Tag: pubmed

Trials. 2021 Nov 7;22(1):780. doi: 10.1186/s13063-021-05755-y.

ABSTRACT

Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly challenging given the complexities of what is both practical and ethical to randomize. We are often faced with the difficult decision between having weak trials or not having a trial at all. In a recent article, Dr. Atle Fretheim argues that statistically underpowered studies are still valuable, particularly in conjunction with other similar studies in meta-analysis in the context of the DANMASK-19 trial, asking “Surely, some trial evidence must be better than no trial evidence?” However, informative trials are not always feasible, and feasible trials are not always informative. In some cases, even a well-conducted but weakly designed and/or underpowered trial such as DANMASK-19 may be uninformative or worse, both individually and in a body of literature. Meta-analysis, for example, can only resolve issues of statistical power if there is a reasonable expectation of compatible well-designed trials. Uninformative designs may also invite misinformation. Here, we make the case that-when considering informativeness, ethics, and opportunity costs in addition to statistical power-“nothing” is often the better choice.

PMID:34743755 | DOI:10.1186/s13063-021-05755-y

Br J Nutr. 2021 Oct 7:1-8. doi: 10.1017/S0007114521004049. Online ahead of print.

ABSTRACT

This study aims to evaluate the interaction effect of socio-economic environment (SEE) in the relationship between the eating location (EL) and diet quality, in children and adolescents. Data included Portuguese children and adolescents (3-17 years) from a National Dietary Survey Sample (IAN-AF 2015/2016, n 987). Dietary intake was obtained by 2-d food diaries (children) or 2-24-h-recall (adolescents). Participants were classified into four groups of EL: ‘Home’, ‘Other homes’, ‘School’ and ‘Restaurants’. Diet quality was measured as a higher adherence to a healthy eating pattern. A previous developed socio-economic classification was used, and participants were grouped as belonging to a low socio-economic environment (LSE) or middle-high socio-economic environment (MHSE). Linear regression models were used to evaluate the association between EL and diet quality, stratified by the SEE. A statistically significant interaction effect was found (P < 0·01) for the SEE in the association between EL and diet quality. After adjustment for potential confounders, in LSE, participants belonging to ‘Other homes’ (β = -2·07; 95 % CI:-3·70, -0·44) and ‘Restaurants’ (β = -3·31; 95 % CI: -5·08, -1·54) had lower scores in the diet quality score, comparing to ‘Home’. In MHSE, comparing with ‘Home’, ‘Restaurants’ showed lower diet quality (β = -1·56; 95 % CI:-2·65, -0·48), while the ‘School’ had better diet quality (β = 0·90; 95 % CI: 0·16, 1·64). The SEE influences the association between EL and diet quality and, belonging to more disadvantaged SEE, might represent a higher risk of unhealthy eating habits when eating out-of-home.

PMID:34743770 | DOI:10.1017/S0007114521004049

J Orthop Surg Res. 2021 Nov 7;16(1):662. doi: 10.1186/s13018-021-02814-7.

ABSTRACT

OBJECTIVE: To investigate the relationship between the infection rate and the timing of replacement of temporary external fixators with internal fixation, and the timing of immediate or delayed internal fixation after removal of temporary external fixation in the staging treatment modality of open fractures of extremities.

METHODS: A retrospective analysis was performed on 122 cases of open fractures of extremities. External fixators were applied at the early stage and replaced with internal fixation when the condition of soft tissues improved and inflammatory indexes dropped to the normal range or showed a steady downward trend. Depending on the carrying time of external fixators after wound closure or healing, the patients were divided into three groups; the carrying time of groups A, B, and C was ≤ 14 days, 15-28 days, and > 28 days, respectively. Depending on the immediate or delayed internal fixation after removal of external fixator, patients were divided into group a (immediate internal fixation after removal of external fixator) and group b (delayed internal fixation after removal of external fixator, 5-7 days later).

RESULTS: The infection rates of groups A, B, and C were 6.5%, 5.9%, and 23.3%, respectively. The differences among the three groups were statistically significant (P < 0.05). The infection rates of different Gustilo-Anderson fractures were as follows: no cases of infection out of 10 cases with type I fracture (0%); two cases of infection out of 35 cases with type II fracture (5.7%); three cases of infection out of 36 cases with IIIa fracture (8.3%); five cases of infection out of 28 cases with IIIB fracture (17.9%); and five cases of infection out of 13 cases with IIIC fracture (38.5%). The differences among the five groups were statistically significant.

CONCLUSIONS: The occurrence of infection of open fractures of extremities is associated with the fracture severity (Gustilo classification). For open fractures of Gustilo types I and II, the final internal fixation should be placed as soon as possible when the recovery of general and local conditions is good and the infection is controlled.

PMID:34743751 | DOI:10.1186/s13018-021-02814-7

Orphanet J Rare Dis. 2021 Nov 7;16(1):472. doi: 10.1186/s13023-021-02098-4.

ABSTRACT

BACKGROUND: Individuals with Williams syndrome (WS) have an elevated risk for anxiety disorders throughout the life span, making it a research priority to identify the individual factors associated with anxiety. Most of the existing literature is based on questionnaire data and suggests that impaired executive functions (EF) increase the risk for anxiety in WS. The aim of this study was to use direct measures by trained clinicians to investigate the effects of general intelligence, inhibition, sustained attention, and working memory on anxiety in WS, to further elucidate potential underlying mechanisms.

METHOD: Twenty-four individuals with WS participated in the study (mean age: 29 years, range: 9-53 years), together with at least one of their parents. The MINI international neuropsychiatric interview for DSM-5 was completed to establish clinical diagnosis of anxiety, and the Clinical Global Impression Scale – Severity was used for an expert rating of symptom severity. Intellectual abilities were measured using the Wechsler scales, and attention and inhibition using the Conner’s Continuous Performance Test. In addition, a parent-report questionnaire measuring EF, learning and memory was collected.

RESULTS: In contrast to the apriori hypothesis, there was no significant association between anxiety and core elements of EF such as working memory, sustained attention, and inhibition (i.e. the process of restraining one’s impulses or behaviour). Using ordinal logistic regression analyses, we showed that decreasing intelligence quotient (IQ) and age are associated with elevated anxiety. We confirmed these results in between-groups analyses (anxiety disorder vs no current anxiety disorder), and low IQ was associated with higher risk of having an anxiety diagnosis. In addition, Bayesian statistics gave substantial evidence for no significant association between anxiety and inhibition.

CONCLUSION: By using direct measures of psychological pathology and functioning, the current results provide a deeper characterisation of the WS phenotype and provide novel insights into the potential mechanisms underpinning anxiety.

PMID:34743752 | DOI:10.1186/s13023-021-02098-4

BMC Complement Med Ther. 2021 Nov 8;21(1):278. doi: 10.1186/s12906-021-03415-x.

ABSTRACT

BACKGROUND: Henoch-Schönlein purpura nephritis (HSPN) is listed as the most common secondary glomerular diseases among children. Approximately 15 to 20% of children eventually could develop into chronic renal failure. Chinese patent herbal medicine Huaiqihuang (HQH) has been widely used in children with HSPN. This study aimed to evaluate the effectiveness and safety of HQH for HSPN in children, so as to provide evidence for clinical use.

METHODS: Randomized controlled trials (RCTs) on HQH for HSPN in children were searched in eight Chinese and English databases from their inception to December 2020. We included children with HSPN received HQH combined with conventional medicine. Cochrane “Risk of bias” tool was used to assess methodological quality, and “Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach” to summarize the certainty of evidence for main findings. Effect estimates were presented as risk ratio (RR), mean difference (MD) or standardized mean difference (SMD) with 95% confidence interval (CI) in meta-analyses using RevMan 5.3. Data not suitable for statistical pooling were synthesized qualitatively.

RESULTS: In total seven RCTs were identified. Compared with conventional medicine alone, HQH plus conventional medicine showed the better effect in improving clinical cure rate (RR 1.58; 95%CI 1.17 to 2.14; n = 6) and total effective rate (RR 1.34; 1.16 to 1.54; n = 6); reducing urine sediment erythrocyte count (MD -9.23; – 10.76 to – 7.69; n = 3) and urine β2 micro-globulin level (MD -0.09; – 0.12 to – 0.06; n = 2). No serious adverse event was recorded in all included trials.

CONCLUSIONS: Limited evidence showed HQH combined with conventional medicine had a beneficial effect for children with HSPN, and the side effects were mild. HQH may be a promising complementary therapy. However, long term follow-up, high quality and multicenter RCTs are required to confirm the findings.

PMID:34743723 | DOI:10.1186/s12906-021-03415-x

J Cardiothorac Surg. 2021 Nov 7;16(1):325. doi: 10.1186/s13019-021-01709-2.

ABSTRACT

BACKGROUND: To investigate the relationship of pericoronary adipose tissue (PCAT) with coronary artery stenosis using dual-layer spectral detector CT (SDCT).

METHODS: 99 patients were retrospectively divided into normal group, non-significant stenosis group and significant stenosis group (n = 33 in each group). Fat attenuation index (FAI) 40kev, spectral curve slope (λHU), effective atomic number (Eff-Z) and epicardial fat volume (EFV) were quantitatively evaluated of the narrowest part of the lesion tissue by SDCT.

RESULTS: There were significant differences in PCAT parameters on SDCT (FAI40keV, λHU, Eff-Z and EFV) among the three groups (P < 0.05). FAI40keV, λHU, and Eff-Z in significant stenosis group were statistically different from those in normal group and non-significant stenosis group (P < 0.05). FAI40keV, λHU, and Eff-Z in non-significant stenosis group were statistically different from significant stenosis group (P < 0.05). EFV in normal group were significantly lower in non-significant stenosis group and significant stenosis group (P < 0.001). Univariate and multivariate logistic regression analyses identified FAI40keV (OR = 1.50, 95%CI 1.01 to 1.09) and λHU (OR = 6.81, 95%CI 1.87 to 24.86) as independent predictors of significant stenosis. FAI40keV and λHU had quite good discrimination, with an AUC of 0.84 and 0.80 respectively.

CONCLUSION: FAI40keV, λHU, and Eff-Z on SDCT in significant stenosis group were significantly different from normal and non-significant stenosis group while EFV in normal group were significantly different from non-significant stenosis group and significant stenosis group. FAI40kev and λHU were risk factors for significant stenosis.

PMID:34743735 | DOI:10.1186/s13019-021-01709-2

BMC Pulm Med. 2021 Nov 8;21(1):354. doi: 10.1186/s12890-021-01717-x.

ABSTRACT

BACKGROUND: Intravenous immunoglobulin (IVIG) has been used as an immunomodulatory therapy to counteract severe systemic inflammation in coronavirus disease 2019 (COVID-19). But its use in COVID-19 related acute respiratory distress syndrome (ARDS) is not well established.

METHODS: We conducted a retrospective analysis of electronic health records of COVID-19 patients admitted to intensive care units (ICUs) at Hazm Mebaireek General Hospital, Qatar, between March 7, 2020 and September 9, 2020. Patients receiving invasive mechanical ventilation for moderate-to-severe ARDS were divided into two groups based on whether they received IVIG therapy or not. The primary outcome was all-cause ICU mortality. Secondary outcomes studied were ventilator-free days and ICU-free days at day-28, and incidence of acute kidney injury (AKI). Propensity score matching was used to adjust for confounders, and the primary outcome was compared using competing-risks survival analysis.

RESULTS: Among 590 patients included in the study, 400 received routine care, and 190 received IVIG therapy in addition to routine care. One hundred eighteen pairs were created after propensity score matching with no statistically significant differences between the groups. Overall ICU mortality in the study population was 27.1%, and in the matched cohort, it was 25.8%. Mortality was higher among IVIG-treated patients (36.4% vs. 15.3%; sHR 3.5; 95% CI 1.98-6.19; P < 0.001). Ventilator-free days and ICU-free days at day-28 were lower (P < 0.001 for both), and incidence of AKI was significantly higher (85.6% vs. 67.8%; P = 0.001) in the IVIG group.

CONCLUSION: IVIG therapy in mechanically ventilated patients with COVID-19 related moderate-to-severe ARDS was associated with higher ICU mortality. A randomized clinical trial is needed to confirm this observation further.

PMID:34743710 | DOI:10.1186/s12890-021-01717-x

World J Surg Oncol. 2021 Nov 7;19(1):323. doi: 10.1186/s12957-021-02416-x.

ABSTRACT

BACKGROUND: Removing more inframesenteric nodes is not only significantly increases the likelihood of finding metastasis for endometrial cancer, but also can add survival advantage. As most patients diagnosed with endometrial cancer are overweight or obesity, a high efficiency approach is important. Aim of this study was to compare the surgical outcomes of extraperitoneal laparoscopic, transperitoneal laparoscopic, and laparotomic para-aortic lymphadenectomy in endometrial carcinoma staging.

METHODS: We retrospectively reviewed data of all patients diagnosed with primary endometrial carcinoma who were treated at the Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center from 1 January 2017 to 31 December 2019. The numbers of para-aortic lymph nodes, surgical time, complications, blood loss and hospital stay were compared. The patients’ medical records and pathological reports were carefully reviewed. Statistical significance was defined as p < 0.05.

RESULTS: We retrospectively compared patients who underwent extraperitoneal laparoscopy (Group E, n = 20), transperitoneal laparoscopy (group T, n = 21), and laparotomy (group L, n = 135). The median number of para-aortic lymph nodes was significantly higher in group E than in groups T and L (9.5, 5, and 6, respectively; p = 0.004 and 0.0004, respectively). All patients in group E underwent successfully dissection to the renal vessel level. The median operation time was significantly shorter in group L than in groups T and E (94, 174, and 233 min, respectively; p < 0.0001). The median estimated blood loss volume was higher in group L than in groups T and E (200, 100, and 142.5 ml, respectively; all comparisons p < 0.001), and the length of hospital stay was significantly longer in group L than in Groups T and E (6, 5, and 6 days, respectively; all comparisons p < 0.001).

CONCLUSION: The extraperitoneal laparoscopic approach for staging endometrial carcinoma harvested higher numbers of para-aortic lymph nodes which could be considered for endometrial carcinoma staging, especially for para-aortic lymph node harvest.

PMID:34743715 | DOI:10.1186/s12957-021-02416-x

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