Category: Statistics

Pharmacol Rep. 2022 May 27. doi: 10.1007/s43440-022-00371-2. Online ahead of print.

ABSTRACT

BACKGROUND: G protein-coupled receptor 35 (GPR35) is involved in the carcinogenesis; however, limited data exist on its relevance for overall survival (OS) and disease-specific survival (DSS) in patients with cancer.

METHODS: We have examined The Cancer Genome Atlas dataset to check the relations between GPR35 expression pattern and OS or DSS of patients with colorectal cancer (CRC).

RESULTS: The performed analysis showed a negative association between positive GPR35 expression Z score and OS in males, which remains statistically significant in advanced stages of colon (COAD) and rectal (READ) adenocarcinoma combined.

CONCLUSIONS: These findings suggest the prognostic value of early testing of GPR35 in male patients with an increased risk of CRC development and warrant further clinical confirmation.

PMID:35622222 | DOI:10.1007/s43440-022-00371-2

Sleep Breath. 2022 May 27. doi: 10.1007/s11325-022-02641-y. Online ahead of print.

ABSTRACT

BACKGROUND: Hypoglossal nerve stimulator (HGNS) is a therapeutic option for moderate to severe obstructive sleep apnea (OSA). Improved patient selection criteria are needed to target those most likely to benefit. We hypothesized that the pattern of negative effort dependence (NED) on inspiratory flow limited waveforms recorded during sleep, which has been correlated with the site of upper airway collapse, would contribute to the prediction of HGNS outcome. We developed a machine learning (ML) algorithm to identify NED patterns in pre-treatment sleep studies. We hypothesized that the predominant NED pattern would differ between HGNS responders and non-responders.

METHODS: An ML algorithm to identify NED patterns on the inspiratory portion of the nasal pressure waveform was derived from 5 development set polysomnograms. The algorithm was applied to pre-treatment sleep studies of subjects who underwent HGNS implantation to determine the percentage of each NED pattern. HGNS response was defined by STAR trial criteria for success (apnea-hypopnea index (AHI) reduced by > 50% and < 20/h) as well as by a change in AHI and oxygenation metrics. The predominant NED pattern in HGNS responders and non-responders was determined. Other variables including demographics and oxygenation metrics were also assessed between responders and non-responders.

RESULTS: Of 45 subjects, 4 were excluded due to technically inadequate polysomnograms. In the remaining 41 subjects, ML accurately distinguished three NED patterns (minimal, non-discontinuous, and discontinuous). The percentage of NED minimal breaths was significantly greater in responders compared with non-responders (p = 0.01) when the response was defined based on STAR trial criteria, change in AHI, and oxygenation metrics.

CONCLUSION: ML can accurately identify NED patterns in pre-treatment sleep studies. There was a statistically significant difference in the predominant NED pattern between HGNS responders and non-responders with a greater NED minimal pattern in responders. Prospective studies incorporating NED patterns into predictive modeling of factors determining HGNS outcomes are needed.

PMID:35622197 | DOI:10.1007/s11325-022-02641-y

Int Ophthalmol. 2022 May 27. doi: 10.1007/s10792-022-02331-4. Online ahead of print.

ABSTRACT

PURPOSE: The molecules human interleukin (IL-18), the soluble cluster of differentiation (sCD40), platelet factor 4 variant 1 (PF4V1), and neutrophil gelatinase-associated lipocalin (NGAL) are all markers of inflammation in biological systems and are linked to prognosis in several inflammatory diseases as well. Since there is no study in which the above-mentioned molecules are studied together in ocular Behçet’s disease (OBD), the aim of this study is to reveal whether these molecules are activity markers in active (OABD) and inactive (OIBD) disease.

METHODS: 30 OABD and 30 OIBD and 30 healthy individuals were included in the study. IL-18, sCD40, PF4V1, and NGAL molecules were studied in blood samples by the ELISA method.

RESULTS: When OABD and OIBD were compared to healthy individuals, the levels of IL-18, sCD40, PF4V1, and NGAL molecules were found to be statistically significant. These values were even more significantly higher in patients with OABD.

CONCLUSION: When ROC values of IL-18, sCD40, PF4V1, and NGAL are evaluated, it is clear that these four molecules can be used as biomarkers to aid activity and diagnosis in OBD.

PMID:35622217 | DOI:10.1007/s10792-022-02331-4

Aliment Pharmacol Ther. 2022 May 27. doi: 10.1111/apt.17050. Online ahead of print.

ABSTRACT

BACKGROUND: Low-dose aspirin is a risk factor for peptic ulcer disease but previous, population-based cohort studies may have underestimated the low-dose aspirin risk because they did not use a new-user design. Gastrointestinal bleeding occurs more frequently early after initiation of low-dose aspirin therapy than in later years.

AIM: To assess the associations of low-dose aspirin with gastric and duodenal ulcer incidence in prevalent- and new-user design.

METHODS: Multivariate Cox regression models in the German ESTHER study (N = 7737) and the UK Biobank (N = 213,598) with more than 10 years of follow-up.

RESULTS: In the prevalent-user design, there was no significant association between low-dose aspirin and gastric ulcer observed in both cohorts. Furthermore, low-dose aspirin was weakly, statistically significantly associated with prevalent duodenal ulcer in the UK Biobank (hazard ratio [95% confidence interval]: 1.27 [1.07-1.51]) but not in the ESTHER study (1.33 [0.54-3.29]). When restricting the exposure to only new users, the hazard ratios for incident gastric and duodenal ulcer disease were 1.82 [1.58-2.11] and 1.66 [1.36-2.04] in the UK Biobank, respectively, and 2.83 [1.40-5.71] and 3.89 [1.46-10.42] in the ESTHER study, respectively.

CONCLUSIONS: This study shows that low-dose aspirin is an independent risk factor for both gastric and duodenal ulcers. The associations were not significant or weak in the prevalent-user design and strong and statistically significant in the new-user design in both cohorts. Thus, it is important to weigh risks against benefits when low-dose aspirin treatment shall be initiated and to monitor adverse gastrointestinal symptoms after the start of low-dose aspirin therapy.

PMID:35621052 | DOI:10.1111/apt.17050

Curr Med Res Opin. 2022 May 27:1-21. doi: 10.1080/03007995.2022.2079262. Online ahead of print.

ABSTRACT

OBJECTIVE: To understand physician preferences for various attributes of pediatric combination vaccines.

METHODS: An online survey was completed by 400 US physicians (pediatricians and family physicians) who routinely administer vaccines to infants aged 1-12 months in outpatient settings. Respondents completed a discrete choice experiment (DCE) by selecting their preferred options from different hypothetical vaccine profiles with systematic variation in the levels of five attributes: vaccine presentation, number of injections administered at a single visit, completion rates, timeliness rates (within 30 days of recommended age), and years of availability for routine use, assuming similar cost, safety, and efficacy. Odds ratios and relative attribute importance scores were estimated using a random parameters logit model.

RESULTS: Physicians (mean age 50.40 years, 52.5% women) preferred combination vaccines that reduced the number of injections administered at a single visit, facilitated higher completion and timeliness rates for the primary DTaP series, were available as a pre-filled syringe rather than vial for reconstitution, and had been available for routine use for more than 1 year. All odds ratios were statistically significant. Physicians were twice as likely to prefer administering 2 injections in a single visit instead of 3. The most important attribute was the number of injections administered at a single visit (relative importance 38%), followed by timeliness, completion rates, and vaccine presentation; years a vaccine has been available was the least important.

CONCLUSION: US physicians prefer pediatric combination vaccines that enable fewer injections to be administered at a single visit, facilitate higher completion and timeliness rates, are offered as a pre-filled syringe, and have been available for routine use for more than 1 year. The most important attribute of pediatric combination vaccines was a reduction in the number of injections administered at a single visit.

PMID:35621019 | DOI:10.1080/03007995.2022.2079262

Minerva Pediatr (Torino). 2022 May 27. doi: 10.23736/S2724-5276.22.06766-0. Online ahead of print.

ABSTRACT

BACKGROUD: The deprivation of components that exercise the body and mind by children and adolescents can lead to numerous long-term consequences in terms of physical health (cardiovascular diseases, bone problems, high cholesterol, obesity) and mental health (depression, low self-esteem and social isolation).

METHODS: This investigation intended to identify a profile of self-concept and self-esteem, on the academic performance of middle-school children between practitioners of curricular physical education and extracurricular sport activities. The participants consisted of a total of 107 students, 55 (51.4%) were males and 52 (48.6%) were female, aged between 10 and 12 years. A total of 41 children (38.3%) attending the fifth grade and 66 children (61.7%) the sixth grade were randomly selected. The data collection instrument, Self-concept of Susan Harter validated for the Portuguese population was used and it was proceeded to a descriptive and inferential statistics data analysis to confront the mean levels of self-concept, global self-esteem and academic performance.

RESULTS: As an influence of hours of weekly practice, we found statistically significant differences in terms of academic performance, that is, as the student practices more hours of physical exercise, there is a tendency for the student to obtain better academic results.

CONCLUSIONS: Apparently, the practice of extracurricular sport activities by students promotes a significant evolution in the formation of self-concept and academic performance, as well as suggesting a positive evolutionary trend in the formation of self-esteem of students who practice the several extracurricular sports.

PMID:35620993 | DOI:10.23736/S2724-5276.22.06766-0

Curr Med Res Opin. 2022 May 27:1-32. doi: 10.1080/03007995.2022.2083324. Online ahead of print.

ABSTRACT

OBJECTIVE: Analysis and comparison of country-level data from the VISIONARY study, examining treatment outcomes with the topical fixed-dose combination of preservative-free tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) who were insufficiently treated with or unable to tolerate either beta-blocker or prostaglandin analogue (PGA) topical monotherapy.

METHODS: A European, prospective, observational study was conducted in 11 countries. Adults with OAG/OHT were switched to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Statistical analysis examined changes in mean standard deviation (SD) intraocular pressure (IOP) from baseline at Week 4, Week 12 and Month 6. Data were documented for each eye separately at baseline and during follow up visits, with the eye reported to have the higher IOP (mmHg), as measured using Goldmann applanation tonometry, being selected for analysis (study eye). Country-level subanalysis examined outcomes by prior monotherapy, diagnosis and timing of dosing for those countries recruiting ≥20 patients (Country-level Subanalysis Population). Two-sided paired t-test was used to assess significance regarding mean IOP reduction from baseline and a compound symmetry covariance model was used in cross-country comparisons regarding variation in IOP change from baseline. Treatment-related adverse events (AEs) were evaluated.

RESULTS: Mean (SD) age among patients recruited to the VISIONARY study ranged between 63.9 (11.8) to 72.4 (10.6) years across all countries. The majority of participants (>50%) were female in each country. The Country-level Subanalysis Population included 551 eyes. Mean (SD) IOP was significantly reduced from baseline in each country at Week 4, Week 12 and Month 6 (p < 0.0001). Mean IOP reduction at Month 6 ranged from 5.0 mmHg (22.6%, Hungary) to 7.8 mmHg (31.8%, Latvia) and varied significantly between countries (p < 0.001). The greatest reductions were in Latvia and Russia, where baseline IOP was highest. Country-level IOP reductions were significant irrespective of prior monotherapy, diagnosis or dosing time (p < 0.0001). Most treatment-related AEs occurred in the UK (26 events, 73% mild). One serious AE was reported (Russia, status asthmaticus). Tolerability with PF tafluprost/timolol FC therapy was rated as good/very good by most patients (85.7-100%) in all countries.

CONCLUSION: Subanalysis of VISIONARY study data revealed significant IOP reductions following a switch to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Cross-country variation was likely due to baseline IOP differences. Within country, outcomes were consistent regardless of diagnosis, dosing or prior monotherapy. Treatment was generally well tolerated.

PMID:35621005 | DOI:10.1080/03007995.2022.2083324

Laryngoscope. 2022 May 27. doi: 10.1002/lary.30231. Online ahead of print.

ABSTRACT

OBJECTIVE: Evaluate the effects of α-difluoromethylornithine (DFMO) on hearing thresholds as part of a randomized, double-blind, placebo-controlled trial.

METHODS: Subjects were randomized and assigned to the control (placebo) or experimental (DFMO) group. DFMO or placebo were administered orally (500 mg/m² /day) for up to 5 years.

RESULTS: Subjects taking DFMO had, on average, increased hearing thresholds from baseline across the frequency range compared to subjects in the control group. Statistical analysis revealed this was significant in the lower frequency range.

CONCLUSIONS: This randomized controlled trial revealed the presence of increased hearing thresholds associated with long-term DFMO use. As a whole, DFMO may help prevent and treat certain types of cancers; however, it can result in some degree of hearing loss even when administered at low doses. This study further highlights the importance of closely monitoring hearing thresholds in subjects taking DFMO. Laryngoscope, 2022.

PMID:35620919 | DOI:10.1002/lary.30231

Int J Nurs Pract. 2022 May 27:e13067. doi: 10.1111/ijn.13067. Online ahead of print.

ABSTRACT

AIM: This study aimed to compare the effects of breastfeeding, breast milk odour and mother’s heartbeat sounds on perceived pain during heel lance procedures in term newborns.

DESIGN: This was a randomized three-group experimental study.

METHODS: The sample of the study consisted of 90 newborns. The data were collected using pulse oximeter, fetal hand doppler, voice recorder, loudspeaker, a data collection form and the ALPS-Neo Pain and Stress Assessment Scale for Newborn Infants.

RESULTS: During the procedure, newborns in the breast milk odour group had high levels of pain and stress, those in the mother’s heartbeat sounds group had mild pain and stress, and those in the breastfeeding group had no pain and stress. Additionally, a statistically significant difference was found between their crying times. This difference was the highest for newborns in the breast milk odour group, followed by the mother’s heartbeat sounds and breastfeeding groups, respectively.

CONCLUSION: Breastfeeding and mother’s heartbeat sounds, which are non-pharmacological pain relief methods, are effective in neonatal pain management. However, breast milk odour is not effective for pain control in newborns. Further studies should examine the efficacy combinations of these methods.

PMID:35620884 | DOI:10.1111/ijn.13067

BJOG. 2022 May 27. doi: 10.1111/1471-0528.17240. Online ahead of print.

ABSTRACT

OBJECTIVES: To examine the association between race and preeclampsia(PE) and gestational hypertension(GH) after adjustment for factors in maternal characteristics and medical history in screening study from the Fetal Medicine Foundation (FMF) in England, and to perform a systematic review and meta-analysis of studies on PE.

METHODS: In the FMF data regression analysis was performed to examine the association between race and PE or GH. Literature search to December 2021 was carried out to identify peer-reviewed publications on race and PE.

MAIN OUTCOME MEASURE: Relative risk of PE and GH in women of black, South Asian and East Asian race by comparison to white women.

RESULTS: In the FMF study there were 168,966 singleton pregnancies without major abnormalities delivering at ≥24 weeks’ gestation. In black women the respective risk of total-PE and preterm-PE was 2-fold and 2.5-fold higher and risk of GH was 25% higher, in South Asian women there was a 1.5-fold higher risk of preterm-PE but not total-PE, and in East Asian women there was no statistically significant difference in risk of hypertensive disorders. The literature search identified 19 studies that provided data on several million of pregnancies, but 17 were at moderate or high-risk of bias and only three provided risks adjusted for some maternal characteristics; consequently, these studies did not provide accurate contribution of different racial groups to the prediction of PE.

CONCLUSION: In women of black and South Asian origin the risk of PE, after adjustment for confounders, is higher than in white women.

PMID:35620879 | DOI:10.1111/1471-0528.17240