Category: Statistics

Cornea. 2021 Sep 29. doi: 10.1097/ICO.0000000000002837. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to demonstrate the safety and effectiveness of a single TearCare procedure compared with a single LipiFlow procedure in treatment of the dry eye disease associated with meibomian gland dysfunction.

METHODS: In a multicenter, masked, randomized controlled trial, 135 subjects received a single TearCare (TC) treatment (n = 67) or a single LipiFlow (LF) treatment (n = 68) at baseline and were followed up for 1 month posttreatment. Tear film breakup time, meibomian gland function, and corneal and conjunctival staining scores were assessed as dry eye signs at baseline, 2 weeks, and 1 month; dry eye symptoms were assessed using the Ocular Surface Disease Index, Symptom Assessment in Dry Eye, and eye dryness questionnaires at baseline and 1 month.

RESULTS: At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively. The mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores were significantly reduced (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5 in the TC group and 34.9 ± 26.9, 38.0 ± 25.9, and 23.4 ± 17.7 in the LF group, respectively. There were no statistically significant differences for any result between the groups. However, the TC group demonstrated numerically greater improvements consistently in all signs and symptoms. Device-related ocular adverse events were reported in 3 patients in the TC group (superficial punctate keratitis, chalazion, and blepharitis) and 4 patients in the LF group (blepharitis, 2 cases of foreign body sensation, and severe eye dryness).

CONCLUSIONS: A single TearCare treatment significantly alleviates the signs and symptoms of dry eye disease in patients with meibomian gland dysfunction and is equivalent in its safety and effectiveness profile to LipiFlow treatment as shown in this 1-month follow-up study.

PMID:34581297 | DOI:10.1097/ICO.0000000000002837

Anal Methods. 2021 Sep 28. doi: 10.1039/d1ay01163d. Online ahead of print.

ABSTRACT

Exhaled breath analysis is an interesting and promising approach for the diagnostics of various diseases. Being non-invasive, convenient and simple, this approach has tremendous potential utility for further translation into clinical practice. In this study, gas chromatography-mass spectrometry (GC-MS) and quartz microbalance sensor-based “electronic nose” were applied for analysis of the exhaled breath of 40 lung cancer patients and 40 healthy individuals. It was found that the electronic nose was unable to distinguish the samples of different groups. However, the application of GC-MS allowed identifying statistically significant differences in compound peak areas and their ratios for investigated groups. Diagnostic models were created using random forest classifier based on peak areas and their ratios with the sensitivity and specificity of peak areas (ratios) of 85.7-96.5% (75.0-93.1%) and 73.3-85.1% (90.0-92.5%) on training data and 63.6-75.0% (72.7-100.0%) and 50.0-69.2% (76.9-84.6%) on test data, respectively. The exhaled breath samples of lung cancer patients and healthy volunteers could be distinguished by GC-MS with the use of individual compounds, but application of their ratios could help to determine specific differences between investigated groups and the level the influence of individual metabolism features alternating from one person to another as well as daily instrument reproducibility deviations. The electronic nose has to be significantly improved to apply it to lung cancer diagnostics of exhaled breath analysis and the influence of water vapour has to be lowered to increase the sensitivity of the sensors to detect lung cancer biomarkers.

PMID:34581316 | DOI:10.1039/d1ay01163d

ASAIO J. 2021 Sep 24. doi: 10.1097/MAT.0000000000001582. Online ahead of print.

ABSTRACT

Anticoagulation management in pediatric extracorporeal membrane oxygenation (ECMO) is challenging with multiple laboratory measures utilized across institutions without consensus guidelines. These include partial thromboplastin time (PTT), thromboelastography (TEG), and antifactor Xa (aXa). We aimed to evaluate the consistency of TEG R-time, PTT, and aXa correlation to bivalirudin and heparin dosing. We conducted a single-center restrospective review of pediatric ECMO cases from 2018 to 2020 anticoagulated with bivalirudin or heparin. We collected up to 14 serial simultaneous TEG R-time, PTT, and aXa measurements over a 7 day ECMO course with corresponding bivalirudin or heparin dosing. We analyzed the correlation between bivalirudin, heparin, and the three measurements of anticoagulation. A total of 67 ECMO runs, 32 bivalirudin, and 35 heparin, and more than 1,500 laboratory values, of which >80% simultaneous, were analyzed. When assessing correlations at the individual patient level, there was no consistent correlation between dosing and at least one laboratory parameter in the majority of patients. Furthermore, 44% of the bivalirudin cohort and 37% of the heparin cohort exhibited no correlation with any parameters. There were statistically significant correlations only between bivalirudin and heparin dosing and the sum total of the different laboratory tests. These inconsistencies highlight the importance of multimodality testing of anticoagulation in the management of pediatric ECMO anticoagulation and cannot be relied on in isolation from bedside clinical judgment.

PMID:34581287 | DOI:10.1097/MAT.0000000000001582

Neurol Res. 2021 Sep 28:1-10. doi: 10.1080/01616412.2021.1975226. Online ahead of print.

ABSTRACT

INTRODUCTION: Peripheral nerve traumas are common injuries in young adult population. The myriad of techniques and medications have been defined to obtain better recovery but none of them was proved to have superior effect. This study aims to determine the anti-fibrotic effect of the decorin on sciatic nerve injury in order to enhance functional outcome.

MATERIALS AND METHODS: 24 12-week-old male Sprague-Dawley rats (350-400 gr) were divided into four groups. The sciatic nerve was dissected and exposed; a full-thickness laceration was created 1.5 cm proximal to the bifurcation point and 1.5 cm distal to where it originated from the lumbosacral plexus. Motor and sensory tests were conducted before and after the operations for evaluating the nerve healing.

RESULTS: There was a statistically significant difference between DCN bolus and PBS bolus group. (p<0.0001, p&lt;0.05) in neuromotor tests. Increase of the latency was significantly lower in DCN bolus and infusion group when compared with the PBS bolus group. (p&lt;0,001). All operated gastrocnemius muscles were atrophic compared with the contralateral side. The differences between the averages in the sciatic functional index, the improvement of the DCN infusion group was 8.6 units better than the PBS group and 4.4 units better than the DCN bolus group. When the amount of stimulation was 10 mV at the proximal segment in electromyography, there was no significant difference between the DCN bolus and sham groups. (p&gt; 0.05, p = 0.6623).

CONCLUSION: Decorin protein reduces the fibrosis and enhances the motor and sensory recovery both clinically and histologically. Despite the high cost, short half-life and production issues, this protein could be administered after the microsurgical repair but more studies are required to overcome the limitations.

PMID:34581256 | DOI:10.1080/01616412.2021.1975226

Ir J Psychol Med. 2021 Sep 28:1-8. doi: 10.1017/ipm.2021.63. Online ahead of print.

ABSTRACT

OBJECTIVES: Cyberbullying is increasingly recognised as a threat for young people’s mental health. Young people and their families may not know how to stay safe online or how to respond following unsafe internet experiences. This study aimed to examine Child and Adolescent Mental Health Service (CAMHS) staff perceived knowledge, practice and attitudes towards cyberbullying (CB) and internet safety (IS), and their training needs.

METHODS: A descriptive, survey design was used. 59 CAMHS clinicians completed a study specific online survey examining their knowledge, practice, attitudes and training needs regarding CB and IS. Frequency and descriptive statistics were conducted on participant responses.

RESULTS: Clinicians reported that risky internet behaviour and CB were frequent experiences reported by youth attending their clinical practice. Professionals were aware of potential adverse effects on the young person, including social withdrawal, low self-esteem, anxiety, self-injurious behaviour and suicidal thoughts. Training for young people on online behaviour and good digital citizenship skills was a highly endorsed preference. The majority of respondents felt CAMHS staff have a role in supporting families and managing IS and identified training and resource materials as strategies to assist them in this regard.

CONCLUSIONS: Findings support a need for clinicians to regularly inquire about internet use, safety and adverse online experiences. The ongoing development of resources and training in CB and IS for CAMHS clinicians, children and caregivers is necessary. Further research is warranted due to the small sample size and the subjective nature of the current study.

PMID:34581261 | DOI:10.1017/ipm.2021.63

J Obstet Gynaecol. 2021 Sep 28:1-8. doi: 10.1080/01443615.2021.1945017. Online ahead of print.

ABSTRACT

We sought to determine the prevalence of female sexual dysfunction (FSD) and to examine the influence of age, menopausal state and quality of life (QoL) on the female sexual function (FSF) of healthy women and those with benign gynaecological disease. With this purpose, we conducted a cross-sectional study, based on self-report questionnaires (sociodemographic, WHOQOL-BREF and FSFI), enrolling 107 women. Some 51.6% (n = 55) were diagnosed with FSD. We found no statistical significant differences between grouped reason for consultation and FSFI total score (p = .72) and its domains (p > .05). The results showed a negative strong correlation between age and FSFI total score (S= -0.71) and a positive moderate correlation between WHOQOL-BREF and FSFI total scores (S = 0.39). We observed statistically significant differences between menopausal state and FSFI total score (p = .001). In conclusion, the prevalence of FSD in our population was 51.6%. Our study results reveal that a reduction in FSFI scores has a negative impact on QoL and vice versa, regardless of the reason for consultation. Elderly age and postmenopausal state have deleterious effects on FSF.Impact statementWhat is already known on this subject? Poor QoL can adversely affect FSF and vice versa. The study of FSF is relatively recent and there is controversy regarding the deleterious effects of elderly age and menopause on FSF. The prevalence of FSD is difficult to precisely determine, given the studies’ use of different definitions for FSD and the highly heterogeneous study populations, as well as the types of tests and questionnaires employed. Sexual difficulties are problems seldom discussed between patients and their physicians. Lack of time, misconceptions, shame and frustration, considering sexuality as too intimate to discuss in the doctor’s office, uncertainty regarding therapeutic options and insufficient training of health professionals are just some of the reasons mentioned for not addressing sexual dysfunction in a general consultation.What do the results of this study add? Our study is the first research in Spain on the impact of age, menopause and QoL on gynaecological patients´ FSF. Our results indicate that an impaired FSF could be related to poorer well-being and QoL; however, benign gynaecological disease does not appear to affect FSF. Elderly age and postmenopausal state can have deleterious effects on FSF.What are the implications of these findings for clinical practice and/or further research? Sexuality is an important aspect of QoL. Therefore, gynaecologists should discuss issues of sexuality with their patients in routine visits, especially in case of elderly and postmenopausal women. In addition, gynaecologists should train in the diagnosis and treatment of the female sexual dysfunction.

PMID:34581247 | DOI:10.1080/01443615.2021.1945017

J Sports Sci. 2021 Sep 28:1-10. doi: 10.1080/02640414.2021.1982516. Online ahead of print.

ABSTRACT

This study investigated the effect of crank length on biomechanical parameters and muscle activity during standing cycling. Ten participants performed submaximal cycling trials on a stand-up bicycle using four crank lengths. Joint angles, moments, powers, and works of the lower limbs were calculated from motion data and pedal reaction forces. Electromyographic (EMG) data were recorded from gluteus maximus (GM), vastus medialis, rectus femoris, biceps femoris (BF), gastrocnemius medialis, soleus, and tibialis anterior, and used to obtain the integrated EMG. Statistical parametric mapping was employed to analyse the biomechanical parameters throughout the pedalling cycle. Knee and hip flexion angles and hip power increased at the initiation (0-20%) of pedalling with increasing crank length, while the BF and GM muscle activities increased during propulsion (20-40%). Additionally, increasing the crank length resulted in increased knee power absorption during upstroke phase (70-100%). Peak knee extension moment increased with decreasing crank length during propulsion, but the moment at a short crank length during propulsion was comparable to fast walking. Consequently, longer crank lengths require increased propulsion power by the lower limb muscles during standing cycling compared to shorter crank lengths. Therefore, shorter crank lengths are recommended for stand-up bicycles to avoid fatigue.

PMID:34581253 | DOI:10.1080/02640414.2021.1982516

AIDS Care. 2021 Sep 28:1-9. doi: 10.1080/09540121.2021.1981218. Online ahead of print.

ABSTRACT

Understanding factors related to suboptimal adherence to antiretroviral therapy (ART) and detectable viral load (VL), especially among vulnerable populations, is needed to improve HIV outcomes. The Caribbean is highly impacted by HIV and socioeconomic inequalities, but few studies have been conducted there to explore food insecurity among people with HIV and factors associated with viral suppression in this vulnerable population. Using baseline data from a pilot intervention trial among people living with HIV and food insecurity in the Dominican Republic, we examined psychosocial and behavioral factors associated with viral suppression, ART adherence, and competing needs. Among participants (n = 115), 61% had a detectable VL; the strongest factor associated with detectable VL was having missed taking ART in the last six months due to not having food (OR = 2.68, p = 0.02). Greater odds of reporting missed ART doses due to not having food were associated with severe food insecurity (OR = 4.60, p = 0.006), clinical depression (OR = 2.76, p = 0.018), Haitian background (OR = 6.62 p = 0.017), and internalized HIV stigma (OR = 1.09, p = 0.041), while lower odds were associated with social support (OR = 0.89, p = 0.03) and having health insurance (OR = 0.27, p = 0.017). Ensuring that people with HIV and food insecurity have food to take with their ART is essential for viral suppression.

PMID:34581230 | DOI:10.1080/09540121.2021.1981218

J Endovasc Ther. 2021 Sep 28:15266028211047954. doi: 10.1177/15266028211047954. Online ahead of print.

ABSTRACT

PURPOSE: Hybrid aortic arch repair (HAR) has been implemented for extended aortic arch and descending thoracic aortic disease since 2012 in our institution. This study aimed to estimate the early and mid-term efficacy and safety of HAR.

MATERIALS AND METHODS: From 2007 to 2019, 56 patients underwent HAR for extended aortic arch disease, and 75 patients underwent total arch replacement (TAR) for arch-limited disease. HAR comprises 3 procedures: replacement of the aorta, reconstruction of all arch vessels, and thoracic endovascular aortic repair (TEVAR) from zone 0 to the descending aorta after cardiopulmonary bypass is off in 1 stage. The type II-1 HAR procedure, in which the ascending aorta and aortic arch distal to the brachiocephalic artery are replaced, was the most frequently selected procedure (40/56 patients). The outcomes of the type II-1 HAR procedure were compared with those of TAR using the Cox regression analysis.

RESULTS: The median follow-up period was 36 months. In HAR, the operative mortality, in-hospital mortality, and postoperative permanent neurological deficits were not observed. The paraplegia rate was 1.8%. TEVAR-related complications occurred in 3 patients. Among the patients with non-ruptured atherosclerotic aortic arch aneurysm (31 type II-1 HAR patients and 36 TAR patients, the postoperative respiratory support time in those who underwent type II-1 HAR was quicker than in those who underwent TAR (p<0.01). The rate of 6 year freedom from all-cause death in type II-1 HAR (83.1%) was numerically higher than that in TAR (74.7%), and the rate of 6 year freedom from surgery-related complications in type II-1 HAR (90.3%) was numerically lower than that in TAR (96.9%) due to the occurrence of TEVAR-related complications, and the rate of 6 year freedom from reintervention to the descending thoracic aorta in type II-1 HAR (100%) seemed to be better than that in TAR (83.7%). However, Cox regression analysis did not reveal any statistical difference between the 2 procedures.

CONCLUSIONS: HAR, especially the type II-1 procedure, can treat extended aortic arch disease with acceptable survival outcomes. The development of TEVAR technology will further improve the outcomes of HAR in the future.

PMID:34581224 | DOI:10.1177/15266028211047954

J Am Heart Assoc. 2021 Sep 28:e021748. doi: 10.1161/JAHA.120.021748. Online ahead of print.

ABSTRACT

Background The treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30-day mortality, 30-day readmission, and length of stay after TAVR and SAVR. Methods and Results We conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30-day mortality; secondary end points were 30-day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2-way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7-year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67-0.86]; 2016: HR, 0.39 [95% CI, 0.36-0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63-0.73]; 2016: HR, 0.43 [95% CI, 0.41-0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84-1.98]; 2019: HR, 5.34 [95% CI, 5.22-5.45]). These results were consistent in full aortic valve replacement hospitals. Conclusions The rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U-shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long-term implications of lowering risk profiles across treatment options to guide case selection and clinical care.

PMID:34581191 | DOI:10.1161/JAHA.120.021748