Non-randomized Experimental Study Research Articles

The effect of amino acid-oral rehydration solution (Enterade®) on chemotherapy related diarrhea and quality of life in solid tumor cancer patients: A non-randomized experimental study.

The purpose of this study was to evaluate use of a proprietary amino acid-oral rehydration solution (AA-ORS) known as Enterade® to reduce the severity of chemotherapy related diarrhea (CRD), to improve patient reported Quality of Life (QOL), and to reduce treatment holds, delays, dose modifications, prevention of weight loss, and subjective improvement of associated gastrointestinal mucositis physical symptoms. An experimental pilot study without randomization in a single population with two separate measurements over time was performed in a National Cancer Institute (NCI) designated cancer center in the South-Central United States. The variables included sociodemographic data, cancer diagnosis, chemotherapy treatment regimens, Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade of diarrhea, stool consistency using the Bristol Stool Scale, use of antidiarrheals, associated gastrointestinal mucositis symptoms affecting QOL, and QOL measured with the Functional Assessment of Chronic Illness Therapy-Diarrhea survey. A total of 22 participants enrolled in the study. Sixteen completed both the pre-survey and post survey. A statistically significant difference was not found between the patient's subjective report of quality of life when comparing pre and post survey responses. There was a statistically significant improvement from baseline in the QOL questions specific to bowel concerns due to diarrhea with a mean pre-survey response score of 35.3 versus a post survey score of 29.2 (p=.003). There was a reduction in the CTCACE grade of diarrhea demonstrating a reduction in the frequency of stools per day (p=.001) and a change in the consistency of stools moving from watery to more formed stools using the Bristol Stool Scale (p=.049). Use of AA-ORS in this study was found to be useful in the reduction of CRD in patients receiving systemic oncology therapies. This study needs to be replicated with a larger, more inclusive sample size to further support the use of AA-ORS in the reduction of CRD and QOL.

Effects of reducing sedentary behaviour duration by increasing physical activity, on cognitive function, brain function and structure across the lifespan: a systematic review protocol

IntroductionGreater engagement in sedentary behaviours has been related to poorer cognitive functions in epidemiological research. However, the effects of reducing sedentary behaviour duration on cognitive function, brain function, and structure...

Remdesivir Therapy versus Standard Care in Hospitalized Pregnant Women with Moderate and Severe COVID-19 in a Tertiary Care Center of Dubai: A Quasi-experimental Study

Background: Pregnant women with COVID-19 are more likely to be hospitalized and require respiratory support than non-pregnant women. There is little published data on Remdesivir use in pregnant women with COVID-19. We aimed to investigate the clinical course and obstetric outcomes for pregnant women with COVID-19 administered Remdesivir versus standard therapy.
 Methods: We conducted a non-randomized quasi experimental study among 100 pregnant women with moderate or severe COVID-19 who were admitted to a tertiary care hospital in Dubai between 18 January and 31 March 2021. We compared women receiving Remdesivir (treatment arm) and women receiving standard therapy (control arm).
 Results: More women in the Remdesivir group had normal vaginal delivery (n=17, 39.5%) than controls (n=9, 20.5%). Newborn Apgar scores at 1 and 5 minutes were similar in both groups. The mean standard deviation time to recovery and discharge was lower for patients receiving Remdesivir than controls (8.4\(\pm\)3.3 versus 13.6\(\pm\)9.2 days). Fewer treated patients required intensive care; at 60- day follow-up, all women on Remdesivir were doing well whereas six (12.0%) women on standard therapy had died.
 Conclusions: Pregnant women with moderate or severe COVID-19 treated early with Remdesivir showed an overall better clinical course and outcomes than those on standard therapy.

Outcome and Evaluation of Intestinal Obstruction Due to Bands in Virgin Abdomen: A Prospective Study

Introduction: Some major hospitals and clinics still insist on exploratory surgery when they evaluate a case of Intestinal obstruction in a patient with an otherwise virgin abdomen. Objective: The purpose of this research is to identify the causes of SBO in people who have never performed abdominal surgery. Materials and Methods: Multicentered based nonrandomized quasi experimental prospective study was performed in Northern International Medical College, Dhaka, Bangladesh from January 2018 to December 2021.Total number of patients n=60 treated for Intestinal obstruction due to bands in virgin abdomen. Follow up data, operative and pathologic findings were examined to determine the etiology of SBO. Results: Sixty patients met inclusion criteria; abdominal exploration was performed in 50 patients (83%) and 10 patients (17%) were managed non-operatively. Exploration was therapeutic in 29 (58%), negative in 20 (40%) and non-therapeutic in one patient (2%). Overall, 8 patients (13%) were diagnosed with a malignancy: right-sided colon cancer (n=3), small bowel (SB) neuroendocrine tumor (n=2), SB lymphoma (n=2) and carcinomatosis peritonei (n=1); six patients were diagnosed at the time of the initial exploration and two patients were diagnosed during follow up. Upon Prospective Study, both SB neuroendocrine tumors and one SB lymphoma were visible on the initial imaging. Leukocytosis (p=.03) and no recent weight loss (p=.04) were associated with negative exploration. Conclusion: Patients with a "virgin abdomen" generally have a non-threatening form of Intestinal obstruction in its earliest stages. Careful evaluation of imaging investigations is required for spotting early warning symptoms of a more serious illness. If the patient prefers non-surgical treatment, they will need to have a recent colonoscopy and give relevant examination findings history.

Secondary prevention of acute coronary syndrome by reducing depression and anxiety

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction Cardiovascular disease is expected to reach an annual mortality rate of 23 million individuals by 2030, primarily due to acute coronary syndrome (ACS) and cerebrovascular events. Simply stating the mortality associated with cardiovascular disease underrepresents its true burden considering the associated disability, healthcare expenditure, and loss of quality of life. Specifically, there has been increasing interest in the prevalence of depression and anxiety post-ACS as depressive and anxious symptoms are seen in up to 45% and 30% of patients, respectfully. These symptoms are associated with increased morbidity and mortality as well as decreased quality of life. Thus, it is crucial that secondary prevention be prioritized in this population with a specific focus on psychological wellbeing. Purpose The purpose of the present systematic review is to summarize the current literature on secondary prevention following ACS via interventions aimed at reducing depression and anxiety. Methods A systematic review was conducted of the databases PubMed, EMBASE, Web of Science, ClinicalTrials.gov, and Cochrane for studies which implemented an intervention to improve depression or anxiety in patients following ACS. Results The initial literature search identified 6,536 studies, of which 97 were added for inclusion with a total of 23,965 participants. Study design comprised 83 randomized control trials, two quasi-experimental studies, and 12 non-randomized experimental studies. The majority of interventions which significantly reduced symptoms of post-ACS anxiety involved modified cardiac rehabilitation programs (20%), aromatherapy (13%), and initiation of a new therapeutic (11%). Conversely, the majority of post-ACS interventions which significantly improved depressive symptoms involved therapy (24%), modified cardiac rehabilitation (24%), and initiation of a new therapeutic (20%). Notably, all aromatherapy (n=6), arts-based (n=3), exercise (n=7), meditation (n=3), and nature therapy (n=1) intervention studies extracted reported significant improvement in either depression or anxiety scores. Conclusions Depressive and anxious symptoms following ACS are associated with increased risk of death, rehospitalization, and poor quality of life. Programs which involve modified cardiac rehabilitation programs, aromatherapy, therapeutic agents, and therapy may increase secondary prevention of ACS by improving symptoms of depression and anxiety. Due to the heterogeneity of the programs identified, significant differences in sample size across studies, and the variety of depression/anxiety scales used, a large-scale randomized control trial comparing intervention efficacy is needed. Such a trial, as well as the present systematic review, may improve secondary prevention of ACS by identifying strategies to reduce depression and anxiety in this population.

Diagnostic accuracy of antigen-detection rapid diagnostic tests for diagnosis of COVID-19 in low-and middle-income countries: A systematic review and meta-analysis.

Antigen detection rapid diagnostic tests (Ag-RDTs) used for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein are inexpensive, faster and easy to use alternative of Nucleic Acid Amplification Test (NAAT) for diagnosis of Coronavirus disease 2019 (COVID-19). In this systematic review and meta-analysis, we assessed the diagnostic accuracy of Ag-RDTs in low and middle-income countries (LMICs). We included studies that evaluated the diagnostic accuracy of Ag-RDTs (sensitivity and specificity) against reverse transcription-polymerase chain reaction (RT-PCR) as a reference standard. The study population comprised of people living in LMICs irrespective of age and gender, who had undergone testing for COVID-19. We included peer reviewed prospective or retrospective cohort studies, cross-sectional studies, case control studies, randomized clinical trials (RCTs) as well as non-randomized experimental studies which addressed the review question. A systematic search was conducted in PubMed, CINAHL, Embase, Scopus, and Google Scholar to identify studies published between 1 January, 2020 and 15 August, 2021. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool was used to assess the methodological quality of studies. The analysis was done using Review Manager 5.4 and R software 4.0.2. From the total of 12 diagnostic accuracy studies with 4,817 study participants, pooled sensitivity and specificity were 78.2% and 99.5% respectively. Sensitivity was marginally higher in subgroup analysis based on studies with low risk of bias and applicability concerns (78.9%) and studies using SD Biosensor Ag-RDT (79.4%). However, an inverse relation between cycle threshold (Ct) and sensitivity of Ag-RDT was not seen. The review demonstrated pooled sensitivity value approaching the minimum performance requirement for diagnosis of COVID-19 by WHO with specificity value meeting the specified requirement. Ag-RDTs, therefore have the potential to be used as a screening tool for SARS-CoV-2 detection in low resource settings where RT-PCR might not be readily accessible. However, false negative results need to be interpreted with caution.

Effects of vegetables consumption before carbohydrates on blood glucose and GLP-1 levels among diabetic patients in Indonesia

Type 2 Diabetes Mellitus (T2DM) is the prominent public health issue. Pharmacotherapy and diet modification should be integrated into T2DM management. To investigate the effects of vegetables consumption before carbohydrates on blood glucose and GLP-1 levels in T2DM patients. A non-randomized quasi experimental study was conducted to recruit T2DM patients who attended at the Gatot Soebroto Central Army Hospital, Jakarta, Indonesia from April to May 2016. The Lemeshow's formula was used to determine sample size. A total of 12 non-diabetic and 24 diabetic patients were participated in our study. Glucose levels were measured using a routine hexokinase method while serum GLP-1 levels were determined using the ELISA. The student t-test was used to compare two groups with parametric data. The significant difference was at P < 0.05. Our data showed that T2DM patients who consumed vegetables before carbohydrates, had relatively stable glucose levels at 0, 60 and 120 mins (164.25 ± 86.89 vs 183.5 ± 55.96 vs 167.83 ± 65.53, P = 0.163) and stay lowered within the normal range compared to T2DM patients who consumed vegetables after carbohydrates (165.08 ± 67.89 vs 241.92 ± 68.03 vs 204.92 ± 81.76, P = 0.022). Additionally, GLP-1 levels remained stable after 60 and 120 min at day 1 (P = 0.816) and day 3 (P = 0.955). Vegetables consumption before carbohydrate is a promising and simple method of diabetes diet for maintaining blood glucose and GLP-1 levels and preventing from vascular complication.

Различия модуляции ответов мозга на эмоциональные стимулы у мужчин и женщин при биполярной депрессии

Study Objective: To investigate the prognostic and therapeutically significant characteristics in neurophysiological reactivity of male and female patients with bipolar depression. Study Design: comparative controlled non-randomized clinical experimental study. Materials and Methods. 53 patients (26 men and 27 women) with bipolar depression were examined before the start of their psychopharmacotherapy. They were aged from 21 to 59 years. There were no significant differences between men and women on the Hamilton Depression and Anxiety Scale. The groups of healthy volunteers included 23 men and 29 women of the corresponding age. The participants sorted the photos, 80 of which were images of angry/aggressive people or animals, and 80 had neutral expressions. Simple figures (keys) were displayed 2 seconds before the pictures, their connection with the photographs was not explained. A 128-channel electroencephalogram was recorded and the brain responses elicited by the keys were analyzed. Differences (p &lt; 0.05) between neutral and emotional conditions were defined as emotional modulation (EM). Study Results. EM differences in male and female patients were more pronounced than in the control groups. In women with bipolar depression, EM was consistently located in the posterior areas of the cortex from 100 ms to the end of the analysis period. The EM for the P100 component was missing, and the EM topography for P200 was closer to normal than in men. The EM of components N170 and P380 in patients differed depending on their sex and differed from EM of healthy controls of the same sex. Conclusions. The EM of the brain activity in patients with bipolar depression differs from the EM of healthy people. The differences depend on the gender of the patient and affect several components of the evoked brain activity. This suggests that it is important to take into account the gender of the subjects when studying affective disorders in patients. Keywords: emotional modulation, high-density EEG, bipolar depression, implicit learning, facial expression, anger.

Myoelectric Activity and Fatigue in Low-Load Resistance Exercise With Different Pressure of Blood Flow Restriction: A Systematic Review and Meta-Analysis.

Background: Low-load resistance exercise (LL-RE) with blood flow restriction (BFR) promotes increased metabolic response and fatigue, as well as more pronounced myoelectric activity than traditional LL-RE. Some studies have shown that the relative pressure applied during exercise may have an effect on these variables, but existing evidence is contradictory.Purpose: The aim of this study was to systematically review and pool the available evidence on the differences in neuromuscular and metabolic responses at LL-RE with different pressure of BFR.Methods: The systematic review and meta-analysis was reported according to PRISMA items. Searches were performed in the following databases: CINAHL, PubMed, Scopus, SPORTDiscus and Web of Science, until June 15, 2021. Randomized or non-randomized experimental studies that analyzed LL-RE, associated with at least two relative BFR pressures [arterial occlusion pressure (AOP)%], on myoelectric activity, fatigue, or metabolic responses were included. Random-effects meta-analyses were performed for MVC torque (fatigue measure) and myoelectric activity. The quality of evidence was assessed using the PEDro scale.Results: Ten studies were included, all of moderate to high methodological quality. For MVC torque, there were no differences in the comparisons between exercise with 40–50% vs. 80–90% AOP. When analyzing the meta-analysis data, the results indicated differences in comparisons in exercise with 15–20% 1 repetition maximum (1RM), with higher restriction pressure evoking greater MVC torque decline (4 interventions, 73 participants; MD = −5.05 Nm [95%CI = −8.09; −2.01], p = 0.001, I2 = 0%). For myoelectric activity, meta-analyses indicated a difference between exercise with 40% vs. 60% AOP (3 interventions, 38 participants; SMD = 0.47 [95%CI = 0.02; 0.93], p = 0.04, I2 = 0%), with higher pressure of restriction causing greater myoelectric activity. This result was not identified in the comparisons between 40% vs. 80% AOP. In analysis of studies that adopted pre-defined repetition schemes, differences were found (4 interventions, 52 participants; SMD = 0.58 [95%CI = 0.11; 1.05], p = 0.02, I2 = 27%).Conclusion: The BFR pressure applied during the LL-RE may affect the magnitude of muscle fatigue and excitability when loads between 15 and 20% of 1RM and predefined repetition protocols (not failure) are prescribed, respectively.Systematic Review Registration: [http://www.crd.york.ac.uk/prospero], identifier [CRD42021229345].

Promoting urinary continence with nonpharmacological interventions in Parkinson's disease.

Background: The evidence of nonpharmacological interventions promoting urinary continence in Parkinson's disease is low and rehabilitation nurses do not give it a high priority. Aim: To examine the effects of a urinary incontinence management program on continence and quality of life in persons with Parkinson's disease in inpatient rehabilitation. The acceptance of the intervention and the knowledge of the nurses were also of interest. Methods: A nonrandomized experimental study was conducted. The data collection commenced with a control group followed by an intervention group. A structured urinary incontinence management was performed in the intervention phase. This includes incontinence assessment, care planning, individual interventions, discharge planning, and telephone support at home. Results: Urinary continence and quality of life were enhanced in both groups; however, improvements were higher in the intervention group but the differences were not significant. Knowledge of the nurses about urinary incontinence improved during the study duration. The acceptance of the intervention was high. Conclusions: A structured urinary continence management may improve urinary continence in persons suffering from Parkinson's disease. In clinical practice it is important to perform a detailed assessment to identify problems regarding urinary incontinence.

Propranolol significantly reduced DNA polymerase β expression in patients with essential tremor

Background Essential tremor (ET) is the most common movement disorder. Propranolol is a first-line medication for ET. We aimed to evaluate the effect of propranolol on the expression of poly (ADP-ribose) polymerase 1 (PARP1) and DNA polymerase beta (POLB) genes, which are known to be related to neurodegenerative diseases, in patients with ET. MethodsThirty-five healthy volunteers and thirty-five patients followed up with essential tremors were included in a non-randomized control experimental study. Expressions of PARP1 and POLB genes were compared between the control group and the patient group. In addition, pre- and post-treatment gene expression levels and Fahn-Tolosa-Marin tremor scale values of the patient group were compared after 8 weeks of propranolol treatment. The Wilcoxon rank and Mann Whitney U tests were used to analyze the data. ResultsAt baseline, PARP1 expression was significantly lower in the ET group than in the control group. (p&lt;0.001). POLB gene expression was significantly higher in the pre-treatment ET group than in the controls (p&lt;0.05). There was no significant difference in PARP1 expression levels before and after 8 weeks of propranolol treatment. POLB gene expression was significantly higher in the pre-treatment group than in the post-treatment group (p&lt;0.001). ConclusionPropranolol significantly decreased POLB gene expression but there was no significant difference in PARP1 gene expression levels in the patient group, after 8 weeks of propranolol treatment.

Towards an inclusive digital literacy: An experimental intervention study in a rural area of Brazil.

About half of the world's population remains without access to internet in an era of digital transformation. In this study, we aimed to investigate the impact of implementing the use of logic and mathematics through digital literacy on a population of elementary school students in a town in Northeast Brazil. In a non-randomized experimental longitudinal intervention study, 5th-grade students were followed during one semester. They underwent observational testing during class with the use of scales to evaluate their activities in a digital environment, and they were evaluated with respect to their ability to use digital devices. A logic/math assessment was applied prior to and at the end of the course for intervention group and compared to a control group. Questionnaires were used to assess the educators', legal guardians' and students’ perceptions on digital habits and their respective sociodemographic features. The intervention consisted of a 16-h long course developed consisting of 8 2-h long classes which focused on digital technology, digital culture, and computational thinking. The students had a strong interest in the classes. Although some students did not have prior contact with computers, their development was outstanding. Digital literacy competencies and technology-use behavior increased throughout the semester independent of family income and use of digital devices at home. Students progressively improved their interaction with the computer (e.g. touchpad and typing skills) and their confidence in the digital environment. Students’ scores on the logic/math assessment showed significant improvement. This was not observed in the control group, demonstrating the importance of this type of intervention even with one provided by a 16-h course.Supplementary InformationThe online version contains supplementary material available at 10.1007/s10639-021-10711-z.

Synergistic Effect of Coconut Water and Garlic Tincture on Lipids and Oxidative Profile of Albino Rats Treated with High Fat Diet and Alcohol

Aim: This study evaluated the combined effect of coconut water and garlic tincture on lipid and antioxidants profile of albino rats fed with high fat diet and alcohol.&#x0D; Study Design: This study is a non-randomized experimental study design.&#x0D; Place and Duration of Study: Rivers State University Chemical Pathology Laboratory, Department of Medical Laboratory Science, the study was done between 20th November, 2018-30th June 2019.&#x0D; Methodology: A total number of 45 Wister albino rats were used with the weight ranged from 120-200 grams. The animals were grouped into two major groups, the control Group A and the test Group B. Blood samples were collected via cardiac puncture into heparinized bottle for standard laboratory investigation of lipid profile, and Superoxide dismutase (SOD), Total antioxidant capacity (TAC) and Malondialdehide (MDA). Plasma SOD and MDA were determined using ELISA methods, TAC was determined using FRAP Colorimetric method while lipid profile were determined using enzymatic method.&#x0D; Results: The results revealed that, alcohol induced oxidative stress group exhibited significant differences in MDA levels amongst the groups, and no significance differences in SOD and TAC levels as compared with negative control groups. There were significant differences in the Total Cholesterol and low density lipoprotein levels, amongst the groups. However, these changes appear to improve with coconut water and garlic tincture treatment. Treatment with coconut water alone following 30% alcohol treatment, showed a significant decrease in MDA level, no significant increase in SOD and TAC. Similar observation was recorded for the garlic tincture treatment alone. Treatment with low dose of combined coconut water with garlic tincture following 30% alcohol treatment, shows significant decrease in MDA level, significant increase in SOD, no significant increase in TAC. Treatment with low and higher doses of combined coconut water with garlic tincture following HFD treatment showed similar results, no significant decrease in TG levels, a significant decrease in MDA, TC and LDL levels, a significant increase in TAC and HDL levels and no significant increase in SOD. However, no difference was observed at higher dose. Histological findings revealed changes in hepatocellular architecture, such as inflammatory cell aggregates, dilation of sinosidal space, fatty droplet after treatment with alcohol and high fat diet. However, upon garlic tincture and coconut water treatment, there was amelioration of these abnormalities.&#x0D; Conclusion: The mixture of coconut water and garlic tincture seem to exerted an antioxidant and antiatherogenic effect on alcohol-induced oxidative stress and HFD-induced dyslipidaemia in rats.

Choosing an ideal second layer cover in snodgrass repair for various types of hypospadias.

In this study, we aimed to assess the results of tunica vaginalis flap (TVF), dorsal preputial dartos flap (DPF), and spongioplasty alone as additional cover after neourethra formation in a Snodgrass repair for various types of hypospadias as per the selection criteria decided. This was a non-randomized experimental study of 97 patients with primary hypospadias treated via Snodgrass repair using various second layers (tunica vaginalis flap, dorsal preputial dartos flap, and spongiosum alone) as per the selection criteria in a single center by a single surgeon. The outcome of the procedure was assessed in terms of cosmesis, chordee correction, urinary stream, and uroflowmetry. Of the 97 patients, we used dorsal preputial dartos flap in 42 (43.3%), tunica vaginalis in 38 (39.2%), and spongioplasty only in 17 (17.5%) for primary hypospadias. Urethrocutaneous fistula developed in four patients (three in DPF and one in the TVF groups). One patient each had skin necrosis, hematoma, and wound dehiscence in the DPF group. In the spongioplasty only group, one patient had meatal stenosis which was treated by meatoplasty after failing repeated periodic calibration. DPF should be preferably used for distal penile and TVF for mid and proximal penile hypospadias to ensure excellent result with minimum complications. Spongioplasty only as a second layer is sufficient to avoid the complications wherever it is thick and robust.

Are There Effective Intervention Strategies Available to Improve Physical Literacy in Adults? A Critically Appraised Topic

Clinical Scenario: Physical inactivity among adults is prevalent. Physical literacy is a potential modifiable factor that, if targeted effectively, may increase physical activity and decrease the risk of health conditions that are associated with physical inactivity. Clinical Question: Are there effective intervention strategies available to improve physical literacy in adults? Summary of Key Findings: Two nonrandomized experimental studies were included. Both studies assessed changes in physical literacy before and after a physical literacy intervention using two different sets of physical literacy outcome measures. Clinical Bottom Line: There is currently Level 2, limited quality, patient-oriented evidence that indicates that physical literacy can be improved in an adult population. The creation of a valid and reliable physical literacy outcome measure for adults is a necessary next step to enhance knowledge about physical literacy among adults. Future research should use a randomized control trial design to test the efficacy of physical literacy interventions with valid and reliable outcome measures. Strength of Recommendation: There is Level 2, limited quality, patient-oriented evidence for physical literacy interventions among adults. Due to the limited number of, and lack of consistency between studies, the authors did not make a formal grade recommendation.

Effectiveness of a physical activity intervention program using peer support among sedentary women in Thiruvananthapuram City, India: results of a non-randomized quasi experimental study

Background: Interventions to promote physical activity are very limited in India. The objective of this study was to assess the effectiveness and sustainability of a peer support based physical activity (PA) intervention targeting sedentary women in Thiruvananthapuram City, India . Methods: We used a non-randomized quasi-experimental study design with a comparison group. Using the Global Physical Activity Questionnaire (GPAQ) classifications, 401 sedentary women aged 18-64 years were selected by multistage cluster sampling and enrolled into the intervention (n=200) and control (n=201) arms. For the intervention arm, a culturally relevant intervention was delivered to the community stakeholders, participants and peer leaders at three subsequent intensities: intense (three months), less intense (three months) and no intervention (six months). The intervention consisted of a non-communicable disease (NCD) risk assessment, educational workshop, group counselling sessions, goal setting, handbook and peer support. The control participants received printed information on NCDs and their risk factors. PA assessments and anthropometric measurements were made at baseline, 4 th, 7 th and 13 th months. Mixed model analysis was done to assess the difference in PA levels between groups at various time points. Results: The proportion of women who were physically active (≥600 MET minutes per week) was significantly higher in the intervention arm compared to the control arm at 4 th (58.5 % vs 10%, p= 0.001), 7 th (48.5% vs 6%, p= 0.001)) and 13 th month (29.6 % vs 0.6%, p =0.001), respectively. Improvements from baseline PA expended by the intervention arm compared to the control arm in MET-min / week were 990, 575, and 466 at 4 th, 7 th and 13 th months, respectively. Conclusions: A PA intervention using peer support was found to be effective among women in India. Improvements in PA in the intervention arm decreased over time particularly after the no-intervention phase indicating the need for integrating it with community organizations.

Effectiveness of a physical activity intervention program using peer support among sedentary women in Thiruvananthapuram City, India: results of a non-randomized quasi experimental study.

Background: Interventions to promote physical activity are very limited in India. The objective of this study was to assess the effectiveness and sustainability of a peer support based physical activity (PA) intervention targeting sedentary women in Thiruvananthapuram City, India . Methods:We used a non-randomized quasi-experimental study design with a comparison group. Using the Global Physical Activity Questionnaire (GPAQ) classifications, 401 sedentary women aged 18-64 years were selected by multistage cluster sampling and enrolled into the intervention (n=200) and control (n=201) arms. For the intervention arm, a culturally relevant intervention was delivered to the community stakeholders, participants and peer leaders at three subsequent intensities: intense (three months), less intense (three months) and no intervention (six months). The intervention consisted of a non-communicable disease (NCD) risk assessment, educational workshop, group counselling sessions, goal setting, handbook and peer support. The control participants received printed information on NCDs and their risk factors. PA assessments and anthropometric measurements were made at baseline, 4 th, 7 th and 13 th months. Mixed model analysis was done to assess the difference in PA levels between groups at various time points. Results: The proportion of women who were physically active (≥600 MET minutes per week) was significantly higher in the intervention arm compared to the control arm at 4 th (58.5 % vs 10%, p= 0.001), 7 th (48.5% vs 6%, p= 0.001)) and 13 th month (29.6 % vs 0.6%, p =0.001), respectively. Improvements from baseline PA expended by the intervention arm compared to the control arm in MET-min / week were 990, 575, and 466 at 4 th, 7 th and 13 th months, respectively. Conclusions: A PA intervention using peer support was found to be effective among women in India. Improvements in PA in the intervention arm decreased over time particularly after the no-intervention phase indicating the need for integrating it with community organizations.

The Effects of Caffeine on Voice: A Systematic Review

Caffeine is considered a dehydrating agent due to its diuretic effects and influences the body's fluid balance. The relationship between voice and hydration has been widely investigated and it is accepted that inadequate hydration has detrimental effects on phonation. Since dehydration negatively affects the vocal folds and caffeine is considered a dehydrating agent, it can be hypothesized that voice might be negatively affected by caffeine intake. This systematic review aims to summarize and appraise the available evidence regarding the effects of caffeine on voice. Randomized and non-randomized experimental studies of healthy participants were retrieved following an electronic searching of six databases in June 2020. No publication, language or date restrictions were applied. Data extraction of relevant data and risk of bias assessment was conducted independently by two reviewers. Five non-randomized experimental studies were deemed eligible for inclusion. The format of the administered interventions in the included studies was either liquid (coffee) or solid (caffeine tablets). Reported outcome measures used to examine the effects of caffeine on phonation consisted of acoustic, aerodynamic and (auditory & self-) perceptual. No measures were adversely affected by caffeine consumption. Clinicians commonly advise patients to refrain from caffeine, as caffeine intake increases diuresis with subsequent effects on fluid balance. Such imbalances can potentially induce dehydration which can be detrimental to phonation. This notion cannot be supported empirically, as the evidence is deemed unreliable and no firm conclusions can be elicited to guide clinical practice. The results of this review demonstrate the lack of research in the field and the necessity for future investigations in order to inform evidence-based practice through reliable and valid outcomes.

Effects of Drawing Therapy on Pediatric Oncology Patients

A small but significant number of children and adolescents with cancer experience severe physical and psychological distress. Previous studies have shown that drawing therapy positively affects relieving psychological problems. However, the effect of drawing therapy on pediatric oncology patients has not been established by systematic review. The aim of this study was to determine the effect of drawing therapy on the pediatric oncology population. PubMed, EMBASE, MEDLINE, Cochrane, PsycINFO, CINAHL, and Chinese databases including CNKI, Wanfang, VIP, and CBM were searched. Studies published in the English and Chinese languages up to December 2019 were screened, and randomized controlled trials and nonrandomized experimental studies of drawing therapy interventions for pediatric oncology patients were reviewed. Screening was undertaken independently by 2 reviewers. The review protocol was registered with PROSPERO (registration number: CRD42020178365). Eight studies were included. Three studies were randomized controlled trials, and 5 studies were nonrandomized experimental studies. Seven studies showed that drawing therapy had positive effects on reducing depression and anxiety and improving quality of life. However, 1 study showed a contradictory result, that is, participants had an increased anxiety level after intervention. Drawing therapy is effective in improving negative emotions, relieving somatic symptoms, and increasing social communication for pediatric oncology patients. Drawing therapy may be considered an adjuvant psychological intervention strategy for pediatric oncology patients. Meanwhile, more rigorous studies are needed to address the deficiencies of small number size and methodological weakness.

Comparative effect of physical exercise versus statins on improving arterial stiffness in patients with high cardiometabolic risk: A network meta-analysis.

The comparative analysis of the effect of several doses of statins against different intensities of physical exercise on arterial stiffness (a measure of cardiovascular risk) could shed light for clinicians on which method is most effective in preventing cardiovascular disease (CVD) and be used to inform shared decision-making between doctors and patients. This study was aimed at analyzing the effect, in high cardiometabolic risk patients, of different statins doses and exercise intensities on arterial stiffness (a measure of cardiovascular risk) by integrating all available direct and indirect evidence in network meta-analyses. We systematically searched MEDLINE, Embase, SPORTDiscus, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science databases from their inception to February 28, 2020; for unpublished trials, we also searched ClinicalTrials.gov. We searched for studies concerning the effect of statins or physical exercise on arterial stiffness, measured by pulse wave velocity (PWV). For methodological quality assessment, Cochrane Collaboration's tool for assessing risk of bias (RoB2) was used. A network geometry graph was used to assess the strength of the evidence. Comparative evaluation of the interventions effect was performed by conducting a standard pairwise meta-analysis and a network meta-analysis (NMA) for direct and indirect comparisons between interventions and control/nonintervention. A total of 22 studies were included in the analyses (18 randomized controlled trials (RCTs) and 4 nonrandomized experimental studies), including 1,307 patients with high cardiometabolic risk from Asia (3 studies), Oceania (2 studies), Europe (10 studies), North America (5 studies), and South America (2 studies). The overall risk of bias assessed with RoB2 was high in all included studies. For standard pairwise meta-analysis and NMA, high-intensity exercise versus control (mean difference (MD) -0.56; 95% CI: -1.01, -0.11; p = 0.015 and -0.62; 95% CI: -1.20, -0.04; p = 0.038, respectively) and moderate statin dose versus control (MD -0.80, 95% CI: -1.59, -0.01; p = 0.048 and -0.73, 95% CI: -1.30, -0.15; p = 0.014, respectively) showed significant MDs. When nonrandomized experimental studies were excluded, the effect on high-intensity exercise versus control and moderate statin dose versus was slightly modified. The main limitation of this study was that the magnitude of the effect of the exercise interventions could be underestimated due to regression toward the mean bias because the baseline cardiometabolic risk profile of patients in the physical exercise intervention trials was healthier than those in the statins ones; consequently, more modest improvements in physical exercise interventions compared to statins interventions can be expected. Additionally, we might consider as limitations the small study sizes, the heterogeneous patient groups, the focus on a proxy endpoint (PWV), and the high risk of bias. In this NMA, we found that although many patients could benefit from statins for reducing CVD risk, our results support that, considering the beneficial effects of high-intensity exercise on arterial stiffness, it would be worthwhile to refocus our attention on this type of exercise as an effective tool for the prevention of CVD. PROSPERO CRD42019123120.