Category: Statistics

Neurology. 2023 Oct 17:10.1212/WNL.0000000000207766. doi: 10.1212/WNL.0000000000207766. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Neonatal brain injury is a common and devastating diagnosis conferring lifelong challenges for children and families. The role of mechanical forces applied to the head, often referred to as “birth trauma”, are often considered though evidence for this association is lacking. The objective of this study was to investigate the association between common types of neonatal brain injury and scalp swelling using a novel method to quantify scalp swelling as an unbiased proxy for mechanical forces applied to the head.

METHODS: Case-control study using population-based, prospectively collected tertiary care center databases and healthy controls from the Human Connectome Development Project.

INCLUSION: infants born 32-42 weeks gestational age and MRI in the first 9 days.

OUTCOMES: healthy neonates, hypoxic ischemic encephalopathy (HIE) with or without brain injury, or stroke (ischemic or hemorrhagic). Volume of scalp swelling was objectively quantified by a novel imaging method blinded to brain injury. Variables included mode of delivery and use of instrumentation.

STATISTICAL TESTS: Kruskal-Wallis test, chi square, multivariable and multinomial logistic regression.

RESULTS: There were 309 infants included (55% male): 72 healthy controls, 77 HIE without brain injury on MRI, 78 HIE with brain injury, and 82 with stroke (60 ischemic, 22 hemorrhagic). Scalp swelling was present in 126 (40.8%, 95% CI 35.2-46.5%) with no difference in proportions between outcome groups. Median volume was lower in healthy controls (2.4mL, IQR 1.1-5.6) than those with HIE with brain injury (RRR 1.1, 95% CI 1.05-1.2), HIE without brain injury (RRR 1.1, 95% CI 1.06-1.2) and hemorrhagic stroke (RRR 1.1, 95% CI 1.05-1.2), but not ischemic stroke (RRR 1.1, 95% CI 0.99-1.2). Scalp swelling was associated with instrumented delivery (OR 2.1, 95% CI 1.0-4.1), but not associated with increased odds of brain injury in those with HIE (OR 1.5, 95% CI 0.76-3.30). Scalp swelling measures were highly reliable (ICC=0.97).

DISCUSSION: “Birth trauma” quantified by scalp swelling volume was more common in infants with difficult deliveries but not associated with greater odds of brain injury due to hypoxia or stroke. These results may help parents and practitioners to dissociate the appearance of trauma with the risk of brain injury.

PMID:37848334 | DOI:10.1212/WNL.0000000000207766

Neurology. 2023 Oct 17:10.1212/WNL.0000000000207750. doi: 10.1212/WNL.0000000000207750. Online ahead of print.

ABSTRACT

BACKGROUND: Deep brain stimulation (DBS) of the ventral tegmental area (VTA) is a surgical treatment option for selected patients with refractory chronic cluster headache (CCH). We aimed to identify clinical and structural neuroimaging factors associated with response to VTA DBS in CCH.

METHODS: This prospective observational cohort study examines consecutive patients with refractory CCH treated with VTA DBS by a multidisciplinary team in a single tertiary neuroscience centre as part of usual care. Headache diaries and validated questionnaires were completed at baseline and regular follow up intervals. All patients underwent T1-weighted structural MRI prior to surgery. We compared clinical features using multivariable logistic regression, and neuroanatomical differences using voxel-based morphometry (VBM) between responders and non-responders.

RESULTS: Over a ten-year period, 43 patients (mean age 53 years, SD 11.9), including 29 males, with a mean duration of CCH 12 years (SD 7.4), were treated and followed up for at least one year (mean follow-up duration 5.6 years). Overall, there was a statistically significant improvement in median attack frequency from 140 to 56 per month (Z = -4.95, p <0.001), attack severity from 10/10 to 8/10 (Z = -4.83, p <0.001) and duration from 110 to 60 minutes (Z = -3.48, p <0.001). Twenty-nine (67.4%) patients experienced ≥50% improvement in attack frequency and were therefore classed as responders. There were no serious adverse events. The most common side effects were discomfort or pain around the battery site (seven patients) and transient diplopia and/or oscillopsia (six patients). There were no differences in demographics, headache characteristics, or comorbidities between responders and non-responders. VBM identified increased neural density in non-responders in several brain regions, including the orbitofrontal cortex, anterior cingulate cortex, anterior insula, and amygdala which were statistically significant (p <0.001).

DISCUSSION: VTA DBS showed no serious adverse events, and, although there was no placebo control, was effective in approximately two-thirds of patients at long-term follow up. This study did not reveal any reliable clinical predictors of response. However, non-responders had increased neural density in brain regions linked to processing of pain and autonomic function, both of which are prominent in the pathophysiology of CCH.

PMID:37848331 | DOI:10.1212/WNL.0000000000207750

BMJ Open. 2023 Oct 17;13(10):e074571. doi: 10.1136/bmjopen-2023-074571.

ABSTRACT

INTRODUCTION: The relationship of acute right heart dysfunction (RHD) with long-term cardiopulmonary dysfunction and its’ associated morbidity has not been clearly elucidated. We propose a prospective, observational study to assess the natural history of acute RHD using a combination of imaging, functional and qualitative assessment methods, including the recently described combination of simultaneous maximal effort cardiopulmonary exercise testing and stress echocardiography.

METHODS AND ANALYSIS: We propose a single-centre study of patients ≥18 years admitted to either the intensive care or respiratory close observation units with RHD on transthoracic echocardiography (TTE). Participants will undergo a repeat TTE ~72 hours after the initial study, with a final TTE performed prior to discharge in patients who have a prolonged (>1 week) stay. Inpatient clinical, biochemical and therapeutic indices will be collected contemporaneously. At ~6 months postdischarge, participants will undergo evaluation with validated symptom assessment tools (Dyspnoea-12 and PAH-SYMPACT Questionnaires) and a combined maximal effort cardiopulmonary exercise test and stress echocardiogram. This study is an observational, hypothesis-generating study with a recruitment target of 100 patients established based on typical admission rates of the relevant hospital departments. Measures of central tendency and dispersion will be used to describe the cohort. Inferential statistics will be used to compare the two a priori defined groups of those whose RHD had resolved prior to hospital discharge and those whose dysfunction persisted at time of discharge.

ETHICS AND DISSEMINATION: This study has received ethics approval from the local ethics committee (Nepean and Blue Mountains Local Health District approval, project 2021/ETH12111). Written informed consent will be sought from all patients prior to recruitment. The results will be submitted for publication in a relevant peer-reviewed journal and presented at an appropriate national/international conference.

STUDY REGISTRATION: Australian New Zealand Clinical Trials Registry, ANZCTR12623000309684.

PMID:37848309 | DOI:10.1136/bmjopen-2023-074571

BMJ Open. 2023 Oct 17;13(10):e072187. doi: 10.1136/bmjopen-2023-072187.

ABSTRACT

INTRODUCTION: The goal of this study is to gain firsthand insights from individuals with a history of opioid use disorder (OUD) using medication for OUD on their experiences with postoperative pain care. This study also seeks to describe the experiences of nurses caring for individuals with OUD, and the challenges they may face managing complaints of pain in this population. Research suggests that hospitals can significantly enhance the quality of the care they deliver by investigating an individual’s experience in the care setting. These insights will allow for the development of strategies for nurses to deepen their understanding of and, therefore, advocate and improve care for, this vulnerable and often stigmatised population.

METHODS AND ANALYSIS: A qualitative descriptive study will be conducted consisting of a prescreening and demographics questionnaire, and individual semistructured interviews with approximately 10-15 individuals with OUD having recently undergone surgery and 10-15 nurses providing care for this population for a total of 20-30 interviews. This approach involves the collection of separate but complementary data (ie, perceptions of individuals with OUD and nurses) concerning the phenomena of postoperative pain management. Sampling will continue until data saturation is reached. Descriptive statistics and thematic analysis will then be used. Reporting will adhere to the Standards for Reporting Qualitative Research checklist.

ETHICS AND DISSEMINATION: This study received approval from the Institutional Review Board at Northeastern University. Alongside peer-reviewed journal publications, the findings will be presented at relevant conferences, and a plain language summary will be distributed to the study participants.

PMID:37848308 | DOI:10.1136/bmjopen-2023-072187

BMJ Open. 2023 Oct 17;13(10):e072462. doi: 10.1136/bmjopen-2023-072462.

ABSTRACT

OBJECTIVES: To investigate trends in the incidence rate and main indication for revision hip replacement (rHR) over the past 15 years in the UK.

DESIGN: Repeated national cross-sectional study from 2006 to 2020.

SETTING/PARTICIPANTS: rHR procedures were identified from the National Joint Registry for England, Wales, Northern Ireland, the Isle of Man and the States of Guernsey. Population statistics were obtained from the Office for National Statistics.

MAIN OUTCOME MEASURES: Crude incidence rates of rHR.

RESULTS: The incidence rate of rHR doubled from 11 per 100 000 adults in 2006 (95% CI 10.7 to 11.3) to a peak of 22 per 100 000 adults (95% CI 22 to 23) in 2012, before falling to 17 per 100 000 adults in 2019 (95% CI 16 to 17) (24.5% decrease from peak). The incidence rate of rHR reduced by 39% in 2020 compared with 2019 (during the COVID-19 pandemic). The most frequent indications for rHR between 2006 and 2019 were loosening/lysis (27.8%), unexplained pain (15.1%) and dislocation/instability (14.7%). There were incremental increases in the annual number and incidence rates of rHR for fracture, infection, dislocation/instability and a decrease in rHR for aseptic loosening/lysis.

CONCLUSIONS: The incidence rate of rHR doubled from 2006 to 2012, likely due to high early failure rates of metal-on-metal hip replacements. The incidence of rHR then decreased by approximately 25% from 2012 to 2019, followed by a large decrease during the COVID-19 pandemic. The decrease in the number of rHR performed for aseptic loosening/lysis may reflect improved wear and implant longevity. Increased healthcare resource will be required to care for the increasing numbers of patients undergoing rHR for fracture and infection.

PMID:37848303 | DOI:10.1136/bmjopen-2023-072462

BMJ Open. 2023 Oct 17;13(10):e079407. doi: 10.1136/bmjopen-2023-079407.

ABSTRACT

INTRODUCTION: Preschoolers and school-aged children with congenital heart disease (CHD) are at higher risk of attention deficit hyperactivity disorder (ADHD) compared with the general population. To this day, no randomised controlled trial (RCT) aiming to improve attention has been conducted in young children with CHD. There is emerging evidence indicating that parent-child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations.

METHODS AND ANALYSIS: This is a single-blind, two-centre, two-arm trial during which 24 children with CHD and their parents will be randomly assigned to (1) a parent-child yoga intervention in addition to standard clinical care or (2) standard clinical care alone. All participants will undergo standardised assessments: (1) at baseline, (2) immediately post-treatment and (3) 6 months post-treatment. Descriptive statistics will be used to estimate the feasibility and neurodevelopmental outcomes. This feasibility study will evaluate: (1) recruitment capacity; (2) retention, drop-out and withdrawal rates during the yoga programme and at the 6-month follow-up; (3) adherence to the intervention; (4) acceptability of the randomisation process by families; (5) heterogeneity in the delivery of the intervention between instructors and use of home-based exercises between participants; (6) proportion of missing data in the neurodevelopmental assessments and (7) SD of primary outcomes of the full RCT in order to determine the future appropriate sample size.

ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Research Ethics Board of the Sainte-Justine University Hospital. The findings will be disseminated in peer-reviewed journals and conferences and presented to the Canadian paediatric grand round meetings.

TRIAL REGISTRATION NUMBER: NCT05997680.

PMID:37848299 | DOI:10.1136/bmjopen-2023-079407

BMJ Open. 2023 Oct 17;13(10):e077702. doi: 10.1136/bmjopen-2023-077702.

ABSTRACT

OBJECTIVE: The implementation of point-of-care ultrasound (POCUS) in general practice varies, but it is unknown what determines this variation. The purpose of this study was to explore (1) the overall proportion of POCUS-users among general practitioners (GPs), (2) the current use of POCUS by GPs, (3) factors related to the implementation of POCUS in general practice and (4) GPs’ concerns related to POCUS use in general practice.

DESIGN: An online survey was distributed in June 2019.

SETTING: General practice.

PARTICIPANTS: GPs working in office-based primary care clinics in Denmark.

MAIN OUTCOME MEASURES: The questionnaire was developed using mixed methods and included questions about participants’ characteristics, past POCUS training and experience, capability, opportunity and motivation for using POCUS in the primary care setting. Results were summarised using descriptive statistics. Association between GPs’ background characteristics and POCUS use was tested using logistics regression.

RESULTS: Responses were analysed from 1216 questionnaires corresponding to 36.4% of all GPs in Denmark. The majority (72.3%) of participants had previous POCUS experience, 14.7% had access to a POCUS device and 11.5% used POCUS. Several factors motivated participants to use POCUS. However, barriers existed such as lack of remuneration and high workload. Additionally, many GPs questioned their ability to scan with sufficient diagnostic accuracy and the impact of POCUS on the consultation. Of non-users, 28.7% believed they would be using POCUS in the future.

CONCLUSION: Although, the majority of GPs had past experience with POCUS and felt motivated to use it, few had implemented POCUS. Several factors influenced the GPs’ capability, opportunity and motivation for using POCUS and several concerns were registered by non-users.

PMID:37848298 | DOI:10.1136/bmjopen-2023-077702

Clin Transplant. 2023 Oct 17:e15166. doi: 10.1111/ctr.15166. Online ahead of print.

ABSTRACT

BACKGROUND: Appendicitis in pancreatic transplant recipients can be challenging to diagnose and manage. Incidental appendicectomy (IA) during pancreas transplantation obviates the risk of appendicitis but potentially at the cost of increased operating time or early post-operative complications. This study reviewed the value of IA at a single center.

METHODS: This was a retrospective study of patients who underwent a pancreas transplant in our unit from January 1st, 2012 to December 31st, 2020, with end of follow-up on May 21st, 2023; recipients were grouped by whether or not an IA was performed during pancreas transplantation. Donor, recipient, operative, and graft outcomes were compared between the two groups. Post-transplant complications related to appendiceal pathology (or IA) were recorded and classified.

RESULTS: Two hundred forty-three patients underwent a pancreas transplant; 227 (93%) patients had an appendix in situ at transplantation, and of these 53 (23%) underwent an IA and 174 (77%) did not. There were no statistically significant differences in operative time (p = .06) or hospital stay (p = .50) between the two groups. In the IA cohort, there were no Clavien-Dindo Grade III-V complications relating to the appendicectomy. In those that did not undergo an IA, two patients (1%) subsequently required appendicectomy due to appendicitis. Comparison of pancreatic graft survival showed no statistically significant difference between the groups (p = .44).

CONCLUSIONS: This study suggests that IA is effective at reducing risks of post-transplant appendiceal complications without significantly prolonging inpatient stay or impairing graft survival. These data support the consideration of undertaking an IA for all patients undergoing a pancreas transplant.

PMID:37848266 | DOI:10.1111/ctr.15166

CMAJ Open. 2023 Oct 17;11(5):E956-E968. doi: 10.9778/cmajo.20210337. Print 2023 Sep-Oct.

ABSTRACT

BACKGROUND: Most children who need emergency care visit general emergency departments and urgent care centres; the weighted pediatric readiness score (WPRS) is currently used to evaluate emergency departments’ readiness for pediatric patients. The aim of this study was to determine whether a higher WPRS was associated with decreased mortality and improved health care outcomes and utilization.

METHODS: We conducted a systematic review of cohort and cross-sectional studies on emergency departments that care for children (age ≤ 21 yr). We searched MEDLINE (Ovid), Embase (Ovid), the Cochrane Library (Wiley), CINAHL (EBSCO), Global Health (Ovid) and Scopus from inception until July 29, 2022. Articles identified were screened for inclusion by 2 independent reviewers. The primary outcome was mortality, and the secondary outcomes were health care outcomes and utilization. We used the Newcastle-Ottawa Scale to assess for quality and bias of the included studies. The I ² statistic was calculated to quantify study heterogeneity.

RESULTS: We identified 1789 articles. Eight articles were included in the final analysis. Three studies showed an inverse association between highest WPRS quartile and pediatric mortality (pooled odds ratio [OR] 0.45, 95% confidence interval [CI] 0.26 to 0.78; I ² = 89%, low certainty of evidence) in random-effects meta-analysis. Likewise, 1 study not included in the meta-analysis also reported an inverse association with a 1-point increase in WPRS (OR 0.93, 95% CI 0.88 to 0.98). One study reported that the highest WPRS quartile was associated with shorter length of stay in hospital (β -0.36 days, 95% CI -0.61 to -0.10). Three studies concluded that the highest WPRS quartile was associated with fewer interfacility transfers. The certainty of evidence is low for mortality and moderate for the studied health care outcomes and utilization.

INTERPRETATION: The data suggest a potential inverse association between the WPRS of emergency departments and mortality risk in children. More studies are needed to refute or confirm these findings.

PROTOCOL REGISTRATION: PROSPERO-CRD42020191149.

PMID:37848258 | DOI:10.9778/cmajo.20210337

Cold Spring Harb Perspect Biol. 2023 Oct 17:a041439. doi: 10.1101/cshperspect.a041439. Online ahead of print.

ABSTRACT

The significance of prezygotic isolation for speciation has been recognized at least since the Modern Synthesis. However, fundamental questions remain. For example, how are genetic associations between traits that contribute to prezygotic isolation maintained? What is the source of genetic variation underlying the evolution of these traits? And how do prezygotic barriers affect patterns of gene flow? We address these questions by reviewing genetic features shared across plants and animals that influence prezygotic isolation. Emerging technologies increasingly enable the identification and functional characterization of the genes involved, allowing us to test established theoretical expectations. Embedding these genes in their developmental context will allow further predictions about what constrains the evolution of prezygotic isolation. Ongoing improvements in statistical and computational tools will reveal how pre- and postzygotic isolation may differ in how they influence gene flow across the genome. Finally, we highlight opportunities for progress by combining theory with appropriate data.

PMID:37848246 | DOI:10.1101/cshperspect.a041439