scholarly journals Artificial intelligence-assisted clinical decision support for childhood asthma management: A randomized clinical trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0255261
Author(s):  
Hee Yun Seol ◽  
Pragya Shrestha ◽  
Joy Fladager Muth ◽  
Chung-Il Wi ◽  
Sunghwan Sohn ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Primary Care ◽  
Clinical Trial ◽  
Decision Support ◽  
Intervention Group ◽  
Asthma Management ◽  
Clinical Decision ◽  
Control Group ◽  
Asthma Care ◽  
Significant Difference

Rationale Clinical decision support (CDS) tools leveraging electronic health records (EHRs) have been an approach for addressing challenges in asthma care but remain under-studied through clinical trials. Objectives To assess the effectiveness and efficiency of Asthma-Guidance and Prediction System (A-GPS), an Artificial Intelligence (AI)-assisted CDS tool, in optimizing asthma management through a randomized clinical trial (RCT). Methods This was a single-center pragmatic RCT with a stratified randomization design conducted for one year in the primary care pediatric practice of the Mayo Clinic, MN. Children (<18 years) diagnosed with asthma receiving care at the study site were enrolled along with their 42 primary care providers. Study subjects were stratified into three strata (based on asthma severity, asthma care status, and asthma diagnosis) and were blinded to the assigned groups. Measurements Intervention was a quarterly A-GPS report to clinicians including relevant clinical information for asthma management from EHRs and machine learning-based prediction for risk of asthma exacerbation (AE). Primary endpoint was the occurrence of AE within 1 year and secondary outcomes included time required for clinicians to review EHRs for asthma management. Main results Out of 555 participants invited to the study, 184 consented for the study and were randomized (90 in intervention and 94 in control group). Median age of 184 participants was 8.5 years. While the proportion of children with AE in both groups decreased from the baseline (P = 0.042), there was no difference in AE frequency between the two groups (12% for the intervention group vs. 15% for the control group, Odds Ratio: 0.82; 95%CI 0.374–1.96; P = 0.626) during the study period. For the secondary end points, A-GPS intervention, however, significantly reduced time for reviewing EHRs for asthma management of each participant (median: 3.5 min, IQR: 2–5), compared to usual care without A-GPS (median: 11.3 min, IQR: 6.3–15); p<0.001). Mean health care costs with 95%CI of children during the trial (compared to before the trial) in the intervention group were lower than those in the control group (-$1,036 [-$2177, $44] for the intervention group vs. +$80 [-$841, $1000] for the control group), though there was no significant difference (p = 0.12). Among those who experienced the first AE during the study period (n = 25), those in the intervention group had timelier follow up by the clinical care team compared to those in the control group but no significant difference was found (HR = 1.93; 95% CI: 0.82–1.45, P = 0.10). There was no difference in the proportion of duration when patients had well-controlled asthma during the study period between the intervention and the control groups. Conclusions While A-GPS-based intervention showed similar reduction in AE events to usual care, it might reduce clinicians’ burden for EHRs review resulting in efficient asthma management. A larger RCT is needed for further studying the findings. Trial registration ClinicalTrials.gov Identifier: NCT02865967.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

The effect of continuous care model-based intervention on the quality of sleep in menopausal women: A clinical trial study

2019 ◽  
Author(s):  
Farzaneh AKBARI ◽  
sousan Heydarpour ◽  
Nader Salari
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Control Group ◽  
Quality Of Sleep ◽  
Care Model ◽  
Continuous Care ◽  
Menopausal Women ◽  
Significant Difference ◽  
The Difference

Abstract BACKGROUND Sleep disorder, brings in many physical, behavioral, and mental problems. Applying continuous care model leads to proper recognition of the patient’s problems and involves the patient in solving health problems. This study aimed to determine the effect of continuous care model on the quality of sleep in menopausal women. METHODS AND MATERIALS A random clinical trial study was carried out with participation of 110 menopausal women visiting Kermanshah-based clinics (the west of Iran) in 2017. The participants were randomly assigned to intervention (n=55) and control (n=55) groups. The control group received the routine cares and in addition to the routine cares the intervention group attended four weekly group consultation sessions (60-90min). The quality of sleep in the two groups was assessed using Pittsburg Sleep Quality Index before, immediately after, and one month after the intervention. Data analyses were done using independent t-test, ANOVA with frequent measures, Friedman’s test, Wilcoxon’s post hoc test, and X2 test in SPSS (24). RESULTS The mean scores of quality of sleep before and after the intervention were significantly different in the intervention group (p=0.001). There was no significant difference between the two groups in terms of quality of sleep before (p=0.140) and immediately after the intervention (p=0.168). However, one month after, the difference between the two groups was significant (P<0.001). CONCLUSION Implementation of the continuous care model led to an improvement of quality of sleep in the menopausal women.

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

scholarly journals Effect of lifestyle education based on Pender model on health-promoting behaviors in HIV positive individuals: A randomized clinical trial study

2020 ◽  
Author(s):  
Farah Khani ◽  
Shahzad Pashaeypoor ◽  
Nasrin Nikpeyma
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Interpersonal Relationships ◽  
Spiritual Growth ◽  
Intervention Group ◽  
Control Group ◽  
Hiv Patients ◽  
Health Promoting Behaviors ◽  
Significant Difference ◽  
Health Promoting

Background & Aim: Human Immunodeficiency Virus (HIV) prevalence is increasing, and this disease has become a crisis for the modern world. Today, the survival of patients has been increased, such that HIV is considered a chronic disease. So, Paying attention to health-promoting intervention is necessary. Thus, the current study aims to determine the effect of educating lifestyle based on the Pender model on health-promoting behaviors in HIV patients. Methods & Materials: In this randomized clinical trial study, 70 HIV patients who had inclusion criteria were selected and then divided into intervention and control groups randomly. The intervention group received 6 one-hour education sessions weekly based on Pender lifestyle (nutrition, physical activity, stress management, spiritual growth, interpersonal relationships, and health responsibility). A demographic questionnaire and HPLP2 were used, which were completed by both groups before the intervention and 8 weeks after the intervention. Chi-Square, Fisher, Independent t, and ANCOVA statistical tests and SPSS 16 software were used to analyze data. Results: results showed that there was no significant difference in various dimensions of health-promoting lifestyle between two groups before intervention. However, intervention group scores for nutrition (28.08±6.23 vs. 23.58±6.04), physical activity (22.26±6.46 vs. 16.39±6.09), stress management (25.03±5.14 vs. 19.96±6.41), spiritual growth (29.49±6.11 vs. 25.45±8.54), interpersonal relationships (29.17±6.14 vs. 23.11±7.45) and health responsibility (28.36±6.06 vs. 23.89±5.74) were significantly higher than control group 8 weeks after intervention. Moreover, the total score of health-promoting behaviors had a significant difference in the intervention group compared to the control group (166.7±28.43 vs. 134.5±35.68, p<0.001). Conclusion: Based on the findings, it can be said that educating lifestyle based on the Pender model causes HIV patients to use health-promoting behaviors, which are recommended as a useful theory-based program for managers and providers of health services.

scholarly journals Pain Experience with Micro-osteoperforations during Initial Orthodontic Alignment: A Randomized Clinical Trial.

2020 ◽  
Vol 9 (4) ◽  
pp. 309-318
Author(s):  
Azaitun Akma Shahrin ◽  
◽  
Sarah Haniza Abdul Ghani ◽  
Noraina Hafizan Norman ◽  
◽  
...  
Keyword(s):  
Clinical Trial ◽  
Repeated Measures ◽  
Pain Perception ◽  
Tooth Movement ◽  
Intervention Group ◽  
Orthodontic Tooth Movement ◽  
Control Group ◽  
Initial Alignment ◽  
Significant Difference ◽  
Fixed Appliances

Objetive: The objective of this clinical trial was to investigate the perception of pain during initial maxillary alignment with an adjunctive procedure of micro-osteoperforations (MOPs) compared to conventional orthodontics. Material and methods: This study design was a single-centre, two-arm parallel prospective randomised clinical trial. Thirty consecutive adult subjects (25 females and 5 males; mean age ± SD, 22.66 ± 3.27 years) with 5-8mm moderate upper labial segment crowding were randomly allocated using block randomisation into intervention and control group. All subjects had first premolar extractions, bonded conventional fixed appliances and 0.014-inch nickel-titanium archwire was placed for initial alignment. The intervention group received a 3-mm deep MOPs procedure under local anaesthesia using a Propel device (PROPEL Ortho Singapore) on the labiogingival aspect between the maxillary incisors. Both groups received a set of 100 mm visual analogue scale to complete over the first week, recording pain at 24 hours, 3 days and 1 week. Data were analysed using repeated-measures analysis of variance (ANOVA). Results: There was a statistically significant difference observed in perceived pain levels between MOPs and the control group on day 1, day 3 and day 7 postoperatively. Pain perception was significantly lower in the intervention group at all time points. Conclusion: Accelerating orthodontic tooth movement with MOPs did not accentuate pain perceived during initial maxillary alignment with fixed appliances.

scholarly journals Effects of Levothyroxine Treatment on Lipid Profile in Subclinical Hypothyroidism: A Randomized Clinical Trial

2015 ◽  
Vol 4 (2) ◽  
pp. 72-77
Author(s):  
Karoon Shahebrahimi ◽  
Rozita Naseri ◽  
Tahereh Sadat Kalantarian ◽  
Mehrali Rahimi ◽  
Farid Najafi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Profile ◽  
Subclinical Hypothyroidism ◽  
Serum Lipids ◽  
Intervention Group ◽  
Control Group ◽  
Significant Difference ◽  
Before And After ◽  
Clinically Significant ◽  
Levothyroxine Treatment

Background: Studies demonstrated controversial results on subclinical hypothyroidism (SCH) regarding lipid profile alteration with or without Levothyroxine treatment. The purpose of this study is to investigate the effects of Levothyroxine on serum lipids in SCH. Materials and Methods: One hundred patients with SCH referred to Taleghani hospital in Kermanshah were recruited and randomly assigned into the intervention or the control group. Patients in intervention group received Levothyroxine 50-75 micrograms for three months. Patients in control group received the same placebo with the same dose and duration. Lipid profile was measured before and after the trial and the changes were compared between groups. (IRCT code: 138903244179N1). Results: Triglyceride, Total Cholesterol, LDL, HDL and Lipoprotein-A were measured before and after treatment. None of the factors showed significant difference either between or within groups, before and after the treatment (P<0.05). Conclusion: Treating with Levothyroxine does not have any clinically significant impact on lipid profile in SCH patients which indicates that we should not expect SCH patients to use Levothyroxine solely for lipid profile alternation, except those with other clinical indications for treatment.[GMJ.2015;4(2):72-77]

scholarly journals Effectiveness of a Group Educational Intervention – Prolact - In Primary Care to Promote Exclusive Breastfeeding. A Cluster Randomized Clinical Trial.

2021 ◽  
Author(s):  
María Jesús Santamaría-Martín ◽  
Susana Martín Iglesias ◽  
Christine Schwarz ◽  
Milagros Rico-Blázquez ◽  
Julián Alexander Portocarrero-Nuñez ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Educational Intervention ◽  
Exclusive Breastfeeding ◽  
Intervention Group ◽  
Control Group ◽  
Usual Practice ◽  
Factors Associated ◽  
Cluster Randomized

Abstract Background: The rates of exclusive breastfeeding at 6 months in Spain are far from the target recommended by the World Health Organization, which is 50% by 2025. Evidence of the effectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the effectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6 months compared to the usual practice in primary care.Method: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads (215 in the control group and 219 in the intervention group) who breastfed exclusively in the first 4 weeks of the infant's life and agreed to participate were included. The main outcome variable was exclusive breastfeeding at 6 months. Secondary variables were the type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the effectiveness, the difference in the proportions of dyads with exclusive breastfeeding at 6 months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6 months, a multilevel logistic regression model was fitted. All analyses were performed according to intention to treat.Results: The percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. The PROLACT intervention obtained an RR of 2.53 (95% CI 1.54-4.15) and an NNT of 7 (95% CI 5-14). The factors associated with exclusive breastfeeding at 6 months were the PROLACT intervention, OR 3.51 (95% CI 1.55-7.93); age > 39 years, OR 2.79 (95% CI 1.02-7.6); previous breastfeeding experience, OR 2.61 (95% CI 1.29-5.29); monthly income/person > 833.33 €, OR 2.15 (95% CI: 0.996-4.65); planning to start work before the infant was 6 months old, OR 0.35 (0.19-0.63); and use of a pacifier, OR 0.58 (95% CI 0.30-1.11).Conclusions: The PROLACT group educational intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months.Trial registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).

Beneficial effects of pelvic floor muscle exercises on sexual function among postmenopausal women: a randomised clinical trial

Sexual Health ◽  
2018 ◽  
Vol 15 (5) ◽  
pp. 396 ◽  
Author(s):  
Soheila Nazarpour ◽  
Masoumeh Simbar ◽  
Hamid Alavi Majd ◽  
Fahimeh Ramezani Tehrani
Keyword(s):  
Clinical Trial ◽  
Sexual Function ◽  
Pelvic Floor ◽  
Postmenopausal Women ◽  
Pelvic Floor Muscle ◽  
Intervention Group ◽  
Randomised Clinical Trial ◽  
General Information ◽  
Control Group ◽  
Significant Difference

Background The adverse effects of menopause on sexual function could be mitigated by pelvic floor muscle (PFM) training. This study aimed to investigate the effects of PFM exercises on sexual function in postmenopausal women. Methods: A randomised clinical trial was conducted among 97 Iranian postmenopausal women, aged 40 to 60 years. The participants’ baseline sexual functions were assessed using the Female Sexual Function Index (FSFI) questionnaire. They were then randomly designated to two groups: (1) the intervention group, which received specific instructions on PFM exercises and was followed up on a weekly basis; and (2) the control group, which received general information on menopause. After 12 weeks, the sexual functions of the participants were reassessed. Results: No significant difference was initially observed between the two groups in terms of demographic and socioeconomic characteristics and total scores of FSFI. After the intervention, however, the scores of arousal, orgasm and satisfaction were significantly higher in the intervention group (3.10, 4.36, and 4.84 vs 2.75, 3.89, and 4.36 respectively; P < 0.05). Conclusion: PFM exercises have the potential to improve the sexual function of postmenopausal women and are thus suggested to be included in healthcare packages designed for postmenopausal women.

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