Korean populations. In this study, we aimed to examine the prevalence of the RNF213 p.R4810K variant in Chinese patients with AIS or transient ischaemic attack and identify the phenotype of the carriers.

METHODS: We analysed data from the Third China National Stroke Registry. All included participants were divided into two groups by carrier status of the p.R4810K variant. The aetiological classification was conducted according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. The presence of ICAS and extracranial arterial stenosis (ECAS) was defined as 50%-99% stenosis or occlusion of any intracranial and extracranial artery. Logistic regression models and Cox regression models were used to evaluate the association of the p.R4810K variant with TOAST classification, stenosis phenotypes and clinical outcomes.

RESULTS: A total of 10 381 patients were enrolled, among which 56 (0.5%) had the heterozygote GA genotype for p.R4810K. The variant carriers were younger (p=0.01), and more likely to suffer from peripheral vascular disease (p=0.04). The p.R4810K variant was associated with large-artery atherosclerosis (LAA) (adjusted OR=1.94, 95% CI 1.13 to 3.33), anterior circulation stenosis (adjusted OR=2.12, 95% CI 1.23 to 3.65) and ECAS (adjusted OR=2.29, 95% CI 1.16 to 4.51). Nevertheless, the p.R4810K variant was not associated with recurrence, poor functional outcome and mortality at 3 months and 1 year.

CONCLUSIONS: The RNF213 p.R4810K variant was associated with LAA, anterior circulation stenosis and ECAS in Chinese patients. Given the low carrying rate and only 1-year follow-up information, caution should be taken to interpret our findings in no statistically significant association between the p.R4810K variant and stroke prognosis in Chinese patients.

PMID:37137523 | DOI:10.1136/svn-2022-002276

BMJ. 2023 May 3;381:e073538. doi: 10.1136/bmj-2022-073538.

NO ABSTRACT

PMID:37137496 | DOI:10.1136/bmj-2022-073538

J Matern Fetal Neonatal Med. 2023 Dec;36(1):2208251. doi: 10.1080/14767058.2023.2208251.

ABSTRACT

OBJECTIVE: Severe preeclampsia diagnosed at or prior to 34 weeks is an indication for preterm delivery. Many patients with severe preeclampsia develop fetal growth restriction as a result of the placental dysfunction associated with both conditions. The ideal mode of delivery in cases of preterm severe preeclampsia with fetal growth restriction remains controversial, with providers often proceeding directly to cesarean delivery rather than attempting a trial of labor due to theoretic concerns about the harms of labor in the face of placental dysfunction. There are limited data supporting this approach. This study evaluates whether the presence of fetal growth restriction affects the ultimate mode of delivery or neonatal outcomes among pregnancies with severe preeclampsia undergoing induction of labor at or before 34 weeks.

METHODS: This was a retrospective cohort study of singletons with severe preeclampsia undergoing induction of labor ≤ 34 weeks at a single center between January 2015 and April 2022. The primary predictor was fetal growth restriction, defined as estimated fetal weight < 10th percentile for gestational age on ultrasound. Mode of delivery and neonatal outcomes were compared between those with and without fetal growth restriction using Fisher’s exact and Kruskal-Wallis tests, and multivariate logistic regression was used to obtain adjusted odds ratios.

RESULTS: 159 patients were included (N = 117 without fetal growth restriction, N = 42 with fetal growth restriction). There was no difference in vaginal delivery between the groups (70% vs 67%, p = .70). While those with fetal growth restriction had a higher incidence of respiratory distress syndrome and longer neonatal hospital stay, these differences were not statistically significant after adjusting for gestational age at delivery. There were no significant differences in other neonatal outcomes, including Apgar score, cord blood gases, intraventricular hemorrhage, necrotizing enterocolitis, neonatal sepsis, and neonatal demise.

CONCLUSION: For pregnancies complicated by severe preeclampsia that require delivery ≤ 34 weeks, the likelihood of successful vaginal delivery following induction of labor does not differ based on presence of fetal growth restriction. Furthermore, fetal growth restriction is not an independent risk factor for adverse neonatal outcomes in this population. Induction of labor should be considered a reasonable approach and should be routinely offered to patients with concurrent preterm severe preeclampsia and fetal growth restriction.

PMID:37137495 | DOI:10.1080/14767058.2023.2208251

BMJ. 2023 May 3;381:e074778. doi: 10.1136/bmj-2023-074778.

ABSTRACT

OBJECTIVES: To evaluate the risks of any menstrual disturbance and bleeding following SARS-CoV-2 vaccination in women who are premenopausal or postmenopausal.

DESIGN: A nationwide, register based cohort study.

SETTING: All inpatient and specialised outpatient care in Sweden from 27 December 2020 to 28 February 2022. A subset covering primary care for 40% of the Swedish female population was also included.

PARTICIPANTS: 2 946 448 Swedish women aged 12-74 years were included. Pregnant women, women living in nursing homes, and women with history of any menstruation or bleeding disorders, breast cancer, cancer of female genital organs, or who underwent a hysterectomy between 1 January 2015 and 26 December 2020 were excluded.

INTERVENTIONS: SARS-CoV-2 vaccination, by vaccine product (BNT162b2, mRNA-1273, or ChAdOx1 nCoV-19 (AZD1222)) and dose (unvaccinated and first, second, and third dose) over two time windows (one to seven days, considered the control period, and 8-90 days).

MAIN OUTCOME MEASURES: Healthcare contact (admission to hospital or visit) for menstrual disturbance or bleeding before or after menopause (diagnosed with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes N91, N92, N93, N95).

RESULTS: 2 580 007 (87.6%) of 2 946 448 women received at least one SARS-CoV-2 vaccination and 1 652 472 (64.0%) 2 580 007 of vaccinated women received three doses before the end of follow-up. The highest risks for bleeding in women who were postmenopausal were observed after the third dose, in the one to seven days risk window (hazard ratio 1.28 (95% confidence interval 1.01 to 1.62)) and in the 8-90 days risk window (1.25 (1.04 to 1.50)). The impact of adjustment for covariates was modest. Risk of postmenopausal bleeding suggested a 23-33% increased risk after 8-90 days with BNT162b2 and mRNA-1273 after the third dose, but the association with ChAdOx1 nCoV-19 was less clear. For menstrual disturbance or bleeding in women who were premenopausal, adjustment for covariates almost completely removed the weak associations noted in the crude analyses.

CONCLUSIONS: Weak and inconsistent associations were observed between SARS-CoV-2 vaccination and healthcare contacts for bleeding in women who are postmenopausal, and even less evidence was recorded of an association for menstrual disturbance or bleeding in women who were premenopausal. These findings do not provide substantial support for a causal association between SARS-CoV-2 vaccination and healthcare contacts related to menstrual or bleeding disorders.

PMID:37137493 | DOI:10.1136/bmj-2023-074778

Eur J Haematol. 2023 May 3. doi: 10.1111/ejh.13987. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence regarding health-related quality of life (HRQoL) in patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD) is lacking. Evaluating HRQoL was a secondary objective of the HOVON 113 MSC trial. Here we describe the outcomes of the EQ-5D-5L, EORTC QLQ-C30, and FACT-BMT for all adult patients who completed these questionnaires at baseline (i.e., before the start of treatment; n = 26).

METHODS: Descriptive statistics were used to describe baseline patient and disease characteristics, EQ-5D dimension scores and values, EQ VAS scores, EORTC QLQ-C30 scale/item and summary scores, and FACT-BMT subscale and total scores.

RESULTS: The mean EQ-5D value was 0.36. In total, 96% of the patients reported problems with usual activities, 92% with pain/discomfort, 84% with mobility, 80% with self-care, and 72% with anxiety/depression. The mean EORTC QLQ-C30 summary score was 43.50. Mean scale/item scores ranged from 21.79 to 60.00 for functioning scales, from 39.74 to 75.21 for symptom scales, and from 5.33 to 91.67 for single items. The mean FACT-BMT total score was 75.31. Mean subscale scores ranged from 10.09 for physical well-being to 23.94 for social/family well-being.

CONCLUSION: Our study showed that HRQoL in patients with SR-aGvHD is poor. Improving HRQoL and symptom management in these patients should be a top priority.

PMID:37137484 | DOI:10.1111/ejh.13987

South Med J. 2023 May;116(5):410-414. doi: 10.14423/SMJ.0000000000001554.

ABSTRACT

OBJECTIVE: The purpose of this study was to describe the local communities served by major teaching hospitals.

METHODS: Using a dataset of hospitals around the United States provided by the Association of American Medical Colleges, we identified major teaching hospitals (MTHs) using the Association of American Medical Colleges’ definition of those with an intern-to-resident bed ratio above 0.25 and more than 100 beds. We defined the local geographic market surrounding these hospitals as the Dartmouth Atlas hospital service area (HSA). Using MATLAB R2020b software, data from each ZIP Code Tabulation Area from the US Census Bureau’s 2019 American Community Survey 5-Year Estimate Data tables were grouped by HSA and attributed to each MTH. One-sample t tests were used to evaluate for statistical differences between the HSAs and the US average data. We further stratified the data into regions as defined by the US Census Bureau: West, Midwest, Northeast, and South. One-sample t tests were used to evaluate for statistical differences between MTH HSA regional populations with their respective US regional population.

RESULTS: The local population surrounding 299 unique MTHs covered 180 HSAs and was 57% White, 51% female, 14% older than 65 years old, 37% with public insurance coverage, 12% with any disability, and 40% with at least a bachelor’s degree. Compared with the overall US population, HSAs surrounding MTHs had higher percentages of female residents, Black/African American residents, and residents enrolled in Medicare. In contrast, these communities also showed higher average household and per capita income, higher percentages of bachelor’s degree attainment, and lower rates of any disability or Medicaid insurance.

CONCLUSIONS: Our analysis suggests that the local population surrounding MTHs is representative of the wide-ranging ethnic and economic diversity of the US population that is advantaged in some ways and disadvantaged in others. MTHs continue to play an important role in caring for a diverse population. To support and improve policy related to the reimbursement of uncompensated care and care of underserved populations, researchers and policy makers must work to better delineate and make transparent local hospital markets.

PMID:37137475 | DOI:10.14423/SMJ.0000000000001554

South Med J. 2023 May;116(5):405-409. doi: 10.14423/SMJ.0000000000001557.

ABSTRACT

OBJECTIVES: Recent disease modeling suggests that pandemics are likely to increase in frequency and severity. As such, medical educators must learn from their experiences with coronavirus disease 2019 (COVID-19) to develop systematic strategies for ensuring that medical students receive hands-on training in the management of emerging diseases. Here, we outline the process by which the Florida International University Herbert Wertheim College of Medicine developed and updated guidelines for student participation in the care of patients with COVID-19 and report on students’ experiences.

METHODS: During the 2020-2021 academic year, Florida International University Herbert Wertheim College of Medicine students were not permitted to care for patients with COVID-19; however, academic year 2021-2022 guidelines did permit fourth-year students on subinternships or Emergency Medicine rotations to voluntarily care for patients with COVID-19. At the end of the 2021-2022 academic year, students completed an anonymous survey about their experience caring for patients with COVID-19. Likert-type and multiple-choice questions were analyzed using descriptive statistics and the short-answer responses were analyzed qualitatively.

RESULTS: One hundred two students (84%) responded to the survey. Sixty-four percent of respondents opted to provide care for patients with COVID-19. Most students (63%) cared for patients with COVID-19 during their required Emergency Medicine Selective. Twenty-eight percent of students wished they had more COVID-19 patient care opportunities, and 29% did not feel prepared to care for patients with COVID-19 on their first day of residency.

CONCLUSIONS: Many graduating students felt unprepared to care for patients with COVID-19 during residency and many wished they had had more opportunities to care for patients with COVID-19 during medical school. Curricular policies must evolve to allow students to gain competency in the care of patients with COVID-19 so that they are prepared for day one of residency.

PMID:37137474 | DOI:10.14423/SMJ.0000000000001557