Tag: statistics

Respir Res. 2021 Nov 7;22(1):287. doi: 10.1186/s12931-021-01876-9.

ABSTRACT

BACKGROUND: The mannitol test is an indirect bronchial challenge test widely used in diagnosing asthma. Response to the mannitol test correlates with the level of eosinophilic and mast cell airway inflammation, and a positive mannitol test is highly predictive of a response to anti-inflammatory treatment with inhaled corticosteroids. The response to mannitol is a physiological biomarker that may, therefore, be used to assess the response to other anti-inflammatory treatments and may be of particular interest in early phase studies that require surrogate markers to predict a clinical response. The main objectives of this review were to assess the practical aspects of using mannitol as an endpoint in clinical trials and provide the clinical researcher and respiratory physician with recommendations when designing early clinical trials.

METHODS: The aim of this review was to summarise previous uses of the mannitol test as an outcome measure in clinical intervention studies. The PubMed database was searched using a combination of MeSH and keywords. Eligible studies included intervention or repeatability studies using the standard mannitol test, at multiple timepoints, reporting the use of PD₁₅ as a measure, and published in English.

RESULTS: Of the 193 papers identified, 12 studies met the inclusion criteria and data from these are discussed in detail. Data on the mode of action, correlation with airway inflammation, its diagnostic properties, and repeatability have been summarised, and suggestions for the reporting of test results provided. Worked examples of power calculations for dimensioning study populations are presented for different types of study designs. Finally, interpretation and reporting of the change in the response to the mannitol test are discussed.

CONCLUSIONS: The mechanistic and practical features of the mannitol test make it a useful marker of disease, not only in clinical diagnoses, but also as an outcome measure in intervention trials. Measuring airway hyperresponsiveness to mannitol provides a novel and reproducible test for assessing efficacy in intervention trials, and importantly, utilises a test that links directly to underlying drivers of disease.

PMID:34743708 | DOI:10.1186/s12931-021-01876-9

HIV Res Clin Pract. 2021 Nov 8:1-9. Online ahead of print.

ABSTRACT

Background: Different antiretroviral therapies (ARTs) may have differing effects on central nervous system (CNS) function. We assessed CNS pharmacodynamic effects of switching integrase inhibitors in people-with-HIV (PWH).Methods: PWH on tenofovir-DF/emtricitabine plus raltegravir 400 mg twice daily with suppressed plasma HIV RNA and without overt neuropsychiatric symptoms were randomly allocated on a 1:2 basis to remain on raltegravir or switch to dolutegravir 50 mg once daily for 120 days. Pharmacodynamic parameters assessed included cognitive function (z-score of 7 domains), patient-reported outcome measures (PROMs; PHQ-9 and Beck’s depression questionnaires), cerebral metabolite ratios measured by proton magnetic resonance spectroscopy (H¹-MRS) and plasma and cerebrospinal fluid (CSF) HIV RNA. Pharmacokinetic parameters were also assessed in plasma and CSF. Changes and factors associated with changes in pharmacodynamics parameters were assessed.Results:In 20 subjects (19 male, 14 white ethnicity, median age 43 years (IQR: 11.5) and CD4 + count 717 (SD: 298) cells/µL), over 120 days there were no statistically significant changes in cognitive function [mean z-score difference (95%CI) -0.004 (-0.38/0.37); p = 0.98], PROMs [PHQ-9 median score change: 0 in control arm, -0.5 switch arm (p = 0.57); Beck’s depression questionnaire: -1.5 control arm, -1.0 switch arm (p = 0.38)], nor cerebral metabolite ratios between study arms. CSF HIV RNA was <5 copies/mL at baseline and day 120 in all subjects. Geometric mean pre-dose CSF dolutegravir concentration was 7.6 ng/mL (95% CI: 5.2-11.1).Conclusions:Switching integrase inhibitor in virologically suppressed PWH without overt neuropsychiatric symptoms resulted in no significant changes in an extensive panel of CNS pharmacodynamics parameters.

PMID:34743666

BMC Surg. 2021 Nov 7;21(1):395. doi: 10.1186/s12893-021-01394-x.

ABSTRACT

BACKGROUND: Purely ligamentous Lisfranc injuries are mainly caused by low energy damage and often require surgical treatment. There are several operative techniques for rigid fixation to solve this problem clinically. This study evaluated the effect of using the Tightrope system to reconstruct the Lisfranc ligament for elastic fixation.

METHODS: We retrospectively analyzed 11 cases with purely ligamentous Lisfranc injuries treated with the Tightrope system from 2016 to 2019, including 8 male and 3 female. X-ray was performed regularly after operation to measure the distance between the first and second metatarsal joint and the visual analogue scale (VAS) score was used to evaluate pain relief. American orthopedic foot & ankle society (AOFAS) and Maryland foot score were recorded at the last follow-up.

RESULTS: The average follow-up time was 20.5 months (range, 17-24). There was statistically significant difference in the distance between the first and second metatarsal joint and VAS score at 3 months, 6 months, and the last follow-up when compared with preoperative values (P < 0.05).Mean of postoperative AOFAS mid-foot scale and Maryland foot score were 92.4 ± 4.3, 94.1 ± 3.5, respectively. The Tightrope system was not removed and the foot obtained better biomechanical stability. No complications occurred during the operation.

CONCLUSION: Tightrope system in the treatment of purely ligamentous Lisfranc injuries can stabilize the tarsometatarsal joint and achieve satisfactory effect.

PMID:34743702 | DOI:10.1186/s12893-021-01394-x

Physiother Theory Pract. 2021 Nov 7:1-16. doi: 10.1080/09593985.2021.1999355. Online ahead of print.

ABSTRACT

BACKGROUND: Children with hemiplegic cerebral palsy (CP) are at risk of reduced upper limb function and poorer quality of life than their typically developing peers. Although upper limb impairments have potential negative impact on the health-related quality of life (HRQOL) in children with hemiplegic CP, the efficacy of upper limb rehabilitation approaches aiming to improve upper limb impairments on HRQOL has not been adequately investigated.

OBJECTIVE: This study compares the efficacy of two modes of activity-based upper limb rehabilitation (modified constraint-induced movement therapy [mCIMT] and bimanual training [BIM]) on HRQOL outcomes in children with hemiplegic CP mainstreamed in regular schools.

METHODS: Thirty children with hemiplegic CP aged between 7 and 11 years (mean age 8.53 ± 1.54 years) who had functional ability levels of I-III according to the Manual Ability Classification System (MACS), Gross Motor Classification System (GMFCS), and Communication Function Classification System (CFCS) were randomly assigned to receive mCIMT or BIM training. Result: Both mCIMT and BIM yielded statistically significant improvements in all HRQOL domains immediately after the 10-week interventions (P < .001), which were retained at 16 weeks.

CONCLUSION: While there were some differences in the intervention effects, both of these upper limb rehabilitation approaches based on intensive unimanual or bimanual activity may be beneficial for improving perceived life satisfaction related to physical activity, general mood, family, friends, and school among children with hemiplegic CP mainstreamed in regular schools.

PMID:34743663 | DOI:10.1080/09593985.2021.1999355

Infect Dis (Lond). 2021 Nov 7:1-10. doi: 10.1080/23744235.2021.1995627. Online ahead of print.

ABSTRACT

BACKGROUND: Understanding the factors that affect the transmissibility of SARS-CoV-2 remains important to keep transmission low and maximize the health benefits of vaccination. We assessed the factors associated with the transmissibility of SARS-CoV-2 based on contact tracing data.

METHODS: From 1 October to 9 December 2020, 29,385 laboratory-confirmed SARS-CoV-2 cases (index cases, i.e. the first identified laboratory-confirmed cases or with the earliest symptom onset in a setting) and 64,608 traced contacts were identified in Greece. We assessed the prevalence of symptoms in cases, calculated secondary attack rates and assessed factors associated with infectivity and susceptibility to infection.

RESULTS: There were 11,232 contacts secondarily infected (secondary attack rate: 17.4%, 95% CI:17.0-17.8). Contacts aged 0-11 and 12-17 years were less susceptible to infection than adults 65 years or older (odds ratio (OR) [95% CI]: 0.28 [0.26-0.32] and 0.44 [0.40-0.49], respectively). Index cases aged 65 years or older were more likely to infect their contacts than other adults or children/adolescents. The odds of infection [95% CI] were higher in contacts exposed within the household (1.71 [1.59-1.85] vs. other) and in cases with cough (1.17 [1.11-1.25] vs. no cough). There was an interaction between the age of the index and the age of the contact with contacts 65 years or older having a higher probability of infection when exposed to cases of similar age than to children.

CONCLUSIONS: Our findings highlight the role of age and age mixing in infectivity and susceptibility to SARS-CoV-2 infection. Precautions are necessary for individuals 65 or older as they have higher infectivity and susceptibility in contact with their peers.

PMID:34743646 | DOI:10.1080/23744235.2021.1995627

Nurs Open. 2021 Nov 6. doi: 10.1002/nop2.1101. Online ahead of print.

ABSTRACT

AIMS: To explore the practice effect of establishing an integrated treatment process by stroke emergency nurses in general hospitals for acute ischaemic stroke (AIS).

DESIGN: Compared the time spent in each link before and after the establishment of AIS integrated treatment.

METHODS: Since March 2016, we set up a team of emergency stroke nurses (ESN), trained and assessed the knowledge of emergency stroke, and set up a post of ESN.

RESULTS: The median time of admission-judgement, admission-establishment of venous access, admission-cranial CT examination and admission-intravenous thrombolytic therapy was statistically significantly shortened after the implementation of the integrated treatment process of AIS coordinated by stroke emergency nurses (p < .01). The new treatment process of AIS further shortens the time of each treatment link and promotes the timeliness.

PMID:34741501 | DOI:10.1002/nop2.1101

Nurs Open. 2021 Nov 6. doi: 10.1002/nop2.1120. Online ahead of print.

ABSTRACT

AIM: The aim of this study was to investigate operating theatre nurses (OTNs) with managerial responsibility, and their self-rated clinical competence and need for competence development in perioperative nursing.

DESIGN: A cross-sectional study was applied using a modified version of Professional Nurse Self-Assessment Scale of Clinical Core Competence I.

METHOD: Data were collected from 303 OTNs in Sweden, 80 of whom indicated that they had managerial responsibility. Statistics analysis was used to identify the relationships between background variables to compare OTNs with and without managerial responsibility and their need for competence development.

RESULTS: OTNs with an academic degree and managerial responsibility self-rated their clinical competence higher compared with OTNs without an academic degree. It also turned out that OTNs with RN education and 1-year advanced nursing in theatre care, and master’s 60 credits had a lower need for competence development in cooperation and consultation, professional development and critical thinking.

PMID:34741502 | DOI:10.1002/nop2.1120

Cell Prolif. 2021 Nov 6:e13154. doi: 10.1111/cpr.13154. Online ahead of print.

ABSTRACT

Impaired apoptosis is one of the hallmarks of cancer, and almost all of the non-surgical approaches of eradicating tumour cells somehow promote induction of apoptosis. Indeed, numerous studies have stated that non-ionizing non-thermal extremely low-frequency magnetic fields (ELF-MF) can modulate the induction of apoptosis in exposed cells; however, much controversy exists in observations. When cells are exposed to ELF-EMF alone, very low or no statistically significant changes in apoptosis are observed. Contrarily, exposure to ELF-EMF in the presence of a co-stressor, including a chemotherapeutic agent or ionizing radiation, can either potentiate or inhibit apoptotic effects of the co-stressor. In our idea, the main point neglected in interpreting these discrepancies is “the cellular stress responses” of cells following ELF-EMF exposure and its interplay with apoptosis. The main purpose of the current review was to outline the triangle of ELF-EMF, the cellular stress response of cells and apoptosis and to interpret and unify discrepancies in results based on it. Therefore, initially, we will describe studies performed on identifying the effect of ELF-EMF on induction/inhibition of apoptosis and enumerate proposed pathways through which ELF-EMF exposure may affect apoptosis; then, we will explain cellular stress response and cues for its induction in response to ELF-EMF exposure; and finally, we will explain why such controversies have been observed by different investigators.

PMID:34741480 | DOI:10.1111/cpr.13154

Acta Paediatr. 2021 Nov 6. doi: 10.1111/apa.16176. Online ahead of print.

ABSTRACT

AIM: Interleukin (IL)-1 receptor like-1, encoded by the IL1RL1 gene, is a receptor for IL-33. In European birth cohorts, IL1RL1 rs102082293, rs10204137 (rs4988955), rs13424006 and rs13431828 (rs13048661) variations were associated with asthma at school age. In a Dutch multi-center study, IL1RL1 rs1921622 variation was associated with severe bronchiolitis. We evaluated the associations of these five IL1RL1 variations with asthma and lung function at school age after hospitalisation for bronchiolitis in infancy.

METHODS: Follow-up data, including impulse oscillometry at age 5-7 and flow-volume spirometry at age 11-13 years, and the IL1RL1 genotype data were available for 141 children followed until 5-7 and for 125 children followed until 11-13 age years after bronchiolitis in infancy. The IL1RL1 rs10204137 and rs4988955, and the IL1RL1 rs13048661 and rs13431828, are 100% co-segregating in the Finnish population.

RESULTS: The variant IL1RL1 rs13048661/13431828 genotype was constantly associated with increased asthma risk by various definitions at 5-7 and 11-13 years of ages. The result was confirmed with analyses adjusted for current confounders and early-life environment-related factors. Statistical significances were lost, when maternal asthma and atopic dermatitis in infancy were included in the model.

CONCLUSION: IL1RL1 rs13048661/13431828 variation was associated with post-bronchiolitis asthma outcomes at school age.

PMID:34741482 | DOI:10.1111/apa.16176

Mil Med. 2021 Nov 6:usab442. doi: 10.1093/milmed/usab442. Online ahead of print.

ABSTRACT

BACKGROUND: Maternal obstetric morbidity is a growing concern in the USA, where rates of maternal morbidity exceed Europe and most developed countries. Prior studies have found that obstetric case volume affects maternal morbidity, with low-volume facilities having higher rates of morbidity. However, these studies were done in civilian healthcare systems that are different from the Military Health System (MHS). This study evaluates whether obstetric case volume impacts severe maternal morbidity (SMM) in military hospitals located in the continental United States.

METHODS: This cross-sectional study included all military treatment facilities (MTFs) (n = 35) that performed obstetric deliveries (n = 102,959) from October 2015 to September 2018. Data were collected from the MHS Data Repository and identified all deliveries for the study time period. Severe maternal morbidity was defined by the Centers for Disease Control. The 30-day readmission rates were also included in analysis. Military treatment facilities were separated into volume quartiles for analysis. Univariate logistic regressions were performed to determine the impact of MTF delivery volume on the probability of SMM and 30-day maternal readmissions.

RESULTS: The results for all regression models indicate that the MTF delivery volume had no significant impact on the probability of SMM. With regard to 30-day maternal readmissions, using the upper middle quartile as the comparison group due to the largest number of deliveries, MTFs in the lower middle quartile and in the highest quartile had a statistically significant higher likelihood of 30-day maternal readmissions.

CONCLUSION: This study shows no difference in SMM rates in the MHS based on obstetric case volume. This is consistent with previous studies showing differences in MHS patient outcomes compared to civilian healthcare systems. The MHS is unique in that it provides families with universal healthcare coverage and access and provides care for approximately 40,000 deliveries annually. There may be unique lessons on volume and outcomes in the MHS that can be shared with healthcare planners and decision makers to improve care in the civilian setting.

PMID:34741453 | DOI:10.1093/milmed/usab442