Tag: statistics

Undersea Hyperb Med. 2021 Fourth-Quarter;48(4):425-430.

ABSTRACT

Central retinal artery occlusion (CRAO) is a condition that causes sudden vision loss due to obstruction of the retinal artery, typically from a thrombotic or embolic source. It is often associated with atherosclerotic risk factors, including cardiovascular disease, diabetes, hyperlipidemia, and a history of cerebrovascular disease. CRAO often leads to a poor visual outcome as well as neovascularization of the iris, retina, and optic disc, which can exacerbate vision loss and cause pain. While there are several treatment modalities for CRAO, few have been proven to be effective in decreasing the effects of neovascularization. The use of hyperbaric oxygen (HBO2) therapy is often used in the treatment of CRAO due to its ease of use and relatively benign side effect profile. This study aims to assess the degree of improvement in visual acuity (VA) and neovascularization following HBO2. Our data ultimately shows that 20% of patients developed neovascularization after HBO2 compared to 29.8% of those who did not undergo HBO2 (p<.05). Our findings suggest that HBO2 has a statistically significant protective effect against neovascularization and may improve long-term visual acuity.

PMID:34847306

Spine (Phila Pa 1976). 2021 Nov 29. doi: 10.1097/BRS.0000000000004296. Online ahead of print.

ABSTRACT

STUDY DESIGN: Prospective cohort study.

OBJECTIVE: Among patients with cervical spondylotic myelopathy (CSM), we aimed to evaluate the extent to which: (1) pre-operative cervical sagittal alignment is associated with health-related quality of life, function, and symptoms; (2) surgery leads to changes in cervical sagittal alignment; and (3) post-operative cervical sagittal alignment is associated with health-related quality of life, function, and symptoms at 12 months of follow-up.

SUMMARY OF BACKGROUND DATA: The importance of maintaining or improving cervical sagittal alignment in the surgical management of patients with CSM has not been established.

METHODS: We measured C2-C7 cobb angle, T1 slope, and C2-C7 cervical sagittal vertical axis (cSVA). We tested for associations with Neck Disability Index, Pain Scales for neck and arm pain, EuroQol 5D, Short Form 12 (SF-12) Physical and Mental Component Summaries (PCS and MCS), and modified Japanese Orthopaedic Association scores. We adjusted for potential confounders using multiple linear regression, and we performed various pre-specified subgroup (cSVA >40 mm, surgical approach) and sensitivity analyses.

RESULTS: Among 250 patients, adjusted analyses yielded significant inverse associations prior to surgery between each of cSVA and T1 slope with SF12 PCS (T1 slope: -0.14, 95% CI -0.26 to -0.01, p = 0.03; C2-C7 cSVA: -0.13, 95% CI -0.21 to -0.05 p < 0.01). Surgery was associated with a small but statistically significant increase in cSVA across the cohort (+5.8 mm (SD 11.7), p < 0.01) but no change in cobb angle or T1 slope. At 12-months after surgery, there were no significant associations between alignment parameters or change in alignment and any measures of health-related quality of life, function, or symptoms. Results were consistent across subgroup and sensitivity analyses.

CONCLUSIONS: Increased cSVA and T1 slope were associated with inferior health-related quality of life at presentation among patients with CSM, but no significant associations were observed following surgical treatment.Level of Evidence: 3.

PMID:34845179 | DOI:10.1097/BRS.0000000000004296

Ann Hepatobiliary Pancreat Surg. 2021 Nov 30;25(4):472-476. doi: 10.14701/ahbps.2021.25.4.472.

ABSTRACT

BACKGROUNDS/AIMS: Hepaticojejunostomy (HJ) for bilioenteric continuity is generally performed with interrupted sutures. This study compares the safety, economics, short- and long-term outcomes of continuous suture hepaticojejunostomy (CSHJ) and interrupted suture hepaticojejunostomy (ISHJ).

METHODS: A retrospective cohort analysis involving all HJs between January 2014 and December 2018 was conducted. Patients with type IV or V biliary strictures, duct diameter < 8 mm and/or associated vascular injury, and liver transplant recipients were excluded. Patient demographics, preoperative parameters including diagnosis, intra-operative parameters including type and number of sutures, suture time, and postoperative morbidity (based on Clavien-Dindo classification) were recorded. Patients were followed up to 60 months. McDonald’s Grade A and B outcomes were considered favorable. Cost according to suture type and number (polydioxanone 3-0/5-0 mean cost, US$ 9.26/length; polyglactin 3-0/4-0 mean cost, US$ 6.56/length), and operation room charge (US$ 67.47/hour) were compared between the two techniques. Statistical analysis was performed using IBM SPSS ver. 22 software.

RESULTS: A total of 556 eligible patients (468 patients undergoing ISHJ and 88 undergoing CSHJ; 47% [n = 261] with malignant and 53% [n = 295] with benign pathology) were analyzed. The two groups were similar. Number of sutures, cost, time, and postoperative bile leak were significantly higher in the ISHJ group. Bile leak occurred in 54 patients (6 CSHJ, 48 ISHJ). Septic shock-induced death occurred in 16 cases (3 CSHJ, 13 ISHJ). Morbidity and the anastomotic stricture rates were comparable in both groups.

CONCLUSIONS: CSHJ is a safe, economical, and worthy of routine use.

PMID:34845118 | DOI:10.14701/ahbps.2021.25.4.472

Curr Opin Allergy Clin Immunol. 2021 Nov 29. doi: 10.1097/ACI.0000000000000801. Online ahead of print.

ABSTRACT

PURPOSE OF REVIEW: The development and progression of chronic respiratory diseases are impacted by a complex interplay between genetic, microbial, and environmental factors. Here we specifically summarize the effects of environmental exposure on asthma, allergic rhinitis, and chronic rhinosinusitis. We furthermore discuss how digital health technology may aid in the assessment of the environmental exposure of patients and how it may be of added value for them.

RECENT FINDINGS: It is well established that one gets allergic symptoms if sensitized and exposed to the same allergen. Viruses, bacteria, pollutants, irritants, and lifestyle-related factors modify the risk of getting sensitized and develop symptoms or may induce symptoms themselves. Understanding these processes and how the various factors interact with each other and the human body require big data and advanced statistics. Mobile health technology enables integration of multiple sources of data of the patients’ exposome and link these to patient outcomes. Such technologies may contribute to the increased understanding of the development of chronic respiratory disease.

SUMMARY: Implementation of digital technologies in clinical practice may in future guide the development of preventive strategies to tackle chronic respiratory diseases and eventually improve outcomes of the patient.

PMID:34845137 | DOI:10.1097/ACI.0000000000000801

BMJ Open. 2021 Nov 29;11(11):e056191. doi: 10.1136/bmjopen-2021-056191.

ABSTRACT

INTRODUCTION: Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach-preserving PD variants exist: pylorus preservation PD (ppPD) or pylorus resection PD (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, for example, adjuvant chemotherapy. Evidence is lacking to assess, which variant of PD entails fewer postoperative DGE.

METHODS AND ANALYSIS: The protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE within 30 days after index surgery in a German real-world setting. A total of 984 adults undergoing elective PD for any indication will be randomised in a 1:1 ratio. Patients will be recruited at about 30 hospitals being members of the StuDoQ|Pancreas registry established by the German Society of General and Visceral Surgery. The postoperative follow-up for each patient will be 30 days. The primary analysis will follow an intention-to-treat approach and applies a binary logistic random intercepts model. Secondary perioperative outcomes include overall severe morbidity (Clavien-Dindo classification), blood loss, 30-day all-cause mortality, postoperative hospital stay and operation time. Complication rates and adverse events will be closely monitored.

ETHICS AND DISSEMINATION: This protocol was approved by the leading ethics committee of the Medical Faculty of the Ludwig-Maximilians-Universität, Munich (reference number 19-221). The results will be published in a peer-reviewed journal and presented at international conferences. Study findings will also be disseminated via the website (http://www.dgav.de/studoq/pylorespres/).

TRIAL REGISTRATION NUMBER: DRKS-ID: DRKS00018842.

PMID:34845079 | DOI:10.1136/bmjopen-2021-056191

BMJ Open. 2021 Nov 29;11(11):e047836. doi: 10.1136/bmjopen-2020-047836.

ABSTRACT

BACKGROUND: ‘Weekend effect’ is a term used to describe the increased mortality associated with weekend emergency admissions to hospital, in contrast with admission on weekdays. The objective of the present study is to determine whether the weekend effect is present in hospitals in Catalonia.

METHODS: We analysed all urgent admissions in Catalonia in 2018, for a group of pathologies. Two groups were defined (those admitted on a weekday and those admitted on a weekend). We obtained mortality at 3, 7, 15 and 30 days, and applied a proportions test to both groups. Additionally, we used Cox’s regression for mortality at 30 days, using the admission on a weekend as the exposition, adjusting by socioeconomic and clinical variables. We used the hospital discharge database and the Central Registry of the Insured Population.

RESULTS: 72 427 admissions for the selected pathologies during 2018 were found. No statistically significant differences in mortality at 30 days (p=0.524) or at 15 days (p=0.119) according to the day of admission were observed. However, significant differences were found in mortality at 7 days (p=0.025) and at 3 days (p=0.002). The hazard rate associated with the weekend was 1.13 (95% CI: 1.04 to 1.23). By contrast, the adjusted HR of the weekend interaction with time was 0.99 (95% CI: 0.99 to 1.00).

CONCLUSIONS: There is a weekend effect, but it is not constant in time. This could suggest the existence of dysfunctions in the quality of care during the weekend.

PMID:34845065 | DOI:10.1136/bmjopen-2020-047836

BMJ Open. 2021 Nov 29;11(11):e055227. doi: 10.1136/bmjopen-2021-055227.

ABSTRACT

OBJECTIVES: To analyse the prevalence of sexual violence (SV) and associated factors in Spanish young adults in the last year and before, during and after the COVID-19 lockdown.

DESIGN: Cross-sectional study based on the online ‘SV in Young People Survey’ (2020).

SETTING: Non-institutionalised population residing in Spain.

PARTICIPANTS: 2515 men and women aged 18-35 years old. The participants were obtained from a probability based, online closed panel of adults aged 16 or older that is representative of the non-institutionalised population. The sample designed includes quotas by sex, age, region and country of origin.

OUTCOMES MEASURES AND ANALYSES: SV victimisation by sociodemographics, sexual attraction and couple-related characteristics during the past year and before, during and after the COVID-19 lockdown (March-June 2020). Prevalence ratios were calculated using robust Poisson regression models.

RESULTS: In Spain, 8.5% of young people experienced SV during the past year. The greatest prevalence was observed in women with bisexual attraction (17.5%) and in men with homosexual attraction (14.2%). During the COVID-19 lockdown, the prevalence of SV victimisation was lower (1.9%), but unwanted intercourses increased, affecting 64.4% of those exposed to SV during the period. People with homosexual or bisexual attraction were more likely to experience SV in all of the studied periods (PRbefore: 2.01; p<0.001; PRduring: 2.63 p=0.002; PRafter: 2.67; p<0.001). Women were more likely than men to experience SV prior to the lockdown, while no cohabitation increased the likelihood to experience SV after this period CONCLUSIONS: SV victimisation in Spanish youth is high. During COVID-19, there were changes in the magnitude of factors associated with SV. It seems that SV events decreased in people who did not live with their partners, but unwanted intercourses increased. The development of prevention strategies to address SV in youth should take into account social inequalities by sex, sexual orientation and origin.

PMID:34845078 | DOI:10.1136/bmjopen-2021-055227

Proc Natl Acad Sci U S A. 2021 Dec 7;118(49):e2116427118. doi: 10.1073/pnas.2116427118.

ABSTRACT

Acute myeloid leukemia (AML) patients rarely have long first remissions (LFRs; >5 y) after standard-of-care chemotherapy, unless classified as favorable risk at presentation. Identification of the mechanisms responsible for long vs. more typical, standard remissions may help to define prognostic determinants for chemotherapy responses. Using exome sequencing, RNA-sequencing, and functional immunologic studies, we characterized 28 normal karyotype (NK)-AML patients with >5 y first remissions after chemotherapy (LFRs) and compared them to a well-matched group of 31 NK-AML patients who relapsed within 2 y (standard first remissions [SFRs]). Our combined analyses indicated that genetic-risk profiling at presentation (as defined by European LeukemiaNet [ELN] 2017 criteria) was not sufficient to explain the outcomes of many SFR cases. Single-cell RNA-sequencing studies of 15 AML samples showed that SFR AML cells differentially expressed many genes associated with immune suppression. The bone marrow of SFR cases had significantly fewer CD4⁺ Th1 cells; these T cells expressed an exhaustion signature and were resistant to activation by T cell receptor stimulation in the presence of autologous AML cells. T cell activation could be restored by removing the AML cells or blocking the inhibitory major histocompatibility complex class II receptor, LAG3. Most LFR cases did not display these features, suggesting that their AML cells were not as immunosuppressive. These findings were confirmed and extended in an independent set of 50 AML cases representing all ELN 2017 risk groups. AML cell-mediated suppression of CD4⁺ T cell activation at presentation is strongly associated with unfavorable outcomes in AML patients treated with standard chemotherapy.

PMID:34845035 | DOI:10.1073/pnas.2116427118

CMAJ. 2021 Nov 29;193(47):E1798-E1806. doi: 10.1503/cmaj.210659.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has had a major impact on access to health care resources. Our objective was to estimate the impact of the COVID-19 pandemic on the incidence of childhood cancer in Canada. We also aimed to compare the proportion of patients who enrolled in clinical trials at diagnosis, presented with metastatic disease or had an early death during the first 9 months of the COVID-19 pandemic compared with previous years.

METHODS: We conducted an observational study that included children younger than 15 years with a new diagnosis of cancer between March 2016 and November 2020 at 1 of 17 Canadian pediatric oncology centres. Our primary outcome was the monthly age-standardized incidence rates (ASIRs) of cancers. We evaluated level and trend changes using interventional autoregressive integrated moving average models. Secondary outcomes were the proportion of patients who were enrolled in a clinical trial, who had metastatic or advanced disease and who died within 30 days. We compared the baseline and pandemic periods using rate ratios (RRs) and 95% confidence intervals (CIs).

RESULTS: Age-standardized incidence rates during COVID-19 quarters were 157.7, 164.6, and 148.0 per million, respectively, whereas quarterly baseline ASIRs ranged between 150.3 and 175.1 per million (incidence RR 0.93 [95% CI 0.78 to 1.12] to incidence RR 1.04 [95% CI 0.87 to 1.24]). We found no statistically significant level or slope changes between the projected and observed ASIRs for all new cancers (parameter estimate [β], level 4.98, 95% CI -15.1 to 25.04, p = 0.25), or when stratified by cancer type or by geographic area. Clinical trial enrolment rate was stable or increased during the pandemic compared with baseline (RR 1.22 [95% CI 0.70 to 2.13] to RR 1.71 [95% CI 1.01 to 2.89]). There was no difference in the proportion of patients with metastatic disease (RR 0.84 [95% CI 0.55 to 1.29] to RR 1.22 [0.84 to 1.79]), or who died within 30 days (RR 0.16 [95% CI 0.01 to 3.04] to RR 1.73 [95% CI 0.38 to 15.2]).

INTERPRETATION: We did not observe a statistically significant change in the incidence of childhood cancer, or in the proportion of children enrolling in a clinical trial, presenting with metastatic disease or who died early during the first 9 months of the COVID-19 pandemic, which suggests that access to health care in pediatric oncology was not reduced substantially in Canada.

PMID:34844937 | DOI:10.1503/cmaj.210659

Clin Cancer Res. 2021 Nov 29:clincanres.3131.2021. doi: 10.1158/1078-0432.CCR-21-3131. Online ahead of print.

ABSTRACT

PURPOSE: Metastatic hormone receptor-positive (HR-positive), HER2-negative breast cancer is an important cause of cancer mortality. Endocrine treatment with or without additional targeted therapies has been the mainstay of treatment. This trial was designed to evaluate the combination of fulvestrant plus everolimus versus fulvestrant, everolimus and anastrozole compared to fulvestrant alone in the first-line treatment of advanced HR-positive, HER2-negative breast cancer.

EXPERIMENTAL DESIGN: This randomized placebo-controlled trial included postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had received no prior systemic therapy for metastatic disease. Participants were randomized to one of three treatment arms and the primary outcome was progression-free survival (PFS), comparing combinations of fulvestrant and everolimus with or without anastrozole to fulvestrant alone. Circulating tumor cells (CTC), as measured with two different methods, and circulating tumor DNA (ctDNA) were evaluated serially prior to treatment and the beginning of the second cycle of therapy.

RESULTS: Due in part to changes in clinical practice, the study was closed after accruing only 37 participants. There was no evidence that everolimus-containing combination treatment improved PFS or overall survival relative to fulvestrant alone. When modeled continuously, an association was observed of baseline CTC and ctDNA with poorer survival.

CONCLUSION: Although power of the study was limited, the findings were unable to support the routine use of everolimus combination endocrine therapy in the first-line treatment of advanced hormone-sensitive breast cancer. Prognostic impact of baseline ctDNA and copy number variations in CTC was demonstrated.

PMID:34844978 | DOI:10.1158/1078-0432.CCR-21-3131