Tag: statistics

Minerva Med. 2022 Mar 10. doi: 10.23736/S0026-4806.22.07847-8. Online ahead of print.

ABSTRACT

BACKGROUND: The well-known COVID-19 pandemic totally transformed people’s lives, paving the way to various psychopathological symptoms. In particular, patients may experience a short- and long-term decreasing in their wellbeing. In this vein, the aim of this paper is to assess the COVID-19 patients’ psychopathological profile (Post Traumatic Stress Disorder, distress, anxiety and depression symptoms), detecting possible differences linked to the ventilatory treatments.

METHODS: Outpatients who recovered from COVID-19 were asked to provide socio-demographic and clinical information, and to complete a brief psychological screening evaluation (Impact of Event Scale-Revised – IES-R, Depression Anxiety Stress Scale – DASS-21).

RESULTS: Overall, after informed consent, 163 Italian patients took part in this research. Of them, 31,9% did not undergo any ventilatory therapy, 27,6% undertook oxygen therapy; 28,2% underwent noninvasive mechanical ventilation and 12.3% received invasive mechanical ventilation. Although no statistically significant differences were revealed among patients stratified by spontaneous breathing or ventilatory therapies, they reported statistically significant more depression (4.5+5.2 vs 3.5+3.2; p=.017) and anxiety (4.3+4.5 vs 2.4+2.6; p<.00001) symptoms than normative groups. Moreover, patients experiencing COVID-19 disease as a trauma, complained statistically significant higher levels of depression, anxiety and stress symptoms than who did not describe a clinically relevant traumatic experience (p<0.001).

CONCLUSIONS: Thus, this study suggests to healthcare professionals to consider COVID-19 experience as a potential real trauma for patients and underlines the necessity to define patients’ psychopathological profile in order to propose tailored and effective preventive and supportive psychological interventions.

PMID:35266658 | DOI:10.23736/S0026-4806.22.07847-8

Leadersh Health Serv (Bradf Engl). 2022 Mar 14;ahead-of-print(ahead-of-print). doi: 10.1108/LHS-05-2021-0040.

ABSTRACT

PURPOSE: This study aims to compare nurses’ authentic leadership and perceptions of the safety climate and concepts association according to different areas of work and types of hospitals.

DESIGN/METHODOLOGY/APPROACH: A cross-sectional design was used to conduct this comparative study on 314 Jordanian nurses. The Authentic Leadership Questionnaire (ALQ) and the Safety Climate Survey (SCS) were used.

FINDINGS: Nurses in private hospitals were more educated. True leadership was mild. Unit nurses had higher ALQ and subscale mean scores. Armed forces hospitals had the highest ALQ subscales, while governmental hospitals had the lowest. The ALQ mean scores favored military hospitals. Governmental hospitals have a negative safety climate. Unit nurses had a higher SCS mean than ward nurses. Military, governmental and private hospitals are rated the safest. Nurses benefited from higher SCS scores in military hospitals. Nurses’ ALQ and safety climate perceptions were moderately positive.

RESEARCH LIMITATIONS/IMPLICATIONS: A larger, randomized and equal-sized sample is recommended in future studies to conclude different areas of work and hospitals. It is also recommended to report the confidence interval in further studies using different statistical methods, increasing confidence when interpreting statistical significance variables. Other mediating, moderating and predicting variables could be studied and compared across different areas of work and types of hospitals. Sample characteristics should be handled as confounding variables in the next planned study using various ways to control confounding variables such as randomization, restriction, matching, regression and statistical control. The authors plan to statistically control for the confounding variables by entering them into the regression model. Future studies could investigate safety culture; both safety culture and safety climate are formative and inclusive terms (Experts Insight, 2017).

PRACTICAL IMPLICATIONS: This paper fills in the gap in the literature and practice. Authentic leadership is associated with safety climate perceptions and varies across different areas of work and hospitals. Interventions are required to improve safety climate perceptions and promote authentic leadership in all settings and hospitals. Military hospitals ranked the highest in nurses’ perceptions of authentic leadership and safety climate.

SOCIAL IMPLICATIONS: The current study’s favorable association between authentic leadership and safety climate measurement would apply to many high-risk institutions, including public and private hospitals. It becomes necessary to include the impacts of authentic leadership on the safe climate within the nursing curriculum and continuing education courses. This may be put into action by executing a hands-on activity, followed by information and reflection conversations that highlight the link between authentic leadership and safety climate measurement. According to the findings of this study, authentic leadership appears to be a basic block in making a difference in nurses’ views of safety climate.

ORIGINALITY/VALUE: Authentic leadership style is a relatively new concept in the health-care sector, and its link to safety climate security still needs empirical evidence. It is still unclear how leadership resulted in more effective outcomes (Maziero et al., 2020). Few studies investigated both the concepts of authentic leadership and the nursing safety climate (Dirik and Intepeler, 2017; Lee et al., 2019a; Woo and Han, 2018). Aside from the scarcity of studies, no study has compared “working area,” “department” or “hospital type” concepts. Few comparative studies have been conducted using concepts of interest. For example, authentic leadership was linked to empowerment and burnout (Laschinger et al., 2013) and nurses’ satisfaction with safety climates (Vatani et al., 2021). No research has examined authentic leadership in Jordan’s nursing and health-care context. Few studies focused on the safety climate other than authentic leadership (Abualrub et al., 2012) or the safety culture in Jordan rather than the safety climate (Khater et al., 2015).

PMID:35266654 | DOI:10.1108/LHS-05-2021-0040

J Mass Spectrom. 2022 Apr;57(4):e4817. doi: 10.1002/jms.4817.

ABSTRACT

The study of short (SCFAs) and branched chain fatty acids (BCFAs) in human stool related to gastrointestinal diseases, gut microbiota, metabolism, and diet has dramatically increased. As a result, a fast, reliable method with minimal pretreatment is needed for quantification of these metabolites (acetic, propionic, isobutyric, butyric, isovaleric, valeric, and caproic acid) in stool. Therefore, a GC-MS method meeting this criterion was developed. A bias sampling study showed no statistical difference (p > 0.05) in analyte means when comparing 100 mg subsamples of homogenized to non-homogenized samples (n = 6, p values 0.153-0.910). Stool samples were homogenized, diluted with 80:20 water:methanol (v/v), and adjusted to a pH of 1.5-2.5. Samples were vortexed, centrifuged, and directly injected into the GC-MS using pulsed splitless injection offering twofold-to-threefold signal enhancement over a 10:1 split injection. DB-FATWAX Ultra Inert Polyethylene Glycol (PEG) Column showed no peak tailing, reduced responses, or retention time shifts after 1,476 stool injections, while other columns failed before 361 injections. Intra- and inter-day accuracy for stool supernatant samples ranged from -10.21% to 8.88% and -13.25% to 9.91%, while intra- and inter-day precision ranged from 0.21% to 1.21% and 0.89% to 2.84% coefficient of variation (CV), respectively. This method demonstrates excellent linearity (0.9999-1.0000) and low limits of quantification (1.50-8.01 μM). Stool samples proved stable stored at -20°C up to 28 days, and recoveries ranged from 85.04% to 106.59%. Matrix effects in stool are non-significant determined by comparing standard and stool supernatant calibration curve slopes (p > 0.05).

PMID:35266592 | DOI:10.1002/jms.4817

Hepatology. 2022 Mar 10. doi: 10.1002/hep.32453. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Large spontaneous portosystemic shunt (SPSS) is associated with increased risk of hepatic encephalopathy (HE) in patients undergoing transjugular intrahepatic portosystemic shunt (TIPS). This study aimed to evaluate whether prophylactic embolization of large SPSS at the time TIPS creation could reduce the incidence of post-TIPS HE in patients with cirrhosis and variceal bleeding.

METHOD: From June 2014 to August 2017, 56 patients with cirrhosis and large SPSS planning to undergo TIPS for the prevention of variceal bleeding were randomly assigned (1:1) to receive TIPS alone (TIPS group, n=29) or TIPS plus simultaneous SPSS embolization (TIPS+E group, n=27). The primary endpoint was overt HE.

RESULTS: TIPS placement and SPSS embolization was successful in all patients. During a median follow-up of 24 months, the primary endpoint was met in 15 patients (51.7%) in the TIPS group and 6 patients (22.2%) in the TIPS+E group (p=0.045). The 2-year cumulative incidence of overt HE was significantly lower in the TIPS+E group compared with TIPS group (21.2% vs 48.3%; HR: 0.38, 95%CI, 0.15-0.97; p=0.043). The 2-year incidence of recurrent bleeding (TIPS+E vs TIPS: 15.4% vs 25.1%, p=0.522), shunt dysfunction (12.3% vs 18.6%, p=0.593), death (15.0% vs 6.9%, p=0.352) and other adverse events was not significantly different between the two groups.

CONCLUSION: In patients with cirrhosis treated with TIPS for variceal bleeding, concurrent large SPSS embolization reduced the risk for overt HE without increasing other complications. Concurrent large SPSS embolization should therefore be considered for prophylaxis of post-TIPS HE.

PMID:35266571 | DOI:10.1002/hep.32453

Acad Emerg Med. 2022 Mar 10. doi: 10.1111/acem.14481. Online ahead of print.

ABSTRACT

BACKGROUND: The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.

METHODS: Severely injured children (0 up to 18^th birthday) were randomized into a double-blind randomized trial of 1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/hr infusion over 8 hours, 2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/hr infusion over 8 hours, or 3) normal saline placebo bolus and infusion. The trial was conducted at 4 pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month.

RESULTS: A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified.

CONCLUSION: Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.

PMID:35266589 | DOI:10.1111/acem.14481

Biom J. 2022 Mar 10. doi: 10.1002/bimj.202000393. Online ahead of print.

ABSTRACT

In clinical practice, the composition of missing data may be complex, for example, a mixture of missing at random (MAR) and missing not at random (MNAR) assumptions. Many methods under the assumption of MAR are available. Under the assumption of MNAR, likelihood-based methods require specification of the joint distribution of the data, and the missingness mechanism has been introduced as sensitivity analysis. These classic models heavily rely on the underlying assumption, and, in many realistic scenarios, they can produce unreliable estimates. In this paper, we develop a machine learning based missing data prediction framework with the aim of handling more realistic missing data scenarios. We use an imbalanced learning technique (i.e., oversampling of minority class) to handle the MNAR data. To implement oversampling in longitudinal continuous variable, we first perform clustering via k$k$ -mean trajectories. And use the recurrent neural network (RNN) to model the longitudinal data. Further, we apply bootstrap aggregating to improve the accuracy of prediction and also to consider the uncertainty of a single prediction. We evaluate the proposed method using simulated data. The prediction result is evaluated at the individual patient level and the overall population level. We demonstrate the powerful predictive capability of RNN for longitudinal data and its flexibility for nonlinear modeling. Overall, the proposed method provides an accurate individual prediction for both MAR and MNAR data and reduce the bias of missing data in treatment effect estimation when compared to standard methods and classic models. Finally, we implement the proposed method in a real dataset from an antidepressant clinical trial. In summary, this paper offers an opportunity to encourage the integration of machine learning strategies for handling of missing data in the analysis of randomized clinical trials.

PMID:35266565 | DOI:10.1002/bimj.202000393

J Am Geriatr Soc. 2022 Mar 10. doi: 10.1111/jgs.17736. Online ahead of print.

ABSTRACT

BACKGROUND: Poor functional status is highly prevalent among older patients hospitalized for HF and marks a downward inflection point in functional and prognostic trajectories. We assessed the prognostic value of 6-min walk test after transitional cardiac rehabilitation in older patients hospitalized for heart failure (HF).

METHODS: We studied 759 patients aged ≥60 years who had been transferred to six inpatient rehabilitation facilities (IRF) from acute care hospitals after a hospitalization for acute HF. The primary outcome was 3-year all-cause mortality. We used multivariable Cox analysis to determine the association between 6-min walk distance (6MWD) at discharge from the IRFs and the primary outcome, adjusting for established predictors of death. The optimal cutoff for 6MWD was considered as the one that maximized the chi-square statistic.

RESULTS: Mean age was 75 ± 8 years. 6MWD significantly increased from admission to discharge (145 to 210 m; p < 0.001). The optimal cutoff for 6MWD was 198 m. After full adjustment, the hazard ratio for each 50 m-increase in discharge 6MWD was 0.90 (0.87-0.94; p < 0.001) and that for discharge 6MWD dichotomized at the optimal cutoff 0.48 (0.38-0.60; p < 0.001). The incidence rate of death/100 person-years for the patients who walked >198 m was 13.0 (10.0-15.5) compared with 30.8 (26.9-35.4) for those who walked <198 m. A statistically significant interaction of discharge 6MWD with left ventricular ejection fraction (EF) on the risk of death was observed (p value for interaction 0.047).

CONCLUSIONS: A rehabilitation intervention provided in the critical hospital-to-home transition period to older patients hospitalized for HF resulted in improved functional capacity. Increasing levels of functional capacity following rehabilitation were closely associated with decreasing risk of death; this association was significantly stronger for the subgroup with preserved EF.

PMID:35266550 | DOI:10.1111/jgs.17736

Bioinformatics. 2022 Mar 10:btac152. doi: 10.1093/bioinformatics/btac152. Online ahead of print.

ABSTRACT

SUMMARY: The genetic architecture of complex traits can be influenced by both many common regulatory variants with small effect sizes and rare deleterious variants in coding regions with larger effect sizes. However, the two kinds of genetic contributions are typically analyzed independently. Here we present GenRisk, a python package for the computation and the integration of gene scores based on the burden of rare deleterious variants and common-variants based polygenic risk scores. The derived scores can be analyzed within GenRisk to perform association tests or to derive phenotype prediction models by testing multiple classification and regression approaches. GenRisk is compatible with VCF input file formats.

AVAILABILITY AND IMPLEMENTATION: GenRisk is an open source publicly available python package that can be downloaded or installed from Github (https://github.com/AldisiRana/GenRisk).

SUPPLEMENTARY INFORMATION: GenRisk documentation is available online at https://genrisk.readthedocs.io/en/latest/.

PMID:35266528 | DOI:10.1093/bioinformatics/btac152

Adv Nutr. 2022 Mar 10:nmac025. doi: 10.1093/advances/nmac025. Online ahead of print.

ABSTRACT

Kiwifruit have known positive effects on digestion. During clinical intervention trials using kiwifruit to improve constipation, upper gastrointestinal (GI) symptoms such as abdominal discomfort and pain, indigestion, and reflux were also alleviated. We aimed to evaluate the evidence for upper GI symptom relief by kiwifruit in clinical trials on participants with functional constipation (FC), irritable bowel syndrome with constipation (IBS-C), and healthy participants, and to elucidate which symptoms may be relieved and whether a difference exists between the effects of gold and green kiwifruit. We executed a systematic scoping review of three electronic databases from 1947 through January 2021 to identify clinical trials that reported effects of green or gold kiwifruit or kiwifruit compounds on upper GI symptoms as secondary outcomes in healthy participants or participants with FC or IBS-C. Studies were divided into those using the Gastrointestinal Symptom Rating Score (GSRS) and those using alternative measurement tools. GSRS outcomes were pooled and statistically analysed, non-GSRS outcomes were summarised. We identified 12 clinical trials with a total of 661 participants (124 control, 537 receiving intervention) providing evidence for symptom relief of upper GI symptoms by kiwifruit intake. Only 5 of the 12 clinical trials used the GSRS to assess upper GI symptom relief. We found good evidence that green kiwifruit may reduce abdominal discomfort and pain, and some evidence that kiwifruit consumption may attenuate indigestion. Pooled GSRS outcome analysis indicates an average reduction of -0.85 (95% CI [-1.1, -0.57], Z = 6.1) in abdominal pain scores and -0.33 (95% CI [-0.52, -0.15], Z = -3.5) in indigestion scores with habitual kiwifruit consumption. While the number of studies reporting on upper GI symptom relief with a comparable measurement is limited, there is consistent evidence for efficacy of kiwifruit on upper GI symptom relief. More research to strengthen the evidence is recommended.

PMID:35266507 | DOI:10.1093/advances/nmac025

Rheumatology (Oxford). 2022 Mar 10:keac150. doi: 10.1093/rheumatology/keac150. Online ahead of print.

ABSTRACT

OBJECTIVES: Secondary inefficacy with infusion reactions and anti-drug antibodies (2NDNR) occurs in 14% of SLE patients receiving repeated rituximab courses. We evaluated baseline clinical characteristics, efficacy and safety of obinutuzumab, a next-generation humanised type-2 anti-CD20 antibody licensed for haematological malignancies in SLE patients with 2NDNR to rituximab.

METHODS: We collated data from SLE patients receiving obinutuzumab for secondary non-response to rituximab in BILAG centres. Disease activity was assessed using BILAG-2004, SLEDAI-2K and serology before, and 6 months after, obinutuzumab 2x1000mg infusions alongside methylprednisolone 100 mg.

RESULTS: All 9 patients included in the study received obinutuzumab with concomitant oral immunosuppression. At 6 months post-obinutuzumab, there were significant reductions in median SLEDAI-2K from 12 to 6 (p= 0.014) and total BILAG-2004 score from 21 to 2 (p= 0.009). Complement C3 and dsDNA titres improved significantly (both p= 0.04). Numerical, but not statistically significant improvements were seen in C4 levels. Of 8/9 patients receiving concomitant oral prednisolone at baseline (all >10mg/day), 5/8 had their dose reduced at 6 months. 4/9 patients were on 5 mg/day and were in Lupus Low Disease Activity State following obinutuzumab. After obinutuzumab, 6/9 patients with peripheral B cell data achieved complete depletion including 4/4 assessed with highly-sensitive assays. 1/9 obinutuzumab non-responder required cyclophosphamide therapy. 1 unvaccinated patient died from COVID-19.

CONCLUSIONS: Obinutuzumab appears to be effective and steroid-sparing in renal and non-renal SLE patients with secondary non-response to rituximab. These patients have severe disease with few treatment options but given responsiveness to B cell depletion, switching to humanised type-2 anti-CD20 therapy is a logical approach.

PMID:35266512 | DOI:10.1093/rheumatology/keac150