Controlled Intervention Study Research Articles

The prevention of adverse pregnancy outcomes by periodontal treatment during pregnancy (PROBE) intervention study-A controlled intervention study: Protocol paper.

Pregnancy increases the risk of periodontitis due to the increase in progesterone and estrogen. Moreover, periodontitis during pregnancy is associated with development of pregnancy and birth related complications. The aim of this study is to determine, whether periodontal treatment during pregnancy can reduce systemic inflammation and lower the risk of adverse pregnancy and birth related outcomes. The PROBE study is a non-randomized controlled intervention study conducted among 600 pregnant women with periodontitis. The women will be recruited among all pregnant women at two Danish hospitals in Region Zealand during their nuchal translucency scan and will subsequently be screened for periodontitis. The intervention group includes 300 pregnant women, who will be offered state-of-the-art periodontal treatment during pregnancy. The control group includes additional 300 pregnant women, who will be offered periodontal treatment after giving birth. Outcome measures include periodontal measures, inflammatory, hormonal and glycaemic markers as well as the prevalence of preterm birth risk, low birth weight and risk markers of gestational diabetes mellitus (GDM) and preeclampsia that will be collected from all screened women and further during pregnancy week 20 and pregnancy week 35 for women enrolled in the intervention. The study's findings will be published in peer reviewed journals and disseminated at national and international conferences and through social media. The PROBE study is designed to provide important new knowledge as to whether periodontal treatment during pregnancy can reduce the prevalence of complications related to pregnancy and birth. The study was registered on clinicaltrials.gov (NCT06110143).

Imaging diagnosis and treatment results of arteriovenous fistulas stenosis complication among hemodialysis patients

ABSTRACT Introduction: Percutaneous transluminal angioplasty (PTA) presents several advantages in addressing arteriovenous fistula (AVF) stenosis compared to surgical approaches. In addition, Doppler ultrasonography (DUS) serves as a noninvasive technique for stenosis measurement and access flow volume calculation. This study aimed to evaluate the agreement in stenosis diagnosis using PTA and DUS before intervention and to assess the effectiveness of the PTA method after intervention. Method: A non - controlled intervention study involved 15 chronic HD patients with a mature AVF in place for over three months, presenting AVF stenosis ≥ 50%, who underwent PTA intervention. Correlation analysis was employed to assess the similarity of AVF stenosis evaluations using DUS and PTA. The study also compared pre - and post - intervention indicators to evaluate the effectiveness of PTA intervention. Results: The results indicated a strong positive correlation between the two techniques (r = 0.997, r2 = 0.994, p < 0.001). Following intervention, all patients were considered successful, with significant reductions observed in various indicators, including alterations in murmurs along AVF, VAPR, the number of patients with AVF stenosis ≥ 50% on DUS, and none with Qmin < 500 mL/min. Conclusion: This study recommends utilizing DUS to evaluate stenosis before contemplating PTA intervention, owing to the correlation and similarity observed in the results of AVF stenosis examination between these two techniques. Ultimately, our research endorses PTA intervention as the preferred method for HD patients with AVF stenosis, considering the observed enhancements in clinical, hemodialysis, and DUS parameters

Psychophysiological effects of walking in forests and urban built environments with disparate road traffic noise exposure: study protocol of a randomized controlled trial

BackgroundStress is a widespread phenomenon and reality of everyday life, entailing negative consequences for physical and psychological wellbeing. Previous studies have indicated that exposure to greenspaces and nature-based interventions are promising approaches to reducing stress and promoting restoration. However, an increasing percentage of the population lives in urban regions with limited opportunities to spend time in greenspaces. In addition, urban settings typically feature increased levels of noise, which represents a major environmental stressor. Although various studies have compared the effects of exposure to greenspaces versus urban built environments, evidence of the effects of noise in this context is very limited. Psychophysiological benefits of exposure to greenspaces compared to urban built environments reported in earlier studies might be less (or at least not only) due to features of the greenspaces than to additional stressors, such as road traffic noise in the urban built environment. Hence, differences in the effects attributed to greenness in previous studies may also be due to potentially detrimental noise effects in comparison settings. This paper reports the study protocol for a randomized, controlled intervention study comparing the effects of walking in forest versus urban built environments, taking road traffic noise exposure during walks in the respective settings into account.MethodsThe protocol envisages a field study employing a pretest–posttest design to compare the effects of 30-min walks in urban built environments and forests with different road traffic noise levels. Assessments will consist of self-reported measures, physiological data (salivary cortisol and skin conductance), an attention test, and noise, as well as greenness measurements. The outcomes will be restoration, stress, positive and negative affect, attention, rumination, and nature connectedness.DiscussionThe results will inform about the restorative effect of walking in general, of exposure to different types of environments, and to different noise levels in these sites. The study will provide insights into the benefits of walking and nature-based interventions, taking into account the potential detrimental effects of noise exposure. It will thus facilitate a better understanding of low-threshold interventions to prevent stress and foster wellbeing.Trial registrationISRCTN48943261; Registered 23.11.2023.

Complementary and Alternative Medicine to Treat Fibromyalgia Symptoms. A Systematic Review.

This study aims to investigate the current evidence for the use of complementary and alternative medicine (CAM) in fibromyalgia (FM). A systematic review was conducted searching for PubMed, Scopus, CINAHL, PsycInfo, and Web of Science databases. Randomized controlled trials published up to December 2023 in peer-reviewed journals were included. Methodological quality was assessed by the Quality Assessment of Controlled Intervention Studies tool. A total of 216 articles were identified and 15 constituted the final sample. The type of CAM most used was traditional Chinese medicine (60%), and the most common instrument used was the Fibromyalgia Impact Questionnaire (60%). Our review was grouped into four themes based on the origin of the therapies: 1) Traditional Chinese Medicine; 2) Japanese natural harmonization (eg, Reiki); 3) Ayurvedic Medicine; and 4) Other non-drug therapies. Our systematic review showed that there is a wide range of CAMs used to treat FM. Most of the clinical trials have shown significant results for the effectiveness of these interventions in both physical and mental health outcomes of FM as compared to control groups. However, the heterogeneity of the interventions and outcomes warrants further studies on this topic.

Increasing patient safety due to an implemented ward pharmacist in an interprofessional cancer care team evaluated in a prospective, controlled intervention study

Increasing patient safety due to an implemented ward pharmacist in an interprofessional cancer care team evaluated in a prospective, controlled intervention study

Structured diary introspection training: A kind of critical thinking training method can enhance the Pro-C creativity of interior designers

Pro-C creativity refers to professional creativity, which plays a key role in designing novel and practical works for designers in practical work. In order to verify the significance of critical thinking and Pro-C creativity and explore how to improve Pro-C creativity through critical thinking training, we carried out two studies. In Study 1, we recruited 58 designers using a longitudinal research approach and employed the California Critical Thinking Skills Test (CCTST) and the California Critical Thinking Disposition Inventory (CCTDI) to measure designers' critical thinking. Designers were tasked with completing assignments related to Pro-C level of creativity A, and their creativity was assessed by experts. Through a one-year follow-up analysis, we examined how their critical thinking influenced Pro-C creativity in the design domain. The results of the cross-lagged analysis indicate that scores on critical thinking positively predicted the creativity levels of designers one year later. Study 2 is a controlled intervention study. We developed an intervention program for training critical thinking, named the "Structured diary introspection Training Method", which is based on the online technique. Through a 21-day critical thinking training intervention, the results of repeated measures analysis of variance showed that, compared to the control group, designers in the intervention group scored significantly higher in a creative task related to designing a living room. Our findings support critical thinking as an important predictor of Pro-C creativity in the real world and provide a feasible training program for those who need to improve their Pro-C creativity.

Examining the training design and training transfer of a boundary management training: A randomized controlled intervention study

AbstractIn our mobile working world, boundaries between work and non‐work domains are more and more blurred, which can impair professionals' recovery and well‐being. Consequently, managing work–non‐work boundaries represents an important challenge for professionals. Research suggests that boundary work tactics conveyed in boundary management interventions may promote recovery and well‐being. However, the efficacy of boundary work tactics is largely unknown, as well as theoretical mechanisms that may explain the effectiveness of boundary management interventions in regard of both training design and training transfer. Building on the social cognitive theory of self‐regulation, we develop a web‐based boundary management training. Based on the integrated training transfer and effectiveness model, we evaluate its effects on the three levels of training effectiveness: (1) perceived learning, (2) cognitions and behaviours, with boundary control and boundary creation as indicators, and (3) recovery and well‐being. Results of our randomized controlled intervention study show several expected changes in boundary creation, suggesting that drawing on the social cognitive theory of self‐regulation for training design can result in effective behaviour change. Intervention effects on recovery and well‐being are more ambiguous, hinting at the power but likewise potential limitations of boundary creation.

Glycemic response to meals with a high glycemic index differs between morning and evening: a randomized cross-over controlled trial among students with early or late chronotype.

Glycemic response to the same meal depends on daytime and alignment of consumption with the inner clock, which has not been examined by individual chronotype yet. This study examined whether the 2-h postprandial and 24-h glycemic response to a meal with high glycemic index (GI) differ when consumed early or late in the day among students with early or late chronotype. From a screening of 327 students aged 18-25years, those with early (n = 22) or late (n = 23) chronotype participated in a 7-day randomized controlled cross-over intervention study. After a 3-day observational phase, standardized meals were provided on run-in/washout (days 4 and 6) and intervention (days 5 and 7), on which participants received a high GI meal (GI = 72) in the morning (7 a.m.) or in the evening (8 p.m.). All other meals had a medium GI. Continuous glucose monitoring was used to measure 2-h postprandial and 24-h glycemic responses and their variability. Among students with early chronotype 2-h postprandial glucose responses to the high GI meal were higher in the evening than in the morning (iAUC: 234 (± 92) vs. 195 (± 91) (mmol/L) × min, p = 0.042). Likewise, mean and lowest 2-h postprandial glucose values were higher when the high GI meal was consumed in the evening (p < 0.001; p = 0.017). 24-h glycemic responses were similar irrespective of meal time. Participants with late chronotype consuming a high GI meal in the morning or evening showed similar 2-h postprandial (iAUC: 211 (± 110) vs. 207 (± 95) (mmol/L) × min, p = 0.9) and 24-h glycemic responses at both daytimes. Diurnal differences in response to a high GI meal are confined to those young adults with early chronotype, whilst those with a late chronotype seem vulnerable to both very early and late high GI meals. Registered at clinicaltrials.gov (NCT04298645; 22/01/2020).

Acid-Base Balance in Healthy Adults: Beneficial Effects of Bicarbonate and Sodium-Rich Mineral Water in a Randomized Controlled Trial: The BicarboWater Study

Background. Noncommunicable diseases (NCDs) are a global health challenge. The complex etiology of NCDs involves genetic, environmental, and lifestyle factors, including dietary habits. Chronic latent metabolic acidosis has been associated with an increased risk of NCDs. Alkalizing diets and mineral water consumption have shown promise in improving acid-base balance and potentially impacting NCDs. Methods. In this randomized controlled intervention study, the effect of drinking 1,500–2,000 mL of mineral water daily on acid-base balance was evaluated. Ninety-four healthy participants were divided into two groups: one consumed mineral water with a high bicarbonate and sodium content (HBS, n = 49) and the other consumed mineral water with a low bicarbonate and sodium content (LBS, n = 45). Changes in venous blood gas and urinary acid-base parameters were measured over a short-term (3 days) and long-term (28 days) intervention period. Potential renal acid load (PRAL) and nutrient intake were calculated at baseline and after 28 days. Results. HBS water consumption led to increased urinary pH (24-hour urine and spontaneous urine, both p&lt;0.001) and bicarbonate levels (p&lt;0.001), accompanied by reduced titratable acids (p&lt;0.001) and ammonium (p&lt;0.001), resulting in a lower renal net acid excretion (p&lt;0.001). These changes occurred in the short term and persisted until the end of the study. LBS consumption showed no significant effects on urinary pH but led to a slight decrease in bicarbonate (p&lt;0.001) and NH4+ (p&lt;0.001), resulting in a slight decrease in NAE (p=0.011). Blood gas changes were modest in both groups. Mineral water consumption in the HBS group altered dietary intake of sodium and chloride, contributing to changes in PRAL values. Conclusion. The study demonstrates that the consumption of mineral water high in bicarbonate and sodium (1,500 mL–2,000 mL/day) can positively influence urinary acid-base parameters and reduce NAE, suggesting potential benefits in maintaining acid-base balance without adverse effects on human health. These findings highlight the importance of mineral water composition in acid-base regulation. This trial is registered with DRKS00025341.

Do Character Strengths-Based Interventions Change Character Strengths? Two Randomized Controlled Intervention Studies

Character strengths-based interventions are effective for increasing well-being. However, whether such interventions also change character strengths has never been tested. In Study 1, we studied the effects of seven different variants of character strengths-based interventions on well-being, ill-being, and character strengths traits and states (i.e., frequency of behavior during one week). We analyzed data of N = 1,163 participants (82.3% women, aged 18 to 78; Md = 45) who were randomized to seven intervention conditions lasting one week; (1) learning about the VIA classification of character strengths, (2) learning about one’s own strengths, using signature strengths (3) in a new way, (4) with a minor challenge, (5) with a larger challenge, (6) for other people, (7) forming a strengths-based habit, or a placebo control condition (early memories). Results showed that using signature strengths in a new way led to increased well-being, social well-being, as well as character strengths states and traits. Forming a strengths-based habit also increased well-being and character strengths states. No effects on ill-being were found. In Study 2, we tested a four-week multi-component program that combined several interventions tested in Study 1 in a sample of N = 254 participants (77.8% women, aged 19 to 87; Md = 42). Compared to a waitlist control group, the intervention condition showed increases in well-being and character strengths states, and reductions in stress and neuroticism. We conclude that character strengths interventions may not only affect well-being but also character strengths states and traits, as well as broader personality traits such as neuroticism.

The effect of hope intervention on the anxiety, hope and symptom levels of patients in palliative care: A pilot randomized controlled trial

Background: One of the main aims of palliative care is the management of symptoms that disturb the person. There are very limited studies to determine the increase of hope through hope intervention and its effect on symptom levels.Objective: This study has been carried out to determine the effect of hope intervention on anxiety, hope, and symptom levels of patients under palliative care.Method: This research is a randomized controlled intervention study. The sample of the study consisted of 42 patients who were treated as inpatients in a palliative care center in Turkey. A "hope intervention program" (three consecutive days, three sessions) was implemented on the intervention group. Measurement tools were applied three times before the intervention, on the 8th day and on the 15th day after the intervention. The research data were collected using a Personal Information Form, the Herth Hope Index, the Hospital Anxiety Depression Scale, and the Edmonton Symptom Assessment Scale. The data were analyzed in the SPSS 25.0 program using independent sample t-tests, ANOVA in repeated measurements, Bonferroni Post-Hoc tests, chi-square tests, Pearson correlation, and regression analysis.Results: There was a statistically significant difference in the Herth Hope Index scores of the intervention group on the 8th and 15th day after intervention (p<.05), and patients in the control group had a higher hope level. A statistically significant difference was found between the anxiety score measurements of the patients in the intervention group before intervention, on the 8th day and 15th day (p<.05), however, no statistically significant difference was found between the anxiety scores of the intervention and control groups. No statistically significant difference was found between symptoms of nausea, anxiety, insomnia, and shortness of breath between the intervention and control groups.Conclusion: Hope intervention increased the hope status of patients receiving palliative care and reduced the level of anxiety. In palliative care, it is recommended to use hope intervention programs that support and contribute to the maintenance of hope.

Differences in prescribing errors between electronic prescribing and traditional prescribing among medical students: A randomized pilot study.

This randomized controlled pilot study aimed to assess the differences in the frequency, type and severity of prescribing errors made by medical students when assessed in an electronic (e-)prescribing system compared to a traditional prescribing method (e.g., typing out a prescription). Fourth year medical students in the period of 1 November to 31 July 2023, were asked to participate in this single-centre prospective, randomized, controlled intervention study. Participants performed a prescribing assessment in either an e-prescribing system (intervention group) or in a more traditional prescribing platform (control group). The prescriptions were checked for errors, graded and categorized. Differences in prescribing errors, error categories and severity were analysed. Out of 334 students, 84 participated in the study. Nearly all participants (98.8%) made 1 or more prescribing errors, primarily involving inadequate information errors. In the intervention group, more participants made prescribing errors involving the prescribed amount (71.4 vs. 19.0%; P< .01), but fewer involving administrative errors (2.4 vs. 19.0%; P= .03). Prescribing-method-specific errors were identified in 4.8 and 40.5% of the intervention and control group, respectively, with significant differences in overlapping errors as well. This pilot study shows the importance of training e-prescribing competencies in medical curricula, in addition to traditional prescribing methods. It identifies prescribing-method-specific prescribing errors and emphasizes the need for further research to define e-prescribing competencies. Additionally, the need for an accessible real-life-like e-prescribing environment tailored to educators and students is essential for effective learning and incorporation of e-prescribing into medical curricula.

Benefit of breath-holding training on the concept of recreational freediving in healthy adults – a systematic literature review

Background. breathing is a crucial process that commences at the moment of birth and ceases with one's passing. Through breathing, essential oxygen is supplied to all the body's parts, organs, and cells, sustaining life. Some numerous breathing techniques to optimize the advantages of breath-holding exercises. Freediving training is believed to be able to increase respiratory efficiency. The exercise is done by controlling of breathing and a stable heart rate so human can hold breath for a while, dive deeper and dive safely. These techniques are also employed in the preparation and meditation of postures, enhancing the focus and clarity of the mind to maximize the benefits of the practice. Methods. All studies were screened on an individual basis, considering a set of specific criteria and key data such as affiliation of authors, type of study, year of publication, type of breath-hold exercise benefit in healthy. The study was designed in accordance with the standards of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta Analyzes). Results. Based on the systematic review process, selected and extracted data for each article obtained, a detailed description of the researcher's name, title, research design, respondents, strengths and research results, and research limitations are summarized. The inclusion criteria: International Journal and Research Design include Controlled Intervention Studies, Observational Cohort and Cross-Sectional Studies, Case-Control Studies, Case Series Studies, and Articles containing elements of breath hold benefit training. Quality assessment tools of the paper use NHLBI with low, and medium, assessment criteria. In this systematic review process, 230 Article collections were using Scopus, Pubmed and GS Databases with the keywords namely breath hold "AND" training “AND” benefit.. The stage continued by searching for the duplicate articles and obtained 34 out of 230 databases so that 196 articles were obtained before the screening stage. The first screening stage continued by excluding the title and abstract and obtained 160 articles from the 196 databases, so 36 articles were obtained at the screening stage. The next stage was eligibility, excluding 11 articles based on IMRAD (Introduction, Method, Result, and Discussion)is not clear, excluding 5 article Systematic Review, and excluding 6 article study reports were not included where finally meet 14 articles were evaluated for eligibility based on the title and abstract as well as the entire article excluded on inclusion and exclusion were obtained that matched the article criteria to be reviewed in this study Conclusion.This comprehensive review highlights a number of studies exploring the relationship between breath-holding exercises and associated health benefits. These studies cover a wide range of aspects, including the impact of physical activity on freedive training, the benefits of diaphragmatic breathing on lung function, and the effectiveness of mental imagery (MI) training in improving breath-hold performance. Additionally, studies have shown significant improvements in cardiorespiratory function in individuals with bronchial asthma, chronic obstructive pulmonary disease, and cancer. These improvements were evidenced by positive changes in pulse rate, blood pressure, respiratory function measurements, and overall quality of life.

Five-Week, Low-Intensity Blood Flow Restriction Rowing Improves V̇o2max in Elite Rowers.

Held, S, Rappelt, L, Rein, R, Deutsch, J-P, Wiedenmann, T, and Donath, L. Five-week, low-intensity, blood flow restriction rowing improves V̇o2max in elite Rowers. J Strength Cond Res XX(X): 000-000, 2024-This controlled intervention study examined the effects of low-intensity rowing with blood flow restriction (BFR) on maximal oxygen uptake (V̇o2max), peak power output during ramp testing (PPO), and 2000-m time trial performance (P2k). Eleven, highly elite, male rowers (22.1 ± 1.6 years; 92.6 ± 3.8 kg; 1.93 ± 0.04 m; 7.9. ± 2.2 years rowing experience; 20.4 ± 2.0 h·w-1 training volume; 11.9 ± 1.1 session per week) trained 5 weeks without BFR (Base) followed by a 5-week BFR intervention period. BFR of the lower limb was applied through customized elastic wraps. BFR took place 3 times a week (accumulated net pBFR: 60 min·wk-1; occlusion per session: 2 times 10 min·session-1) and was used exclusively at low intensities (<2 mmol·L-1). V̇o2max, PPO, and P2k were examined before, between, and after both intervention periods. Bayesian's credible intervals revealed relevantly increased V̇o2max +0.30 L·min-1 (95% credible interval: +0.00 to +0.61 L·min-1) adaptations through BFR. By contrast, PPO +14 W (-6 to +34 W) and P2k -5 W (-14 to +3 W) were not noticeably affected by the BFR intervention. This study revealed that 15 sessions of BFR application with a cumulative total BFR load of 5 h over a 5-week macrocycle increased V̇o2max remarkably. Thus, pBFR might serve as a promising tool to improve aerobic capacity in highly trained elite rowers.

Interdialytic weight gain and low dialysate sodium concentration in patients on chronic hemodialysis: a systematic review and meta-analysis.

The present systematic review and meta-analysis aimed at evaluating the effect of low dialysate sodium concentration on interdialytic weight gain (IDWG) in chronic hemodialysis patients. Studies were eligible for inclusion if they were English language papers published in a peer-reviewed journal and met the following inclusion criteria: (1) studies in adult patients (over 18years of age), (2) included patients on chronic hemodialysis since at least 6months; (3) compared standard (138-140mmol/l) or high (> 140mmol/l) dialysate sodium concentration with low (< 138mmol/l) dialysate sodium concentration; (4) Included one outcome of interest: interdialytic weight gain. Medline, PubMed, Web of Science, and the Cochrane Library were searched for the quality of reporting for each study was performed using the Quality Assessment Tool of Controlled Intervention Studies of the National Institutes of Health. The quality of reporting of each cross-over study was performed using the Revised Cochrane Risk of Bias (RoB) tool for cross-over trials as proposed by Ding et al. RESULTS: Nineteen studies (710 patients) were included in the analysis: 15 were cross-over and 4 parallel randomized controlled studies. In cross-over studies, pooled analysis revealed that dialysate sodium concentration reduced IDWG with a pooled MD of - 0.40kg (95% CI - 0.50 to - 0.30; p < 0.001). The systematic review of four parallel, randomized, studies revealed that the use of a low dialysate sodium concentration was associated with a significant reduction of the IDWG in two studies, sustained and almost significant (p = 0.05) reduction in one study, and not significant reduction in one study. Low dialysate sodium concentration reduces the IDWG in prevalent patients on chronic hemodialysis.

BCAAs as Ergogenic Aids: Exploring Their Impact on Exercise-Induced Muscle Damage

This research delves into the multifaceted realm of Branched-Chain Amino Acids (BCAAs) as potential ergogenic aids, specifically exploring their impact on exercise-induced muscle damage. The investigation spans an extensive literature review of studies conducted in the United States from 2010 to 2023, synthesizing diverse methodologies and outcomes. The study employs a systematic approach, considering randomized controlled trials, observational studies, and intervention studies to provide a comprehensive understanding of the nuanced relationship between BCAAs and exercise-induced muscle damage. Findings reveal varied outcomes, suggesting BCAAs may influence markers such as Creatine Kinase levels, recovery time, and muscle soreness. However, inconsistencies and individual variations underscore the complexity of this interaction. The paper also elucidates the biochemical mechanisms through which BCAAs act, addressing considerations for optimal dosage, timing, and potential side effects. Practical implications are drawn for athletes and fitness enthusiasts, emphasizing personalized approaches within the broader context of sports nutrition. Acknowledging limitations, the study concludes with a call for continued research, refining methodologies and advancing the understanding of BCAAs in optimizing athletic performance and recovery.

Effects of triple therapy on disease burden in patients of GOLD groups C and D: results from the observational COPD cohort COSYCONET

BackgroundRandomized controlled trials described beneficial effects of inhaled triple therapy (LABA/LAMA/ICS) in patients with chronic obstructive pulmonary disease (COPD) and high risk of exacerbations. We studied whether such effects were also detectable under continuous treatment in a retrospective observational setting.MethodsData from baseline and 18-month follow-up of the COPD cohort COSYCONET were used, including patients categorized as GOLD groups C/D at both visits (n = 258). Therapy groups were defined as triple therapy at both visits (triple always, TA) versus its complement (triple not always, TNA). Comparisons were performed via multiple regression analysis, propensity score matching and inverse probability weighting to adjust for differences between groups. For this purpose, variables were divided into predictors of therapy and outcomes.ResultsIn total, 258 patients were eligible (TA: n = 162, TNA: n = 96). Without adjustments, TA patients showed significant (p < 0.05) impairments regarding lung function, quality of life and symptom burden. After adjustments, most differences in outcomes were no more significant. Total direct health care costs were reduced but still elevated, with inpatient costs much reduced, while costs of total and respiratory medication only slightly changed.ConclusionWithout statistical adjustment, patients with triple therapy showed multiple impairments as well as elevated treatment costs. After adjusting for differences between treatment groups, differences were reduced. These findings are compatible with beneficial effects of triple therapy under continuous, long-term treatment, but also demonstrate the limitations encountered in the comparison of controlled intervention studies with observational studies in patients with severe COPD using different types of devices and compounds.

Medical clowns improve sleep and shorten hospitalization duration in hospitalized children

Intervention by medical clowns was proven to have a positive effect in reducing stress and anxiety, increasing cooperation and improving the child's experience prior to a medical procedure and during the various stages of hospitalization. Sleep has long been known to be essential for recovery from injury and sickness, improving immune functions, and there is an emerging understanding of the restorative role quality sleep has on health and diseases. Hospitalized children are more exposed to sleep disorders and sleep deprivation due to the hospitalized environment, anxiety, and illness. Different behavioral interventions to promote sleep were previously studied in hospitalized children, some showing potential benefits. In this study, we sought to examine the ability of medical clowns to positively impact the child's sleep during hospitalization. The study is an observational matching (case–control) interventional study which took place at the department of pediatrics in Carmel Medical Center. Forty-two hospitalized children ages 2–17 were included in two equal groups of intervention or control. Children in the control group were recruited based on a method of matching the chief complaint plus the medical diagnosis and age of the children in the intervention group in a 1:1 matching. The children's sleep parameters were objectively evaluated for two consecutive nights using an Actigraph device and subjectively by parent's questionnaire. Additional factors such as hospital length of stay and demographics were also monitored. The study group had an encounter with a medical clown (15–30 min) before bedtime on either the first or the second night, and the control group was not exposed to a medical clown at all. We then compared the data from both groups using unpaired t-tests. Hospitalized children exposed to a medical clown prior to bedtime (n = 21) and children not exposed to a medical clown (n = 21) were comparable in age and clinical characteristics. The study group had a significantly delayed wake-up time compared to the control group (06:59 ± 46 min vs. 07:26 ± 42 min, p < 0.05) (mean difference of 27 min). Night's duration (from bedtime to wake-up) was significantly longer in the study versus the control group (570 ± 76 vs. 500 ± 66.1 min, p < 0.05), a total mean increase of 70 min, and sleep efficiency were significantly increased (92.3 ± 4.6% vs. 87.9 ± 8.7%, p < 0.05). Within the clown group, when comparing nights with and without exposure to a medical clown, total sleep time was prolonged by a mean of 54 min on the night of the intervention (518 ± 74 min vs. 464 ± 59 min, p < 0.01), and the total wake time during the night were reduced (52 ± 27 min vs. 77 ± 61 min, P < 0.05), mean difference of 25 min), mainly by reduction of wake period after sleep onset (WASO) (42 ± 25 min vs. 66 ± 58 min, p < 0.05), mean difference of 24 min). Regarding general medical outcomes, hospital stay was significantly shorter in the clown group vs. control (104 ± 42 h vs. 128 ± 42 h, p < 0.05), a mean reduction of 23 h—nearly an entire day. An encounter with a medical clown before bedtime in hospitalized children positively affects sleep parameters, which may be of great importance for healing in general. The clown intervention was also shown to shorten the hospital stay. Larger scale studies are warranted to establish these findings.

Vitamin B12 Ameliorates Pesticide-Induced Sociability Impairment in Zebrafish (Danio rerio): A Prospective Controlled Intervention Study

Constant exposure to a variety of environmental factors has become increasingly problematic. A variety of illnesses are initiated or aided by the presence of certain perturbing factors. In the case of autism spectrum disorder, the environmental component plays an important part in determining the overall picture. Moreover, the lack of therapies to relieve existing symptoms complicates the fight against this condition. As a result, animal models have been used to make biomedical research easier and more suited for disease investigations. The current study used zebrafish as an animal model to mimic a real-life scenario: acute exposure to an increased dose of pesticides, followed by prospective intervention-based therapy with vitamin B12 (vit. B12). It is known that vit. B12 is involved in brain function nerve tissue, and red blood cell formation. Aside from this, the role of vit. B12 in the redox processes is recognized for its help against free radicals. To investigate the effect of vit. B12, fish were divided into four different groups and exposed to a pesticide mixture (600 μg L−1 fipronil + 600 μg L−1 pyriproxyfen) and 0.24 μg L−1 vit. B12 for 14 days. The impact of the compounds was assessed daily with EthoVision XT 11.5 software for behavioral observations, especially for sociability, quantified by the social interaction test. In addition, at the end of the study, the activities of superoxide dismutase (SOD), glutathione peroxidase (GPx), and malondialdehyde (MDA) were measured. The results showed significant improvements in locomotor activity parameters and a positive influence of the vitamin on sociability. Regarding the state of oxidative stress, high activity was found for SOD and GPx in the case of vit. B12, while fish exposed to the mixture of pesticides and vit. B12 had a lower level of MDA. In conclusion, the study provides new data about the effect of vit. B12 in zebrafish, highlighting the potential use of vitamin supplementation to maintain and support the function of the organism.

Infant lung function and early skin barrier impairment in the development of asthma at age 3 years.

Largely unexplored, we investigated if lower lung function, impaired skin barrier function by transepidermal water loss (TEWL), eczema, and filaggrin (FLG) mutations in infancy were associated with asthma in early childhood. From the factorially designed randomized controlled intervention study PreventADALL, we evaluated 1337/2394 children from all randomization groups with information on asthma at age 3 years, and at age 3 months either lung function, TEWL, eczema, and/or FLG mutations. Lower lung function was defined as the time to peak tidal expiratory flow to expiratory time (tPTEF /tE ) <0.25, and skin barrier impairment as a high TEWL >9.50 g/m2 /h. Eczema was clinically observed, and DNA genotyped for FLG mutations. Asthma was defined as asthma-like symptoms (≥3 episodes of bronchial obstruction) between age 2-3 years as well as a history of doctor-diagnosed asthma and/or asthma medication use. Associations were analyzed in logistic regression models, presented with adjusted ORs (aOR) and 95% confidence intervals (CI). Lower lung function and skin barrier impairment were associated with asthma in general; aOR (95% CI) 5.4 (2.1, 13.7) and 1.6 (1.1, 2.5), while eczema and FLG mutations were associated with asthma in children with atopic dermatitis or allergic sensitization only. Stratifying for sex, the risk of asthma was only increased in boys with lower lung function; aOR (95% CI) 7.7 (2.5, 23.6), and in girls with FLG mutations; aOR (95% CI) 3.5 (1.5, 8.2). Lower lung function and impaired skin barrier function in infancy may increase the risk of asthma at age 3 years.