Tag: nevin manimala

J Adv Nurs. 2022 Feb 15. doi: 10.1111/jan.15178. Online ahead of print.

ABSTRACT

AIM: To evaluate the effectiveness of a nurse-led smartphone-based self-management programme (NSSMP) on improving self-efficacy, promoting diabetes self-care, increasing health-related quality of life (HRQoL) and decreasing HbA1c, acute complications and unplanned medical consultation for people with poorly controlled type 2 diabetes compared with a nurse-led diabetic service (NDS).

DESIGN: A two-arm randomized controlled trial with repeated measures was conducted.

METHODS: Participants were recruited from June 2018 to September 2020. Eligible participants were assigned to either the intervention or control group randomly. Participants assigned to intervention group received the 6-month NSSMP, while those in the control group received existing NDS provided by the study hospital. Outcomes were measured at baseline, and at 3 and 6 months from baseline.

RESULTS: A total of 114 participants were recruited. There were no significant interactions between group and time for all the outcomes except for blood glucose testing activities (F = 4.742, p = .015). Both groups had reduced HbA1c over 6 months. The intervention group had a lower HbA1c than the control group at follow-ups, but the differences were not statistically significant. None of the participants had acute diabetes complications at follow-up. Similarly, the differences in the number of unplanned medical consultation at 6-month follow-up between two groups were statistically insignificant.

CONCLUSION: The NSSMP is as effective as existing NDS provided by the study hospital in improving most of the outcomes. NSSMP can liberate valuable time for nurses to provide care to critically ill patients and supports healthcare resource constraints in the current COVID-19 pandemic.

IMPACT: The existing diabetes service is labour intensive as nurses are required to deliver education, follow-up telephone calls to trace blood sugar monitoring and provide therapeutic consultations and necessary referrals. The outbreak of COVID-19 pandemic has added further strain on the overworked professionals. NSSMP provides an alternative programme that is just as effective, to reduce nurses’ workload by delegating them back to the individuals through self-management strategies. This enables nurses to increase contact time with patients, and individuals to take onus of their disease through increased self-efficacy, facilitated by technology.

CLINICAL TRIAL: This study is registered under clinical registration number NCT03088475.

PMID:35170786 | DOI:10.1111/jan.15178

Lasers Surg Med. 2022 Feb 16. doi: 10.1002/lsm.23524. Online ahead of print.

ABSTRACT

BACKGROUND: A previous multi-center clinical study of low energy (20% power), single-pass helium plasma dermal resurfacing (HPDR) showed positive results but did not fully reveal the true potential of this novel technology. A second multi-center clinical study, reported herein, was therefore undertaken to evaluate efficacy and safety of high energy (40%), double pass HPDR for treatment of facial rhytids (ClinicalTrials.gov Identifier: NCT04185909).

METHODS: Fifty-five eligible subjects seeking improvement in facial rhytids were enrolled for study at one of four investigational sites. All subjects underwent full-face HPDR treatment. The forehead, nose, cheeks, and peri-oral treatment zones were treated at 40% power with two passes whereas the peri-orbital and jawline/mandibular zones were treated at 20% power (up to 40% for jawline/mandibular zone) and one or two passes. Photographic images of the face were captured using the VISIA-CR system. Three-month posttreatment Fitzpatrick Wrinkle and Elastosis Scale (FWS) scores were compared to baseline scores as determined by blinded independent photographic reviewers (IPRs) and study investigators.

RESULTS: Blinded IPRs and study investigators observed a ≥1-point FWS improvement in 100% of subjects with mean change in IPR FWS from baseline to the 90-day visit of -3.6 (±1.2). 96.4% of subjects indicated “improvement” in appearance at the 90-day visit utilizing the modified Global Aesthetic Improvement Scale. Evaluation of VISIA-CR data revealed statistically significant improvements in wrinkles, brown spots, and pore counts. Overall, 269 Adverse Events in 55 subjects were reported; most were mild-moderate in severity (99.3%), anticipated (86.2%), and of relatively short duration with most having resolved within 30 days (60.6%) of treatment.

CONCLUSION: Treatment of facial rhytids with high energy, double pass HPDR as detailed herein enables a marked improvement in FWS that parallels or surpasses competing technologies. VISIA-CR analysis demonstrates additional improvements in skin quality with statistically significant quantitative improvements in brown spots and enlarged pores as well as wrinkles. Effective rhytid effacement combines with high subject satisfaction and few unanticipated adverse events for a reasonable benefit-risk ratio.

PMID:35170772 | DOI:10.1002/lsm.23524

Clin Cardiol. 2022 Feb 16. doi: 10.1002/clc.23795. Online ahead of print.

ABSTRACT

BACKGROUND: Real-world data on atrial fibrillation (AF) ablation outcomes in obese populations have remained scarce, especially the relationship between obesity and in-hospital AF ablation outcome.

HYPOTHESIS: Obesity is associated with higher complication rates and higher admission trend for AF ablation.

METHODS: We drew data from the US National Inpatient Sample to identify patients who underwent AF ablation between 2005 and 2018. Sociodemographic and patients’ characteristics data were collected, and the trend, incidence of catheter ablation complications and mortality were analyzed, and further stratified by obesity classification.

RESULTS: A total of 153 429 patients who were hospitalized for AF ablation were estimated. Among these, 11 876 obese patients (95% confidence interval [CI]: 11 422-12 330) and 10 635 morbid obese patients (95% CI: 10 200-11 069) were observed. There was a substantial uptrend admission, up to fivefold, for AF ablation in all obese patients from 2005 to 2018 (p < .001). Morbidly obese patients were statistically younger, while coexisting comorbidities were substantially higher than both obese and nonobese patients (p < .01) Both obesity and morbid obesity were significantly associated with an increased risk of total bleeding, and vascular complications (p < .05). Only morbid obesity was significantly associated with an increased risk of ablation-related complications, total infection, and pulmonary complications (p < .01). No difference in-hospital mortality was observed among obese, morbidly obese, and nonobese patients.

CONCLUSION: Our study observed an uptrend in the admission of obese patients undergoing AF ablation from 2005 through 2018. Obesity was associated with higher ablation-related complications, particularly those who were morbidly obese.

PMID:35170775 | DOI:10.1002/clc.23795

J Periodontol. 2022 Feb 16. doi: 10.1002/JPER.21-0502. Online ahead of print.

ABSTRACT

BACKGROUND & AIM: The aim of this study was to test a non-submerged reconstructive approach for peri-implantitis osseous defects, by removing the prosthetic components, augmenting of the infraosseous bony compartment, and flap re-adaptation around the replaced healing abutments, without obtaining a primary wound closure.

METHODS: Twenty-nine implants in 24 patients were treated. Implant suprastructures were removed at the time of the intervention, to aid with the debridement process which included curettage, implantoplasty, air-power driven devices, and locally delivered antibiotics. The infraosseous part of peri-implant defects were augmented using a composite bone graft and an absorbable membrane to be secured around the replaced healing abutments without attempting to submerge the implants. After 8 months, direct peri-implant defect measurements were obtained to serve as the primary outcome. Secondary outcomes included of radiographic bone changes, and probing depth (PD) and bleeding on probing (BOP) changes at 12 months.

RESULTS: At the time of the surgical re-entry (8 months), a statistically significant clinical and radiographic defect fill was observed (average of 2.33 mm, and 1.63 mm, respectively). Approximately 3 months after crown replacement, 12 months from the surgical intervention, a significant PD (1.51 mm) and BOP (65%) reduction were also noted.

CONCLUSIONS: Considering its limitations, the utilized non-submerged approach (with removal of implant crowns) led to significant improvements in clinical (defect fill, PD, BOP) and radiographic outcomes. This article is protected by copyright. All rights reserved.

PMID:35170752 | DOI:10.1002/JPER.21-0502

Am J Clin Nutr. 2022 Feb 16:nqac047. doi: 10.1093/ajcn/nqac047. Online ahead of print.

ABSTRACT

BACKGROUND: High glycemic index (GI) diets have been linked to elevated risk of cardiometabolic diseases. One possible underlying mechanism comes from high GI diet’s potential to promote lipid peroxidation.

OBJECTIVES: We aim to evaluate whether and to what extent dietary carbohydrate quality and quantity are associated with systemic levels of lipid peroxidation in females.

DESIGN: In this cross-sectional analysis of 2163 middle-aged females, a subset of the Shanghai Women’s Health Study, we measured lipid peroxidation biomarkers F2-isoprostanes (F2-IsoPs) and its metabolite 2,3-dinor-5,6-dihydro-15-F2t-IsoP (F2-IsoP-M) in urine. The quality of carbohydrate was defined by dietary GI, assessed using a validated food-frequency questionnaire via in-person interviews. A multivariable linear regression model with restricted cubic spline functions was used to evaluate the association of measured biomarkers with carbohydrate intake and dietary GI.

RESULTS: After adjustment for potential confounding factors such as cigarette smoking, BMI, comorbidities among others, we found that F2-IsoP-M concentrations were positively associated with both carbohydrate intake and dietary GI. Carbohydrate intake and dietary GI were weakly correlated (r = 0.12). When further mutually adjusted for the two factors, the positive association with F2-IsoP-M remained statistically significant for GI (P = 0.004) but not for carbohydrate intake (P = 0.50). Compared with those in the 10th percentile of dietary GI, fold-increases (95% CI) in F2-IsoP-M concentrations for those in the 30th, 50th, 70th, and 90th percentiles were 1.03 (1.00, 1.07), 1.06 (1.01, 1.10), 1.09 (1.03, 1.14), and 1.13 (1.05, 1.21), respectively. Moreover, there appeared a threshold regarding the association between dietary GI and F2-IsoP-M concentrations, with the dose-effect slope of GI being 2.3-times greater when GI ≥ 75 relative to GI < 75.

CONCLUSIONS: This study provides evidence that the quality of dietary carbohydrate may be more important than the quantity of the intake with regard to systemic lipid peroxidation.

PMID:35170729 | DOI:10.1093/ajcn/nqac047

Nicotine Tob Res. 2022 Feb 16:ntac043. doi: 10.1093/ntr/ntac043. Online ahead of print.

ABSTRACT

INTRODUCTION: Tobacco use disorder is a complex behavior with a strong genetic component. Genome-wide association studies (GWAS) on smoking behaviors allows for the creation of polygenic risk scores (PRSs) to approximate genetic vulnerability. However, the utility of smoking-related PRSs in predicting smoking cessation in clinical trials remains unknown.

METHODS: We evaluated the association between polygenic risk scores and bioverified smoking abstinence in a meta-analysis of two randomized, placebo-controlled smoking cessation trials. PRSs of smoking behaviors were created using the GWAS and Sequencing Consortium of Alcohol and Nicotine use (GSCAN) consortium summary statistics. We evaluated the utility of using individual PRS of specific smoking behavior vs. combined genetic risk that combines PRS of all four smoking behaviors. Study participants came from the Transdisciplinary Tobacco Use Research Centers (TTURC) Study (1,091 smokers of European descent), and the Genetically Informed Smoking Cessation Trial (GISC) Study (501 smokers of European descent).

RESULTS: PRS of later age of smoking initiation (OR [95% CI]: 1.20, [1.04-1.37], p=0.0097) was significantly associated with bioverified smoking abstinence at end of treatment. In addition, the combined PRS of smoking behaviors also significantly predicted bioverified smoking abstinence (OR [95% CI] 0.71 [0.51-0.99], p=0.045).

CONCLUSIONS: PRS of later age at smoking initiation may be useful in predicting smoking cessation at the end of treatment. A combined PRS may be a useful predictor for smoking abstinence by capturing the genetic propensity for multiple smoking behaviors.

IMPLICATIONS: There is a potential for polygenic risk scores to inform future clinical medicine, and a great need for evidence on whether these scores predict clinically meaningful outcomes. Our meta-analysis provides early evidence for potential utility of using polygenic risk scores to predict smoking cessation amongst smokers undergoing quit attempts, informing further work to optimize use of polygenic risk scores in clinical care.

PMID:35170738 | DOI:10.1093/ntr/ntac043

Am J Clin Nutr. 2022 Feb 16:nqac044. doi: 10.1093/ajcn/nqac044. Online ahead of print.

ABSTRACT

BACKGROUND: Energy deficiency can result in menstrual disturbances and compromised bone health in women, a condition known as the Female Athlete Triad.

OBJECTIVE: The REFUEL randomized controlled trial assessed the impact of increased energy intake on bone health and menstrual function in exercising women with menstrual disturbances.

METHODS: Exercising women with oligo/amenorrhea were randomized to an intervention group (Oligo/Amen+Cal, n=40, 21.3±0.5 yrs, 55.0±1.0kg, 20.4±0.3 kg/m2) who increased energy intake 20-40% above baseline energy needs for 12 months or a control group (Oligo/Amen Control, n=36, 20.7±0.5 yrs, 59.1±1.3kg, 21.3±0.4 kg/m2). Energy intake and expenditure, metabolic and reproductive hormones, body composition, and areal bone mineral density (aBMD) were assessed.

RESULTS: The Oligo/Amen+Cal group improved energy status (increased body mass (2.6±0.4 kg), body mass index (0.9±0.2 kg/m2), fat mass (2.0±0.3 kg), body fat percentage (2.7±0.4%), and insulin-like growth factor 1 (37.4±14.6 ng/ml)) compared to the control group and experienced a greater likelihood of menses (p<0.05). Total body and spine aBMD remained unchanged (p>0.05). Both groups demonstrated decreased femoral neck aBMD at month 6 (-0.006 g/cm2, 95%CI: -0.011, -0.0002 time main effect p=0.043) and month 12 (-0.011 g/cm2, 95%CI: -0.021, -0.001, time main effect p=0.023). Both groups demonstrated a decrease in total hip aBMD at month 6 (-0.006 g/cm2, 95%CI: -0.011, -0.002, time main effect p=0.004).

CONCLUSIONS: Although higher dietary energy intake increased weight, body fat and menstrual frequency, bone mineral density was not improved, compared to the control group. The 12-month intervention may have been too short and the increase in energy intake (∼352 kcal/day), while sufficient to increase menstrual frequency, was insufficient to increase estrogen or improve aBMD. Future research should refine the optimal nutritional and/or pharmacological intervention(s) for the recovery of bone health in athletes and exercising women with oligo/amenorrhea. Clinical Trial Registry Number: NCT00392873 https://www.clinicaltrials.gov/ct2/show/NCT00392873.

PMID:35170727 | DOI:10.1093/ajcn/nqac044

ESC Heart Fail. 2022 Feb 15. doi: 10.1002/ehf2.13849. Online ahead of print.

ABSTRACT

AIMS: Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high surgical risk. The PASCAL system represents a novel device, potentially augmenting the toolkit for TEER. The aim of this study was to assess and compare short and 1 year safety and efficacy of the PASCAL and MitraClip systems for TEER.

METHODS AND RESULTS: Procedural, short, and 1 year outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip cases were investigated. Matching was based on clinical, laboratory, echocardiographic, and functional characteristics. The primary endpoints assessed were procedural success [as defined by the Mitral Valve Academy Research Consortium (MVARC)], residual MR, functional class, and a composite endpoint comprising death, heart failure hospitalization, and mitral valve re-intervention. We found for the PASCAL and the matched MitraClip cohort no significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) success rates. Accordingly, the overall MR reduction and improvement in New York Heart Association (NYHA) class were comparable (1 year follow-up: MR ≤ 2 95% vs. 93.6%, P = 1.0; NYHA ≤ 2 57.1% vs. 66.7%, P = 0.59). The composite outcome revealed no statistically significant difference between both devices (1 year follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 1 year follow-up a significantly higher rate of patients with none or trace MR in the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device implantations due to an elevated transmitral gradient was higher in PASCAL interventions (9.8% vs. 1.2%, P = 0.04).

CONCLUSIONS: Transcatheter edge-to-edge repair using the PASCAL or MitraClip device results in favourable and comparable outcomes regarding safety, efficacy, and clinical improvement after 1 year.

PMID:35170230 | DOI:10.1002/ehf2.13849

Nurs Open. 2022 Feb 16. doi: 10.1002/nop2.1168. Online ahead of print.

ABSTRACT

AIM: The purpose of the study is to evaluate the effectiveness of sodium bicarbonate and zinc chloride mouthwashes on oral mucositis and quality of life in patients undergoing chemotherapy.

DESIGN: The present study was a randomized controlled trial study.

METHODS: One hundred forty-four patients with a cancer diagnosis were randomly assigned into three groups: sodium bicarbonate mouthwash (n = 48), zinc chloride mouthwash (n = 48) and placebo group (n = 48). The severity of mucositis and quality of life were examined blindly at the baseline and 3-week follow-up.

RESULTS: The grade of oral mucositis decreased at the end of the third weeks in the sodium bicarbonate and zinc chloride groups rather than the placebo group (p < .001). The severity of oral mucositis in the sodium bicarbonate and zinc chloride groups decreased from end of the first week until third week (p < .001). In addition, there was significant difference in the severity of oral mucositis among the groups at the end of the second (p = .014) and the third weeks (p < .001). Also, there was a statistically significant difference in quality of life scores between the sodium bicarbonate and zinc chloride mouthwash with the placebo group (p < .001).

CONCLUSION: Zinc chloride and sodium bicarbonate mouthwashes were effective in treating and reducing the severity of oral mucositis, and subsequently improving quality of life in patients with cancer under chemotherapy. Therefore, we can recommend zinc chloride and sodium bicarbonate at the beginning of chemotherapy to improve oral health and promoting quality of life in these patients.

PMID:35170247 | DOI:10.1002/nop2.1168

Clin Transl Sci. 2022 Feb 15. doi: 10.1111/cts.13209. Online ahead of print.

ABSTRACT

Selumetinib is an oral, potent, and highly selective allosteric MEK1/2 inhibitor approved for the treatment of pediatric patients (aged ≤2 years) with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. A granule formulation of selumetinib is under development to improve dosing precision for younger pediatric patients who may be unable to swallow capsules. This phase I crossover study investigated the effect of food on the pharmacokinetic (PK) properties of selumetinib capsule and granule formulations. Healthy male volunteers were randomized to receive selumetinib granules (25 mg) or capsules (50 mg [2 × 25 mg]) under fasted or fed conditions (a low-fat meal). Plasma concentrations and PK parameters were determined less than or equal to 48 h postdose. Safety and tolerability were assessed. Across 24 volunteers, selumetinib was absorbed quickly, with a time to maximum concentration (T_max ) ranging from ~1-3 h. Geometric mean ratios (90% confidence interval [CI]) for maximum plasma concentration (C_max ) in the fed versus fasted state were 0.61 (90% CI 0.51-0.72) and 0.40 (90% CI 0.33-0.48) for the granule and capsule formulations, respectively, whereas geometric mean ratios (90% CI) for area under the plasma drug concentration-time curve in the fed versus fasted state were 0.97 (90% CI 0.91-1.02) and 0.62 (90% CI 0.55-0.70), respectively. Levels of less than 10% conversion to the N-desmethyl selumetinib metabolite were observed. Selumetinib was well-tolerated, with only a few adverse events of mild intensity reported. Selumetinib administration with a low-fat meal resulted in lower C_max and longer T_max for both formulations versus fasted conditions. However, area under the curve for selumetinib granules was similar under fasted and fed conditions. Overall, these findings support further development of this formulation for pediatric patients.

PMID:35170228 | DOI:10.1111/cts.13209