Tag: statistics

J Eur Acad Dermatol Venereol. 2022 Apr 26. doi: 10.1111/jdv.18184. Online ahead of print.

ABSTRACT

BACKGROUND: Reactivation of the varicella-zoster virus (VZV), which causes herpes zoster (HZ, synonym: shingles) in humans, can be a rare adverse reaction to vaccines. Recently, reports of cases after COVID-19 vaccination have arisen.

OBJECTIVES: The aim of this study was to assess if the frequency of HZ is found to increase after COVID-19 vaccination in a large cohort, based on real-world data. As a hypothesis, the incidence of HZ was assumed to be significantly higher in subjects who received a COVID-19 vaccine (Cohort I) versus unvaccinated individuals (Cohort II).

METHODS: Initial cohorts of 1,095,086 vaccinated and 16,966,018 unvaccinated patients were retrieved from the TriNetX database, and were matched on age and gender in order to mitigate confounder bias.

RESULTS: After matching, each cohort accounted for 1,095,086 patients. For the vaccinated group (Cohort I), 2,204 subjects developed HZ within 60 days of COVID-19 vaccination, while among Cohort II, 1,223 patients were diagnosed with HZ within 60 days after having visited the clinic for any other reason (i.e., not vaccination). The risk of developing shingles was calculated as 0.20% and 0.11% for cohort I and cohort II, respectively. The difference was statistically highly significant (p < 0.0001; log-rank test). The risk ratio and odds ratio were 1.802 (95% confidence interval [CI] = 1.680; 1.932) and 1.804 (95% CI = 1.682; 1.934).

CONCLUSIONS: Consistent with the hypothesis, a higher incidence of HZ was statistically detectable post-COVID-19 vaccine. Accordingly, eruption of HZ may be a rare adverse drug reaction to COVID-19 vaccines. Even though the molecular basis of VZV reactivation remains murky, temporary compromising of VZV-specific T cell-mediated immunity may play a mechanistic role in post-vaccination pathogenesis of HZ. Note that VZV reactivation is a well-established phenomenon both with infections and with other vaccines (i.e., this adverse event is not COVID-specific).

PMID:35470920 | DOI:10.1111/jdv.18184

Cochrane Database Syst Rev. 2022 Apr 26;4:CD013714. doi: 10.1002/14651858.CD013714.pub2.

ABSTRACT

BACKGROUND: Hirschsprung-associated enterocolitis (HAEC) is a leading cause of serious morbidity and potential mortality in children with Hirschsprung’s disease (HD). People with HAEC suffer from intestinal inflammation, and present with diarrhoea, explosive stools, and abdominal distension. Probiotics are live microorganisms with beneficial health effects, which can optimise gastrointestinal function and gut flora. However, the efficacy and safety of probiotic supplementation in the prevention of HAEC remains unclear.

OBJECTIVES: To assess the effects of probiotic supplements used either alone or in combination with pharmacological interventions on the prevention of Hirschsprung-associated enterocolitis.

SEARCH METHODS: We searched CENTRAL, PubMed, Embase, the China BioMedical Literature database (CBM), the World Health Organization International Clinical Trials Registry, ClinicalTrials.gov, the Chinese Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, and Clinical Trials Registry-India, from database inception to 27 February 2022. We also searched the reference lists of relevant articles and reviews for any additional trails.

SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing probiotics and placebo, or any other non-probiotic intervention, for the prevention of HAEC were eligible for inclusion.

DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias of the included studies; disagreements were resolved by discussion with a third review author. We assessed the certainty of evidence using the GRADE approach. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) for dichotomous outcomes.

MAIN RESULTS: We included two RCTs, with a total of 122 participants. We judged the overall risk of bias as high. We downgraded the evidence due to risk of bias (random sequence generation, allocation concealment, and blinding) and small sample size. The evidence is very uncertain about the effect of probiotics on the occurrence of HAEC (OR 0.58, 95% CI 0.10 to 3.43; I² = 74%; 2 studies, 120 participants; very low-certainty evidence). We found one included study that did not measure serious adverse events and one included study that reported no serious adverse events related to probiotics. Probiotics may result in little to no difference between probiotics and placebo in relation to the severity of children with HAEC at Grade I (OR 0.66, 95% CI 0.14 to 3.16; I² = 25%; 2 studies, 120 participants; low-certainty evidence). The effects of probiotics on the severity of HAEC at Grade II are very uncertain (OR 1.14, 95% CI 0.01 to 136.58; I² = 86%; 2 studies, 120 participants; very low-certainty evidence). Similarly, the evidence suggests that probiotics results in little to no difference in relation to the severity of HAEC at Grade III (OR 0.43, 95% CI 0.05 to 3.45; I² = 0%; 2 studies, 120 participants; low-certainty evidence). No overall mortality or withdrawals due to adverse events were reported. Probiotics may result in little to no difference in the recurrence of episodes of HAEC compared to placebo (OR 0.85, 95% CI 0.24 to 3.00; 1 study, 60 participants; low-certainty evidence).

AUTHORS’ CONCLUSIONS: There is currently not enough evidence to assess the efficacy or safety of probiotics for the prevention of Hirschsprung-associated enterocolitis when compared with placebo. The presence of low- to very-low certainty evidence suggests that further well-designed and sufficiently powered RCTs are needed to clarify the true efficacy of probiotics.

PMID:35470864 | DOI:10.1002/14651858.CD013714.pub2

Ear Hear. 2022 Apr 25. doi: 10.1097/AUD.0000000000001226. Online ahead of print.

ABSTRACT

OBJECTIVES: Tinnitus is the perception of sound without an external source, affecting quality of life that can cause severe distress in approximately 1 to 3% of the population of people with tinnitus. Randomized controlled trials of cognitive behavioral therapy for tinnitus have demonstrated its effectiveness in improving quality of life, but the effects of their implementation on a large scale in routine practice remains unknown. Therefore, the main purpose of this study was to examine the effects of stepped-care cognitive behavioral therapy for tinnitus delivered in a tertiary audiological center of a regional hospital. Second, we wished to examine predictors of favorable outcome.

DESIGN: Four hundred three adults with chronic tinnitus were enrolled in this prospective observational study (at 3 months, N=334, 8 months, N=261; 12 months, N=214). The primary outcome was health-related quality of life as measured by the Health Utilities Index III (HUI-III) at 12 months. Secondary outcomes were self-reported levels of tinnitus-related distress, disability, affective distress and tinnitus-related negative beliefs and fear. Measures were completed pre-intervention at 3 months, 8 months, and 12 months. Multilevel modeling was used to examine effects and their predictors.

RESULTS: Younger participants with lower levels of tinnitus distress were more likely to dropout while those with higher tinnitus distress at baseline and quality of life were more likely to receive step 2 of treatment. MLM analyses revealed, with one exception, no relation between any baseline variable and outcome change over time. Most participants’ improvement exceeded minimally clinical important difference criteria for quality of life, tinnitus-related handicap, and tinnitus distress.

CONCLUSIONS: Results from this large pragmatic study complements those from randomized controlled trials of cognitive behavioral therapy for chronic tinnitus distress and supports its implementation under “real-world” conditions.

PMID:35470813 | DOI:10.1097/AUD.0000000000001226

Ear Hear. 2022 Apr 25. doi: 10.1097/AUD.0000000000001225. Online ahead of print.

ABSTRACT

OBJECTIVES: Pediatric hearing impairment, regardless of degree and type, has a detrimental effect on speech perception, cognition, oral language development, academic outcomes, and literacy. Hearing assessment in the clinic is limited to 8 kHz although humans can hear up to 20 kHz. Hearing impairment in the extended high frequencies (EHFs > 8 kHz) can occur despite clinically normal hearing. However, to date, the nature and effects of EHF hearing impairment in children remain unknown. The goals of the present study were to determine the effects of EHF hearing impairment on speech-in-noise recognition in children and to examine whether hearing impairment in the EHFs is associated with altered cochlear functioning in the standard frequencies.

DESIGN: A volunteer sample of 542 participants (4 to 19 years) with clinically normal audiograms were tested. Participants identified with EHF impairment were assigned as cases in a subsequent case-control study. EHF loss was defined as hearing thresholds greater than 20 dB in at least one EHFs (10, 12.5, or 16 kHz). Speech recognition thresholds in multi-talker babble were measured using the digit triplet test. Distortion product otoacoustic emissions (f2 = 2, 3, 4, and 5 kHz) were measured to assess cochlear functioning.

RESULTS: Thresholds in the EHFs were as reliable as those in the standard frequency range. Thirty-eight children had EHF hearing impairment regardless of a clinically normal audiogram. A linear mixed-effects model revealed that children with EHF hearing impairment had higher (poorer) mean speech recognition threshold than children with normal EHF sensitivity (estimate = 2.14 dB, 95% CI: 1.36 to 3.92; effect size = small). The overall magnitude of distortion product otoacoustic emissions was lower for children with EHF impairment (estimate = -2.47 dB, 95% CI: -4.60 to -0.73; effect size = medium). In addition, the pure-tone average for standard audiometric frequencies was relatively higher for EHF-impaired children (estimate = 3.68 dB, 95% CI: 2.56 to 4.80; effect size = small).

CONCLUSIONS: Hearing impairment in the EHFs is common in children despite clinically normal hearing and can occur without a history of otitis media. EHF impairment is associated with poorer speech-in-noise recognition and preclinical cochlear deficits in the lower frequencies where hearing thresholds are normal. This study highlights the clinical need to identify EHF impairments in children.

PMID:35470812 | DOI:10.1097/AUD.0000000000001225

J Obstet Gynaecol. 2022 Apr 26:1-8. doi: 10.1080/01443615.2022.2049723. Online ahead of print.

ABSTRACT

A mathematical mixed effect model was established to analyse the factors of neonatal hypoglycaemia of gestational diabetes mellitus (GDM). 229 cases of GDM patients were enrolled in this study. The data were analysed by logarithmic transformation of non-normal distribution. Furthermore, the mathematical model was used to analyse influencing factors of hypoglycaemia of neonatal from women with GDM. The results showed that the blood glucose distribution level had a trend of increasing with time, which indicates that it is necessary to strengthen blood glucose intervention of newborns from GDM maternal and provides a data for the timely detection of hypoglycaemia in GDM newborns. Furthermore, we successfully established the GDM newborn blood glucose level mixed mathematical model. From this model, we calculated the GDM newborn blood glucose normal confidence interval based on mixed factors. The results indicate that the minimum value of blood glucose level in GDM newborns did not exceed the risk level 2.2 mmol/L. We concluded that the mathematical mixed effect model is successfully established, from which the change discipline of blood glucose level of newborn from GDM parturient are found. Impact statementWhat is already known on this subject? The morbidity of gestational diabetes mellitus (GDM) in China has been increased. However, the clinical data is difficult to be collected and the data that is used for statistics is not enough, which makes it difficult to understand the neonatal hypoglycaemia of GDM more clearly.What do the results of this study add? In this study, we successfully established a mathematical mixed effect model of neonatal hypoglycaemia of women with GDM, which can investigate the influence factor of hypoglycaemia of newborn from women with GDM to find the discipline of blood glucose level of newborn from GDM parturient via mathematical model.What are the implications of these findings for clinical practice and/or further research? Our research helps to better understand and improve the health problem of pregnant women with GDM and their newborn babies.

PMID:35470764 | DOI:10.1080/01443615.2022.2049723

J Osteopath Med. 2022 Apr 26. doi: 10.1515/jom-2021-0228. Online ahead of print.

ABSTRACT

CONTEXT: Race is a social construct, not a biological or genetic construct, utilized to categorize people based on observable traits, behaviors, and geographic location. Findings from the Human Genome Project demonstrated that humans share 99.9% of their DNA; despite this evidence, race is frequently utilized as a risk factor for diagnosis and prescribing practices. Diagnosing and treating people based on race is known as race-based medicine. Race-based medicine perpetuates biases and diverts attention and resources from the social determinants of health that cause racial health inequities. Minimal research has examined medical students’ understanding of race-based medicine.

OBJECTIVES: The purpose of this study was to assess osteopathic medical students’ knowledge, beliefs, and experiences with race-based medicine.

METHODS: We conducted a descriptive, cross-sectional survey study to assess osteopathic medical students’ knowledge, beliefs, and experiences with race-based medicine. An electronic, anonymous survey was distributed to all osteopathic medical students enrolled at a medical school in the Midwest with three campuses during the 2019-2020 academic year. Participants completed a brief demographic questionnaire and the Race-Based Medicine Questionnaire. Descriptive and inferential statistics were conducted utilizing SPSS statistical software version 28.0, and statistical significance was defined as a p<0.05. Open-ended questions were analyzed utilizing content and thematic analyses.

RESULTS: A total of 438 of the 995 osteopathic medical students consented to participate in the study, for a response rate of 44.0%. Among those participants, 221 (52.0%) reported that they had heard of the term “race-based medicine.” Familiarity with the term differed by racial background (χ [2] = 24.598, p<0.001), with Black or African American participants indicating greater familiarity with the term compared to all other races. Of the participants familiar with race-based medicine, 79 (44.4%) provided the correct definition for the term; this finding did not differ by any sociodemographic variable. Part of the way through the questionnaire, all participants were provided the correct definition of “race-based medicine” and asked if they thought medical schools should teach race-based medicine. The majority of participants (n=231, 61.4%) supported the teaching of race-based medicine. Qualitative findings elaborated on participants’ support or opposition for teaching race-based medicine in medical school. Those in support explained the importance of teaching historical perspectives of race-based medicine as well as race as a data point in epidemiology and its presence on board examinations, whereas those in opposition believed it contradicted osteopathic principles and practice.

CONCLUSIONS: Findings showed half of the participants were familiar with race-based medicine, and among those, less than half knew the definition of the term. Highlighting osteopathic philosophy and its focus on the whole person may be one approach to educating osteopathic medical students about race-based medicine.

PMID:35470644 | DOI:10.1515/jom-2021-0228

Orthop Surg. 2022 Apr 26. doi: 10.1111/os.13261. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the mechanical stability and clinical efficacy of minimally invasive percutaneous TightRope® systems applied via gun-shaped reduction forceps for unstable posterior pelvic ring fractures.

MATERIALS AND METHODS: This study consists of two parts: a clinical retrospective study and a randomized controlled biomechanical test. For the clinical study, a retrospective analysis of posterior pelvic ring fractures was performed between June 2015 and May 2020. Eighteen patients underwent surgery using two TightRope® systems to fix a broken posterior pelvic ring because of unstable AO type C1 and C2 pelvic ring fractures. The patients were followed up for at least 2 years, and all patients were evaluated using the Majeed scoring system and vertical displacement. In the biomechanical tests, six embalmed adult pelvic specimens were used. The fractures were subjected to TightRope®, IS screw, and TBP fixation in a randomized block design. The specimens were placed in a biomechanical testing machine in a standing neutral posture. A cyclic vertical load of up to 500 N was applied, and the displacement of the specimens was recorded by the testing machine. The ultimate load in each group of specimens was recorded. The displacement and ultimate load were compared and analyzed by statistical methods.

RESULTS: At a mean follow-up of 38.89 ± 8.72 months, the functional Majeed score was excellent in 14 patients and good in four patients. The final radiological examinations showed that the outcome was excellent in 14 patients and good in four patients. In these patients, no serious clinical complications were found. Weight-bearing was delayed in four patients. In biomechanical tests, the displacement of the specimens fixed with TightRope® was significantly lower than that of the specimens fixed with TBP (P < 0.05) when the load ranged from 300 to 500 N. The displacement in the IS screw group was significantly lower than that in either the TBP or TightRope® group (P < 0.05) when the load ranged from 0 to 500 N. The ultimate load in the IS screw group (1798 ± 83.53 N) was significantly greater than that in the TBP group (1352 ± 74.41 N) (t = 9.78, P < 0.0001) and the TightRope® group (1347 ± 54.28 N) (t = 11.11, P < 0.0001). However, no significant difference was observed between the TightRope® and TBP groups (t = 0.13, P = 0.90).

CONCLUSION: Percutaneous posterior TightRope® system shows strong stability in mechanical experiments and shows good results in clinical follow-up while this system has certain advantages in lower surgical requirements and lower risk of related nerve and vascular structural damage.

PMID:35470582 | DOI:10.1111/os.13261

J Diabetes. 2022 Apr;14(4):271-281. doi: 10.1111/1753-0407.13262.

ABSTRACT

BACKGROUND: This study profiles ceramides extracted from visceral and subcutaneous adipose tissue of human subjects by liquid chromatography-mass spectrometry to determine a correlation with status of diabetes and gender.

METHODS: Samples of visceral and abdominal wall subcutaneous adipose tissue (n = 36 and n = 31, respectively) were taken during laparoscopic surgery from 36 patients (14 nondiabetic, 22 diabetic and prediabetic) undergoing bariatric surgery with a body mass index (BMI) >35 kg/m² with ≥1 existing comorbidity or BMI ≥40 kg/m² . Sphingolipids were extracted and analyzed using liquid chromatography-mass spectrometry.

RESULTS: After logarithm 2 conversion, paired analysis of visceral to subcutaneous tissue showed differential accumulation of Cer(d18:1/16:0), Cer(d18:1/18:0), and Cer(d18:1/24:1) in visceral tissue of prediabetic/diabetic female subjects, but not in males. Within-tissue analysis showed higher mean levels of ceramide species linked to insulin resistance, such as Cer(d18:1/18:0) and Cer(d18:1/16:0), in visceral tissue of prediabetic/diabetic patients compared with nondiabetic subjects and higher content of Cer(d18:1/14:0) in subcutaneous tissue of insulin-resistant female patients compared with prediabetic/diabetic males. Statistically significant differences in mean levels of ceramide species between insulin-resistant African American and insulin-resistant Caucasian patients were not evident in visceral or subcutaneous tissue.

CONCLUSIONS: Analysis of ceramides is important for developing a better understanding of biological processes underlying type 2 diabetes, metabolic syndrome, and obesity. Knowledge of the accumulated ceramides/dihydroceramides may reflect on the prelipolytic state that leads the lipotoxic phase of insulin resistance and may shed light on the predisposition to insulin resistance by gender.

PMID:35470585 | DOI:10.1111/1753-0407.13262

Orthod Craniofac Res. 2022 Apr 26. doi: 10.1111/ocr.12580. Online ahead of print.

ABSTRACT

AIMS: to assess palatal volume, surface area and linear dimensions across sagittal and vertical components of malocclusion.

METHODS: Pre-treatment cephalographs and dental casts of 178 non-growing patients (88 males, 90 females, age 25.81±8.23years) were used for classification in sagittal malocclusion groups: Class I (n=48), Class II division 1 (n=42), Class II division 2 (n=40), and Class III (n=48); and in vertical divergence groups based on the MP/SN angle: hypodivergent (n=35), normodivergent (n=95), and hyperdivergent (n=48). Dental casts were scanned and palatal measurements recorded: palatal width, depth, and interdental distances; palatal surface area (PSA, mm² ) and volume (PV, mm³ ). A 3-way ANOVA was used to compare palatal dimensions across groups. Pearson product-moment correlations were employed to assess associations among variables.

RESULTS: PSA and PV (in both sex groups) were not statistically significantly different across sagittal malocclusions and vertical patterns. Significant differences were depicted more among the vertical divergence groups than sagittal groups. Correlations between PSA and PV and palatal dimensions were low to moderate. Predictability of PSA and PV ranged between 15 and 18%.

CONCLUSION: The finding of similar palatal volume and surface area, on average, across malocclusions possibly underscores the limitations of environmental influences within the inherited orofacial phenotype. The vertical facial pattern seems to be more interactive with palatal dimensions than sagittal relations. Studies of palatal changes following orthodontic and orthognathic treatments are warranted.

PMID:35470544 | DOI:10.1111/ocr.12580

Infancy. 2022 Apr 26. doi: 10.1111/infa.12471. Online ahead of print.

ABSTRACT

During the first 2 years of life, an infant’s vocabulary grows at an impressive rate. In the current study, we investigated the impact of three challenges that infants need to overcome to learn new words and expand the size of their vocabulary. We used longitudinal eye-tracking data (n = 118) to assess sequence learning, associative learning, and probability processing abilities at ages 6, 10, and 18 months. Infants’ ability to efficiently solve these tasks was used to predict vocabulary size at age 18 months. We demonstrate that the ability to make audio-visual associations and to predict sequences of visual events predicts vocabulary size in toddlers (accounting for 20% of the variance). Our results indicate that statistical learning in some, but not all, domains have a role in vocabulary development.

PMID:35470540 | DOI:10.1111/infa.12471