Category: Statistics

Psychother Psychosom. 2021 Jul 20:1-12. doi: 10.1159/000517504. Online ahead of print.

ABSTRACT

INTRODUCTION: Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress.

OBJECTIVE: To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe.

METHODS: We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes.

RESULTS: Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer V = 0.007, p = 0.90, RR = 0.96; 95% CI 0.52-1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer V = 0.13, p = 0.01, RR = 0.50; 95% CI 0.29-0.87).

CONCLUSIONS: This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified.

PMID:34350902 | DOI:10.1159/000517504

Respiration. 2021 Jul 23:1-12. doi: 10.1159/000517034. Online ahead of print.

ABSTRACT

RATIONALE: The long-term safety and effectiveness of bronchoscopic lung volume reduction with Zephyr endobronchial valves in subjects with severe homogeneous emphysema with little to no collateral ventilation beyond 3 months have yet to be established.

METHODS: Ninety-three subjects were randomized to either bronchoscopic lung volume reduction with Zephyr valves or standard of care (SoC) (1:1). Zephyr valve subjects were assessed at 3, 6, and 12 months. SoC subjects were assessed at 3 and 6 months; they were then offered crossover to Zephyr valve treatment.

RESULTS: The mean group difference (Zephyr valve – SoC) for change in FEV1 from baseline to 6 months was 16.3 ± 22.1% (mean ± SD; p < 0.001). Secondary outcomes showed the mean between-group difference for the six-minute walk distance of +28.3 ± 55.3 m (p = 0.016); St. George’s Respiratory Questionnaire, -7.51 ± 9.56 points (p < 0.001); modified Medical Research Council, -0.42 ± 0.81 points (p = 0.019); BODE index, -0.85 ± 1.39 points (p = 0.006); and residual volume of -430 ± 830 mL (p = 0.011) in favor of the Zephyr valve group. At 6 months, there were significantly more responders based on the minimal clinically important difference for these same measures in the Zephyr valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of subjects with respiratory serious adverse events was higher in the Zephyr valve group compared to SoC during the first 30 days post-procedure but not statistically different for the Zephyr valve and SoC groups from 31 days to 6 months, and stable in the Zephyr valve group out to 12 months. There were 2 deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr valve group out to 12 months.

CONCLUSIONS: Bronchoscopic lung volume reduction with Zephyr valves in subjects with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months, with benefits maintained out to 12 months.

PMID:34350884 | DOI:10.1159/000517034

Sex Dev. 2021 Jul 21:1-7. doi: 10.1159/000517055. Online ahead of print.

ABSTRACT

In this article international trends in surgical practice in girls with congenital adrenal hyperplasia (CAH) are evaluated. All cases that had been classified in the I-CAH/I-DSD registry as 46,XX CAH and who were born prior to 2017 were identified. Centers were approached to obtain information on surgical decision making. Of the 330 included participants, 208 (63.0%) presented within the first month of life, and 326 (98.8%) cases were assigned female. Genital surgery had been performed in 250 (75.8%). A total of 64.3, 89.2, and 96.8% of cases residing in Europe, South America and Asia, respectively, had at least one surgery. In a logistic regression model for the probability of surgery before the second birthday (early surgery) over time an increase of probability for early vaginal surgery could be identified, but not for clitoral surgery or both surgeries combined. Genitoplasty in girls with CAH remains controversial. This large international study provides a snapshot of current practice and reveals geographical and temporal differences. Fewer surgeries were reported for Europe, and there seems to be a significant trend towards aiming for vaginal surgery within the first 2 years of life.

PMID:34350892 | DOI:10.1159/000517055

Rinsho Ketsueki. 2021;62(7):801-808. doi: 10.11406/rinketsu.62.801.

ABSTRACT

Parental age at birth has been investigated in patients diagnosed with pediatric cancer. The Japan Children’s Cancer Registry1985-2007 recruited 5,510 patients with leukemia and 8,782 with other cancers. The proportion of patients born to mother and father aged >40 years showed a higher trend in leukemia than that in other cancers (odds ratio [OR] 1.41, p=0.057), especially in <12-month-old infants born to mother aged >40 years (OR 2.55, p=0.031). We then divided 27,335 patients diagnosed in 1969-2006 into every 8-year birth cohorts to compare proportions of mothers with prenatal medical irradiation. The OR of leukemia was higher than that of other cancers in 1969-1976 (1.25) or 1977-1984 (1.39), which reached statistical significance. We have also studied caregiver’s exposure to anticancer drugs. In 15 pediatric patients with cancer who received cyclophosphamide (CPM), the concentration was measured using mothers and medical staff’s urine. Five of 7 infants’ and 2 of 8 adolescent’s mothers showed increased urine CPM levels. CPM was not detected in any medical staff’s samples. Maternal exposure to anticancer drugs should also be considered. Efforts of reducing the genotoxicity in both infants and mothers are crucial for pediatric cancer prevention.

PMID:34349065 | DOI:10.11406/rinketsu.62.801

J Prosthodont Res. 2021 Aug 4. doi: 10.2186/jpr.JPR_D_20_00163. Online ahead of print.

ABSTRACT

PURPOSE: This study investigated changes in the retentive force of telescopic crowns fabricated by combining a zirconia primary crown and a fiber-reinforced composite (FRC) secondary crown.

METHODS: Primary zirconia crowns were produced with a nominal convergence angle of 0°. Forty-eight secondary crowns were milled from FRC and divided into three study groups (n=16/group) based on milling parameters and post-milling adjustment. The offset parameter used for the final milling step of the inner crown surface was adjusted for a tight initial fit in Group 1 (milling offset: +10 µm, i.e., 2 × 10 µm = 20 µm lower inner diameter compared with the CAD file of the crown) and for improved initial fit (milling offset: -10 µm, i.e., an enlargement of the inner crown diameter by 2 × 20 µm = 40 µm in relation to Group 1) in Groups 2 and 3. The inner surfaces of the secondary crowns were polished with diamond paste in Groups 1 and 2, and silicon points were used for Group 3. The retentive force was measured using a universal testing device. The secondary crown was placed on the primary crown, with the final fitting force set to a load of 100 N. This test was conducted before and after aging (10,000 insertion/removal cycles) under dry and wet conditions. A generalized linear model was used to estimate the differences in the retentive force to elucidate the effects of the milling parameters and polishing methods.

RESULTS: We realized an initial retentive force of approximately 10 N. In Groups 2 and 3, the difference was statistically significant between the dry and wet conditions before aging (P < 0.05). There was no significant difference between the dry and wet conditions after aging in any of the groups (P > 0.05).

CONCLUSIONS: An adequate initial retentive force can be achieved with telescopic crowns combining zirconia and FRC.

PMID:34349081 | DOI:10.2186/jpr.JPR_D_20_00163

J Neurointerv Surg. 2021 Aug 4:neurintsurg-2021-017585. doi: 10.1136/neurintsurg-2021-017585. Online ahead of print.

ABSTRACT

BACKGROUND: There is no consensus on the most effective endovascular technique to use in patients with acute ischemic stroke due to terminal internal carotid artery (ICA) occlusion. The aim of this study was to compare safety and efficacy of the aspiration technique (AT) and combined technique (CT) as first-line approach in terminal ICA occlusions.

METHODS: We performed a retrospective analysis of prospectively collected databases from seven Italian stroke centers. Patients were divided into two subgroups according to the first-line approach: AT group or CT group. We followed the STROBE guidelines for cohort studies. We used Chi-square test, one-way and multivariate ANOVA analysis, together with contrast analysis and post hoc tests, logistic regression and Pearson’s bivariate correlation for the statistical analyses.

RESULTS: Between January 2018 and August 2020, 353 patients were treated for a terminal ICA occlusion, with either AT or CT. CT was associated with a higher Thrombolysis in Cerebral Infarction (TICI) 2B-3 after the first pass (51.0% vs 26.9%) and at the end of the procedure (84% vs 73.3%) and with an improved clinical outcome at discharge (modified Rankin Scale (mRs) 0-2 of 47.8% vs 34.0%) and at 3 months’ follow-up (mRs 0-2 of 56.5% vs 38.9%) compared with AT.

CONCLUSION: Thrombectomy of terminal ICA occlusions obtained using CT as first-line approach demonstrated better technical and functional outcomes in comparison with AT.

PMID:34349012 | DOI:10.1136/neurintsurg-2021-017585

Rinsho Ketsueki. 2021;62(7):733-738. doi: 10.11406/rinketsu.62.733.

ABSTRACT

Despite the challenges involved in studying the epidemiology of a rare disease, the last two decades have provided considerable information regarding the probable causes of childhood leukemia, in which current evidence suggests an important role for genetic susceptibility and external factors originating from the environment. The genome-wide association study approach has led to the identification of several associated genes, thereby confirming the polygenic nature of childhood leukemia. Ongoing studies have shown that many of these loci, which were originally identified in populations of European ancestry, are also important in the Japanese population. Regarding potential external exposures, increasing evidence is becoming available to elucidate the role of infectious agents and the influence of immune maturation in early life. Epidemiological evidence supports the prevailing hypotheses related to the effect of population mixing on transient increases in the childhood leukemia rates, as well as the role of delayed exposures to common infections in propagating an aberrant immune response and subsequent leukemia risk. Future advances in the investigation of childhood leukemia and other rare diseases along with coordinated studies and collaborations are needed, owing to stringent sample size requirements to support statistically robust comparisons and opportunities for independent validation.

PMID:34349056 | DOI:10.11406/rinketsu.62.733

Neurology. 2021 Aug 4:10.1212/WNL.0000000000012482. doi: 10.1212/WNL.0000000000012482. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the association between midlife plasma amyloid-beta (Aβ_1-42, Aβ_1-40, Aβ₄₂:Aβ₄₀) and risk of MCI and dementia.

METHODS: Plasma Aβ₄₂ and Aβ₄₀ were retrospectively measured using a fluorimetric bead-based immunoassay in a subsample of the Atherosclerosis Risk in Communities cohort study. We investigated the relationship of plasma Aβ₄₂, Aβ₄₀, and Aβ₄₂:Aβ₄₀ ratio measured in midlife, late-life, and the change from midlife to late-life, to risk of MCI, dementia, and combined MCI/dementia outcomes in late-life (from 2011-19). We used multinomial logistic regressions estimating relative risk ratios (RRR) of these cognitive outcomes vs cognitively normal adjusted for age, sex, education, site-race, APOE, hypertension, diabetes, and body mass index.

RESULTS: A total of 2284 participants were included (midlife mean age=59.2±5.2, 57% female, 22% Black). Each doubling of midlife Aβ₄₂:Aβ₄₀ was associated with 37% lower risk of MCI/dementia (RRR=0.63, 95% CI: 0.46, 0.87), but only up to approximately the median (spline model threshold 0.20). Every standard deviation increase in plasma Aβ₄₂ (10 pg/mL) was associated with 13% lower risk of MCI/dementia (RRR=0.87, 95% CI: 0.77, 0.98), whereas every standard deviation increase in plasma Aβ₄₀ (67 pg/mL) was associated with 15% higher risk of MCI/dementia (RRR=1.15, 95% CI: 1.01, 1.29). Associations were comparable, but slightly weaker statistically, when repeating models using late-life plasma Aβ predictors. Aβ₄₂ and Aβ₄₀ increased from midlife to late-life, but changes were not associated with cognitive outcomes.

CONCLUSION: Midlife measurement of plasma Aβ may have utility as a blood-based biomarker indicative of risk for future cognitive impairment.

PMID:34349010 | DOI:10.1212/WNL.0000000000012482

Heart. 2021 Aug 4:heartjnl-2021-319410. doi: 10.1136/heartjnl-2021-319410. Online ahead of print.

ABSTRACT

OBJECTIVE: To test the hypothesis that ventricular and atrial function are different between patients with transposition of the great arteries (TGA) after arterial switch operation (ASO) and healthy controls.

METHODS: 103 consecutive patients with TGA (median age: 16.7 years, 4.3-39.6 years, 71.8% male) were compared with 77 controls (median age: 15.4 years, 6.3-43.2 years, 66.2% male). Biventricular and biatrial function were assessed using standard cardiovascular magnetic resonance (CMR) techniques and feature tracking. Group comparison was performed with conventional non-parametrical statistics and machine learning methods to find the variables most discriminative between patients and controls. These variables were used to build a multivariable logistic regression model to assess the case-control status.

RESULTS: Markers of left and right ventricular function (LV; RV) (ejection fraction, MAPSE, TAPSE, LV long-axis strain) as well as LV global longitudinal (-20.7 (-24.1; -17.9) vs -23.7 (-26.1; -21.6), p<0.001), circumferential (-29.4 (-32.2; -26.5) vs -30.5 (-33.6; 29), p=0.001) and atrial longitudinal strain (left atrium (LA): 23.3 (18.6; 28.8) vs 36.7 (30.7; 44), p<0001; right atrium: 21.7 (18.2; 27.8) vs 34.9 (26.9; 40.3), p<0.001) were reduced in patients compared with controls using non-parametrical testing. The logistic regression model including the most discriminative variables from univariate and machine learning analysis demonstrated significant differences between patients and controls only for TAPSE and LA global longitudinal strain.

CONCLUSIONS: Biventricular and biatrial function are largely preserved after ASO for TGA. Using a comprehensive CMR protocol along with statistical machine learning methods and a regression approach, only RV longitudinal function and LA function are significantly impaired.

PMID:34349009 | DOI:10.1136/heartjnl-2021-319410

Open Heart. 2021 Aug;8(2):e001653. doi: 10.1136/openhrt-2021-001653.

ABSTRACT

BACKGROUND: The clinical effectiveness of ablating non-paroxysmal atrial fibrillation (non-PAF) relies on proper patient selection. We developed and validated a scoring system to predict non-PAF ablation outcomes.

METHODS: Data on 416 non-PAF ablations were analysed using binary logistic regression at a London centre. Identified preprocedural variables, which independently predicted freedom from atrial tachyarrhythmia. Twenty-one possible predictive variables and a model with c-statistic 0.751-explained outcome variation in London at mean follow-up 12±3 months. An additive point score (range 0-9) was developed-the FLAME score: female=1; long-lasting persistent atrial fibrillation=1; left atrial diameter in mm: 40 to <45 = 1, 45 to <50 = 2, 50 to <55=3, ≥55 =4; mitral regurgitation (MR) mild to moderate=1; extreme comorbidity=2. Extreme comorbidities include severe MR, moderate mitral stenosis, mitral replacement, hypertrophic cardiomyopathy or congenital heart disease.

RESULTS: The FLAME score was applied to data (882 non-PAF ablations) at a Californian centre, and predicted the outcome of both single (p<0.0001) and multiple (p<0.0001) procedures. For first ablation (follow-up 2.1 years (median, IQR 1.0-4.1)), FLAME score: 0-1 predicts 62% success, 2-4 44% and ≥5 29% (P_trend <0.0001). After the final ablation (mean procedures: 1.4±0.6, follow-up 1.8 years (median, IQR 0.8-3.6)), FLAME score: 0-1 predicts 81% success, 2-4 65% and ≥5 44% (P_trend <0.0001).

CONCLUSIONS: FLAME score is easily calculated, derived in London, and predicted single and multiple procedural outcomes for non-PAF ablations in California. In patients with a high score, even multiple procedures are usually ineffective.

PMID:34348972 | DOI:10.1136/openhrt-2021-001653