Parallel Randomized Clinical Trial Research Articles

Effectiveness of systemic acupuncture in the control of urinary incontinence following radical prostatectomy: a randomized clinical trial.

To evaluate the effectiveness of acupuncture associated with pelvic floor muscle training for the control of urinary incontinence following radical prostatectomy. Open-label, parallel randomized clinical trial. The intervention group (n = 33) underwent eight sessions of systemic acupuncture associated with pelvic floor muscle training and the control group (n = 31) performed only pelvic floor muscle training. The outcome variable was urinary incontinence assessed by the Pad Test and Daily Pad Used, before treatment (T0), after four weeks (T1) and after eight weeks of treatment (T2). Data analysis was performed using a longitudinal model of Generalized Estimating Equations, significance level of 0.05. The control group showed greater urinary loss compared to the intervention group at T1 (p = 0.006) and at T2 (p < 0.001). Both groups showed improvement in the level of urinary incontinence over time, but the improvement was greater in the intervention group (p < 0.001). Acupuncture associated with pelvic floor muscle training was effective in reducing urinary incontinence in prostatectomized men.Brazilian Registry of Clinical Trials:RBR-3jm5y2.

Effect of fertility health awareness strategies on fertility knowledge and childbearing in young married couples (FertStart): study protocol for an effectiveness-implementation hybrid type I multicentre three-arm parallel group open-label randomised clinical trial

IntroductionBirth rates have been declining in many advanced societies including Singapore. We designed two interventions with vastly different resource requirements, which include fertility education, personalised fertility information and a behavioural...

A Randomized Clinical Trial of the Effect of Zinc Supplement on Depression and Anxiety in the Elderly

Background: Anxiety and depression in the elderly are considered important mental disorders. Objective: This study was designed to determine the effect of zinc Supplementation on depression and anxiety in the elderly. Methods: This study was a parallel randomized clinical trial. A total of 150 elderly aged 60 years and older were allocated into intervention and control groups by using the quadruple blocking method. The elderly in the intervention group received a daily dose of 30 mg zinc supplementation pill for 70 days and the elderly in the control group did not receive this supplement. Depression and anxiety in the elderly were measured using the Geriatric Depression Scale and the Beck Anxiety Inventory, respectively. A significance level of 0.05 was considered for all statistical tests. Results: After the intervention, the mean scores of depression and anxiety in the elderly were significantly decreased in the intervention group, as compared with the control group. Moreover, after the intervention, the serum zinc level in the elderly was significantly increased in the intervention group, as compared with the control group (P&lt;0.05). Conclusion: The use of zinc supplements improved depression and anxiety in the elderly. Therefore, it is recommended to use zinc supplements as a new therapeutic strategy for the prevention and treatment of depression and anxiety in the elderly. Registration No: This research was registered in the Iranian clinical trial system with code IRCT2017071635110N1.

Left Ventricular End-Diastolic Pressure and B-Type Natriuretic Peptide Levels Guidance of Low-Dose Furosemide Treatment to Prevent Contrast-Induced Nephropathy in Patients with Percutaneous Coronary Intervention: A Randomized Controlled Trial

Objective. We aimed to explore the preventive effect of low-dose furosemide administration guided by left ventricular end-diastolic pressure (LVEDP) and B-type natriuretic peptide (BNP) based on adequate hydration on contrast-induced nephropathy (CIN) in patients with percutaneous coronary intervention (PCI). Methods. This parallel randomized clinical trial was conducted at a tertiary hospital in China. A total of 1053 consecutive patients (71.98% men) who underwent PCI at our hospital were enrolled. Pre-PCI plasma BNP levels were recorded. Patients enrolled received a continuous intravenous infusion of normal saline starting 4 h before PCI until 24 h after surgery. LVEDP was measured immediately after surgery. Patients in the control group received intravenous furosemide injection (20 mg). Patients in the experimental group received furosemide if they showed LVEDP ≥15 mmHg, a post-PCI BNP level ≥100 pg/mL, and/or a post-PCI BNP value &gt; 150% of the pre-PCI value. The primary and secondary outcome measures were serum creatinine levels, glomerular filtration rate, and creatinine clearance rate measured before and after PCI. CIN incidence was compared between the two groups. Logistic regression analysis was used to study the risk factors for CIN. Results. CIN incidence was significantly higher in the control group than in the experimental group ( P &lt; 0.05 ). Logistic regression analysis showed that elevated LVEDP and BNP levels were risk factors. As LVEDP increased, the CIN incidence also increased (odds ratio (OR) 1.038, 95% confidence interval (CI) 1.006–1.070). The OR of BNP was 1.001 (95% CI 1.000–1.002). Conclusions. Low-dose furosemide administration guided by LVEDP or BNP is superior to direct low-dose administration on the basis of adequate hydration during PCI. This trial is registered with ChiCTR-IOR-14005250

The effect of metformin and myoinositol on metabolic outcomes in women with polycystic ovary syndrome: role of body mass and adiponectin in a randomized controlled trial.

To compare the effects of insulin sensitizers metformin (MET) and myo-inositol (MI) on adiponectin levels and metabolic characteristics in women with polycystic ovary syndrome (PCOS) with respect to their body mass index (BMI). In this open label, parallel randomized clinical trial, 66 women with PCOS (33 normal-weight and 33 overweight/obese) were randomized to either MI (4g/day) or MET (1500mg/day) for a period of 6months. Serum concentration of adiponectin, hormonal and metabolic laboratory outcomes and clinical assessment of BMI, body composition and Ferriman-Gallwey score (FG score) were evaluated before and after treatment. After the 6-month intervention, comparison between MET and MI in time to treatment analysis showed no significant differences between the two treatments for all analyzed parameters. Only borderline significantly lower AUC glucose was found in the MET group in comparison to the MI group (p = 0.071). The main effect of treatment was shown for glucose concentration at 120min OGTT (p = 0.032) and testosterone (p = 0.002). The main effect of time was shown for body mass (p = 0.004), waist circumference (p < 0.001), BMI (p = 0.003), body fat mass (p = 0.001), adiponectin (p = 0.020), fasting glucose (p = 0.001), testosterone (p = 0.015), SHBG (p = 0.013), 17OH progesterone (p = 0.008), LH (p = 0.004) and estradiol (p = 0.014). Our study showed similar effects of MET and MI on BMI, body composition, hormonal profile, metabolism of glucose and insulin, and adiponectin level. The two insulin sensitizers, MET and MI, were useful in reducing BMI and improving body composition without significant differences between the two treatments in PCOS women. ISRCTN13199265. Trial registration date: 14.04.2021. (ISRCTN Registry), retrospectively registered.

Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision

The conventional 2.2-mm clear corneal incision is relatively narrow compared with the sleeves of Phaco handpieces, resulting in friction at the incision site and increased risk of incision-related Descemet membrane detachment (DMD). The modified 2.2-mm incision only enlarged internal width to 3.0 mm, forming a trapezoid incision shape, which may reduce the friction of surgical instruments and decrease the risk of incisional DMD. To compare the incidence of incision-related DMD between eyes undergoing modified vs conventional 2.2-mm incision phacoemulsification for hard nuclear age-related cataract. This double-masked, parallel randomized clinical trial was conducted from July 22, 2019, to January 22, 2020, at Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. The study included patients with age-related cataract and nuclear opalescence grade of 4.0 or greater based on the Lens Opacities Classification System III. Patients were enrolled in this study according to the following inclusion criteria: (1) age between 65 to 90 years; (2) pupil size of 6 mm or greater after dilation; (3) Lens Opacities Classification System III nuclear opalescence grade of 4.0 or more; and (4) corneal endothelial cell density greater than 1500 cells/mm2. Modified (enlarged internal width to 3.0 mm) or conventional 2.2-mm incision phacoemulsification with intraocular lens implantation. Incidence of incision-related DMD at postoperative day 1. A total of 130 eyes of 130 patients were randomized into the conventional group (n = 65) or the modified group (n = 65). The mean (SD) age of participants was 74.5 (5.9) years and 74.3 (6.0) years in the conventional and modified groups, respectively. A total of 26 participants in the conventional group (40%) and 27 in the modified group (42%) were men. Compared with eyes in the conventional group, the incidence of DMD in eyes in the modified group was significantly lower at postoperative day 1 (difference, 26.15; 95% CI, 9.60-42.71; P = .003). The difference at postoperative day 7 was 16.92 (95% CI, 2.91-30.94; P = .02). The length of DMD (postoperative day 1: difference, 0.188; 95% CI, 0.075-0.301; P = .002) and maximal corneal thickness at incision site (postoperative day 1: difference, 0.032; 95% CI, 0.006-0.057; P = .02; postoperative day 7: difference, 0.019; 95% CI, 0.003-0.035; P = .02) were lower in the modified group, while visual quality parameter modulation transfer function (postoperative day 1: difference, -0.033; 95% CI, -0.064 to -0.001; P = .04) was higher. No difference was observed between the 2 groups in best-corrected visual acuity, central corneal endothelium loss, or surgically induced astigmatism at any follow-up time. There were no intraoperative complications in the 2 groups. These findings suggest that modified 2.2-mm trapezoid incision phacoemulsification reduces the incidence of DMD for hard nuclear age-related cataract at postoperative day 1 and might be considered in patients at high risk of incision-related DMD, although the clinical relevance cannot be determined with certainty from this trial. ClinicalTrials.gov identifier: NCT04014699.

The Potential Role of Aerosolized Colistin in the Ventilator-Associated Pneumonia Management Caused by Multidrug-Resistant Gram-Negative Bacteria: A Randomized Clinical Trial

Background: Infections caused by multidrug-resistant (MDR) pathogen have caused a resurgence of interest in colistin. To date, information about the effectiveness of Aerosolized Colistin (AS) is very limited in the treatment of Ventilator-Associated Pneumonia (VAP). The aim of this study is to evaluate the efficacy and safety of AS in conjunction with intravenous (IV) colistin in patients with VAP, caused by MDR Gram-Negative Bacteria (GNB).&#x0D; Methods: This parallel randomized clinical trial was conducted on patients with VAP in the Intensive Care Unit (ICU) ward. 27 patients allocated to the intervention or the control group. Patients in the intervention group received IV Colistin based on glomerular filtration rate along with aerosolized Colistin, 2 million units three times a day. In the control group, only IV Colistin was administered. For all patients, Procalcitonin (PCT), sputum culture, and Clinical Pulmonary Infection Score (CPIS) were evaluated and compared as outcome measures at the specified period of time.&#x0D; Results: Negative sputum culture was achieved in 9 (80%) out of 11 patients in the AS-IV Colistin group after seven days of therapy versus 9 (56.25%) out of 16 in the control group (P= 0.01). PCT and CPIS scores were not significantly different between two groups (P=0.21, P= 0.62). Furthermore, nephrotoxicity and neurotoxicity were not seen.&#x0D; Conclusion: AS Colistin lead to earlier negative sputum culture without increasing risk of nephrotoxicity and neurotoxicity, and could potentially be a beneficial adjunctive approach in the management of MDR-VAP.

A Parallel Randomized Clinical Trial for Comparison of Two Methods of Maggot Therapy, Free-Range Larvae and Larval-bag, in Diabetic Ulcer (Wagner 2).

In the present study, the efficiency of two formulations of maggot therapy: free-range larvae on the wounds and larvae in a special bag (larval-bag), was compared for healing diabetic ulcers with Wagner 2 diabetic ulcer. This study was conducted as a parallel randomized clinical trial. Out of 281 patients with Wagner grade 2 diabetic ulcers referred to the wound clinic, 54 patients who met the inclusion criteria were randomly assigned to intervention groups. The disinfected larvae of Lucilia sericata were put on the wounds with 2 methods, free-range larvae and larval-bag. Follow up was done at every 48 h interval until the full appearance of granulated tissues. The main measures were wound bed preparation, removing of necrotic tissues, appearing of granulated tissues, and removing of bacterial infections in the wounds. Statistical analysis based on the Kaplan-Meier curve and the Wilcoxon (Breslow) test showed a significant reduction in wound healing time by using free-range larvae in comparison with larval-bag (P = .03). The median time to debridement was 4 days in the free-range larval group (95% confidence interval: 3-9 days) while it was 9 days in the larval-bag group (95% confidence interval: 5-16 days). Debridement rate (proportion of removed necrotic tissue surfaces) at any time in the free-ranged larvae group was 1.78 times that of the bagged larvae group (95% confidence interval 1.01-3.15, P = .036). There was no significant difference between free-range larval use and larval-bag in the acceptability of maggot therapy by patients (P = .48). It can be concluded that both of two formulations of the larval therapy (free-range larvae and larval-bag) could be recommended for cleaning out and bed preparation of diabetic ulcers. However, using free-range larvae is hardly recommended on the wounds which are eligible to use.

Tooth alignment and pain experience with A-NiTi versus Cu-NiTi: a randomized clinical trial

BackgroundNickel-titanium (NiTi) archwires are routinely used for initial leveling and alignment of teeth in orthodontic treatment. This study aimed to clinically compare the level of pain and tooth alignment in orthodontic treatment with A-NiTi versus Cu-NiTi archwires.MethodsIn this parallel randomized clinical trial, 88 orthodontic patients (12–25 years) with an irregularity index > 2 mm in the anterior site of the lower dental arch who required non-extraction orthodontic treatment of the lower arch were randomized into two age- and sex-matched groups (n = 44) for treatment with A-NiTi and Cu-NiTi initial archwires. Each archwire was used for 6 weeks. After 6 weeks, the irregularity index was measured, and the level of pain was scored using the Modified McGill pain questionnaire (MPQ) and visual analog scale (VAS) according to the time of onset and duration of pain, and analgesic intake. Data were analyzed by paired t test, independent samples t test, and Chi-square test (P < 0.05).ResultsThe irregularity index significantly decreased in both groups after 6 weeks of treatment (P < 0.001). However, the difference in this respect was not significant between the two groups (P > 0.05). Pain perception (P = 0.487), duration of pain (P = 0.546), and analgesic intake (P = 0.102) were not significantly different between the two groups either.ConclusionBoth A-NiTi and Cu-NiTi archwires are equally effective for tooth alignment in the anterior site of the lower dental arch and have no significant difference with regard to the level of pain experienced by patients.Trial registration number: IRCT20190705044102N1 and Name of the registry: Iranian registry of clinical trials (https://irct.ir/) Date of registration: September, 26, 2019

Strengthening the success rate of suprapubic aspiration in infants by integrating point-of-care ultrasonography guidance: A parallel-randomized clinical trial.

BackgroundUrinary tract infection (UTI) is a common disease in childhood. A sterile collection of urine samples using suprapubic aspiration (SPA) and bladder catheterization (BC) is helpful for rapid and accurate diagnosis of UTI in infants. With the advent of point-of-care ultrasound (POCUS), the use of ultrasound by non-radiologists at the patient’s bedside, great advancement has been noticed in various medical fields. Considering the importance and advantages of using POCUS in the physical examination and guiding procedures, the authors aimed to compare urine sampling’s success rate by SPA, BC, and POCUS guided SPA (POCUS-SPA) in infants performed by three pediatricians.Materials and methodsThis study is a randomized clinical trial conducted on 114 neonates and infants with suspected UTI admitted to 17-Shahrivar children’s hospital from April 2017 to September 2019. Neonates and infants were randomly assigned to three groups of BC, SPA, and POCUS-SPA. The primary outcome was the success of sampling defined by obtaining 1cc of urine in each method. The secondary outcome was assessing the pain level.ResultsResults showed that the POCUS-SPA had the highest success rate in urine sampling, and a statistically significant relation was noted among the three groups (P = 0.0001). From 38 patients in each group, 37 patients of POCUS-SPA (97.4%), 34 patients of BC (89.5%), and 23 patients of SPA (60.5%) had a successful sampling. Most of the patients in all three groups experienced severe pain.ConclusionsIn the current study, results showed that the POCUS-SPA significantly increased the success rate of urine sampling and most of the patients in all three groups had severe pain. Based on the shortage of access to radiologists in emergency setups, it seems that the POCUS-SPA by the pediatricians can be one of the most appropriate and applicable diagnostic methods in infants with UTI.

The Effect of the Web-Based Communication between a Nurse and a Family Member on the Perceived Stress of the Family Member of Patients with Suspected or Confirmed COVID-19: A Parallel Randomized Clinical Trial.

The aim of this study was to identify the effect of web-based communication between a nurse and a family member of a patient with COVID-19 on his/her perceived stress. In this multicenter parallel randomized controlled trial, 67 family members of COVID-19 patients admitted to the Intensive Care Unit (ICU) were investigated. In the intervention group, web-based communication was performed for four consecutive days for 10 to 15 minutes. The Perceived Stress Scale (PSS-14) were completed in both groups before and after the intervention. Mean and standard deviation of perceived stress scores in the two groups were not significantly different (p = 0.26) before the intervention; however, after the intervention, the mean PSS-14 in the intervention group was significantly lower than that of the control group (p < 0.001). Due to the need to follow the physical and social distancing to protect against Coronavirus disease, the use of web-based communication recommended in future studies.

The Effect of Sexual Assertiveness Training on women’s genital self-image: A Randomized Clinical Trial

Background & aim: The genital self-image refers to women's attitudes, beliefs, and feelings about their genitalia and genital system that are involved in sexual intercourse. Sexual assertiveness is individuals' ability to meet their sexual needs. Considering the dearth of study on women�s genital self-image, this study aimed to evaluate the effectiveness of a sexual assertiveness training program on women�s genital self-image. Methods: This parallel randomized clinical trial was performed on 60 married women referred to Imam Reza Health Center in Mashhad during September and October 2016. A sample size of 30 subjects was assigned to intervention and control groups. The training classes including two 90 minutes sessions were held once a week for 2 consecutive weeks. The tools for data collection consisted of Hulbert sexual assertiveness and women�s genital self-image questionnaires. A pretest was completed in two groups at the beginning of the study and a post-test was done for both groups one week after training the intervention group. To analyze data student t-test, paired t-test, Mann-Whitney, Wilcoxon, Chi-square and one-way analysis of variance were used. Results: The score of genital self-image was the same in two groups before carrying out the intervention (z= -1.762, p= 0.780). However, following the implementation of training program the two groups showed significant differences and the score of genital self-image  was higher in intervention group (z = - 4.077, p E� 0.001).  Conclusion: Sexual assertiveness training can improve women�s genital self-image. So it is recommended to tailor training programs to enhance women's genital self-image, particularly, in women with sexual dysfunction in order to improve their sexual health.

Efficacy of Metformin on Pregnancy Outcome in Healthy Overweight Pregnant Women; A Double-Blinded Parallel Randomized Clinical Trial

Background Maternal obesity increases the risk of pregnancy complications such as preeclampsia, postpartum hemorrhage, weight gain and the need for cesarean section. We compared the role of metformin on pregnancy outcome in overweight mothers. Materials and Methods: This double-blinded parallel randomized clinical trial was carried out on 360 pregnant women at 12-16 gestational weeks who referred to the gynecology clinic of Motahari hospital, Urmia, Iran, during 2019 to 2020. The intervention group received 1000 mg of metformin orally every day up to the end of pregnancy. Demographic and clinical characteristics of patients such as age, gravidity, parity, preterm infant weight, live birth, abortion, previous delivery method, maternal weight, body mass index, birth weight, delivery method, blood sugar at birth, gestational age at birth, neonatal hypoglycemia, infant mortality and anomalies were also recorded. Finally, the pregnancy outcomes (gravidity, parity, abortion and weight) were compared between the two groups. Results: Of 180 patients, 169 patients remained in the intervention group and 171 patients remained in the control group based on the eligibility criteria. In the control group, 13 patients (7.6%), and in the intervention group, five patients (2.9%) had preeclampsia and high blood pressure during pregnancy (P= 0.053). In the control group, the mean maternal weight gain during pregnancy was 10.22 ± 3.3 kg and in the intervention group was 7.6 ± 2.3 kg (P 0.05). Conclusion The administration of 1000 mg metformin daily has been shown to be effective in preventing overweight in pregnancy, but has not affected the birth weight. Metformin did not have any side effects on pregnancy outcomes.

Photobiomodulation Therapy by 820 nm Diode Laser on Nonsurgical Periodontal Treatment of Smoker and Nonsmoker Patients: A Single-Blind Parallel Randomized Clinical Trial.

The effect of smoking on nonsurgical periodontal treatment (SRP) is known, but the adjunct use of photobiomodulation (PBMT) to SRP has not been fully investigated in smokers. This study aimed to assess the effect of 820nm diode laser on SRP in smoker/nonsmoker. Sixty patients (smokers/n=30, nonsmokers/n=30) were enrolled in this parallel-arm clinical study. All patients were divided into two main groups: SRP and PBMT+SRP. In PMBT+SRP groups, 7.96Jcm-2 energy was applied by 820nm diode laser at baseline and first, second and third weeks after SRP. Periodontal pocket depth (PPD), gingival index (GI), plaque index (PI) and clinical attachment level (CAL) were recorded, and also gingival crevicular fluid (GCF) samples were collected at baseline and 6w after SRP. Total antioxidant capacity (TAOC) and total oxidative status (TOS) in GCF were analyzed. PBMT+SRP groups showed a statistically significant decrease in PPD and CAL, not in GI and PI compared with SRP alone. There were no statistically significant differences between smokers and nonsmokers in clinical data at six weeks after treatment. Although TAOC levels were increased in PMBT groups, TOS levels were decreased in all groups at the comparison of baseline and 6w after SRP. Adjunct use of 820nm diode laser on SRP may improve the clinical parameters in smoker or nonsmoker patient with periodontitis.

The impact of computer-based cognitive training intervention on the quality of life among elderly people: a randomized clinical trial

BackgroundThrough the process of normal aging, cognitive decline would cause a lower level of functioning in real life. This flow might interfere with health-related quality of life (QoL). The purpose of this study is to investigate the effect of computer-based cognitive intervention on increasing QoL of elderly people.MethodsA total number of 52 community-dwelling older adults participated in this study. This community scored ≥ 21 in the Mini-Mental State Examination (MMSE) and a clock drawing test score ≥ 4 from health centers in Tehran, Iran. This study is a parallel group stratified randomized clinical trial. The intervention group received a 45-min cognitive training session twice a week for 10 sessions, using Attentive Rehabilitation of Attention and Memory (ARAM) software focusing on selective attention and working memory. QoL was evaluated as a primary outcome. The control group participated in educational workshops.ResultsFrom fifty-two persons, only one participant was excluded from the study in the intervention group during follow-up. Results revealed by increasing cognitive function, improvement occurred in QoL (F = 13.417, p value < 0.001, partial eta-squared = 0.324) as a primary outcome in the intervention group. Among eight domains of QoL, there was significant increasing in domain of role limitations due to emotional problems (F = 4.007, p value = 0.021, partial eta-squared = 0.059), social functioning (F = 2.423, p value = 0.044, partial eta-squared = 0.004), and role limitations due to physical health (F = 10.749, p value < 0.001, partial eta-squared = 0.026).ConclusionsBased on the results, ARAM showed transition and long-term effects on QoL in elderly people by improving cognitive functions such as selective attention and working memory.Trial registrationIranian Registry of Clinical Trials IRCT2016122731602N1. Registered on June 21, 2017

Effectiveness of Molecular Testing Techniques for Diagnosis of Indeterminate Thyroid Nodules

Approximately 20% of thyroid nodules display indeterminate cytology. Molecular testing can refine the risk of malignancy and reduce the need for diagnostic hemithyroidectomy. To compare the diagnostic performance between an RNA test (Afirma genomic sequencing classifier) and DNA-RNA test (ThyroSeq v3 multigene genomic classifier). This parallel randomized clinical trial of monthly block randomization included patients in the UCLA Health system who underwent thyroid biopsy from August 2017 to January 2020 with indeterminate cytology (Bethesda System for Reporting Thyroid Cytopathology category III or IV). Molecular testing with the RNA test or DNA-RNA test. Diagnostic test performance of the RNA test compared with the DNA-RNA test. The secondary outcome was comparison of test performance with prior versions of the molecular tests. Of 2368 patients, 397 were eligible for inclusion based on indeterminate cytology, and 346 (median [interquartile range] age, 55 [44-67] years; 266 [76.9%] women) were randomized to 1 of the 2 tests. In the total cohort assessed for eligibility, 3140 thyroid nodules were assessed, and 427 (13.6%) nodules were cytologically indeterminate. The prevalence of malignancy was 20% among indeterminate nodules. The benign call rate was 53% (95% CI, 47%-61%) for the RNA test and 61% (95% CI, 53%-68%) for the DNA-RNA test. The specificities of the RNA test and DNA-RNA test were 80% (95% CI, 72%-86%) and 85% (95% CI, 77%-91%), respectively (P = .33); the positive predictive values (PPV) of the RNA test and DNA-RNA test were 53% (95% CI, 40%-67%) and 63% (95% CI, 48%-77%), respectively (P = .33). The RNA test exhibited a higher PPV compared with the prior test version (Afirma gene expression classifier) (54% [95% CI, 40%-67%] vs 38% [95% CI, 27%-48%]; P = .01). The DNA-RNA test had no statistically significant difference in PPV compared with its prior version (ThyroSeq v2 next-generation sequencing) (63% [95% CI, 48%-77%] vs 58% [95% CI, 43%-73%]; P = .75). Diagnostic thyroidectomy was avoided in 87 (51%) patients tested with the RNA test and 83 (49%) patients tested with the DNA-RNA test. Surveillance ultrasonography was available for 90 nodules, of which 85 (94%) remained stable over a median of 12 months follow-up. Both the RNA test and DNA-RNA test displayed high specificity and allowed 49% of patients with indeterminate nodules to avoid diagnostic surgery. Although previous trials demonstrated that the prior version of the DNA-RNA test was more specific than the prior version of the RNA test, the current molecular test techniques have no statistically significant difference in performance. ClinicalTrials.gov Identifier: NCT02681328.

Lian gong as a Therapeutic Treatment Option in Primary Care for Patients with Dizziness: A Randomized Controlled Trial.

Introduction Dizziness is one of the most common reasons for seeking primary health care. Vestibular rehabilitation (VR) is a conventional treatment method for peripheral balance disorders that effectively decreases symptoms. Lian gong [LG] is believed to benefit patients with dizziness and to reduce the impact of the condition on quality of life by stimulating visual fixation, attention, body balance, and neuroplasticity. Objective The present study aimed to evaluate the effects of LG on the impact of dizziness on quality of life and fear of falling in primary health care patients. Methods This was a two-arm, parallel randomized clinical trial that included 36 patients with dizziness not caused by central changes. After specific medical evaluations and indications for treatment, the participants were randomly assigned to 3 groups: the LG group ( n = 11), the VR group ( n = 11), and the control group ( n = 14). The interventions were conducted collectively over a period of 12 weeks. Results Lian gong reduced the influence of dizziness on quality of life in physical (1.8 points, 95% confidence interval [CI]: 0.2–3.4), functional (4.0 points, 95% CI: 2.1–5.9), and emotional domains of quality of life (4.4 points, 95% CI: 1.7–7.2), with no differences compared with VR. There were similar concerns among the groups about the risk of falling. Conclusion Lian gong was shown to be an effective balance rehabilitation strategy to reduce the impact of dizziness on quality of life, with similar results to those of VR.

A multicenter randomized controlled trial protocol to evaluate the effectiveness of an educational intervention on fertility knowledge, intention and behavior among Iranian new couples

BackgroundRecent evidence shows that men and women have inadequate fertility knowledge which may negatively affect their childbearing decisions in future. Given the fact that decision making for fertility needs accurate information, targeted educational interventions especially through media are needed to improve knowledge regarding the best age of fertility, factors affecting fertility potential and fertility options available for sub-fertile couples. Aim of the study is to evaluate whether a fertility educational program can be effective in increasing fertility knowledge, childbearing intention and the planned pregnancy rate among couples referring to premarital counselling centers.MethodsThis study is a parallel randomised clinical trial with pre-test/post-test design. We will recruit 1240 marrying couples referring for compulsory premarital counselling in public health centers through stratified sampling in five metropolitan cities of Iran. The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing verbal and virtual educational package at five time episodes (one verbal session and four virtual sessions) within 4 weeks. The primary outcomes are fertility knowledge, childbearing intention and the first planned pregnancy rate (positive pregnancy test) and the secondary outcomes include contraception method use, miscarriage and unplanned pregnancy. Participants will respond to a self-administered demographic/reproductive characteristics questionnaire, the Cardiff Fertility Knowledge Scale (CFKS) and the childbearing intention questionnaire.Data will be collected through online questionnaires at baseline and 3, 12 and 18 months after the intervention. Data will be analyzed using Chi-square or Fisher-exact test for categorical variables, Independent sample t-test for normally distributed quantitative variables and Mann–Whitney U test for non-normally distributed quantitative variables. To compare the outcomes between the two groups over the time, repeated measures ANOVA will be used. We hypothesize that the positive impact of increasing the fertility knowledge is the reduced involuntarily childlessness.DiscussionThe findings are proposed to inform government policies and public education strategies aiming at supporting childbearing among young couples who postpone their first pregnancy while they might not have any important social and economic obstacles.Trial registrationThis study was approved by Iranian Registry of Clinical Trials (IRCT), Number: IRCT20201005048925N1, Date of registration: 2020-10-12.

Prophylactic dressings in the prevention of pressure ulcer related to the use of personal protective equipment by health professionals facing the COVID-19 pandemic: A randomized clinical trial.

Device‐related pressure injury (DRPI) is a serious problem that is affecting professionals working on the front lines against COVID‐19 due to the prolonged use of personal protective equipment (PPE). In addition to the physical and psychological integrity of professionals, these injuries can compromise the quality of care. Therefore, using technologies to prevent this adverse effect is an urgent matter. This is a parallel two‐arm randomized clinical trial without the use of a control group to compare the use of foam and extra‐thin hydrocolloid in preventing DRPI associated with the use of PPE by health professionals working on the front lines against coronavirus. In total, 88 professionals were divided into two groups: foam and hydrocolloid. Data were collected using two instruments and related to demographic and professional characteristics and skin evaluation. Each volunteer received one of the dressings, both with the same dimensions and arranged over similar regions, and data were gathered at baseline and after 6 or 12 hours. Descriptive and inferential analytic statistical methods were used; the significance level adopted was 5%. No participant developed DRPI, but four areas with hyperemia were observed in the foam group (two in the forehead, one in the cheeks, and one in the nose bridge), as well as four areas with hyperemia in the hydrocolloid group (two in the nose bridge, one in the right ear, and one in the left ear). There was no difference between the groups regarding skin conditions and discomfort (P > .05). The average cost obtained was $ 5.8/person and $ 4.4/person in the foam group and the hydrocolloid group, respectively, considering the dressing measurements. The results show that foam and extra‐thin hydrocolloid were effective in preventing DRPI associated with the use of PPE.

Antenatal cardiotocography with and without computer analysis in high-risk pregnancy: a randomized clinical trial

Cardiotocography or nonstress test is a technical means of recording the fetal heartbeat and uterine contractions for antenatal monitoring. This study aimed to evaluate whether antepartum cardiotocography with computer analysis (computerized cardiotocography) increases the incidence of cesarean delivery in women with high-risk pregnancies but without intrauterine growth restriction. This was a parallel group nonblinded randomized clinical trial of singletons with high-risk pregnancies admitted for inpatient monitoring between 24 0/7 and 37 6/7 weeks' gestation. Eligible participants were randomly allocated in a 1:1 ratio to antenatal monitoring with either standard cardiotocography or computerized cardiotocography. Women randomized to the computerized cardiotocography arm received cardiotocographic monitoring with computerized analysis in a central monitoring station. The primary outcome was the incidence of cesarean delivery. Overall, 28 women were enrolled in this trial. In addition, 14 women were randomized to the computerized cardiotocography group and 14 women to the control group. No woman was excluded after randomization or lost to follow-up. Cesarean delivery occurred in 9 women (64.3%) in the computerized cardiotocography group and 9 women (64.3%) in the control group (relative risk, 1.00; 95% confidence interval, 0.21-4.69).There was no significant between-group difference in preterm birth, gestational age at delivery, Apgar score, and birthweight. Among women with high-risk pregnancies, use of computerized cardiotocography for antenatal monitoring did not result in a significant increase in cesarean delivery compared with standard cardiotocography. The results of this single-center randomized trial require confirmation in multicenter studies.